ImageScan HD

High Frequency lntraoral X- Ray System

User Manual

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Table of Contents

Chapter 1 Safety and Precautions .............................................................................................................. 1

1.1 General Safety Tips.......................................................................................................................... 1
1.2 Safety Symbols ........................................................................................................................... 3

Chapter 2 Introduction ................................................................................................................................. 4

2.1 ImageScan HD X-Ray Equipment ............................................................................................. 4
2.2 Indication for Use ........................................................................................................................ 4
2.3 This Manual ................................................................................................................................. 4
2.4 Included System Components .................................................................................................... 5

Chapter 3 Know Your ImageScan HD ........................................................................................... 6

3.1 Key Components Identification ................................................................................................... 6
3.2 System Labels ............................................................................................................................. 7
3.3 ImageScan HD Reach Dimensions and Movements .................................................. 9
3.4 ImageScan HD Wall mount Configurations ................................................................................ 15
3.5 Keypad Console ......................................................................................................................... 19
3.5.1 Graphical LCD Display.......................................................................................................... 19
3.5.2 Keypad .................................................................................................................................. 19

Chapter 4 Operating ImageScan HD .......................................................................................................... 21

4.1 Before You Begin ....................................................................................................................... 21
4.2 Positioning the Patient ............................................................................................................... 21
4.3 Achieving the Best Image Quality .............................................................................................. 22
4.4 Power Turn-On Procedure ......................................................................................................... 23
4.5 ImageScan HD Operating Procedure Summary ........................................................................ 24
4.6 Exposure Settings and Tables............................................................................................................. 24
4.6.1 Default Exposure Program Presets ...................................................................................... 24
4.6.2 Default Exposure Values ................................................................................................................ 24
4.6.3 Prep Beep Settings ............................................................................................................... 24
4.7 Delivering an Exposure Procedure ............................................................................................ 24

Chapter 5 Using the Keypad Console ....................................................................................................... 29

5.1 Selecting a Preset Mode ............................................................................................................ 29
5.2 Selecting kV ............................................................................................................................... 29
5.3 Configuring the Defaults............................................................................................................. 30
5.4 Console Events .......................................................................................................................... 31

Chapter 6 Maintenance ............................................................................................................................... 32

6.1 Cleaning and Disinfecting .......................................................................................................... 32
6.2 Caring For Your Equipment ........................................................................................................ 32
6.3 Shipping, Long Term Storage and Tube Seasoning................................................................... 32
6.4 Preventive Maintenance............................................................................................................. 33
6.5 Disposal of the Unit .................................................................................................................... 33

Chapter 7 Troubleshooting and Error Codes ........................................................................................... 34

Chapter 8 Measurement Techniques ............................................................................................................. 36

8.1 Direct Measurement method ...................................................................................................... 36
8.2 Indirect Measurement method ................................................................................................... 38
Annex A: Technical Specifications ................................................................................................... 39
Annex B: Declaration of Conformity ................................................................................................ 43
Annex C: Guidance and Manufacturer’s Declaration ..................................................................... 44
Annex D: Contact Details .................................................................................................................. 46

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List of Illustrations
Figure 1 ImageScan HD Key Component Identification .................................................................... 6
Figure 2 ImageScan HD Label Location ............................................................................................ 9
Figure 3 Wall Mounted ImageScan HD 15" Support Tube Fully Extended
Right Side and Top Views .................................................................................................... 9
Figure 4 Wall Mounted ImageScan HD 24" Support Tube Fully Extended
Right Side and Top Views ................................................................................................... 10
Figure 5 Wall Mounted ImageScan HD 33" Support Tube Fully Extended
Right Side and Top Views ................................................................................................... 10
Figure 6 Wall mounth ImageScan HD Ground Clearance & Horizontally Extended ........................ 11
Figure 7 Wall mounth ImageScan HD Vertically Extended .............................................................. 11
Figure 8 Floor Mount ImageScan HD Fully Extended Dimensions .................................................. 12
Figure 9 Floor Mount ImageScan HD Sweep Angle ......................................................................... 12
Figure 10 Floor Mount ImageScan HD Extended Dimensions ........................................................... 13
Figure 11 Floor Mount ImageScan HD - Top View ............................................................................. 13
Figure 12 Floor Mount ImageScan HD - Storage Dimensions ........................................................... 14
Figure 13 ImageScan HD Keypad Console and Wall Mounting Configurations ................................. 15
Figure 14 ImageScan HD Keypad Console with LED display ............................................................ 19
Figure 15 Doorbell switch ................................................................................................................... 19
Figure 16 Remote Keypad Console ................................................................................................... 19
Figure 17 Horizontal Angulation ......................................................................................................... 22
Figure 18 Paralleling Technique.................................................................................................................... 23
Figure 19 Home Screen...................................................................................................................... 25
Figure 20 Home Screen with S Highlighted ........................................................................................ 25
Figure 21 mA parameter modified and accepted ................................................................................ 25
Figure 22 X-Ray - Preparing ............................................................................................................... 26
Figure 23 X-Ray - Exposing ............................................................................................................... 26
Figure 24 X-Ray - Results .................................................................................................................. 26
Figure 25 Start-up Screen .................................................................................................................. 29
Figure 26 Home Screen...................................................................................................................... 29
Figure 27 Mode Selection Screen................................................................................................................................. 29
Figure 28 Automatic mode ................................................................................................................. 29
Figure 29 Manual mode ...................................................................................................................... 30
Figure 30 Configuration Screen .......................................................................................................... 30
Figure 31 Stand-by Screen ................................................................................................................. 31
Figure 32 Error Display ....................................................................................................................... 31
Figure 33 kV Feed-back circuit ........................................................................................................... 36
Figure 34 Test points .......................................................................................................................... 36
Figure 35 mA Feed-back circuit .......................................................................................................... 37
Figure 36 Exposure time measurements............................................................................................ 38
Figure 37 kV measurement using kVp sensor .................................................................................... 38
Figure A-1 X-Ray Tube Insert Rating Chart ......................................................................................... 40
Figure A-2 X-Ray Tube Insert Thermal Data ........................................................................................ 40
Figure A-3 Heating and Cooling Curve ................................................................................................ 41

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 List of Tables
Table A Key Description...................................................................................................................... 20
Table 1 Default Exposure Values for Short/Long Cone R1 (Film). ......................................................27
Table 2 Default Exposure Values for Short/Long Cone R2. ............................................................... 27
Table 3 Default Exposure Values for Short Cone R3 ......................................................................... 28
Table 4 Default Exposure Values for Long Cone R3 ........................................................................... 28
Table 5 Attention / Warning Messages. ............................................................................................... 31
Table 6 Tube seasoning ...................................................................................................................... 33
Table 7 Error Codes ............................................................................................................................34
Table 8 Troubleshooting Tips ................................................................................................................... 35
Table A1 Tube-Head Specifications ..................................................................................................... 39
Table A2 X-Ray Tube Insert Specifications .......................................................................................... 39
Table A3 Mechanical Dimensions and Weight ..................................................................................... 41
Table A4 Mains Power Requirements .................................................................................................. 42
Table A5 Environmental Conditions ...................................................................................................... 42
Table C1 Guidance and Manufacturer’s Declaration –
Electromagnetic Emissions – For all EQUIPMENT and SYSTEMS...................................... 44
Table C2 Guidance and Manufacturer’s Declaration –
Electromagnetic Immunity – For all EQUIPMENT and SYSTEMS ....................................... 45
Table C3 Guidance and Manufacturer’s Declaration – Electromagnetic Immunity –
for all EQUIPMENT and SYSTEMS that are not LIFE-SUPPORTING. ................................ 46

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iv
 Chapter 1: Safety and Precautions

• Users must exercise every precaution to ensure personnel safety, and be

familiar with the warnings and cautions presented throughout this manual and
summarized below.
• Make sure to read and understand the safety related instructions.
• Make sure not to modify any component of the ImageScan HD system.
Any modification may result in violation of compliance to the standards.
Imageworks shall not be responsible for any modification causing violation
of compliance, compromise on safety, performance deterioration or any
other adverse effects.
• Warranty of this equipment will be void in the event of any modification done to the
equipment, misuse of the equipment and opening or servicing by unauthorized
personnel.

