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EN109-1631750-48 IFU
Technical Data
Electrical info
Mains voltage:
100 - 240 Volt ± 10%
Frequency:
50/60 Hz
Max. power consumption:
50 VA
Patient leakage current:
typically, 1 μA (requirements IEC < 10 μA)
Idem single fault condition:
typically, 2 μA (requirements IEC < 50 μA)
Main Unit
Dimensions
(cm)
Weight
(grams)
1631.901 and 1631.902
21 x 19 x 9
1152 and 1137
1631.903
29 x 19 x 9
1524
1631.904
22 x 16 x 14
1707
1629.901
22 x 12 x 9
930
Technical modifications reserved
Safety and performance standards
IEC 60601-1
General requirements for the safety of electrical medical
systems
Safety class according to IEC 60601-1
Class I type BF
IEC 60601-2-5
Particular requirements for the safety of ultrasonic
therapy equipment
Medical device classification
IIa; Rule 9 Annex IX of 93/42/EEC
This equipment complies with all requirements of the
Medical Device Directive (93/42/EEC)
21 CFR 1050.10
This equipment complies with all requirements of 21
CFR 1050.10. Performance Standard for Ultrasonic
Therapy devices
