Hologic Affirm User manual

Service Manual
For Software Version 1.8
Part Number MAN-04069
Revision 002
June 2016

Affirm Breast Biopsy Guidance System Service Manual
Table of Contents
MAN-04069 Revision 002 v
Table of Contents
List of Figures _________________________________________________________________ ix
List of Tables __________________________________________________________________ xi
1: Introduction __________________________________________________________________1
1.1 Preface ......................................................................................................................................................................1
1.2 Intended Use............................................................................................................................................................1
1.3 User Profiles.............................................................................................................................................................1
1.3.1 Mammography Technologist ....................................................................................................................1
1.3.2 Radiologists, Surgeons ...............................................................................................................................1
1.3.3 Medical Physicist ........................................................................................................................................2
1.4 Training Requirements........................................................................................................................................... 2
1.5 Quality Control Requirements..............................................................................................................................2
1.6 Where to Find Technical Description Information.............................................................................................2
1.7 Warranty Statement................................................................................................................................................ 3
1.8 Technical Support ...................................................................................................................................................3
1.9 Product Complaints................................................................................................................................................3
1.10 Hologic Cybersecurity Statement .........................................................................................................................3
1.11 Descriptions of Warnings, Cautions, and Notes ................................................................................................4
2: General Information___________________________________________________________5
2.1 System Overview....................................................................................................................................................5
2.2 How to Handle the Biopsy Guidance Module....................................................................................................6
2.3 Safety ........................................................................................................................................................................7
2.4 Warnings and Precautions..................................................................................................................................... 7
2.5 Compliance..............................................................................................................................................................8
2.5.1 Compliance Requirements ........................................................................................................................8
2.6 Symbols ....................................................................................................................................................................9
2.7 Label Locations .......................................................................................................................................................9
3: Installation __________________________________________________________________11
3.1 Overview................................................................................................................................................................11
3.2 Unpacking.............................................................................................................................................................. 11
3.3 Preinstallation Check............................................................................................................................................11
3.4 Install the Internal Gantry Biopsy Guidance Module Cables ......................................................................... 12
3.5 Installation of Components .................................................................................................................................13
3.5.1 Attach the Biopsy Guidance Module ..................................................................................................... 13
3.5.2 Attach the Biopsy Control Module......................................................................................................... 14
3.5.3 Mount the Tabletop Stand .......................................................................................................................15

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4: Verification and Removal _____________________________________________________17
4.1 System Verifications .............................................................................................................................................17
4.1.1Confirm the Host Connection .................................................................................................................17
4.1.2 Biopsy Staging ...........................................................................................................................................18
4.2 Installation and Removal of Accessories ...........................................................................................................20
4.2.1 The Biopsy Device Holder.......................................................................................................................20
4.2.2 The Needle Guides ...................................................................................................................................21
4.3 Removal of Main Components ...........................................................................................................................22
4.3.1 Biopsy Control Module............................................................................................................................22
4.3.2 Biopsy Guidance Module ........................................................................................................................22
5: Calibration Procedures _______________________________________________________23
5.1 Required Tools and Equipment ..........................................................................................................................23
5.2 Front Needle Guide Alignment ..........................................................................................................................25
5.2.1 Alignment for Standard Approach.........................................................................................................25
5.3 Biopsy Guidance Hardware ................................................................................................................................26
5.4 Geometry Calibration...........................................................................................................................................26
5.5 STX Calibration .....................................................................................................................................................27
5.5.1 STX Calibration for Standard Approach................................................................................................27
5.6 Biopsy Calibration Interaction ............................................................................................................................29
5.7 The QAS Test .........................................................................................................................................................29
5.7.1 QAS Test for Standard Needle Approach .............................................................................................29
5.8 Dose Calibration....................................................................................................................................................31
6: Care and Cleaning____________________________________________________________33
6.1 Preventive Maintenance.......................................................................................................................................33
6.2For General Cleaning............................................................................................................................................34
6.2.1 How to Clean the Biopsy Control Module Screen................................................................................34
6.2.2 To Prevent Possible Injury or Equipment Damage ..............................................................................35
Appendix A: System Specifications ______________________________________________37
A.1 Affirm System Measurements.............................................................................................................................37
A.2 Biopsy Guidance Module ....................................................................................................................................37
A.3 Biopsy Control Module........................................................................................................................................38
Appendix B: System Messages and Alerts_________________________________________39
B.1 Audible Alerts .......................................................................................................................................................39
B.2 Error Messages ......................................................................................................................................................39
Appendix C: Hardware Range Calibration ________________________________________41
C.1 Hardware Range Calibration ..............................................................................................................................41

