CSO sirius+ User manual

INSTRUCTIONS FOR USE
sirius+
COSTRUZIONE STRUMENTI OFTALMICI
1/174
EN
COSTRUZIONE STRUMENTI OFTALMICI
phone: [phone] | fax: [phone]
[email protected] | www.csoitalia.it
0051
Corneal Topograph/Tomograph
IFU327EN00 - 01/2021

sirius+ | IFU327EN00 - 01/2021
INSTRUCTIONS FOR USE
This document is the property of
CSO Costruzione Strumenti Oftalmici srl.
Any reproduction, even partial, it is prohibited.
1/56
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 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
2SAFETY....................................................................................................... 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
3DEVICE 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
4DEVICE 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
4.4.1How 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

INSTRUCTIONS FOR USE
sirius+ | IFU327EN00 - 01/2021
This document is the property of
CSO Costruzione Strumenti Oftalmici srl.
Any reproduction, even partial, it is prohibited.
2/56
4.8 HOW TO TURN OFF THE DEVICE............................................................................ 47
5ORDINARY MAINTENANCE...................................................................... 48
5.1 SAFETY WARNINGS ........................................................................................... 48
5.2 CLEANING AND DISINFECTION.............................................................................. 48
5.2.1 Recommended products for cleaning and disinfection ....................................... 49
5.2.2 Classification of the device for hygiene and safety............................................. 50
5.2.3 Device cleaning .................................................................................................. 51
5.2.4 Cleaning the applied parts.................................................................................. 52
5.2.5 Cleaning the optical components ....................................................................... 52
5.3 DEVICE CALIBRATION ......................................................................................... 52
5.4 SPARE PARTS AND ACCESSORIES LIST ..................................................................... 53
5.5 TROUBLESHOOTING .......................................................................................... 54

sirius+ | IFU327EN00 - 01/2021
INSTRUCTIONS FOR USE
This document is the property of
CSO Costruzione Strumenti Oftalmici srl.
Any reproduction, even partial, it is prohibited.
3/56
1INTRODUCTION
The device is the result of a long research period, conducted by
experts to give the product technical innovation, quality and design.
The device can be easily used thanks to the guided manual capture
and the electronic control of all the functions of the device.
1.1 SYMBOLS
Within the instructions for use, on the package or on the device, there
can be the following symbols:
Symbol
Meaning
Caution
Danger of electric shock
Read the instructions for use
General obligation
Note. Useful information for the user
General prohibition sign
Manufacturer
CE Marking (Directive 93/42/EEC). Identification number of the
notified body (IMQ).