KaVo ESTETICA E50 Life, Инструкция по эксплуатации

Страница: 13 / 162

Instructions for use ESTETICA E50 Life
2 Safety | 2.2 Intended use
The KaVo ESTETICA E50 Life equipment system is a dental treatment centre in
accordance with ISO 7494 equipped with a patient chair in accordance with ISO
6875. This KaVo product is designed for use in dentistry only and may only be
used by trained medical personnel. Any other type of use is not permitted.
"Proper use" includes compliance with all information in the Instructions for Use
and ensuring that all inspections and service tasks are performed.
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, 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.
13 / 162