13 Safety Regulations
Consult operating instructions before using this device.
13.1 Electrical Safety
The MA 41 audiometer is a B patient applied part according to
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. It is
recommended that you use this device in an electrostatically
controlled environment. To avoid the risk of electric shock, this
equipment must only be connected to supply mains with protective
earth.
13.2 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, warranties may
be void if these checks are not done.
The use of non-calibrated audiometers can lead to incorrect test results and is
not advisable.
13.3 Device Control
The user of the instrument should perform a subjective instrument check once
a week.
13.4 Operation
The instrument should only be handled and operated by trained personnel
(audiologists, ENT doctors or personnel with similar qualifications).
To Next Page
Loading...
