COBRA HD | IFUCOBRAHDEN00
INSTRUCTIONS FOR USE
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CSO Costruzione Strumenti Oftalmici srl.
Any reproduction, even partial, it is prohibited.
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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 ........................................................................ 14
2.5 MEDICAL ELECTRICAL DEVICES CLASSIFICATION ......................................................... 15
2.6 ENVIRONMENTAL CONDITIONS ............................................................................. 15
2.7 DISPOSAL AT THE END THE USEFUL LIFE ................................................................... 16
2.8 MANUFACTURER DECLARATIONS .......................................................................... 18
2.8.1 Electromagnetic emissions ................................................................................. 18
3 DEVICE DESCRIPTION .............................................................................. 22
3.1 PROVISION DESCRIPTION..................................................................................... 22
3.1.1 Device Cobra HD ................................................................................................. 24
3.1.2 Power supply ...................................................................................................... 26
3.1.3 Chin rest ............................................................................................................. 27
3.1.4 Electric table (optional) ...................................................................................... 28
3.2 TECHNICAL DATA .............................................................................................. 29
4 DEVICE USE ............................................................................................. 30
4.1 HOW TO INSTALL THE DEVICE ............................................................................... 30
4.2 HOW TO CONNECT THE DEVICE ............................................................................. 32
4.3 HOW TO PLACE THE ELECTRIC CABLES ..................................................................... 34
4.4 HOW TO TURN ON THE DEVICE ............................................................................. 35
4.5 ADJUST THE CHIN REST ....................................................................................... 36
4.6 HOW TO CAPTURE THE IMAGE .............................................................................. 38
4.7 HOW TO CHANGE THE PAPER FOR CHIN CUP ............................................................ 40
4.8 HOW TO TURN OFF THE DEVICE ............................................................................ 41
5 ORDINARY MAINTENANCE ...................................................................... 42
5.1 SAFETY WARNINGS ............................................................................................ 42
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