1.1 General Safety Tips

Radiation Safety This X-Ray equipment may be dangerous to the patient and the operator
unless safe exposure parameters and operating instructions are observed.
• Follow proper X-Ray radiation safety rules.
• Do not allow non-prescribed exposures.
• The system should be used only by dentists or trained & qualified dental
staff.
• Always point the X-Ray tube-head at the area to be imaged.
• Patients should be provided with lead apron and thyroid collar while being
exposed.
• The operator should wear proper X-Ray shielding protection.
• The operator should be at a distance of at least 2 meters away from the
tube-head while carrying out the procedure.
• The operator should not be standing in the direction of the X-Ray. The
operator should always stand away from the X-Ray beam and behind the
tube-head.

Electrical Safety Always switch off the main power when cleaning and disinfecting the unit.
The unit contains lethal high voltages. Do not attempt to open covers or repair
the unit yourself or with the help of non-certified service personnel. Contact your
authorized dealer.
This is an ORDINARY MEDICAL EQUIPMENT without protection against
ingress of liquids. Water or any other liquid should be prevented from leaking
into the equipment, as they may cause short circuit and/or corrosion.
Mechanical Safety Where complete safeguarding of the equipment is not possible, due care must
be taken to ensure that no part of the user’s or patient’s body or clothing can be
trapped or injured by any part of the equipment. In particular, make sure that
fingers are not caught or pinched during scissor arm movement.
Electromagnetic This equipment complies with EMI regulations. Interference between the unit
Interference and other sensitive electronics can occur under extreme conditions. Do not
use the X-Ray equipment in close conjunction with other sensitive devices or
devices which create high electromagnetic disturbance.
Physical Injury Exercise caution when operating the mechanical scissor arm. Since the arm
mechanism allows free movement with minimal force, a swinging arm can
inadvertently cause injuries.
The swinging joints on the arm are potential pinch points. Use caution while
operating the arm.

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Chapter 1: Safety and Precautions

Installation and Installation and service of ImageScan HD must only be done by an authorized
Service service engineer. Consult the factory or dealer as necessary.
Make sure that ImageScan HD is assembled and installed in compliance with all
applicable laws and recommendations concerning electrical safety.
Explosion This equipment must not be used in the presence of flammable or potentially
Safety explosive disinfecting gases or vapors, which could ignite causing personal
injury and/or damage to the equipment. If such disinfectants are used, the
vapor must be allowed to disperse before using the equipment.
This equipment is not suitable for use in the presence of anaesthetic gases.
Floor Mount Care must be taken for the movement and positioning of ImageScan HD Floor
Mount.
The Floor Mount system is meant for limited movement inside the clinic and is
not suitable for Transport applications. Before moving the Floor Mount system
around, the scissor arms must be folded to avoid unnecessary damage to the
system.
The wheel locks should be unlocked before moving the system. After the system
is placed at the desired location, the wheel locks should be put in lock position.
This equipment is meant for limited movement within a clinic or hospital room.
Adequate care should be taken while moving on ramp or on an uneven surface.

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 Chapter 1: Safety and Precautions

1.2 Safety Symbols

The following safety related symbols are found on the equipment.

Caution Symbol
This symbol indicates the user to be cautious and refer to the user manual for
safe operating instructions.
Protective Earth Ground

Mains Earth Ground is required for continued protection against shock hazards.
Type of Insulation

Class 1, Type B Insulation. Protection against electric shock

(UL60601-1:2003). Requires protective Earth Connection.

High Voltage

Dangerous voltages present.

Caution: X-Ray
X-Ray Source Assembly / Tube-head capable of generating X-Rays. This X-
Ray unit may be dangerous to patient & operators unless safe exposure factors
and operating instructions are observed.

WEEE Symbol
Indicates that the unit conforms with WEEE Directive 2002/96/EC and must be
disposed of only at the appropriate facilities for recovery and recycling.
X-Ray Emission Status

X-Ray Emission /ON

Focal Spot

Mains Neutral Connection

Mains Line Connection

Follow Instructions for use

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Chapter 2: Introduction

2.1. ImageScan HD X-Ray Equipment

The ImageScan HD High Frequency Intraoral X-Ray has been engineered and manufactured to provide
many years of reliable service. The system houses two microprocessors, one for control/supervisory
functions and another to provide the user/machine interface. The technology incorporates feedback
circuits to ensure accuracy and reproducibility of X-Ray output for dental diagnostic radiography.
ImageScan HD will create radiographs of excellent quality, performing equally well using any image
receptor.
The High Frequency Intraoral X-Ray is hereafter referred to as ImageScan HD in this manual. Review
and follow the guidelines included in this User's Manual to thoroughly become familiar with the operating
and safety procedures. This will ensure that your ImageScan HD gives you the highest level of service.

2.2. Indication for Use

The ImageScan High Frequency Intraoral X-Ray is to be used as a source of X-Rays in Dental radiography. Only
trained professionals should use this device. Federal law prohibits the sale of this device to individuals
other than trained professionals. Use of this device, other than as described in this manual, may result
in injury.

2.3. This Manual

This manual is not to be used as a replacement for training in radiography. The document contains basic
operation instructions, identification of parts, system labels and safety guidelines for the ImageScan HD
models listed below. Additionally, troubleshooting tips are provided should the equipment not perform as
intended.
The following are guidelines for using this manual.

Alerts users to important instructions that require caution when

operating the unit since they are related to safety.

This symbol points to an important detail / tip in the operation of the

unit. Read carefully to avoid any problems.

This manual describes the user interface of the keypad Console

using images as shown to the left. These images are indicative
only and the values displayed may differ from the actual values
unless specified otherwise.

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 Chapter 2: Introduction

2.4. Included System Components

The Wall Mounted ImageScan HD system is available in three model configurations using
different Straight Arm assembly.

Top Level Variants

ImageScan HD Intraoral X-Ray Floor Mount
Wall Mounted ImageScan HD High Frequency Intraoral X-Ray with 15" Straight Arm
Wall Mounted ImageScan HD High Frequency Intraoral X-Ray with 24" Straight Arm
Wall Mounted ImageScan HD High Frequency Intraoral X-Ray with 33" Straight Arm

Unpack each component and verify that items listed below are received as appropriate. If any
item is missing or damaged, notify your authorized dealer.

Description Part No.

Wall Mounted 15" Straight Arm without remote switch 303-001201-0
Wall Mounted 24" Straight Arm without remote switch 303-001202-0
ImageScan HD High Wall Mounted 33" Straight Arm without remote switch 303-001203-0
Frequency Intraoral
Wall Mounted 15" Straight Arm with remote switch
X-Ray
(One only) Wall Mounted 24" Straight Arm with remote switch
Wall Mounted 33" Straight Arm with remote switch
Floor Mount 303-001204-0
Contents
Note: The Tube-head is shipped attached to the Scissor Arm
15" Long 309-000422-0
Straight Arm Assembly
24" Long 309-000423-0
for Wall Mount (one only)
33" Long 309-000424-0
Scissor Arm Assembly Wall Mount (includes cables) 309-000425-0
Scissor Arm Assembly Floor Mount (includes cables) 309-000425-1
70kVp 8mA Tube-head Assembly(0.4FS) 309-001207-0
Base Unit Assembly Wall Mount 309-001205-0
Base Unit Assembly Floor Mount 309-001206-0
Exposure Switch with Cable 309-000428-0
Template for Wall Plate (Single Stud Mounting) Installations 207-001473-0
Lead Extension Cone Assembly 309-000208-0
16" Wall Plate with template (Optional) 205-001474-0
Remote Keypad Console with template (Optional) 309-001210-0
Doorbell Switch with template (Optional) 309-000432-0

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Chapter 3: Know Your ImageScan HD

3.1 Key Component Identification

As shown in Figure 1, ImageScan HD is comprised of the following components:

1. Base Unit (Both Wall mount and Floor Mount Units)
The Base Unit provides mounting support for the straight arm and scissor arm with attached
tube-head. It provides system power connection and application via the Mains Power Line
Cord and the Mains Power ON/OFF Switch. Overall operational control for ImageScan HD is
also provided via the Keypad Console.
2. Keypad Console (Both Wall mount and Floor Mount Units)
The Keypad Console is the user/machine interface providing all functional operating controls of
the ImageScan HD system. Consisting of a LCD display and keypad, the console keypad allows
both automatic and manual selections of exposure parameters while the resultant operation
status is shown via the LCD display.
3. Straight Arm (Wall mount Units)
The Straight Arm provides the horizontal space away from the wall-mounted Base Unit. Available
in 15, 24 and 33 - inch lengths to meet the reach requirements of the installation site.
4. Scissor Arm (Both Wall mount and Floor Mount Units)
The Scissor Arm consists of a vertical and horizontal arm joined via a double joint. This design
enables smooth linear and upward motion transitions while allowing the attached tube-head to
remain balanced in all positions.
5. Mobile Support Platform (Floor Mount Units)
The Mobile Support Platform provides a stable portable operating base for ImageScan HD Floor
Mount
6. Tube-head with Beam Limiting Device (Both Wall mount and Floor Mount Units)
Provides 60 kV – 70 kV voltage range (adjustable in 1 kV steps) and 4 mA – 8 mA current
range (adjustable in 1 mA steps) to reduce exposure times and the amount of radiation
absorbed by the patient. The tube-head is equipped with a beam limiting device with a 220mm
source to skin distance and 60mm beam diameter at the output. The tube-head is connected
to the arm by means of a rotating contact, allowing 540 degree horizontal rotation and 310
degree vertical rotation.

