Philips Azurion Instructions For Use

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Instructions for

Use

English
4523 001 01511

Philips Azurion
Release 2.2
Contents
1 Introduction 16
1.1 About These Instructions for Use 16

1.2 Electronic Instructions for Use 16

1.3 Intended Use of the System 17

1.4 Compatibility 18

1.5 Training 18

1.6 Help and Guidance 18

2 Safety 20
2.1 Emergency Procedures 20

2.1.1 Clinical Emergency 20

2.1.2 Cardiopulmonary Resuscitation 20

2.1.3 Emergency Stop 21

2.2 Reporting a Serious Incident 21

2.3 Electrical Safety 22

2.4 Mechanical Safety 23

2.5 Explosion Safety 23

2.6 Fire Safety 24

2.7 Electromagnetic Compatibility 24

2.8 Radiation Safety 25

2.8.1 Pediatric Radiation Guidelines 27

2.9 Hazardous Substances 27

3 About the System 29


3.1 Equipment in the Examination Room 29

3.1.1 Stand 30

3.1.2 FlexArm Stand (Option) 31

3.1.3 FlexMove (Option) 32

3.1.4 Optical Imaging System (Option) 33

3.1.5 Patient Table 34

3.1.6 Control Module 36

3.1.7 Touch Screen Module 37

3.1.8 Monitor Configuration 38

3.1.9 FlexVision (Option) 39

3.1.10 Foot Switch 40

3.1.11 Wireless Foot Switch (Option) 41

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3.1.12 Hand Switches 45

3.1.13 Viewpad 46

3.1.14 Mouse and Mouse Table (Option) 47

3.1.15 Sterile Covers 48

3.2 Equipment in the Control Room 48

3.2.1 Review Module 49

3.2.2 Touch Screen Module 50

3.2.3 FlexSpot (Option) 51

3.2.4 Additional FlexSpot (Option) 51

4 Starting and Stopping the System 52


4.1 Starting the System 52

4.1.1 Accessing the System in an Emergency 53

4.1.2 Switching On Only the Monitors (Option) 53

4.2 Restarting the System 54

4.3 Mains Power Failure 54

4.3.1 Uninterruptible Power Supply (Option) 55

4.4 Restarting after Emergency Power Off 55

4.5 Stopping the System 55

5 Preparing a Patient Study 56


5.1 Patient Database 56

5.2 ProcedureCards 57

5.3 Scheduling a Study from the Hospital Worklist 58

5.4 Scheduling a Study Manually 59

5.5 Adding a Study 59

5.6 Editing a Scheduled Study 60

5.7 Checking the Available Disk Storage Space 60

5.8 Starting a Study 61

5.9 Positioning the Patient on the Table 61

5.9.1 Using Patient Straps 62

5.9.2 Changing the Patient Orientation 64

6 Preparing the System 66


6.1 Safety Information 66

6.2 Touch Screen Module 66

6.2.1 Touch Screen Module Swing Arm 67

6.2.2 Starting an Application 68

6.2.3 Using the Mouse (Option) 70

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Contents

6.2.4 Managing Notifications 70

6.2.5 Closing an Application 70

6.2.6 Removing an Unavailable Application 71

6.2.7 Customizing the Applications Window 71

6.2.8 Using Cleaning Mode 72

6.3 Control Modules 72

6.3.1 Repositioning the Control Module 73

6.3.2 Selecting the Tableside Position for the Control Module 73

6.4 Stand Movements 74

6.4.1 Positioning the Stand 75

6.4.2 Positioning the FlexArm Stand (Option) 75

6.4.3 Positioning the Stand with the FlexMove Option 78

6.5 Collision Prevention 79

6.5.1 BodyGuard 79

6.5.2 Intelligent Collision Prevention 80

6.5.3 Collision Prevention Override 81

6.5.4 Collision Indicators 82

6.6 Positioning the Monitor Ceiling Suspension 85

6.7 Positioning the Monitor Boom 86

6.8 Positioning the Table 87

6.8.1 Adjusting the Table Height 87

6.8.2 Floating the Tabletop 88

6.8.3 Tilting the Table 88

6.8.4 Cradling the Table 89

6.8.5 Pivoting the Table 89

6.8.6 Swiveling the Table 90

6.9 Using an OR Table 91

6.9.1 Maquet Operating Table 92

6.9.2 TruSystem Operating Table 94

6.9.3 Using a TruSystem Table with the FlexMove Option 95

6.9.4 Fitting Sterile and Disposable Covers in a (Hybrid) OR Environment 97

6.10 Using Radiation Shields 98

6.10.1 Attaching and Positioning the Table-Mounted Radiation Shield 99

6.10.2 Positioning the Ceiling-Suspended Radiation Shield 101

6.10.3 Using a Third-Party Radiation Shield 101

6.11 Using Sterile Covers 102

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Contents

7 Performing Procedures 103


7.1 General Acquisition Workflow 103

7.2 Enabling X-ray 104

7.3 X-ray On Indicators 104

7.3.1 Audible Signals 105

7.4 Acquiring Images 106

7.4.1 System Readiness 106

7.4.2 Acquiring Fluoroscopy Images 107

7.4.3 Using Shutters and Wedges 110

7.4.4 Acquiring Exposure Images 114

7.4.5 Zero Dose Positioning 115

7.5 Acquiring Images in an Emergency 116

7.6 Intelligent System Recovery 117

7.7 Locking and Unlocking Stand and Table Movements 117

7.8 Using Automatic Position Control 118

7.8.1 Matching a Reference Image 119

7.8.2 Moving to a Stored Position 120

7.8.3 Moving to a Predefined Position 120

7.8.4 Moving Only the Table 121

7.8.5 Moving the Stand along a Pathway (FlexArm Option Only) 121

7.9 Isocentering 122

7.9.1 Recalling the Isocenter Position 123

7.10 Image Orientation 123

7.11 Selecting a Different Preset for FlexVision 124

7.11.1 Saving a Modified Preset for FlexVision 125

7.11.2 Displaying Patient Comfort Movies on FlexVision 125

7.12 Using Switchable Monitors 126

7.13 Injector Coupling 127

7.13.1 Uncoupled Operation 127

7.13.2 Coupled Operation 127

7.14 Multiphase Acquisition 128

7.14.1 Changing Multiphase Acquisition Settings 129

7.15 Bolus Chase 129

7.15.1 Acquiring a Contrast Series 130

7.15.2 Acquiring a Mask Series (Optional) 132

7.16 Roadmap Pro 132

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7.16.1 Using Roadmap Pro 133

7.16.2 Using SmartMask 133

7.17 ECG Triggering 134

7.18 Rotational Scans 135

7.18.1 Performing a Fixed Rotational Scan 135

7.18.2 Performing a Free Rotational Scan 136

7.18.3 CBCT 137

7.18.4 CBCT Dual 139

7.18.5 CardiacSwing 140

7.19 Electrophysiology Procedures 145

7.20 Previewing Series and Images for Automatic Archiving 146

7.21 Ending a Study 146

7.22 Dose Reports 147

7.22.1 Viewing a Secondary Capture Dose Report 147

7.22.2 Printing a Secondary Capture Dose Report 148

8 Reviewing 149
8.1 Instant Parallel Working 149

8.2 Reviewing a Series using the Review Window 149

8.3 Reviewing a Series using the Touch Screen Module 150

8.4 Using the Interventional Room Pointer 152

8.5 Protecting and Unprotecting Studies 153

8.6 Reviewing Historical Data for a Scheduled Patient 153

8.7 Importing Studies or Series for Review 154

8.7.1 Importing Studies or Series from a Network Location 154

8.7.2 Importing Studies and Series from USB Device, CD, or DVD 154

8.8 Bolus Chase Reconstruction 156

8.8.1 Tasks 156

8.8.2 Reconstruction 157

8.8.3 Processing 160

8.9 Resolving a Patient Mix 160

9 Processing 162
9.1 Zooming 163

9.2 Panning 164

9.3 Adjusting Contrast and Brightness 165

9.4 Enhancing Edges in Images 166

9.5 Inverting Images 166

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9.6 Adding Annotations 167

9.6.1 Adding a Text Annotation 167

9.6.2 Adding an Arrow 167

9.6.3 Adding an Ellipse 168

9.6.4 Adding a Rectangle 169

9.6.5 Adding a Solid Rectangle 169

9.6.6 Adding a Polyline 170

9.7 Drawing Markers 170

9.8 Cropping Images 173

9.9 Using Subtraction 174

9.9.1 Changing the Subtraction Mask 174

9.9.2 Adjusting the Mask Position 175

9.10 Using Landmarking 175

9.11 Creating a View Trace Image 176

9.12 Copying Images and Series to Reference Windows 177

9.13 Creating a Snapshot 177

9.14 Flagging Images 178

9.15 Creating Measurements 178

9.15.1 Creating a Distance Measurement 179

9.15.2 Creating a Distance Measurement on the Touch Screen Module 179

9.15.3 Creating a Polyline Measurement 180

9.15.4 Creating a Ratio Measurement 180

9.15.5 Creating an Angle Measurement 181

9.15.6 Creating an Open Angle Measurement 181

9.15.7 Manual Calibration 182

10 Exporting and Printing 185


10.1 Exporting Data 185

10.1.1 Exporting Data to a USB Flash Memory Drive 185

10.1.2 Exporting Data to CD/DVD 187

10.1.3 Exporting Data to a PACS 189

10.1.4 Exporting Data Using Drag and Drop 190

10.2 Printing 191

10.3 Viewing System Tasks in the Job Viewer 192

11 2D Quantitative Analysis (Option) 194


11.1 Acquiring X-ray Images 194

11.2 Starting 2D Quantitative Analysis 195

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Contents

11.3 Calibration Guidelines 195

11.4 QCA / QVA 197

11.4.1 QCA / QVA Tasks 197

11.4.2 Select Series Task 198

11.4.3 Calibration Task 198

11.4.4 Analysis Task 200

11.4.5 Result Task 203

11.5 LVA / RVA 204

11.5.1 LVA / RVA Tasks 205

11.5.2 Select Series Task 205

11.5.3 Calibration Task 205

11.5.4 End Diastole (ED) Task 208

11.5.5 End Systole (ES) Task 210

11.5.6 Editing the Contour 212

11.5.7 Result Task 213

11.6 Managing Results 219

11.6.1 Saving a Result Page 219

11.6.2 Reviewing a Saved Result Page 219

11.6.3 Deleting a Result Page 219

11.7 2D-QA Settings 219

11.7.1 Changing Default Calibration Settings 220

11.7.2 Changing QCA / QVA Default Curve Display Settings 220

11.7.3 Changing LVA Default Settings 221

11.7.4 Changing RVA Default Settings 222

12 Using Other Equipment 224


12.1 Accessories and Detachable Parts 224

12.1.1 Additional Table Accessory Rail 224

12.1.2 Accessory Rail Clamps 225

12.1.3 Drip Stand 225

12.1.4 Arm Supports 226

12.1.5 Cerebral Filter 230

12.1.6 Peripheral X-ray Filters 230

12.1.7 Head Support 231

12.1.8 Mattress 231

12.1.9 Neuro Wedge 232

12.1.10 Patient Straps 232

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Contents

12.1.11 Ratchet Compressor 233

12.1.12 Tabletop Accessory Clamps 234

12.1.13 Handgrip and Clamp Set 234

12.1.14 Viewpad 235

12.1.15 XperGuide Laser Tool (Option) 236

12.2 Third-Party Interfaces 239

12.2.1 Declarations of Compatibility 239

12.2.2 Connecting an Injector 239

12.2.3 Connecting Video Feeds 240

12.3 Other Devices 240

12.3.1 MultiSwitch (Option) 240

12.3.2 Wall Connection Box (Option) 241

12.3.3 Intercom (Option) 241

12.3.4 Equipment Rack (Option) 242

12.3.5 Pedestal (Option) 242

12.3.6 8-Meter Cable Assembly Kit (Option) 243

13 User Customization 245


13.1 Changing Your Password 245

13.2 Viewing System and License Information 246

13.3 Setting the Date and Time 246

13.4 Changing the Date and Time Formats 247

13.5 Changing the Physician List 247

13.6 Managing Presets from the Control Room 248

13.6.1 Creating a New Preset (in the Control Room) 249

13.6.2 Editing a Preset (in the Control Room) 250

13.6.3 Copying or Moving a Preset (in the Control Room) 250

13.6.4 Deleting a Preset (in the Control Room) 250

13.6.5 Managing Preset Groups from the Control Room 250

13.7 Managing FlexVision Presets Using the Touch Screen Module 252

13.7.1 Creating a New Preset (Using the Touch Screen Module) 253

13.7.2 Editing a Preset (Using the Touch Screen Module) 254

13.7.3 Copying or Moving a Preset (Using the Touch Screen Module) 254

13.7.4 Changing the Order of Presets (Using the Touch Screen Module) 255

13.7.5 Deleting a Preset (Using the Touch Screen Module) 255

13.7.6 Managing FlexVision Preset Groups Using the Touch Screen Module 255

13.8 Changing Automatic Position Control Settings 256

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Contents

13.9 Customizing APC Positions for X-ray Protocols 258

13.10 Changing Viewing Preferences 259

13.11 Changing Display Preferences 260

13.12 Customizing Predefined Annotations 260

13.13 Changing Print Settings 261

14 System Administration 263


14.1 Changing Regional Settings 263

14.2 Configuring Audit Trail Settings 264

14.3 Managing Users and System Logon 264

14.3.1 Adding and Deleting Users 265

14.3.2 Resetting a User's Password 265

14.4 Changing General Patient and Workflow Settings 266

14.5 Enabling and Disabling Storage Device Export and Import 267

14.6 Mapping RIS Codes to ProcedureCards 268

14.7 DICOM Settings 268

14.7.1 Configuring Local Settings 269

14.7.2 Configuring Worklist Management and the Modality Performed Procedure


Step (MPPS) Manager 270

14.7.3 Configuring Remote Systems 271

14.7.4 Configuring DICOM Printers 272

14.8 Configuring Export Protocols 273

14.9 Configuring Automatic Data Transfer 275

14.10 Network Configuration 276

14.11 Enabling or Disabling Remote Support 276

14.11.1 Using the Remote Connection Diagnosis Tool 277

14.12 Customizing APC Pathways 277

14.13 Managing ProcedureCards 279

14.13.1 Changing the Default ProcedureCard 279

14.13.2 Creating a New ProcedureCard 280

14.13.3 Editing a ProcedureCard 280

14.13.4 Copying a ProcedureCard 282

14.13.5 Moving a ProcedureCard 282

14.13.6 Deleting a ProcedureCard 282

14.13.7 Managing ProcedureCard Groups 283

14.13.8 Importing, Exporting and Restoring ProcedureCards 284

14.14 Exporting Settings 285

Azurion Release 2.2 Instructions for Use 11 Philips 4523 001 01511
Contents

14.15 Importing Settings 285

14.16 Restoring Factory Default Settings 286

15 Maintenance 287
15.1 Planned Maintenance Program 287

15.2 Cleaning and Disinfecting 288

15.2.1 Cleaning Workflow 289

15.2.2 Preparation Task 290

15.2.3 Manual Cleaning 291

15.2.4 Manual Disinfecting 293

15.2.5 Incompatible Cleaning and Disinfection Agents 295

15.2.6 Supplementary Information about Cleaning 295

15.2.7 Cleaning the Ceiling Rails 296

15.3 Removing and Replacing the Anti-Scatter Grid 296

15.3.1 Removing the Anti-Scatter Grid 296

15.3.2 Replacing the Anti-Scatter Grid 297

15.4 Replacing Batteries 297

15.4.1 Wireless Foot Switch Battery 298

15.5 User Quality Control Mode 298

15.6 User Verification Test 298

15.6.1 Automatic Exposure Control Test 299

15.6.2 Beam Limitation Check 299

15.7 Viewing and Testing Network Connections 300

15.8 Activating the Screen Saver 301

15.9 Viewing Audit Logs 301

15.10 Saving Information for Technical Support 302

15.10.1 Saving a Series for Technical Support 302

15.10.2 Saving a Log File for Technical Support 302

15.11 Enabling Remote Assistance 302

15.12 Updating the System Software 303

15.13 Showing the Monitor Test Image 306

15.14 CBCT Calibration 306

15.15 Environmental Impact of the System 306

15.16 Disposing of the System 307

16 Security 309
16.1 Customer Role in the Product Security Partnership 309

16.1.1 Risks Related to Security 309

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Contents

16.1.2 Detecting Security Failures 309

16.2 Malware Protection 310

16.2.1 Security Updates 311

16.2.2 Whitelist Protection 311

17 Technical Information 312


17.1 Geometry 312

17.1.1 Beam Carriers 312

17.1.2 FlexArm Beam Carrier (Option) 315

17.1.3 Beam Carriers with FlexMove (Option) 315

17.1.4 Patient Table 316

17.1.5 Monitor Ceiling Suspension 319

17.1.6 Monitor Boom 321

17.1.7 Springarm Monitor Ceiling Suspension 321

17.1.8 Alternative Monitor Support Systems 321

17.1.9 Accessories and Detachable Parts 321

17.1.10 Examination Light 323

17.1.11 Ceiling-Suspended Radiation Shield 323

17.2 User Interface 324

17.2.1 Wireless Foot Switch 324

17.3 X-ray Generation 324

17.3.1 X-ray Generator 324

17.3.2 X-ray System Configuration 327

17.3.3 Collimator 331

17.3.4 Anti-Scatter Grid 331

17.4 Imaging 331

17.4.1 Detectors 331

17.5 System-Level Information 334

17.5.1 Environmental Requirements 334

17.5.2 Mains Power 335

17.5.3 Wall Connection Box 336

17.5.4 Network Data 337

17.5.5 System Settings Influencing the Radiation Dose 338

17.5.6 Typical Reference Air Kerma (Rate) Values 349

17.5.7 Protection Against Stray Radiation 397

17.5.8 Electromagnetic Compatibility 409

17.5.9 Equipment Labels 415

Azurion Release 2.2 Instructions for Use 13 Philips 4523 001 01511
Contents

17.5.10 Symbols Used on the Equipment 426

18 Regulatory Information 430


18.1 Frequently Used Functions 430

18.2 Applied Parts 430

18.3 System Version 431

18.4 Third Party Software 432

18.5 Installation and Equipment Connections 432

18.6 Contacting the Manufacturer 435

19 Quick Reference 437


19.1 WorkSpot 437

19.1.1 Acquisition Monitor 437

19.1.2 Review Monitor 439

19.2 FlexSpot (Option) 441

19.2.1 FlexSpot Primary Monitor 442

19.2.2 FlexSpot Secondary Monitor 443

19.2.3 Additional FlexSpot 443

19.3 FlexVision (Option) 443

19.4 Touch Screen Module 445

19.4.1 Touch Screen Gestures 446

19.5 Status Area 447

19.5.1 Status Area - Monoplane System 447

19.5.2 Status Area - Biplane System 451

19.5.3 Collision Indicators 458

19.6 Toolbars 461

19.7 Global Tools 463

19.8 Control Modules 463

19.8.1 Monoplane Control Module 464

19.8.2 Biplane Control Modules 466

19.8.3 FlexArm Control Module (Option) 469

19.9 Review Module 471

19.10 Using the Mouse 472

19.11 Viewpad 472

19.12 Bolus Chase Reconstruction Main Window Toolbars 474

19.13 Bolus Chase Reconstruction Overview Image Window Toolbar 475

20 Glossary 476
20.1 Definitions 476

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Contents

20.1.1 Windows, Panels, Views, and Viewports 476

20.1.2 Patient Table: Doctor Side and Nurse Side 477

20.1.3 Working Area 478

20.1.4 Dose Related Definitions 478

20.1.5 Dose Model 481

20.1.6 Interventional Tools 482

20.1.7 Injector Control Methods 483

20.2 Abbreviations 483

Azurion Release 2.2 Instructions for Use 15 Philips 4523 001 01511
Introduction About These Instructions for Use

1 Introduction
Welcome to the Azurion Instructions for Use. Before using the system, read these Instructions for Use,
especially the information contained in the Safety section.

1.1 About These Instructions for Use


These Instructions for Use are intended to assist you in the safe and effective operation of the system.

Important safety information is provided in the following ways:

WARNING
A warning alerts you to a potential serious outcome, adverse event, or safety hazard. Failure to
observe a warning may result in death or serious injury to the operator or patient.

CAUTION
A caution alerts you when special care is necessary for the safe and effective use of the system.
Failure to observe a caution may result in moderate personal injury or damage to the equipment,
and presents a remote risk of more serious injury or environmental pollution.

NOTE Notes highlight unusual points as an aid to the operator.

An electronic version of these instructions for use is available to view within the system. A set of printed
Emergency Instruction Cards is also provided.

These Instructions for Use may describe some products or features that are not available in all
countries. Please contact your local sales representative for the availability of products and features in
your region.

1.2 Electronic Instructions for Use


These Instructions for Use are available to view on the screen while you are using the system.

• To open the Electronic Instructions for Use, do one of the following:


– On the Help menu in the review window, click Help.

– In the control room, select the review window and then press F1 on the keyboard.

• To move the window containing the electronic Instructions for Use, drag the header bar to the
desired location on the screen.
• To browse topic headings, use the table of contents in the left pane of the viewing window.
• To expand and close topic headings, click the arrow next to the heading. If a heading does not have
an arrow next to it, it cannot be expanded further.
• To go directly to a topic, click the corresponding heading in the table of contents. The topic is
displayed in the right pane of the viewing window.
• To move backward or forward through your browsing history, click Back or Forward.
• To close the electronic Instructions for Use, click Close.

Searching the Electronic Instructions for Use


You can search the electronic Instructions for Use using keywords to help you find topics of interest.

Azurion Release 2.2 Instructions for Use 16 Philips 4523 001 01511
Introduction Intended Use of the System

1 Click inside the search box and enter the keywords for your search query.

2 Click Search or press Enter to display the search results in the search window.

3 To view a topic, click it in the search results.

1.3 Intended Use of the System


CAUTION
In the United States, Federal law restricts this device to sale, distribution, and use by, or on the order
of, a physician.

Product Description
The Azurion series consists of a number of monoplane and biplane systems with different detector sizes
(12”, 15” and 20”).

Indications for Use / Medical Purpose


The Azurion series (within the limits of the used operating room table) is intended for use to perform:
• Image guidance in diagnostic, interventional, and minimally invasive surgery procedures for the
following clinical application areas: vascular, non-vascular, cardiovascular, and neuro procedures.
• Cardiac imaging applications including diagnostics, interventional and minimally invasive surgery
procedures.

Additionally:
• The Azurion series can be used in a hybrid operating room.
• The Azurion series contains a number of features to support a flexible and patient-centric
procedural workflow.

The Azurion series is intended for all human patients of all ages. Patient weight is limited to the
specification of the patient table.

Intended Operator Profile


The Azurion series is intended to be used and operated by adequately trained, qualified, and
authorized healthcare professionals who have an understanding of the safety information and
emergency procedures as defined by local laws and regulations for radiation workers and staff.

Clinical Environment
The Azurion series is a fixed and stationary system that can be used in a clinical environment fulfilling
the local laws and regulations for radiological X-ray systems in sterile and non-sterile environments.

General Safety and Effectiveness


To facilitate safe and efficacious operation of the system by a trained healthcare professional,
instructions for use are provided as part of the device labeling and training is provided during system
handover.

Contraindications
Avoid using the system with patients who are pregnant or who may possibly be pregnant. However, the
risk may be outweighed by the benefit of diagnosing or treating a serious condition. It is the
responsibility of the personnel operating the system to make the decision. Avoid using the system in
case of existing radiation injury (operator or patient).

Azurion Release 2.2 Instructions for Use 17 Philips 4523 001 01511
Introduction Compatibility

Operating Principle
The system uses X-ray generation, detection and image processing for medical imaging, and
additionally displays images from other sources (for example ultrasound). The control mechanisms are
input devices and controls for, for example, geometry and table movements. The system provides
feedback by audible and visual means.

1.4 Compatibility
Third-party components or systems can be connected to the Azurion system if they meet one of the
following conditions:
• They are connected to the public interfaces of the Azurion system. For more information, see Third-
Party Interfaces (page 239).
• They make use of the public DICOM interface of the Azurion system.
• They are declared as compatible with the Azurion system by Philips Medical Systems.

WARNING
Do not connect third-party components or systems to the Azurion system unless they meet one of
the conditions stated above.

For information about declarations of compatibility, see the following website:

www.philips.com/doc_library

More information is available from the manufacturer. See Contacting the Manufacturer (page 435).

1.5 Training
Do not attempt to operate the system without adequate training in accordance with local laws or
regulations.

As a minimum level of training, you should read and understand these Instructions for Use. Application
training is also available. More information is available from the manufacturer. See Contacting the
Manufacturer (page 435).

1.6 Help and Guidance


Help and guidance are available in the user interface while you are using the system.

Help Button
The Help button is available in the task panel. When you click the button, a help box is displayed
containing information for using associated functions.

If multiple help boxes are available, only one help box can be displayed at a time. If you open a second
help box, the first box is automatically closed.

To close a help box, click Close.

Electronic Instructions for Use


To open the Electronic Instructions for Use, do one of the following:

Azurion Release 2.2 Instructions for Use 18 Philips 4523 001 01511
Introduction Help and Guidance

• On the Help menu in the review window, click Help.


• In the control room, select the review window and then press F1 on the keyboard.

You can also download the Instructions for Use from the following website:

www.philips.com/doc_library

Task Guidance
Guidance for performing tasks may sometimes be displayed as instructions on the screen.

Tooltips
Pause the pointer over a button to display a tooltip that provides information about the function.

Azurion Release 2.2 Instructions for Use 19 Philips 4523 001 01511
Safety Emergency Procedures

2 Safety
Philips Medical Systems products are designed to meet stringent safety standards. All medical electrical
equipment requires proper installation, operation, and maintenance to ensure personal safety and
correct operation.

WARNING
Do not use the system if you suspect that any part of the equipment is defective. Operation of the
system in a defective state could lead to fatal or serious injury. It could also lead to clinical
misdiagnosis or clinical mistreatment.

For information about verifying the functionality of the system, see User Verification Test (page 298). If
you suspect that any part of the equipment is defective, contact technical support.

WARNING
Never attempt to remove, modify, override or frustrate any safety device on the system. Interfering
with safety devices could lead to fatal or other serious personal injury.

Only qualified and authorized personnel may operate, repair, or maintain this equipment. "Qualified"
means those legally permitted to operate this type of medical electrical equipment in the jurisdictions in
which the equipment is being used, and "authorized" means those authorized by the owner of the
equipment.

Personnel operating the equipment and personnel in the examination room must observe all laws and
regulations that apply to the operation of this equipment. If in doubt, do not use it.

Product Symbols
For information about the symbols that are used with this product, refer to the Technical Information
section or to the following website:

www.symbols.philips.com

2.1 Emergency Procedures


You should read and understand the emergency procedures in this section before using the system.

NOTE In a hospital environment, an emergency power-off switch may be installed to interrupt the
mains power supply to the system. For more information, contact technical support.

2.1.1 Clinical Emergency


In the event of a clinical emergency, use this procedure to reset the system to its default position and
provide all-round access to the patient.

1 Press and hold the Reset Geo button on the control module in the examination room.

2 Move the stand or tabletop to provide access to the patient.

2.1.2 Cardiopulmonary Resuscitation


In the event of a clinical emergency involving a patient requiring cardiopulmonary resuscitation (CPR),
directly start the CPR procedure.

CPR is possible in any tabletop position. However, to make CPR easier to perform, follow this
procedure.

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Safety Reporting a Serious Incident

NOTE If a TruSystem OR table is in use, refer to the Emergency Instructions Card supplied with the
system for details of how to position the TruSystem table for CPR.

1 Move the detector away from the patient.

2 Ensure that there is all-round access to the patient.

If applicable, pivot the table to improve access. For more information, see Pivoting the
Table (page 89).

3 Move the patient above the table base to reduce the effect of flexing of the tabletop.

4 Adjust the tabletop height to an appropriate height.

5 Perform CPR.

2.1.3 Emergency Stop


To stop all system movements during an emergency in the examination room, press the emergency
STOP button.

The emergency STOP button is located on the control module.

Figure 1 Emergency Stop button

1 Press STOP on the control module.

All motorized movements are stopped. You can manually rotate the stand and push the monitor
ceiling suspension.

Floating the tabletop after an emergency stop action depends on the following conditions:
• If the tilt option is not installed, you can float the tabletop transversely and longitudinally.
• If the VA brake option is installed, it is not possible to float the tabletop.
• If the tilt option is installed, and the VA brake option is not installed, you can float the table
transversely but not longitudinally.

2 To reset the system and restart it, press and hold the Power On button for approximately two
seconds.

For more information, see Restarting the System (page 54).

2.2 Reporting a Serious Incident


If a serious incident occurs in relation to the device, it should be reported to the manufacturer and the
competent authority of the country where you are located.

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Safety Electrical Safety

For contact details, see Contacting the Manufacturer (page 435).

A serious incident means any incident that directly or indirectly led to, might have led to, or in case of
recurrence, could lead to, any of the following:
• The death of a patient, user, or other person.
• The serious deterioration of the state of health (temporary or permanent) of a patient, user, fetus, or
other person.
• A serious public health threat.

2.3 Electrical Safety


Follow the electrical safety guidelines in this section. Failure to do so could cause serious or fatal injury
to the patient, and could damage the equipment.

The room where the system is used must comply with all applicable laws and regulations, or regulations
concerning electrical safety for this type of equipment. The combination of the system and the
connected equipment must comply with the requirements for medical electrical systems as specified in
the IEC 60601-1 standard.

Voltages
Dangerous electrical voltages are present within the system. Covers or cables should only be removed
by qualified and authorized service personnel.

Do not touch electrical connectors on the patient table or on the monitor ceiling suspension while
simultaneously touching the patient. Connector contact pins may carry low voltages that are safe to
touch, but that may be harmful to the patient.

Electrical Grounding (Earth)


You can only connect medical equipment to the system if that equipment is galvanically isolated from
the system. For medical equipment interfacing using Ethernet, video, or USB, galvanic isolation is
ensured by using a wall connection box. For more information, contact technical support.

Protection Against Patient Leakage Current


An equipotential ground connection point is provided at the base of the patient table. If an operating
table is installed, the ground connection point is located on the surgery wall connection box. For more
information, contact technical support.

Cables
Electrical current may still be present in cables that are no longer connected to the system, but that are
still connected to the wall connection box. Store these cables on the cable holder outside the patient
environment. If the cable holder is located inside the patient environment, ensure that the connectors
are covered with a rubber cap. If a cap is not available, take precautions to prevent cable connectors
from coming into contact with liquids.

Do not use multiple socket outlets or extension cables for installing or connecting any part of the
system. Such cables can compromise the electrical safety of the system, especially for equipment in the
examination room near the patient.

Cleaning
Do not use cleaning agents or damp cloths on connector contact pins. For more information, see
Cleaning and Disinfecting (page 288).

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Safety Mechanical Safety

2.4 Mechanical Safety


This section provides information about how to avoid collisions when using the system.

Stand and Table


WARNING
During manual and motorized movements of the stand or the table, the operator is responsible for
the safety of patient, staff, and equipment. Avoid collisions to prevent serious injury to patient and
staff, or damage to the equipment.

Collisions may occur in the following situations:


• With the stand in any position, the tabletop may hit the stand during the longitudinal, transverse,
and height movements of the tabletop. Collisions may also occur during tilt movements, if
applicable.
• With the stand at the head end of the tabletop, the stand may hit the tabletop during angulation or
rotation movements.

The system is installed with safety devices to help you avoid collisions during motorized movements:
• Mechanical devices, such as slip clutches and motor current thresholds, are installed to limit harm or
damage during a collision.
• Movement controls need to be continuously activated by the operator to start and continue a
motorized movement. Releasing the control stops the movement. (The exception to this is if the
alternating Float Tabletop mode is configured on your system. In this case, pressing and releasing
the pan handle alternately releases and activates the tabletop brake.)
• The BodyGuard function senses distances between the stand and other objects and slows the
movement speed when an object is detected within a certain distance of a sensor. The BodyGuard
function does not prevent all collisions, but if a collision occurs, the collision force will be lower
because of the reduced movement speed.
• Intelligent Collision Prevention (iCP) prevents collisions between the tabletop, the X-ray tube, and
the stand. In a biplane system, iCP also prevents collisions between the frontal stand and the lateral
stand.
• Collision switches on the lateral stand can detect a collision and stop motorized movements.

Monitor Ceiling Suspension


Use caution when moving the monitor ceiling suspension. Take care not to trap the patient between the
monitor ceiling suspension and the table.

Electrophysiology Systems
Third-party Electrosphysiology systems may interfere with the BodyGuard sensor on the X-ray tube
cover. When such systems are activated, the sensor on the X-ray tube cover is not reliable, and the
stand may collide with the Electrophysiology equipment under the tabletop.

2.5 Explosion Safety


Using the system in an environment for which it was not designed can cause fire or explosion.

Do not use the system in the presence of explosive gases or vapors, such as certain anaesthetic gases.

Do not use flammable or potentially explosive disinfectant sprays. For more information, see Cleaning
and Disinfecting (page 288).

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Safety Fire Safety

2.6 Fire Safety


Fire regulations for the type of medical environment being used should be fully observed, applied, and
enforced. Using the system in an environment for which it was not designed can cause fire or explosion.

Fire extinguishers should be available for both electrical and non-electrical fires. Only use fire
extinguishers on electrical or chemical fires that are specifically labeled for those purposes. Using water
or other liquids on an electrical fire can cause fatal or serious personal injury.

If it is safe to do so, switch off the system before attempting to fight a fire. This reduces the risk of
electric shocks.

2.7 Electromagnetic Compatibility


This section provides guidance for using the system while maintaining electromagnetic compatibility in
your environment.

Medical electrical products require special precautions regarding electromagnetic compatibility, and
should be installed and put into service according to information provided in the accompanying
documents.

The Azurion medical electrical system, further referred to as the system, is intended for use in a
professional healthcare environment. Operation in any other environment may compromise
electromagnetic compatibility. The system should not be directly connected to the public low-voltage
power supply network.

WARNING
The use of accessories, transducers, and cables other than those specified for this equipment may
result in increased electromagnetic emissions or decreased electromagnetic immunity and result in
improper operation.

WARNING
The equipment should not be used adjacent to, or stacked with, other equipment. If adjacent or
stacked use is necessary, the responsible organization must verify that all equipment operates
normally in the configuration in which it will be used.

WARNING
Do not acquire X-ray images while actively using electrosurgical devices (for example,
electrosurgical knives), or cardiac defibrillators. The electromagnetic interference generated by
these devices may reduce image quality, resulting in additional exposure series being required.

WARNING
Portable RF communications equipment (including peripherals such as antenna cables and external
antennas) should be used no closer than 30 cm (12 in) to any part of the equipment and cables of the
system. Otherwise, degradation of the performance of the equipment could result.

CAUTION
Do not use X-ray images acquired during an electrophysiology mapping procedure for diagnostic
purposes since electromagnetic interference generated by the mapping equipment may reduce
image quality. These images are for non-diagnostic viewing only.

The system complies with relevant international and national laws and standards (IEC60601-1-2) on
electromagnetic compatibility for this type of product, when it is installed and used as intended. These
laws and standards define both the permissible electromagnetic emission levels from the system and its
required immunity to electromagnetic interference from external sources.

Other electronic products that exceed the limits defined in these standards could, in unusual
circumstances, affect the operation of the system. Note the following:

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Safety Radiation Safety

• Radio services operating in frequency bands and disturbance characteristics that are not covered by
CISPR11 may be disturbed. If safety critical radio services are used in or near the facility where the
system is used, the responsible organization should evaluate the risks associated with radio
disturbance.
• Mobile devices can affect medical electrical equipment. Use caution when using such devices within
the specified range of medical electrical devices.

For more information, see Electromagnetic Compatibility (technical information) (page 409).

2.8 Radiation Safety


WARNING
The system is intended for procedures in which air kerma levels can be high enough during normal
use to constitute a risk of deterministic effects. To manage these risks, follow the radiation guidelines
in this section.

In accordance with IEC 60601-1-3:2008 (5.2.4.5 Deterministic Effects) and IEC 60601-2-54:2009
(203.5.2.4.5.101 Dosimetric Information), these Instructions for Use provide measures to take to reduce
the risk of deterministic effects, for the intended use of the system. In general, you should work in
accordance with the ALARA (As Low As Reasonably Achievable) radiation safety principles: minimize
radiation time, maintain distance from the source and provide shielding. More specifically, the following
measures should be taken to minimize the deterministic effects of X-ray radiation on the patient (in
order of workflow):

Patient Safety
• Never radiate unless absolutely necessary and only radiate for as short a time as possible.
• Select an appropriate X-ray protocol for the current procedure:
– For exposure, select an X-ray protocol with the lowest possible framespeed.
– For exposure, select an X-ray protocol with the lowest possible dose level.
– For fluoroscopy, select the fluoroscopy flavor with the lowest dose level.
– For vascular procedures, make appropriate use of the multiphase speeds and do not use higher
frame rates than are necessary.
– For user-selected X-ray protocols, allow optimized operation for indicated clinical protocols.
• Immobilize the patient to prevent the need to reacquire images due to patient movement.
• Select the appropriate patient type.
• Select the largest suitable field size for the current procedure (per X-ray plane).
• Use the radiation disable switch at all times to prevent accidental exposure to radiation (except
when the radiation procedure is in progress).
• Shield sensitive organs when they are exposed to the beam or are in proximity to it.
• Use caution if the patient has acute skin burns or acute hair loss.
• Minimize the duration of radiation in fluoroscopy and exposure acquisition. Modifying settings like
collimation, can also be performed while the last image hold image is displayed.
• Collimate as much as possible and position the detector as close as possible to the object.
• Keep the patient as far as possible from the X-ray source, using the table height setting.
• Keep the focal spot to skin distance as large as possible.
• Use different X-ray beam projections, to spread radiation over the skin.
• Avoid oblique projections, in order to reduce the depth of tissue irradiated.
• Consider using fluoroscopy instead of exposure acquisition.
• Clear the primary beam of unnecessary objects. They may cause adverse affects such as
unnecessary patient dose and misinterpretation of images.
• Release and depress the hand switch or foot switch again when the requested X-ray does not start
or stop automatically.
• Position the patient and the system as accurately as possible without using radiation.

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Safety Radiation Safety

• Continuous X-ray exposure for patients with implanted medical devices such as pacemakers or
defibrillators could cause a malfunction. Avoid placing the device directly in the beam and minimize
X-ray exposure time.
• Check the patient for pregnancy before X-ray exposure.

Staff Safety
• Make full use of the system’s radiation protection features, devices, accessories, and procedures
that are available to you as the operator. For more information, see Using Radiation
Shields (page 98).
• Always wear a lead apron and use badges to monitor the radiation received.
• Wear thyroid and eye protection devices.
• Stay as far away from the radiated object as possible.
• Use caution if any member of staff has a chronic radiation injury.
• Remove all unnecessary obscuring objects from the primary beam (including the operator’s hands).
• Keep the X-ray source under the table.
• Do not attempt to remove, modify, override, or frustrate any safety device on the equipment.

NOTE When door contacts should give a warning for radiation using the room warning light, the
configuration of the door contacts should be implemented by the user.

More Information
The following table summarizes the effects of the most significant measures on skin dose rate, air kerma
rate, dose area product, and staff dose.

Effect on skin Effect on Effect on DAP- Effect on staff


Measure dose rate Ref.AK-rate rate dose
Selecting the appropriate X-ray protocol + + + +
dose level
Reducing framespeed (by X-ray protocol/ + + + +
multiphase)
Selecting the largest field size + + - -
Limiting the duration of fluoroscopy/expo- + + + +
sure
Applying proper collimation and wedges 0 0 + +
Increasing the distance from the patient to + 0 0 0
the X-ray source (at a constant SID)
Minimizing the SID at a constant table + + 0 0
height
Using different X-ray beam projections + 0 0 0
Avoiding oblique projections + + + +
+ = positive effect (less dose), - = negative effect (more dose), 0 = no significant effect

Patient thickness also influences the deterministic effects of X-ray radiation.

For more information about improving radiation safety during procedures, see the following sections:
• System Settings Influencing the Radiation Dose (page 338)
• Protection Against Stray Radiation (page 397)
• Additional Filtering (page 402)

You are strongly urged to read the current recommendations of the International Commission on
Radiological Protection, and in the United States, with those of the US National Council for Radiological
Protection.
• ICRP, Pergamon Press, Oxford, New York, Beijing, Frankfurt, São Paulo, Sydney, Tokyo, Toronto.
• NCRP, Suite 800, 7910 Woodmont Avenue, Bethesda, Maryland 20814, USA.

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Safety Hazardous Substances

2.8.1 Pediatric Radiation Guidelines


When performing pediatric radiation, you should follow these guidelines:
• Follow the guidelines provided in Radiation Safety (page 25).
• Do not radiate when it is not necessary. Use a non-ionizing radiation modality whenever possible
(for example, ultrasound).
• Remove any objects in the beam that are not radiolucent or that are not necessary to perform the
procedure (for example, mattresses, pillows, tubes).
• Select the correct patient type and the correct examination protocol for the anatomy.
• Select the lowest fluoroscopy flavor with the lowest dose.
• Position the detector as close as possible to the patient.
• Use electronic zoom instead of detector zoom.
• Use collimation as much as possible to protect areas outside the region of interest. Exclude eyes,
thyroid, breast, and gonads when possible. When possible, perform collimation on the Last Image
Hold image. Use semi-permeable wedges.
• Consider using Fluoro Store as an alternative to acquisition.
• Radiate for the shortest time possible, use the Last Image Hold image to review the anatomy rather
than live fluoroscopy.
• Consider using the diagnostic reference level (DRL) for pediatric radiology.
• Use a protective apron to protect the child's genitals during X-ray exposure.
• Use proper collimation for pediatric patients to avoid unnecessary X-ray exposure.
• The child's guardian should accompany the child to avoid unnecessary re-examination due to
patient movement during the examination.

Before you use the equipment for pediatric cases, Philips recommends reviewing generally available
resources on pediatric imaging, such as the following:
• The U.S. Food and Drug Administration
www.fda.gov/Radiation-EmittingProducts/RadiationEmittingProductsandProcedures/
MedicalImaging/ucm298899.htm
• The Alliance for Radiation Safety in Pediatric Imaging
www.imagegently.org
• The Society for Pediatric Radiology
www.pedrad.org

2.9 Hazardous Substances


Parts of the system may contain hazardous substances that must be disposed of in accordance with
local, state, or federal laws.

Item Lead (Pb) Mercury (Hg) Cadmium (Cd)


Electronic modules
Flat screens
Detector
Radiation shielding
Collimator
Grid
X-ray tube assembly
Electromechanical parts

: Indicates that this substance, as contained in all materials for this part, is below the limit required in GB/T 26572.
: Indicates that this substance, as contained in at least one of the materials used for this part, is above the limit required
in GB/T 26572.

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Safety Hazardous Substances

Hexavalent Chromium Polybrominated Biphenyls Polybrominated Diphenyl


Item (Cr6+) (PBB) Ethers (PBDE)
Electronic modules
Flat screens
Detector
Radiation shielding
Collimator
Grid
X-ray tube assembly
Electromechanical parts

: Indicates that this substance, as contained in all materials for this part, is below the limit required in GB/T 26572.
: Indicates that this substance, as contained in at least one of the materials used for this part, is above the limit required
in GB/T 26572.

WARNING
California's Proposition 65 requires Philips Medical Systems to provide reasonable safety warning
Information when a released substance is above safe harbor levels. The internal components of this
product may contain substances that, when exposed, are known to the State of California to cause
cancer or reproductive harm. Based on the risk assessment performed by Philips, there is no risk or
low risk to patient or hospital staff. Service personnel may be exposed to internal components while
servicing the equipment. For information about risks to service personnel, refer to the service
documentation.

For more information on California's Proposition 65, see the following websites:
• www.philips.com/about/sustainability
• www.p65warnings.ca.gov

REACH Declaration
REACH requires that Philips Medical Systems provides chemical content information for Substances of
Very High Concern (SVHC) if they are present above 0.1% of the product weight. Components within
electric and electronic equipment may contain phthalates above the threshold. The SVHC list is
updated on a regular basis. For the most up-to-date list of products containing SVHC above the
threshold, refer to the following Philips website:

www.philips.com/about/sustainability/reach

Perchlorate Materials
In this product, perchlorate material is present in lithium coin cells and batteries. Special handling may
apply for these materials. For more information, refer to the following website:

www.dtsc.ca.gov/hazardouswaste/perchlorate

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About the System Equipment in the Examination Room

3 About the System


The system is available in the following configurations.

Monoplane Systems
• Azurion M12: A ceiling or floor-mounted monoplane system with a 12-inch flat detector.
• Azurion M15: A floor-mounted monoplane system with a 15-inch flat detector.
• Azurion M20: A ceiling or floor-mounted monoplane system with a 20-inch flat detector.
• Azurion M20 OR: A ceiling-mounted monoplane system with a 20-inch flat detector and an
interface for an OR table.

Biplane Systems
All biplane systems have a floor-mounted frontal stand and a ceiling-mounted lateral stand:
• Azurion B12/12: A biplane system with a 12-inch flat detector on the frontal stand and a 12-inch flat
detector on the lateral stand.
• Azurion B20/12: A biplane system with a 20-inch flat detector on the frontal stand and a 12-inch flat
detector on the lateral stand.
• Azurion B20/15: A biplane system with a 20-inch flat detector on the frontal stand and a 15-inch flat
detector on the lateral stand.
• Azurion B12/12 OR: A biplane system with a 12-inch flat detector on the frontal stand and a 12-inch
flat detector on the lateral stand, and an interface for an OR table.
• Azurion B20/12 OR: A biplane system with a 20-inch flat detector on the frontal stand and a 12-inch
flat detector on the lateral stand, and an interface for an OR table.
• Azurion B20/15 OR: A biplane system with a 20-inch flat detector on the frontal stand and a 15-inch
flat detector on the lateral stand, and an interface for an OR table.

3.1 Equipment in the Examination Room

Figure 2 General system components in the examination room

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About the System Equipment in the Examination Room

Legend
1 Frontal stand (for monoplane systems, the stand 7 Patient table
may be floor or ceiling-mounted)
2 Lateral stand (biplane systems only) 8 Control module
3 Detector 9 Mouse and mouse table (option)
4 X-ray tube 10 Touch screen module and viewpad holder
5 Collimator 11 Monitors
6 Foot switch 12 Monitor ceiling suspension

3.1.1 Stand
The stand allows you to position the detector and X-ray tube in relation to the patient table using the
control module.

Monoplane Stand

Figure 3 The monoplane stand can be floor-mounted (left) or ceiling-mounted (right)

Biplane Stands

Figure 4 Two views of the frontal stand and lateral stand of a neuro biplane system

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About the System Equipment in the Examination Room

3.1.2 FlexArm Stand (Option)


The FlexArm stand is a ceiling-mounted monoplane stand with a 20-inch detector.

Figure 5 FlexArm stand (option)

The FlexArm stand allows you to perform the following actions:


• Acquire images with the detector oriented in the clinically preferred way, independent of the
position of the stand and the position of anatomical objects. This is known as image beam rotation.
For example, both of the following situations are possible and would produce the same image:
– Position the stand at 45 degrees on the nurse side and orient the detector in a landscape
position.
– Position the stand parallel to the table and orient the detector at 45 degrees.
• Move the stand longitudinally and transversely, enabling off-center imaging without moving the
patient table (for radial access, for example).
• Park the stand in a standby position and move it into the working position when needed during the
procedure without interfering with staff or third-party equipment, such as anesthesia equipment.

For more information about positioning the FlexArm stand, see Positioning the FlexArm Stand
(Option) (page 75).

If desired, stand movements to unwanted positions can be blocked by service configuration. For more
information, contact technical support.

Image Beam Rotation


When the detector is patient-aligned (set to landscape or portrait orientation) and you turn the stand
through any position between -135 and 135 degrees, the alignment of the detector is automatically
maintained with the region of interest in the isocenter. (The stand may perform additional
compensating movements as you turn it using the stand joystick.) Therefore, the FlexArm stand position
is not restricted to doctor, head, or nurse side. The region of interest is also maintained in the isocenter
if you tilt or cradle the tabletop.

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About the System Equipment in the Examination Room

Off-Center Imaging
Transverse movements allow you to image a region of interest that is outside the table, for example, the
patient's arm.

3.1.3 FlexMove (Option)


FlexMove allows you to park the stand in a stand-by position and then move it into position when
needed during the procedure.

If the FlexMove option is installed, the stand moves longitudinally and transversely on ceiling-mounted
rails. For more information, see Positioning the Stand with the FlexMove Option (page 78).

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About the System Equipment in the Examination Room

Figure 6 FlexMove option

3.1.4 Optical Imaging System (Option)


If installed, this option will not be enabled until the relevant application becomes available.

The Optical Imaging System will provide intra-operative image guidance and consists of video cameras
positioned around the detector. The video stream of each camera will be used by specific Philips
applications.

If the Optical Imaging System hardware is installed, ensure that the windows on the BodyGuard are
clean and use a sterile cover with window inserts at the location of the camera.

Figure 7 Optical Imaging System (option)

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About the System Equipment in the Examination Room

3.1.5 Patient Table


The patient table allows you to position the patient in several different ways to suit the procedure that
you are performing.

Figure 8 Patient table

Available movements depend on the type of table and the configured options:
• Manual or motorized tabletop float for longitudinal and transverse movements
• Height adjustment
• Tilt (when the table is tilted, longitudinal float movements are motorized, while transverse
movements can still be performed manually)
• Cradle
• Pivot
• Swivel

NOTE The Swivel option is not applicable for the patient table when using the FlexArm option,
which provides full body coverage using stand movements.

Table movements are controlled using the control module. Some of these functions may not be
available on your system. For more information, see Positioning the Table (page 87).

The patient table has an accessory rail that is used to mount additional equipment such as the control
module, touch screen module, and radiation shields.

The maximum permissible weight on the tabletop is 275 kg (600 lbs). This includes the weight of all
accessories that are attached to the tabletop.

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About the System Equipment in the Examination Room

Figure 9 Control module and touch screen module on the accessory rail

Pan Handle (Option)


You can use the pan handle to release the tabletop brakes and float the tabletop.

Figure 10 Pan handle

1 Clamp the pan handle to the accessory rail or to the tabletop.

2 Tighten the locking lever to secure the pan handle.

The function of the pan handle is configured by a service engineer and corresponds to the function
configured for the Float Tabletop function on the control module:
• Alternating mode: When you press and release the pan handle, the tabletop brake is released and
you can float the table. Press and release the pan handle again to activate the tabletop brake.
• Direct mode: When you press and hold the pan handle, the tabletop brake is released and you can
float the table. Release the pan handle to activate the tabletop brake.
If your table has a tilt function, you can only float the tabletop longitudinally using the pan handle when
the table is not tilted.

Table Interface Panel


The table interface panel is located at the rear of the table base and provides additional connectivity to
the system.

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About the System Equipment in the Examination Room

The interfaces on the table interface panel provide a safe and standardized method for installing third
party equipment and do not impose limitations on table movements. For more information, contact
technical support.

Figure 11 Table interface panel on the rear side of the table base

Connectors
1 Potential equalization points Ground (earth) connection points (x4)
2 Injector connection (optional) A connector can be installed in this position for a rack-mounted injector
(if a connector is not installed, a blanking plate is used)
3 Foot switch connectors Connectors for the foot switches
4 28-pin connector Connector for pedestal-mounted injectors
5 23-pin connector Connector for external ECG and Physio equipment
6 Secondary circuit outlet connector 230 V (50/60 Hz)

Table Base Accessory Rail


The table base accessory rail can carry equipment up to 10 kg. The maximum torque load (moment) is
30 Nm.

Figure 12 Table base accessory rail

3.1.6 Control Module


The control module provides the controls required to adjust the position of the table and stand, and to
perform image functions during acquisition.

Up to three control modules can be used with each system.

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About the System Equipment in the Examination Room

• The control module at the tableside in the examination room can be attached to the accessory rail
in three positions: doctor side, nurse side, and foot end.
• The second control module in the examination room can be mounted on a pedestal (optional). The
pedestal can be positioned anywhere in the examination room.
• A third (optional) control module can be located in the control room.

The functions that are available on the control module and the layout of controls depend on the
options installed on your system.

Figure 13 Monoplane control module

Figure 14 FlexArm/FlexMove control module (option)

Figure 15 Biplane control modules: geometry control module (left) and imaging control module (right)

For more information, see Control Modules (page 463).

3.1.7 Touch Screen Module


You can use the touch screen module to select monitor layouts and presets, control acquisition settings,
select images for review or post-processing, and access applications such as Interventional Tools.

The touch screen module is mounted on a swing arm that can be positioned to provide access from the
same side of the tabletop or from the opposite side.

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About the System Equipment in the Examination Room

Figure 16 Touch screen module in the examination room

You can control functions for multiple applications concurrently using the touch screen module.
Depending on the active procedure or the system configuration, some functions may not be available.

Up to three touch screen modules can be used with each system.


• The touch screen module at the tableside in the examination room can be attached to the
accessory rail in any position: doctor side, nurse side, or foot end.
• A second touch screen module in the examination room can be mounted on a pedestal (optional).
The pedestal can be positioned anywhere in the examination room.
• A third (optional) touch screen module can be located in the control room.

If you are using multiple touch screen modules, the following rules apply:
• You can use different applications on each touch screen module.
• If you use the same application on multiple touch screen modules, the modules are fully linked.

The touch screen module can be placed within the reach of the patient. The maximum temperature of
the enclosure of the module can be up to 48 degrees. For safe use, ensure that the patient does not
make contact with the module for more than 1 minute.

For more information about the touch screen module, see the following sections:
• Touch Screen Module (page 66)
• Touch Screen Module (page 445) (Quick Reference)

3.1.8 Monitor Configuration


For a monoplane system, there is always at least one monitor in the examination room that displays live
and reference images. For a biplane system, there are always at least two monitors, and the live images
for the frontal and lateral channels are always synchronized and displayed side by side. Additional
monitors to display reference images can be configured at installation.

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About the System Equipment in the Examination Room

Figure 17 Standard monitor layout in the examination room

Legend
1 Status area 4 Reference 2 view
2 Live view 5 Reference 3 view
3 Reference 1 view 6 Touch screen module

NOTE The position of the status area may vary, depending on the selected preset.

Monitors can be mounted in either of the following configurations:


• Monitor ceiling suspension. For more information, see Positioning the Monitor Ceiling
Suspension (page 85).
• Monitor boom. For more information, see Positioning the Monitor Boom (page 86).

Switchable Monitors (Option)


The switchable monitors option allows you to manage up to 16 displays in the examination room and
display video and applications originating from the Azurion system and up to 11 video sources from
auxiliary systems.

You can choose what is displayed on each monitor using the touch screen module. For more
information, see Using Switchable Monitors (page 126).

3.1.9 FlexVision (Option)


FlexVision is a single ultra-high-definition monitor situated in the examination room. It replaces
individual monitors and allows you to display and control multiple applications on one monitor.

Figure 18 FlexVision (option) layout in the examination room

Legend
1 Status bar 5 Application view
2 Reference 1 view 6 Application workstation
3 Reference 2 view 7 X-ray workstation

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About the System Equipment in the Examination Room

Legend
4 Live view 8 Touch screen module

The monitor can be mounted in either of the following configurations:


• Monitor ceiling suspension. For more information, see Positioning the Monitor Ceiling
Suspension (page 85).
• Monitor boom. For more information, see Positioning the Monitor Boom (page 86).

The monitor displays available applications in windows. You can choose which applications to display in
each window and select different preset layouts according to your workflow. For more information, see
the following sections:
• Selecting a Different Preset for FlexVision (page 124)
• Managing FlexVision Presets Using the Touch Screen Module (page 252)

NOTE When a third-party video source has no patient identification, the hospital should have a
procedure in place to assess the video feeds on the large screen without the risk of mixing up
patient data.

NOTE When third-party video sources are too bright (for example, ultrasound), you can reposition
the third-party video feed on the large screen.

3.1.10 Foot Switch


You can control fluoroscopy and exposure using the foot switch.

The function assigned to each pedal on the foot switch is configured when your system is installed.

Monoplane Foot Switch

Figure 19 Monoplane foot switch

Depending on how your system is configured, three of the following functions may be assigned to the
monoplane foot switch.

Symbol Function

Perform fluoroscopy Prepare and perform single-shot exposure

Prepare and perform exposure Switch the room light on and off

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About the System Equipment in the Examination Room

Biplane Foot Switch

Figure 20 Biplane foot switch

Depending on how your system is configured, six of the following functions may be assigned to the
biplane foot switch.

Symbol Function

Select channel Prepare and perform exposure

Perform fluoroscopy on the frontal channel Prepare and perform single-shot exposure

Perform fluoroscopy on the lateral channel Switch the room light on and off

Perform biplane fluoroscopy

Additional Foot Switch


If an additional foot switch is available, it provides the same functions as the standard foot switch. X-ray
can be started from either foot switch in the examination room.

Wireless Foot Switch (Option)


A wireless foot switch option is available. For more information, see Wireless Foot Switch
(Option) (page 41).

3.1.11 Wireless Foot Switch (Option)


The wireless foot switch provides the same functions as the wired foot switch delivered with the X-ray
system.

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About the System Equipment in the Examination Room

NOTE The wireless foot switch generates, uses, and can radiate radio frequency energy and, if not
installed and used in accordance with the instruction manual, may cause harmful
interference to radio communications.

There is no guarantee that radio interference will not occur in a particular installation. If this equipment
does cause harmful interference to radio or television reception, which can be determined by turning
the equipment off and on, contact technical support.

The wireless foot switch must be installed by a qualified service engineer with a Philips installation kit.
Contact a Philips representative for details.

NOTE The wireless foot switch is not intended for patient contact. It is classified as insulation class
II.

Identification Labels
During installation, the wireless foot switch is paired with the X-ray system, so that the foot switch
activates functions only on the matching X-ray system.

A sheet of self-adhesive identification labels is supplied with the wireless foot switch. We recommend
that you use these labels to identify the foot switch and the X-ray system.

The sheet of labels provides 6 pairs of printed numbers. Attach one label to the recess in the upper-
right corner of the foot switch, and then attach the matching label to a clearly visible location on the X-
ray system. Blank labels are also provided, in case you want to use your own identification marks.

Figure 21 Location of the recess for identification labels

Function Labels
The pedal functions of the wireless foot switch are configurable by technical support. Any of the
following functions can be assigned to a pedal. When the foot switch has been configured, a sticker
indicating the function should be placed next to or on the pedal. The stickers used to indicate functions
depend on the model of your foot switch. For more information about the model types, see Equipment
Labels (page 415) (refer to the wireless foot switch labels in that section).

Type 1 Type 2 Function

Fluoroscopy

Fluoroscopy - biplane

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About the System Equipment in the Examination Room

Type 1 Type 2 Function

Fluoroscopy - frontal channel

Fluoroscopy - lateral channel

Select exposure channel

Prepare and expose

Single shot exposure

Room lighting

Care and Maintenance


When the wireless foot switch is not in use, or during transport or storage, keep it in a cool, dry place.

This wireless foot switch contains lithium-ion batteries. It must be disposed of according to local, state,
and federal laws regarding the disposal of lithium-ion batteries. If you cannot dispose of the wireless
foot switch in your area, return it to the manufacturer for disposal.

If the battery of the wireless foot switch is depleted within 2 days after a complete charge, contact
technical support for a replacement battery. The battery may only be removed and replaced by a
qualified service engineer.

Switching the Wireless Foot Switch On and Off


NOTE You should ensure that the battery of the wireless foot switch is fully charged prior to using
it. If the battery is depleted during a procedure, the foot switch will switch off. In this case,
connect the charger to the foot switch and continue to use it. Take care not to damage the
cable of the charger when moving equipment around the examination room (for example,
when moving carts or beds). Alternatively, connect a wired foot switch to the auxiliary foot
switch connector.

NOTE If you use the wireless foot switch with the charger connected, you should ensure that the
wireless foot switch is positioned to allow the charger to be easily disconnected if necessary.

Before using the system, check that the wireless foot switch functions with the system. If identification
labels have been used, check that the labels attached to the system and to the foot switch match. For
more information, see Identification Labels (page 42).

The wireless foot switch may be put in a sterile plastic cover.

1 Switch the wireless foot switch on using the power switch on the back of the foot switch.

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About the System Equipment in the Examination Room

Figure 22 Wireless foot switch power switch (monoplane foot switch shown as an example, also
applicable for the biplane foot switch)

2 Check the status of the indicator lights on the wireless foot switch to ensure that it has sufficient
charge and that the wireless connection is operational.

The battery usage indications given in the table below are based on typical use patterns. The status
of the battery indicator light depends on the model of your foot switch. For more information about
the model types, see Equipment Labels (page 415) (refer to the wireless foot switch labels in that
section).

Battery Indicator Type 1 Type 2


Green Battery charge level is between Battery charge level should pro-
25% and 100%. vide more than 40 hours of use.
Red Battery charge level is between Battery charge level should pro-
0% and 25%. vide 20 to 40 hours of use.
Red, flashing every 0.5s Not applicable Battery charge level will provide
less than 20 hours of use.
Red, flashing rapidly Not applicable Battery charge level is less than
1.5%. Charge the wireless foot
switch battery before use.
Green, flashing Battery is charging. Battery is charging.

Wireless Indicator Type 1 and Type 2


Off Wireless connection is operational.

Red There is an error in the wireless connection. Do not use the foot switch.

Wait for the wireless connection indicator to go out before using the foot
switch. If the red indicator light is on for longer than 10 seconds, switch
the foot switch off and then on again.

3 To switch the wireless foot switch off, use the power switch on the back of the foot switch.

Charging the Wireless Foot Switch Battery


A charger is supplied to recharge the battery of the wireless foot switch.

NOTE Use only the charger supplied with the wireless foot switch. Using any other charger may
cause damage to the foot switch and void the warranty.

1 Remove the cap from the charging port on the back of the wireless foot switch.

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About the System Equipment in the Examination Room

Figure 23 Wireless foot switch charging port (monoplane foot switch shown as an example, also
applicable for the biplane foot switch)

2 Connect the charger to the charging port. Ensure that you align the dots on the charger cable and
the charging port.

The battery indicator on the wireless foot switch flashes green while the foot switch is charging.

NOTE If you use the wireless foot switch with the charger connected, you should ensure that
the wireless foot switch is positioned to allow the charger to be easily disconnected if
necessary.

A normal, complete charge cycle takes more than 12 hours. We recommend that you charge the battery
every week, or when the battery status indicator turns red. The battery has built-in safety devices to
protect it from overcharging.

The duration of use after charging depends on the model of your foot switch. For more information
about the model types, see Equipment Labels (page 415) (refer to the wireless foot switch labels in that
section).
• For the type 1 wireless foot switch, a complete charge lasts for one week of use.
• For the type 2 wireless foot switch, a charge of between 6 to 8 hours provides up to 8 hours of
continuous use.

NOTE If the battery of the wireless foot switch is depleted within 2 days after a complete charge,
contact technical support for a replacement battery. The battery may only be removed and
replaced by a qualified service engineer.

3.1.12 Hand Switches


The system has multiple hand switches to control different functions.

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About the System Equipment in the Examination Room

Figure 24 Swivel hand switch (left), speed controller (middle), exposure hand switch (right)

Swivel Hand Switch


You use the swivel hand switch to swivel the table towards the head end or towards the foot end.

NOTE The Swivel option is not applicable for the patient table when using the FlexArm option,
which provides full body coverage using stand movements.

Speed Controller
You use the speed controller to control the speed of longitudinal table movements when acquiring
images for Bolus Chase Reconstruction.

The speed controller is automatically enabled when you select an X-ray protocol for bolus chase. You
control the table speed by pressing the trigger. The more you press the trigger, the faster the table
moves.

Exposure Hand Switch


You use the exposure hand switch to control the exposure function. The hand switch has a single button
that you press in two stages:
• Pressing the button to the first stage prepares the system for exposure.
• Pressing the button to the second stage activates exposure.

3.1.13 Viewpad
The viewpad is a handheld remote control that you can use to control viewing and processing functions
from anywhere in the examination room.

Figure 25 Viewpad

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About the System Equipment in the Examination Room

When you activate a function on the viewpad, the function is applied to the viewport that currently has
focus. A viewpad icon is displayed in the middle of the viewport for a moment, and is then displayed in
the top bar of the viewport.

The viewpad is an infrared remote control. The infrared transmitter is located on the front of the
viewpad. If the transmitter is obstructed, signals are not transmitted. The receiver is located in the
monitor ceiling suspension, above the monitors. A light on the receiver indicates that the selected
command has been received. The viewpad should be used inside a transparent sterile cover (not
supplied by Philips Medical Systems).

A laser pointer is located on the front of the viewpad. You activate the laser pointer using the button on
the underside of the viewpad. The quality of the laser pointer is affected when using a sterile cover.

NOTE Do not point the laser into people’s eyes, as there is a risk of injury.

The viewpad is battery-powered. For more information about replacing the batteries, see Replacing
Batteries (page 297).

NOTE Do not open the cover of the viewpad (not including the battery compartment cover). For
maintenance, contact technical support. If the cover is damaged, do not use the viewpad
and call technical support for a replacement.

NOTE Do not use the viewpad when more than one Azurion system is in use in the same room.

NOTE Infrared signals from the viewpad may interfere with other infrared-controlled equipment in
the same room. Before using the viewpad in a procedure, check that there is no interference
with other equipment.

When not in use, store the viewpad in the holder provided on the side of the touch screen module.

For more information, see the following sections:


• Accessories and detachable parts: Viewpad (page 235).
• Quick reference: Viewpad (page 472).

Viewpad Laser Aperture


The laser aperture of the viewpad is indicated with an arrow in the following illustration.

Figure 26 Viewpad laser aperture

3.1.14 Mouse and Mouse Table (Option)


A wireless mouse is available as an option in the examination room to assist with operating the system.

You use the mouse with a mouse table mounted on the table accessory rail. The mouse should be used
inside a sterile cover (not supplied by Philips Medical Systems).

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About the System Equipment in the Control Room

Figure 27 Mouse and mouse table (option)

Figure 28 Attaching the mouse table to the accessory rail

3.1.15 Sterile Covers


We recommend that you use sterile covers to prevent contamination of the system and maintain a
sterile environment. It is the responsibility of the hospital to supply and fit sterile covers when needed.

3.2 Equipment in the Control Room


The control room usually contains two monitors that display the acquisition window and the review
window.

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About the System Equipment in the Control Room

Figure 29 Equipment in the control room

Legend
1 Touch screen module 4 Mouse
2 Monitors 5 Keyboard
3 Review module

The acquisition window displays live X-ray images and is used to change procedure settings, and to
schedule procedures. When acquisition is not being performed, you can use this monitor to perform
other tasks such as reviewing images and post-processing.

The review window allows you to work with studies and series from any patient. While acquisition is
being performed in the examination room, you can use the review window in the control room to work
in parallel and perform tasks such as reviewing and post-processing, for any study, including studies
and series that do not relate to the acquisition patient. For more information, see Instant Parallel
Working (page 149).

The control room may also contain additional equipment and workspots:
• Touch screen module
• Review module
• FlexSpot (option)
• Additional FlexSpot (option)
• Slave monitors (up to a maximum of three)

3.2.1 Review Module


The review module is located in the control room and provides controls for reviewing images in the
acquisition window.

You can also perform some general functions using the review module, for example, switching the
system on and off, disabling radiation, disabling geometry movements, and resetting the fluoroscopy
buzzer.

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About the System Equipment in the Control Room

Figure 30 Review module

For more information, see Review Module (page 471).

3.2.2 Touch Screen Module


An optional touch screen module can be installed in the control room.

Figure 31 Touch screen module in the control room

You can control functions for multiple applications concurrently using the touch screen module.
Depending on the active procedure or the system configuration, some functions may not be available.

Up to three touch screen modules can be used with each system.


• The touch screen module at the tableside in the examination room can be attached to the
accessory rail in any position: doctor side, nurse side, or foot end.
• A second touch screen module in the examination room can be mounted on a pedestal (optional).
The pedestal can be positioned anywhere in the examination room.
• A third (optional) touch screen module can be located in the control room.

If you are using multiple touch screen modules, the following rules apply:
• You can use different applications on each touch screen module.
• If you use the same application on multiple touch screen modules, the modules are fully linked.

For more information, see Touch Screen Module (page 445).

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About the System Equipment in the Control Room

3.2.3 FlexSpot (Option)


If the FlexSpot option is installed, the monitors in the control room are replaced by up to two larger
wide-screen monitors (called the primary and secondary monitors) that are capable of displaying
multiple applications.

For more information, see FlexSpot (Option) (page 441).

3.2.4 Additional FlexSpot (Option)


Additional FlexSpot is an extension to the FlexSpot option, consisting of an additional wide-screen
monitor, mouse, and keyboard, located either in the control room or the examination room.

The interface is identical to FlexSpot with the following exceptions:


• Only one application can be displayed at a time.
• In the menu bar, only the application selector and the keyboard lock icons are available.
• The status area can be hidden to make the main display area larger.

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Starting and Stopping the System Starting the System

4 Starting and Stopping the System


This section provides information about starting and stopping the system during normal use. For
information about stopping the system in an emergency, see Emergency Stop (page 21).

You start and stop the system using the review module.

Figure 32 Review module

Legend
1 Power On
2 Power Off
3 Video Only

4.1 Starting the System


1 On the review module, press and hold Power On for 2 seconds.

NOTE Avoid operating any of the controls while the system is powering on, as this may inhibit
the start-up process.

2 Release the button when the indicator begins to flash.

The indicator light stays on when the start-up process is complete.

Figure 33 System startup screen

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Starting and Stopping the System Starting the System

The system takes 5 minutes from switching on until all functionality is available.

3 If your work schedule includes tasks performed on a separate workstation, switch the workstation
on and log on to it to avoid a delay during the procedure.

4 When the logon screen appears, do the following:

a Click the arrow in the User Name box and select your user name.

b Enter your password in the Password box.

c Select Log On or press Enter.

Figure 34 Logon screen

If your password has expired, a dialog box is displayed allowing you to change your password. You
are asked to enter your existing password and to set your new password.

4.1.1 Accessing the System in an Emergency


Depending on the system configuration, you can access the system in an emergency without logging
on.

1 If the system is not switched on, press and hold Power On on the review module until the indicator
light stops flashing.

2 In the logon screen, click Emergency.

The system is available in emergency access mode. This mode allow you to perform an emergency
procedure, but has reduced functionality.

For information about configuring the system to allow emergency access, see Managing Users and
System Logon (page 264).

4.1.2 Switching On Only the Monitors (Option)


This option allows you to use the monitors without switching the X-ray system on. You can then view
images or perform a procedure that does not involve the system, such as ultrasound.

This option is available if your system has the FlexVision or FlexSpot option installed, along with the
switchable monitors option.

• Press Video Only on the review module for at least 2 seconds.

The monitors are switched on and the mouse is available for configuring the screen layout.

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Starting and Stopping the System Restarting the System

4.2 Restarting the System


NOTE If control of the system starts to deviate from its expected behavior, you should restart the
system.

There are two methods for restarting the system.


• Warm restart: Use this method when you are trying to resolve a software-related issue with the
system. This is the standard method for restarting the system.
• Cold restart: Use this method when you are trying to resolve a hardware-related issue with the
system.

We recommend that you perform a cold restart of the system every day. During a cold restart important
data is saved, which assists with remote servicing.

If you stop the system using the emergency STOP button, you must restart the system before you can
use it again. For more information, see Emergency Stop (page 21).

• To perform a warm restart, press and hold Power On on the review module.

A warm restart takes 90 seconds until the system is fully functional. Fluoroscopy is possible after 60
seconds.

NOTE After a warm restart, X-ray is enabled.

• To perform a cold restart, do the following:

a On the review module, press and hold Power Off.

b Release the button when the indicator light begins to flash.

c After the system has completely shut down, wait 10 seconds.

d On the review module, press and hold Power On.

NOTE Do not operate any of the controls while the system is powering on, as this may
inhibit the start-up process.

A cold restart of the system takes 6 minutes from initiation of the cold restart until all system
functionality is available.

4.3 Mains Power Failure


The system is powered by the hospital mains power supply. The stability of the mains power supply
may vary over time and can sometimes be interrupted.

In the event of a mains power failure, the system behaves as follows:


• All stored patient and system data is preserved.
• All mechanical, non-balanced movements are blocked.

If a mains power failure occurs during a clinical procedure, you should do one of the following:
• Transport the patient to another system to continue the procedure.
• Wait until the hospital mains power supply is restored, and then restart the system to continue the
procedure.

When the hospital’s back-up power system is active, the system takes measures to conserve power.
Functions that cause high power consumption are disabled. Low-load fluoroscopy is still possible, as
well as patient and beam positioning functions. This ensures that you can always free the patient from
the system.

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Starting and Stopping the System Restarting after Emergency Power Off

NOTE The last acquired series may be lost if the power failure occurs during the acquisition, or
shortly after the series was acquired.

4.3.1 Uninterruptible Power Supply (Option)


An option is available to provide a limited amount of power to the system during mains power failure
using an uninterruptible power supply (UPS).

The optional uninterruptible power supply allows the system to perform a controlled shutdown if the
hospital mains power supply is interrupted. All data is backed up during the shutdown. For more
information, contact technical support.

Other compatible uninterruptible power supplies can be connected to the system, which allow full
functionality or reduced functionality for a limited time when mains power fails. However, such parts are
not categorized as options for the system. For more information, contact technical support.

4.4 Restarting after Emergency Power Off


Following an emergency power off situation, the system will enter an emergency power off state.

This is indicated by a flashing indicator light above the Power On button on the review module.

To restart the system after an emergency power off situation, you must use the following procedure.

1 When the indicator light above the Power On button stops flashing, press and hold Power On for
more than 2 seconds.

4.5 Stopping the System


Switching the system off automatically logs you off. Alternatively, you can log off without switching the
system off, and leave the system available for the next operator.

• To log off, select System from the menu bar of the review window, and then select Log Off.

• To switch the system off, press Power Off on the review module for 3 seconds.

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Preparing a Patient Study Patient Database

5 Preparing a Patient Study


You can schedule and prepare a patient study in advance of a procedure. You select, edit, and start the
study from the patient database.

5.1 Patient Database


When you open the patient database, the system automatically retrieves a list of scheduled studies
from the system's database.

If configured to do so, the system can also retrieve a list of scheduled studies from the hospital worklist.

You open the patient database by clicking the patient selector in the upper left corner of the acquisition
window or the review window.

1
2

Figure 35 Patient database

Legend
1 List selector
2 Patient list
3 Study details

Use the list selector to filter the studies displayed in the patient list.

Icon Label Description


In Progress Displays the details of the study currently in progress

Scheduled Displays studies scheduled in the database

Suspended Displays studies that have been started but not completed

Completed Displays studies that have been completed

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Preparing a Patient Study ProcedureCards

Icon Label Description


All Patients Displays all studies in the database

You can sort the patient list to make studies easier to find.
• Clicking on each column heading sorts the column in ascending order.
• Clicking on the column heading again, sorts the same column in descending order. An arrow in the
column heading indicates that a column has been sorted and in which order (ascending or
descending).

You can change the order columns are displayed in by dragging a column heading to a new location.

You can also show or hide columns by right-clicking on any column heading and selecting the columns
to show or hide.

If you select All Patients, the status of each study is displayed using icons.

Icon Status Description


Scheduled The procedure is scheduled and has not been started.

In progress The procedure has been started and is the current acquisition study.

Suspended The procedure has been started but was not completed, and is not the current acquisition
study. You can resume the procedure at an appropriate time.
Completing The procedure has been completed but some automatic processes, data transfers, or stor-
ing activities may still be underway in the background.
Completed with an The procedure has been completed but some errors were encountered. To find out more in-
error formation about the errors, use the job viewer.
Completed The procedure has been completed and all automatic processes, data transfers, or storing
activities were successfully carried out.
Imported The study has been imported from the archive.

Importing The study is currently importing from the archive.

Imported with er- The study was imported from the archive but errors were encountered. To find out more in-
rors formation about the errors, use the job viewer.

NOTE If an automatic transfer of data fails while a procedure is completing, the procedure's status
may remain as Completing. To find out more information about why completion may have
failed, use the job viewer.

For more information, see Viewing System Tasks in the Job Viewer (page 192).

Quick Search
A search box is available above the patient list, allowing you to search the patient database.

Search results appear automatically as you enter search text. The search is not case-sensitive.

When you enter search text, the icon changes to allow you to clear the search text if desired. You can
clear the search text by clicking Clear.

5.2 ProcedureCards
A ProcedureCard is a digital card that contains predefined procedure settings such as acquisition
protocols, patient orientation, and imported documents for procedure instructions.

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Preparing a Patient Study Scheduling a Study from the Hospital Worklist

The system provides predefined ProcedureCards that are divided into procedure groups. You can also
create your own ProcedureCards and save them in your own groups.

If your system has the FlexSpot or FlexVision option installed, ProcedureCards also contain predefined
screen layouts.

If the Interventional Workspot is connected to the X-ray system, you can configure settings for
supported Interventional Tools in a ProcedureCard on the X-ray system.

ProcedureCards provide the following information to the system:


• The default X-ray settings for use in the study.
• The X-ray setting selections that are available to you during the study.
• The desired patient orientation.
• The default preset for the FlexSpot option, if installed.
• The default preset for the FlexVision option, if installed.
• Settings for supported Interventional Tools, if connected.
• Guidance notes for the study.

For more information, see Managing ProcedureCards (page 279).

5.3 Scheduling a Study from the Hospital Worklist


If the patient that you are scheduling a study for is not displayed in the worklist, you can search for the
patient in the hospital worklist.

1 Click the patient selector in the upper-left corner of the review window or the acquisition window to
display the patient database.

2 Do one of the following:


• Click Scheduled to see the list of scheduled procedures.

• Click All Patients to see all procedures in the local database.

3 Click Add from Worklist.

4 To find a patient in the worklist, do one of the following:


• Enter the patient’s surname, patient ID, or accession number, and click Search.

• To display a list of all patients in the worklist scheduled for this system, leave the fields blank
and click Search.

If the patient you are searching for was scheduled to be examined on another system, you may
need to search again using different Station AE-Title and Modality values.

If you cannot find the patient in the worklist, you may need to add the patient manually. For more
information, see Scheduling a Study Manually (page 59).

You can change the ProcedureCard selected for the study by editing the study. For more
information, see Editing a Scheduled Study (page 60).

5 Select the patient in the patient list.

6 Click Add to Schedule.

When you schedule a study from the hospital worklist, the ProcedureCard is automatically selected
based on the DICOM RIS code recorded for the study in the hospital worklist. For more information, see
Mapping RIS Codes to ProcedureCards (page 268).

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Preparing a Patient Study Scheduling a Study Manually

5.4 Scheduling a Study Manually


You can schedule a study for a patient who is not available in the worklist.

1 Click the patient selector in the upper-left corner of the review window or the acquisition window to
display the patient database.

2 Do one of the following:


• Click Scheduled to see the list of scheduled procedures.

• Click All Patients to see all procedures in the local database.

3 Click Add Patient to display the Add Patient dialog box.

4 In the upper section of the Add Patient dialog box, enter the details of the patient.

5 In the middle section of the Add Patient dialog box, enter the details of the study.

If you select Auto in the Patient Type box, the system automatically selects an appropriate patient
type based on the patient's height and weight.

6 In the lower section of the Add Patient dialog box, do the following to select the ProcedureCard:

a Click the ProcedureCard Group list and select the group that contains the ProcedureCard that
you want to use.

b Select the ProcedureCard.

If you do not select a ProcedureCard, the default ProcedureCard is used. For more information,
see Changing the Default ProcedureCard (page 279).

7 Do one of the following:


• To add the procedure to the schedule list without starting the procedure yet, click Add to
Schedule in the review window or the acquisition window.
• To add the procedure to the schedule list and start the procedure immediately, click Start
Procedure in the acquisition window.

5.5 Adding a Study


You can add a new study to a patient in the worklist if a patient is undergoing a repeat study.

1 Right-click the patient in the worklist and then click Add Study in the shortcut menu.

The Add Patient dialog box is displayed, with the patient's demographic information already
inserted.

2 In the middle section of the Add Patient dialog box, enter the details of the study.

If you select Auto in the Patient Type box, the system automatically selects an appropriate patient
type based on the patient's height and weight.

3 In the lower section of the Add Patient dialog box, do the following to select the ProcedureCard:

a Click the ProcedureCard Group list and select the group that contains the ProcedureCard that
you want to use.

b Select the ProcedureCard.

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Preparing a Patient Study Editing a Scheduled Study

If you do not select a ProcedureCard, the default ProcedureCard is used. For more information,
see Changing the Default ProcedureCard (page 279).

4 Do one of the following:


• To add the procedure to the schedule list without starting the procedure yet, click Add to
Schedule in the review window or the acquisition window.
• To add the procedure to the schedule list and start the procedure immediately, click Start
Procedure in the acquisition window.

5.6 Editing a Scheduled Study


You can edit a scheduled study to change or add details, or to change the ProcedureCard.

1 Click the patient selector in the upper left corner of the acquisition window or the review window.

2 Select the patient in the patient list and click Edit.

3 To change or add details, use the Study Details tab.

If the study was imported from the hospital worklist, you can only change information about the
patient type, size and weight. For more information about importing studies from the hospital
worklist, see Scheduling a Study from the Hospital Worklist (page 58).

4 To change the ProcedureCard, use the Procedures tab.

If you change the ProcedureCard, the settings associated with the new ProcedureCard selected are
applied to the system when you select the study for acquisition.

5 Click Save to save your changes.

Alternatively, click Back to Schedule to return to the patient database without saving your changes.

5.7 Checking the Available Disk Storage Space


Before starting a study and acquiring images, you should check that the system has sufficient storage
capacity.

You can check the available storage capacity by looking in the notification area. The following icons
indicate the status of the storage disk.

Icon Status
The storage disk has capacity. Position the pointer over the icon to see the percentage of the disk space
available.

Available disk space is low. Unprotected studies may be overwritten. You should delete studies or export
important data to an appropriate location to create more space.

Available disk space is critically low. You may not be able to store the study. You should delete studies or
export important data to an appropriate location to create more space.

On biplane systems, storage capacity is indicated for each channel.

For more information about protecting or archiving important data, see the following sections:
• Protecting and Unprotecting Studies (page 153)
• Exporting Data (page 185)

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Preparing a Patient Study Starting a Study

5.8 Starting a Study


If a study has been scheduled, you can select it and start it.

You can only start a study from the acquisition window.

1 Click the patient selector in the upper-left corner of the acquisition window.

2 Click Scheduled to see the list of scheduled studies.

If the patient or study is not displayed in the list of scheduled studies, you may need to search the
hospital worklist or add the patient manually.

For more information, see the following sections:


• Scheduling a Study from the Hospital Worklist (page 58)
• Scheduling a Study Manually (page 59)

3 Select the patient in the list and click Start Procedure.

5.9 Positioning the Patient on the Table


Positioning the patient correctly on the table before sterile preparation prevents the need to reposition
the patient during the study.

NOTE Disable geometry movements and X-ray while performing the following actions:
• Positioning the patient on the tabletop.
• Removing the patient from the tabletop.
• Preparing the patient for the procedure.

The maximum permissible weight on the table is 275 kg / 600 lbs. This includes the weight of all
accessories that are attached to the table.

NOTE The maximum permissible load of an operating table differs from the standard table. For
more information, refer to the Instructions for Use supplied with the operating table.

1 If the tilt or cradle options are installed, position the tabletop at 0 degrees tilt and 0 degrees cradle.

2 If the pivot option is installed, you can pivot the table to improve accessibility while transferring the
patient. To pivot the tabletop do the following:

a Move the tabletop all the way towards the head end (fully extended from the table base) to
make it easier to pivot.

b Turn and hold the Pivot Lock switch on the control module until the unlock indicator light
changes color from white.

The Pivot Lock switch delay prevents unintentional unlocking during patient transfer.

c Push the tabletop to the desired pivot position.

There are detent positions at +13 degrees and -13 degrees, or you can pivot the tabletop
between +90 degrees and -180 degrees.

d Ensure that the pivot lock is engaged.

The pivot lock engages automatically 10 seconds after the pivot movement. The unlock indicator
light switches to white when the pivot lock is engaged.

For more information, see Pivoting the Table (page 89).

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Preparing a Patient Study Positioning the Patient on the Table

3 Move the tabletop all the way towards the foot end (fully retracted toward the table base).

4 Raise or lower the tabletop to a convenient height for transferring the patient.

5 Remove control modules and the radiation shield if they are attached to the accessory rail between
the trolley and the tabletop.

You can replace these items after the patient has been transferred.

6 Transfer the patient on to the tabletop and place the patient into the correct position.

Figure 36 Transfer the patient with the table fully retracted toward the table base

The required patient orientation for the selected ProcedureCard is shown in the X-ray Settings task
panel. If the patient orientation is different, change the patient orientation in the task panel. For
more information, see Changing the Patient Orientation (page 64).

NOTE Ensure that the patient, the control module, and the touch screen module are positioned
in such a way that the patient cannot touch or come in contact with the modules.

7 If you pivoted the table to transfer the patient, do the following to return the table to the desired
procedure position:

a Unlock the pivot lock and pivot the table.

b Ensure that the pivot lock is engaged before continuing with patient preparation.

5.9.1 Using Patient Straps


Use patient straps to ensure patient safety before starting tilt or cradle movements of the tabletop.

If you use sterile sheets to cover the patient, they might obscure the visibility of the straps. If the patient
is covered by sterile sheets, check that the patient is secured with straps before starting tilt or cradle
movements.

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Figure 37 Using patient straps

Ensure that the straps are applied correctly around the accessory rail of the table.

Figure 38 Applying patient straps around the accessory rail

A label showing the correct use of the straps is located on both sides of the table between the strap
location holes.

Figure 39 Patient straps label

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Figure 40 Patient straps: incorrect use and correct use

NOTE For patients with disabilities that do not allow the recommended use of straps, it is your
responsibility to decide how best to use the tilt or cradle functions while minimizing the risk
of harm to the patient.

5.9.2 Changing the Patient Orientation


The default patient orientation for the procedure is determined by the ProcedureCard. You can change
the patient orientation to suit the procedure that you are performing, and to match the patient's actual
position on the table.

Orientation Symbol

Patient facing up with their head at the head end of the table

Patient facing up with their head at the foot end of the table

Patient facing down with their head at the head end of the table

Patient facing down with their head at the foot end of the table

You can change the patient orientation using the acquisition window or the touch screen module.

1 To change the patient orientation using the acquisition window, do the following:

a Select the X-ray Settings task.

b In the task panel, click the Patient Orientation icon and select the patient orientation.

NOTE Surgical view cannot be enabled in the X-ray Settings task.

2 To change the patient orientation using the touch screen module, do the following:

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Preparing a Patient Study Positioning the Patient on the Table

a Select the X-ray Acquisition application.

b Tap the X-ray Settings task.

c Tap the Patient Orientation icon in the upper-right corner and select the patient orientation.

d To enable surgical view, tap the Patient Orientation icon in the upper-right corner, and then
switch Surgical View to On.

When surgical view is enabled, images are reversed left to right.

For more information, see Image Orientation (page 123).

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6 Preparing the System


The procedures in this section describe the preferred stand and table positions in relation to the
procedure types.

6.1 Safety Information

Patient Safety
Ensure that the patient's fingers do not become jammed between the table and stand during motorized
movement of the stand in the transverse direction.

When moving the detector towards the patient, take care that the detector's front plate does not hit any
small objects, such as the patient's nose.

When the patient's arm is positioned on the catheter arm support, ensure that the patient's arm or
fingers do not become jammed between the arm support and the stand during table or stand
movements.

Hospital Staff Safety


While floating the tabletop, ensure that other staff members do not become trapped between the
tabletop and other equipment in the examination room.

It is possible to access the longitudinal guiding mechanism from underneath the tabletop. Serious injury
may result if any part of the body becomes trapped in the mechanism.

Safety Devices
For information about safety devices for stand and table movements, see Collision
Prevention (page 79).

Unintentional Activation
WARNING
Ensure that unintentional activation of the control module buttons does not occur by the patient,
sterile covers, or other means. This can cause serious injury to the patient or any other person.

Foot Switch
Ensure that the foot switch is not unintentionally activated during geometry movement or swivel
movement of the table base.

If the foot switch is fitted with a sterile cover, do not fit the cover too tightly. This is to ensure that when
one pedal is pressed the cover does not activate other pedals.

Spillage of Liquids
Prevent spillage of liquids, which may bring live parts of the equipment into contact with conductive
enclosures or direct contact with the operator, other personnel, or the patient.

6.2 Touch Screen Module


You can use the touch screen module to select monitor layouts and presets, control acquisition settings,
select images for review or post-processing, and access applications such as Interventional Tools.

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When multiple touch screen modules are used, each module provides identical functionality, but
different applications can be opened on each module. You can start multiple applications on one touch
screen module and switch between applications without closing running applications.

The touch screen module starts automatically when the system starts and displays the application that
is currently in the upper-left position on the first page in the Applications window. (For more
information, see Customizing the Applications Window (page 71).) When the system is switched off,
the touch screen module automatically shuts down.

Figure 41 Touch screen module

Legend
1 Active application 5 Fluoro Store button (stores fluoroscopy images
from the current series while the button is pressed)
2 Applications button (displays the Applications win- 6 Stopwatch button (starts or stops the stopwatch
dow) display on one of the monitors in the examination
room)
3 Active application tab 7 X-ray button (enables or disables X-ray)
4 Application tabs for running applications

You use touch gestures to activate and control applications on the touch screen module. For more
information, see Touch Screen Gestures (page 446).

NOTE If you press a function on the touch screen module for longer than seven seconds, the
function will automatically deactivate. To continue, press the function again.

If the mouse option is installed, you can activate compatible applications on the touch screen module
and then use the mouse to control them.

If FlexVision (option) is installed, the touch screen module also provides an on-screen mouse and
keyboard.

6.2.1 Touch Screen Module Swing Arm


The swing arm allows you to use the touch screen module from either side of the table without needing
to reposition it on the accessory rail.

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1 To attach the swing arm to the accessory rail, do the following:

a Ensure the clamp on the swing arm is open.

b Place the swing on the accessory rail at the desired position.

c Close the clamp by pulling it toward you.

Figure 42 Attaching the swing arm to the accessory rail

2 Position the touch screen module as desired.


• Keep the swing arm folded to use the touch screen module at the same side of the table.
• Extend the swing arm and rotate the touch screen module to use it from the other side of the
table.

Figure 43 Positioning the touch screen module with the swing arm

3 To remove the swing arm from the accessory rail, release the clamp and lift the swing arm and the
touch screen module off the rail.

6.2.2 Starting an Application


1 To start an application on the touch screen module, tap Applications in the lower-left corner of the
module.

The Applications window is displayed providing an overview of available applications.

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Figure 44 Applications window

If there are more applications available than can be shown on one page of thumbnails, additional
pages are indicated below the thumbnails.

Figure 45 Indicator showing that multiple pages are available

2 To view additional pages of applications (if available), swipe left or right to view them.

3 Tap the application that you want to start.

The touch screen module starts the application and displays available functions.

NOTE You can open several applications concurrently on the touch screen module.

If another application is already running when you start a new application, it is not closed. It is still
available as a tab at the bottom of the window. If an event occurs in a running application that is not
currently active, the tab blinks to inform you that there is a new event in the application.

4 To switch to another running application, tap the corresponding tab at the bottom of the module's
display.

Figure 46 Application tabs

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6.2.3 Using the Mouse (Option)


If the mouse option is installed, compatible applications are displayed in the Applications window with
a mouse outline symbol in the upper-right corner above the thumbnail. The application where mouse
control is active is displayed with a solid mouse symbol.

Figure 47 Left: Mouse control is active for this application. Right: Mouse control is available for this
application

When you start an application that is compatible with the mouse option, mouse control is automatically
transferred to the newly active application.

6.2.4 Managing Notifications


Special notifications require affirmative action to dismiss them. Special notifications are displayed on all
modules regardless of the active application.

1 To dismiss a notification, do one of the following:


• Tap Close in the upper-right corner of the notification.

• Swipe the notification to the left or right.

2 To reset the buzzer when the Reset Fluoroscopy Buzzer notification is displayed, tap Reset.

Figure 48 Reset Fluoroscopy Buzzer notification

6.2.5 Closing an Application


1 To close an application that is running on the touch screen module, tap Close on the application's
tab at the bottom of the window.

Figure 49 Closing an application

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NOTE If the application that you want to close is not the active application and its Close button
is not visible, tap the tab to make it visible.

When you close an application, the application in the first tab to the right becomes the active
application. If there are no tabs to the right, the application tab to the left becomes the active
application.

When you close the last available tab, the Applications window is displayed.

6.2.6 Removing an Unavailable Application


If the connection to an application is interrupted, the following animated symbol is displayed in the
application window and on the application thumbnail.

Figure 50 Trying to reconnect to an unavailable application

If the connection to the application cannot be restored after a couple of minutes, the following symbol
is displayed in the application window and on the application thumbnail.

Figure 51 The application is unavailable

You can remove unavailable applications using the Applications window.

1 Tap Applications in the lower-left corner of the touch screen module.

2 Press and hold for one second the thumbnail of the unavailable application that you want to
remove.

A trash icon (Delete) is displayed in the upper-right corner above the thumbnail.

NOTE The trash icon is displayed on all unavailable applications.

3 Tap Delete to remove the application.

NOTE You can only remove applications that are unavailable.

4 If desired, tap Delete on other unavailable application thumbnails to remove them.

5 To exit this mode, tap an empty space in the Applications window, or tap an available application.

6.2.7 Customizing the Applications Window


1 Tap Applications in the lower-left corner of the touch screen module to display the Applications
window.

2 To move an application thumbnail, do the following:

a Press and hold the thumbnail.

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After a short pause, the thumbnail enlarges to indicate that you can move it.

b Drag the thumbnail to another position and release it.

The other thumbnails are automatically repositioned.

3 To move an application thumbnail to another page (if multiple pages are available), do the
following:

a Press and hold the thumbnail and move it to the edge of the window.

After a short pause, the next or previous page is displayed.

Dragging the thumbnail to the left edge of the window displays the previous page and dragging
it to the right edge displays the next page, when available.

b Position the thumbnail as desired on the page.

NOTE It is not possible to create a new page by dragging a thumbnail.

4 To set the application that is displayed when the system starts, move the application thumbnail to
the upper-left position on the first page.

6.2.8 Using Cleaning Mode


The touch screen module provides a dedicated cleaning mode, allowing you to clean the module
without inadvertently activating a function.

1 Tap Applications in the lower-left corner of the touch screen module.

2 In the Applications window, tap the Cleaning Mode application thumbnail.

Figure 52 Cleaning Mode application thumbnail

While the Cleaning Mode application is active, all functions on the module are unavailable.

3 To close the Cleaning Mode application after cleaning the module, press and hold anywhere on the
module's display for three seconds.

The module displays user guidance and a timer that counts down as you press the display.

6.3 Control Modules


The control module provides a combination of controls to adjust the position of the stand and table,
and to perform imaging functions during acquisition.

You can position the control modules at convenient positions around the table by mounting the
modules on the accessory rail.

Do not attach more than two modules to the accessory rail.

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6.3.1 Repositioning the Control Module


You can reposition the control module to a more convenient position for the study being performed.

Figure 53 Attaching the control module (left) and removing the control module (right)

1 To remove the control module from the accessory rail, grip it from the front with one hand, with your
thumb on top and your fingers on the lock release bar.

2 Press the lock release bar to release the module and lift the module upwards.

The module can now be lifted off the accessory rail and moved to another position.

3 To attach the control module to the accessory rail, press the lock release bar to open the lock.

4 Place the lock over the accessory rail and push the module down until the back edge of the module
housing is flush with the accessory rail, and then release the lock release bar.

5 Ensure that the control module cables are supported by the cable guides.

6 If you repositioned the control module to a different side of the table, you must select the correct
tableside position using the Orientation switch. For more information, see Selecting the Tableside
Position for the Control Module (page 73).

6.3.2 Selecting the Tableside Position for the Control Module


To ensure that stand movements remain logical for each position in which the control module can be
mounted, the Orientation switch located on the under side of the module must be set to the
appropriate position.

• When mounting the control module on the doctor side, the switch must point to the left.
• When mounting the control module on the nurse side, the switch must point to the right.
• When mounting the control module at the foot end, the switch must point towards the tabletop.

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Figure 54 Control module (underside) and Orientation switch

For definitions of table positions, see Patient Table: Doctor Side and Nurse Side (page 477).

When the Orientation switch on the under side of the control module is in the correct position, the
movement of the stand is logical compared to the direction in which the switches are operated.

6.4 Stand Movements


You position the stand in the working position using the control module.

The following working positions are available:


• Head side
• Doctor side
• Nurse side

Figure 55 Positioning the stand at the head end (left) and nurse side (right)

For more information, see Patient Table: Doctor Side and Nurse Side (page 477).

Rotation and angulation movements are motorized with variable speed. The greater the deflection of
the switch on the control module, the faster the stand moves. For normal operation these speeds are 0
- 25 degrees per second (lower maximum speeds can be configured by technical support). If the stand
is not in its working area, the maximum speeds are reduced to 8 degrees per second (not applicable for
floor-mounted M20 systems or systems using the FlexArm option).

WARNING
All motorized movements should take place in the field of view of the operator.

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The direction of movement is affected by the position of the Orientation switch on the underside of the
control module. For more information, see Selecting the Tableside Position for the Control
Module (page 73).

6.4.1 Positioning the Stand


This procedure provides information for preparing the stand. This procedure is applicable when the
FlexArm option is not installed.

WARNING
All motorized movements should take place in the field of view of the operator.

For information about using the stand with the FlexArm option, see Positioning the FlexArm Stand
(Option) (page 75).

1 Check the table lock status, and lock or unlock the table as appropriate during the procedure.

For more information, see Locking and Unlocking Stand and Table Movements (page 117).

2 If the table has the tilt option installed, ensure that the table is not tilted.

3 If the table has the pivot option installed, ensure that the table is not pivoted.

4 Set the detector source-to-image distance to the maximum.

5 Place the patient on the table in the desired position.

For more information, see Positioning the Patient on the Table (page 61).

6 Move the stand to the desired position.

For more information, see Patient Table: Doctor Side and Nurse Side (page 477).

7 Move the tabletop into the desired position.

8 Adjust the stand rotation and angulation for the required projections.

9 For additional positioning of the region of interest, use table movements.

For more information, see Isocentering (page 122).

10 If your system has a rotatable detector, rotate the detector to the desired position (portait or
landscape).

11 Move the detector as close as possible to the patient.

6.4.2 Positioning the FlexArm Stand (Option)


This section provides information for positioning the FlexArm stand (option) in preparation for a
procedure.

WARNING
All motorized movements should take place in the field of view of the operator.

For information about using the stand without the FlexArm option, see Positioning the Stand (page 75).

The FlexArm stand provides longitudinal and transverse movements, and free detector rotation.

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Figure 56 FlexArm stand (option)

The stand joystick on the control module provides intuitive control of the stand for consistent
movements from any position:
• To move the stand longitudinally and transversely, push the joystick in the desired direction of
movement. For example, to move the stand transversely, push the joystick in the corresponding
direction from your point for view.
• To rotate the stand around the vertical axis, turn the joystick in the desired direction.

Figure 57 Stand joystick on the control module

When you make longitudinal and transverse movements with the FlexArm stand, it moves at a reduced
speed for the first two seconds and then continues at the maximum speed. This allows you to make
small, precise movements for accurate positioning of the region of interest, particularly when using a
small field of view.

1 Check the table lock status, and lock or unlock the table as appropriate during the procedure.

For more information, see Locking and Unlocking Stand and Table Movements (page 117).

2 Set the detector source-to-image distance to the maximum.

3 Place the patient on the table in the desired position.

For more information, see Positioning the Patient on the Table (page 61).

4 Move the tabletop to the desired position.

5 Move the stand to the desired position using the stand joystick on the control module.

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Figure 58 FlexArm stand joystick on the control module

a Turn the joystick to rotate the stand around the vertical axis.

