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USER MANUAL • Owandy-RX AC • 2/2020 • NXACEN160A
User Manual – Owandy-RX AC
CAUTION
PROTECTION AGAINST RADIATIONS
“The general principles regarding safety and protection of workers and people” must always be applied when using the unit:
1. Justifi cation of the practice
2. Protection Optimisation
3. Reduction of the limits of individual dose and risks
The Owandy-RX AC is a medical device that generates X-rays; therefore, both the patients and the operator are exposed to risks due to ionizing
radiation. The physician must assess the actual need for X-ray exposure.
All personnel present during an X-ray examination must comply with safety regulations concerning protection against radiation. For their own
safety, the operator must always keep a distance of more than 2 meters (6 ft.) and out of the path of the X-ray beam, in order to avoid the exposi-
tion to the stray radiation.
The Owandy-RX AC medical device must be used in compliance with the local standards in force and with the international directives concerning
radiation protection.
The device must comply with the guidelines and indications provided by an accredited specialist in radiation protection, who will recommend, if
necessary, additional shields or precautions for every specifi c case.
The device installation site must be shielded in compliance with the local standards in force to protect the operator, patient and other people
against X-rays.
The Owandy-RX AC device is intended to be used solely by surgeons, dentists and qualifi ed and authorized physicians. The operator must:
- determine, when appropriate, the possible need for sedation and the related operating methods and appropriate precautions for the patient
- supervise the entire X-ray examination procedure, paying attention to the indications and information from the unit.
The device must be used only for diagnostic purposes by qualifi ed and authorized dentists and/or physicians.
The operator and other personnel must keep clear from the patient during the scan.
The personnel involved in the radiographic examination must take all the safety measures concerning radiation protection.
It is the operator’s responsibility to protect the patient against unnecessary or excessive radiation doses.
Additional protection devices (aprons, collars, etc) are required to protect the patient from radiation.
Before exposing patients with pacemakers, contact the manufacturer of the latter to ensure that the X-rays generated by Owandy-RX AC do not
interfere with its functionality.
Owandy-RX AC generates X-rays: before using this X-ray system please refer to the regulation in force in your area concerning paediatric
patients, pregnant women and anyone with health issues that contraindicate the use of X-rays. Investigate and make sure of this condition before
starting the exposure.
This symbol indicates X-ray hazard.
