Hologic Affirm User manual

Affirm
®
Breast Biopsy Guidance System
Service Manual
For Software Versions 1.10/2.1
Part Number MAN-05754
Revision 002
August 2019

© 2018-2019 Hologic, Inc. Printed in the USA. This manual was originally written in English.
Hologic, Selenia, Dimensions, 3Dimensions, Affirm, and associated logos are trademarks and/or registered trademarks of
Hologic, Inc., and/or its subsidiaries in the United States and/or other countries. All other trademarks, registered trademarks,
and product names are the property of their respective owners.
This product may be protected by one or more U.S. or foreign patents as identified at www.Hologic.com/patents.
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Affirm Breast Biopsy Guidance System Service Manual
Table of Contents
MAN-05754 Revision 002 v
Table of Contents
List of Figures _________________________________________________________________ ix
List of Tables __________________________________________________________________ xi
1: Introduction __________________________________________________________________1
1.1 Intended Use............................................................................................................................................................1
1.2 User Profiles............................................................................................................................................................. 1
1.2.1 Mammography Technologist..................................................................................................................1
1.2.2 Radiologists, Surgeons.............................................................................................................................1
1.2.3 Medical Physicist ......................................................................................................................................2
1.3 Training Requirements...........................................................................................................................................2
1.4 Quality Control Requirements..............................................................................................................................2
1.5 Where to Find Technical Description Information............................................................................................. 2
1.6 Warranty Statement................................................................................................................................................ 3
1.7 Technical Support ...................................................................................................................................................3
1.8 Product Complaints................................................................................................................................................3
1.9 Hologic Cybersecurity Statement .........................................................................................................................3
1.10 Symbols .................................................................................................................................................................... 4
1.11 Descriptions of Warnings, Cautions, and Notes ................................................................................................5
2: General Information___________________________________________________________7
2.1 System Overview ....................................................................................................................................................7
2.2 How to Handle the Biopsy Guidance Module.................................................................................................... 8
2.3 Safety Information ..................................................................................................................................................9
2.4 Warnings and Precautions.....................................................................................................................................9
2.5 Compliance ............................................................................................................................................................ 10
2.5.1 Compliance Requirements .................................................................................................................... 10
2.6 Label Locations ..................................................................................................................................................... 11
3: Installation, Verification, and Removal _________________________________________13
3.1 Add Licensed Features......................................................................................................................................... 13
3.2 Unpacking..............................................................................................................................................................16
3.3 Preinstallation Check............................................................................................................................................ 16
3.4 Biopsy Guidance Module Components.............................................................................................................17
3.5 Biopsy Control Module Components ................................................................................................................ 18
3.6 Installation of the Main Components................................................................................................................. 20
3.6.1 Install the Internal Gantry Biopsy Guidance Module Cables...........................................................20
3.6.2 Attach the Biopsy Guidance Module...................................................................................................21
3.6.3 Attach the Biopsy Control Module ...................................................................................................... 22
3.7 System Verifications ............................................................................................................................................. 23
3.7.1 Confirm the Host Connection...............................................................................................................24
3.7.2 Verify in CalTool .................................................................................................................................... 25

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3.8 Installation and Removal of Accessories ...........................................................................................................25
3.8.1 Tabletop Stand for Affirm System........................................................................................................25
3.8.2 Biopsy Compression Paddles................................................................................................................26
3.8.3 Needle Guide ..........................................................................................................................................26
3.8.4 Biopsy Device Adapter ..........................................................................................................................28
3.8.5 Biopsy Device ..........................................................................................................................................28
3.8.6 Lateral Arm and Lateral Arm Accessories..........................................................................................29
3.9 Removal of the Main Components .....................................................................................................................42
3.9.1 Biopsy Control Module..........................................................................................................................42
3.9.2 Biopsy Guidance Module ......................................................................................................................42
3.9.3 Tabletop Stand for the Affirm System .................................................................................................43
3.9.4 Storage Case for the Lateral Arm .........................................................................................................43
4: Calibration Procedures _______________________________________________________45
4.1 Required Tools and Equipment ..........................................................................................................................45
4.2 Front Needle Guide Alignment ..........................................................................................................................46
4.2.1 Alignment for Standard Approach ......................................................................................................47
4.2.2 Alignment for Lateral Approach ..........................................................................................................47
4.3 Biopsy Guidance Hardware ................................................................................................................................48
4.4 Geometry Calibration...........................................................................................................................................48
4.5 STX Calibration .....................................................................................................................................................49
4.5.1 STX Calibration for Standard Approach .............................................................................................49
4.5.2 STX Calibration for Lateral Approach.................................................................................................51
4.6 Biopsy Calibration Interaction ............................................................................................................................53
4.7 The QAS Test .........................................................................................................................................................53
4.7.1 QAS Test for Standard Needle Approach...........................................................................................54
4.7.2 QAS Test for Lateral Needle Approach...............................................................................................56
4.8 Dose Calibration....................................................................................................................................................59
5: Care and Cleaning____________________________________________________________61
5.1 Preventive Maintenance.......................................................................................................................................61
5.2 For General Cleaning............................................................................................................................................62
5.2.1 How to Clean the Biopsy Control Module Screen .............................................................................62
5.2.2 To Prevent Possible Injury or Equipment Damage............................................................................63
Appendix A System Specifications _______________________________________________65
A.1 Affirm System Measurements.............................................................................................................................65
A.2 Lateral Arm Measurements.................................................................................................................................66
A.3 Biopsy Guidance Module ....................................................................................................................................67
A.4Lateral Arm............................................................................................................................................................67
A.5 Biopsy Control Module ........................................................................................................................................67

