14
OPERATOR'S MANUAL
EN
1.8. SAFETY WARNINGS
1.8.1. CONDITIONS OF USE
In order to use the device in safe conditions, refer to the following paragraphs in the manual.
1.8.2. GENERAL SAFETY
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Before leaving the surgery, deactivate the main switch of the device.
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The device is not protected against liquid penetration (Class IPX0 – common protection).
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The device is not suitable for use in the presence of a mixture of flammable anaesthetic gas with oxygen or nitrous
oxide.
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Portable telecommunications devices (RF) may interfere with the X-ray device; use in the vicinity of the X-ray
device should therefore be prohibited.
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The device must be looked after and kept in perfect efficiency.
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The device must never be left unattended when it is on or ready to start, in particular in the presence of minors or
in general persons not authorised for its use.
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The manufacturer declines all responsibility (civil and penal) for any abuse, negligence or improper use of the
device.
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Unauthorised technicians that modify the device replacing parts or components with others different from those
used by the manufacturer assume the same responsibility as the manufacturer.
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Computers, monitors, printers, mice, keyboards and other devices connected to the X-ray device must be in
compliance with the ISO, IEC and EN standards or the respective local regulations.
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The manufacturer is not responsible for problems or malfunctions of parts or components not approved by the
manufacturer and not in compliance with the standards installed by qualified technicians acknowledged by the
manufacturer.
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Do not use electronic devices that do not comply with IEC 60601-1-2:2007 in proximity of life-support equipment
(e.g. pacemakers or heart stimulators) and hearing aids. Before using any electronic device in health facilities,
always check that it is compatible with the other equipment present.
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The X-ray tube contains insulating mineral oil. This oil is potentially hazardous if ingested or if it comes into contact
with the skin or mucous membranes. In the event of a defect or fault, the oil may leak out. Avoid direct contact with
the oil and do not inhale the vapours.
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Do not eat, drink or smoke near the device.
1.8.3. SAFETY DURING X-RAY DEVICE MOVEMENTS
The X-ray device carries out movements in the vicinity of the patient and the operator.
During the execution of the X-rays, the operator controls the movements by holding down dedicated buttons.
The reset procedure must be carried out before the patient accesses the device.
The operator must stand at a suitable distance from the moving parts. Movements can be stopped at any time
by pressing the emergency button.
During all the movements of the X-ray device, the operator must:
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closely watch over the patient, and if there is a risk of collision between the X-ray device and the patient,
immediately interrupt the movement by releasing the control button;
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not allow the patient to assume incorrect positions (resting the hands or other parts of the body in inappropriate
areas) or to move away from the examination area.
The operator must be careful not to interfere with the sensor movement during its servo-controlled activation.
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