KaVo ESTETICA E30 Instructions For Use Manual page 11

The KaVo ESTETICA E30 equipment system is a dental treatment centre in ac-
cordance 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 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 these instruction for use for hardware and software, and they are
installed and set up according to the descriptions of these components.
▪ in the case of repairs, the requirements of IEC 62353 (DIN VDE 0751-1)
"Repeat tests and tests before start-up of electrical items of medical equip-
ment 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 start-up of medical
devices.
▪ Current occupational safety regulations.
▪ Current accident prevention regulations.
Regular performance of maintenance and safety checks is essential for the per-
manent assurance of the operating and functional safety of the KaVo product
and for the prevention of damage and hazards.
Testing and maintenance intervals: Maintenance must be performed once a
year, the safety check (STK) at intervals of 2 years. Shorter intervals for the
safety check may be specified by the tester if necessary.
The following persons are authorised to repair and service 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).
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Instructions for use ESTETICA E30
2 Safety | 2.2 Purpose – Proper use