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Affirm Breast Biopsy Guidance System User Guide

Table of Contents

MAN-06411-002 Revision 003 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 Biopsy Guidance Module Components ............................................................................................................. 13

3.2 Biopsy Control Module Components ................................................................................................................ 15

3.3 Installation of the Main Components ................................................................................................................. 16

3.3.1 Attach the Biopsy Guidance Module ................................................................................................... 16

3.3.2 Attach the Biopsy Control Module ...................................................................................................... 17

3.4 Installation and Removal of Accessories ........................................................................................................... 18

3.4.1 Biopsy Compression Paddles................................................................................................................ 18

3.4.2 Needle Guide .......................................................................................................................................... 18

3.4.3 Biopsy Device Adapter .......................................................................................................................... 20

3.4.4 Biopsy Device .......................................................................................................................................... 20

3.4.5 Lateral Arm and Lateral Arm Accessories .......................................................................................... 21