Hologic Brevera - Introduction to Brevera Breast Biopsy System

Brevera Breast Biopsy System User Guide
Table of Contents
MAN-04303-002 Revision 006 v
Table of Contents
List of Figures _________________________________________________________________ xi
List of Tables _________________________________________________________________xiii
1: Introduction __________________________________________________________________1
1.1 Preface ...................................................................................................................................................................... 1
1.2 Indications for Use .................................................................................................................................................. 1
1.3 Contraindications .................................................................................................................................................... 1
1.4 Essential Performance ............................................................................................................................................ 1
1.5 System Capabilities ................................................................................................................................................. 2
1.6 User Profiles............................................................................................................................................................. 3
1.6.1 Mammography Technologist .................................................................................................................. 3
1.6.2 Radiologists, Surgeons ............................................................................................................................. 3
1.6.3 Medical Physicist ...................................................................................................................................... 3
1.7 Where to Find the Installation Instructions ......................................................................................................... 3
1.8 Where to Find Technical Description Information ............................................................................................. 3
1.9 Warranty Statement ................................................................................................................................................ 4
1.10 Technical Support ................................................................................................................................................... 4
1.11 Product Complaints ................................................................................................................................................ 4
1.12 Hologic Cybersecurity Statement ......................................................................................................................... 4
1.13 Where to Obtain Copies of the Manuals .............................................................................................................. 5
1.14 Terms and Definitions ............................................................................................................................................ 5
1.15 Descriptions of Warnings, Cautions, and Notes ................................................................................................ 5
2: General Information ___________________________________________________________7
2.1 System Overview .................................................................................................................................................... 7
2.2 Safety Information .................................................................................................................................................. 8
2.3 Warnings and Precautions ..................................................................................................................................... 8
2.4 Interlocks ................................................................................................................................................................ 14
2.5 Compliance ............................................................................................................................................................ 14
2.5.1 Compliance Requirements .................................................................................................................... 14
2.5.2 Compliance Statements ......................................................................................................................... 15
2.6 Symbols .................................................................................................................................................................. 16
2.7 Label Locations ..................................................................................................................................................... 19
3: Components, Controls, and Indicators __________________________________________21
3.1 System Components ............................................................................................................................................. 21
3.1.1 Imaging Cabinet Components .............................................................................................................. 25
3.1.2 Suction Canister Components .............................................................................................................. 26
3.1.3 Biopsy Device Components .................................................................................................................. 27