Permissible Environmental Conditions For Transport And Storage:
Temperature -10 to +35°C
Relative humidity 5 to 95%
Atmospheric pressure 500 to 1060hPa
Expected Service Life:
7 years
Essential Performance
BS EN 60601-1 defines Essential Performance as:
“Performance necessary to achieve freedom from unacceptable risk”
Functions of the Combination 860, the absence or degradation of which
could result in a hazardous situation are:
Maximum ultrasound intensity 3W/cm
2
Maximum stimulation output 100mA CC or 140V CV
Maximum treatment time 30 minutes
Loss or degradation of these functions due to EM disturbances (eg.
electrostatic discharges or mains voltage dips) may cause temporary loss of
output but this is not considered to be hazardous.
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