Hologic Affirm User manual

User Guide
For Software Version 1.8
Part Number MAN-04068
Revision 002
June 2016

Affirm Breast Biopsy Guidance System User Guide
Table of Contents
MAN-04068 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: How to Install or Remove the System___________________________________________11
3.1 Installation of Components .................................................................................................................................11
3.1.1 Biopsy Guidance Module Components................................................................................................. 11
3.1.2 Biopsy Control Module Components .................................................................................................... 12
3.1.3 Attach the Biopsy Guidance Module ..................................................................................................... 13
3.1.4 Attach the Biopsy Control Module......................................................................................................... 14
3.2 Installation and Removal of Accessories ...........................................................................................................15
3.2.1 Biopsy Compression Paddles..................................................................................................................15
3.2.2 Biopsy Device Holder...............................................................................................................................16
3.2.3 Needle Guides...........................................................................................................................................17
3.2.4 Tabletop Stand for the Affirm System ................................................................................................... 18