Hologic Affirm, Руководство пользователя

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Affirm User Guide
Table of Contents
MAN-03209 Revision 005 v
Table of Contents
List of Figures ________________________________________________________________ vii
List of Tables __________________________________________________________________ ix
1: Introduction __________________________________________________________________1
1.1 Intended Use............................................................................................................................................................ 1
1.2 Intended Use for the User Guide .......................................................................................................................... 1
1.3 Product Complaints ................................................................................................................................................ 1
1.4 Technical Support ................................................................................................................................................... 1
1.5 Quality Control ....................................................................................................................................................... 1
1.6 Installation Instructions ......................................................................................................................................... 1
1.7 User Profiles............................................................................................................................................................. 2
1.7.1 Mammography Technologist ..................................................................................................................... 2
1.7.2 Radiologists, Surgeons ................................................................................................................................ 2
1.7.3 Medical Physicist ......................................................................................................................................... 2
1.8 Training Requirements........................................................................................................................................... 3
1.9 Terms and Definitions ............................................................................................................................................ 3
1.10 International Symbols ............................................................................................................................................ 4
1.11 Warnings, Cautions, and Notes ............................................................................................................................ 5
2: General Information ___________________________________________________________7
2.1 System Description ................................................................................................................................................. 7
2.2 How to Handle the Biopsy Guidance Module.................................................................................................... 8
2.3 Biopsy Guidance Module Components ............................................................................................................... 9
2.4 Biopsy Control Module Components ................................................................................................................ 10
2.5 Safety ...................................................................................................................................................................... 11
2.6 Warnings and Precautions ................................................................................................................................... 11
2.7 Compliance Information ...................................................................................................................................... 13
2.7.1 Requirements .............................................................................................................................................. 13
2.7.2 Label Locations........................................................................................................................................... 13
3: How to Install or Remove the System ___________________________________________15
3.1 Installation of Components ................................................................................................................................. 15
3.1.1 How to Attach the Biopsy Guidance Module ........................................................................................ 15
3.1.2 How to Attach the Biopsy Control Module ........................................................................................... 16
3.2 Installation and Removal of Accessories ........................................................................................................... 18
3.2.1 Biopsy Compression Paddles ................................................................................................................... 18
3.2.2 Biopsy Device Holder ................................................................................................................................ 18
3.2.3 Needle Guides ............................................................................................................................................ 19
3.2.4 Affirm Table-top Stand ............................................................................................................................. 20
3.3 Removal of Main Components ........................................................................................................................... 21
3.3.1 Biopsy Control Module ............................................................................................................................. 21
3.3.2 Biopsy Guidance Module ......................................................................................................................... 21