CSO MS39 AS-OCT - Default Chapter; Table of Contents

MS-39 AS-OCT| IFU302EN00 - 03/2019
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1 INTRODUCTION ......................................................................................... 3
1.1 SYMBOLS .......................................................................................................... 3
1.1.1 Device symbols ..................................................................................................... 4
1.2 GENERAL WARNINGS ........................................................................................... 4
1.3 NORMATIVE REFERENCES ..................................................................................... 5
1.3.1 Community directives ........................................................................................... 5
1.3.2 Technical standards .............................................................................................. 5
1.3.3 Quality management systems standards ............................................................. 5
1.4 WARRANTY ....................................................................................................... 6
1.5 MANUFACTURER IDENTIFICATION ........................................................................... 7
2 SAFETY ....................................................................................................... 8
2.1 SAFETY WARNINGS .............................................................................................. 8
2.2 DEVICE IDENTIFICATION ...................................................................................... 10
2.2.1 Registration data in the Medical Devices List ..................................................... 10
2.2.2 Device data plate................................................................................................ 10
2.2.3 Power supply data plate ..................................................................................... 11
2.3 INTENDED USE .................................................................................................. 12
2.4 MEDICAL DEVICES CLASSIFICATION ........................................................................ 17
2.5 MEDICAL ELECTRICAL DEVICES CLASSIFICATION ......................................................... 18
2.6 ENVIRONMENTAL CONDITIONS ............................................................................. 18
2.7 DISPOSAL AT THE END THE USEFUL LIFE ................................................................... 19
2.8 MANUFACTURER DECLARATIONS .......................................................................... 21
2.8.1 Electromagnetic emissions ................................................................................. 21
3 DEVICE DESCRIPTION .............................................................................. 24
3.1 PROVISION DESCRIPTION..................................................................................... 24
3.1.1 Device MS -39 AS-OCT ........................................................................................ 26
3.1.2 Power supply unit ............................................................................................... 27
3.1.3 Chin rest ............................................................................................................. 28
3.1.4 Ophthalmic table ................................................................................................ 29
3.1.5 Personal Computer ............................................................................................. 30
3.2 TECHNICAL DATA .............................................................................................. 31
4 DEVICE USE ............................................................................................. 33
4.1 HOW TO INSTALL THE DEVICE ............................................................................... 33
4.2 HOW TO CONNECT THE DEVICE ............................................................................. 37
4.3 HOW TO PLACE ELECTRIC CABLES .......................................................................... 38
4.4 HOW TO TURN ON THE DEVICE ............................................................................. 39
4.5 HOW TO ADJUST THE CHIN REST ........................................................................... 40
4.6 HOW TO CAPTURE THE IMAGE .............................................................................. 42
4.7 HOW TO CHANGE THE CHIN CUP PAPERS .............................................................. 44
4.8 HOW TO TURN OFF THE DEVICE ............................................................................ 45
5 ORDINARY MAINTENANCE ...................................................................... 46