System Overview; Indications For Use; Principles Of Operation; Intended User Profile - Vatech EzRay Chair User Manual

3.

System Overview

The EQUIPMENT is an intra-oral dental X-ray system intended for intra-oral imaging. It
consists of an X-ray generator, X-ray controller, beam limiting device, an operation
panel, and a mechanical arm. The X-ray controller allows for accurate exposure
control, and the adjustable mechanical arm allows for easy positioning. The system
can be used with an imaging system.
3.1

Indications for Use

The EQUIPMENT is a dental X-ray system (extra-oral X-ray source system) intended
for use by a trained and qualified dentist or dental technician for both adult and
pediatric subjects for producing diagnostic dental radiographs for treatment of
diseases of the teeth, jaw, and other oral structures using intra-oral image receptors.
3.2

Principles of Operation

X-rays are emitted when a high voltage is supplied to the X-ray tube assembly which
frees electrons from the cathode. They hit anode to produce X-rays. The equipment
acquires images by emitting X-rays continuously on the human tooth.
3.3

Intended User Profile

Considerations
Education
Knowledge
Language
understanding
Experience
EzRay Chair (VEX-S300C) User Manual
Requirement Description
A licensed dentist or dental hygiene, radiologist and
graduates of relevant bachelor's degree (national
qualifications)
The operator must have understood:
treatment and diagnosis of dental disease

terms and guidance of diagnostic medical

radiation devices
device connection, installation and operating

conditions.
The operator must have understood:
the English or Korean manuals (or other

languages provided).
The operator must have understood:
objectives and effects of treatment and diagnosis

of dental disease using diagnostic medical
radiation devices
normal operation of diagnostic medical radiation

devices
the contents of the user manual.

3. System Overview
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