General safety information
Page 8 of 34
1.3 Manufacturer's responsibility
The manufacturer may only be regarded as responsible for the safety,
reliability and suitability for use of the devices if:
• Assembly, expansions, resetting, changes or repairs are performed by
individuals authorised by the manufacturer.
• The electrical installation in the room in question complies with the
relevant requirements and regulations (e.g. VDE 0100, VDE 0107 or IEC
specifications).
• The devices are used in accordance with the instructions for use and the
country-specific regulations and national deviations are observed.
• The conditions stated in the technical data are observed.
Any other use exept those described in the operating instruction is not intended and will result
in an exclusion of warranty and liability
The manufacturer undertakes to accept old devices as per the German Electrical and
Electronic Device Act (ElektroG).
1.4 Operator's obligation to exercise diligence
The operator is responsible for the proper operation of the medical device. In line with the
German Medical Device Operator Ordinance (MPBetreibV), the user must perform a wide
range of duties and also assume responsibility when handling medical devices within the
framework of his activities. Only qualified personnel may operate the Vibrasat
®
Pro .
Whenever the Vibrasat
®
Pro is handled and used, precise knowledge and compliance with
these instructions for use is necessary. The devices may only be operated by persons with
the necessary training or knowledge and experience.
The devices are subject to special precautionary measures with respect to
electromagnetic compatibility (EMC) and must be installed and operated in
accordance with the EMC guidelines.
If one of the devices no longer works properly due to a malfunction, the
device must not be used any further and must be inspected by the technical
service.
Performance and safety may be impaired if Original Equipment Manufacturer device parts
are not used.
All work that requires tools must be performed by the manufacturer's technical service or
parties authorised by the latter.
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