Affirm Breast Biopsy Guidance System Service Manual
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Appendix B System Messages and Alerts _________________________________________69
B.1 Audible Alerts ....................................................................................................................................................... 69
B.2 Error Messages ...................................................................................................................................................... 69
B.3 Acquisition Workstation Messages ....................................................................................................................71
Appendix C Hardware Range Calibration_________________________________________73
C.1 Hardware Range Calibration ..............................................................................................................................73
Appendix D Biopsy Device Evaluation Procedure _________________________________77
D.1 Introduction........................................................................................................................................................... 77
D.1.1 Please Read Prior to Performing Calibration......................................................................................77
D.1.2 Hologic Factory-Verified Biopsy Devices ........................................................................................... 78
D.2 Configuring Device and Needle ......................................................................................................................... 78
D.2.1 Biopsy Device Parameters.....................................................................................................................78
D.2.2 Needle Validation Process..................................................................................................................... 82
D.3 Configuring the Wire Localization Needle .......................................................................................................88
D.3.1 Wire Localization Needle Guides......................................................................................................... 88
D.3.2 Wire Localization Parameters...............................................................................................................89
D.3.3 Validate the Wire Localization Needle................................................................................................ 90
D.3.4 Calculate and Confirm the New Wire Localization Needle Parameters ........................................ 91
D.3.5 Adjust the Needle Length on the Acquisition Workstation .............................................................92
D.3.6 Validate Needle ......................................................................................................................................92
Appendix E Field Replaceable Units (FRUs)_______________________________________93
E.1 Biopsy Control Module - Field Replaceable Units ...........................................................................................93
E.2 Biopsy Guidance Module - Field Replaceable Units........................................................................................ 94
E.3 Lateral Arm - Field Replaceable Units ...............................................................................................................95
E.4 Accessories - Field Replaceable Units ................................................................................................................ 97
Glossary of Terms______________________________________________________________99
Index ________________________________________________________________________101

