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
