FDM Technical Data and Operating Instructions
6 CONTROL MEASURES, PREPARATION, DISPOSAL .............................................................. 43
6.1 MANDATORY PERIODIC INSPECTIONS AND STK ............................................................................. 43
6.2 CHECKING THE FDM SENSOR ...................................................................................................... 44
6.2.1 Control measures ...................................................................................................................... 44
6.2.2 Calibration measures ................................................................................................................ 44
6.3 TROUBLESHOOTING ..................................................................................................................... 45
6.4 CLEANING AND DISINFECTION ....................................................................................................... 46
6.4.1 Cleaning .................................................................................................................................... 46
6.4.2 Manuelle Desinfektion ............................................................................................................... 46
6.5 DISPOSAL ................................................................................................................................... 47
6.5.1 Packaging ................................................................................................................................. 47
6.5.2 Disposal of electronics .............................................................................................................. 47
7 SAFETY STANDARDS AND SYSTEM CLASSIFICATION ........................................................ 48
7.1 CLASSIFICATION ACC. TO ANNEX IX OF DIRECTIVE 93/42/EEC ...................................................... 48
7.2 SAFETY OF MEDICAL ELECTRICAL DEVICES .................................................................................... 48
7.2.1 Connecting the FDM-System to other electrical devices .......................................................... 48
7.2.2 Vicinity of the patient / test person ............................................................................................ 49
7.2.3 Use of multiple sockets ............................................................................................................. 50
7.3 ELECTROMAGNETIC COMPATIBILITY GUIDELINE & MANUFACTURER DECLARATION .......................... 51
7.4 DECLARATION OF CONFORMITY MEDICAL PLATFORMS .................................................................... 54
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