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Appendix D: Biopsy Device Evaluation Procedure _________________________________45
D.1 Introduction........................................................................................................................................................... 45
D.1.1 Please Read Prior to Performing Calibration........................................................................................45
D.1.2 Hologic Factory-Verified Biopsy Devices.............................................................................................. 46
D.2 Configuring Device and Needle ......................................................................................................................... 47
D.2.1 Add or Edit Biopsy Device Information................................................................................................ 47
D.2.2 Needle Validation Process....................................................................................................................... 49
D.3 Configuring the Wire Localization Needle .......................................................................................................53
D.3.1 Validate the Wire Localization Needle ..................................................................................................53
D.3.2 Calculate and Confirm the New Wire Localization Needle Parameters........................................... 54
D.3.3 Adjust the Needle Length on the Acquisition Workstation................................................................54
D.3.4 Validate Needle......................................................................................................................................... 55
Appendix E: Field Replaceable Units (FRUs) ______________________________________57
E.1 Biopsy Control Module - Field Replaceable Units ........................................................................................... 57
E.2 Biopsy Guidance Module - Field Replaceable Units........................................................................................ 57
E.3 Accessories - Field Replaceable Units ................................................................................................................58
Glossary of Terms______________________________________________________________59
Index _________________________________________________________________________61

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List of Figures
Figure 1: Affirm Biopsy System on the Selenia Dimensions Mammography System .............................................5
Figure 2: How to Lift the Biopsy Guidance Module.....................................................................................................6
Figure 3: How to Store the Biopsy Guidance Module ..................................................................................................6
Figure 4: Label Location....................................................................................................................................................9
Figure 5: Affirm System Icon Location ......................................................................................................................... 11
Figure 6: Gantry/Biopsy Guidance Module Cables ....................................................................................................12
Figure 7: Installation of the Biopsy Guidance Module............................................................................................... 13
Figure 8: Attachment of the Biopsy Control Module..................................................................................................14
Figure 9: Home Screen .................................................................................................................................................... 17
Figure 10: Service Screen ................................................................................................................................................ 17
Figure 11: Function Buttons and Data on the Biopsy Tab..........................................................................................18
Figure 12: How to Attach a Biopsy Device Holder .....................................................................................................20
Figure 13: How to Install the Needle Guides............................................................................................................... 21
Figure 14: Admin Screen Showing QAS Test ..............................................................................................................30
Figure 15: Device Field in the Biopsy Tab ....................................................................................................................30
Figure 16: Affirm Biopsy Guidance Module................................................................................................................37
Figure 17: X-axis Reference Hole Locations and Y-axis Lead Screw Adjustment ..................................................41
Figure 18: Placing the Y-axis Dowel Pin....................................................................................................................... 42
Figure 19: Hologic ASY-08307 (left) and TLS-02799 (right) Targeting Phantoms................................................... 45
Figure 20: Biopsy Device Parameters............................................................................................................................ 48
Figure 21: Offset Measurement, Device in Extended (post fired) Position.............................................................. 50
Figure 22: Adapter Surface to the Center of Needle Barrel........................................................................................53
Figure 23: Length Measurement.................................................................................................................................... 53

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List of Tables
Table 1: Calibration Target List...................................................................................................................................... 28
Table 2: Calibrations........................................................................................................................................................29
Table 3: Service Engineer Preventive Maintenance Schedule ................................................................................... 33
Table 4: Affirm System Audible Alerts.........................................................................................................................39
Table 5: Affirm System Error Messages........................................................................................................................ 39
Table 6: Hologic Factory-Verified Biopsy Devices...................................................................................................... 46
Table 7: Biopsy Device Parameters ...............................................................................................................................47
Table 8: Recommended FRUs - Biopsy Control Module (BCM) ............................................................................... 57
Table 9: Recommended FRUs - Biopsy Guidance Module (BGM) ...........................................................................57
Table 10: Recommended FRUs - Accessories............................................................................................................... 58

