KaVo 1.008.3500, Инструкция по эксплуатации

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Instructions for use EXPERTsurg LUX – 1.008.3500
3 Description of the product | 3.1 Intended use
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3 Description of the product
3.1 Intended use
NOTE
The EXPERTsurg LUX is approved for use in surgical theatres.
This KaVo product is intended only for use in the field of dentistry, for surgery
to expose and dissect oral tissue structures or endodontic treatments (e.g. peri-
odontal gap, gingiva, bone, jaw, extractions, implantations) and must be used
by expert medical staff only. Any other type of use is not permitted.
"Intended use" also includes compliance with all of the information in the in-
structions for use and ensuring that all inspection and servicing work is per-
formed as scheduled.
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 indications for use must be applied and followed.
The functional safety and proper condition of the device must be checked be-
fore each use of the device.
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.
According to these regulations, the user is required:
▪ to only use equipment that is operating correctly
▪ to comply with the specified intended use
▪ to protect him or herself, the patient and third parties from hazards
▪ to prevent contamination from the product
To guarantee the consistent readiness for use and to preserve the value of the
KaVo product, the recommended maintenance services must be carried out in 2
year intervals.
NOTE
The permitted work is described in the Technician's Instructions available to
the trained service staff.
Operators, equipment managers and users in Germany are obliged to operate
their equipment in compliance with the medical device law ("MPG"). The main-
tenance services encompass all the test tasks required in accordance with § 6
of the operator ordinance ("MPBetreiberV").
After servicing, interventions, and repairs of the device, the device must be
tested according to DIN EN IEC 62353 (according to the state of the art) before
re-use.