Hologic selenia dimensions User manual

User Guide
For Software Version 5.0/5.1/5.2
Part Number MAN-03270
Revision 003
September 2014

Selenia User Guide
Table of Contents
MAN-03270 Revision 003 v
Table of Contents
List of Figures _________________________________________________________________ ix
List of Tables __________________________________________________________________ xi
Chapter 1 Introduction___________________________________________________________1
1.1 Intended Uses..........................................................................................................................................................1
1.1.1 Indications For Use ......................................................................................................................................2
1.1.2 Contraindications......................................................................................................................................... 2
1.1.3 Potential Adverse Effects............................................................................................................................2
1.2 Intended Use for the User Guide..........................................................................................................................2
1.3 Summary of Clinical Studies.................................................................................................................................2
1.4 Product Complaints................................................................................................................................................2
1.5 Technical Support ................................................................................................................................................... 2
1.6 Hologic Cybersecurity Statement .........................................................................................................................3
1.7 Quality Control Requirements..............................................................................................................................3
1.8 Installation Instructions .........................................................................................................................................3
1.9 User Profiles.............................................................................................................................................................4
1.9.1 Mammography Technologist .....................................................................................................................4
1.9.2 Radiologist ....................................................................................................................................................4
1.9.3 Medical Physicist .........................................................................................................................................4
1.10 Training Requirements...........................................................................................................................................4
1.11 Terms and Definitions............................................................................................................................................5
1.12 International Symbols ............................................................................................................................................7
1.13 Warnings, Cautions, and Notes ............................................................................................................................8
Chapter 2 General Information ___________________________________________________9
2.1 Warnings and Precautions.....................................................................................................................................9
2.2 Radiation Safety .................................................................................................................................................... 13
2.2.1 Exposure Duration..................................................................................................................................... 13
2.2.2 Operator Radiation Shield........................................................................................................................13
2.2.3 Patient Face Shield..................................................................................................................................... 13
2.2.4 Exam Room Door Indicators ....................................................................................................................13
2.3 Mechanical Safety ................................................................................................................................................. 13
2.4 Emergency Off Switches ......................................................................................................................................14
2.5 Interlocks................................................................................................................................................................ 14
2.6 Compliance............................................................................................................................................................ 14
2.6.1 Compliance Requirements........................................................................................................................ 14
2.6.2 Compliance Statements............................................................................................................................. 15
2.7 Label Locations .....................................................................................................................................................17