Fona XPan 3D Plus, Руководство по эксплуатации

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Operating Instructions
6
Safety measures during switch-on Following extreme temperature fluctuations, condensate formation may
occur; therefore please do not switch on the device until normal room
temperature has been reached (see chapter 7.1, Preparing for exposure).
Electromagnetic Compatibility This unit may be operated in a residential/hospital area, provided it is
used under the responsibility of a trained medical operator, and following
the recommendations reported in chapter 13, Electromagnetic
Compatibility.
FONA XPan 3D Plus needs special precautions regarding EMC, and
needs to be installed and put into service according to the EMC
information provided in Chapter 13.
Portable and mobile Radio Frequency communications equipment can
affect medical electrical equipment like FONA XPan 3D Plus.
The use of accessories and cables other than those provided, with the
exception of accessories and cables sold by the FONA as replacement
parts for internal components, may result in increased emissions or
decreased immunity of the device.
FONA XPan 3D Plus should not be used adjacent to or stacked with
other equipment; if adjacent or stacked use is necessary, FONA XPan 3D
Plus. should be observed to verify normal operation in the configuration in
which it will be used.
Interference with medical devices
by radio telephones To guarantee the operational safety of medical devices, it is
recommended that the operation of mobile radio telephones in the
medical practice or hospital is prohibited.
Malfunction of electronic units/
devices which are worn on the
patient's body In order to prevent failure of electronic units and data storage devices,
e.g. radio-controlled watch and telephone card, etc., it is essential that
these be removed prior to X-ray exposure.
Laser light localizers used This product incorporates Class 1 lasers as light localizers for the
positioning of the patient. They must not be used for other purposes. A
minimum distance of 100 mm must be maintained between the eye and
the laser. Avoid unnecessary exposure of the eyes and pay attention that
the beams are not intercepted by any optical device.
Electrical safety Trained and qualified technicians only are authorized to remove covers
and have access to power circuits.
Power supply lines must comply with safety legislation and have ground
terminals for protective earth connection.
Explosion This unit cannot be used in presence of flammable gases or vapours.
Radiation protection guidelines X-ray equipment produces ionizing radiation that may be harmful if not
properly controlled. It is therefore recommended that the equipment be
operated by trained personnel only, in accordance with existing law.
Exposure to ionizing radiation is of particular concern in pediatric
patients. It is thus recommended to follow the specific pediatric protocol
available on the unit. Refer also to the Image Gently in Dentistry
Campaign
materials (http://www.imagegently.org/Roles-What-can-I-
do/Parent/Dentist) for best practices in pediatric X-ray imaging.
Observe the applicable health physics regulations. The radiation
protection facilities should be used.
The operator should remain as far away from the X-ray tube as the cable
of the release button permits (in the designated significant zone of
occupancy for the operator).
With the exception of the patient, no other persons may remain in the
room while the exposure is being made. Under exceptional
circumstances a third person, however not belonging to the dental
practice, may then assist.
Maintain visual contact with the patient and the unit during the exposure
and in case of faulty operation, immediately discontinue the exposure by
releasing the X-ray button.