This function allows you to position the stand at the head of the table or at either side,
depending on your workflow. When you rotate the stand in the vertical axis, the selected
projection is automatically maintained, allowing you to create space as needed during an
intervention.

b Push the joystick in the direction that you want to move the stand to bring it to the region of
interest.

It is possible to move the stand manually using the handles and brake controls on the side of the
stand. There is a brake to control longitudinal movement and a brake to control movement around
the vertical axis. If you move the stand out of its working area for motorized movements, a guidance
message is displayed in the status area indicating the stand is out of range. Move the stand back to
the working area manually to continue with motorized movement.

6 Adjust the stand rotation and angulation for the required projections.

7 To set the detector to a patient-aligned orientation (landscape or portrait), do one of the following:
• To set the detector to landscape orientation, push and hold the detector switch to the left until
the detector stops moving and the indicator light illuminates.

• To set the detector to portrait orientation, push and hold the detector switch to the right until
the detector stops moving and the indicator light illuminates.

NOTE It is recommended to set the detector to a patient-aligned orientation. When the


detector is patient-aligned and you turn the stand around the vertical axis (for example,
to or from the side position), the alignment of the detector is automatically maintained
with the region of interest in the isocenter.

8 To rotate the detector freely to align with a region of interest, turn the detector switch until the
detector is in the desired position.

When you rotate the detector, the collimator rotates automatically to maintain the selected field
size.

NOTE Be aware that when the detector is in a free position and is not patient-aligned
(landscape or portrait orientation), its orientation towards the patient is not maintained
during stand movements around the vertical axis (the detector keeps its orientation
relative to the stand).

NOTE The landscape and portrait orientation functions (push the detector switch left or right)
should only be used to align the detector to these orientations. If you use these functions
to rotate the detector to an arbitrary angle between landscape and portrait orientation,
the image will not be full size.

NOTE When you turn the stand or rotate the detector, the rotation direction of the detector and
collimator is determined by the system to maintain an optimal range of freedom for
successive movements. The detector and collimator may rotate in the direction contrary

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to your expectation, but the desired orientation is always attained. This is called
"switching" and a guidance message is displayed in the status area when the system
performs a switching movement.

9 Move the detector as close as possible to the patient.

For information about isocentering the region of interest, see Isocentering (page 122).

10 To move the stand to a new region of interest, move the stand longitudinally or transversely.

11 To park the stand, move it transversely to side of the examination room at the head end or the foot
end of the room.

Parking the stand creates space around the patient table for cleaning or for procedures that do not
require X-ray imaging. When you move the stand towards the wall to park it, it automatically rotates
to provide maximum space. If the stand is parked during an intervention, and the patient table is not
moved, you can move the stand back to the working position automatically to resume imaging.

You can also move the FlexArm stand using automatic position control. A dedicated Pathway function
allows you to select a stored destination position and move the stand automatically along a predefined
path. For example, the Pathway function can be configured to move the stand between the park
position and the working position. For more information, see the following sections:
• Using Automatic Position Control (page 118)
• Customizing APC Pathways (page 277)

6.4.3 Positioning the Stand with the FlexMove Option


The FlexMove option provides longitudinal and transverse movements for a ceiling-mounted stand.

WARNING
All motorized movements should take place in the field of view of the operator.

Figure 59 FlexMove geometry

• To perform manual movements, do the following:

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a Press and hold the Longitudinal/Transverse movement brake release key on the stand.

b Use the handgrips to push or pull the stand to the desired position.

c To stop the movement, release the key.

• To perform motorized movements, use the Move Beam XY Motorized switch on the control module.

6.5 Collision Prevention


The Azurion system uses the BodyGuard function and the Intelligent Collision Prevention (iCP) function
to protect the patient by slowing system movement speeds when an object is sensed within a certain
safety distance.

WARNING
During manual and motorized movements of the stand or the table, the operator is responsible for
the safety of patient, staff, and equipment. Avoid collisions to prevent serious injury to patient and
staff, or damage to the equipment.

CAUTION
If a collision occurs involving any part of the system, contact technical support.

If a collision occurs that causes any equipment cover to break or become detached, you should do the
following:
• Finish the case
• Switch off the power
• Contact technical support

6.5.1 BodyGuard
The stand is fitted with BodyGuard sensors around the detector. Depending on the stand in use, sensors
may also be located around the X-ray tube and collimator housing.

The BodyGuard function prevents collisions with the patient during normal use of the system, when the
patient is lying on the table and the table is not pivoted more than 13 degrees (if the pivot option is
installed). When the patient is not lying on the table, or when the table is pivoted more than 13 degrees,
then the BodyGuard function cannot fully safeguard the patient during rotation and angulation
movements. BodyGuard cannot prevent all collisions, but if a collision occurs, the collision force will be
lower because of the reduced movement speed.

Collisions involving the frontal stand are detected by current sensing and, depending on the stand in
use, force sensing. Collisions involving the lateral stand are detected by collision switches. Collisions
involving the table are detected by force sensors during table height movement.

BodyGuard sensors are switched off when the stand is performing the following movements:
• Rotational scan
• High-speed rotational scan
• Bolus chase

To ensure that the path is clear in these situations, a trial run is performed. To prevent a collision, the
patient should remain stationary between the trial run and the acquisition run, which is performed at a
higher speed.

Note the following information concerning the BodyGuard function:

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Preparing the System Collision Prevention

• Do not place a solid object that is not electrically conductive on the patient. Such objects cannot be
detected by the BodyGuard sensor and a collision may occur.
• The BodyGuard sensor has a blind spot in its center. Small objects, such as the patient's nose or a
very small child (for example, a baby of less than 1 kg) may not be detected when approached from
directly above.
• When the tabletop is fully extended towards the stand, do not lower it, and do not angulate the
stand cranially as the tabletop can collide with the inside of the stand, trapping the patient’s fingers.
• BodyGuard sensors must be kept dry, otherwise the BodyGuard function operates with reduced
efficiency and reduced speed.
• If the BodyGuard becomes defective, stand movements are only possible at reduced speed.

BodyGuard Off Below Table


The BodyGuard function can be customized such that certain BodyGuard sensors are switched off
when they are below the table. When the sensors are switched off, BodyGuard does not prevent a
collision with an object below the level of the tabletop. When the stand is positioned at the doctor or
nurse side, the BodyGuard sensor on top of the stand remains switched on, to prevent a collision with
the operator's legs.

Keep Maximum SID


This function keeps the detector in the maximum SID position to prevent it from hitting objects while
performing APC movements. Recalling a stand position may cause a collision. If necessary, stop the
recall function and position the stand using the control module. For more information about how to
configure this function, contact technical support.

6.5.2 Intelligent Collision Prevention


Intelligent Collision Prevention (iCP) prevents collisions between the tabletop, the X-ray tube, and the
stand. In a biplane system, iCP also prevents collisions between the frontal stand and the lateral stand.

The iCP function incorporates safe zones and safeguards the patient, equipment, and personnel by
preventing the stand from colliding with objects in these zones.

Figure 60 iCP safe zones (left: coronal view, right: side view)

Legend
1 Protective zone
2 Extended protective zone
3 Finger-pinching zone

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The movement speed of the stand is reduced if the iCP function detects that it is approaching a safe
zone. If the movement continues, iCP stops the movement before the stand enters the safe zone.

iCP monitors the following safe zones:


• The protective zone around the patient.
• The extended protective zone around the patient's arms.
• The finger-pinching zone between the edge of the tabletop at the head side and the stand.
• The wall zone, which extends 50 cm (approximately 20 inch) from the walls to prevent collisions
with personnel (FlexArm option only).
• A speed reduction zone is monitored to prevent collisions with the X-ray tube in any of the
following situations:
– A Maquet table is in use with the universal tabletop attached (or when an unknown tabletop is
attached).
– A TruSystem table is in use with the universal tabletop attached (or when an unknown tabletop
is attached).

The iCP function allows you to resume movement in a controlled way:


• If the movement is toward a safe zone, a small movement step is made.
• If the FlexArm option is in use and the movement is toward a safe zone, the movement continues at
reduced speed.
• If the movement is neither toward or away from a safe zone, the movement continues at reduced
speed.
• If the movement is away from a safe zone, the movement continues at normal speed.

To prevent the risk of pinched fingers for the patient, motorized stand and tabletop movements stop at
a distance of at least 2.5 cm (1 inch) between the stand and the tabletop. This is applicable for patients
up to the maximum patient weight on the table, except during motorized movement in override mode.

Stand - Table Clearance (FlexArm and FlexMove options only)


The iCP function prevents collisions between the stand and the table. Ensure that no part of the patient
can become jammed between the stand and tabletop and that the stand does not collide with the
tabletop during motorized movement of the stand. When the stand is positioned away from the stored
position, the L-arm may rotate during position recall movements, and there is a possibility that it may hit
the tabletop.

Stand - Airflow Channel Clearance (FlexMove option only)


The iCP function prevents collisions between the stand and the airflow channel. The position of the
stand (propeller or roll angle) is taken into consideration.

6.5.3 Collision Prevention Override


You can override the collision prevention functions when the movement is blocked, by releasing the
movement switch and reactivating it within 5 seconds.

It is the responsibility of the operator to ensure that collisions with the patient or equipment do not
occur while the override function is active.

When you activate the override function, a message is displayed in the status area, and a repeating
beep sound can be heard. The maximum movement speed during override is reduced compared to
normal movements. The override function is deactivated and normal movements are available again if
the requested movement is no longer being limited by the collision prevention system.

NOTE The override function is a configurable function and it may not be enabled on your system.

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Table Height Collision Override


If you need to perform CPR, you can override the force sensor that stops table height and tilt
movements.

The table is equipped with a force sensor measuring the force vertically applied to the surface of the
tabletop. Normally the measured force is determined by the patient weight. During motorized
movement, if a collision force exceeding the safety threshold is detected, the movement stops and is
briefly reversed.

To override the force sensor, release the table tilt switch or table height switch and then re-apply the
switch movement within 5 seconds to continue the movement. If no switch movements are performed
within 5 seconds, override mode is deactivated and table movements are stopped.

NOTE There are no audible signals during table height collision override mode.

6.5.4 Collision Indicators


When a collision is detected, a collision indicator is displayed in the following locations:
• In the status area of the live X-ray window in the examination room.
• In the status area of the acquisition window in the control room.

Icon Description

A detector collision has been detected

A detector collision has been detected by the force sensor

A stand collision has been detected (depending on the stand in use)

A tube collision has been detected

A collision with a person or object in the wall zone has been detected (FlexArm option)

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Icon Description

A collision of the frontal stand and the lateral stand has been detected

A lateral stand collision has been detected

A detector collision on the lateral stand has been detected

A tube collision on the lateral stand has been detected

The X-ray beam is misaligned. The image size is reduced. Align the detector to portrait or landscape
orientation.

A table collision has been detected

A collision between the stand and the table has been detected

A collision between the lateral stand and the table has been detected

A table collision has been detected and the protective zone has been activated.

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Icon Description

A table collision has been detected and the extended protective zone has been activated.

A table collision has been detected and the finger-pinching zone has been activated.

The table position is unknown and movement speed has been reduced.

A table collision has been detected and prevented.

A collision between the table and the stand has been detected and prevented.

A collision between the system and a tabletop-mounted component has been detected and pre-
vented.

A collision between the stand and a tabletop-mounted component has been detected and preven-
ted.

A collision between the stand and a tabletop-mounted component has been detected and preven-
ted.

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Icon Description

A collision between the stand and a tabletop-mounted component has been detected and preven-
ted.

For more information, see the following sections:


• Status Area (page 447)
• Intelligent Collision Prevention (page 80)

6.6 Positioning the Monitor Ceiling Suspension


WARNING
Do not allow the patient to touch the lower handgrip of the monitor ceiling suspension. It is not an
applied part and should not come into contact with the patient.

WARNING
Do not mount any equipment on the lower handgrip of the monitor ceiling suspension that is not
regarded as an applied part.

For more information, see Applied Parts (page 430).

1 Press and hold the motorized movement buttons to adjust the height of the monitor ceiling
suspension.

Figure 61 Monitor ceiling suspension height movement buttons

2 Push or pull the handgrip to adjust the horizontal and vertical position of the monitor ceiling
suspension.

3 Push or pull the handgrip to rotate the monitor ceiling suspension.

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6.7 Positioning the Monitor Boom


The monitor boom can be moved by releasing color-coded brakes using buttons positioned on either
side of the handgrip. You can also freely rotate the monitor frame or adjust its height without releasing a
brake.

An X-ray indicator light is positioned on the upper corner of the handgrip on either side.

Figure 62 X-ray indicator light

1 To move the monitor boom from its parking position, do the following:

a Press the green brake release button on the side handgrip of the monitor boom and pull the
handgrip to move the upper arm toward the patient table.

Figure 63 Brake release button for the upper arm

b Press the blue brake release button on the side handgrip of the monitor boom and pull or push
the handgrip to adjust the position of the lower arm in the working position.

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Figure 64 Brake release button for the lower arm

NOTE You can release both brakes at the same time by pressing the button between the
color-coded brake release buttons. However, it is recommended to release one brake
at a time for better control of the movement of the monitor boom.

c Pull or push the handgrip to adjust the orientation or the height of the monitor boom.

Figure 65 Moving the monitor boom manually

2 To move the monitor boom back to its parking position, release the brakes as appropriate and push
the monitor boom away from the patient table to the desired position.

NOTE When moving the lower arm, ensure that it is below the height of the upper arm to avoid
a collision.

6.8 Positioning the Table


These sections provide guidance on using the table positioning functions.

6.8.1 Adjusting the Table Height


You can adjust the height of the table to ensure the region of interest is in the appropriate position.

For more information about positioning the region of interest in the isocenter, see
Isocentering (page 122).

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1 Clear all objects from the path of the table.

2 Using the control module, adjust the table height until the region of interest is in the middle of the
field of view.

This can be aided with fluoroscopy.

6.8.2 Floating the Tabletop


You can float the tabletop transversely and longitudinally to assist in positioning the region of interest.

Depending on your system configuration, transverse and longitudinal movements may be manual or
motorized.

1 Clear all objects from the path of the table.

2 Using the control module, float the table and center the region of interest in the middle of the field
of view.

This can be aided with fluoroscopy.

6.8.3 Tilting the Table


The tilt function allows you to tilt the tabletop from -17 degrees to +17 degrees.

WARNING

Beware of finger entrapment. Do not place your fingers on the table bellows during tilting.

Figure 66 Tilting the table

1 Clear all objects from the path of the table.

2 Press and hold Tilt until the desired angle is reached.

If the synchro tilt option is available and the working position is set to doctor side or nurse side, the
table height automatically adjusts during the tilt movement to ensure the region of interest stays in
the isocenter.

3 To float the tabletop when it is tilted, press the Float Tabletop control on the control module, and
then push the Float Tabletop control in the direction that you want to move the tabletop.

To assist with moving the tabletop with heavy patients, longitudinal movements are automatically
motorized when you use Float Tabletop with a tilted tabletop. Transverse movements are not
motorized, even when the tabletop is tilted.

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6.8.4 Cradling the Table


The cradle function allows you to cradle the tabletop from -15 degrees to +15 degrees.

Figure 67 Cradling the table

1 Clear all objects from the path of the table.

2 Press and hold Cradle until the desired angle is reached.

6.8.5 Pivoting the Table


The pivot function allows you to pivot the tabletop for improved accessibility during patient transfer, or
to position the tabletop for a procedure.

1 Clear all objects from the path of the table.

2 To pivot the table from the head end, extend the tabletop to the head end to make pivoting the
table easier.

If the procedure or room arrangements require you to pivot the table from the foot end, do not
extend the table, so that less force is necessary to perform the pivot movement.

3 Unlock the table pivot lock by turning and holding the Pivot Lock switch on the control module until
the unlock indicator light changes color from white.

4 Push the table to the desired angle.

There are detent positions at +13 degrees and -13 degrees, or you can pivot the tabletop between
+90 degrees and -180 degrees.

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Figure 68 Range of pivot movement

NOTE If the table is pivoted by more than 13 degrees, the BodyGuard cannot prevent collisions
with the patient during rotation and angulation movements.

NOTE The pivot lock engages automatically after 10 seconds if you do not pivot the table
within that time.

5 Before continuing with your task, ensure that the pivot lock is engaged.

The unlock indicator light on the control module switches to white when the pivot lock is engaged.

6.8.6 Swiveling the Table


The swivel function is available for systems using a floor-mounted stand with a 20-inch detector. It
allows you to position the table for entire body imaging.

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Figure 69 Swiveling the table

1 Clear all objects from the path of the table.

2 Press and hold the direction button on the swivel hand switch.

Figure 70 Swivel hand switch

6.9 Using an OR Table


You can use an OR table with the Azurion X-ray system. The level of integration depends on the OR
table used, and available functions are described in this section.

The Azurion X-ray system is compatible with OR tables from the following manufacturers:
• Maquet Magnus table from Getinge, referred to as Maquet in these Instructions for Use.
• TruSystem table from Hillrom (Trumpf), referred to as TruSystem in these Instructions for Use.

For more information, see Compatibility (page 18).

Tableside Modules
Tableside modules can be mounted on the OR table. During patient transfer to or from the table, the
tableside modules can be parked on a pedestal (option) in the examination room.

Geometry Set-Up and BodyGuard


When using an OR table, the following functions are not available:
• Automatic stop at work positions 1 or 2 during motorized longitudinal movement of the stand
• BodyGuard Off Below Table (optional function)

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When using an OR table, the automatic BodyGuard override (ABO) function is available. When an object
is sensed, this function allows stand movements and transverse or longitudinal movements of the table
to continue at a safe speed.

When using an OR table with the FlexArm stand, the automatic BodyGuard override function is not
available. In this case, table movement stops and only continues at a safe speed when you restart the
movement action.

Collision Detection
WARNING
When moving the table, take care to avoid collisions with the stand.

The Intelligent Collision Prevention (iCP) function prevents collisions between the stand and the OR
table.

When a collision is detected, the following actions are performed:


• All table movements are stopped.
• A user message is displayed, and an acoustic signal sounds.

Normal movement is restored when the collision is resolved.

NOTE If the X-ray system is switched off, the collision detection system will not function when
table movement is controlled with the OR table controls.

Accessories
The following accessories can be used with an OR table.
• Arm support board (not available with the TruSystem OR table)
• Shoulder support board
• Peripheral X-ray filters
• Cerebral filter (not available with the FlexArm option)
• Neuro wedge
• Ceiling-suspended radiation shield
• Accessory bracket for ceiling suspended radiation shield

NOTE Additional accessories may be available from the manufacturer of the OR table. However,
these accessories have not been tested for use with the Azurion X-ray system. Refer to the
information provided by the manufacturer.

Parking the Stand


If the optional ceiling rail extension is installed, you can park the stand so that it is out of the way of the
table. The optional ceiling rail extension is available at the head end or at the foot end.

6.9.1 Maquet Operating Table


The Maquet operating table consists of the operating table column and tabletop. The tabletop is
available in the following configurations:
• Universal tabletop: Suitable for a range of surgery applications, using a base plate and additional
jointed modules to allow patient positioning.
• Radiolucent tabletop: Suitable for interventional procedures and minimally invasive operations.

NOTE Do not use straps from Philips to secure the patient during movements. Refer to the Maquet
documentation for details of how to secure the patient.

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Startup and Shutdown


Startup and shutdown of the Maquet operating table is managed by the X-ray system. It is not
necessary to power it on or off.

Patient Transfer
During patient tabletop transfer, the X-ray system may be switched on or off. If the X-ray system is
switched on, table movement functions on the control module of the X-ray system are locked.

Patient Orientation
The Maquet operating table features a blue dot on the table base. When the upper part of the patient's
body is on the same side as the blue dot, the patient orientation for the Maquet operating table is
Normal (patient's head at the head end of the table). Otherwise, the patient orientation is Reversed
(patient's head at the foot end of the table).

Patient orientation functions on each system are linked; when the patient orientation is changed on the
Maquet operating table, the patient orientation indication of the patient's head at the head end of the
table or at the foot end of the table is updated on the X-ray system (the indication of the patient facing
up or facing down is not updated). The displayed rotation angle and angulation angle are also updated.

Operation Modes
A subset of table functions is available using the control module of the X-ray system.

Function Universal Tabletop Radiolucent Tabletop


Basic table functions (longitudinal, transverse, height, and
Yes Yes
cradle movements)
Isocentric tilt No Yes
SyncraTilt No Yes
Automatic Position Control (APC) No Yes
Bolus chase (FDPA) No Yes
Table locking (whole system) Yes Yes
Emergency stop Yes Yes
Reset geometry (not available when the stand and table are
No Yes
locked)
Compatibility with Interventional Tools Yes (with universal frame) Yes

Alternatively, full control of the table is provided on a dedicated Maquet remote control module or
joystick. For details of the Maquet user interface controls, refer to the documentation supplied with the
Maquet operating table.

NOTE To prevent unintentional movement of the Maquet table during procedures that require
imaging, it is recommended that you do not use the Maquet controls, and instead use the
two-step approach of the Philips controls: unlock the table and use the movement controls.

NOTE The large size of the universal tabletop may make 3D acquisition difficult to
perform.

NOTE Any movement function can be started from either the control module or the Maquet user
interface controls in the examination room. However, if a movement function is activated on
each module at the same time, all movements are blocked until the movement function on
both modules is deactivated.

NOTE If movements are blocked on the control module after changing the tabletop, first activate
the desired movement using the Maquet user interface controls. The control module will then
be enabled again for further movements.

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NOTE If the geometry is locked by the control module and the X-ray system is switched off, the
Maquet table is automatically unlocked. Table functions are still available using the Maquet
remote control module.

6.9.2 TruSystem Operating Table


The TruSystem operating table consists of the operating table column and tabletop. The tabletop is
available in the following configurations:
• Carbon FloatLine OR tabletop: Suitable for cardio and vascular interventional procedures.
• Carbon Spine OR tabletop: Suitable for spine surgery applications.
• SQ14 X-TRA OR tabletop: Suitable for universal surgery applications.
• Universal tabletop: Suitable for universal surgery applications.

You can change the tabletop using the TruSystem shuttle and table docking system.

NOTE When docking the shuttle to change the tabletop, ensure that the stand is parked. This
provides space for the shuttle and prevents interference from the X-ray system's collision
prevention features while docking the tabletop.

NOTE Do not use straps from Philips to secure the patient during movements. Refer to the
TruSystem documentation for details of how to secure the patient.

Startup and Shutdown


When the X-ray system is switched off, it is still possible to use the TruSystem table.

WARNING
After the X-ray system is switched on, do not move the table until the X-ray system is fully
operational.

Patient Transfer
During patient tabletop transfer, the X-ray system may be switched on or off. If the X-ray system is
switched on, table movement functions on the control module of the X-ray system are locked.

Operation Modes
A subset of table functions is available using the control module of the X-ray system.

NOTE Table functions are not available using the control module if the FlexMove option is
installed. For more information, see Using a TruSystem Table with the FlexMove
Option (page 95).

Tabletop
Function Carbon FloatLine Carbon Spine SQ14 X-TRA Universal
Basic table functions (longitudinal,
transverse, height, and cradle move- Yes Yes Yes Yes
ments)
Isocentric tilt No No No No
SyncraTilt No No No No
Automatic Position Control (APC) Yes Yes Height only No
Bolus chase (FDPA) No No No No
Table locking (whole system) Yes Yes Yes Yes
Emergency stop Yes Yes Yes Yes

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Tabletop
Function Carbon FloatLine Carbon Spine SQ14 X-TRA Universal
Reset geometry (not available when Limited: only the Limited: only the
the stand and table are locked) middle segment segment moun-
Yes Yes (mounted directly ted directly on
on the column) is the column is re-
reset set
Compatibility with Interventional Tools Yes Yes Yes Yes

Alternatively, you can control the TruSystem table using a dedicated remote control or a control panel
on the table column. For details of the TruSystem user interface controls, refer to the documentation
supplied with the TruSystem operating table.

WARNING
When moving the X-ray system or the table manually or under motor control, take care to avoid
collisions with the patient or objects.

NOTE To prevent unintentional movement of the TruSystem table during procedures that require
imaging, it is recommended that you do not use the TruSystem controls, and instead use the
two-step approach of the Philips controls: unlock the table and use the movement controls.

NOTE The large size of the universal tabletop may make 3D acquisition difficult to
perform.

NOTE Any movement function can be started from either the control module or the TruSystem user
interface controls in the examination room. If a movement function is activated on each
module at the same time, the function activated on the TruSystem user interface has priority.

6.9.3 Using a TruSystem Table with the FlexMove Option


If you are using a TruSystem table with the FlexMove option, some limitations on the operation of the
TruSystem table apply.

Table Control
NOTE When the FlexMove option is installed, the control module cannot be used to control the
TruSystem table.

The TruSystem table can be controlled using the remote control supplied with the table, or using the
emergency control panel on the table base.

When moving the table towards the tube or towards the flat detector, the table stops at a distance of
approximately 5 cm from the tube or detector cover.

A collision message appears on the X-ray system display. In this situation it is not possible to move the
table in any direction.

NOTE Be aware that the user message disappears after some time, but table movement is still
inhibited. In this situation the table can be moved in table override mode. The restriction can
be canceled by moving the stand away from the table.

When the table has been stopped by BodyGuard, the table can be moved in override mode. The
override mode works when the table override joystick is moved downwards and a table movement
button is pressed simultaneously. Alternatively, you can use the emergency control panel on the table
base which will override movement restrictions.

If the movement has been stopped by BodyGuard, the table can also move again when BodyGuard is
no longer active because the stand has been moved away. The table override joystick does not have to
be used in this situation.

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As long as the override mode is active, a beep sound is heard and a BodyGuard user message is shown.

CAUTION
It is possible for the table to collide with the X-ray system. The table will not stop by itself.

X-ray System Controls


If you are moving the X-ray system towards the TruSystem table and the X-ray system stops because it
is too close (5 cm) to the table, you can move the X-ray system away from the table without overriding.

When BodyGuard is activated it is possible to move the X-ray system closer to the table at a lower
speed.

During a warm restart procedure and in the X-ray system's fast fluoroscopy mode, you can move the
table.

Figure 71 Control module

Legend
1 Emergency stop
2 Table override

Emergency Stop
The emergency stop button stops any motorized movement by switching the geometry functions off.
The geometry functions become operational again after a geometry restart.

To perform a geometry restart, press Power On on the review module.

Table Override
Move the joystick downward to activate the override mode.

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3 0 4

Figure 72 Top view of the patient table

Legend
1 Doctor side 3 Head end
2 Nurse side 4 Foot end

WARNING
The system has limited collision prevention functionality when using a TruSystem table in
combination with the FlexMove option. When moving the X-ray system or the table manually or
under motor control, take care to avoid collisions with the patient or objects.

NOTE The X-ray system patient orientation position information is inaccurate since it is based on
the horizontal table position and is independent of the position of the TruSystem table.

Rotational Scan
After defining the end position for the rotational scan, TruSystem table movements are blocked.

The table is enabled again once the rotational scan has been performed.

If the rotational scan procedure is stopped before the scan is completed, the table is only enabled
again once another procedure is selected.

6.9.4 Fitting Sterile and Disposable Covers in a (Hybrid) OR Environment


CAUTION
You should always use disposable sterile covers with the system when using it in a (hybrid) OR
environment to avoid contact with the equipment. Preventing contamination in this way makes
cleaning the equipment easier.

Sterile and non-sterile covers and sheets for the equipment can be purchased from Ecolab. For details,
please refer to the Ecolab website:

www.ecolab.com

NOTE Any covers that are positioned under the table, or that are moved under the table during the
procedure, must be considered as not sterile.

NOTE If there is any doubt regarding a cover's sterility, consider it not sterile.

NOTE A new set of sterile covers must be used for each procedure.

The following covers are provided in the sterile covers package:


• Stand bottom cover
• Stand top cover
• Detector cover
• Cable harness cover

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1 Park the stand in the standby parking position, with the detector above and the tube below.

NOTE If you cannot easily reach the top part of the stand, turn the stand to the lateral position.

2 From the sterile cover set package, take the stand bottom cover, which is identified with a sticker
displaying a tube image.

3 Place the stand bottom cover over the tube and the bottom inner part of the stand.

4 Open the glued stickers and attach the inner part of the stand bottom cover to the bottom inner part
of the stand.

5 Take the cable harness cover, which is identified with a sticker displaying an arrow.

6 Open the glued stickers and begin to attach it along the length of the left side of the cover, and then
along the length of the right side.

7 Take the stand top cover, which is the biggest piece of the cover set package, and which is identified
with a sticker displaying a detector image.

8 Starting with the opening indicated with the identification sticker, place the stand top cover around
the top part of the detector, ensuring that the elasticated end surrounds the flat round connection
part of the detector.

9 Open the glued stickers and attach the stand top cover to the inner part of the stand from top to
bottom.

10 Take the detector cover, which is the smallest piece of the sterile covers package.

11 Place the detector cover over the detector, ensuring that the elasticated end surrounds the flat
round connection part of the detector.

A separate cover package can be purchased from Microtek for the touch screen module. The
Instructions for Use supplied with the touch screen module cover package provide guidance on fitting
the cover.

Standard covers can be used for the foot switch, which should be covered with a plastic cover or bag.

6.10 Using Radiation Shields


Radiation shields provide additional protection against stray radiation. You can use a table-mounted
radiation shield and a ceiling-suspended radiation shield with the system.

The table-mounted and ceiling-suspended radiation shields are 0.5 mm lead (Pb) equivalent. For
optimal protection, use the table-mounted and ceiling-suspended radiation shields together with lead
aprons.

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Figure 73 Combined use of the radiation shields

Before using the radiation shields, check that the shielding material is not damaged. The shields should
be free from cracks or tears. It is strongly recommended to check the shields visually on a regular basis
and whenever there is a possibility that the shield may have been damaged.

Remove the table-mounted radiation shield from the table accessory rail before tilting or cradling the
tabletop, as it may come loose during the movement. When the tabletop is cradled, the protection
provided by the table-mounted radiation shield is reduced.

Collisions may occur with the radiation shields when positioning the stand or the monitor ceiling
suspension. Take care to avoid collisions as this may damage the equipment.

6.10.1 Attaching and Positioning the Table-Mounted Radiation Shield


NOTE Do not fit the table-mounted radiation shield to the additional table accessory rail.

1 If desired, place a sterile bag over the radiation shield and apron.

2 Hold the radiation shield with your right hand on the clamping device and your left hand on the arm
of the shield.

3 Slide the jaws of the clamping device on to the tabletop accessory rail.

4 Turn the knob of the clamping device clockwise to clamp the radiation shield to the accessory rail.

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Figure 74 Attaching the radiation shield with the clamping device

5 The radiation shield can be placed in the following positions:


• Working position with both the lower and upper shield in use.
• Working position with the lower shield only in use (the upper shield is folded down).
• Parking position (shield stowed under the table).

6 To use the upper shield, lift the shield upward until the pins drop into the notches.

Figure 75 Using the upper shield

7 To park the radiation shield, fold down the upper shield if deployed and push the lower shield
underneath the table.

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6.10.2 Positioning the Ceiling-Suspended Radiation Shield

Figure 76 Ceiling-suspended radiation shield in the working position

1 If desired, place a sterile bag over the apron of the shield and part of the lead acrylic shield,
securing the bag in the two notches.

2 Move the shield to the desired position using the suspension arm.

3 Tilt the shield to the desired position.

6.10.3 Using a Third-Party Radiation Shield


You can use your own radiation shield, provided it complies with the following requirements.

General requirements for all radiation shields:


• Shields shall have a minimum lead equivalent of 0.5 mm.
• Shields shall comply with IEC 61331-n:2014.

If the radiation shield is to be mounted on the accessory rail of the patient table, the following
requirements apply:
• The radiation shield shall respect the maximum weight and torque limits of the longitudinal
accessory rail:

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– The combined weight of accessories mounted on the accessory rail shall not exceed 50 kg.
– The combined torque shall not exceed 180 Nm.
• The shield shall be at least 500 mm wide.
• The shield shall have a part that overlaps the ceiling suspended radiation shield to provide optimal
protection against stray radiation.
• When the table is at its maximum height, the distance between the ground and the lower edge of
the shield shall not exceed 40 cm.

If the radiation shield is to be mounted on the monitor ceiling suspension or the dual ceiling mount, the
following requirements apply:
• Check that the suspension arm of your radiation shield can be installed.
• When mounting the radiation shield on the monitor ceiling suspension, the weight of the shield and
suspension arm shall not exceed 30 kg. The maximum torque load that can be applied is 341 Nm.
• When mounting the radiation shield on the dual ceiling mount, the weight of the shield and
suspension arm shall not exceed 77 kg. The maximum torque load that can be applied is 341 Nm.
• The shield shall be at least 500 mm wide.

Figure 77 Ceiling mounting options for a third-party radiation shield

6.11 Using Sterile Covers


Detailed procedures for fitting sterile covers are the responsibility of the healthcare environment.

Place a thin sheet of sterilized plastic over the tabletop, control modules, and pan handle. The viewpad,
touch screen module, mouse and mouse table, radiation shields, foot switch, and detector must be
covered separately.

NOTE When using a sterile cover on the touch screen module, ensure that the cover is fitted tightly
to avoid problems when using the touch screen for actions such as dragging.

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7 Performing Procedures
You can perform procedures and acquire images when a patient study has been scheduled or started.
Before performing procedures with the equipment, read and follow the guidelines contained in
Radiation Safety (page 25).

WARNING
If you misuse radiography (exposure) on purpose for real-time imaging, the image display delay may
be longer than for radioscopy (fluoroscopy).

WARNING
Misinterpreting still images as live images could lead to serious patient injury. When images
displayed are live, the following icon is displayed:

In a biplane system, the X-ray status icon is displayed for each channel.

WARNING
Do not acquire X-ray images while actively using electrosurgical devices (for example,
electrosurgical knives), or cardiac defibrillators. The electromagnetic interference generated by
these devices may reduce image quality, resulting in additional exposure series being required.

When you start a study, the ProcedureCard that you selected when preparing the study provides the X-
ray protocols. While performing the procedure, you can change the ProcedureCard and the X-ray
protocol settings. For more information, see the following sections:
• ProcedureCards (page 57)
• Starting a Study (page 61)

Many of the procedures described in these Instructions for Use are further supported by the extended
functionality of Interventional Tools. For more information, see Interventional Tools (page 482).

Before acquiring new images, you should check that the system has sufficient storage capacity and
protect or archive important data if necessary. For more information, see Checking the Available Disk
Storage Space (page 60).

7.1 General Acquisition Workflow


These steps provide a general workflow for performing a study. Details of performing specific study
types are available in dedicated procedures in this section.

1 Select a scheduled patient study from the patient database.

For more information, see Patient Database (page 56).

2 Select the desired X-ray protocol in the X-ray Settings task in X-ray Acquisition application on the
touch screen module, or in the acquisition window.

The desired ProcedureCard is already selected within the scheduled study. For more information,
see ProcedureCards (page 57).

3 Position the region of interest.

For more information, see the following sections:


• Positioning the Patient on the Table (page 61)
• Isocentering (page 122)

4 Start acquisition.

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For more information, see Acquiring Images (page 106).

5 When the study is complete, close the study.

For more information, see Ending a Study (page 146).

7.2 Enabling X-ray


To use the system for imaging, you need to enable X-ray. You can do this using the review module or
the touch screen module.

You can see on the touch screen module if X-ray is enabled or disabled. The following symbols are
used:

Symbol Status

X-ray is disabled

X-ray is enabled

1 To enable X-ray using the review module, press Enable X-ray.

When X-ray is disabled, the indicator light is on.

When X-ray is enabled, the indicator light is off.

2 To enable X-ray using the touch screen module, tap X-ray Disabled.

7.3 X-ray On Indicators


For safety reasons, the system is provided with several indicators to show that X-ray is active.

The following paragraphs describe the indicators and their locations.

Indication Box
An indication box is installed in the examination room. It provides indicator lights for when the system is
ready for exposure (green) and when X-ray is on (yellow). When X-ray is on, the indication box also
provides an audible signal.

Figure 78 Indication box: X-ray On indicator light (left) and Ready for Exposure indicator light (right)

NOTE Even if the Ready for Exposure indicator light is not lit, it is still possible to start fluoroscopy.

Outside Indicator
At least one indicator light is positioned outside the examination room, next to each door. The light is lit
when a foot or hand switch is pressed to initiate fluoroscopy or exposure.

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Monitor Ceiling Suspension Indicator


An indicator light is mounted on each side of the monitor ceiling suspension in the examination room.
The light is lit when a foot or hand switch is pressed to initiate fluoroscopy or exposure.

NOTE The 2-fold and 3-fold monitor booms do not have an indicator light.

NOTE When a third-party frame is used, the indicator light is on the monitor ceiling suspension
auxiliary kit.

Live Image Indicator


When fluoroscopy or exposure is active, an X-ray on indicator icon is displayed in the live image
window.

In a biplane system, the X-ray status icon is displayed for each channel.

Status Area
When fluoroscopy or exposure is active, an X-ray on indicator icon is displayed in the status area. For
more information, see Status Area (page 447).

7.3.1 Audible Signals


The system is equipped with audible signals which can be used to signal when fluoroscopy or exposure
are active, to prevent unintended radiation.

The three audible signals, which can be configured by technical support, are:
• Fluoroscopy buzzer
• High level fluoroscopy buzzer
• Exposure buzzer

Fluoroscopy Buzzer
With the fluoroscopy buzzer configured and the high level fluoroscopy buzzer not configured, if
fluoroscopy is activated at the low/normal or high flavors the buzzer sound is a continuously audible
signal.

With the fluoroscopy buzzer and high level fluoroscopy buzzer configured, if fluoroscopy is activated at
the low/normal fluoroscopy flavors, the buzzer sound is a continuously audible signal. When using the
high fluoroscopy flavor, the buzzer sound is a repeating 2 pulses audible signal every 2 seconds.

High Level Fluoroscopy Buzzer


With the high level fluoroscopy buzzer configured and the fluoroscopy buzzer not configured, if
fluoroscopy is activated at the high fluoroscopy flavor the buzzer sound will be a repeating 2 pulses
(audible) signal every 2 seconds. The buzzer does not sound if fluoroscopy is activated at the low/
normal fluoroscopy flavors.

Exposure Buzzer
When the exposure buzzer is configured, if exposure is activated the buzzer sound will be a
continuously audible signal. When the exposure buzzer is not configured, the buzzer does not sound if
exposure is activated.

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7.4 Acquiring Images


You can acquire fluoroscopy images or exposure images. Exposure images are automatically stored, but
you can also manually store fluoroscopy images.

When acquiring images, the X-ray protocol settings in use are displayed in the status area in the control
room and the examination room.

You cannot perform fluoroscopy and exposure at the same time. However, when using a biplane
system, you can perform either fluoroscopy or exposure on both channels simultaneously.

You can only acquire images when the system is ready to do so. For more information, see System
Readiness (page 106).

7.4.1 System Readiness


The readiness of the system to perform procedures is indicated in the status area.

The status area indicates the system status using the following symbols:

Symbol Status

The system is ready for acquisition. Exposure and fluoroscopy are possible.

The system is not ready for exposure acquisition. Fluoroscopy is possible.

X-ray is disabled.

X-ray is on.

Exposure is selected.

Fluoroscopy is selected.

A combination of these symbols is used to advise you of the readiness of the system. The following
table shows examples of these combinations and their meanings.

If the system is not ready, you should observe the guidance given in the messages displayed in the
status area.

Indication Meaning

The system is ready and exposure is active

The system is ready and fluoroscopy is active

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Indication Meaning

The system is not ready for exposure

The system is not ready for exposure but fluoroscopy is active

7.4.2 Acquiring Fluoroscopy Images


Fluoroscopy is the generation of X-ray images at low air kerma rates.

During fluoroscopy, the following indications are displayed in the status area in the control room and
the examination room:
• X-ray on indicator
• Fluoroscopy parameters
• Fluoroscopy flavor

Setting the Fluoro Flavor


You can choose which level of fluoroscopy to use. These fluoroscopy levels are known as flavors.

There are three fluoroscopy flavors.

Standard System System with ClarityIQ (Option)


Low Low
Normal Medium
High Normal

You can change the default fluoroscopy flavor before initiating fluoroscopy. The default flavor is defined
when the system is installed.

Each flavor provides a different dose level, and can also differ for each group of X-ray protocols.

The indicator lights on the control module indicate which flavor is active.

You can set the fluoroscopy flavor in the following locations:


• Control module
• Touch screen module
• Acquisition window in the control room
• Live X-ray window in the examination room

1 To set the fluoroscopy flavor using the control module, press + or -.

Control Module Indicator Lights Standard System System with ClarityIQ (Option)
One Low Low
Two Normal Medium
Three High Normal

2 To set the fluoroscopy flavor using the touch screen module, do the following:

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a Tap the X-ray Settings task.

b In the fluoroscopy panel, select the desired flavor from the list.

3 To set the fluoroscopy flavor in the acquisition window, do the following:

a Click the X-ray Settings task.

b Expand the Fluoroscopy task panel.

c Select the desired flavor from the list.

Performing Fluoroscopy
Fluoroscopy is the generation of X-ray images at low air kerma rates.

WARNING
Misinterpreting still images as live images could lead to serious patient injury. When images
displayed are live, the following icon is displayed:

In a biplane system, the X-ray status icon is displayed for each channel.

Ensure that you have selected and started the required study in the patient database. For more
information, see Starting a Study (page 61).

1 Position the patient.

For more information, see Positioning the Patient on the Table (page 61).

2 To start fluoroscopy, press the corresponding pedal on the foot switch.

During fluoroscopy, the X-ray on indicator light is on. For more information, see X-ray On
Indicators (page 104).

3 (Optional step) While fluoroscopy is in progress, a staff member can select the X-ray protocol for
the next acquisition in the X-ray Settings task of the X-ray Acquisition application on the touch
screen module.

The X-ray protocol is queued and activated when the current acquisition ends.

4 To stop fluoroscopy, release the foot switch.

The following symbol is displayed in the top right-hand corner of the image, indicating that this is a
Last Image Hold image:

You can see the unsaved fluoroscopy series in the Series task control panel. When a fluoroscopy
series is unsaved, the pictorial displayed in the pictorial index has a diagonal line pattern applied so
that you can immediately recognize that the series is not saved.

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Figure 79 Unsaved fluoroscopy series pictorial

Storing Fluoroscopy Series and Images


You can store acquired fluoroscopy series and images in the patient’s file.

You can retrieve them in the Series task.

You can store individual images while you are performing fluoroscopy, and store a fluoroscopy series
after acquiring it.

1 Start fluoroscopy.

For more information, see Acquiring Fluoroscopy Images (page 107).

2 To store (or grab) individual images while you are performing fluoroscopy, do one of the following:
• On the control module, press and hold Fluoro Store.

• On the lower bar of the touch screen module, tap and hold Fluoro Store.

• On the toolbar of the acquisition window, click and hold Fluoro Store.

NOTE If you press a function on the touch screen module for longer than seven seconds, the
function will automatically deactivate. To continue, press the function again. To store
images over a longer period than seven seconds, use Fluoro Store on the control module.

Each image acquired while you hold the Fluoro Store button is stored. When you review the
images, the following symbol is displayed in the top right-hand corner of the image, indicating that
it is a stored image:

NOTE If you change the fluoroscopy flavor or the detector size during fluoroscopy, the Fluoro
Store function is stopped and all images stored up to that point are cleared.

3 To store the series, do the following:

a Stop fluoroscopy.

The last image in the acquired series is displayed as a Last Image Hold image.

b Do one of the following:

– On the control module, press Fluoro Store.

– On the lower bar of the touch screen module, tap Fluoro Store.

– On the toolbar of the acquisition window, click Fluoro Store.

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The fluoroscopy series is stored. When you review the series, the following symbol is displayed in
the top right-hand corner of each image, indicating that it is a stored series:

Resetting the Fluoroscopy Buzzer


When the cumulative fluoroscopy time reaches 5 minutes, you are given an audible signal.

The indicator lights flash at the Reset Fluoroscopy Buzzer buttons on the review module and the
control module, and a notification is displayed on the touch screen module.

NOTE Fluoroscopy is switched off automatically after 10 minutes of uninterrupted


fluoroscopy.

1 To switch off the audible signal, do one of the following:


• On the control module or on the review module, press Reset Fluoroscopy Buzzer.

• On the touch screen module, tap Reset.

2 Continue with fluoroscopy if appropriate.

Using Dual Fluoroscopy


If the X-ray protocol you are using is configured to do so, you can use dual fluoroscopy to view two live
fluoroscopy images. Live fluoroscopy is displayed in the live window, with a second live image displayed
in a reference window.

You can switch dual fluoroscopy on or off in the acquisition window or using the touch screen module.

Dual fluoroscopy is activated automatically if the X-ray protocol is configured to do so, or when you
zoom a last image hold fluoroscopy image. For example, when Roadmap is switched on. In the
examination room, the Roadmap or SmartMask image is displayed in the acquisition window, and the
fluoroscopy image is displayed in the reference window. For more information, see the following
sections:
• Using Roadmap Pro (page 133)
• Using SmartMask (page 133)

1 Select the X-ray Settings task.

2 To switch dual fluoroscopy on, select Dual Fluoro.

NOTE The Dual Fluoro function is also available in Roadmap task.

Dual fluoroscopy is switched on and a second live image is displayed in an available reference
window. You can manipulate the image in the live window, for example by applying zoom or
subtraction, to assist with performing the procedure.

7.4.3 Using Shutters and Wedges


Shutters and wedges reduce the amount of stray radiation, which improves image quality.

Using shutters and wedges is also an important step to restrict the exposed patient area to the region of
interest and minimize the X-ray dose.

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You can adjust shutters and wedges using the control module and the touch screen module.

Shutters
Shutters are collimators used to limit the width and height of the irradiated area, and to improve the
quality of the image. The rectangular shutters operate in pairs. The vertical shutters move together and
the horizontal shutters move together. Shutter position is displayed as a graphic overlay with white
dashed lines when making adjustments in the Last Image Hold image without the use of fluoroscopy.

Wedges
Wedges are filters used to reduce the X-ray intensity of the irradiated area and improve the quality of
the image. There are two wedges that are controlled independently, each with their own switch. Wedge
position is displayed as a graphic overlay when making adjustments in the Last Image Hold image
without the use of fluoroscopy. A blue dashed line represents the left wedge and a green dashed line
represents the right wedge.

Adjusting Shutters on the Control Module


You adjust the shutters using the shutter switch.

For more information, see Control Modules (page 463).

1 When using a biplane system, select the desired channel.

The symbol for the selected channel illuminates. Pressing the button repeatedly cycles through the
following options:

Illuminated Symbol Selected Channel

Frontal channel

Lateral channel

2 Push the switch, left and right to adjust the vertical shutters.

3 Push the switch, up and down to adjust the horizontal shutters.

4 Press down on the switch to reset the shutters to automatic collimation.

The shutters move to the edge of the image area.

Adjusting Shutters on the Touch Screen Module


You can adjust the vertical and horizontal shutter positions using the touch screen module.

The shutters can only be adjusted on the touch screen module after acquiring an image. On biplane
systems, a biplane acquisition is needed to adjust the shutters on both channels.

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Figure 80 Shutter controls on the touch screen module (biplane system shown)

1 On the touch screen module, select the X-ray Acquisition application.

2 Select the Collimation task.

3 When using a biplane system, adjustments are applied to the channel represented by the main
image. To change the channel, tap the mini viewport.

4 To move the horizontal shutters or the vertical shutters independently, do the following:

a Tap Shutters.

b Tap + and - to increase and decrease the horizontal shuttered area.

c Tap + and - to increase and decrease the vertical shuttered area.

5 To reset the shutters to the default positions, tap Reset Shutters.

Adjusting Wedges on the Control Module


You adjust wedges on the control module using the left and right wedge switches.

For more information, see Control Modules (page 463).

1 When using a biplane system, select the desired channel.

The symbol for the selected channel illuminates. Pressing the button repeatedly cycles through the
following options:

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Illuminated Symbol Selected Channel

Frontal channel

Lateral channel

2 Rotate the appropriate switch to rotate the wedge filter.

3 Push the switches left and right to adjust the relevant wedge position.

4 Press down on the switch to reset the relevant wedge to just outside the imaging area.

Adjusting Wedges on the Touch Screen Module


You can adjust the positions of the wedge filters using the touch screen module.

The wedges can only be adjusted on the touch screen module after acquiring an image. On biplane
systems, a biplane acquisition is needed to adjust the wedges on both channels.

Figure 81 Adjusting wedges on the touch screen module (biplane system shown)

The left wedge is displayed in blue. The right wedge is displayed in green.

1 On the touch screen module, select the X-ray Acquisition application.

2 Select the Collimation task.

3 When using a biplane system, adjustments are applied to the channel represented by the main
image. To change the channel, tap the mini viewport.

4 To adjust the position of each wedge by dragging, drag the handle for the desired wedge to a new
position.

Dragging the wedge allows you to move the wedge laterally and to rotate the wedge
simultaneously. Dragging the wedge up and down while dragging left and right, rotates the wedge.

5 To adjust the position of the left or right wedges using the control buttons, do the following:

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a Tap Wedges.

b Tap the left or right arrow buttons to move each wedge left or right until the desired position is
reached.

c Tap the rotation buttons to rotate each wedge clockwise or counterclockwise until the desired
position is reached.

6 Tap Reset to reset the desired wedge filter to the default position.

Using Automatic Wedge Following


The system can automatically position the wedges according to the stand rotation and angulation
angles.

For example, in 2D cardiac applications the system automatically positions wedges over the lung area
to prevent over exposure. During geometry movement the wedges move in parallel, remaining
positioned over the lung area. For cardiac procedures the system default is set to on.

1 On the touch screen module, select the X-ray Acquisition application.

2 Select the Collimation task.

3 Tap Auto Wedge Follow to set the function on or off as desired.

7.4.4 Acquiring Exposure Images


Exposure is the acquisition of X-ray images, resulting in a series of individual images.

Ensure that you have selected and started the required study in the patient database. For more
information, see Starting a Study (page 61).

The X-ray settings are configured by the X-ray protocol selected in the ProcedureCard being used. For
more information, see ProcedureCards (page 57).

Before and during exposure, the following indications are displayed in the status area of the acquisition
window in both the control room and the examination room:
• System readiness
• X-ray on indicator
• Exposure parameters (for each channel in biplane systems), kV, mA, mAs, and ms

NOTE Some of the steps in this procedure describe how to adjust the frame speed and the dose
level to change the number of images captured per second and to adjust the image quality.
For some X-ray protocols, these settings cannot be adjusted.

1 Position the patient.

You can use fluoroscopy to position the patient. For more information, see the following sections:
• Positioning the Patient on the Table (page 61)
• Acquiring Fluoroscopy Images (page 107)

2 Check that the system is ready to acquire exposure images.

For more information, see System Readiness (page 106).

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3 To change the number of images acquired per second, do the following:

a Select the X-ray Settings task.

b If you are using the acquisition window, click the Exposure expander to open the menu.

c Select a new Frame Speed.

4 To adjust the image quality by changing the dose level used, do the following:

a Select the X-ray Settings task.

b If you are using the acquisition window, click the Exposure expander to open the menu.

c Select a new Dose Level.

5 To start acquiring exposure images, press the exposure hand switch or the exposure foot switch.

Pressing the exposure hand switch button to the first stage prepares the system for exposure.
Pressing the button to the second stage activates exposure.

Figure 82 Exposure hand switch

During acquisition, the X-ray on indicator light is on.

6 To stop acquiring images, release the exposure hand switch or foot switch.

If the X-ray protocol in use is configured to automatically replay the series, then this starts
automatically when you stop acquiring images. If this is not configured for the X-ray protocol you
are using, the last image in the acquired series is displayed.

The following symbol is displayed in the top right-hand corner of all images in the acquired series,
indicating that these are Last Image Hold images:

7.4.5 Zero Dose Positioning


When you have acquired an image, you can reposition the center of the image without using X-ray to
determine the new center position.

NOTE This function is not available when using a TruSystem table.

1 Move the table to a new position using the float tabletop control on the control module.

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Figure 83 Repositioning the image center

The center of the image is displayed as a target overlay in the X-ray window.

2 When the new center position has been achieved, you can acquire a new image.

NOTE If desired, this function can be turned off in the procedure


settings.

NOTE In the following circumstances, the target overlay is not displayed:


• Fluoroscopy or exposure is active.
• The live image viewports are in series overview mode (as opposed to image overview
mode).
• There is a projection mismatch between the geometry of the displayed image and the
current geometry (including table pivot and swivel position, if applicable).
• If a rotatable detector is in use and it is not set to 0 degrees or 90 degrees.
• The table pivot is not in the work area, if applicable.
• The table swivel is not in an end position, if applicable.

7.5 Acquiring Images in an Emergency


In an emergency, you can start a study without logging on and without having previously scheduled the
patient, by using the emergency access mode. While you are using the system in emergency access
mode, you can acquire images but other system functions are not available.

When you operate the system in emergency access mode, you cannot review other studies. You can
only acquire new images and series. You can review the images and series that you acquire while in
emergency access mode but if you end the procedure, you cannot open it again until you have logged
onto the system.

For more information about configuring the system to allow emergency access without logging on, see
Managing Users and System Logon (page 264).

You can start an emergency study without entering any patient details. You can still find the study in the
patient database by looking for the time and date of the study contained in the Patient ID.

1 If the system is not switched on, press and hold Power On on the review module until the indicator
light stops flashing.

2 In the logon screen, click Emergency.

The system is available in emergency access mode. This mode allows you to perform an emergency
procedure, but has reduced functionality.

A study is started immediately using the default ProcedureCard and a menu is displayed allowing
you to select the ProcedureCard for the study.

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3 To change the ProcedureCard, do the following:

a Select the patient in the patient list and click Edit.

b Select the appropriate ProcedureCard Group from the drop-down list.

c Select an alternative ProcedureCard.

4 If you are able to, enter any available patient information in the Study Details tab.

NOTE You cannot add or change patient details once images have been acquired. If you have
not entered the patient's details before acquiring images, you can add the patient to the
system later when you are logged on and use the Resolve Patient Mix wizard to
associate the acquired series with the patient. For more information, see Resolving a
Patient Mix (page 160).

5 To start the study, click Back to Procedure.

6 Perform the necessary procedure.

7 To end the study, do the following:

a Click End Procedure.

A dialog box is displayed with a warning, reminding you that you are in emergency access mode
and that the acquired data will not be accessible if you end the procedure.

b To close the dialog box and continue the study, click Cancel.

c To end the study, click OK.

The study ends and the Add Patient window is displayed, allowing you start another study if
necessary.

8 To start a new study in emergency access mode, click Start Procedure and repeat steps 2 to 6.

9 If all studies are complete and emergency access is no longer needed, click System and select Log
Off to exit emergency access mode and return to the logon screen.

7.6 Intelligent System Recovery


The system is equipped with intelligence to monitor the performance of system processes, so that
actions can be initiated to recover from unexpected loss of functionality. This can include stopping and
restarting software functions, or restarting hardware components, including a warm restart of the whole
system.

Note the following information:


• User guidance may be displayed to inform you about the recovery situation.
• System design separates processes that are essential for performing fluoroscopy from other, lower
priority processes. This enables the system to safeguard the fluoroscopy function so that, if a
serious problem is detected, you can finish the examination safely, including removing a catheter
when necessary.
• In extreme situations, a cold restart might be necessary to recover from unexpected situations.

7.7 Locking and Unlocking Stand and Table Movements


The stand and table locks prevent unintended movements of the stand and the table.

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Performing Procedures Using Automatic Position Control

The procedure below uses the touch screen module but you can also lock and unlock all geometry
movements using the review module in the control room.

1 On the touch screen module, select the X-ray Acquisition application.

2 Tap the X-ray Settings task.

3 Tap the Lock icon in the upper-right corner and select the lock that you want to apply or release.

The following options are available:

Lock Locked Unlocked


All

Fully locks the stand movements and the table move-


ments.
Table

Prevents the table from moving in any direction.

Table Lateral

Prevents the table from moving in the transverse direc-


tion, for example, in bolus chase procedures.

When a lock is applied, the Lock icon displays the corresponding icon with the lock symbol
highlighted.

When no locks are applied, the Lock icon displays the Table icon with the lock symbol dimmed.

7.8 Using Automatic Position Control


You can use automatic position control (APC) to move the stand and table to positions based on live or
reference images, to previously stored positions, or to predefined projections.

The following movements are available with automatic position control:


• Image: moves the stand and table to match an available reference image.
• Stored: moves the stand and table to a previously stored position.
• Pre-defined: moves the stand to a predefined rotation and angulation. Default projections and
user-defined projections are available.
• Table: moves the table to a previously stored position (only motorized movements are included).
• Pathway (FlexArm option only): moves the stand along a pathway to a stored position through
predefined intermediate positions.

NOTE Depending on the configuration of your system, some movement options may not be
available.

Before the system moves to the selected position, the source-to-image distance (SID) is maximized to
avoid collisions. It returns to its configured setting when the movements finish unless otherwise
configured in the procedure card.

NOTE This does not apply for Pre-defined movements.

The positions of the following items are also restored when the system reaches the selected position:
• Detector rotation
• Field of view
• Shutters and wedges

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Performing Procedures Using Automatic Position Control

If the system does not move when you activate a position using APC, ensure that the stand is in the
working position.

For table movements, the following guidance applies:


• If the table is fully locked, only stand movements are activated.
• If the pivot option is installed, ensure that the table is in the working position (pivot ±13 degrees).

1 On the touch screen module, select the X-ray Acquisition application.

2 Tap the Live view tab.

3 Tap the C-arm and Table task.

4 Tap the Full System APC tab.

Figure 84 Full System APC tab of the C-arm and Table task

Legend
1 C-arm and Table task 4 Available positions
2 APC functions 5 Movement preview
3 Selected position 6 User guidance

5 Select the APC function that you want to use to move the system.
• Matching a Reference Image (page 119) (see the following task)
• Moving to a Stored Position (page 120)
• Moving to a Predefined Position (page 120)
• Moving Only the Table (page 121)
• Moving the Stand along a Pathway (FlexArm Option Only) (page 121)

7.8.1 Matching a Reference Image


The Image function allows you to move the stand and table to the position displayed in the live view or
one of the reference views.

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Performing Procedures Using Automatic Position Control

1 Tap the Image tab.

2 Select one of the available positions.

• Live: the position displayed in the Live view.


• Reference: the position displayed in one of the reference views.
• 3D Image: the target position supplied by the 3D application on the Interventional Workspot
with the minimum source-to-image distance.

NOTE If X-ray is active, the position in the Live view cannot be recalled.

If the series in the selected view is replaying, the stand and table move to the position of the initial
image in the series.

The stand and table image provides an indication of the resulting stand orientation and the
direction of table movements (if applicable) if the selected position is recalled. Parts that move if
the selected position is recalled are highlighted.

3 Press and hold Accept on the control module until the stand and table reach the selected position.

7.8.2 Moving to a Stored Position


The Stored function allows you to move the stand and table to a previously stored position.

1 Tap the Stored tab.

2 Select a stored position.

The stand and table image provides an indication of the resulting stand orientation and the
direction of table movements (if applicable) if the selected position is recalled. Parts that move if
the selected position is recalled are highlighted.

3 Press and hold Accept on the control module until the stand and table reach the selected position.

4 To store the current stand and table position, tap Store Current Stand and Table Position.

The newly stored position is added to the top of the list.

5 To delete a stored stand and table position, select it and then tap Delete next to the selected
position.

7.8.3 Moving to a Predefined Position


The Pre-defined function allows you to move the stand to a predefined projection.

Pre-defined positions do not include table positions and the source-to-image distance is not recalled.

1 Tap the Pre-defined tab.

2 Select a predefined projection.

3 Press and hold Accept on the control module until the stand and table reach the selected
projection.

The next predefined projection is automatically selected so that you can continue movements by
pressing Accept again when appropriate.

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Performing Procedures Using Automatic Position Control

7.8.4 Moving Only the Table


The Table function allows you to store and recall the current position of the table for future recall.

You can also turn the table locks on and off in the Table tab:
• Table: Prevents the table from moving in any direction.

• Table Lateral: Prevents the table from moving in the transverse direction.

1 Tap the Table tab.

2 Tap Store Current Table Position to store the table position.

If a table position has been previously stored, it is overwritten with the new position.

3 After moving the table, do one of the following to move it back to the stored position:

• To move the table to the stored height, longitudinal position, and transverse position, tap Table
All.

The table image displays the direction of the resulting table movements when the position is
recalled.
• To move the table to the stored height only, tap Table Height.

The table image displays the resulting height movement when the position is recalled.
• Press and hold Accept on the control module until the table reaches the selected position.

NOTE If a table position is not yet stored, the default table position is used.

7.8.5 Moving the Stand along a Pathway (FlexArm Option Only)


The Pathway function allows you to move the FlexArm stand along a predefined pathway to a stored
end position.

1 Tap the Pathway tab.

2 Select a pathway.

The symbol next to a pathway indicates what kind of pathway it is.

Symbol Symbol

A pathway with multiple positions

A pathway with only one position

If the stand is in a position where it cannot be recalled for the selected pathway, the system
displays a message that the stand is out of range.

3 Press and hold Accept on the control module until the stand and table (if applicable) reach the final
position.

Depending on how the pathway has been configured, a table movement at the beginning or end of
the pathway may or may not occur.

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Performing Procedures Isocentering

If the movement of the stand is interrupted while it is moving along the pathway, press and hold
Accept again until the stand reaches the final position.

Pathways can be created or customized using the System Customization function. For more
information, see Customizing APC Pathways (page 277).

7.9 Isocentering
For some types of procedure it is important that the anatomical region of interest is in the isocenter.

The isocenter of the stand is the point around which the detector and the tube rotate.

Figure 85 Isocenter of the stand

1 On the touch screen module, select the X-ray Acquisition application.

2 Tap the C-arm and Table task.

3 If the stand is not already in the anterior-posterior position, do one of the following:
• Tap the Pre-defined tab, select AP, then press Accept on the control module to move the stand.

• Position the stand at 0 degrees of rotation.

4 Using the control module, float the table and center the region of interest in the middle of the field
of view.

This can be aided with fluoroscopy.

5 Reposition the stand by doing one of the following:


• Select LAT on the touch screen module, then press Accept on the control module to move the
stand.
• Rotate the stand to 90 degrees

6 Using the control module, adjust the table height until the region of interest is in the middle of the
field of view.

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Performing Procedures Image Orientation

This can be aided with fluoroscopy.

7 In the C-arm and Table task on the touch screen module, do the following:

a Tap the Table tab.

b Tap Store Current Table Position.

The region of interest is in the isocenter and this table position is stored. A message is displayed in the
status area of the acquisition window when this table position, the isocenter, is recalled.

7.9.1 Recalling the Isocenter Position


After saving the isocenter position, you can recall it if you have moved the table to another position.

You recall the isocenter position using the touch screen module.

1 On the touch screen module, select the X-ray Acquisition application.

2 Tap the C-arm and Table task.

3 Tap the Table tab.

4 Ensure that all table movement locks are off.

For more information, see Locking and Unlocking Stand and Table Movements (page 117).

5 To recall the stored table height only, tap Table Height.

6 To recall the stored table position, tap Table All.

7 Press and hold Accept on the control module until the table stops moving.

When the table has reached the stored isocenter position, the following icon is displayed in the
status area.

NOTE If you release Accept before the table has stopped, press and hold the button again. The
table will continue to move to the isocenter position.

7.10 Image Orientation


The image orientation is determined by the patient orientation which is set by the ProcedureCard.

You can change the patient orientation in the X-ray protocol settings to match the actual patient
orientation. For more information, see Changing the Patient Orientation (page 64).

WARNING
Image orientation is determined by the patient orientation, which is set by the ProcedureCard in use.
Different image orientations are possible depending upon the settings in use. You should ensure that
the image orientation is appropriate for the procedure you are performing.

For more information, see ProcedureCards (page 57).

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Performing Procedures Selecting a Different Preset for FlexVision

Diagnostic View
For most procedures, images are displayed for a patient orientation where the patient is in the supine
position with their head at the head end of the table. The image is displayed with the patient's head at
the top of the image, and their face towards you as the viewer. This is known as the diagnostic view.

Surgical View
For some procedures it may be necessary to position the patient differently, for example face-down on
the table. When the image is displayed with the patient's head at the top but facing away from you as
the viewer, this is known as the surgical view. When surgical view is enabled, images are reversed left to
right. The following symbol is displayed with images acquired in surgical view:

7.11 Selecting a Different Preset for FlexVision


Presets are predefined window and content layouts. You can edit presets to provide a layout that suits
your workflow, and that displays the applications you want to use.

The preset layout for FlexVision is predefined in the selected ProcedureCard in use but you can select a
different layout to use for the study.

1 On the touch screen module, tap the application selector.

2 Tap FlexVision to display available presets.

Figure 86 FlexVision preset menu

Legend
1 Preset groups list
2 Available presets
3 Task panel

Each preset is depicted with a thumbnail image showing the predefined screen layout and
applications.

3 Tap the desired preset to select it and apply it to the the FlexVision monitor.

4 To change the applications displayed during a study, do the following:

a Tap Change Content.

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An image of the layout is displayed showing each application as an icon in each window.

b Drag the applications you want to use to the desired window positions on the layout image.

Your changes are applied immediately on the FlexVision monitor.

5 To reset the preset to its original settings, do the following:

a Tap Select Preset.

b Tap Reset.

For more information, see Managing FlexVision Presets Using the Touch Screen Module (page 252).

7.11.1 Saving a Modified Preset for FlexVision


If you have modified the window content during a study, you can save it as a preset for future use.

1 On the touch screen module, tap the application selector.

2 Tap FlexVision.

3 Tap Change Content.

4 Tap Save As.

5 Select a preset group from the list.

6 Enter a name for the new preset using the on-screen keyboard.

7 To close the dialog box without saving the preset, tap Cancel.

8 To save the preset, tap Save.

7.11.2 Displaying Patient Comfort Movies on FlexVision


When not acquiring X-ray images, you can display a patient comfort movie on the FlexVision monitor.

NOTE The movie cannot be started while X-ray acquisition is in progress.

1 On the touch screen module, tap the application selector.

2 Tap FlexVision.

3 Tap ComfortThemes.

Available patient comfort movies are displayed.

4 To start playing a movie, do one of the following:


• Double-tap a movie.
• Tap a movie to select it and then tap Play.

The movie starts playing on the FlexVision monitor. The top bar and the status area remain visible
while the movie is playing. Notifications are displayed on top of the movie.

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Performing Procedures Using Switchable Monitors

NOTE You cannot create screenshots while the movie is active.

5 To dismiss the patient comfort movie, tap Stop on the selected movie.

The movie is dismissed automatically if you start X-ray acquisition or interact with the top bar or
status area using a mouse.

7.12 Using Switchable Monitors


Using this option, you can choose which applications or video sources to display on each monitor in the
examination room and save that configuration for future use.

To be able to switch video sources in this way, the switchable monitors option must be installed on your
system.

Figure 87 Switching monitors using the touch screen module

Legend
1 Monitors 3 Toolbar
2 Additional monitors 4 Applications or video sources

1 On the touch screen module, tap the application selector.

2 Tap Switchable Monitors.

3 Identify the monitor and the application or video source you want to display on it.

The system can manage a maximum of 16 monitors. If more than 8 monitors are installed, tabs are
used on the touch screen module, each displaying a maximum of 8 monitors.

4 Drag the application or video source on to the monitor.

Each monitor is identified by a sticker on the upper left corner. This number corresponds to the
monitor number on the touch screen module.

Figure 88 Monitor identification sticker

You can display the same application or video source on more than one monitor.

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Performing Procedures Injector Coupling

5 To reset the monitors and undo your changes, tap Reset.

6 To save your changes, tap Save.

This saved configuration is saved as the default configuration, and is used the next time that the
systems starts.

7.13 Injector Coupling


Timing of contrast injection and X-ray imaging can be coupled in order to synchronize the acquisition of
images to the flow of contrast medium.

WARNING
Only use an injector system that has a compatibility statement for the X-ray system in use. Using any
other injector system may result in the injection of an excessive amount of contrast medium. The
operator is responsible for the amount of contrast medium administered to the patient.

Injection timing and exposure is calculated depending on the selected settings. You can manually adjust
the X-ray delay time determined by the protocol settings. The value range is from 0 to 40 seconds, in
steps of 0.5 seconds.

Two modes of injector coupling operation are available:


• Coupled: In coupled mode, you can have one or two-switch operation modes.
• Uncoupled: In uncoupled mode, the hand and foot switches control X-ray only, and injection is
controlled by the injector hand switch.

For more information, see the following:


• Connecting an Injector (page 239)
• Injector Control Methods (page 483)
.

7.13.1 Uncoupled Operation


You can acquire images with injector coupling uncoupled.

When injector coupling is uncoupled, you must trigger the injector manually at the appropriate time
using the injector hand switch.

You can select uncoupled operation using the touch screen module or the acquisition window.

1 Select the X-ray Settings task.

2 Select the X-ray protocol.

3 If injector coupling is on, tap Coupling to switch injector coupling off.

4 Start and stop injection by pressing and releasing the injector hand switch.

5 Start and stop acquisition by pressing and releasing the hand switch or the foot switch.

7.13.2 Coupled Operation


You can control injection of contrast medium automatically using injector coupling.

You can specify a delay between injection of contrast and acquisition of images to ensure that the
contrast is visible at the region of interest. This is known as the X-ray delay.

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Performing Procedures Multiphase Acquisition

NOTE Coupled operation is not available for every X-ray protocol.

You can configure the system to uncouple after every exposure series to prevent unintentional injection
of contrast medium. The system can be customized by technical support, so that the injector is not
uncoupled after each exposure series and procedure change, but is only uncoupled following selection
of a new patient.

1 Select the X-ray Settings task.

2 Select the X-ray protocol.

3 If injector coupling is off, tap Coupling to switch injector coupling on.

4 Adjust the X-ray delay time using + or -.

5 Prepare the injector.

Contrast is not injected until exposure starts.

6 Press the exposure hand or foot switch to start acquisition and if you are using a two-switch
method, press the injector switch to start contrast medium injection.

A timer bar representing the X-ray delay count-down in seconds is displayed in the middle of the
acquisition window. When the count-down is completed, X-ray acquisition starts automatically.

For more information about using one or two-switch methods, see Injector Control
Methods (page 483).

7 Release the hand or foot switch to stop acquisition and contrast medium injection.

7.14 Multiphase Acquisition


Multiphase acquisition is used for vascular applications only.

During multiphase acquisition, you have direct control over the acquisition speed and duration. The
acquisition is separated into a maximum of three phases and is used when a constant frame rate is not
needed throughout the duration of the exposure.

You can adjust the duration of each phase in seconds and the image speed in frames per second. You
may also switch between the second and third phases, if you want to slow the frame rate down or
speed it up during long acquisition series.

Multiphase acquisition is usually enabled automatically for the appropriate X-ray protocols. This is
configured when the system is installed.

NOTE The image speed (frame rate) is limited by the image speed chosen in the Multiphase Acq.
settings in the X-ray Settings task.

1 Select the X-ray Settings task in the acquisition window or in the X-ray Acquisition application on
the touch screen module.

2 Select the desired procedure.

3 Start acquisition.

When X-ray is active, the controls to adjust the image speed and phase duration are not displayed.
These are replaced by a phase button, displaying the selected image speed for each phase.

4 To move between phases and change the image speed, tap the desired phase button.

Images are acquired at the new image speed shown for the selected phase.

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Performing Procedures Bolus Chase

You can only switch to a phase if the relevant phase button is enabled.

7.14.1 Changing Multiphase Acquisition Settings

1 On the touch screen module, select the X-ray Acquisition application.

2 Select the X-ray Settings task.

3 Tap Multiphase Acq. to display the multiphase acquisition settings screen.

4 Set the image speed (frame rate) in frames per second, for each phase:

• Tap + to increase the image speed.


• Tap - to decrease the image speed.

5 Set the duration of each phase.

• Tap + to increase the duration.


• Tap - to decrease the duration.

The phase duration is displayed in seconds.

6 If desired, tap Coupling to switch injector coupling on.

7 Set the X-ray delay time in seconds.

For more information about acquiring images using multiple phases, including changing the image
speed during acquisition, see Multiphase Acquisition (page 128).

7.15 Bolus Chase


You use the bolus chase procedure to acquire images of the vessels in the lower extremities. You control
the speed of the table as you chase the contrast bolus down the legs.

You acquire a bolus chase series with contrast using the Bolus Chase procedure. If desired, you can
acquire a mask series without contrast after the bolus chase series. After acquisition, the Bolus Chase
Reconstruction application automatically reconstructs the images for review. For more information, see
Bolus Chase Reconstruction (page 156).

The following guidance is recommended for acquiring a bolus chase series:


• Use peripheral X-ray filters for optimal image quality. For more information, see Peripheral X-ray
Filters (page 230).
• To improve the accuracy of the reconstruction, place a bolus chase reconstruction ruler in the view,
parallel to the table, during acquisition.
• At least five contrast images are required to create a reconstruction.

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Performing Procedures Bolus Chase

1 2

Figure 89 Bolus chase table positions and movement

Legend
1 Start position 3 Table travel distance (maximum 100 cm / 39.4 in)
2 End position 4 Table movement

7.15.1 Acquiring a Contrast Series


To acquire a contrast series for Bolus Chase Reconstruction, you chase the contrast bolus along the
patient's legs.

Before starting the procedure, ensure that the stand is positioned at either the nurse or doctor side and
that all objects have been cleared from the table path.

1 Park the lateral stand in the parking position.

2 Position the patient on the table.

For more information, see Positioning the Patient on the Table (page 61).

3 Position the peripheral X-ray filters.

For more information, see Peripheral X-ray Filters (page 230).

4 Immobilize the patient's legs.

5 To select the bolus chase X-ray protocol, do the following.

a On the touch screen module, select the X-ray Acquisition application.

b Select the X-ray Settings task.

The X-ray protocols displayed are the ones associated with the currently selected
ProcedureCard.

c Tap Bolus Chase.

If Bolus Chase is not visible in the list of X-ray protocols, tap Other, select Peripherals, and then
select Bolus Chase from the full list of available X-ray protocols.

6 If your system has a rotatable detector, position the detector in landscape or portrait position.

7 To allow you to raise the table to its highest position, raise the detector to the highest possible
position.

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Performing Procedures Bolus Chase

8 Raise the table to the maximum height.

9 Set the field of view to the maximum size.

10 Center the region of interest at the start position.

11 Reduce the distance between the patient and the detector to the minimum possible.

12 Lock transverse movements of the table by doing the following:

a On the touch screen module, tap the Table task.

b Tap Lateral to switch the transverse table lock on.

13 Use fluoroscopy to confirm that the patient is in the correct position, by moving the table from the
start position to the end position.

14 If necessary, adjust the patient's lateral position by moving the patient on the tabletop.

NOTE Do not unlock table transverse movements.

15 Reposition the table longitudinally at the start position.

16 Switch Injector Coupling on.

For more information, see Injector Coupling (page 127).

17 Prepare the injector.

18 Start acquisition by pressing and holding the hand switch.

NOTE BodyGuard is disabled during image acquisition.

19 When the contrast bolus reaches the bottom of the image on the monitor, start moving the tabletop
using the speed controller.

Figure 90 Speed controller

20 Use the speed controller to control the speed of the table so that the contrast bolus remains close
to the bottom of the image.

The speed controller is proportional; the harder you press the switch, the faster the tabletop moves.

21 Release the speed controller when the contrast reaches the patient's feet.

22 Stop the acquisition by releasing the hand switch when the contrast bolus arrives.

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Performing Procedures Roadmap Pro

After acquiring a contrast series, Bolus Chase Reconstruction is started in the review window and the
acquired images are reconstructed. For more information, see Bolus Chase Reconstruction (page 156).

7.15.2 Acquiring a Mask Series (Optional)


Acquiring a mask series allows you to view subtracted images in Bolus Chase Reconstruction.

1 For optimal subtraction results, ensure that the patient remains immobilized as much as possible
during the whole procedure.

2 After acquiring the contrast series, wait 30-60 seconds before acquiring the mask series to reduce
the possibility of imaging venous filling.

3 Press and hold the speed control hand switch until the table has returned to the start position.

4 Start acquisition by pressing and holding the hand switch.

The tabletop automatically repeats the movement from the contrast series.

5 Release the hand switch when the exposure stops.

Exposure stops automatically when the same number of images have been acquired as during the
contrast series.

Bolus Chase Reconstruction automatically uses the mask series to display subtracted images.

6 While reviewing the series, you can use Subtraction On / Off to view subtracted images or contrast
images.

You can acquire additional mask series, if desired.

7.16 Roadmap Pro


Roadmap Pro allows you to superimpose a mask image of the vessel tree to improve visibility of
catheters, devices, and materials.

Roadmap Pro is 2D subtracted fluoroscopy and is acquired in two phases:


• The first phase is the vessel mask. This is used to create the mask onto which the live fluoroscopy is
superimposed.
• The second phase is the device phase. This phase is to view the device, for example a catheter,
wire, or coil, under fluoroscopy over the vessel mask.

To ensure that the subtracted fluoroscopy image is not disturbed by unintentional movement of the
tabletop or stand during a critical procedure, you should lock the table and geometry movements
during Roadmap Pro. For more information, see Locking and Unlocking Stand and Table
Movements (page 117).

WARNING
Misinterpreting still images as live images could lead to serious patient injury. When images
displayed are live, the following icon is displayed:

In a biplane system, the X-ray status icon is displayed for each channel.

WARNING
When using overlay images in a procedure, you should ensure that the overlay image and the main
image are properly aligned. Misaligned images may cause clinical misdiagnosis or clinical
mistreatment.

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Performing Procedures Roadmap Pro

7.16.1 Using Roadmap Pro


Using Roadmap Pro, you can produce a vessel map to use with live fluoroscopy.

You can do this using the touch screen module or the acquisition window.

1 On the touch screen module, select the X-ray Acquisition application.

2 Select the X-ray Settings task.

3 If you are using the touch screen module, tap Roadmap to open the Roadmap menu.

4 To switch Roadmap on, do one of the following:


• On the touch screen module, tap Roadmap.
• In the acquisition window, click the Roadmap expander in the task panel and click On.

• Press Roadmap on the control module.

5 To select the clinical mode, do one of the following:


• On the touch screen module, tap the desired Mode name.
• In the acquisition window, select the mode from the Mode list in the task panel.

6 Start fluoroscopy.

For more information, see Performing Fluoroscopy (page 108).

7 When the subtracted image is created, inject the contrast.

For more information, see Injector Coupling (page 127).

8 Stop fluoroscopy when the vessel tree is fully visible (maximum opacification).

9 To adjust the transparency of the image, tap + or - on the touch screen module for the following
masks:

• Vessel
• Device

NOTE You can only adjust transparency when fluoroscopy is not active.

10 Start fluoroscopy for the clinical procedure.

11 Insert the device when the subtracted vessel map is visible.

7.16.2 Using SmartMask


SmartMask allows you to use a previously acquired image as a vessel mask.

You can choose the image that you want to use for SmartMask. SmartMask images must have the same
projection and source-to-image distance settings as the current acquisition settings, but they can be
from a different series for the same patient.

1 Identify the series containing the desired image and open the series for review.

For more information, see the following sections:


• Reviewing a Series using the Review Window (page 149)
• Reviewing a Series using the Touch Screen Module (page 150)

2 Select the image for the vessel mask in the acquisition window using the touch screen module or
the viewpad.

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Performing Procedures ECG Triggering

3 When the desired image is displayed in the live window, enable SmartMask by doing one of the
following:
• On the control module, press SmartMask.

• In the X-ray Settings task of the X-ray Acquisition application on the touch screen module,
select Roadmap and then select SmartMask.

4 Start fluoroscopy.

For more information, see Performing Fluoroscopy (page 108).

After subtraction, the current image is set as the SmartMask image.

5 Insert the device.

7.17 ECG Triggering


ECG triggering allows you to acquire images in the same phase of the heart cycle. The ECG signal is
used to generate the ECG trigger pulses with an adjustable delay.

To be able to start ECG triggered exposure or fluoroscopy, establish a proper ECG signal. The system is
ready to start, but waits a limited period of time for an ECG signal. The system does not generate X-ray
before the ECG signal is recognized. ECG triggering is only applicable for fluoroscopy and a limited set
of exposure procedures.

NOTE For Single Shot triggering, only one image is generated this way.

By default, ECG triggering is not activated. Once activated, the settings remain valid until switched off or
a new patient is selected. Selecting a procedure that is not supported by ECG triggering, for example,
rotational scan or bolus chase, automatically deactivates ECG triggering and the controls in the ECG
triggering task panel are unavailable.

When ECG triggering is activated, the system monitors the trigger pulses (also during standby). If for any
reason the trigger pulses are not present for 2 seconds or more, the system message ECG signal absent
is displayed. The system message is removed when the trigger pulses are present again, or when ECG
triggering is deactivated.

NOTE A system message is also displayed 2 seconds after every trigger pulse, when the heart rate
is less than 30 bpm.

1 Select the X-ray Settings task.

2 If you are using the acquisition window, do the following:

a Click the expander in the control panel relating to the type of procedure you are performing
(Fluoroscopy or Exposure).

If the X-ray protocol you are using supports ECG triggering, the ECG-Triggering expander is
displayed.

b Expand the ECG-Triggering expander.

c To switch ECG triggering on, click On.

3 If you are using the touch screen module, do the following:

a Tap More and select ECG Triggering.

The ECG-Triggering task panel is displayed.

b Tap either Fluoro ECG or Exposure ECG, to switch the desired function on.

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The system replaces the fluoroscopy flavor indication or the exposure series speed indication in
the live window with the ECG indication.

NOTE For ‘Single Shot’ procedures, the indication in the live window remains as ‘Single
Shot’.

If injector coupling is on, it is automatically switched off.

4 Increase or decrease the Trigger Delay time as appropriate.

The accuracy of the delay time is limited. The selected delay should relate to the current heart rate
of the patient and desired heart rate phase, for example, end diastole or end systole.

5 Initiate fluoroscopy or exposure as appropriate for the selected ECG triggering.

The controls on the touch screen module are unavailable during fluoroscopy and exposure.

Images are acquired according to the current heart rate of the patient. After every R-top of the ECG
signal plus the selected trigger delay, one image is acquired. If another trigger pulse is received
during the delay period, (for example, when the ECG signal is too high) then that trigger pulse is
ignored.

6 On completion of the selection or adjustment, tap X to close the task panel.

7.18 Rotational Scans


Rotational scans, or 3D-Rotational Angiography (3D-RA), are used to acquire a 3D perception of an
anatomy.

A fixed rotational scan is predefined and you cannot alter the start and end positions.

A free rotational scan allows you to define the start and end position of the scan.

NOTE BodyGuard sensors are switched off during a rotational scan.

When performing a rotational scan, the following requirements apply:


• The table must not be pivoted.
• The isocenter must be centered between the rails. User guidance is provided when the isocenter is
out of position.

7.18.1 Performing a Fixed Rotational Scan


1 Position the region of interest in the isocenter.

For more information, see Isocentering (page 122).

2 On the touch screen module, select the X-ray Acquisition application.

3 Select the X-ray Settings task.

4 Select the rotational scan X-ray protocol you want to use.

Functions for step 1 Settings are displayed.

5 Configure the X-ray protocol settings for the type of scan that you want to perform.

a Turn the detector switch on the control module until the detector is in landscape or portrait
orientation.

If the FlexArm option is installed, do one of the following:

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– To set the detector to landscape orientation, push and hold the detector switch to the left
until the detector stops moving.

– To set the detector to portrait orientation, push and hold the detector switch to the right
until the detector stops moving.

b Select the maximum source-to-image distance.

c Select the desired field of view.

6 Turn Injector Coupling on or off as desired.

a If you turn Injector Coupling on, set the X-ray Delay time.

7 Tap Next.

Functions for step 2 Isocenter are displayed.

To return to step 1 and change the settings, tap Edit.

8 Follow the on-screen guidance to position the region of interest in the isocenter.

9 Tap Next.

Functions for step 3 Check Path is Clear are displayed.

To return to step 2 and reposition the region of interest, tap Re-isocenter.

10 Clear all objects from the rotational arc of the stand.

11 Follow the on-screen guidance to move the stand to the end position and then the start position.

When the stand reaches the start position, functions for step 4 Acquisition are automatically
displayed.

12 If injector coupling is turned on, prepare the injector.

13 Instruct the patient not to move during the acquisition.

14 Follow the on-screen guidance to perform the acquisition.

NOTE BodyGuard is disabled during acquisition.

7.18.2 Performing a Free Rotational Scan


If the FlexArm option is installed, you can perform a rotational scan from the following positions:
• Head side
• Doctor side
• Nurse side
• Between +135 degrees and -135 degrees

Rotational scans can be subtracted by acquiring two series. Best practice is to acquire a mask series
followed by a contrast series.

1 Position the stand in the desired work position.

2 Position the region of interest in the isocenter.

For more information, see Isocentering (page 122).

3 On the touch screen module, select the X-ray Acquisition application.

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4 Select the X-ray Settings task.

5 Tap Rotational Scan.

Functions for step 1 Settings are displayed.

6 Configure the X-ray protocol settings for the type of scan that you want to perform.

a Turn the detector switch on the control module until the detector is in landscape or portrait
orientation.

If the FlexArm option is installed, do one of the following:


– To set the detector to landscape orientation, push and hold the detector switch to the left
until the detector stops moving.

– To set the detector to portrait orientation, push and hold the detector switch to the right
until the detector stops moving.

b Select the maximum source-to-image distance.

c Select the desired field of view.

7 Turn Injector Coupling on or off as desired.

a If you turn Injector Coupling on, set the X-ray delay time.

8 Tap Next.

Functions for step 2 Isocenter are displayed.

To return to step 1 and change the settings, tap Edit.

9 Follow the on-screen guidance to position the region of interest in the isocenter.

10 Tap Next.

Functions for step 3 Check Path is Clear are displayed.

To return to step 2 and reposition the region of interest, tap Re-isocenter.

11 Clear all objects from the rotational arc of the stand.

12 Follow the on-screen guidance to move the stand to the end position and then the start position.

13 When the stand is in the start position, tap Next.

Functions for step 4 Acquisition are displayed.

14 If injector coupling is turned on, prepare the injector.

15 Instruct the patient not to move during the acquisition.

16 Follow the on-screen guidance to perform the acquisition.

NOTE BodyGuard is disabled during acquisition.

7.18.3 CBCT
The CBCT procedure consists of a rotational scan. The acquired images are automatically sent to the
Interventional Workspot.

This procedure is only available on systems fitted with the 20-inch flat detector.

For biplane systems, this procedure is only available on the frontal channel.

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For information about CBCT calibration, see CBCT Calibration (page 306).

To be able to use CBCT, the table should be positioned within the following ranges:
• Table Pivot Angle:
– -5 to 5 degrees
– 175 to 185 degrees
– -175 to -185 degrees
• Table Swivel Angle:
– -1 to 1 degrees
– 179 to 181 degrees
– -179 to -181 degrees

NOTE Depending on your version of the Interventional Workspot, it may be possible to acquire the
rotational scan with a tilted and cradled table.

NOTE You must be logged on to the Interventional Workspot before starting the acquisition. We
recommend that you switch the workstation on and log on at the start of your work schedule
to avoid a delay.

NOTE BodyGuard is disabled during image acquisition.

1 Position the stand in the working position.

2 Position the region of interest in the isocenter.

For more information, see Isocentering (page 122).

3 Select the X-ray Settings task.

4 Select the CBCT procedure.

For more information, see CBCT Procedure Selection (page 138).

5 Turn the detector switch on the control module until the detector is in landscape orientation.

a If the FlexArm option is installed, push and hold the detector switch on the control module to
the left to set the detector in landscape orientation.

The indicator light illuminates when the detector reaches the orientation.

6 Select the maximum source-to-image distance.

7 Clear all objects from the rotational arc of the stand.

8 Follow the instructions given on the touch screen module to confirm the end position.

9 Follow the instructions given on the touch screen module to confirm the start position.

10 Instruct the patient not to move during the acquisition.

11 To start acquisition, press the hand switch or foot switch until exposure stops.

CBCT Procedure Selection

Duration [s]
Protocol Speed [fps] (approximate) Position Detail
CBCT HQ 30fps -21s 30 21 Head High
CBCT LD 30fps -10s 30 10 Head Low
CBCT HQ 60fps -10s 60 10 Head High
CBCT LD 60fps - 5s 60 5 Head Low

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Duration [s]
Protocol Speed [fps] (approximate) Position Detail
CT Cranial Stent 48 cm / 19" 30 21 Head High
CT Cranial Stent 27 cm / 10.5" 30 21 Head High
CT Cranial Stent 22 cm / 8.5" 30 21 Head High
CBCT Prop (open) HQ - 5s 60 5 Head High
CBCT Dual Prop (open) HQ - 5s 60 5 Head High
CBCT Prop (open) LD - 5s 60 5 Head Low
CBCT Dual Prop (open) LD - 5s 60 5 Head Low
CBCT Prop open - 4s 60 4 Head Low
CBCT Roll - 5s 60 5 Side High
CBCT Dual Roll - 8s 60 8 Side High
VasoCT I.A. 22 cm / 8.5" 30 21 Head High
VasoCT I.A. 27 cm / 10.5" 30 21 Head High
VasoCT I.V. 22 cm / 8.5" 30 21 Head High
VasoCT I.V. 27 cm / 10.5" 30 21 Head High
HD = High Dose, LD = Low Dose, ( ) = optional

NOTE Some of these application protocols may not be available, depending on the X-ray
equipment in use and the purchased options.

7.18.4 CBCT Dual


The CBCT Dual procedure is a dual phase scan that consists of a forward phase and a backward phase.
The acquired images are automatically sent to the Interventional Workspot.

Contrast is used during the forward phase of the scan to visualize the arteries. After a brief pause,
known as the scan interval, the backward phase is acquired. While the contrast medium has washed out
of the arteries, the lesion holds the contrast medium for slightly longer, allowing the lesion to be
visualized in the backward phase.

This procedure is only available on systems fitted with the 20-inch flat detector.

For biplane systems, this procedure is only available on the frontal channel.

For information about CBCT calibration, see CBCT Calibration (page 306).

NOTE You must be logged on to the Interventional Workspot before starting the acquisition. We
recommend that you switch the workstation on and log on at the start of your work schedule
to avoid a delay.

NOTE If the exposure switch is released after the forward scan, the backward scan is canceled.

NOTE BodyGuard is disabled during image acquisition.

1 Position the stand in the working position.

2 Position the region of interest in the isocenter.

For more information, see Isocentering (page 122).

3 Select the X-ray Settings task.

4 Select the CBCT Dual Phase procedure.

5 Adjust the interval time if desired.

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6 Turn the detector switch on the control module until the detector is in landscape orientation.

a If the FlexArm option is installed, push and hold the detector switch on the control module to
the left to set the detector in landscape orientation.

The indicator light illuminates when the detector reaches the orientation.

7 Select the maximum source-to-image distance.

8 Clear all objects from the rotational arc of the stand.

9 Switch Injector Coupling on or off as desired.

a If you switch Injector Coupling on, set the X-ray delay time.

10 Follow the instructions given on the touch screen module to confirm the end position.

11 Press Accept on the control module to move to the end position.

12 Follow the instructions given on the touch screen module to confirm the start position.

13 Press Accept on the control module to move to the start position.

14 Instruct the patient about the breathing procedure.

15 Start acquisition.

16 Continue to hold the exposure switch at the end of the forward phase.

17 Using the counter displayed in the live X-ray window or the acquisition window as a guide, instruct
the patient to breathe during the interval time, and to hold their breath at the beginning of the
backward phase.

18 At the end of the backward phase release the exposure hand or foot switch.

7.18.5 CardiacSwing
CardiacSwing provides a dual-axis rotation for either the left or right coronary artery. The acquisition
series combines both rotation and angulation movement of the stand, which covers most of the routine
coronary projections in a single sweep.

Dedicated X-ray protocols for the left and right coronaries are included in the system. CardiacSwing is
used with the stand positioned for a cardiac study.

Contrast medium can be injected either manually or via an injector, care should be taken that contrast is
present throughout the coronary tree for the duration of the swing.

1 Turn the detector switch on the control module until the detector is in landscape orientation.

a If the FlexArm option is installed, push and hold the detector switch on the control module to
the left to set the detector in landscape orientation.

The indicator light illuminates when the detector reaches the orientation.

2 Select the maximum source-to-image distance

3 Select the desired field of view.

4 Center the region of interest in the lateral position.

You may find it helpful to set this position as the isocenter so you can recall it later.

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5 Center AP: position the catheter tip in left upper quadrant of the detector.

6 Clear all objects from the rotational arc of the stand.

7 On the touch screen module, select the X-ray Acquisition application.

8 Select the X-ray Settings task.

9 Tap CardiacSwing in the list of available X-ray protocols.

If CardiacSwing is not visible in the list of X-ray protocols associated with the currently selected
ProcedureCard, select the Cardiac settings and tap CardiacSwing.

10 Select the desired detailed settings.

For more information, see CardiacSwing Procedure Selection (page 141).

11 If you are using an injector, do the following:

a Tap Injector Coupling to switch injector coupling on.

b Set the X-ray delay time.

12 Tap Next.

13 Press and hold Accept on the control module until the stand reaches the end position.

14 Press and hold Accept on control module until the stand reaches the start position.

15 If injector coupling is switched on, prepare the injector.

The system is now ready to acquire images.

16 Instruct the patient not to move during the acquisition.

17 Start acquisition by pressing the hand switch until exposure stops.

NOTE BodyGuard is disabled during image acquisition.

CardiacSwing Procedure Selection


For CardiacSwing procedures, the recommended field of view is 30 cm (11.6 inch) when using a 12-inch
detector, and 27 cm (10.5 inch) or greater when using a 15-inch or 20-inch detector.

To optimize imaging, the artery should be filled from first to last image of the swing procedure. It is
recommended to begin the injection 0.5 seconds prior to acquisition of the first image. If you are using a
power injector set an X-ray delay time on the system for 0.5 seconds.

All procedures are performed with the following settings:


• Stand position: head end
• Framerate: 15 fps or 25 fps

Exposure Time Injection Duration


Procedure [seconds] [seconds] Clinical Area
LCA CRA 30 5s 5.3 5.8 Left coronary
LCA CRA 35 5s
5.8 6.3 Left coronary
(Best practice)
LCA CRA 40 5s
Floor-mounted stand with 5.8 6.3 Left coronary
12-inch detector only
RCA LAO 3s 3.7 4.2 Right coronary

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Exposure Time Injection Duration


Procedure [seconds] [seconds] Clinical Area
RCA AP 4s
4.1 4.5 Right coronary
(Best practice)
Left coronary
LCA/RCA RAO-CAU ->
4.1 4.6 Right coronary
LAO-CRA 4s
Grafts
Left coronary
LCA/RCA LAO-CAU ->
4.1 4.6 Right coronary
RAO-CRA 4s
Grafts

LCA Trajectories
CRAN

40

30

20

10

RAO LAO
60 50 40 30 20 10 0 10 20 30 40 50 60

10

20

30

CAUD
Figure 91 Small curve for all patients: LCA CRA 30 5s

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CRAN

40

30

20

10

RAO LAO
60 50 40 30 20 10 0 10 20 30 40 50 60

10

20

30

CAUD
Figure 92 Medium curve for all patients: LCA CRA 35 5s (best practice for LCA)

CRAN

40

30

20

10

RAO LAO
60 50 40 30 20 10 0 10 20 30 40 50 60

10

20

30

CAUD
Figure 93 Large curve for normal or thin patients: LCA CRA 40 5s

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RCA Trajectories
CRAN

40

30

20

10

RAO LAO
60 50 40 30 20 10 0 10 20 30 40 50 60

10

20

30

CAUD
Figure 94 Standard curve for all patients: RCA LAO 3s

CRAN

40

30

20

10

RAO LAO
60 50 40 30 20 10 0 10 20 30 40 50 60

10

20

30

CAUD
Figure 95 Standard curve for all patients: RCA AP 4s

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LCA, RCA, and Graft Trajectories


CRAN

40

30

20

10

RAO LAO
60 50 40 30 20 10 0 10 20 30 40 50 60

10

20

30

CAUD
Figure 96 Swing for coronary and grafts: LCA/RCA RAO-CAU -> LAO-CRA 4s

CRAN

40

30

20

10

RAO LAO
60 50 40 30 20 10 0 10 20 30 40 50 60

10

20

30

CAUD
Figure 97 Swing for coronary and grafts: LCA/RCA LAO-CAU -> RAO-CRA 4s

7.19 Electrophysiology Procedures


CAUTION
Do not use X-ray images acquired during an electrophysiology mapping procedure for diagnostic
purposes since electromagnetic interference generated by the mapping equipment may reduce
image quality. These images are for non-diagnostic viewing only.

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7.20 Previewing Series and Images for Automatic Archiving


If your system is configured to do so, series and images are automatically archived when you end a
study.

You can preview the series and images that will be automatically archived at any time. For more
information, see Configuring Automatic Data Transfer (page 275).

1 Click Archive Preview in the global tools panel.

A dialog box is displayed showing the series and images to be archived.

If there is more than one archive destination, the dialog box displays a section for each specific
archive destination and the series and images to be archived to that destination.

The following icons indicate whether the whole series or only some images in the series are to be
archived.

Icon Description

The series will be archived

Only some images in the series will be archived

2 To exclude a series from archiving, select the series and click Exclude.

You can select multiple series for exclusion. When a series is excluded, a message is displayed on
the pictorial and the pictorial image is dimmed.

NOTE Excluded series can be exported manually.

3 To undo any changes that you have made and start again, if desired, click Undo Changes.

4 Click Done to save your changes and close the dialog box.

7.21 Ending a Study


When you end a study, you can choose which status to apply to each of the procedure steps performed
within the study.

When you end a study, the system may be configured to automatically archive series and images
associated with the study. You can check which series and images will be archived before you end the
study.

You can only end a study from the acquisition window.

1 To end the study, do one of the following:


• Click End Procedure in the acquisition window.
• Click End Procedure in the patient database, if the patient database is open.

A dialog box is displayed and you are prompted to select how to end the study.

The dialog box displays the steps performed in the study.

2 For each procedure step performed, select a status.

If no X-ray images have been acquired in the study, the following options are available:

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• Complete
• Keep Scheduled

If X-ray images have been acquired, the following options are available:
• Complete (displayed only when MPPS is not configured)
• Discontinue (displayed only when MPPS is configured)
• Suspend

3 If you selected Discontinue for one or more procedure step, select the appropriate reason for
discontinuing each discontinued step.

4 To preview the series and images that will be archived when you end the study, click Archive
Preview.

A dialog box is displayed showing the series and images that will be archived. For more information,
see Previewing Series and Images for Automatic Archiving (page 146).

5 To end the study, click OK.

7.22 Dose Reports


Dose reports can be created automatically when a study is completed. A dose report contains dose
information for each series and for the whole study.

DICOM Radiation Structured Dose Report


A DICOM radiation structured dose report is created automatically when a study is completed. This
report cannot be viewed on the system, but it is automatically exported to a network destination (for
example, a workstation that can display structured reports). For more information, see Configuring
Automatic Data Transfer (page 275).

Secondary Capture Dose Report


A secondary capture dose report is a photo image of a dose report. This type of dose report is created
automatically if your system is configured to do so. For more information, see Changing General Patient
and Workflow Settings (page 266).

A secondary capture dose report is stored with the study and is identified by a report pictorial in the
task panel. It can be viewed on the system and printed. You can also export the dose report to a
network destination or storage device. For more information, see Exporting Data (page 185).
Additionally, secondary capture dose reports are automatically exported to a network destination. For
more information, see Configuring Automatic Data Transfer (page 275).

7.22.1 Viewing a Secondary Capture Dose Report


You can view a secondary capture dose report in the viewing application in the review window.

To view a dose report, you must complete the associated study.

Dose reports are saved when a study is completed. They are saved as photo images and are available
to view in the Series task control panel.

1 Load the desired patient study.

2 Select the Series tab in the control panel.

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3 Select All Images or Photo Images in the image selector drop-down list.

4 Click the dose report pictorial in the image list.

The dose report is displayed in the viewer.

7.22.2 Printing a Secondary Capture Dose Report


Secondary capture dose reports are created as images and can be printed.

