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1.3 Operator population
Operation of this medical device is limited only to certified, capable, and qualified dental
professionals in their regular place of business. The operator must master and comply with the
rules of dental practice in accordance with science and principles of medical hygiene, such as the
cleaning, disinfection, and sterilization of medical devices.
This medical device may be used regardless of the characteristics of the (adult) operator, such as
weight, age, height, sex, and nationality. The operator should wear gloves. The operator must not
be the patient.
Operators should not have:
•
Vision problems, unless wearing a form of vision correction.
•
A disability of the upper limbs (gripping a rotary tool).
•
Hearing problems (use of audible indicators, depending on the device).
•
Memory or concentration problems (settings, sequences, or care protocols, etc.).
Special operator training:
•
No special training other than basic professional training is required to operate this
medical
device.
1.4 Patient population
This medical device is intended for use with the following patient population: children, teenagers,
adults, and senior citizens.
