2.3
Purpose – Intended use
2.3.1
General information
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.
This KaVo product is intended for use in dentistry only. Any other type of use is
not permitted.
"Proper use" includes compliance with all instructions for use and the inspection
and maintenance intervals.
The user must ensure that the unit works properly and is in satisfactory condition
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
Note
The product must be cleaned and serviced according to instructions if it is not to
be used for an extended period of time.
Note
Any waste which is generated must be recycled or disposed of in a manner
which is safe both for people and for the environment. This must be done in strict
compliance with all applicable national regulations.
Questions on proper disposal of the KaVo product can be answered by the KaVo
branch.
2.3.2
Product-specific
The DIAGNOcam is designed exclusively to support the identification of open or
incipient carious lesions above the gingiva and for monitoring the progress of
such lesions.
Indications:
▪ Detection of smooth surface caries
▪ Detection of occlusal carries
▪ Detection of proximal caries
▪ Detection of initial caries
▪ Detection of secondary caries
▪ Detection of cracks
Instructions for use DIAGNOcam 2170
2 Safety | 2.3 Purpose – Intended use
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