CSO sirius+, Instructions For Use Manual, Page: 3 / 60

| IFU327EN00 - 01/2021
INSTRUCTIONS FOR USE
This document is the property of
CSO Costruzione Strumenti Oftalmici srl.
Any reproduction, even partial, it is prohibited.
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1 INTRODUCTION ......................................................................................... 3
1.1 S
YMBOLS
.......................................................................................................... 3
1.1.1 Device symbols ..................................................................................................... 4
1.2 G
ENERAL WARNINGS
........................................................................................... 4
1.3 N
ORMATIVE
R
EFERENCES
..................................................................................... 5
1.3.1 Community directives ........................................................................................... 5
1.3.2 Technical standards .............................................................................................. 5
1.3.3 Quality management systems standards ............................................................. 5
1.4 W
ARRANTY
....................................................................................................... 6
1.5 M
ANUFACTURER IDENTIFICATION
........................................................................... 7
2 SAFETY ....................................................................................................... 8
2.1 S
AFETY WARNINGS
.............................................................................................. 8
2.2 D
EVICE 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 I
NTENDED USE
.................................................................................................. 11
2.4 M
EDICAL DEVICES CLASSIFICATION
........................................................................ 16
2.5 M
EDICAL ELECTRICAL DEVICES CLASSIFICATION
......................................................... 17
2.6 E
NVIRONMENTAL CONDITIONS
............................................................................. 17
2.7 D
ISPOSAL AT THE END OF THE USEFUL LIFE
.............................................................. 18
2.8 M
ANUFACTURER DECLARATIONS
.......................................................................... 20
2.8.1 Electromagnetic emissions ................................................................................. 20
3 DEVICE DESCRIPTION .............................................................................. 23
3.1 S
UPPLY DESCRIPTION
......................................................................................... 23
3.1.1 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 ............................................................................................. 29
3.2 T
ECHNICAL DATA
.............................................................................................. 30
4 DEVICE USE ............................................................................................. 32
4.1 H
OW TO INSTALL THE DEVICE
............................................................................... 32
4.2 H
OW TO CONNECT THE DEVICE
............................................................................. 37
4.3 H
OW TO PLACE ELECTRIC CABLES
.......................................................................... 38
4.4 H
OW 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 H
OW TO ADJUST THE CHIN CUP
............................................................................ 42
4.6 H
OW TO CAPTURE THE IMAGE
.............................................................................. 45
4.7 H
OW TO REPLACE CHIN CUP PAPERS
...................................................................... 46