Description Of The Product; Intended Use - KaVo MASTERsurg LUX Wireless Instructions For Use Manual

3 Description of the product

3.1 Intended use

Note
The MASTERsurg LUX Wireless is approved for use in surgical theatres.
This KaVo product is intended only for use in the field of dentistry, for surgery to ex-
pose and dissect oral tissue structures or endodontic treatments (e.g. periodontal gap,
gingiva, bone, jaw, extractions, implantations) and must be used by expert medical
staff only. 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.
The user must ensure that the unit works properly and is in satisfactory condition be-
fore each use.
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.
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
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 inter-
vals.
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.
Note
The permitted work is described in the Technician's Instructions available to the
trained service staff.
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 med-
ical devices operator ordinance (Medizinprodukte-Betreiberverordnung, MPBetreibV).
After servicing, interventions, and repairs of the device, the device must be tested ac-
cording to IEC 62353 (according to the state of the art) before re-use.
Instructions for use MASTERsurg LUX Wireless REF 1.009.1200
3 Description of the product | 3.1 Intended use
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