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17 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
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)
Check of ultrasound output parameters
(7)
Visual inspection of the ultrasonic transducers for cracks
(8)
Visual inspection of the ultrasonic transducer leads and connectors
(9)
Electrical safety according to VDE 0751
9.1 Earth-conductor resistance
(including lead 3 m)
9.2 Substitute device leakage current
9.3 Substitute patient leakage current
IONOSON-Jubilee
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
IONOSON-Jubilee
PHYSIOMED Elektromedizin AG
Limiting value according
VDE 0751
0,3 Ohm
Manufacturer's Recommendations
Value first measured
1 mA
5 mA
(new instrument)
0,150 Ohm
0,700 mA
0,100 mA
55
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