3 Foreword
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3. Foreword
3.1 Scope of application
The HyperLight Hand-held Dental X-ray System is indicated for use only
by a trained and qualified dentist or dental technician for both adult and
pediatric subjects as an extraoral diagnostic dental X-ray source to produce
X-ray images using intraoral image receptors.
This device must only be used in hospital environments, clinics or dental
offices by trained and qualified dental personnel and not used in the oxygen-
rich environment.
3.2 Contraindications
The device is designed for use with patients of any overall health status,
as solely determined by the practitioner, with the following considerations for
specific circumstances:
•
Pregnant women. The medical practitioner must weigh the benefits
conferred by use of the device against the potential hazard to the pregnant
woman and fetus resulting from radiation exposure. If use of the device is
considered justified, the practitioner must take the appropriate precautions,
such as use of radiation safety garments, to limit radiation exposure beyond
the maxillofacial complex.
•
Pediatric. The medical practitioner must weigh the benefits conferred
by use of the device against the potential hazard to the child resulting from
radiation exposure, considering the maturity of the child’s physical
development. If use of the device is considered justified, the practitioner
must take the appropriate precautions, such as use of radiation safety
garments, to limit radiation exposure beyond the maxillofacial complex.
•
Patients with medical conditions causing involuntary movements. For
patients who experience seizures or who have been diagnosed with
conditions such as Parkinson’s Disease which can cause difficulty in
controlling physical movements, the medical practitioner must weigh the
benefits conferred by use of the device against the potential hazard to the
patient resulting from additional radiation exposure due to a re-scan in the
event that an involuntary movement renders an image unusable for
diagnostic purposes.
