Manufacturer's Recommendations - Physiomed PHYSIOSON-Expert Operating Instructions Manual

15 Manufacturer's Recommendations

UNIT:
MANUFACTURER:
The apparatus has to undergo a safety regulation control every 18 months.
E X T E N T :
(1) Visual inspection of the apparatus, extras and accompanying papers
(2) Functional testing of instrument and accessories
(3) Check of output parameters
(4) Visual inspection of the ultrasonic transducers for cracks
(5) Visual inspection of the ultrasonic transducer leads and connectors
(6) Electrical safety according to VDE 0751
6.1 Earth-conductor resistance
(including lead 3 m)
6.2 Substitute device leakage current
6.3 Substitute patient leakage current
PHYSIOSON-Expert
M A N U F A C T U R E R ' S R E C O M M E N D A T I O N S
S A F E T Y R E G U L A T I O N S C O N T R O L
according to Medical Devices Directive
PHYSIOSON-Expert
PHYSIOMED ELEKTROMEDIZIN AG
Limiting value according
Manufacturer's Recommendations
VDE 0751
0.3 Ohm
1 mA
5 mA
Value first measured
(new apparatus)
0.150 Ohm
0.700 mA
0.100 mA
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