Polydoros RFX
Instructions for use
5021-0-1002
3 von 64
Table of contents
Page
Table of contents ........................................................................................................................... 3
Document Effectivity .................................................................................................................... 6
Introduction ................................................................................................................................... 8
1.1
General Information ........................................................................................................................................................................ 8
1.1.1
Product lnformation ........................................................................................................................................................... 8
1.1.1.1
High-voltage Generator Models ........................................................................................................................... 8
1.1.1.2
Slide-in Module Service Parts ................................................................................................................................. 9
1.1.1.3
Console Models............................................................................................................................................................... 9
1.1.1.4
Intended use ..................................................................................................................................................................... 9
1.1.1.5
Improper Use .................................................................................................................................................................... 9
1.1.1.6
Indications .......................................................................................................................................................................... 9
1.1.1.7
Contra indications ...................................................................................................................................................... 10
1.1.1.8
Intended patient population ............................................................................................................................... 10
1.1.1.9
Intended user ................................................................................................................................................................ 10
1.1.2
Document Information.................................................................................................................................................. 11
1.1.2.1
Purpose of this Document .................................................................................................................................... 11
1.1.2.2
Text Layout ...................................................................................................................................................................... 11
1.1.2.3
Illustrations ...................................................................................................................................................................... 12
1.1.2.4
Value Statement .......................................................................................................................................................... 13
1.1.3
Acronyms and Abbreviations .................................................................................................................................... 13
1.1.4
Laws, Standards, and Regulations ........................................................................................................................... 14
1.1.4.1
High-voltage generator .......................................................................................................................................... 14
1.1.4.2
Mini Console .................................................................................................................................................................. 15
1.2
Safety Information ......................................................................................................................................................................... 16
1.2.1
Installation, Repair, or Modifications ...................................................................................................................... 16
1.2.2
Staff Qualification .............................................................................................................................................................. 17
1.2.2.1
Operating Staff .............................................................................................................................................................. 17
1.2.2.2
Installation, Maintenance and Repair Staff .................................................................................................. 17
1.2.3
Safety lnstructions............................................................................................................................................................. 17
1.2.3.1
Unpacking Hazards .................................................................................................................................................... 17
1.2.3.2
Installation Hazards .................................................................................................................................................... 17
1.2.3.3
Operating Hazards...................................................................................................................................................... 18
1.2.4
Cleaning and Disinfection and Sterilization ...................................................................................................... 21
1.2.4.1
High-voltage generator .......................................................................................................................................... 21
1.2.4.2
Mini Console .................................................................................................................................................................. 21