1.5T 8CH Breast Coil by Sentinelle - SM - Doc1111870 - 1

User Manual
Vanguard® Breast MRI Tabletop Coil

1.5T, 63.86 MHz
For use with GE Signa™ HDx and HDxt 1.5T Systems
SMI-0517 Rev. 101
Copyright© 2011 Sentinelle Medical, a Division of Hologic

Sentinelle Medical
555 Richmond St. W.
Suite 800, P.O. Box 301
Toronto, ON, Canada, M5V 3B1 Emergo Europe
Phone: (North America) 1-866-735-3744 Molenstraat 15
(International) 1-416-366-4994 2513 BH, The Hague
Fax: 1-647-258-0299 The Netherlands
www.hologic.com Phone: +31 70 345 8570
Fax: +31 70 346 7299
SMI-0517 Rev. 101 - User Manual

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Sentinelle Medical, a Division of Hologic
555 Richmond St. W. Suite 800, P.O. Box 301
Toronto, Ontario, Canada M5V 3B1
Phone (including Technical Support): (North America) 1-866-735-3744
(International) 1-416-366-4994
Fax: 1-647-258-0299
Email: service@hologic.com
Service Hours: 8:00am - 5:00pm Eastern Standard Time (EST) Monday-Friday
www.sentinellemedical.com
Copyright© 2011 Sentinelle Medical, a Division of Hologic

All rights reserved. No part of this document may be reproduced, transcribed, transmitted, distributed,
modified, merged or translated into any language in any form by any means – graphic, electronic, or
mechanical, including but not limited to photocopying, recording, taping or information storage and
retrieval systems – without the prior written consent of Sentinelle Medical.
DISCLAIMER OF WARRANTIES AND LIMITATION OF LIABILITIES
Sentinelle Medical has taken due care in preparing this document and the programs and data on the
electronic media accompanying this document including research, development, and testing.
This document describes the state of Sentinelle Medical’s knowledge respecting the subject matter herein at
the time of its publication, and may not reflect its state of knowledge at all times in the future. Sentinelle
Medical has carefully reviewed this document for technical accuracy. If errors are suspected, the user
should consult with Sentinelle Medical prior to proceeding. Sentinelle Medical makes no expressed or
implied warranty of any kind with regard to this document or the programs and data on the electronic media
accompanying this document.
Sentinelle Medical makes no representation, condition or warranty to the user or any other party with
respect to the adequacy of this document or accompanying media for any particular purpose or with respect
to its adequacy to produce a particular result. The user’s right to recover damages caused by fault or
negligence on the part of Sentinelle Medical shall be limited to the amount paid by the user to Sentinelle
Medical for the provision of this document. In no event shall Sentinelle Medical be liable for special,
collateral, incidental, direct, indirect or consequential damages, losses, costs, charges, claims, demands, or
claim for lost profits, data, fees or expenses of any nature or kind.
Product names listed are trademarks of their respective manufacturers. Company names listed are
trademarks or trade names of their respective companies.
Vanguard is a registered trademark of Sentinelle Medical.
Verity is a trademark of Sentinelle Medical.
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Table of Contents
PREFACE .....................................................................................................................................................................7
REGULATORY NOTIFICATION INFORMATION ............................................................................................................. 7
ABOUT THIS GUIDE ................................................................................................................................................... 7
Symbols and Safety Notices .................................................................................................................................. 8
Other Manual Conventions .................................................................................................................................10
PATIENT AND SYSTEM SAFETY WARNINGS ..............................................................................................................10
CONTACTING SENTINELLE MEDICAL ........................................................................................................................12
REPORTING INCIDENTS .............................................................................................................................................13
ELECTROSTATIC DISCHARGE (ESD) SAFETY............................................................................................................13
ELECTROMAGNETIC ENVIRONMENT INFORMATION ..................................................................................................13
CHAPTER 1 THE VANGUARD SYSTEM......................................................................................................17
SYSTEM CLASSIFICATION .........................................................................................................................................17
INDICATIONS AND CONTRAINDICATIONS FOR USE....................................................................................................17
Indications for Use ..............................................................................................................................................17
Contraindications for Use ...................................................................................................................................18
SPECIFICATIONS .......................................................................................................................................................18
Coil System Specifications ..................................................................................................................................18
Patient Support Specifications: ...........................................................................................................................18
Compatible Biopsy Devices .................................................................................................................................19
SYSTEM COMPONENTS .............................................................................................................................................20
PATIENT SUPPORT SETUP .........................................................................................................................................22
Anti-Tip Velcro straps .........................................................................................................................................22
Catchment Tray ...................................................................................................................................................22
Using the Headrest ..............................................................................................................................................23
THE COILS ................................................................................................................................................................23
Coil Naming ........................................................................................................................................................24
Coil File Software Installation ............................................................................................................................24
Coil Configurations .............................................................................................................................................24
Coil Setup ............................................................................................................................................................26
The Vanguard Cable ...........................................................................................................................................28
INSERTING AND CONNECTING THE COILS .................................................................................................................29
Using the Immobilization System ........................................................................................................................31
COIL SERVICE ...........................................................................................................................................................31
COIL STORAGE .........................................................................................................................................................32
CHAPTER 2 QUALITY ASSURANCE (QA) ..................................................................................................33
INSTRUCTIONS FOR MR IMAGING ON PHANTOMS .....................................................................................................33
8-CHANNEL BILATERAL BREAST SNR VERIFICATION WITH SPHERICAL PHANTOMS ...............................................33
4-CHANNEL BILATERAL BREAST SNR VERIFICATION WITH SPHERICAL PHANTOMS ...............................................36
TROUBLESHOOTING TIPS FOR QA TESTING ON SPHERICAL PHANTOMS ...................................................................39
8-CHANNEL BILATERAL BREAST SNR VERIFICATION WITH RECTANGULAR PHANTOMS .........................................40

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CHAPTER 3 PATIENT POSITIONING AND PREPARATION GUIDELINES ........................................43
WEIGHT SUPPORT .....................................................................................................................................................44
BREAST POSITIONING GUIDELINES ...........................................................................................................................44
ARM POSITIONING ....................................................................................................................................................45
Arms-Back Positioning........................................................................................................................................47
Arms-Forward Positioning .................................................................................................................................47
IV MANAGEMENT ....................................................................................................................................................48
CHAPTER 4 IMAGING WITH THE VANGUARD .......................................................................................49
SAFETY PRECAUTIONS..............................................................................................................................................49
IMAGING PROCEDURE...............................................................................................................................................49
Checklist ..............................................................................................................................................................49
System Setup and Patient Positioning .................................................................................................................50
Post-Examination Procedures.............................................................................................................................52
CHAPTER 5 INTERVENTIONAL PROCEDURES WITH THE VANGUARD .........................................53
SAFETY PRECAUTIONS..............................................................................................................................................53
Safety Notices for Interventional Procedures......................................................................................................54
EQUIPMENT CHECKLIST ...........................................................................................................................................54
Unilateral Intervention........................................................................................................................................54
Bilateral Intervention ..........................................................................................................................................55
BIOPSY SUPPLIES NOT INCLUDED (RECOMMENDED) ................................................................................................55
Sterile Tray ..........................................................................................................................................................55
Disposables Non-Sterile ......................................................................................................................................56
Post Procedure Prep Checklist ...........................................................................................................................56
Other Required Equipment Not Supplied by Sentinelle Medical.........................................................................56
INTERVENTIONAL PROCEDURE .................................................................................................................................56
Frames and Coils Setup for Bilateral Procedures ..............................................................................................56
Frames and Coils Setup for Unilateral Procedures ............................................................................................57
Patient Positioning ..............................................................................................................................................58
POST-EXAMINATION PROCEDURES...........................................................................................................................60
CHAPTER 6 MAINTENANCE .........................................................................................................................61
STORAGE AND OPERATING CONDITIONS ..................................................................................................................61
INSPECTION ..............................................................................................................................................................61
SPECIAL CARE REQUIREMENTS ................................................................................................................................62
Cleaning ..............................................................................................................................................................62
REPLACEABLE COMPONENTS/ACCESSORIES ............................................................................................................64
APPENDIX A..............................................................................................................................................................69
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Table of Figures
Figure 1: Patient Support and Accessory Components ........................................................................... 20
Figure 2: RF Components ....................................................................................................................... 21
Figure 3: Padding Components............................................................................................................... 21
Figure 4: Patient Support on SignaTM Patient Table ............................................................................... 22
Figure 5: Securing the Patient Support with the Anti-Tip Velcro straps ................................................ 22
Figure 6: Inserting the Catchment Tray .................................................................................................. 23
Figure 7: Adjusting Headrest Height ...................................................................................................... 23
Figure 8: Adjusting Headrest Angle ....................................................................................................... 23
Figure 9: Bilateral Imaging Components and Setup (Without Padding) ................................................ 26
Figure 10: Unilateral Intervention Setup and Components (Without Padding) ........................................ 27
Figure 11: Bilateral Intervention Setup and Components (Without Padding) .......................................... 28
Figure 12: Vanguard Cable Covered with Body Pad................................................................................ 28
Figure 13: Inserting a Lateral Array Coil ................................................................................................. 29
Figure 14: Connecting the Lateral Array Coil .......................................................................................... 30
Figure 15: Inserting the Medial Array Coil .............................................................................................. 30
Figure 16: The Vanguard Immobilization System.................................................................................... 31
Figure 17: Adjusting Vertical Lock .......................................................................................................... 31
Figure 18: Adjusting Horizontal Lock ...................................................................................................... 31
Figure 19: Sentinelle Medical Companion Cart ....................................................................................... 32
Figure 20: Phantom Positioner Setup for 8-Channel Coils ....................................................................... 34
Figure 21: Phantom Setup for 8-Channel Coils ........................................................................................ 34
Figure 22: Landmark on the Phantoms ..................................................................................................... 34
Figure 23: Screen Capture - MCQA Tool Start ........................................................................................ 35
Figure 24: Screen Capture - MCQA Tool Finished .................................................................................. 36
Figure 25: Phantom Positioner Setup for 4-Channel Coils ....................................................................... 37
Figure 26: Phantom Setup for 4-Channel Coils ........................................................................................ 37
Figure 27: Landmark on the Phantoms ..................................................................................................... 37
Figure 28: Screen Capture - MCQA Tool Start ........................................................................................ 38
Figure 29: Screen Capture - MCQA Tool Finish...................................................................................... 39
Figure 30: MCQA Tool Warning Message .............................................................................................. 40
Figure 31: Positioning Phantoms in Holder .............................................................................................. 40
Figure 32: Placing ROIs Over Signal in Phantom .................................................................................... 40
Figure 33: Padding Setup .......................................................................................................................... 43
Figure 34: Patient Lying Prone on the Vanguard ..................................................................................... 43
Figure 35: Breast Positioning Guidelines for Small, Medium and Large Breasts .................................... 44
Figure 36: Breast Anatomy ....................................................................................................................... 45
Figure 37: Arms-Back Position ................................................................................................................ 46
Figure 38: Arms-Forward Position ........................................................................................................... 46
Figure 39: Incorrect Hand Positioning...................................................................................................... 46
Figure 40: Correct Hand Positioning ........................................................................................................ 46
Figure 41: Inserting an Immobilization Plate ........................................................................................... 50
Figure 42: Immobilization Frame Set at Optimal Height ......................................................................... 51
Figure 43: Removing Clear Immobilization Plates................................................................................... 57
Figure 44: Inserting Biopsy Grid .............................................................................................................. 57
Figure 45: Removing Clear Immobilization Plates................................................................................... 58
Figure 46: Inserting Biopsy Grid .............................................................................................................. 58
Figure 47: Pulling Breast Tissue Down (Grid Removed to Show Detail) ................................................ 60