Wall Mounted ImageScan HD ImageScan HD Floor Mount

Figure 1. ImageScan HD Key Component Identification

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 Chapter 3: Know Your ImageScan HD

3.2 System Labels

This section shows the required system labels that are affixed on the unit. Refer to Figure 2 for the
location of each label by the corresponding item number below the label.

Illustration 1: Straight Arm Label (#1) Illustration 2: FDA Label (#2)

Illustration 3: Angular Tape (#15)

Illustration 5: X-Ray Control Console Label

(#4)

Illustration 7. X-Rays Caution Label (#6)

Illustration 4: Warning Label
(#3)

Manufactured For:
ImageWorks ImageWorks
SMK Imaging LLC
8 Westchester Plaza,
Suite 112 Elmsford, Manufactured by:
NY10523 USA Skanray Technologies Pvt. Ltd
Plot No. 15 - 17,
Distributed by: Hebbal Industrial Area,
ImageWorks Mysore, INDIA- 570016

Illustration 8: Manufacturer Label

(#7)

Illustration 6: Danger Label

(#5)

Illustration 9: System Label (#8)

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Chapter 3: Know Your ImageScan HD

Illustration 10: 3rd Ed-UL Mark Label (#9)(Proposed)

Illustration 11: Base Unit Label (#11)

Illustration 12: Base Unit Sl. No. Label (#10)

Illustration 13: Tube Housing label
for focal sport 0.4 (#12)

Illustration 14: Tube Housing Sl. No. Label (#13) Illustration 15: Scissor Arm Label (#14)

Illustration 17: Extension Cone

Label (Optional) (#17)

Illustration 16: L-Arm Dome Label (#16)

Illustration 19: Casted Base Label (#19)

Illustration 18: Base Column Label (#18) Illustration 20: Angular Tape Floor Mount (#20)

Illustration 22: CE Marking Label Illustration 21: Position Indicator Arrow (#21)
(#22)(Proposed)

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 Chapter 3: Know Your ImageScan HD

Figure 2. ImageScan HD System Label Location (Refer section 3.2, Page 12 for System Labels)

3.3 ImageScan HD Reach Dimensions and Movements

Figures 3 through 12 show minimum and maximum clearances, dimensions and sweep angles for both
the wall mounted and Floor Mount units.

15" Straight Arm

15" (380mm) 51" (1300mm)

2" (58mm)

58" (1465mm)

4" (108mm)
62" (1575mm)
6" (165mm)

170° to 190°

210° to 230°

Figure 3. Wall Mounted ImageScan HD 15" Support Tube Fully Extended Right Side and Top Views

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Chapter 3: Know Your ImageScan HD

24" Straight Arm

24" (610mm) 51" (1300mm)

2" (58mm)

67" (1695mm) 6" (165mm)

4" (108mm)
71" (1803mm)

170° to 190°

210° to 230°

Figure 4. Wall Mounted ImageScan HD 24" Support Tube Fully Extended Right Side and Top Views

33" Straight Arm

33" (830mm) 51" (1300mm)

2" (58mm)

75" (1915mm)
6" (165mm)
4" (108mm)
80" (2032mm)

170° to 190°

210° to 230°

Figure 5. Wall Mounted ImageScan HD 33" Support Tube Fully Extended Right Side and Top Views

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 Chapter 3: Know Your ImageScan HD

Figure 6. Wall Mounted ImageScan HD Ground Clearance & Horizontally Extended

Figure 7. Wall Mounted ImageScan HD Vertically Extended

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Chapter 3: Know Your ImageScan HD

71" (1795mm)

Figure 8. Floor Mount ImageScan HD Fully Extended Dimensions

30° to 40°

30° to 40°

Figure 9. Floor Mount ImageScan HD Sweep Angle

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 Chapter 3: Know Your ImageScan HD

48”±0.5” (1219mm)

37”±0.5” (935mm)

Figure 10. Floor Mount ImageScan HD Extended Dimensions

39" (992mm)

Figure 11. Floor Mount ImageScan HD - Top view

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Chapter 3: Know Your ImageScan HD

77”±0.5” (1956mm)

5.5"±0.5” (140mm)

36"±0.5” (914mm)

View A. Right Side View View B. Front View

Figure 12. Floor Mount ImageScan HD - Storage Dimensions

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 Chapter 3: Know Your ImageScan HD

3.4 ImageScan HD Wall mount Configurations

Figure 13: ImageScan HD Keypad Console and Wall mounting Configurations

Note:
(For Configurations 2 - 7)

1. RJ45-8P8C 35' Cable: CAT-

5 24AWG 4-Twisted Pair 1:1
Connection. Similar to
BELDEN P/N 1624R
2. RJ11-6P4C 35' Cable: Center
4 Positions Populated 1:1
Connection. Similar to P/N
A2521
#B
3. 3Wire, 35' Cable: Shielded or
Un- shielded Cable AWG 20-
28. P/N LAPP0028503
4. 2 Wire shielded or unshielded
cable AWG 20-28 P/N
LAPP0028502

Can use Internal Keypad Console and Internal Exposure Switch

RJ45 (8P8C) with single door bell switch

Can use both Keypad Consoles (internal and remote) with Internal Exposure Switch and single door bell
15
switch.

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Chapter 3: Know Your ImageScan HD

RJ45 (8P8C) with DOUBLE DOORBELL SWITCH

Can use both Keypad Consoles (internal and remote) with Internal Exposure Switch and double door bell
switch

3 WIRE WITH SINGLE DOORBELL SWITCH

Can use Internal Keypad Console with Internal Exposure Switch and single door bell switch

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 Chapter 3: Know Your ImageScan HD

3 WIRE WITH DOUBLE DOORBELL SWITCH

Can use Internal Keypad Console with Internal Exposure Switch and double door bell switch

RJ11 (6P4C) WITH SINGLE DOORBELL SWITCH

Can use Internal Keypad Console with Internal Exposure Switch and single door bell switch

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Chapter 3: Know Your ImageScan HD

RJ11 (6P4C) WITH DOUBLE DOORBELL SWITCH

Can use Internal Keypad Console with Internal Exposure Switch and double door bell switch

ImageScan HD Floor Mount unit is powered directly through a Hospital-grade Plug.

For ImageScan HD Floor Mount unit, exposure is given using Internal Exposure
Switch as in Wall Mount Configuration 1.

ImageScan HD Wall mounting Configurations

Single Stud Mounting 2 Stud Mounting

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 Chapter 3: Know Your ImageScan HD

3.5 Keypad Console

All functional operating control of ImageScan HD is provided by the keypad Console located on the
base unit, consisting of a LCD display and keypad. Apart from this, Remote Keypad Console (External
Console with Doorbell Switch) and Doorbell Switch also is available as an optional accessory. This
additional console will be used for different configurations of console as illustrated in Section 3.4. It
allows both automatic and manual selections of exposure parameters. The location of the panel
controls and indicators are shown by Figure 14, while the function of each is described on the
following page.

3.5.1 Graphical LCD Display

The LCD display on the keypad Console offers a rich user interface, displaying the selected exposure
parameters along with many other user-friendly features. The screen components of the home screen
are shown by Figure 14.
3.5.2 Keypad
In addition to the LCD display, the keypad Console contains 8 keys and exposure LED indicator. These
keys are used to select the exposure parameters. ImageScan HD simplifies the process of selecting
exposure parameters using pre-programmed settings for every combination of image receptor, adult/
child and tooth anatomy as described by
section 4.7, Selecting an Exposure set of this manual. Additionally, an audible signal (beep) sounds to
confirm keypad button selection and when certain errors occur. This alert is also heard during any X-ray
emission occurrence.

