Hologic Affirm User manual

User Guide
For Software Version 1.7
Part Number MAN-03209
Revision 005
January 2015

Affirm User Guide
Table of Contents
MAN-03209 Revision 005 v
Table of Contents
List of Figures ________________________________________________________________ vii
List of Tables __________________________________________________________________ ix
1: Introduction __________________________________________________________________1
1.1 Intended Use............................................................................................................................................................1
1.2 Intended Use for the User Guide..........................................................................................................................1
1.3 Product Complaints................................................................................................................................................1
1.4 Technical Support ...................................................................................................................................................1
1.5 Quality Control .......................................................................................................................................................1
1.6 Installation Instructions .........................................................................................................................................1
1.7 User Profiles.............................................................................................................................................................2
1.7.1 Mammography Technologist ..................................................................................................................... 2
1.7.2 Radiologists, Surgeons ................................................................................................................................2
1.7.3 Medical Physicist .........................................................................................................................................2
1.8 Training Requirements...........................................................................................................................................3
1.9 Terms and Definitions............................................................................................................................................3
1.10 International Symbols ............................................................................................................................................4
1.11 Warnings, Cautions, and Notes ............................................................................................................................5
2: General Information___________________________________________________________7
2.1 System Description ................................................................................................................................................. 7
2.2 How to Handle the Biopsy Guidance Module.................................................................................................... 8
2.3 Biopsy Guidance Module Components...............................................................................................................9
2.4 Biopsy Control Module Components ................................................................................................................ 10
2.5 Safety ...................................................................................................................................................................... 11
2.6 Warnings and Precautions................................................................................................................................... 11
2.7 Compliance Information...................................................................................................................................... 13
2.7.1 Requirements..............................................................................................................................................13
2.7.2 Label Locations...........................................................................................................................................13
3: How to Install or Remove the System___________________________________________15
3.1 Installation of Components ................................................................................................................................. 15
3.1.1 How to Attach the Biopsy Guidance Module........................................................................................ 15
3.1.2 How to Attach the Biopsy Control Module ........................................................................................... 16
3.2 Installation and Removal of Accessories ...........................................................................................................18
3.2.1 Biopsy Compression Paddles...................................................................................................................18
3.2.2 Biopsy Device Holder................................................................................................................................ 18
3.2.3 Needle Guides............................................................................................................................................19
3.2.4 Affirm Table-top Stand .............................................................................................................................20
3.3 Removal of Main Components ........................................................................................................................... 21
3.3.1 Biopsy Control Module............................................................................................................................. 21
3.3.2 Biopsy Guidance Module ......................................................................................................................... 21

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4: How to Use the System _______________________________________________________23
4.1 System Verifications .............................................................................................................................................23
4.1.1 Confirm the Host Connection ..................................................................................................................23
4.1.2 The QAS Test ..............................................................................................................................................23
4.2 Biopsy Control Module Screens..........................................................................................................................26
4.2.1 Home Screen...............................................................................................................................................26
4.2.2 Target Guidance Screen ............................................................................................................................26
4.2.3 Jog Mode Screen.........................................................................................................................................30
4.2.4 Select Target Screen ...................................................................................................................................32
4.3Selenia Dimensions...............................................................................................................................................33
4.3.1 Biopsy Views ..............................................................................................................................................33
4.3.2 C-Arm Stereo Modes .................................................................................................................................35
4.3.3 Biopsy Tab...................................................................................................................................................38
4.3.4 Stereotactic Lesion Targeting ...................................................................................................................41
4.3.5 Lesion Targeting with Tomosynthesis ....................................................................................................42
4.3.6 Post Biopsy..................................................................................................................................................43
4.3.7 Printing Stereo Images ..............................................................................................................................43
5: Care and Cleaning____________________________________________________________45
5.1 General Information .............................................................................................................................................45
5.2 Preventive Maintenance Schedule......................................................................................................................45
5.3 For General Cleaning............................................................................................................................................46
5.3.1 How to Clean the Biopsy Control Module Screen.................................................................................46
5.3.2 To Prevent Possible Injury or Equipment Damage ...............................................................................47
5.4 Geometry Calibration...........................................................................................................................................47
5.4.1Geometry Calibration Procedure.............................................................................................................47
6: Troubleshooting _____________________________________________________________49
6.1 Audible Alerts .......................................................................................................................................................49
6.2 Error Messages ......................................................................................................................................................50
Appendix A: System Specifications ______________________________________________51
A.1 Affirm Measurements ..........................................................................................................................................51
A.2 Biopsy Guidance Module ....................................................................................................................................51
A.3 Biopsy Control Module........................................................................................................................................51
Appendix B: Forms _____________________________________________________________53
B.1 QAS Test Checklist ...............................................................................................................................................53
Appendix C: CNR Correction for Biopsy __________________________________________55
C.1 CNR Correction for Stereotactic Biopsy.............................................................................................................55
C.1.1 AEC Table 0 (Standard Stereotactic Biopsy Dose).................................................................................55
C.2 CNR Correction for Biopsy Under Tomosynthesis Option.............................................................................55
C.2.1 AEC Table 0 (Tomosynthesis Option: Standard Tomo Dose)..............................................................55
Index _________________________________________________________________________57

