Expected service life:
7 years
Essential Performance
BSEN 60601-1 defines Essential Performance as:
“Performance necessary to achieve freedom from unacceptable risk”
Functions of the EMS960/970, the absence or degradation of which could
result in a hazardous situation are:
Maximum stimulation output 100mA CC or 140V CV
Maximum treatment time 30 minutes
Loss or degradation of these functions due to EM disturbances (e.g.
electrostatic discharges or mains voltage dips) may cause temporary loss
of output but this is not considered to be hazardous.
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