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Figure 48: Automatic Fiducial Marker in Grid ......................................................................................... 60
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Preface
Regulatory Notification Information
Federal Law restricts this device to sale by or on the order of a physician.
CAUTION
The Vanguard must be installed and put into service according to the EMC
information provided in this document. The Vanguard should be used only in a
shielded location.
Portable and mobile RF communications equipment can affect the Vanguard.
Using accessories, cables and transducers other than those designed for the
Vanguard may significantly degrade electromagnetic emissions and immunity
performance. Do not use accessories, transducers and cables other than those
specified in this manual.
About This Guide

This manual describes the functions, features, use, safety precautions, and
maintenance for the Sentinelle Breast MRI Tabletop with 2/4/8-Channel Coil
Array for GE SignaTM 1.5T, collectively referred to in this guide as the Vanguard.
To use the Vanguard safely and effectively, it is essential that you review and
familiarize yourself with this manual in its entirety before using the system.
The Vanguard is also available in a 4-channel configuration or an 8-channel
Imaging-only configuration.
For an imaging-only configuration, sections that involve intervention or biopsy
related items are not applicable.
NOTE: To upgrade to a complete system, contact your Sentinelle Medical sales
representative.
The graphics, figures, and medical images used in this manual are examples only.
The display and design may vary on your system.
NOTE: Biopsy grids are not included with the GE catalog offering. These products
can only be ordered directly from Sentinelle Medical.

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Symbols and Safety Notices
The following symbols are used on Sentinelle Medical products to highlight
information which, if not correctly followed, will directly impact patient and/or
operator safety.
Table 1: Packaging and Safety Symbols

Safety Notice Meaning
A red DANGER symbol is used to identify conditions or
actions for which a specific hazard is known to exist. These
conditions or actions will cause severe personal injury, death
or substantial property damage if the instructions are not
DANGER
followed.
An orange WARNING symbol is used to identify conditions
or actions for which a specific hazard is known to exist.
These conditions or actions may cause severe personal
injury or substantial property damage if the instructions are
WARNING
not followed.
A yellow CAUTION symbol is used to identify conditions
or actions for which a potential hazard may exist. These
conditions or actions may cause minor personal injury or
CAUTION property damage if the instructions are not followed.
IEC 60601 Type BF (body field) Applied Part.
Class II (double-insulated) electrical equipment.
Electrostatic Discharge (ESD) sensitivity.
Follow instructions for use.
Manufacturer of the device.
NRTL (Nationally Recognized Testing Laboratories) safety

testing and compliance.
Conformity with the essential requirements set out in the

European Directives.
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Authorized representative for Europe.
Range of acceptable temperature conditions for shipping

and storage.
Acceptable range of relative humidity for shipping and

storage.
Acceptable range of atmospheric pressure for shipping and

storage.
Do not cross or loop cables and/or ECG leads; arcing and

patient burns can result.
Ensure cables or body parts are not pinched during patient

support travel into or out of the scanner.
No part of the Vanguard shall be disposed of in land fill.

Return the device to Sentinelle Medical for disposal.
Locked.
Unlocked.
Left.
Medial.
Right.

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Other Manual Conventions
The following styles are used throughout this manual.
• A NOTE provides additional helpful information. It may emphasize
information regarding special tools or techniques, items to check before
proceeding, or factors to consider about a concept or task. Notes are always
italicized.
• Information in Bold Sans-serif type indicates scanner software text as it
appears on the screen.
Patient and System Safety Warnings

The following general warning statements apply to scanning with this system in a
magnetic resonance (MR) scanner. For additional safety information, review the
warnings and safety standards in your MR system documentation.
Table 2: General Warning Statements

Patients must not form a loop with any body parts while
scanning. For example, they cannot touch any part of the
right hand or arm to any part of the left hand or arm. This
could cause a burn at the point of contact. Use pads to
prevent any part of the patient’s body from touching metal
on the patient table. Educate the patient accordingly and
check the patient’s position immediately before the scan.
This coil system is only compatible with GE SignaTM 1.5T
Scanners. The system is compatible with scanner software
Version 23.0_V01 or later.
WARNING
Remove unused or improperly connected coils, cables, and

gating leads from the MR scanner before performing a scan.
Cables can become hot if they are left on the patient table
when they are not connected to the scanner.
Ensure the patient is not wearing damp clothing. This may
interfere with proper operation of the system.
All clothing containing metallic objects must be removed
from the patient prior to exam.
The use of medicinal products in transdermal patches may
cause burns to underlying skin. All transdermal patches
must be removed and the skin thoroughly cleaned prior to
using the system as per your institution's MRI safety
protocol.
Check that the cable or lead(s) do not touch the sides of the
MR scanner.
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Exposure of the patient to radio frequency magnetic fields
may increase the potential for local excessive heating of the
patient. Immediately stop the MR scan acquisition if the
WARNING patient complains of a tingling and/or heating sensation.
All personnel using the Vanguard must be trained by an
MRI technician training program accredited in the region
where the device is being used.
All personnel using the Vanguard must receive instruction
in the proper connection and handling of the system and
should be familiar with this User Manual.
Auxiliary equipment (such as gating equipment, vital sign
monitoring systems and RF coils) that has not been
specifically tested and approved for use in an MR
environment may result in burns or other injuries to the
patient. This equipment may also interfere with the proper
operation of this system.
Coils are not suitable for use in the presence of flammable
anaesthetics in combination with air, oxygen or nitrous
oxide.
Service personnel must have specialized training to ensure
the safe operating condition of the coil and table system.
Only properly trained and qualified personnel are authorized
to service any components.
The patient’s body and extremities must not contact the
inner surface of the MR bore. Burning may occur.
Patients that are sedated, unconscious or are experiencing a
loss of feeling in any body part should not be scanned. These
patients would not be able to alert the operator as to
excessive heating and associated tissue damage.
Before using the Vanguard, check to ensure there is no
external damage. Do not use a coil if the housing or cable is
broken. Do not use coils, cables, or gating leads with
exposed metal surfaces or abraded insulation.
No modifications to the system are allowed. Further, any
modification must be completed by trained Sentinelle
Medical service personnel only as changes to the system
may impact safety of the system.
Ensure the Vanguard cable is located centrally in the
scanner. Do not run the Vanguard cable along the edge of
the bore.
CAUTION

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Position the patient and the coils and cable as prescribed in
this User Manual.
CAUTION
Ensure that the coil cable does not directly contact any part
of the patient.
Ensure the Vanguard Cable is not connected to the LPCA
when lowering the scanner table.
The Vanguard cable must be covered with the body pad
before operation.
To avoid tipping, use the Velcro straps to secure the
Vanguard.
Keep limbs away from the gap between the Vanguard and
the scanner while raising and lowering the MR patient table.
Do not reach under any of the guards while the MR patient
table is being raised and lowered.
Ensure the patient's feet do not overhang the end of the
patient table while docking to the scanner.
To avoid possible patient injury, do not use the automatic
button to advance the patient into the scanner. Use the
manual advance button and watch for potential contact of
the patient with the bore as they advance into the scanner.
Avoid using the Vanguard adjacent to or stacked with other
equipment. If this is not avoidable, observe the equipment to
verify that it operates normally.
Do not cross or loop cables and/or ECG leads; this may
result in arcing and patient burns.
Contacting Sentinelle Medical

