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Electrical Safety Testing in accordance with EN 62/353
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Substitute for device discharge current.
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Substitute for patient discharge current.
With regard to recurring safety technical controls, the measured values must
not exceed 1.5 times the values first measured or 0.9 times the limit values in
accordance with EN 62/353.
Measuring the output value.
Subsequently, the results together with date and name of the person or
company who has carried out the testing are to be documented in the
medicine product book or to be extended. If the device is not functionally or
operationally in order, it is to be repaired or the operator of the device is to be
informed with regard to the danger emanating from the device.
Attention
If failures or defects occur during testing and which could cause possible
danger to patients, employees or third persons, the device must no longer
be operated.
Regular Ultrasound Head Checks
The ultrasound head must be checked at least once a month with regard to
function. During the check and in particular, the ultrasound head must be
examined for possible damage, for example cracks, otherwise liquids could
penetrate the ultrasound head. In addition, the connecting cable insulation
should be checked for damage. All contacts for the connecting plug must be
intact and present.
The SONIC vital XTcoloR must not be operated if the ultrasound head, the
connecting cable or the connecting plug are defective.