Figure 14. ImageScan HD Keypad Console with LCD

Display

Figure 16. Remote keypad Console

Figure 15. Door Bell switch

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Chapter 3: Know Your ImageScan HD

Table A. Key description

No Color: Idle / Standby

Exposure Status Green: Ready to Deliver X-Ray
LED Indicator Orange: Exposure in Progress
Red: Operation Fault

Navigate up or down a list menu.

+/- Keys
Increment or decrement parameter value.

Logo (Seconds /
Toggles between Seconds / mA
Milli Ampere)

Toggles between Adult & Child Preset.

Adult / Child
Top LED : Adult
Preset Key
Bottom LED: Child

Tooth selection Key Each press selects different tooth in sequential mode.

Canine/Incisor
Canine/Incisor LED ON - Enable
LED OFF - Disable

Bitewing
Bitewing LED ON - Enable
LED OFF - Disable

Pre-Molar
Pre-Molar LED ON - Enable
LED OFF - Disable

Molar
Molar LED ON - Enable
LED OFF - Disable

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 Chapter 4: Operating ImageScan HD

4.1 Before You Begin

Make sure that the operator has read and understood this manual regarding
operation of the system. Users must exercise every precaution to ensure
personal safety, and be familiar with the warnings presented throughout this
manual and summarized in Chapter 1 (Page 7).
Government regulators may require that only a licensed operator may use
this equipment. Check with your dealer regarding regulations.
Regulator Approvals Installation and use of radiation generating equipment is regulated by the
government or its authorized agencies in most countries. Check with your local
dealer regarding site approvals or usage requirements.

The operator should be well acquainted with the radiation protection methods for
both the operator and patient before using this equipment.

Majority of repeat exposures and inferior X-Ray images are attributed to

the storage, handling, use and developing of X-Ray films rather than the
Film Development
equipment itself. Make sure that the image capture films are stored and used
per instructions.

Let the patient know that he/she is going to be exposed to X-Ray.

Avoid X-Rays or take necessary precautions when X-Raying pregnant
patients.

4.2 Positioning the Patient

Adults
The patient shall be seated and made comfortable so that he/she does not
move during the exposure. Make sure to place protective aprons and shields
over the patient where necessary.

Children For young patients, it may be required that a guardian be available near
the patient. In such cases, instruct the guardian to be on the same side of
the X-Ray port; away from the X-Ray beam and behind the tube-head. The
guardian shall wear radiation protective clothing.

The Position Indicating Device (PID), also referred to as the Cone, should be
Position Indicating
Device used to approximate the area of X-Ray exposure.

The tube-head has an built-in focus to skin distance of 220mm

± 5mm. This is also referred as short cone distance,which is the
safe distance at
which the skin can be positioned.
Optionally, the operator can use long cone. Long cone will
increase the focus to skin position distance from 220mm ± 5mm
to 300mm ± 5mm

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Chapter 4: Operating ImageScan HD

4.3 Achieving the Best Image Quality

ImageScan HD is engineered to provide the best platform for dental radiographic imaging. However, the best
results are obtained when the equipment is used properly per the manufacturer's specifications. Practicing the
following positioning techniques will help the user make the best out of the equipment’s output.

Patient's Head Position

 Patient’s head should be as straight as possible.
 The patient should not move during the exposure.

Cone Position
 Cone should be positioned in such a way that the central axis of the cone is perpendicular
to the teeth and should be as close to the area being imaged as possible.
 In general, the vertical angulation of the cone should be at +45° for maxilla teeth and -10°
for Mandible teeth.
 The horizontal angulation of the cone should also be maintained to achieve
perpendicularity with respect to the teeth as shown by Figure 17 below.

The angle of the cone is indicated on the scale

located on the vertical joint of the tube-head.

M – Molar
P – Pre-Molar
C – Canine

Maxilla Mandible
ML
Sagittal Plane

0°

P 80 - 90°
60 - 75° M
70 - 80°
70 - 80°
M 45°
80 - 90° P

0°
C
Sagittal
Plane ML

Figure 17. Horizontal Angulation

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 Chapter 4: Operating ImageScan HD

The Image Receptor and holder are not part of supplied accessories.

Image Receptor Holder

 Using an image receptor holder and head positioning device is recommended since it gives precise
control over the area to be imaged.

Placement of Image Receptor Inside the Patient's Mouth

The image receptor should be placed parallel to the long axis of the teeth as shown by Figure 18.

CR Central Ray: an imaginary

beam of X-Rays in the exact
center of the position
indicating device.

CR

CR perpendicular
to long axis of
tooth & film

Film parallel to
Long axis long axis of tooth
of tooth

Figure 18. Paralleling Technique

Refer to Chapter 5 for details on navigating the

Keypad Console for setup and operation of
ImageScan HD

4.4 Power Turn-On Procedure

Turn on ImageScan HD by performing the following steps:
1. Place the Main Power Switch located on the bottom of the Base Unit to the ON ( I ) position. See
Figure 1.(Page 11)

Do not press any keypad keys during self test period.

Any input will be considered an error at this time.

2. On power up, observe that the system self check function initiates and the console display's
Start-up Screen as shown by Figure 25 (Page 34).
3. Immediately following a successful self test, the console displays a home
screen as shown by Figure 19 (page 30).

24
Chapter 4: Operating ImageScan HD

4.5 ImageScan HD Operating Procedure Summary

1. Turn on ImageScan HD by performing the Power Turn-On Procedure provided in section 4.4.
2. Introduce the receptor into the patient’s mouth according to the chosen technique as shown
by Figures 17 and 18 (bisecting or parallel - Page 27, 28).
3. Move the tube-head beam limiter near the patient and direct it exactly towards the tooth to be
examined.
4. Arrange the tube-head with an angle suitable for the required exposure and positioning.
5. Move as far away as the Exposure switch cable allows, in a direction opposite to the X-ray
beam emission while maintaining visual contact with the keypad Console and the patient.

Refer to Tables 1 through 4 (Page 32 to 33) for estimated exposure values of

minimum patient dose that can be modified per user requirement in
Custom mode.

6. Create an exposure by performing the Exposure Delivery Procedure provided in section 4.7.
Make sure to refer to Chapter 5 for details on navigating the keypad Console for setup and
operation of ImageScan HD as necessary.

4.6 Exposure Settings and Tables

4.6.1 Default Exposure Program Presets

By default the keypad console boots into R1, Short cone, Adult, Canine/Incisor Presets. The default or
start-up exposure program is the exposure program set to operate ImageScan HD upon power turn-on
of the unit. The default exposure program can be changed using the keypad Console by performing the
Setting a Preset as the Start-up Mode procedure provided in section 5.2.

4.6.2 Default Exposure Values

Estimated exposure values (kV,mA & S) listed by Tables 1 through 4 (Page 32 to 33) are for minimum
patient dose and can be modified per user requirement later. Refer to the tables below for Default
Exposure Values for specific ImageScan HD application modes and options.

Table 1. Default Exposure Values for Short/Long Cone R1 (Film)

Table 2. Default Exposure Values for Short/Long Cone R2 (Custom)

Table 3. Default Exposure Values for Short Cone R3 (Custom)

Table 4. Default Exposure Values for Long Cone R3 (Custom)

4.6.3 Prep Beep Settings:

 Off - When the exposure switch is pressed, there will be no beep sound during prepara-
tion and gives
continuous long beep during exposure.
 On - When the exposure switch is pressed, there will be fluttered beep sound during
preparation and
continuous long beep during exposure.
 Partial - When the exposure switch is pressed, a single beep is given to indicate the start
of X-ray preparation. Following this, there is silence until the start of the actual exposure.
During exposure, there will be continuous long beep.

4.7 Exposure Delivery Procedure

The moment the keypad console displays the Home screen, the unit is ready to deliver an exposure. This
section describes the preparations that can be done before delivering an exposure and what happens
during the procedure

25
 Chapter 4: Operating ImageScan HD

Bring the console back to home screen as shown in figure 19.

Here the user can modify the mA, and S value The defaults
(kV, Cone, and Preset mode) can be set during Configuration
time (See Section 5.3).