Use the following information to contact Sentinelle Medical to report an incident
or for technical support:
Phone (Including Technical Support): 1-866-735-3744 (North America)
1-416-366-4994 (International)
Fax: 1-647-258-0299
Email: service@hologic.com
Service hours are 8:00am - 5:00pm Eastern Standard Time (EST), Monday-Friday.
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Reporting Incidents
Contact Sentinelle Medical immediately to report any incident and/or injury to a
patient, operator or maintenance employee that occurred as a result of using the
Vanguard.
If an accident occurs as a result of using the Vanguard, do not operate the
equipment until an authorized investigation has been conducted.
For contact information, see Contacting Sentinelle Medical above.
Electrostatic Discharge (ESD) Safety

Do not touch the pins of connectors identified with the ESD warning symbol.
Do not use these connectors without taking ESD precautions. This includes:
• methods to prevent electrostatic charge build-up (for example, air
conditioning, humidification, conductive floor coverings, non-synthetic
clothing),
• discharging your body to earth or a large metal object,
• grounding yourself by means of a wrist strap to earth.
Electromagnetic Environment Information

This equipment receives RF electromagnetic energy. The system operates at a
frequency of 63.86 MHz, over a bandwidth of 128 kHz. Other equipment may
interfere with the Vanguard even if it complies with CISPR emission
requirements.
The Vanguard must be used in the electromagnetic environment described below.
Table 3: Electromagnetic Environment (Emissions)
Emissions test Classification Electromagnetic Environment
Guidance
RF emissions CISPR 11 Group 2 The Vanguard must receive
electromagnetic energy to perform its
intended function. Nearby electronic
equipment may be affected.
RF emissions CISPR 11 Class A The Vanguard must be used only in a

shielded location with a minimum RF
Harmonic emissions Not
shielding effectiveness and, for each
IEC 61000-3-2 Applicable
cable that exits the shielded location, a
Voltage Not minimum RF filter attenuation of 20
fluctuations/flicker Applicable dB over a minimum frequency range
emissions IEC of 30 MHz to 300 MHz.
61000-3-3
NOTE: It is essential that the actual RF shielding effectiveness and filter
attenuation of the shielded location be verified to ensure that they meet or exceed
the specified minimum values.

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Table 4: Electromagnetic Environment (Immunity)
Immunity IEC 60601 Classification Electromagnetic
test test level level Environment Guidance
Electrostatic ±6 kV contact ±6 kV contact Floors should be wood,
discharge ±8 kV air ±8 kV air concrete or ceramic tile. If
(ESD) IEC floors are covered with
61000-4-2 synthetic material, the relative
humidity should be at least
30%.
Electrical fast ±2 kV for Not Mains power quality should be
transient/burst power supply Applicable that of a typical commercial or
IEC 61000-4-4 lines ±1 kV for hospital environment.
input/output
lines
Surge IEC ±1 kV line(s) Not Mains power quality should be
61000-4-5 to line(s) ±2 Applicable that of a typical commercial or
kV line(s) to hospital environment.
earth
Voltage dips, <5% UT Not Mains power quality should be
short (>95% dip in Applicable that of a typical commercial or
interruptions UT) for 0,5 hospital environment. If the
and voltage cycle 40% UT Vanguard must operate
variations on (60% dip in continuously during power
power supply UT) for 5 mains interruptions, it must be
input lines IEC cycles 70% powered from an
61000-4-11 UT (30% dip uninterruptible power supply
UT = 230 Vac in UT) for 25 or a battery.
cycles <5%
UT (>95% dip
in UT) for 5
sec
Power 3 A/m Not Power frequency magnetic
frequency (50 Applicable fields should be at levels
Hz) magnetic characteristic of a typical
field IEC location in a typical
61000-4-8 commercial or hospital
environment.
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Table 5: Electromagnetic Environment (Conducted/Radiated)
Immunity IEC 60601 Classification Electromagnetic
test test level level Environment Guidance
Conducted RF 3 Vrms 150 3 Vrms The Vanguard must be used
IEC 61000-4-6 kHz to 80 only in a shielded location with
MHz a minimum RF shielding
effectiveness and, for each
cable that enters the shielded
location, a minimum RF filter
attenuation of 20 dB from a
minimum frequency range of
30 MHz to 300 MHz (See the
previous table.) Field strengths
outside the shielded location
from fixed RF transmitters, as
determined by an
electromagnetic site survey,
should be less than 3 V/m.
Radiated RF 3 V/m 80 MHz 3 V/m Interference may occur in the
IEC 61000-4-3 to 2,5 GHz vicinity of known RF
transmitting devices and
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.
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. An electromagnetic site survey will assess the electromagnetic
environment due to fixed RF transmitters. If the measured field strength in the
location where equipment is used exceeds the applicable RF compliance levels,
the equipment should be observed to verify normal operation. If abnormal
performance is observed, you may need to re-orient or relocate the equipment or
use a location with higher RF shielding effectiveness and filter attenuation.

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Chapter
1
Chapter 1 The Vanguard System
The Vanguard is a dedicated breast MR imaging coil and interventional system. It
consists of a patient support with breast immobilization system and an attached
2/4-channel or 8-channel coil system.
For clinical imaging, clear immobilization plates in the immobilization frames

help minimize motion artifacts due to patient motion during scanning.
For interventional procedures, sterile, single-use disposable biopsy grids* are used
to both immobilize the breast and provide access windows for biopsy needle
guidance.
* Biopsy grids are not included with the GE catalog offering. These products can
only be ordered directly from Sentinelle Medical.
System Classification
The Vanguard System is classified according to IEC 60601-1 as follows:
• Type BF Applied Part
• Degree of Protection against Ingress of Water: IPX0
• Equipment not suitable for use in the presence of a Flammable Anaesthetic
mixture with Air or Oxygen or Nitrous Oxide
• Mode of Operation: Continuous operation
Indications and Contraindications for Use

Indications for Use
The Vanguard is designed to provide magnetic resonance (MR) images of breast
anatomy when used in conjunction with an MR scanner. The images can be
interpreted by a trained physician. When used with a single-use sterile biopsy
grid*, the Vanguard permits access to the breast anatomy for biopsy and
localization procedures that can be performed by a trained physician.
* Biopsy grids are not included with the GE catalog offering. These products can
only be ordered directly from Sentinelle Medical.

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Contraindications for Use
The following contraindications for use relate to the strong magnetic field of the
MR scanner:
Table 6: Contraindication Safety Notices
Scanning is contraindicated for patients who have electrically,
magnetically or mechanically activated implants such as cardiac
pacemakers, or who rely on electrically, magnetically or
DANGER mechanically activated external life support systems. The
magnetic and electromagnetic fields produced by the MR scanner
and coil may interfere with the operations of these devices.
Scanning patients with intracranial aneurysm clips is
contraindicated unless the physician is certain that the clip is not
magnetically active.
Examination by MR equipment requires particular caution in the
following cases:
• patients with implanted surgical clips (haemostatic clips) or
CAUTION
other ferromagnetic materials, which the magnetic field may
dislodge
• patients with certain types of intrauterine devices (IUDs)
• patients engaged in occupations or activities which may cause
accidental implantation of ferromagnetic materials, or who
may have embedded metal fragments from military activities
• patients with permanent (tattoo) eye-liner or with facial
make-up (severe eyelid irritation has been reported)
• patients with compromised thermoregulatory systems
• patients with metal implants (these may cause artifacts in the
diagnostic images)
• patients with implanted prosthetic heart valves
• patients who are pregnant
See also Safety Notices for Interventional Procedures on page 53.
Specifications
Coil System Specifications
• Field Strength: 1.5T
• Frequency: 63.86MHz
Patient Support Specifications:

• Maximum patient weight: 158.8kg (350lb)
• Maximum load on each Patient Support arch: 45.4kg (100lb)
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For details on correct patient positioning to support the maximum patient weights
listed, please refer to the Patient Positioning and Preparation Guidelines Chapter,
beginning on page 43.
Compatible Biopsy Devices

The following MRI-compatible biopsy devices are mechanically compatible with
the Vanguard.
• Suros ATEC
• Suros ATEC Petite
• SenoRx EnCor 7G
• SenoRx EnCor 10G
• SenoRx EnCor 14G
• Mammotome J&J 8G 115mm and 145mm
• Mammotome J&J 11G 115mm and 145mm
• Bard VACORA 10G 118mm and 140mm
• Bard VACORA 14G 116mm and 138mm
• WireLoc 14G and 18G*
* Any gauge that fits in the needle block is compatible, however only 14G and 18G
are options in the Sentinelle Medical Aegis software product.
NOTE: Biopsy grids and biopsy devices are not included with the GE catalog
offering.

