1.8.7. PROTECTION AGAINST RADIATION
This system is an X-ray equipment. As such, it exposes patients and operators to risks from radiation. It must
be used in compliance with the safety standards set forth by the radiological protection regulation in force in
the country of use. Following are some of the provisions:
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Control the emission of X-rays exclusively from the control workstation, the exam room must be suitably
shielded (if required by the local regulations in force).
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Make sure that the doors of the X-ray room are closed before starting the exam.
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During the emission, only the patient should stay in the exam room. If it is necessary for the operator to
remain during the exam (e.g. when the patient is not self-sufficient and requires assistance), he/she must
wear protective equipment against scattered radiation and, in any case, no parts of his/her body should
ever be exposed to direct X-ray emission.
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During the system's initialisation procedure, nobody is allowed in the exam room and its doors must
remain closed. Authorised personnel must always be present outside the room until the projection is
completed.
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Pay attention not to release the emission button too soon. Please note that during an exposure cycle,
radiation can be emitted several times. Wait for the exposure cycle to be completed.
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Always observe the following points:
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Stay at least 2 metres away from the X-ray source during exposure. For installations in Canada, the
minimum distance is 3 metres.
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All persons that are not directly involved with the patient should stay outside the exam room, or behind
a lead or lead glass shielding during exposure.
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Make sure that the operator is able to communicate with the patient both verbally and visually.
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If required, use a dosimeter for personal monitoring.
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Full use must be made of all radiation protection devices, accessories, and procedures available to protect
the patient and operator from X-ray radiation, especially for child.
1.8.8. APPLIED PARTS
The parts that, during standard use, necessarily come into contact with the patient, so that the device may carry out its
functions correctly, are: chinrest, bite piece and hygienic protections, craniostat and handles.
The non-applied parts that may come into contact with patient are the external covers and the patient arm.
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Patients may not be assisted by pregnant women or minors
OPERATOR'S MANUAL
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