Figure 19. Home Screen

Selecting an Exposure Set proceed as follows

An exposure set is a combination of patient type and tooth anatomy which the console uses as an
index to retrieve the exposure parameters. For each mode, there are 8 presets available. To select
one from these 8 exposure set, use the patient type key and the tooth anatomy keys.
E.g. to take X-Ray image of canine of a child
1. Press the key to select child (bottom LED),
2. Press Tooth Selection Key and select Canine ( LED Turns ON indicates selection of respective
Teeth) (show the image of “Tooth Key”)

Modifcation of mA & S values proceed as follows

Highlight the parameter

By default parameter 'S' is Highlighted )

If values of mA is Highlighted and to be altered,change

the values by using +/- keys.

If values of S to be altered,select by pressing ) until the

parameter is Highlighted and change using +/- keys.
Figure 20. Home Screen Modify the parameter
with S highlighted Press +/- keys the required number of times to change the
highlighted parameter. The parameter being changed to
indicate the operation.

Accept the change

The set parameters are accepted automatically.

Figure 21. mA parameter

modified
and accepted

26
Chapter 4: Operating ImageScan HD

Now press Exposure Switch or Remote Exposure Button

on the Doorbell switch to initiate the exposure.
Here the unit prepares itself to deliver the exposure. This stage
might take a few seconds. An Audible beep sound depends on
Prep beep settings (See section 4.6.3) and the X-Ray status
indication LED illuminates green.
Stop or abort an exposure by simply pressing any key other
Figure 22. X-Ray - Preparing than the Exposure Switch.

The Exposure Switch must be kept depressed

throughout the entire exposure. Releasing the
Exposure Switch before the
end of the exposure terminates the emission
with the message displaying "X-RAY ABORTED" .

Verify that an audible beep occurs and the screen shows

the radiation icon while the exposure is being delivered.
The X-Ray status indication LED also illuminates orange.

Figure 23. X-Ray - Exposing

If you need to abort while delivering an

exposure, simply release the Exposure
Switch.

Once the exposure is completed (or aborted while delivering), the

X-Ray results screen displays the actual values of kV, mA and S
sensed.

The Exposure Switch may be released once the X-Ray

Results screen displays. If the Exposure Switch is continued to
be held, the next exposure will not be initiated.

Results screen would show ABORTED rather than DONE

when the exposure procedure was aborted.
Figure 24. X-Ray - Results
The results screen is shown for 5 seconds if not interrupted by
any key press (except the Exposure Switch). The screen returns
to Home screen and is ready for the next exposure.

The tube-head needs to cool down before proceeding to the next exposure.
This waiting period depends on the specific exposure duration selected for the last
exposure. If an attempt is made to conduct an exposure during this waiting period,
the console displays a message request- ing the operator to wait for the remaining
amount of time required by the tube-head to cool down.

27
 Chapter 4: Operating ImageScan HD

Table 1. Default Exposure Values for Short/Long Cone R1 (Film)

Validated Exposure Values (kV, mA & S) mentioned below are for minimum patient dose
and can be modified as per user requirement.

Time (S)
Slow Fast
Anatomy kV mA
Cone
Short Long Short Long
Bitewing 70 6 0.22 0.71 0.18 0.56

Canine 70 6 0.2 0.63 0.16 0.5

Adult
Molar 70 6 0.22 0.71 0.18 0.56

Pre-Molar 70 6 0.2 0.63 0.16 0.5

Bitewing 70 6 0.16 0.5 0.13 0.32

Canine 70 6 0.14 0.45 0.11 0.32

Child
Molar 70 6 0.16 0.5 0.13 0.32

Pre-Molar 70 6 0.14 0.45 0.11 0.32

Table 2. Default Exposure Values for Short/Long Cone R2 (Custom)

Estimated Exposure Values (kV, mA & S) mentioned below are for minimum patient dose and
can be modified as per user requirement.

Time (S)
Anatomy kV mA Cone
Short Long

Bitewing 70 6 0.18 0.56

Canine 70 6 0.16 0.5

Adult
Molar 70 6 0.18 0.56

Pre-Molar 70 6 0.16 0.5

Bitewing 70 6 0.13 0.32

Canine 70 6 0.11 0.32

Child
Molar 70 6 0.13 0.32

Pre-Molar 70 6 0.11 0.32

28
Chapter 4: Operating ImageScan HD

Table 3. Default Exposure Values for Short Cone R3 (Custom)

Estimated Exposure Values (kV, mA & S) mentioned below are for minimum
patient dose and can be modified as per user requirement.

Time (S)
Anatomy kV mA Cone
Short

Bitewing 70 6 0.14

Canine 70 6 0.16
Adult
Molar 70 6 0.14

Pre-Molar 70 6 0.16

Bitewing 70 6 0.13

Canine 70 6 0.13
Child
Molar 70 6 0.13

Pre-Molar 70 6 0.13

Table 4. Default Exposure Values for Long Cone R3 (Custom)

Estimated Exposure Values (kV, mA & S) mentioned below are for minimum
patient dose and can be modified as per user requirement.

Time (S)
Anatomy kV mA Cone
Long
Bitewing 70 6 0.14
Canine 70 6 0.16
Adult
Molar 70 6 0.14

Pre-Molar 70 6 0.16

Bitewing 70 6 0.13
Canine 70 6 0.13
Child
Molar 70 6 0.13

Pre-Molar 70 6 0.13

29
 Chapter 5: Using the Keypad Console

The keypad Console is the user interface allowing the operator to control the X-Ray system and
get feedback from it. This section describes how to use the console to complete specific tasks. As a
preface, the stages through which the console passes before it becomes operable are described first.

Power up - Indication
On power up, the console displays the Start-up Screen as
shown on the left. Following this, the console performs self
test. The keypad, beeper and LCD backlight are checked. Do
not press any keys (including exposure switch) during self
test period.
Figure 25: Start-up Screen

Home Screen
Immediately following a successful self test the console
displays a screen similar to the one shown on the left. This
screen displays current selection of exposure parameters,
exposure mode details and accessories selected (cone type
and film speed).

A 'READY' icon at the top right corner of the display indicates

Figure 26: Home Screen that the system is ready to deliver an exposure.

5.1 Selecting a Preset Mode

A Preset Mode is a collection of exposure parameters (kV, mA and S) suitable for a particular type of
image receptor. The keypad Console of ImageScan HD provides a total of three user modes of
operation, which include:
 One factory programmed default modes, R1 (Film)
 Two custom modes : R2 & R3
Each mode provides 8 sets of exposure parameters based on the patient type and tooth anatomy.
The factory programmed modes varies the exposure duration to suite the accessories (cone type and
film speed) selected.
Change the Preset Mode by performing the procedure provided below.
Mode Selection Screen
Go to Configuration menu as explained in Section 5.3.
Use the +/- keys to navigate within the list. Press these
buttons until the desired mode is highlighted
Select Set Exposure Mode by pressing key.
A screen similar to the one shown on the left side appears
on the display.

User can select one mode among these by pressing

Figure 27: Mode Selection key.
Screen By pressing key to returns home screen with the
newly selected mode abbreviated on the top right side of
the display.

30
Chapter 5: Using the Keypad Console

5.2 Selecting kV
kV can be modified only in Manual mode.
To set Automatic mode proceed as follows.

Go to Configuration menu as explained in Section 5.3.

Set Select kV option in Configuration menu by using
key.
In Select kV as shown in figure 28, set Automatic mode by
pressing key
In Automatic mode, user cannot modify the kV value.
Figure 28 : Automatic mode

To modify kV value in manual mode proceed as follows.

Go to Configuration menu as explained in Section 5.3.
Set Select kV option in Configuration menu by using
key.
In Select kV as shown in figure 28, set manual mode by
using key.
Use Up/Down key to select the required kV and set kV
Figure 29 : Manual mode
value, by pressing key as shown in figure 29.

5.3 Configuring the Defaults

To set the parameters like kV, modes and cone as required, proceed as follows.
Press +/- key simultaneously to access configuration menu (during start up logo)
The user can set/access the following options as shown in the Figure 30

Figure 30: Configuration Screen

31
 Chapter 5: Using the Keypad Console

 Use +/- key to navigate within Configuration menu.

 Press key to accept currently highlighted item.
 Press key to return previous menu.

5.4 Console Events

This section describes the special events displayed in the Keypad console. For Attention/ Warning mes-
sages, refer Table 5 and for error codes refer Table 7.

Inactive
Absence of any activity for 5 minutes continuously on the
console causes the system to go to a state of inactivity. This
is marked by the screen indicating a message as shown on
the left side along with the display backlight driven into a
‘breathing’ state.
Figure 31. Stand-by Press any key to bring the console back to the Home screen
Screen
Error
Any error occurring in the system is reported by the console
as follows.
• Displays an error message with an error code and
additional messages (example code shown is CN009).
• Display backlight turns RED
• An exposure can not be delivered until the issue is
Figure 32. Error Display resolved.