Affirm Breast Biopsy Guidance System Service Manual
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List of Figures
Figure 1: Affirm Biopsy System on the Selenia Dimensions Mammography System .............................................7
Figure 2: How to Lift the Biopsy Guidance Module .....................................................................................................8
Figure 3: How to Store the Biopsy Guidance Module ..................................................................................................8
Figure 4: Biopsy Guidance Module Label Location....................................................................................................11
Figure 5: Lateral Arm Serial Number Label Location ................................................................................................11
Figure 6: Affirm System Icon Location .........................................................................................................................16
Figure 7: Biopsy Guidance Module............................................................................................................................... 17
Figure 8: Biopsy Control Module ..................................................................................................................................19
Figure 9: Gantry/Biopsy Guidance Module Cables ....................................................................................................20
Figure 10: Installation of the Biopsy Guidance Module ............................................................................................. 21
Figure 11: Attachment of the Biopsy Control Module................................................................................................22
Figure 12: Home Screen .................................................................................................................................................. 24
Figure 13: Service Screen ................................................................................................................................................24
Figure 14: Installation of the Needle Guide Holder on the Standard Device Mount............................................. 27
Figure 15: Installation of the Needle Guide on the Standard Needle Guide Holder .............................................27
Figure 16: Attaching a Biopsy Device Adapter to Device Mount (Standard) .........................................................28
Figure 17: Lateral Arm Components............................................................................................................................. 29
Figure 18: Left Needle Approach of Lateral Arm (Blue)............................................................................................ 31
Figure 19: Right Needle Approach of Lateral Arm (Yellow)..................................................................................... 31
Figure 20: Installing Lateral Arm Stand over Image Receptor.................................................................................. 32
Figure 21: Removing the Needle Guide Holder from the Standard Device Mount............................................... 33
Figure 22: Installing Lateral Arm to Device Mount .................................................................................................... 34
Figure 23: Lateral Arm Mounting Side Selection Screen............................................................................................ 35
Figure 24: Attaching Blue Needle Guide Holder to Needle Guide Rods (Left Needle Approach)...................... 36
Figure 25: Attaching Yellow Needle Guide Holder to Needle Guide Rods (Right Needle Approach)............... 36
Figure 26: Installing Disposable Needle Guide on Needle Guide Holder (Lateral Arm)...................................... 37
Figure 27: Carriage Lever Locked and Unlocked Positions....................................................................................... 37
Figure 28: Locked and Unlocked Positions of Device Mount Lever......................................................................... 38
Figure 29: Installing Device Mount onto Lateral Arm Carriage ...............................................................................38
Figure 30: Lock Levers in Fully Locked Position......................................................................................................... 39
Figure 31: Scales and Positioning for X-Stop and Carriage........................................................................................ 40
Figure 32: Installing X-Stop on Lateral Arm ................................................................................................................ 41
Figure 33: Affirm System Tabletop Stand ....................................................................................................................43
Figure 34: Lateral Arm and Storage Case.....................................................................................................................44
Figure 35: Admin Screen Showing QAS Test .............................................................................................................. 54
Figure 36: QAS Test Info Dialog Box ............................................................................................................................ 55
Figure 37: Device Field in the Biopsy Tab ....................................................................................................................55
Figure 38: Admin Screen Showing Lateral Arm QAS Test........................................................................................57
Figure 39: Lateral QAS Test Info Dialog Box ............................................................................................................... 58
Figure 40: Device Field in the Biopsy Tab ....................................................................................................................58
Figure 41: Affirm Biopsy Guidance Module................................................................................................................ 65
Figure 42: Lateral Arm....................................................................................................................................................66

Affirm Breast Biopsy Guidance System Service Manual
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Figure 43: X-axis Reference Hole Locations and Y-axis Lead Screw Adjustment...................................................73
Figure 44: Placing the Y-axis Dowel Pin .......................................................................................................................74
Figure 45: Hologic ASY-08307 Targeting Phantom.....................................................................................................77
Figure 46: Biopsy Device Parameters - Standard Mount............................................................................................80
Figure 47: Additional Biopsy Device Parameters - Standard Mount .......................................................................81
Figure 48: Biopsy Device Parameters - Front Edge for Lateral Arm.........................................................................82
Figure 49: Biopsy Device Parameters - Body Size for Lateral Arm...........................................................................82
Figure 50: Needle Offset with Biopsy Device in Extended (post-fired) Position ....................................................84
Figure 51: Front Edge (FE) Measurement with Biopsy Device in Extended (post-fired) Position .......................85
Figure 52: Body Size (BS) Measurement with Biopsy Device in Extended (post-fired) Position..........................85
Figure 53: Needle Wire Localization Parameters - Front Edge for Lateral Arm.....................................................89
Figure 54: Needle Wire Localization Parameters - Body Size for Lateral Arm .......................................................89
Figure 55: Needle Offset with Wire Loc Needle Adapter Installed..........................................................................90
Figure 56: Front Edge Distance with Wire Loc Needle Adapter Installed (Left Approach) .................................90
Figure 57: Body Size Measurement with Wire Loc Needle Adapter Installed (Left Approach)...........................91

