Instructions for use DIAGNOcam 2170 U
2 Safety | 2.3 Purpose – Intended use
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2.3 Purpose – Intended use
2.3.1 General
The overarching guidelines and/or national laws, national regulations and the
rules of technology applicable to medical devices for startup and use of the
KaVo product for the intended indications for use 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 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.
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
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 strict com-
pliance with all applicable national regulations in a manner which is safe both
for people and the environment.
If you have any questions regarding proper disposal of the KaVo product,
please contact the KaVo branch.
2.3.2 Product-specific
The DIAGNOcam 2170 is a diagnostic aid for the detection of open or incipient
carious lesions above the gingiva and for monitoring the progress of such le-
sions.
Indications:
▪ Detection of smooth surface caries
▪ Detection of occlusal carries
▪ Detection of proximal caries
▪ Detection of initial caries
▪ Detection of secondary caries
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