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System Components
The following figures show the Vanguard components in each type of system.
Imaging-only
4-Ch Option
Complete
System
8-Ch
# Component Qty
1 Patient Support 1
2 Shoulder Support with Velcro kit 2
3 Headrest 1
4 Left Horizontal Slider Assembly 1
5 Right Horizontal Slider Assembly 2
6 Left Immobilization Frame 1
7 Right Immobilization Frame 1
8 Immobilization Plate 2
9 Contralateral Breast Support 1
10 Catchment Tray 1
11 Velcro Straps (not shown) 2
12 Imaging Phantom (not shown) 2
Figure 1: Patient Support and Accessory Components
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Imaging-only
4-Ch Option
Complete
System
8-Ch
# Component Qty
1 Vanguard Breast Cable System 1
2 Medial Array Coil 1
3 Left Lateral Array Coil 1
4 Right Lateral Array Coil 1
5 Left Single Loop Coil 1
6 Right Single Loop Coil 1
7 Medial Plug 1
Figure 2: RF Components
# Component
1 Body Pad
2 Body Wedge Pad
3 Headrest Pad
4 Shoulder Support Pads
5 Foot Rest Pad
6 Front Pad with Hand Separation
Flap
7 Medial Array Pad
8 Hip Wedge Pad
Figure 3: Padding Components

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NOTE: For instructions on how to arrange the padding for optimal patient
comfort, see the Patient Positioning and Preparation Guidelines Chapter,
beginning on page 43.
Patient Support Setup

The Vanguard should be placed feet first on the GE Signa patient table toward the
bore so the Vanguard Cable, located at the foot end of the patient support, can be
securely plugged into the scanner.
TM
Figure 4: Patient Support on Signa Patient Table
Anti-Tip Velcro straps

To prevent the patient support from tipping, ensure the anti-tip Velcro straps are
properly attached before allowing a patient to mount the patient support. Insert a
Velcro strap into the slots on each side of the GE table, then slide and fasten them
to the Vanguard.
Figure 5: Securing the Patient Support with the Anti-Tip Velcro straps
Catchment Tray
For unilateral and bilateral interventional procedures the catchment tray must be in
place. This is a safety mechanism ensuring the MR guided needle device can
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safely be directed into the breast tissue. During interventional procedures, you may
want to drape the catchment tray with an absorbent pad to catch any spills that
happen during the procedure.
Figure 6: Inserting the Catchment Tray
Using the Headrest

The headrest cushion is attached to a movable stand. To adjust the height, unlock
the headrest by turning the knob on the side, as shown in the figure below on the
left. Adjust the angle of the headrest by pulling out the handle at the front as shown
in the figure below on the right.
A mirror is available to allow the patient to see outside the bore during scanning.
Adjust the mirror position after the height and angle of the headrest have been
adjusted for comfort.
If the headrest is in its lowest height and angle position, remove the mirror by
pulling it directly away from the headrest to avoid interference.
Figure 7: Adjusting Headrest Height Figure 8: Adjusting Headrest Angle
The Coils
The Vanguard coils consist of an 8-channel configuration, and an interchangeable
4-channel and 2-channel configuration. The coils can be changed or reconfigured,
depending upon the particular imaging requirement.

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An Imaging-only option comprises an 8-channel coil set only. A 4-channel option
comprises 4-channel and 2-channel coils for both imaging and interventional
work.
NOTE: To upgrade to a complete system, contact your Sentinelle Medical sales
representative.
Coil Naming
For consistency and ease of use, this manual uses simplified coil names, not the
coil names as they are listed on the coil labels. The following table maps the
technical name of each coil as it appears on the coil label to the common name for
the coil used in this manual.
Table 7: Coil Name Cross-reference
Coil Label Name Coil Common Name
Lateral Array Coil Right Right Lateral Array Coil

Lateral Array Coil Left Left Lateral Array Coil
Medial Array Coil Medial Array Coil
Lateral Single Loop Coil Left Left Single Loop Coil
Lateral Single Loop Coil Right Right Single Loop Coil
Coil File Software Installation

The Sentinelle coil file Version 23.0_V01 or later must be installed by a trained
Sentinelle Medical or GE Medical service representative.
Coil Configurations
The scanner will automatically select the appropriate configuration when a valid
coil combination is connected. The following table describes the various coil
arrangements, available for specific procedural requirements.
Table 8: Available Coil Configurations

Receptacle
Imaging-Only
Procedure L M R Coil
4-Ch System
Configuration
Complete
on MRI
System
8-Ch
8-Ch Left Medial Right Select coil 8ch

Bilateral Lateral Array Lateral Bilat HD Breast
Array by
Imaging Array Coil Array Sentinelle
Coil Coil
Use 8Brst BL TT
SMI
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Receptacle
Imaging-Only
Procedure L M R Coil
4-Ch System
Configuration
Complete
on MRI
System
8-Ch
Unilateral Lateral Array Lateral Bilat HD Breast
Array by
Imaging Array Coil Array Sentinelle
Coil Coil
Left Breast use:
8Brst Lt TT SMI
Right Breast
use: 8Brst Rt TT
SMI
Bilateral Single Array Single Bilat Biopsy HD
Breast Array by
Imaging/ Loop Coil Loop Sentinelle
Intervention Coil Coil
Use 4Brst BLI
TT SMI
Unilateral Left Medial Right Select coil 2ch
Intervention Single Plug Single Unilat Biopsy
HD Breast Array
Loop Loop by Sentinelle
Coil Coil
Use 2Brst Int TT
SMI

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Coil Setup
The following figures show the Vanguard’s general set up for bilateral breast
imaging, unilateral interventional and bilateral interventional procedures.
# Component
1 Right Lateral Array Coil
2 Clear Immobilization Plate
3 Medial Array Coil
4 Immobilization Frame
5 Left Lateral Array Coil
Figure 9: Bilateral Imaging Components and Setup (Without Padding)
NOTE: Use single loop coils in place of lateral array coils for a 4-channel system.
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# Component
2 Biopsy Grid
3 Contralateral Breast Support
4 Place Right and Left Single Loop
Coils in Immobilization Frames
Figure 10: Unilateral Intervention Setup and Components (Without Padding)
About the Contralateral Breast Support

The contralateral breast support holds the contralateral breast away to improve
medial access during unilateral interventional procedures. The design of the breast
support allows the breast of interest to fall further into the aperture for increased
lateral posterior access to the breast during intervention.

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# Component
1 Right Single Loop Coil in
Immobilization Frame
2 Biopsy Grid
3 Medial Array Coil
5 Left Single Loop Coil in
Immobilization Frame
Figure 11: Bilateral Intervention Setup and Components (Without Padding)
The Vanguard Cable

The Vanguard cable connects the Vanguard to the scanner.
A "System Ready" green light appears on the Interface Box when the Vanguard
cable is properly plugged in. Do not scan if the cable is unplugged.
The Vanguard cable must be covered with the body pad before operation.
CAUTION
Figure 12: Vanguard Cable Covered with Body Pad
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Inserting and Connecting the Coils
To insert a lateral coil, press it into the frame and connect the cable to the interface
box. To insert the medial coil, place it in the notch in the middle of the patient
support and connect the cable to the interface box. The plugs are keyed to ensure
the correct orientation.
Reverse these steps to remove the coils.
NOTE: The connectors on the coils and medial plug are covered with a plastic cap
to protect the connector pins from being bent or damaged. You must remove the
cover from the connector before you can plug a coil or the medial plug into the
interface box. It is recommended that you replace these covers on the connectors
when you remove the coils or medial plug to protect them during transportation
and storage.
Figure 13: Inserting a Lateral Array Coil

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Figure 14: Connecting the Lateral Array Coil
Figure 15: Inserting the Medial Array Coil
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Using the Immobilization System
The Vanguard immobilization system holds the breast immobile during scanning.
The following figure illustrates the Vanguard immobilization system and
components.
# Component
1 Patient Support Arch
3 Lever for Immobilization Frame
Release
4 Horizontal Lock
5 Vertical Lock
Figure 16: The Vanguard Immobilization System
Each immobilization frame can be adjusted both vertically and horizontally

(anterior/posterior and medial/lateral). Each direction has its own locking
mechanism (See the figures below).
To move the immobilization frame up or down, release the vertical lock and move
it up or down in its slider. When it is in the desired vertical position, push the lever
to lock it in place.
To move the immobilization frame left or right, release the horizontal lock and
move the slider left or right along the slider rail. Push the lever to lock the slider
when it is in the desired position.
Figure 17: Adjusting Vertical Lock Figure 18: Adjusting Horizontal

Lock
Coil Service
The coils cannot be serviced on site, they must be returned for servicing by a
trained representative. Contact your Sentinelle Medical service representative if
your coils require servicing (see Contacting Sentinelle Medical on page 12).

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Coil Storage
For coil storage, the Sentinelle Medical Companion Cart (part number
4000474-51) is available for purchase. The cart can be used to store coils and coil
components. The detachable cabinet can be used as a mobile tray during
interventional procedures. Please contact your Sentinelle Medical sales
representative for purchasing details.
Figure 19: Sentinelle Medical Companion Cart
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Chapter
2
Chapter 2 Quality Assurance (QA)
Instructions for MR Imaging on Phantoms
Sentinelle Medical recommends that the coils be checked for imaging integrity on
a regular basis by performing the Quality Assurance (QA) procedure. The QA
procedure involves a phantom scan, visually inspecting the QA images, and
calculating the signal-to-noise ratio. The phantoms used for the QA scan are part
of GE's Unified Phantom Set (GE Model 46-317586G1). The instructions below
apply only to the Sentinelle Vanguard system.
NOTE: If small bubbles are apparent on the sides of the phantom, tap the outside
of the phantom until these bubbles disappear.
There are two types of QA tests: tests for use with spherical phantoms, and a test
for use with rectangular phantoms. Use the appropriate test(s) for the phantoms at
your site.
8-Channel Bilateral Breast SNR Verification with Spherical

Phantoms
To run the 8-channel bilateral breast SNR verification:
1. Place the Vanguard on the MR scanner table.
2. Install and connect the 8-channel coil set and plug the Vanguard cable into
the receptacle.
3. Move the coils to their most lateral position and raise them to their highest
vertical position.

