Hologic Selenia - default chapter; Table of Contents

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