Affirm User Guide
Table of Contents
MAN-03209 Revision 005 vii
List of Figures
Figure 1: Affirm on the Selenia Dimensions ..................................................................................................................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.................................................................................................................................9
Figure 5: Biopsy Control Module ..................................................................................................................................10
Figure 6: Label Location..................................................................................................................................................13
Figure 7: Installation of the Biopsy Guidance Module...............................................................................................15
Figure 8: Attachment of the Biopsy Control Module..................................................................................................16
Figure 9: How to Install the Needle Guides.................................................................................................................19
Figure 10: Affirm Table-top Stand.................................................................................................................................20
Figure 11: Home Screen on the Biopsy Control Module............................................................................................23
Figure 12: Admin Screen.................................................................................................................................................24
Figure 13: Device Field in the Biopsy Tab ....................................................................................................................24
Figure 14: The Home Screen...........................................................................................................................................26
Figure 15: Target Guidance Screen................................................................................................................................27
Figure 16: Green Differential Cells................................................................................................................................28
Figure 17: Yellow and Red Cells....................................................................................................................................28
Figure 18: Alert Sounds are Audible.............................................................................................................................29
Figure 19: Alert Sounds are Muted ...............................................................................................................................29
Figure 20: Jog Mode Screen............................................................................................................................................31
Figure 21: Select Target Screen.......................................................................................................................................32
Figure 22: Add a Biopsy View Screen...........................................................................................................................33
Figure 23: Edit Biopsy View Screen...............................................................................................................................34
Figure 24: Stereo Mode ...................................................................................................................................................36
Figure 25: C-Arm Mode ..................................................................................................................................................36
Figure 26: System Status Icon.........................................................................................................................................37
Figure 27: System Status Menu......................................................................................................................................37
Figure 28: System Defaults Screen.................................................................................................................................37
Figure 29: The Biopsy Tab ..............................................................................................................................................38
Figure 30: Slice Indicator.................................................................................................................................................38
Figure 31: Function Buttons and Data on the Biopsy Tab..........................................................................................39
Figure 32: Stereo Pair Print Screen ................................................................................................................................43

Affirm User Guide
Table of Contents
MAN-03209 Revision 005 ix
List of Tables
Table 1: Components of the Biopsy Guidance Module ................................................................................................9
Table 2: Components of the Biopsy Control Module..................................................................................................10
Table 3: How to Use the Sound Button ........................................................................................................................29
Table 4: The C-Arm Stereo Mode Button .....................................................................................................................36
Table 5: How to Select the C-Arm Stereo Mode ..........................................................................................................37
Table 6: Radiologic Technologist Preventive Maintenance Schedule.......................................................................45
Table 7: Affirm Audible Alerts ......................................................................................................................................49
Table 8: Affirm Error Messages .....................................................................................................................................50

Affirm User Guide
Chapter 1: Introduction
MAN-03209 Revision 005 Page 1
1: Introduction
1.1 Intended Use
United States federal law restricts this device to use 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.
1.2 Intended Use for the User Guide
Always refer to the User Guide for instructions on using the system.
1.3 Product Complaints
Report any complaints or problem 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 title page for contact information.)
1.4 Technical Support
Refer to the title page of this manual for contact information for product support.
1.5 Quality Control
Facilities that are ACR accredited must follow the 1999 Stereotactic Breast Biopsy Quality
Control Manual. Facilities that are not ACR accredited can follow the above manual or
perform the QAS Test described in this manual at the required interval.
1.6 Installation Instructions
Installation instructions are available in the Service Manual.
Chapter 1:

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Chapter 1: Introduction
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1.7 User Profiles
1.7.1 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.
•Knows about Stereotactic breast biopsy procedures.
•Knows 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.
1.7.2 Radiologists, Surgeons
•Meets all requirements that apply to the location in which the Physician operates.
•Knows about Stereotactic breast biopsy procedures.
•Knows how to operate a computer and its peripherals.
•Understands sterile procedures.
•Gives local anesthesia.
•Knows about basic surgical procedures for core biopsy.
1.7.3 Medical Physicist
•Meets all requirements that apply to the location in which the Medical Physicist
operates.
•Knows about mammography.
•Has experience with digital imaging.
•Knows how to operate a computer and its peripherals.

