KaVo INTRAsurg 300 Instructions For Use Manual page 10

Instructions for use INTRAsurg 300 / INTRAsurg 300 plus
2 Safety | 2.2 Purpose – Proper use
This KaVo product is intended only for use in the field of dentistry, for surgery to
expose and dissect oral tissue structures (such as the periodontal gap, gingiva,
bone, the jaw, extractions and implantations). 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.
The user must ensure that that the unit works properly and is in a satisfactory con‐
dition before each use.
During use, national legal regulations must be observed, in particular:
▪ the applicable health and safety regulations
▪ the applicable accident prevention regulations
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
To guarantee constant readiness for use and maintenance of value of the KaVo
product, the recommended annual servicing must be done.
Yearly safety inspections are required.
KaVo recommends an annual service check. In this service check, the safety checks
are performed according to
The safety check involves the following tests: Visually inspect the medical device
and accessories; check the ratings of fuses that are accessible from outside; pro‐
tective conductor check and leakage current measurements as per IEC
62353:2007; medical device function test with reference to accompanying docu‐
mentation.
Authorized to repair and service the KaVo product:
▪ Technicians with appropriate product training from KaVo branches
▪ Technicians of authorized 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).
After servicing, manipulation or repair of the device, the device must be tested ac‐
cording to IEC 62353:2007 (state of the art) before it is used again.
Check the parameters of the device settings after servicing. Enter the service pa‐
rameters in the table on the last page.
IEC 62353:2007 as well as calibration.
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