SCHWIND Amaris 500E - Table of Contents; Content

USER MANUAL (Instruction for Use) SW 6.1
General Information
Version 6.1.6 dated 2020-01-31 EN Page 3 of 201
Content
Dear Customer ...................................................................................................................... 2
Content 3
List of Figures ...................................................................................................................... 10
List of Tables ....................................................................................................................... 13
1 GENERAL INFORMATION ............................................................................... 14
1.1 System Identification Data ........................................................................ 14
1.2 Symbols for Warnings, Precautionary Measures and Notes .................. 15
1.3 Notes on the User Manual ......................................................................... 15
1.4 Scope of Documentation ........................................................................... 16
1.5 Declaration of Manufacturer ...................................................................... 16
1.6 Liability of the Manufacturer ..................................................................... 17
1.7 Warranty ...................................................................................................... 18
1.8 License Agreement ..................................................................................... 19
1.9 Copyright ..................................................................................................... 19
1.10 Trademarks ................................................................................................. 19
2 SAFETY ............................................................................................................ 20
2.1 General Safety Notes ................................................................................. 20
2.2 Regulations for Medical Devices ............................................................... 20
2.3 Restrictions of Use and Safety Precautions ............................................. 21
2.4 Manufacturer’s Responsibility ................................................................... 22
2.4.1 Training of User and Operating Personnel .......................................................... 22
2.4.2 Protective Measures of the Manufacturer ............................................................ 23
2.4.3 Conformity with Safety Standards ....................................................................... 23
2.5 Operator’s Responsibility ........................................................................... 25
2.5.1 Patient Safety ........................................................................................................ 25
2.5.2 Device Safety ......................................................................................................... 26
2.5.3 Electrical Safety ..................................................................................................... 26
2.5.4 Patient Bed Interlock ............................................................................................. 27
2.5.5 Laser Warning Lamp and Door Interlock ............................................................. 27
2.5.6 Protective Glasses ................................................................................................. 28