Table 5: Attention / Warning Messages

Attention/Warning Messages Screen Condition

Tube cooling Home EXPOSURE key pressed after an
Please wait exposure and before the cooling
<n> seconds period expires.
System error. Home After fixing an internal error while
<error code> exposing.
Please retry
ERROR Home After an internal error that requires
<error code> user / service intervention.
Please restart

32
Chapter 6: Maintenance

6.1 Cleaning and Disinfecting

Important: Turn OFF ImageScan HD Wall mount or turn OFF and unplug the ImageScan
HD Floor Mount Unit. Wait for 5 minutes before proceeding with service.
Active internal circuits remain connected to main voltage even when main
power switch is turned off.

• Use a soft damp cloth to clean the outside surfaces of the equipment
• Do not spray or let the cleaning fluid enter the unit.
• Periodic disinfecting of the unit is required for hygiene. Disinfect with a
compatible low or intermediate level instrument grade disinfectant
after cleaning.
• Use a non-acetone based disinfectant liquid.

Cleaning Methods. In order to ensure proper hygiene, especially when protective barriers are not
used between each patient, clean and disinfect ImageScan HD by thoroughly performing the following
procedures:

Important: Make sure that the unit is completely dry before plugging in or turning power back on.

Exterior Surfaces: Wipe the outside surfaces with a disposable towel moistened with water. Dry the
external surface with disposable towels.
Parts in Contact with the Patient’s Skin: To ensure proper cleaning of these parts, periodic
disinfection with an approved EPA Non Corrosive Surface Disinfectant is recommended. Clean any
remaining disinfectant residue from the system with a disposable towel moistened with water.

6.2 Caring For Your Equipment

 Do not allow the unit to impact with any hard surfaces.
 Switch off the unit when leaving for the day or when not used for a long time.
 Ensure that the unit is not subject to direct sunlight.
 Do not force the arm mechanisms or tube-head into a position it is not designed for.
There are movement stoppers provided.
 Avoid swinging the arms or rotating the tube-head in a sudden jerky manner.
 Avoid free swinging of the arms or tube-head. Always guide the movements with your
hand.
 Do not hang external loads or weights on the tube-head or Straight Arm. The arm and
base units are designed for its own weight and may not hold an additional weight.
 Schedule and carry out periodic maintenance checks.
6.3 Shipping, Long Term Storage and Tube seasoning
 Use the original packing box for shipping / transporting the unit.
 When not using for a long time, cover the unit with dust proof covers and ensure the unit
is not exposed to harsh environments.
 In case of non-usage for long period (>6 months) X-Ray Tube Seasoning is
recommended. Cover the X-Ray port with Lead .Using the Keypad Console set the
parameters per Table below . Give Exposure and repeat exposure 5 times for each
combination of kV, mA and S. After all the exposures are completed, the Unit is ready
for use.

33
 Chapter 6: Maintenance

Table 6:

kV mA Time(S)
60 4 0.04
60 6 0.04
60 8 0.04
60 4 0.50
60 6 0.50
60 8 0.20
65 4 0.04
65 6 0.04
65 8 0.04
65 4 0.50
65 6 0.50
65 8 0.20
70 4 0.04
70 6 0.04
70 8 0.04
70 4 0.50
70 6 0.50
70 8 0.20

6.4 Preventive Maintenance

 For continued service support, ensure you have entered into an annual maintenance
program with your dealer. This will ensure that qualified engineers periodically keep a check
on the equipment.
 It is advised that the unit be subject to a maintenance schedule once every year (after 1st
year of usage) .
 All servicing should be done by qualified personnel.

The interior of the Main Assembly is only accessible by removing hardware

with tools and should only be opened and serviced by an authorized
ImageWorks’ Dealer Service representative. Call your authorized
Imageworks’ dealer for service. Since the interior of the unit contains high
voltage components, failure to heed this warning may result in equipment
damage, personal injury and/or death.

6.5 Disposal of the Unit

Some parts of the equipment contain material and fluids which must be disposed of at appropriate
recycling centers conforming to all local, state and federal regulations. In particular the equipment
contains the following materials and or components:
Tube-head: external packages in non-biodegradable plastic, dielectric oil, lead, copper, brass,
aluminium, tungsten.
Power supply and remote control: external packages in non biodegradable plastic, iron,
populated printed circuit boards, copper.
Tube-head extension: iron, aluminium, copper & silicon rubber.
Important: The Manufacturer and the Distributor do not accept any responsibility for
the disposal of equipment or parts discarded by the user and the related
costs.

34
Chapter 7: Troubleshooting & Error codes

ImageScan HD has been designed with safety features to protect the patient and operator in case
of failure of an electrical component. The system automatically checks for errors and will report a
malfunction by means of an error code on the Keypad Console display. These error codes are listed
in the Table 7 below. The table lists the code and identifies the corresponding equipment operational
fault. The corrective action for the error code is provided by Table 8, which also lists observed
problems and their potential source.

Table 7. Error Codes

Error Code Error

CN001 Communication error

CN002 Console and tube-head are incompatible

CN003 X-Ray preparation time-out

CN004 Anode arc fault

CN005 Cathode arc fault

CN006 Over kV fault

CN007 Over mA fault

CN008 kV regulation fault

CN009 Filament open fault

CN010 Filament limit fault

CN011 CAN fault

KB001 Key jam error

35
 Chapter 7: Troubleshooting & Error codes

Table 8 provides troubleshooting tips to help the user recover from an equipment fault condition. It lists
observed problems as well as recommends the corrective actions.

Table 8. Troubleshooting Tips

Observed Problem Recommended Action

1. Error state with display indicating Switch off mains power. Wait for 2 minutes and then Switch
CNXXX error code on mains power.
If the problem persists, contact authorized service personnel.

2. Error state with display indicating Ensure none of the console keys are active.
KB001 error code
Switch off mains power. Wait for 2 minutes. Switch on mains
power and make sure that none of the console keys are
pressed.
If the problem persists, contact authorized service personnel.

3. The unit does not power on when Check for loose contact at the wall socket end.
mains is switched on.
Or the wall outlet is not receiving power. Check local electrical
circuit for trips.
Switch off mains power. Wait for 2 minutes. Switch on mains
power.
If the problem persists, contact authorized service personnel.

4. No X-Ray image even through the Verify film development and storage method. The films
unit indicates normal exposure could be damaged or the chemicals could be contaminated.
Contact authorized service personnel to validate exposure
quality.

5. The mechanical Straight Arm is This can be due to normal wear and tear or using excess
drifting and does not stay in set force on the arms.
position.
Get the spring tension adjusted by an authorized service
engineer.
Contact authorized service personnel.

6. Poor image quality Please make sure that following points are observed.

• Correct exposure values are selected for the anatomy.

• When using film as image receptor its storage and
processing are as recommended by the manufactur-
er.

• Positioning of tube-head and receptor is proper.

• Patient is positioned stably during imaging.
If the problem persists, contact authorized service personnel.

36
Chapter 8: Measurement Techniques

8.1 Direct measurement method

Instruments used in kV, mA and timer accuracies measurement

S/N Description Make Model Remarks
01 DSO, 200Mhz YOKOGAW DLM2024 Any Equivalent equipment
A can be used (with valid
calibration)
Abbreviations used:
kV= Tube potential ,
mA=Tube Current
S= Exposure time
DSO=Digital storage oscilloscope
Tube Potential testing method:
Tube potential measurement is direct method by using potential divider and DSO as shown below. Potential
divider is inbuilt into the ImageSKAN HD and measurement point TP2 on the control board(refer figure 34)
provided for hooking measuring probe.

Figure 33. kV Feed Figure 34. Test Points

back circuit
Test procedure:
(Production test will be performed with nominal input voltage 110Vac, 60Hz.)

1. Connect the probe of the DSO to TP2 (kV feedback) with respect to ground (mounting screw) of control
board as shown in the Figure 34.

2. Switch ON the AC mains.

Indication on Control board: The fault LED D10 on test control board should not glow red. The LED D7 on
test control board should glow (green color) and the LED D6 (green color) on test control board should be
blinking every 1 sec (approx).
Indication on Console board:
[Note:Do not press any key when console displays the message SELF TEST]
All LED’s should glow during self test & LCD will display all 3 (Red, Green & Blue) colours in sequence.
Console should boot into the home screen without displaying any error message.

