Manufacturer's Recommendations - Physiomed vocaSTIM-Master Operating Instructions Manual

16 Manufacturer's Recommendations

UNIT:
MANUFACTURER:
Instrument has to undergo a safety regulation control every 18 months.
E X T E N T :
1. Visual inspection of the instrument, extras and accompanying papers
2. Function of controls and indicators
3. Functional testing of instrument and accessories
4. Curve shapes of output parameters
5. Output current at the patient connector
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
vocaSTIM - Master
®
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
vocaSTIM ® -Master
PHYSIOMED ELEKTROMEDIZIN AG
Limiting value according
Manufacturer's Recommendations
VDE 0751
0.3 Ohm
1.0 mA
5.0 mA
Value first measured
(new instrument)
0.150 Ohm
0.700 mA
0.100 mA
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