zebris 01243005, Technical Data And Operating Instructions

Page: 3 / 54

zebris Medical GmbH FDM Technical Data and Operating Instructions Page 3/54
6 CONTROL MEASURES, PREPARATION, DISPOSAL .............................................................. 43
6.1 M
ANDATORY PERIODIC INSPECTIONS AND
STK ............................................................................. 43
6.2 C
HECKING THE
FDM S
ENSOR
...................................................................................................... 44
6.2.1 Control measures ...................................................................................................................... 44
6.2.2 Calibration measures ................................................................................................................ 44
6.3 T
ROUBLESHOOTING
..................................................................................................................... 45
6.4 C
LEANING AND DISINFECTION
....................................................................................................... 46
6.4.1 Cleaning .................................................................................................................................... 46
6.4.2 Manuelle Desinfektion ............................................................................................................... 46
6.5 D
ISPOSAL
................................................................................................................................... 47
6.5.1 Packaging ................................................................................................................................. 47
6.5.2 Disposal of electronics .............................................................................................................. 47
7 SAFETY STANDARDS AND SYSTEM CLASSIFICATION ........................................................ 48
7.1 C
LASSIFICATION ACC
.
TO
A
NNEX
IX
OF
D
IRECTIVE
93/42/EEC ...................................................... 48
7.2 S
AFETY 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 E
LECTROMAGNETIC COMPATIBILITY
G
UIDELINE
& M
ANUFACTURER
D
ECLARATION
.......................... 51
7.4 D
ECLARATION OF CONFORMITY MEDICAL PLATFORMS
.................................................................... 54