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4. Place the phantom positioners on either side of the medial coil as shown in
the figure below.
Figure 20: Phantom Positioner Figure 21: Phantom Setup for

Setup for 8-Channel Coils 8-Channel Coils
5. Add the spherical GE phantoms and move the coils to their lowest position.
Adjust the coils medially so that they lightly touch the phantoms as shown
in the figure above.
6. Landmark using the notch on the edge of the patient support as shown
below.
Figure 22: Landmark on the Phantoms
7. Do not start a new patient. Instead, open the Tools box and start the Service
Browser.
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8. In the Service Browser, select the Image Quality tab.
9. In the side menu, select Multi-Coil QA Tool, then Click here to start this
tool. The application starts, as shown below.
Figure 23: Screen Capture - MCQA Tool Start
10. Click Start and answer Yes in the dialog that appears.

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The MCQA Tool will run for approximately 5 minutes, testing each
channel in the system independently. When the tests are complete, the
MCQA Tool displays the test results as shown below.
Figure 24: Screen Capture - MCQA Tool Finished
11. If the MCQA indicates that the test failed, check that all coils are connected
properly and run the test again. If the test fails a second time, contact your
service representative.
4-Channel Bilateral Breast SNR Verification with Spherical

Phantoms
To run the 4-channel bilateral breast SNR verification:
1. Place the Vanguard on the MR scanner table.
2. Install and connect the 4-channel coil set and plug the Vanguard cable into
the receptacle.
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3. Move the coils to their most lateral position and raise them to their highest
vertical position.
4. Place the phantom positioners on either side of the medial coil as shown in
the figure below.
Figure 25: Phantom Positioner Figure 26: Phantom Setup for

Setup for 4-Channel Coils 4-Channel Coils
5. Add the spherical GE phantoms and move the coils to their lowest position.
Adjust the coils medially so that they lightly touch the phantoms as shown
in the figure above.
6. Landmark using the notch on the edge of the patient support as shown
below.
Figure 27: Landmark on the Phantoms
7. Do not start a new patient. Instead, open the Tools box and start the Service
Browser.

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8. In the Service Browser, select the Image Quality tab.
9. In the side menu, select Multi-Coil QA Tool, then Click here to start this
tool. The application starts, as shown below.
Figure 28: Screen Capture - MCQA Tool Start
10. Click Start and answer Yes in the dialog that appears.
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The MCQA Tool will run for approximately 5 minutes, testing each
channel in the system independently. When the tests are complete, the
MCQA Tool displays the test results as shown below.
Figure 29: Screen Capture - MCQA Tool Finish
11. If the MCQA indicates that the test failed, check that all coils are connected
properly and run the test again. If the test fails a second time, contact your
service representative.
Troubleshooting Tips for QA Testing on Spherical Phantoms

Keep the following tips in mind when running the MCQA test:
• Ensure that no patient scan has been started before beginning the MCQA
procedure. Exit out of any open patients.
• Landmark the coils before starting the MCQA tool.

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• Use only the spherical GE phantoms (GE Model 2360034) and the Sentinelle
phantom positioners.
• Verify that the lateral coil A/P position is correct.
• Ensure that all coils are touching the phantoms.
• When the MCQA tool starts, you may see the message shown below. If so,
click Yes to continue.
Figure 30: MCQA Tool Warning Message
8-Channel Bilateral Breast SNR Verification with Rectangular

Phantoms
1. Insert the Vanguard cable into the receptacle.
2. Set up coils for a routine bilateral breast exam using the 8-channel setup.
For optimal results, position both lateral coils at the same height. Align the
tops of the lateral coils approximately one inch higher than the top of the
medial coil.
3. Slide one imaging phantom (part number 5000268-11) between the medial
and each lateral coil. Position both phantoms so they are just touching the
Medial Array Coil. Lock the horizontal lock. Advance the patient support
into the bore.
Figure 31: Positioning Phantoms Figure 32: Placing ROIs Over

in Holder Signal in Phantom
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4. At the MR console, prescribe the following scan.
Patient Information:
Patient ID: "geservice"
Patient Name: SMI_ <Date> (for example SMI_26FEB10)
Patient Weight: "180lbs"
Coil Configuration:
Select currently connected
8ch Bilat HD Breast Array by Sentinelle
8 BrstBL SMI
Description: 8Ch SNR
Imaging Parameters:
Scan Plane: "Coronal"
Field of View: "32 cm"
Pulse Sequence: "SE (Spin Echo)"
TR: "450 ms"
TE: "14 ms"
Start Location: "S0.0"
End Location: "I0.0"
# Slices: "1"
Slice Thickness: "5 mm"
Spacing: "0"
NEX: "1"
Matrix Size: "256x256"
BW: "15.63 kHz"
5. Click Save Prescription when done, select the Q/A exam then click the
small arrow below scan.
6. Select Research > Download > Modify CVs.
7. Type "saveinter" as the CV name, and "1" as the value. Click Accept, then
click on the small arrow next to Scan > Research > Download, then scan.
8. Display all images in the series, page through images 1 through 16, and
verify that some signal is being received from all channels. Note that
channels placed far away from the slice may have low signal.
9. Display the last image in the series using the image viewer found in the
browser. Draw three rectangular regions of interest (ROIs) as shown in the
figure above.

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10. Record the mean value for the left ROI in the Left Signal Mean section of
the Quality Assurance SNR Table found in the Appendix on page 69.
Record the mean value for the right ROI in the Right Signal Mean section
of the Table.
11. Finally, record the standard deviation for the ROI in the region outside of
both phantom signals in the image in the Noise Standard Deviation
section of the Quality Assurance SNR Table.
12. Calculate the Signal-to-Noise Ratio (SNR) and record it in the Quality
Assurance SNR Table. SNR is computed using the following equation:
(Left Signal Mean + Right Signal Mean) / 2
SNR =
Noise Standard Deviation
NOTE: All values should be entered into the Quality Assurance SNR Table
provided in the Appendix section of this manual and compared with baseline SNR
measurements (values from tests performed during installation). Acceptable SNR
values should have a variance of ±25% of the baseline values. Larger or smaller
value may be indicative of problems with the coils or imaging system. If these
values are not within an acceptable range, please contact Sentinelle Medical. For
contact information, see Contacting Sentinelle Medical on page 12.
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Chapter
3
Chapter 3 Patient Positioning and
Preparation Guidelines
This chapter describes how to position the Vanguard pads for optimum comfort.
See the following figure for the recommended pad placement. In all cases, use the
body pad and the body wedge pad. Ensure that the body wedge pad covers the edge
of the patient support below the ribs.
# Component
1 Front Pad
2 Headrest Pad
3 Medial Array Pad
4 Shoulder Support Pads
5 Body Wedge Pad
6 Hip Wedge Pad
7 Body Pad
8 Foot Rest Pad
Figure 33: Padding Setup
Figure 34: Patient Lying Prone on the Vanguard

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Weight Support
Refer to the Specifications table on page 18 of this manual for maximum patient
weight specifications.
To correctly support the patient’s weight, the patient support must be properly
seated on the MRI table stretcher.
Advise the patient not to place their hands on the coil elements when mounting
and dismounting the system. Putting weight on the coils may damage them.
CAUTION
Breast Positioning Guidelines

The figure below depicts guidelines for proper breast positioning. The general rule
implies that the inferior border of the breast aligns just within the border of the
medial coil. The inferior border of the breast should never be positioned further
inferior than the border of the medial coil.
Figure 35: Breast Positioning Guidelines for Small, Medium and Large
Breasts
NOTE: It may be helpful to remove the Immobilization Frame to get a clearer view
of how the breast is positioned. Replace the Immobilization Frame when the breast
is positioned correctly.
The figure below depicts the anatomy of the breast. Position the patient such that
the scan will include the anatomy of interest.
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# Anatomical Feature
1 Axillary Lymph Nodes
2 Pectoralis Minor Muscle
3 Pectoralis Major Muscle
4 Lung
5 Heart
6 Cooper’s Ligaments
7 Parenchyma
8 Skin
9 Nipple
10 Inframammary fold
Figure 36: Breast Anatomy
Arm Positioning
Sentinelle Medical recommends arms-back positioning. If the patient’s arms will
not fit between the arches of the patient support, use the arms-forward positioning.
Shoulder supports and shoulder support pads provide additional patient comfort by
reducing sternum and rib pressure when using the arms-back position, but are not
recommended for arms-forward positioning.

