Manufacturer’s Recommendations
52
PHYSIOTHERM-S
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:
PHYSIOTHERM-S
MANUFACTURER:
PHYSIOMED ELEKTROMEDIZIN AG
Instrument has to undergo a safety regulation control every 24 months.
E X T E N T:
1.
Check housing, power cable, electrode connection sockets, electrode cables, plate electrodes,
diplodes, diodes and rubber capacitor electrodes for deformations and damages.
2.
Correct function of indicators
3.
Correct display of operating modes
4.
Accuracy check of timer (+/- 5s), time setting
5.
Correct function of power switch
6.
Verification of power output using a neon indicator
7.
Electrical test according to IEC 601-1
normal condition
single fault condition
7.1 Earth leakage current
≤ 0.5 mA
≤ 1.0 mA
7.2 Housing leakage current
≤ 0.1 mA
≤ 0.5 mA
7.3 Protective conductor resistance
100 mOhm