OM265EN issue 16
20
Essential Performance
BS EN 60601-1 defines Essential Performance as:
“Performance necessary to achieve freedom from unacceptable risk”
Functions of the EMS265, the absence or degradation of which could
result in a hazardous situation are:
Timer: The treatment shall be limited to a maximum of 30 minutes.
Maximum output power: Shall not exceed 1200W pulsed
Shall not exceed 480W continuous
The device is therapeutic. Provided the treatment time or output
powers are not exceeded then death or serious deterioration of
health is very unlikely to occur in normal operation. If the treatment is
halted for any reason, then there will be no hazardous situation.
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.
To Next Page
Loading...
Need help?
General