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If the patient is in the arms-forward position, the hand separation pad must be
used between patient’s hands so that a loop is not created.
Figure 37: Arms-Back Position Figure 38: Arms-Forward Position
Figure 39: Incorrect Hand Figure 40: Correct Hand

Positioning Positioning
The following table describes how to position the shoulder supports and pads.
Table 9: Shoulder Support Placement
Image Instruction
Step 1.
Attach shoulder support pad to shoulder
support.
Position immobilization frame approximately
50mm (two inches) from arch.
Step 2.
Place shoulder support with attached shoulder
support pad between the immobilization frame
and the arch. Make sure the tabs on the shoulder
support "feet" are positioned in the grooves on
the patient support.
The immobilization frame should fit under the
medial side of the support.
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Image Instruction
Step 3.
Repeat steps 1 and 2 for the opposite shoulder
support.
The supports should be placed as far laterally as
possible before the patient is placed on the
tabletop.
The body wedge pad should be pulled up to
meet the shoulder support pads ensuring there is
no gap between the body wedge pad and the
edge of the patient support.
NOTE: Make sure the shoulder support stays in

place during the procedure. This will help
relieve pressure on the patient's sternum.
Arms-Back Positioning
When positioning patients with their arms back:
• Ensure their arms are by their sides.
• Remove the front pad for better air flow. The front pad is optional for
arms-back positioning.
• Use shoulder support bridges and pads to support torso weight and release
pressure from the sternum. The shoulder support bridges and pads can be
added after positioning the coils.
• Use the hip wedge pad. Raising the hips flattens the back and relieves pressure
on the sternum. Placing the hip wedge pad under the body wedge pad may
increase comfort for some patients.
• Adjust the headrest height – the head should be aligned with spine to help
release pressure from the sternum.
• Use foot rest pad. Position the foot rest pad with the edge aligned with the
patient’s knees, supporting the feet.
Arms-Forward Positioning
When positioning patients with their arms forward:
• If the patient is in the arms-forward position, the hand separation pad must be
used between patient’s hands so that a loop is not created.

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• Use the front pad to comfort the arms. Note that the patient’s arms might
become numb with arms-forward positioning.
• Remove the shoulder support pads.
• Use the hip wedge pad. Raising the hips flattens the back and relieves pressure
on the sternum. Placing the hip wedge pad under the body wedge pad may
increase comfort for some patients.
• Use foot rest pad. Position the foot rest pad with the edge aligned with the
patient’s knees, supporting the feet.
IV Management
Intravenous protocols differ from site to site. Follow the protocol established at
your facility.
• For unilateral interventional procedures, the IV is ideally inserted into the arm
opposite to the side of the biopsy. This arm can be positioned over the patient's
head for easy access during the procedure.
• Have the injection pump ready before the patient enters the exam room.
• While patient is being positioned on the Vanguard, attach the extension tubing
to IV.
• With the patient lying with their arms back, loop the extension tubing over
patient’s thumb. Extend the tubing over the patient’s back and secure the
position with tape i.e. you can place a piece of tape over the patient’s shoulder.
• Flush IV with saline to ensure proper position. Feel the flush go through the
arm. Ask the patient if there is any pain.
• As the patient is shuttled into scanner, ensure the extension tubing and other
pieces of equipment lie within the patient support and never outside the patient
support arches.
To avoid possible patient injury, do not use the automatic button to advance the
patient into the scanner. Use the manual advance button and watch for potential
contact of the patient with the bore as they advance into the scanner.
CAUTION
• Position the injector close to the MR scanner.
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Chapter
4
Chapter 4 Imaging with the Vanguard
This chapter outlines how to set up and use the Vanguard for bilateral breast
imaging. Use the same procedure, adjusted appropriately, for unilateral breast
imaging.
Safety Precautions
Do not handle the electrical pins in the connector housings of the system plug, the
coil connectors in the cable tray, or the coils. Electrostatic discharge could
damage the equipment.
CAUTION
Keep limbs away from the gap between the Vanguard and the scanner while
raising and lowering the MR patient table.
Patients must not form a loop with any body parts while scanning. For example,
they cannot touch any part of the right hand or arm to any part of the left hand or
arm. This could cause a burn at the point of contact. Use pads to prevent any part
of the patient’s body from touching metal on the patient table. Educate the patient
accordingly and check the patient’s position immediately before the scan.
Imaging Procedure
Checklist
• 2 Lateral Array Coils, or 2 Single Loop Coils for 4-channel imaging if that
configuration is available with your system
• 1 Medial Array Coil
• 2 Clear Immobilization Plates
• Padding

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System Setup and Patient Positioning
1. Adjust the Vanguard padding to accommodate for patient size and comfort.
Larger patients may require less padding. See the Patient Positioning and
Preparation Guidelines Chapter, beginning on page 43 for details.
2. Wipe down all padding with an approved disinfectant (see Cleaning on
page 62) and lay clean linens on all surfaces that may contact the patient.
3. Open the immobilization frames to their most lateral position.
4. Attach the appropriate coils and insert clear immobilization plates. See
Inserting and Connecting the Coils on page 29 for more information.
Figure 41: Inserting an Immobilization Plate
5. Open the cover of the interface box under the ramp pad and connect the
lateral array coils (left and right) and medial array coil to the connection
ports.
6. Ensure the Vanguard cable is plugged into the correct scanner port and the
green light is on.
7. Ensure the patient is wearing appropriate hearing protection.
8. Lower the scanner table.
9. Assist the patient onto the Vanguard. Patients can steady themselves with
the patient support arches as they lower their breasts into the aperture.
10. Position the patient’s arms as per the guidelines in the Patient Positioning
and Preparation Guidelines Chapter, beginning on page 43.
11. Ensure the patient is aligned centrally on the patient support.
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12. The patient may have to adjust their position so that their breasts are
centered with respect to the immobilization plates.
13. Pull the breast tissue down and away from the chest wall ensuring no tissue
is caught on the posterior side of the immobilization plate or sternum
support.
14. Smooth breast tissue on the lateral side with thumb to remove mammary
fold.
15. With the coil set at optimal height, release the horizontal lock on the slider
and move it medially to offer immobilization but not compression of the
breast. Lock the slider. Repeat positioning for the contralateral breast.
NOTE: This figure shows the immobilization frames set at optimal height,
with the gap between the lower edge of the rectangular feature and the
bottom round feature aligned at the 2 cm mark on the vertical scale.
Figure 42: Immobilization Frame Set at Optimal Height
16. Adjust the headrest as needed.

17. Relieve pressure on the patient’s sternum by positioning the hip wedge pad
to raise the hips and flatten the back. If a hip wedge pad is not available, a
pillow in the same position will suffice.
18. Place the foot rest pad under the patient’s legs to improve comfort.
19. Advance the patient into the MR scanner, landmark on the centre of the
coils and advance patient support to scan.
20. Proceed with the imaging protocol.

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Post-Examination Procedures
1. Shuttle the patient out of the MR scanner.
2. Release the immobilization frames.
3. Assist the patient off the Vanguard.
4. Clean all Vanguard surfaces following the instructions in the Maintenance
Chapter, beginning on page 61.
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Chapter
5
Chapter 5 Interventional Procedures with the
Vanguard
This chapter describes how to set up and use the Vanguard for unilateral and
bilateral interventional procedures.
NOTE: This chapter is not applicable to an 8-channel imaging-only system.
Always review the patient’s previous imaging to find where the target is before the
exam. This allows you to set up the Vanguard properly and optimize patient
positioning.
Safety Precautions
Do not handle the electrical pins in the connector housings of the system plug, the
coil connectors in the cable tray, or the coils. Electrostatic discharge could
damage the equipment.
CAUTION
Keep limbs away from the gap between the Vanguard and the scanner while
raising and lowering the MR patient table.
Patients must not form a loop with any body parts while scanning. For example,
they cannot touch any part of the right hand or arm to any part of the left hand or
arm. This could cause a burn at the point of contact. Use pads to prevent any part
of the patient’s body from touching metal on the patient table. Educate the patient
accordingly and check the patient’s position immediately before the scan.

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Safety Notices for Interventional Procedures
The following safety notices apply specifically to interventional procedures with
the Vanguard.
Performing interventional procedures on female patients with breast implants
may cause the implant to rupture.
If a biopsy has previously been performed, do not use MR reference images
WARNING created before the biopsy. Create new MR images in case the anatomy changed as
a result of the biopsy.
Perform a biopsy only when both the marker and lesion are located within an
ellipsoid with the following axial expansions about the magnet iso-centre: x
(right/left) = 44 cm, y (anterior/posterior) = 26 cm, z (head/feet) = 26 cm. Objects
outside this area may not be accurately represented in images due to due to the
presence of significant field inhomogeneities, which could result in the biopsy
missing the lesion.
To select the reference position, select only slices that run parallel to the grid
(sagittal slices). Measure the slices without slice distance and a slice thickness
less than or equal to 2 mm.
Select the tip of the marker to compute the reference position.
Use a needle block that corresponds to the diameter of the needle thickness.
Use biopsy needles whose lengths correspond to the calculated puncture depth.
CAUTION To correctly position the needle, take the length of the needle block into account.
Consult the documentation provided by the needle vendor regarding selecting the
correct needle depth.
Equipment Checklist
Unilateral Intervention
• 1 Contralateral Breast Support
• 1 Right Single Loop Coil
• 1 Left Single Loop Coil
• Medial Plug
• 2 Biopsy Grids
• MRI Biopsy Worksheet (Provided by Sentinelle Medical or your needle
vendor)
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Bilateral Intervention
• 1 Right Single Loop Coil
• 1 Left Single Loop Coil
• 1 Medial Array Coil
• 2 Biopsy Grids
• MRI Biopsy Worksheet (Provided by Sentinelle Medical or your needle
vendor)
Biopsy Supplies Not Included (Recommended)

