System Overview; Indications For Use; Principles Of Operation; Intended User Profile - VATECH EzRay Air Portable Manuel D'utilisation

3.

System Overview

The device, a portable dental X-ray system, operates on 21.6 V
rechargeable Li-ion polymer battery pack. The portable X-ray system is an X-ray
generating device that is mainly designed for dental examination (teeth and jaw). The
portable X-ray system is composed of an X-ray generating part with an X-ray tube
including a device controller, a power controller, a user interface, a beam limiting part,
a backscatter shield, and an optional Remote Exposure Switch. The device is
designed to diagnose teeth and jaw through X-ray exposure using intra-oral image
receptors.
3.1

Indications for Use

EzRay Air Portable (Model: VEX-P300) is an extraoral diagnostic dental X-ray source
to produce X-ray images using intraoral image receptors. It is indicated for use by a
dentist or a dental technician for both adult and pediatric patients.
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 device
acquires images by emitting X-rays continuously on the human tooth.
3.3

Intended User Profile

Considerations
Education
Knowledge
Language
understanding
Experience
EzRay Air Portable (Model: VEX-P300) 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
supplied by a
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