Affirm Breast Biopsy Guidance System Service Manual
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MAN-05754 Revision 002 xi
List of Tables
Table 1: Components of the Biopsy Guidance Module ..............................................................................................18
Table 2: Components of the Biopsy Control Module.................................................................................................. 19
Table 3: Components of the Lateral Arm .....................................................................................................................29
Table 4: Calibration Target List......................................................................................................................................50
Table 5: Lateral Arm Calibration Target Coordinates List (in mm).......................................................................... 52
Table 6: Calibrations........................................................................................................................................................ 53
Table 7: Service Engineer Preventive Maintenance Schedule ...................................................................................61
Table 8: Affirm System Audible Alerts......................................................................................................................... 69
Table 9: Affirm System Error Messages........................................................................................................................ 69
Table 10: Acquisition Workstation Messages .............................................................................................................. 71
Table 11: Hologic Factory-Verified Biopsy Devices....................................................................................................78
Table 12: Biopsy Device Parameters (see also following four figures).....................................................................79
Table 13: Wire Localization (Loc) Needle Guides ....................................................................................................... 88
Table 14: Wire Localization (Loc) Parameters (see also following two figures) .....................................................89
Table 15: Recommended FRUs - Biopsy Control Module (BCM) ............................................................................. 93
Table 16: Recommended FRUs - Biopsy Guidance Module (BGM) ......................................................................... 94
Table 17: Recommended FRUs - Lateral Arm Assembly ...........................................................................................95
Table 18: Recommended FRUs - Lateral Arm Carriage Assembly........................................................................... 96
Table 19: Recommended FRUs - Lateral Arm Removable X-axis Stop Assembly..................................................96
Table 20: Recommended FRUs - Lateral Arm Needle Guide RH Assembly........................................................... 96
Table 21: Recommended FRUs - Lateral Arm Needle Guide LH Assembly........................................................... 96
Table 22: Recommended FRUs - Lateral Arm Device Mount Single Position Assembly ...................................... 97
Table 23: Recommended FRUs - Accessories............................................................................................................... 97

Affirm Breast Biopsy Guidance System Service Manual
Chapter 1: Introduction
MAN-05754 Revision 002 Page 1
1: Introduction
Read all this information carefully before operating the system. Follow all warnings and
precautions as stated in this manual. Keep this manual available during procedures.
Physicians should tell patients about all potential risks and adverse events described in
this manual with respect to the operation of the system.
Note
Hologic configures some systems to meet specific requirements. Your system
configuration may not have all the options and accessories included in this manual.
1.1 Intended Use
Caution: Federal law restricts this device to sale by or on the order of a physician.
The Affirm®breast biopsy guidance system is an optional accessory for the Selenia®
Dimensions®and 3Dimensions™ digital mammography and digital tomosynthesis
systems. Its function is to localize lesions accurately in the breast in three dimensions. It
is intended to provide targeting guidance for interventional procedures such as biopsy,
presurgical localization, or treatment devices.
1.2 User Profiles
1.2.1 Mammography Technologist
• Meets all requirements that apply to the location in which the Mammography
Technologist operates.
• Completed training on the mammography system.
• Has training in mammography positions.
• Understands stereotactic breast biopsy procedures.
• Understands how to operate a computer and its peripherals.
• Can lift 20 pounds to shoulder height with two hands (necessary for upright
stereotactic systems).
• Understands sterile procedures.
1.2.2 Radiologists, Surgeons
• Meets all requirements that apply to the location in which the Physician operates.
• Understands stereotactic breast biopsy procedures.
• Understands how to operate a computer and its peripherals.
• Understands sterile procedures.
• Gives local anesthesia.
• Understands basic surgical procedures for core biopsy.
Chapter 1

Affirm Breast Biopsy Guidance System Service Manual
Chapter 1: Introduction
Page 2 MAN-05754 Revision 002
1.2.3 Medical Physicist
• Meets all requirements that apply to the location in which the Medical Physicist
operates.
• Understands mammography.
• Has experience with digital imaging.
• Understands how to operate a computer and its peripherals.
1.3 Training Requirements
In the United States, users must be Registered Radiologic Technologists meeting criteria
to perform mammography. The mammography users must meet all applicable MQSA
personnel requirements under FDA guidelines for conventional and digital
mammography.
The user has options available for training, which include but are not limited to:
• Onsite applications training by a Hologic Clinical Services Specialist
• Onsite on the job training also known as peer training
Additionally, the user manual is a guide for directions on how to use the system.
All users must make sure that they receive training on correct operation of the system
before use on patients.
Hologic does not accept the responsibility for injury or damage from incorrect system
operation.
1.4 Quality Control Requirements
Perform all Quality Control tests within the correct time frame.
1.5 Where to Find Technical Description Information
Technical description information is available in the Service Manual.

