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Affirm

Breast Biopsy Guidance System

Service Manual

For Software Versions 1.10/2.1

Part Number MAN-05754

Revision 002

August 2019

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
Add Licensed Features25
Unpacking28
Preinstallation Check28
Figure 6: Affirm System Icon Location28
Biopsy Guidance Module Components29
Figure 7: Biopsy Guidance Module29
Biopsy Control Module Components30
Table 1: Components of the Biopsy Guidance Module30
Figure 8: Biopsy Control Module31
Table 2: Components of the Biopsy Control Module31
Installation of the Main Components32
Install the Internal Gantry Biopsy Guidance Module Cables32
Figure 9: Gantry/Biopsy Guidance Module Cables32
Attach the Biopsy Guidance Module33
Figure 10: Installation of the Biopsy Guidance Module33
Attach the Biopsy Control Module34
Figure 11: Attachment of the Biopsy Control Module34
System Verifications35
Confirm the Host Connection36
Figure 12: Home Screen36
Figure 13: Service Screen36
Verify in Caltool37
Installation and Removal of Accessories37
Tabletop Stand for Affirm System37
Biopsy Compression Paddles38
Needle Guide38
Figure 14: Installation of the Needle Guide Holder on the Standard Device Mount39
Figure 15: Installation of the Needle Guide on the Standard Needle Guide Holder39
Biopsy Device Adapter40
Biopsy Device40
Figure 16: Attaching a Biopsy Device Adapter to Device Mount (Standard)40
Lateral Arm and Lateral Arm Accessories41
Figure 17: Lateral Arm Components41
Table 3: Components of the Lateral Arm41
Figure 18: Left Needle Approach of Lateral Arm (Blue)43
Figure 19: Right Needle Approach of Lateral Arm (Yellow)43
Figure 20: Installing Lateral Arm Stand over Image Receptor44
Figure 21: Removing the Needle Guide Holder from the Standard Device Mount45
Figure 22: Installing Lateral Arm to Device Mount46
Figure 23: Lateral Arm Mounting Side Selection Screen47
Figure 24: Attaching Blue Needle Guide Holder to Needle Guide Rods (Left Needle Approach)48
Figure 25: Attaching Yellow Needle Guide Holder to Needle Guide Rods (Right Needle Approach)48
Figure 26: Installing Disposable Needle Guide on Needle Guide Holder (Lateral Arm)49
Figure 27: Carriage Lever Locked and Unlocked Positions49
Figure 28: Locked and Unlocked Positions of Device Mount Lever50
Figure 29: Installing Device Mount Onto Lateral Arm Carriage50
Figure 30: Lock Levers in Fully Locked Position51
Figure 31: Scales and Positioning for X-Stop and Carriage52
Figure 32: Installing X-Stop on Lateral Arm53
Removal of the Main Components54
Biopsy Control Module54
Biopsy Guidance Module54
Tabletop Stand for the Affirm System55
Storage Case for the Lateral Arm55
Figure 33: Affirm System Tabletop Stand55
Figure 34: Lateral Arm and Storage Case56
4: Calibration Procedures57
Required Tools and Equipment57
Front Needle Guide Alignment58
Alignment for Standard Approach59
Alignment for Lateral Approach59
Biopsy Guidance Hardware60
Geometry Calibration60
STX Calibration61
STX Calibration for Standard Approach61
Table 4: Calibration Target List62
STX Calibration for Lateral Approach63
Table 5: Lateral Arm Calibration Target Coordinates List (in MM)64
Biopsy Calibration Interaction65
The QAS Test65
Table 6: Calibrations65
QAS Test for Standard Needle Approach66
Figure 35: Admin Screen Showing QAS Test66
Figure 36: QAS Test Info Dialog Box67
Figure 37: Device Field in the Biopsy Tab67
Figure 40: Device Field in the Biopsy Tab67
QAS Test for Lateral Needle Approach68
Figure 38: Admin Screen Showing Lateral Arm QAS Test69
Figure 39: Lateral QAS Test Info Dialog Box70
Dose Calibration71
5: Care and Cleaning73
Preventive Maintenance73
Table 7: Service Engineer Preventive Maintenance Schedule73
For General Cleaning74
How to Clean the Biopsy Control Module Screen74
To Prevent Possible Injury or Equipment Damage75
Appendix A System Specifications77
Affirm System Measurements77
Figure 41: Affirm Biopsy Guidance Module77
Lateral Arm Measurements78
Figure 42: Lateral Arm78
Biopsy Guidance Module79
Lateral Arm79
Biopsy Control Module79
Appendix B System Messages and Alerts81
Audible Alerts81
Error Messages81
Table 8: Affirm System Audible Alerts81
Table 9: Affirm System Error Messages81
Acquisition Workstation Messages83
Table 10: Acquisition Workstation Messages83
Appendix C Hardware Range Calibration85
Hardware Range Calibration85
Appendix D Biopsy Device Evaluation Procedure89
Introduction89
Please Read Prior to Performing Calibration89
Hologic Factory-Verified Biopsy Devices90
Configuring Device and Needle90
Biopsy Device Parameters90
Table 11: Hologic Factory-Verified Biopsy Devices90
Table 12: Biopsy Device Parameters (See also Following Four Figures)91
Needle Validation Process94
Configuring the Wire Localization Needle100
Wire Localization Needle Guides100
Table 13: Wire Localization (Loc) Needle Guides100
Wire Localization Parameters101
Table 14: Wire Localization (Loc) Parameters (See also Following Two Figures)101
Validate the Wire Localization Needle102
Calculate and Confirm the New Wire Localization Needle Parameters103
Adjust the Needle Length on the Acquisition Workstation104
Validate Needle104
Appendix E Field Replaceable Units (Frus)105
Biopsy Control Module - Field Replaceable Units105
Table 15: Recommended Frus - Biopsy Control Module (BCM)105
Biopsy Guidance Module - Field Replaceable Units106
Table 16: Recommended Frus - Biopsy Guidance Module (BGM)106
Lateral Arm - Field Replaceable Units107
Table 17: Recommended Frus - Lateral Arm Assembly107
Table 18: Recommended Frus - Lateral Arm Carriage Assembly108
Table 19: Recommended Frus - Lateral Arm Removable X-Axis Stop Assembly108
Table 20: Recommended Frus - Lateral Arm Needle Guide RH Assembly108
Table 21: Recommended Frus - Lateral Arm Needle Guide LH Assembly108
Accessories - Field Replaceable Units109
Table 22: Recommended Frus - Lateral Arm Device Mount Single Position Assembly109
Table 23: Recommended Frus - Accessories109
Glossary of Terms111
Index113

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