3. Command exposures through operator console with kV,mA and S settings shown in table below. Press &
hold exposure button till exposure done signal comes in the LCD display. Measure and Record the voltage
on Oscilloscope . Tube potential signal measured from DSO are multiplied by Design factor 80/6. Each
measured tube potential is verified with rejection limit.

37
 Chapter 8: Measurement Techniques

Tube kV Tube Current, Exposure Time

60, 65 & 70 4mA, 0.04s 4 m A , 6mA, 0.04s 6 m A , 8mA, 0.04s 8mA,
3.5s 3.5s 0.2s
4. Rejection limit :
Design: 3%.
To be measured by a DSO having accuracy < ±2%.
Difference between kV Command to kV actual shall be <±5%
Tube Current testing method :
Tube current measurement is direct method by using shunt/Sensing resistor, 750Ohms, +/- 1% and
DSO as shown below. Current sensing circuit is inbuilt into the ImageSKAN HD and measurement point
TP5 provided for hooking measuring probe.

Figure 35. mA Feed back circuit

Test procedure:
(Production test will be performed with nominal input voltage 110Vac, 60Hz).
1. Connect the probe of the DSO to TP5 (mA feedback) with respect to ground (mounting screw) of
control board as shown in the Figure 34.
2. Switch ON the AC mains.
Indication on Control board: The fault LED D10 on test control board should not glow red. The LED D7
on test control board should glow (green colour) and the LED D6 (green colour) on test control board
should be blinking every 1 sec (approx).
Indication on Console board:
[Note: Do not press any key when console displays the message SELF TEST]
All LED’s should glow during self test & LCD will display all 3 (Red, Green & Blue) colours in sequence.
Console should boot into the home screen without displaying any error message.
3. Command exposures through operator console with kV,mA and S settings shown in table below.
Press & hold exposure button till exposure done signal comes in the LCD display. Measure and Record
the voltage on Oscilloscope. Tube current calculated from DSO signal multiplied by scaling factor of
(8/6). Measured Tube current reading are verified with rejection unit.

Tube kV, S
curren
t loading (mA)
4 60, 0.04 60, 3.5 70, 0.04 70, 3.5
8 60, 0.04 60, 0.2 70, 0.04 70, 0.2
4. Rejection limit:
Design:3%
To be measured by a DSO having accuracy < ±2%.
Difference between mA Command to mA actual shall be <±5%
Exposure time test method:
Exposure time measurement is direct method by using DSO as shown below. Exposure time is measured
across test points TP2 and Ground (Chassis).
The exposure time is the time measured between start of kV waveform and start of falling edge from Final
Value.
38
 Chapter 8: Measurement Techniques

Figure 36. Exposure Time measurement

Test procedure:

1. Connect The probe of the DSO to TP2 (kV feedback) with respect to ground (mounting screw) of
control board as shown in the Figure 34.

2. Switch ON the AC mains.

Indication on Control board: The fault LED D10 on test control board should not glow red. The LED D7
on test control board should glow (Green colour) and the LED D6 (Green colour) on test control board
should be blinking every 1 sec (approx).
Indication on Console board:
[Note: Do not press any key when console displays the message SELF TEST]
All LED’s should glow during self test & LCD will display all 3 (Red, Green & Blue) colours in sequence.
Console should boot into the home screen without displaying any error message.

3. Command exposures through operator console with kV, mA and S settings shown in table below. Press
& hold exposure button till exposure done signal comes in the LCD display. Measure and Record the time
on Oscilloscope. % Of Error is calculated between set time (command) and measured time as
%Error=((Measured time- Set Time)/Set time) x 100%
Example: % Error with 0.04S exposure time= ((0.0398 - 0.04) / 0.04) x 100 = -0.005 x 100 = -0.5%
Each measured value is verified with rejection limit.
kV mA S
70 6 0.04, 0.40, 2, 3.5
70 8 0.04,0.2
Rejection limit set +/- 10% of set exposure time
8.2 Indirect Measurement method:

S/N Description Make Model Remarks

01 Accu-pro Radcal 9096 Any Equivalent equipment
02 Kvp sensor Radcal 40×12-W can be used (with valid
calibration)
Test Procedure:
Place the kVp sensor at 25cm from the focal spot. Visually center the kVp probe in the x-ray beam path
such that the beam will strike sensor in the probe as shown in the picture below Once aligned, deliver an
exposure(protocol:70kV,8mA,0.04S) and capture the wave form in the oscilloscope.

Acceptance criteria: No over shoot in the kV waveform

Figure 37. kV measurement using kVp sensor

39
 Annex A: Technical Specifications

Table A1. Tube-head Specifications

Description Specification

Generator Type High Frequency, Microprocessor Controlled, Constant Potential (DC)

Control of High Voltage Closed Loop
High Voltage Range 60kV – 70kV Settable (Step size 1kV)
Accuracy of High Voltage < ± 5%
High Voltage Ripple
> 200kHz
Frequency

Low Frequency Ripple (≤ 10kHz) shall be less than 2% p to p measured @ 70kV/8mA

High Voltage Ripple
High Frequency Ripple (≤ 50kHz) shall be less than 10% p to p measured @ 70kV/8mA

High Voltage Rise Time < 3ms

Control of Tube Current Closed Loop
Tube-head current range 4mA – 8mA Settable (Step size 1mA)
Accuracy of current < ± 5%
Maximum Exposure Time 3.5 seconds up to 6mA (7- 8mA @<= 0.2sec max)
Minimum Exposure Time 0.04 s
Exposure Timer Accuracy < ± 10%
Maximum Electrical Input 560W at 70kV, 8mA
Duty Cycle 1:15 Adaptive & auto limit based on temperature.
Additional X-Ray filtration Minimum 2.0 mm Al equivalent @ 70 kV
Total X-Ray filtration >2.5 mm AL/70 kV

Minimum source to skin 220 mm ± 5mm (in-built)

distance 300 mm ± 5mm with optional cone
X-Ray field (at collimator tip) Circular, diameter ≤ 60 mm @ SSD of 220 mm and 300 mm

Leakage radiation @ 1m < 0.88 mGy/h (100 mR/h)

Leakage radiation technique 70 kV, 8 mA, 1 s

Tube-head Outer Covers PC ABS Plastic with Glossy Finish

PID / Cone Material/Exten-

Silicone Rubber/Aluminium/Markrolon - 2407
sion Cone

Table A2. X-Ray Tube Insert Specifications

Parameters Specification
Tube Insert Model OX/70-4
Focal Spot (IEC60336) 0.4
Anode material Tungsten
Anode angle 16°
Insert Inherent filtration 0.5 mm Al equivalent @ 70 kV
Anode thermal capacity 7 kJ

40
Annex A: Technical Specifications

Figure A-1. X-Ray Tube Insert Rating Chart

Figure A-2. X-Ray Tube Insert Thermal Data

41
 Annex A: Technical Specifications

Figure A-3. Heating and Cooling Curve

Table A3. Mechanical Dimensions and Weight

Description Comment/Value
Wall Mount
15" Straight Arm - 93 lbs max
Total Weight of System (including Packing Carton)
24" Straight Arm - 95 Ibs max
(without Remote Switch & Optional Wall Plate(2 Stud))
33" Straight Arm - 98 lbs max
Floor Mount - 230 lbs max

Weight of Tube-head 13.2 lbs (Approx.)

