KaVo 0.622.5000, Instructions For Use Manual

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Instructions for use ARCUSevo - 1.005.0900 / ARCUS - 0.622.5000
2 Safety | 2.2 Intended use
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"Proper use" includes compliance with all instructions for use and the inspection
and maintenance intervals.
The overarching guidelines and/or national laws, national regulations and the
rules of technology applicable to medical devices for startup and use of the
KaVo product for the intended indications for use 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, servicing
and assembly.
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.
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.
The services encompass all the test tasks required in accordance with § 6 of the
medical devices operator ordinance (Medizinprodukte-Betreiberverordnung, MP-
BetreibV).
Note
The product must be reprocessed and serviced according to instructions be-
fore and after extended period of time in which it is not used. Only use hy-
gienic perfect products on the patient!
Note
Only accessories licensed for use with this machine may be used.
Note
All components contacting the patient's mucous membranes must be steril-
ised before the initial start-up.