The dose report for a procedure is available as a pictorial in the task panel.

1 To add the dose report to the print preview, do one of the following:
• Select the dose report pictorial in the control panel and click Add to Print Preview in the global
tools panel.
• Right click on the dose report pictorial in the control panel and select Add Series to Print
Preview.

2 To launch the print application, click More Tools and then select Print Preview.

The print application is launched and a preview of the report is displayed, including the dose report.

3 Compile any other desired elements of the report.

4 Click Print to print the report.

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8 Reviewing
You can review a series or an image in the examination room using the viewpad or the optional mouse,
or in the control room using the mouse or the review module.

You select a series or image for review using the pictorial index in the Series task in the acquisition
window, the review window, or in the X-ray Acquisition application on the touch screen module.

Series are listed in a pictorial index. A yellow border around a pictorial indicates that this is the
displayed image or series in the main display area. Biplane series are always displayed with the frontal
series and lateral series side by side in the Series task. When you select a biplane series, the
corresponding series on the other channel is also selected.

If the pictorial display area is not sufficient to display all the pictorials, a slide bar appears to the side of
the display which you use to scroll through the pictorials. You can also apply a filter In the Series task
navigation panel to find the series you are looking for.

If the X-ray protocol is configured to do so, after acquiring a series the series is displayed in the main
display area, automatically replaying the images in the series.

For fluoroscopy, if the X-ray protocol is not configured to automatically replay the series, the last image
acquired in the series is displayed. This is the last image hold function.

NOTE When handling personal data, do so in accordance with the privacy policies that apply in
your healthcare environment and privacy laws that apply in your region.

For more information, see the following sections:


• Windows, Panels, Views, and Viewports (page 476)
• Acquisition Monitor (page 437)
• Review Monitor (page 439)
• Review Module (page 471)
• Viewpad (page 472)

8.1 Instant Parallel Working


While acquisition is being performed in the examination room, you can use the review window in the
control room to work in parallel and perform tasks such as reviewing and post-processing, for any
study, including studies and series that do not relate to the acquisition patient.

You select a study or series for review using the patient list in the review window. For more information,
see Reviewing a Series using the Review Window (page 149).

When you review a study or series that is not related to the acquisition patient, a warning is displayed in
the review window reminding you that you are not reviewing the acquisition patient. You can dim this
warning, but while you are reviewing a series or study that is not from the acquisition patient, it is
always displayed.

8.2 Reviewing a Series using the Review Window


You can review a series for any patient in the review window using the mouse or review module in the
control room, or the viewpad or optional mouse in the examination room.

The following procedure describes a single method but you can also perform many of the actions using
either the mouse, the review module, or the viewpad depending upon the situation. For more
information, see Review Module (page 471) and Viewpad (page 472).

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Reviewing Reviewing a Series using the Touch Screen Module

1 Click the Series task in the review window to select a series for review.

2 To change the way series are listed in the control panel, do one of the following:
• Click Show pictorials to display the series as pictorials.

• Click Show details to display the series as a list.

3 Do one of the following:


• Click a series to open it in the main display area.
• Double-click a series to open it in the main display area and automatically replay the images in
the series.

NOTE Biplane series are always displayed with the frontal series and lateral series side by side
in the Series task. When you select a biplane series, the corresponding series on the other
channel is also selected.

4 To control the replay of the images in a series, do the following:

a To replay the series, click Play.

b To pause the series, click Pause

c To review the previous or next image in the series, click Previous image or Next image.

d To review the previous or next series, click Previous series or Next series.

e To change the frame rate used when replaying the images, click Frame Rate and adjust the
slider to the desired number of images per second.

NOTE When reviewing biplane images, only one movie toolbar is displayed. Movie playback
and displayed images are synchronized for the frontal and lateral images.

5 To replay all images and series in the study, click Cycle All.

6 To display an overview of all images in the selected series, click Image Overview.

7 To display one image from each of the available series for the patient, click Series Overview.

8 To review a particular type of image, select one of the following filters from the list:
• Acquired Images
• Photo Images
• Flagged Images

8.3 Reviewing a Series using the Touch Screen Module


You can review a series for the acquisition patient using the touch screen module.

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Reviewing Reviewing a Series using the Touch Screen Module

The following procedure describes a single method but you can also perform many of the actions using
either the mouse, the review module, or the viewpad depending upon the situation. For more
information, see Review Module (page 471) and Viewpad (page 472).

When you review a biplane series on the touch screen module, instead of the frontal image and lateral
image displayed side by side as in the review window, the frontal image is displayed in the main
viewport, and the lateral image is displayed in a mini viewport within the main viewport.

Figure 98 Mini viewport in the main viewport

To swap the image in the main viewport with the image in the mini viewport, tap the mini viewport.

To reposition the mini viewport, touch the mini viewport and drag it to a new location.

1 On the touch screen module, select the X-ray Acquisition application.

2 Select the Series task.

3 Tap a series in the task panel to open it in the main display area.

NOTE Biplane series are always displayed with the frontal series and lateral series side by side
in the Series task. When you select a biplane series, the corresponding series on the other
channel is also selected.

4 To replay the images in a series, do the following:

a To replay the series, tap Play.

b To pause the series, tap Pause

c To review the previous or next image in the series, tap Previous image or Next image.

d To review the previous or next series, tap Previous series or Next series.

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Reviewing Using the Interventional Room Pointer

5 To replay all images and series in the study, tap Cycle All.

6 To display an overview of all images in the selected series, tap Image Overview.

7 To display one image from each of the available series for the patient, tap Series Overview.

8 To review a particular type of image, select one of the following filters from the list:
• Acquired Images
• Photo Images
• Flagged Images

8.4 Using the Interventional Room Pointer


You can display the interventional room pointer on an image in a viewport to indicate a region of
interest temporarily. The pointer is visible in any window (in the examination room and the control
room) and on any touch screen module that also displays the image.

You can access the Interventional Room Pointer function from the examination room or the control
room, using either the workstation or the touch screen module.

Figure 99 Interventional room pointer

1 To display the pointer using the workstation, click Interventional Room Pointer on the toolbar of the
viewport.

NOTE The Interventional Room Pointer function is grouped with the Markers function on the
toolbar. You may need to click the arrow next to the Markers button to access the
Interventional Room Pointer function.

a Move the mouse to move the pointer on the image.

b To remove the pointer from the image, click Interventional Room Pointer on the toolbar again.

2 To display the pointer using the touch screen module, tap and hold on the image in the viewport.

a Drag your finger to move the pointer on the image.

b To remove the pointer from the image, lift your finger off the touch screen module.

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Reviewing Protecting and Unprotecting Studies

8.5 Protecting and Unprotecting Studies


If the system's storage is full, the system automatically deletes data that is not protected to make space
for newly acquired images. You can protect individual studies to prevent deletion.

1 Click the patient selector in the upper-left corner of the acquisition window or the review window.

2 Select a study in the list.

3 To protect the study, right-click the study and click Protect Study.

4 To unprotect a study which is already protected, right-click the study and click Unprotect Study.

You can configure the system to protect every study upon completion. For more information, see
Changing General Patient and Workflow Settings (page 266).

8.6 Reviewing Historical Data for a Scheduled Patient


You can review historical studies and series for a scheduled patient.

When you have selected a patient in the patient list, you can view all the studies that are available for
that patient. This includes studies and series available on the local database and archived studies and
series available on the network.

1 Click the patient selector in the upper-left corner of the review window to display the patient
database.

2 Select a scheduled patient in the patient list.

3 Click the History tab.

All available studies and series for the selected patient are displayed, including archived studies and
series that are available on the network. If a series is available in the local patient database, a
pictorial is displayed. If a series is an archived series, a pictorial image is not displayed.

Studies are displayed in acquisition date order by default, with the most recent first.

4 To view a study in the local patient database, do the following:

a Find the study in the list.

b Select the series that you want to view within the study.

c Click View.

5 To view an archived study, do the following:

a Find the study in the list.

b Select the series that you want to review within the study.

To import more than one archived series at a time, select the check box in the top left corner of
each series that you want to import.

c Click Import.

The selected series are imported from the network archive to the local database.

d Select the imported series that you want to view.

e Click View.

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Reviewing Importing Studies or Series for Review

8.7 Importing Studies or Series for Review


You can import studies or series from a network location, a CD or DVD, or a USB device for review on
the system.

8.7.1 Importing Studies or Series from a Network Location

1 Open the patient database.

2 Click the network location that you want to import from.

A search panel is displayed, allowing you to find the patient and study you are looking for.

3 Enter some appropriate search terms and click Search.

A patient list is displayed showing studies matching your search criteria.

4 Select the desired patient study in the list.

The study details are displayed below the patient list.

5 To import the whole study, click Import.

6 To import a series from the study, click the Series tab.

The available series are displayed. No previews are shown in the pictorials as the series are not in
the local patient database.

7 Select the series you want to import.

8 Click Import.

When the import process is complete, a preview image is displayed in the pictorial.

9 If you want to cancel the import process, click Stop.

8.7.2 Importing Studies and Series from USB Device, CD, or DVD
NOTE USB devices may contain malicious software that could steal personal information or cause
the system to malfunction. You should always scan a USB device for malicious software
before connecting it to the system.

1 If you are importing from a USB device, insert the device into one of the USB ports on the monitor in
the control room.

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Reviewing Importing Studies or Series for Review

Figure 100 Inserting a USB flash memory drive

2 If you are importing from a CD or DVD, insert the disc into the CD/DVD drive.

3 Open the patient database.

4 Click the device that you want to import from.

If the device is password-protected or encrypted, enter the password in the dialog box displayed
and click Unlock.

NOTE The system supports BitLocker encryption. Other encryption tools are not supported.

A patient list is displayed showing the available studies from the selected device.

5 Select the desired patient study in the list.

The study details are displayed below the patient list.

6 To import the whole study, click Import.

A dialog box is displayed requesting you to confirm your action.

7 Confirm your import by doing the following:


• Click Link to import the data and merge patient details. Use this option if the data that you are
importing belongs to a patient who already has studies on the system.
• Click Import to import the data without merging patient details.
• Click Cancel to cancel the import.

If you click Link, a further dialog box is displayed. Check that the patient details are correct and then
click Link Data to import the data and merge the patient details. Alternatively, click Cancel to close
the dialog box without importing the data.

8 To import a series from the study, click the Series tab.

The available series are displayed. No previews are shown in the pictorials as the series are not
stored in the local patient database.

9 Select the series that you want to import and click Import.

NOTE Do not remove the USB device, the CD, or the DVD until the import process is complete
(the progress of the import process is displayed).

When the import process is complete, a preview image is displayed in the pictorial.

10 If you want to cancel the import process, click Stop.

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Reviewing Bolus Chase Reconstruction

8.8 Bolus Chase Reconstruction


Bolus Chase Reconstruction is a software tool that is available as an option on the system. It creates an
overview image of the arteries in the patient’s legs by automatically stitching together successive
images acquired with the Bolus Chase procedure or the FDPA procedure.

The overview image is intended to assist you in viewing the original images. The overview image is not
intended to be used for diagnosis. Actual diagnosis (for example, analysis of occlusions) should be
based on information contained in the original X-ray images.

For information about acquiring X-ray images, see Bolus Chase (page 129).

NOTE Imported images cannot be used to create an overview image in Bolus Chase
Reconstruction.

The Bolus Chase Reconstruction screen provides the following views and task panels.

5 7
1

2
4 6

8
3

Figure 101 Bolus Chase Reconstruction

Legend
1 Task selection panel 5 Overview image toolbar
2 Task panel 6 Main view (displaying original or subtracted images)
3 Global tools 7 Main view toolbar
4 Overview image 8 Navigation toolbar

8.8.1 Tasks
Bolus Chase Reconstruction provides the following tasks:

Reconstruction: This task allows you to view the reconstructed overview image. You use the overview
image to assist you with navigation and analysis of the original images.

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Reviewing Bolus Chase Reconstruction

Processing: This task provides tools for adding annotations and creating measurements in the images.

You use the task selection panel to move to the next task when the current task is complete. You can
also move back to a previous task and repeat it, if desired. The task panel provides functions associated
with the current task.

8.8.2 Reconstruction
After you acquire a bolus chase series, Bolus Chase Reconstruction starts automatically and
reconstructs an overview image.

If a patient other than the acquisition patient is being reviewed in the review window, that patient is
automatically closed and the bolus chase series for the acquisition patient is opened.

When a bolus chase mask series is also available for the acquisition patient, you can create a subtracted
view of the reconstruction image.

NOTE You can start Bolus Chase Reconstruction manually in the control room for a patient other
than the acquisition patient by opening a previously acquired bolus chase series in the
patient database. To start the application, click More Tools and then click Bolus Chase
Reconstruction.

NOTE Reconstructions are saved automatically.

Reviewing the Reconstruction


After automatic reconstruction of the bolus chase series, an overview image is displayed alongside the
original acquisition images.

NOTE The reconstructed image is only for overview and navigation. It is not intended for diagnostic
purposes. Clinical conclusions should be based on and verified using the original images.

The Reconstruction task is opened, providing a control panel containing tools for managing
reconstructions.

1 Review the overview image and the original images to verify whether the complete peripheral artery
is visible, or if any occlusions are present.

Use the overview image as a reference when navigating through the original images.

2 To view the original image corresponding to a particular point in the overview image, click the point
in the overview image.

A line is displayed in the overview image as a marker, and the corresponding original image is
displayed in the main view. You can drag the marker line to adjust its position.

3 To view the original images in the series or to review the series as a movie, use the navigation
toolbar at the bottom of the main view.

The navigation toolbar provides the following controls:

Control Function

Play Plays the original images as a movie

Stop Stops movie playback

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Reviewing Bolus Chase Reconstruction

Control Function

Next image Displays original images sequentially forward through the series

Previous image Displays original images sequentially backward through the series

You can also control image navigation using the following actions:
• Double-click in the main view to start and stop movie playback.
• With movie playback stopped, rotate the wheel button down to view the next image, or rotate
the wheel button up to view the previous image.

The following functions are not available when reviewing the series as a movie:
• Annotations
• Measurements
• Snapshots
• Printing

4 To view original images in the main view with the anatomy fixed in place, do the following:

• Display the desired location in the overview image.


• Select Fixed Anatomy in the Reconstruction control panel.

When the anatomy is fixed and you click Next image or Previous image in the navigation toolbar,
sequential images are displayed higher or lower in the main view so that the anatomy in each image
is displayed in the same position in the view. Fixing the anatomy assists you with reviewing a region
of interest in a series of the original images.

NOTE When Fixed Anatomy is enabled, the movie review function cannot be used.

5 To zoom the original images in the main view, click Zoom on the main view toolbar and do the
following:

• To zoom in, drag upward.


• To zoom out, drag downward.

You can also zoom the view directly by pressing Ctrl and rotating the wheel button, even when the
Zoom tool is not selected.

NOTE The overview image cannot be zoomed.

6 To pan the original images in the main view, click Pan on the main view toolbar and drag the image
to pan the view.

You can also pan the view directly by dragging with the right mouse button, even when the pan tool
is not selected. The overview image cannot be panned.

7 To adjust the brightness and contrast of the overview image or the original images, click
Brightness / Contrast on the corresponding toolbar and do the following:

• Drag the pointer upward to decrease the brightness level.


• Drag the pointer downward to increase the brightness level.
• Drag the pointer to the right to decrease the contrast level.
• Drag the pointer to the left to increase the contrast level.

You can also adjust the brightness and contrast directly by pressing Ctrl and dragging with the
middle mouse button, even when the brightness/contrast tool is not selected.

8 To invert the gray values of the overview image or the original images, click Invert on the
corresponding toolbar.

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Reviewing Bolus Chase Reconstruction

9 To create a snapshot of the overview image or of the original image displayed in the main view, click
Snapshot on the corresponding toolbar.

Before creating a snapshot, ensure that the appropriate level of patient information is displayed in
the image using the Image overlays tool in the global tools panel.

The snapshot is saved in the patient database under the current study.

10 To send the overview image or the currently displayed original image to a reference view in the
examination room, click Copy to Reference on the corresponding toolbar.

Depending on the configuration of your X-ray system, you can choose to send the image to
reference view 1, reference view 2, or reference view 3.

11 To reset the overview image or the original images to their default presentation state, click Reset in
the corresponding toolbar.

12 To hide the overview image and display only the original images, select Hide Reconstruction in the
Reconstruction control panel.

13 If another bolus chase reconstruction is available for the patient, you can select the reconstruction
in the Existing Reconstructions panel of the Reconstruction control panel.

The bolus chase reconstruction that is currently selected for investigation is indicated with an icon in
the Existing Reconstructions panel.

14 If the currently displayed bolus chase series is not suitable, you can acquire another bolus chase
series for the patient. To view the newly acquired series, click Select Series in the Reconstruction
control panel.

If you acquired a new contrast series and a new mask series, you can select both series in the Select
Series dialog box.

15 To delete a reconstruction, right-click the reconstruction in the Existing Reconstructions panel and
click Delete in the shortcut menu.

Using a Mask
If a mask acquisition series (without contrast) is available, you can apply the mask and create a
subtracted image.

1 Acquire a mask series.

The mask series is automatically processed and applied to the current contrast series and a
subtracted overview image is displayed. The subtracted original images are displayed in the main
view.

The subtracted reconstruction is also selected in the Existing Reconstructions panel in the task
panel.

2 Review the subtracted series.

3 To manually combine part of the subtracted background with the subtracted overview image or the
subtracted original images, click Landmarking on the corresponding toolbar and do the following:

• Drag the pointer upward to decrease the visibility of landmarks (increase transparency).
• Drag the pointer downward to increase the visibility of landmarks (decrease transparency).

Landmarking is useful for orientation purposes.

4 To turn subtraction off in the main view and view the original unsubtracted images, click Subtraction
On / Off on the toolbar.

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Reviewing Resolving a Patient Mix

5 To turn subtraction back on, click Subtraction On / Off again.

6 If desired, you can acquire a new mask series.

The new mask series is automatically processed and applied to the current contrast series and a
subtracted overview image is displayed. The subtracted original images are displayed in the main
view.

7 To use a different mask series that you have already acquired, click Remask in the Reconstruction
task panel.

The Remask dialog box is displayed, showing available mask series.

8 Select a mask series in Remask dialog box and click OK.

Subtraction is automatically applied using the new mask series.

8.8.3 Processing
You can add annotations and measurements to the original images and to the overview image.

For more information, see the following sections:


• Adding Annotations (page 167)
• Creating Measurements (page 178)

8.9 Resolving a Patient Mix


If you believe images have been stored for the wrong patient, you can move them to the correct patient
using the Resolve Patient Mix wizard.

NOTE If the patient to whom you want to move the series (the destination patient) is not in the
patient list, you must add the patient before using the wizard. For more information, see
Scheduling a Study Manually (page 59).

1 To start the wizard, do the following:

a Click the patient selector in the upper-left corner of the acquisition window.

b Select the patient whose folder contains the series you want to move.

c Right-click on the patient and click Resolve Patient Mix in the shortcut menu.

2 Verify that the source patient is correct, and click Next.

3 Select the series to move to the destination patient.

You can select more than one series at a time if you believe more than one series needs to be
moved. To select more than one series, select the check box in the top left corner of each series to
be moved.

4 Click Next.

5 Select the destination study by doing the following:

a Select the destination patient in the list.

A list of available destination studies for the selected patient is displayed.

b Select the destination study in the list.

6 Click Next.

7 Verify that the series to be moved and the destination patient are correct.

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Reviewing Resolving a Patient Mix

8 If they are correct, click Finish.

NOTE After you move the series, dose information is applied as follows:
• The dose information for the whole source study is added to the destination
patient. As a result, the displayed dose information for the destination patient
may be higher than the actual dose that the patient has received.
• The dose information is not removed from the source patient.

9 Click Close to close the wizard.

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Processing

9 Processing
After acquiring images or opening a series, you can perform image processing functions.

In the Processing task, you can perform the following image processing functions:
• Zoom and pan images
• Adjust contrast, brightness and edge enhancements
• Add text and graphical annotations
• Add freehand markers
• Crop images (electronic shutters)
• Apply vascular tools
• Create view trace images
• Perform measurements
• Start quantitative analysis

When performing processing actions, you select the appropriate task in the task selection panel and the
images are displayed in the main display area. For more information, see the following sections:
• Windows, Panels, Views, and Viewports (page 476)
• Acquisition Monitor (page 437)
• Review Monitor (page 439)
• Toolbars (page 461)

Processing Biplane Images


When processing biplane images, you can set the scope of your modifications to just the frontal or
lateral image, independently to either image, or automatically to both images.

To set the processing scope, click Link Image Processing on the toolbar.
• Biplane Unlinked: Changes can be applied independently to both the frontal and lateral images
• Biplane Linked: Changes applied to one image are automatically applied to both the frontal and
lateral images

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Processing Zooming

Figure 102 Link Image Processing options

Legend
1 Biplane Unlinked image processing 3 Biplane Unlinked with focus on the frontal image
2 Biplane Linked image processing 4 Biplane Unlinked with focus on the lateral image

Resetting Processing Changes


You can reset processing changes by tapping Reset All Settings in the task panel of the Processing task
in the X-ray Acquisition application on the touch screen module.

This function resets the image or series to the presentation state at acquisition, with the following
exceptions:
• The zoom center is always set to the image center.
• The zoom factor is always set to 1.
• Annotations, markers, and measurements are not removed.

NOTE This function is only available on the touch screen module.

9.1 Zooming
You can zoom images using the mouse or the touch screen module. When using the mouse, you can
zoom images in the acquisition window and the review window. When using the touch screen module,
you can zoom images in the acquisition window.

1 Select the Processing task, and then click or tap Zoom and Pan.

NOTE Zoom is also available on the toolbar in the acquisition window or review window.

2 To zoom using the mouse, do the following:

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Processing Panning

• To zoom in, drag upward.


• To zoom out, drag downward.

a To zoom the current image only, select Adjust current image only in the control panel.

3 To zoom using the touch screen module, use the Zoom controls.

NOTE You can also zoom with touch gestures on the touch screen module. For more
information, see Touch Screen Gestures (page 446).

a To select whether your changes apply to the current image only or to all images, tap Scope and
select an option.

– Apply changes to the current image only.


– Apply changes to all images in the series.

4 To display the complete image in the center of the view again, click or tap Reset in the control
panel.

9.2 Panning
You can pan images using the mouse or the touch screen module. When using the mouse, you can pan
images in the acquisition window and the review window. When using the touch screen module, you
can pan images in the acquisition window. Panning allows you to view different areas of a zoomed
image.

1 Select the Processing task, and then click or tap Zoom and Pan.

NOTE Pan is also available on the toolbar in the acquisition window or review window.

2 To pan using the mouse, drag the image in the desired direction.

a To pan the current image only, select Adjust current image only in the control panel.

3 To pan using the touch screen module, use the Pan controls.

NOTE You can also pan by dragging directly on the touch screen module. For more information,
see Touch Screen Gestures (page 446).

a To select whether your changes apply to the current image only or to all images, tap Scope and
select an option.

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Processing Adjusting Contrast and Brightness

– Apply changes to the current image only.


– Apply changes to all images in the series.

4 To display the complete image in the center of the view again, click Reset in the control panel.

9.3 Adjusting Contrast and Brightness


To assist you when reviewing images, you can adjust the contrast and brightness levels independently.

1 To adjust contrast and brightness using the mouse directly on the image, click Contrast and
brightness on the toolbar in the acquisition window or review window, and do the following:
• Drag upward to decrease the brightness level.
• Drag downward to increase the brightness level.
• Drag to the right to decrease the contrast level.
• Drag to the left to increase the contrast level.

2 To adjust contrast and brightness in the task panel, do the following:

a Select the Processing task and click Contrast, Brightness, Edge.

b Adjust the Contrast and brightness sliders.

c To apply the changes to the current image only, select Adjust current image only.

3 To adjust contrast and brightness on the touch screen module, do the following:

a Select the X-ray Acquisition application.

b Select the Processing task and tap CBE.

c Use the Contrast and brightness controls.

d To select whether your changes apply to the current image only or to all images, tap Scope and
select an option.

– Apply changes to the current image only.


– Apply changes to all images in the series.

4 To reset your changes, click or tap Reset in the task panel.

You can also reset your changes by clicking Reset Image Processing on the toolbar in the
acquisition window or review window.

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Processing Enhancing Edges in Images

9.4 Enhancing Edges in Images


To assist you when reviewing images, you can use the edge enhancement function to sharpen edges
and make them clearer.

1 To enhance edges using the mouse directly on the image, click Edge enhancements on the toolbar
in the acquisition window or review window, and do the following:
• Drag upward to make edges sharper.
• Drag downward to make edges softer.

2 To adjust edge enhancement in the task panel, do the following:

a Select the Processing task and click Contrast, Brightness, Edge.

b Adjust the Edge enhancements slider.

c To apply the changes to the current image only, select Adjust current image only.

3 To adjust edge enhancement on the touch screen module, do the following:

a Select the X-ray Acquisition application.

b Select the Processing task and tap CBE.

c Use the Edge enhancements controls.

d To select whether your changes apply to the current image only or to all images, tap Scope and
select an option.

– Apply changes to the current image only.


– Apply changes to all images in the series.

4 To reset your changes, click or tap Reset in the task panel.

You can also reset your changes by clicking Reset Image Processing on the toolbar in the
acquisition window or review window.

9.5 Inverting Images


You can invert images when reviewing and processing.

1 Select the Processing task, and then click or tap Contrast, Brightness, Edge (CBE).

2 Click or tap Invert.

3 To switch the invert function off, click or tap Invert again.

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Processing Adding Annotations

9.6 Adding Annotations


You can add annotations to images using the Processing task.

The following types of annotations are available:


• Text annotation, using predefined labels or your own text
• Arrow
• Ellipse
• Rectangle
• Solid rectangle
• Polyline

NOTE You can copy and paste annotations using the standard PC keyboard shortcuts: Ctrl+C and
Ctrl+V.

Annotations are saved with the images, and they are available if you open the images in another
application on your system.

9.6.1 Adding a Text Annotation


You can add a text annotation using your own text or predefined text.

1 Click the Processing task, and then click Annotations to display the available options.

2 To apply an annotation to all images in the series, instead of just the selected image, select
Annotate All Images in the task panel before creating the annotation.

3 Click Free Format Text in the task panel, and then click in the image at the location where you want
to add the annotation.

The Free Format Text function is also available on the toolbar and in the shortcut menu when you
right-click a location in the image.

4 Do one of the following:


• Type your own text in the annotation, and then press Enter or click outside the annotation.
• Click the arrow at the end of the annotation and select a predefined annotation. For more
information, see Customizing Predefined Annotations (page 260).

NOTE To edit an annotation after creating it, click the annotation, and then edit the text.

5 To change the appearance of an annotation, right-click it and select an option from the shortcut
menu.

You can change the following characteristics, when available:


• Color
• Font Size
• Line Thickness

6 To move an annotation, drag it to a new location.

7 To delete an annotation, select the annotation, and then click Delete in the task panel.

You can also delete an annotation (or just an annotation's text label, if applicable) from the shortcut
menu after right-clicking the annotation.

9.6.2 Adding an Arrow


You can add an arrow annotation with a text label.

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Processing Adding Annotations

1 Click the Processing task, and then click Annotations to display the available options.

2 To apply an annotation to all images in the series, instead of just the selected image, select
Annotate All Images in the task panel before creating the annotation.

3 Click Arrow + Text in the task panel.

4 Click in the image at the location where you want to place the point of the arrow, and then click
again at the end of the arrow.

5 Do one of the following:


• Type your own text in the label, and then press Enter or click outside the label.
• Click the arrow at the end of the label and select a predefined annotation.
• To create the annotation without a text label, press Enter or click outside the label without
entering any text.

NOTE To edit a text label after creating an annotation, click the label, and then edit the text.

6 To change the appearance of an annotation, right-click it and select an option from the shortcut
menu.

You can change the following characteristics, when available:


• Color
• Font Size
• Line Thickness

7 To move an arrow or its text label, drag it to a new location.

8 To edit an arrow, drag an end point to a new location.

9 To delete an annotation, select the annotation, and then click Delete in the task panel.

You can also delete an annotation (or just an annotation's text label, if applicable) from the shortcut
menu after right-clicking the annotation.

9.6.3 Adding an Ellipse


1 Click the Processing task, and then click Annotations to display the available options.

2 Click Ellipse in the task panel, and then do the following (creating an ellipse requires three mouse
clicks):

• In the image, click to start drawing the ellipse.


• Move the pointer and click to set the length (long axis) of the ellipse.
• Click again to set the width (short axis) of the ellipse.

3 To change the appearance of an annotation, right-click it and select an option from the shortcut
menu.

You can change the following characteristics, when available:


• Color
• Font Size
• Line Thickness

4 To move an ellipse, drag it to a new location.

NOTE Before dragging an ellipse, move the pointer over the border of the ellipse.

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Processing Adding Annotations

5 To edit an ellipse, move the pointer over the ellipse, and then drag a control point to change the
shape of the ellipse.

6 To delete an annotation, select the annotation, and then click Delete in the task panel.

You can also delete an annotation (or just an annotation's text label, if applicable) from the shortcut
menu after right-clicking the annotation.

9.6.4 Adding a Rectangle


1 Click the Processing task, and then click Annotations to display the available options.

2 Click Rectangle in the task panel.

3 In the image, drag diagonally across the location where you want to place the rectangle.

4 To change the appearance of an annotation, right-click it and select an option from the shortcut
menu.

You can change the following characteristics, when available:


• Color
• Font Size
• Line Thickness

5 To move a rectangle, drag it to a new location.

NOTE Before dragging a rectangle, move the pointer over the border of the rectangle.

6 To edit a rectangle, move the pointer over the rectangle, and then drag a control point to change the
shape of the rectangle.

7 To delete an annotation, select the annotation, and then click Delete in the task panel.

You can also delete an annotation (or just an annotation's text label, if applicable) from the shortcut
menu after right-clicking the annotation.

9.6.5 Adding a Solid Rectangle


You can use a solid rectangle annotation to cover sensitive personal data in photo images that you want
to export.

1 Click the Processing task, and then click Annotations to display the available options.

2 Click Solid Rectangle in the task panel.

3 In the image, drag diagonally across the location where you want to place the rectangle.

4 To move a rectangle, drag it to a new location.

5 To edit a rectangle, move the pointer over the rectangle, and then drag a control point to change its
shape.

6 To delete an annotation, select the annotation, and then click Delete in the task panel.

You can also delete an annotation (or just an annotation's text label, if applicable) from the shortcut
menu after right-clicking the annotation.

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Processing Drawing Markers

9.6.6 Adding a Polyline


1 Click the Processing task, and then click Annotations to display the available options.

2 Click Polyline in the task panel.

3 In the image, click at the start point of the line.

4 Click at intermediate points in the line.

You can set as many intermediate points as you want.

5 Double-click at the end point of the line.

6 To change the appearance of an annotation, right-click it and select an option from the shortcut
menu.

You can change the following characteristics, when available:


• Color
• Font Size
• Line Thickness

7 To move a polyline, drag it to a new location.

8 To edit a polyline, do any of the following:


• Drag an end point or an intermediate point to a new location.
• To create a new point, click on the line between points and then drag the new point to a new
location.
• To delete a point, right-click the point and then click Delete Point.

9 To apply an annotation to all images in the series, instead of just the selected image, select
Annotate All Images in the task panel before creating the annotation.

10 To delete an annotation, select the annotation, and then click Delete in the task panel.

You can also delete an annotation (or just an annotation's text label, if applicable) from the shortcut
menu after right-clicking the annotation.

9.7 Drawing Markers


You can draw freehand markers on an overlay in a viewport to add guidance or information about the
displayed image, or to indicate a region of interest. Markers are visible in any window (in the
examination room and the control room) and on any touch screen module that also displays the image.

You can access the Markers function from the examination room or the control, using either the
workstation or the touch screen module.

1 Display the image that you want to overlay a marker on.

You can overlay markers on any acquired X-ray image, including fluoroscopy images that are not
stored.

2 To display the Markers task panel using the workstation, do the following:

a Select the Processing task in the task selection panel.

b Click Markers on the toolbar of the viewport.

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Processing Drawing Markers

NOTE The Markers function is grouped with the Interventional Room Pointer function on the
tool bar. You may need to click the arrow next to the Interventional Room Pointer
button to access the Markers function.

The Markers task panel is displayed and the Free Draw function is already selected.

3 To display the Markers task panel using the touch screen module, do the following:

a Select the X-ray Acquisition application.

b Select the Processing task in the task selection panel.

c Tap More in the panel on the right side of the touch screen module and then tap Markers.

The Markers task panel is displayed.

Legend
1 Free Draw 3 Undo
2 Available colors 4 Redo

d Tap Free Draw in the Markers task panel.

NOTE You can also tap and hold on the image viewport on the touch screen module to start
drawing a marker. This action also displays the Markers task panel. You can perform this
action in either the Series task or the Processing task.

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Processing Drawing Markers

Figure 103 Tap and hold to create a marker on the touch screen module

4 Select a color for the marker in the Markers task panel.

You cannot change the color of a marker after creating it.

5 Use the mouse or your finger to draw a marker.

You can draw as many markers as desired.

NOTE When using the touch screen module, you can perform the following interactions:
• To draw a straight line, touch the screen with two fingers.
• To draw a round shape, touch the screen with three fingers.

While using these gestures, a preview is displayed on the touch screen module. You can adjust the
marker while your fingers are still touching the module. The marker is drawn on the image when you
release your fingers.

Markers are displayed on all images in the series, and on all images acquired after creating markers.
However, markers are removed if there is significant movement of the geometry.

Markers are displayed during X-ray acquisition and when viewing the series as a movie. In dual
fluoroscopy mode, markers are displayed on both viewports and are zoomed according to the zoom
factor of the displayed image.

On biplane systems, you can overlay markers on either channel but they are only displayed on
images in the same channel.

6 To pan or zoom while drawing markers, do the following:

a Tap Free Draw to deactivate the Markers function.

b Drag with your finger to pan or pinch in or out to zoom.

c Tap Free Draw again to continue drawing markers.

7 To undo or redo your actions, click or tap Undo or Redo in the Markers task panel.

8 To remove markers from the overlay, click or tap Remove All.

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Processing Cropping Images

All markers are removed automatically when you select a new study for acquisition.

9 When you have finished drawing markers, click or tap Close in the upper-right corner of the Markers
task panel.

NOTE Markers are not stored or exported with the series. However, if you copy a series to a
reference view, markers are also copied and they are converted to standard annotations.

9.8 Cropping Images


Cropping an image allows you to hide parts of the viewed image that are not of interest. This does not
affect the stored image. Crop lines are also known as electronic shutters.

1 Click the Processing task in the acquisition or review windows.

2 Click Image Cropping in the control panel.

Shutter lines are displayed at the edges of the image.

Figure 104 Shutter lines when cropping an image

3 To move the left and right, and top and bottom lines together, select the Use symmetric lines check
box.

For example, moving the left shutter line to the right when using symmetric lines, will also cause the
right shutter line to move to the left.

4 To set each line to move independently, clear the Use symmetric lines check box.

5 To move a line, drag it to the desired position.

NOTE The shutter lines disappear in the acquisition window when acquisition starts or when a
new task is selected in the control panel. To move the shutter lines after they have
disappeared, you must first reselect Image Cropping in the control panel.

6 To reset all image processing changes, click Reset in the control panel, or click Reset Image
Processing on the toolbar.

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Processing Using Subtraction

9.9 Using Subtraction


Subtraction can assist with orientation in the anatomy when reviewing series, and can help you
visualize blood vessels in soft tissue by removing details that do not relate to the contrast-filled vessels.

Subtraction uses a mask image. You can select the mask from the same series, or subtract one series
from another series.

1 Open the series that you want to perform postprocessing on.

2 Select the Processing task.

3 Select Vascular Tools.

4 To start subtraction, do one of the following:

a To use a single mask image, select Image Subtraction.

This function subtracts all images in a series from one single mask image.

NOTE You can also select Image Subtraction using the toolbar.

b To subtract one series from another series, select Series Subtraction

This function subtracts all images in a series from the corresponding images (images with the
same image number) in another series from the same study.

9.9.1 Changing the Subtraction Mask


You can change the mask used for subtraction by selecting another image from the current series or by
selecting another series within the same study. This is also known as remasking.

Ensure that subtraction is switched on. For more information, see Using Subtraction (page 174).

1 Select the Processing task.

2 Select Vascular Tools.

3 If you are using the touch screen module, tap Remask.

4 If you are using Image Subtraction, use one of the following functions to select a new mask image:


Sets the current image as the new mask image. Before using this function, navigate to
the desired mask image. This function is also available on the toolbar.

Sets the last image in the current series as the new mask image.

Sets the image before the current mask image as the new mask image.

Sets the image after the current mask image as the new mask image.

5 If you are using Series Subtraction, do one of the following to select a new mask series:

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Processing Using Landmarking


Sets the series before the current mask series as the new mask series.

Sets the series after the current mask series as the new mask series.

6 To reset the mask to the default mask used during acquisition, select Reset.

9.9.2 Adjusting the Mask Position


If the mask image and the live image are not aligned, for example, due to patient movement, you can
adjust the position of the mask image.

Ensure that subtraction is switched on. For more information, see Using Subtraction (page 174).

1 Select the Processing task, and then select Vascular Tools.

2 Select Pixel Shift.

NOTE You can also select Pixel Shift using the toolbar.

3 Select the Scope to determine what images to apply the repositioning to.

• Apply changes to all images in the series.


• Apply changes to the current image only.
• Apply changes to the current image and preceding images.
• Apply changes to the current image and all following images.

4 To adjust the position of the mask image using the mouse, drag the mask image to the new position.

5 To adjust the position of the mask image using the touch screen module, tap the arrow
corresponding to the desired direction.

6 To reset the mask image position, click or tap Reset.

9.10 Using Landmarking


Landmarking allows you to fade in background anatomy when reviewing images.

You can only apply Landmarking if subtraction is switched on.

1 To adjust landmarking using the mouse directly on the image, right-click the image, click
Landmarking, and then do one of the following:
• To increase transparency, drag upward.
• To decrease transparency, drag downward.

2 To adjust landmarking in the control panel, do the following:

a Select the Processing task and click Vascular Tools.

b click On in the Landmarking control panel

c Adjust the Landmarking slider.

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Processing Creating a View Trace Image

d To apply the changes to the current image only, select Adjust current image only.

NOTE You can also select Landmarking using the toolbar.

3 To adjust landmarking on the touch screen module, do the following:

a Select the X-ray Acquisition application.

b Select the Processing task, tap Vascular Tools, and then tap Landmarking.

c Use the Landmarking controls.

d To select whether your changes apply to the current image only or to all images, tap Scope and
select an option.

– Apply changes to the current image only.


– Apply changes to all images in the series.

4 To turn landmarking on or off, click Landmarking on the toolbar.

5 To reset your changes, click or tap Reset in the task panel.

You can also reset your changes by clicking Reset Image Processing on the toolbar in the
acquisition window or review window.

9.11 Creating a View Trace Image


View Trace creates a single image showing the whole vessel tree filled with contrast. The system
creates this image by adding together images that you select from the series.

To use View Trace, the series that you are reviewing must contain images with contrast medium.

NOTE While creating a view trace image, other processing tools are unavailable.

1 Navigate to the image that you want to use as the starting point.

2 Click the Processing task in the acquisition or review window.

3 Click View Trace.

The View Trace control panel opens and the view trace image is displayed.

4 Select the contrast medium in use.


• Iodine
• CO2

5 To add the current image to the view trace image, click Add.

The image is added to the view trace image and the next image is displayed. The following symbol
is displayed:

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Processing Copying Images and Series to Reference Windows

6 To move to the next image without adding the current image to the view trace image, click Skip.

7 To remove the last image added from view trace image, click Undo Last.

8 To save the view trace image, click Save.

9 To cancel the creation of the view trace image, click Exit.

The View Trace control panel closes.

NOTE An unsaved view trace image is not saved automatically.

9.12 Copying Images and Series to Reference Windows


You can copy an image or series to a reference window. Depending on your system configuration, either
two or three reference windows are available.

In the control room, reference windows that are in use are displayed as tabs in the header area. In the
examination room, separate reference windows or viewports are used.

1 To copy an image, navigate to the desired image, do one of the following:


• Click Copy image to Reference 1. On a biplane system, the image with focus is copied. If neither
image has focus, the frontal image is copied.
• Click Copy image to Reference 2. On a biplane system, the image with focus is copied. If neither
image has focus, the lateral image is copied.
• Click Copy image to Reference 3. On a biplane system, the image with focus is copied. If neither
image has focus, both images are copied.

2 To copy the series, right-click on the current image, select Copy to Reference in the shortcut menu,
and do one of the following:
• Click Copy series to Reference 1. On a biplane system, the series from the frontal channel is
copied.
• Click Copy series to Reference 2. On a biplane system, the series from the lateral channel is
copied.
• Click Copy series to Reference 3. On a biplane system, the series with focus is copied. If neither
series has focus, both series are copied.

3 To view an image or series copied to a reference window, click on the corresponding reference tab
in the header area of the review monitor, or refer to the appropriate window or viewport in the
examination room.

9.13 Creating a Snapshot


You can create a snapshot of an image, including any annotations on the image. Snapshots are stored
in the relevant patient study as photo images.

1 Navigate to the desired image.

2 Do one of the following:

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Processing Flagging Images

• On the toolbar, click Copy as photo image.

• Right-click on the image and select Copy as photo image.

The snapshot is stored as a photo image within the patient study.

9.14 Flagging Images


You can flag one or more images to create a selection for exporting or printing.

1 To flag a particular image, use the navigation toolbar to display the image, and then click Flag on
the toolbar.

You can display and flag other images in the series using this method.

2 To flag all images in the current series, click the arrow next to the Flag tool on the toolbar and select
Flag Series.

Images that have been flagged display a flag symbol in the upper-right corner:

9.15 Creating Measurements


You can create measurements on images using the Measurements task panel in the Processing task.

NOTE You can also display the Measurements task panel using the Measurements button in the
top bar of a viewport in any task.

The following types of measurements are available:


• Distance
• Polyline
• Ratio
• Angle
• Open Angle

Measurements are saved with the images, and they are available if you open the images in another
application on your system.

Calibration
Calibration is required to obtain absolute values with distance measurements. If the current series has
already been calibrated, the calibration factor is displayed with an option to re-calibrate, if desired. If
the series not yet been calibrated and automatic calibration is available, you can accept the calibration
factor and continue with measurement.

To accept the automatic calibration factor, click Accept in the Calibration task panel.

When you accept the calibration factor, the information is added to the image information overlay on
the image.

CAUTION
If you use automatic calibration for measurements or quantitative analysis, the region of interest
must be positioned as close to the isocenter as possible during acquisition. If the region of interest is
not in the isocenter, the calibration factor will not be correct and measurements will not be accurate.

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Processing Creating Measurements

If automatic calibration is not available, you should calibrate the series manually. For more information,
see Manual Calibration (page 182).

NOTE If you accept the calibration factor, measurement values are displayed in millimeters. If you
do not accept the calibration factor, measurement values are displayed in pixels.

Accuracy
Accuracy of length measurements, when calibrated automatically, is ±5% when the measured object is
in the isocenter and where the length of the object is at least 50 pixels on the monitor.

Accuracy of angle measurements is ±2 degrees.

9.15.1 Creating a Distance Measurement


NOTE You can also perform this task using the touch screen module. See Creating a Distance
Measurement on the Touch Screen Module (page 179).

1 Select the Processing task and click Measurements to display the Measurements task panel.

NOTE You can also display the Measurements task panel using the Measurements button in the
top bar of a viewport in any task.

2 If the automatic calibration factor is available, click Accept.

If the automatic calibration factor is not available, you should perform manual calibration before
creating a measurement. For more information, see Manual Calibration (page 182).

3 Click Distance.

4 Click on the image at the start point of the measurement, then click again at the end point.

The measurement and its value are displayed on the image.

5 To move a measurement, drag it to a new location.

6 To edit a measurement, drag an end point to a new location.

7 To delete a measurement, select the measurement and click Delete in the task panel.

You can also delete the selected measurement using Delete on the keyboard, or from the shortcut
menu after right-clicking a measurement.

9.15.2 Creating a Distance Measurement on the Touch Screen Module


1 On the touch screen module, select the X-ray Acquisition application.

2 Select the Processing task.

3 Select Measurements in the task panel on the right.

4 In the Measurements task panel, select Distance.

If the image is not calibrated, a user message is displayed over the image indicating that automatic
calibration will be applied. Tap OK to accept the message.

5 To create a measurement, do one of the following:

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Processing Creating Measurements

• Tap at the start of the measurement and then tap again at the end of the measurement.
• Tap and hold at the start of the measurement and then drag to the end of the measurement.

The measurement and its value are displayed on the image.

6 If the automatic calibration factor is available, click Accept.

If the automatic calibration factor is not available, you should perform manual calibration before
creating a measurement. For more information, see Manual Calibration (page 182).

7 To edit a measurement, tap the start point or the end point to select it, and then drag it to a new
position.

When you select a point, a ring is briefly displayed around the point to indicate that it is selected.
The end point is automatically selected when you create a measurement.

8 To remove all measurements from the image, tap Remove All.

All measurements are removed from the current channel. For linked images, measurements are
removed from both channels.

9.15.3 Creating a Polyline Measurement


1 Select the Processing task and click Measurements to display the Measurements task panel.

NOTE You can also display the Measurements task panel using the Measurements button in the
top bar of a viewport in any task.

2 If the automatic calibration factor is available, click Accept.

If the automatic calibration factor is not available, you should perform manual calibration before
creating a measurement. For more information, see Manual Calibration (page 182).

3 Click Polyline.

4 In the image, click at the start point of the line.

5 Click at intermediate points in the line.

You can set as many intermediate points as you want.

6 Double-click at the end point of the line.

7 To move a measurement, drag it to a new location.

8 To edit a measurement, do any of the following:

• Drag any of the points on the line to a new location.


• To delete a point, right-click the point and then click Delete Point.

9 To delete a measurement, select the measurement and click Delete in the task panel.

You can also delete the selected measurement using Delete on the keyboard, or from the shortcut
menu after right-clicking a measurement.

9.15.4 Creating a Ratio Measurement


A ratio measurement displays the difference between two distances as a percentage.

1 Select the Processing task and click Measurements to display the Measurements task panel.

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Processing Creating Measurements

NOTE You can also display the Measurements task panel using the Measurements button in the
top bar of a viewport in any task.

2 If the automatic calibration factor is available, click Accept.

If the automatic calibration factor is not available, you should perform manual calibration before
creating a measurement. For more information, see Manual Calibration (page 182).

3 Click Ratio.

4 Click in the image at the start point of the first distance line, then click again at the end point.

5 Click at the start point of the second distance line, then click again at the end point.

The two distance lines are displayed in the image, and the ratio of the second distance to the first
distance is indicated.

6 To move a measurement, drag it to a new location.

7 To edit a measurement, drag an end point to a new location.

8 To delete a measurement, select the measurement and click Delete in the task panel.

You can also delete the selected measurement using Delete on the keyboard, or from the shortcut
menu after right-clicking a measurement.

9.15.5 Creating an Angle Measurement


An angle measurement displays the angle between two angle legs that are joined at the apex.

1 Select the Processing task and click Measurements to display the Measurements task panel.

NOTE You can also display the Measurements task panel using the Measurements button in the
top bar of a viewport in any task.

2 If the automatic calibration factor is available, click Accept.

If the automatic calibration factor is not available, you should perform manual calibration before
creating a measurement. For more information, see Manual Calibration (page 182).

3 Click Angle.

4 Click in the image at the end of the first angle leg.

5 Click at the apex of the angle.

6 Click at the end of the second leg.

The angle and its value are displayed in the image.

7 To move a measurement, drag it to a new location.

8 To edit a measurement, drag an end point or the apex to a new location.

9 To delete a measurement, select the measurement and click Delete in the task panel.

You can also delete the selected measurement using Delete on the keyboard, or from the shortcut
menu after right-clicking a measurement.

9.15.6 Creating an Open Angle Measurement


An open angle measurement displays the angle between two lines that are not joined at an apex.

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Processing Creating Measurements

1 Select the Processing task and click Measurements to display the Measurements task panel.

NOTE You can also display the Measurements task panel using the Measurements button in the
top bar of a viewport in any task.

2 If the automatic calibration factor is available, click Accept.

If the automatic calibration factor is not available, you should perform manual calibration before
creating a measurement. For more information, see Manual Calibration (page 182).

3 Click Open Angle.

4 Click in the image at the start point of the first line, then click again at the end point.

5 Click at the start point of the second line, then click again at the end point.

The two lines and the value of the angle between them are displayed in the image.

6 To move a measurement, drag it to a new location.

7 To edit a measurement, drag an end point to a new location.

8 To delete a measurement, select the measurement and click Delete in the task panel.

You can also delete the selected measurement using Delete on the keyboard, or from the shortcut
menu after right-clicking a measurement.

9.15.7 Manual Calibration


To ensure accurate measurements, the measurement function must be calibrated.

You can perform manual calibration using one of the following methods:
• Catheter
• Distance
• Sphere

NOTE When performing manual calibration on biplane images, you must perform calibration on
frontal image and the lateral image separately.

Catheter Calibration
You perform catheter calibration by tracing the centerline of a catheter in the image.

You can perform catheter calibration on either a straight catheter segment or a curved segment, but you
should always use a non-tapered segment. Using a tapered segment for calibration will result in
incorrect measurement results.

1 In the Calibration and Measurements task panel, click Manual Calibration to display the
Calibration dialog box.

2 In the Cal. Method list, select Catheter.

3 If you want to change the series on which to perform calibration, click Change and select an
available series.

The currently selected series is used by default. The selected series number is displayed in the task
panel.

4 Click Draw in the control panel and do the following:

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Processing Creating Measurements

• Click on the centerline of the catheter at the desired start point.


• Click again to place a point further along the centerline.
• Continue placing points along the centerline, and then double-click at the desired end point.

For additional information, click Help in the control panel.

5 To hide or show the contour of the catheter as you work, select or clear Hide in the control panel.

6 To edit a contour, click Edit in the control panel, and do one of the following:
• Click along the walls of the catheter in the image and then double-click on the last position to
complete the contour.
• Drag along the walls of the catheter in the image to correct the position of the contour.

7 When the contours are complete, select the catheter size from the list in the control panel.

If the desired catheter size is not available, you can type it directly in the box.

8 You can delete the calibration at any time and start over by clicking Delete in the task panel.

9 To complete manual calibration, click Accept and Close.

Distance Calibration
You perform distance calibration by marking a known distance in the image.

1 In the Calibration and Measurements task panel, click Manual Calibration to display the
Calibration dialog box.

2 In the Cal. Method list, select Distance.

3 If you want to change the series on which to perform calibration, click Change and select an
available series.

The currently selected series is used by default. The selected series number is displayed in the task
panel.

4 Click Draw in the control panel and do the following:

• Click in the image at the desired start point of the line.


• Click again at the desired end point.

5 To hide or show the line, select or clear Hide in the control panel.

6 To edit the line, click Edit in the control panel, and do the following:

a Move the pointer over the start point or the end point

b Drag the point to a new position.

7 After drawing the line, select the distance in the list in the control panel.

If the desired distance is not available, you can type it directly in the box.

8 You can delete the calibration at any time and start over by clicking Delete in the task panel.

9 To complete manual calibration, click Accept and Close.

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Processing Creating Measurements

Sphere Calibration
You perform sphere calibration by identifying a sphere of a known size in the image.

1 In the Calibration and Measurements task panel, click Manual Calibration to display the
Calibration dialog box.

2 In the Cal. Method list, select Sphere.

3 If you want to change the series on which to perform calibration, click Change and select an
available series.

The currently selected series is used by default. The selected series number is displayed in the task
panel.

4 Click Draw in the control panel.

5 Click a sphere in the image to identify it.

6 To hide or show the sphere contour, select or clear Hide in the control panel.

7 To edit the sphere, click Edit in the control panel, and do any of the following:
• To move the sphere, drag the center of the sphere to a new position.
• To change the diameter of the sphere, drag the circumference of the sphere.

8 When the sphere is defined, select the diameter in the list in the control panel.

If the desired diameter is not available, you can type it directly in the box.

9 You can delete the calibration at any time and start over by clicking Delete in the task panel.

10 To complete manual calibration, click Accept and Close.

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Exporting and Printing Exporting Data

10 Exporting and Printing


The following sections provide information about how to export the images that you acquired during a
patient study. Printing functions are also provided on the system if a printer is available.

10.1 Exporting Data


You can export locally stored data to network locations or to storage devices in either DICOM or PC
formats.

You can export complete studies or selected series and images from a study to a network location, a
DICOM archive, or to a storage device such as USB flash memory drives or CD/DVD.

When you export biplane images, the frontal and lateral images are always exported together.

You can export images in the following formats:

Destination Supported Formats


USB memory device DICOM, PNG, MPEG4
PACS, Xcelera, MultiModality Viewer DICOM
DVD DICOM, PNG, MPEG4

CAUTION
Do not use images in PNG or MPEG4 format for diagnostic purposes. Such images are for non-
diagnostic viewing only.

You can also configure the system to export data automatically when you acquire images or when you
close a study, by customizing the export protocols in use. For more information about customizing
export protocols and automatic data transfer, see Configuring Export Protocols (page 273) and
Configuring Automatic Data Transfer (page 275).

NOTE Export protocols and automatic data transfer settings can only be customized by a system
administrator.

10.1.1 Exporting Data to a USB Flash Memory Drive


You can export data from either the Series task or from the patients list to a USB flash memory drive in
either DICOM or PC format, allowing you to view the study, series, or images on another system or
computer.

Ensure you have the desired study open in the Series task in the review window, or that you have the
patients list open and the study available.

You can select images or series to export and you can export more than one study, series, or image at a
time.

NOTE When handling personal data, do so in accordance with the privacy policies that apply in
your healthcare environment and privacy laws that apply in your region.

NOTE USB devices may contain malicious software that could steal personal information or cause
the system to malfunction. You should always scan a USB device for malicious software
before connecting it to the system.

1 Ensure that the appropriate level of patient information is displayed in the images using the Image
overlays tool in the global tools panel.

2 Insert a USB flash memory drive into one of the USB ports at the side of the left monitor.

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Exporting and Printing Exporting Data

Regardless of the position of the review and acquisition monitors (left or right) within the control
room, the USB ports are always situated in the left monitor.

Figure 105 Inserting a USB flash memory drive

If the device is password-protected, enter the password in the dialog box displayed and click
Unlock.

3 Select the studies, series or images you want to export.

To select more than one study, series, or image at a time, do one of the following:
• In the Series task, hold down the Ctrl key and click each of the images or series you want to
export.
• In the Series task, click the first image or series you want to export and then click the check box
in the top left corner of each additional pictorial you want to select.
• In the patients list, hold down the Ctrl key and click each of the studies you want to export.

NOTE Biplane series are always displayed with the frontal series and lateral series side by side
in the Series task. When you select a biplane series, the corresponding series on the other
channel is also selected.

4 Do one of the following:


• In the Series task, right click one of the selected pictorials and select Save To.
• In the patients list, click Save To.

The Save To dialog panel is displayed.

5 Ensure Selected images is selected.

To change the images you want to export, you can choose one of the following options:
• Selected images 1
• Selected series
• All series 2
• All acquired series
• Photo Images
• Reference images
• Flagged images
1
This option is only available if you have selected specific images to export.
2
This option is not available if you have selected specific images to export.

The series or images being exported are listed below your selection.

6 To select a DICOM format for export, do the following:

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Exporting and Printing Exporting Data

a Select the Format to use for exporting, from the DICOM Formats section of the drop-down list.

For all DICOM formats, the list displays the export protocols available. For more information on
changing export protocol settings, see Configuring Export Protocols (page 273).

b To include a standard DICOM viewer on the USB drive, select Include DICOM Viewer.

7 To select a PC format for export, do the following:

a Select the Format to use for exporting, from the PC Formats section of the drop-down list.

You can select a PC format which allows you to export a series as an MPEG4 movie, and images
as PNG photos.

b Enter a filename for the exported data.

If you are exporting more than one series or image, each file will be exported using the name
you enter with a consecutive number added.

8 Select USB in the Destination list.

The amount of free space on the USB drive is displayed with a colored bar:
• Green: more than 20% space is available
• Orange: between 10% and 20% space is available
• Red: less than 10% space is available

The default destination for a USB drive is the root folder of the drive.

9 To select a subfolder within the USB drive, do the following:

a Click Browse.

b Select the desired subfolder.

c Click OK.

10 To de-identify the images, do the following:

a Select De-Identify.

b For each of the patients listed, enter an alternative De-Identified Name.

NOTE Personal data in photo images cannot be de-identified. You can use a solid rectangle
annotation to cover sensitive personal data in photo images that you want to export. For
more information, see Adding a Solid Rectangle (page 169).

11 Click Save to export the data.

12 Click Cancel to close the dialog panel without exporting data.

10.1.2 Exporting Data to CD/DVD


You can export data from either the Series task or from the patients list to a CD/DVD in either DICOM or
PC format, allowing you to view the study, series, or images on another system or computer.

NOTE CD-RW is an unreliable medium and is not recommended for archiving purposes.

Ensure you have the desired study open in the Series task in the review window, or that you have the
patients list open and the study available.

You can select images or series to export and you can export more than one study, series, or image at a
time.

NOTE When handling personal data, do so in accordance with the privacy policies that apply in
your healthcare environment and privacy laws that apply in your region.

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Exporting and Printing Exporting Data

1 Select the studies, series or images you want to export.

To select more than one study, series or image at a time, do one of the following:
• In the Series task, hold down the Ctrl key and click each of the images or series you want to
export.
• In the Series task, click the first image or series you want to export and then click the check box
in the top left corner of each additional pictorial you want to select.
• In the patients list, hold down the Ctrl key and click each of the studies you want to export.

NOTE Biplane series are always displayed with the frontal series and lateral series side by side
in the Series task. When you select a biplane series, the corresponding series on the other
channel is also selected.

2 Do one of the following:


• In the Series task, right click one of the selected pictorials and select Save To.
• In the patients list, click Save To.

The Save To dialog panel is displayed.

3 Ensure Selected images is selected.

To change the images you want to export, you can choose one of the following options:
• Selected images 1
• Selected series
• All series 2
• All acquired series
• Photo Images
• Reference images
• Flagged images
1
This option is only available if you have selected specific images to export.
2
This option is not available if you have selected specific images to export.

The series or images being exported are listed below your selection.

4 To select a DICOM format for export, do the following:

a Select the Format to use for exporting, from the DICOM Formats section of the drop-down list.

For all DICOM formats, the list displays the export protocols available. For more information on
changing export protocol settings, see Configuring Export Protocols (page 273).

b To include a standard DICOM viewer on the CD/DVD, select Include DICOM Viewer.

5 To select a PC format for export, do the following:

a Select the Format to use for exporting, from the PC Formats section of the drop-down list.

You can select a PC format which allows you to export a series as an MPEG4 movie, and images
as PNG photos.

b Enter a filename for the exported data.

If you are exporting more than one series or image, each file will be exported using the name
you enter with a consecutive number added.

6 Select DVD in the Destination list.

7 To de-identify the images, do the following:

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Exporting and Printing Exporting Data

a Select De-Identify.

b For each of the patients listed, enter an alternative De-Identified Name.

NOTE Personal data in photo images cannot be de-identified. You can use a solid rectangle
annotation to cover sensitive personal data in photo images that you want to export. For
more information, see Adding a Solid Rectangle (page 169).

8 Click Save to export the data.

9 Click Cancel to close the dialog panel without exporting data.

If the exporting process is interrupted for any reason while the disc is being written, for example by
restarting the system while the export is still in progress, it is possible that the external CD/DVD
drive fails to open. If the external CD/DVD drive fails to open or cannot be opened as normal
following a failed export process, switch the external CD/DVD drive off or disconnect its power
cable. When you switch the external CD/DVD drive on again, the disc tray should open normally.

10.1.3 Exporting Data to a PACS


If the system is connected to a Picture Archiving and Communication System (PACS) network location,
you can export DICOM format data to the selected PACS.

NOTE When handling personal data, do so in accordance with the privacy policies that apply in
your healthcare environment and privacy laws that apply in your region.

This procedure can be performed from either the Series task or from the patients list.

Ensure you have the desired study open in the Series task in the review window, or that you have the
patients list open and the study available.

1 Select the studies, series or images you want to export.

To select more than one study, series or image at a time, do one of the following:
• In the Series task, hold down the Ctrl key and click each of the images or series you want to
export.
• In the Series task, click the first image or series you want to export and then click the check box
in the top left corner of each additional pictorial you want to select.
• In the patients list, hold down the Ctrl key and click each of the studies you want to export.

NOTE Biplane series are always displayed with the frontal series and lateral series side by side
in the Series task. When you select a biplane series, the corresponding series on the other
channel is also selected.

2 Do one of the following:


• In the Series task, right click one of the selected pictorials and select Save To.
• In the patients list, click Save To.

The Save To dialog panel is displayed.

3 Ensure Selected images is selected.

To change the images you want to export, you can choose one of the following options:
• Selected images 1
• Selected series
• All series 2
• All acquired series
• Photo Images
• Reference images
• Flagged images

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Exporting and Printing Exporting Data

1
This option is only available if you have selected specific images to export.
2
This option is not available if you have selected specific images to export.

The series or images being exported are listed below your selection.

4 Select the Format to use for exporting, from the DICOM Formats section of the drop-down list.

For all DICOM formats, the list displays the export protocols available. For more information on
changing export protocol settings, see Configuring Export Protocols (page 273).

Data exported in PC formats cannot be exported to PACS locations.

5 Select the desired PACS network location in the Destination list.

6 To de-identify the images, do the following:

a Select De-Identify.

b For each of the patients listed, enter an alternative De-Identified Name.

NOTE Personal data in photo images cannot be de-identified. You can use a solid rectangle
annotation to cover sensitive personal data in photo images that you want to export. For
more information, see Adding a Solid Rectangle (page 169).

7 Click Save to export the data.

NOTE Before using exported images for diagnostic purposes, the system on which these images
are displayed should be validated using a representative set of exported images.

10.1.4 Exporting Data Using Drag and Drop


You can export studies or series quickly by dragging and dropping the desired data directly from the
patient list.

Ensure that the desired patient study is available in the patients list. If the device that you want to copy
to is password-protected, ensure that you know the password.

Ensure that the default export protocol is set as desired; this protocol is used when you export using
drag and drop. For more information on setting the default export protocol, see Configuring Export
Protocols (page 273).

NOTE When handling personal data, do so in accordance with the privacy policies that apply in
your healthcare environment and privacy laws that apply in your region.

1 Open the patient database by clicking the patient selector in the upper left corner of the the review
window.

2 To export a study using drag and drop, do the following:

a Select the desired study in the patient list.

b Drag and drop the study from the patients list onto the desired device or network location to the
left.

If the data cannot be exported to the desired location for any reason, the pointer changes to
indicate this.

3 To export a series from a study, do the following:

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Exporting and Printing Printing

a Select the desired study in the patient list.

b Select the Series tab.

c Drag and drop the desired series from the series list onto the desired device or network location
to the left.

If the data cannot be exported to the desired location for any reason, the pointer changes to
indicate this.

10.2 Printing
You use the print preview function to select images and dose reports and compose a print job for the
active study. You can then print the job on transparent film or on paper, using any printer that is
connected to the system.

Printing is performed in the background, so that there is no interference with the clinical workflow.

NOTE When handling personal data, do so in accordance with the privacy policies that apply in
your healthcare environment and privacy laws that apply in your region.

1 Use the navigation toolbar to display the image that you want to print in the main window.

2 Click Add to Print Preview in the global tools panel.

NOTE If you add a biplane image to Print Preview, both the frontal and lateral images are
added. If Optimize for biplane image printing is selected in the Print application settings,
they are printed side by side unless you change the page layout to 1x1 or a single column.
For more information, see Changing Print Settings (page 261).

3 To launch the print application, click More Tools and select Print Preview.

4 To add more images to the print preview, do the following:

a Click the viewer application tab.

b Select the Series task.

c Click the image to add in the task control panel.

d Click Add to Print Preview in the global tools panel.

e To return to the print application, click the print tab.

5 Select the following settings using the drop-down lists in the control panel.

• Printer
• Media size
• Media type (only applicable for DICOM printers)
• Orientation
• Page layout
• Image information
• Number of copies

6 To de-identify the images, do the following:

a Select De-Identify.

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Exporting and Printing Viewing System Tasks in the Job Viewer

NOTE Dose reports cannot be de-identified.

b For each of the patients listed, enter an alternative De-Identified Name.

7 Select the pages or page range you want to print.

Selecting All prints all of the pages in the print job.

If you want to print specific pages only, select the page range radio button and enter the pages or
range of pages you want to print.

To print a single page, enter the page number.

To print a page range, enter the page range using a dash. For example, to print pages 1 to 5, enter
1-5.

To print single pages and page ranges together, separate the page numbers with a comma. For
example, to print pages 1 to 5 and page 8 only, enter 1-5, 8.

8 To delete all images from the print job and start over, click Clear Preview in the control panel.

9 To delete selected images from the print job, do the following:

a Select the image to be deleted in the print preview.

Images can be selected in the print preview by selecting the check box in the top left corner of
the image.

b Click Delete Selected Images.

10 Select how you want the pages collated.


• Collated
• Uncollated

If you print more than one copy of the print job, or more than one copy of a page range, you can
choose to collate the pages. If you select collated pages, each copy of the print job is printed
individually in page order. If you select uncollated pages, all copies of each page are printed
together.

11 Click Print to print the print job or the selected pages.

10.3 Viewing System Tasks in the Job Viewer


Using the job viewer, you can see import, export, and print tasks being carried out by the system.

The job viewer displays tasks that are waiting or that resulted in errors and allows you to see what
errors were encountered.

You can also delete, abort, or repeat jobs.

1 On the System menu, click Job Viewer.

The job viewer is displayed.

The job viewer contains tabs for each type of task:


• All Jobs
• Export
• Import
• Print
• MPPS

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Exporting and Printing Viewing System Tasks in the Job Viewer

NOTE The MPPS tab is only shown if a Modality Performed Procedure Step Manager is
enabled. For more information, see Configuring Worklist Management and the Modality
Performed Procedure Step (MPPS) Manager (page 270).

If an error is encountered, the relevant tab displays a warning symbol.

2 Click on the relevant tab to find the job you are looking for.

Each tab displays the following information for each task:


• Name
• Type
• Location
• Status
• Submitted Time
• Progress

3 Select the job in the list.

4 To see more information about a task, click More Info.

More details about the task are displayed including any error messages and any available
recommendations for action.

Close the job details by clicking Close.

5 To delete a task, click Delete.

6 To cancel a task which is running or waiting, click Cancel.

7 To restart or repeat a task, click Redo.

8 To close the job viewer, click Close.

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2D Quantitative Analysis (Option) Acquiring X-ray Images

11 2D Quantitative Analysis (Option)


2D Quantitative Analysis is a dedicated suite of analysis applications that allow you to analyze
angiographic X-ray images using computational models to obtain quantitative information about
vessels and vessel obstructions, ventricular volumes, and ventricular wall motion. 2D-QA provides semi-
automatic contour detection of vessels, catheters, and the left ventricle.

11.1 Acquiring X-ray Images


Accurate results in 2D-QA can only be obtained with good quality images of the correct type and after
performing an accurate calibration. The following sections provide guidance for acquiring images for
use in 2D-QA.

CAUTION
You should take steps to prevent foreshortening in images to be used for analysis or calibration in
2D-QA.

CAUTION
If you intend to use automatic calibration during analysis, the object under investigation should be
placed as close to the isocenter as possible during image acquisition (within at most 5 cm).

CAUTION
Analysis results may not be accurate if a non-standard regression formula is used.

CAUTION
Analysis results may not be accurate in the following circumstances:
• The acquisition angles of the series used for analysis are out of range for the selected LVA / RVA
volume model or regression formula.
• The geometry positions of the calibration image and the analysis image are significantly
different.
• Catheter calibration is performed with a catheter that is less than 6 French.

CAUTION
RVA cannot be used with monoplane pediatric RV series.

General Guidance
• 2D-QA only supports exposure images.

• Avoid using images with insufficient image quality, such as low contrast, high noise, or overlapping
structures.
• Position the calibration object close to the position of the object under investigation.
• Objects under investigation should be evenly filled with contrast agent. If the contrast between an
object and its background is insufficient, the semi-automatic contour detection process cannot
detect contours properly.

NOTE CO2 should not be used as contrast agent when acquiring series for QVA.

Guidance for QCA and QVA


• Prevent foreshortening of objects by using projections where the object under analysis is in a plane
parallel to the image detector.
• Avoid imaging with strong noise, background structures, or overlapping vessels.
• Avoid imaging at 50/60 fps as the decreased resolution in these images affects the accuracy of the
results.

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2D Quantitative Analysis (Option) Starting 2D Quantitative Analysis

Guidance for LVA and RVA


• Use an acquisition speed of at least 15 fps to allow selection of images from non-ectopic beats and
in a proper end-diastolic and end-systolic phase.
• Acquire images from angles as prescribed for the various volume and wall motion methods.
• Instruct the patient in the use of breath-holding techniques for acquisition of images for wall motion
analysis.

11.2 Starting 2D Quantitative Analysis


1 Click the Processing task to display the image processing tools.

2 Click Measurements to display the Measurements task panel.

3 In the Open Analysis Tool section, click the desired analysis tool button to start the analysis.
• Quantitative Coronary Analysis

• Quantitative Vascular Analysis

• Left Ventricular Analysis

• Biplane Left Ventricular Analysis

• Right Ventricular Analysis

• Biplane Right Ventricular Analysis

NOTE To open only the frontal image or the lateral image of a biplane series in an analysis
application, right-click the image, point to Open With, and then click a monoplane
application.

11.3 Calibration Guidelines


A projection of an anatomical object on an X-ray detector is geometrically magnified. If you want to
perform a realistic measurement in the corresponding X-ray image, you have to compensate for that
magnification. This is done through performing a calibration on the X-ray image, and determining a
calibration factor (CF) in units of millimeter/pixel.

There are two main types of calibration:


• Auto calibration can be used when the anatomy is in isocenter. For objects at this location, 2D-QA
knows all relevant distances that are needed for automatic computation of the geometrical
magnification and the calibration factor. No further user input is required.
• Manual calibration is applicable for any location in the X-ray beam. The calibration factor for the
anatomy under investigation is computed with help of a calibration object of known size positioned
nearby. The user marks the calibration object and indicates its actual size.

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2D Quantitative Analysis (Option) Calibration Guidelines

Note that errors in the calibration factor directly translate into proportional errors in QCA/QVA distance
measurements. In the computation of volumes in LVA/RVA, these errors even multiply by a factor of 2 to
3. Therefore it is important to adhere to the following guidelines for accurate calibration.

Avoid foreshortened views on the calibration object and the anatomy.


• This is important in distance calibration and for all measurements in anatomical regions of interest.

Position the calibration object and the object under investigation accurately.
• If you intend to use auto calibration, the object under investigation must be placed as close to the
isocenter as possible during image acquisition (within at most 5 cm).
• If you intend to use manual calibration (catheter, sphere, or distance), the calibration object must be
placed as close as possible to the anatomy under investigation.
• Differences in height between the anatomy and the isocenter (in auto calibration), or between the
anatomy and the calibration object (in manual calibration) cause differences in geometrical
magnification. This leads to additional errors in the calibration factor of 1-1.5% for each centimeter of
difference in height.

Auto calibration, or intermediate sized objects for manual Calibration, is preferred.


• Preferably use auto calibration when the anatomy under investigation is sufficiently close to the
isocenter (within at most 5 cm). Most images are usually acceptable for auto calibration.
• In case auto calibration is not applicable, catheter calibration is usually considered as the most
convenient option. However, when used in combination with modern small-diameter (4-6 French)
catheters, it is also the least accurate option (see the following table). If possible, use distance
calibration on a sizing catheter or sphere calibration instead.
• In general, the accuracy of manual calibration increases with the object size or distance used. Do
not use small calibration objects for manual calibration. If possible, choose a calibration object of
intermediate size (a few centimeters) for optimal accuracy.

Overview of Calibration Factor Accuracy

Calibration method (specification CF accuracy for properly positioned Additional errors in CF from inaccu-
condition) objects rate positioning or views
Auto calibration Accurate 1 1-1.5% for each centimeter of differ-
ence in height between isocenter and
anatomy
Distance calibration (over distance of a Accurate 1 1-1.5% for each centimeter of differ-
few cm) ence in height between object and
anatomy.
This method is sensitive to foreshort-
ening in the image
Sphere calibration (with metal ball of a Accurate 1 1-1.5% for each centimeter of differ-
few cm diameter) ence in height between sphere and
anatomy

Catheter calibration 2 (catheter of 6 Less accurate: approximately 7% error 1-1.5% for each centimeter of differ-
French diameter filled with contrast introduced 4 ence in height between catheter and
agent 3) anatomy

Note 1: Accurate means that the small deviation from this source does not adversely affect overall measurement accuracy.
Note 2: As verified for commonly used catheters. Due to the small diameter of modern catheters and diversity in their walls,
obtainable accuracies may vary with catheter brand and size.
Note 3: CO2 should not be used as contrast agent when acquiring series for QVA.
Note 4: Errors from using unfilled catheters or catheters below 6 French can be 20% or more.

Errors in the calibration factor propagate proportionally into QCA/QVA distance measurement. Relative
errors multiply with a factor of approximately 2 to 3 in the LVA/RVA computations of absolute ventricle
volumes. Ejection fraction, however, is not affected by these calibration inaccuracies.

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2D Quantitative Analysis (Option) QCA / QVA

Guidance for Manual Catheter Calibration


• Use a radiopaque catheter.
• Use a filled catheter to improve detection and accuracy.
• Philips Medical Systems does not recommend catheter calibration on empty catheters or catheters
below 6 French, as this may lead to an inaccurate calibration factor. The error can be 20% or more.
2D-QA does not support catheters below 4 French.
• To improve accuracy, avoid low dose and high frame rates.

Guidance for Manual Sphere Calibration


It is possible to use two different series for imaging the sphere and the anatomy under investigation.
However, ensure that the sphere and the anatomy have the same geometrical magnification in the X-
ray image. This means that the images are acquired with the following characteristics:
• The same X-ray focus-object distance and same object-detector distance.
• The same angulation and rotation angles.
• The same table height.

Checking calibration accuracy for your preferred catheter


1 Position a catheter and a ruler close together, acquire images, and then perform catheter
calibration.

2 In the X-ray image perform a QCA length measurement along the catheter between two marks on
the ruler and compare your result with the actual distance from the ruler.

11.4 QCA / QVA


The QCA and QVA applications have similar tasks, and they are described together in the following
sections.

Quantitative Coronary Analysis (QCA)


You use QCA to mark the contours of a coronary artery in the heart, analyze a stenosis, and create,
store and print reports of the analysis.

Quantitative Vascular Analysis (QVA)


You use QVA to mark the contours of aortic and peripheral arteries, analyse a stenosis, and create, store
and print reports of the analysis.

NOTE CO2 should not be used as contrast agent when acquiring series for QVA.

11.4.1 QCA / QVA Tasks


A set of predefined tasks is used to ensure coronary or vascular analysis is performed in a logical way.

The QCA and QVA applications provide the following tasks in order:
• Select Series
• Calibration
• Analysis
• Result

When a series is selected, the system progresses automatically to the Calibration task.

When the calibration factor is accepted, the system progresses automatically to the Analysis task.

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2D Quantitative Analysis (Option) QCA / QVA

NOTE Auto calibration is available if the appropriate image attributes in the selected series (source
image distance, source object distance, and image plane pixel spacing) did not change
during acquisition. If you choose auto calibration in this case, ensure that the region of
interest is in the isocenter.

11.4.2 Select Series Task


You use the Select Series task to select an image series for analysis.

NOTE Only XA exposure images can be used for analysis.

NOTE Series with image pixel sizes greater than 0.225 mm for QCA and greater than 0.4 mm for
QVA are suboptimal for analysis.

NOTE You can decrease the detector field size or decrease the frame speed to obtain smaller pixel
sizes.

1 Click Select Series in the task panel.

2 Select the desired image series in the Select Series dialog box and click Select to open the series.

11.4.3 Calibration Task


To allow accurate measurement during analysis and to ensure that measurements are displayed in
relevant units, the image must be calibrated.

NOTE You can configure default settings for calibration using the Customization screen. For
details, see Changing Default Calibration Settings (page 220).

You can perform calibration automatically or manually using the Calibration task.

Conditions
For accurate manual calibration, follow these guidelines:
• Position the calibration object close to the position of the anatomy under investigation.
• Choose a calibration object of intermediate size (a few centimeters) for optimal accuracy.

For manual catheter calibration, follow these guidelines:


• Use a radiopaque catheter.
• Use a filled catheter to improve detection.
• Use catheters for calibration that are at least 6 French. Catheters below 4 French are not supported.
• Ensure that the external catheter size as provided by the manufacturer is accurate.

Ensure that the image quality is good and that the contrast between the calibrating object and the
background is good.

Automatic Calibration
2D-QA can calculate the calibration factor automatically if the required information is available in the
image series.

1 Click the Calibration task.

The Auto calibration method is automatically selected if the required information is available in the
image series.

2 To accept the calibration factor, click Accept and Continue.

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Manual Calibration
You can perform manual calibration using one of the following methods:
• Catheter
• Distance
• Sphere

Catheter Calibration
You perform catheter calibration by tracing the centerline of a catheter in the image.

You can perform catheter calibration on either a straight catheter segment or a curved segment, but you
should always use a non-tapered segment. Using a tapered segment for calibration will result in
incorrect measurement results.

1 Use the navigation toolbar to review the series and select an image to be used for calibration.

NOTE You can change the calibration image at any time by clicking Change in the control panel
and selecting a different image.

2 Click the Calibration task.

3 Click Catheter in the Select calibration method list.

4 Click Draw in the control panel and do the following:

• Click on the centerline of the catheter at the desired start point.


• Click again to place a point further along the centerline.
• Continue placing points along the centerline, and then double-click at the desired end point.

For additional information, click Help in the control panel.

5 To hide or show the contour of the catheter as you work, select or clear Hide in the control panel.

6 To edit a contour, click Edit in the control panel, and do one of the following:
• Click along the walls of the catheter in the image and then double-click on the last position to
complete the contour.
• Drag along the walls of the catheter in the image to correct the position of the contour.

7 When the contours are complete, select the catheter size from the list in the control panel.

If the desired catheter size is not available, you can type it directly in the box.

8 You can delete the calibration at any time and start over by clicking Delete in the task panel.

9 To accept the calibration factor, click Accept and Continue in the control panel.

Distance Calibration
You perform distance calibration by marking a known distance in the image.

1 Use the navigation toolbar to review the series and select an image to be used for calibration.

NOTE You can change the calibration image at any time by clicking Change in the control panel
and selecting a different image.

2 Click the Calibration task.

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2D Quantitative Analysis (Option) QCA / QVA

3 Click Distance in the Select calibration method list.

4 Click Draw in the control panel and do the following:

• Click in the image at the desired start point of the line.


• Click again at the desired end point.

5 To hide or show the line, select or clear Hide in the control panel.

6 To edit the line, click Edit in the control panel, and do the following:

a Move the pointer over the start point or the end point

b Drag the point to a new position.

7 You can delete the calibration at any time and start over by clicking Delete in the task panel.

8 After drawing the line, select the distance in the list in the control panel.

If the desired distance is not available, you can type it directly in the box.

9 To accept the calibration factor, click Accept and Continue in the control panel.

Sphere Calibration
You perform sphere calibration by identifying a sphere of a known size in the image.

1 Use the navigation toolbar to review the series and select an image to be used for calibration.

NOTE You can change the calibration image at any time by clicking Change in the control panel
and selecting a different image.

2 Click the Calibration task.

3 Click Sphere in the Select calibration method list.

4 Click a sphere in the image to identify it.

5 To hide or show the sphere contour, select or clear Hide in the control panel.

6 To edit the sphere, click Edit in the control panel, and do any of the following:
• To move the sphere, drag the center of the sphere to a new position.
• To change the diameter of the sphere, drag the circumference of the sphere.

7 You can delete the calibration at any time and start over by clicking Delete in the task panel.

8 When the sphere is defined, select the diameter in the list in the control panel.

If the desired diameter is not available, you can type it directly in the box.

9 To accept the calibration factor, click Accept and Continue in the control panel.

11.4.4 Analysis Task


You use the Analysis task to identify and mark the contours of the coronary or vascular artery.

You can analyze subtracted and unsubtracted images in QVA, but you can analyze only unsubtracted
images in QCA.

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Defining the Region of Interest


You can define the contours of a region of interest automatically (“one-click” method), or by manually
placing points along the centerline of the vessel.

At any time, you can delete the contours and start over by selecting Delete in the control panel.

Defining the Region of Interest Automatically

This is also known as the “one-click” method. Measurements and graphs are displayed when the region
of interest is defined.

1 Click the Analysis task.

2 Click Identify Vessel Segment in the control panel.

3 Double-click on the stenosis in the center of the vessel to detect the contour of the vessel.

4 To adjust the contour, see Editing the Contour (page 201).

Detected contours may not be correctly aligned with the vessel wall if there is insufficient contrast in the
image, or if a bifurcation or overlapping vessels are present.

Defining the Region of Interest Manually

This method allows you to define the region of interest by placing points along the centerline of the
vessel. Measurements and graphs are displayed when the region of interest is defined.

1 Click the Analysis task.

2 Click Identify Vessel Segment in the control panel and do the following:

• Click the centerline of the vessel at the proximal part to place the start point of the region of
interest.
• Continue placing points along the centerline and double-click to place the end point and to
detect the contour of the vessel.

Editing the Contour


If the contour for the vessel segment is not satisfactory, you can edit the contour manually.

When editing a contour, you must start and finish the edit on the existing contour. The pointer changes
to indicate that you are close enough to the contour.

For additional information, click Help in the control panel.

1 In the analysis task, click Edit.

2 To edit the contour by clicking, do the following:

• Click the contour at the start point of the section to be edited.


• Continue placing points along the vessel wall and then double-click on the contour at the end
point of the edit.

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Figure 106 Editing the contour

3 To edit the contour by dragging, drag a point on the contour to the correct position on the vessel
wall.

4 To undo your last edit, click Undo Last Edit in the control panel.

Adjusting Measurements
You can adjust the analysis measurements by moving reference lines in the image or in the graph.

When you move a reference line, diameters, lengths, and percentages are automatically updated in the
Analysis Results panel.

When you move the minimum lesion diameter reference line, the reference lines in the image and in the
graph are displayed at the new position, but the system-defined reference line is maintained.

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Figure 107 Stenosis measurement reference lines

Legend
1 Proximal boundary 3 Distal boundary
2 Minimum lesion diameter (MLD) 4 Contour

1 To reposition the point of stenosis, drag the minimum lesion diameter to a new position.

2 To reposition the proximal boundary, drag the green reference line to a new position.

3 To reposition the distal boundary, drag the blue reference line to a new position.

4 To show or hide plaque within the segment, click Show/Hide Plaque in the control panel.

5 To show or hide the segment contour, click Show/Hide Contour in the control panel.

11.4.5 Result Task


You use the Result task to view analysis results from QCA and QVA.

The result page displays the analysis results, the analyzed image, and analysis graphs. Any warnings
associated with the analysis results are also displayed.

Accuracy of QCA / QVA Results

QCA

QCA Analysis Results Accuracy (Systematic Error) Precision (Random Error)


Vessel diameter < 0.2 mm (for diameters ≤ 1 mm) < 0.2 mm
< 0.1 mm (for diameters > 1 mm)
Vessel segment length < 1.0 mm < 2.0 mm

Vessel diameter accuracy is specified for measurements performed on a vessel placed in the isocenter,
using automatic calibration.

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Vessel segment length accuracy is specified for distances up to 50 mm between user-defined markers
on an unforeshortened view of a vessel placed in the isocenter, using automatic calibration.

NOTE Using an inaccurate calibration factor (due to, for example, foreshortening, inaccurate
position of the calibration object, or calibration on a small diameter catheter) may lead to
additional errors in measured lengths and diameters.

QVA

QVA Analysis Results Accuracy (Systematic Error) Precision (Random Error)


Vessel diameter < 0.2 mm (for diameters ≤ 20 mm) < 0.2 mm
< 1% (for diameters > 20 mm)
Vessel segment length < 1.0 mm < 2.0 mm

Vessel diameter accuracy is specified for measurements performed on a vessel placed in the isocenter,
using automatic calibration.

Vessel segment length accuracy is specified for distances up to 50 mm between user-defined markers
on an unforeshortened view of a vessel placed in the isocenter, using automatic calibration.

NOTE Using an inaccurate calibration factor (due to, for example, foreshortening, inaccurate
position of the calibration object, or calibration on a small diameter catheter) may lead to
additional errors in measured lengths and diameters.

References
Computations in 2D-QA are performed according to methods described in medical literature.

Author Article
Reiber, J.H.C. et al. On-line quantification of coronary angiograms with the DCI system. MedicaMundi, 34, no. 3,
1989. pp. 89-98.
Van der Zwet P.M.J. et al. A new approach for the automated definition of path lines in digitized coronary angiograms.
Int. J. Cardiac Imaging, 5, no. 2-3, 1990. pp. 75-83.
Van der Zwet, P.M.J. et al. An on-line system for the quantitative analysis of coronary arterial segments. Computers in
Cardiology, 1990.
Austen, W.G. et al. A reporting system on patients evaluated for coronary artery disease. Report of the Ad Hoc
Committee for grading of coronary artery disease. Council on Cardio-vascular Surgery,
American Heart Association. Circulation 51, no. 2, 1975. pp. 7-40.
Reiber, J.H.C. et al. Assessment of dimensions and image quality of coronary contrast catheters from cine an-
giograms. Catheterization and Cardio-vascular Diagnosis, 11, 1985, pp. 521-531.

11.5 LVA / RVA


The LVA and RVA applications have similar tasks, and they are described together in the following
sections.

Additional steps that are required for Biplane LVA and Biplane RVA are indicated where appropriate.

Left Ventricle Analysis (LVA)


You use LVA to establish end diastolic (ED) and end systolic (ES) contours of the left ventricle, to
determine ventricular volumes and wall motion. You can create, store and print reports of the analysis.

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Right Ventricle Analysis (RVA)


You use RVA to establish end diastolic (ED) and end systolic (ES) contours of the right ventricle, to
determine ventricular volumes and wall motion. You can create, store and print reports of the analysis.

11.5.1 LVA / RVA Tasks


A set of predefined tasks is used to ensure left or right ventricle analysis is performed in a logical way.

The LVA and RVA applications provide the following tasks in order:
• Select Series
• Calibration
• End Diastole
• End Systole
• Result

After you select a series, the Calibration task is automatically opened.

After you complete calibration, the End Diastole task is automatically opened.

NOTE Auto calibration is available if the appropriate image attributes in the selected series (source
image distance, source object distance, and image plane pixel spacing) did not change
during acquisition. If you choose auto calibration in this case, ensure that the region of
interest is in the isocenter.

11.5.2 Select Series Task


You use the Select Series Task to select a series for analysis.

NOTE Only XA exposure images can be used for analysis.

NOTE Series with characteristics outside the following ranges are suboptimal for analysis:
• Series with image pixel sizes greater than 1 mm.
• Series with frame rate less than 15 fps.
• Series captured with angulation and rotation angles that do match the angle
requirements for the selected volume method/regression formula.

1 Click Select Series in the tasks panel.

2 Select the desired image series in the Select Series dialog box and click Select to open the series.

11.5.3 Calibration Task


To allow accurate measurement during analysis and to ensure that measurements are displayed in
relevant units, the image must be calibrated.

NOTE You can configure default settings for calibration using the Customization screen. For
details, see Changing Default Calibration Settings (page 220).

You can perform calibration automatically using Auto Calibration, or manually using the Calibration
task.

If you are only interested in calculating the ejection fraction, you can skip calibration for monoplane LVA
and monoplane RVA.

Conditions
For manual calibration, follow these guidelines:

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• Position the calibration object close to the position of the anatomy under investigation.
• Choose a calibration object of intermediate size (a few centimeters) for optimal accuracy.
For LVA/RVA, the use of catheter calibration is not recommended. Relative errors from calibration
are multiplied by a factor of up to three when computing (ventricle) volumes.

For manual catheter calibration, follow these guidelines:


• Use a radiopaque catheter.
• Use a filled catheter to improve detection.
• Use catheters for calibration that are at least 6 French. Catheters below 4 French are not supported.
• Ensure that the external catheter size as provided by the manufacturer is accurate.

Ensure that the image quality is good and that the contrast between the calibrating object and the
background is good.

Automatic Calibration
2D-QA can calculate the calibration factor automatically if the required information is available in the
image series.

1 Click the Calibration task.

The Auto calibration method is automatically selected if the required information is available in the
image series.

2 To accept the calibration factor, click Accept and Continue.

Manual Calibration
You can perform manual calibration using one of the following methods:
• Catheter
• Distance
• Sphere

Catheter Calibration
You perform catheter calibration by tracing the centerline of a catheter in the image.

You can perform catheter calibration on either a straight catheter segment or a curved segment, but you
should always use a non-tapered segment. Using a tapered segment for calibration will result in
incorrect measurement results.

1 Use the navigation toolbar to review the series and select an image to be used for calibration.

NOTE You can change the calibration image at any time by clicking Change in the control panel
and selecting a different image.

2 Click the Calibration task.

3 Click Catheter in the Select calibration method list.

4 Click Draw in the control panel and do the following:

• Click on the centerline of the catheter at the desired start point.


• Click again to place a point further along the centerline.
• Continue placing points along the centerline, and then double-click at the desired end point.

For additional information, click Help in the control panel.

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5 To hide or show the contour of the catheter as you work, select or clear Hide in the control panel.

6 To edit a contour, click Edit in the control panel, and do one of the following:
• Click along the walls of the catheter in the image and then double-click on the last position to
complete the contour.
• Drag along the walls of the catheter in the image to correct the position of the contour.

7 If you are using Biplane LVA/RVA: Trace the centerline of the catheter in both the frontal image and
the lateral image.

8 When the contours are complete, select the catheter size from the list in the control panel.

If the desired catheter size is not available, you can type it directly in the box.

9 You can delete the calibration at any time and start over by clicking Delete in the task panel.

10 To accept the calibration factor, click Accept and Continue in the control panel.

Distance Calibration
You perform distance calibration by marking a known distance in the image.

1 Use the navigation toolbar to review the series and select an image to be used for calibration.

NOTE You can change the calibration image at any time by clicking Change in the control panel
and selecting a different image.

2 Click the Calibration task.

3 Click Distance in the Select calibration method list.

4 Click Draw in the control panel and do the following:

• Click in the image at the desired start point of the line.


• Click again at the desired end point.

5 To hide or show the line, select or clear Hide in the control panel.

6 To edit the line, click Edit in the control panel, and do the following:

a Move the pointer over the start point or the end point

b Drag the point to a new position.

7 If you are using Biplane LVA/RVA: Mark the line in both the frontal image and the lateral image.

8 You can delete the calibration at any time and start over by clicking Delete in the task panel.

9 After drawing the line, select the distance in the list in the control panel.

If the desired distance is not available, you can type it directly in the box.

10 To accept the calibration factor, click Accept and Continue in the control panel.

Sphere Calibration
You perform sphere calibration by identifying a sphere of a known size in the image.

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1 Use the navigation toolbar to review the series and select an image to be used for calibration.

NOTE You can change the calibration image at any time by clicking Change in the control panel
and selecting a different image.

2 Click the Calibration task.

3 Click Sphere in the Select calibration method list.

4 Click a sphere in the image to identify it.

5 To hide or show the sphere contour, select or clear Hide in the control panel.

6 To edit the sphere, click Edit in the control panel, and do any of the following:
• To move the sphere, drag the center of the sphere to a new position.
• To change the diameter of the sphere, drag the circumference of the sphere.

7 If you are using Biplane LVA/RVA: Mark the sphere in both the frontal image and the lateral image.

8 You can delete the calibration at any time and start over by clicking Delete in the task panel.

9 When the sphere is defined, select the diameter in the list in the control panel.

If the desired diameter is not available, you can type it directly in the box.

10 To accept the calibration factor, click Accept and Continue in the control panel.

11.5.4 End Diastole (ED) Task


You use the End Diastole task to select the ED image from the series and to define a contour on the
image.

When defining a contour in LVA, you can use either a semi-automatic method or a manual method.

When defining a contour in RVA, you can only use the manual method.

Selecting the ED Image


Before you define the ED contour, you must select a suitable image that shows the ED position.

If the ECG is available, it is displayed with the series to assist you with identifying the ED position.

1 Click End Diastole in the tasks panel.

2 Use the navigation toolbar to review the series and select an image that shows the ED position.

Defining the ED Contour Semi-Automatically in LVA


To define a contour semi-automatically in LVA, you place three key points on the selected image.

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Figure 108 LVA semi-automatic ED contour detection

After placing the points, the contour is displayed and the ED volume (EDV) is displayed in a panel in the
lower-right corner.

1 Click Semi-Automatic in the control panel.

2 Click on the superior border of the aortic root.

3 Click on the inferior border of the aortic root.

4 Click on the apex.

5 If you are using Biplane LVA: Perform this process on both the frontal image and the lateral image
so that the contour is detected in each image.

6 If you want to delete the contour and start over, click Delete in the control panel.

If the contrast level in the image is insufficient, the contour may not be correctly defined. You can
manually edit the contour to correct it: see Editing the Contour (page 212).

Defining the ED Contour Manually


To define a contour manually, you place points along the ventricle wall.

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Figure 109 ED manual contour definition

1 Click Manual in the control panel.

2 Click on the superior border of the aortic root (LVA) or the pulmonary root (RVA) to start the contour.

3 Click further along the ventricle wall to place the next point of the contour.

4 Continue placing points along the ventricle wall through the cardiac apex until you reach the inferior
border of the aortic root (LVA) or the pulmonary root (RVA).

5 Double-click on the inferior border of the aortic root (LVA) or the pulmonary root (RVA) to complete
the contour.

6 If you are using Biplane LVA/RVA: Perform this process on both the frontal image and the lateral
image so that the contour is detected in each image.

7 If you want to delete the contour and start over, click Delete in the control panel.

11.5.5 End Systole (ES) Task


You use the End Systole task to select the ES image from the series and to define a contour on the
image.

When defining a contour in LVA, you can use either a semi-automatic method or a manual method.

When defining a contour in RVA, you can only use the manual method.

Selecting the ES Image


Before you define the ES contour, you must select a suitable image that shows the ES position.

The ECG is displayed with the series to assist you with identifying the ES cardiac phase.

NOTE Ensure that the ES image that you select is in the same cardiac cycle as the ED image that
you selected in the End Diastole task.

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1 Click the End Systole task.

2 Use the navigation toolbar to review the series and select an image that shows the ES cardiac
phase.

Defining the ES Contour Semi-Automatically in LVA


To define a contour semi-automatically in LVA, you place three key points on the selected image.

After defining the ES contour, both the ED and ES contours are displayed in each image in the series.
The contours are highlighted when you view the image used to define the contour.

Figure 110 LVA semi-automatic ES contour detection

The main analysis results are displayed in a panel in the lower right corner.

1 Click Semi-Automatic in the control panel.

2 Click on the superior border of the aortic root.

3 Click on the inferior border of the aortic root.

4 Click on the apex.

5 If you are using Biplane LVA: Perform this process on both the frontal image and the lateral image
so that the contour is detected in each image.

6 If you want to delete the contour and start over, click Delete in the control panel.

7 Use the navigation toolbar to check the accuracy of the ED and ES contours in each image of the
series.

If the contrast level in the image is insufficient, the contour may not be correctly defined. You can
manually edit the contour to correct it: see Editing the Contour (page 212).

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Defining the ES Contour Manually


To define a contour manually, you place points along the ventricle wall.

After defining the ES contour, both the ED and ES contours are displayed in each image in the series.
The contours are highlighted when you view the image used to define the contour. The main analysis
results are also displayed in a panel in the lower right corner.

Figure 111 ES manual contour definition

1 Click Manual in the control panel.

2 Click on the superior border of the aortic root (LVA) or the pulmonary root (RVA) to start the contour.

3 Click further along the ventricle wall to place the next point of the contour.

4 Continue placing points along the ventricle wall through the cardiac apex until you reach the inferior
border of the aortic root (LVA) or the pulmonary root (RVA).

5 Double-click on the inferior border of the aortic root (LVA) or the pulmonary root (RVA) to complete
the contour.

6 If you are using Biplane LVA/RVA: Perform this process on both the frontal image and the lateral
image so that the contour is detected in each image.

7 If you want to delete the contour and start over, click Delete in the control panel.

8 Use the navigation toolbar to check the accuracy of the ED and ES contours in each image of the
series.

11.5.6 Editing the Contour


If the contour is not accurately defined, you can edit it manually.

When editing a contour, you must start and finish the edit on the existing contour. The pointer changes
to indicate that you are close enough to the contour.

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For additional information, click Help in the control panel.

1 Click Edit in the control panel.

2 Click the contour at the start point of the section to be edited.

3 Continue placing points along the vessel wall and then double-click on the contour at the end point
of the edit.

4 If you are using Biplane LVA/RVA: You can edit the contour in either the frontal image or the lateral
image as desired, or you can edit the contour in both images.

5 To undo your last edit, click Undo Last Edit in the control panel.

11.5.7 Result Task


Ventricle analysis results are displayed in the Result task.

This task displays the analysis results and the selected ED image with the ED and ES contours
indicated. Any warnings associated with the analysis results are also displayed.

Analysis Results
The ED or ES Volume calculation is based on the contour and the calibration factor, using the
calculation model selected in the customization settings.

A first iteration for the volume is calculated with the selected volume method. The volume displayed in
the report is corrected with a regression formula.

Indexed values can be calculated when the patient’s demographic information is available.

2D-QA has been thoroughly checked and tested. The software is designed to produce a mathematical
model as described in the medical literature or medical research. Philips Medical Systems cannot be
held responsible in any way for any inaccuracies of any nature resulting from the use of this software. If
the calibration guidelines are not followed, the absolute measurements may be inaccurate or
unreliable.

Analysis Results Description Formula (if applicable)


Ejection Fraction (EF) The Ejection Fraction is calculated EF (%) = (EDV-ESV) ÷ EDV × 100%
based on the ED Volume and the ES
Volume.
Cardiac Output This item indicates the amount of Cardiac Output (l/min) = Stroke Vol-
blood that the heart pumps through ume ÷ 1000 × BPM
the circulatory system in a minute. The
Cardiac Output is calculated as the
Stroke Volume times the heart rate in
Beats Per Minute.
Cardiac Index The Cardiac Index is the Cardiac Out- Cardiac Index (l/min/m2) = Cardiac
put indexed with Body Surface Area Output ÷ BSA
Heart Rate (BPM) The Heart Rate is indicated in Beats Per Minute.
Body Surface Area (BSA) Body Surface Area is calculated from the patient’s height and weight. BSA can be
used to generate indexed results.
Index Method The index method used to calculate indexed results.
Volume Method The selected volume method.

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Analysis Results Description Formula (if applicable)


ED Volume Regression The formula used with the volume method to calculate the ED volume.
ES Volume Regression The formula used with the volume method to calculate the ES volume.
Contour Correction Indicates whether contours were manually corrected during analysis.
Calibration Object The calibration method used and the size of the calibration object.
Calibration Factor The calibration factor calculated by the system using the inputs in the Calibration
task.
Series The series number of the series used for analysis.
ED Image The image number of the image used as the selected ED image.
ES Image The image number of the image used as the selected ES image.
Projection (Frontal/Lateral for biplane The projection used during acquistion (RAO/LAO).
systems)
ED Volume (EDV) The ED volume is calculated from using the volume method and the ED regres-
sion method.
The Indexed ED Volume is displayed if the patient’s demographics are available.
ES Volume (ESV) The ES volume is calculated from using the volume method and the ES regres-
sion method.
The Indexed ES Volume is displayed if the patient’s demographics are available.
Stroke Volume (SV) The Stroke Volume is calculated as the SV (ml) = EDV - ESV
difference of the ED Volume and the Indexed SV (ml/m2) = SV ÷ BSA
ES Volume.
The Indexed StrokeVolume is dis-
played if the patient’s demographics
are available.

