Manufacturer's Recommendations - Physiomed Jubilee Operating Instructions Manual

Manufacturer's Recommendations

12 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 the instrument and accessories
(4) Curve shapes of output parameters
(5) Output current at the patient connector
(6) Electrical safety according to EN 62353
6.1 Earth-conductor resistance
(including lead 3 m)
6.2 Substitute device leakage current
6.3 Substitute patient leakage current
50
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
PHYSIOMED-Jubilee
PHYSIOMED ELEKTROMEDIZIN AG
Limiting value according
EN 62353
0.3 Ohm
1 mA
5 mA
Value first measured
(new instrument)
0.150 Ohm
0.700 mA
0.100 mA
PHYSIOMED-Jubilee