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1.7.1. INSTALLATION CONDITIONS
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The system must not be used if it shows any electrical, mechanical or radiation defect. Like for all medical electrical
systems, this device requires proper installation, use, maintenance and service with the aim of assuring safe and
efficient operation.
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The entire system must be installed by a technician authorised by the Manufacturer under supervision of a Qualified
Expert.
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The room where the system is installed must exclusively be for medical use and designed by an expert in protection
against the risks associated with exposure to radiation in accordance with the regulations in force in the country of
use.
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For Europe, the electric system in the room where the device is installed must be in conformity with the IEC 60364-
7-710 standards (requirements for electric systems in rooms used for medical purposes).
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The X-ray system requires special precautions with respect to electromagnetic compliance and must be installed
in accordance with the recommendations given in the paragraph "Electromagnetic safety" in this manual.
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The maximum dimensions reached while the unit is being handled must be taken into consideration to avoid
banging into any objects present in the room. Refer to the dimensional diagram in the service manual.
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The installation must allow audio-visual communication between the operator and the patient during execution of
the examination.
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The system can be installed in the following configurations:
1. wall mounting;
2. on the floor surface with a static baseplate (optional).
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Installation not in compliance with the instructions provided by the manufacturer might cause increased
electromagnetic emission of the X-ray system and reduce its immunity to disturbances.
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In particular, use a screened cable for connection of the X-ray remote control and make the connection as specified
in the technical manual.
For further details, refer to the installation template and the detailed instructions given in the service manual.
1.7.2. CONDITIONS OF USE
The device should exclusively be used by suitably trained and authorised persons (dentists and paramedics).
For installations in CANADA, make sure you comply with the following indications from Health Canada.
(a) 3D imaging should not be used for `routine' screening (or 'screening') examinations. 3D imaging
examinations must be indicated by the patient's clinical needs. Each exam must be justified by demonstrating
that the benefits outweigh the risks.
(b) The use of lead aprons with thyroid collars for patients is required.
(c) Prior to imaging, women of childbearing age should be asked if they are pregnant or possibly pregnant. If
so, the patient should not undergo the exam unless an accredited radiologist from a hospital setting has been
consulted to discuss, with the patient and operator, the benefits and risks associated with this type of
procedure along with other possible exam types.
(d) The operator should be protected by distance and shielding and should only be in the exam room close to
the patient on those rare occasions when the patient requires assistance. If the operator is required to remain
in the exam room, he or she must be protected with a lead apron with a thyroid collar.
In case of claims or need of technical assistance, users in Brazil are required to contact the following email
address: servico.odontologico@cefla.it
EN
OPERATOR'S MANUAL
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