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...........................................................................................................11
2.4
MEDICAL DEVICES CLASSIFICATION...........................................................................17
2.5
MEDICAL ELECTRICAL DEVICES CLASSIFICATION .......................................................17
2.6
ENVIRONMENTAL CONDITIONS.................................................................................18
2.7
DISPOSAL AT THE END THE USEFUL LIFE....................................................................19
2.8
MANUFACTURER DECLARATIONS .............................................................................21
2.8.1 Electromagnetic emissions ................................................................................. 21
3
DEVICE DESCRIPTION ..................................................................24
3.1
PROVISION DESCRIPTION ..........................................................................................24
3.1.1 Device ANTARES ................................................................................................. 26
3.1.2 Power supply ...................................................................................................... 27
3.1.3 Chin rest ............................................................................................................. 28
3.1.4 Electric table (optional) ...................................................................................... 29
3.2
TECHNICAL DATA.......................................................................................................29
4
DEVICE USE .................................................................................31
4.1
HOW TO INSTALL THE DEVICE ...................................................................................31
4.2
HOW TO CONNECT THE DEVICE.................................................................................33
4.3
HOW TO PLACE THE ELECTRIC CABLES ......................................................................35
4.4
HOW TO TURN ON THE DEVICE.................................................................................36
4.5
ADJUST THE CHIN REST..............................................................................................37
4.6
HOW TO CAPTURE THE IMAGE..................................................................................39
4.7
HOW TO CHANGE THE PAPER FOR CHIN CUP............................................................41
4.8
HOW TO TURN OFF THE DEVICE................................................................................42
5
ORDINARY MAINTENANCE..........................................................43
5.1
SAFETY WARNINGS....................................................................................................43
5.2
DEVICE CLEANING ...................................................................................................................... 43
