Chapter 1 - Introduction; Essential Performance; Intended Use Of The Device - GENDEX GX S-700 Manual Del Usuario

Chapter
1
This User Manual contains original instructions by Gendex Dental Systems for safe set-up, use
and maintenance of the Gendex GXS-700. 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
No modification of this equipment is allowed.
The essential performance of the Gendex GXS-700 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 misdiagnosis, 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, where inadequate alignment may result in
repeated X-ray exposures, subjecting the patient to additional ionizing
radiation that would present an unacceptable risk to the patient;
•
The ability of the single use sensor sheaths must be used to isolate the
sensor from the patient, where cross-contamination would present an
unacceptable risk to the patient.

Intended Use of the Device

The GXS-700 is a USB-driven digital sensor which is intended to acquire patient
dental intraoral radiography images. The GXS-700 shall be operated by healthcare
professionals, who are educated and competent to perform the acquisition of dental
intraoral radiographs. Specific educational requirements are determined by state and/
English
Introduction
1-1