Essential Performance; Indications For Use - KaVo DEXIS Titanium Manuel De L'utilisateur

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1.2

Essential Performance

The essential performance of the DEXIS Titanium sensor systems compris-
es:
• The ability of the sensor to capture X-ray images suitable for recognition
of normal anatomical structures, dental pathologies, and abnormal con-
ditions, where inadequate images may result in misdiagnosis, subject-
ing the patient to incorrect or unnecessary dental procedures that would
present an unacceptable risk to the patient;
• The ability of the sensor holder to align the sensor with the X-ray source
for imaging the desired anatomy.
• The ability of the single use sensor sheaths to isolate the sensor from the
patient, where cross-contamination could present an unacceptable risk
to the patient.
1.3

Indications for Use

The DEXIS sensor is a USB-driven digital sensor which is intended to ac-
quire dental intra-oral radiographic images. The DEXIS sensor shall be op-
erated by healthcare professionals, who are educated and competent to
perform the acquisition of dental intra-oral radiographs.
The DEXIS sensor can be used either in combination with special position-
ing devices to facilitate positioning and alignment with the x-ray beam or it
may also be positioned by hand with the assistance of the patient.
WARNING
Take the necessary steps to protect yourself from radiation. For
proper operator positioning, refer to the 'Instructions for Use' of
your intraoral X-ray equipment.
WARNING
Under no circumstances should the dental professional hold the
sensor by hand during X-ray exposure.
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