Hologic 3Dimensions - Table of Contents

3Dimensions System User Guide
Table of Contents
MAN-05085-002 Revision 002 v
DRAFT Preview Copy-Generated May 30, 2018
Table of Contents
List of Figures _________________________________________________________________ xi
List of Tables _________________________________________________________________ xv
1: Introduction __________________________________________________________________1
1.1 Intended Use............................................................................................................................................................ 1
1.1.1 Contraindications ..................................................................................................................................... 1
1.2 Potential Adverse Effects of Mammography Systems on Health .................................................................... 2
1.3 System Capabilities ................................................................................................................................................. 2
1.4 About the Genius 3D Mammography Exam ...................................................................................................... 2
1.5 More Information About Tomosynthesis ............................................................................................................ 3
1.6 About C-View and Intelligent 2D ......................................................................................................................... 5
1.6.1 C-View and Intelligent 2D Software ...................................................................................................... 5
1.6.2 C-View and Intelligent 2D Warnings .................................................................................................... 5
1.6.3 C-View and Intelligent 2D Theory of Operation .................................................................................. 6
1.7 User Profiles............................................................................................................................................................. 6
1.7.1 Mammography Technologist .................................................................................................................. 6
1.7.2 Radiologist ................................................................................................................................................. 6
1.7.3 Medical Physicist ...................................................................................................................................... 7
1.8 Training Requirements .......................................................................................................................................... 7
1.9 Quality Control Requirements .............................................................................................................................. 7
1.10 Where to Find the Installation Instructions ......................................................................................................... 7
1.11 Where to Find Technical Description Information ............................................................................................. 7
1.12 Warranty Statement ................................................................................................................................................ 8
1.13 Technical Support ................................................................................................................................................... 8
1.14 Product Complaints ................................................................................................................................................ 8
1.15 Hologic Cybersecurity Statement ......................................................................................................................... 8
1.16 Symbols .................................................................................................................................................................... 9
1.17 Descriptions of Warnings, Cautions, and Notes .............................................................................................. 10
1.18 Document Conventions ....................................................................................................................................... 10
2: General Information __________________________________________________________11
2.1 System Overview .................................................................................................................................................. 11
2.1.1 C-Arm Overview .................................................................................................................................... 12
2.2 Safety Information ................................................................................................................................................ 13
2.3 Warnings and Precautions ................................................................................................................................... 13
2.4 Emergency Off Switches ...................................................................................................................................... 17
2.5 Interlocks ................................................................................................................................................................ 18
2.6 Compliance ............................................................................................................................................................ 18
2.6.1 Compliance Requirements .................................................................................................................... 18
2.6.2 Compliance Statements ......................................................................................................................... 20
2.7 Label Locations ..................................................................................................................................................... 21