Affirm Breast Biopsy Guidance System Service Manual
Chapter 1:Introduction
MAN-04069 Revision 002 Page 1
1: Introduction
1.1 Preface
Read all of this information carefully before installation and operation. 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.
1.2 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® digital mammography system. 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.
1.3 User Profiles
1.3.1 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.
1.3.2 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.
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Chapter 1: Introduction
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1.3.3 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.
1.4 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 wrong system
operation.
1.5 Quality Control Requirements
Perform all Quality control tests within the correct time frame.
1.6 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-04069 Revision 002 Page 3
1.7 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.
1.8 Technical Support
Refer to the title page of this manual for contact information for product support.
1.9 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.
1.10 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.

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Chapter 1: Introduction
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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-04069 Revision 002 Page 5
2: General Information
2.1 System Overview
The Affirm breast biopsy guidance system attaches to the C-arm of the Selenia
Dimensions mammography 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 procedure, motors in the Affirm system move the biopsy device in X and Y
directions. Z-axis movement is manual.
The Tube Arm on the Selenia Dimensions system moves separately from the
Compression Arm to permit the acquisition of stereotactic and tomosynthesis images for
targeting. The types of images you can acquire are contingent on your Selenia
Dimensions system licensing. Refer to the Selenia Dimensions 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
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2.2 How to Handle the Biopsy Guidance Module
Caution:
To prevent damage or alignment problems with the Needle Guidance Stage, be
careful when you move the Biopsy Guidance Module.
Caution:
The Affirm Biopsy Guidance Module weighs 15 pounds. When you move it, be sure
to have a secure grip on the handles.
Only lift the Biopsy Guidance Module with the handles.
Figure 2: How to Lift the Biopsy Guidance Module
When the Biopsy Guidance Module is not in use, put the device on its back.
Figure 3: How to Store the Biopsy Guidance Module

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Chapter 2:General Information
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2.3 Safety
Read and understand this manual before you use the system. Keep this manual available
during the patient exams.
Always follow all the instructions in this manual. Hologic does not accept the
responsibility for injury or damage from incorrect system operation. Hologic can
schedule training at your site.
The system has protective devices, but the Technologist must understand how to safely
operate the system. The Technologist must remember the health hazards of x rays.
Do not connect this equipment to any system or component not described in this manual.
A combination of components must have the data to validate the safety of the patient,
personnel, and the environment. Any additional certification becomes the responsibility
of the user.
2.4 Warnings and Precautions
WARNING!
After power failure, remove the patient from the system before you
apply power.
Warning:
You make x rays when you use the procedures in this manual.
Warning:
C-arm movement is motorized.
Warning:
The Tube Arm movement is motorized.
Warning:
Only qualified users can use this system.
Warning:
Do not use this equipment if any faults or problems are detected.
Warning:
The user must schedule preventive maintenance by an approved Service
Engineer.

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Warning:
The user or a Service Engineer must correct problems before the system is
used.
Warning:
Do not leave the patient unattended during the procedure.
Warning:
Keep the hands of the patient away from all buttons and switches at all times.
Caution:
To prevent damage or misalignment, be careful when you move the Affirm system.
Caution:
The Affirm Biopsy Guidance Module weighs 15 pounds. When you move it, be sure
to have a secure grip on the handles.
Note
The system does not have any parts that are serviced by the user.
2.5 Compliance
This section describes the system compliance requirements and the responsibilities of the
manufacturer.
2.5.1 Compliance Requirements
The manufacturer is responsible for the effects of safety, reliability, and performance of
this equipment, with the following provisions:
•The equipment is used in accordance with the User Guide.
•Assembly operations, extensions, re-adjustments, modifications, or repairs are
performed by authorized persons only.