VINTAGE | IFU320EN01.00 - 02/2022
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 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
2.3 INTENDED USE.................................................................................................. 11
2.4 MEDICAL DEVICES CLASSIFICATION ........................................................................ 12
2.5 MEDICAL ELECTRICAL DEVICES CLASSIFICATION......................................................... 13
2.6 ENVIRONMENTAL CONDITIONS ............................................................................. 13
2.7 DISPOSAL AT THE END OF THE USEFUL LIFE .............................................................. 14
2.8 MANUFACTURER DECLARATIONS .......................................................................... 16
2.8.1 Electromagnetic emissions ................................................................................. 16
3DEVICE DESCRIPTION .............................................................................. 17
3.1 SUPPLY DESCRIPTION ......................................................................................... 17
3.1.1 VINTAGE ophthalmic unit ................................................................................... 19
3.1.2 Command keypad on the structure .................................................................... 22
3.1.3 Chin rest (optional) ............................................................................................. 23
3.1.4 Drawer (optional) ............................................................................................... 24
3.1.5 Chair (optional) .................................................................................................. 25
3.2 ACCESSORIES FOR PLACING THE DEVICE (OPTIONAL) ..................................................26
3.3 TECHNICAL DATA .............................................................................................. 27
3.4 OPHTHALMIC UNIT BULK..................................................................................... 28
4DEVICE USE ............................................................................................. 29
4.1 HOW TO INSTALL THE OPHTHALMIC UNIT ................................................................ 29
4.2 HOW TO INSTALL STICKER PAD FOR PLACING THE DEVICE ON THE TABLE TOP .................... 29
4.3 HOW TO PLACE THE CHIN REST ............................................................................. 31
4.4 HOW TO PLACE DEVICES ON THE TABLE TOP............................................................. 32
4.5 HOW TO CONNECT THE OPHTHALMIC UNIT.............................................................. 34
4.6 HOW TO TURN ON THE OPHTHALMIC UNIT .............................................................. 35
4.7 HOW TO RESET THE CHAIR................................................................................... 37
4.8 HOW TO SET FUNCTIONS .................................................................................... 38
