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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
1.3.1Community 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 Device data plate................................................................................................ 10
2.3 INTENDED USE.................................................................................................. 10
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
3DEVICE DESCRIPTION .............................................................................. 22
3.1 PROVISION DESCRIPTION..................................................................................... 22
3.1.1 Accessory device Polaris ..................................................................................... 24
3.1.2 Tools kit .............................................................................................................. 25
3.2 TECHNICAL DATA .............................................................................................. 26
4DEVICE USE ............................................................................................. 27
4.1 HOW TO INSTALL THE DEVICE ............................................................................... 27
4.2 HOW TO CONNECT THE DEVICE............................................................................. 30
4.3 HOW TO PLACE THE ELECTRIC CABLES..................................................................... 32
4.4 HOW TO INSERT THE FILM IN THE DEVICE LIGHTING HEAD............................................33
4.5 HOW TO TURN ON THE DEVICE ............................................................................. 33
4.6 ADJUST THE CHIN REST ....................................................................................... 34
4.7 HOW TO VISUALIZE THE IMAGE............................................................................. 36
4.8 HOW TO ANALYZE THE LIPID FILM.......................................................................... 37
4.9 HOW TO ANALYZE THE INFERIOR TEAR MENISCUS HEIGHT............................................37
4.10 HOW TO ANALYZE THE TEAR FILM STABILITY AND REGULARITY ...................................... 39
4.11 HOW TO ANALYZE THE CORNEAL SURFACE REGULARITY............................................... 40
4.12 HOW TO CAPTURE THE IMAGE.............................................................................. 41
4.13 HOW TO TURN OFF THE DEVICE ............................................................................ 41
5ORDINARY MAINTENANCE...................................................................... 43
