Maico MA 53, Руководство по эксплуатации

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Operating Instructions MA 53
Geba_MA53_e_13a.doc 52 851 430/3 11/11
14 Safety Regulations
14.1 Electrical Safety:
The MA 52 audiometer is constructed to comply with protection
class II 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.
14.2 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 we will
drop our liability if these checks are not done.
The use of non-calibrated audiometers is not allowed.
14.3 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 next page). For your own security, you should copy the enclosed
list, fill it in once a week and store it in your files.
14.4 Operation:
Only skilled personnel (Audiologists, ENT professionals or other with
equivalent knowledge) should operate the instrument.
14.5 Patient Safety:
Please note that if connection is made to standard equipment like printers and
network, special precautions must be taken in order to maintain medical
safety. Connecting this device to other devices in order to make a system may
cause the safety specifications to be invalid. It is therefore recommended to
insert a galvanic separation between the device and the host computer, unless
the computer is battery operated or supplied by a medical approved power
supply. Galvanic separation must fulfill the EN 60 601-1.