Physiomed PHYSIOSON-Expert, Руководство по эксплуатации

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Manufacturer’s Recommendations
15 Manufacturer’s Recommendations
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
UNIT:
PHYSIOSON-Expert
MANUFACTURER:
PHYSIOMED ELEKTROMEDIZIN AG
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
Limiting value according
VDE 0751
Value first measured
(new apparatus)
6.1 Earth-conductor resistance
(including lead 3 m)
0.3 Ohm 0.150 Ohm
6.2 Substitute device leakage current
1 mA 0.700 mA
6.3 Substitute patient leakage current
5 mA 0.100 mA
PHYSIOSON-Expert
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