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Chapter 1: Introduction
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1.8 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.
1.9 Terms and Definitions
Affirm
The breast biopsy guidance system for the Selenia Dimensions
Biopsy Control
Module
The user control device for the Affirm breast biopsy guidance
system
Biopsy Guidance
Module
Holds and operates the biopsy device. Responds to commands
from the Biopsy Control Module to move the device into position
and do the biopsy.
Comm
Communication
Diff
Differential
C-Arm Mode
Lets the C-arm and Tube Arm to move together to the Needle
Approach angle for the Localization procedure.
Exposure
Technique
Combination of x ray parameters (kVp, mAs, filter) for an acquired
image
Needle
Approach Angle
The angle of incidence of the needle to the breast
QAS
Quality Assurance Standard
Safety Margins The minimum space allowed between the biopsy device needle
that is installed and components of the Selenia Dimensions system.
Stereo Mode
Lets the Tube Arm rotate for acquisition of stereotactic images
while the C-arm stays in position.
Stereotactic
Procedure
A type of examination that allows stereotactic views at the
Acquisition Workstation.
Stereotactic View
A specialized image view that causes the application to capture a
stereotactic images.
Stroke Margin
The safety margin (in mm) that remains between the fired needle
position and the breast platform.

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Chapter 1: Introduction
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Tomosynthesis
An imaging procedure which combines a number of projections
taken at different angles. The tomosynthesis images can be
reconstructed to show focal planes (slices) within the object
(Tomosynthesis option).
View
The combination of one x-ray image and a specified set of
conditions for image acquisition.
X-axis •The (lateral) axis from left to right across the biopsy
window
Y-axis •The (longitudinal) axis from front to back above the biopsy
window
Z-axis •The (vertical) axis through the biopsy window
1.10 International 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

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Chapter 1: Introduction
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1.11 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
the damage to equipment, loss of data, or damage to files
in software applications.
Note Notes show additional information.

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Chapter 2: General Information
MAN-03209 Revision 005 Page 7
2: General Information
2.1 System Description
The Affirm attaches to the Selenia Dimensions. A biopsy device attaches to the Affirm. X-
and Y-axes motors in the Affirm move the biopsy device left or right and forward or back.
Z-axis movement is manual. The Affirm Biopsy system has two main components:
•Biopsy Guidance Module
•Biopsy Control Module
The Tube Arm on the Selenia Dimensions moves separately from the Compression Arm
to allow the acquisition of stereotactic images for the procedure. Refer to the Selenia
Dimensions User Guide for complete information about that system.
Affirm licensing displays on the Acquisition Workstation screen as "Stereo Licensed".
Refer to Licensing Setup in System Tools of the Operating System.
Figure 1: Affirm on the Selenia Dimensions
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 Biopsy Guidance Module Components
The Biopsy Guidance Module installs on the front of the Selenia Dimensions. A lock lever
(item 8) secures this module in position. A cable (item 7) connects to the Selenia
Dimensions for operation of the biopsy guidance system.
Figure 4: Biopsy Guidance Module
Table 1: Components of the Biopsy Guidance Module
# Name Description
1
Attachment Hooks
Two on each side hold the Biopsy Guidance Module on the Selenia
Dimensions gantry.
2
Handles
One on each side. Hold both handles to lift the Biopsy Guidance
Module.
3
Z-axis Control Knobs
Rotate either knob to move the biopsy device along the Z-axis.
4
Z-axis Slide Rail
Holds the biopsy device holder and provides the track for Z-axis
movements.
5
Front Needle Guide
Attaches to the Needle Guide Mount on the Biopsy Device Holder.
6
Biopsy Device Holder
Holds the biopsy device. Moves along the Z-axis Slide Rail when a
Z-axis Control Knob is rotated.
7
Cable
Connects to Selenia Dimension to bring power to the Affirm.
8
Lock Lever
One on each side. Engage both levers to lock the Biopsy Guidance
Module in position and on the Selenia Dimensions gantry.
9 Receptacle Accepts the cable from the Biopsy Control Module.

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2.4 Biopsy Control Module Components
The Biopsy Control Module attaches to either the left or right handle on the Biopsy
Guidance Module with a bracket (item 5). The display screen (item 2) is a touch screen for
the user to perform the desired tasks. Motor Enable buttons (item 3) on either side of this
module (and at the rear) activate motorized movement of the biopsy device.
Figure 5: Biopsy Control Module
Table 2: Components of the Biopsy Control Module
# Name Description
1
Cable
Connects to Biopsy Guidance Module.
2
Display Screen
Shows targets, system status, name of the biopsy device, and safety
margins. Touch buttons allow option selection.
3
Motor Enable Buttons
Front and back button pairs on either side of the display. Press the
front and back buttons of either side at the same time to activate a
motor movement.
4
Articulating Arm Lock
and Release
Rotate to release the lock and adjust the module. Rotate in the
opposite direction to lock the arm and hold the module in the new
position.
5
Attachment Bracket
Attaches to either handle of the Biopsy Guidance Module.