14
gbo Medizintechnik
AG 2009
Version 1.0
3 Maintenance
Functionality, reliability and safety characteristics of the
Stereodynator
are guaranteed only upon
handling the device 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 need maintenance work done by the user.
3.1 Safety
Controls
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
recommended to have the device checked by the manufacturer or by a service agency authorized by
him at 12- months intervals.
The check shall consist of at least the following criteria:
•
Electrical safety check in accordance with the test plan of the manufacturer.
•
Check of the device in respect of external integrity.
•
Check of all display and operating elements in respect of damages.
•
Check of all inscriptions in respect of legibility.
