Safety Regulations; Electrical Safety; Measurement Safety; Operation - Maico easyTymp Operating Manual

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easyTymp® Operating Manual

7 Safety Regulations

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

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

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).

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.

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