Setting the Patient Demographics


Some analysis results depend on correctly defined patient demographics, such as the patient’s height,
weight, and heart rate.

The patient’s height and weight allows the Body Surface Area (BSA) to be calculated, which in turn
allows indexed analysis results to be calculated. When available, the patient’s height and weight are
automatically retrieved from the patient database, otherwise you can enter them manually.

The patient’s heart rate allows the Cardiac Output and the Cardiac Index to be calculated. The patient’s
heart rate is automatically entered if this information is available in the patient database, or you can
enter the information manually.

You can edit the acquisition patient’s demographics using the following procedure.

1 In the control panel, click Edit Patient Demographics.

2 If the patient’s height and weight information is not displayed, or if it is incorrect, enter the correct
information.

3 Enter the patient’s heart rate.

4 Click OK to close the dialog box and return to the Result task.

Volume Methods

Volume Methods: Area Length method


The Area Length method is based on a model of a three-dimensional ellipsoid that is symmetric around
its long axis. The resulting volume is corrected with an appropriate regression formula.

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Volume Methods: Simpson method


The Simpson method, or slice summation method, is based on a set of circular slices of equal thickness
perpendicular to the long axis. The resulting volume is corrected with an appropriate regression
formula.

Regression Formulas
The volume calculated from a two-dimensional image has to be corrected to be used as a
representation of the three dimensional left ventricle volume. A standard regression formula is used
during analysis. This can be changed in the customization settings.

CAUTION
Analysis results may not be accurate if a non-standard regression formula is used.

NOTE The results of the analysis are heavily influenced by the used regression formula, therefore
care should be taken when selecting these factors.

NOTE For standardization, it is recommended to use the same predefined method and regression
formulas throughout the department.

Predefined Regression Formula


Different volume correction formulas are defined to correct the ED and ES Volumes. The correction
formulas are defined in the customization screens and depend on the volume calculation method
selected (for both monoplane and biplane).

User Defined Regression Formula


The calculation of corrected volumes is as follows (for both monoplane and biplane):
• EDVcorr = [user defined factor] * EDVcalc + [user defined constant]
• ESVcorr = [user defined factor] * ESVcalc + [user defined constant]

You are free to define optimal formulas to correct the ED and ES volumes. User-defined factors can be
different for the Area Length method or the Simpson method.

If you are only interested in the percentage EF, this can be obtained by skipping the calibration
procedure.

The formula that is used for the results in the report is indicated in the report.

Wall Motion Results


Wall Motion results are not displayed by default. To include Wall Motion results in the results page,
select the Wall Motion options in the control panel:
• Slager Wall Motion
• Centerline Wall Motion

Slager Wall Motion Results (LVA only)


Slager Wall Motion results are calculated for LVA only. The result page includes an image showing a
representation of the Slager wall motion model, and graphs showing color-coded information
concerning the contribution to overall EF from each area of the heart wall.

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Figure 112 Slager Wall Motion

The Slager Wall Motion method is based on a contraction model and is described in medical literature:
• Slager, C.J., Hooghoudt, T.E.H., et al., “Quantitative assessment of regional left ventricular motion
using endocardial landmarks”
• Slager, D.J., Hooghoudt, T.E.H., et al., “Left ventricular contour segmentation from anatomical
landmark trajectories and its application to wall motion analysis”

The method is used to describe the displacement between the end diastole and end systole of
particular points on the left ventricular wall. The calculations are based on images in standard RAO 30-
degree projection, which is also required for the volume calculation utilized.

The left side of the results page shows a composite graph of CREF (Regional Contribution to global
Ejection Fraction) values for the 20 segments. CREF values are derived from systolic wall displacement
data and left ventricular long-axis shortening. The individual anterior and posterior CREF values of the
patient are superimposed and connected by straight lines.

To compare the quantitative results with those provided by the usual visual interpretation, the left
ventricular boundary is divided into 5 anatomical regions, denoted Anterobasal, Anterolateral, Apical,
Diaphragmatic, and Posterobasal. The segments are assigned to these regions and the CREF values for
the regions are plotted as well.

In LVA results, the gray band represents the wall motion parameters for a normal patient population,
collected by the Thorax Center, Erasmus University and the University Hospital Dijkzigt, Rotterdam, The
Netherlands. The gray band shows the average normal value ±2 standard deviations.

The left side of the results page shows the ED image chosen for left ventricular (EF) analysis with the
contours accepted during the analysis. Left ventricular segmental wall motion is computed along 20
straight lines, calculated from a mathematical expression derived from anatomical landmark trajectories
in normal patients.

The 20 lines result from 20 well-defined ED contour points or segments, 10 anterior and 10 posterior.
The point or segment numbers are plotted along the contour. A center of contraction is defined for each
pair of 2 opposite ED contour points.

Centerline Wall Motion Results (LVA / RVA)


Centerline Wall Motion results can be displayed for both LVA and RVA. The result page includes an
image showing a representation of the detected wall motion, a table showing kinetic parts, and graphs
showing normalized motion and standard deviation.

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Figure 113 Centerline Wall Motion

The Centerline Wall Motion method is described in medical literature: Sheehan, F.H. “Advantages and
applications of the centerline method for characterizing regional ventricular function”.

The Centerline Wall Motion method describes the displacement between the ED and ES of particular
points on the ventricular wall. The calculations are based on images in standard RAO 30-degree
projection, which is also required for the used volume calculation.

Between the ED and ES contours a centerline is defined. 100 Equidistant chords perpendicular to this
centerline are defined. Only 50 chords are shown in the graphic display. The chords are defined in such
a way that they do not cross each other.

Besides the image with the contours and chords, a table indicates the hyperkinetic parts (more than two
standard deviations of normal movement) and the hypokinetic parts (less than minus two standard
deviations of normal movement).

Graphs are also displayed, indicating normalized motion and standard deviation based on the lengths
of the chords. The vertical axis represents the length, the horizontal axis the location of the
measurement points over the ventricular wall.

In LVA results, the gray band represents the wall motion parameters for a normal population. The gray
band represents the wall motion parameters for a normal patient population, as described in the
above-mentioned article by Sheehan. The gray band shows the average normal value ±2 standard
deviations. This is not available in RVA results.

References
Computations in 2D Quantitative Analysis are performed according to methods described in medical
literature.

LVA

Author Article
Sandler, H. and Dodge, H.T The use of single plane angiocardiograms for the calculation of left ventricular volume in
man. American Heart Journal, 75, (3), 1968, pp 325-334.
Folland, E.D. and Parisi, A.F., Ventricular volume and function, in: Textbook of two-dimensional echocardiography, Tala-
no, J.V. and Gardin, J.M. (eds), Grune & Stratton (New York), p. 165, 1983.

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2D Quantitative Analysis (Option) LVA / RVA

Author Article
Reiber, J.H.C., Viddeleer, Left ventricular regression equations from single plane cine and digital X-ray ventriculo-
A.R., Koning, G. et al. grams revisited, International Journal of Cardiac Imaging, 12: 69-78, 1996.
Brower, P.W., Meester, G.T., Quantification of ventricular performance: A computer-based system for the analysis of an-
Hugenholtz, P.G. giographic data, Cath. and Cardiovasc. Diagn., 1, pp. 133-155, 1975.
Brower, P.W. and Meester, Quantification of left ventricular function in patients with coronary disease, in: Clinical and
G.T. research applications of engineering principles, University Park Press (Baltimore), chap. 16,
1979.
McHale, P.A. and Greenfield, Evaluation of several geometric models for estimation of left ventricular circumferential wall
J.C., stress, Circ. Res, 33, pp. 303-312, 1973.
Yang, S.S., Bentivoglio, L.G., From cardiac catheterization data to hemodynamic parameters, 3rd edition, F.A. Davis
et al. Company (Philadelphia), p. 42, 1988.
Koning, G., Brand, M. van Usefulness of digital angiography in the assessment of left ventricular ejection fraction,
den, Zorn, I., et al. Cath. and Cardiovasc. Diagn., 21, pp. 185-194, 1990.
Kennedy, J.W., Trenholme, Left ventricular volume and mass from single-plane cineangiocardiograms. A comparison of
S.E. and Kasser, I.S. anteroposterior and right anterior oblique methods. American Heart Journal, 1970, p 348.
Lange, P.E., Onnasch, et al., Angiocardiographic left ventricular volume determination. Accuracy as determined from hu-
man casts and clinical application. Eur. J. Cardiology, 1978, vol. 8.
Dodge, H.T., Sandler H. et al. The use of biplane angiography for measurement of left ventricular volume in man.
Am.Heart, 1960, vol.60.

RVA

Author Article
Arcilla RA, Tsai P, Thilenius Angiographic method for volume estimation of right and left ventricles. Chest 1971; 60(5):
O, Ranniger K. 446–454.
Boak JG, Bove AA, Kreulen A geometric basis for calculation of right ventricular volume in man. Cathet Cardiovasc Di-
T, Spann JF. agn 1977; 3(3): 217–230.
Ferlinz J. Measurements of right ventricular volumes in man from single plane cineangiograms. A
comparison to the biplane approach. Am Heart J 1977; 94(1): 87–90.
Gentzler RD, Briselli MF, Angiographic estimation of right ventricular volume in man. Circulation 1974; 50(2): 324–
Gault JH. 330.
Krebs W, Erbel R, Schweizer Right ventricular volume determination by two-dimensional echocardiography and radiog-
P, et al. raphy in model hearts using a subtraction method. Z Kardiol 1982; 71(6): 413–420.
Lange PE, Onnasch D, Farr Analysis of left and right ventricular size and shape, as determined from human casts. de-
FL, Malerczyk V, Heintzen scription of the method and its validation. Eur J Cardiol 1978; 8(4–5): 431–448.
PH.
Thilenius OG, Arcilla RA. Angiographic right and left ventricular volume determination in normal infants and children.
Pediatr Res 1974; 8(2): 67–74.
Grothues F, Moon JC, Bel- Interstudy reproducibility of right ventricular volumes, function, and mass with cardiovascu-
lenger NG, Smith GS, Klein lar magnetic resonance. Am Heart J 2004; 147(2): 218–223.
HU, Pennell DJ.
Helbing WA, Rebergen SA, Quantification of right ventricular function with magnetic resonance imaging in children with
Maliepaard C, et al. normal hearts and with congenital heart disease. Am Heart J 1995; 130(4): 828–837.
Rominger MB, Bachmann Right ventricular volumes and ejection fraction with fast cine mr imaging in breath-hold
GF, Pabst W, Rau WS. technique: applicability, normal values from 52 volunteers, and evaluation of 325 adult car-
diac patients. J Magn Reson Imaging 1999; 10(6): 908–918.
Graham TP Jr, Jarmakani Right ventricular volume determinations in children. normal values and observations with
JM, Atwood GF, Canent RV volume or pressure overload. Circulation 1973; 47(1): 144–153.
Jr.
Lange PE, Onnasch D, Farr Angiocardiographic right ventricular volume determination. accuracy, as determined from
FL, Heintzen PH. human casts, and clinical application. Eur J Cardiol 1978; 8(4–5): 477–501.
Shimazaki Y, Kawashima Y, Angiographic volume estimation of right ventricle. re-evaluation of the previous methods.
Mori T, Beppu S, Yokota K. Chest 1980; 77(3): 390–395.
Ferlinz J, Gorlin R, Cohn PF, Right Ventricular performance in patients with coronary artery disease. Circulation 1975;
Herman MV. 52(4): 608–615.

Azurion Release 2.2 Instructions for Use 218 Philips 4523 001 01511
2D Quantitative Analysis (Option) Managing Results

Author Article
Helbing WA, Niezen RA, Le Right ventricular diastolic function in children with pulmonary regurgitation after repair of
Cessie S, Geest RJvan der, tetralogy of fallot: volumetric evaluation by magnetic resonance velocity mapping. J Am
Ottenkamp J, Roos Ade. Coll Cardiol 1996; 28(7): 1827–1835.
Ferlinz J. Angiographic assessment of right ventricular volumes and ejection fraction. Cathet Cardio-
vasc Diagn 1976; 2(1): 5–14.
Lange PE, Onnasch D, Beur- Angiographic volume determination of the right ventricle. Ann Radiol (Paris) 1978; 21(4–5):
ich HW, Heintzen PH. 369–374.
Beier J, Wellnhofer E, Os- Accuracy and precision of angiographic volumetry methods for left and right ventricle. Int J
wald H, Fleck E. Cardiol 1996; 53(2): 179–188.
Dubel HP, Romaniuk P, Investigation of human right ventricular cast specimens. Cardiovasc Intervent Radiol 1982;
Tschapek A. 5(6): 296–303.
Wellnhofer E, Krulls-Munch A New Methodologic approach for determining right ventricular volumes from transesopha-
J, Sauer U, Oswald H, Fleck geal echocardiography. Z Kardiol 1994; 83(7): 482–494.
E

11.6 Managing Results


You can review, save, or delete results pages in the Result task.

If results pages of the currently selected analysis application have already been saved for the current
study, they are displayed in the Existing result pages list in the control panel.

11.6.1 Saving a Result Page


When you save a result page, it is stored in the patient database with the current study.

1 When the analysis is complete, click the Result task.

2 Click Save Result.

11.6.2 Reviewing a Saved Result Page


You can review a saved result page in the Result task.

Only results pages for the currently selected analysis application can be reviewed.

In the Existing result pages pane, scroll through the saved result pages and select the desired page.

11.6.3 Deleting a Result Page


You can delete a previously saved result page in the Result task.

In the Existing result pages list, scroll through the saved result pages, right-click the desired page and
click Delete.

11.7 2D-QA Settings


The following sections provide information about customizing the 2D-QA according to your preferred
workflow.

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11.7.1 Changing Default Calibration Settings


NOTE Changes that any user makes to the customization settings are applied for all users.

1 On the System menu, click Customization.

2 On the left side of the screen, in the Measurements and Analysis section, click Calibration and
Vessel Analysis.

3 Change the following settings, as desired:

Item Settings Notes


Default Manual Calibration Catheter This setting determines which man-
ual calibration method is selected by
Distance
default if automatic calibration is not
Sphere available.
Predefined catheter size values To change a predefined size, select You cannot enter a catheter size less
(French) the item and enter a new value. than 4 French.
To add an additional size, enter the
value in the box.
To remove an item, select the value and press BACKSPACE.
Predefined distance values (mm) To change a predefined distance, select the item and enter a new value.
To add an additional distance, enter the value in the box.
To remove an item, select the value and press BACKSPACE.
Predefined sphere size values (mm) To change a predefined size, select the item and enter a new value.
To add an additional size, enter the value in the box.
To remove an item, select the value and press BACKSPACE.

NOTE In the Calibration and Vessel Analysis panel, you can also change the default curve
settings. For details, see Changing QCA / QVA Default Curve Display
Settings (page 220).

4 To undo any changes that you have made in the Calibration and Vessel Analysis panel, click Undo
Changes.

5 Alternatively, to restore the system settings to default values, click Reset Default.

Item Default Settings Input Range


Default Manual Calibration Catheter Not applicable
Predefined catheter size values 4, 4.5, 5, 5.5, 6, 6.5, 7 4 French to 12 French
(French)
Predefined distance values (mm) 10, 15, 35, 50 10 mm to 100 mm
Predefined sphere size values (mm) 45, 50, 55 10 mm to 100 mm

6 Click Save to save your changes.

11.7.2 Changing QCA / QVA Default Curve Display Settings


1 On the System menu, click Customization.

2 On the left side of the screen, in the Measurements and Analysis section, click Calibration and
Vessel Analysis.

3 Change the following setting, as desired:

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Item Settings
Default Curve Display Diameter
Diameter & Area

4 Click Save to save your changes.

11.7.3 Changing LVA Default Settings


1 On the System menu, click Customization.

2 On the left side of the screen, in the Measurements and Analysis section, click Left Ventricle
Analysis.

3 Change the following settings, as desired:

Item Settings Notes


Default Index method BSA The cardiac output is always indexed
to BSA, irrespective of the selected
BSA^1.219
index method.
Weight
Monoplane Volume Method List Area Length
Simpson
Monoplane Regression Formulas Area Length

RAO30, EDV, ESV = 0.783, Vcalc = –3.759, Adults/Children

RAO30, EDV, ESV = 0.810, Vcalc = 1.9, Adults/Children

RAO30, EDV, ESV = 0.822, Vcalc = 0, Adults/Children

Simpson

RAO30, EDV, ESV = 0.737, Vcalc = –4.649, Adults/Children

You can select a predefined regression formula, or you can enter a user-de-
fined formula in the boxes provided.
Biplane Volume Method List Area Length
Biplane Regression Formulas RAO30/LAO60, EDV, ESV = 0.989, Vcalc = –8.1, Adults/Children

You can select a predefined regression formula, or you can enter a user-de-
fined formula in the boxes provided.
Rotation Range Enter a range in the boxes in which warnings are suppressed.
Angulation Range Enter a range in the boxes in which warnings are suppressed.

4 To undo any changes that you have made in the Left Ventricle Analysis panel, click Undo Changes.

5 Alternatively, to restore the system settings to default values, click Reset Default.

Item Default Settings Input Range


Default index method BSA Not applicable
LVA Monoplane Volume Methods Area Length Not applicable
List
LVA Monoplane Regression formula EDV, ESV = 0.783, Vcalc = –3.759 Not applicable
LVA Biplane Volume Methods List Area Length Not applicable
LVA Biplane Regression formula EDV, ESV = 0.989, Vcalc = –8.1 Not applicable

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Item Default Settings Input Range


LVA Rotation/Angulation Range –10 degrees to +10 degrees –20 degrees to +20 degrees

6 Click Save to save your changes.

11.7.4 Changing RVA Default Settings


1 On the System menu, click Customization.

2 On the left side of the screen, in the Measurements and Analysis section, click Right Ventricle
Analysis.

3 Change the following settings, as desired:

Item Settings
Default Index method BSA
BSA^1.219
Weight
Age Threshold Enter a value in the box to specify the child/adult age threshold.
Monoplane Volume Method List Pyramid
Monoplane Regression Formulas RAO30, EDV, ESV = 0.898, Vcalc = 3.862, Adults

You can select a predefined regression formula, or you can enter a user-de-
fined formula in the boxes provided.
Biplane Volume Method List Area Length
Simpson
Biplane Regression Formulas Area Length

AP/Lateral, EDV, ESV = 0.779, Vcalc = –1.807, Adults

RAO30/LAO60, EDV, ESV = 0.79, Vcalc = 0.238, Adults

RAO45/LAO45, EDV, ESV = 0.737, Vcalc = –1.435, Adults

RAO60/LAO30, EDV, ESV = 0.749, Vcalc = 0.836, Adults

Any projection, EDV, ESV = 0.76, Vcalc = –0.2, Adults

AP/Lateral, EDV, ESV = 0.898, Vcalc = 2.8, Children

AP/Lateral, EDV, ESV = 0.68, Vcalc = 0, Children

Simpson

AP/Lateral, EDV, ESV = 0.649, Vcalc = 0, Children

You can select a predefined regression formula, or you can enter a user-de-
fined formula in the boxes provided.
Rotation Range Enter a range in the boxes in which warnings are suppressed.
Angulation Range Enter a range in the boxes in which warnings are suppressed.

4 To undo any changes that you have made in the Right Ventricle Analysis panel, click Undo
Changes.

5 Alternatively, to restore the system settings to default values, click Reset Default.

Item Default Settings Input Range


Default index method BSA Not applicable
RVA Age Threshold 16 years 1 year to 120 years
RVA Monoplane Volume Methods Pyramid only - not customizable Not applicable
List

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Item Default Settings Input Range


RVA Monoplane Regression formula EDV, ESV = 0.898, Vcalc = 3.862 Not applicable
RVA Biplane Volume Methods List Area Length Not applicable
RVA Biplane Regression formula EDV, ESV = 0.779, Vcalc = –1.807 Not applicable
RVA Rotation/Angulation Range –10 degrees to +10 degrees –20 degrees to +20 degrees

6 Click Save to save your changes.

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Using Other Equipment Accessories and Detachable Parts

12 Using Other Equipment


The system is designed for use with other optional and integrated systems and equipment. These
Instructions for Use provide basic information on how the system interfaces with other equipment. For
information on how to use the other equipment, you should refer to the Instructions for Use supplied
with the equipment.

12.1 Accessories and Detachable Parts


This section provides information about accessories and detachable parts that are available with the
system.

12.1.1 Additional Table Accessory Rail


You can use the additional table accessory rail to position modules and accessories closer to the head
of the tabletop.

The maximum load on the additional table accessory rail must not exceed 100 N downwards (limited by
the table), and a maximum torque of 40 Nm downwards and 20 Nm upwards (limited by the table).

The additional table accessory rail is available as EU and US versions (the US version has a black
anodized finish). The modules that are designed for the EU version do not fit correctly on the US
version; the modules may become detached from the rail.

1 Open the clamps on the additional table accessory rail, position the rail on the edge of the tabletop,
and then close the clamps to secure the rail.

Figure 114 Additional table accessory rail

2 Attach modules to the additional table accessory rail.

The additional table accessory rail can be used for 2 modules, or 1 module and surgical accessories.
The maximum weight may not exceed 10 kg. If you attach a surgical accessory on the additional
table accessory rail, which will be placed over the table width, the maximum weight may not exceed
4 kg over the middle of the table.

3 Ensure that all cables are fitted to the cable supports.

4 To remove the additional table accessory rail, do the following:

a Remove the modules and attach them to the standard table accessory rail.

b Remove the additional table accessory rail from the tabletop.

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12.1.2 Accessory Rail Clamps


Accessory rail clamps allow you to attach compatible accessories to the table accessory rail.

1 Slide the clamp on to the accessory rail.

Figure 115 Positioning the clamp on the accessory rail

2 Fit an accessory in the clamp.

Figure 116 Fitting an accessory in the clamp

3 Turn the knob on the clamp so that the clamp and accessory are firmly attached to the accessory
rail.

When a clamp does not have an accessory fitted, it should be removed from the rails.

12.1.3 Drip Stand


You can attach the drip stand to the table accessory rail to hang bags of fluid. The maximum load for
the drip stand is 2 kg on each hook.

1 Attach a rail accessory clamp to the accessory rail and fit the drip stand into the rail accessory
clamp.

2 Tighten the clamp to secure the drip stand.

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Figure 117 Fitting the drip stand

3 To adjust the height of the drip stand, loosen the height adjustment clamp, adjust the height of the
drip stand, and then tighten the clamp.

12.1.4 Arm Supports


The following arm supports are available for use with the system:
• Set of elbow supports: Used for patient comfort and to prevent the patient's arms from hanging over
the side of the table.
• Arm support board: Used to support the patient's arm during brachio-cephalic catheterization
procedures.
• Shoulder support board. Used to support both arms during brachio-cephalic catheterization
procedures.
• Height-adjustable arm support: Used to manage blood flow during venous digitial subtraction
angiography (DSA).

Using the Elbow Support

1 Position the patient on the table before using the elbow support.

2 Slide the elbow support under the patient between the tabletop and the mattress.

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Using Other Equipment Accessories and Detachable Parts

Figure 118 Positioning the elbow support

3 Position the patient's arm on the elbow support.

Using the Arm Support Board

1 Position the patient on the table before using the arm support board.

2 Attach the foam pad to the arm support board ensuring that the arm support board is passed
through the loop of the pad.

Figure 119 Attaching the foam pad to the arm support board

3 With the foam pad facing upward, slide the arm support board under the patient's shoulder
between the tabletop and the mattress.

4 Position the patient's arm on the arm support board.

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Figure 120 Positioning the patient's arm

Using the Shoulder Support Board

1 Slide the shoulder support board between the mattress and the tabletop, and under the patients'
shoulder.

Figure 121 Using the shoulder support board

2 Position the patient's arm on the support board.

Using the Height-Adjustable Arm Support


NOTE The height-adjustable arm support cannot be used for X-ray procedures on the arm. In such
cases, use the arm support board. For more information, see Using the Arm Support
Board (page 227).

1 Position the patient on the table.

For more information, see Positioning the Patient on the Table (page 61).

2 Fit the tabletop accessory clamp to the tabletop at the desired position, and tighten the locking
lever.

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Figure 122 Fitting the tabletop accessory clamp to the tabletop

3 Do one of the following:


• Attach the arm support extension to the arm support, and adjust the length of the extension as
necessary.

Figure 123 Using the arm support extension


• Attach the arm support handgrip to the arm support, and adjust the position of the handgrip as
necessary.

Figure 124 Using the arm support handgrip

4 Fit the arm support into the accessory clamp, and tighten the locking lever.

5 Cover the arm support with a biocompatible material, such as tissue paper or a sheet, to avoid direct
contact with the patient.

6 Set the angle of the arm support and position the patient's arm on the support.

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12.1.5 Cerebral Filter


The cerebral filter improves the overall image quality during neuro-angiographic procedures.

NOTE The cerebral filter is not available with the FlexArm option.

1 To fit the cerebral filter, push the cerebral filter into the rim of the X-ray tube housing.

Figure 125 Fitting the cerebral filter

2 To remove the cerebral filter, inserting your finger into the filter hole and lift the filter out of the rim
of the X-ray tube housing.

12.1.6 Peripheral X-ray Filters


Peripheral X-ray filters minimize patient movements during lower peripheral angiography procedures.

Figure 126 Peripheral X-ray filters

The center filter is marked to facilitate measurements in acquired images. The marks are spaced
approximately 5 cm (2 inches) apart.

1 Position the central peripheral filter carefully between the patient's legs, with the wide end at the
patient's feet and the narrow end as high up as possible.

WARNING
The peripheral X-ray filters contain copper. You must use a sheet or cover to avoid direct contact
with the patient's skin.

2 Immobilize the patient's legs at knee and ankle using straps.

For patients with genu varum (O), the patient's knees should be slightly lifted and supported
underneath, and then strapped closely together.

For patients with genu valgum (X), the patient's knees should be slightly lifted and supported
underneath, and then the patient's ankles should be strapped closely together.

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3 Position the side filters as close as possible to the sides of the patient's legs, with the wide end at
the patient's feet.

4 Fit the filters to the shape of the patient's legs to avoid gaps between the filters and the legs.

12.1.7 Head Support


The head support improves patient comfort and minimizes head movements during a procedure.

1 Place the base of the head support at the head end of the table with the rectangular side towards
the mattress, but not on the mattress.

2 Place the shaped head support on the head support base and align the markers.

Figure 127 Positioning the head support

3 Position the patient so that the patient's head lies comfortably in the head support.

4 For extra support, attach the head band.

Figure 128 Positioning the patient in the head support

You can use the neuro wedge with the head support. For more information about the neuro wedge, see
Neuro Wedge (page 232).

12.1.8 Mattress
The mattress provides comfort for the patient and spreads the weight of the patient evenly.

There are three types of mattress available:


• Standard
• Cardio
• Neuro

NOTE The mattress does not contain latex.

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Before positioning the patient on the mattress, open the air plug to allow the mattress to expand and
contract properly with the weight of the patient.

Close the air plug while cleaning the mattress. When the mattress is not in use, the air plug can be
pushed all the way in to the mattress.

12.1.9 Neuro Wedge


You can use the neuro wedge to position the patient's head in the isocenter position during neuro-
radiology procedures. The neuro wedge should be used with the head support. For more information
about the head support, see Head Support (page 231).

1 Slide the tapered end of the neuro wedge under the mattress at the head end of the table so that
only the rectangular portion of the wedge is visible.

2 Position the head support on top the rectangular part of the neuro wedge.

3 Position the patient so that the patient's head lies comfortably in the head support.

Figure 129 Positioning the neuro wedge

12.1.10 Patient Straps


Use patient straps to ensure patient safety before starting tilt or cradle movements of the tabletop.

Figure 130 Using patient straps

Ensure that the straps are applied correctly around the accessory rail of the table.

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Using Other Equipment Accessories and Detachable Parts

Figure 131 Applying patient straps around the accessory rail

For more information, see Using Patient Straps (page 62).

12.1.11 Ratchet Compressor


The ratchet compressor applies moderate compression to the patient and minimizes patient movement.
This improves visualization of internal organs.

1 Position the unit on the edge of the table and tighten the attachments underneath the unit.

2 Push the release lever down to release the compression band.

3 Pass the compression band over the patient and back under the table, and then put the end of the
band over the compression band roller.

Figure 132 Fitting the compression band

4 Turn the ratchet winder to increase the compression.

Take care to control the amount of compression.

5 To decrease the compression, push the release lever down.

6 To release the compression band when the procedure is finished, do the following:

a Push the release lever down.

b Release the band from the compression band roller.

c Remove the unit from the edge of the table.

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12.1.12 Tabletop Accessory Clamps


Tabletop accessory clamps allow you to attach compatible accessories to the tabletop.

1 Slide the clamp on to the edge of the tabletop.

Figure 133 Sliding the clamp on to the edge of the tabletop

2 Secure the clamp by tightening the lever [1] on the underside of the clamp.

Figure 134 Securing the clamp to the tabletop

3 Fit an accessory in the clamp and tighten the lever [2] on the side of the clamp.

When a clamp does not have an accessory fitted, it should be removed from the tabletop.

12.1.13 Handgrip and Clamp Set


The handgrip and clamp set provides safety and comfort for the patient during tilt or cradle movements.

1 Attach a tabletop accessory clamp on each side of the table at the appropriate position.

Figure 135 Fitting the tabletop accessory clamp

2 Fit the handgrips in the clamps and tighten the locking levers.

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Figure 136 Positioning the handgrips

12.1.14 Viewpad
The viewpad is a handheld remote control that you can use to control viewing and processing functions
from anywhere in the examination room.

Figure 137 Viewpad

When you activate a function on the viewpad, the function is applied to the viewport that currently has
focus. A viewpad icon is displayed in the middle of the viewport for a moment, and is then displayed in
the top bar of the viewport.

The viewpad is an infrared remote control. The infrared transmitter is located on the front of the
viewpad. If the transmitter is obstructed, signals are not transmitted. The receiver is located in the
monitor ceiling suspension, above the monitors. A light on the receiver indicates that the selected
command has been received. The viewpad should be used inside a transparent sterile cover (not
supplied by Philips Medical Systems).

A laser pointer is located on the front of the viewpad. You activate the laser pointer using the button on
the underside of the viewpad. The quality of the laser pointer is affected when using a sterile cover.

NOTE Do not point the laser into people’s eyes, as there is a risk of injury.

The viewpad is battery-powered. For more information about replacing the batteries, see Replacing
Batteries (page 297).

NOTE Do not open the cover of the viewpad (not including the battery compartment cover). For
maintenance, contact technical support. If the cover is damaged, do not use the viewpad
and call technical support for a replacement.

NOTE Do not use the viewpad when more than one Azurion system is in use in the same room.

NOTE Infrared signals from the viewpad may interfere with other infrared-controlled equipment in
the same room. Before using the viewpad in a procedure, check that there is no interference
with other equipment.

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Using Other Equipment Accessories and Detachable Parts

When not in use, store the viewpad in the holder provided on the side of the touch screen module.

For more information, see the following sections:


• Equipment in the examination room: Viewpad (page 46)
• Quick reference: Viewpad (page 472)

Viewpad Laser Aperture


The laser aperture of the viewpad is indicated with an arrow in the following illustration.

Figure 138 Viewpad laser aperture

12.1.15 XperGuide Laser Tool (Option)


The XperGuide laser tool is a positioning aid. It is attached to the patient table for use during
percutaneous interventional procedures.

NOTE The XperGuide laser tool contains a laser with the IEC classification of class 1 laser product.
Avoid exposing eyes to the laser at any time.

NOTE Do not use the laser tool for investigation. The laser tool is for alignment only.

The laser tool marks the needle entry point on the skin, and assists the user holding the needle in the
correct position and orientation.

Figure 139 Laser tool and charger

The laser tool is used in the laser tool holder, which is attached to the table using a tabletop accessory
clamp.

The laser aperture of the laser tool is indicated with an arrow in the following illustration.

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Figure 140 Laser tool laser aperture

Figure 141 Laser tool holder

Sterile disposable covers are not supplied with the laser tool and must be obtained locally.

Switching the XperGuide Laser Tool On and Off


1 To switch the laser tool on, press the power button on the top of the tool.

When the laser tool is switched on, the indicator light on the button is illuminated.

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Figure 142 XperGuide laser tool power button

2 To switch the laser tool off, press the power button again.

Charging the XperGuide Laser Tool


Keep the laser tool charger in the control room (out of the patient environment).

1 Connect the laser tool charger to the mains.

When the red indicator light on the laser tool charger is illuminated, the charger is connected to the
mains.

2 Insert the laser tool to the charger.

Figure 143 XperGuide Laser Tool Charger

When the green indicator light is illuminated, the laser tool is charging.

When the green indicator light switches off the laser tool is fully charged.

3 Disconnect the laser tool charger from the mains.

4 Recharge the laser tool after each use to ensure the availability of the laser for the next procedure.

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12.2 Third-Party Interfaces


This section provides information about connecting compatible third-party equipment to the system.

12.2.1 Declarations of Compatibility


Philips Medical Systems has defined declarations of compatibility for a variety of third-party
components and systems. A declaration of compatibility implies that a third-party component or
system and the Azurion system are verified for mutual compatibility when operated in accordance with
the manufacturers' instructions.

The declaration of compatibility means that the third-party component or system and the Azurion
system, when used together, do not adversely affect the following:
• The intended use and essential performance of either system.
• The safety and effectiveness of either system.

12.2.2 Connecting an Injector


To connect an injector to the system, you use a specific connector on the interface panel on the rear
side of the table base.

Figure 144 Injector connectors on the rear interface panel

Legend
1 Connector for injectors in non-pedestal configuration
2 Connector for injectors in pedestal configuration

Ask your Philips representative for a compatibility statement for the injector device that you want to
connect to your system.

Non-Pedestal Configuration
In the non-pedestal configuration, only the injector head and injector display unit are located in the
examination room. The injector base unit is located in the technical room. An additional injector display
unit can also be located in the control room. Injector connection [1] is used in this configuration.

Pedestal Configuration
In the pedestal configuration, the entire injector is located in the examination room except for an
optional injector display unit in the control room. The injector is placed on a movable pedestal and can

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be easily connected and disconnected from the X-ray system using a Burndy connector. The Burndy
connector is located at the rear interface panel at the table base (item [2] in the illustration).

If you are using an OR table, the rear interface panel at the table base cannot be used. Instead, a
surgery wall connection box is provided in the examination room, but at a greater distance from the
table.

12.2.3 Connecting Video Feeds


There are several possibilities for connecting third-party devices to the Philips interventional X-ray
system to display video feeds.

Video feeds from third-party devices can be shown on the following:


• FlexVision or a dedicated Philips monitor.
• A third-party monitor, powered by the third-party system, but integrated within the monitor ceiling
suspension.
• Switchable monitors using the MultiSwitch option.
• Control room monitors

Video feeds from the Philips interventional X-ray system can be displayed on third-party monitors.

NOTE Philips cannot guarantee the image quality or coordination of video feeds displayed on
third-party monitors.

The wall connection box assists with connecting third-party devices.

For more information, contact a Philips representative.

12.3 Other Devices


This section provides infomation about additional equipment that can be used with the system.

12.3.1 MultiSwitch (Option)


The MultiSwitch option allows you to connect up to three Philips PCs and switch between them using a
single, shared WorkSpot (monitor, keyboard, and mouse). These Philips PCs are supplied with the
system and can be used to run Philips applications such as Xcelera, Interventional Workspot, and
IntelliSpace Portal.

Figure 145 MultiSwitch unit

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The MultiSwitch unit is located on the WorkSpot table. You switch the WorkSpot interface to one of the
connected Philips PCs manually using the button on the front of the MultiSwitch unit. An indicator light
on the MultiSwitch unit shows the selected input. Input selection is performed in sequential order.

The control room connection box houses the mains power connections for the following devices:
• MultiSwitch unit
• Ethernet switch
• Connected Philips PCs

Power for the WorkSpot, the connection box, and the associated devices (including the connected
Philips PCs) is provided by the system.

12.3.2 Wall Connection Box (Option)


The wall connection box provides connection points to the system for ethernet, video, and USB.

You can connect additional equipment to the system using a wall connection box.

NOTE While a wall connection box provides connection points for additional equipment, it does not
provide power to connected equipment.

Wall connection boxes can be installed as desired in the control room, the examination room, and the
technical room.

For more information about the technical specification of the wall connection box, see the following
sections:
• Wall Connection Box (page 336)
• Installation and Equipment Connections (page 432)

12.3.3 Intercom (Option)


An optional intercom is available to assist communication between the control room and the
examination room.

Two intercom units are installed: one in the control room and one in the examination room.

Figure 146 Intercom unit

The following controls are used to operate the intercom.

Control Description

Switch the intercom on and off. The indicator light is on when the intercom is switched on.

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Control Description

Press and hold to speak.

Volume control.

12.3.4 Equipment Rack (Option)


The ceiling-suspended equipment rack is a space-saving unit which helps you keep the examination
room tidy by consolidating the separate equipment carriers associated with EP procedures, for
example, and by streamlining cabling.

Additional power and network connection points are integrated with the equipment rack.

Figure 147 Equipment rack

For information on using and maintaining the equipment rack, refer to the Instructions for Use supplied
with the equipment rack.

12.3.5 Pedestal (Option)


You can use the pedestal as a primary or secondary point of control for the system.

You can position the control module and the touch screen module on the pedestal. You can then
position the pedestal in a more convenient position in the examination room, if desired.

WARNING
Do not push or lean against the pedestal.

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WARNING
Do not attach any modules other than the control module or the touch screen module to the
pedestal.

Figure 148 Pedestal

To support certain system configurations, you can use a compatible, ceiling-suspended equipment rack
as an alternative to the pedestal.

12.3.6 8-Meter Cable Assembly Kit (Option)


You can use an 8-meter cable assembly kit to connect other equipment to the system and to hospital
power (for example, Philips CX50 ultrasound cart).

NOTE If the 8 meter cable assembly kit is disconnected from the equipment, it is possible that the
cable could be left on the floor with live voltage still present in the connection plug. This
presents a risk of electric shock if fluids make contact with the connectors. To prevent this
risk, the connection plug must be covered with the rubber cap attached to the connector
after disconnecting the equipment cable, and the cable must be stored on the wall bracket
next to the wall connection box.

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Figure 149 8-meter cable assembly kit

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User Customization Changing Your Password

13 User Customization
You can customize the system’s functionality and configuration to suit the way you want to use it. You
can view or configure the following settings without a system administrator account.
• System and licence information including hospital and department names
• Date and time settings
• Physician list
• FlexSpot presets and preset groups
• FlexVision presets and preset groups
• Automatic position control settings
• X-ray protocols
• Viewing, processing and display preferences
• Annotations
• Quantitative analysis settings
• Print settings

NOTE Before you make changes to system customization settings, you should consider exporting
the existing settings so you can import them later if you need to. Settings can only be
imported or exported by a system administrator.

13.1 Changing Your Password


It is important to ensure your password remains private at all times and it is good practice to change
your password regularly.

You can change your password at any time when logged into the system. If you forget your password,
your system administrator can reset it for you. For more information about resetting a password, see
Resetting a User's Password (page 265).

To change your own password, ensure you are logged into the system and do the following:

1 In the review window, click System and select Change Password.

A dialog box is displayed requesting you to enter your old password and to set your new password.

2 Check the User Name displayed is correct.

If the User Name displayed is not yours, you must log out of the system and log in using your own
user name and password.

3 Enter your Old Password.

4 Enter your New Password.

You must follow these rules when setting a password:


• The password field cannot be empty.
• Passwords cannot contain user names.
• Passwords must conform to the password policy settings.
• If password complexity is enabled, passwords must contain characters from three of the
following categories:
– Uppercase letters
– Lower case letters
– Numbers (0 through 9)
– Non-alphabetic characters (for example: ! $ # %)

For more information about password policy settings, see Managing Users and System
Logon (page 264).

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5 Enter your new password again in Confirm Password.

6 Do one of the following:

a To close the dialog box without changing your new password, click Cancel.

b To close the dialog box and change your password, click Apply.

13.2 Viewing System and License Information


You can view basic information about the system and the licenses installed on the system.

1 On the System menu, click Customization to display the System Customization window.

2 In the General settings group, click System and License Information.

System and license information is displayed in the right pane:


• Hospital and department names
• Local system ID
• Computer and host names
• IP and MAC addresses
• Installed hardware and software licenses

3 To close the System Customization window, click Close.

13.3 Setting the Date and Time


You can choose whether the date and time should be set manually or automatically.

1 On the System menu, click Customization to display the System Customization window.

2 In the General settings group, click Date and Time Settings.

3 To set the date and time automatically using a time server, enable the Time Server by selecting
Enabled.

If the time server is enabled, the date and time is automatically synchronized after startup when a
connection with the time server is established. A manually entered date and time is overwritten
when the date and time are automatically synchronized. The time and date is synchronized hourly
when the system is connected to the time server. The system date and time cannot be changed
manually if the time server is enabled.

If the time server is Enabled, ensure that the correct host name or IP address for the time server is
entered in the field below the radio buttons.

4 To set the date and time manually, do the following:

a Select Disabled for the time server.

b Select the correct date from the System Date drop-down calendar.

c Enter the correct time in the System Time field.

5 Select the correct Time Zone from the list.

6 To undo any changes you have made, click Undo Changes.

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7 To save your changes, click Save.

8 To close the System Customization window, click Close.

13.4 Changing the Date and Time Formats


The system displays both short and long versions of the date and time. You can change the way that
they are displayed to suit your local preferences.

1 On the System menu, click Customization to display the System Customization window.

2 In the General settings group, click Date and Time Settings.

3 Select the formats to be used for Short Date and Long Date from the available lists.

4 Select the formats to be used for Short Time and Long Time from the drop-down lists.

5 Select which day should be regarded as the First Day of the Week from the drop-down list.

6 To undo any changes you have made, click Undo Changes.

7 To save your changes, click Save.

8 To close the System Customization window, click Close.

13.5 Changing the Physician List


You can add, remove, or change the names of physicians used on the system. Instead of removing a
physician from the system, you can choose whether physicians are visible on the system.

1 On the System menu, click Customization to display the System Customization window.

2 In the General settings group, click Physician List.

3 To change a physician’s details do the following:

a Select the physician in the Physician List.

Physician Details are displayed beside the Physician List.

b Change the Physician Details.

4 To add a new physician do the following:

a Click New.

A new physician is added to the Physician List with the name New Physician.

b Select the new physician in the Physician List.

c Change the Physician Details to display the correct name.

d If desired, you can hide the physician on the system by clearing the check box beside the
physician's name in the Physician List.

NOTE When a physician is added, they are visible on the system by default.

5 To delete a physician, click Delete and confirm that you want to delete the physician.

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6 To undo any changes you have made, click Undo Changes.

7 To save your changes, click Save.

8 To close the System Customization window, click Close.

13.6 Managing Presets from the Control Room


You can edit, create, and delete presets for use with FlexSpot and FlexVision, from the FlexSpot primary
monitor in the control room. If FlexSpot is not installed, you can manage FlexVision presets from the
review monitor.

Your system must have FlexSpot or FlexVision equipment installed before you can manage presets.

Presets are predefined screen layouts. Using these preset layouts, you can define your preferred screen
layout to assist you during a study. You manage FlexSpot and FlexVision presets in the same way.

For information about managing presets in the examination room, see Managing FlexVision Presets
Using the Touch Screen Module (page 252).

1 3
4

Figure 150 FlexSpot Presets Manager dialog box (the FlexVision Presets Manager is similar)

Legend
1 Presets Group list 3 Current preset
2 Toolbar 4 Function buttons

1 To manage FlexSpot presets, click FlexSpot and select Manage Presets.

The FlexSpot Presets Manager is displayed.

2 To manage FlexVision presets, click FlexSpot and select Manage FlexVision Presets.

The FlexVision Presets Manager is displayed.

3 To use the selected preset on the system now, click Activate.

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The selected preset is displayed on the system monitors.

4 Click Close to close the dialog box.

13.6.1 Creating a New Preset (in the Control Room)


You can create new presets to suit your workflow.

1 Select the desired preset group in the Presets Group list.

2 Click New.

The New Preset dialog box is displayed.

Figure 151 New Preset dialog box

Legend
1 Layout selection lists 4 Preset name
2 Preset thumbnail for the acquisition window 5 Available applications
3 Preset thumbnail for the review window 6 Save button

Your monitor configuration is depicted in the dialog box as thumbnail images. For FlexVision, only
one monitor is shown.

3 For each monitor depicted, select the desired layout using the lists above each monitor thumbnail
image.

Available screen layouts show how windows are arranged. You can assign applications to specific
windows in a later step. The layouts also indicate the location of the status area. For standard
layouts, the default position of the status area is on the left side. For layouts that contain two high-
definition (HD) viewports, the status area can be positioned at the top or bottom. You can change
this in a later step.

4 Enter a name for your preset in the box below the preset thumbnails.

5 Drag the applications you want to be displayed in your preset, from the application list to the
desired positions on the monitors.

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6 To save your preset, click Save.

Your preset is saved within the selected preset group.

7 To close the dialog box without saving your preset, click Cancel.

13.6.2 Editing a Preset (in the Control Room)


You can edit existing presets to better suit your workflow.

1 Select the preset group containing the preset that you want to edit.

2 In the list, select the preset that you want to edit.

3 Click Edit.

A dialog box is displayed.

4 Edit the preset as desired.

5 To save your changes, click Save.

6 To close the dialog box without saving your changes, click Cancel.

13.6.3 Copying or Moving a Preset (in the Control Room)


You can create a copy of a preset and save the copy to a different preset group, or you can move a
preset to a different preset group, removing it from the original group.

1 Select the preset group containing the preset that you want to copy or move.

2 In the list, select the preset that you want to copy or move.

3 Do one of the following:


• To copy the preset, click Copy To.
• To move the preset, click Move To. The preset will be removed from the original preset group.

4 In the dialog box, select the preset group that you want to copy or move the preset to.

5 Click OK.

13.6.4 Deleting a Preset (in the Control Room)


You can delete presets if they are no longer needed.

1 Select the preset group containing the preset that you want to delete.

2 In the list, select the preset that you want to delete.

3 Click Delete.

13.6.5 Managing Preset Groups from the Control Room


You can create, rename, reorder, and delete preset groups for FlexSpot and FlexVision from the control
room.

Presets are organized into groups allowing you to choose which group to add a preset to.

For information about managing preset groups in the examination room, see Managing FlexVision
Preset Groups Using the Touch Screen Module (page 255).

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Figure 152 Manage Preset Groups dialog box (FlexVision similar)

Legend
1 Function buttons
2 Preset groups list

1 To manage FlexSpot presets, click FlexSpot and select Manage Presets.

The FlexSpot Presets Manager is displayed.

2 To manage FlexVision presets, click System and select Manage FlexVision Presets.

The FlexVision Presets Manager is displayed.

3 Click Manage Preset Groups.

The Manage Preset Groups dialog box is displayed.

4 To create a new presets group, do the following:

a Click New.

A dialog box is displayed.

b Enter a name for the new group.

c To save the new group, click OK.

d To close the dialog box without saving the new group, click Cancel.

5 To rename a preset group, do the following:

a Select the desired group in the list.

b Click Rename.

A dialog box is displayed.

c Enter a new name for the group.

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d To save the new group name, click OK.

e To close the dialog box without saving the new group name, click Cancel.

6 To delete a preset group, do the following:

a Select the desired group in the list.

b Click Delete.

A confirmation message is displayed.

c To delete the group, click OK.

d To close the confirmation message without deleting the group, click Cancel.

7 To reorder the preset groups in the list, do the following:

a Select the preset you want to move.

b Click the arrows to move the preset up and down within the list.

8 To restore the factory default preset groups, click Restore factory default presets.

9 Click Close to close the dialog box.

13.7 Managing FlexVision Presets Using the Touch Screen Module


Presets are predefined screen layouts for the FlexVision option. Default presets are provided, or you
can define your own presets to suit your workflow.

The following procedures provide guidance for managing presets using the touch screen module. For
information about managing presets from the control room, see Managing Presets from the Control
Room (page 248).

NOTE These functions are not available if the FlexVision option is not installed.

1 To display the Manage Presets window, do the following:

a On the touch screen module, tap the application selector.

b Tap FlexVision.

c Tap Manage Presets.

The Manage Presets window provides functions for creating, editing, deleting, and organizing
presets and preset groups.

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Figure 153 Manage Presets window

Legend
1 Manage Presets button 3 Function buttons
2 Preset groups list 4 Available presets

Each preset is depicted with a thumbnail image showing its screen layout and assigned
applications.

2 Perform one of the following tasks:


• Create a new preset.
• Edit or delete a preset.
• Copy or move a preset.
• Change the display order of presets.
• Manage preset groups.

These tasks are described in the following sections.

13.7.1 Creating a New Preset (Using the Touch Screen Module)


You can create new presets to suit your workflow.

NOTE When you create a new preset, the system automatically includes applications that are
mandatory for the current situation in the examination room. You cannot remove mandatory
applications from the preset, but to prevent applications from being defined as mandatory,
arrange the situation in the examination room accordingly. For example, to create a preset
that does not include the live lateral application as a mandatory, park the lateral stand or
disable X-ray before creating the preset.

1 Tap New in the Manage Presets window.

The New Preset dialog box is displayed. On-screen guidance is provided for creating a new preset.

2 Step 1/4: Select a screen layout and tap Next.

Available screen layouts show how windows are arranged. You can assign applications to specific
windows in a later step. The layouts also indicate the location of the status area. For standard
layouts, the default position of the status area is on the left side. For layouts that contain two high-

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definition (HD) viewports, the status area can be positioned at the top or bottom. You can change
this in a later step.

3 Step 2/4: Select the applications that you want to include in the preset and tap Next.

As you select applications, the system indicates how many empty windows remain.

4 Step 3/4: Do the following to configure the preset:

a If desired, rearrange the applications in the layout.

Initially, the system arranges the applications automatically. You can rearrange applications by
dragging them.

b If desired, reposition the status area by tapping one of the four indicators on the right side of the
window.

c Tap Next when the preset is configured as desired.

5 Step 4/4: To save the new preset, do the following:

a Select a preset group from the list.

b Enter a name for the preset.

c Tap Complete.

13.7.2 Editing a Preset (Using the Touch Screen Module)


You can edit existing presets to better suit your workflow.

1 In the preset group list in the Manage Presets window, select the group that contains the preset
that you want to edit.

2 Select the preset that you want to edit.

3 Tap Edit.

The Edit Preset dialog box is displayed. On-screen guidance is provided steps for editing the preset.

NOTE The Edit Preset dialog box provides the same steps as the New Preset dialog box. The
settings that are already saved for the preset are displayed in each page of the dialog
box, allowing you to make changes, if desired.

4 Step 1/4: If desired, select a different screen layout and tap Next.

5 Step 2/4: Select the applications that you want to include in the preset and tap Next.

6 Step 3/4: Configure the preset as desired and tap Next.

You can rearrange the applications or reposition the status area.

7 Step 4/4: If desired, select a different presets group or enter a new name for the preset, and then
tap Complete.

13.7.3 Copying or Moving a Preset (Using the Touch Screen Module)


You can create a copy of a preset and save the copy to a different preset group, or you can move a
preset to a different preset group, removing it from the original group.

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1 In the preset group list in the Manage Presets window, select the group that contains the preset
that you want to copy or move.

2 Select the preset that you want to copy or move.

3 Tap More and do one of the following:


• To copy the preset, tap Copy To.

• To move the preset, tap Move To. The preset will be removed from the original preset group.

4 In the dialog box, select the preset group that you want to copy or move the preset to.

5 Tap OK.

13.7.4 Changing the Order of Presets (Using the Touch Screen Module)
You can change the display order of presets, for example, to make commonly used presets easier to
select.

1 In the Manage Presets window, tap More.

2 Tap Change Order.

3 Select the preset that you want to move.

4 Tap Left or Right to move the preset to the desired position in the list.

5 Tap Save.

13.7.5 Deleting a Preset (Using the Touch Screen Module)


You can delete presets if they are no longer needed.

1 In the preset group list in the Manage Presets window, select the group that contains the preset
that you want to delete.

2 Select the preset that you want to delete.

3 Tap Delete.

13.7.6 Managing FlexVision Preset Groups Using the Touch Screen Module
You can create, rename and delete preset groups for FlexVision using the touch screen module.

Preset groups allow you to group presets to make them easier to find or to group related presets
together.

For information about managing preset groups from the control room, see Managing Preset Groups
from the Control Room (page 250).

1 On the touch screen module, tap the application selector.

2 Tap FlexVision.

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3 Tap Manage Presets.

4 Tap More and select Manage Groups.

5 To create a new preset group, do the following:

a Tap New.

A new preset group is added to the list of available preset groups with the name My Preset
Group.

b Select the new preset group in the list and perform step 6 to rename the preset group.

6 To rename a preset group, do the following:

a Select desired preset group in the list.

b Tap More and select Rename.

The keyboard on the touch screen module is enabled.

c Edit the preset group name using the keyboard on the touch screen module.

d To exit without renaming the preset group, tap Cancel.

e To rename the preset group, tap Save.

7 To delete a preset group, do the following:

NOTE Deleting a preset group will delete all presets contained in the preset group.

a Select desired preset group in the list.

b Tap More and select Delete.

A confirmation dialogue box is displayed.

c To close the dialog box without deleting the preset group, tap Cancel.

d To delete the preset group, tap Delete.

The preset group is deleted, including all presets contained within it.

8 To restore the factory default preset groups, do the following:

NOTE Restoring the factory default preset groups will overwrite all existing presets and preset
groups, including customized presets and preset groups.

a Tap More and select Restore Defaults.

A confirmation dialogue box is displayed.

b To close the dialog box without restoring the factory default preset groups, tap Cancel.

c To restore the factory default preset groups, tap Delete.

The factory default preset groups and presets are restored. Customized presets and preset
groups are deleted.

13.8 Changing Automatic Position Control Settings


You can customize the Automatic Position Control (APC) settings in the system for future use.

The system allows you to change, rename, copy, delete, and add new APC positions. You can also store
the current geometry for future use as an APC position.

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1 On the System menu, click Customization to display the System Customization window.

2 In the X-ray Application settings group, click APC Positions.

If you are using a biplane system, the APC Positions dialog box allows you to select between
Monoplane or Biplane positions. You can use Monoplane positions on a biplane system, in which
case, only the position information for the frontal channel is stored.

3 To rename an existing APC position, do the following:

a Select the APC position in the Position Name list.

The APC Position Details are displayed.

b Enter a new name in the Position Name field.

The Position Name list is automatically updated.

4 To change the settings of a monoplane position, do the following:

a Select Monoplane.

b Select the APC position in the Position Name list.

c Set the Rotation Angle for the frontal stand using the slider or by entering a number in the box.

NOTE The labels used to indicate Rotation Angle and Angulation Angle depend on the
setting that is configured for Rotation/Angulation Display Flavor.

d Set the Angulation Angle using the slider or by entering a number in the box.

e Set the Source Image Distance using the slider or by entering a number in the box.

f Select the Detector Orientation from the drop-down list.

5 To change the settings of a biplane position, do the following:

a Select Biplane.

b Select the APC position in the Position Name list.

c In the Frontal section, configure the following settings:

– Set the Rotation Angle using the slider or by entering a number in the box.

NOTE The labels used to indicate Rotation Angle and Angulation Angle depend on the
setting that is configured for Rotation/Angulation Display Flavor. This also
applies to the angles in the Lateral section.
– Set the Angulation Angle using the slider or by entering a number in the box.
– Set the Source Image Distance using the slider or by entering a number in the box.
– Select the Detector Orientation from the drop-down list.

d In the Lateral section, configure the following settings:

– Set the Rotation Angle using the slider or by entering a number in the box.
– Set the Angulation Angle using the slider or by entering a number in the box.
– Set the Source Image Distance using the slider or by entering a number in the box.

6 To add a new position, do the following:

a Click New.

A new position is added to the list with the name New APC Position.

b Select the new position in the Position Name list.

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User Customization Customizing APC Positions for X-ray Protocols

c Enter a new Position Name.

d Configure the position settings as described above.

7 To copy an existing position, do the following:

a Click Copy.

A new position is added to the list and is identified as a copy.

b Select the copied position in the Position Name list.

c Enter a new Position Name.

d Configure the position settings as described above.

8 To delete a position:

a Select the desired position in the Position Name list.

b Click Delete.

c Confirm that you want to delete the position.

9 To undo any changes you have made, click Undo Changes.

10 To save your changes, click Save.

NOTE The changes take effect after the next system shutdown and startup.

11 To close the System Customization window, click Close.

13.9 Customizing APC Positions for X-ray Protocols


You can customize the automatic position control settings that are available for each X-ray protocol.

Each X-ray protocol is associated with a defined list of automatic position control settings. You can
change which positions can be recalled for each X-ray protocol.

NOTE Before you can select an automatic position control position, it must exist in the list of
available positions.

For more information about managing automatic position control positions, see Changing Automatic
Position Control Settings (page 256).

1 On the System menu, click Customization to display the System Customization window.

2 In the X-ray Application settings group, click X-ray Protocols.

3 Select the desired X-ray protocol in the X-ray Protocols list.

The list displays the parent X-ray protocols by default. You can expand each parent protocol to
allow you to select a child protocol.

Changing the available positions for a parent protocol will make the selected positions available for
all the child protocols contained within the parent protocol.

Changing the available positions for a child protocol will make the selected positions available only
in the child protocol.

4 In the Details area, select the APC Positions you want to be available for the selected X-ray
protocol.

5 To change the order the selected positions are displayed in the system, do the following:

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a In the APC Positions Order list, select the position you want to move.

b Click the up or down buttons to move the position up or down in the list.

6 To undo any changes you have made, click Undo Changes.

7 To save your changes, click Save.

NOTE The changes take effect after the next system shutdown and startup.

8 To close the System Customization window, click Close.

13.10 Changing Viewing Preferences


You can change some viewing settings to suit the way you use the system.

The viewing settings you can change are:


• The X-ray image displayed when you open a series.
• The way that navigation and replay is managed between series.
• Maximum series and study replay times.
• The way that angles are displayed on the system.

1 On the System menu, click Customization to display the System Customization window.

2 In the X-ray Application settings group, click Viewing and Processing.

3 To change the default image displayed when you open a series, select an option in the Default
Active X-ray Image list.

The following options are available:


• First image: displays the first image in the series.
• Middle image: displays the middle image in the series.

The default selection is Middle image.

4 To change the way that navigation works when you reach the beginning or end of a study, select an
option in the Image Navigation Model list.

The following options are available:


• Navigate images in all series: image navigation does not stop at the end of the current series,
but continues to the next available series for in the selected study.
• Stop at the beginning and at the end of the series: image navigation stops at the beginning or
end of the current series.
• Step through the images in a loop: image navigation of the current series continues until
stopped.

5 To specify a maximum length of time for series image replay, enter a value in seconds for Replay
Time Out.

6 To specify a maximum length of time for study image replay, enter a value in seconds for Study
Cycle Replay Time Out.

7 To change the way that angles are displayed on the system, select the angle flavor in the Rotation/
Angulation Display Flavor list.

The following options are available:

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• Cardio (LAO/RAO, CRAN/CAUD)


• Vascular (Rot, Ang)

8 To specify which reference window the dual fluoroscopy image is sent to when Dual Fluoro is
turned on, select a window in the Dual Fluoro Output list.

9 To set the default filter that is used when reviewing series, select an option in the Default Review
Series Filter list.

The following options are available:


• Acquired Images
• Photo Images
• All Images
• Flagged Images

10 To specify which items are displayed by default in the image information overlay, select or clear
check boxes in the Default Image Information settings.

11 To undo any changes you have made, click Undo Changes.

12 To save your changes, click Save.

NOTE The changes take effect after the next system shutdown and startup.

13 To close the System Customization window, click Close.

13.11 Changing Display Preferences


To ensure the correct mouse movements between screens, you can select the control monitor
configuration you are using.

You can also specify a waiting time for screen saver activation.

1 On the System menu, click Customization to display the System Customization window.

2 In the X-ray Application settings group, click Viewing and Processing.

3 To ensure the correct mouse movements between the acquisition and review windows, select the
configuration you are using in the Displays and Mouse Control settings.

4 To change the waiting time before the screen saver is activated, select a suitable time in the Screen
Saver Wait Time list.

5 To immediately activate the screen saver, click Activate Screen Saver.

Moving the mouse or pressing any key on the keyboard will deactivate the screen saver.

6 To undo any changes you have made, click Undo Changes.

7 To save your changes, click Save.

NOTE The changes take effect after the next system shutdown and startup.

8 To close the System Customization window, click Close.

13.12 Customizing Predefined Annotations


Some annotations are predefined but you can customize them.

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When customizing predefined annotations, you can change the text, the color and the size for each
annotation.

1 On the System menu, click Customization to display the System Customization window.

2 In the X-ray Application settings group, click Annotations.

A list of predefined annotations is displayed, with details for the selected annotation shown in the
Annotation Details.

3 To create a new annotation, do the following:

a Click New.

A new annotation is added to the list with the text New annotation.

b Select the new annotation in the list and edit the annotation (step 6).

4 To copy an existing annotation, do the following:

a Click Copy.

A new annotation is added to the list and is marked as a copy of the original annotation.

b Select the copied annotation in the list and edit the annotation (step 6).

5 To edit an existing annotation, do the following:

You can see a preview of the annotation in the Annotation Details.

a Select the desired annotation in the Annotations list.

b To change the text of the annotation, enter new text in the Annotation Details.

c To change the size of the annotation, select a size.

d To change the default color of the annotation, click on a color to select it.

6 To delete an annotation, do the following:

a Select the desired annotation in the Annotations list.

b Click Delete.

A confirmation dialog box is displayed.

c To cancel without deleting the annotation, click Cancel.

d To delete the annotation, click OK.

7 To undo any changes you have made, click Undo Changes.

8 To save your changes, click Save.

9 To close the System Customization window, click Close.

13.13 Changing Print Settings


You can change the default printer settings and the information shown on printed pages.

When printing an image, you can show or hide additional information on the page.
• Patient details
• Study description

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• Physician
• Hospital name

You can also specify which default printer and media types to use.

NOTE When handling personal data, do so in accordance with the privacy policies that apply in
your healthcare environment and privacy laws that apply in your region.

1 On the System menu, click Customization to display the System Customization window.

2 In the Print Application settings group, click Print.

3 Select the desired information in the Page Header and Footer Information by selecting or clearing
the desired check boxes.

4 Set each of the Print Preferences as desired.

NOTE If you select Optimize for biplane image printing, frontal and lateral images are printed
side by side unless you change the page layout to 1x1 or a single column.

5 To undo any changes you have made, click Undo Changes.

6 To save your changes, click Save.

7 To close the System Customization window, click Close.

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System Administration Changing Regional Settings

14 System Administration
With a system administrator account, you can customize many aspects of the system's functionality to
suit the way the system is used in your hospital. To change the following settings you must have a
system administrator user account.
• Regional settings
• Audit trail
• Users and logon requirements
• Patient Administration, including storage devices
• RIS code mapping / ProcedureCard mapping
• DICOM configuration
• Export protocols
• Automatic data transfer
• ProcedureCards
• Importing and exporting settings

NOTE Before you make changes to system customization settings, you should consider exporting
the existing settings so you can import them later if you need to. For more information, see
Exporting Settings (page 285).

14.1 Changing Regional Settings


You can change the language used in the system, and the way measurements, numbers, and timings are
displayed, to suit your local preferences.

The system user interface supports several languages and you can change the language in use. The
Instructions for Use within the system can also be viewed in different languages.

NOTE You can view the Instructions for Use in a different language than that used for the user
interface since the Instructions for Use are available in a larger number of languages than
the user interface supports.

1 On the System menu, click Customization to display the System Customization window.

2 In the General settings group, click Regional Settings .

3 To change the system user interface language, select the desired Language.

4 To change the language you use to provide inputs and the associated keyboard layout, select the
desired Input Language and Keyboard.

5 To change the Instructions for Use language, select the desired Instructions for Use Language.

6 Select the desired Decimal Symbol to use from the drop-down list.

7 Select the Digit Grouping Symbol to use from the drop-down list.

8 Select the Measurement System to use from the drop-down list.

9 Select the format used to display fluoroscopy timings from the Fluoro Time Display Format drop-
down list.

10 Select the units used to display detector size from the Detector Size Display Unit drop-down list.

11 To undo any changes you have made, click Undo Changes.

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12 To save your changes, click Save.

NOTE The changes take effect after the next system shutdown and startup.

13 To close the System Customization window, click Close.

14.2 Configuring Audit Trail Settings


You can configure the settings used in the system to produce audit logs.

1 On the System menu, click Customization to display the System Customization window.

2 In the General settings group, click Audit Trail.

3 To enable the Local Audit Trail, select Enabled.

4 To enable the Remote Audit Trail, select Enabled and configure the following repository settings.

a Enter the Host Name or IP Address of the central audit repository.

b Click the Network Protocol box and select a protocol for communication with the central audit
repository.

c Enter the Port Number for communication with the central audit repository.

d To enable secure communication, select Use Authentication.

e To enable the use of encryption, select Use Encryption.

This option is only available if Use Authentication is selected.

f If Use Authentication is selected, click the Certificate box and select a local certificate to use for
authentication.

5 Click Test Connection.

The result of the test is indicated by an icon.

Test successful

Test failed

If the test fails, more information is provided.

6 To undo any changes you have made, click Undo Changes.

7 To save your changes, click Save.

NOTE The changes take effect after the next system shutdown and startup.

8 To close the System Customization window, click Close.

14.3 Managing Users and System Logon


You can manage user accounts and allow emergency access, or configure the system to log on
automatically when started.

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1 On the System menu, click Customization to display the System Customization window.

2 In the General settings group, click System Logon.

3 To enable automatic logon when the system starts, select the System automatic logon check box
and select the Automatic logon User Name to be used from the drop-down list.

4 To enable emergency system access, select the Allow emergency system access check box.

5 To change password policy, do one or all of the following:


• Enter the Maximum password age (days).
• Enter the Minimum password length (characters).
• Enable or disable Password complexity.

6 To change a user account’s details, select the user account in the User Accounts list and change the
user account’s details in the Details area.

7 To undo any changes you have made, click Undo Changes.

8 To save your changes, click Save.

9 To close the System Customization window, click Close.

14.3.1 Adding and Deleting Users


A system administrator can create, change, or delete user accounts.

You add and delete users in the System Logon dialog box.

1 In the System Logon dialog panel, click New.

A new user is displayed in the list with the name New User.

2 Select the new user in the User Accounts list.

3 Enter a User Name in the Details section.

NOTE You cannot change the user name after saving the new user’s details.

4 Enter the user's Full Name and a Description if desired.

5 Select the appropriate User Group.

The User Group selected sets the level of access that the user has within the system. Users are
normally grouped as clinical users or system administrators.

6 Click Save to save the new user’s details.

7 To delete a user, select the user in the list, click Delete and then confirm that you want to delete the
user account.

14.3.2 Resetting a User's Password


As a system administrator, you can reset a user's password.

You can reset a user’s password in the System Logon dialog panel. For information about changing your
own password, see Changing Your Password (page 245).

1 Select the user in the User Accounts list.

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The user’s details are displayed in the Details section.

2 Click Reset Password.

A dialog box is displayed.

3 Enter a New Password.

You must follow these rules when setting a password:


• The password field cannot be empty.
• Passwords cannot contain user names.
• Passwords must conform to the password policy settings.
• If password complexity is enabled, passwords must contain characters from three of the
following categories:
– Uppercase letters
– Lower case letters
– Numbers (0 through 9)
– Non-alphabetic characters (for example: ! $ # %)

For more information about password policy settings, see Managing Users and System
Logon (page 264).

4 Enter the same password in Confirm Password.

NOTE The password entered in Confirm Password must match the password entered in New
Password.

5 Do one of the following:

a To close the dialog box without resetting the user's password, click Cancel.

b To close the dialog box and reset the user's password, click Apply.

14.4 Changing General Patient and Workflow Settings


You can customize general workflow settings and specify sizes for the different patient types.

If the system local storage is full, the system automatically deletes data that is not protected to make
space available for newly acquired images. You can configure the system to protect every study upon
completion.

You can configure the system to automatically start procedures that have been provided from XperIM.

You can simplify the DICOM workflow to automatically mark all procedures as completed, and to
automatically produce a dose report when a procedure is closed.

You can change these basic patient and workflow settings:


• Preventing automatic study deletion
• Enabling a simplified DICOM workflow
• Enabling automatic dose reporting
• Neonatal, infant and child age limits
• Adult circumference limits
• Default patient type
• Enabling support for Chinese, Japanese, and Korean (CJK) ideographic characters
• Making the system compliant with requirements from the United States Department of Veterans
Affairs (VA)

1 On the System menu, click Customization to display the System Customization window.

2 In the General settings group, click Workflow.

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System Administration Enabling and Disabling Storage Device Export and Import

3 To protect every study upon completion, select the Prevent Automatic Study Deletion check box.

You can allow an individual study to be deleted by manually removing the protection for that study.
For more information about protecting and unprotecting studies, see Protecting and Unprotecting
Studies (page 153).

4 To automatically mark procedures as completed when closed, select the Simplified DICOM
Workflow check box.

5 To enable automatic dose reporting when a procedure is closed, select the Automatic Dose Report
check box and select the type of report you want to produce.

6 Enter or change the age limits for pediatric patient types.

7 Enter or change the circumference limits for adult patient types.

NOTE There is no circumference limit for the largest adult patient type.

8 To change the default patient type, select the Default radio button beside the desired default
patient type to be used.

9 To undo any changes you have made, click Undo Changes.

10 To save your changes, click Save.

11 To close the System Customization window, click Close.

14.5 Enabling and Disabling Storage Device Export and Import


Export of data to storage devices (USB flash memory drive or CD/DVD) is enabled by default. You can
disable this function if needed.

You can also change the default setting for anonymizing patient data for export to a USB flash memory
drive or to CD/DVD.

You can also include a DICOM viewing application on the storage device with the patient data.

1 On the System menu, click Customization to display the System Customization window.

2 In the General settings group, click Workflow.

3 To disable Storage Device Export and Import, select Disabled.

4 To automatically include a DICOM viewing application with exported patient data, select Include
DICOM Viewer.

5 To anonymize patient data exported to a USB flash memory drive, select Default De-Identify Upon
USB Export.

6 To anonymize patient data exported to CD/DVD, select Default De-Identify Upon CD/DVD Export.

7 To undo any changes you have made, click Undo Changes.

8 To save your changes, click Save.

9 To close the System Customization window, click Close.

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System Administration Mapping RIS Codes to ProcedureCards

14.6 Mapping RIS Codes to ProcedureCards


You can map the codes used in the hospital’s Radiology Information System (RIS) to ProcedureCards on
the system.

When you import a patient's details from a radiology information system, mapping allows you to apply
the correct ProcedureCard in the Azurion system for the intended clinical procedure.

The system collects a list of all RIS codes used in scheduled procedures, or you can enter new codes
manually.

1 On the System menu, click Customization to display the System Customization window.

2 In the General settings group, click RIS Code Mapping.

A list of RIS codes is displayed, showing the ProcedureCard that each one is mapped to. The DICOM
attribute that is used for the RIS code mapping is displayed above the list.

If a RIS code is not mapped to a ProcedureCard, a warning symbol is displayed.

You can sort each column in ascending or descending order by clicking the RIS Code or Mapped
ProcedureCard column heading.

3 To use an alternative DICOM attribute for the RIS code mapping, click the arrow in the DICOM
Mapping Attribute box and select an attribute.

4 To add a new RIS code, do the following:

a Click New.

A new RIS code called New RIS Code is added to the list.

b Select the new RIS code and enter the correct RIS code in the RIS Code Details box.

c Click Save to save the new RIS code.

5 Select the RIS code to be mapped.

The RIS code details are displayed.

6 Select the ProcedureCard group from the Cards Group drop-down list.

The ProcedureCards relating to the selected group are displayed.

7 Select the ProcedureCard you want to map to the RIS code.

8 To undo any changes you have made, click Undo Changes.

9 To save your changes, click Save.

10 To close the System Customization window, click Close.

14.7 DICOM Settings


You can customize the system's DICOM settings.

DICOM Settings are available in General settings group for the following items:
• Local system
• Worklist and MPPS

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• Remote systems
• DICOM Printers

14.7.1 Configuring Local Settings


You can configure DICOM settings for the local system and enable the use of secure communication.

You can configure these local DICOM settings using the DICOM Settings menu.

The following items are read-only and cannot be changed:


• IP address
• Default gateway IP address

1 On the System menu, click Customization to display the System Customization window.

2 In the General settings group, click DICOM Settings.

The Local System tab is displayed by default.

3 To change the Application Entity Title, enter a new title in the AE Title field.

4 To change the port number in use, enter a new port number in the Port Number field.

5 To configure secure communication, click Advanced Settings and continue with the task in
Configuring Secure Communication on the Local System (page 269).

6 To undo any changes you have made, click Undo Changes.

7 To save your changes, click Save.

8 To close the System Customization window, click Close.

Configuring Secure Communication on the Local System


You can configure secure communication and manage certificates from trusted certification authorities.

You can import and delete certificates, and choose which local system certificate to use for secure
communications.

1 If the Local System tab is not already displayed, do the following:

a On the System menu, click Customization to display the System Customization window.

b In the General settings group, click DICOM Settings.

2 Click Advanced Settings.

The Advanced DICOM Settings dialog box is displayed.

3 To enable secure communication, select Use Authentication.

4 To enable the use of encryption, select Use Encryption.

This option is only available if Use Authentication is selected.

NOTE For correct implementation of secure communication between the local system and
remote systems, ensure that the secure communication settings are configured in the
same way on the local system and the remote systems. If the settings do not match,
import and export jobs between the local system and a remote system may fail.

5 To change the certificate used for secure communications:

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a Select the certificate to be used, in the Local System Certificates list.

If a certificate has expired, a warning is displayed for the certificate in the list. You cannot use an
expired certificate.

b Click Use in Secure Communication.

6 To import a certificate:

a Click Import in the Local System Certificates list or in the Trusted Certification Authorities
Certificates list.

The Import Certificate dialog panel is displayed.

b Select the certificate file to be imported.

c Click Cancel to close the dialog panel without importing a certificate.

d Click Import to import the selected certificate.

7 To delete a certificate:

a Select the certificate to be deleted.

b Click Delete.

c Confirm that you want to delete the certificate.

8 To undo any changes you have made, click Undo Changes.

9 To save your changes, click Save.

10 To close the Advanced DICOM Settings dialog box, click Close.

11 To close the System Customization window, click Close.

14.7.2 Configuring Worklist Management and the Modality Performed Procedure Step
(MPPS) Manager
You can enable or disable worklist management and the MPPS manager.

1 On the System menu, click Customization to display the System Customization window.

2 In the General settings group, click DICOM Settings.

The Local System tab is displayed by default.

3 Select the WLM/MPPS tab.

4 To enable worklist management, select Enabled in the Worklist Management section.

5 To enable the MPPS manager, select Enabled in the Modality Performed Procedure Step Manager
section.

6 Enter the following mandatory information for worklist management and for the MPPS manager:

• AE Title
• Host Name or IP Address
• Port Number

7 Select the time period to be used for automatic querying of scheduled procedures.

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8 To enable secure communication, select Use Authentication.

9 To enable the use of encryption, select Use Encryption.

This option is only available if Use Authentication is selected.

10 Click Test Connection.

The result of the test is indicated by an icon.

Test successful

Test failed

If the test fails, more information is provided.

11 To disable worklist management, select Disabled in the Worklist Management section.

12 To disable the MPPS manager, select Disabled in the Modality Performed Procedure Step Manager
section.

13 To undo any changes you have made, click Undo Changes.

14 To save your changes, click Save.

15 To close the System Customization window, click Close.

14.7.3 Configuring Remote Systems


You can configure the settings for other DICOM-compatible systems connected to the same hospital
network as the Azurion system.

1 On the System menu, click Customization to display the System Customization window.

2 In the General settings group, click DICOM Settings.

3 Click the Remote Systems tab.

A list of remote systems is displayed (DICOM nodes).

4 To view the settings that are configured for an existing remote system, select a system in the list.

The Remote System Settings and Services settings are displayed, providing information about the
selected remote system and the services it supports.

5 To add a new remote system, click Add below the list of remote systems.

A new remote system is added to the list. You can now configure the settings of the new system.

6 To configure a system's settings in the Remote System Settings section, select the system in the list
and do the following:

a Enter the Name of the remote system.

b Click the Template Type box and select a template.

The template defines the services that available on the remote system. Available services are
indicated with a selected check box in the Services section.

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c To enable secure communication, select Use Authentication.

d To enable the use of encryption, select Use Encryption.

This option is only available if Use Authentication is selected.

NOTE For correct implementation of secure communication between the local system and
remote systems, ensure that the secure communication settings are configured in the
same way on the local system and the remote systems. If the settings do not match,
import and export jobs between the local system and a remote system may fail.

7 To configure the services of the selected remote system in the Services section, do the following:

a Select a service in the Service list.

b Configure the service's settings as desired

– AE Title
– Host Name or IP Address
– Port Number
– DICOM Presentation State Support
– JPEG Compression
– Monitor Type

8 To test the configuration of a remote system, click Test Connection.

The connection to the system is tested and the result is displayed in the remote systems list next to
the system name.

a If a test fails, click Status Details to display more information about the test result.

9 To test all remote system connections, click Test All below the list of remote systems.

10 To remove a remote system, click Remove and confirm that you want to remove the system.

11 To undo any changes you have made, click Undo Changes.

12 To save your changes, click Save.

13 To close the System Customization window, click Close.

14.7.4 Configuring DICOM Printers


You can add, reconfigure, test, calibrate, and remove DICOM printers that are connected to the system's
network.

1 On the System menu, click Customization to display the System Customization window.

2 In the General settings group, click DICOM Settings.

The Local System tab is displayed by default.

3 Select the DICOM Printers tab.

A list of DICOM printers is displayed.

The printer list can be sorted by clicking on the column headings to sort each column in ascending
or descending order.

4 To reconfigure an existing printer, perform the following procedure:

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a Select the desired printer in the list.

The settings for the selected printer are displayed in the Printer Settings section.

b Change the desired printer setting in the Printer Settings section.

5 To add a new printer, perform the following procedure:

a Click Add.

A new printer is added to the list.

b Select the new printer.

c Enter the Printer Settings for the new printer.

d To enable secure communication, select Use Authentication.

e To enable the use of encryption, select Use Encryption.

This option is only available if Use Authentication is selected.

f Click Save to save your changes.

6 To test an individual printer's connection, click Test Connection.

The connection to the printer is tested and the result is displayed in the printer list next to the
printer name.

The result of the test is indicated by an icon.

Test successful

Test failed

7 To test all printer connections, click Test All.

8 To calibrate a printer, click Printer Calibration.

9 To remove a printer, click Remove and confirm that you want to remove the printer.

10 To undo any changes you have made, click Undo Changes.

11 To save your changes, click Save.

12 To close the System Customization window, click Close.

14.8 Configuring Export Protocols


You can configure how and when the system exports images by configuring the export protocols.

An export protocol specifies whether an export occurs automatically or manually, what format the
images will be, and where they will be exported to.

You can edit, copy and delete an existing export protocol, or create a new one.

When editing or creating a protocol, you can configure the following options:
• Manual or automatic export
• Protocol name

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System Administration Configuring Export Protocols

• Default destination
• Field of view, size and quality
• When automatic exports occur
• What images are automatically exported

1 On the System menu, click Customization to display the System Customization window.

2 In the General settings group, click Export Protocols.

3 To change the default protocol:

a Select the desired protocol in the list.

b Click Set as Default.

4 To add a new protocol:

a Click New.

A new protocol is added to the list with the name New export protocol.

b Select the new export protocol in the list.

c Edit the Export Protocol Details.

The following settings are recommended:

Settings Options Notes


Processing Format Processed (Recommen- Default option. Image processing is applied to the im-
ded) age before export.
Unprocessed The image is not processed. Processing parameters are
described in private DICOM attributes (only IntelliSpace
Portal can handle this correctly).

Select Unprocessed only for export to IntelliSpace Por-


tal or to a workstation where measurements are per-
formed on image data (for example, quantitative anal-
ysis).
Image Size Do Not Downscale (Rec- Default option
ommended for vascular
images)
1024x1024 The resolution is limited to 1k2. This has no impact on
cardio images.
512x512 The resolution is limited to 5122. The file size is reduced.
Image Quality Normal 8 bits/pixel The file size is reduced.
High 12 bits/pixel (Rec- The file size is twice as large as Normal image quality.
ommended)

d Click Save to save the new protocol details.

5 To add a new protocol based on an existing protocol:

a Select the desired protocol in the list.

b Click Copy the selected export protocol.

c Edit the Export Protocol Details.

The following settings are recommended:

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System Administration Configuring Automatic Data Transfer

Settings Options Notes


Processing Format Processed (Recommen- Default option. Image processing is applied to the im-
ded) age before export.
Unprocessed The image is not processed. Processing parameters are
described in private DICOM attributes (only IntelliSpace
Portal can handle this correctly).

Select Unprocessed only for export to IntelliSpace Por-


tal or to a workstation where measurements are per-
formed on image data (for example, quantitative anal-
ysis).
Image Size Do Not Downscale (Rec- Default option
ommended for vascular
images)
1024x1024 The resolution is limited to 1k2. This has no impact on
cardio images.
512x512 The resolution is limited to 5122. The file size is reduced.
Image Quality Normal 8 bits/pixel The file size is reduced.
High 12 bits/pixel (Rec- The file size is twice as large as Normal image quality.
ommended)

d Click Save to save the new protocol details.

6 To edit an existing protocol:

a Select the desired protocol in the list.

b Edit the Export Protocol Details.

NOTE If the export protocol has no default destination specified, a warning symbol is
displayed in the list.

c Click Save to save the new protocol details.

7 To delete a protocol:

a Select the desired protocol in the list.

b Click Delete the selected export protocol.

c Confirm that you want to delete the protocol.

8 To undo any changes you have made, click Undo Changes.

9 To save your changes, click Save.

10 To close the System Customization window, click Close.

14.9 Configuring Automatic Data Transfer


You can configure what types of images and data are exported automatically, and what format is used.

For each X-ray protocol, you can specify how you want the system to manage the automatic transfer of
image data, by selecting the export protocols to use.

For non-X-ray image data (snapshots, analysis reports, and dose reports), you can select the
destination for data based on the data type or the X-ray protocol used to acquire it.

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System Administration Network Configuration

1 On the System menu, click Customization to display the System Customization window.

2 In the General settings group, click Automatic Data Transfer.

The X-ray Image Data tab is displayed by default.

3 Select the desired X-ray protocol.

4 Select the export protocol to use for each image type.

5 Set the non X-ray image preferences using the following procedure:

a Select the Non X-ray Image Data tab.

b Select the export protocol to use for each data type.

6 To undo any changes you have made, click Undo Changes.

7 To save your changes, click Save.

8 To close the System Customization window, click Close.

14.10 Network Configuration


You can configure standard network settings on the system.

1 On the System menu, click Customization to display the System Customization window.

2 In the General settings group, click Network Configuration.

In the Network Configuration panel, the current network status of the system is displayed in the
Network Adapter section. You can Disable or Enable the network adapter as desired.

3 To set the IP address settings of the system, click the IPv4 Settings tab or the IPv6 Settings tab,
depending on the networking protocol in use, and configure the IP address settings according to the
requirements of your network.

If you are unsure of how to configure these settings, contact your network administrator.

4 Configure the DNS Settings according to the requirements of your network.

If you are unsure of how to configure these settings, contact your network administrator.

The network configuration of the system is displayed in the Network Details panel. If you have
made changes to the network configuration, click Refresh to display the latest settings.

5 To undo any changes you have made, click Undo Changes.

6 To save your changes, click Save.

7 To close the System Customization window, click Close.

14.11 Enabling or Disabling Remote Support


You can enable remote support to allow technical support to monitor the system, or you can disable
this service to prevent remote monitoring.

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System Administration Customizing APC Pathways

1 On the System menu, click Customization to display the System Customization window.

2 In the General settings group, click Remote Support.

3 To enable remote support, select Enabled in the Remote Support panel.

When remote support is enabled, technical support can remotely track the system.

a Select any of the following support options:

– Allow the system to send diagnostic data: This option sends diagnostic data and alerts to
technical support.
– Allow Remote Assistance: This option allows technical support to provide remote
assistance by screen sharing. You retain the ability to stop screen sharing if desired.
– Allow the system to receive and install software updates: This option allows the system to
download updates automatically for installation by technical support or by a hospital
administrator.
– Allow Remote Connection Diagnostics: This option allows access to a diagnostic tool if the
network connection to remote support is lost. For more information, see Using the Remote
Connection Diagnosis Tool (page 277).

4 To disable remote support, select Disabled.

5 To undo any changes you have made, click Undo Changes.

6 To save your changes, click Save.

7 To close the System Customization window, click Close.

14.11.1 Using the Remote Connection Diagnosis Tool


If the remote connection diagnosis tool is enabled and the network connection to the remote support
server (PRS Portal) is lost, you can create a report to assist technical support with diagnosing the
connection problem.

To use the remote connection diagnosis tool, the following option must be selected in the Remote
Support panel: Allow Remote Connection Diagnostics. For more information, see Enabling or Disabling
Remote Support (page 276). It is only necessary to perform this task when requested by technical
support.

1 If the network connection to the PRS Portal is lost, click the Remote Connection Diagnosis Tool icon
in the status area of the control room monitor.

The Remote Connection Diagnosis Tool dialog box is displayed.

2 Click Run Test to create a report of the network connection problem.

3 To view the details of the network connection problem, click View Report.

4 Click Export Report to save the report to another location.

5 Send the report to technical support to diagnose the connection problem.

14.12 Customizing APC Pathways


APC pathways allow you to define a pathway for the system to follow when moving to a predefined
position using automatic position control. APC pathways are only available when using the FlexArm
stand (option).

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System Administration Customizing APC Pathways

Using the System Customization function, you can create new APC pathways and modify or delete
existing pathways. An APC pathway consists of one or more stored positions. When multiple positions
are stored, the stand moves along the APC pathway through the positions in the order that they are
stored. For example, you can configure a pathway to move the stand from the park position to the
working position. The APC pathways that you configure here are displayed in the Pathway tab of the C-
arm and Table task on the touch screen module.

1 On the System menu, click Customization to display the System Customization window.

2 In the X-ray Application settings group, click APC Pathway.

Guidance for creating a pathway is available in the APC Pathway panel.

3 Click New below the Pathway list.

4 Enter a descriptive name for the pathway in the Name box.

5 Move the stand to the first position along the desired pathway.

NOTE This position is not the starting position of the pathway. It is the first position that the
stand moves to from whatever position the stand is in when the pathway is recalled
using the touch screen module.

6 Click Store below the Positions list.

7 To include the current table position in the pathway settings, set the Table Included toggle button
to On.

The table position can only be included with the first position or the last position in the pathway.

When the pathway is recalled using the touch screen module, positions are recalled in the order
that they appear in the Positions list.

8 Continue to store positions along the desired pathway.

9 To delete a position, select the position in the Positions list and click Delete.

a To delete multiple positions at once, select the positions while holding down the Ctrl key, and
then click Delete.

10 To rearrange the order of the pathways in the Pathway list, select a pathway, and then click the up
arrow or down arrow below the list.

The symbol next to a pathway in the Pathway list indicates what kind of pathway it is.

Symbol Type of Pathway

A pathway with multiple positions

A pathway with only one position

11 To delete a pathway, select the pathway in the Pathway list and click Delete.

12 To undo any changes you have made, click Undo Changes.

13 To save your changes, click Save.

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System Administration Managing ProcedureCards

The changes are immediately available on the touch screen module.

14 To close the System Customization window, click Close.

14.13 Managing ProcedureCards


You can create, edit, copy, move, and delete ProcedureCards to suit the studies you are performing.

A ProcedureCard is a predefined collection of settings that you can associate with a study. When you
schedule a study, you can choose which ProcedureCard is used and this will provide the system
settings used for the study.

You can manage ProcedureCards within the system, allowing you to create, edit and organize the
ProcedureCards to suit how you use the system.

Figure 154 ProcedureCards Manager

Legend
1 ProcedureCard selection area
2 ProcedureCard details

14.13.1 Changing the Default ProcedureCard


You can change the default ProcedureCard used for studies.

For more information on ProcedureCards, see ProcedureCards (page 57).

1 In the review window, click System and select Manage ProcedureCards.

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System Administration Managing ProcedureCards

The ProcedureCards Manager is displayed.

2 Select the ProcedureCard Group containing the desired ProcedureCard.

3 Select the desired ProcedureCard.

4 Click Set as Default.

The selected ProcedureCard is now the default ProcedureCard.

5 Click OK to close the ProcedureCards Manager.

14.13.2 Creating a New ProcedureCard


You can create new ProcedureCards for use with studies.

You can also create a new ProcedureCard by copying an existing ProcedureCard and changing the
settings.

1 In the review window, click System and select Manage ProcedureCards.

The ProcedureCards Manager is displayed.

2 Select the ProcedureCard Group that you want to place the new ProcedureCard in.

3 Create a new ProcedureCard by doing one of the following:


• Click New.

• Copy an existing ProcedureCard.

For more information about copying a ProcedureCard, see Copying a ProcedureCard (page 282).

A new ProcedureCard with the default title My ProcedureCard is created and is visible in the list.
You can edit this new ProcedureCard to apply the desired settings. For more information about
editing ProcedureCards, see Editing a ProcedureCard (page 280).

14.13.3 Editing a ProcedureCard


You can edit the settings of a ProcedureCard.

The changes that you make affect all scheduled studies that have this ProcedureCard selected.

1 In the review window, click System and select Manage ProcedureCards.

The ProcedureCards Manager is displayed.

2 Select the ProcedureCard Group containing the desired ProcedureCard.

3 Select the desired ProcedureCard.

4 To edit general ProcedureCard information, do the following:

a Select the General tab.

b Edit the general ProcedureCard information as desired.

5 To edit the available X-ray settings, do the following:

a Select the X-ray Acquisition tab.

b Select the X-ray protocols available for use with the ProcedureCard.

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System Administration Managing ProcedureCards

c Set the default X-ray protocol for the ProcedureCard.

d Reorder the X-ray protocols as desired.

6 To change the preset screen layout used for the FlexSpot option, if installed, do the following:

a Select the FlexSpot tab.

b Change the preset group by selecting a new group from the list.

c Select the new preset to use.

7 To change the preset screen layout used for the FlexVision option, if installed, do the following:

a Select the FlexVision tab.

b Change the preset group by selecting a new group from the list.

c Select the new preset to use.

8 To edit the instructions included with the ProcedureCard, do the following:

a Select the Instructions tab.

b To rename an existing document, click Rename the selected bookmark, enter a new name and
click OK.

c To preview an existing document, select the document and click View the selected bookmark.

The document is displayed in a viewer.

d To delete a document from the ProcedureCard, select the document and click Delete.

9 To include new external documents for the ProcedureCard, do the following:

a Select the Instructions tab.

b Click Add External.

The XPS documents library list is displayed, showing previously uploaded documents and a
preview window.

c To preview a document, select it in the XPS documents library.

d To add a document which has been previously uploaded, select the document and click Add.

e To upload a new document from a USB flash memory drive, click Import from USB and select
the document you want to import, then click Add.

f To delete a document, select it and click Delete.

g To close the dialog box without adding a document, click Cancel.

10 To configure settings for an application on the Interventional Workspot, if connected, do the


following:

a Select the Interventional Tools tab.

b Configure the settings for the application.

11 To check all settings in the ProcedureCard, do the following:

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System Administration Managing ProcedureCards

a Select the Summary tab.

b Check the settings displayed for each section.

12 To save your changes, click Save.

13 To close the ProcedureCards Manager without saving your changes, click Cancel.

14.13.4 Copying a ProcedureCard


You can copy a ProcedureCard to use as the basis for a new ProcedureCard.

ProcedureCards are copied within the same ProcedureCard Group. You can move a copied
ProcedureCard to another ProcedureCard group. For more information about moving ProcedureCards,
see Moving a ProcedureCard (page 282).

1 In the review window, click System and select Manage ProcedureCards.

The ProcedureCards Manager is displayed.

2 Select the ProcedureCard Group containing the desired ProcedureCard.

3 Select the desired ProcedureCard.

4 Click Copy.

The ProcedureCard is copied within the same ProcedureCard group and is saved with the same
name and marked as a copy.

14.13.5 Moving a ProcedureCard


You can move a ProcedureCard to another ProcedureCard group.

For example, you can copy a ProcedureCard and then move the copy to another group. For more
information about copying ProcedureCards, see Copying a ProcedureCard (page 282).

1 In the review window, click System and select Manage ProcedureCards.

The ProcedureCards Manager is displayed.

2 Select the ProcedureCard Group containing the desired ProcedureCard.

3 Select the desired ProcedureCard.

4 Click Move To.

A dialog box is displayed where you can choose which group you want to move the ProcedureCard
to.

5 Select the desired group from the list.

6 Click OK.

The ProcedureCard is moved to the selected group.

14.13.6 Deleting a ProcedureCard


You can delete a ProcedureCard so that it is no longer displayed in the list of available cards.

If you delete a ProcedureCard which is selected for use in a scheduled study, the study will use the
default ProcedureCard.

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System Administration Managing ProcedureCards

1 In the review window, click System and select Manage ProcedureCards.

The ProcedureCards Manager is displayed.

2 Select the ProcedureCard Group containing the desired ProcedureCard.

3 Select the desired ProcedureCard.

4 Click Delete.

A confirmation message is displayed asking you to confirm that you want to delete the
ProcedureCard.

5 To delete the ProcedureCard, click Delete.

6 To close the confirmation message without deleting the ProcedureCard, click Cancel.

14.13.7 Managing ProcedureCard Groups


You can create, rename, reorder, and delete ProcedureCard groups.

ProcedureCards are organized into groups allowing you to choose which group to add a ProcedureCard
to.

1 In the review window, click System and select Manage ProcedureCards.

The ProcedureCards Manager is displayed.

2 Click Edit ProcedureCard groups.

The Edit ProcedureCard Groups dialog box is displayed.

3 To create a new ProcedureCards group, do the following:

a Click New.

A dialog box is displayed.

b Enter a name for the new group.

c To save the new group, click OK.

d To close the dialog box without saving the new group, click Cancel.

4 To rename a ProcedureCards group, do the following:

a Select the desired group in the list.

b Click Rename.

A dialog box is displayed.

c Enter a new name for the group.

d To save the new group name, click OK.

e To close the dialog box without saving the new group name, click Cancel.

5 To delete a ProcedureCard group, do the following:

a Select the desired group in the list.

b Click Delete.

A confirmation message is displayed.

c To delete the group, click OK.

d To close the confirmation message without deleting the group, click Cancel.

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System Administration Managing ProcedureCards

6 To reorder the groups in the list, do the following:

a Select the ProcedureCard you want to move.

b Click the arrows to move the ProcedureCard up and down within the list.

7 Click OK to close the dialog box.

14.13.8 Importing, Exporting and Restoring ProcedureCards


You can import and export ProcedureCards from storage devices like a USB flash memory drive, or from
a network location.

You can also restore the factory default ProcedureCard set.

NOTE When you import or restore ProcedureCards, all currently available ProcedureCards are
deleted and replaced by the imported or restored set of ProcedureCards. Before you import
or restore ProcedureCards, you should consider exporting the existing set of ProcedureCards
so you can import them later if you need to.

1 In the review window, click System and select Manage ProcedureCards.

The ProcedureCards Manager is displayed.

2 To export ProcedureCards from the system, do the following:

a Click Export ProcedureCards.

A dialog box is displayed allowing you to select the folder you want to export ProcedureCards
to.

b Click Browse, select the folder you want to use and click OK.

c Enter a name for the set of ProcedureCards you are exporting.

d To close the dialog box without exporting the ProcedureCards, click Cancel.

e To export the ProcedureCards to the selected folder, click Export.

3 To import ProcedureCards to the system, do the following:

a Click Import ProcedureCards.

A dialog box is displayed allowing you to select the folder you want to import ProcedureCards
from.

b Click Browse, select the folder containing the ProcedureCards and click OK.

c To close the dialog box without importing the ProcedureCards, click Cancel.

d To import the ProcedureCards from the selected folder, click Import.

NOTE All currently available ProcedureCards are deleted and replaced by the imported
ProcedureCards.

4 To restore the factory default ProcedureCard set, do the following:

a Click Restore the factory default ProcedureCards.

A dialog box is displayed asking you to confirm that you want to restore the factory default
ProcedureCard set.

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System Administration Exporting Settings

NOTE All currently available ProcedureCards are deleted and replaced by the factory
default ProcedureCards.

b To close the dialog box without restoring the factory default ProcedureCards, click Cancel.

c To restore the factory default ProcedureCard set, click Restore Defaults.

14.14 Exporting Settings


You can save system customization settings to allow you to import them later.

NOTE Before you make changes to system customization settings, you should consider exporting
the existing settings so you can import them later if you need to.

1 On the System menu, click Customization to display the System Customization window.

2 Click Export Settings.

3 Click Browse and select the directory for the settings to be saved to.

4 Enter a name for the export file.

5 To export the settings, click OK.

6 To close the System Customization window, click Close.

14.15 Importing Settings


You can import previous system customization settings that have been saved.

You can choose which settings to import from an import file to ensure you only import the settings you
need.

1 On the System menu, click Customization to display the System Customization window.

2 Click Import Settings.

A dialog box is displayed allowing you to select the file you want to import settings from, and which
settings you want to import.

3 Do one of the following:


• Select the directory that you want to Import Settings From.
• Click Browse, select the directory that you want to use and click OK.

4 Select the check boxes for each of the settings you want to import.

NOTE The settings you select are imported from the file you have chosen, and will replace the
current settings. This might cause some functionality to be unavailable after importing.
To resolve any inconsistencies, update the detailed settings of the DICOM settings,
export settings, and automatic data transfer settings.

5 To import the selected settings, click Import.

6 To close the System Customization window, click Close.

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System Administration Restoring Factory Default Settings

14.16 Restoring Factory Default Settings


You can restore the system’s settings to the factory default settings, if required.

You can choose which settings are be restored, allowing you to retain some customized settings.

NOTE Before you restore the factory default settings, you should consider exporting the existing
settings so you can import them later if you need to.

1 On the System menu, click Customization to display the System Customization window.

2 Click Restore Factory Default Settings.

The Restore Factory Default Settings dialog panel is displayed allowing you to select the settings
that you want to restore to factory default settings.

3 Select the check box for each of the settings that you want to restore.

NOTE The settings that you select will be restored to the factory default settings, replacing the
current settings. This might cause some functionality to be unavailable.

4 To close the dialog box without restoring the settings to the factory defaults, click Cancel.

5 To restore the selected settings to the factory default settings, click Restore Defaults.

6 To close the System Customization window, click Close.

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Maintenance Planned Maintenance Program

15 Maintenance
This product requires proper operation, planned maintenance, and checks that the user must perform
routinely. These tasks are essential to keep the product operating safely, effectively, and reliably.

WARNING
Maintenance of the system by persons without appropriate training, or using unapproved spare
parts, accessories, or detachable parts, may void the manufacturer's warranty. Such maintenance
carries serious risk of personal injury and damage to the system.

Clinical application is not allowed during maintenance and service.

NOTE The assembly of medical electrical systems and modifications during the actual service life,
require evaluation to the requirements of IEC 60601-1.

15.1 Planned Maintenance Program


To ensure that maintenance is performed at the required intervals, the responsible organization (the
owner of the equipment) should issue a request to the maintenance organization for maintenance to be
carried out in accordance with the planned maintenance program described in this section.

Planned maintenance may only be carried out by qualified and authorized personnel, and is
comprehensively described in the service documentation. For more information, see Safety (page 20).

Philips Medical Systems provides a full planned maintenance and repair service on both a call basis
and a contract basis. Full details are available from your Philips representative.

