Chapter
1
This User Manual contains original instructions by Dental Imaging Technologies
Corporation for safe set-up, use and maintenance of the DEXIS sensor. The user
must be able to read and understand the written language of the manual.
It also contains technical specifications of the system and basic information on how
the system works.
Please read this manual carefully before starting to use the device, paying particular
attention to warnings, especially safety warnings. Operators are strongly urged to
comply with the current recommendations of the International Commission on
Radiological Protection and, in the United States, the US National Council for
Radiological Protection.
Essential Performance
WARNING
In the event of a sensor malfunction or a noticeable change in image
quality, it is recommended to immediately cease the use of the device
on the patient and call Technical Support at 1-888-883-3947.
WARNING
No modification of this equipment is allowed.
The essential performance of the DEXIS sensor system comprises:
•
The ability of the sensor to capture X-ray images suitable for
recognition of normal anatomical structures, dental pathologies,
and abnormal conditions, where inadequate images may result in
mis-diagnosis, subjecting 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.
English
Introduction
1-1