KaVo KaVo Primus 1058 Life TM, Инструкция по эксплуатации

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Instructions for use Primus 1058 Life
2 Safety | 2.2 Purpose – Proper use
"Proper use" includes compliance with all information in the Instructions for Use
and ensuring that all inspections and service tasks are performed.
The KaVo service table 1568 is an accessory of KaVo treatment centres that do
not feature a dentist element mounted to the unit. The KaVo Service table 1568
serves as a support surface for the dentist during the treatment. The service
table 1568 can be used as a support for trays and for attachment of the X-ray
viewer 1440. The mobile support system allows the KaVo Service table 1568 to
be moved to the proper position.
The overarching guidelines and/or national laws, national regulations and the
rules of technology applicable to medical devices for start-up and use of the
KaVo product for the intended purpose must be applied and followed.
KaVo accepts liability for the safety, reliability, and performance of components
supplied by KaVo, provided:
▪ installation, instructions, expansions, adjustments, changes or repairs were
carried out by technicians trained by KaVo or third parties authorised by
KaVo, or by the personnel of authorised distributors.
▪ the unit was operated in accordance with the instructions for use, care and
installation.
▪ the IT components supplied by the operator meet the technical require-
ments in the present instruction for use for hardware and software, and are
installed and set up according to the descriptions of these components.
▪ in the case of repairs, the requirements of IEC 62353 "Recurrent tests and
tests before start-up of electrical items of medical electrical equipment and
systems - general regulations" are met in full.
It is a responsibility of the user:
▪ to only use equipment that is operating correctly,
▪ to protect him or herself, the patient and third parties from hazards, and
▪ to prevent contamination from the product
The applicable national legal regulations must be observed during the use of the
device, in particular the following:
▪ Applicable regulations governing the connection and startup of medical
devices.
▪ Current occupational safety regulations.
▪ Current accident prevention regulations.
Regular servicing and safety checks are essential for the permanent assurance
of the operating and functional safety of the KaVo product and for the preven-
tion of damage and hazards.
Testing and maintenance intervals: Maintenance must be performed once a
year, the safety checks at intervals of 2 years. Shorter intervals for the safety
checks may be specified by the tester if necessary.
The following persons are authorised to conduct repairs and servicing and the
safety check on the KaVo product:
▪ Technicians of KaVo branch offices after appropriate product training.
▪ Specifically KaVo-trained technicians of KaVo franchised dealers.
In Germany, operators, equipment managers and users are obliged to operate
their equipment in accordance with the MPG regulations.
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