Task Frequency Required Personnel


Check the labels Every 6 months User
Check the emergency stop circuit Every 6 months Technician
Visually inspect the system Every 6 months Technician
Adjust the generators Every 6 months Technician
Perform the level 1 IQ tests Every 6 months Technician
Perform the air kerma rate verification Every 6 months Technician
Check the fixation of the ceiling mounted equipment 1 year after installation Technician
Check the coolant levels Every year Technician
Adjust the detectors Every year Technician
Check the ceiling rails Every year Technician
Clean the ceiling rails Every year User/technician
Perform mechanical maintenance of the frontal stand Every year Technician
Adjust the frontal stand Every year Technician
Perform mechanical maintenance of the lateral stand Every year Technician
Adjust the lateral stand Every year Technician
Check the mechanical fixation of the monitor ceiling sus- Every year Technician
pension
Perform mechanical maintenance of the FlexArm option, if Every year Technician
installed
Perform mechanical maintenance of the FlexMove option, if Every year Technician
installed
Check the X-ray protection devices Every year Technician
Check the ECG and injector relays Every year Technician
Perform mechanical maintenance of the patient table Every year Technician

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Maintenance Cleaning and Disinfecting

Task Frequency Required Personnel


Perform mechanical maintenance in the technical room Every year Technician
Replace the batteries of the operator controls Every year User/technician
Check the counter-balanced support arms and installed Every year User/technician
equipment
Check the electrical safety Every 2 years Technician
Check the X-ray safety Every 2 years Technician
Clean the top side of the FlexMove carriage, if installed Every 2 years Technician
Clean the FlexMove cable chain plate, if installed Every 2 years Technician
Replace the battery pack of the 1 phase UPS option, if in- Every 3 years Technician
stalled
Perform extended mechanical maintenance of the patient Every 4 years Technician
table
Lubricate the FlexMove bearings, if installed Every 6 years Technician
Replace the cooling hoses Every 15 years Technician

You should ensure that the planned maintenance program is fully up to date before using the product
with a patient.

Philips Medical Systems will make the required information available that assists technical support
personnel to repair those parts of the equipment that are designated by Philips Medical Systems as
repairable by qualified and authorized technical support personnel.

For a complete list of consumables, contact technical support.

15.2 Cleaning and Disinfecting


Insufficient cleaning of residues that remain on the equipment after procedures may lead to patient
infection from polluted parts. Follow these guidelines to ensure that the system is properly cleaned and
disinfected.

When cleaning and disinfecting the system, follow these general guidelines:
• Do not allow liquids to enter the system. This may cause corrosion or electrical damage.
• Do not apply cleaning liquid or spray directly onto the system. Always use a cloth dampened with
the cleaning product.
• The patient straps and ratchet compressor band should be laundered instead of subjected to
surface disinfection.
• Do not use corrosive or abrasive agents or pads.
• When cleaning scratched or worn painted surfaces, it is to be expected that some additional paint is
removed.
• Before cleaning the mattress, close the air plug to prevent liquids from entering. After cleaning the
mattress, open the air plug to allow the mattress to expand and contract properly when the patient
is positioned on it.

NOTE You should always comply with local instructions, regulations, and guidelines concerning
hygiene.

These cleaning and disinfecting instructions only apply to the X-ray system and do not apply to other
equipment in the room. Cleaning instructions for other equipment are described in the accompanying
documents of the equipment. If cleaning or disinfecting is needed at the interface of third-party
equipment with the X-ray system, dismount the equipment before cleaning or disinfecting. You should
also dismount third-party equipment if you need to clean or disinfect it with agents that are not
compatible with the X-ray system.

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Maintenance Cleaning and Disinfecting

NOTE Always follow the manufacturer's instructions for the cleaning agents or disinfectants that
you use.

15.2.1 Cleaning Workflow

The cleaning and disinfecting workflow consists of the following tasks:


• Preparation
• Manual cleaning
– Cleaning
– Rinsing
– Drying
• Manual disinfecting
– Disinfecting
– Rinsing
– Drying

Initial treatment of the equipment is not required for effective cleaning and disinfecting.

NOTE The manual cleaning step is recommended for effective disinfection. However, it can be
skipped if there are no visible residues, such as dust, dirt, or organic material.

NOTE It is recommended to complete the cleaning and disinfecting workflow for one part before
moving to the next part. This avoids over-exposing parts to cleaning and disinfection agents.

Cleaning and Disinfecting Frequency


The following figure and table indicate the frequency with which different parts of the equipment
should be cleaned and disinfected.

Figure 155 Part types, indicated by numbers

Recommended Disinfection Re- Recommended


Cleaning Re- Cleaning Fre- quired after Disinfection Fre-
Part Type quired? quency Cleaning? quency
1: Tabletop and parts that come in di- Yes After each pa- Yes After each pa-
rect contact with the patient, such as tient. tient
the mattress and head support

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Maintenance Cleaning and Disinfecting

Recommended Disinfection Re- Recommended


Cleaning Re- Cleaning Fre- quired after Disinfection Fre-
Part Type quired? quency Cleaning? quency
2: Detector housing, X-ray tube hous- Yes Daily1 Yes Daily1
ing, and parts that may come in con-
tact with the patient
3: Stand, C-arc, table support, foot Yes Weekly When contami- When contami-
switch, and monitor ceiling suspension nated nated
(including monitors)
4: Ceiling rails and all parts outside the Yes Weekly When contami- When contami-
operating room nated nated
Note 1: Depending on the level of contamination, cleaning and disinfection may be required after each patient (for exam-
ple, if there are visible residues).

NOTE Fabric accessories (for example, the ratchet compression band) should be washed after each
patient.

15.2.2 Preparation Task


You should prepare the equipment for cleaning and disinfecting before starting these tasks.

Note the following guidance:


• Disassembly of the medical device is not required.
• Testing the equipment to determine whether cleaning is necessary is not required.
• Pre-cleaning the equipment to remove debris is not required.

The following tools are required:


• Goggles, gloves, and protective equipment are required for cleaning staff, according to the hospital
regulations.
• Ready-to-use wipes
• If ready-to-use wipes are not available, then dry, lint-free wipes that do not leave residues should
be used.

NOTE Ready-to-use wipes are recommended as they are already prepared with the correct
amount of a suitable agent. This eliminates errors, reduces the time required for the task,
and ensures effective cleaning and disinfection.

The following tools are recommended:


• A soft toothbrush or equivalent is recommended but not necessary to remove residues from corners
and openings, such as the accessory rail.

1 Remove any sterile covers from the tube, detector, and table modules after each patient.

2 Remove accessories attached to the accessory rail if there are visible residues under or around the
clamps and moving parts.

For information about removing accessories from the accessory rail, see Using Other
Equipment (page 224).

3 Frontal stand: Position the C-arc so that you can reach all surfaces and the detector housing and X-
ray tube housing are easily accessible.

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Figure 156 Positioning the C-arc for cleaning and disinfection

4 Lateral stand: The lateral stand can be cleaned while it is in the parking position.

5 Position detector as close to the X-ray tube as possible, so that the surface of the carriage
mechanism is accessible

6 Remove the anti-scatter grid (it should be cleaned and disinfected separately).

For more information, see Removing and Replacing the Anti-Scatter Grid (page 296).

7 If you are performing daily or weekly cleaning and disinfection, switch the system off.

It is not necessary to switch the system off when cleaning and disinfecting the system between
patients.

15.2.3 Manual Cleaning


This section provides details of a validated manual procedure for cleaning, rinsing, and drying the
equipment. Automatic cleaning of the equipment is not possible.

The recommended order for cleaning is as follows:

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Figure 157 Recommended cleaning order

Recommended Cleaning Order


1 Ceiling suspension and ceiling rails
2 Floor stand / ceiling stand (both types of stand are shown in the figure above)
3 C-arc
4 Detector and tube
5 Mattress, tabletop, and accessory rail (clean from the head end to the foot end)
6 Accessories and user interface modules attached to the accessory rail
7 Table base
8 Foot switch
9 Monitor ceiling suspension (clean from top to bottom)

1 Use any of the following cleaning agents:


• Regular cleaning agent that is available to hospital staff.
• Mild detergent.
• Ready-to-use wipes.

NOTE For ease of use, ready-to-use wipes are recommended.

2 If ready-to-use wipes are not available, apply the cleaning agent to dry, lint-free wipes.

Never apply the cleaning agent directly to the equipment. Doing so may lead to ingress of liquid.
Spraying can cause a fire risk or rust as aerosol cleaning agent may get inside the equipment.

3 Clean the parts of the system with a linear motion.

The contact time of the cleaning agent with the equipment is not relevant.

4 While cleaning, change wipes as necessary and at least between cleaning each part of the
equipment.

5 Continue cleaning until all visible residues are removed.

6 After cleaning all parts of the equipment, rinse the equipment with damp, lint-free wipes using a
linear motion.

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Wipes can be dampened with tap water or demineralized water. The temperature of the water
should be between 15°C and 35°C.

7 After rinsing all parts of the equipment, dry the equipment with a dry, lint-free wipe using a linear
motion.

You should always dry the equipment after rinsing it. Continue drying the equipment until it is visibly
dry. Drying agent is not required.

15.2.4 Manual Disinfecting


This section provides details of a validated manual procedure for disinfecting, rinsing, and drying the
equipment. Automatic disinfection of the equipment is not possible.

When preparing your own disinfection solution, use any of the agents in the following table.
Alternatively, contact the manufacturer for a list of approved brands that have been tested and
approved. For details, see Contacting the Manufacturer (page 435).

NOTE If you use a brand of disinfectant other than one recommended by the manufacturer, you
should check its safety data sheet (available from the manufacturer of the brand) to verify
that the active ingredients and their concentrations are within the limits indicated in the
following table. Be aware that there may be additional ingredients in other branded
disinfectants that are not suitable.

Sprays and vapor-based disinfectants should not be used as the vapor may enter the system and cause
corrosion or electrical damage.

Active Ingredient Concentration


Ethyl alcohol 45% - 70%
Isopropyl alcohol 70% – 95%
Ethyl alcohol and isopropyl alcohol mixtures 50% - 60%
Hydrogen peroxide 6% – 7%
Chlorhexidine (0.5%) in ethanol or isopropyl alcohol 70% – 95%
Sodium Hypochlorite 0.5% – 0.6% (limit the usage)

NOTE For ease of use, ready-to-use wipes are recommended.

The recommended order for disinfecting is as follows:

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Figure 158 Recommended disinfecting order

Recommended Disinfection Order


1 Ceiling suspension and ceiling rails
2 Floor stand / ceiling stand (both types of stand are shown in the figure above)
3 C-arc
4 Detector and tube
5 Mattress, tabletop, and accessory rail (disinfect from the head end to the foot end)
6 Accessories and user interface modules attached to the accessory rail
7 Table base
8 Foot switch
9 Monitor ceiling suspension (disinfect from top to bottom)

1 If ready-to-use wipes are not available, apply the disinfection agent to dry, lint-free wipes.

Never apply the disinfection agent directly to the equipment. Doing so may lead to ingress of liquid.
Spraying can cause a fire risk or rust as aerosol disinfection agent may get inside the equipment.

2 Disinfect the first part of the system by linear motion with wipes, from the top to the bottom of each
item of equipment.

For effective disinfection, the disinfectant should remain in contact with the part for five minutes.
Wipe the item for a minimum of 30 seconds and then wait for the remaining duration before
continuing.

NOTE If you use a branded disinfectant, refer to the information supplied with the disinfectant
for details of the recommended contact time.

NOTE For quaternary disinfectants (Quat type), it is recommended to apply the disinfectant
twice.

3 While disinfecting, change wipes as necessary and at least between disinfecting each part of the
equipment.

4 Rinse the part with damp, lint-free wipes using a linear motion.

Wipes can be dampened with tap water or demineralized water. The temperature of the water
should be between 15°C and 35°C.

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NOTE If you use a branded disinfectant, rinsing may not be required. Check the instructions
supplied with the disinfectant.

5 Dry the part with a dry, lint-free wipe using a linear motion.

You should always dry a part after rinsing it. Drying agent is not required.

NOTE If you use a branded disinfectant, drying may not be required. Check the instructions
supplied with the disinfectant.

6 Repeat this procedure for all parts of the equipment.

7 If you removed any accessories or user interfaces from the accessory rail, replace them on the rail.

For information about attaching accessories to the accessory rail, see Using Other
Equipment (page 224).

15.2.5 Incompatible Cleaning and Disinfection Agents

Part Not Compatible With Effects


Cover below the tabletop Alcohol-based disinfectants or chlor- Coloring and gloss change
oxylenol 5%
Arm support Alcohol-based disinfectants or chlor- Coloring and gloss change
oxylenol 5%
Arm board of the adjustable arm sup- Alcohol-based disinfectants or chlor- Coloring and gloss change
port oxylenol 5%
Speed controller hand switch Heamo sol Regular, 1% solution, or Mi- Gloss change
crobac Forte
Azurion tags Chloroxylenol 5% Deformation
Neuro wedge Chloroxylenol 5% Deformation
(Out of scope of disinfection)
Mattress Long-term exposure to chloroxylenol Deformation
5%
Cover of the table tilt movement Alcohol-based disinfectants, chloroxy- Deformation
lenol 5%, or Bacillol
Monitor ceiling suspension Isopropyl alcohol -
Ceiling-mounted radiation shield Ethyl alcohol, ethyl and isopropyl al- -
cohol mixture, or chlorhexidine (0.5%)
in ethanol or isopropyl alcohol

15.2.6 Supplementary Information about Cleaning

Degradation or Limitations of the Process


Cleaning and disinfecting the equipment in accordance with these instructions is not known to lead to
degradation that might limit the service life of the equipment.

The service life of the equipment is not known to be limited by the number of cleaning cycles
performed.

Inspect the equipment parts before using the system after cleaning and disinfection. Table accessories
such as mattresses, head supports or arm supports may deteriorate over time. For example, a hole in
the foil of a mattress can be a source of contamination and indicates that the mattress should be
replaced.

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Maintenance Removing and Replacing the Anti-Scatter Grid

Inspection and Maintenance


Calibration after cleaning and disinfection is not needed.

Lubrication after cleaning and disinfection is not needed because only the outer surfaces of the
equipment covers are cleaned.

15.2.7 Cleaning the Ceiling Rails


The ceiling rails should be cleaned according to the planned maintenance program to prevent dust and
debris from being released from the rails and polluting the air flow around the table. Polluted air and
contaminated parts of the X-ray system may infect the patient.

1 Clean the ceiling rail track to remove dirt.

Insufficient cleaning may result in clots of dirt that degrade the performance of longitudinal
movements.

2 When present, check the fixation of the longitudinal brake strip and clean the strip with alcohol.

15.3 Removing and Replacing the Anti-Scatter Grid


This procedure provides guidance for removing and replacing the anti-scatter grid.

To prevent damage to the grid, observe the following guidance:


• Do not drop the grid.
• Do not apply excessive force to the grid.
• Do not use the grid to carry objects.
• Do not expose the grid to temperatures above 40°C (104°F).
• Do not store the grid in direct sunlight or near heat sources such as heaters or cooling fan outlets.
• Do not store the grid in cabinets with heat dissipating components.
• Do not sterilize the grid, or immerse it in water.
• Do not expose the grid to steam cleaners.

NOTE If you are using a ClarityIQ system, do not remove the grid before acquisition, as the image
quality will not be optimal. The grid should only be removed for cleaning.

15.3.1 Removing the Anti-Scatter Grid


Take care to avoid damaging either the detector or the anti-scatter grid during the following procedure.

Figure 159 Removing the anti-scatter grid

1 Rotate the stand to the lateral position shown in the figure below.

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Figure 160 Positioning the detector for removal of the anti-scatter grid

2 Move the tabletop just below the detector.

3 Move the spring-loaded locking sliders toward the center of the anti-scatter grid.

4 Carefully remove the grid from the detector.

15.3.2 Replacing the Anti-Scatter Grid


Take care to avoid damaging either the detector or the anti-scatter grid during the following procedure.

NOTE Before replacing the anti-scatter grid, ensure that it is clean and free from debris.

Figure 161 Replacing the anti-scatter grid

1 Insert the locating tabs on the anti-scatter grid in the corresponding slots of the detector casing.

2 Pull back the locking sliders and push the grid towards the detector until it is flush with the detector
casing and release the locking sliders.

3 Ensure that the locating tabs are correctly positioned in the detector casing and the grid locking
sliders are correctly engaged.

15.4 Replacing Batteries


For safe operation, you should replace the batteries in battery-operated equipment at regular intervals.

The batteries of the following items should be replaced regularly:

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• Viewpad
• Wireless mouse

CAUTION
Always remove the batteries if the equipment will not be used for some time.

1 To replace the batteries, open the battery compartment cover on the rear or underside of the
equipment.

2 Remove the old batteries.

NOTE Batteries harm the environment. Dispose of batteries responsibly.

3 Insert new batteries of the correct type in the position indicated in the battery compartment.

The viewpad and the wireless mouse use AA batteries.

4 Replace the battery compartment cover.

15.4.1 Wireless Foot Switch Battery


If the battery of the wireless foot switch is depleted within two days after a complete charge, contact
technical support for a replacement battery. The battery may only be removed and replaced by a
qualified service engineer.

15.5 User Quality Control Mode


To enable X-ray dose-related acceptance and constancy testing, the equipment provides a User
Quality Control Mode (UQCM) to perform X-ray dose-related tests.

UQCM is intended for trained hospital radiation physicists or service engineers and comprises special
user quality control procedures that are accessible by using a service dongle. This dongle is only made
available by Philips Medical Systems once the user has followed the appropriate training. For more
information, see Contacting the Manufacturer (page 435).

In case of failure of the measurements performed under UQCM, contact technical support.

15.6 User Verification Test


Perform this procedure to verify system functionality.

1 Test the collimator functions using fluoroscopy and confirm that the X-ray on indicators are on while
X-ray is active.

For more information about X-ray on indicators, see X-ray On Indicators (page 104).

2 Test the table and the stand movements without using X-ray.

3 Perform the following test using a user-defined phantom for constancy evaluation.

a Position the stand in a vertical position.

b Place the phantom on the table and in the X-ray beam.

c For constancy evaluation, use a fixed source-to-image distance and a consistent choice for field
of view.

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d Perform fluoroscopy and check whether the X-ray indications are as expected, and that the kV
and mA values are within the expected ranges for the constancy evaluation.

e Perform a digital cardiac or vascular exposure series and check whether the X-ray indications
are as expected, and the kV and mA values are within the expected ranges for the constancy
evaluation.

15.6.1 Automatic Exposure Control Test


1 Select a pulsed fluoroscopy X-ray protocol.

2 Close the shutters to apply full collimation.

3 Perform pulsed fluoroscopy twice and note the exposure parameters.

The kV value must reach the maximum programmed value (for example 110 kV) with no error
message occurring. This test also includes a test of the grid switch at the highest kV value.

15.6.2 Beam Limitation Check


You can perform the beam limitation check as needed If it is suspected that the beam limiting device
(shutters) are malfunctioning.

1 Reset the shutters.

2 Position the tabletop horizontally and adjust it to maximum height.

3 Position the stand with the X-ray beam perpendicular to the tabletop.

4 Position two lead rulers crosswise on the tabletop and use tape to attach the rulers.

5 Move the detector as close as possible to the rulers.

6 Select a field size such that the rulers span the height and width of the entire screen (see figure
below).

7 Acquire a fluoroscopy image.

8 Float the tabletop to position the center of the intersection of the two lead rulers in the center of
the image.

9 Acquire a fluoroscopy image and write down the ruler values (A1 to D1), corresponding to the edges
of the image.

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10 Position an adequately sized film cassette or digital film cassette on top of the rulers.

11 Expose the film (or digital film) by acquiring fluoroscopy.

The maximum density of the developed film should be 0.9 ± 0.1.

12 Write down the ruler values (A2 to D2).

13 Determine the distance [X] in cm between the focal spot and the tabletop.

NOTE The position of the focal spot is indicated at the outside cover of the tube housing.

14 For each edge (A to D) calculate the following:

(Value 2 - Value 1) ≤ X/50.

EXAMPLE

A1 = 7; A2 = 6.8 and X = 85. Therefore the formula gives:

(6.8 - 7) ≤ 85/50 = 0.2 ≤ 1.7, which is acceptable.

If any calculated value is larger than X/50, the beam limiting device is malfunctioning and you
should contact technical support.

15.7 Viewing and Testing Network Connections


You can view and test the system's network connections to assist in troubleshooting.

1 To view the system's network connections, do one of the following in the review window:
• Click System and select System Connectivity Overview.
• Click the connection status icon in the notification area.

The following icons are used in the notification area to indicate the connection status:

No connectivity problems have been detected.

Connectivity problems have been detected.

The Network Connections dialog box is displayed showing a list of the system's network
connections with information about each connection and its status.

2 To view the information for a network connection, select the connection in the list.

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The following icons are used in the Network Connections dialog box to indicate the connection
status:

The connection is operational.

The connection has an error.

Information about the selected network connection is displayed below the list and includes the
name and status of the connection, when the last successful connection was made and some
recommendations for appropriate action you can take.

If you are a system administrator, you are shown more detailed information about each connection.

3 To test an individual connection, do the following:

a Select the desired connection in the Network Connections dialog box.

b Click Test Connection.

The status of the connection and its associated information is refreshed.

15.8 Activating the Screen Saver


For occasions when you want to blank the monitors, you can activate the screen saver.

1 Ensure all geometry movements are stopped and that X-ray is not active.

2 Click System in the review window and select Activate Screen Saver.

A dialog box is displayed requesting you to confirm that you wish to activate the screen saver.

3 Do one of the following:


• To close the dialog box without activating the screen saver, click Cancel.
• To activate the screen saver, click Activate.

The screen saver is displayed.

4 To deactivate the screen saver, move the mouse or press any key or mouse button.

15.9 Viewing Audit Logs


If you are logged on as a system administrator, you can view an audit trail of actions carried out on the
system.

1 Click System and select View Audit Logs.

The Audit Trail Viewer is displayed showing the list of actions carried out on the system.

2 To find for a specific action in the audit log, enter text in the search field and click Search.

Matching search results are displayed.

3 To close the Audit Trail Viewer, click Close.

For more information about audit trail settings, see Configuring Audit Trail Settings (page 264).

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15.10 Saving Information for Technical Support


You can save information on the system for use by technical support.

The system allows you to save the following information:


• Images
• Log files

15.10.1 Saving a Series for Technical Support


If you encounter a problem with a series, you can save it to help with technical support.

When you save a series for technical support, the system saves the series that is displayed in the review
window.

1 Ensure that the series you want to save is displayed in the review window.

2 In the review window, click System and select Save Series for Technical Support.

The series is saved and is available to assist in technical support activities.

15.10.2 Saving a Log File for Technical Support


If you encounter an error or a problem in the system, you can save a log file that Technical Support can
use to assist in resolving the problem.

1 In the review window, click System and select Save Log File for Technical Support.

A dialog box is displayed asking you to confirm that you want to save the log file.

2 To close the dialog box without saving the log file, click Cancel.

3 To save the log file, click Save.

The following icons are displayed in the notification area, indicating the status of the saving
operation:

The log file is being saved.

The log file is saved (displayed for 5 seconds when saving is complete).

15.11 Enabling Remote Assistance


You can enable remote assistance for immediate access by a remote user or schedule a remote
assistance session to allow access during a specified time period.

You can also enable remote viewing as an alternative to remote assistance. Remote viewing allows a
remote user to view the active window, but not control the system.

1 Select System in the review window, and then select Enable/Disable Remote Assistance.

The Remote Assistance dialog box is displayed.

2 To enable remote assistance for immediate access, do the following:

a Select Enable Remote Access.

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Remote assistance is enabled. An icon in the notification area indicates the status of the remote
assistance function.

Remote assistance is enabled but not in use.

Remote assistance is enabled and in use.

b To switch to remote viewing while remote access is enabled, select Switch to Remote View.

c To switch remote assistance off, select Disable Remote Access.

3 To enable remote viewing instead of remote assistance, do the following:

a Select Enable Remote View.

b To switch to remote access while remote viewing is enabled, select Switch to Remote Access.

c To switch remote viewing off, select Disable Remote Viewing.

4 To schedule a remote assistance session, do the following:

a Select Schedule Session Later.

b Enter a date and time in the Start Date and Start Time boxes.

c Enter a date and time in the End Date and End Time boxes.

These entries define the schedule when the system will be accessible by a remote user.

d (Optional step) To allow a remote user to access the system during the defined schedule
without requiring confirmation by the hospital user, select Automatically accept incoming
connections.

e Select Enable Remote Access.

Remote assistance remains switched off until the defined schedule begins.

f If you want to cancel the scheduled remote assistance session before it begins, select Cancel
Schedule.

15.12 Updating the System Software


You can download and install system software updates when they become available.

Check to ensure updates are available for your system.

If updates are available, an icon is displayed in the notification area at the bottom of the review window.

Software updates are provided as individual packages which you can download and install separately.
You do this using the Software Updates dialog box.

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Figure 162 Software updates dialog box

Legend
1 Software update package list
2 Download queue

1 If software updates are available, do one of the following:


• Click System and select Software Updates.

• Click the software update icon in the notification area.

The Software Updates dialog box is displayed. Software update packages are shown in a list.

2 Filter the list using the filter check boxes.

• Select Show installed successfully to include all successfully installed software update
packages.
• Select Show install failed to include all software update packages that failed to install.

Each software update package has an icon displaying its status.

Ready for download / Retry download

Download queued

Downloading

Download paused

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Download invalid / installation failed

Ready to install

Installing

Installed

3 To download a software update package that is ready for download, select it in the list and click
Download or Add to Download Queue.

You can select more than one software update package at a time, by holding down the Ctrl key on
the keyboard and clicking each of the packages you want to download.

The software update package is shown in the download queue and the progress of the download is
displayed.

Once downloading is complete, the status of the package changes.

4 To abort a download, do the following:

a Select the download you want to abort in the download queue.

You can select more than one download at a time, by holding down the Ctrl key on the
keyboard and clicking each of the downloads you want to abort.

b Click Abort Download to stop the selected download and remove it from the download queue.

5 To pause a download, select the download and click Pause.

6 To resume all paused downloads, click Resume All

7 To install a downloaded package, do the following:

a Select the package in the software update package list and click Install.

A confirmation dialog box is displayed, showing the estimated time required to install the
selected package.

b Click Install to install the package, or click Cancel to close the dialog box without installing the
package.

If you choose to install the package, its status changes in the software update package list.

Installation is performed automatically. If the installation is successful, this is shown in the


software update package list.

If an installation fails, an error message is displayed.

NOTE If a software update package installation fails, the system is not ready for clinical
use. If this occurs, contact technical support for assistance.

8 To close the dialog box, click Close.

Downloading of software update packages continues.

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15.13 Showing the Monitor Test Image


To assist with maintenance, you can make the system display the Society of Motion Pictures and
Television Engineers (SMPTE) test image.

When the test image is displayed, you cannot use the system.

1 Ensure that the service application is not in use and that a remote assistance session is not being
performed.

2 Click System in the review window and select Show Monitor Test Image.

A dialog box is displayed, requesting you to confirm that you want to display the test image.

3 Do one of the following:


• To close the dialog box without displaying the test image, click No.
• To display the test image, click Yes.

4 To stop displaying the image and restore the system to normal use, press any key or mouse button.

15.14 CBCT Calibration


You can perform CBCT calibration without assistance from technical support. For example, you should
perform CBCT calibration if you notice artifacts in CBCT acquisitions. Calibration should not be
performed from inside the examination room.

NOTE The following procedure is automated. Follow the instructions provided on-screen, and
interact with the system when instructed to do so.

1 On the System menu, click CBCT Calibration.

2 In the CBCT Calibration dialog box, select a Scan Type:


• Propeller
• Roll

3 Follow the instructions provided in the CBCT Calibration dialog box to position the stand and table
for the calibration procedure.

4 (FlexMove only) On the control module, use the Move Beam XY Motorized joystick to position the
stand in the transverse zero position.

You can also do this by selecting a procedure in which the stand moves automatically to the
transverse zero position.

5 Click Start Calibration and press and hold the acquisition hand switch or foot switch.

The system performs the calibration procedure.

6 Release the acquisition hand switch or foot switch when the system indicates that the calibration
procedure is finished.

7 To stop the calibration procedure while it is in progress, click Abort.

15.15 Environmental Impact of the System


You can assess the environmental impact of the system by measuring the typical energy consumption
during various operational modes.

To reduce the environmental impact of the system, switch it off when it is not in use. However, bear in
mind any clinical limitations that might make switching the system off impractical.

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For information, visit the following website and select one of the available guides:

www.cocir.org/initiatives/ecodesign-initiative/saving-energy

15.16 Disposing of the System


Final disposal is when the equipment or system is disposed of in such a way that it can no longer be
used for its intended purpose. Philips Medical Systems is concerned about protecting the natural
environment and ensuring continued safe and effective use of the system through proper support,
maintenance and training.

Hospital staff should not de-install the system prior to disposal. Contact the manufacturer to arrange for
the system to be de-installed in a safe manner. For contact details, see Contacting the
Manufacturer (page 435).

Philips Medical Systems equipment is designed and manufactured to comply with relevant guidelines
for environmental protection. As long as the system is properly operated and maintained it presents no
risk to the environment. However, the equipment may contain materials which could be harmful to the
environment if disposed of incorrectly. Use of such materials is essential for the implementation of
certain functions and for meeting certain statutory and other requirements.

The system, or any part of it, should not be disposed of with industrial or domestic waste. The system
may contain materials such as lead, tungsten or oil, or other hazardous substances that can cause
serious environmental pollution.

Contact the manufacturer for information about disposing of the system. For contact details, see
Contacting the Manufacturer (page 435)

NOTE Computer disks and media from the system could contain personal data. Contact the
manufacturer for information about disposing of these items.

Recycling
Philips Medical Systems supports responsible organizations with recovery of reusable parts, recycling
useful materials, and the safe and effective disposal of equipment.

The WEEE Recycling passport of this product can be requested through the following website:

www.medical.philips.com/main/about/sustainability/recycling/index.wpd

Disposing of the Wireless Foot Switch Battery


This wireless foot switch contains lithium-ion batteries. It must be disposed of according to local, state,
and federal laws regarding the disposal of lithium-ion batteries. If you cannot dispose of the wireless
foot switch in your area, return it to the manufacturer for disposal.

Passing the System on to Another User


If the system is passed to another organization, it must be in its complete state, including all product
support documentation.

You should make the new user aware of the support services that Philips Medical Systems provides.
Before passing on the system or taking it out of service, all patient data must be deleted and
unrecoverable on the system. It should be backed up elsewhere, if necessary.

Passing medical electrical products on to a new responsible organization may create serious technical,
medical, and legal risks. Such risks can arise even if the system is given away. A responsible organization
is strongly advised to seek advice from a Philips representative before committing to passing on any
product.

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Once the system has been passed on to a new user, the previous user may still receive important
safety-related information. In many jurisdictions there is a clear duty on the previous user to
communicate such safety-related information to new users. Previous users who are unable or
unprepared to do this should inform Philips Medical Systems about the new user.

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Security Customer Role in the Product Security Partnership

16 Security

16.1 Customer Role in the Product Security Partnership


Philips Medical Systems recognizes that the security of its products is an important part of your facility's
in-depth security strategy. However, these benefits can only be realized if you implement a
comprehensive, multi-layered strategy (including policies, processes, and technologies) to protect
information and systems from external and internal threats.

Following industry-standard practice, your strategy should address physical security, operational
security, procedural security, risk management, security policies, and contingency planning. The
practical implementation of technical security elements varies by site and may employ a number of
technologies, including firewalls, virus-scanning software, and authentication technologies.

As with any computer-based system, protection must be provided such that firewalls or other security
devices are in place between the medical system and any externally accessible systems. The USA
Veterans Administration has developed a widely used Medical Device Isolation Architecture for this
purpose. Such perimeter and network defenses are essential elements in a comprehensive medical
device security strategy.

The latest information on security and privacy, including recommended customer actions, can be found
on the following website:

www.philips.com/productsecurity

NOTE You should check the system's published cyber security status regularly on this website.

16.1.1 Risks Related to Security


To ensure the confidentiality, integrity, and availability of the device and related data, you should assess
the risks to security based on the following recommendations.

• Implement network and physical access controls to limit the likelihood of compromise. For more
information, see Customer Role in the Product Security Partnership (page 309).
• Monitor the manufacturer's product security recommendations on a regular basis. For more
information, see Malware Protection (page 310).

The assessment should be repeated whenever changes are made to the network. Such changes
include:
• Changes in the network configuration
• Connection of additional items to the network
• Disconnection of items from the network
• Updates or upgrades to items that are connected to the network

16.1.2 Detecting Security Failures


Azurion is designed to handle errors, including security failures, and restricts user access to the
application level only. The system provides logging capabilities for local and remote services that
support diagnostics and forensics.

Security failures arising from user actions display error messages for the user and create audit events
according to the IHE ATNA integration profile.

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Security Malware Protection

Network communication failures are audited. An error message is displayed for the user when user
interaction is required.

System failures are handled depending on the nature and severity of the failure and may result in
changes to the workflow, error messages, logging, or audit events. For example, software that is not on
the whitelist is not executed and the failure is logged.

A number of security features have been implemented in this product. It is recommended to contact
technical support to activate these features, in cooperation with the IT specialist of the hospital. These
features are described below.

Encryption of Personal Data


When personal data is stored on the system, this feature ensures that the media cannot be misused
when removed from the system or site.

Secure DICOM Transfer


When medical images or data are transmitted over a network, this feature ensures that the data is not
modified by intruders during transmission, as well as ensuring that the data cannot be read if it is
intercepted and displayed.

This feature can be switched on or off for each network node, if required.

Audit Trail
Any user action involving personal data is logged to allow analysis as to whether any hostile action has
been performed on the personal data.

Network Time Synchronization


This function ensures that every device on the network uses the same clock so that all relevant user
actions and data transmissions, including audit trail actions, can be checked in chronological order.

This function can be configured by the service engineer during installation.

16.2 Malware Protection


Philips Medical Systems systematically analyzes sources of information related to cyber security
vulnerabilities to assess the equipment's cyber security risk. To ensure the proper functioning of the
medical device, Philips Medical Systems may recommend specific customer or service actions, or issue
service recommendations to update, alter, or even replace the equipment's protection mechanisms.

The latest information, including the Product Security Policy Statement and recommended customer
actions, can be found on the following website:

www.philips.com/productsecurity

NOTE You should regularly check the published equipment’s cyber security status on the website
mentioned above.

Despite preventive measures already implemented, a remote possibility remains that the equipment
may become infected with malware. When malware is detected, or when you notice that unfamiliar
behavior or degraded performance occurs repeatedly, including after switched off and on again, you
should contact technical support for an inspection. When the inspection confirms the infection, be sure
to take measures to contain and remove the source of infection. Technical support will reinstall the
equipment's software to bring the equipment back into specification. Technical support can also assist
in accessing the equipment’s event log, which may provide information useful for the investigation.

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Security Malware Protection

16.2.1 Security Updates


This equipment incorporates protection mechanisms against the intrusion of malware such as viruses.
Without proper cyber security maintenance, the effectiveness of these provisions may degrade over
time, since malware is continuously altered to target newly discovered vulnerabilities.

The systematic analysis on cyber security vulnerabilities includes an assessment on the applicability
and need for applying security updates taking into account mitigating circumstances in the intended
use and design of this equipment.

Security updates alter the equipment’s design and thus require proper validation and approval by
Philips Medical Systems. Security updates are deployed by the Philips Service organization and are
only to be installed by authorized service engineers according to Philips maintenance procedures for
medical devices.

The latest information, including recommended customer actions, can be found on the following
website:

www.philips.com/productsecurity

16.2.2 Whitelist Protection


Whitelist protection software is installed on this equipment. The whitelist identifies all trusted software,
which is allowed to execute on the equipment.

The protection software prohibits the execution of untrusted software, thus effectively blocking
malware before damage is done. Instead of relying on frequent updates, as for antivirus software, it
offers proactive protection against a wide spectrum of malware and malware alterations.

Since only known trusted software is allowed to run, no regular updates are required.

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Technical Information Geometry

17 Technical Information
The following sections provide information and data tables about the specification of the system.

17.1 Geometry

17.1.1 Beam Carriers

Floor-Mounted Stand with 12-Inch Detector


The X-ray beam field is always aligned with the image receptor area and the reference axis is always
perpendicular to the image receptor plane.

Item Specification
Rotation speed 0 - 25 degrees/s (variable)
These speeds are only valid when the stand is in its working
position, otherwise the maximum speed is 8°/s
Angulation speed 0 - 25 degrees/s (variable)
These speeds are only valid when the stand is in its working
position, otherwise the maximum speed is 8 degrees/s
Projection angles Angulation: 45 degrees caudal to 45 degrees cranial
Rotation: 120 degrees LAO to 120 degrees RAO
Isocenter to floor 106.5 cm (41.9 inch)
Focal spot to isocenter 76.5 cm (30.1 inch)
Focal spot to detector (source-to-image distance) 89.0 to 123.5 cm (35.0 to 48.6 inch)
Detector movement speed Toward the patient: 10 cm/s
Away from the patient: 20 cm/s
Throat depth 105 cm (41.3 inch)
Motorized stand rotation 90 degrees left to 90 degrees right at 12 degrees/s
Rotational scan From 120 degrees RAO (-rotation) to 120 degrees LAO (+ro-
tation) at a speed of up to 55 degrees/s

Ceiling-Mounted Stand with 12-Inch Detector


The X-ray beam field is always aligned with the image receptor area and the reference axis is always
perpendicular to the image receptor plane.

Item Specification
Rotation speed 0 - 25 degrees/s (variable)
These speeds are only valid when the stand is in its working
position, otherwise the maximum speed is 8 degrees/s
Angulation speed 0 - 25 degrees/s (variable)
These speeds are only valid when the stand is in its working
position, otherwise the maximum speed is 8 degrees/s
Projection angles with the stand positioned at the head end Angulation: 45 degrees caudal to 45 degrees cranial
of the table Rotation: 120 degrees LAO to 120 degrees RAO
Projection angles with the stand positioned at the side of Angulation: 120 degrees caudal to 120 degrees cranial
the table Rotation: 45 degrees LAO to 45 degrees RAO
Isocenter to floor 106.5 cm (41.9 inch)
Focal spot to isocenter 76.5 cm (30.1 inch)
Focal spot to detector (source-to-image distance) 89.0 to 123.5 cm (35.0 to 48.6 inch)
Detector movement speed Toward the patient: 10 cm/s
Away from the patient: 20 cm/s

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Item Specification
Throat depth 105 cm (41.3 inch)
Longitudinal movement (manual or motorized) 260 cm (102.4 inch)
With extended ceiling rail (option): 410 cm (161.4 inch)
Motorized longitudinal movement speed (option) 15 cm/s
Motorized stand rotation 90 degrees left to 90 degrees right at 12 degrees/s
Rotational scan Propeller movement: From 120 degrees RAO (-rotation) to
120 degrees LAO (+rotation) at a speed of up to 55
degrees/s
Roll movement: From 45 degrees LAO to 45 degrees RAO at
a speed of up to 30 degrees/s
Minimum ceiling height 270 cm (106 inch)

Floor-Mounted Stand with 15-Inch Detector


The X-ray beam field is always aligned with the image receptor area and the reference axis is always
perpendicular to the image receptor plane.

Item Specification
Rotation speed 0 - 25 degrees/s (variable)
These speeds are only valid when the stand is in its working
position, otherwise the maximum speed is 8 degrees/s
Angulation speed 0 - 25 degrees/s (variable)
These speeds are only valid when the stand is in its working
position, otherwise the maximum speed is 8 degrees/s
Projection angles Angulation: 90 degrees caudal to 90 degrees cranial
Rotation: 120 degrees LAO to 185 degrees RAO
Isocenter to floor 114.5 cm (45.1 inch)
Focal spot to isocenter 81 cm (31.9 inch)
Focal spot to detector (source-to-image distance) 89.5 to 119.5 cm (35.2 to 47.1 inch)
Detector movement speed Toward the patient: 10 cm/s
Away from the patient: 15 cm/s
Throat depth 90 cm (35.4 inch)
Motorized stand rotation 90 degrees left to 90 degrees right at 12 degrees/s
Rotational scan From 120 degrees LAO (+rotation) to 185 degrees RAO (-ro-
tation) at a speed of up to 55 degrees/s

Floor-Mounted Stand with 20-Inch Detector


The X-ray beam field is always aligned with the image receptor area and the reference axis is always
perpendicular to the image receptor plane.

Item Specification
Rotation speed 0 - 25 degrees/s (variable)
These speeds are only valid when the stand is in its working
position, otherwise the maximum speed is 8 degrees/s
Angulation speed 0 - 25 degrees/s (variable)
These speeds are only valid when the stand is in its working
position, otherwise the maximum speed is 8 degrees/s
Projection angles Angulation: 90 degrees caudal to 90 degrees cranial
Rotation: 120 degrees LAO to 185 degrees RAO
Isocenter to floor 114.5 cm (45.1 inch)
Focal spot to isocenter 81 cm (31.9 inch)
Focal spot to detector (source-to-image distance) 89.5 to 119.5 cm (35.2 to 47 inch)
Detector movement speed Toward the patient: 10 cm/s
Away from the patient: 15 cm/s

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Item Specification
Throat depth 90 cm (35.4 inch)
Motorized stand rotation 90 degrees left to 90 degrees right at 12 degrees/s
Rotational scan From 185 degrees RAO (-rotation) to 120 degrees LAO (+ro-
tation) at a speed of up to 55 degrees/s

Ceiling-Mounted Stand with 20-Inch Detector


The X-ray beam field is always aligned with the image receptor area and the reference axis is always
perpendicular to the image receptor plane.

Item Specification
Rotation speed 0 - 25 degrees/s (variable)
These speeds are only valid when the stand is in its working
position, otherwise the maximum speed is 8 degrees/s
Angulation speed 0 - 25 degrees/s (variable)
These speeds are only valid when the stand is in its working
position, otherwise the maximum speed is 8 degrees/s
Projection angles with the stand positioned at the head end Angulation: 90 degrees caudal to 90 degrees cranial
of the table Rotation: 120 degrees LAO to 185 degrees RAO
Projection angles with the stand positioned at the side of Angulation: 185 degrees caudal to 120 degrees cranial
the table Rotation: 90 degrees LAO to 90 degrees RAO
Isocenter to floor 106.5 cm (41.93 inch)
Focal spot to isocenter 81 cm (31.9 inch)
Focal spot to detector (source-to-image distance) 89.5 to 119.5 cm (35.2 to 47 inch)
Detector movement speed Toward the patient: 10 cm/s
Away from the patient: 15 cm/s
Throat depth 90 cm (35.4 inch)
Longitudinal movement (manual or motorized) 260 cm (102.4 inch)
With extended ceiling rail (option): 410 cm (161.4 inch)
Motorized longitudinal movement speed (option) 15 cm/s
Motorized stand rotation 90 degrees left to 90 degrees right at 12 degrees/s
Rotational scan Propeller movement: From 185 degrees RAO (-rotation) to
120 degrees LAO (+rotation) at a speed of up to 55
degrees/s
Roll movement: From 90 degrees LAO to 90 degrees RAO
at a speed of up to 40 degrees/s
Minimum ceiling height 270 cm (106 inch)

Lateral Beam Carriers for Biplane Systems


The X-ray beam field is always aligned with the image receptor area and the reference axis is always
perpendicular to the image receptor plane.

Item Specification
Detector size 12-inch (FD12) or 15-inch (FD15)
Detector orientation Fixed (non-rotatable)
Rotation speed 8 degrees/s (also for combined frontal and lateral move-
ments)
Angulation speed 8 degrees/s
Roll angle L-arc C: 0 degrees to +90 degrees
L-arc N: -115 degrees to -27 degrees
Propeller angle (skew) -45 degrees to +45 degrees

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Item Specification
Isocenter to floor (depending on the system in use) B12/12: 106.5 cm (41.9 inch)
B20/12: 114.0 cm (44.9 inch)
B20/15: 114.0 cm (44.9 inch)
Focal spot to detector (source-to-image distance) FD12: 87.8 to 130.6 cm (34.6 to 51.4 inch)
FD15: 87.4 to 130.2 cm (34.4 to 51.3 inch)
Detector movement speed Toward the patient: 6 cm/s
Away from the patient: 9 cm/s
Longitudinal movement (manual or motorized) 315 cm (124 inch)
Motorized longitudinal movement speed (option) Outside the working area: 12 cm/s
Inside the working area: 6 cm/s

17.1.2 FlexArm Beam Carrier (Option)


The X-ray beam field is always aligned with the image receptor area and the reference axis is always
perpendicular to the image receptor plane.

Item Specification
Rotation speed 0 - 25 degrees/s (variable)
Angulation speed 0 - 25 degrees/s (variable)
Projection angles with the stand positioned at the head end Angulation: 90 degrees caudal to 90 degrees cranial
of the table Rotation: 120 degrees LAO to 185 degrees RAO
Projection angles with the stand positioned at the side of Angulation: 185 degrees caudal to 120 degrees cranial
the table Rotation: 90 degrees LAO to 90 degrees RAO
Isocenter to floor 106.5 cm (41.93 inch)
Focal spot to isocenter 81 cm (31.9 inch)
Focal spot to detector (source-to-image distance) 89.5 to 119.5 cm (35.2 to 47 inch)
Detector movement speed Toward the patient: 10 cm/s
Away from the patient: 15 cm/s
Throat depth 90 cm (35.4 inch)
Longitudinal movement (manual or motorized) 285 cm (112.2 inch)
With extended ceiling rail (option): 430 cm (169.3 inch) or
635 cm (250.0 inch)
Motorized longitudinal movement speed (option) 15 cm/s
Motorized stand rotation -135 degrees to 135 degrees at 12 degrees/s
Rotational scan Propeller movement: From 185 degrees RAO (-rotation) to
120 degrees LAO (+rotation) at a speed of up to 55
degrees/s
Roll movement: From 90 degrees LAO to 90 degrees RAO
at a speed of up to 40 degrees/s
Minimum ceiling height 270 cm (106 inch)

17.1.3 Beam Carriers with FlexMove (Option)


The X-ray beam field is always aligned with the image receptor area and the reference axis is always
perpendicular to the image receptor plane.

Item Specification
Rotation speed 0 - 25 degrees/s (variable)
These speeds are only valid when the stand is in its working
position, otherwise the maximum speed is 8 degrees/s

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Technical Information Geometry

Item Specification
Angulation speed 0 - 25 degrees/s (variable)
These speeds are only valid when the stand is in its working
position, otherwise the maximum speed is 8 degrees/s
Projection angles with the stand positioned at the head end Angulation: 90 degrees caudal to 90 degrees cranial
of the table Rotation: 120 degrees LAO to 185 degrees RAO
Projection angles with the stand positioned at the side of Angulation: 185 degrees caudal to 120 degrees cranial
the table Rotation: 90 degrees LAO to 90 degrees RAO
Isocenter to floor 106.5 cm (41.9 inch)
Focal spot to isocenter 81 cm (31.9 inch)
Focal spot to detector (source-to-image distance) 89.5 to 119.5 cm (35.2 to 47 inch)
Detector movement speed Toward the patient: 10 cm/s
Away from the patient: 15 cm/s
Throat depth 90 cm (35.4 inch)
Longitudinal movement (manual or motorized) With FlexMove normal ceiling rail: 440 cm (137.2 inch)
With FlexMove extended ceiling rail: 540 cm (212.5 inch)
Motorized longitudinal movement speed (option) 15 cm/s
Transverse movement (manual or motorized) 260 cm (102.3 inch)
Motorized transverse movement speed 15 cm/s
Motorized stand rotation 90 degrees left to 90 degrees right at 12 degrees/s
Rotational scan Propeller movement: From 185 degrees RAO (-rotation) to
120 degrees LAO (+rotation) at a speed of up to 55
degrees/s
Roll movement: From 45 degrees LAO to 45 degrees RAO at
a speed of up to 40 degrees/s
Ceiling height Maximum: 310 cm (122 inch)
Minimum: 290 cm (114.2 inch)

17.1.4 Patient Table

AD7 Patient Table


The patient table is available with a neuro tabletop or a cardio tabletop. The cardio tabletop can be
used for a wide range of applications, including vascular and non-vascular procedures.

The following figure indicates dimensions for the neuro tabletop and cardio tabletop.

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Technical Information Geometry

Figure 163 Tabletop dimensions: Neuro (top) and Cardio (bottom)

Specification
Maximum patient weight 250 kg
Maximum weight of all accessories (total) 50 kg
Maximum permissible mass (patient plus accessories) 275 kg
Additional allowable force for Cardio Pulmonary Resuscita- 500 N
tion (CPR)
Maximum load on the table accessory rail as a result of ac- 50 kg
cessories (maximum 40 kg on a maximum distance of 0.45 Torque: 184 Nm
m from the table accessory rail, either horizontal or not) Inertia: 19 kgm2
Maximum load on the additional table accessory rail as a 10 kg
result of accessories Torque downward: 40 Nm
Torque upward: 20 Nm
The table can be fixed in all positions with use of the brakes -

Additional Accessory Weight


It is possible to increase the maximum permissible weight of accessories by reducing the maximum
permissible patient weight under the following conditions:
• An additional 25 kg above the current maximum weight limit of 50 kg is allowed, increasing the
maximum weight of all accessories to 75 kg.
• The maximum patient weight is reduced to 200 kg.
• The additional accessory weight should be evenly distributed over the entire length of the two table
accessory rails at the nurse side and doctor side of the tabletop.
• Additional accessory weight should not be placed on the table accessory rail at the foot end of the
tabletop.

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Movements

Movements Specifications
Transverse movement Manual or motorized (optional)
Transverse movement stroke -180 to +180 mm
Transverse motorized movement speed 60 mm/s
Longitudinal movement For a table without the tilt/cradle option, movement is man-
ual or motorized (optional).
For a table with the tilt/cradle option, movement is always
motorized.
Longitudinal movement stroke 1200 mm
For a table with the tilt/cradle option, motorized movement
stroke depends on the tilt angle.
Longitudinal motorized movement speed 150 mm/s
For a table with the tilt/cradle option, motorized movement
speed depends on the tilt angle.
Height movement Motorized

Height movement stroke1 740-1020 mm


• Without adaption plate
• Without tilt/cradle option

Height movement stroke1 770-1050 mm


• With adaption plate
• Without tilt/cradle option

Height movement stroke1 790-1040 mm


• Without adaption plate
• With tilt/cradle option

Height movement stroke1 820-1070 mm


• With adaption plate
• With tilt/cradle option

Height movement stroke1 870-1120 mm


• With swivel option
• With tilt/cradle option

Height movement stroke1 820-1100 mm


• With swivel option
• Without tilt/cradle option
Height movement speed 30 mm/s
Pivot movement Manual
Pivot movement angle Configurable as one of the following ranges:
• +180 degrees to -90 degrees
• +90 degrees to -180 degrees
Pivot movement angle with swivel option +180 degrees to -90 degrees
Pivot movement mechanical arret positions • 0 degrees
• ±13 degrees
• ±90 degrees

Tilt movement2 Motorized

Tilt movement angle range2 -16.5 degrees to +16.5 degrees

Tilt movement speed2 2 degrees/s

Cradle movement 2 Motorized

Cradle movement angle 2 -15 degrees to +15 degrees

Cradle movement speed 2 3 degrees/s

Swivel movement Motorized


Swivel movement stroke 782 mm
Swivel movement speed 20 degrees/s

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Movements Specifications
Note 1: The table height is the distance between the upper side of the tabletop and the floor.
Note 2: Not applicable for a table without the tilt/cradle option.

17.1.5 Monitor Ceiling Suspension

Weight, Load, and Dimensions

MCS Max. total weight (kg) Width x Height x Depth (mm)


2-fold 115 850 x 590 x 400 (monoplane only)
4-fold 155 1250 x 1150 x 524
6-fold 180 1424 x 1150 x 524

Movement Range
Movement ranges are approximate.

Vertical (mm)
MCS Longitudinal (mm) Lateral (mm) Ceiling height 2900 mm
2-fold 3600 3000 520 (monoplane only)
4-fold 3600 3000 320
6-fold 3600 3000 320

Actuator

Item Specification
Mains voltage 230 V
Mains frequency 50 / 60 Hz
Maximum power consumption 500 W
Maximum speed 12 mm/s (0.5 in/s)

FlexVision (XL) Monitor Ceiling Suspension

Dimensions and Weight

MCS Width [mm] Height [mm] Depth [mm] Weight [kg]


1-fold (XL) 1750 1150 250 220
3-fold (XL) 1750 1450 250 260

Movement Range

Horizontal Horizontal Vertical [mm]


Ceiling height
Rotation [de- Ceiling height 2900 mm and
MCS grees] X-axis [mm] Y-axis [mm] below 2900 mm above
3-fold (one large 330 3000 3600 Not available 320
screen, two op-
tional 27-inch
monitors)

NOTE Vertical movement is only available where ceiling height permits.

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Actuator
When available, vertical movement is provided by the actuator.

Item Specification
Mains voltage 230 V
Mains frequency 50 / 60 Hz
Maximum power consumption 500 W
Maximum speed 12 mm/s (0.5 in/s)

Supported Monitor Combinations


The following combinations of supported monitors can be used.

NOTE A combination of the monitors listed below can be combined with dummy monitors or any
other monitors. However, the number of monitors mounted must not exceed the maximum-
fold MCS configuration. That is, only 6 monitors can be mounted in a 6-fold MCS.

2-fold MCS supports two 27-inch monitors.

4-fold MCS supports three or four 27-inch monitors.

6-fold MCS supports the following configurations:


• Four, five, or six 27-inch monitors.
• Four 27-inch monitors with two other supported monitors.

1-fold XL MCS supports one 58-inch monitor.

3-fold XL MCS supports one 58-inch monitor and two 27-inch monitors.

MCS Cabling Interface


The monitor ceiling suspension and the monitor boom provide the following cabling for an optional
monitor.

Cabling

Item Specification
Mains supply 100-240 Vac
50-60 Hz
Protective earth
Video signal DVI-D input connector
DVI-D output connector
Multiple frequencies up to 1920 x 1200, 60Hz

The mains supply and protective earth can be connected as a part of the system. Alternatively, if the
monitor and its related equipment need to be electrically and galvanically isolated, the monitor can be
connected separately from the system.

Optional Monitor

Item Specification
Mounting interface VESA interface
100 x 100 mm
Maximum power consumption 100 W

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17.1.6 Monitor Boom

Configuration
The monitor boom is available in the following configurations.

Configuration Weight
1-fold monitor boom with one FlexVision monitor (58-inch, option) 159.9 kg
3-fold monitor boom with one FlexVision monitor (58-inch, option) and two 27- 185.9 kg
inch rear-view monitors
4-fold monitor boom with four 27-inch monitors 128.9 kg
6-fold monitor boom with four 27-inch monitors and two 27-inch rear-view mon- 154.9 kg
itors

Movement Range

Item Range
Upper arm (horizontal) 1400 mm
Lower arm (horizontal) 1015 mm
Total (horizontal) 2415 mm

17.1.7 Springarm Monitor Ceiling Suspension


NOTE The springarm monitor ceiling suspension is only available for Azurion 3 series systems.

The springarm monitor ceiling suspension is available in the following configurations:


• 2-fold springarm monitor ceiling suspension for two 27-inch (9 kg) monitors.
• 3-fold springarm monitor ceiling suspension for one 27-inch (9 kg) monitor and two 19-inch (5 kg)
monitors.

A dummy monitor can be used to substitute one of the monitors in either configuration. Additional
components cannot be mounted in the springarm monitor ceiling suspension.

17.1.8 Alternative Monitor Support Systems


If preferred, an approved alternative monitor support system can be used to position additional
monitors in the examination room.

For more information, refer to the Instructions for Use supplied with the monitor support system.

17.1.9 Accessories and Detachable Parts


This section provides details of accessories and detachable parts that can be used with the system.

Item Identification 1
Additional table accessory rail 4598 012 9567X
Additional table accessory rail (US version) 4598 012 9568X
Anti-scatter grids FD12 9896 010 6943X
FD15 9896 010 6905X
FD20 9896 010 6904X
FD20 (Neuro grid) 9896 010 7372X

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Item Identification 1
Arm supports Set of elbow supports 4598 007 0274X
Height-adjustable arm support 4598 007 5211X
Shoulder support board 4598 008 2855X
Arm support board 4598 007 5903X
Arm support board pad for Azurion series 3 4598 011 1026X
Arm support board pad for Azurion series 5 4598 016 0938X
Arm support board pad for Azurion series 7 4598 011 1022X
Cable supports 4598 006 5949X
Drip stand 9896 002 0633X
Filters Cerebral filter (not applicable for the FlexArm option) 9896 001 3362X
Peripheral X-ray filter 9896 000 3241X
Head support 4598 007 4807X
Mattresses Standard mattress for Azurion series 3 4598 011 1024X
Standard mattress for Azurion series 5 4598 016 0935X
Standard mattress for Azurion series 7 4598 011 1020X
Cardio mattress for Azurion series 3 4598 011 1025X
Cardio mattress for Azurion series 5 4598 016 0936X
Cardio mattress for Azurion series 7 4598 011 1021X
Neuro mattress for Azurion series 3 4598 011 1028X
Neuro mattress for Azurion series 5 4598 016 0937X
Neuro mattress for Azurion series 7 4598 011 1023X
Mouse table 4598 007 4805X
Neuro wedge 4598 007 9790X
Pan handle 4598 007 4803X
Ratchet compressor 4598 007 2220X
Table accessory rail clamps 9896 002 0461X
Table tilt and cradle accessories Patient straps 9896 002 0453X
Handgrip and clamp set 4598 007 4462X
Table-mounted radiation shield 9896 000 7720X
Touch screen module swing arm 4598 013 2471X
Touch screen module swing arm (US version) 4598 013 2232X
Viewpad Cardio 4598 006 7815X
Vascular 4598 006 7818X
Wireless mouse 4598 004 7453X
XperGuide laser tool 9896 002 1207X

1
X can be any number between 1 and 9.

XperGuide Laser Tool

XperGuide Laser Tool Specification

Item Specification
Type Laser with affixed optics to convert it into a crosshair laser
Laser classification IEC 60825-1:2007 Class 1 Laser Product
Wavelength 635 nm

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Item Specification
Power output assembly <0.4 mW
Weight (including laser, holder, and battery) 0.3 kg

The following statement on compliance applies to the XperGuide laser tool:

Complies with FDA performance standards for laser products except for conformance with IEC 60825-1
Ed. 3., as described in Laser Notice No. 56, dated May 8, 2019.

Guidance for Using the XperGuide Laser Tool


• Avoid exposing eyes to the laser at any time.
• Do not use the laser tool for investigation. The laser tool is for alignment only.
• The laser tool contains a laser with the IEC classification Class 1 Laser Product.

XperGuide Laser Tool Charger


The charger of the XperGuide laser tool is classified as Class II according to IEC 60601-1.

17.1.10 Examination Light

Item Specification
Light intensity 60,000 lux at 1 m
Color temperature 4300 K
Color rendering index 95
Focusable light field size 13 to 19 cm (5.1 to 7.5 inch)
Working distance 70 to 140 cm (27.6 to 55.1 inch)
Lamp type LED 1.2 A / 24V DC, 28 W
Mains power 100 to 240 V AC, 50 to 60 Hz
Weight < 15 kg
Maximum radiation in field 210 W/m2 at 1 m
Temperature increase in head area 0.5 °C (0.9°F)

17.1.11 Ceiling-Suspended Radiation Shield


The ceiling suspended radiation shield comprises:

• 75/90 cm counter-balanced, two-section suspension arm


• 40 x 50 cm tiltable lead acrylic shield, lead equivalence 0.5 mm Pb
• 35 x 50 cm lead apron, lead equivalence 0.5 mm Pb.
The total weight of the radiation shield and arm is 19 kg.

Accessory Bracket
The accessory bracket for mounting the ceiling suspended radiation shield comprises:
• Mounting spigot with a 32 mm diameter groove for securing the ceiling suspended radiation shield.
• Mechanical rating: 341 Nm maximum.

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Technical Information User Interface

17.2 User Interface

17.2.1 Wireless Foot Switch


The specifications that apply depend on the model of your foot switch. For more information about the
model types, see Equipment Labels (page 415) (refer to the wireless foot switch labels in that section).

Item Type 1 Specification Type 2 Specification


Frequency range 2.4000 GHz to 2.4835 GHz 2402 MHz to 2480 MHz
Channel spacing 500 KHz 2 MHz
Modulation 2-FSK, MSK Gaussian Frequency Shift Keying (GFSK)
Adaptive frequency-hopping on 40 channels
Range 10 m in open field 10 m in open field
Conformity • Europe: EN 300440, EN 301489, EN • Europe: EN 301489, EN 300328 v2.1.1, EN
60950, EN 50371 60950-1, FCC 15.247
• USA: FCC Part 15C, single modular, FCC • USA: FCC, Part 15B, single Modular, FCC
identifier XK5-SW100AMBINT Identifier: XK5-SW24LE
• Canada: RSS-210 Issue 7, 5158A- • Canada: RSS-210 Issue 7, 5158A-SW24LE
SW100AMBINT

The system reaction time is up to 80 ms longer when the wireless foot switch is used, compared to
using the hand switch or the wired foot switch.

17.3 X-ray Generation

17.3.1 X-ray Generator

Technical Data According to IEC 60601-2-54


This section contains X-ray generator specific information. Information about system specific usage of
the X-ray generator is described in the next section.

Methods of Measurement

Item Method
X-ray tube voltage Tube voltage is measured with the aid of balanced high-voltage bleeders in the high volt-
age circuit
X-ray tube current Tube current is measured on the cathode side in the rectified high-voltage circuit of the X-
ray generator
Load time Load time is measured between 75% ±7.5% peak voltage of the high-voltage rise edge and
75% ±7.5% peak voltage of the high-voltage fall edge
Current-time product Current-time product is measured on the cathode side in the rectified high voltage circuit of
the HV generator between 75% ±7.5% peak voltage of the high-voltage rise edge and 75%
±7.5% peak voltage of the high-voltage fall edge

Parameter/Ranges

IEC 60601-2-54 Output Parameter Mode Loading Factor


§ 201.7.9.2.1.101 a Maximum X-ray tube voltage and Radiographic (Inter- 125 kV, 720 mA
highest X-ray tube current at that mittent)
voltage

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IEC 60601-2-54 Output Parameter Mode Loading Factor


§ 201.7.9.2.1.101 b Maximum X-ray tube current and Radiographic (Inter- 1000 mA, 100 kV
highest X-ray tube voltage at that mittent)
current
§ 201.7.9.2.1.101 c Combination of X-ray tube current Radiographic (Inter- 1000 mA, 100 kV
and X-ray tube voltage resulting in mittent)
highest output power
§ 201.7.9.2.1.101 d Highest constant output power at Radiographic (Inter- 100 kW, 1000 mA
100 kV, 0.1s mittent)
§ 201.7.9.2.1.101 e The lowest current time product or Radiographic (Inter- 0.1 mAs
the combination of loading factors mittent)
resulting in the lowest current time
product
§ 201.7.9.2.1.101 f Nominal shortest irradiation time AEC Not applicable: no photo time tech-
(AEC exposures) nique
§ 201.7.9.2.1.101 f Ranges of tube load factors control- AEC Ranges of tube load factors deter-
led by AEC mined by X-ray protocol. The maxi-
mum range is: 40 – 125 kV; 10 –
1000 mA. Tolerances according to
§203.6.4.3.104.3 and
§203.6.4.3.104.4

According to IEC 60601-2-54 Section 201.7.2.7

Electrical Data - Generator


Power supply For systems using the cur- 380 V – 480 V ±10%, 50 Hz / 60 Hz, 3 – phase, switched
rent catalog number and fused (50 A slow blow) by system PDU
For systems using the previ- 400 V – 480 V ±10%, 50 Hz / 60 Hz, 3 – phase, switched
ous catalog number and fused (50 A slow blow) by system PDU
Radiography Maximum voltage power 125 kV
X-ray tube current 1000 mA
Nominal electrical power 100 kW (100 kV, 1000 mA, 0.1 s)
Maximum electrical power • 100 kW
• 1000 mA at 100 kV
• 800 mA at 125 kV
Continuous output 1.5 kW (for example, 9 fpm at 100 kW, 0.1 s)
High-voltage generation Converter
Ripple DC voltage
Power supply cooling unit Cooling Unit: 230 V ±10%, maximum 3.0 A, 50 Hz / 60 Hz, 1
– phase switched and fused by system PDU
Duty cycle The generator can be used continuously as long as average
power limitations described in X-ray System Configura-
tion (page 327) are satisfied.

Radiography with Automatic Exposure Control


mAs 0.01 mAs…10 mAs
Switching times 3.0 ms…10 ms

Radiography without Automatic Exposure Control


Tube voltage 40 kV…125 kV adjustable in steps of 1 kV or according to a sequence the steps of which
roughly correspond to an exposure increment. In the case of tubes with lower maximum
voltage this is limited accordingly.
Tube current For kV-mA-s and kV-mAs techniques this can be adjusted in steps 1
10 m A...1000 mA

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Radiography without Automatic Exposure Control


mAs range 0.1 mAs…2000 mAs
Adjustable in steps 1
Exposure times 1 ms…16 s
Adjustable in steps 1
Note 1: Steps selectable on system level

Pulsed fluoroscopy with Grid Control


Tube voltage 40 kV - 125 kV
Tube current 10 mA - 200 mA (depending on the tube configuration)

IEC 60601-2-54 Section 203.6.4.3.104

Exposure Certeray X-ray Generator (Typical Range of Application)


Certeray Performance Requested by Standard
Tube voltage ± (5%) ± 10%
Tube current-time product ± (3% + 0.2 mAs) ± (10% + 0.2 mAs)
Tube current ± (5% + 1.0 mA) ± 20%
(Tp ≥ 35 ms)
± (8% + 1.0 mA)
(1 < Tp < 35 ms)
Exposure time ± (10% + 1 ms) ± (10% + 1 ms)
mAs post-exposure display ± (3% + 0.2 mAs)
Post-exposure time display ± (2% + 0.1 ms)

IEC 60601-2-54, Cl.203.6.5


The system adapts the exposure settings by varying one or more loading factors, based on the source-
to-image distance and objects in the beam using automatic exposure control. The following graphs
show an example of the range and inter-relationship of loading factors for a single X-ray protocol.

Figure 164 Loading factors (Left Coronary, 15 fps) - pulse width and tube voltage

Legend
1 Tube voltage (kV)
2 Pulse width (ms)

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Figure 165 Loading factors (Left Coronary, 15 fps) - tube current and voltage

Legend
1 Tube voltage (kV)
2 Tube current (mA)

Compatibility
The Certeray iX High Voltage generator is compatible with the following tubes made by Philips Medical
Systems:
• MRC 200+ 0508 ROT-GS 1003
• MRC 200+ 0407 ROT-GS 1004
• MRC 200+ 0407 ROT-GS 1008

Labels
For information about labels, see Equipment Labels (page 415).

17.3.2 X-ray System Configuration

X-ray Tube Usage

Monoplane Systems Current Catalog Number Previous Catalog Number X-ray Tube Assembly
Azurion 3 M12 722221 722063 MRC 200+ 0508 ROT-GS
1003
Azurion 3 M15 722222 722064 MRC 200+ 0407 ROT-GS
1004
Azurion 5 M12 722227 - MRC 200+ 0508 ROT-GS
1003
Azurion 5 M20 722228 - MRC 200+ 0407 ROT-GS
1004
Azurion 7 M12 722223 722078 MRC 200+ 0508 ROT-GS
1003
Azurion 7 M20 722224 722079 MRC 200+ 0407 ROT-GS
1004

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Technical Information X-ray Generation

Frontal X-ray Tube Lateral X-ray Tube


Biplane Systems Current Catalog No. Previous Catalog No. Assembly Assembly
Azurion 7 B12 722225 722067 MRC 200+ 0508 MRC 200+ 0508
ROT-GS 1003 ROT-GS 1003
Azurion 7 B20 722226 722068 MRC 200+ 0407 MRC 200+ 0508
ROT-GS 1004 ROT-GS 1003

FlexArm Option Current Catalog Number Previous Catalog Number X-ray Tube Assembly
Azurion 7 M20 722224 722079 MRC 200+ 0407 ROT-GS
1008

MRC 200+ 0508 ROT-GS 1003 and cooling unit CU 3101


NOTE If your system has been upgraded, the X-ray tube may be MRC 200 0508 ROT-GS 1003.
Any differences in specification are indicated below.

Item Specification
Maximum voltage Fluoroscopy: 125 kV1
Exposure: 125 kV
Maximum tube current Large focus: 1063 mA at 80 kV
Small focus: 563 mA at 80 kV
Tube current for pulsed fluoroscopy with grid control 10 mA - 200 mA
Continuous loadability (at 23°C) 4000 W
(MRC 200: 3200 W)
Nominal focal spot values 0.5/0.8 mm (IEC 60336:2005)
Note 1: Normal usage is 120 kV. For low load fluoroscopy, 125 kV is possible.

• Maximus ROTALIX Ceramic tube MRC 200+ 0508 ROT-GS 1003 with anode heat storage capacity
of 6.4 MHUeff and maximal 45 and 85 kW short time load.
– MRC 200: Anode heat storage capacity of 2.4 MHU
• Grid switching at pulsed fluoroscopy
• Tube housing ROT-GS 1003 for oil-cooled X-ray tube with thermal safety switch
• Cooling unit heat exchanger for direct and continuous forced cooling with oil
• Rotor control
• High-voltage cables
• Cover parts

MRC 200+ 0407 ROT-GS 1004 and cooling unit CU 3101


NOTE If your system has been upgraded, the X-ray tube may be MRC 200 0407 ROT-GS 1004.
Any differences in specification are indicated below.

Item Specification
Maximum voltage Fluoroscopy: 125 kV1
Exposure: 125 kV
Maximum tube current Large focus: 813 mA at 80 kV
Small focus: 353 mA at 85 kV
Tube current for pulsed fluoroscopy with grid control 10 mA - 160 mA
Continuous loadability (at 23°C) 4000 W
(MRC 200: 3200 W)
Nominal focal spot values 0.4/0.7 mm (IEC 60336:2005)
Note 1: Normal usage is 120 kV. For low load fluoroscopy, 125 kV is possible.

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Technical Information X-ray Generation

• Maximus ROTALIX Ceramic tube MRC 200+ 0407 ROT-GS 1004 with anode heat storage capacity
of 6.4 MHUeff and maximal 30 and 65 kW short time load
– MRC 200: Anode heat storage capacity of 2.4 MHU
• Grid switching at pulsed fluoroscopy
• Tube housing ROT-GS 1004 for oil-cooled X-ray tube with thermal safety switch
• Cooling unit heat exchanger for direct and continuous forced cooling with oil
• Rotor control
• High Voltage cables
• Cover parts

MRC 200+ 0407 ROT-GS 1008 and cooling unit CU 3101

Item Specification
Maximum voltage Fluoroscopy: 125 kV1
Exposure: 125 kV
Maximum tube current Large focus: 813 mA at 80 kV
Small focus: 353 mA at 85 kV
Tube current for pulsed fluoroscopy with grid control 10 mA - 160 mA
Continuous loadability (at 23°C) 4000 W
Nominal focal spot values 0.4/0.7 mm (IEC 60336:2005)
Note 1: Normal usage is 120 kV. For low load fluoroscopy, 125 kV is possible.

• Maximus ROTALIX Ceramic tube MRC 200+ 0407 ROT-GS 1008 with anode heat storage capacity
of 6.4 MHUeff and maximal 30 and 65 kW short time load
• Grid switching at pulsed fluoroscopy
• Tube housing ROT-GS 1008 for oil-cooled X-ray tube with thermal safety switch
• Cooling unit heat exchanger for direct and continuous forced cooling with oil
• Rotor control
• High Voltage cables
• Cover parts

Assembly of X-ray tube and collimator (X-ray source assembly)

Item Specification
Loading factors corresponding to the maximum 125 kV, 28 mA (3500 W)
specified energy input to anode in one hour when
applied at the nominal X-ray tube voltage
Maximum symmetrical radiation field MRC 200+ 0508 ROT-GS 1003: 28 x 28 cm at 1 m distance
MRC 200+ 0407 ROT-GS 1004: 35 x 35 cm at 1 m distance
MRC 200+ 0407 ROT-GS 1008: 35 x 35 cm at 1 m distance

Tube Output Power

MRC 200+ 0508 ROT-GS MRC 200+ 0407 ROT-GS MRC 200+ 0407 ROT-GS
Exposure 1003 1004 1008
Highest electric power (X- 85 kW (125 kV, 680 mA) 65 kW (125 kV, 520 mA) 65 kW (125 kV, 520 mA)
ray tube current and X-ray
tube voltage resulting in
highest electric power)
Highest electric output 85 kW (850 mA) 65 kW (650 mA) 65 kW (650 mA)
power at 100kV, 0.1s (X-ray
tube current)

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Technical Information X-ray Generation

MRC 200+ 0508 ROT-GS MRC 200+ 0407 ROT-GS MRC 200+ 0407 ROT-GS
Exposure 1003 1004 1008
Maximum X-ray tube volt- 125 kV, 680 mA 125 kV, 520 mA 125 kV, 520 mA
age and highest X-ray tube
current at that voltage
Maximum X-ray tube cur- 1063 mA, 80 kV 813 mA, 80 kV 813 mA, 80 kV
rent and highest X-ray tube The maximum tube current
voltage at that current cannot be reached with the
current system configura-
tion.
Minimum X-ray tube current 10 mA, 40 kV 10 mA, 40 kV 10 mA, 40 kV
and lowest X-ray tube volt-
age at that current
The lowest current time 0.1 mAs (10 mA, 10 ms) 0.1 mAs (10 mA, 10 ms) 0.1 mAs (10 mA, 10 ms)
product (loading factors at
the lowest current time
product)
Note: Values ±10%.

Fluoroscopy with Grid MRC 200+ 0508 ROT-GS MRC 200+ 0407 ROT-GS MRC 200+ 0407 ROT-GS
Switch 1003 1004 1008
Highest electric power (X- 25 kW (125 kV, 200 mA) 20 kW (125 kV, 160 mA) 20 kW (125 kV, 160 mA)
ray tube current and X-ray
tube voltage resulting in
highest electric power)
Highest electric output 20 kW (200 mA) 16 kW (160 mA) 16 kW (160 mA)
power at 100kV, 0.1s (X-ray
tube current)
Maximum X-ray tube volt- 125 kV1, 200 mA 125 kV1, 160 mA 125 kV1, 160 mA
age and highest X-ray tube
current at that voltage
Minimum X-ray tube volt- 40 kV, 10 mA 40 kV, 10 mA 40 kV, 10 mA
age and lowest X-ray tube
current at that voltage
Maximum X-ray tube cur- 200 mA, 125 kV 160 mA, 125 kV 160 mA, 125 kV
rent and highest X-ray tube
voltage at that current
Minimum X-ray tube current 10 mA, 40 kV 10 mA, 40 kV 10 mA, 40 kV
and lowest X-ray tube volt-
age at that current
The lowest current time 0.007 mAs (2 mA, 3.5 ms) 0.007 mAs (2 mA, 3.5 ms) 0.007 mAs (2 mA, 3.5 ms)
product (loading factors at
the lowest current time
product)
Note 1: Normal usage is 120 kV. For low load fluoroscopy, 125 kV is possible.
General notes:
• Values ±10%.
• Fluoroscopy is available in pulsed fluoroscopy mode only.

Accuracy of Dosimetric Indications and Automatic Control System

Dosimetric Indication Accuracy


Accuracy of the reference air kerma ±35% (above 100 mGy)
Accuracy of reference air kerma rate ±35% (above 6 mGy/min)
Accuracy of cumulative dose area product ±35% (above 2.5 Gy∙cm2)
Coefficient of variation of the automatic control system <0.05

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Technical Information Imaging

The dosimetric indications for reference air kerma (rate) and cumulative dose area product are
calculated using the acquisition parameters and a calibration procedure with a reference dose meter in
the equipment. When the optional dose area product meter is used, the dose indications come directly
from this instrument.

All given reference air kerma (rate) values have an accuracy of ±35%, in accordance with IEC
60601-2-43:2010, 203.6.4.5.

17.3.3 Collimator

Item Specification
Minimum field size <2x2 mm at 1 m source-to-image distance
Inherent filtration (without spectral filter) 0.2 mm Al equivalent at 75 kV
Maximum shutter operational speed at 1 m source-to-im- 20 cm/s
age distance
Maximum wedge operational speed at 1 m source-to-image 10 cm/s
distance
Maximum wedge operational rotational speed 90 degrees/s
Maximum collimator rotational speed (FlexArm option only) 55 degrees/s

17.3.4 Anti-Scatter Grid

Detector Type Line Rate [lines/cm] Grid Ratio Focal Spot Distance [cm]
FD12 N74 r14 f105
FD15 N70 r13 f100
FD20 N44 r12 f105

17.4 Imaging

17.4.1 Detectors

12-Inch Detector

Item Specification
Detector 30 cm (11.6 inch) diagonal square, triple mode flat detector
subsystem
Field size (available at all source-to-image positions) Display value - diagonal Length x width
30 cm (11.6 inch), square 21 x 21 cm (8.2 x 8.2 inch)
27 cm (10.5 inch), square 19 x 19 cm (7.4 x 7.4 inch)
22 cm (8 inch), square 16 x 16 cm (6.0 x 6.0 inch)
19 cm (7 inch), square 13.5 x 13.5 cm (5.3 x 5.3 inch)
15 cm (6 inch), square 11 x 11 cm (4.3 x 4.3 inch)
Pixel size 154 x 154 µm
Detective quantum efficiency (DQE) 77% at 0 lp/mm
Spatial resolution properties: MTF
• 1.0 lp/mm: 59%
• 2.0 lp/mm: 30%
Nyquist: 3.25 lp/mm

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Item Specification
Dynamic range Linear within 2% from 2500 nGy in fluoroscopy mode to
50000 nGy in exposure mode (dependent upon operating
mode)
Output digital video Field size: Maximum resolu- Minimum resolution:
tion:
30 cm 1340 x 1340 664 x 664
27 cm 1232 x 1232 960 x 960
22 cm 1016 x 1016 508 x 508
19 cm 864 x 864 432 x 432
15 cm 720 x 720 360 x 360
Geometrical fill factors Photodiode (optical fill factor): 63%
Scintillator (X-ray fill factor): 100%

15-Inch Detector

Item Specification
Detector 26 x 33 cm (10 x 13 inch) 7 mode Flat Detector subsystem
Field size (available at all source-to-image positions) Display value - diagonal Length x width
39 cm (15.2 inch), rectangu- 29 x 26 cm (11.4 x 10.2 inch)
lar
37 cm (14.4 inch), square 26 x 26 cm (10.2 x 10.2 inch)
31 cm (13 inch), square 22 x 22 cm (8.7 x 8.7 inch)
27 cm (10.5 inch), square 19 x 19 cm (7.4 x 7.4 inch)
22 cm (8 inch), square 16 x 16 cm (6.0 x 6.0 inch)
19 cm (7 inch), square 13.5 x 13.5 cm (5.3 x 5.3 inch)
15 cm (6 inch), square 11 x 11 cm (4.3 x 4.3 inch)
Pixel size 184 x 184 µm
Detective quantum efficiency (DQE) 70% at 0 lp/mm
Spatial resolution properties: MTF:
• 1.0 lp/mm: 59%
• 2.0 lp/mm: 30%
Nyquist: 2.7 lp/mm
Dynamic range Linear within 2% from 2500 nGy in fluoroscopy mode to
45000 nGy in exposure mode (dependent upon operating
mode)
Output digital video Field size: Maximum resolu- Minimum resolution:
tion:
39 cm 2000 x 1688 1000 x 844
37 cm 1688 x 1688 844 x 844
31 cm 1340 x 1340 664 x 664
27 cm 1232 x 1232 960 x 960
22 cm 1016 x 1016 508 x 508
19 cm 864 x 864 432 x 432
15 cm 720 x 720 360 x 360
Geometrical fill factors Photodiode (optical fill factor): 63%
Scintillator (X-ray fill factor): 100%

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20-Inch Detector

Item Specification
Detector 30 x 40 cm (11.6 x 16 inch) (48 cm / 18.9 inch diagonal) 8-
mode flat detector subsystem
Field size (available at all source-to-image positions) Display value - diagonal Length x width
48 cm (19 inch), rectangular 38 x 30 cm (15.0 x 11.8 inch)
42 cm (17 inch), square 30 x 30 cm (11.8 x 11.8 inch)
37 cm (14.4 inch), square 26 x 26 cm (10.2 x 10.2 inch)
31 cm (13 inch), square 22 x 22 cm (8.7 x 8.7 inch)
27 cm (10.5 inch), square 19 x 19 cm (7.4 x 7.4 inch)
22 cm (8 inch), square 16 x 16 cm (6.0 x 6.0 inch)
19 cm (7 inch), square 13.5 x 13.5 cm (5.3 x 5.3 inch)
15 cm (6 inch), square 11 x 11 cm (4.3 x 4.3 inch)
Detector rotation 90 degrees
Detector rotation time 3s
Maximum detector rotation speed 45 degrees/s
Pixel size 154 x 154 µm
Detective quantum efficiency (DQE) 77% at 0 lp/mm
Spatial resolution properties: MTF:
• 1.0 lp/mm: 59%
• 2.0 lp/mm: 30%
Nyquist: 3.25 lp/mm
Dynamic range Linear within 2% from 2500 nGy in fluoroscopy mode to
50000 nGy in exposure mode (dependent upon operating
mode)
Output digital video Field size: Maximum resolu- Minimum resolution:
tion:
48 cm 1920 x 1448 960 x 742
42 cm 1904 x 1904 952 x 952
37 cm 1688 x 1688 844 x 844
31 cm 1432 x 1432 716 x 716
27 cm 1232 x 1232 616 x 616
22 cm 1016 x 1016 508 x 508
19 cm 864 x 864 432 x 432
15 cm 720 x 720 360 x 360
Geometrical fill factors Photodiode (optical fill factor): 63%
Scintillator (X-ray fill factor): 100%

20-Inch Detector (FlexArm Option)

Item Specification
Detector 30 x 40 cm (11.6 x 16 inch) (48 cm / 18.9 inch diagonal) 8-
mode flat detector subsystem

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Technical Information System-Level Information

Item Specification
Field size (available at all source-to-image positions) Display value - diagonal Length x width
48 cm (19 inch), rectangular 38 x 30 cm (15.0 x 11.8 inch)
42 cm (17 inch), square 30 x 30 cm (11.8 x 11.8 inch)
37 cm (14.4 inch), square 26 x 26 cm (10.2 x 10.2 inch)
31 cm (13 inch), square 22 x 22 cm (8.7 x 8.7 inch)
27 cm (10.5 inch), square 19 x 19 cm (7.4 x 7.4 inch)
22 cm (8 inch), square 16 x 16 cm (6.0 x 6.0 inch)
19 cm (7 inch), square 13.5 x 13.5 cm (5.3 x 5.3 inch)
15 cm (6 inch), square 11 x 11 cm (4.3 x 4.3 inch)
Detector rotation 270 degrees
Maximum detector rotation speed 45 degrees/s
Pixel size 154 x 154 µm
Detective quantum efficiency (DQE) 77% at 0 lp/mm
Spatial resolution properties: MTF:
• 1.0 lp/mm: 59%
• 2.0 lp/mm: 30%
Nyquist: 3.25 lp/mm
Dynamic range Linear within 2% from 2500 nGy in fluoroscopy mode to
50000 nGy in exposure mode (dependent upon operating
mode)
Output digital video Field size: Maximum resolu- Minimum resolution:
tion:
48 cm 1920 x 1448 960 x 742
42 cm 1904 x 1904 952 x 952
37 cm 1688 x 1688 844 x 844
31 cm 1432 x 1432 716 x 716
27 cm 1232 x 1232 616 x 616
22 cm 1016 x 1016 508 x 508
19 cm 864 x 864 432 x 432
15 cm 720 x 720 360 x 360
Geometrical fill factors Photodiode (optical fill factor): 63%
Scintillator (X-ray fill factor): 100%

17.5 System-Level Information

17.5.1 Environmental Requirements

Operation

Environmental Condition Range (Minimum to Maximum)


Ambient temperature +10°C to +30°C (50°F to + 86°F)
Relative humidity 20% to 80%
Pressure 70 kPa to 106 kPa (0 to 3000 m altitude)
(700 hPa to 1060 hPa)

NOTE To allow unrestricted air flow around the cabinets of the system, do not place any items on
top of the cabinets.

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Technical Information System-Level Information

Transport and Storage

Environmental Condition Range (Minimum to Maximum)


Temperature -25°C to +70°C (-13°F to 158°F)
Relative humidity 5% to 95%
Pressure 70 kPa to 110 kPa (0 to 3000 m altitude)
(700 hPa to 1100 hPa)

Equipment IP Ratings

Equipment IP Rating Protection


System IPX0 Not protected
Wireless mouse IPX0 Not protected
Patient support table base IPX1 Protected against vertically falling water drops
Patient support tabletop IPX2 Protected against vertically falling water drops
when enclosure tilted up to 15 degrees
Viewpad IPX2 Protected against vertically falling water drops
when enclosure tilted up to 15 degrees
Review module IPX2 Protected against vertically falling water drops
when enclosure tilted up to 15 degrees
Pan handle IP03 Protected against spraying water
Control module IPX4 Protected against splashing water
Touch screen module IP44 Protected against splashing water
X-ray hand switch IP54 Protected against splashing water and dust
Foot switch (wired and wireless) IPX8 Protected against the effects of continuous immer-
sion in water

Heat Emission
The following table provides information about average heat emission during clinical use.

Equipment Heat Emission


Basic system Examination room: 1900 W
• Monitor ceiling suspension containing one large moni- Monoplane system:
tor and four small monitors in the examination room • Control room: 500 W
• One workstation with two small monitors in the control • Technical room: 2400 W
room Biplane system:
• Control room: 700 W
• Technical room: 4000 W
Additional large monitor Additional 500 W
Additional small monitor Additional 80 W
Additional workstation Additional 300 W

17.5.2 Mains Power


According to the IEC60601-1 definition, the system is classified as class I equipment for continuous
operation.

System

Configuration Settings
Recording mode of operation Continuous
Supply configurations 3 phase Y, 4 wires (L1, L2, L3, PE)

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Configuration Settings
Mains voltage (±10%), long time current, peak current, frequency 3~380 V, 80 A, 338 Apk, 50/60 Hz
3~400 V, 76 A, 330 Apk, 50/60 Hz
3~415 V, 73 A, 325 Apk, 50/60 Hz
3~440 V, 69 A, 315 Apk, 50/60 Hz
3~480 V, 63 A, 300 Apk, 50/60 Hz
Momentary power 100 kVA MAX
Maximum resistance at the mains input terminal of the system 380 V: 74 mOhm
For current catalog numbers: 722221, 722222, 722223, 722224, 400 V: 140 mOhm
722225, 722226, 722227, and 722228 415 V: 215 mOhm
440 V: 325 mOhm
480 V: 465 mOhm
Maximum resistance at the mains input terminal of the system 400 V: 140 mOhm
For previous catalog numbers: 722063, 722064, 722067, 722068, 415 V: 215 mOhm
722078, and 722079 440 V: 325 mOhm
480 V: 465 mOhm

NOTE All connected phase wires shall have an upstream disconnect switch (80 A to 125 A) and a
mains fuse or overcurrent breaker with a rating of 80 A to 125 A with gG characteristics (slow
blow).

NOTE All installations and wiring up to the incoming mains power shall be installed and verified to
comply with applicable local regulations.

NOTE Input wiring shall be at least 6AWG (13.3 mm2).

Additional Equipment

Equipment Mains Voltage Mains Frequency Maximum Power Consumption


Wireless Foot Switch Charger 100 - 240 V AC 50 / 60 Hz 26 W
XperGuide Laser Tool Charger 100 - 240 V AC 50 / 60 Hz 6 W (approximately)
Wall Connection Box 100 - 240 V AC 50 / 60 Hz 40 W
Equipment Rack 100 - 240 V AC 50 / 60 Hz 3680 W

17.5.3 Wall Connection Box


The wall connection box provides galvanic isolated connections between the system and external
equipment. Galvanic isolation ensures that the power source and grounding of the system and external
equipment remain separated.

NOTE Cables to connect external equipment are supplied with the Wall connection box.

The wall connection box provides the following interfaces.

Video Connection

Item Specification
Standard DVI 1.0
Connector type DVI-I
Cable length (external equipment side) 3 m DVI-I to DVI-I cable
3 m VGA to DVI-I cable
Supported resolutions Up to 1920 x 1200 x 60 Hz (WUXGA)
Supported clock frequencies 25-165 MHz
DVI lanes supported 1
Supported features EDID / DDC2, Hot Plug Detect optional

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USB Connection (Optional)

Specification
Standard USB 1.1
Supported speeds Normal speed and full speed (maximum 12 Mbps)
Cable length (external equipment side) 3m

Ethernet Connection

Specification
Standard IEEE Std. 802.3u/x (1000 Mbps)
Connector type RJ45 shielded, CAT7 compliant
Cable length (external equipment side) 3m

AC Power Input

Specification
Cable length (molded cable for EU and US) 3m
Un (nominal voltage rating) 100 – 240 V
In (nominal current rating) 1A
Fn (nominal frequency rating) 50 / 60 Hz
Sn (nominal apparent power rating) 40 VA
Fuse 1 A slow blow
Pollution degree 2

DC Power Output

Specification
Cable length 30 m
Voltage 5V
Amperage 1A

Wall Connection Box in the Examination Room


The wall connection box in the examination room should be mounted with the external interface
connectors facing downwards.

17.5.4 Network Data


NOTE Transfer speeds depend on the local situation (network load, network devices, and the
external station).

DICOM Image Interface

Item Specification
Maximum Ethernet transfer speed 1 Gbit/s
Transfer speed for images 2 Mbit/s

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RIS/CIS DICOM Interface

Item Specification
Maximum Ethernet transfer speed 1 Gbit/s

17.5.5 System Settings Influencing the Radiation Dose


The following sections provide additional information about system settings that influence the radiation
dose.

You should also refer to the radiation guidelines given in Radiation Safety (page 25) for measures to
reduce patient and staff dose, and to shield stray radiation.

X-ray Protocol Selection


The parameters as preset by X-ray protocol selection are related to each other, and they have been
tuned for an optimal image quality for a specific procedure.

Examples of these parameters are:


• Dose control mode (such as cine, test shot-lockin, CBCT).
• Timing mode (series, single-shot for cardiac, vascular).
• Dose control curve (for kV, mA, ms, detector-dose).
• Requested detector dose rate – for fluoroscopy only.
• Requested detector dose per image – for exposure only.
• Fluoroscopy frame speed (per fluoroscopy flavor).
• Exposure frame speed (for example, for cardiac procedures 7.5, 15, or 30 fps).
• Multiphase settings (for example, for vascular procedure: the duration and frame speed per phase).
• Spectral filter (mm Al + mm Cu).

The following examples give the reference air kerma values for typical cardiac, neuro, and vascular X-
ray protocols.

Reference Air Kerma (mGy/


System X-ray Protocol image)
12-inch detector Pediatric Pediatrics 15 fps Normal 0.195
Cardiac Left Coronary 15 fps Normal 0.196
Head Cerebral 2 fps Normal 5.051
Head Cerebral 4 fps Normal 5.049
Thorax Lungs 3 fps 2.522
12-inch detector with Clari- Cardio Pediatric <40 kg Cine 15 fps Low 0.019
tyIQ (option)
Cardio Pediatric >40 kg Cine 15 fps Low 0.037
Cardiac Left Coronary 15 fps Low 0.036
Cerebral Cerebral 2 fps Low 0.978
Cerebral Cerebral 4 fps Low 0.978
Thorax Lungs 3 fps 1.208
Measurement conditions: patient type: default, field size: 30 cm. All other settings in accordance with Reference Air Kerma
Measurement Setup (page 395).

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Reference Air Kerma (mGy/


System X-ray Protocol image)
15-inch detector Pediatric Pediatrics 15 fps Normal 0.126
Cardiac Left Coronary 15 fps Normal 0.125
Head Cerebral 2 fps Normal 2.785
Head Cerebral 4 fps Normal 2.784
Thorax Lungs 3 fps 4.312
15-inch detector with Clari- Cardio Pediatric <40 kg Cine 15 fps Low 0.012
tyIQ (option)
Cardio Pediatric >40 kg Cine 15 fps Low 0.023
Cardiac Left Coronary 15 fps Low 0.023
Cerebral Cerebral 2 fps Low 0.573
Cerebral Cerebral 4 fps Low 0.572
Thorax Lungs 3 fps 0.700
Measurement conditions: patient type: default, field size: 39 cm. All other settings in accordance with Reference Air Kerma
Measurement Setup (page 395).

Reference Air Kerma (mGy/


System X-ray Protocol image)
20-inch detector Pediatric Pediatrics 15 fps Normal 0.105
Cardiac Left Coronary 15 fps Normal 0.102
Head Cerebral 2 fps Normal 2.279
Head Cerebral 4 fps Normal 2.280
Thorax Lungs 3 fps 1.140
20-inch detector with Clari- Cardio Pediatric <40 kg Cine 15 fps Low 0.010
tyIQ (option)
Cardio Pediatric >40 kg Cine 15 fps Low 0.019
Cardiac Left Coronary 15 fps Low 0.018
Head Cerebral 2 fps Low 0.463
Head Cerebral 4 fps Low 0.463
Thorax Subclavian 3 fps 0.795
Measurement conditions: patient type: default, field size: 48 cm. All other settings in accordance with Reference Air Kerma
Measurement Setup (page 395).

The following examples give the reference air kerma rate for the three fluoroscopy flavors for a typical
cardiac X-ray protocol.

System X-ray Protocol Flavor Reference Air Kerma Rate (mGy/s)


12-inch detector Pediatric Low 0.183
Pediatric Normal 0.434
Pediatric High 0.684
Cardiac Low 0.238
Cardiac Normal 0.517
Cardiac High 0.719
12-inch detector with ClarityIQ (op- Cardio Pediatric Low 0.061
tion)
Cardio Pediatric Medium 0.092
Cardio Pediatric Normal 0.144
Cardiac Low 0.145
Cardiac Medium 0.214
Cardiac Normal 0.501
Measurement conditions: patient type: default, field size: 30 cm. All other settings in accordance with Reference Air Kerma
Measurement Setup (page 395).

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System X-ray Protocol Flavor Reference Air Kerma Rate (mGy/s)


15-inch detector Pediatric Low 0.112
Pediatric Normal 0.246
Pediatric High 0.412
Cardiac Low 0.121
Cardiac Normal 0.353
Cardiac High 0.421
15-inch detector with ClarityIQ (op- Cardio Pediatric Low 0.038
tion)
Cardio Pediatric Medium 0.057
Cardio Pediatric Normal 0.087
Cardiac Low 0.090
Cardiac Medium 0.132
Cardiac Normal 0.322
Measurement conditions: patient type: default, field size: 39 cm. All other settings in accordance with Reference Air Kerma
Measurement Setup (page 395).

System X-ray Protocol Flavor Reference Air Kerma Rate (mGy/s)


20-inch detector Pediatric Low 0.096
Pediatric Normal 0.217
Pediatric High 0.384
Cardiac Low 0.101
Cardiac Normal 0.296
Cardiac High 0.366
20-inch detector with ClarityIQ (op- Cardio Pediatric Low 0.032
tion)
Cardio Pediatric Medium 0.048
Cardio Pediatric Normal 0.074
Cardiac Low 0.076
Cardiac Medium 0.113
Cardiac Normal 0.271
Measurement conditions: patient type: default, field size: 48 cm. All other settings in accordance with Reference Air Kerma
Measurement Setup (page 395).

For an overview of a number of frequently used exposure procedures and fluoroscopy flavors, under
defined measurement conditions, see Typical Reference Air Kerma (Rate) Values (page 349).

Patient Type
Although the system has an automatic dose control mechanism that compensates for the various
depths of irradiated tissue, in some cases the image quality needs to be improved for very obese or
very thin patients. This is achieved by the system by removing or adding spectral filtering.

The patient type selection may have an effect on the resulting reference air kerma. For optimal image
quality, you should select a patient type that matches the actual patient thickness. You can change the
patient type by editing the scheduled study. For more information about editing study details, see
Editing a Scheduled Study (page 60).

You can select one of the following patient types:

Patient Type Weight


Neonate <5 kg
Infant 5 - 15 kg

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Patient Type Weight


Child 15 - 40 kg
Small Adult 40 - 55 kg
Normal Adult 55 - 70 kg
Large Adult 70 - 90 kg
Very Large Adult >90 kg

The table above provides guidance for manual patient type selection. You can also select the
Automatic patient type. In this case the system automatically selects an appropriate patient type for
each study based on the patient's age, height, and weight, which can be entered while scheduling the
patient.

For some applications and procedures, the dose settings are equal for all patient types. In these cases
the automatic dose control mechanism manages all depths of irradiated tissue without loss of image
quality, and the patient type selection has no effect on the reference air kerma (rate). Examples are:
fluoroscopy, roadmap, and vascular peripheral. The settings for the default patient type are used if no
specific X-ray protocols are defined for the selected patient type.

For other applications and procedures, the patient type selection will influence the reference air kerma.
See the following example for cardiac procedures:

System Patient Type Reference Air Kerma (mGy/image)


12-inch detector Neonate 0.041
• Cardiac procedure
Infant 0.074
• Left Coronary
• 15 fps Normal Child, Small Adult 0.117
Default 0.196
Large Adult, Very Large Adult 0.197
12-inch detector Neonate 0.043
• Pediatrics procedure
Infant 0.074
• Pediatric
• 15 fps Normal Child, Small Adult 0.115
Default 0.195
Measurement conditions: field size: 30 cm. All other settings in accordance with Reference Air Kerma Measurement Set-
up (page 395).

System Patient Type Reference Air Kerma (mGy/image)


15-inch detector Neonate 0.024
• Cardiac procedure
Infant 0.046
• Left Coronary
• 15 fps Normal Child, Small Adult 0.072
Default 0.125
Large Adult, Very Large Adult 0.110
15-inch detector Neonate 0.024
• Pediatrics procedure
Infant 0.039
• Pediatric
• 15 fps Normal Child, Small Adult 0.072
Default 0.126
Measurement conditions: field size: 39 cm. All other settings in accordance with Reference Air Kerma Measurement Set-
up (page 395).

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System Patient Type Reference Air Kerma (mGy/image)


20-inch detector Neonate 0.020
• Cardiac procedure
Infant 0.039
• Left Coronary
• 15 fps Normal Child, Small Adult 0.059
Default 0.102
Large Adult, Very Large Adult 0.089
20-inch detector Neonate 0.021
• Pediatrics procedure
Infant 0.034
• Pediatric
• 15 fps Normal Child, Small Adult 0.061
Default 0.105
Measurement conditions: field size: 48 cm. All other settings in accordance with Reference Air Kerma Measurement Set-
up (page 395).

For more information about the influence of patient thickness on the air kerma, see Influence of Oblique
Projections (page 343).

Field Size
In general, the requested detector dose needs to be larger for smaller field sizes to compensate for
increasing perceived noise at smaller field sizes. Therefore, the air kerma and air kerma rate is larger for
smaller field sizes.

NOTE Consider zooming fluoroscopy images with appropriate collimation, instead of using a small
field size. Digital zooming does not influence the air kerma.

NOTE Unlike air kerma, dose area product decreases at smaller field sizes, so using a small field
size decreases the risk of stochastic effects. For example, for pediatric procedures, a small
field size may be more appropriate.

For every fluoroscopy flavor and every exposure X-ray protocol, a programmable dose ratio for each
field size and for each X-ray plane is available. The dose ratio indicates for each available field size the
percentage detector dose increase, compared to the detector dose at the largest field size.

In the examples below, reference air kerma increases approximately proportionally with the dose ratio
numbers. The same applies to reference air kerma rate for fluoroscopy. The measurement conditions
used are in accordance with Reference Air Kerma Measurement Setup (page 395). The following values
are for non-ClarityIQ systems.

