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3.7.2 PATIENT POPULATION RESTRICTION
The user is the only person who can decide whether to treat his/her patients.
3.7.3 APPLIED PART(S)
The handpiece, the connexion cable and the connector are considered applied parts within the meaning of international
standard IEC 60601-1.
3.8 BASIC SAFETY AND ESSENTIAL PERFORMANCE
3.8.1 NORMAL CONDITIONS OF USE
The normal conditions of use the cameras are the following:
• Storage
• Installation
• Use
• Maintenance
• Disposal
3.8.2 ESSENTIAL PERFORMANCE
Within the meaning of the applicable electromedical device safety standard, the manufacturer has determined that none of
the functions of the cameras are essential performance.
A lack of performance such as loss of image does not lead to unacceptable risk, because the procedure can be continued either
by changing the camera or by direct observation with the naked eye assisted by a mirror.
A degradation of performance such as an erroneous image does not entail an unacceptable risk because the analysis of the
image lies in the responsibility of the dental practitioner and his or her clinical judgment, experience, and training. The device
solely functions as an aid to visualization. In case of non-performance, the clinical procedure can be continued either by
exchanging the camera for another one or by direct observation using a dental inspection mirror.
3.9 LIFETIME
• The dental cameras and docking stations lifetime are 7 years.
• SOPROTIPS and C50TIPS lifetime are 50 steam sterilization cycles.
• The protective sheaths are single-use devices.
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