CSO sirius+ - Introduction; Device and Manual Symbols

sirius+ | IFU327EN00 - 01/2021
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CSO Costruzione Strumenti Oftalmici srl.
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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 unit data plate .............................................................................. 11
2.3 INTENDED USE .................................................................................................. 11
2.4 MEDICAL DEVICES CLASSIFICATION ........................................................................ 16
2.5 MEDICAL ELECTRICAL DEVICES CLASSIFICATION ......................................................... 17
2.6 ENVIRONMENTAL CONDITIONS ............................................................................. 17
2.7 DISPOSAL AT THE END OF THE USEFUL LIFE .............................................................. 18
2.8 MANUFACTURER DECLARATIONS .......................................................................... 20
2.8.1 Electromagnetic emissions ................................................................................. 20
3 DEVICE DESCRIPTION .............................................................................. 23
3.1 SUPPLY DESCRIPTION ......................................................................................... 23
3.1.1 Device sirius+ ...................................................................................................... 25
3.1.2 Power supply unit ............................................................................................... 26
3.1.3 Chin rest ............................................................................................................. 27
3.1.4 Ophthalmic table ................................................................................................ 28
3.1.5 Personal Computer ............................................................................................. 29
3.2 TECHNICAL DATA .............................................................................................. 30
4 DEVICE USE ............................................................................................. 32
4.1 HOW TO INSTALL THE DEVICE ............................................................................... 32
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
4.4.1 How to perform device calibration ..................................................................... 39
4.4.2 How to create a new patient .............................................................................. 41
4.4.3 How to create a new examination ...................................................................... 41
4.5 HOW TO ADJUST THE CHIN CUP ............................................................................ 42
4.6 HOW TO CAPTURE THE IMAGE .............................................................................. 45
4.7 HOW TO REPLACE CHIN CUP PAPERS ...................................................................... 46