Dose ratio (%) 100 110 130 155 185


12-Inch Detector Field Size (cm) 30 27 22 19 15
X-ray Protocol Patient Type Reference Air Kerma (mGy/image)
Head Cerebral 2 fps Low Default 2.447 2.719 3.273 3.981 4.874

Dose ratio (%) 100 110 130 150 180 215 260
15-Inch Detector Field Size (cm) 39 37 31 27 22 19 15
X-ray Protocol Patient Type Reference Air Kerma (mGy/image)
Head Cerebral 2 fps Low Default 1.392 1.535 1.838 2.158 2.630 3.227 4.002

Dose ratio (%) 100 130 145 170 200 240 280 330
20-Inch Detector Field Size (cm) 48 42 37 31 27 22 19 15
X-ray Protocol Patient Type Reference Air Kerma (mGy/image)
Head Cere- 2 fps Default 1.148 1.503 1.682 1.986 2.359 2.865 3.391 4.059
bral Low

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NOTE The dose ratio numbers may differ for each procedure and for each fluoroscopy
flavor.

Multiphase Settings
The vascular exposure procedure contains the default duration and frame speed per phase.

For these procedures it is possible to manually change the frame speed and duration per phase. For
more information about changing frame speed and duration, see Changing Multiphase Acquisition
Settings (page 129).

The reference air kerma is defined per image and will not change at different frame speeds. However,
the cumulative skin dose is directly related to the frame speed and so, if the frame speed in one phase
is reduced by 50%, the cumulative skin dose in that phase is also reduced by 50%.

Conclusion: Consider lowering the frame speed, if possible.

Shutters and Wedges


When you apply proper collimation, direct irradiation of body parts not needed for the procedure is
prevented.

This reduces the dose area product and the staff dose, although the reference air kerma and the (peak)
skin dose are not influenced.

In general, for example, 25% collimation of the irradiated area will reduce the dose area product by 25%.

Using the wedges reduces the radiation intensity in a user-defined area and improves the image quality.
The wedges also reduce the dose area product and the staff dose.

The amount of radiation that is reduced by the wedges depends, for example, on the amount of the
image coverage by the wedges.

Source-to-Image Distance
When the source-to-image distance is increased by a factor x, the system increases the skin dose by a
factor x2 to maintain the requested detector dose.

Hence, the source-to-image distance should be kept to a minimum (for a given source skin distance), so
that the requested detector dose is reached with as low as possible skin dose. It is also important to
keep the distance between the patient and the detector as small as possible. This improves image
sharpness and, when combined with collimation, causes less staff dose (decreased scatter).

Table Height
The table height at a constant source-to-image distance does not influence the reference air kerma
(rate), and the indicated air kerma (rate) value, as these are only applicable at the patient entrance
reference point.

To minimize the skin dose (rate), the X-ray source must be as far from the skin as possible.

Influence of Oblique Projections


Due to the absorption of radiation in human tissue, the X-ray field strength is reduced by a factor 2,
approximately every 3 cm.

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For example, if the patient thickness is 27 cm, the X-ray beam loses intensity within the body by a factor
of 512 (2(27/3)). This shows that a thicker patient requires a larger entrance dose than a thin patient, to
obtain the same detector dose.

The same applies to oblique projections of the X-ray beam since an oblique view generally increases
the perceived patient thickness. This can be seen in the figure below where distance 2 (oblique) is
considerably larger than distance 1.

Figure 166 Patient thickness

The following examples show that the resulting air kerma is larger for a 30 cm PMMA than for a 20 cm
PMMA patient thickness, when measured at the same system settings for three typical exposure
procedures.

12-Inch Detector

Patient Thickness 20 cm PMMA 30 cm PMMA


Reference Air
Kerma (mGy/ Air Kerma
System X-ray Protocol image) (mGy/image)
12-inch detector Cardiac Left Coronary 15 fps Normal 0.196 0.912
Head Cerebral 2 fps Normal 5.051 14.068
Thorax Lungs 3 fps 2.522 7.491
12-inch detector with Cardiac Left Coronary 15 fps Low 0.036 0.200
ClarityIQ (option)
Head Cerebral 2 fps Low 0.978 6.749
Thorax Lungs 3 fps 1.208 6.460

Measurement conditions: patient type: default, field size: 30 cm. All other settings are in accordance
with Reference Air Kerma Measurement Setup (page 395), except for the different phantom
thicknesses.

15-Inch Detector

Patient Thickness 20 cm PMMA 30 cm PMMA


Reference Air
Kerma (mGy/ Air Kerma
System X-ray Protocol image) (mGy/image)
15-inch detector Cardiac Left Coronary 15 fps Normal 0.125 0.600
Head Cerebral 2 fps Normal 2.785 12.919
Thorax Lungs 3 fps 4.312 5.208
15-inch detector with Cardiac Left Coronary 15 fps Low 0.023 0.123
ClarityIQ (option)
Head Cerebral 2 fps Low 0.573 4.018
Thorax Lungs 3 fps 0.700 4.119

Measurement conditions: patient type: default, field size: 39 cm. All other settings are in accordance
with Reference Air Kerma Measurement Setup (page 395), except for the different phantom
thicknesses.

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20-Inch Detector

Patient Thickness 20 cm PMMA 30 cm PMMA


Reference Air
Kerma (mGy/ Air Kerma
System X-ray Protocol image) (mGy/image)
20-inch detector Cardiac Left Coronary 15 fps Normal 0.102 0.558
Head Cerebral 2 fps Normal 2.279 12.305
Thorax Lungs 3 fps 1.140 4.956
20-inch detector with Cardiac Left Coronary 15 fps Low 0.018 0.110
ClarityIQ (option)
Head Cerebral 2 fps Low 0.463 3.765
Thorax Lungs 3 fps 0.569 3.861

Measurement conditions: patient type: default, field size: 48 cm. All other settings are in accordance
with Reference Air Kerma Measurement Setup (page 395), except for the different phantom
thicknesses.

Exposure and Fluoroscopy Time to Reach the 2 Gy Limit


To reduce the risk of skin injuries, it is important to know after approximately how much exposure or
fluoroscopy time the 2 Gy air kerma value will be reached (according to IEC 60601-1-3:2008, 5.2.4.5b).

The time remaining until the 2 Gy limit is reached for each study is displayed in the status area. For
more information, see Status Area (page 447).

The number of exposure frames to reach 2 Gy (assuming no fluoroscopy) can be calculated by dividing
2000 mGy by the reference air kerma value per frame (as given in Typical Reference Air Kerma (Rate)
Values (page 349), in mGy/image, for some of the most frequently used procedures).

The duration to reach 2 Gy in minutes is determined by dividing the number of exposure frames by the
frame rate (fps) of the procedure, and dividing this by 60.

For fluoroscopy, the duration to reach 2 Gy in minutes (assuming no exposures) is determined by


dividing 2000 mGy by the reference air kerma rate given in Typical Reference Air Kerma (Rate)
Values (page 349) and dividing this by 60.

Exposure
The following example shows the number of exposures and time required to reach the 2 Gy limit, for a
few typical exposure settings, and for a normal and an obese patient:

12-Inch Detector

Patient Thickness 20 cm PMMA 30 cm PMMA


Refer- Refer-
ence Air ence Air
Kerma Time at Kerma Time at
(mGy/ # Exp. constant (mGy/ # Exp. constant
System X-ray Protocol image) Needed fps image) Needed fps
12-inch Cardiac Left Cor- 15 fps 0.196 10185 11 min 0.912 2194 2.4 min
detector onary Normal
Head Cerebral 2 fps 5.051 396 3.3 min 14.068 142 1.2 min
Normal
Head Cerebral 4 fps 5.049 396 1.7 min 15.413 130 0.5 min
Normal
Thorax Lungs 3 fps 2.522 793 4.4 min 7.491 267 1.5 min

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Patient Thickness 20 cm PMMA 30 cm PMMA


Refer- Refer-
ence Air ence Air
Kerma Time at Kerma Time at
(mGy/ # Exp. constant (mGy/ # Exp. constant
System X-ray Protocol image) Needed fps image) Needed fps
12-inch Cardiac Left Cor- 15 fps 0.036 55221 61.4 min 0.200 10022 11.1 min
detector onary Low
with
Head Cerebral 2 fps 0.978 2045 17 min 6.749 296 2.5 min
ClarityIQ
Low
(option)
Head Cerebral 4 fps 0.978 2044 8.5 min 6.749 296 1.2 min
Low
Thorax Lungs 3 fps 1.208 1656 9.2 min 6.460 310 1.7 min

15-Inch Detector

Patient Thickness 20 cm PMMA 30 cm PMMA


Refer- Refer-
ence Air ence Air
Kerma Time at Kerma Time at
(mGy/ # Exp. constant (mGy/ # Exp. constant
System X-ray Protocol image) Needed fps image) Needed fps
15-inch Cardiac Left Cor- 15 fps 0.125 16044 17.8 min 0.600 3335 3.7 min
detector onary Normal
Head Cerebral 2 fps 2.785 718 6 min 9.478 211 1.8 min
Normal
Head Cerebral 4 fps 2.784 718 5 min 9.843 203 0.8 min
Normal
Thorax Lungs 3 fps 4.312 464 2.6 min 5.208 384 2.1 min
15-inch Cardiac Left Cor- 15 fps 0.023 88265 98.1 min 0.123 16281 18.1 min
detector onary Low
with
Head Cerebral 2 fps 0.573 3490 29.1 min 4.018 498 4,1 min
ClarityIQ
Low
(option)
Head Cerebral 4 fps 0.572 3494 14.6 min 3.504 571 2.4 min
Low
Thorax Lungs 3 fps 0.700 2856 15.9 min 4.119 486 2.7 min

20-Inch Detector

Patient Thickness 20 cm PMMA 30 cm PMMA


Refer- Refer-
ence Air ence Air
Kerma Time at Kerma Time at
(mGy/ # Exp. constant (mGy/ # Exp. constant
System X-ray Protocol image) Needed fps image) Needed fps
20-inch Cardiac Left Cor- 15 fps 0.102 19515 21.7 min 0.558 3585 4.0 min
detector onary Normal
Head Cerebral 2 fps 2.279 877 7.3 min 12.305 163 1.4 min
Normal
Head Cerebral 4 fps 2.280 877 3.7 min 10.064 199 0,8 min
Normal
Thorax Lungs 3 fps 1.140 1754 9.7 min 4.956 404 2.2 min

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Patient Thickness 20 cm PMMA 30 cm PMMA


Refer- Refer-
ence Air ence Air
Kerma Time at Kerma Time at
(mGy/ # Exp. constant (mGy/ # Exp. constant
System X-ray Protocol image) Needed fps image) Needed fps
20-inch Cardiac Left Cor- 15 fps 0.018 108243 120.3 0.110 18141 20.2 min
detector onary Low min
with
Head Cerebral 2 fps 0.463 4321 36 min 3.765 531 4.4 min
ClarityIQ
Low
(option)
Head Cerebral 4 fps 0.463 4323 18 min 3.283 609 2.5 min
Low
Thorax Lungs 3 fps 0.569 3512 19.5 min 3.861 518 2.9 min

Fluoroscopy
The following examples show the time required to reach the 2 Gy limit, for a few typical fluoroscopy
flavor settings, and for a normal and an obese patient:

12-Inch Detector

Patient Thickness 20 cm PMMA 30 cm PMMA


Reference Air Reference Air
X-ray Proto- Kerma Rate Kerma Rate
System col Flavor (mGy/s) Time required (mGy/s) Time required
12-inch detec- Cardiac Low 0.238 140 min 1.358 25 min
tor
Cardiac Normal 0.517 64 min 2.251 15 min
Head Low 0.189 177 min 0.878 38 min
12-inch detec- Cardiac Low 0.145 231 min 0.644 52 min
tor with Clari-
Cardiac Normal 0.501 67 min 2.269 15 min
tyIQ (option)
Head Low 0.185 181 min 0.431 77 min

Measurement conditions: patient type: default, field size: 30 cm. All other settings are in accordance
with Reference Air Kerma Measurement Setup (page 395).

15-Inch Detector

Patient Thickness 20 cm PMMA 30 cm PMMA


Reference Air Reference Air
X-ray Proto- Kerma Rate Kerma Rate
System col Flavor (mGy/s) Time required (mGy/s) Time required
15-inch detec- Cardiac Low 0.121 275 min 0.725 46 min
tor
Cardiac Normal 0.353 94 min 1.446 23 min
Head Low 0.169 197 min 0.722 46 min
15-inch detec- Cardiac Low 0.090 370 min 0.421 79 min
tor with Clari-
Cardiac Normal 0.322 104 min 1.525 22 min
tyIQ (option)
Head Low 0.121 275 min 0.362 92 min

Measurement conditions: patient type: default, field size: 39 cm. All other settings are in accordance
with Reference Air Kerma Measurement Setup (page 395).

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20-Inch Detector

Patient Thickness 20 cm PMMA 30 cm PMMA


Reference Air Reference Air
X-ray Proto- Kerma Rate Kerma Rate
System col Flavor (mGy/s) Time required (mGy/s) Time required
20-inch de- Cardiac Low 0.101 330 min 0.656 51 min
tector
Cardiac Normal 0.296 113 min 1.328 25 min
Head Low 0.366 91 min 0.601 55 min
20-inch de- Cardiac Low 0.076 437 min 0.387 86 min
tector with
Cardiac Normal 0.113 295 min 1.415 24 min
ClarityIQ (op-
tion) Head Low 0.271 123 min 0.363 92 min

Measurement conditions: patient type: default, field size: 48 cm. All other settings are in accordance
with Reference Air Kerma Measurement Setup (page 395).

Conclusion: The time to reach the 2 Gy limit is longer when the patient thickness decreases.

NOTE As the total dose is a combination of exposure and fluoroscopy, the total time to reach 2 Gy
for each will be less than calculated above.

Source-to-Skin Distance Spacer


The system can be equipped with a spacer on the X-ray tube housing, around the X-ray beam, which
will maintain, a minimum source-to-skin distance of 38 cm. According to 21 CFR 1020.32(g), the spacer
is mandatory in the USA.

For specific surgical applications, which require a source-to-skin distance of less than 38 cm, the spacer
can be removed. The spacer must be re-installed when the surgical application has been completed.

WARNING
Removing the source-to-skin distance spacer may increase the skin dose by 60%, when the X-ray
source is placed against the patient’s skin.

The source-to-skin distance without the spacer is 30 cm, which conforms with international standards
IEC 60601-2-43:2010, and IEC 60601-2-54:2009.

Figure 167 Stand without the spacer (left) and with the spacer (right)

Azurion Release 2.2 Instructions for Use 348 Philips 4523 001 01511
Technical Information System-Level Information

Figure 168 FlexArm stand (option) without the spacer (left) and with the spacer (right)

17.5.6 Typical Reference Air Kerma (Rate) Values


In accordance with IEC 60601-2-43, these Instructions for Use specify the Reference Air Kerma (Rate)
values for a number of frequently used X-ray protocols and the levels of protection provided by the
system against stray radiation. All dose values are automatically determined by the system, based on
the X-ray protocol selected.

This section gives the actual reference air kerma (rate) values for a number of frequently used X-ray
protocols and fluoroscopy flavors.

The measuring conditions are as defined in Reference Air Kerma Measurement Setup (page 395). The
values are only applicable for the factory default X-ray protocol settings, without overrides.

All given reference air kerma (rate) values have an accuracy of ±50%, in accordance with IEC
60601-2-43:2010 203.5.2.4.5.101c.

M12 Systems

Radioscopy (Fluoroscopy) - M12 Systems

Field of View 0 1 2 3 4
Field Size (cm) 30 27 22 19 15
Patient
Procedure Flavor Type Reference Air Kerma (mGy/s)
Cardio Low Default 0.233 0.254 0.296 0.349 0.420
Norm Default 0.512 0.664 0.850 0.861 0.876
High Default 0.709 0.770 0.884 1.026 1.183
Pediatrics Low Default 0.183 0.199 0.233 0.276 0.328
Norm Default 0.433 0.470 0.539 0.611 0.698
High Default 0.684 0.731 0.792 0.864 0.951
EP Low Default 0.087 0.095 0.112 0.132 0.157
Norm Default 0.206 0.224 0.261 0.308 0.365
High Default 0.247 0.269 0.313 0.368 0.436
EP Mapping Low Default 0.043 0.048 0.056 0.068 0.082
Norm Default 0.103 0.112 0.131 0.154 0.184
High Default 0.123 0.135 0.157 0.184 0.218
Head Low Default 0.184 0.252 0.291 0.299 0.310
Norm Default 0.472 0.503 0.565 0.641 0.734
High Default 0.753 0.815 0.937 1.094 1.278

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Technical Information System-Level Information

Field of View 0 1 2 3 4
Field Size (cm) 30 27 22 19 15
Patient
Procedure Flavor Type Reference Air Kerma (mGy/s)
Spine Low Default 0.184 0.252 0.291 0.299 0.310
Norm Default 0.472 0.503 0.565 0.641 0.734
High Default 0.753 0.815 0.937 1.094 1.278
Thorax Low Default 0.184 0.252 0.291 0.299 0.310
Norm Default 0.472 0.503 0.565 0.641 0.734
High Default 0.753 0.815 0.937 1.094 1.278
Abdomen Low Default 0.184 0.252 0.291 0.299 0.310
Norm Default 0.472 0.503 0.565 0.641 0.734
High Default 0.753 0.815 0.937 1.094 1.278
Peripheral Low Default 0.184 0.252 0.291 0.299 0.310
Norm Default 0.472 0.503 0.565 0.641 0.734
High Default 0.753 0.815 0.937 1.094 1.278

Radiography (Exposure) - M12 Systems

Field of View 0 1 2 3 4
Field Size (cm) 30 27 22 19 15
Procedure X-ray Protocol Patient Type Reference Air Kerma (mGy/image)
Cardio Left Coronary Default 0.104 0.113 0.130 0.152 0.178
15 fps Low
Infant 0.074 0.079 0.088 0.099 0.114
Large Adult, Very 0.104 0.113 0.130 0.152 0.178
Large Adult
Neonate 0.040 0.044 0.051 0.062 0.074
Rotational Scan Default 0.195 0.212 0.244 0.282 0.329
Prop Ang0 4s
Infant 0.063 0.068 0.078 0.090 0.106
Neonate 0.040 0.044 0.051 0.062 0.074
Pediatrics 15 fps Contrast Nor- Default 0.195 0.212 0.244 0.282 0.329
mal
Child, Small Adult 0.115 0.125 0.145 0.169 0.198
Infant 0.074 0.079 0.088 0.099 0.114
Neonate 0.043 0.047 0.054 0.064 0.076
Prop Free Position Default 0.201 0.218 0.252 0.293 0.342
Neonate, Infant 0.043 0.047 0.054 0.064 0.076
EP 15 fps Default 0.115 0.125 0.145 0.169 0.198
Prop 4s Default 0.228 0.231 0.235 0.240 0.246
Neonate, nfant 0.148 0.150 0.152 0.156 0.161
Large Adult, Very 0.228 0.231 0.235 0.240 0.246
Large Adult
EP Mapping 7.5 fps low Default 0.017 0.018 0.021 0.026 0.031
3D EP Prop 4s Default 0.228 0.231 0.235 0.240 0.246
Neonate, Infant 0.148 0.150 0.152 0.156 0.161
Large Adult, Very 0.228 0.231 0.235 0.240 0.246
Large Adult

Azurion Release 2.2 Instructions for Use 350 Philips 4523 001 01511
Technical Information System-Level Information

Field of View 0 1 2 3 4
Field Size (cm) 30 27 22 19 15
Procedure X-ray Protocol Patient Type Reference Air Kerma (mGy/image)
Head Cerebral 2 fps nor- Default 4.895 5.436 6.540 7.701 8.502
mal
Child 3.153 3.378 3.820 4.379 5.072
Neonate, Infant 3.153 3.378 3.820 4.379 5.072
Aortic Arch 3 fps Default 7.304 8.113 9.713 11.788 12.894
Spine 4 fps Default 2.050 2.279 2.739 3.335 4.088
2 fps Default 2.566 2.851 3.428 4.172 5.113
Thorax Lungs 2 fps Default 2.446 2.719 3.269 3.950 4.361
Subclavian 3 fps Default 9.046 10.673 10.810 10.972 11.183
Abdomen Abdomen Default 3.824 4.242 5.101 6.198 7.578
3 fps Large Adult, Very 3.317 3.681 4.434 5.398 6.620
Large Adult
Iliac / Pelvis 3 fps Default 7.297 8.108 9.730 11.842 14.472
Peripheral Upper Legs 3 fps Default 6.608 7.334 8.209 8.933 9.781
Lower Legs 1 fps Default 8.229 8.644 9.320 10.125 11.043

Roadmap - M12 Systems

Field of View 0 1 2 3 4
Field Size (cm) 30 27 22 19 15
Patient
Procedure Mode Type Reference Air Kerma (mGy/image)
Cardio Navigate Default 0.383 0.486 0.490 0.496 0.503
UnSubtract Default 0.383 0.486 0.490 0.496 0.503
Pediatrics Navigate Default 0.383 0.486 0.490 0.496 0.503
UnSubtract Default 0.383 0.486 0.490 0.496 0.503
EP Navigate Default 0.383 0.486 0.490 0.496 0.503
EP Mapping Navigate Default 0.383 0.486 0.490 0.496 0.503
Head Navigate Default 0.383 0.486 0.490 0.496 0.503
Carotid Default 0.381 0.461 0.465 0.470 0.476
Coil Default 1.818 2.020 2.428 2.951 3.611
Spine UnSubtract Default 0.383 0.486 0.490 0.496 0.503
Navigate Default 0.383 0.486 0.490 0.496 0.503
Stent Default 0.381 0.461 0.465 0.470 0.476
Thorax UnSubtract Default 0.383 0.486 0.490 0.496 0.503
Navigate Default 0.383 0.486 0.490 0.496 0.503
Intervention Default 0.381 0.461 0.465 0.470 0.476
Abdomen UnSubtract Default 0.383 0.486 0.490 0.496 0.503
Navigate Default 0.383 0.486 0.490 0.496 0.503
Stent Default 0.381 0.461 0.465 0.470 0.476
Peripheral UnSubtract Default 0.383 0.486 0.490 0.496 0.503
Navigate Default 0.383 0.486 0.490 0.496 0.503

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Technical Information System-Level Information

M12 Systems with ClarityIQ Option

Radioscopy (Fluoroscopy) - M12 Systems with ClarityIQ

Field of View 0 1 2 3 4
Field Size (cm) 30 27 22 19 15
Patient
Procedure Flavor Type Reference Air Kerma (mGy/s)
Cardio Clarity Low Default 0.147 0.159 0.184 0.214 0.250
Medium Default 0.217 0.236 0.274 0.322 0.380
Normal Default 0.512 0.553 0.635 0.737 0.858
Cardio Pediatrics Clarity Low Default 0.061 0.066 0.078 0.091 0.109
<40 kg
Medium Default 0.092 0.100 0.116 0.135 0.158
Normal Default 0.144 0.157 0.181 0.211 0.248
Cardio Pediatrics Clarity Low Default 0.061 0.066 0.078 0.091 0.109
>40 kg
Medium Default 0.092 0.100 0.116 0.135 0.158
Normal Default 0.144 0.157 0.181 0.211 0.248
EP Clarity Low Default 0.044 0.047 0.055 0.064 0.073
Medium Default 0.086 0.094 0.109 0.127 0.147
Normal Default 0.106 0.116 0.135 0.159 0.189
EP Mapping Clarity Low Default 0.044 0.047 0.055 0.064 0.073
Medium Default 0.086 0.094 0.109 0.127 0.147
Normal Default 0.106 0.116 0.135 0.159 0.189
Head Clarity Low Default 0.189 0.202 0.229 0.263 0.307
Medium Default 0.306 0.334 0.389 0.447 0.514
Normal Default 0.557 0.604 0.697 0.813 0.951
Spine Clarity Low Default 0.189 0.202 0.229 0.263 0.307
Medium Default 0.306 0.334 0.389 0.447 0.514
Normal Default 0.557 0.604 0.697 0.813 0.951
Thorax Clarity Low Default 0.189 0.202 0.229 0.263 0.307
Medium Default 0.306 0.334 0.389 0.447 0.514
Normal Default 0.557 0.604 0.697 0.813 0.951
Abdomen Clarity Low Default 0.189 0.202 0.229 0.263 0.307
Medium Default 0.306 0.334 0.389 0.447 0.514
Normal Default 0.557 0.604 0.697 0.813 0.951
Peripheral Clarity Low Default 0.147 0.159 0.184 0.214 0.250
Medium Default 0.217 0.236 0.274 0.322 0.380
Normal Default 0.512 0.553 0.635 0.737 0.858

Radiography (Exposure) - M12 Systems with ClarityIQ

Field of View 0 1 2 3 4
Field Size (cm) 30 27 22 19 15
Procedure X-ray Protocol Patient Type Reference Air Kerma (mGy/image)
Cardio Clarity Left Coronary 15 Default 0.037 0.040 0.047 0.055 0.065
fps Low
Rotational Scan Default 0.195 0.212 0.244 0.282 0.329
Prop Ang0 4s
Infant 0.063 0.068 0.078 0.090 0.106
Neonate 0.040 0.044 0.051 0.062 0.074

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Technical Information System-Level Information

Field of View 0 1 2 3 4
Field Size (cm) 30 27 22 19 15
Procedure X-ray Protocol Patient Type Reference Air Kerma (mGy/image)
Cardio Pediatrics 15 fps Contrast low Default 0.019 0.020 0.023 0.028 0.032
Clarity <40 kg
15 fps Contrast nor- Default 0.030 0.033 0.039 0.046 0.055
mal
Cardio Pediatrics 15 fps Contrast low Default 0.037 0.040 0.047 0.055 0.065
Clarity >40 kg
Neonate, Infant, 0.019 0.020 0.023 0.028 0.032
Child
15 fps Contrast nor- Default 0.077 0.084 0.097 0.113 0.133
mal
Neonate, Infant, 0.030 0.033 0.039 0.046 0.055
Child
EP Clarity 15 fps Default 0.037 0.040 0.047 0.055 0.065
Prop 4s Default 0.228 0.231 0.235 0.240 0.246
Neonate, Infant 0.148 0.150 0.152 0.156 0.161
Large Adult, Very 0.228 0.231 0.235 0.240 0.246
Large Adult
EP Mapping Clarity 7.5 fps Default 0.037 0.040 0.047 0.055 0.065
3D EP Prop 4s Default 0.228 0.231 0.235 0.240 0.246
Neonate, Infant 0.148 0.150 0.152 0.156 0.161
Large Adult, Very 0.228 0.231 0.235 0.240 0.246
Large Adult
Head Clarity Cerebral 2 fps low Default 0.990 1.099 1.318 1.602 1.953
Aortic Arch 3 fps Default 1.423 1.580 1.895 2.305 2.810
Spine Clarity 4 fps Default 1.133 1.260 1.519 1.852 2.273
2 fps Default 1.134 1.260 1.518 1.853 2.273
Thorax Clarity Lungs 2 fps Default 1.221 1.357 1.630 1.986 2.432
Subclavian 3 fps Default 1.722 1.912 2.289 2.774 3.378
Abdomen Clarity 3 fps low Default 0.797 0.884 1.060 1.285 1.569
Iliac / Pelvis 3 fps Default 3.890 4.322 5.202 6.340 7.138
Peripheral Clarity Upper Legs 3 fps Default 1.128 1.254 1.502 1.688 1.903
Lower Legs 1 fps Default 2.064 2.285 2.732 3.302 4.006

Roadmap - M12 Systems with ClarityIQ

Field of View 0 1 2 3 4
Field Size (cm) 30 27 22 19 15
Patient
Procedure Mode Type Reference Air Kerma (mGy/image)
Cardio Clarity Navigate Default 0.175 0.188 0.213 0.243 0.279
UnSubtract Default 0.175 0.188 0.213 0.243 0.279
Cardio Pediatrics Clari- Navigate Default 0.175 0.188 0.213 0.243 0.279
ty <40 kg
UnSubtract Default 0.175 0.188 0.213 0.243 0.279
Cardio Pediatrics Clari- Navigate Default 0.175 0.188 0.213 0.243 0.279
ty >40 kg
UnSubtract Default 0.175 0.188 0.213 0.243 0.279
EP Clarity Navigate Default 0.175 0.188 0.213 0.243 0.279
UnSubtract Default 0.175 0.188 0.213 0.243 0.279
EP Mapping Clarity Navigate Default 0.175 0.188 0.213 0.243 0.279
UnSubtract Default 0.175 0.188 0.213 0.243 0.279

Azurion Release 2.2 Instructions for Use 353 Philips 4523 001 01511
Technical Information System-Level Information

Field of View 0 1 2 3 4
Field Size (cm) 30 27 22 19 15
Patient
Procedure Mode Type Reference Air Kerma (mGy/image)
Head Clarity Navigate Default 0.175 0.188 0.213 0.243 0.279
Coil Default 0.335 0.372 0.447 0.542 0.661
UnSubtract Default 0.175 0.188 0.213 0.243 0.279
Spine Clarity Navigate Default 0.175 0.188 0.213 0.243 0.279
Coil Default 0.236 0.262 0.314 0.382 0.467
UnSubtract Default 0.175 0.188 0.213 0.243 0.279
Thorax Clarity UnSubtract Default 0.175 0.188 0.213 0.243 0.279
Navigate Default 0.175 0.188 0.213 0.243 0.279
Abdomen Clarity UnSubtract Default 0.175 0.188 0.213 0.243 0.279
Navigate Default 0.175 0.188 0.213 0.243 0.279
Peripheral Clarity UnSubtract Default 0.175 0.188 0.213 0.243 0.279
Navigate Default 0.175 0.188 0.213 0.243 0.279

M15 Systems

Radioscopy (Fluoroscopy) - M15 Systems

Field of View 0 1 2 3 4 5 6
Field Size (cm) 39 37 31 27 22 19 15
Patient
Procedure Flavor Type Reference Air Kerma (mGy/s)
Cardio Low Default 0.121 0.132 0.155 0.179 0.214 0.251 0.313
Norm Default 0.353 0.380 0.432 0.484 0.557 0.634 0.754
High Default 0.421 0.454 0.519 0.586 0.680 0.780 0.936
Pediatrics Low Default 0.112 0.121 0.140 0.161 0.190 0.227 0.274
Norm Default 0.246 0.266 0.307 0.349 0.403 0.466 0.546
High Default 0.412 0.440 0.494 0.549 0.626 0.712 0.786
EP Low Default 0.051 0.055 0.065 0.075 0.090 0.108 0.130
Norm Default 0.121 0.132 0.154 0.176 0.207 0.248 0.300
High Default 0.144 0.157 0.184 0.212 0.253 0.305 0.372
EP Mapping Low Default 0.025 0.028 0.032 0.037 0.045 0.054 0.066
Norm Default 0.060 0.066 0.077 0.088 0.104 0.124 0.150
High Default 0.072 0.078 0.092 0.106 0.127 0.152 0.186
Head Low Default 0.169 0.183 0.214 0.246 0.293 0.355 0.435
Norm Default 0.287 0.309 0.356 0.403 0.473 0.550 0.640
High Default 0.388 0.417 0.477 0.537 0.624 0.728 0.859
Spine Low Default 0.132 0.143 0.166 0.191 0.227 0.273 0.334
Norm Default 0.285 0.307 0.354 0.401 0.470 0.547 0.636
High Default 0.473 0.508 0.583 0.657 0.763 0.892 1.054
Thorax Low Default 0.123 0.133 0.155 0.178 0.211 0.254 0.310
Norm Default 0.287 0.309 0.356 0.403 0.473 0.550 0.640
High Default 0.476 0.512 0.587 0.661 0.768 0.897 1.060

Azurion Release 2.2 Instructions for Use 354 Philips 4523 001 01511
Technical Information System-Level Information

Field of View 0 1 2 3 4 5 6
Field Size (cm) 39 37 31 27 22 19 15
Patient
Procedure Flavor Type Reference Air Kerma (mGy/s)
Abdomen Low Default 0.132 0.143 0.166 0.191 0.227 0.273 0.334
Norm Default 0.285 0.307 0.354 0.401 0.470 0.547 0.636
High Default 0.473 0.508 0.583 0.657 0.763 0.892 1.054
Peripheral Low Default 0.132 0.143 0.166 0.191 0.227 0.273 0.334
Norm Default 0.285 0.307 0.354 0.401 0.470 0.547 0.636
High Default 0.473 0.508 0.583 0.657 0.763 0.892 1.054

Radiography (Exposure) - M15 Systems

Field of View 0 1 2 3 4 5 6
Field Size (cm) 39 37 31 27 22 19 15
Procedure X-ray Protocol Patient Type Reference Air Kerma (mGy/image)
Cardio Left Coronary Default 0.064 0.069 0.080 0.091 0.106 0.125 0.148
15 fps Low Infant 0.046 0.049 0.055 0.060 0.068 0.078 0.090
Large Adult, 0.063 0.068 0.079 0.090 0.105 0.123 0.146
Very Large Adult
Neonate 0.024 0.026 0.030 0.034 0.041 0.050 0.061
Rotational Scan Default 0.123 0.132 0.153 0.173 0.201 0.235 0.278
Prop Ang0 4s Infant 0.039 0.042 0.047 0.053 0.061 0.071 0.085
Neonate 0.024 0.026 0.030 0.034 0.041 0.050 0.061
Pediatrics 15 fps Contrast Default 0.126 0.136 0.157 0.177 0.206 0.241 0.282
Normal
Child, Small 0.072 0.078 0.091 0.103 0.120 0.141 0.167
Adult
Infant 0.039 0.042 0.047 0.053 0.062 0.072 0.086
Neonate 0.024 0.026 0.030 0.035 0.041 0.050 0.062
Prop Free Posi- Default 0.122 0.131 0.151 0.172 0.201 0.235 0.276
tion
Neonate, Infant 0.027 0.029 0.033 0.037 0.043 0.050 0.060
EP 15 fps Default 0.072 0.078 0.091 0.103 0.120 0.141 0.167
15 fps Default 0.072 0.078 0.091 0.103 0.120 0.141 0.167
EP Map- 7.5 fps low Default 0.010 0.011 0.013 0.015 0.017 0.021 0.025
ping
15 fps normal Default 0.072 0.078 0.091 0.103 0.120 0.141 0.167
Head Cerebral 2 fps Default 2.785 3.068 3.675 4.316 5.260 6.448 7.902
normal
Child 1.770 1.883 2.124 2.373 2.730 3.198 3.838
Neonate, Infant 1.770 1.883 2.124 2.373 2.730 3.198 3.838
Aortic Arch 3 fps Default 4.312 4.750 5.671 6.635 6.729 6.880 7.020
Spine 4 fps Default 1.172 1.291 1.548 1.815 2.214 2.714 3.365
2 fps Default 1.466 1.615 1.934 2.271 2.767 3.394 4.209
Thorax Lungs 2 fps Default 1.399 1.543 1.848 2.168 2.624 2.896 3.234
Subclavian 3 fps Default 5.338 5.881 7.014 8.201 9.940 11.254 11.316
Abdomen Abdomen Default 2.616 2.883 3.446 4.047 4.925 6.030 6.554
3 fps Large Adult, 2.264 2.500 2.991 3.520 4.290 5.262 6.538
Very Large Adult
Iliac / Pelvis 3 Default 4.250 4.687 5.605 6.578 7.999 9.805 12.139
fps

Azurion Release 2.2 Instructions for Use 355 Philips 4523 001 01511
Technical Information System-Level Information

Field of View 0 1 2 3 4 5 6
Field Size (cm) 39 37 31 27 22 19 15
Procedure X-ray Protocol Patient Type Reference Air Kerma (mGy/image)
Peripheral Upper Legs 3 fps Default 3.784 4.169 4.974 5.551 6.044 6.621 7.326
Lower Legs 1 fps Default 4.732 5.209 5.774 6.193 6.737 7.343 8.098

Roadmap - M15 Systems

Field of View 0 1 2 3 4 5 6
Field Size (cm) 39 37 31 27 22 19 15
Patient
Procedure Mode Type Reference Air Kerma (mGy/image)
Cardio Navigate Default 0.198 0.244 0.269 0.296 0.351 0.411 0.443
UnSubtract Default 0.198 0.244 0.269 0.296 0.351 0.411 0.443
Pediatrics Navigate Default 0.198 0.244 0.269 0.296 0.351 0.411 0.443
UnSubtract Default 0.198 0.244 0.269 0.296 0.351 0.411 0.443
EP Navigate Default 0.198 0.244 0.269 0.296 0.351 0.411 0.443
EP Mapping Navigate Default 0.198 0.244 0.269 0.296 0.351 0.411 0.443
Head Navigate Default 0.246 0.266 0.307 0.330 0.401 0.437 0.443
Carotid Default 0.212 0.225 0.252 0.279 0.318 0.342 0.347
Coil Default 1.064 1.171 1.401 1.645 2.001 2.450 3.037
Spine UnSubtract Default 0.246 0.266 0.307 0.330 0.401 0.437 0.443
Navigate Default 0.246 0.266 0.307 0.330 0.401 0.437 0.443
Stent Default 0.212 0.225 0.252 0.279 0.318 0.342 0.347
Thorax UnSubtract Default 0.246 0.266 0.307 0.330 0.401 0.437 0.443
Navigate Default 0.246 0.266 0.307 0.330 0.401 0.437 0.443
Intervention Default 0.212 0.225 0.252 0.279 0.318 0.342 0.347
Abdomen UnSubtract Default 0.246 0.266 0.307 0.330 0.401 0.437 0.443
Navigate Default 0.246 0.266 0.307 0.330 0.401 0.437 0.443
Stent Default 0.212 0.225 0.252 0.279 0.318 0.342 0.347
Peripheral UnSubtract Default 0.246 0.266 0.307 0.330 0.401 0.437 0.443
Navigate Default 0.246 0.266 0.307 0.330 0.401 0.437 0.443

M15 Systems with ClarityIQ Option

Radioscopy (Fluoroscopy) - M15 Systems with ClarityIQ

Field of View 0 1 2 3 4 5 6
Field Size (cm) 39 37 31 27 22 19 15
Patient
Procedure Flavor Type Reference Air Kerma (mGy/s)
Cardio Clarity Low Default 0.090 0.098 0.112 0.127 0.149 0.175 0.206
Medium Default 0.132 0.142 0.165 0.187 0.220 0.259 0.310
Normal Default 0.322 0.346 0.397 0.447 0.517 0.604 0.710
Cardio Pediatrics Low Default 0.038 0.041 0.047 0.054 0.063 0.075 0.090
Clarity <40 kg
Medium Default 0.057 0.061 0.071 0.081 0.096 0.114 0.136
Normal Default 0.087 0.094 0.109 0.125 0.146 0.172 0.204

Azurion Release 2.2 Instructions for Use 356 Philips 4523 001 01511
Technical Information System-Level Information

Field of View 0 1 2 3 4 5 6
Field Size (cm) 39 37 31 27 22 19 15
Patient
Procedure Flavor Type Reference Air Kerma (mGy/s)
Cardio Pediatrics Low Default 0.038 0.041 0.047 0.054 0.063 0.075 0.090
Clarity >40 kg
Medium Default 0.057 0.061 0.071 0.081 0.096 0.114 0.136
Normal Default 0.087 0.094 0.109 0.125 0.146 0.172 0.204
EP Clarity Low Default 0.027 0.029 0.033 0.038 0.044 0.052 0.061
Medium Default 0.053 0.057 0.066 0.075 0.087 0.103 0.121
Normal Default 0.063 0.069 0.080 0.091 0.108 0.128 0.153
EP Mapping Clarity Low Default 0.027 0.029 0.033 0.038 0.044 0.052 0.061
Medium Default 0.053 0.057 0.066 0.075 0.087 0.103 0.121
Normal Default 0.063 0.069 0.080 0.091 0.108 0.128 0.153
Head Clarity Low Default 0.121 0.131 0.147 0.163 0.187 0.217 0.255
Medium Default 0.186 0.202 0.234 0.267 0.316 0.367 0.427
Normal Default 0.343 0.370 0.426 0.482 0.563 0.661 0.784
Spine Clarity Low Default 0.121 0.131 0.147 0.163 0.187 0.217 0.255
Medium Default 0.186 0.202 0.234 0.267 0.316 0.367 0.427
Normal Default 0.343 0.370 0.426 0.482 0.563 0.661 0.784
Thorax Clarity Low Default 0.121 0.131 0.147 0.163 0.187 0.217 0.255
Medium Default 0.186 0.202 0.234 0.267 0.316 0.367 0.427
Normal Default 0.343 0.370 0.426 0.482 0.563 0.661 0.784
Abdomen Clarity Low Default 0.121 0.131 0.147 0.163 0.187 0.217 0.255
Medium Default 0.186 0.202 0.234 0.267 0.316 0.367 0.427
Normal Default 0.343 0.370 0.426 0.482 0.563 0.661 0.784
Peripheral Clarity Low Default 0.090 0.098 0.112 0.127 0.149 0.175 0.206
Medium Default 0.132 0.142 0.165 0.187 0.220 0.259 0.310
Normal Default 0.322 0.346 0.397 0.447 0.517 0.604 0.710

Radiography (Exposure) - M15 Systems with ClarityIQ

Field of View 0 1 2 3 4 5 6
Field Size (cm) 39 37 31 27 22 19 15
Procedure X-ray Protocol Patient Type Reference Air Kerma (mGy/image)
Cardio Clarity Left Coronary 15 Default 0.023 0.025 0.029 0.033 0.038 0.045 0.054
fps Low
Rotational Scan Default 0.125 0.135 0.155 0.175 0.204 0.238 0.280
Prop Ang0 4s
Infant 0.039 0.042 0.047 0.053 0.061 0.071 0.085
Neonate 0.024 0.026 0.030 0.034 0.041 0.050 0.061
Cardio Pedia- 15 fps Contrast Default 0.012 0.013 0.015 0.017 0.020 0.023 0.028
trics Clarity <40 low
kg
15 fps Contrast Default 0.018 0.020 0.023 0.027 0.032 0.038 0.046
normal
Cardio Pedia- 15 fps Contrast Default 0.023 0.025 0.029 0.033 0.038 0.045 0.054
trics Clarity >40 low
Neonate, Infant, 0.012 0.013 0.015 0.017 0.020 0.023 0.028
kg
Child
15 fps Contrast Default 0.048 0.052 0.060 0.069 0.081 0.094 0.112
normal
Neonate, Infant, 0.018 0.020 0.023 0.027 0.032 0.038 0.046
Child

Azurion Release 2.2 Instructions for Use 357 Philips 4523 001 01511
Technical Information System-Level Information

Field of View 0 1 2 3 4 5 6
Field Size (cm) 39 37 31 27 22 19 15
Procedure X-ray Protocol Patient Type Reference Air Kerma (mGy/image)
EP Clarity 15 Fps Default 0.023 0.025 0.029 0.033 0.038 0.045 0.054
EP Mapping 7.5 fps Default 0.023 0.025 0.029 0.033 0.038 0.045 0.054
Clarity
Head Clarity Cerebral 2 fps Default 0.573 0.631 0.754 0.885 1.076 1.315 1.625
low
Aortic Arch 3 Default 0.817 0.900 1.076 1.261 1.534 1.876 2.319
fps
Spine Clarity 4 fps Default 0.492 0.542 0.651 0.766 0.933 1.150 1.429
2 fps Default 0.492 0.543 0.650 0.765 0.934 1.149 1.428
Thorax Clarity Lungs 2 fps Default 0.700 0.772 0.924 1.085 1.321 1.620 2.010
Subclavian 3 Default 0.988 1.090 1.301 1.523 1.848 2.253 2.773
fps
Abdomen Clari- 3 fps low Default 0.460 0.507 0.605 0.709 0.861 1.051 1.299
ty
Iliac / Pelvis 3 Default 2.264 2.500 2.991 3.520 4.290 5.262 6.538
fps
Peripheral Upper Legs 3 Default 0.641 0.706 0.827 0.923 1.059 1.216 1.390
Clarity fps
Lower Legs 1 Default 1.184 1.303 1.553 1.812 2.132 2.402 2.730
fps

Roadmap - M15 Systems with ClarityIQ

Field of View 0 1 2 3 4 5 6
Field Size (cm) 39 37 31 27 22 19 15
Patient
Procedure Mode Type Reference Air Kerma (mGy/image)
Cardio Clarity Navigate Default 0.096 0.103 0.117 0.130 0.150 0.174 0.203
UnSubtract Default 0.096 0.103 0.117 0.130 0.150 0.174 0.203
Cardio Pediatrics Navigate Default 0.096 0.103 0.117 0.130 0.150 0.174 0.203
Clarity <40 kg
UnSubtract Default 0.096 0.103 0.117 0.130 0.150 0.174 0.203
Cardio Pediatrics Navigate Default 0.096 0.103 0.117 0.130 0.150 0.174 0.203
Clarity >40 kg
UnSubtract Default 0.096 0.103 0.117 0.130 0.150 0.174 0.203
EP Clarity Navigate Default 0.096 0.103 0.117 0.130 0.150 0.174 0.203
UnSubtract Default 0.096 0.103 0.117 0.130 0.150 0.174 0.203
EP Mapping Clari- Navigate Default 0.096 0.103 0.117 0.130 0.150 0.174 0.203
ty
UnSubtract Default 0.096 0.103 0.117 0.130 0.150 0.174 0.203
Head Clarity Navigate Default 0.096 0.103 0.117 0.130 0.150 0.174 0.203
Coil Default 0.192 0.211 0.253 0.296 0.360 0.441 0.544
UnSubtract Default 0.096 0.103 0.117 0.130 0.150 0.174 0.203
Spine Clarity Navigate Default 0.096 0.103 0.117 0.130 0.150 0.174 0.203
Coil Default 0.145 0.160 0.192 0.225 0.273 0.334 0.413
UnSubtract Default 0.096 0.103 0.117 0.130 0.150 0.174 0.203
Thorax Clarity UnSubtract Default 0.096 0.103 0.117 0.130 0.150 0.174 0.203
Navigate Default 0.096 0.103 0.117 0.130 0.150 0.174 0.203
Abdomen Clarity UnSubtract Default 0.096 0.103 0.117 0.130 0.150 0.174 0.203
Navigate Default 0.096 0.103 0.117 0.130 0.150 0.174 0.203

Azurion Release 2.2 Instructions for Use 358 Philips 4523 001 01511
Technical Information System-Level Information

Field of View 0 1 2 3 4 5 6
Field Size (cm) 39 37 31 27 22 19 15
Patient
Procedure Mode Type Reference Air Kerma (mGy/image)
Peripheral Clarity Navigate Default 0.096 0.103 0.117 0.130 0.150 0.174 0.203
UnSubtract Default 0.096 0.103 0.117 0.130 0.150 0.174 0.203

M20 Systems

Radioscopy (Fluoroscopy) - M20 Systems

Field of View 0 1 2 3 4 5 6 7
Field Size (cm) 48 42 37 31 27 22 19 15
Patient
Procedure Flavor Type Reference Air Kerma (mGy/s)
Cardio Low Default 0.102 0.129 0.143 0.166 0.193 0.230 0.268 0.328
Norm Default 0.302 0.367 0.399 0.451 0.510 0.588 0.664 0.784
High Default 0.372 0.458 0.501 0.569 0.649 0.754 0.857 1.017
Pediatrics Low Default 0.096 0.119 0.131 0.150 0.173 0.205 0.237 0.273
Norm Default 0.217 0.269 0.294 0.336 0.386 0.450 0.503 0.584
High Default 0.384 0.463 0.499 0.558 0.625 0.688 0.743 0.826
EP Low Default 0.047 0.060 0.066 0.074 0.085 0.098 0.115 0.128
Norm Default 0.104 0.132 0.146 0.167 0.200 0.226 0.277 0.317
High Default 0.123 0.157 0.173 0.201 0.234 0.279 0.324 0.397
EP Mapping Low Default 0.024 0.030 0.033 0.037 0.043 0.049 0.058 0.065
Norm Default 0.052 0.066 0.073 0.083 0.100 0.113 0.138 0.159
High Default 0.062 0.078 0.086 0.100 0.117 0.139 0.162 0.198
Head Low Default 0.113 0.141 0.155 0.178 0.206 0.236 0.267 0.299
Norm Default 0.244 0.301 0.329 0.376 0.448 0.532 0.594 0.662
High Default 0.406 0.495 0.541 0.615 0.701 0.814 0.927 1.105
Spine Low Default 0.113 0.141 0.155 0.178 0.206 0.236 0.267 0.299
Norm Default 0.244 0.301 0.329 0.376 0.448 0.532 0.594 0.662
High Default 0.406 0.495 0.541 0.615 0.701 0.814 0.927 1.105
Thorax Low Default 0.113 0.141 0.155 0.178 0.206 0.236 0.267 0.299
Norm Default 0.244 0.301 0.329 0.376 0.448 0.532 0.594 0.662
High Default 0.406 0.495 0.541 0.615 0.701 0.814 0.927 1.105
Abdomen Low Default 0.113 0.141 0.155 0.178 0.206 0.236 0.267 0.299
Norm Default 0.244 0.301 0.329 0.376 0.448 0.532 0.594 0.662
High Default 0.406 0.495 0.541 0.615 0.701 0.814 0.927 1.105
Peripheral Low Default 0.113 0.141 0.155 0.178 0.206 0.236 0.267 0.299
Norm Default 0.244 0.301 0.329 0.376 0.448 0.532 0.594 0.662
High Default 0.406 0.495 0.541 0.615 0.701 0.814 0.927 1.105

Azurion Release 2.2 Instructions for Use 359 Philips 4523 001 01511
Technical Information System-Level Information

Radiography (Exposure) - M20 Systems

Field of View 0 1 2 3 4 5 6 7
Field Size (cm) 48 42 37 31 27 22 19 15
X-ray Pro-
Procedure tocol Patient Type Reference Air Kerma (mGy/image)
Cardio Left Coro- Default 0.053 0.066 0.073 0.083 0.096 0.112 0.128 0.153
nary
15 fps Low Infant 0.039 0.048 0.052 0.057 0.064 0.072 0.080 0.093
Large Adult, 0.052 0.065 0.072 0.082 0.095 0.111 0.126 0.151
Very Large
Adult
Neonate 0.021 0.025 0.028 0.032 0.037 0.044 0.052 0.064
Rotational Default 0.103 0.128 0.140 0.160 0.184 0.214 0.244 0.291
Scan
Prop Ang0 Infant 0.034 0.041 0.044 0.050 0.056 0.065 0.074 0.089
4s
Neonate 0.021 0.025 0.028 0.032 0.037 0.044 0.052 0.064
Pediatrics 15 fps Con- Default 0.105 0.130 0.142 0.163 0.186 0.217 0.247 0.293
trast Nor-
Child, Small 0.060 0.075 0.083 0.095 0.109 0.127 0.145 0.173
mal
Adult
Infant 0.034 0.041 0.044 0.050 0.056 0.065 0.074 0.089
Neonate 0.021 0.025 0.028 0.032 0.037 0.044 0.052 0.064
Prop Free Default 0.101 0.127 0.139 0.159 0.182 0.213 0.243 0.289
Position
Neonate, In- 0.023 0.028 0.030 0.034 0.039 0.046 0.052 0.063
fant
EP 15 fps Default 0.060 0.075 0.083 0.095 0.109 0.127 0.145 0.173
Prop 4s Default 0.115 0.147 0.184 0.186 0.188 0.190 0.193 0.196
Neonate, In- 0.073 0.095 0.120 0.121 0.123 0.125 0.127 0.129
fant
Large Adult, 0.115 0.147 0.184 0.186 0.188 0.190 0.193 0.196
Very Large
Adult
EP Map- 7.5 fps low Default 0.009 0.011 0.013 0.014 0.016 0.018 0.022 0.024
ping
3D EP Prop Default 0.115 0.147 0.184 0.186 0.188 0.190 0.193 0.196
4s
Neonate, In- 0.073 0.095 0.120 0.121 0.123 0.125 0.127 0.129
fant
Large Adult, 0.115 0.147 0.184 0.186 0.188 0.190 0.193 0.196
Very Large
Adult
Head Cerebral 2 Default 2.295 3.004 3.359 3.973 4.718 5.731 6.779 8.103
fps normal
Child 1.525 1.899 2.044 2.282 2.565 2.945 3.354 3.884
Neonate, In- 1.603 1.899 2.044 2.282 2.565 2.945 3.354 3.884
fant
Aortic Arch Default 3.505 4.585 5.127 6.061 7.047 7.121 7.210 7.299
3 fps
Spine 4 fps Default 0.963 1.259 1.408 1.664 1.976 2.403 2.842 3.554
2 fps Default 1.203 1.572 1.759 2.082 2.470 3.003 3.555 4.445
Thorax Lungs 2 fps Default 1.148 1.502 1.682 1.987 2.357 2.727 2.962 3.245
Subclavian Default 4.318 5.645 6.318 7.456 8.830 10.706 11.747 12.554
3 fps

Azurion Release 2.2 Instructions for Use 360 Philips 4523 001 01511
Technical Information System-Level Information

Field of View 0 1 2 3 4 5 6 7
Field Size (cm) 48 42 37 31 27 22 19 15
X-ray Pro-
Procedure tocol Patient Type Reference Air Kerma (mGy/image)
Abdomen Abdomen Default 2.140 2.799 3.131 3.699 4.389 5.335 6.304 6.395
3 fps Large Adult, 1.856 2.431 2.719 3.214 3.817 4.643 5.496 6.877
Very Large
Adult
Iliac / Pel- Default 3.476 4.546 5.089 6.010 7.138 8.669 10.255 12.255
vis 3 fps
Peripheral Upper Legs Default 3.069 4.004 4.483 5.297 5.845 6.370 6.869 7.481
3 fps
Lower Legs Default 3.810 4.981 5.557 6.109 6.568 7.144 7.688 8.335
1 fps

Roadmap - M20 Systems

Field of View 0 1 2 3 4 5 6 7
Field Size (cm) 48 42 37 31 27 22 19 15
Patient
Procedure Mode Type Reference Air Kerma (mGy/image)
Cardio Navigate Default 0.207 0.257 0.280 0.320 0.366 0.423 0.456 0.460
UnSubtract Default 0.207 0.257 0.280 0.320 0.366 0.423 0.456 0.460
Pediatrics Navigate Default 0.207 0.257 0.280 0.320 0.366 0.423 0.456 0.460
UnSubtract Default 0.207 0.257 0.280 0.320 0.366 0.423 0.456 0.460
EP Navigate Default 0.207 0.257 0.280 0.320 0.366 0.423 0.456 0.460
EP Map- Navigate Default 0.207 0.257 0.280 0.320 0.366 0.423 0.456 0.460
ping
Head Navigate Default 0.207 0.257 0.280 0.320 0.366 0.423 0.456 0.460
Carotid Default 0.184 0.219 0.236 0.263 0.294 0.334 0.355 0.358
Coil Default 0.869 1.137 1.273 1.504 1.784 2.167 2.559 3.203
Spine UnSubtract Default 0.207 0.257 0.280 0.320 0.366 0.423 0.456 0.460
Navigate Default 0.207 0.257 0.280 0.320 0.366 0.423 0.456 0.460
Stent Default 0.184 0.219 0.236 0.263 0.294 0.334 0.355 0.358
Thorax UnSubtract Default 0.207 0.257 0.280 0.320 0.366 0.423 0.456 0.460
Navigate Default 0.207 0.257 0.280 0.320 0.366 0.423 0.456 0.460
Interven- Default 0.184 0.219 0.236 0.263 0.294 0.334 0.355 0.358
tion
Abdomen UnSubtract Default 0.207 0.257 0.280 0.320 0.366 0.423 0.456 0.460
Navigate Default 0.207 0.257 0.280 0.320 0.366 0.423 0.456 0.460
Stent Default 0.184 0.219 0.236 0.263 0.294 0.334 0.355 0.358
Peripheral UnSubtract Default 0.207 0.257 0.280 0.320 0.366 0.423 0.456 0.460
Navigate Default 0.207 0.257 0.280 0.320 0.366 0.423 0.456 0.460

Azurion Release 2.2 Instructions for Use 361 Philips 4523 001 01511
Technical Information System-Level Information

M20 Systems with ClarityIQ Option

Radioscopy (Fluoroscopy) - M20 Systems with ClarityIQ

Field of View 0 1 2 3 4 5 6 7
Field Size (cm) 48 42 37 31 27 22 19 15
Patient
Procedure Flavor Type Reference Air Kerma (mGy/s)
Cardio Clarity Low Default 0.077 0.096 0.105 0.119 0.137 0.160 0.182 0.216
Medium Default 0.115 0.142 0.156 0.179 0.205 0.241 0.276 0.333
Normal Default 0.277 0.340 0.370 0.420 0.478 0.555 0.630 0.748
Cardio Pedia- Low Default 0.032 0.040 0.044 0.051 0.058 0.068 0.079 0.095
trics Clarity <40
Medium Default 0.048 0.060 0.066 0.076 0.087 0.103 0.119 0.143
kg
Normal Default 0.074 0.093 0.101 0.117 0.134 0.157 0.180 0.214
Cardio Pedia- Low Default 0.032 0.040 0.044 0.051 0.058 0.068 0.079 0.095
trics Clarity >40
Medium Default 0.048 0.060 0.066 0.076 0.087 0.103 0.119 0.143
kg
Normal Default 0.074 0.093 0.101 0.117 0.134 0.157 0.180 0.214
EP Clarity Low Default 0.030 0.030 0.030 0.034 0.039 0.046 0.052 0.062
Medium Default 0.059 0.059 0.059 0.068 0.078 0.091 0.104 0.123
Normal Default 0.076 0.076 0.076 0.087 0.101 0.119 0.137 0.166
EP Mapping Low Default 0.030 0.030 0.030 0.034 0.039 0.046 0.052 0.062
Clarity
Medium Default 0.059 0.059 0.059 0.068 0.078 0.091 0.104 0.123
Normal Default 0.076 0.076 0.076 0.087 0.101 0.119 0.137 0.166
Head Clarity Low Default 0.103 0.128 0.139 0.155 0.179 0.209 0.234 0.264
Medium Default 0.157 0.196 0.215 0.248 0.297 0.355 0.395 0.441
Normal Default 0.288 0.356 0.389 0.446 0.511 0.595 0.681 0.814
Spine Clarity Low Default 0.103 0.128 0.139 0.155 0.179 0.209 0.234 0.264
Medium Default 0.157 0.196 0.215 0.248 0.297 0.355 0.395 0.441
Normal Default 0.288 0.356 0.389 0.446 0.511 0.595 0.681 0.814
Thorax Clarity Low Default 0.103 0.128 0.139 0.155 0.179 0.209 0.234 0.264
Medium Default 0.157 0.196 0.215 0.248 0.297 0.355 0.395 0.441
Normal Default 0.288 0.356 0.389 0.446 0.511 0.595 0.681 0.814
Abdomen Clari- Low Default 0.103 0.128 0.139 0.155 0.179 0.209 0.234 0.264
ty
Medium Default 0.157 0.196 0.215 0.248 0.297 0.355 0.395 0.441
Normal Default 0.288 0.356 0.389 0.446 0.511 0.595 0.681 0.814
Peripheral Low Default 0.077 0.096 0.105 0.119 0.137 0.160 0.182 0.216
Clarity
Medium Default 0.115 0.142 0.156 0.179 0.205 0.241 0.276 0.333
Normal Default 0.277 0.340 0.370 0.420 0.478 0.555 0.630 0.748

Azurion Release 2.2 Instructions for Use 362 Philips 4523 001 01511
Technical Information System-Level Information

Radiography (Exposure) - M20 Systems with ClarityIQ

Field of View 0 1 2 3 4 5 6 7
Field Size (cm) 48 42 37 31 27 22 19 15
X-ray Proto-
Procedure col Patient Type Reference Air Kerma (mGy/image)
Cardio Clari- Left Coro- Default 0.019 0.023 0.026 0.030 0.034 0.040 0.047 0.056
ty nary 15 fps
Low
Rotational Default 0.105 0.130 0.142 0.163 0.187 0.217 0.247 0.293
Scan Prop
Infant 0.034 0.041 0.044 0.050 0.056 0.065 0.074 0.089
Ang0 4s
Neonate 0.021 0.025 0.028 0.032 0.037 0.044 0.052 0.064
Cardio Pe- 15 fps Con- Default 0.010 0.012 0.013 0.015 0.018 0.021 0.024 0.028
diatrics Clari- trast low
ty <40 kg
15 fps Con- Default 0.015 0.019 0.021 0.024 0.028 0.034 0.039 0.048
trast normal
Cardio Pe- 15 fps Con- Default 0.019 0.023 0.026 0.030 0.034 0.040 0.047 0.056
diatrics Clari- trast low
Neonate, In- 0.010 0.012 0.013 0.015 0.018 0.021 0.024 0.028
ty >40 kg
fant, Child
15 fps Con- Default 0.041 0.051 0.056 0.064 0.074 0.087 0.099 0.118
trast normal
Neonate, In- 0.015 0.019 0.021 0.024 0.028 0.034 0.039 0.048
fant, Child
EP Clarity 15 fps Default 0.019 0.023 0.026 0.030 0.034 0.040 0.047 0.056
Prop 4s Default 0.115 0.147 0.184 0.186 0.188 0.190 0.193 0.196
Neonate, In- 0.073 0.095 0.120 0.121 0.123 0.125 0.127 0.129
fant
Large Adult, 0.115 0.147 0.184 0.186 0.188 0.190 0.193 0.196
Very Large
Adult
EP Mapping 7.5 fps Default 0.019 0.023 0.026 0.030 0.034 0.040 0.047 0.056
Clarity
3D EP Prop Default 0.115 0.147 0.184 0.186 0.188 0.190 0.193 0.196
4s
Neonate, In- 0.073 0.095 0.120 0.121 0.123 0.125 0.127 0.129
fant
Large Adult, 0.115 0.147 0.184 0.186 0.188 0.190 0.193 0.196
Very Large
Adult
Head Clarity Cerebral 2 Default 0.466 0.609 0.682 0.805 0.957 1.159 1.370 1.639
fps low
Aortic Arch 3 Default 0.666 0.870 0.975 1.151 1.365 1.656 1.959 2.339
fps
Spine Clarity 4 fps Default 0.534 0.698 0.781 0.923 1.098 1.336 1.585 1.899
2 fps Default 0.534 0.699 0.781 0.923 1.098 1.336 1.583 1.898
Thorax Clari- Lungs 2 fps Default 0.574 0.751 0.841 0.993 1.179 1.433 1.695 2.030
ty
Subclavian 3 Default 0.801 1.047 1.172 1.384 1.641 1.988 2.345 2.793
fps
Abdomen 3 fps low Default 0.602 0.787 0.880 1.040 1.236 1.501 1.778 2.126
Clarity
Iliac / Pelvis Default 0.574 0.751 0.840 0.993 1.180 1.432 1.695 2.029
3 fps
Peripheral Upper Legs 3 Default 0.521 0.681 0.761 0.866 0.976 1.121 1.250 1.397
Clarity fps
Lower Legs 1 Default 0.953 1.245 1.393 1.642 1.944 2.227 2.458 2.740
fps

Azurion Release 2.2 Instructions for Use 363 Philips 4523 001 01511
Technical Information System-Level Information

Roadmap - M20 Systems with ClarityIQ

Field of View 0 1 2 3 4 5 6 7
Field Size (cm) 48 42 37 31 27 22 19 15
Patient
Procedure Mode Type Reference Air Kerma (mGy/image)
Cardio Clarity Navigate Default 0.083 0.101 0.109 0.122 0.138 0.159 0.179 0.211
UnSubtract Default 0.083 0.101 0.109 0.122 0.138 0.159 0.179 0.211
Cardio Pedia- Navigate Default 0.083 0.101 0.109 0.122 0.138 0.159 0.179 0.211
trics Clarity <40
UnSubtract Default 0.083 0.101 0.109 0.122 0.138 0.159 0.179 0.211
kg
Cardio Pedia- Navigate Default 0.083 0.101 0.109 0.122 0.138 0.159 0.179 0.211
trics Clarity >40
UnSubtract Default 0.083 0.101 0.109 0.122 0.138 0.159 0.179 0.211
kg
EP Clarity Navigate Default 0.083 0.101 0.109 0.122 0.138 0.159 0.179 0.211
UnSubtract Default 0.083 0.101 0.109 0.122 0.138 0.159 0.179 0.211
EP Mapping Navigate Default 0.083 0.101 0.109 0.122 0.138 0.159 0.179 0.211
Clarity
UnSubtract Default 0.083 0.101 0.109 0.122 0.138 0.159 0.179 0.211
Head Clarity Navigate Default 0.083 0.101 0.109 0.122 0.138 0.159 0.179 0.211
Coil Default 0.156 0.205 0.229 0.271 0.321 0.389 0.460 0.575
Unsubtract Default 0.083 0.101 0.109 0.122 0.138 0.159 0.179 0.211
Spine Clarity Navigate Default 0.083 0.101 0.109 0.122 0.138 0.159 0.179 0.211
Coil Default 0.156 0.205 0.229 0.271 0.321 0.389 0.460 0.575
Unsubtract Default 0.083 0.101 0.109 0.122 0.138 0.159 0.179 0.211
Thorax Clarity UnSubtract Default 0.083 0.101 0.109 0.122 0.138 0.159 0.179 0.211
Navigate Default 0.083 0.101 0.109 0.122 0.138 0.159 0.179 0.211
Abdomen Clari- UnSubtract Default 0.083 0.101 0.109 0.122 0.138 0.159 0.179 0.211
ty
Navigate Default 0.083 0.101 0.109 0.122 0.138 0.159 0.179 0.211
Peripheral UnSubtract Default 0.083 0.101 0.109 0.122 0.138 0.159 0.179 0.211
Clarity
Navigate Default 0.083 0.101 0.109 0.122 0.138 0.159 0.179 0.211

B12/12 Systems

Radioscopy (Fluoroscopy) - B12/12 Systems, Frontal Stand

Field of View 0 1 2 3 4
Field Size (cm) 30 27 22 19 15
Patient
Procedure Flavor Type Reference Air Kerma (mGy/s)
Cardio Low Default 0.233 0.254 0.296 0.349 0.420
Norm Default 0.512 0.664 0.850 0.861 0.876
High Default 0.709 0.756 0.884 1.026 1.183
Pediatrics Low Default 0.183 0.199 0.233 0.276 0.328
Norm Default 0.433 0.470 0.539 0.611 0.698
High Default 0.684 0.731 0.792 0.864 0.951
EP Low Default 0.087 0.095 0.112 0.132 0.157
Norm Default 0.206 0.224 0.261 0.308 0.365
High Default 0.247 0.269 0.313 0.368 0.436

Azurion Release 2.2 Instructions for Use 364 Philips 4523 001 01511
Technical Information System-Level Information

Field of View 0 1 2 3 4
Field Size (cm) 30 27 22 19 15
Patient
Procedure Flavor Type Reference Air Kerma (mGy/s)
EP Mapping Low Default 0.043 0.048 0.056 0.068 0.082
Norm Default 0.103 0.112 0.131 0.154 0.184
High Default 0.123 0.135 0.157 0.184 0.218
Head Low Default 0.184 0.252 0.291 0.299 0.310
Norm Default 0.472 0.503 0.565 0.641 0.734
High Default 0.753 0.815 0.937 1.094 1.278
Spine Low Default 0.184 0.252 0.291 0.299 0.310
Norm Default 0.472 0.503 0.565 0.641 0.734
High Default 0.753 0.815 0.937 1.094 1.278
Thorax Low Default 0.184 0.252 0.291 0.299 0.310
Norm Default 0.472 0.503 0.565 0.641 0.734
High Default 0.753 0.815 0.937 1.094 1.278
Abdomen Low Default 0.184 0.252 0.291 0.299 0.310
Norm Default 0.472 0.503 0.565 0.641 0.734
High Default 0.753 0.815 0.937 1.094 1.278
Peripheral Low Default 0.184 0.252 0.291 0.299 0.310
Norm Default 0.472 0.503 0.565 0.641 0.734
High Default 0.753 0.815 0.937 1.094 1.278

Radioscopy (Fluoroscopy) - B12/12 Systems, Lateral Stand

Field of View 0 1 2 3 4
Field Size (cm) 30 27 22 19 15
Patient
Procedure Flavor Type Reference Air Kerma (mGy/s)
Cardio Low Default 0.263 0.287 0.334 0.395 0.479
Norm Default 0.576 0.749 0.957 0.970 0.987
High Default 0.802 0.850 0.997 1.155 1.349
Pediatrics Low Default 0.206 0.225 0.264 0.311 0.371
Norm Default 0.500 0.540 0.630 0.722 0.825
High Default 0.774 0.830 0.937 1.043 1.145
EP Low Default 0.099 0.108 0.128 0.153 0.182
Norm Default 0.232 0.252 0.294 0.348 0.415
High Default 0.279 0.303 0.353 0.416 0.493
EP Mapping Low Default 0.049 0.054 0.064 0.077 0.093
Norm Default 0.116 0.126 0.147 0.174 0.208
High Default 0.139 0.152 0.176 0.208 0.247
Head Low Default 0.209 0.287 0.332 0.342 0.355
Norm Default 0.543 0.581 0.657 0.750 0.857
High Default 0.848 0.919 1.058 1.233 1.444
Spine Low Default 0.209 0.287 0.332 0.342 0.355
Norm Default 0.543 0.581 0.657 0.750 0.857
High Default 0.848 0.919 1.058 1.233 1.444

Azurion Release 2.2 Instructions for Use 365 Philips 4523 001 01511
Technical Information System-Level Information

Field of View 0 1 2 3 4
Field Size (cm) 30 27 22 19 15
Patient
Procedure Flavor Type Reference Air Kerma (mGy/s)
Thorax Low Default 0.209 0.287 0.332 0.342 0.355
Norm Default 0.543 0.581 0.657 0.750 0.857
High Default 0.848 0.919 1.058 1.233 1.444
Abdomen Low Default 0.209 0.287 0.332 0.342 0.355
Norm Default 0.543 0.581 0.657 0.750 0.857
High Default 0.848 0.919 1.058 1.233 1.444
Peripheral Low Default 0.209 0.287 0.332 0.342 0.355
Norm Default 0.543 0.581 0.657 0.750 0.857
High Default 0.848 0.919 1.058 1.233 1.444

Radiography (Exposure) - B12/12 Systems, Frontal Stand

Field of View 0 1 2 3 4
Field Size (cm) 30 27 22 19 15
Procedure X-ray Protocol Patient Type Reference Air Kerma (mGy/image)
Cardio Left Coronary Default 0.104 0.113 0.130 0.152 0.178
15 fps Low
Infant 0.074 0.079 0.088 0.099 0.114
Large Adult, Very 0.104 0.113 0.130 0.152 0.178
Large Adult
Neonate 0.040 0.044 0.051 0.062 0.074
Rotational Scan Default 0.195 0.212 0.244 0.282 0.329
Prop Ang0 4s
Infant 0.063 0.068 0.078 0.090 0.106
Neonate 0.040 0.044 0.051 0.062 0.074
Pediatrics 15 fps Contrast Nor- Default 0.195 0.212 0.244 0.282 0.329
mal
Child, Small Adult 0.115 0.125 0.145 0.169 0.198
Infant 0.074 0.079 0.088 0.099 0.114
Neonate 0.043 0.047 0.054 0.064 0.076
Prop Free Position Default 0.201 0.218 0.252 0.293 0.342
Neonate, Infant 0.043 0.047 0.054 0.064 0.076
EP 15 fps Default 0.115 0.125 0.145 0.169 0.198
Prop 4s Default 0.228 0.231 0.235 0.240 0.246
Neonate, nfant 0.148 0.150 0.152 0.156 0.161
Large Adult, Very 0.228 0.231 0.235 0.240 0.246
Large Adult
EP Mapping 7.5 fps low Default 0.017 0.018 0.021 0.026 0.031
3D EP Prop 4s Default 0.228 0.231 0.235 0.240 0.246
Neonate, Infant 0.148 0.150 0.152 0.156 0.161
Large Adult, Very 0.228 0.231 0.235 0.240 0.246
Large Adult
Head Cerebral 2 fps nor- Default 4.895 5.436 6.540 7.701 8.502
mal
Child 3.153 3.378 3.820 4.379 5.072
Neonate, Infant 3.153 3.378 3.820 4.379 5.072
Aortic Arch 3 fps Default 7.304 8.113 9.713 11.788 12.894
Spine 4 fps Default 2.050 2.279 2.739 3.335 4.088
2 fps Default 2.566 2.851 3.428 4.172 5.113

Azurion Release 2.2 Instructions for Use 366 Philips 4523 001 01511
Technical Information System-Level Information

Field of View 0 1 2 3 4
Field Size (cm) 30 27 22 19 15
Procedure X-ray Protocol Patient Type Reference Air Kerma (mGy/image)
Thorax Lungs 2 fps Default 2.446 2.719 3.269 3.950 4.361
Subclavian 3 fps Default 9.046 10.673 10.810 10.972 11.183
Abdomen Abdomen Default 3.824 4.242 5.101 6.198 7.578
3 fps Large Adult, Very 3.317 3.681 4.434 5.398 6.620
Large Adult
Iliac / Pelvis 3 fps Default 7.297 8.108 9.730 11.842 14.472
Peripheral Upper Legs 3 fps Default 6.608 7.334 8.209 8.933 9.781
Lower Legs 1 fps Default 8.229 8.644 9.320 10.125 11.043

Radiography (Exposure) - B12/12 Systems, Lateral Stand

Field of View 0 1 2 3 4
Field Size (cm) 30 27 22 19 15
Procedure X-ray Protocol Patient Type Reference Air Kerma (mGy/image)
Cardio Left Coronary Default 0.117 0.128 0.147 0.172 0.201
15 fps Low
Infant 0.081 0.087 0.097 0.110 0.126
Large Adult, Very 0.117 0.128 0.147 0.172 0.201
Large Adult
Neonate 0.048 0.052 0.061 0.072 0.086
Rotational Scan Default - - - - -
Prop Ang0 4s
Infant - - - - -
Neonate - - - - -
Pediatrics 15 fps Contrast Nor- Default 0.222 0.240 0.276 0.320 0.372
mal
Child, Small Adult 0.131 0.142 0.164 0.191 0.224
Infant 0.081 0.087 0.097 0.110 0.126
Neonate 0.048 0.052 0.061 0.072 0.086
Prop Free Position Default - - - - -
Neonate, Infant - - - - -
EP 15 fps Default 0.131 0.142 0.164 0.191 0.224
Prop 4s Default - - - - -
Neonate, nfant - - - - -
Large Adult, Very - - - - -
Large Adult
EP Mapping 7.5 fps low Default 0.019 0.021 0.024 0.029 0.035
3D EP Prop 4s Default - - - - -
Neonate, Infant - - - - -
Large Adult, Very - - - - -
Large Adult
Head Cerebral 2 fps nor- Default 5.654 6.278 7.554 8.391 9.281
mal
Child 3.491 3.739 4.233 4.860 5.655
Neonate, Infant 3.491 3.739 4.233 4.860 5.655
Aortic Arch 3 fps Default 8.478 9.399 11.276 13.029 13.856
Spine 4 fps Default 1.806 2.011 2.428 2.967 3.648
2 fps Default 2.258 2.517 3.035 3.711 4.557
Thorax Lungs 2 fps Default 2.827 3.142 3.779 4.305 4.760
Subclavian 3 fps Default 10.511 12.386 12.544 12.732 12.977

Azurion Release 2.2 Instructions for Use 367 Philips 4523 001 01511
Technical Information System-Level Information

Field of View 0 1 2 3 4
Field Size (cm) 30 27 22 19 15
Procedure X-ray Protocol Patient Type Reference Air Kerma (mGy/image)
Abdomen Abdomen Default 4.429 4.923 5.908 7.179 8.778
3 fps Large Adult, Very 3.842 4.264 5.131 6.253 7.653
Large Adult
Iliac / Pelvis 3 fps Default 8.449 9.387 11.287 13.710 16.755
Peripheral Upper Legs 3 fps Default 6.048 6.336 6.894 7.585 8.413
Lower Legs 1 fps Default 6.790 7.107 7.707 8.437 9.318

Roadmap - B12/12 Systems, Frontal Stand

Field of View 0 1 2 3 4
Field Size (cm) 30 27 22 19 15
Patient
Procedure Mode Type Reference Air Kerma (mGy/image)
Cardio Navigate Default 0.383 0.486 0.490 0.496 0.503
UnSubtract Default 0.383 0.486 0.490 0.496 0.503
Pediatrics Navigate Default 0.383 0.486 0.490 0.496 0.503
UnSubtract Default 0.383 0.486 0.490 0.496 0.503
EP Navigate Default 0.383 0.486 0.490 0.496 0.503
EP Mapping Navigate Default 0.383 0.486 0.490 0.496 0.503
Head Navigate Default 0.383 0.486 0.490 0.496 0.503
Carotid Default 0.381 0.461 0.465 0.470 0.476
Coil Default 1.818 2.020 2.428 2.951 3.611
Spine UnSubtract Default 0.383 0.486 0.490 0.496 0.503
Navigate Default 0.383 0.486 0.490 0.496 0.503
Stent Default 0.381 0.461 0.465 0.470 0.476
Thorax UnSubtract Default 0.383 0.486 0.490 0.496 0.503
Navigate Default 0.383 0.486 0.490 0.496 0.503
Intervention Default 0.381 0.461 0.465 0.470 0.476
Abdomen UnSubtract Default 0.383 0.486 0.490 0.496 0.503
Navigate Default 0.383 0.486 0.490 0.496 0.503
Stent Default 0.381 0.461 0.465 0.470 0.476
Peripheral UnSubtract Default 0.383 0.486 0.490 0.496 0.503
Navigate Default 0.383 0.486 0.490 0.496 0.503

Roadmap - B12/12 Systems, Lateral Stand

Field of View 0 1 2 3 4
Field Size (cm) 30 27 22 19 15
Patient
Procedure Mode Type Reference Air Kerma (mGy/image)
Cardio Navigate Default 0.434 0.549 0.554 0.560 0.569
UnSubtract Default 0.434 0.549 0.554 0.560 0.569
Pediatrics Navigate Default 0.434 0.549 0.554 0.560 0.569
UnSubtract Default 0.434 0.549 0.554 0.560 0.569
EP Navigate Default 0.434 0.549 0.554 0.560 0.569
EP Mapping Navigate Default 0.434 0.549 0.554 0.560 0.569

Azurion Release 2.2 Instructions for Use 368 Philips 4523 001 01511
Technical Information System-Level Information

Field of View 0 1 2 3 4
Field Size (cm) 30 27 22 19 15
Patient
Procedure Mode Type Reference Air Kerma (mGy/image)
Head Navigate Default 0.434 0.549 0.554 0.560 0.569
Carotid Default 0.423 0.514 0.517 0.524 0.531
Coil Default 2.110 2.344 2.812 3.418 4.181
Spine UnSubtract Default 0.434 0.549 0.554 0.560 0.569
Navigate Default 0.434 0.549 0.554 0.560 0.569
Stent Default 0.423 0.514 0.517 0.524 0.531
Thorax UnSubtract Default 0.434 0.549 0.554 0.560 0.569
Navigate Default 0.434 0.549 0.554 0.560 0.569
Intervention Default 0.423 0.514 0.517 0.524 0.531
Abdomen UnSubtract Default 0.434 0.549 0.554 0.560 0.569
Navigate Default 0.434 0.549 0.554 0.560 0.569
Stent Default 0.423 0.514 0.517 0.524 0.531
Peripheral UnSubtract Default 0.434 0.549 0.554 0.560 0.569
Navigate Default 0.434 0.549 0.554 0.560 0.569

B12/12 Systems with ClarityIQ Option

Radioscopy (Fluoroscopy) - B12/12 Systems with ClarityIQ, Frontal Stand

Field of View 0 1 2 3 4
Field Size (cm) 30 27 22 19 15
Patient
Procedure Flavor Type Reference Air Kerma (mGy/s)
Cardio Clarity Low Default 0.147 0.159 0.184 0.214 0.250
Medium Default 0.217 0.236 0.274 0.322 0.380
Normal Default 0.512 0.553 0.635 0.737 0.858
Cardio Pediatrics Clarity Low Default 0.061 0.066 0.078 0.091 0.109
<40 kg
Medium Default 0.092 0.100 0.116 0.135 0.158
Normal Default 0.144 0.157 0.181 0.211 0.248
Cardio Pediatrics Clarity Low Default 0.061 0.066 0.078 0.091 0.109
>40 kg
Medium Default 0.092 0.100 0.116 0.135 0.158
Normal Default 0.144 0.157 0.181 0.211 0.248
EP Clarity Low Default 0.044 0.047 0.055 0.064 0.073
Medium Default 0.086 0.094 0.109 0.127 0.147
Normal Default 0.106 0.116 0.135 0.159 0.189
EP Mapping Clarity Low Default 0.044 0.047 0.055 0.064 0.073
Medium Default 0.086 0.094 0.109 0.127 0.147
Normal Default 0.106 0.116 0.135 0.159 0.189
Head Clarity Low Default 0.189 0.202 0.229 0.263 0.307
Medium Default 0.306 0.334 0.389 0.447 0.514
Normal Default 0.557 0.604 0.697 0.813 0.951
Spine Clarity Low Default 0.189 0.202 0.229 0.263 0.307
Medium Default 0.306 0.334 0.389 0.447 0.514
Normal Default 0.557 0.604 0.697 0.813 0.951

Azurion Release 2.2 Instructions for Use 369 Philips 4523 001 01511
Technical Information System-Level Information

Field of View 0 1 2 3 4
Field Size (cm) 30 27 22 19 15
Patient
Procedure Flavor Type Reference Air Kerma (mGy/s)
Thorax Clarity Low Default 0.189 0.202 0.229 0.263 0.307
Medium Default 0.306 0.334 0.389 0.447 0.514
Normal Default 0.557 0.604 0.697 0.813 0.951
Abdomen Clarity Low Default 0.189 0.202 0.229 0.263 0.307
Medium Default 0.306 0.334 0.389 0.447 0.514
Normal Default 0.557 0.604 0.697 0.813 0.951
Peripheral Clarity Low Default 0.189 0.202 0.229 0.263 0.307
Medium Default 0.306 0.334 0.389 0.447 0.514
Normal Default 0.557 0.604 0.697 0.813 0.951

Radioscopy (Fluoroscopy) - B12/12 Systems with ClarityIQ, Lateral Stand

Field of View 0 1 2 3 4
Field Size (cm) 30 27 22 19 15
Patient
Procedure Flavor Type Reference Air Kerma (mGy/s)
Cardio Clarity Low Default 0.165 0.180 0.208 0.243 0.286
Medium Default 0.245 0.267 0.309 0.363 0.429
Normal Default 0.575 0.623 0.715 0.829 0.968
Cardio Pediatrics Clarity Low Default 0.069 0.075 0.087 0.103 0.123
<40 kg
Medium Default 0.104 0.114 0.132 0.155 0.181
Normal Default 0.163 0.177 0.205 0.241 0.285
Cardio Pediatrics Clarity Low Default 0.069 0.075 0.087 0.103 0.123
>40 kg
Medium Default 0.104 0.114 0.132 0.155 0.181
Normal Default 0.163 0.177 0.205 0.241 0.285
EP Clarity Low Default 0.050 0.054 0.063 0.073 0.086
Medium Default 0.101 0.110 0.127 0.149 0.174
Normal Default 0.120 0.131 0.153 0.180 0.214
EP Mapping Clarity Low Default 0.050 0.054 0.063 0.073 0.086
Medium Default 0.101 0.110 0.127 0.149 0.174
Normal Default 0.120 0.131 0.153 0.180 0.214
Head Clarity Low Default 0.213 0.230 0.264 0.308 0.360
Medium Default 0.346 0.377 0.436 0.503 0.585
Normal Default 0.628 0.682 0.787 0.918 1.076
Spine Clarity Low Default 0.213 0.230 0.264 0.308 0.360
Medium Default 0.346 0.377 0.436 0.503 0.585
Normal Default 0.628 0.682 0.787 0.918 1.076
Thorax Clarity Low Default 0.213 0.230 0.264 0.308 0.360
Medium Default 0.346 0.377 0.436 0.503 0.585
Normal Default 0.628 0.682 0.787 0.918 1.076
Abdomen Clarity Low Default 0.213 0.230 0.264 0.308 0.360
Medium Default 0.346 0.377 0.436 0.503 0.585
Normal Default 0.628 0.682 0.787 0.918 1.076

Azurion Release 2.2 Instructions for Use 370 Philips 4523 001 01511
Technical Information System-Level Information

Field of View 0 1 2 3 4
Field Size (cm) 30 27 22 19 15
Patient
Procedure Flavor Type Reference Air Kerma (mGy/s)
Peripheral Clarity Low Default 0.213 0.230 0.264 0.308 0.360
Medium Default 0.346 0.377 0.436 0.503 0.585
Normal Default 0.628 0.682 0.787 0.918 1.076

Radiography (Exposure) - B12/12 Systems with ClarityIQ, Frontal Stand

Field of View 0 1 2 3 4
Field Size (cm) 30 27 22 19 15
Procedure X-ray Protocol Patient Type Reference Air Kerma (mGy/image)
Cardio Clarity Left Coronary 15 Default 0.037 0.040 0.047 0.055 0.065
fps Low
Rotational Scan Default 0.195 0.212 0.244 0.282 0.329
Prop Ang0 4s
Infant 0.063 0.068 0.078 0.090 0.106
Neonate 0.040 0.044 0.051 0.062 0.074
Cardio Pediatrics 15 fps Contrast low Default 0.019 0.020 0.023 0.028 0.032
Clarity <40 kg
15 fps Contrast nor- Default 0.030 0.033 0.039 0.046 0.055
mal
Cardio Pediatrics 15 fps Contrast low Default 0.037 0.040 0.047 0.055 0.065
Clarity >40 kg
Neonate, Infant, 0.019 0.020 0.023 0.028 0.032
Child
15 fps Contrast nor- Default 0.077 0.084 0.097 0.113 0.133
mal
Neonate, Infant, 0.030 0.033 0.039 0.046 0.055
Child
EP Clarity 15 fps Default 0.037 0.040 0.047 0.055 0.065
Prop 4s Default 0.228 0.231 0.235 0.240 0.246
Neonate, Infant 0.148 0.150 0.152 0.156 0.161
Large Adult, Very 0.228 0.231 0.235 0.240 0.246
Large Adult
EP Mapping Clarity 7.5 fps Default 0.037 0.040 0.047 0.055 0.065
3D EP Prop 4s Default 0.228 0.231 0.235 0.240 0.246
Neonate, Infant 0.148 0.150 0.152 0.156 0.161
Large Adult, Very 0.228 0.231 0.235 0.240 0.246
Large Adult
Head Clarity Cerebral 2 fps low Default 0.990 1.099 1.318 1.602 1.953
Aortic Arch 3 fps Default 1.423 1.580 1.895 2.305 2.810
Spine Clarity 4 fps Default 1.133 1.260 1.519 1.852 2.273
2 fps Default 1.134 1.260 1.518 1.853 2.273
Thorax Clarity Lungs 2 fps Default 1.221 1.357 1.630 1.986 2.432
Subclavian 3 fps Default 1.722 1.912 2.289 2.774 3.378
Abdomen Clarity 3 fps low Default 0.797 0.884 1.060 1.285 1.569
Iliac / Pelvis 3 fps Default 3.890 4.322 5.202 6.340 7.138
Peripheral Clarity Upper Legs 3 fps Default 1.128 1.254 1.502 1.688 1.903
Lower Legs 1 fps Default 2.064 2.285 2.732 3.302 4.006

Azurion Release 2.2 Instructions for Use 371 Philips 4523 001 01511
Technical Information System-Level Information

Radiography (Exposure) - B12/12 Systems with ClarityIQ, Lateral Stand

Field of View 0 1 2 3 4
Field Size (cm) 30 27 22 19 15
Procedure X-ray Protocol Patient Type Reference Air Kerma (mGy/image)
Cardio Clarity Left Coronary 15 Default 0.042 0.045 0.053 0.062 0.073
fps Low
Rotational Scan Default - - - - -
Prop Ang0 4s
Infant - - - - -
Neonate - - - - -
Cardio Pediatrics 15 fps Contrast low Default 0.021 0.023 0.026 0.031 0.036
Clarity <40 kg
15 fps Contrast nor- Default 0.034 0.037 0.044 0.052 0.061
mal
Cardio Pediatrics 15 fps Contrast low Default 0.042 0.045 0.053 0.062 0.073
Clarity >40 kg
Neonate, Infant, 0.021 0.023 0.026 0.031 0.036
Child
15 fps Contrast nor- Default 0.087 0.095 0.110 0.128 0.150
mal
Neonate, Infant, 0.034 0.037 0.044 0.052 0.061
Child
EP Clarity 15 fps Default 0.042 0.045 0.053 0.062 0.073
Prop 4s Default - - - - -
Neonate, Infant - - - - -
Large Adult, Very - - - - -
Large Adult
EP Mapping Clarity 7.5 fps Default 0.042 0.045 0.053 0.062 0.073
3D EP Prop 4s Default - - - - -
Neonate, Infant - - - - -
Large Adult, Very - - - - -
Large Adult
Head Clarity Cerebral 2 fps low Default 1.143 1.269 1.524 1.849 2.258
Aortic Arch 3 fps Default 1.646 1.827 2.192 2.660 3.250
Spine Clarity 4 fps Default 1.250 1.387 1.673 2.039 2.502
2 fps Default 1.248 1.388 1.672 2.040 2.500
Thorax Clarity Lungs 2 fps Default 1.410 1.567 1.882 2.292 2.804
Subclavian 3 fps Default 1.993 2.210 2.647 3.203 3.901
Abdomen Clarity 3 fps low Default 0.921 1.022 1.225 1.486 1.813
Iliac / Pelvis 3 fps Default 3.984 4.435 5.339 6.520 7.354
Peripheral Clarity Upper Legs 3 fps Default 1.304 1.445 1.662 1.862 2.102
Lower Legs 1 fps Default 2.391 2.645 3.161 3.816 4.503

Roadmap - B12/12 Systems with ClarityIQ, Frontal Stand

Field of View 0 1 2 3 4
Field Size (cm) 30 27 22 19 15
Patient
Procedure Mode Type Reference Air Kerma (mGy/image)
Cardio Clarity Navigate Default 0.175 0.188 0.213 0.243 0.279
UnSubtract Default 0.175 0.188 0.213 0.243 0.279
Cardio Pediatrics Clari- Navigate Default 0.175 0.188 0.213 0.243 0.279
ty <40 kg
UnSubtract Default 0.175 0.188 0.213 0.243 0.279

Azurion Release 2.2 Instructions for Use 372 Philips 4523 001 01511
Technical Information System-Level Information

Field of View 0 1 2 3 4
Field Size (cm) 30 27 22 19 15
Patient
Procedure Mode Type Reference Air Kerma (mGy/image)
Cardio Pediatrics Clari- Navigate Default 0.175 0.188 0.213 0.243 0.279
ty >40 kg
UnSubtract Default 0.175 0.188 0.213 0.243 0.279
EP Clarity Navigate Default 0.175 0.188 0.213 0.243 0.279
UnSubtract Default 0.175 0.188 0.213 0.243 0.279
EP Mapping Clarity Navigate Default 0.175 0.188 0.213 0.243 0.279
UnSubtract Default 0.175 0.188 0.213 0.243 0.279
Head Clarity Navigate Default 0.175 0.188 0.213 0.243 0.279
Coil Default 0.335 0.372 0.447 0.542 0.661
Unsubtract Default 0.175 0.188 0.213 0.243 0.279
Spine Clarity Navigate Default 0.175 0.188 0.213 0.243 0.279
Coil Default 0.236 0.262 0.314 0.382 0.467
Unsubtract Default 0.175 0.188 0.213 0.243 0.279
Thorax Clarity UnSubtract Default 0.175 0.188 0.213 0.243 0.279
Navigate Default 0.175 0.188 0.213 0.243 0.279
Abdomen Clarity UnSubtract Default 0.175 0.188 0.213 0.243 0.279
Navigate Default 0.175 0.188 0.213 0.243 0.279
Peripheral Clarity UnSubtract Default 0.175 0.188 0.213 0.243 0.279
Navigate Default 0.175 0.188 0.213 0.243 0.279

Roadmap - B12/12 Systems with ClarityIQ, Lateral Stand

Field of View 0 1 2 3 4
Field Size (cm) 30 27 22 19 15
Patient
Procedure Mode Type Reference Air Kerma (mGy/image)
Cardio Clarity Navigate Default 0.196 0.210 0.238 0.272 0.313
UnSubtract Default 0.196 0.210 0.238 0.272 0.313
Cardio Pediatrics Clari- Navigate Default 0.196 0.210 0.238 0.272 0.313
ty <40 kg
UnSubtract Default 0.196 0.210 0.238 0.272 0.313
Cardio Pediatrics Clari- Navigate Default 0.196 0.210 0.238 0.272 0.313
ty >40 kg
UnSubtract Default 0.196 0.210 0.238 0.272 0.313
EP Clarity Navigate Default 0.196 0.210 0.238 0.272 0.313
UnSubtract Default 0.196 0.210 0.238 0.272 0.313
EP Mapping Clarity Navigate Default 0.196 0.210 0.238 0.272 0.313
UnSubtract Default 0.196 0.210 0.238 0.272 0.313
Head Clarity Navigate Default 0.196 0.210 0.238 0.272 0.313
Coil Default 0.387 0.429 0.516 0.626 0.764
Unsubtract Default 0.196 0.210 0.238 0.272 0.313
Spine Clarity Navigate Default 0.196 0.210 0.238 0.272 0.313
Coil Default 0.387 0.429 0.516 0.626 0.764
Unsubtract Default 0.196 0.210 0.238 0.272 0.313
Thorax Clarity UnSubtract Default 0.196 0.210 0.238 0.272 0.313
Navigate Default 0.196 0.210 0.238 0.272 0.313

Azurion Release 2.2 Instructions for Use 373 Philips 4523 001 01511
Technical Information System-Level Information

Field of View 0 1 2 3 4
Field Size (cm) 30 27 22 19 15
Patient
Procedure Mode Type Reference Air Kerma (mGy/image)
Abdomen Clarity UnSubtract Default 0.196 0.210 0.238 0.272 0.313
Navigate Default 0.196 0.210 0.238 0.272 0.313
Peripheral Clarity UnSubtract Default 0.196 0.210 0.238 0.272 0.313
Navigate Default 0.196 0.210 0.238 0.272 0.313

B20/12 Systems

Radioscopy (Fluoroscopy) - B20/12 Systems, Frontal Stand

Field of View 0 1 2 3 4 5 6 7
Field Size (cm) 48 42 37 31 27 22 19 15
Patient
Procedure Flavor Type Reference Air Kerma (mGy/s)
Cardio Low Default 0.125 0.158 0.174 0.201 0.232 0.274 0.314 0.379
Norm Default 0.338 0.412 0.447 0.503 0.567 0.651 0.731 0.847
High Default 0.423 0.521 0.568 0.643 0.730 0.842 0.951 1.112
Pediatrics Low Default 0.115 0.144 0.158 0.181 0.208 0.243 0.278 0.315
Norm Default 0.253 0.313 0.343 0.390 0.443 0.501 0.557 0.645
High Default 0.428 0.514 0.553 0.615 0.663 0.724 0.782 0.871
EP Low Default 0.059 0.075 0.082 0.093 0.104 0.118 0.136 0.149
Norm Default 0.130 0.162 0.178 0.203 0.243 0.273 0.331 0.375
High Default 0.151 0.191 0.211 0.244 0.282 0.332 0.381 0.460
EP Mapping Low Default 0.030 0.037 0.041 0.046 0.053 0.060 0.070 0.077
Norm Default 0.065 0.081 0.089 0.102 0.121 0.136 0.166 0.187
High Default 0.076 0.096 0.105 0.122 0.141 0.166 0.191 0.230
Head Low Default 0.140 0.175 0.192 0.221 0.254 0.288 0.321 0.354
Norm Default 0.285 0.353 0.386 0.439 0.518 0.602 0.667 0.737
High Default 0.462 0.567 0.618 0.700 0.796 0.921 1.040 1.203
Spine Low Default 0.140 0.175 0.192 0.221 0.254 0.288 0.321 0.354
Norm Default 0.285 0.353 0.386 0.439 0.518 0.602 0.667 0.737
High Default 0.462 0.567 0.618 0.700 0.796 0.921 1.040 1.203
Thorax Low Default 0.140 0.175 0.192 0.221 0.254 0.288 0.321 0.354
Norm Default 0.285 0.353 0.386 0.439 0.518 0.602 0.667 0.737
High Default 0.462 0.567 0.618 0.700 0.796 0.921 1.040 1.203
Abdomen Low Default 0.140 0.175 0.192 0.221 0.254 0.288 0.321 0.354
Norm Default 0.285 0.353 0.386 0.439 0.518 0.602 0.667 0.737
High Default 0.462 0.567 0.618 0.700 0.796 0.921 1.040 1.203
Peripheral Low Default 0.140 0.175 0.192 0.221 0.254 0.288 0.321 0.354
Norm Default 0.285 0.353 0.386 0.439 0.518 0.602 0.667 0.737
High Default 0.462 0.567 0.618 0.700 0.796 0.921 1.040 1.203

Azurion Release 2.2 Instructions for Use 374 Philips 4523 001 01511
Technical Information System-Level Information

Radioscopy (Fluoroscopy) - B20/12 Systems, Lateral Stand

Field of View 0 1 2 3 4
Field Size (cm) 30 27 22 19 15
Patient
Procedure Flavor Type Reference Air Kerma (mGy/s)
Cardio Low Default 0.337 0.366 0.428 0.504 0.594
Norm Default 0.672 0.878 1.118 1.118 1.118
High Default 0.936 0.983 1.152 1.323 1.525
Pediatrics Low Default 0.264 0.287 0.331 0.385 0.449
Norm Default 0.608 0.642 0.732 0.827 0.937
High Default 0.882 0.933 1.013 1.108 1.213
EP Low Default 0.132 0.144 0.166 0.193 0.224
Norm Default 0.302 0.328 0.379 0.441 0.516
High Default 0.353 0.382 0.440 0.512 0.602
EP Mapping Low Default 0.066 0.072 0.084 0.099 0.116
Norm Default 0.151 0.164 0.189 0.221 0.258
High Default 0.176 0.191 0.220 0.256 0.301
Head Low Default 0.293 0.402 0.456 0.456 0.456
Norm Default 0.633 0.678 0.761 0.861 0.976
High Default 1.000 1.080 1.236 1.424 1.643
Spine Low Default 0.293 0.402 0.456 0.456 0.456
Norm Default 0.633 0.678 0.761 0.861 0.976
High Default 1.000 1.080 1.236 1.424 1.643
Thorax Low Default 0.293 0.402 0.456 0.456 0.456
Norm Default 0.633 0.678 0.761 0.861 0.976
High Default 1.000 1.080 1.236 1.424 1.643
Abdomen Low Default 0.293 0.402 0.456 0.456 0.456
Norm Default 0.633 0.678 0.761 0.861 0.976
High Default 1.000 1.080 1.236 1.424 1.643
Peripheral Low Default 0.293 0.402 0.456 0.456 0.456
Norm Default 0.633 0.678 0.761 0.861 0.976
High Default 1.000 1.080 1.236 1.424 1.643

Azurion Release 2.2 Instructions for Use 375 Philips 4523 001 01511
Technical Information System-Level Information