Straight Arm Material Aluminum

Type of painting Glossy

Mounting type Base Unit adapters for Wall mounted or Floor Mount

15" Straight Arm - 62"

Extended Arm Reach 24" Straight Arm - 71"
33" Straight Arm - 80"

Height of unit with Arms folded (Wall Mount) 49" ± 0.5

Height of unit with Arms folded (Floor Mount) 77" ± 0.5

Straight Arm Rotation about Base 180° ± 10°

Scissor Arm Swing (Wall Mount) 220° ± 10°

Scissor Arm Swing (Floor Mount) 70° ± 10°

Tube-head swivel on horizontal plane 530° ± 10°

Tube-head rotation about Vertical Plane 305° ± 5°

Pull Force of Scissor Arm about Straight Arm < 2 kg

Pull Force of Straight Arm about base unit Assy < 4 kg

Scissor Arm Opening Force (Wall Mount & Floor Mount) < 1.5 kg

Pull Force of Scissor Arm about Base Column Assy < 2.5 kg

42
Annex A: Technical Specifications

Table A4. Mains Power Requirements

Description Requirement

Line voltage range 100-110 / 230-240V AC ± 10%,

Range of line-voltage regulation for ± 1% maximum at 90 VAC, 60Hz

operation at maximum line current
Line frequency Nominal: 60/50 Hz
Range: 54Hz to 66Hz
Momentary Current (70kV, 8mA) 11A @ 100V AC and
4A @ 240V AC
Momentary Power (70kV, 8mA) 1.1 kVA @ 100V AC and
0.96 kVA @ 240V AC
Standby Current 250mA maximum
Line resistance <= 0.4 Ohm at 100V AC and
<= 0.8 Ohm at 240V AC
Current Peak 30 A for 2 ms at mains turn on
Input Power Factor >0.9 during any exposure
Electrical Classification Class I, Type B
Line, Neutral and Ground, 1-Phase
Electrical Connection
(Ground is Mandatory)

Table A5. Environmental Conditions

Description Specification

Operating conditions Temperature: 50°F to 104°F

Humidity: 25% to 75%

Altitude: 1500m

Conditions for transport and storage Temperature: -22°F to 158°F

Humidity: 95% non condensing

Altitude: 3500m

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 Annex B: Declaration of Conformity

B1: Name and Description of Product

Medical device name:
ImageScan High Frequency Intraoral X-Ray
Medical device model:
ImageScan High Frequency Intraoral X-Ray
303-001201-0 : ImageScan Wall mount 0.4FS High Frequency Intra oral X-ray with 15”
Straight Arm
303-001202-0 : ImageScan Wall mount 0.4FS High Frequency Intra oral X-ray with 24”
Straight Arm
303-001203-0 : ImageScan Wall mount 0.4FS High Frequency Intra oral X-ray with 33”
Straight Arm
303-001204-0 : ImageScan Floor Mount 0.4FS High Frequency Intra oral X-ray
Medical device Type: Dental X-Ray System
Medical device classification: IIb-Rule 10 -MDD, Class II FDA

B2: Standards under which conformity is declared:

ANSI/AAMI ES60601-1: 2005 + C1:09 + A2:10
IEC 60601-1: 2005 + CORR. 1: 2006 + CORR. 2:2007
CAN/CSA-C22.2 No. 60601-1: 2008
IEC 60601-1-2:2006
IEC 60601-1-3: 2008
IEC 60601-2-65 :2012
IEC 60601-2-28: 2010
21 CFR, Subchapter J,
CMDR SOR/98-282

B3: Marking :
The products described herein conform to the UL safety marking(Proposed).

CE marking (Proposed)

0843
B4: Declaration
The products described herein, are designed, manufactured, inspected, tested, and released
by Skanray Technologies Pvt Ltd, a contract manufacturer for ImageWorks,Inc., In accordance
with FDA's 21CFR, Part 820, ISO 9001:2008 and ISO 13485:2003.

B5: Authorized Representative

SMK Imaging LLC
8 Westchester Plaza, Suite 112
Elmsford, NY 10523 USA
1-914.592.6100 - Voice
1-800.592.6666 - Toll Free
1-914.592.6148 - Fax
Web: www.imageworkscorporation.com

44
Annex C: Guidance & Manufacturer's Declaration

According to: EN 60601-1-2: 2001 + A1:2006

(Group 1, class A, for use in Hospitals) (Not LIFE-SUPPORTING)
ImageWorks High Frequency Intraoral X-Ray is tested per applicable IEC standards, to be used under
electromagnetic environment specified below. The customer or the user of ImageWorks High Frequency
Intraoral X-Ray should assure that it is used in such an environment.

Table C1. Guidance and Manufacturer’s Declaration –

Electromagnetic Emissions For all EQUIPMENT and SYSTEMS

Electromagnetic
Emissions Test Compliance
Environment - Guide

ImageScan HDHigh Frequency Intraoral X-Ray uses

RF energy only for its internal function. Therefore, its
RF emissions EN 55011 Group 1
RF emissions are very low and are not likely to cause
any interference in nearby electronic equipment.

RF emissions EN 55011 Class A

Harmonic emissions EN 61000-3-2 Class A ImageScan HD High Frequency Intraoral X-Ray is

suitable for use in all establishments, other than
domestic establishments and those directly connected
to the public low-voltage power supply network
supplying buildings used for domestic purposes.

Voltage fluctuations/flicker
Complies
EN 61000-3-3

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Annex C: Guidance & Manufacturer's Declaration

Table C2. Guidance and Manufacturer’s Declaration –

Electromagnetic Immunity For all EQUIPMENT and SYSTEMS
Electromagnetic
Immunity Test EN 60601 Test Level Compliance Level
Environment - Guidance
Floors should be wood,
Electrostatic dis- concrete or ceramic tile. If the
± (2, 4, 6) kV contact ± (2, 4, 6) kV contact
charge (ESD) EN floor is covered with synthetic
± (2, 4, 8) kV air ± (2, 4, 8) kV air
61000-4-2 material, the relative humidity
should be at least 30 %.

Electrical fast tran- ± 2 kV for power ± 2 kV for power supply Mains power quality should be
sient/burst EN 61000- supply lines lines that of a typical commercial or
4-4 ± 1 kV for Signal lines ± 1 kV for Signal lines hospital environment.

± 1 kV Differential Mains power quality should be

± 1 kV Differential mode
Surge EN 61000-4-5 mode that of a typical commercial or
± 2 kV Common mode
± 2 kV Common mode hospital environment.

< 5 % UT < 5 % UT
(> 95 % dip in UT) (> 95 % dip in UT)
for 0,5 cycle for 0,5 cycle

Mains power quality should be

that of a typical commercial
40 % UT 40 % UT
or hospital environment. If
(60 % dip in UT) (60 % dip in UT)
the user of the ImageScan
Voltage dips, short for 5 cycles for 5 cycles
High Frequency Intraoral X-
interruptions &
Ray requires continued
voltage variations on
operation during power
power supply input 70 % UT (30 % dip in 70 % UT (30 % dip in UT) mains interruptions, it is
lines UT) for 25 cycles for 25 cycles recommended that this
EN 61000-4-11
High Frequency Intraoral X-
Ray be powered from an
uninterruptible power supply
or a battery.
< 5 % UT < 5 % UT
(> 95 % dip in UT) (> 95 % dip in UT)
for 5 sec for 5 sec

Power frequency magnetic

Power frequency fields should be at levels
(50/60 Hz) magnetic 3 A/m 3 A/m characteristic of a typical
field EN 61000-4-8 location in a typical commercial
or hospital environment.

46
Annex C: Guidance & Manufacturer's Declaration

Table C3. Guidance and Manufacturer’s Declaration - Electromagnetic Immunity -

for all EQUIPMENT and SYSTEMS that are not LIFE-SUPPORTING

EN 60601 Test Electromagnetic Environment – Guid-

Immunity Test Compliance Level
Level ance
Conducted RF 3 Vrms 3 Vrms Portable/mobile RF communications equipment
EN 61000-4-6 50 kHz to 80 MHz 150 kHz to 80 MHz should be used no closer to any part of the
Imageworks High Frequency Intraoral X-Ray,
including cables, than the recommended
separation distance calculated from the equation
applicable to the frequency of the transmitter.
Recommended separation distance

d=1,2 √P
d=1,2 √P 80 MHz to 800 MHz
d=2,3 √P 800 MHz to 2,5 GHz

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).

Radiated RF 3 V/m 3 V/m Field strengths from fixed RF transmitters, as

EN 61000-4-3 80 MHz to 2,5 GHz 80 MHz to 2,5 GHz determined by an electromagnetic site survey,a
should be less than the compliance level in
each frequency range.
Interference may occur in the vicinity of equipment
marked with the following

At 80 MHz and 800 MHz, the higher frequency range applies.

These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and
reflection from structures, objects and people.
a Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless) telephones and land
mobile radios, amateur radio, AM and 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 ImageScan HD is
used exceeds the applicable RF compliance level above, the ImageScan HD High Frequency Intraoral X-Ray
should be observed to verify normal operation. If abnormal performance is observed, additional measures
may be necessary, such as reorienting or relocating the ImageScan HD High Frequency Intraoral X-Ray.
b Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m.

Annex D: Contact Details

Corporate Head Quarters/ Factory SMK Imaging LLC
and Technical Support 8 Westchester Plaza, Suite 112
Elmsford, NY 10523 USA
1-914.592.6100 - Voice
1-800.592.6666 - Toll Free
1-914.592.6148 - Fax
Web: www.imageworkscorporation.com

47