Hologic Affirm

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Affirm

Breast Biopsy Guidance System

User Guide

For Software Versions 1.11 and 2.2

Part Number MAN-06411-002

Revision 003

July 2021

Main Page

Table of Contents5
List of Figures9
List of Tables11
1: Introduction13
Intended Use13
User Profiles13
Mammography Technologist13
Radiologists, Surgeons13
Medical Physicist14
Training Requirements14
Quality Control Requirements14
Where to Find Technical Description Information14
Warranty Statement15
Technical Support15
Product Complaints15
Hologic Cybersecurity Statement15
Symbols16
Descriptions of Warnings, Cautions, and Notes17
2: General Information19
System Overview19
Figure 1: Affirm Biopsy System on the Selenia Dimensions Mammography System19
How to Handle the Biopsy Guidance Module20
Figure 2: How to Lift the Biopsy Guidance Module20
Figure 3: How to Store the Biopsy Guidance Module20
Safety Information21
Warnings and Precautions21
Compliance22
Compliance Requirements22
Label Locations23
Figure 4: Biopsy Guidance Module Label Location23
Figure 5: Lateral Arm Serial Number Label Location23
3: Installation, Verification, and Removal25
Biopsy Guidance Module Components25
Figure 6: Biopsy Guidance Module25
Table 1: Components of the Biopsy Guidance Module26
Biopsy Control Module Components27
Figure 7: Biopsy Control Module27
Table 2: Components of the Biopsy Control Module27
Installation of the Main Components28
Attach the Biopsy Guidance Module28
Figure 8: Installation of the Biopsy Guidance Module28
Attach the Biopsy Control Module29
Figure 9: Attachment of the Biopsy Control Module29
Installation and Removal of Accessories30
Biopsy Compression Paddles30
Needle Guide30
Figure 10: Installation of the Needle Guide Holder on the Standard Device Mount31
Figure 11: Installation of the Needle Guide on the Standard Needle Guide Holder31
Biopsy Device Adapter32
Biopsy Device32
Figure 12: Attaching a Biopsy Device Adapter to the Device Mount (Standard)32
Lateral Arm and Lateral Arm Accessories33
Figure 13: Lateral Arm Components33
Table 3: Components of the Lateral Arm34
Figure 14: Left Needle Approach of Lateral Arm (Blue)35
Figure 15: Right Needle Approach of Lateral Arm (Yellow)35
Figure 16: Installing the Lateral Arm Stand over the Image Receptor36
Figure 17: Removing the Needle Guide Holder from the Standard Device Mount37
Figure 18: Installing the Lateral Arm on the Device Mount38
Figure 19: Selection Screen for the Lateral Arm Mounting Side39
Figure 20: Attaching the Blue Needle Guide Holder to the Needle Guide Rods (Left Needle Approach)40
Figure 21: Attaching the Yellow Needle Guide Holder to the Needle Guide Rods (Right Needle Approach)40
Figure 22: Installing a Disposable Needle Guide on a Needle Guide Holder (Lateral Arm)41
Figure 23: Carriage Lever Locked and Unlocked Positions42
Figure 24: Locked and Unlocked Positions of Device Mount Lever42
Figure 25: Installing Device Mount Onto Lateral Arm Carriage43
Figure 26: Attaching the Biopsy Device Adapter to the Device Mount (Lateral Arm)44
Figure 27: Lock Levers in Fully Locked Position45
Figure 28: Scales and Positioning for the X-Stop and Carriage46
Figure 29: Installing the X-Stop on the Lateral Arm47
System Verifications48
Confirm the Host Connection48
Figure 30: Home Screen on the Biopsy Control Module48
Removal of the Main Components49
Biopsy Control Module49
Biopsy Guidance Module49
Tabletop Stand for the Affirm System50
Figure 31: Affirm System Tabletop Stand50
Storage Case for the Lateral Arm51
Figure 32: Lateral Arm and Storage Case51
4: User Interface - Biopsy Control Module53
Biopsy Control Module Screens53
Home Screen53
Figure 33: Home Screen53
Target Guidance Screen54
Figure 34: Target Guidance Screen54
Figure 35: Target Guidance Screen for Lateral Arm55
Figure 36: Green Differential Cells56
Figure 37: Yellow and Red Cells56
Figure 38: Alert Sounds Are Audible57
Figure 39: Alert Sounds Are Muted57
Table 4: How to Use the Sound Button57
Jog Mode Screen58
Figure 40: Jog Mode Screen58
Figure 41: Jog Mode Screen for Lateral Arm59
Select Target Screen60
Figure 42: Select Target Screen60
5: Biopsy63
Biopsy Views63
Add a Biopsy View64
Edit a Biopsy View66
C-Arm Stereo Modes67
C-Arm Rotation in the C-Arm Stereo Modes67
Table 5: the C-Arm Stereo Mode Button68
How to Select the C-Arm Stereo Mode for Image Acquisition69
Table 6: How to Select the C-Arm Stereo Mode69
Biopsy Tab70
Biopsy Options71
Stereotactic 2D Lesion Targeting74
Verify the Position of the Biopsy Device75
Lesion Targeting with Tomosynthesis Guidance76
Verify the Position of the Biopsy Device77
Project Targets on Post-Fire Scout Image77
Lesion Targeting Using Multi-Pass78
Post Biopsy82
Printing Stereo Pair Images82
6: Quality Control83
Required Quality Control Procedures83
QAS Test83
Table 7: Required Procedures83
QAS Test for Standard Needle Approach84
QAS Test for Lateral Needle Approach87
Geometry Calibration90
Geometry Calibration Procedure90
7: Care and Cleaning91
General Information91
Preventive Maintenance Schedule91
Table 8: Radiologic Technologist Preventive Maintenance Schedule91
Table 9: Radiologic Technologist Preventive Maintenance Schedule92
Service Preventive Maintenance Schedule93
Table 10: Service Engineer Preventive Maintenance Schedule93
For General Cleaning94
How to Clean the Biopsy Control Module Screen94
To Prevent Possible Injury or Equipment Damage95
Appendix A: System Specifications97
Affirm System Measurements97
Lateral Arm Measurements98
Biopsy Guidance Module99
Lateral Arm99
Biopsy Control Module99
Appendix B: System Messages and Alerts101
Audible Alerts101
Error Messages101
Table 11: Affirm System Audible Alerts101
Table 12: Affirm System Error Messages101
Acquisition Workstation Messages103
Table 13: Acquisition Workstation Messages103
Appendix C: CNR Correction for Biopsy105
CNR Correction for Stereotactic 2D Biopsy105
AEC Table 0 (Standard Stereotactic 2D Biopsy Dose)105
CNR Correction for Biopsy under Tomosynthesis Option105
AEC Table 0 (Tomosynthesis Option: Standard Tomo Dose)105
Appendix D: Forms107
QAS Test Checklist107
QAS Test Checklist for the Lateral Arm108
Appendix E: Ancillary Parts for Biopsy109
Hologic Factory-Verified Biopsy Devices109
Table 14: Hologic Factory-Verified Biopsy Devices109
Wire Localization Needle Guides110
Table 15: Wire Localization (Loc) Needle Guides110
Glossary of Terms111
Index113

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