Radiography (Exposure) - B20/12 Systems, Frontal Stand

Field of View 0 1 2 3 4 5 6 7
Field Size (cm) 48 42 37 31 27 22 19 15
X-ray Pro-
Procedure tocol Patient Type Reference Air Kerma (mGy/image)
Cardio Left Coro- Default 0.061 0.076 0.083 0.095 0.108 0.125 0.142 0.168
nary
15 fps Low Infant 0.046 0.054 0.058 0.064 0.071 0.081 0.090 0.104
Large Adult, 0.060 0.075 0.082 0.093 0.107 0.124 0.141 0.166
Very Large
Adult
Neonate 0.025 0.032 0.035 0.040 0.046 0.054 0.063 0.076
Rotational Default 0.116 0.143 0.157 0.179 0.204 0.236 0.267 0.314
Scan
Prop Ang0 Infant 0.039 0.048 0.052 0.058 0.066 0.076 0.086 0.101
4s
Neonate 0.025 0.032 0.035 0.040 0.046 0.054 0.063 0.076
Pediatrics 15 fps Con- Default 0.118 0.146 0.160 0.181 0.206 0.238 0.269 0.317
trast Nor-
Child, Small 0.069 0.086 0.094 0.107 0.123 0.142 0.161 0.188
mal
Adult
Infant 0.039 0.048 0.052 0.058 0.066 0.076 0.086 0.101
Neonate 0.025 0.032 0.035 0.040 0.046 0.054 0.063 0.076
Prop Free Default 0.114 0.142 0.155 0.177 0.202 0.234 0.265 0.314
Position
Neonate, In- 0.027 0.033 0.036 0.041 0.047 0.054 0.062 0.074
fant
EP 15 fps Default 0.069 0.086 0.094 0.107 0.123 0.142 0.161 0.188
Prop 4s Default 0.141 0.180 0.225 0.225 0.225 0.225 0.225 0.225
Neonate, In- 0.094 0.121 0.153 0.153 0.153 0.153 0.153 0.153
fant
Large Adult, 0.141 0.180 0.225 0.225 0.225 0.225 0.225 0.225
Very Large
Adult
EP Map- 7.5 fps low Default 0.011 0.014 0.015 0.017 0.019 0.022 0.025 0.028
ping
3D EP Prop Default 0.141 0.180 0.225 0.225 0.225 0.225 0.225 0.225
4s
Neonate, In- 0.094 0.121 0.153 0.153 0.153 0.153 0.153 0.153
fant
Large Adult, 0.141 0.180 0.225 0.225 0.225 0.225 0.225 0.225
Very Large
Adult
Head Cerebral 2 Default 2.856 3.713 4.139 4.848 5.711 6.852 7.867 8.549
fps normal
Child 1.839 2.207 2.384 2.677 3.022 3.482 3.945 4.534
Neonate, In- 1.839 2.207 2.384 2.677 3.022 3.482 3.945 4.534
fant
Aortic Arch Default 4.232 5.502 6.139 7.198 8.155 8.155 8.155 8.155
3 fps
Spine 4 fps Default 1.197 1.555 1.734 2.034 2.390 2.870 3.350 4.127
2 fps Default 1.495 1.944 2.168 2.540 2.993 3.591 4.184 5.163
Thorax Lungs 2 fps Default 1.427 1.857 2.068 2.426 2.677 2.938 3.189 3.492
Subclavian Default 5.136 6.669 7.447 8.718 10.268 11.183 11.737 12.575
3 fps

Azurion Release 2.2 Instructions for Use 376 Philips 4523 001 01511
Technical Information System-Level Information

Field of View 0 1 2 3 4 5 6 7
Field Size (cm) 48 42 37 31 27 22 19 15
X-ray Pro-
Procedure tocol Patient Type Reference Air Kerma (mGy/image)
Abdomen Abdomen Default 2.619 3.406 3.801 4.455 5.243 6.296 7.334 7.334
3 fps Large Adult, 2.306 2.995 3.342 3.922 4.613 5.530 6.457 7.953
Very Large
Adult
Iliac / Pel- Default 4.262 5.538 6.173 7.243 8.517 10.218 11.918 14.041
vis 3 fps
Peripheral Upper Legs Default 3.690 4.793 5.292 5.691 6.142 6.705 7.241 7.869
3 fps
Lower Legs Default 4.509 5.620 5.922 6.361 6.850 7.454 8.029 8.708
1 fps

Radiography (Exposure) - B20/12 Systems, Lateral Stand

Field of View 0 1 2 3 4
Field Size (cm) 30 27 22 19 15
Procedure X-ray Protocol Patient Type Reference Air Kerma (mGy/image)
Cardio Left Coronary Default 0.137 0.148 0.170 0.197 0.227
15 fps Low Infant 0.095 0.101 0.113 0.128 0.145
Large Adult, Very 0.138 0.148 0.170 0.196 0.227
Large Adult
Neonate 0.063 0.068 0.078 0.091 0.107
Rotational Scan Default - - - - -
Prop Ang0 4s Infant - - - - -
Neonate - - - - -
Pediatrics 15 fps Contrast Default 0.252 0.271 0.310 0.356 0.408
Normal
Child, Small Adult 0.153 0.166 0.189 0.219 0.253
Infant 0.095 0.101 0.113 0.128 0.145
Neonate 0.063 0.068 0.078 0.091 0.107
Prop Free Position Default - - - - -
Neonate, Infant - - - - -
EP 15 fps Default 0.153 0.166 0.189 0.219 0.253
Prop 4s Default - - - - -
Neonate, Infant - - - - -
Large Adult, Very - - - - -
Large Adult
EP Mapping 7.5 fps low Default 0.024 0.027 0.031 0.036 0.042
3D EP Prop 4s Default - - - - -
Neonate, Infant - - - - -
Large Adult, Very - - - - -
Large Adult
Head Cerebral 2 fps nor- Default 7.227 7.589 8.276 9.092 10.049
mal
Child 4.242 4.550 5.153 5.904 6.819
Neonate, Infant 4.242 4.550 5.153 5.904 6.819
Aortic Arch 3 fps Default 10.577 11.581 12.244 13.006 13.861
Spine 4 fps Default 2.441 2.684 3.173 3.783 4.519
2 fps Default 3.050 3.352 3.962 4.729 5.646

Azurion Release 2.2 Instructions for Use 377 Philips 4523 001 01511
Technical Information System-Level Information

Field of View 0 1 2 3 4
Field Size (cm) 30 27 22 19 15
Procedure X-ray Protocol Patient Type Reference Air Kerma (mGy/image)
Thorax Lungs 2 fps Default 3.692 3.915 4.264 4.683 5.161
Subclavian 3 fps Default 12.819 14.979 14.979 14.979 14.979
Abdomen Abdomen Default 5.656 6.215 7.351 8.767 10.456
3 fps Large Adult, Very 4.985 5.485 6.475 7.726 9.217
Large Adult
Iliac / Pelvis 3 fps Default 10.803 11.882 14.028 16.732 19.956
Peripheral Upper Legs 3 fps Default 6.762 7.096 7.749 8.528 9.433
Lower Legs 1 fps Default 7.254 7.608 8.292 9.091 10.024

Roadmap - B20/12 Systems, Frontal Stand

Field of View 0 1 2 3 4 5 6 7
Field Size (cm) 48 42 37 31 27 22 19 15
Patient
Procedure Mode Type Reference Air Kerma (mGy/image)
Cardio Navigate Default 0.233 0.287 0.313 0.356 0.405 0.466 0.496 0.496
UnSubtract Default 0.233 0.287 0.313 0.356 0.405 0.466 0.496 0.496
Pediatrics Navigate Default 0.233 0.287 0.313 0.356 0.405 0.466 0.496 0.496
UnSubtract Default 0.233 0.287 0.313 0.356 0.405 0.466 0.496 0.496
EP Navigate Default 0.233 0.287 0.313 0.356 0.405 0.466 0.496 0.496
EP Map- Navigate Default 0.233 0.287 0.313 0.356 0.405 0.466 0.496 0.496
ping
Head Navigate Default 0.233 0.287 0.313 0.356 0.405 0.466 0.496 0.496
Carotid Default 0.201 0.240 0.258 0.287 0.320 0.363 0.383 0.383
Coil Default 1.065 1.383 1.544 1.810 2.129 2.553 2.984 3.670
Spine UnSubtract Default 0.233 0.287 0.313 0.356 0.405 0.466 0.496 0.496
Navigate Default 0.233 0.287 0.313 0.356 0.405 0.466 0.496 0.496
Stent Default 0.201 0.240 0.258 0.287 0.320 0.363 0.383 0.383
Thorax UnSubtract Default 0.233 0.287 0.313 0.356 0.405 0.466 0.496 0.496
Navigate Default 0.233 0.287 0.313 0.356 0.405 0.466 0.496 0.496
Interven- Default 0.201 0.240 0.258 0.287 0.320 0.363 0.383 0.383
tion
Abdomen UnSubtract Default 0.233 0.287 0.313 0.356 0.405 0.466 0.496 0.496
Navigate Default 0.233 0.287 0.313 0.356 0.405 0.466 0.496 0.496
Stent Default 0.201 0.240 0.258 0.287 0.320 0.363 0.383 0.383
Peripheral UnSubtract Default 0.233 0.287 0.313 0.356 0.405 0.466 0.496 0.496
Navigate Default 0.233 0.287 0.313 0.356 0.405 0.466 0.496 0.496

Roadmap - B20/12 Systems, Lateral Stand

Field of View 0 1 2 3 4
Field Size (cm) 30 27 22 19 15
Procedure Mode Patient Type Reference Air Kerma (mGy/image)
Cardio Navigate Default 0.493 0.623 0.623 0.623 0.623
UnSubtract Default 0.493 0.623 0.623 0.623 0.623

Azurion Release 2.2 Instructions for Use 378 Philips 4523 001 01511
Technical Information System-Level Information

Field of View 0 1 2 3 4
Field Size (cm) 30 27 22 19 15
Procedure Mode Patient Type Reference Air Kerma (mGy/image)
Pediatrics Navigate Default 0.493 0.623 0.623 0.623 0.623
UnSubtract Default 0.493 0.623 0.623 0.623 0.623
EP Navigate Default 0.493 0.623 0.623 0.623 0.623
EP Mapping Navigate Default 0.493 0.623 0.623 0.623 0.623
Head Navigate Default 0.493 0.623 0.623 0.623 0.623
Carotid Default 0.464 0.567 0.567 0.567 0.567
Coil Default 2.691 2.963 3.501 4.172 4.983
Spine UnSubtract Default 0.493 0.623 0.623 0.623 0.623
Navigate Default 0.493 0.623 0.623 0.623 0.623
Stent Default 0.464 0.567 0.567 0.567 0.567
Thorax UnSubtract Default 0.493 0.623 0.623 0.623 0.623
Navigate Default 0.493 0.623 0.623 0.623 0.623
Intervention Default 0.464 0.567 0.567 0.567 0.567
Abdomen UnSubtract Default 0.493 0.623 0.623 0.623 0.623
Navigate Default 0.493 0.623 0.623 0.623 0.623
Stent Default 0.464 0.567 0.567 0.567 0.567
Peripheral UnSubtract Default 0.493 0.623 0.623 0.623 0.623
Navigate Default 0.493 0.623 0.623 0.623 0.623

B20/12 Systems with ClarityIQ Option

Radioscopy (Fluoroscopy) - B20/12 Systems with ClarityIQ, Frontal Stand

Field of View 0 1 2 3 4 5 6 7
Field Size (cm) 48 42 37 31 27 22 19 15
Patient
Procedure Flavor Type Reference Air Kerma (mGy/s)
Cardio Clarity Low Default 0.089 0.111 0.121 0.138 0.157 0.181 0.205 0.241
Medium Default 0.134 0.166 0.182 0.208 0.238 0.278 0.316 0.377
Normal Default 0.313 0.385 0.419 0.474 0.537 0.620 0.701 0.827
Cardio Pedia- Low Default 0.039 0.048 0.053 0.060 0.069 0.080 0.091 0.109
trics Clarity <40
Medium Default 0.057 0.071 0.078 0.089 0.103 0.120 0.137 0.159
kg
Normal Default 0.087 0.108 0.118 0.135 0.155 0.179 0.203 0.240
Cardio Pedia- Low Default 0.039 0.048 0.053 0.060 0.069 0.080 0.091 0.109
trics Clarity >40
Medium Default 0.057 0.071 0.078 0.089 0.103 0.120 0.137 0.159
kg
Normal Default 0.087 0.108 0.118 0.135 0.155 0.179 0.203 0.240
EP Clarity Low Default 0.035 0.035 0.035 0.040 0.046 0.053 0.059 0.068
Medium Default 0.070 0.070 0.070 0.079 0.090 0.105 0.117 0.136
Normal Default 0.090 0.090 0.090 0.102 0.118 0.138 0.158 0.189
EP Mapping Low Default 0.035 0.035 0.035 0.040 0.046 0.053 0.059 0.068
Clarity
Medium Default 0.070 0.070 0.070 0.079 0.090 0.105 0.117 0.136
Normal Default 0.090 0.090 0.090 0.102 0.118 0.138 0.158 0.189

Azurion Release 2.2 Instructions for Use 379 Philips 4523 001 01511
Technical Information System-Level Information

Field of View 0 1 2 3 4 5 6 7
Field Size (cm) 48 42 37 31 27 22 19 15
Patient
Procedure Flavor Type Reference Air Kerma (mGy/s)
Head Clarity Low Default 0.123 0.148 0.160 0.178 0.208 0.244 0.273 0.305
Medium Default 0.187 0.234 0.256 0.294 0.346 0.402 0.445 0.493
Normal Default 0.330 0.409 0.447 0.509 0.580 0.672 0.762 0.905
Spine Clarity Low Default 0.123 0.148 0.160 0.178 0.208 0.244 0.273 0.305
Medium Default 0.187 0.234 0.256 0.294 0.346 0.402 0.445 0.493
Normal Default 0.330 0.409 0.447 0.509 0.580 0.672 0.762 0.905
Thorax Clarity Low Default 0.123 0.148 0.160 0.178 0.208 0.244 0.273 0.305
Medium Default 0.187 0.234 0.256 0.294 0.346 0.402 0.445 0.493
Normal Default 0.330 0.409 0.447 0.509 0.580 0.672 0.762 0.905
Abdomen Clari- Low Default 0.123 0.148 0.160 0.178 0.208 0.244 0.273 0.305
ty
Medium Default 0.187 0.234 0.256 0.294 0.346 0.402 0.445 0.493
Normal Default 0.330 0.409 0.447 0.509 0.580 0.672 0.762 0.905
Peripheral Low Default 0.123 0.148 0.160 0.178 0.208 0.244 0.273 0.305
Clarity
Medium Default 0.187 0.234 0.256 0.294 0.346 0.402 0.445 0.493
Normal Default 0.330 0.409 0.447 0.509 0.580 0.672 0.762 0.905

Radioscopy (Fluoroscopy) - B20/12 Systems with ClarityIQ, Lateral Stand

Field of View 0 1 2 3 4
Field Size (cm) 30 27 22 19 15
Patient
Procedure Flavor Type Reference Air Kerma (mGy/s)
Cardio Clarity Low Default 0.200 0.217 0.249 0.288 0.333
Medium Default 0.300 0.325 0.374 0.434 0.505
Normal Default 0.673 0.726 0.827 0.952 1.095
Cardio Pediatrics Clarity Low Default 0.087 0.095 0.109 0.127 0.148
<40 kg
Medium Default 0.130 0.141 0.160 0.183 0.211
Normal Default 0.198 0.215 0.247 0.287 0.333
Cardio Pediatrics Clarity Low Default 0.087 0.095 0.109 0.127 0.148
>40 kg
Medium Default 0.130 0.141 0.160 0.183 0.211
Normal Default 0.198 0.215 0.247 0.287 0.333
EP Clarity Low Default 0.061 0.066 0.076 0.086 0.097
Medium Default 0.124 0.134 0.154 0.174 0.198
Normal Default 0.148 0.161 0.186 0.217 0.253
EP Mapping Clarity Low Default 0.061 0.066 0.076 0.086 0.097
Medium Default 0.124 0.134 0.154 0.174 0.198
Normal Default 0.148 0.161 0.186 0.217 0.253
Head Clarity Low Default 0.267 0.287 0.327 0.375 0.432
Medium Default 0.429 0.461 0.522 0.599 0.687
Normal Default 0.744 0.804 0.921 1.062 1.230
Spine Clarity Low Default 0.267 0.287 0.327 0.375 0.432
Medium Default 0.429 0.461 0.522 0.599 0.687
Normal Default 0.744 0.804 0.921 1.062 1.230

Azurion Release 2.2 Instructions for Use 380 Philips 4523 001 01511
Technical Information System-Level Information

Field of View 0 1 2 3 4
Field Size (cm) 30 27 22 19 15
Patient
Procedure Flavor Type Reference Air Kerma (mGy/s)
Thorax Clarity Low Default 0.267 0.287 0.327 0.375 0.432
Medium Default 0.429 0.461 0.522 0.599 0.687
Normal Default 0.744 0.804 0.921 1.062 1.230
Abdomen Clarity Low Default 0.267 0.287 0.327 0.375 0.432
Medium Default 0.429 0.461 0.522 0.599 0.687
Normal Default 0.744 0.804 0.921 1.062 1.230
Peripheral Clarity Low Default 0.267 0.287 0.327 0.375 0.432
Medium Default 0.429 0.461 0.522 0.599 0.687
Normal Default 0.744 0.804 0.921 1.062 1.230

Radiography (Exposure) - B20/12 Systems with ClarityIQ, Frontal Stand

Field of View 0 1 2 3 4 5 6 7
Field Size (cm) 48 42 37 31 27 22 19 15
X-ray Proto-
Procedure col Patient Type Reference Air Kerma (mGy/image)
Cardio Clari- Left Coro- Default 0.022 0.027 0.030 0.034 0.039 0.046 0.053 0.063
ty nary 15 fps
Low
Rotational Default 0.118 0.146 0.159 0.181 0.206 0.239 0.269 0.317
Scan Prop
Infant 0.039 0.048 0.052 0.058 0.066 0.076 0.086 0.101
Ang0 4s
Neonate 0.025 0.032 0.035 0.040 0.046 0.054 0.063 0.076
Cardio Pe- 15 fps Con- Default 0.012 0.015 0.016 0.018 0.021 0.024 0.027 0.032
diatrics Clari- trast low
ty <40 kg
15 fps Con- Default 0.018 0.023 0.025 0.029 0.034 0.040 0.045 0.052
trast normal
Cardio Pe- 15 fps Con- Default 0.022 0.027 0.030 0.034 0.039 0.046 0.053 0.063
diatrics Clari- trast low
Neonate, In- 0.012 0.015 0.016 0.018 0.021 0.024 0.027 0.032
ty >40 kg
fant, Child
15 fps Con- Default 0.047 0.058 0.064 0.073 0.083 0.097 0.110 0.130
trast normal
Neonate, In- 0.018 0.023 0.025 0.029 0.034 0.040 0.045 0.052
fant, Child
EP Clarity 15 fps Default 0.022 0.027 0.030 0.034 0.039 0.046 0.053 0.063
Prop 4s Default 0.141 0.180 0.225 0.225 0.225 0.225 0.225 0.225
Neonate, In- 0.094 0.121 0.153 0.153 0.153 0.153 0.153 0.153
fant
Large Adult, 0.141 0.180 0.225 0.225 0.225 0.225 0.225 0.225
Very Large
Adult
EP Mapping 7.5 fps Default 0.022 0.027 0.030 0.034 0.039 0.046 0.053 0.063
Clarity
3D EP Prop Default 0.141 0.180 0.225 0.225 0.225 0.225 0.225 0.225
4s
Neonate, In- 0.094 0.121 0.153 0.153 0.153 0.153 0.153 0.153
fant
Large Adult, 0.141 0.180 0.225 0.225 0.225 0.225 0.225 0.225
Very Large
Adult

Azurion Release 2.2 Instructions for Use 381 Philips 4523 001 01511
Technical Information System-Level Information

Field of View 0 1 2 3 4 5 6 7
Field Size (cm) 48 42 37 31 27 22 19 15
X-ray Proto-
Procedure col Patient Type Reference Air Kerma (mGy/image)
Head Clarity Cerebral 2 Default 0.570 0.741 0.827 0.969 1.141 1.367 1.595 1.882
fps low
Aortic Arch 3 Default 0.815 1.059 1.181 1.385 1.629 1.956 2.280 2.689
fps
Spine Clarity 4 fps Default 0.672 0.875 0.975 1.142 1.345 1.614 1.883 2.221
2 fps Default 0.673 0.875 0.974 1.142 1.344 1.612 1.882 2.221
Thorax Clari- Lungs 2 fps Default 0.713 0.928 1.036 1.213 1.429 1.713 1.999 2.355
ty
Subclavian 3 Default 0.965 1.254 1.398 1.639 1.928 2.313 2.699 3.180
fps
Abdomen 3 fps low Default 0.748 0.972 1.084 1.272 1.497 1.793 2.095 2.465
Clarity
Iliac / Pelvis Default 0.714 0.927 1.034 1.214 1.428 1.714 1.998 2.356
3 fps
Peripheral Upper Legs 3 Default 0.631 0.802 0.868 0.973 1.097 1.236 1.366 1.523
Clarity fps
Lower Legs 1 Default 1.127 1.465 1.633 1.915 2.123 2.384 2.625 2.911
fps

Radiography (Exposure) - B20/12 Systems with ClarityIQ, Lateral Stand

Field of View 0 1 2 3 4
Field Size (cm) 30 27 22 19 15
Procedure X-ray Protocol Patient Type Reference Air Kerma (mGy/image)
Cardio Clarity Left Coronary 15 Default 0.050 0.055 0.063 0.073 0.085
fps Low
Rotational Scan Default - - - - -
Prop Ang0 4s
Infant - - - - -
Neonate - - - - -
Cardio Pediatrics 15 fps Contrast low Default 0.027 0.029 0.033 0.038 0.044
Clarity <40 kg
15 fps Contrast nor- Default 0.043 0.047 0.054 0.061 0.070
mal
Cardio Pediatrics 15 fps Contrast low Default 0.050 0.055 0.063 0.073 0.085
Clarity >40 kg
Neonate, Infant, 0.027 0.029 0.033 0.038 0.044
Child
15 fps Contrast nor- Default 0.102 0.110 0.126 0.146 0.169
mal
Neonate, Infant, 0.043 0.047 0.054 0.061 0.070
Child
EP Clarity 15 fps Default 0.050 0.055 0.063 0.073 0.085
Prop 4s Default - - - - -
Neonate, Infant - - - - -
Large Adult, Very - - - - -
Large Adult
EP Mapping Clarity 7.5 fps Default 0.050 0.055 0.063 0.073 0.085
3D EP Prop 4s Default - - - - -
Neonate, Infant - - - - -
Large Adult, Very - - - - -
Large Adult
Head Clarity Cerebral 2 fps low Default 1.456 1.602 1.894 2.258 2.696
Aortic Arch 3 fps Default 2.097 2.305 2.725 3.247 3.878

Azurion Release 2.2 Instructions for Use 382 Philips 4523 001 01511
Technical Information System-Level Information

Field of View 0 1 2 3 4
Field Size (cm) 30 27 22 19 15
Procedure X-ray Protocol Patient Type Reference Air Kerma (mGy/image)
Spine Clarity 4 fps Default 1.659 1.821 2.154 2.569 3.064
2 fps Default 1.658 1.824 2.156 2.570 3.064
Thorax Clarity Lungs 2 fps Default 1.841 2.022 2.393 2.849 3.407
Subclavian 3 fps Default 2.477 2.724 3.222 3.839 4.585
Abdomen Clarity 3 fps low Default 1.927 2.119 2.505 2.988 3.564
Iliac / Pelvis 3 fps Default 1.840 2.024 2.392 2.850 3.407
Peripheral Clarity Upper Legs 3 fps Default 1.589 1.685 1.869 2.093 2.348
Lower Legs 1 fps Default 2.897 3.181 3.760 4.258 4.743

Roadmap - B20/12 Systems with ClarityIQ, Frontal Stand

Field of View 0 1 2 3 4 5 6 7
Field Size (cm) 48 42 37 31 27 22 19 15
Patient
Procedure Mode Type Reference Air Kerma (mGy/image)
Cardio Clarity Navigate Default 0.093 0.113 0.122 0.137 0.154 0.177 0.199 0.232
UnSubtract Default 0.093 0.113 0.122 0.137 0.154 0.177 0.199 0.232
Cardio Pedia- Navigate Default 0.093 0.113 0.122 0.137 0.154 0.177 0.199 0.232
trics Clarity <40
UnSubtract Default 0.093 0.113 0.122 0.137 0.154 0.177 0.199 0.232
kg
Cardio Pedia- Navigate Default 0.093 0.113 0.122 0.137 0.154 0.177 0.199 0.232
trics Clarity >40
UnSubtract Default 0.093 0.113 0.122 0.137 0.154 0.177 0.199 0.232
kg
EP Clarity Navigate Default 0.093 0.113 0.122 0.137 0.154 0.177 0.199 0.232
UnSubtract Default 0.093 0.113 0.122 0.137 0.154 0.177 0.199 0.232
EP Mapping Navigate Default 0.093 0.113 0.122 0.137 0.154 0.177 0.199 0.232
Clarity
UnSubtract Default 0.093 0.113 0.122 0.137 0.154 0.177 0.199 0.232
Head Clarity Navigate Default 0.093 0.113 0.122 0.137 0.154 0.177 0.199 0.232
Coil Default 0.192 0.249 0.278 0.325 0.383 0.459 0.536 0.660
Unsubtract Default 0.093 0.113 0.122 0.137 0.154 0.177 0.199 0.232
Spine Clarity Navigate Default 0.093 0.113 0.122 0.137 0.154 0.177 0.199 0.232
Coil Default 0.192 0.249 0.278 0.325 0.383 0.459 0.536 0.660
Unsubtract Default 0.093 0.113 0.122 0.137 0.154 0.177 0.199 0.232
Thorax Clarity UnSubtract Default 0.093 0.113 0.122 0.137 0.154 0.177 0.199 0.232
Navigate Default 0.093 0.113 0.122 0.137 0.154 0.177 0.199 0.232
Abdomen Clari- UnSubtract Default 0.093 0.113 0.122 0.137 0.154 0.177 0.199 0.232
ty
Navigate Default 0.093 0.113 0.122 0.137 0.154 0.177 0.199 0.232
Peripheral UnSubtract Default 0.093 0.113 0.122 0.137 0.154 0.177 0.199 0.232
Clarity
Navigate Default 0.093 0.113 0.122 0.137 0.154 0.177 0.199 0.232

Azurion Release 2.2 Instructions for Use 383 Philips 4523 001 01511
Technical Information System-Level Information

Roadmap - B20/12 Systems with ClarityIQ, Lateral Stand

Field of View 0 1 2 3 4
Field Size (cm) 30 27 22 19 15
Patient
Procedure Mode Type Reference Air Kerma (mGy/image)
Cardio Clarity Navigate Default 0.222 0.238 0.268 0.305 0.346
UnSubtract Default 0.222 0.238 0.268 0.305 0.346
Cardio Pediatrics Clari- Navigate Default 0.222 0.238 0.268 0.305 0.346
ty <40 kg
UnSubtract Default 0.222 0.238 0.268 0.305 0.346
Cardio Pediatrics Clari- Navigate Default 0.222 0.238 0.268 0.305 0.346
ty >40 kg
UnSubtract Default 0.222 0.238 0.268 0.305 0.346
EP Clarity Navigate Default 0.222 0.238 0.268 0.305 0.346
UnSubtract Default 0.222 0.238 0.268 0.305 0.346
EP Mapping Clarity Navigate Default 0.222 0.238 0.268 0.305 0.346
UnSubtract Default 0.222 0.238 0.268 0.305 0.346
Head Clarity Navigate Default 0.222 0.238 0.268 0.305 0.346
Coil Default 0.493 0.542 0.641 0.764 0.890
Unsubtract Default 0.222 0.238 0.268 0.305 0.346
Spine Clarity Navigate Default 0.222 0.238 0.268 0.305 0.346
Coil Default 0.493 0.542 0.641 0.764 0.890
Unsubtract Default 0.222 0.238 0.268 0.305 0.346
Thorax Clarity UnSubtract Default 0.222 0.238 0.268 0.305 0.346
Navigate Default 0.222 0.238 0.268 0.305 0.346
Abdomen Clarity UnSubtract Default 0.222 0.238 0.268 0.305 0.346
Navigate Default 0.222 0.238 0.268 0.305 0.346
Peripheral Clarity UnSubtract Default 0.222 0.238 0.268 0.305 0.346
Navigate Default 0.222 0.238 0.268 0.305 0.346

B20/15 Systems

Radioscopy (Fluoroscopy) - B20/15 Systems, Frontal Stand

Field of View 0 1 2 3 4 5 6 7
Field Size (cm) 48 42 37 31 27 22 19 15
Patient
Procedure Flavor Type Reference Air Kerma (mGy/s)
Cardio Low Default 0.122 0.155 0.171 0.197 0.228 0.269 0.309 0.372
Norm Default 0.323 0.393 0.426 0.480 0.543 0.623 0.696 0.786
High Default 0.423 0.521 0.568 0.643 0.730 0.842 0.951 1.112
Pediatrics Low Default 0.112 0.140 0.154 0.176 0.203 0.237 0.271 0.309
Norm Default 0.253 0.313 0.343 0.390 0.443 0.501 0.557 0.645
High Default 0.428 0.514 0.553 0.615 0.663 0.724 0.782 0.871
EP Low Default 0.058 0.073 0.081 0.091 0.103 0.118 0.136 0.149
Norm Default 0.127 0.158 0.173 0.198 0.237 0.266 0.325 0.368
High Default 0.148 0.188 0.207 0.239 0.277 0.326 0.375 0.452

Azurion Release 2.2 Instructions for Use 384 Philips 4523 001 01511
Technical Information System-Level Information

Field of View 0 1 2 3 4 5 6 7
Field Size (cm) 48 42 37 31 27 22 19 15
Patient
Procedure Flavor Type Reference Air Kerma (mGy/s)
EP Mapping Low Default 0.030 0.037 0.041 0.046 0.053 0.060 0.070 0.077
Norm Default 0.065 0.081 0.089 0.102 0.121 0.136 0.166 0.187
High Default 0.076 0.096 0.105 0.122 0.141 0.166 0.191 0.230
Head Low Default 0.136 0.171 0.188 0.216 0.249 0.282 0.315 0.348
Norm Default 0.275 0.341 0.373 0.426 0.503 0.589 0.657 0.731
High Default 0.444 0.545 0.594 0.674 0.767 0.887 0.987 1.122
Spine Low Default 0.136 0.171 0.188 0.216 0.249 0.282 0.315 0.348
Norm Default 0.275 0.341 0.373 0.426 0.503 0.589 0.657 0.731
High Default 0.444 0.545 0.594 0.674 0.767 0.887 0.987 1.122
Thorax Low Default 0.136 0.171 0.188 0.216 0.249 0.282 0.315 0.348
Norm Default 0.275 0.341 0.373 0.426 0.503 0.589 0.657 0.731
High Default 0.444 0.545 0.594 0.674 0.767 0.887 0.987 1.122
Abdomen Low Default 0.136 0.171 0.188 0.216 0.249 0.282 0.315 0.348
Norm Default 0.275 0.341 0.373 0.426 0.503 0.589 0.657 0.731
High Default 0.444 0.545 0.594 0.674 0.767 0.887 0.987 1.122
Peripheral Low Default 0.136 0.171 0.188 0.216 0.249 0.282 0.315 0.348
Norm Default 0.275 0.341 0.373 0.426 0.503 0.589 0.657 0.731
High Default 0.444 0.545 0.594 0.674 0.767 0.887 0.987 1.122

Radioscopy (Fluoroscopy) - B20/15 Systems, Lateral Stand

Field of View 0 1 2 3 4 5 6
Field Size (cm) 39 37 31 27 22 19 15
Patient
Procedure Flavor Type Reference Air Kerma (mGy/s)
Cardio Low Default 0.262 0.285 0.330 0.376 0.443 0.519 0.616
Norm Default 0.524 0.564 0.641 0.714 0.823 0.941 1.054
High Default 0.696 0.751 0.858 0.961 1.112 1.282 1.493
Pediatrics Low Default 0.188 0.204 0.236 0.267 0.313 0.366 0.418
Norm Default 0.451 0.489 0.561 0.628 0.715 0.810 0.930
High Default 0.680 0.728 0.818 0.905 0.993 1.087 1.202
EP Low Default 0.095 0.104 0.121 0.137 0.162 0.190 0.224
Norm Default 0.220 0.239 0.276 0.313 0.367 0.431 0.512
High Default 0.271 0.293 0.338 0.383 0.448 0.523 0.617
EP Mapping Low Default 0.048 0.053 0.061 0.070 0.082 0.097 0.115
Norm Default 0.113 0.123 0.141 0.160 0.188 0.219 0.260
High Default 0.134 0.145 0.169 0.191 0.226 0.264 0.314
Head Low Default 0.212 0.231 0.271 0.311 0.370 0.438 0.517
Norm Default 0.497 0.531 0.600 0.668 0.767 0.878 1.019
High Default 0.774 0.835 0.957 1.075 1.248 1.444 1.668
Spine Low Default 0.212 0.231 0.271 0.311 0.370 0.438 0.517
Norm Default 0.497 0.531 0.600 0.668 0.767 0.878 1.019
High Default 0.774 0.835 0.957 1.075 1.248 1.444 1.668

Azurion Release 2.2 Instructions for Use 385 Philips 4523 001 01511
Technical Information System-Level Information

Field of View 0 1 2 3 4 5 6
Field Size (cm) 39 37 31 27 22 19 15
Patient
Procedure Flavor Type Reference Air Kerma (mGy/s)
Thorax Low Default 0.212 0.231 0.271 0.311 0.370 0.438 0.517
Norm Default 0.497 0.531 0.600 0.668 0.767 0.878 1.019
High Default 0.774 0.835 0.957 1.075 1.248 1.444 1.668
Abdomen Low Default 0.212 0.231 0.271 0.311 0.370 0.438 0.517
Norm Default 0.497 0.531 0.600 0.668 0.767 0.878 1.019
High Default 0.774 0.835 0.957 1.075 1.248 1.444 1.668
Peripheral Low Default 0.212 0.231 0.271 0.311 0.370 0.438 0.517
Norm Default 0.497 0.531 0.600 0.668 0.767 0.878 1.019
High Default 0.774 0.835 0.957 1.075 1.248 1.444 1.668

Radiography (Exposure) - B20/15 Systems, Frontal Stand

Field of View 0 1 2 3 4 5 6 7
Field Size (cm) 48 42 37 31 27 22 19 15
X-ray Pro-
Procedure tocol Patient Type Reference Air Kerma (mGy/image)
Cardio Left Coro- Default 0.061 0.076 0.083 0.095 0.108 0.125 0.142 0.168
nary
15 fps Low Infant 0.046 0.054 0.058 0.064 0.071 0.081 0.090 0.104
Large Adult, 0.060 0.075 0.082 0.093 0.107 0.124 0.141 0.166
Very Large
Adult
Neonate 0.025 0.032 0.035 0.040 0.046 0.054 0.063 0.076
Rotational Default 0.116 0.143 0.157 0.179 0.204 0.236 0.267 0.314
Scan
Prop Ang0 Infant 0.039 0.048 0.052 0.058 0.066 0.076 0.086 0.101
4s
Neonate 0.025 0.032 0.035 0.040 0.046 0.054 0.063 0.076
Pediatrics 15 fps Con- Default 0.118 0.146 0.160 0.181 0.206 0.238 0.269 0.317
trast Nor-
Child, Small 0.069 0.086 0.094 0.107 0.123 0.142 0.161 0.188
mal
Adult
Infant 0.039 0.048 0.052 0.058 0.066 0.076 0.086 0.101
Neonate 0.025 0.032 0.035 0.040 0.046 0.054 0.063 0.076
Prop Free Default 0.114 0.142 0.155 0.177 0.202 0.234 0.265 0.314
Position
Neonate, In- 0.027 0.033 0.036 0.041 0.047 0.054 0.062 0.074
fant
EP 15 fps Default 0.069 0.086 0.094 0.107 0.123 0.142 0.161 0.188
Prop 4s Default 0.141 0.180 0.225 0.225 0.225 0.225 0.225 0.225
Neonate, In- 0.094 0.121 0.153 0.153 0.153 0.153 0.153 0.153
fant
Large Adult, 0.141 0.180 0.225 0.225 0.225 0.225 0.225 0.225
Very Large
Adult

Azurion Release 2.2 Instructions for Use 386 Philips 4523 001 01511
Technical Information System-Level Information

Field of View 0 1 2 3 4 5 6 7
Field Size (cm) 48 42 37 31 27 22 19 15
X-ray Pro-
Procedure tocol Patient Type Reference Air Kerma (mGy/image)
EP Map- 7.5 fps low Default 0.011 0.014 0.015 0.017 0.019 0.022 0.025 0.028
ping
3D EP Prop Default 0.141 0.180 0.225 0.225 0.225 0.225 0.225 0.225
4s
Neonate, In- 0.094 0.121 0.153 0.153 0.153 0.153 0.153 0.153
fant
Large Adult, 0.141 0.180 0.225 0.225 0.225 0.225 0.225 0.225
Very Large
Adult
Head Cerebral 2 Default 2.856 3.713 4.139 4.848 5.711 6.852 7.867 8.549
fps normal
Child 1.839 2.207 2.384 2.677 3.022 3.482 3.945 4.534
Neonate, In- 1.839 2.207 2.384 2.677 3.022 3.482 3.945 4.534
fant
Aortic Arch Default 4.232 5.502 6.139 7.198 8.155 8.155 8.155 8.155
3 fps
Spine 4 fps Default 1.195 1.556 1.734 2.034 2.393 2.869 3.352 4.126
2 fps Default 1.495 1.944 2.168 2.540 2.993 3.591 4.184 5.163
Thorax Lungs 2 fps Default 1.427 1.856 2.071 2.428 2.657 2.919 3.169 3.474
Subclavian Default 5.136 6.669 7.447 8.718 10.268 11.183 11.737 12.575
3 fps
Abdomen Abdomen Default 2.619 3.406 3.801 4.455 5.243 6.296 7.334 7.334
3 fps Large Adult, 2.306 2.995 3.342 3.922 4.613 5.530 6.457 7.953
Very Large
Adult
Iliac / Pel- Default 4.262 5.538 6.173 7.243 8.517 10.218 11.918 14.041
vis 3 fps
Peripheral Upper Legs Default 3.690 4.793 5.292 5.691 6.142 6.705 7.241 7.869
3 fps
Lower Legs Default 4.509 5.620 5.922 6.361 6.850 7.454 8.029 8.708
1 fps

Radiography (Exposure) - B20/15 Systems, Lateral Stand

Field of View 0 1 2 3 4 5 6
Field Size (cm) 39 37 31 27 22 19 15
X-ray Proto-
Procedure col Patient Type Reference Air Kerma (mGy/image)
Cardio Left Coronary Default 0.100 0.108 0.124 0.139 0.162 0.188 0.219
15 fps Low Infant 0.070 0.074 0.083 0.092 0.105 0.119 0.138
Large Adult, Very 0.100 0.108 0.124 0.139 0.162 0.188 0.219
Large Adult
Neonate 0.046 0.049 0.057 0.064 0.076 0.089 0.093
Rotational Default - - - - - - -
Scan
Prop Ang0 4s Infant - - - - - - -
Neonate - - - - - - -

Azurion Release 2.2 Instructions for Use 387 Philips 4523 001 01511
Technical Information System-Level Information

Field of View 0 1 2 3 4 5 6
Field Size (cm) 39 37 31 27 22 19 15
X-ray Proto-
Procedure col Patient Type Reference Air Kerma (mGy/image)
Pediatrics 15 fps Contrast Default 0.187 0.202 0.231 0.258 0.299 0.344 0.399
Normal
Child, Small 0.113 0.122 0.141 0.158 0.184 0.212 0.248
Adult
Infant 0.067 0.072 0.081 0.091 0.105 0.121 0.142
Neonate 0.045 0.049 0.057 0.065 0.077 0.090 0.108
Prop Free Po- Default - - - - - - -
sition
Neonate, Infant - - - - - - -
EP 15 fps Default 0.113 0.122 0.141 0.158 0.184 0.212 0.248
Prop 4s Default - - - - - - -
Neonate, Infant - - - - - - -
Large Adult, Very - - - - - - -
Large Adult
EP Map- 7.5 fps low Default 0.018 0.019 0.023 0.026 0.030 0.036 0.042
ping
3D EP Prop 4s Default - - - - - - -
Neonate, Infant - - - - - - -
Large Adult, Very - - - - - - -
Large Adult
Head Cerebral 2 fps Default 5.093 5.597 6.615 7.258 7.985 8.807 9.820
normal
Child 3.253 3.482 3.925 4.368 5.019 5.788 6.784
Neonate, Infant 3.253 3.482 3.925 4.368 5.019 5.788 6.784
Aortic Arch 3 Default 7.351 8.097 9.561 11.031 11.031 11.031 11.031
fps
Spine 4 fps Default 1.705 1.877 2.216 2.559 3.068 3.662 4.436
2 fps Default 2.135 2.346 2.770 3.197 3.837 4.587 5.550
Thorax Lungs 2 fps Default 2.561 2.815 3.328 3.784 4.159 4.581 5.098
Subclavian 3 Default 8.863 9.750 11.532 13.286 14.407 15.756 15.756
fps
Abdomen Abdomen Default 4.597 5.056 5.972 6.896 8.273 9.885 10.475
3 fps Large Adult, Very 4.063 4.474 5.289 6.105 7.326 8.734 10.568
Large Adult
Iliac / Pelvis 3 Default 7.471 8.209 9.708 11.214 13.446 16.044 19.432
fps
Peripheral Upper Legs 3 Default 5.559 5.823 6.331 6.821 7.514 8.299 9.268
fps
Lower Legs 1 Default 5.969 6.247 6.778 7.286 8.013 8.810 9.809
fps

Roadmap - B20/15 Systems, Frontal Stand

Field of View 0 1 2 3 4 5 6 7
Field Size (cm) 48 42 37 31 27 22 19 15
Patient
Procedure Mode Type Reference Air Kerma (mGy/image)
Cardio Navigate Default 0.233 0.287 0.313 0.356 0.405 0.466 0.496 0.496
UnSubtract Default 0.233 0.287 0.313 0.356 0.405 0.466 0.496 0.496
Pediatrics Navigate Default 0.233 0.287 0.313 0.356 0.405 0.466 0.496 0.496
UnSubtract Default 0.233 0.287 0.313 0.356 0.405 0.466 0.496 0.496

Azurion Release 2.2 Instructions for Use 388 Philips 4523 001 01511
Technical Information System-Level Information

Field of View 0 1 2 3 4 5 6 7
Field Size (cm) 48 42 37 31 27 22 19 15
Patient
Procedure Mode Type Reference Air Kerma (mGy/image)
EP Navigate Default 0.233 0.287 0.313 0.356 0.405 0.466 0.496 0.496
EP Map- Navigate Default 0.233 0.287 0.313 0.356 0.405 0.466 0.496 0.496
ping
Head Navigate Default 0.233 0.287 0.313 0.356 0.405 0.466 0.496 0.496
Carotid Default 0.201 0.240 0.258 0.287 0.320 0.363 0.383 0.383
Coil Default 1.065 1.383 1.544 1.810 2.129 2.553 2.984 3.670
Spine UnSubtract Default 0.233 0.287 0.313 0.356 0.405 0.466 0.496 0.496
Navigate Default 0.233 0.287 0.313 0.356 0.405 0.466 0.496 0.496
Stent Default 0.201 0.240 0.258 0.287 0.320 0.363 0.383 0.383
Thorax UnSubtract Default 0.233 0.287 0.313 0.356 0.405 0.466 0.496 0.496
Navigate Default 0.233 0.287 0.313 0.356 0.405 0.466 0.496 0.496
Interven- Default 0.201 0.240 0.258 0.287 0.320 0.363 0.383 0.383
tion
Abdomen UnSubtract Default 0.233 0.287 0.313 0.356 0.405 0.466 0.496 0.496
Navigate Default 0.233 0.287 0.313 0.356 0.405 0.466 0.496 0.496
Stent Default 0.201 0.240 0.258 0.287 0.320 0.363 0.383 0.383
Peripheral UnSubtract Default 0.233 0.287 0.313 0.356 0.405 0.466 0.496 0.496
Navigate Default 0.233 0.287 0.313 0.356 0.405 0.466 0.496 0.496

Roadmap - B20/15 Systems, Lateral Stand

Field of View 0 1 2 3 4 5 6
Field Size (cm) 39 37 31 27 22 19 15
Procedure Mode Patient Type Reference Air Kerma (mGy/image)
Cardio Navigate Default 0.367 0.396 0.452 0.474 0.578 0.671 0.778
UnSubtract Default 0.367 0.396 0.452 0.474 0.578 0.671 0.778
Pediatrics Navigate Default 0.367 0.396 0.452 0.474 0.578 0.671 0.778
UnSubtract Default 0.367 0.396 0.452 0.474 0.578 0.671 0.778
EP Navigate Default 0.367 0.396 0.452 0.474 0.578 0.671 0.778
EP Mapping Navigate Default 0.367 0.396 0.452 0.474 0.578 0.671 0.778
Head Navigate Default 0.365 0.394 0.450 0.472 0.577 0.623 0.623
Carotid Default 0.362 0.385 0.431 0.473 0.534 0.568 0.568
Coil Default 1.865 2.052 2.429 2.799 3.361 4.019 4.852
Spine UnSubtract Default 0.365 0.394 0.450 0.472 0.577 0.623 0.623
Navigate Default 0.365 0.394 0.450 0.472 0.577 0.623 0.623
Stent Default 0.362 0.385 0.431 0.473 0.534 0.568 0.568
Thorax UnSubtract Default 0.365 0.394 0.450 0.472 0.577 0.623 0.623
Navigate Default 0.365 0.394 0.450 0.472 0.577 0.623 0.623
Intervention Default 0.362 0.385 0.431 0.473 0.534 0.568 0.568
Abdomen UnSubtract Default 0.365 0.394 0.450 0.472 0.577 0.623 0.623
Navigate Default 0.365 0.394 0.450 0.472 0.577 0.623 0.623
Stent Default 0.362 0.385 0.431 0.473 0.534 0.568 0.568
Peripheral UnSubtract Default 0.365 0.394 0.450 0.472 0.577 0.623 0.623
Navigate Default 0.365 0.394 0.450 0.472 0.577 0.623 0.623

Azurion Release 2.2 Instructions for Use 389 Philips 4523 001 01511
Technical Information System-Level Information

B20/15 Systems with ClarityIQ Option

Radioscopy (Fluoroscopy) - B20/15 Systems with ClarityIQ, Frontal Stand

Field of View 0 1 2 3 4 5 6 7
Field Size (cm) 48 42 37 31 27 22 19 15
Patient
Procedure Flavor Type Reference Air Kerma (mGy/s)
Cardio Clarity Low Default 0.086 0.107 0.117 0.133 0.152 0.177 0.201 0.240
Medium Default 0.130 0.161 0.177 0.202 0.231 0.270 0.307 0.368
Normal Default 0.301 0.369 0.403 0.456 0.517 0.596 0.674 0.796
Cardio Pedia- Low Default 0.037 0.046 0.051 0.058 0.067 0.078 0.089 0.106
trics Clarity <40
Medium Default 0.055 0.069 0.076 0.087 0.100 0.116 0.133 0.158
kg
Normal Default 0.084 0.105 0.115 0.132 0.151 0.176 0.201 0.240
Cardio Pedia- Low Default 0.037 0.046 0.051 0.058 0.067 0.078 0.089 0.106
trics Clarity >40
Medium Default 0.055 0.069 0.076 0.087 0.100 0.116 0.133 0.158
kg
Normal Default 0.084 0.105 0.115 0.132 0.151 0.176 0.201 0.240
EP Clarity Low Default 0.030 0.030 0.030 0.034 0.039 0.045 0.051 0.060
Medium Default 0.061 0.061 0.061 0.069 0.079 0.092 0.104 0.121
Normal Default 0.075 0.075 0.075 0.086 0.099 0.117 0.133 0.159
EP Mapping Low Default 0.035 0.035 0.035 0.040 0.046 0.053 0.059 0.068
Clarity
Medium Default 0.070 0.070 0.070 0.079 0.090 0.105 0.117 0.136
Normal Default 0.090 0.090 0.090 0.102 0.118 0.138 0.158 0.189
Head Clarity Low Default 0.123 0.148 0.160 0.179 0.208 0.244 0.273 0.305
Medium Default 0.185 0.232 0.255 0.293 0.346 0.402 0.445 0.493
Normal Default 0.320 0.395 0.432 0.491 0.561 0.651 0.738 0.875
Spine Clarity Low Default 0.123 0.148 0.160 0.179 0.208 0.244 0.273 0.305
Medium Default 0.185 0.232 0.255 0.293 0.346 0.402 0.445 0.493
Normal Default 0.320 0.395 0.432 0.491 0.561 0.651 0.738 0.875
Thorax Clarity Low Default 0.123 0.148 0.160 0.179 0.208 0.244 0.273 0.305
Medium Default 0.185 0.232 0.255 0.293 0.346 0.402 0.445 0.493
Normal Default 0.320 0.395 0.432 0.491 0.561 0.651 0.738 0.875
Abdomen Clari- Low Default 0.123 0.148 0.160 0.179 0.208 0.244 0.273 0.305
ty
Medium Default 0.185 0.232 0.255 0.293 0.346 0.402 0.445 0.493
Normal Default 0.320 0.395 0.432 0.491 0.561 0.651 0.738 0.875
Peripheral Low Default 0.123 0.148 0.160 0.179 0.208 0.244 0.273 0.305
Clarity
Medium Default 0.185 0.232 0.255 0.293 0.346 0.402 0.445 0.493
Normal Default 0.320 0.395 0.432 0.491 0.561 0.651 0.738 0.875

Radioscopy (Fluoroscopy) - B20/15 Systems with ClarityIQ, Lateral Stand

Field of View 0 1 2 3 4 5 6
Field Size (cm) 39 37 31 27 22 19 15
Patient
Procedure Flavor Type Reference Air Kerma (mGy/s)
Cardio Clarity Low Default 0.146 0.158 0.182 0.205 0.239 0.278 0.327
Medium Default 0.217 0.235 0.271 0.306 0.358 0.418 0.492
Normal Default 0.495 0.534 0.609 0.683 0.791 0.911 1.063

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Field of View 0 1 2 3 4 5 6
Field Size (cm) 39 37 31 27 22 19 15
Patient
Procedure Flavor Type Reference Air Kerma (mGy/s)
Cardio Pediatrics Low Default 0.062 0.068 0.078 0.088 0.104 0.121 0.143
Clarity <40 kg
Medium Default 0.093 0.101 0.117 0.132 0.153 0.178 0.207
Normal Default 0.141 0.153 0.177 0.199 0.233 0.271 0.318
Cardio Pediatrics Low Default 0.062 0.068 0.078 0.088 0.104 0.121 0.143
Clarity >40 kg
Medium Default 0.093 0.101 0.117 0.132 0.153 0.178 0.207
Normal Default 0.141 0.153 0.177 0.199 0.233 0.271 0.318
EP Clarity Low Default 0.039 0.043 0.049 0.055 0.064 0.074 0.086
Medium Default 0.079 0.085 0.098 0.110 0.128 0.148 0.171
Normal Default 0.090 0.098 0.113 0.128 0.150 0.175 0.206
EP Mapping Clarity Low Default 0.046 0.050 0.057 0.064 0.075 0.085 0.098
Medium Default 0.091 0.099 0.113 0.127 0.148 0.169 0.194
Normal Default 0.108 0.117 0.135 0.153 0.179 0.209 0.246
Head Clarity Low Default 0.204 0.220 0.250 0.280 0.323 0.371 0.433
Medium Default 0.320 0.347 0.399 0.444 0.511 0.587 0.683
Normal Default 0.532 0.575 0.659 0.741 0.861 0.997 1.156
Spine Clarity Low Default 0.204 0.220 0.250 0.280 0.323 0.371 0.433
Medium Default 0.320 0.347 0.399 0.444 0.511 0.587 0.683
Normal Default 0.532 0.575 0.659 0.741 0.861 0.997 1.156
Thorax Clarity Low Default 0.204 0.220 0.250 0.280 0.323 0.371 0.433
Medium Default 0.320 0.347 0.399 0.444 0.511 0.587 0.683
Normal Default 0.532 0.575 0.659 0.741 0.861 0.997 1.156
Abdomen Clarity Low Default 0.204 0.220 0.250 0.280 0.323 0.371 0.433
Medium Default 0.320 0.347 0.399 0.444 0.511 0.587 0.683
Normal Default 0.532 0.575 0.659 0.741 0.861 0.997 1.156
Peripheral Clarity Low Default 0.204 0.220 0.250 0.280 0.323 0.371 0.433
Medium Default 0.320 0.347 0.399 0.444 0.511 0.587 0.683
Normal Default 0.532 0.575 0.659 0.741 0.861 0.997 1.156

Radiography (Exposure) - B20/15 Systems with ClarityIQ, Frontal Stand

Field of View 0 1 2 3 4 5 6 7
Field Size (cm) 48 42 37 31 27 22 19 15
X-ray Proto-
Procedure col Patient Type Reference Air Kerma (mGy/image)
Cardio Clari- Left Coro- Default 0.022 0.027 0.030 0.034 0.039 0.046 0.053 0.063
ty nary 15 fps
Low
Rotational Default 0.118 0.146 0.159 0.181 0.206 0.239 0.269 0.317
Scan Prop
Infant 0.039 0.048 0.052 0.058 0.066 0.076 0.086 0.101
Ang0 4s
Neonate 0.025 0.032 0.035 0.040 0.046 0.054 0.063 0.076
Cardio Pe- 15 fps Con- Default 0.012 0.015 0.016 0.018 0.021 0.024 0.027 0.032
diatrics Clari- trast low
ty <40 kg
15 fps Con- Default 0.018 0.023 0.025 0.029 0.034 0.040 0.045 0.052
trast normal

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Field of View 0 1 2 3 4 5 6 7
Field Size (cm) 48 42 37 31 27 22 19 15
X-ray Proto-
Procedure col Patient Type Reference Air Kerma (mGy/image)
Cardio Pe- 15 fps Con- Default 0.022 0.027 0.030 0.034 0.039 0.046 0.053 0.063
diatrics Clari- trast low
Neonate, In- 0.012 0.015 0.016 0.018 0.021 0.024 0.027 0.032
ty >40 kg
fant, Child
15 fps Con- Default 0.047 0.058 0.064 0.073 0.083 0.097 0.110 0.130
trast normal
Neonate, In- 0.018 0.023 0.025 0.029 0.034 0.040 0.045 0.052
fant, Child
EP Clarity 15 fps Default 0.022 0.027 0.030 0.034 0.039 0.046 0.053 0.063
Prop 4s Default 0.141 0.180 0.225 0.225 0.225 0.225 0.225 0.225
Neonate, In- 0.094 0.121 0.153 0.153 0.153 0.153 0.153 0.153
fant
Large Adult, 0.141 0.180 0.225 0.225 0.225 0.225 0.225 0.225
Very Large
Adult
EP Mapping 7.5 fps Default 0.022 0.027 0.030 0.034 0.039 0.046 0.053 0.063
Clarity
3D EP Prop Default 0.141 0.180 0.225 0.225 0.225 0.225 0.225 0.225
4s
Neonate, In- 0.094 0.121 0.153 0.153 0.153 0.153 0.153 0.153
fant
Large Adult, 0.141 0.180 0.225 0.225 0.225 0.225 0.225 0.225
Very Large
Adult
Head Clarity Cerebral 2 Default 0.570 0.741 0.827 0.969 1.141 1.367 1.595 1.882
fps low
Aortic Arch 3 Default 0.815 1.059 1.181 1.385 1.629 1.956 2.280 2.689
fps
Spine Clarity 4 fps Default 0.672 0.875 0.975 1.142 1.345 1.614 1.883 2.221
2 fps Default 0.673 0.875 0.974 1.142 1.344 1.612 1.882 2.221
Thorax Clari- Lungs 2 fps Default 0.713 0.928 1.036 1.213 1.429 1.713 1.999 2.355
ty
Subclavian 3 Default 0.965 1.254 1.398 1.639 1.928 2.313 2.699 3.180
fps
Abdomen 3 fps low Default 0.454 0.590 0.659 0.772 0.907 1.091 1.272 1.497
Clarity
Iliac / Pelvis Default 0.714 0.927 1.034 1.214 1.428 1.714 1.998 2.356
3 fps
Peripheral Upper Legs 3 Default 0.631 0.802 0.868 0.973 1.097 1.236 1.366 1.523
Clarity fps
Lower Legs 1 Default 1.127 1.465 1.633 1.915 2.123 2.384 2.625 2.911
fps

Radiography (Exposure) - B20/15 Systems with ClarityIQ, Lateral Stand

Field of View 0 1 2 3 4 5 6
Field Size (cm) 39 37 31 27 22 19 15
Procedure X-ray Protocol Patient Type Reference Air Kerma (mGy/image)
Cardio Clarity Left Coronary Default 0.037 0.040 0.047 0.053 0.062 0.072 0.085
15 fps Low
Rotational Default - - - - - - -
Scan Prop
Infant - - - - - - -
Ang0 4s
Neonate - - - - - - -

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Field of View 0 1 2 3 4 5 6
Field Size (cm) 39 37 31 27 22 19 15
Procedure X-ray Protocol Patient Type Reference Air Kerma (mGy/image)
Cardio Pedia- 15 fps Contrast Default 0.020 0.022 0.025 0.028 0.033 0.038 0.044
trics Clarity <40 low
kg
15 fps Contrast Default 0.032 0.035 0.040 0.046 0.053 0.061 0.070
normal
Cardio Pedia- 15 fps Contrast Default 0.037 0.040 0.047 0.053 0.062 0.072 0.085
trics Clarity >40 low
Neonate, Infant, 0.020 0.022 0.025 0.028 0.033 0.038 0.044
kg
Child
15 fps Contrast Default 0.075 0.081 0.094 0.105 0.122 0.142 0.166
normal
Neonate, Infant, 0.032 0.035 0.040 0.046 0.053 0.061 0.070
Child
EP Clarity 15 fps Default 0.037 0.040 0.047 0.053 0.062 0.072 0.085
Prop 4s Default - - - - - - -
Neonate, Infant - - - - - - -
Large Adult, Very - - - - - - -
Large Adult
EP Mapping 7.5 fps Default 0.037 0.040 0.047 0.053 0.062 0.072 0.085
Clarity
3D EP Prop 4s Default - - - - - - -
Neonate, Infant - - - - - - -
Large Adult, Very - - - - - - -
Large Adult
Head Clarity Cerebral 2 fps Default 1.017 1.119 1.321 1.524 1.830 2.184 2.643
low
Aortic Arch 3 Default 1.451 1.597 1.886 2.175 2.611 3.120 3.771
fps
Spine Clarity 4 fps Default 1.157 1.272 1.504 1.737 2.084 2.490 3.007
2 fps Default 1.157 1.272 1.503 1.736 2.083 2.488 3.011
Thorax Clarity Lungs 2 fps Default 1.281 1.406 1.664 1.918 2.303 2.753 3.327
Subclavian 3 Default 1.706 1.875 2.217 2.557 3.066 3.666 4.434
fps
Abdomen 3 fps low Default 0.806 0.887 1.049 1.210 1.452 1.732 2.097
Clarity
Iliac / Pelvis 3 Default 1.281 1.406 1.664 1.919 2.303 2.750 3.324
fps
Peripheral Upper Legs 3 Default 1.131 1.245 1.470 1.624 1.822 2.043 2.317
Clarity fps
Lower Legs 1 Default 1.979 2.178 2.577 2.971 3.565 4.133 4.639
fps

Roadmap - B20/15 Systems with ClarityIQ, Frontal Stand

Field of View 0 1 2 3 4 5 6 7
Field Size (cm) 48 42 37 31 27 22 19 15
Patient
Procedure Mode Type Reference Air Kerma (mGy/image)
Cardio Clarity Navigate Default 0.093 0.113 0.122 0.137 0.154 0.177 0.199 0.232
UnSubtract Default 0.093 0.113 0.122 0.137 0.154 0.177 0.199 0.232
Cardio Pedia- Navigate Default 0.093 0.113 0.122 0.137 0.154 0.177 0.199 0.232
trics Clarity <40
UnSubtract Default 0.093 0.113 0.122 0.137 0.154 0.177 0.199 0.232
kg

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Field of View 0 1 2 3 4 5 6 7
Field Size (cm) 48 42 37 31 27 22 19 15
Patient
Procedure Mode Type Reference Air Kerma (mGy/image)
Cardio Pedia- Navigate Default 0.093 0.113 0.122 0.137 0.154 0.177 0.199 0.232
trics Clarity >40
UnSubtract Default 0.093 0.113 0.122 0.137 0.154 0.177 0.199 0.232
kg
EP Clarity Navigate Default 0.093 0.113 0.122 0.137 0.154 0.177 0.199 0.232
UnSubtract Default 0.093 0.113 0.122 0.137 0.154 0.177 0.199 0.232
EP Mapping Navigate Default 0.093 0.113 0.122 0.137 0.154 0.177 0.199 0.232
Clarity
UnSubtract Default 0.093 0.113 0.122 0.137 0.154 0.177 0.199 0.232
Head Clarity Navigate Default 0.093 0.113 0.122 0.137 0.154 0.177 0.199 0.232
Coil Default 0.192 0.249 0.278 0.325 0.383 0.459 0.536 0.660
Unsubtract Default 0.093 0.113 0.122 0.137 0.154 0.177 0.199 0.232
Spine Clarity Navigate Default 0.093 0.113 0.122 0.137 0.154 0.177 0.199 0.232
Coil Default 0.192 0.249 0.278 0.325 0.383 0.459 0.536 0.660
Unsubtract Default 0.093 0.113 0.122 0.137 0.154 0.177 0.199 0.232
Thorax Clarity UnSubtract Default 0.093 0.113 0.122 0.137 0.154 0.177 0.199 0.232
Navigate Default 0.093 0.113 0.122 0.137 0.154 0.177 0.199 0.232
Abdomen Clari- UnSubtract Default 0.093 0.113 0.122 0.137 0.154 0.177 0.199 0.232
ty
Navigate Default 0.093 0.113 0.122 0.137 0.154 0.177 0.199 0.232
Peripheral UnSubtract Default 0.093 0.113 0.122 0.137 0.154 0.177 0.199 0.232
Clarity
Navigate Default 0.093 0.113 0.122 0.137 0.154 0.177 0.199 0.232

Roadmap - B20/15 Systems with ClarityIQ, Lateral Stand

Field of View 0 1 2 3 4 5 6
Field Size (cm) 39 37 31 27 22 19 15
Patient
Procedure Mode Type Reference Air Kerma (mGy/image)
Cardio Clarity Navigate Default 0.170 0.182 0.205 0.227 0.260 0.296 0.340
UnSubtract Default 0.170 0.182 0.205 0.227 0.260 0.296 0.340
Cardio Pediatrics Navigate Default 0.170 0.182 0.205 0.227 0.260 0.296 0.340
Clarity <40 kg
UnSubtract Default 0.170 0.182 0.205 0.227 0.260 0.296 0.340
Cardio Pediatrics Navigate Default 0.170 0.182 0.205 0.227 0.260 0.296 0.340
Clarity >40 kg
UnSubtract Default 0.170 0.182 0.205 0.227 0.260 0.296 0.340
EP Clarity Navigate Default 0.170 0.182 0.205 0.227 0.260 0.296 0.340
UnSubtract Default 0.170 0.182 0.205 0.227 0.260 0.296 0.340
EP Mapping Navigate Default 0.170 0.182 0.205 0.227 0.260 0.296 0.340
Clarity
UnSubtract Default 0.170 0.182 0.205 0.227 0.260 0.296 0.340
Head Clarity Navigate Default 0.170 0.182 0.205 0.227 0.260 0.296 0.340
Coil Default 0.341 0.374 0.443 0.511 0.614 0.733 0.872
Unsubtract Default 0.170 0.182 0.205 0.227 0.260 0.296 0.340
Spine Clarity Navigate Default 0.170 0.182 0.205 0.227 0.260 0.296 0.340
Coil Default 0.341 0.374 0.443 0.511 0.614 0.733 0.872
Unsubtract Default 0.170 0.182 0.205 0.227 0.260 0.296 0.340
Thorax Clarity UnSubtract Default 0.170 0.182 0.205 0.227 0.260 0.296 0.340
Navigate Default 0.170 0.182 0.205 0.227 0.260 0.296 0.340

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Field of View 0 1 2 3 4 5 6
Field Size (cm) 39 37 31 27 22 19 15
Patient
Procedure Mode Type Reference Air Kerma (mGy/image)
Abdomen Clarity UnSubtract Default 0.170 0.182 0.205 0.227 0.260 0.296 0.340
Navigate Default 0.170 0.182 0.205 0.227 0.260 0.296 0.340
Peripheral Clarity UnSubtract Default 0.170 0.182 0.205 0.227 0.260 0.296 0.340
Navigate Default 0.170 0.182 0.205 0.227 0.260 0.296 0.340

Examples of Settings with a Relatively High Air Kerma (Rate)


The following table shows examples of exposure procedures that produce a relatively high reference air
kerma value, compared to other procedures, for the different Azurion systems (according to IEC
60601-2-54:2009, 203.5.2.4.5.101b 4):

Patient
System X-ray Protocol Field size type
12-inch detector Head Subclavian 3 fps 15 cm Default
20-inch detector Head Subclavian 3 fps 15 cm Default
12-inch detector with Clari- Head Cerebral 2 fps Normal 15 cm Default
tyIQ (option)
20-inch detector with Clari- Head Cerebral 2 fps Normal 15 cm Default
tyIQ (option)

The following table shows examples of fluoroscopy flavors that produce a relatively high Reference Air
Kerma value, compared to other procedures, for the different Azurion systems (according to IEC
60601-2-54:2009, 203.5.2.4.5.101b 3):

System X-ray Protocol Flavor Field size Patient type


12-inch detector Head High 15 cm Default
20-inch detector Head High 15 cm Default
12-inch detector with Clari- Head Normal 15 cm Default
tyIQ (option)
20-inch detector with Clari- Head Normal 15 cm Default
tyIQ (option)

Measurement conditions: according to Reference Air Kerma Measurement Setup (page 395).

Reference Air Kerma Measurement Setup

12-Inch Detector

Description Setup
Anti-scatter grid In position
Distance from focal spot to entrance surface of the phan- • Frontal: 985 mm (38.78 inch)
tom • Lateral: 1060 mm (41.73 inch)
Distance from focal spot to Image receptor • Frontal: 1210 mm (47.64 inch)
• Lateral: 1300 mm (51.18 inch)
Distance from focal spot to patient entrance reference point Frontal and lateral: 615 mm (24.21 inch)
Distance from focal spot to isocenter Frontal and lateral: 765 mm (30.12 inch)

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Description Setup
Measuring device Unfors Xi meter or RaySafe X2 meter with sensor placed in
the X-ray beam between the focal spot and the phantom,
outside the system measurement field (see the figure be-
low)
Measurement result To determine the measured air kerma, the ratio between the
distance from focal spot to patient entrance reference point
and the distance from focal spot to the measurement de-
vice shall be taken into account
Patient support Out of the primary X-ray beam
Phantom Rectangular blocks of PMMA, total thickness 200 mm (7.87
inch), sides equal to or greater than 250 mm (9.84 inch)
Single-shot exposure After radioscopy (stabilized kV/mA)
Wedge filter Deselected
X-ray beam orientation • Rotation: 90 degrees LAO
• Angulation: 0 degrees CAUD

15-Inch Detector

Description Setup
Anti-scatter grid In position
Distance from focal spot to entrance surface of the phan- • Frontal: 960 mm (37.80 inch)
tom • Lateral: 1075 mm (42.32 inch)
Distance from focal spot to Image receptor • Frontal: 1195 mm (47.05 inch)
• Lateral: 1300 mm (51.18 inch)
Distance from focal spot to patient entrance reference point • Frontal: 660 mm (25.98 inch)
• Lateral: 615 mm (24.21 inch)
Distance from focal spot to isocenter • Frontal: 810 mm (31.89 inch)
• Lateral: 765 mm (30.12 inch)
Measuring device Unfors Xi meter or RaySafe X2 meter with sensor placed in
the X-ray beam between the focal spot and the phantom,
outside the system measurement field (see the figure be-
low)
Measurement result To determine the measured air kerma, the ratio between the
distance from focal spot to patient entrance reference point
and the distance from focal spot to the measurement de-
vice shall be taken into account
Patient support Out of the primary X-ray beam
Phantom Rectangular blocks of PMMA, total thickness 200 mm (7.87
inch), sides equal to or greater than 300 x 400 mm (11.81 x
15.75 inch)
Single-shot exposure After radioscopy (stabilized kV/mA)
Wedge filter Deselected
X-ray beam orientation • Rotation: 90 degrees LAO
• Angulation: 0 degrees CAUD

20-Inch Detector

Description Setup
Anti-scatter grid In position
Distance from focal spot to entrance surface of the phan- 945 mm (37.20 inch)
tom
Distance from focal spot to Image receptor 1195 mm (47.05 inch)
Distance from focal spot to patient entrance reference point 660 mm (25.98 inch)

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Description Setup
Distance from focal spot to isocenter 810 mm (31.89 inch)
Measuring device Unfors Xi meter or RaySafe X2 meter with sensor placed in
the X-ray beam between the focal spot and the phantom,
outside the system measurement field (see the figure be-
low)
Measurement result To determine the measured air kerma, the ratio between the
distance from focal spot to patient entrance reference point
and the distance from focal spot to the measurement de-
vice shall be taken into account
Patient support Out of the primary X-ray beam
Phantom Rectangular blocks of PMMA, total thickness 200 mm (7.87
inch), sides equal to or greater than 300 x 400 mm (11.81 x
15.75 inch)
Single-shot exposure After radioscopy (stabilized kV/mA)
Wedge filter Deselected
X-ray beam orientation • Rotation: 90 degrees LAO
• Angulation: 0 degrees CAUD

Figure 169 Location of the measuring device

Legend
1 System measurement field
2 Measuring device

17.5.7 Protection Against Stray Radiation


This section describes the levels of protection provided by the system against stray radiation.

Zone of Occupancy
The indicated significant zone of occupancy is designated to be used for radiologic procedures
according to the intended use of the equipment.

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For details, see Intended Use of the System (page 17).

Technique factors can be obtained using the Manual X-ray Generator Test in Field Service mode. The
following technique factors are used:
• 125 kV, 10 mA
• No additional filter

6
7

4
1
3

2
3

Figure 170 Technique factors graph (all dimensions are in cm)

Legend
1 Scatter object: 25 x 25 x 15cm PMMA 5 Dose (mGy/hour)
(IEC60601-1-3 / IEC60601-2-54)
2 Radiation shields 6 Dose (mGy/hour) with shield (0.5 mm Pb equiva-
lent)
3 Significant zone of occupation (LxWxH): 60 x 60 x 7 Dose (mGy/hour) without shield
200 cm (located 10 cm from the radiation shield)
4 Height (cm)

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NOTE Radiation shields lower the AK by at least one order of magnitude.

Isokerma Maps for M12 System


The following illustrations show normalized isokerma maps at 100 cm (39.37 in) and 150 cm (59.10 in)
above the floor with swivel out.

The following technique factors are used:


• Fluoroscopy 120 kV
• Source-to-image distance 100 cm
• Field size 10 x 10 cm
• No additional filter

Frontal X-ray Direction

Figure 171 Isokerma map at 100 cm (left) and 150 cm (right) above the floor, μGy/(Gy x cm²)

Lateral X-ray Direction

Figure 172 Isokerma map at 100 cm (left) and 150 cm (right) above the floor, μGy/(Gy x cm²)

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Isokerma Maps for M15 System and M20 System


The following illustrations show normalized isokerma maps at 100 cm (39.37 in) and 150 cm (59.10 in)
above the floor with swivel out.

The following technique factors are used:


• Fluoroscopy 120 kV
• Source-to-image distance 100 cm
• Field size 10 x 10 cm
• No additional filter

Frontal X-ray Direction

Figure 173 Isokerma map at 100 cm (left) and 150 cm (right) above the floor, μGy/(Gy x cm²)

Lateral X-ray Direction

Figure 174 Isokerma map at 100 cm (left) and 150 cm (right) above the floor, μGy/(Gy x cm²)

Isokerma Maps for B20 System


The following illustrations show normalized isokerma maps at 100 cm (39.37 in) and 150 cm (59.10 in)
above the floor with swivel out.

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The following technique factors are used:


• Fluoroscopy 120 kV
• Source-to-image distance 100 cm
• Field size 10 x 10 cm
• No additional filter

Frontal X-ray Direction

Figure 175 Isokerma map at 100 cm (left) and 150 cm (right) above the floor, μGy/(Gy x cm²)

Lateral X-ray Direction

Figure 176 Isokerma map at 100 cm (left) and 150 cm (right) above the floor, μGy/(Gy x cm²)

Isokerma Maps for the FlexArm Stand (Option)


The following illustrations show normalized isokerma maps at 100 cm (39.37 in) and 150 cm (59.10 in)
above the floor.

The following technique factors are used:


• Fluoroscopy 120 kV
• Source-to-image distance 100 cm

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• Field size 10 x 10 cm
• No additional filter

Frontal X-ray Direction

Figure 177 Isokerma map at 100 cm (left) and 150 cm (right) above the floor, μGy/(Gy x cm²)

Lateral X-ray Direction

Figure 178 Isokerma map at 100 cm (left) and 150 cm (right) above the floor, μGy/(Gy x cm²)

Additional Filtering
This section provides information about the effect of filtration on air kerma values.

The maximum attenuation equivalent of the tabletop is 1.59 mm Al (at 75 kV/HVL 3.5 mm Al).

The minimum inherent filtration (at 75 kV/HVL 3.5 mm Al) of the X-ray tube assembly is 2.5 mm Al.

The attenuation equivalent (at 75 kV/HVL 3.5 mm Al) of other materials in the X-ray beam are as
follows:
• X-ray tube assembly cover: <0.3 mm Al equivalent at 75 kV
• DAP-meter: <0.5 mm Al equivalent at 75 kV
• Wedge filter: 1 mm brass (CuZn37 R-019; 22 mm Al equivalent at 75 kV/HVL 3.5 mm Al)

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Depending on the selected procedure, an additional filter (spectral filter) may also be applied by the
system, with the following values (for beam limiting devices with identification number 9896 010
22xxx):

Additional Filter Number Filter Filtration


0 No filter Not applicable
1 0.1 mm Cu + 1.0 mm Al 4.0 mm Al (75 kV/HVL 3.5 mm Al)
2 0.4 mm Cu + 1.0 mm Al 11.0 mm Al (75 kV/HVL 3.5 mm Al)
3 0.9 mm Cu + 1.0 mm Al 21.5 mm Al (75 kV/HVL 3.5 mm Al)

The following table shows air kerma values as a percentage of the curves as a function of the additional
filter selection.

Air Kerma Value (%)


0.5 mm lead 1.0 mm lead 1.5 mm lead
kV Filter No protection equivalence equivalence equivalence
110 0 100 100 100 100
1 66 87 85 76
2 38 69 64 53
3 19 49 47 32
90 0 64 33 34 46
1 39 27 24 31
2 19 20 15 17
3 8.5 12 9.0 9.2
70 0 35 6.0 13 22
1 18 4.1 7.2 12
2 7.1 2.4 3.1 4.6
3 2.3 1.3 1.0 1.9

The following table shows normalized air kerma values as a percentage of the curves as a function of
the additional filter selection.

Normalized Air Kerma Val-


Additional Filter ue (%)
0 100
1 120
2 135
3 150

User Dose and Imaging Information for Cone Beam CT Reconstructions


This section provides information about cone beam CT (CBCT) reconstructions.

Low-Contrast Resolution
Non-stationarity of low-contrast resolution (image noise), was evaluated through 3D reconstructions of
a Catphan 500 phantom (slice CTP515). Visual inspection of this image and similar images shows that
non-stationarity of contrast resolution is negligible: at 10 and 5 Hounsfield Units (HU), discs
representing features of 7 and 15 mm respectively are clearly visible.

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Figure 179 CBCT reconstruction of the Catphan 500 phantom, weighted CT dose (CTDIw) 50 mGy,
reconstruction slice thickness 5.2 mm, WW: 50 H, WL: 26 H, ST: 5.2 mm

For more information about the phantoms used, refer to the following website:

www.phantomlab.com

Mean CT Number
CBCT is calibrated to produce values that are accurate for the Hounsfield scale, using several calibration
methods:
• Detector gain
• Water beam hardening
• Patient scatter
• Intra-detector scatter

Truncation is corrected through parabolic extrapolation of profiles. Accuracy of mean CT numbers is


limited mainly due to variations in the anti-scatter grid (relevant for neuro and abdomen), patient
truncation (relevant for abdomen) and incompleteness of circular orbit (resulting in cone-beam
artifacts). From clinical experience, from 2006 onwards, Philips Medical Systems has observed that the
mean CT number is accurate to within approximately 20 H (neuro) and 50 H (abdomen, depending on
patient size, due to truncation). For the intended use of this product, this level of accuracy is sufficient.

Uniformity
Uniformity within an axial single slice (near the plane of rotation) is dependent on the type of object
scanned. Philips Medical Systems has measured uniformity using water phantoms (19 cm in diameter)
where uniformity is better than 2%. This level of uniformity is also observed with CBCT Head. Uniformity
with CBCT Abdomen is approximately 10%, mainly limited by scatter and truncation. Within axial slices
(near plane of rotation) the uniformity is better than across axial slices. The across axial slice uniformity
is influenced by the combination of object type and the incompleteness of semi-circular orbit of
approximately 200 degrees, resulting in cone-beam artifacts which are clearly recognizable by the user
(streaks).

Modulation Transfer Function


CBCT uses a linear reconstruction algorithm with a single reconstruction kernel. The graph below shows
the measured modulation transfer function (MTF) for a typical CBCT reconstruction.

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Figure 180 CBCT modulation transfer function simulation and measurement

Legend
1 Modulation transfer function (%) 5 3D-RX processing
2 Spatial frequency in the isocenter (lp/mm) 6 Detector
3 Measured modulation transfer function 7 Focal spot blur
4 Total simulation

Spatial Resolution and Distance Measurement


As a practical approach for measuring the MTF, the spatial resolution can be determined using a
Catphan 500 phantom. Here, slice CTP528 is used to determine the spatial resolution for cone beam CT
and 3D-RA reconstructions.

Using high-quality head or body procedures, a spatial resolution better than 5 line pairs per cm
(representing features of 1 mm) can be achieved.

A measurement accuracy better than 5% is achieved for line pairs consisting of more than 3 line-gap
transitions, which still comply to the above mentioned spatial resolution.

Figure 181 Schematic drawing and description of slice CTP528 of the Catphan 500 phantom (gap
indicated on the right side)

Line Pair/cm Gap Size Line Pair/cm Gap Size


1 0.500 cm 11 0.045 cm
2 0.250 cm 12 0.042 cm
3 0.167 cm 13 0.038 cm

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Line Pair/cm Gap Size Line Pair/cm Gap Size


4 0.125 cm 14 0.036 cm
5 0.100 cm 15 0.033 cm
6 0.083 cm 16 0.031 cm
7 0.071 cm 17 0.029 cm
8 0.063 cm 18 0.028 cm
9 0.056 cm 19 0.026 cm
10 0.050 cm 20 0.025 cm
21 0.024 cm

Tomographic Section Thickness


Cone beam CT reconstruction yields isotropic volumes based on scans made with a square-pixels
detector, therefore the MTF along the rotational axis is the same as the MTF in axial slices.

Dose Phantoms
CT dosimetry (CTDI) phantoms are used to determine the dose delivered during a cone beam CT
acquisition. The phantoms consist of circular cylinders of polymethyl methacrylate (PMMA) and are 15
cm long. Their density is 1.19 ± 0.01 g/cc. The phantom for testing CT imaging of the body has a diameter
of 32.0 cm, and the phantom for the head has a diameter of 16.0 cm. The phantoms provide the means
for placement of the dosimeters along their axis of rotation and along a line parallel to the axis of
rotation, 1.0 cm from the outer surface and within the phantom.

Dose Measurements
Actual dose values were measured with a 10 cm long, pencil-shaped ionization chamber.

CTDI Definition
The weighted CTDI dose is calculated with the formula:

CTDIW = 2/3 * (P1 + P2 + P3 + P4) / 4 + 1/3 P5 [Gy]

where Pi is the dose measured with the measurement device in position i.

Figure 182 Dose measurement positions for head (left) and body (right) application areas

CTDI Dose Measurements


The following table indicates CTDI dose measurements for 3D-RA using the largest detector field size.

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CTDI [mGy]
Procedure
Phantom Group Procedure FD20 FD15 FD12 Tolerance1
Head 3D-RA Prop 4s 3 3 6 ±50%
Abdomen 3D-RA Prop 4s 23 19 - ±50%
3D-RA Roll 8s 22 21 - ±50%
Note 1: Due to uncertainties in the dosimeter, X-ray statistics and system variations, the CT dose index (CTDI) has a margin
of ± 50%.

The following table indicates CTDI dose measurements for CBCT using the largest detector field size,
unless otherwise indicated in the procedure name.

Phantom Procedure Group Procedure CTDI [mGy] Tolerance1


Head CBCT HQ 60fps -10s 27 ±50%
Vaso CT I.A. 27cm / 10.5" I.A. 45 ±50%
Vaso CT I.A. 22cm / 8.5" I.A. 34 ±50%
Vaso CT I.V. 27cm / 10.5" I.V. 45 ±50%
Vaso CT I.V. 22cm / 8.5" I.V. 34 ±50%
Abdomen CBCT Closed Prop HQ -5s 2 24 ±50%

CBCT Closed Prop Open LD -5s 14 ±50%


CBCT Closed Roll -5s3 27 ±50%

Note 1: Due to uncertainties in the dosimeter, X-ray statistics and system variations, the CT dose index (CTDI) has a margin
of ± 50%.
Note 2: The same acquisition protocol is applied for CBCT Open and twice for CBCT Dual Phase Prop.
Note 3: The same acquisition protocol is applied twice for CBCT Dual Phase Roll.

High-Contrast Resolution
3D-RA (3D rotational angiography) reconstructions provide high-speed and high-resolution 3D
visualization of vessels and bones anatomy.

A high-contrast phantom is used in the evaluation of 3D-RA head and body procedures. Philips
Medical Systems uses a CsI C-delta (Cesium-Iodine Contrast-difference) phantom. The CsI C-delta
phantom consists of 2 cm thick, 10 cm in diameter circular cylinders of water equivalent plastic
containing CsI rods representing 8 different contrast groups. The contrast groups represent: >2700, 1160,
562, 274, 116, 53, 27 and 14 HU. For each slice two different contrast groups are present each containing
rods of 8 different diameters: 11.3; 8.0; 5.6; 4.0; 2.8; 2.0; 1.4; 1.0 mm. The discs are inserted in elliptical (or
circular) containers of water equivalent plastic depending on procedure used (head or body).

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Figure 183 Projection of the CsI C-Delta phantom displaying two different contrast groups

The readout of the smallest discernable rod diameter gives the contrast resolution. The table shows
representative values for typical head and body 3D-RA reconstructions. Although the same procedures
are used as for CTDI dose measurements, the CTDI dose for the high-contrast resolution measurements
is lower due to the smaller diameter of the CsI C-delta phantom.

Readout for FD Format


Contrast Resolution Group
Acquisition Protocol [HU] 42 cm 22 cm
Head 3D-RA Prop scan 4 s >2700 1 1
1160 1 1
562 1 1
274 1 1
116 1-1.4 2
53 4 C/N limit
27 C/N limit None
14 None None
Abdomen 3D-RA Prop scan >2700 1 1
4s
1160 1 1
562 1 1
274 1 1
116 1.4 2
53 5.7 C/N limit
27 C/N limit None
14 None None

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Readout for FD Format


Contrast Resolution Group
Acquisition Protocol [HU] 42 cm 22 cm
Abdomen 3D-RA Roll scan >2700 1 1
8s
1160 1 1
562 1 1
274 1 1
116 1.4 2
53 5.7 C/N limit
27 C/N limit None
14 None None

17.5.8 Electromagnetic Compatibility


You should only use the system in an electromagnetic environment similar to the environment
described in this section.

The Azurion medical electrical system, further referred to as the system, has been tested and complies
with IEC 60601-1-2:2007 (edition 3: collateral standard - electromagnetic compatibility) and
IEC60601-1-2:2014 (edition 4: collateral standard - electromagnetic disturbances) for medical electrical
equipment.

Emissions Declaration
Within the limits specified in the collateral EMC standards, the medical electrical system does not emit
electromagnetic disturbances that could affect radio services, other equipment or the essential
performance of other medical electrical equipment or medical electrical systems.

Immunity Declaration
Within the limits specified in the collateral EMC standards, the medical electrical system has adequate
immunity to be able to provide its basic safety and essential performance in the presence of
electromagnetic disturbances.

However, be careful when operating the system in a low-humidity environment. Extreme electrostatic
discharge of more than 8 kV on an application workstation in the control room (for example,
Interventional Workspot) may cause unrecoverable damage to the workstation hardware.

Furthermore, some performance degradation may be observed during presence of electromagnetic


disturbances:
• During severe mains power dips (>40%), the control room monitors, powered directly from hospital
mains sockets, may restart. Performance recovers automatically within a few seconds after the
disturbance has ended.
• During severe mains power dips, application workstations (for example, Interventional Workspot),
powered directly from hospital mains sockets, may restart. Performance recovers automatically
within a few minutes after the disturbance has ended.
• Electrical fast transients on mains power lines may cause distortions or blanking on monitors in the
control room. Performance recovers after the disturbance has ended.
• Electrostatic discharge on the control modules may cause the module to reset with flashing LED
indicators. Performance recovers within few seconds after the discharge.

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• Electrostatic discharge on the keyboard or mouse in the control room may cause the keyboard and
mouse to stop working. A cold system restart is required to restore functionality. For more
information, see Restarting the System (page 54).
• Severe electronic fast transients on cables in the technical room may cause distortions or blanking
on the video streams of the Optical Imaging System option (see Optical Imaging System
(Option) (page 33)). Performance recovers after the disturbance has ended.

Intended Use Environment


The system has been designed for the professional healthcare environment and do not require
additional shielding against electromagnetic disturbances. In addition, equipment intended to be used
on or near the patient table has been designed and tested to provide its basic safety and essential
performance in the presence of reasonably foreseeable disturbances caused by the use of surgical
equipment.

Floors should be wood, concrete or ceramic tile. If floors are covered with synthetic material, the
relative humidity should be at least 30%.

Supply mains quality should be that of a typical hospital environment, not exceeding overvoltage
category III for the 3-phase supply mains to the system and not exceeding overvoltage category II for
single phase hospital powered devices.

If the responsible organization requires continued operation during power mains interruptions, it is
recommended that the system is powered from a compatible uninterruptable power supply. Contact a
Philips representative for details.

Portable and mobile RF communications equipment should be used no closer to any part of the system
enclosures, including cables, than the recommended separation distance calculated from the equation
applicable to the frequency of the transmitter.

The recommended separation distance for frequencies between 150 kHz and 800 MHz can be
calculated as: d=1.2√P where P is the maximum output power rating of the transmitter in Watts (W)
according to the transmitter manufacturer and d is the recommended separation distance in meters (m).
For frequencies above 800 MHz the recommended separation distance can be calculated as: d=2.4√P.
For the specified ISM frequencies in the 150 kHz to 80 MHz frequency range, the recommended
separation distance can be calculated as: d=0.6√P.

The table below provides some concrete examples of portable and mobile RF communications
equipment and the recommended separation distance.

Rated effective radiated Recommended separation


Equipment examples power (ERP) distance
HAM radio 1.8 – 4 MHz 1,500 W 50 m
HAM radio 5.3-5.4 MHz 50 W 10 m
GSM phone 890-915 MHz 2W 1m
GSM base station 890-915 MHz 320 W 11 m
DCS1800 phone 1.7-1.8 GHz 4W 5m
DCS1800 base station 1.7-1.8 GHz 200 W 34 m
DECT phone 1.9-2 GHz 0.25 W 1.5 m
RFID 866-868 MHz 2W 1m
RFID 5.7-5.9 GHz (US only) 4W 5m
FM broadcast 88-108 MHz 100,000 W 190 m

Field strengths from fixed RF transmitters, as determined by an electromagnetic site survey, should be
less than the compliance level in each frequency range. Field strengths from fixed transmitters, such as
base stations for radio (cellular/cordless) telephones and land mobile radios, amateur radio, AM and

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FM radio broadcast and TV broadcast cannot be predicted theoretically with accuracy. To assess the
electromagnetic environment due to fixed RF transmitters, an electromagnetic site survey should be
considered. If the measured field strength in the location in which the system is used exceeds the
applicable RF compliance level, the Azurion system should be observed to verify normal operation. If
abnormal performance is observed, additional measures may be necessary, such as re-orientating or
relocating part of the system components.

Interference may occur in the vicinity of equipment marked with the following symbol:

NOTE These guidelines may not apply in all situations. Electromagnetic propagation is affected by
absorption and reflection from structures, objects and people.

The responsible organization should ensure that the environment in which the system is used complies
with the intended use environment. For further details on electromagnetic environments and
environment classification refer to IEC TR 61000-2-5.

Essential Performance
The essential performance of the system (based on IEC60601-1) is: "Maintain fluoroscopy during the
critical part of interventional procedures". It has been determined via EMC risk management and tests
that in rare circumstances with high levels of continuous disturbances at specific frequencies, line or bar
artifacts may be visible in X-ray images with a low signal-to-noise ratio.

Performance
In addition to the required immunity for basic safety and essential performance, the system has been
tested against the performance levels of IEC TR 60601-4-2:2016 (Electromagnetic immunity:
performance).

Electromagnetic Emissions
Electromagnetic emissions tests have been done in standby, movement and X-ray operating modes of
the system. Tests are done per subsystem, subsystem test results are combined to show system level
compliance with the specified limits.

The system uses RF energy only for its internal function. Therefor its RF emissions are very low and are
not likely to cause any interference in nearby electronic equipment.

Overview of standards and EMC emission tests:

Description of emis- 60601-1-2:2007 Edi- 60601-1-2:2014 Edi- 60601-4-2:2016 Per-


sion test Test standard tion 3 tion 4 formance
Conducted disturb- CISPR 11 Group I Group I Not applicable
ance at mains port Class A limits Class A limits
150 kHz – 30 MHz
Radiated disturban- CISPR 11 Group I Group I Not applicable
ces Class A limits Class A limits
30 MHz – 1000 MHz
Radiated disturban- CISPR 32 Applicable for the following enclosures:
ces • Wireless foot switch (including base station)
1 GHz – 6 GHz • Wireless mouse (including receiver dongle)
• DoseAware Xtend (PDM and Hub)

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Description of emis- 60601-1-2:2007 Edi- 60601-1-2:2014 Edi- 60601-4-2:2016 Per-


sion test Test standard tion 3 tion 4 formance
Harmonic distortion IEC 61000-3-2 Not applicable for the 3-phase supply mains because the current rating
is >16A per phase.
Applicable to 1-phase supply mains interfaces. Single-phase supply
mains interfaces are classified as Class-D and have been tested accord-
ing C.10 - Test Conditions for information technology equipment. All in-
terfaces comply with the generic conditions of clause 6.2.1 of the stand-
ard.
Voltage fluctuations IEC 61000-3-3 Not applicable for the 3-phase supply mains because the current rating
and flicker is >16A per phase.
Applicable to 1-phase supply mains interfaces. The equipment is classi-
fied for continuous use. It has been tested according A.11 and complies
with dmax limits of clause 5.

NOTE The emissions characteristics of this equipment make it suitable for use in industrial areas
and hospitals (CISPR 11 class A). If it is used in a residential environment (for which CISPR 11
class B is normally required), this equipment might not offer adequate protection to radio-
frequency communication services. You might need to take mitigation measures, such as
relocating or re-orienting the equipment.

Electromagnetic Immunity
Electromagnetic immunity tests have been done in standby, movement, and X-ray operating modes of
the system. Tests are done on subsystems, operated in a representative end-use scenario using
auxiliary equipment.

Overview of standards and EMC immunity tests:

Description of im- 60601-1-2:2007 Edi- 60601-1-2:2014 Edi- 60601-4-2:2016 Per-


munity test Test standard tion 3 tion 4 formance
Electrostatic dis- IEC 61000-4-2 ±6 kV contact ±8 kV contact ±4 kV contact
charge (ESD) ±2, 4, 8 kV air ±2, 4, 8, 15 kV air ±2, 4, 8 kV air
Radiated RF electro- IEC 61000-4-3 80-2500 MHz 80-2700 MHz 80-2700 MHz
magnetic fields 80% AM 1 kHz 80% AM 1 kHz 80% AM 1 kHz
3 V/m 3 V/m 3 V/m
Proximity fields IEC 61000-4-3 Not applicable Frequencies and levels determined by EMC risk
management. Refer to the table below.
Electrical fast transi- IEC 61000-4-4 ±1 kV (signal ports) ±1 kV (signal ports) ±0.5 kV 100 kHz
ents and bursts ±2 kV (AC power ±2 kV (AC power
ports) ports)
Surges IEC 61000-4-5 1 kV (line-line) ±0.5, 1 kV (line-line) ±0.5, 1 kV (line-line)
2 kV (line/PE) ±0.5, 1, 2 kV (line/PE) ±0.5, 1 kV (line/PE)
±4 kV (3-phase AC
supply mains)
Conducted distur- IEC 61000-4-6 0.15 – 80 MHz 80% 0.15 – 80 MHz 80% 0.15 – 80 MHz 80%
bances, induced by AM 1kHz AM 1 kHz AM 1 kHz
RF fields 3 Vrms 3 Vrms 3 Vrms on system ex-
6 Vrms ISM freq. (refer ternal interface ports
to the table below)
Voltage dips, short in- IEC 61000-4-11 Voltage dips: Voltage dips: Voltage dips:
terruptions and volt- >95%-10 ms, 0% UT 0º, 45º,.. ,315º 0% UT 0º, 180º - 10
age variations on 60%-100 ms, - 10 ms ms
power supply input 30%-500 ms, 0% UT 0º - 20 ms 70% UT 0º - 500 ms
lines Interruptions: >95%-5 70% UT 0º - 500 ms 0% UT 0º - 5000 ms
(3-phase supply s 0% UT 0º - 5000 ms
mains port1 and 1-
phase supply mains
ports not powered
from the system)

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Description of im- 60601-1-2:2007 Edi- 60601-1-2:2014 Edi- 60601-4-2:2016 Per-


munity test Test standard tion 3 tion 4 formance
Power frequency IEC 61000-4-8 50 and 60 Hz 50 Hz 50 Hz
magnetic fields 3 A/m 30 A/m 3 A/m
1
The system has been tested and found to be compliant with the YY0505 and IEC60601-1-2:2004 standards. The voltage
dip and variation tests of clause 36.202.7.a1 (table 210) have not been applied to the 3-phase supply mains interface of this
system because this interface is exempt from these tests by clause 36.202.7.a1 for the following reasons:
• The Azurion system is not life-supporting equipment.
• The rated input current on the 3-phase supply mains interface exceeds 16 A.
• The voltage interruption test of clause 36.202.7.a2 (table 211) has been applied on the 3-phase supply mains interface
and passed.

NOTE UT is the AC mains voltage prior to application of the voltage dip or short interruption test.

The following table of reasonable foreseeable ISM frequencies for conducted disturbance testing has
been determined via EMC risk management.

ISM frequency table 0.15 MHz-80 MHz conducted disturbances induced by RF fields testing:

Frequency band Test frequencies 60601-1-2:2014 Edi- 60601-4-2:2016 Per-


[MHz] [MHz] Modulation tion 4 formance
6.765-6.795 6.765, 6.795 80% AM, 1 kHz 6V 3V
12.5-20 (medical im- 16 80% AM, 1 kHz 6V 3V
plants EN 301 330)
13.553-13.567 13.56 80% AM, 1 kHz 6V 3V
26.957-27.283 26.957, 26.03, 27.283 80% AM, 1 kHz 6V 3V
29-990 (porto base- 29-80, 80% AM, 1 kHz 10 V 3V
stations, erp130W, 1% steps
d=2m)
40.66-40.70 40.66, 40.70 80% AM, 1 kHz 6V 3V

The following table of reasonable foreseeable ISM frequencies for proximity field testing has been
determined via EMC risk management.

ISM frequency table 80MHz-6GHz proximity fields testing:

Frequency band Test frequencies 60601-1-2:2014 Edi- 60601-4-2:2016 Per-


[MHz] [MHz] Modulation tion 4 formance
29-990 (porto base- 80-990, 1% steps 80% AM, 1 kHz 10 V/m 3 V/m
stations, erp 130 W,
d=2m)
380-390 385 Pulse, 18 Hz 27 V/m 6 V/m
401-406 (medical im- 405 Pulse, 18 Hz 27 V/m -
plants EN 301 839)
430-470 4342, 450 Pulse, 18 Hz 28 V/m 9 V/m

704-787 710, 745, 780 Pulse, 217 Hz 9 V/m 3 V/m


800-960 810, 870, 930 Pulse, 18 Hz 33 V/m 9 V/m
1700-1990 1720, 1845, 1970 Pulse, 217 Hz 28 V/m 9 V/m
1900-2000 1920, 1940, 1960, Pulse, 18 Hz 10 V/m -
1980
2400-2570 2410, 2430, .. 2570 Pulse, 217 Hz 28 V/m 9 V/m
5100-5800 5240, 5500, 5785 Pulse, 217 Hz 9 V/m 6 V/m
2
In Germany, Austria, Bosnia and Herzegovina, Croatia, The Former Yugoslav Republic of Macedonia, Liechtenstein, Mon-
tenegro, Portugal, Serbia, Slovenia, and Switzerland, the band 433.05-434.79 MHz (center frequency 433.92 MHz) is desig-
nated for industrial, scientific, and medical (ISM) applications.

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Radio Equipment
The following radio equipment can optionally be integrated with the medical electrical system.
Compliance with the immunity requirements for medical electrical equipment and compliance with
emission limits from 150 kHz to 1000 MHz has been shown via inclusion of the radio equipment in the
EMC subsystem tests. Compliance with the emission limits from 1000 MHz to 6000 MHz was has been
shown by tests on the individual radio equipment.

Radio equipment technical data:

Radio equipment Frequency Power (EIRP) Modulation


Wireless mouse 2400.0-2483.5 MHz < 10 mW Spectrum use: Non-specific
short range device
Wireless foot switch and 2400.0-2483.5 MHz < 10 mW Spectrum use: FHSS
base station Protocol type: Bluetooth®
Type of modulation: FSK
Channel spacing; 1 MHz
Protocol type: Bluetooth
Low Energy
Type of modulation: GFSK
Channel spacing; 2 MHz
DoseAware Xtend hub and (EU version) 868.3 MHz < 5 mW Spectrum use: Non-specific
personal dose meter (PDM) (US version) 918.3 MHz short range device
(Japan version) 927.9 MHz Type of modulation: GFSK
Duty cycle: < 1%
Channel spacing: 100 kHz
Occupied BW: 250 kHz

WARNING
The system may be subject to interference from other equipment using the same frequencies shown
above, even if the other equipment complies with emission requirements for medical devices.

Declaration of Conformity for Radio Equipment


Hereby, Philips Medical Systems Nederland B.V. declares that the radio equipment type Azurion (for
model numbers, see X-ray System Configuration (page 327)) is in compliance with Directive
2014/53/EU.

The full text of the EU declaration of conformity is available on request from the manufacturer (see
Contacting the Manufacturer (page 435)).

For the United States and Canada, the radio conformity is based on radio module license grants:
• Wireless Footswitch (3P and 4P+2), Wireless Base Station
FCC license grant number: XK5-SW100AMBINT or XK5 -SW24LE
IC license grant number: 5158A-SW100AMBINT or 5158A-SW24LE
• Wireless Mouse Logitech M525
FCC license grant number: JNZ-MR0027
IC license grant number: 4418A-MR0027

Cabling Guidance
Philips provides high quality cabling with the system and has evaluated the system to be compliant
with the emission and immunity requirements of the listed standards when installed in accordance with
the accompanying documentation. Cables supplied with the system should be used and replaced by
authorized spare parts.

Cable bundles of the system should be routed separate from foreign cables. For additional guidance on
cable bundling and routing refer to IEC TR 61000-5-2.

User supplied cables may be installed to published system external interfaces provided they comply
with the interface requirements in the accompanying documentation for the external interface. Cables

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should comply with the local regulations and public standards applicable for the interface type
(shielded CAT5e or better for network RJ45 connections, USB cables should be shielded and no longer
than 3 meter, DVI cables should be shielded and no longer than 3 meter). Ground loops via cable
shields should be prevented by using isolating wall connect boxes. Contact your Philips representative
for details.

17.5.9 Equipment Labels


This section provides information about the labels that are used on the system equipment. For an
explanation of the symbols used on the labels, see Symbols Used on the Equipment (page 426).

NOTE The following images are indicative of the actual labels used on the equipment.

