Instructions for Use
Table of Contents
2660021169042 Rev. A 2018-03
2660021169042 Rev. A 2018-03
3 / 246
Table of Contents
1
Safety and Certifications .............................................................................. 9
1.1
Symbols and Labels .............................................................................................................. 9
1.2
Definitions .......................................................................................................................... 10
1.3
Safety ................................................................................................................................. 10
1.3.1
Product Safety................................................................................................................................. 11
1.3.2
Product Safety................................................................................................................................. 14
1.3.3
Optical Safety .................................................................................................................................. 17
1.3.4
Laser Safety and Compliance ........................................................................................................... 19
1.3.5
Electrical Safety ............................................................................................................................... 19
1.3.6
Printer and Peripherals Safety .......................................................................................................... 19
1.3.7
Networking Safety........................................................................................................................... 21
1.3.8
Record and Data Safety ................................................................................................................... 22
1.4
Electromagnetic Compatibility (EMC).................................................................................. 22
1.4.1
Electromagnetic Emissions............................................................................................................... 23
1.4.2
Electromagnetic Immunity ............................................................................................................... 23
1.5
Operator Training and Equipment Maintenance................................................................. 27
1.5.1
Operator Training............................................................................................................................ 27
1.5.2
Equipment Maintenance.................................................................................................................. 27
1.5.3
Notification of Serious Incident........................................................................................................ 28
1.6
RoHS Compliance ............................................................................................................... 28
2
Introduction ............................................................................................... 29
2.1
Scope.................................................................................................................................. 29
2.1.1
Intended Use................................................................................................................................... 29
2.1.2
Indications for Use .......................................................................................................................... 29
2.1.3
Usage.............................................................................................................................................. 29
2.1.4
Essential Performance...................................................................................................................... 30
2.2
Subject/Patient Profile ........................................................................................................ 30
2.3
Operator Profile.................................................................................................................. 30
2.3.1
Intended Demographic (Operators) ................................................................................................. 30
2.3.2
Required Occupational Skills (Operators).......................................................................................... 30
2.3.3
Job Requirements (Operators).......................................................................................................... 31
2.4
Data Analyst Profile............................................................................................................ 31
2.4.1
Intended Demographic (Analysts) .................................................................................................... 31
2.4.2
Required Occupational Skills (Analysts) ............................................................................................ 31
2.4.3
Job Requirements (Analysts) ............................................................................................................ 32
2.5
User Documentation........................................................................................................... 32
2.5.1
Purpose........................................................................................................................................... 32
2.5.2
Access ............................................................................................................................................. 32
2.5.3
Organization ................................................................................................................................... 32
2.5.4
Other Applicable Documents ........................................................................................................... 32
2.5.5
Conventions Used in This Document................................................................................................ 33
2.5.6
Questions and Comments ............................................................................................................... 33
2.6
PLEX® Elite 9000 Technology ............................................................................................ 33
Содержание PLEX Elite 9000
Страница 1: ...PLEX Elite 9000 Version 1 7 Instructions for Use...
Страница 54: ...Empty page for your notes...
Страница 106: ...Empty page for your notes...
Страница 174: ...Empty page for your notes...
Страница 182: ...Empty page for your notes...
Страница 210: ...Empty page for your notes...
Страница 218: ...Empty page for your notes...
Страница 224: ...Empty page for your notes...
Страница 226: ...Empty page for your notes...
Страница 228: ...Empty page for your notes...
Страница 230: ...Empty page for your notes...
Страница 233: ...Instructions for Use Index 2660021169042 Rev A 2018 03 2660021169042 Rev A 2018 03 233 246 Index...
Страница 245: ...Empty page for your notes...