Maico MA 27 Operation Manual page 39

Operation Manual MA 27 / MA 27e
Essential Performance
To generate and present stimulus signals in the audio range as
specified in the applicable IEC 60645 series in normal
conditions.
Absence of these performance features can lead to failure in
diagnosis which is considered as an unacceptable risk to the
patient. Temporary loss of essential performance is not
considered an acceptable risk as long as the loss of performance
is detectable. This could be the loss of power, fuse blow of
system halt with error message.
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