Sirius+ | IFU327EN02.04 - 11/2022
INSTRUCTIONS FOR USE
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1INTRODUCTION......................................................................................... 3
1.1 SYMBOLS .......................................................................................................... 3
1.1.1 Device symbols ..................................................................................................... 4
1.2 GENERAL WARNINGS ........................................................................................... 4
1.3 NORMATIVE REFERENCES ..................................................................................... 5
1.3.1 EU Directives ........................................................................................................ 5
1.3.2 Technical standards.............................................................................................. 5
1.3.3 Quality management system standards............................................................... 5
1.4 WARRANTY ....................................................................................................... 6
1.5 MANUFACTURER IDENTIFICATION ........................................................................... 7
2SAFETY....................................................................................................... 8
2.1 SAFETY WARNINGS .............................................................................................. 8
2.2 DEVICE IDENTIFICATION...................................................................................... 10
2.2.1 Registration data in the List of Medical Devices................................................. 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 DEVICE CLASSIFICATION ......................................................................... 16
2.5 ELECTROMEDICAL DEVICE 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
3DEVICE DESCRIPTION .............................................................................. 23
3.1 SUPPLY DESCRIPTION ......................................................................................... 23
3.1.1 Sirius+ Device ..................................................................................................... 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............................................................................................. 28
3.2 TECHNICAL DATA .............................................................................................. 30
4DEVICE USE ............................................................................................. 32
4.1 HOW TO INSTALL THE DEVICE ............................................................................... 32
4.2 HOW TO CONNECT THE DEVICE............................................................................. 35
4.3 HOW TO ARRANGE THE ELECTRIC CABLES ................................................................ 36
4.4 HOW TO TURN ON THE DEVICE ............................................................................. 37
4.4.1 How to perform device calibration ..................................................................... 37
4.4.2 How to create a new patient .............................................................................. 39
4.4.3 How to create a new examination...................................................................... 39
4.5 HOW TO ADJUST THE CHIN CUP ............................................................................ 40
4.6 HOW TO ACQUIRE AN IMAGE ............................................................................... 43
4.7 HOW TO REPLACE CHIN CUP PAPERS ...................................................................... 44
4.8 HOW TO TURN OFF THE DEVICE ............................................................................ 45