System Label

Figure 184 System label

Stand Label
Labels for the following items can be found on the back of the stand:
• X-ray tube assembly
• Beam limiting device (collimator)
• Image receptor (detector)

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Figure 185 Stand label

Legend
1 Stand type, including: 3 X-ray tube assembly: varies according to system
• Part number (12NC) configuration
• Order number (ON)
• Serial number (SN)
• Date of manufacture
2 Image receptor, including: 4 Beam limiting device, including:
• Manufacturer • Part number (12NC)
• Certification label • Order number (ON)
• Serial number (SN)
• Date of manufacture
• Manufacturer
• Certification label

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Anti-Scatter Grid Label

Figure 186 Anti-scatter grid label

Legend
1 Part number (12NC) and serial number
2 Grid information: actual lines / cm: 43.0

Patient Table
The following label can be found on the connection plate at the base of the table.

Figure 187 Patient table label

The tabletop is a type B applied part, and it carries the following label:

Figure 188 Symbol indicating type B applied part

A label on tabletop indicates the maximum permissible weight on the table including accessories and
modules.

Figure 189 Patient table maximum weight label

Label text: Max. 275 kg

Table Secondary Circuit Outlet


A label for the secondary circuit outlet power socket can be found at the rear of the table base.

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Figure 190 Secondary circuit outlet label

The label text states that the socket provides up to 600 VA at 230 V (50/60 Hz) with a maximum inrush
(surge) current of 90 A.

NOTE Exceeding these ratings risks damage to the system.

The following label near the secondary circuit outlet label indicates the location of a protective
conductor (equipment grounding conductor).

The following label near the POAG-type potential equalization pins indicates the location of potential
equalization for Physio/ECG equipment or injectors. For more information, see Installation and
Equipment Connections (page 432).

Figure 191 Potential equalization label

Table Accessory Rail


The label on the table accessory rail provides information about correct use of patient straps. For more
information, see Using Patient Straps (page 62).

Figure 192 Patient straps label on the table accessory rail

Mattress Label
The label for the mattress provides basic information about the model number, part number, serial
number, and manufacturer.

Figure 193 Mattress label

Table-Mounted Radiation Shield Label


The label for the table-mounted radiation shield provides basic information about the model number,
part number, serial number, and manufacturer.

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Figure 194 Table-mounted radiation shield label

Ceiling-Suspended Radiation Shield


The following label on the ceiling-suspended radiation shield warns the user about collisions with other
equipment.

Figure 195 Collision warning label

A collision may cause damage to the suspension arm, and may result in injury to the patient or the
operator. If a collision occurs, the suspension arm should be inspected by a qualified service technician.

Viewpad Labels
The viewpad has a laser pointing device. The intended use of the laser pointing device is to point at the
images on the display monitors. Do not use this device to point at persons.

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Figure 196 Viewpad product label

The following statement on compliance applies to the viewpad:

Complies with FDA performance standards for laser products except for conformance with IEC 60825-1
Ed. 3., as described in Laser Notice No. 56, dated May 8, 2019.

Figure 197 Viewpad laser warning label

Laser Warning Label Text


Laser 2
Wavelength: 630-640 nm
Maximum output: <1mW
IEC 60825-1:2014

The viewpad laser pointing device is a class 2 laser product. Do not stare into the beam.

Monoplane Wireless Foot Switch Labels


The following labels appear on the monoplane wireless foot switch.

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Figure 198 Product label

Figure 199 FCC standards label

Biplane Wireless Foot Switch


The following labels appear on the biplane wireless foot switch.

Figure 200 Product label

Figure 201 FCC standards label

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Wireless Foot Switch Charging Unit


The following labels appear on the wireless foot switch charging unit.

Figure 202 Product labels

Wall Connection Box

The wall connection box warning label contains the following information:

Legend
1 Warning: read the instructions for use.
2 Warning: connect the device to a mains voltage in
the range of 100 to 240 V.

For more information, see the following sections:


• Wall Connection Box (page 336)
• Installation and Equipment Connections (page 432)

Wall Connection Box WCB 2.x Tx Variant


Labels for the WCB 2.x Tx variant of the wall connection box can be found on the front and side of the
box.

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Figure 203 Wall connection box labels, 2.x Tx variant

The identification label contains the following information:

Label item Content


Type/Model WCB 2.x Tx Full (PRODRIVE)
PN Part number
SN Serial number
12NC 12 digit numeric code
Barcode Scan identification code
— Voltage values, current rating, operat-
ing frequency and fuse rating

For more information, see the following sections:


• Wall Connection Box (page 336)
• Installation and Equipment Connections (page 432)

Wall Connection Box WCB-x Variant


Labels for the WCB-x variant of the wall connection box can be found on the front and side of the box.

Figure 204 Identification label, WCB-x variant

The identification label contains the following information:

Label item Left side Right side


Type/Model WCB-x (PRODRIVE) Fuse rating
PN Part number (PN) Input X1: Voltage values and operating fre-
quency
SN Serial number (SN) Output X2: Voltage values and operating fre-
quency

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Label item Left side Right side


12NC 12 digit numeric code Output X4: Voltage and current values
Barcode Scan identification code —

For more information, see the following sections:


• Wall Connection Box (page 336)
• Installation and Equipment Connections (page 432)

Cabinets
The labels for the X-ray control can be found on the top of the M-cabinet.

Figure 205 Position of labels on the X-ray control unit

The labels for the X-ray generator can be found on the top of the Generator cabinet.

Figure 206 Position of labels on the X-ray generator

XperGuide Laser Tool Label


The label for the XperGuide laser tool provides basic information about the model number, part
number, serial number and manufacturer.

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Figure 207 XperGuide laser tool label

Figure 208 Laser product label

Label text: CLASS 1 LASER PRODUCT

The following statement on compliance applies to the XperGuide laser tool:

Complies with FDA performance standards for laser products except for conformance with IEC 60825-1
Ed. 3., as described in Laser Notice No. 56, dated May 8, 2019.

Monitor Boom
For more information about the following labels, refer to the Instructions for Use supplied with the
monitor boom.

Figure 209 Monitor boom warning label

Label Text
Please don't hang anything on the handle. It may detune the spring arm.

The following label on the spring arm is applicable only for service engineers when adjusting the locking
screws. It warns the service engineer that the spring arm may jump up suddenly.

Figure 210 Locking pin warning label

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Label Text
Personal injury: Do not remove locking pin without adaption installed.

Equipment Rack
The following label indicates the maximum payload for the equipment rack. The actual weight indicated
on the label depends on the options installed in the equipment rack. For more information, refer to the
Instructions for Use supplied with the equipment rack.

Figure 211 Equipment rack maximum payload label

17.5.10 Symbols Used on the Equipment

CE Label
This symbol indicates that the equipment complies with the European Communities regulation. The
number of the notified body is indicated, if applicable.

Canadian Standards Association


This symbol indicates that the equipment has been tested and certified by the Canadian Standards
Association to comply with the applicable U.S. and Canadian Standards.

Regulatory Compliance Mark for Australia and New Zealand


This symbol indicates that the equipment complies with regulations in Australia and New Zealand.

Product Disposal
This symbol indicates that the equipment contains materials that are harmful to the environment if
disposed of incorrectly.

IP Code
IP stands for International Protection. The IP code indicates the degree of protection of an enclosure
and is regulated by IEC 60529. The first digit indicates the degree of protection for dust or solid objects,
and the second digit indicates the protection against ingress of water.

For example:
• IP00 indicates that the enclosure is not protected.
• IP24 indicates that the enclosure is protected against objects larger than 12 mm (fingers), and is
protected against splashing water from any direction.

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Class II Equipment
This symbol indicates that the equipment meets the safety requirements specified for Class II
equipment (without the use of protective earth connection).

Prescription Device
In the United States, Federal law restricts this device to sale, distribution, and use by, or on the order of,
a physician.

Manufacturer
This symbol identifies the medical device manufacturer, as defined in EU Directive 93/42/EEC. The date
of manufacture, as well as the name and address of the manufacturer, can be combined in one symbol.

Manufacturer
This symbol indicates the date when the medical device was manufactured.

Country of Manufacturer
This symbol indicates the country where the manufacturer is located.

Medical Device
This symbol indicates that the item is a medical device.

Catalog Number
This symbol indicates the manufacturer's catalog number so that the medical device can be identified.
This symbol may be shown without the enclosure.

Serial Number
This symbol indicates the manufacturer's serial number so that a specific medical device can be
identified. This symbol may be shown without the enclosure.

Unique Device Identifier


This symbol indicates the unique device identifier.

Order Number
This symbol indicates the order number.

Model Number
This symbol indicates the model number or type number of the product.

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Caution
This symbol indicates that the user should consult the Instructions for Use for details of specific
warnings or precautions that are associated with the medical device.

Consult the Instructions for Use


This symbol instructs the user to consult the Instructions for Use.

eIFU
This symbol instructs the user how to access the electronic version of the Instructions for Use. In the
control room, select the review window and then press F1 on the keyboard.

Caution
This symbol indicates that you should read the Instructions for Use as operator awareness or operator
action is required to avoid undesirable consequences.

Maximum Weight
This symbol indicates the maximum weight that can be applied to the patient table.

Battery
This symbol indicates the number and type of batteries used for the device.

Dangerous Voltage Warning


This symbol indicates that dangerous voltages are present in the associated component. Only trained
personnel may remove the system cover, or otherwise obtain access to system components. There are
no user serviceable parts and you should never attempt to repair this unit.

Intermediate Focal Spot


The value next to this symbol indicates the size of the intermediate focal spot of the X-ray tube.

Large Focal Spot


The value next to this symbol indicates the size of the large focal spot of the X-ray tube.

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Radio Frequency Transmitters


This symbol indicates the presence of radio frequency transmitters.

X-Radiation
This symbol indicates that hazardous X-rays are emitted when the equipment is in operation.

Do Not Push
This symbol indicates that you should not push or lean against the equipment because it may
overbalance and fall over.

Finger Safety
This symbol indicates that there is a risk of fingers becoming pinched in the location of the symbol.

Temperature Limits
This symbol indicates the upper and lower temperature limits within which the system should be used.

Humidity Limits
This symbol indicates the upper and lower humidity limits within which the system should be used.

Atmospheric Pressure Limits


This symbol indicates the upper and lower atmospheric pressure limits within which the system should
be used.

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Regulatory Information Frequently Used Functions

18 Regulatory Information
The system complies with relevant international and national standards and laws.

18.1 Frequently Used Functions


The system provides the following frequently used functions:
• Collimator movements, i.e. shutter movements with hardware button
• Field of view adjustment
• Performing fluoroscopy, for example:
– Selecting the fluoroscopy flavor
– Activating fluoroscopy with the foot switch
– Reviewing in last image hold
– Storing fluoroscopy series and images
• Performing exposure, for example:
– X-ray protocols
– Activating exposure with the foot switch
– Reviewing (image/series stepping and series cycle)
• Stand movements
• Tabletop horizontal and height movements
• Changing the source-to-image distance

18.2 Applied Parts


An applied part is a part of the equipment that in normal use satisfies one of the following conditions:
• The part must come into physical contact with the patient for the equipment to perform its function.
• The part can be brought into contact with the patient.
• The part needs to be touched by the patient.

Normal use is defined as "operation, including routine inspection and adjustments by any OPERATOR,
and stand-by, according to the instructions for use".

The following parts are regarded as applied parts:


• Tabletop: The applied part of the tabletop is defined as 220 cm from the edge of the head end
toward the foot end. Equipment attached to the foot end is not regarded as an applied part.
• Mattress
• Arm supports
• Head-fixing aids
• Patient straps
• Ratchet compressor (band only)
• Handgrips and clamps

The following parts are applied parts supplied by a third-party manufacturer:


• Injectors (a compatibility statement is provided with each injector)
• Operating tables (a compatibility statement is provided with each table)
• Neuro head holder

The following parts are considered accessible by the patient, and are therefore treated as applied parts:
• Table accessory rail
• Additional table accessory rail
• Table-mounted radiation shield
• Rails accessory clamp

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• Tabletop accessory clamp


• Table rail cable guides
• Dripstand
• Peripheral X-ray filter
• Detector cover, including the detector suspension and detector bodyguard
• Detector front plate
• Antiscatter grid and grid suspension
• X-ray tube assembly cover
• Cerebral filter
• Control module (in the examination room)
• Touch screen module (in the examination room)
• Pan handle
• Mouse table

The following parts are supplied by a third-party manufacturer and are treated as applied parts:
• Biosense Carto frame

All applied parts, and parts that are treated as applied parts, that are described in this section, are type
B applied parts. This is indicated by the following symbol:

Figure 212 Symbol indicating type B applied part

18.3 System Version


You can find system version details in the product information screen.

1 On the Help menu, click About.

The product information screen is displayed.

Figure 213 Product information screen

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Legend
1 Product name
2 Product release number
3 Product release date

2 To close the screen, click Close in the upper-right corner.

18.4 Third Party Software


This product uses other software, including open source software, for which licenses and copyright
notices can be found in the following location on the installation medium:

3rd_party_sw\ReadMeLeaflet.txt

18.5 Installation and Equipment Connections


The system equipment must be installed and configured entirely by a trained service engineer as part of
delivery and hand-over.

WARNING
All hospital network connections that are connected to the system must have double insulation
towards the mains voltage, according IEC 60950-1.

During use of the system or due to changes in the place of installation, modifications to the equipment
or configuration may be necessary. This must be carried out by a trained service engineer, or by third
parties expressly authorized by Philips Medical Systems to do so.

The information contained in this chapter is mandatory under the terms of IEC 60601-1 and provides a
guide for correct connection of the equipment.

The system equipment satisfies the terms of IEC 60601-1 and provides inside and outside the patient
environment, the level of safety stipulated in IEC 60601-1 provided that the equipment has been
installed with the electrical safety measures described.

Each of the following equipment forms part of the system.

Azurion X-ray Equipment


The X-ray equipment can consist of the following main parts that are located inside the patient
environment:
• Table with control modules
• Frontal and lateral stands
– Frontal and lateral X-ray tube housing assemblies with beam limiting devices
– Frontal and lateral detector assemblies
• Ceiling suspended monitors
• Optional radiation shields
• Optional examination light
• Optional injector

The X-ray equipment can consist of the following main parts that are located outside the patient
environment:
• Monitors
• Keyboard and mouse
• Control modules

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• Workstations
• Frontal and Lateral X-ray generators and cooling units
• Cabinets for system control/mains power distribution with user interfaces and viewing monitors

Item Specification
IEC or ISO standard IEC / CSA / ANSI / AAMI ES 60601-1
Location of the equipment Partly inside and partly outside the patient environment
Electrical safety measures The electrical connections to other Medical Electrical equipment are according to
IEC 60601-1. Connections have to be made by service personnel according to
service instructions.

Network Workstation and Network Printer

Item Specification
IEC or ISO standard IEC standard
Location of the equipment Outside the patient environment
Electrical safety measures The network workstation or printer shall be connected via Ethernet isolator TN-
X2.

Room Interfaces

Item Specification
IEC or ISO standard IEC / CSA / ANSI / AAMI ES 60601-1
Location of the equipment Inside and outside the patient environment
Electrical safety measures Only Philips Medical Systems service personnel are allowed to make connections
for room interfaces.
Additional cabling and connector is provided by Philips Medical Systems.

Medical DVD Recorder

Item Specification
IEC or ISO standard IEC standard
Location of the equipment Outside the patient environment
Electrical safety measures Refer to the documentation provided by the manufacturer of the equipment

Output to TV or Monitor with CVBS Input

Item Specification
IEC or ISO standard IEC standard
Location of the equipment Outside the patient environment
Electrical safety measures The equipment shall be connected to WVZ out. The TV or monitor shall be a
modern certified TV or monitor with CVBS input, with a certification like CE (Low
Voltage Directive 2006/95/EC) or IEC 60950-1.

Wall Connection Box

Item Specification
IEC or ISO standard IEC / CSA / UL 60950-1
Location of the equipment Inside the patient environment

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Item Specification
Electrical safety measures Additional equipment and system are powered from the same branch circuit of
hospital mains. Their PE domains are separated.
Additional equipment connected using a wall connection box shall (can) be con-
nected to WVB-X(ETH), WVB-X(USB), WVB-X(VIDEO).
It is not permitted to connect IEC 60950 equipment, unless a compatibility ex-
ists.
If the wall connection box is mounted inside the patient environment, the follow-
ing restrictions apply: Ambient temperature shall be below 40°C / 104°F.
Maximum load on 5V output (X4) shall be less than 1A. The wall connection box
shall be mounted such that its location is compliant with Pollution degree 2 (con-
nectors at lower side).

Item Specification
IEC or ISO standard IEC / CSA / UL 60950-1
Location of the equipment Outside the patient environment
Electrical safety measures Additional equipment and system are powered from the same branch circuit of
hospital mains. Their PE domains are separated.
Additional equipment connected using a wall connection box shall (can) be con-
nected to WVB-X(ETH), WVB-X(USB), WVB-X(VIDEO).
If the wall connection box is mounted inside the patient environment, the follow-
ing restrictions apply: Ambient temperature shall be below 35°C / 95°F.
Maximum load on 5V output (X4) shall be less than 1A. The wall connection box
shall be mounted such that its location is compliant with Pollution degree 2 (con-
nectors at lower side).

Item Specification
IEC or ISO standard IEC / CSA / UL 60601-1
Location of the equipment Inside and outside the patient environment
Electrical safety measures Additional equipment and system are powered from the same branch circuit of
hospital mains. Their PE domains are separated.
Additional equipment connected using a wall connection box shall (can) be con-
nected to WVB-X(ETH), WVB-X(USB), WVB-X(VIDEO).
If the wall connection box is mounted inside the patient environment, the follow-
ing restrictions apply: Ambient temperature shall be below 35°C / 95°F.
Maximum load on 5V output (X4) shall be less than 1A. The wall connection box
shall be mounted such that its location is compliant with Pollution degree 2 (con-
nectors at lower side).

Surgery Wall Connection Box

Item Specification
IEC or ISO standard IEC / CSA / ANSI / AAMI ES 60601-1
Location of the equipment Outside the patient environment
Electrical safety measures The surgery wall connection box (SWCB) is used with an OR system.
The connector for the pedestal injector is identical for all injectors (Burndy Met-
alok Bantam 28-pin connector). If this connector is used, a relay is needed within
the SWCB to disconnect the mains supply if the connector is removed. The cur-
rent to be disconnected can go up to 10 A.
The connector for ECG or Physiology equipment is a Burndy Metalok Bantam 23-
pin connector. Because the connector is not safe to touch, the high tension must
be disconnected by means of a relay. The current to be disconnected can go up
to 10 A.
To ground equipment, a grounding cable must be used to connect the equipment
to the SWCB.

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Equipment Rack

Item Specification
IEC or ISO standard ISO11197
Location of the equipment Inside the patient environment
Electrical safety measures The equipment rack offers a number of additional power slots that are powered
from the hospital mains directly.
To assure IEC 60601 compliance within the patient environment it is required
that:
• Only IEC 60601-1 compliant devices are connected to these power slots.
• None of these additional devices has any connection to equipment from the
Azurion configuration.
Disregarding these requirements violates the IEC 60601-1 compliance from the
Azurion system.

Interventional Workspot

Item Specification
IEC or ISO standard IEC / CSA / UL 60950
Location of the equipment Outside the patient environment
Electrical safety measures Video output 2 of the workstation shall be connected via Wall Connection Box to
the video input of a monitor in the examination room either directly or via an op-
tional Multivision switch.
Video output 1 of the workstation shall be connected to the video input of a slave
monitor in the control room either directly or via an optional Multiswitch.
In case of direct connection to slave monitor the mains cable of EP navigator
shall be connected to a hospital mains input.

Patient Table and Rear Panel Interfaces

Item Specification
IEC or ISO standard IEC / CSA / ANSI / AAMI ES 60601-1
Location of the equipment Inside the Patient environment
Electrical safety measures ECG connector: The analogue output of compatible Physio/ECG monitoring
equipment may be connected to the X1 interface on the AD7X(NT) patient table.
When specified in the accompanying documentation of the Physio/ECG equip-
ment, the functional earth plug may be connected to one of the POAG type func-
tional ground pins on the AD7X(NT) patient table.
Injector connector: Compatible contrast injector equipment may be connected to
the X2 interface on the AD7X(NT) patient table. When specified in the accompa-
nying documentation of the Physio/ECG equipment, the functional earth plug
may be connected to one of the POAG type functional ground pins on the
AD7X(NT) patient table.
Secondary Circuit Outlet: Supply mains connection for external certified medical
equipment with a supply voltage rating of 230 Vac not exceeding an input power
rating of 600 VA. Connection of external equipment to this interface is only al-
lowed if the equipment does not have other galvanic connections to supply
mains grounds or building steel (such as unintended ground loops, for example,
using shielded cables shall not be allowed).
Foot switch (2x): Connection of foot switch.

18.6 Contacting the Manufacturer


You can contact the manufacturer by post, by email, or using the Philips website.

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Manufacturer's Address
Postal address Philips Medical Systems Nederland B.V.
Veenpluis 6
5684 PC Best
The Netherlands
Email address healthcare@philips.com
Website address www.philips.com/healthcare

Note that the address is also known as: “Veenpluis 4-6”, which refers to the same physical location.

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19 Quick Reference
This section provides an overview of functions on the system that you can use as a quick reference
when you are familiar with the associated procedures.

19.1 WorkSpot
A WorkSpot consists of two monitors: the acquisition monitor and the review monitor.

The layout of the acquisition monitor and the review monitor is fixed.

In the control room, you use one keyboard and one mouse to interact with both monitors. This allows
you to perform independent tasks in each screen. You can review the acquisition patient on the review
monitor without interrupting the procedure on the acquisition monitor. This is called Instant Parallel
Working. For more information, see Instant Parallel Working (page 149).

19.1.1 Acquisition Monitor


In the WorkSpot configuration, the acquisition monitor displays the acquisition window.

The acquisition window is divided into the following areas:

2 3
Figure 214 Acquisition window

Legend
1 Main navigation area
2 Application area
3 Status area
On biplane systems, the status area is displayed along the bottom edge of the window

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Main Navigation Area


The main navigation area displays the following items:
• Patient selector: Click this button to open the patient database for patient and study administration.

• Patient information panel: This panel displays information about the acquisition patient. The
expander button opens an overview panel containing details of the study, including the
ProcedureCard. Warning messages related to the patient are also displayed here, for example, if the
patient has allergies.
• End Procedure button: Click this button to open the End Procedure window and select how to end
the procedure of the acquisition patient.

Application Area
The application area is divided into three main areas:

1 2 3
Figure 215 Application area in the acquisition window

Legend
1 Control panel
2 Main display area
On biplane systems, images from the frontal chan-
nel and the lateral channel are displayed side by
side, and are synchronized.
3 Status area

• Control panel:
– This panel provides controls and functions associated with the task that you are performing.
– Moving to another task changes the controls and functions available in the control panel.
– The global tools are always available regardless of the task to access activities such as archiving,
printing, and image information.
• Main display area:
– This area displays the images related to the selected X-ray live and reference views. The Live
view is always available and displays the last acquired series or the selected series from the

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acquisition patient. On biplane systems, images from the frontal channel and the lateral channel
are displayed side by side, and are synchronized. Reference views are available when images
from the acquisition patient are saved as reference images. A maximum of three views can be
created. Depending on the active view, the options on the task navigation panel and the main
display area change accordingly.
– The main display area contains a toolbar for manipulating the images and a control panel to
change display of images and movie tools.
– The toolbar and control panel are not always in view. They are automatically hidden if not being
used to create a larger viewing area. Move the pointer over the area to display them again.

Status Area
The status area displays the following items:
• Status icons
• Exposure/Fluoroscopy data
• Stand and detector Information
• Table information
• Dose data
• User guidance
• System information

For more information about the icons used in the status area, see Status Area (page 447).

19.1.2 Review Monitor


In the WorkSpot configuration, the review monitor displays the review window.

You can use the review window for parallel working with series from the acquisition patient or studies
and series from another patient. For more information on parallel working, see Instant Parallel
Working (page 149).

The screen layout of the review window is divided into the following areas:

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Quick Reference WorkSpot

3 4

Figure 216 Review window

Legend
1 Main navigation area 3 Application message area
2 Application area 4 Notification area
On biplane systems, images from the frontal chan-
nel and the lateral channel are displayed side by
side, and are synchronized.

Main Navigation Area


The main navigation area displays the following items:

Patient selector: Click this button to open the patient database for patient and study administration.

Acquisition tabs:
• Viewer tab: Click this tab to view the series currently being reviewed.
• More Tools tab: Click this tab to display a list of available tools. When a tool is selected a tab for the
selected tool is added.

Patient information panel:


• This panel displays information about the acquisition patient. The expander button opens an
overview panel containing details of the study, including the ProcedureCard.
• Warning messages related to the patient are also displayed here, for example, if the patient has
allergies.

Close Study: Click this button to close the study.

System menu: This menu contains options for system configuration.

Help menu: This menu provides access to the following:


• Electronic Instructions for Use
• Information about the system

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Quick Reference FlexSpot (Option)

Application Area
The application area is divided into the following areas:

Task navigation panel: This panel allows you to move between available tasks.

NOTE There is no X-ray Settings task in the review window.

Control panel:
• This panel provides controls and functions associated with the task that you are performing.
• Moving to another task changes the controls and functions available in the control panel.
• The global tools are always available regardless of the task to access activities such as archiving,
printing, and image information.

Main display area:


• This area displays the images related to the selected acquisition tab.
• The main display area contains a toolbar for manipulating the images and a control panel to change
display of images and movie tools.

On biplane systems, images from the frontal channel and the lateral channel are displayed side by side,
and are synchronized.

NOTE If the patient that you are reviewing is different to the acquisition patient then a warning
message is displayed.

Application Message Area


Each application displays its own messages in this area.

Notification Area
This area provides the following additional information about the system:
• Availability of disk storage space.
• Availability of system software updates. This notification is only displayed when updates are
available, or are being downloaded and installed. Click this notification to display the Software
Updates window.
• System connection status. Click this notification to display the System Connectivity Overview
window.
• Job viewer status. Click this notification to display the Job Viewer window.
• Remote assistance status. This notification is only displayed when remote assistance is enable and
active. You can disable remote assistance from a shortcut menu when you right-click this
notification.
• Log file status (a technical support function).
• User name of the currently logged-in user account.
• Date and time.

19.2 FlexSpot (Option)


If the FlexSpot option is installed, the monitors in the control room are replaced by up to two larger
wide-screen monitors (called the primary and secondary monitors) that are capable of displaying
multiple applications in multiple windows.

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Quick Reference FlexSpot (Option)

Figure 217 FlexSport primary monitor (left) and secondary monitor (right)

Legend
1 Top bar 4 Status area
2 Live and reference images (tabs) 5 Secondary monitor
3 Application area

The screen layout of both monitors is customizable and both monitors share a keyboard and a mouse.
You can use the pointer on either monitor allowing you to perform independent tasks in each monitor.

For example, a procedure can continue in the acquisition window while you view the acquired series in
the review window, or while you are reviewing another patient using the review window. This is called
Instant Parallel Working. For more information, see Instant Parallel Working (page 149).

NOTE The acquisition window is always displayed, but you can choose on which monitor to display
it.

19.2.1 FlexSpot Primary Monitor


The status area is always displayed on the FlexSpot primary monitor regardless of where the acquisition
window is displayed.

The primary monitor has three areas that are always displayed:
• Top bar
• Application area
• Status area

Top Bar
Applications: You can drag and drop available applications on to the screen from the top bar.

Presets: Pre-defined screen layouts are displayed here and you can select screen layouts for both the
primary monitor and secondary monitor.

Examination Room: You can manage the applications and presets used in the examination room, from
the control room.

You can select a workstation to connect to the control room USB ports.

Keyboard lock status icons: only displayed if the additional FlexSpot option with a second keyboard is
installed.

FlexSpot menu: You can access FlexSpot and FlexVision preset management, workstation power
management functions and system information.

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Quick Reference FlexVision (Option)

Application Area
The application area is similar to the application area of the acquisition monitor of systems without the
FlexSpot option. For more information, see Acquisition Monitor (page 437).

Status Area
The status area contains the following items:
• Status icons
• Exposure/fluoroscopy data
• Stand and detector information
• Table information
• Dose data
• User guidance
• System information

19.2.2 FlexSpot Secondary Monitor


The FlexSpot secondary monitor does not display the system menus in the header area. To access
items in the System menu (for example, Customization or Manage ProcedureCards), make sure that
the review window is displayed somewhere on one of the two monitors.

19.2.3 Additional FlexSpot


The Additional FlexSpot is situated in the control room or examination room. It is a single-monitor
WorkSpot that can be added to a FlexSpot configuration.

It provides one window displaying one application at a time. Depending on the configuration, you can
change the application that is displayed in the window.

A keyboard and mouse are also provided for this monitor.

19.3 FlexVision (Option)


FlexVision is a single ultra-high-definition monitor situated in the examination room.

The FlexVision monitor has three areas that are always displayed:
• Top bar
• Status area
• Live X-ray window

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Quick Reference FlexVision (Option)

Figure 218 FlexVision monitor screen layout

Legend
1 Top bar
2 Status area (the location of the status area depends
on the selected preset)
3 Live, reference, and application windows (the
screen layout depends on the selected preset)

Top Bar
Applications: You can drag and drop available applications on to the screen from the top bar.

Presets: Pre-defined screen layouts are displayed here and you can select screen layouts.

Status Area
The location of the status area depends on the selected preset. The status area contains the following
items:
• Status icons
• Exposure/fluoroscopy data
• Stand and detector information
• Table information
• Dose data
• User guidance
• System information

On biplane systems, the status area displays separate status items for the frontal channel and the
lateral channel. For more information, see Status Area On FlexVision (Biplane System) (page 455).

Live X-ray Window


The live X-ray window is always displayed and provides details of the acquisition patient.

On-Screen Mouse and Keyboard


When FlexVision is installed, an on-screen keyboard and mouse application may be available on the
touch screen module, depending on the licenses installed on the system. Using the on-screen
keyboard, you can control applications without using the optional mouse at the tableside. The mouse
pointer is controlled using a touchpad on the touch screen module with two buttons for left-click and
right-click actions.

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Quick Reference Touch Screen Module

The on-screen keyboard layout is determined by the language selected in the system's regional
settings. For more information, see Changing Regional Settings (page 263).

You can activate the on-screen keyboard and mouse application using the application selector.

19.4 Touch Screen Module


You use the touch screen module to control acquisition settings, applications, monitor layouts and
presets, and to process acquisition images for review and post-processing in the acquisition window.

The buttons that are available on the module depend on the active procedure or system configuration.

Figure 219 Touch screen module

Legend
1 Active application 5 Fluoro Store button (stores fluoroscopy images
from the current series while the button is pressed)
2 Applications button (displays the Applications win- 6 Stopwatch button (starts or stops the stopwatch
dow) display on one of the monitors in the examination
room)
3 Active application tab 7 X-ray button (enables or disables X-ray)
4 Application tabs for running applications

Applications
When you tap the Applications button, the Applications window is displayed. You can start an
application by tapping it.

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Quick Reference Touch Screen Module

Figure 220 Applications window

If there are more applications available than can be shown on one page of thumbnails, additional pages
are indicated below the thumbnails. Swipe to view the additional pages.

19.4.1 Touch Screen Gestures


You can use touch gestures on the touch screen module.

Gesture Action Effect


Tap Tap the screen on a function Activates the function

Drag Touch an item or region in the window Drags an item on the screen, or pans
and move across the screen the image

Press Press and hold Displays the pointer. You can then drag
the pointer to an item or region of in-
terest. The pointer is hidden when you
remove your finger from the screen

Slide Touch a list item and move up or down Scrolls the list

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Quick Reference Status Area

Gesture Action Effect


Stretch Place two fingers close together on the Zoom in at this position
screen and move them apart

Pinch Place two fingers a distance apart on Zoom out from this position
the screen and move them towards
each other

Double tap Tap the screen twice • If the image is not already
zoomed, a double tap zooms the
image to twice the default magni-
fication
• If the image is already zoomed, a
double tap resets the zoom and
pan settings
Tap the mini viewport twice (biplane Swaps the contents of the mini view-
systems) port and the main viewport

Using Gestures with the Markers Function


When using the touch screen module with the Markers function, you can perform the following
interactions:
• To draw a straight line, touch the screen with two fingers.
• To draw a round shape, touch the screen with three fingers.

19.5 Status Area


The status area displays information about the status of the X-ray system, including settings in use and
messages.

19.5.1 Status Area - Monoplane System


On a monoplane system, the status area is visible on the acquisition window in the control room and in
the live X-ray window in the examination room.

Azurion Release 2.2 Instructions for Use 447 Philips 4523 001 01511
Quick Reference Status Area

Status Area in the Control Room (Monoplane System)

Figure 221 Status area in the control room acquisition window

Legend Description

System status The system is ready for exposure.

System status The system is not ready for exposure.

X-ray status X-ray is on.

X-ray status X-ray is disabled.

3 Tube load The tube is overheated.

Fluoroscopy Fluoroscopy settings are displayed.

Exposure Exposure settings are displayed.


4

- kV
- mA X-ray generator settings
- ms
- LAO Stand rotation angle.
5
- CRAN Stand angulation angle.
6 - SID The actual or target source-to-image distance.
7 - FD The selected detector size.

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Quick Reference Status Area

Legend Description

Table transverse isocen-


8 The transverse offset of the table from the isocenter position.
ter offset 1

Table longitudinal iso-


9 The longitudinal offset of the table from the isocenter position.
center offset 1

Table height isocenter


10 The height offset of the table from the isocenter position.
offset 1

11 Isocenter 1 The table is in the isocenter position.

12 Table tilt 1 The table tilt angle.

13 Table cradle 1 The table cradle angle.

14 Table pivot 1 The table pivot angle.

15 - System information System information, warnings, and error messages.


16 - X-ray protocol The selected procedure settings.
17 - Dose model For more information, see Dose Model (page 481).
Air kerma in skin area
18 - Displays the air kerma rate (mGy/min).
rate 2
19 - Cumulative air kerma Displays the cumulative air kerma (mGy).

20 - Dose area product Displays the cumulative dose area product (Gy cm2).
21 - Total fluoroscopy time Displays the total fluoroscopy time.

System time / stop- Displays the system time. If the stopwatch is active, the stopwatch time is
22
watch displayed.

1
If a collision is detected, this section in the status area displays collision detection warnings and icons.
2
Only displayed if the thorax region is selected.

Status Area in the Examination Room (Monoplane System)

16

13 17

Figure 222 Status area in the examination room live X-ray window

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Quick Reference Status Area

Legend Description

System status The system is ready for exposure.

System status The system is not ready for exposure.

X-ray status X-ray is on.

X-ray status X-ray is disabled.

3 Tube load The tube is overheated.

Fluoroscopy Fluoroscopy settings are displayed.

Exposure Exposure settings are displayed.


4

- kV
- mA X-ray generator settings
- ms
- LAO Stand rotation angle.
5
- CRAN Stand angulation angle.
6 - SID The actual or target source-to-image distance.
7 - FD The selected detector size.

Table transverse isocen-


8 The transverse offset of the table from the isocenter position.
ter offset 1

Table longitudinal iso-


9 The longitudinal offset of the table from the isocenter position.
center offset 1

Table height isocenter


10 The height offset of the table from the isocenter position.
offset 1

11 Isocenter 1 The table is in the isocenter position.

12 Table tilt 1 The table tilt angle.

13 Table cradle 1 The table cradle angle.

14 Table pivot 1 The table pivot angle.

15 - System information System information, warnings, and error messages.


16 - X-ray protocol The selected procedure settings.
17 - Dose model For more information, see Dose Model (page 481).
Air kerma in skin area
18 - Displays the air kerma rate (mGy/min).
rate 2
19 - Cumulative air kerma Displays the cumulative air kerma (mGy).

20 - Dose area product Displays the cumulative dose area product (Gy cm2).
21 - Total fluoroscopy time Displays the total fluoroscopy time.

System time / stop- Displays the system time. If the stopwatch is active, the stopwatch time is
22
watch displayed.

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Quick Reference Status Area

1
If a collision is detected, this section in the status area displays collision detection warnings and icons.
2
Only displayed if the thorax region is selected.

19.5.2 Status Area - Biplane System


On a biplane system, the status area is visible on the acquisition window in the control room. In the
examination room, the status bar is split across the live X-ray window and reference window.

Status Area in the Control Room (Biplane System)

Figure 223 Status area in the control room acquisition window

Legend Description

Channel indicator Frontal channel

Channel indicator Lateral channel

The channel is ready for exposure (when a channel is selected for exposure,
System status
this section of the status area is highlighted)

1 System status The channel is not ready for exposure

X-ray status X-ray is on

X-ray status X-ray is disabled

Tube load The tube is overheated

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Quick Reference Status Area

Legend Description

Fluoroscopy Fluoroscopy settings are displayed

Exposure Exposure settings are displayed


2

- kV
- mA X-ray generator settings
- ms
- LAO Stand rotation angle
3
- CRAN Stand angulation angle
4 - SID The actual or target source-to-image distance
5 - FD The selected detector size
6 - Dose model For more information, see Dose Model (page 481)
7 - mGy/min Air kerma rate
8 - min Fluoro time (for the channel)
9 - mGy Cumulative air kerma

Table tilt 1 The table tilt angle

10 Table cradle 1 The table cradle angle

Table pivot 1 The table pivot angle

Table transverse isocen-


The transverse offset of the table from the isocenter position
ter offset 1

Table longitudinal iso-


The longitudinal offset of the table from the isocenter position
center offset 1
11
Table height isocenter
The height offset of the table from the isocenter position
offset 1

Isocenter 1 The table is in the isocenter position

12 - X-ray protocol The selected procedure settings


13 - fps Exposure speed (selected/actual)
14 - Fluoroscopy flavor The currently selected fluoroscopy flavor

15 - Dose area product Displays the cumulative dose area product (Gy cm2)
16 - Total fluoroscopy time Displays the total fluoroscopy time

System time / stop- Displays the system time. If the stopwatch is active, the stopwatch time is
17
watch displayed

1
If a collision is detected, this section in the status area displays collision detection warnings and icons.
2
Only displayed if the thorax region is selected.

Azurion Release 2.2 Instructions for Use 452 Philips 4523 001 01511
Quick Reference Status Area

Status Area in the Examination Room (Biplane System)

Figure 224 Status area in the examination room live X-ray window and reference window

Legend Description

Channel indicator Frontal channel

Channel indicator Lateral channel

The system is ready for exposure (when a channel is selected for exposure,
System status
this section of the status area is highlighted)

1 System status The system is not ready for exposure

X-ray status X-ray is on

X-ray status X-ray is disabled

Tube load The tube is overheated

Fluoroscopy Fluoroscopy settings are displayed

Exposure Exposure settings are displayed


2

- kV
- mA X-ray generator settings
- ms
- LAO Stand rotation angle
3
- CRAN Stand angulation angle
4 - SID The actual or target source-to-image distance
5 - FD The selected detector size

Azurion Release 2.2 Instructions for Use 453 Philips 4523 001 01511
Quick Reference Status Area

Legend Description

Channel indicator Frontal channel

Channel indicator Lateral channel

7 - Dose model For more information, see Dose Model (page 481)
8 - mGy/min Air kerma rate
9 - min Fluoro time (for the channel)
10 - mGy Cumulative air kerma

System time / stop- Displays the system time. If the stopwatch is active, the stopwatch time is
11
watch displayed

12 - X-ray protocol The selected procedure settings


13 - fps Exposure speed (selected/actual)
14 - Fluoroscopy flavor The currently selected fluoroscopy flavor

Table tilt 1 The table tilt angle

15 Table cradle 1 The table cradle angle

Table pivot 1 The table pivot angle

Table transverse isocen-


The transverse offset of the table from the isocenter position
ter offset 1

Table longitudinal iso-


The longitudinal offset of the table from the isocenter position
center offset 1
16
Table height isocenter
The height offset of the table from the isocenter position
offset 1

Isocenter 1 The table is in the isocenter position

17 - Dose area product Displays the cumulative dose area product (Gy cm2)
18 - Total fluoroscopy time Displays the total fluoroscopy time

1
If a collision is detected, this section in the status area displays collision detection warnings and icons.
2
Only displayed if the thorax region is selected.

Azurion Release 2.2 Instructions for Use 454 Philips 4523 001 01511
Quick Reference Status Area

Status Area On FlexVision (Biplane System)

Legend Description

Channel indicator Frontal channel

Channel indicator Lateral channel

The system is ready for exposure (when a channel is selected for exposure,
System status
this section of the status area is highlighted)

1 System status The system is not ready for exposure

X-ray status X-ray is on

X-ray status X-ray is disabled

Tube load The tube is overheated

Azurion Release 2.2 Instructions for Use 455 Philips 4523 001 01511
Quick Reference Status Area

Legend Description

Fluoroscopy Fluoroscopy settings are displayed

Exposure Exposure settings are displayed


2

- kV
- mA X-ray generator settings
- ms
- LAO Stand rotation angle
3
- CRAN Stand angulation angle
4 - SID The actual or target source-to-image distance
5 - FD The selected detector size

Table tilt 1 The table tilt angle

6 Table cradle 1 The table cradle angle

Table pivot 1 The table pivot angle

7 Isocenter 1 The table is in the isocenter position

Frontal channel system


8 - System information, warnings, and error messages for the frontal channel
messages
Lateral channel system
9 - System information, warnings, and error messages for the lateral channel
messages
- X-ray protocol The selected procedure settings
10 - fps Exposure speed (selected/actual)
- Fluoroscopy flavor The currently selected fluoroscopy flavor
11 - Dose model For more information, see Dose Model (page 481)
12 - mGy/min Air kerma rate
13 - min Fluoro time (for the channel)
14 - mGy Cumulative air kerma

- Dose area product Displays the cumulative dose area product (Gy cm2)
15
- Total fluoroscopy time Displays the total fluoroscopy time

System time / stop- Displays the system time. If the stopwatch is active, the stopwatch time is
16
watch displayed

1
If a collision is detected, this section in the status area displays collision detection warnings and icons.
2
Only displayed if the thorax region is selected.

Azurion Release 2.2 Instructions for Use 456 Philips 4523 001 01511
Quick Reference Status Area

Status Area On FlexSpot (Biplane System)

Legend Description

Channel indicator Frontal channel

Channel indicator Lateral channel

The system is ready for exposure (when a channel is selected for exposure,
System status
this section of the status area is highlighted)

1 System status The system is not ready for exposure

X-ray status X-ray is on

X-ray status X-ray is disabled

Tube load The tube is overheated

Fluoroscopy Fluoroscopy settings are displayed

Exposure Exposure settings are displayed


2

- kV
- mA X-ray generator settings
- ms
- LAO Stand rotation angle
3
- CRAN Stand angulation angle
4 - SID The actual or target source-to-image distance
5 - FD The selected detector size

Azurion Release 2.2 Instructions for Use 457 Philips 4523 001 01511
Quick Reference Status Area

Legend Description

Table tilt 1 The table tilt angle

Table cradle 1 The table cradle angle

Table pivot 1 The table pivot angle

Table transverse isocen-


6 The transverse offset of the table from the isocenter position
ter offset 1

Table longitudinal iso-


The longitudinal offset of the table from the isocenter position
center offset 1

Table height isocenter


The height offset of the table from the isocenter position
offset 1

Isocenter 1 The table is in the isocenter position

7 - System messages System information, warnings, and error messages (for each channel)
- X-ray protocol The selected procedure settings
8 - fps Exposure speed (selected/actual)
- Fluoroscopy flavor The currently selected fluoroscopy flavor
9 - Dose model For more information, see Dose Model (page 481)
10 - mGy/min Air kerma rate
11 - min Fluoro time (for the channel)
12 - mGy Cumulative air kerma

13 - Dose area product Displays the cumulative dose area product (Gy cm2)
14 - Total fluoroscopy time Displays the total fluoroscopy time

System time / stop- Displays the system time. If the stopwatch is active, the stopwatch time is
15
watch displayed

1
If a collision is detected, this section in the status area displays collision detection warnings and icons.
2
Only displayed if the thorax region is selected.

19.5.3 Collision Indicators


When a collision is detected, a collision indicator is displayed in the status area.

Icon Description

A detector collision has been detected

A detector collision has been detected by the force sensor

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Quick Reference Status Area

Icon Description

A stand collision has been detected (depending on the stand in use)

A tube collision has been detected

A collision with a person or object in the wall zone has been detected (FlexArm option)

A collision of the frontal stand and the lateral stand has been detected

A lateral stand collision has been detected

A detector collision on the lateral stand has been detected

A tube collision on the lateral stand has been detected

The X-ray beam is misaligned. The image size is reduced. Align the detector to portrait or landscape
orientation.

A table collision has been detected

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Quick Reference Status Area

Icon Description

A collision between the stand and the table has been detected

A collision between the lateral stand and the table has been detected

A table collision has been detected and the protective zone has been activated.

A table collision has been detected and the extended protective zone has been activated.

A table collision has been detected and the finger-pinching zone has been activated.

The table position is unknown and movement speed has been reduced.

A table collision has been detected and prevented.

A collision between the table and the stand has been detected and prevented.

A collision between the system and a tabletop-mounted component has been detected and pre-
vented.

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Quick Reference Toolbars

Icon Description

A collision between the stand and a tabletop-mounted component has been detected and preven-
ted.

A collision between the stand and a tabletop-mounted component has been detected and preven-
ted.

A collision between the stand and a tabletop-mounted component has been detected and preven-
ted.

19.6 Toolbars

Acquisition and Review Windows

Tool Function Description

Default Default selection

Zoom Zoom the image

Pan Pan the image

Contrast and Brightness Adjust the contrast and brightness of the image

Edge enhancement Sharpen or soften edges in the image

Interventional room pointer Activate the image pointer

Subtraction Switch subtraction on or off

Pixel shift Reposition the mask image

Landmarking Apply landmarking

Fluoro store Store fluoroscopy images

Copy the current image to the Reference 1 window


Copy to Reference 1
On biplane systems, the frontal image is copied.

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Quick Reference Toolbars

Tool Function Description

Copy the current image to the Reference 2 window


Copy to Reference 2
On biplane systems, the lateral image is copied.

Copy the current image to the Reference 3 window


Copy to Reference 3 On biplane systems, images from both channels are copied, and are dis-
played side by side and synchronized.

Flag image Flag the current image

Flag series Flag the current series

Sets the scope when processing biplane images:


• Biplane Unlinked: Changes can be applied independently to both the
Link image processing (bi-
frontal and lateral images
plane systems only)
• Biplane Linked: Changes applied to one image are automatically ap-
plied to both the frontal and lateral images

Snapshot Copy the current image as a photo image

Quantitative Coronary Anal-


Starts Quantitative Coronary Analysis
ysis

Quantitative Vascular Anal-


Starts Quantitative Vascular Analysis
ysis

Left Ventricular Analysis Starts Left Ventricular Analysis

Biplane Left Ventricular


Starts Biplane Left Ventricular Analysis
Analysis

Right Ventricular Analysis Starts Right Ventricular Analysis

Biplane Right Ventricular


Starts Biplane Right Ventricular Analysis
Analysis

Reset Reset image processing

Series Review

Tool Function Description

Play Play the series review

Pause Pause the series review

Next image Display the next image in the series

Previous image Display the previous image in the series

Next series Display the next series in the study

Previous series Display the previous series in the study

Azurion Release 2.2 Instructions for Use 462 Philips 4523 001 01511
Quick Reference Global Tools

Tool Function Description

Frame rate Adjust the frame rate

Cycle all Play all images and series in the study

Image overview Show an overview of all images in the series

Series overview Show an overview of all series in the study

19.7 Global Tools


The global tools are available in all tasks and provide tools for printing images, exporting images, and
displaying patient information.

Tool Function

Exports the image as seen in the main window. You can select the destina-
Export
tion (connected device or location) and the format.

Displays a preview of the series and images to be automatically archived


when the current study is ended. Series and images are automatically ar-
Archive Preview chived if automatic data transfer is configured. For more information about
configuring the system to transfer data automatically, see Configuring Auto-
matic Data Transfer (page 275).

Adds the image as seen in the main window to the print queue. The print
Add to Print Preview
queue can be managed using the Print application.

Provides different levels of patient information that can be displayed on the


image in the main window:
• Full image information
Image overlays • Limited image information
• Minimum image information (mandatory information)
On biplane series, image overlays are displayed for each channel, except for
the patient identification, which is displayed on the frontal image only.

19.8 Control Modules


The control module provides functions for moving the stand and acquiring images.

The following control modules are available:


• Monoplane control module
• Biplane control modules
• FlexArm control module (option)

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Quick Reference Control Modules

19.8.1 Monoplane Control Module

2 3 5
0
1 7 8 10 13

4 6 9 11 12

14 15 16 17 18 19

Figure 225 Monoplane control module

Legend Description
Moves the tabletop in the longitudinal and transverse directions. This func-
1 Float tabletop tion operates only at the table side position. It is disabled in the control
room and at the pedestal.

Tilt table Tilts the table up.

Tilt table Tilts the table down.

Cradle table Cradles the table left.

Cradle table Cradles the table right.

Move stand (longitudi-


3 Moves the stand longitudinally (ceiling-mounted only).
nal)

4 Rotate stand Rotates (swings) the stand.

Resets the stand and table to a default position. This function is disabled in
5 Reset geometry
the control room.
When using automatic position control, this function recalls a selected
stand or table position. The indicator light flashes when a new position is
6 Accept selected or when the stand is moved away from the selected position. The
indicator light is on while the position is being recalled. The indicator light is
off when the selected position is reached.
Stores fluoroscopy images during and after fluoroscopy. If the indicator light
7 Store fluoroscopy is on during fluoroscopy, images are being stored. After fluoroscopy, the in-
dicator light flashes once to indicate images have been stored.

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Quick Reference Control Modules

Legend Description

Reset fluoroscopy buz- Reset the fluoroscopy buzzer. The indicator light flashes when the buzzer is
8
zer activated.

9 Field of view Increases and decreases the detector field of view.

Selects the fluoroscopy level to be used. The three indicator lights show the
selected level. When low load-fluoroscopy is selected the indicator lights
are off.
10 Fluoroscopy flavor
• One indicator light: Low (with ClarityIQ (option): Low)
• Two indicator lights: Normal (with ClarityIQ (option): Medium)
• Three indicator lights: High (with ClarityIQ (option): Normal)

Selects the current image as the SmartMask image. This function is disabled
11 SmartMask
if the selected procedure settings do not support roadmap.

Switches the roadmap function on or off. This function is disabled if the se-
12 Roadmap
lected procedure settings do not support roadmap.

Stops all geometry movements. For information about restarting after an


13 Emergency stop
emergency stop, see Restarting the System (page 54).

Table height Adjusts the height of the table.

14
Table pivot unlock Unlocks the table pivot lock.

Rotate detector Moves the detector between portrait and landscape positions.

15
Source-to-image dis-
Changes the source-to-image distance.
tance

Angulation Controls the angulation position of the stand.

16

Rotation Controls the rotation position of the stand.

17 Shutters Opens and closes the shutters.

18 Left wedge Moves, rotates, and resets the left wedge.

19 Right wedge Moves, rotates, and resets the right wedge.

Azurion Release 2.2 Instructions for Use 465 Philips 4523 001 01511
Quick Reference Control Modules

19.8.2 Biplane Control Modules

Legend Description
Moves the tabletop in the longitudinal and transverse directions. This func-
1 Float tabletop tion operates only at the table side position. It is disabled in the control
room and at the pedestal.

Tilt table Tilts the table up.

Tilt table Tilts the table down.

Cradle table Cradles the table left.

Cradle table Cradles the table right.

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Quick Reference Control Modules

Legend Description

3 Rotate frontal stand Rotates (swings) the frontal stand.

4 Rotate biplane Rotates (swings) the frontal stand and the lateral stand.

Resets the stand and table to a default position. This function is disabled in
5 Reset geometry
the control room.
When using automatic position control, this function recalls a selected
stand or table position. The indicator light flashes when a new position is
6 Accept selected or when the stand is moved away from the selected position. The
indicator light is on while the position is being recalled. The indicator light is
off when the selected position is reached.

Move lateral stand (lon-


7 Moves the lateral stand longitudinally.
gitudinal)

Stops all geometry movements. For information about restarting after an


8 Emergency stop
emergency stop, see Restarting the System (page 54).

Table height Adjusts the height of the table.

9
Table pivot unlock Unlocks the table pivot lock.

Detector position Moves the detector between portrait and landscape positions.
10
Source-to-image dis-
Changes the source-to-image distance of the frontal stand.
tance

Angulation Controls the angulation position of the frontal stand.

11

Rotation Controls the rotation position of the frontal stand.

Source-to-image dis-
12 Changes the source-to-image distance of the lateral stand.
tance

Angulation Controls the angulation position of the lateral stand.

13

Rotation Controls the rotation position of the lateral stand.

Alternates between the acquisition channels: frontal or lateral. The illumina-


14 Select channel
ted symbol indicates the current selection.

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Quick Reference Control Modules

Legend Description
Stores fluoroscopy images during and after fluoroscopy. If the indicator light
15 Store fluoroscopy is on during fluoroscopy, images are being stored. After fluoroscopy, the in-
dicator light flashes once to indicate images have been stored.

Reset fluoroscopy buz- Reset the fluoroscopy buzzer. The indicator light flashes when the buzzer is
16
zer activated.

Increases and decreases the detector field of view on the selected acquisi-
17 Field of view
tion channel: frontal or lateral.
Selects the fluoroscopy level to be used. The three indicator lights show the
selected level. When low load-fluoroscopy is selected the indicator lights
are off.
18 Fluoroscopy flavor
• One indicator light: Low (with ClarityIQ (option): Low)
• Two indicator lights: Normal (with ClarityIQ (option): Medium)
• Three indicator lights: High (with ClarityIQ (option): Normal)

Selects the current image as the SmartMask image. This function is disabled
19 SmartMask
if the selected procedure settings do not support roadmap.

Switches the roadmap function on or off. This function is disabled if the se-
20 Roadmap
lected procedure settings do not support roadmap.

21 Shutters Opens and closes the shutters on the frontal channel.

22 Left wedge Moves, rotates, and resets the left wedge on the frontal channel.

23 Right wedge Moves, rotates, and resets the right wedge on the frontal channel.

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Quick Reference Control Modules

19.8.3 FlexArm Control Module (Option)

Figure 226 FlexArm control module (option)

Legend Description
Moves the tabletop in the longitudinal and transverse directions. This func-
1 Float tabletop tion operates only at the table side position. It is disabled in the control
room and at the pedestal.

Tilt table Tilts the table up.

Tilt table Tilts the table down.

Cradle table Cradles the table left.

Cradle table Cradles the table right.

Move stand (longitudi-


Moves the stand longitudinally.
nal)
3

Rotate stand Rotates (swings) the stand.

4 Not used
Resets the stand and table to a default position. This function is disabled in
5 Reset geometry
the control room.
When using automatic position control, this function recalls a selected
stand or table position, or a selected path. The indicator light flashes when
6 Accept a new position is selected or when the stand is moved away from the selec-
ted position. The indicator light is on while the position is being recalled.
The indicator light is off when the selected position is reached.
Stores fluoroscopy images during and after fluoroscopy. If the indicator light
7 Store fluoroscopy is on during fluoroscopy, images are being stored. After fluoroscopy, the in-
dicator light flashes once to indicate images have been stored.

Reset fluoroscopy buz- Reset the fluoroscopy buzzer. The indicator light flashes when the buzzer is
8
zer activated.

9 Field of view Increases and decreases the detector field of view.

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Quick Reference Control Modules

Legend Description
Selects the fluoroscopy level to be used. The three indicator lights show the
selected level. When low load-fluoroscopy is selected the indicator lights
are off.
10 Fluoroscopy flavor
• One indicator light: Low (with ClarityIQ (option): Low)
• Two indicator lights: Normal (with ClarityIQ (option): Medium)
• Three indicator lights: High (with ClarityIQ (option): Normal)

Selects the current image as the SmartMask image. This function is disabled
11 SmartMask
if the selected procedure settings do not support roadmap.

Switches the roadmap function on or off. This function is disabled if the se-
12 Roadmap
lected procedure settings do not support roadmap.

Stops all geometry movements. For information about restarting after an


13 Emergency stop
emergency stop, see Restarting the System (page 54).

Table height Adjusts the height of the table.

14
Table pivot unlock Unlocks the table pivot lock.

Rotate detector Moves the detector between portrait and landscape positions.

Source-to-image dis-
Changes the source-to-image distance.
tance

15
Reset landscape align-
Moves the detector to the landscape position.
ment

Reset portrait aligne-


Moves the detector to the portrait position.
ment

Angulation Controls the angulation position of the stand.

16

Rotation Controls the rotation position of the stand.

17 Shutters Opens and closes the shutters.

18 Left wedge Moves, rotates, and resets the left wedge.

19 Right wedge Moves, rotates, and resets the right wedge.

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Quick Reference Review Module

19.9 Review Module


The review functions on the review module operate on the active tab in the acquisition window.

Figure 227 Review module

Legend Description
Used to switch the system on or perform a warm restart. The indicator light
1 Power on is on when the system is on or starting. To operate, this button should be
pressed for 2 seconds.

Used to switch the system off. To operate, this button should be pressed for
2 Power off
2 seconds.

Used to switch on the monitors only (video-only mode) in the examination


and control rooms. The indicator light flashes during video-only start up
3 Video on
and is on when the monitors are on in video-only mode. To operate, this
button should be pressed for 2 seconds.

Reset fluoroscopy buz- Reset the fluoroscopy buzzer. The indicator light flashes when the buzzer is
4
zer activated.

Disables and enables stand and table movements. The indicator light is on
Disable geometry
5 when stand and table movements are disabled. To operate, this button
movements
should be pressed for 2 seconds.

6 Disable radiation Disables and enables X-ray. The indicator light is on when X-ray is disabled.

Displays the previous overview page in the series overview and study over-
7 Previous page
1 view.

8 Next page Displays the next overview page in the series overview and study overview.
1

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Quick Reference Using the Mouse

Legend Description

Starts and stops replay of the images within the current series. The indicator
9 Cycle all
light is on when replay is active.

10 Previous series Displays the previous series.

11 Next series Displays the next series.

Switches between overview and single study viewing modes. The indicator
12 Study overview
light is on when overview mode is in use.

Starts and stops replay of the series within the current study. The indicator
13 Series replay
light is on when replay is active.

Displays the previous image in a series. This function is disabled in study


14 Previous image
overview mode.

Displays the next image in a series. This function is disabled in study over-
15 Next image
view mode.

Switches between overview and single image viewing modes. The indicator
16 Series overview
light is on when overview mode is in use.

19.10 Using the Mouse


You can access several function shortcuts with the mouse.

The following functions are available:

Left button: Click to select a tool or item.

Mouse wheel: Rotate to navigate the images of a series or items in a list.

Mouse wheel button: Press and hold to adjust the WW/WL or brightness/contrast settings.

Right button: Click to open the shortcut menu.

Right button: Drag (click and hold) to pan the image.

Mouse wheel button + right button: Drag (click and hold) zoom the image.

19.11 Viewpad
The viewpad is a handheld remote control that you can use to control viewing and processing functions
from anywhere in the examination room.

A laser pointer is located on the front of the viewpad. You activate the laser pointer using the button on
the underside of the viewpad. The quality of the laser pointer is affected when using a sterile cover.

NOTE Do not point the laser into people’s eyes, as there is a risk of injury.

Two versions of the viewpad are available: cardio and vascular. The vascular viewpad has additional
functions.

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Quick Reference Viewpad

1 2 3 1 2 3

4 5 4 5

6 7 6 7

8 9 8 9 16

10 11 12 10 11 12

13 14 15

Figure 228 Viewpad: vascular version (left), cardio version (middle), and underside (right)

Legend
Copies the current image to the Reference 1 window
1 9 Plays the current series in looped movie mode
On biplane systems, the frontal image is copied.
Copies the current image to the Reference 2 win-
2 dow 10 Plays all series of the study in looped movie mode
On biplane systems, the lateral image is copied.
Copies the current image to the Reference 3 win-
dow
Moves the focus of the viewpad between the live X-
3 On biplane systems, images from both channels are 11
ray window and each of the reference windows
copied, and are displayed side by side and
synchronized.
Creates a snapshot of the current image and stores
4 Displays the previous series 12
it with the study
Enables or disables subtraction (vascular viewpad
5 Displays the next series 13
only)
Sets the current image as the mask image for sub-
6 Displays the previous image 14
traction (vascular viewpad only)
Enables or disables landmarking (vascular viewpad
7 Displays the next image 15
only)
8 Displays all series in the study overview 16 Turns the laser pointer on or off

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Quick Reference Bolus Chase Reconstruction Main Window Toolbars

19.12 Bolus Chase Reconstruction Main Window Toolbars


The main window displays the original images from the bolus chase acquisition.

The main window has a dedicated toolbar. It also has a navigation toolbar that you can use for
reviewing images.

Main Window Toolbar


The toolbar in the main window provides tools for manipulating the original images.

Tool Function

Select Selects an object (this is the default tool)

Zoom Zooms the image in or out

Pan Pans the image

Brightness / Contrast Adjusts the brightness or contrast of the image

Edge enhancements Sharpen or soften edges in the image

Turns subtraction on or off (this tool is only available when a mask series
Subtraction On / Off
is available)

Adjusts the amount of subtracted background that is combined with the


Landmarking
subtracted image

Copy to Reference Sends the image to a reference window in the examination room.

Allows you to add an annotation to the image (the type of annotation


Annotations
can be selected from a submenu)

Takes a snapshot of the image displayed and stores it with the current
Snapshot
study in the patient database

Reset Resets the image to its original viewing settings

Navigation Toolbar
The navigation toolbar provides tools for reviewing the original images, either as a movie or by stepping
through images one by one.

Tool Function

Play Plays the original images as a movie

Stop Stops movie playback

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Quick Reference Bolus Chase Reconstruction Overview Image Window Toolbar

Tool Function

Next image Displays original images sequentially forward through the series

Previous image Displays original images sequentially backward through the series

19.13 Bolus Chase Reconstruction Overview Image Window Toolbar


The overview image window in the Bolus Chase Reconstruction application displays the overview image
that is reconstructed when the system receives a bolus chase series.

You can hide the overview image window to focus on the main window, if desired.

The overview image window has a dedicated toolbar, providing tools for manipulating the overview
image.

Tool Function

Select Selects an object in the window (this is the default tool)

Brightness / Contrast Adjusts the brightness or contrast of the image

Turns subtraction on or off (this tool is only available when a mask series
Subtraction On / Off
is available)

Adjusts the amount of subtracted background that is combined with the


Landmarking
subtracted image

Copy to Reference Sends the current image to a reference window in the examination room.

Allows you to add an annotation to the image (the type of annotation


Annotations
can be selected from a submenu)

Takes a snapshot of the image displayed and stores it with the current
Snapshot
study in the patient database

Reset Resets the image to its original viewing settings

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Glossary Definitions

20 Glossary
In this section you can find help with definitions of terms that are used in these Instructions for Use and
explanations of abbreviations.

20.1 Definitions
Definitions of the terms used in the Instructions for Use are provided here.

20.1.1 Windows, Panels, Views, and Viewports


These terms are used to describe the viewing environment in which an application is displayed.

Window: A window is the overall container in which an application is viewed. It contains all the
functions, images, and information that the application provides.

A window can be divided into several areas, depending on the current application:
• Task selection panel: A task selection panel contains the tasks that are applicable for the
application. When you select a task, a dedicated task panel is displayed.
• Task panel: A task panel contains all the functions that you use to complete the selected task.
• View: A view contains information or images that are relevant to the application.
• Viewport: A viewport is a container inside a view that provides additional information that is
relevant to the view. Viewports can contain, for example, orthogonal reference images or numerical
information such as graphs and tables.

Figure 229 Parts of a window

Legend
1 Task selection panel 3 View
2 Task panel 4 Viewport

The terms monitor or screen are not used to describe the software interface of the system. When these
terms are used, they refer to the physical monitor or screen unit.

NOTE The configuration of the monitors and screens used with the system is flexible. A window can
appear on a dedicated monitor in the examination room or in the control room. If the
FlexVision or FlexSpot options are installed, it may appear as part of a larger screen that
can display multiple applications. When describing applications in these Instructions for Use,
it is not always possible to indicate exactly on what monitor or screen that it appears.

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Glossary Definitions

Interacting with Windows


You can enlarge windows and display them full-screen, or you can minimize them to the last position.
You can also manually resize a window by dragging its edge.

To activate the application in a window, click anywhere within the borders of the window. The borders
of the window turn yellow to indicate that the window is selected. Only one window is active at a time.

When you move the pointer over the application window, the toolbar, task navigation panel, and review
toolbar become visible. If there is no interaction in the application window after a few seconds, the
toolbar and review toolbar are automatically hidden. Move the pointer over the area to display them
again.

When you position the pointer within the borders of the window, the header becomes active and the
following interactions are available:
• Click to maximize the window.

• Click to restore the window to the initial size.

• Click to hide the application in a window. When an application is hidden, its icon is shown in the
middle of the window. Click the icon to display the application again.

• Click to create a photo image of the application in the window. The photo image is stored with the
study of the current acquisition patient.

• Click to view the source at the actual pixel size.

• Click to view the source at the actual pixel size. This icon indicates that the source is critical and you
should view the application in this window at the optimal resolution.

• Click to view the source at the actual pixel size and resize the viewport for an optimal fit.

NOTE Only one viewport at a time can be set to actual pixel size.

Interacting with Panels


You can expand panels to make tools or tasks available, and then collapse them to create a less
cluttered environment:
• Click to open the panel or window.

• Click to close the panel or window.

• Click to display more functions.

• Click to close the panel or window.

20.1.2 Patient Table: Doctor Side and Nurse Side


These definitions assume that the patient is supine on the table, with feet toward the table base.

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Glossary Definitions

With this patient orientation, the doctor side is the right side of the table (corresponding to the right side
of the patient), and the nurse side is the left side of the table. The head end of the table is the end
furthest away from the table base, and the foot end is the end nearest to the table base.

3 0 4

Figure 230 Top view of the patient table

Legend
1 Doctor side 3 Head end
2 Nurse side 4 Foot end

20.1.3 Working Area


The working area is where the system performs its normal operation.

The working area is directly related to the position of the tabletop. It encloses the tabletop and its
vicinity, from floor to ceiling, at all times.

Figure 231 Working area

20.1.4 Dose Related Definitions


The following definitions are used in these Instructions for Use.

Patient Entrance Reference Point


The patient entrance reference point is an approximation for the location of the patient’s skin (see IEC
60601-1-3:2008, 3.43 and IEC 60601-2-43:2010, 203.5.2.4.5.101d)).

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Glossary Definitions

NOTE The distance from focal point to the isocenter can be different per type of geometry (see 4.1),
resulting in different reference air kerma values under the same circumstances.

NOTE The patient entry reference point may also be known as the interventional reference point.

It is located on the central axis of the X-ray beam, 15 cm from the isocenter, towards the focal spot.
Depending on the patient’s size, the table height and the direction of the X-ray beam, the PERP may be
outside the patient (as in the left figure), may coincide with the skin surface, or may be inside the patient
(as in the right figure).

Figure 232 Patient entrance reference point

Legend
1 X-ray tube 4 Entrance surface
2 Detector 5 Patient entrance reference point
3 Isocenter 6 Detector dose

Air Kerma (AK)


The amount of kinetic energy released in air by ionizing radiation. Or more precisely, the quotient of
dEtr by dm, where dEtr is the sum of the initial kinetic energies of all the charged particles liberated by
uncharged particles in a mass of dm of air (see IEC 60601-1-3:2008, 3.4 and ICRU 60 (1998)). It is
expressed in mGy, where 1 Gy = 1 Joule / kg (see IEC 60601-2-43:2010, 203.6.4.5).

Air Kerma Rate


The amount of air kerma per unit of time, expressed in mGy/min (see IEC 60601-2-43:2010, 203.6.4.5).

Reference Air Kerma


The air kerma free in air in the primary X-ray beam measured under specific conditions as specified in
Reference Air Kerma Measurement Setup (page 395), and expressed in the patient entrance reference
point (see IEC 60601-1-3:2008, 3.70).

NOTE The reference air kerma value is independent of the actual position of the patient, for
example, the table height, as it is measured at a specific point in space.

For exposure, the reference air kerma is expressed in mGy per image.

Reference Air Kerma Rate


The amount of reference air kerma per unit of time. For fluoroscopy the reference air kerma Rate is
expressed in mGy/min.

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Glossary Definitions

Peak Air Kerma


The highest air kerma that any point of an irradiated surface is exposed to.

Skin Dose
The absorbed dose delivered by ionizing radiation to the patient's skin at the point of irradiation. Skin
dose is expressed in Gy or mGy. Unlike the reference air kerma, this value indicates the actual energy
absorption under the present conditions.

Skin Dose Rate


The skin dose per unit of time, expressed in Gy/s or mGy/s.

Peak Skin Dose


The highest skin dose that any portion of the patient’s skin is exposed to.

Staff Dose
Staff dose is the effective dose received by a healthcare professional during an examination, resulting
primarily from scatter radiation emitted by the patient. The effective dose is expressed in unit mSv
(milliSievert).

Dose Area Product


The product of the area of a cross-section of an X-ray beam and the averaged air kerma over that
cross-section, expressed in Gycm2 (see IEC 60601-2-54:2009, 201.3.203 and IEC 60601-2-43:2010,
203.6.4.5).

Unlike skin dose and air kerma, the dose area product value is independent of the distance to the focal
spot.

NOTE Other vendors might use other units to express the dose area product. This should be taken
into account when comparing dose values of different systems.

Detector Dose
The residual dose at the anti-scatter grid on the detector after the X-rays have passed the patient. The
system uses the detector dose as an input to regulate the amount of X-ray radiation in order to obtain
the proper image quality.

Deterministic Effects
Deterministic effects of ionizing radiation are related on a microbiological scale to cell destruction
caused by high radiation levels. Deterministic effects or tissue reactions may occur when the radiation
dose has exceeded a certain threshold level, which may depend on the irradiated tissue or organ and
on the patient's sensitivity to radiation. When the threshold is exceeded, the severity of the tissue
reactions increases with increased radiation dose.

The effects can be directly related to the radiation exposure. On a microbiological scale, these effects
are related to cell destruction caused by high radiation levels. The threshold dose is typically 2 Gy for
transient skin erythema (redness of the skin) and 3 Gy for temporary hair loss.

The air kerma is a measure to estimate the deterministic effects of ionizing radiation.

Stochastic Effects
Stochastic effects of ionizing radiation are related on a microbiologial scale to cell mutations due to
DNA damage caused by low radiation levels. Such mutations may be controlled and eliminated by the
human body or may develop into cancer on the long term (many years). It is difficult to show a direct
relationship between radiation exposure and cancer for individual cases. The International Commission

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Glossary Definitions

on Radiological Protection assumes that the stochastic risk or probability of developing cancer is linear
with the total radiation dose received, and that there is no threshold as with the deterministic risk.
Unlike the deterministic risk, the stochastic risk does not change if dose is spread over multiple parts of
the body.

The dose area product is a measure to estimate the stochastic effects of ionizing radiation.

Patient Thickness
The depth of tissue irradiated, expressed in cm H2O or cm PMMA.

20.1.5 Dose Model


To determine the applied dose on various parts of the patient’s body and to assist in reducing the
deterministic effects of radiation, a dose model is used.

In this model the human body is divided into four zones.

Figure 233 Body zones

Legend
1 Head 3 Abdomen
2 Thorax 4 Peripheral

The dose model is further refined for the thorax body zone, as defined in the exposure procedure X-ray
protocols.

For the thorax body zone, the skin is modeled as a sphere of 30 cm diameter, positioned around the
isocenter. The surface of this sphere is divided into 10 areas corresponding to different projections of
the X-ray beam: five at the cranial side and five at the caudal side.

Figure 234 Dose model applied in the area corresponding to the current position (rotation and
angulation) of the stand

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Glossary Definitions

Figure 235 Dose model displayed in the dose report

Every body area is divided into a number of spots of approximately 0.5 x 0.5 cm, with one spot for
every degree of beam rotation and angulation.

The radiated skin area corresponds with the part of the skin that is actually irradiated, which depends
on the geometrical projection of the X-ray beam and the position of the collimator shutters.

The exposed body area (shaded grey) is the body area that is covered most by the radiated skin area.

The system keeps track of the peak air kerma that is applied to every irradiated body zone of the sphere
via real-time dose calculation.

You can see the following X-ray dose information:


• The total actual cumulative air kerma for the whole body is shown as a number.
• During radiation, the actual cumulative peak air kerma and the peak air kerma rate of the hottest
spot within the radiated body zone, is shown as a number and as a graphical representation.
• During radiation and standby, the predicted remaining fluoroscopy time until the threshold is
reached is shown for the current X-ray beam projection.
• Visual feedback, for example, a change of color on the screen, when the cumulative peak air kerma
in the radiated body zone becomes higher than a customizable threshold. The default setting is 2
Gy. You are warned that continuing radiating in the current projection might lead to increased risk of
deterministic effects. To solve this, you should change the projection of the X-ray beam so that
another body area is exposed, or modify the system settings as described in X-ray Protocol
Selection (page 338).

The zone dose information is immediately adapted when you change the field size, the source-to-
image distance, the fluoroscopy flavor, or the X-ray beam projection.

20.1.6 Interventional Tools


Interventional Tools extend the functionality of compatible X-ray equipment with 3D imaging during an
interventional procedure.

The Interventional Tools are a suite of software products that help physicians diagnose and treat
medical diseases. The applications are mainly used in the cathlab during an interventional procedure,
and fulfill the following main goals:
• Understanding the situation
• Plan the intervention

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Glossary Abbreviations

• Support the intervention


• Verify the results of the intervention

The Interventional Workspot supports Interventional Tools by providing central data administration
functions such as patient administration, printing and export. A basic viewing application is also
provided. Each Interventional Tool is provided with dedicated Instructions for Use containing details of
using the specific image processing tools associated with the Interventional Tool.

20.1.7 Injector Control Methods


Depending upon your system configuration, you may use either one or two switches when using
contrast injection, in coupled or uncoupled modes.

For all control methods, you must prepare the injector manually at an appropriate time.

Always refer to the instructions for use for your injector for more information about using the injector.

Uncoupled Operation
Since uncoupled operation of a contrast injector does not involve communication between the X-ray
system and the contrast injector, you will use more than one switch when operating in uncoupled mode.
This involves using one switch to operate the injector and another switch (hand switch or foot switch)
on the X-ray system to acquire images.

Coupled Operation One-Switch Method


When using a one-switch method to control contrast injection, you control image acquisition and
contrast injection using the same switch. One-switch operation is a coupled operation mode. When you
press the hand switch or foot switch to acquire images, the X-ray system also controls the injection of
the contrast medium.

Coupled Operation Two-Switch Method


When using a two-switch method in coupled mode, you control image acquisition and contrast
injection using separate switches. When you press the X-ray system hand switch or foot switch to start
acquiring images, you must press the injector control switch simultaneously to inject contrast. The X-ray
system synchronizes image acquisition with contrast arrival through the X-ray delay settings.

20.2 Abbreviations
A guide to the abbreviations that you may find in these Instructions for Use is provided here.

Abbreviation Definition Explanation


2D 2 Dimensional Viewing mode
3D 3 Dimensional Viewing mode
A Amperes Unit of measurement (electric current)
ACQ Acquisition Procedure
AK Air Kerma Dose measurement
Al Aluminum Metallic element
ANG Angulation Geometry setting
AAMI Association for the Advancement of Medical In- National standards organization
strumentation
ANSI American National Standards Institute National standards organization
AP Anterior-Posterior Stand projection

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Glossary Abbreviations

Abbreviation Definition Explanation


APC Automatic Position Control Geometry setting
B12/12 A biplane system with a 12-inch flat detector on System description
the frontal stand and a 12-inch flat detector on
the lateral stand
B20/12 A biplane system with a 20-inch flat detector on System description
the frontal stand and a 12-inch flat detector on
the lateral stand
B20/15 A biplane system with a 20-inch flat detector on System description
the frontal stand and a 15-inch flat detector on
the lateral stand
BCR Bolus Chase Reconstruction Procedure
BPM Beats per Minute Anatomical measurement
BSA Body Surface Area Anatomical measurement
CAU Caudal Stand projection
CAUD Caudal Stand projection
CBCT Cone Beam Computed Tomography Imaging technique
CD Compact Disc Removable storage media
CE Conformité Européenne Product certification mark
CIS Cardiology Information System Network interface
CISPR Comité International Spécial des Perturbations International standards organization
Radioélectriques
(International Special Committee on Radio Inter-
ference)
cm Centimeters Unit of measurement (distance)
CPR Cardiopulmonary Resuscitation Procedure
CRA Cranial Stand projection
CRAN Cranial Stand projection
CSA Canadian Standards Association National standards organization
CT Computed Tomography Imaging technique
CTDI Computed Tomography Dose Index A radiation exposure index in X-ray computed
tomography
Cu Copper Metallic element
DAP Dose Area Product Dose measurement
DHCP Dynamic Host Configuration Protocol Network protocol
DICOM Digital Imaging and Communications in Medicine Image file format (suitable for diagnostic pur-
poses)
DNS Domain Name Server Network configuration item
DVD Digital Versatile Disc Removable storage media
EAC Eurasian Conformity Product certification mark
ECG Electrocardiogram Anatomical measurement
ED End Diastole Anatomical state
EDV End Diastole Volume Anatomical measurement
EF Ejection Fraction Anatomical measurement
EMC Electromagnetic Compatibility Electrical environment
EMF Electromagnetic Fields Electrical environment
EP Electrophysiology Procedure
EPO Emergency Power Off Hardware function
ES End Systole Anatomical state
ESD Electrostatic Discharge Electrical environment

Azurion Release 2.2 Instructions for Use 484 Philips 4523 001 01511
Glossary Abbreviations

Abbreviation Definition Explanation


ESV End Systole Volume Anatomical measurement
F French Unit of measurement (catheters)
FDA Food and Drug Administration US government agency
FDPA Flexible Dynamic Peripheral Angiography Procedure
FPS Frames Per Second Acquisition speed
FOV Field Of View Viewing mode
HD High Definition Viewing mode
HD High Dose Procedure setting (protocol)
HIS Hospital Information System Network interface
hPA Hectopascal Unit of measurement (pressure)
HQ High Quality Procedure setting (protocol)
HU Houndfield Unit (CT numbers) Unit of measurement (radiodensity)
Hz Hertz Unit of measurement (frequency)
I.A. Intra-Arterial Contrast agent delivery method
iCP Intelligent Collision Prevention System equipment
ID Identification Patient information
IEC International Electrotechnical Commission International standards organization
in Inches Unit of measurement (distance)
IP International Protection marking Rating indicating protection against ingress of
particles and liquid (IEC 60529)
IP Internet Protocol Network protocol
I.V. Intravenous Contrast agent delivery method
kg Kilograms Unit of measurement (weight)
kHz Kilohertz Unit of measurement (frequency)
kPA Kilopascal Unit of measurement (pressure)
kV Kilovolts Unit of measurement (electrical potential)
kW Kilowatts Unit of measurement (power)
l liters Unit of measurement (volume)
LAO Left Anterior Oblique Anatomy
lbs Pounds Unit of measurement (weight)
LCA Left Coronary Artery Anatomy
LD Low Dose Procedure setting (protocol)
LED Light Emitting Diode Hardware
LVA Left Ventricular Analysis Postprocessing application
M12 A ceiling or floor-mounted monoplane system System description
with a 12-inch flat detector
M15 A floor-mounted monoplane system with a 15- System description
inch flat detector
M20 A ceiling or floor-mounted monoplane system System description
with a 20-inch flat detector
M20 OR A ceiling-mounted monoplane system with a System description
20-inch flat detector and an interface for an OR
(operating room) table
m Meters Unit of measurement (distance)
mA Milliamperes Unit of measurement (electric current)
MAC Media Access Control Hardware function
MCS Monitor Ceiling Suspension System equipment
min Minutes Unit of measurement (time)

Azurion Release 2.2 Instructions for Use 485 Philips 4523 001 01511
Glossary Abbreviations

Abbreviation Definition Explanation


MLD Minimum Lesion Diameter Anatomical measurement
mm Millimeters Unit of measurement (distance)
mOhm Milliohm Unit of measurement (electrical resistance)
MPEG Motion Picture Experts Group Video file format (not suitable for diagnostic
purposes)
ms Milliseconds Unit of measurement (time)
N Newtons Unit of measurement (force)
OR Operating Room Working environment
PA Posterior-Anterior Stand projection
PACS Picture Archiving and Communication System Hardware
Pb Lead Material
PC Personal Computer Hardware
PE Protective Earth IEC definition
POAG Potential Ausgleich (German term for Potential Equivalent to the IEC definition of Potential
Equalization) Equalization Connector
PMMA Poly(methyl methacrylate) Material (used in phantoms)
PNG Portable Network Graphics Image file format (not suitable for diagnostic
purposes)
PPM Parts Per Million Unit of measurement (concentration)
PROP Propeller Geometry setting
QA Quantitative Analysis Postprocessing application
QCA Quantitative Coronary Analysis Postprocessing application
QVA Quantitative Vascular Analysis Postprocessing application
RA Rotational Angiography Postprocessing application
RAO Right Anterior Oblique Anatomy
RCA Right Coronary Artery Anatomy
RIS Radiology Information System Network interface
ROI Region of Interest Viewing mode
ROT Rotation Geometry setting
RVA Right Ventricular Analysis Postprocessing application
s Seconds Unit of measurement (time)
SID Source-to-Image Distance Geometry setting
SV Stroke Volume Anatomical measurement
TSM Touch screen module System equipment
UL Underwriters Laboratories National certification organization
UPS Uninterruptible Power Supply Hardware
USB Universal Serial Bus Removable storage media
V Volts Unit of measurement (electrical potential)
VA Veterans Affairs Government department (US)
VA Volt-Amperes Unit of measurement (electrical power)
W Watts Unit of measurement (power)
WLM Worklist Manager Network interface
XA X-ray Angiography Procedure
XL Extra large System equipment

Azurion Release 2.2 Instructions for Use 486 Philips 4523 001 01511
Index
- Auto wedge follow 114
Automatic data transfer
2D Quantitative Analysis 182, 194, 195, 197–215, – Settings 275
217–222 Automatic exposure control test 299
– Acquiring images 194 Automatic position control 118, 120, 121, 278
– Calibration 182, 195, 198–200, 205–208 – Customizing 256, 278
– LVA 195, 204–206, 208–215, 217 – Pathways 121, 278
– QCA 195, 197, 198, 200–204
– QVA 195, 197, 198, 200–204
B
– RVA 195, 205, 206, 208–215, 218
– Safety 194 Batteries
– Warnings and cautions 194 – Fitting, removing, and disposing 297, 298
3D Rotational Angiography 135 Beam carriers 312–315
3D-RA 135 – FlexMove 315
3rd-party interfaces 239, 240 Beam limitation check 299
– Injectors 239 BodyGuard 79
– Video feeds 240 – Collision indicators 458
3rd-party products (compatibility) 239 BodyGuard override 81
3rd-party software 432 Bolus chase 129
8-meter cable assembly kit 243 Bolus Chase Reconstruction 156, 157, 159, 160
– Contrast series 130
A – Mask series 132

Abbreviations 483
C
Accessories and detachable parts 224, 321
Accessory rail 224 Cable assembly kit (8-meter) 243
– Additional table accessory rail 224 Calibration 182–184
– Table base accessory rail 36 – CBCT calibration 306
Accessory rail clamps 225 Cardiopulmonary resuscitation (CPR) 20
Accuracy of dosimetric indications 330 Cautions and warnings 20
Acquiring images 106 CBCT (cone beam CT reconstruction) 137–139, 306,
– Emergency 116 403–407
– Exposure 114 CBCT calibration 306
– Fluoroscopy 107 CD/DVD
– General workflow 103 – Enabling and disabling 267
– Multiphase 128 Ceiling-suspended radiation shield (specifications)
Adding a study 59 323
Additional equipment 240 Cerebral filter 230
Additional filters 402 Clamps
Additional FlexSpot 51, 443 – Accessory rail clamps 225
Additional foot switch 41 – Tabletop accessory clamps 234
Annotations 167–170 Cleaning 288, 296
Anti-scatter grid 296, 297, 331 – Ceiling rails 296
APC (automatic position control) 118, 120, 121 – System 288
Applied parts 430 Clinical emergency 20
Archiving 146 Collimation 110, 111
Arm supports 226 – Auto wedge follow 114
– Arm support board 227 Collimator 331
– Elbow support 226 Collision indicators 82
– Height-adjustable arm support 228 – Quick reference 458
– Shoulder support board 228 Collision prevention 79, 80
Audit trail – BodyGuard 79
– Audit log settings 264 – Collision indicators 458
– Viewing audit logs 301 – Intelligent Collision Prevention (iCP) 80
– Override 81, 82
Comfort movies 125

Azurion Release 2.2 Instructions for Use 487 Philips 4523 001 01511
Index

Compatibility 18, 239 Emergency procedures 20, 21


– Declarations of compatibility for third-party – Clinical emergency 20
products 239 – CPR 20
Connections – Emergency power-off 20
– Equipment connections 432 – Emergency stop 21
Contacting the manufacturer 436 Emergency stop 21
Control module 36, 72, 464, 466, 469 Ending a study 146
– Orientation 73 Energy consumption (measuring) 306
– Positioning/repositioning 73 Environmental impact of the system 306
– Quick reference 464, 466, 469 Environmental requirements 334
Control room Equipment rack 242
– System components 49 Essential performance of the system 411
CPR 20 Examination light 323
Customizing the system 245, 278 Examination room
– APC 278 – System components 29
– APC Pathways 278 Explosion safety 23
Exporting
D – CD/DVD 187
– Data 185
Date and time
– Drag and drop 190
– Format 247
– Enabling and disabling 267
– Setting the date and time 246
– Export protocols 273
Default settings 286
– PACS 189
Definitions and terms 476
– System settings 285
– Dose model 481
– USB 185
– Dose related definitions 478
Exposure images
Detachable parts and accessories 224
– Acquiring 114
Detectors 331–333
Diagnostic view 124
F
DICOM 268
– Local settings 269 Fire safety 24
– MPPS manager 270 Fixed rotational scan 135
– Printer settings 272 Flagging images 178
– Remote systems 271 FlexArm 31, 37, 75, 315, 469
– Worklist management 270 FlexMove 32, 78
Disinfecting the system 288 FlexSpot 51, 442
Display preferences 260 – Additional FlexSpot 51, 443
Disposing of the system 307 – Managing preset groups 250
Doctor side (definition) 478 – Managing presets 248–250
Dose model 481 – Primary monitor 442
Dose reports 147, 148 – Secondary monitor 443
Drawing freehand markers on an image 170 FlexVision 39, 125, 443
Drip stand 225 – Managing preset groups 250, 255
Dual fluoroscopy 110 – Managing presets 248–250, 252–255
– Patient comfort movies 125
E – Saving a modified preset 125
– Selecting a preset 124
Electrical safety 22
– Touch screen module 252–255
Electromagnetic compatibility (EMC) 24, 409–412,
Fluoroscopy
414
– Buzzer 110
Electronic Instructions for Use 16
– Dual 110
– Changing the language 16
– Performing fluoroscopy 108
– Searching 16
– Setting the fluoroscopy flavor 107
Electrophysiology 23, 145
– Storing series and images 109
EMC 24, 409–412, 414
– Subtraction 132
Emergency access
Fluoroscopy buzzer
– Acquiring images 116
– Resetting 110
– Enabling and disabling 265
Fluoroscopy images
– Logging on in an emergency 53, 116
– Acquiring 107
Emergency power-off 20

Azurion Release 2.2 Instructions for Use 488 Philips 4523 001 01511
Index

Foot end (definition) 478 – Uncoupled operation 127, 483


Foot switch 40, 41 Injectors 239
– Additional foot switch 41 Installation and equipment connections 432
– Wireless foot switch 41 Instructions for Use
Free rotational scan 136 – About 16
Freehand markers (on-screen) 170 – eIFU 16
Frequently used functions 430 Intelligent Collision Prevention (iCP) 80
Functions Intelligent system recovery 117
– Frequently used 430 Intended use of the system 17
Intercom 241
G Interventional room pointer (on-screen) 152
Interventional Tools (Interventional Workspot) 482
Generator (X-ray) 324
Isocentering 122
Geometry 66
– Recalling the isocenter position 123
– Locking and unlocking movements 118
Isokerma maps 399–401
– Positioning the geometry 66
– Setting up the geometry 66
L
Gestures (touch screen module) 446
Glossary 476, 483 Language settings 263
– Abbreviations 483 Laser tool 236
– Definitions and terms 476 Log files
Grid (anti-scatter) 296, 297, 331 – Audit trail 264
Guidance 19 – Viewing audit logs 301
Logging off 55
H LVA 195, 204–206, 208–215, 217

Hand switch
M
– Exposure hand switch 46
– Speed controller 46 Mains power failure 54
– Swivel hand switch 46 – Uninterruptible power supply 55
Hand switches 46 Mains power specification 335
Handgrip and clamp set 234 Maintenance 287, 288, 298, 306, 307
Hazardous substances 27, 28 – Automatic exposure control test 299
– Perchlorate materials 28 – Beam limitation check 299
– REACH declaration 28 – Calibration 306
Head end (definition) 478 – CBCT calibration 306
Head support 231 – Cleaning the system 288
Help 18 – Disinfecting the system 288
– Disposing of the system 307
I – Passing the system on to another user 307
– Planned maintenance program 287
Image beam rotation 31
– User verification test 298
Image orientation 123, 124
Managing users 265
– Diagnostic view 124
– Adding and deleting users 265
– Surgical view 124
– Changing a user's password 265
Images
Manual calibration 182–184
– Acquiring 106
Manufacturer
– Flagging 178
– Contacting 436
– Repositioning 115
Markers (on-screen, freehand) 170
Imaging chain 331–333
Mattress 231
Importing
Measurements 178–182
– Certificates 269
Measuring typical energy consumption 306
– DICOM data 154
Mechanical safety 23
– Enabling and disabling 267
Monitor boom 39, 86, 321
– From a network 154
Monitor ceiling suspension 23, 39, 85
– From USB device, CD, or DVD 154
– Springarm MCS 321
– System settings 285
Monitor ceiling suspension (specifications) 319–321
Injector control methods (definitions) 483
Monitor configuration 39
Injector coupling 127
Monitors 39, 85, 86, 321
– Coupled operation 127, 483
– FlexSpot 442, 443

Azurion Release 2.2 Instructions for Use 489 Philips 4523 001 01511
Index

– FlexVision 39 Patient table (specifications) 316


– Monitor boom 39, 86, 321 Pedestal 242
– Monitor ceiling suspension 39, 85 Perchlorate materials 28
– Switchable monitors 39, 126 Peripheral X-ray filters 230
– Switching only the monitors on 53 Physician list 247
– Test image 306 Planned maintenance program 287
Monitors (specifications) 319–321 Pointer (on-screen) 152
Mouse 47 Positioning the geometry 74, 75, 118, 120, 121
– Functions 472 – FlexMove 78
Mouse table 47 – Monitor boom 86
MPPS manager – Monitor ceiling suspension 85
– Settings 270 – Stand 74, 75
Multiphase acquisition 128, 129 Positioning the patient 61
– Changing settings 129 Power specification (mains) 335
MultiSwitch 240 Preset groups 250, 255
Presets 248–250, 252–255
N Previewing images for automatic archiving 146
Printer settings 261, 272
Network connections
Printing 191
– Viewing and testing 300
ProcedureCard groups
Network data 337
– Management 283
Neuro wedge 232
ProcedureCards 58, 279
Nurse side (definition) 478
– Copying 282
– Creating 280
O – Default 279
Off-center imaging 31, 32 – Deleting 282
Options – Editing 280
– Equipment rack 242 – Exporting 284
– Intercom 241 – Importing 284
– MultiSwitch 240 – Mapping RIS codes to ProcedureCards 268
– Pedestal 242 – Moving 282
OR table 91–97 – Restoring factory defaults 284
Orientation Procedures
– Control module 73 – Performing procedures 103
– Image orientation 123, 124 Processing 162–170, 173–182
– Patient orientation 64 – Annotations 167–170
– Contrast and brightness 165, 166
P – Copying images to reference windows 177
– Cropping images 173
Pan handle 35 – Flagging images 178
Panel (definition) 476 – Inverting images 166
Panning – Landmarking 175
– Zero dose positioning 115 – Measurements 178–182
Parallel working 149 – Panning 164
Passing the system on to another user 307 – Snapshots 177
Passwords – Subtraction 174, 175
– Changing your password 245 – View Trace 176
– Password policy 265 – Zooming 163
– Resetting a user's password 265 Protecting a study 153
Pathways (Automatic position control) 121, 278
– Configuring 278 Q
Patient comfort movies 125
Patient database 56 QCA 194, 195, 197, 198, 200–204
Patient orientation 64 QVA 194, 195, 197, 198, 200–204
Patient safety
– Radiation 25 R
Patient settings 266
Radiation protection 98, 101
Patient straps 62, 232
– Radiation shields 98, 101
Patient table 34, 87
Radiation safety 25, 26, 98

Azurion Release 2.2 Instructions for Use 490 Philips 4523 001 01511
Index

– Additional filters 402 – Explosion safety 23


– Stray radiation 399–401 – Fire safety 24
Radiation shields 98, 101, 323 – Mechanical safety 23
– Ceiling-suspended 101 – Patient safety 25, 66
– Specifications 323 – Radiation safety 25, 26
– Table-mounted 99 – Serious incidents 22
– Third-party radiation shields 101 – Staff safety 26, 66
Ratchet compressor 233 – Symbols used with the product 20
REACH declaration 28 – Toxic or hazardous substances 27, 28
Reference air kerma 349–397 Scheduling
– Measurement setup 395–397 – Editing 60
Regional settings 263 – From the worklist 58
– Date and time 247 – Manually 59
– Language 263 Screen saver 301
Regulatory information 430 Search
Regulatory requirements 430 – Quick search 57
– Applied parts 430 Secure communication 269
Remote assistance 302 – Local system 269
Remote systems Securing the patient with straps 62, 232
– Settings 271 Security 309–311
Reset fluoroscopy buzzer 70 – Certificates 269
Resolving a patient mix 160 – Changing your password 245
Restarting the system 54 Series task 149, 151
– Restarting after an emergency power off 55 – Selecting series 149, 151
– Restarting after an emergency stop 21 Serious incidents 22
Review module 49 Setting up the geometry 66
– Quick reference 471 Settings
Reviewing 149, 153 – Exporting 285
– Parallel working 149 – Importing 285
– Protecting a study 153 – Restoring default settings 286
– Reviewing historical data 153 Shutters 110, 111
– Selecting a series for review 149, 151 – Touch screen module 111
– Using the review monitor 149 Smart BodyGuard override 81
– Using the touch screen module 151 SmartMask 133
RIS codes Software
– Mapping RIS codes to ProcedureCards 268 – Third-party software 432
Roadmap pro 132, 133 – Updates 303
Room pointer (on-screen) 152 Source-to-image distance 343
Rotational scans 135–137, 139, 140 Speed controller 46
– CardiacSwing 140, 141 Springarm monitor ceiling suspension 321
– CBCT 137 Staff safety
– CBCT Dual 139 – Radiation 26
– Fixed rotational scan 135 Stand 30, 31, 74, 75
– Free rotational scan 136 – FlexMove 32
RVA 195, 205, 206, 208–215, 218 – Locking and unlocking movements 118
– Positioning 74, 75
S Starting the system 52
– Logging on in an emergency 53, 116
Safety 20–26, 28, 409–412, 414
– Switching the system on 52
– Cardiopulmonary resuscitation (CPR) 20
Status area 447, 448, 451
– Clinical emergency 20
– Monoplane system 448, 451
– Electrical grounding 22
– Quick reference 447, 448, 451
– Electrical safety 22
Sterile covers 48, 102
– Electromagnetic compatibility (EMC) 24,
Stopping the system 52
409–412, 414
– Emergency stop 21
– Emergency power-off 20
– Logging off 55
– Emergency procedures 20, 21
Storage devices
– Emergency stop 21
– Enabling and disabling 267
– Essential performance of the system 411
Storage requirements 334

Azurion Release 2.2 Instructions for Use 491 Philips 4523 001 01511
Index

Straps (securing the patient) 62, 232 Tabletop accessory clamps 234
Stray radiation 397, 399–401, 403 Technical support
– Additional filters 402 – Remote assistance 302
– Isokerma maps 399–401 – Saving a log file 302
– Technique factors 398 – Saving an image 302
Studies 59 – Saving information 302
– Adding a study 59 Technique factors 398
– Editing a scheduled study 60 Terms and definitions 476
– Preparing a patient study 56 Third-party interfaces 239, 240
– Scheduling a study from the worklist 58 – Injectors 239
– Scheduling a study manually 59 – Video feeds 240
– Starting a study 61 Third-party products (compatibility) 239
– Status 56 Third-party radiation shields 101
Subtraction 132, 174, 175 Third-party software 432
Surgical view 124 Toolbars 461, 463
Switchable monitors 39, 126 – Bolus chase reconstruction 474, 475
Symbols Tooltips 19
– Customizing 263 Touch screen module 37, 50, 67, 68, 70–72, 445
– Measurement 263 – Gestures 446
Symbols used with the product 20 Toxic substances 27, 28
System – Perchlorate 28
– About the system 29, 431 – REACH declaration 28
System administration 263 Training 18
System components Transferring the patient to the table 61
– Control room 49 Transport requirements 334
– Examination room 29 Tube output power 329
System configuration (X-ray) 327 Type B applied parts 431
– Accuracy of dosimetric indications 330 Typical energy consumption (measuring) 306
– Tube output power 329
System customization 245 U
System equipment
Uninterruptible power supply 55
– Quick reference 437
Updating the system software 303
System functions
USB
– Quick reference 437
– Enabling and disabling 267
System information 431
User verification test 298
– Licenses 246
System logon
– Enabling automatic system logon 265 V
System readiness 106 Verification test (user) 298
System settings influencing radiation dose 338 Video feeds (third-party) 240
System status 106, 447, 448, 451 Video only
– Monoplane status area 448, 451 – Switching only the monitors on 53
System version 431 Viewing preferences 259
Viewpad 46, 235, 472
T Viewport (definition) 476
Table
– Cradling 89 W
– Locking and unlocking movements 118 Wall connection box 241
– Maximum load 61 Wall connection box (specifications) 336
– Pivoting 89 Warnings and cautions 20
– Rear interface panels 36 Wedges 110–113
– Swiveling 91 – Auto wedge follow 114
– Tilting 88 – Touch screen module 113
– Transferring the patient to the table 61 Window (definition) 476
Table (specifications) 316 Wireless foot switch 41, 324
Table base accessory rail 36 – Charging 44
Table height collision override 82

Azurion Release 2.2 Instructions for Use 492 Philips 4523 001 01511
Index

– Switching on and off 43


Workflow
– General acquisition workflow 103
Workflow settings 266
Working area 478
Worklist management
– Settings 270
WorkSpot 437

X
X-ray
– Enabling X-ray 104
X-ray generator 324
X-ray on indicators
– Indication box 104
– Live images 105
– Monitor ceiling suspension 105
– Outside 104
– Status area 105
X-ray protocols
– Customizing 258
X-ray system configuration 327
– Accuracy of dosimetric indications 330
– Tube output power 329
XperGuide laser tool 236, 322

Z
Zero dose positioning 115
Zone of occupancy 398

Azurion Release 2.2 Instructions for Use 493 Philips 4523 001 01511
Index

Azurion Release 2.2 Instructions for Use 494 Philips 4523 001 01511
© Koninklijke Philips N.V., 2016-2021. All rights reserved
Reproduction in whole or in part in any form or by any means, electrical, mechanical or otherwise is prohibited without www.philips.com/healthcare
the written consent of the copyright owner. healthcare@philips.com

4523 001 01511 * 2021-04


Manufacturer's address
Philips Medical Systems Nederland B.V.
Veenpluis 6
0344 5684 PC Best
The Netherlands
This medical device conforms with the applicable requirements set out by the European Union, as demonstrated in the Note that the address is also known as “Veenpluis
Declaration of Conformity. 4-6”, which refers to the same physical location.

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