easyTymp® Operating Manual
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7 Safety Regulations
7.1 Electrical safety:
The instrument is not to be used in environments dealing with explosive material
or equipment. The easyTymp® is constructed to comply with protection class I,
Type B 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
7.2 Measurement Safety:
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
7.3 Operation:
The instrument should only be handled and operated by trained personnel (audiologists, ENT
doctors or personnel who have been trained how to properly use the equipment).
7.4 Patient Safety
:
WARNING: Do not test with the device while charging.
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 and the IEC 60601
series for medical electrical equipment). In addition, all such combinations - systems - shall
comply with the standard 60601-1-1, Safety requirements for medical electrical systems.
Equipment not complying with IEC 60601 shall be kept outside patient environment, as
defined in the standard (at least 1.5 m from the patient).
Any person who connects external equipment to signal input, signal output or other
connectors has created a system and is therefore responsible for the system complying with
the requirements of IEC 60601-1-1. If in doubt, contact your service technician or local
representative for help.