The following list is an example of supplies that may be required when performing
biopsies. These supplies are not provided by Sentinelle Medical. Discuss with the
respective needle vendor specific supplies that are required for the vacuum
assisted device prior to the biopsy date.
Sterile Tray
• Sterile drape on which to place sterile supplies
• Sterile gloves
• Povidone-iodine topical antiseptic swabs
• Local anaesthetic
• Local anaesthetic with Epinephrine
• 3cc Syringe (1)
• 10cc Syringe (2)
• 18G 1½" needle (to draw anaesthetic)
• 25G 1½" needle (for anaesthetic prior to skin nick)
• 22G 3" needle (for anaesthetic administration w/deeper lesion)
• Scalpel (#11)
• 4x4" gauze
• 2x2" gauze
• Thumb forceps

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Disposables Non-Sterile
• Chucks, towels, or absorbent non-sterile material
• Auto or Manual Fiducial markers (2 Auto Fiducials or up to 6 Manual
Fiducials for bilateral interventional procedures, or 1 Auto Fiducial or up to 3
Manual Fiducials for unilateral interventional procedures), or vitamin E
capsules
• Non-sterile gloves
Post Procedure Prep Checklist

• Large Formalin Container (for specimen)
• Pathology information/request form
• Gauze for post biopsy-compression
• Steri-strips™ to close incision
• Medical dressing to cover steri-strips™ (optional)
• Cold pack
• Post-procedure information sheet
• Large sharps container
Other Required Equipment Not Supplied by Sentinelle Medical

• Absorbent Pads
• Post Operative Care Sheet
• Biohazard Waste Containers
Interventional Procedure
Frames and Coils Setup for Bilateral Procedures
Follow these steps to set up the Vanguard for bilateral interventional procedures.
See the next section for setup instructions for unilateral procedures.
1. Unplug and remove the lateral array coils.
2. Position the immobilization frames to their most lateral position.
3. Remove the clear immobilization plates from the immobilization frames
and replace them with sterile biopsy grids.
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Figure 43: Removing Clear Figure 44: Inserting Biopsy
Immobilization Plates Grid
Always follow your clinical gloving procedures to ensure that the sterility
of the grid surfaces is not compromised.
CAUTION
NOTE: The sterile biopsy grid is a single-use device. Reusing this device
risks patient infection and/or the spread of pathogens.
NOTE: Biopsy grids are not included with the GE catalog offering. These
products can only be ordered directly from Sentinelle Medical.
4. Install the single loop coils in the uppermost position in the immobilization
frames, and connect them. If the top or bottom row of the grid is blocked by
the single loop coil, move the single loop coil anteriorly/posteriorly in the
immobilization frame to allow access.
5. If the medial coil is not already in place, insert it and connect it.
Frames and Coils Setup for Unilateral Procedures

Follow these steps to set up the Vanguard for unilateral interventional procedures.
See the previous section for setup instructions for bilateral procedures.
1. Remove the medial and lateral array coils.
2. Remove the clear immobilization plates from the immobilization frames
and replace them with sterile biopsy grids.

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Figure 45: Removing Clear Figure 46: Inserting Biopsy
Immobilization Plates Grid
Always follow your clinical gloving procedures to ensure that the sterility
of the grid surfaces is not compromised.
CAUTION
NOTE: The sterile biopsy grid is a single-use device. Reusing this device
risks patient infection and/or the spread of pathogens.
NOTE: Biopsy grids are not included with the GE catalog offering. These
products can only be ordered directly from Sentinelle Medical.
3. Unlock the horizontal locks of the immobilization frames and slide both
frames to the side of intervention (right for right breast and left for left
breast).
4. Place the contralateral breast support to support the opposite breast during
the procedure. Ensure the support is angled down lateral to medial.
5. Position the medial immobilization frame beside and at the same height as
the contralateral breast support. Lower slightly and lock in place.
6. Position the lateral immobilization frame to its most lateral position.
7. Install the single loop coils in the uppermost position in the immobilization
frames, and connect them. If the top or bottom row of the grid is blocked by
the single loop coil, move the single loop coil anteriorly/posteriorly in the
immobilization frame to allow access.
8. Plug the medial plug into the medial connector.
Patient Positioning
1. Adjust the Vanguard padding to accommodate for patient size and comfort.
Larger patients may require less padding. See the Patient Positioning and
Preparation Guidelines Chapter, beginning on page 43 for details.
2. Wipe down all padding with an approved disinfectant (see Cleaning on
page 62) and lay clean linens on all surfaces that may contact the patient.
and lay clean linens and absorbent pads on the table surface and all surfaces
that may contact the patient, including the Contralateral Breast Support if
present.
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3. Clean and prepare the patient’s breast according to site policies and
procedures.
4. Ensure the patient is wearing appropriate hearing protection.
5. Lower the scanner table.
6. Assist the patient onto the Vanguard. Patients can steady themselves with
the patient support arches as they lower their breasts into the aperture.
For unilateral procedures, the target breast will be between the two biopsy
grids and the opposite breast will rest comfortably on the contralateral
breast support.
For bilateral procedures, each breast will be between a biopsy grid and the
medial array coil.
7. Raise the scanner table for easier patient positioning.
8. Position the patient’s arms as per the guidelines in the Patient Positioning
and Preparation Guidelines Chapter, beginning on page 43.
9. Ensure the patient is aligned centrally on the patient support.
10. Have the patient adjust their position as necessary to ensure that the region
of interest is centered with respect to the biopsy grid.
11. Adjust the headrest as needed.
12. Relieve pressure on the patient’s sternum by positioning the hip wedge pad
to raise the hips and flatten the back. If a hip wedge pad is not available, a
pillow in the same position will suffice.
13. Pull the breast tissue down and away from the chest wall, ensuring no
tissue is caught on the sternum support.
14. (Unilateral procedures only) Apply light immobilization by moving the
medial frame. Once positioned, ensure the medial frame is locked both
horizontally and vertically.
15. Smooth breast tissue on the lateral side with thumb to remove mammary
fold.
16. Apply sufficient immobilization with the lateral grid to keep the breast in
position. The breast should feel like the palm of your hand when fingers are
extended.
17. If you are using a Sentinelle Auto Fiducial, place it in grid window C4.
Otherwise, place your fiducials or vitamin E capsules in grid windows in
close proximity to the target. Document these locations on the appropriate
grid worksheet (provided by Sentinelle Medical or your needle vendor).
NOTE: Sentinelle Auto Fiducials are for use with Sentinelle Medical Aegis
software only. If you are not using Aegis to analyze your MR images, you
must use manual fiducials or vitamin E capsules.

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18. For bilateral procedures, repeat this process (positioning the breast,
applying immobilization with the biopsy grid, and placing fiducials in the
appropriate grid window) for the other breast.
Figure 47: Pulling Breast Tissue Figure 48: Automatic Fiducial

Down (Grid Removed to Show Marker in Grid
Detail)
19. Place the foot rest pad under the patient’s legs to improve comfort.
20. Ensure the Vanguard cable is plugged into the correct scanner port and the
green light is on.
21. Advance the patient into the MR scanner, landmark on the centre of the
coils and advance patient support to scan.
22. Proceed with the imaging protocol.
Post-Examination Procedures
1. Shuttle the patient out of the MR scanner.
2. Release the immobilization frames.
3. Treat the biopsy site according to your site’s recommendations.
4. Assist the patient off the Vanguard.
5. Dispose of the grids in a biohazard container.
6. Clean all Vanguard surfaces following the instructions in the Maintenance
Chapter, beginning on page 61.
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Chapter
6
Chapter 6 Maintenance
Storage and Operating Conditions
Coils and apparatus should be stored at the same room temperature and relative
humidity as the MR scanner. Storing the Vanguard in the MR Suite and scanner
room is acceptable.
When not in the scanner room, transport and store the Vanguard and all
components, except the phantoms, under the conditions described in the following
table. Do not store the phantoms at temperatures below 0º Celsius.
Table 10: Transportation and Storage Environment

Minimum Maximum
Ambient Temperature (°C) -30 +65
Relative Humidity (non-condensing) 10% 95%
Atmospheric Pressure 500 hPa 1060 hPa
Table 11: Operating Conditions

Minimum Maximum
Ambient Temperature (°C) +16 +25
Relative Humidity (non-condensing) 40% 60%
Inspection
Inspect the coils weekly for signs of mechanical damage or breakage. Inspect to
see that the system fits securely in the MR scanner patient table and that the patient
table motion into the scanner is smooth and regular.
Do not use the Vanguard if it has sustained mechanical damage or if patient
support motion is significantly compromised. Contact a Sentinelle Medical
representative immediately for the best course of action.
CAUTION
It is important to inspect the coils to ensure the coil enclosure is not cracked or
otherwise compromised in such a way that it may no longer be watertight. If you

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suspect a coil may be damaged, contact a Sentinelle Medical service
representative. For contact information, see Contacting Sentinelle Medical on
page 12.
Special Care Requirements