Affirm Breast Biopsy Guidance System Service Manual
Chapter 1: Introduction
MAN-05754 Revision 002 Page 3
1.6 Warranty Statement
Except as otherwise expressly stated in the Agreement: i) Equipment manufactured by
Hologic is warranted to the original Customer to perform substantially in accordance
with published product specifications for one (1) year starting from the date of shipment,
or if Installation is required, from the date of Installation (“Warranty Period”); ii) digital
imaging mammography x-ray tubes are warranted for twenty-four (24) months, during
which the x-ray tubes are fully warranted for the first twelve (12) months and are
warranted on a straight-line prorated basis during months 13-24; iii) replacement parts
and remanufactured items are warranted for the remainder of the Warranty Period or
ninety (90) days from shipment, whichever is longer; iv) consumable Supplies are
warranted to conform to published specifications for a period ending on the expiration
date shown on their respective packages; v) licensed Software is warranted to operate in
accordance with published specifications; vi) Services are warranted to be supplied in a
workman-like manner; vii) non-Hologic Manufactured Equipment is warranted through
its manufacturer and such manufacturer’s warranties shall extend to Hologic’s
customers, to the extent permitted by the manufacturer of such non-Hologic
Manufactured Equipment. Hologic does not warrant that use of Products will be
uninterrupted or error-free, or that Products will operate with non-Hologic authorized
third-party products. These warranties do not apply to any item that is: (a) repaired,
moved, or altered other than by Hologic authorized service personnel; (b) subjected to
physical (including thermal or electrical) abuse, stress, or misuse; (c) stored, maintained,
or operated in any manner inconsistent with applicable Hologic specifications or
instructions, including Customer’s refusal to allow Hologic recommended Software
upgrades; or (d) designated as supplied subject to a non-Hologic warranty or on a pre-
release or “as-is” basis.
1.7 Technical Support
Refer to the copyright page of this manual for contact information for product support.
1.8 Product Complaints
Report any complaints or problems in the quality, reliability, safety, or performance of
this product to Hologic. If the device has caused or added to patient injury, immediately
report the incident to Hologic. (See the copyright page for contact information.)
1.9 Hologic Cybersecurity Statement
Hologic continuously tests the current state of computer and network security to
examine possible security problems. When necessary, Hologic provides the updates to
the product.
For Cybersecurity Best Practices documents for Hologic products, refer to the Hologic
Internet site at www.Hologic.com.

Affirm Breast Biopsy Guidance System Service Manual
Chapter 1: Introduction
Page 4 MAN-05754 Revision 002
1.10 Symbols
This section describes the International Symbols on this system.
Potential Equalization terminal
Protective Earth terminal
"On" and "Off" (power) for the computer and display.
Discard electrical and electronic equipment separately from standard waste.
Send decommissioned material to Hologic or contact your service
representative.
Manufacturer
Date of Manufacture
Catalog number
Serial number
Caution
Follow operating instructions

Affirm Breast Biopsy Guidance System Service Manual
Chapter 1: Introduction
MAN-05754 Revision 002 Page 5
1.11 Descriptions of Warnings, Cautions, and Notes
Descriptions of Warnings, Cautions, and Notes used in this manual:
WARNING!
The procedures that you must follow accurately to prevent possible
dangerous or fatal injury.
Warning:
The procedures that you must follow accurately to prevent injury.
Caution:
The procedures that you must follow accurately to prevent damage to equipment,
loss of data, or damage to files in software applications.
Note
Notes show additional information.

Affirm Breast Biopsy Guidance System Service Manual
Chapter 2: General Information
MAN-05754 Revision 002 Page 7
2: General Information
2.1 System Overview
The Affirm breast biopsy guidance system attaches to the C-arm of the Selenia
Dimensions system or the 3Dimensions system. The Affirm biopsy system has two main
components:
• Biopsy Guidance Module
• Biopsy Control Module
A compatible biopsy device attaches to the biopsy guidance module device mount.
During a standard needle approach procedure, motors in the Affirm system move the
biopsy device in X and Y directions. Z-axis movement is manual. The optional Affirm
Lateral Arm Upright Biopsy Accessory installs on the biopsy guidance module to enable
lateral needle approach procedures. When using the lateral arm accessory, X-, Y-, and Z-
axis movement is the same as for standard needle approach. The C-arm is positioned at
0° and the biopsy device is positioned the same way as in a standard needle approach.
Then the needle is manually advanced into the breast along its own X-axis, referred to as
“Lat X.”
The Tube Arm on the Selenia Dimensions and 3Dimensions systems moves separately
from the Compression Arm to permit the acquisition of 2D and tomosynthesis images for
targeting. The types of images you can acquire are contingent on your imaging system
licensing. Refer to the imaging system User Guide for complete information about that
system. The types of biopsies you can perform are contingent on your Affirm system
licensing. To see all your installed licenses, go to Licensing in System Tools.
Figure 1: Affirm Biopsy System on the Selenia Dimensions Mammography System
Figure Legend
1. Biopsy Guidance
Module
2. Biopsy Control
Module
Chapter 2