Operating Instructions MI 34 / MI 34 H
GEBAmi34e.11a.docx
53
850 232/14 08/11
17 Safety Regulations
17.1 Electrical Safety:
The MI 34 tympanometer is constructed to
comply with protection class I, Type BF of the
international standard IEC 601-1
(EN 60601-1) .
Protection from an electric shock is ensured
even without the system earth connection.
The instruments are not intended for
operation in areas with an explosion hazard.
17.2 Measuring security:
To guarantee that the tympanometer
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 centre. 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 tympanometers is
not allowed.
17.3 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 page 55). For
your own security, you should copy the
enclosed list, fill it in once a week and store it
in your files.
17.4 Operation:
Only skilled personnel (Audiologists, ENT
professionals or other with equivalent
knowledge) should operate the instrument.
17.5 Patient Safety:
Warning: Do not take a test while charging
the device via USB cable.
External equipment intended for connection
to signal input, signal output or other
connector, shall comply with relevant IEC
standard (e.g. IEC 60950 for IT equipment