Cleaning
The Sentinelle Medical biopsy grids are sterile, single-use disposable items. The
following parts, however, should be cleaned before and after each use.
NOTE: Use protective gloves to perform these cleaning tasks, and always comply
with your site’s biohazard/blood-borne pathogen safety protocols.
Routine Imaging:
• The Vanguard Immobilization System
• Padding
• Medial Array Coil
• Left and Right Lateral Array Coils
Interventional Imaging:
• The Vanguard Immobilization System
• Padding
• Fiducials
• Left and Right Single Loop Coils
• Medial Array Coil (for Bilateral Interventions)
• Contralateral Breast Support (for Unilateral Interventions)
• Catchment Tray
The cleaning solutions listed in the table below have been tested and are
recommended for cleaning the apparatus and the coils. Use a cotton cloth to clean
the coils, system surfaces, and padding.
The coils are not waterproof and should not be immersed in any liquid. This will
damage the coils and may cause injury.
CAUTION
Do not use cleaning solutions not listed in this table as they may damage the
system. Sentinelle Medical must approve any proposed cleaning solutions.
NOTE: To avoid soiling the coils, place a cotton sheet over the coil surfaces before
positioning the patient. If a coil becomes soiled, clean it as described.
SMI-0517 Rev. 101

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Table 12: Approved Cleaning Solutions
Solution Comments
Warm water Safe for all areas.
Commercial dish washing Safe for all areas.
liquid/water combination
Alcohol solution (70%, Safe for patient support surfaces, coil housings,
isopropyl alcohol, 30% water). and immobilization plates.
Do not apply to Padding surfaces.
Do not apply to adhesive-backed materials such
as labels and Velcro® fasteners.
Hydrogen Peroxide-based Safe for patient support surfaces, coil housings,
® and immobilization plates.
cleaners (e.g., Virox, G-Force
H2O2 and Accel TB™) Do not apply to Padding surfaces.
Do not apply to adhesive-backed materials such
as labels and Velcro® fasteners.
Anticeptizyme Safe for use on immobilization frames, patient
support, and coil housings to break up bodily
fluids as needed.
Virex TB Safe for Padding.
Heptagon II Disinfectant Spray Safe for Padding.
VC 79 Safe for Padding.
NOTES:
• Do not apply tape to the top surface of the padding.
• Do not mark the padding with ink.
• Do not immerse the coil cable in cleaning fluid. Isopropyl alcohol can be used
to wipe the contacts as required.
• If bodily fluids contact immobilization frames or coil enclosures, use the
appropriate decontamination techniques to clean them.
• Clean all waste from the coil using 1:10 bleach/water solution and a cloth.
• Ensure coil enclosure is intact and is not permeable to fluid.
• Coils cannot be sterilized using any autoclaving techniques.

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Replaceable Components/Accessories
The following tables list the system accessories that may be purchased for
replacement:
Table 13: Replaceable RF Components
Part Part Name Sentinelle
Medical Part
Number
Left Single Loop Coil 4000205-11
Right Single Loop Coil 4000204-11
Left Lateral Array Coil 4000203-11
Right Lateral Array Coil 4000202-11
Medial Array Coil 4000209-11
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Medical Part
Number
Interface Box PRD-01504
Medial Plug PRD-01509
Table 14: Replaceable Hardware Accessories

Medical Part
Number
Contralateral Breast Support SVC-00386
Catchment Tray SVC-00331
Headrest SVC-00318

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Medical Part
Number
Left Immobilization Frame SVC-00386
Right Immobilization Frame SVC-00385
Horizontal Slider Assembly SVC-00383

LEFT
Horizontal Slider Assembly SVC-00384

RIGHT
SMI-0517 Rev. 101

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The following table lists the padding accessories that may be purchased for
replacement:
Table 15: Padding Accessories
Medical Part
Number
Body Pad SVC-00328
Body Wedge Pad SVC-00326
Headrest Pad SVC-00308
Shoulder Support Pad SVC-00327
Foot Rest Pad SVC-00320

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Medical Part
Number
Front Pad SVC-00325
Medial Array Pad SVC-00322
Hip Wedge Pad SVC-00309
SMI-0517 Rev. 101

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Appendix A
The following chart can be copied and used when calibrating and checking the
SNR on the Vanguard, as described in the Quality Assurance Chapter, beginning
on page 33.
Table 16: Baseline SNR Measurements
Date Left Signal Right Signal Noise SNR
Mean Mean Standard
Deviation
Table 17: Quality Assurance Record

Date Left Signal Right Signal Noise SNR
Mean Mean Standard
Deviation

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SMI-0517 Rev. 101
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Sentinelle - A Division of Hologic
Breast MRI Disposables Order Form
FROM: SHIP TO:

Hologic, Inc. Address:
6100 Technology Center Drive
Indianapolis, IN 46278 USA
Phone: 317.344.7590
Fax: 317.344.7690 BILL TO:
Toll Free: 877.877.8767 Address:
Email: csfax@hologic.com
Account Number
Purchase Order Number
Account Contact
Account Telephone
Account Fax
* Payment Terms: Net 30 days, freight pre-paid and added to invoice. All shipments are FOB origin.
Number of
Box Price
Part Number/Description Boxes
Qty Per Box
(to be ordered)
5000137-51 (Sterile Biopsy Grids for use with Vanguard)
Biopsy Grids are for use with the Vanguard Breast MRI Table or Tabletops. Supplied
10 $400.00
individually in sterilized boxes of ten, the 48 apertures permit unrestricted access to the
breast.
SM-0511 (Disposable Table Covers)
25 $150.00
Breathable, environmentally-friendly, soft and tailored custom-fit disposable table covers.
SM-0517 (Disposable Headrest Covers)
25 $150.00
Breathable, environmentally-friendly, soft and tailored custom-fit elastic headrest covers.
5000434-11 (Automatic Fiducial Kit)
Kit includes two Automatic Fiducial Markers and one box of Amiga Disposable Fiducial MRI 1 ea $150.00
Spot Markers.
5000435-11 (Automatic Fiducial Marker)
Automatic Fiducial Marker is used in combination with the MRI Spot Markers to provide the
1 ea $50.00
highest level of confidence and accuracy when using Aegis Breast Software for locating
targets within tissue.
4000345-11 (Manual Fiducial Kit)
Kit includes six Manual Fiducial Markers and one box of Amiga Disposable Fiducial MRI Spot 1 ea $150.00
Markers.
5000287-11 (Manual Fiducial Marker)
Automatic Fiducial Marker is used in combination with the MRI Spot Markers to provide the
1 ea $50.00
highest level of confidence and accuracy when using Aegis Breast Software for locating
targets within tissue.
721 (Amiga Disposable Fiducial Spot Markers)
10 $120.00
Amiga Disposable Fiducial MRI Spot Markers are easy to use and highly visible under MRI.
6V-HDM (Batteries for lighting system on Vanguard Table for GE)
Replacement batteries for the Sentinelle Breast MRI Table for GE lighting system come in a 2 $60.00
package of two batteries.
Anticipated Delivery Date: ____________________
CUSTOMER SIGNATURE: ________________________________________________ Date:______________

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SMI-0517 Rev. 101
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User Manual

Vanguard® Breast MRI Tabletop Coil

For use with GE Signa™ HDx and HDxt 1.5T Systems

SMI-0517 Rev. 101

Copyright© 2011 Sentinelle Medical, a Division of Hologic

SMI-0517 Rev. 101 - User Manual

Copyright© 2011 Sentinelle Medical, a Division of Hologic

SMI-0517 Rev. 101

SMI-0517 Rev. 101 - User Manual

SMI-0517 Rev. 101

SMI-0517 Rev. 101 - User Manual

SMI-0517 Rev. 101

About This Guide

SMI-0517 Rev. 101 - User Manual

Table 1: Packaging and Safety Symbols

IEC 60601 Type BF (body field) Applied Part.

Class II (double-insulated) electrical equipment.

Electrostatic Discharge (ESD) sensitivity.

Follow instructions for use.

Manufacturer of the device.

NRTL (Nationally Recognized Testing Laboratories) safety

Conformity with the essential requirements set out in the

SMI-0517 Rev. 101

Authorized representative for Europe.

Range of acceptable temperature conditions for shipping

Acceptable range of relative humidity for shipping and

Acceptable range of atmospheric pressure for shipping and

Do not cross or loop cables and/or ECG leads; arcing and

Ensure cables or body parts are not pinched during patient

No part of the Vanguard shall be disposed of in land fill.

SMI-0517 Rev. 101 - User Manual

Patient and System Safety Warnings

Table 2: General Warning Statements

Remove unused or improperly connected coils, cables, and

SMI-0517 Rev. 101

SMI-0517 Rev. 101 - User Manual

Contacting Sentinelle Medical

SMI-0517 Rev. 101

Electrostatic Discharge (ESD) Safety

Electromagnetic Environment Information

RF emissions CISPR 11 Class A The Vanguard must be used only in a

SMI-0517 Rev. 101 - User Manual

SMI-0517 Rev. 101

NOTE: These guidelines may not apply in all situations. Electromagnetic

SMI-0517 Rev. 101 - User Manual

For clinical imaging, clear immobilization plates in the immobilization frames

Indications and Contraindications for Use

SMI-0517 Rev. 101 - User Manual

See also Safety Notices for Interventional Procedures on page 53.

Patient Support Specifications:

SMI-0517 Rev. 101

Compatible Biopsy Devices

SMI-0517 Rev. 101 - User Manual

SMI-0517 Rev. 101

SMI-0517 Rev. 101 - User Manual

Patient Support Setup

Anti-Tip Velcro straps

SMI-0517 Rev. 101

Figure 6: Inserting the Catchment Tray