KaVo Globus 1078 S, Инструкция по эксплуатации

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for dental purposes only and should only be used by medical professionals. The
product may not be used for a purpose for which it was not intended.
"Proper use" includes following all the instructions for use and ensuring that all in‐
spections 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 are to be applied and complied with.
Responsibility is accepted for the safety, reliability and performance of the compo‐
nents supplied by KaVo provided:
▪ installation, expansions, adjustments, changes or repairs are carried out by
technicians trained by KaVo or third parties authorised by KaVo, or by the per‐
sonnel of authorised distributors.
▪ The device must be operated in accordance with the instructions for use, care
and installation.
▪ The IT components supplied by the operator meet the technical requirements in
these instruction for use for hardware and software, and they are installed and
set up according to the descriptions of these components.
▪ During maintenance, observe all the requirements of VDE 0751-1, "Repeated
tests and test before startup of electronic medical devices and systems - general
guidelines".
Users have a duty to:
▪ Only use equipment that is operating correctly
▪ to protect himself, the patient and third parties from danger.
▪ to avoid contamination from the product
During use, national legal regulations must be observed, in particular:
▪ the applicable health and safety regulations
▪ the applicable accident prevention regulations
To guarantee constant readiness for use and maintenance of value of the KaVo
product, the recommended annual servicing must be done.
The safety checks (SC) must be done at 2-year intervals.
Authorized to repair and service the KaVo product:
▪ Technicians from KaVo branches with appropriate product training
▪ Technicians of authorised dealers specially trained by KaVo
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,
MPBetreibV).
Note
The product must be cleaned and serviced according to instructions if it is not to
be used for a long period.
Note
Only those accessories may be used that are approved for the device.
Instructions for use Globus 1078 S
2 Safety | 2.2 Purpose – Proper use
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