Nu-Tek MT2203 - Safety and Performance Standards; Medical Device Classification; EMC Details

10.6 Safety and Performance standards
IEC 60601-1
General requirements for the safety of electrical medical systems, including Annex 1,
national differences for Australia, Canada and the United States.
Safety class according to IEC 60601-1
class I type BF
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.
This equipment complies with all requirements of the Medical Device Directive (93/42/EEC).
Medical device classification
IIa
21 CFR 1050.10
This equipment complies with all requirements of 21 CFR1050.10, 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.
10.6 EMC details
Medical electrical devices such as the Rehab-series are subject to special precautions with
regard to electromagnetic compatibility (EMC) and must be installed and commissioned in
accordance with the EMC advice given in the instructions for use and accompanying docu-
ments.
Portable and mobile RF communication systems (e.g. mobile phones) may interfere with
medical electrical Rehab-series.
81
0197
Rehab-Series