3. System Overview
EzRay Air Portable (Model: VEX-P300) User Manual 15
ENGLISH
3. System Overview
The device, a portable dental X-ray system, operates on 21.6 V
dc
supplied by a
rechargeable Li-ion battery pack. The portable X-ray system is an X-ray generating
device 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 Requirement Description
Education
A licensed dentist or dental hygiene, radiologist, and
graduates of relevant bachelor’s degree (national
qualifications)
Knowledge
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.
Language
understanding
The operator must have understood:
the English or Korean manuals (or other languages
provided).
Experience
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.
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