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Sonostat
5 Maintenance
Functionality, reliability and safety characteristics of the Sonostat are guaranteed
only if the device is handled in accordance with the operating instructions. Safety
control, maintenance work, repair work and modifications must only be carried out
by the manufacturer or by service agents authorized by him. In case of a failure, parts
which influence the safety of the device must only be replaced by original spare parts
of the manufacturer. The electric installation must correspond to the requirements in
accordance with VDE/IEC. The device does not contain any parts which require
maintenance work by the user.
5.1.1 Safety checks
The device is subject to the provisions of the Medical Device Directive. The safety
controls have to be carried out on the basis of this directive. Thereby, the operator
regulation has to be observed in particular.
Irrespective of the legal rules or beyond the scope of the Medical Device Directive, it
is mandatory to have the device checked at 12-months intervals by the manufacturer
or by a maintenance service authorized by him.
The review must consist at least of the following criteria:
Electrical safety check in accordance with the test plan of the manufacturer
Review of the device and the probes in respect of external integrity
Review of all display and operating elements in respect of damages
Review of all inscriptions in respect of immaculate legibility
Review of power cord and all probe connecting cables
Functional check
5.2 Disposal of equipment and accessories
According to the WEEE Directive 2002/96/EG (waste electrical and electronic
equipment) this device must not be disposed of with the domestic waste. The device
must be returned to the manufacturer for disposal. The manufacturer is committed to
guarantee the disposal of all devices marketed. This is also indicated by the WEEE
sign (crossed out waste container).
gbo Medizintechnik AG
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Version 1.2
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