Operation Manual MA 42
8100460 Rev.7 Ver.1
61
12/15
13.
Safety Regulations
READ THIS ENTIRE MANUAL BEFORE ATTEMPTING TO USE THIS
SYSTEM.
Electrical Safety
The MA 42 audiometer is constructed to comply with protection
class I of the international standard IEC 60601-1 (EN 60601-1).
The instruments are not intended for operation in areas with an
explosion hazard.
Electrostatic discharge (ESD) according to IEC 61000-4-2. Use the
device only in an electrostatic controlled environment. To avoid
the risk of electric shock, this equipment must only be connected
to supply mains with protective earth.
Measuring Security
To guarantee that the audiometer works properly, the instrument has to be
checked and calibrated at least once a year.
The service and calibration must be performed by an authorized service
center. In accordance with the regulations of the EU medical directive we will
drop our liability if these checks are not done.
The use of non-calibrated audiometers is not allowed.
Device Control
The user of the instrument should perform a subjective instrument check once
a week. This check can be done following the list for subjective instrument
check (see Appendix A). For your own security, you should copy the enclosed
list, fill it in once a week and store it in your files.
Operation
The instrument should only be handled and operated by trained personnel
(audiologists, ENT doctors, or personnel with similar qualifications).
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