Enraf Nonius 4 Series - Specifications; Technical and Safety Specifications

Page 68 of 72 EN109-1498751-47 IFU
15 Specifications
Technical data
Mains voltage:
100 - 240 Volt
Frequency:
50/60 Hz
Max. power input:
100 VA
Patient leakage current:
typically, 1 μA
idem single fault condition:
typically, 2 μA
Main Unit
Dimensions stand alone
24 x 32 x 12 cm (w x d x h)
Dimensions on inclination foot
24 x 30.5 x 18.2 cm (w x d x h)
Dimensions on Vacotron
24 x 30.5 x 21.6 cm (w x d x h)
Weight
2 kg
Weight including optional battery
3 kg
Vacotron
Dimensions
24 x 28.6 x 9.3 cm (w x d x h)
Weight
2 kg
Vacuum
continuous and pulsed,
0 – 800 mbar, continuously adjustable
Pulsed Vacuum
pulse : pause = 0.5 : 0.5 seconds, 1 : 1 second
Technical modifications reserved
Safety and performance standards
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).
IEC 60601-1
General requirements for the safety of electrical medical
systems, including Annex I, national differences for
Australia, Canada, and the United States.
IEC 60601-2-5
Particular requirements for the safety of ultrasonic
therapy equipment.
IEC 60601-2-10
Particular requirements for the safety of nerve and
muscle stimulators.
21 CFR 1050.10
This equipment complies with all requirements of 21
CFR 1050.10, Performance Standard for Ultrasonic
Therapy devices.
21 CFR 898
This equipment complies with all requirements of 21
CFR 898, Performance Standard for electrode lead wires
and patient leads.
Safety class according to IEC 60601-1
I
Applied parts
Type B applied part (ultrasound applicator)
Type BF applied part (electrodes)