Zeiss PLEX Elite 9000 - Default Chapter; Table of Contents

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