Hologic Affirm - Table of Contents

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