Hologic Affirm MAN-02866, Instructions For Use Manual

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Affirm Instructions for Use
Table of Contents
Part Number MAN-02866
v
Table of Contents
List of Figures ________________________________________________________________ vii
List of Tables __________________________________________________________________ ix
Preface ________________________________________________________________________ xi
1.0 Intended Use........................................................................................................................................................... xi
2.0 Quality Control ...................................................................................................................................................... xi
3.0 User Profiles........................................................................................................................................................... xii
3.1 Mammography Technologist ....................................................................................................................... xii
3.2 Radiologists, Surgeons .................................................................................................................................. xii
3.3 Medical Physicist ............................................................................................................................................ xii
4.0 Training Requirements ........................................................................................................................................ xii
5.0 Product Complaints ............................................................................................................................................ xiii
6.0 Technical Support ............................................................................................................................................... xiii
7.0 Terms and Definitions ........................................................................................................................................ xiii
8.0 International Symbols .......................................................................................................................................... xv
9.0 Warnings, Cautions, and Notes .......................................................................................................................... xv
General Information _____________________________________________________________1
1.0 System Description ................................................................................................................................................. 1
2.0 How to Handle the Biopsy Guidance Module .................................................................................................... 2
3.0 Biopsy Guidance Module Components ............................................................................................................... 3
4.0 Biopsy Control Module Components .................................................................................................................. 4
5.0 Safety ........................................................................................................................................................................ 5
6.0 Compliance Information ........................................................................................................................................ 7
6.1 Requirements .................................................................................................................................................... 7
6.2 Label Locations ................................................................................................................................................. 7
How to Install or Remove the System ______________________________________________9
1.0 Installation of Components ................................................................................................................................... 9
1.1 How to Attach the Biopsy Guidance Module .............................................................................................. 9
1.2 How to Attach the Biopsy Control Module ................................................................................................ 10
2.0 Installation and Removal of Accessories ........................................................................................................... 11
2.1 Biopsy Compression Paddles ....................................................................................................................... 11
2.2 Biopsy Device Holder .................................................................................................................................... 12
2.3 Needle Guides ................................................................................................................................................ 13
3.0 Removal of Main Components ........................................................................................................................... 14
3.1 Biopsy Control Module ................................................................................................................................. 14
3.2 Biopsy Guidance Module .............................................................................................................................. 14