Myray hyperion X9, Operator'S Manual

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EN OPERATOR'S MANUAL
9
1.7.1. INSTALLATION CONDITIONS
- 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.
- The entire system must be installed by a technician authorised by the Manufacturer under supervision of a Qualified
Expert.
- 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.
- 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).
- 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.
- 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.
- The installation must allow audio-visual communication between the operator and the patient during execution of
the examination.
- The system can be installed in the following configurations:
1. wall mounting;
2. on the floor surface with a static baseplate (optional).
- 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.
- 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).
Use in compliance with national regulations for protection against ionising radiation, e.g.:
(a) Three-dimensional imaging must not be used for routine screening exams. Three-dimensional imaging
exams must be prescribed according to the patient's needs.
(b) Each exam must be justified by evidence that the benefits outweigh the risks.
(c) All patients must wear leaded aprons with thyroid collar.
(d) Before the exam, ask women of reproductive age if they are pregnant or if there is any possibility that they
might be. If there is, the patient should not undergo the exam, unless a radiologist from a trustworthy hospital
is consulted in order to evaluate, together with the patient and the operator, the benefits and the risks
associated with this procedure, taking into account the possibility of choosing a different kind of exam.
(e) The operator must keep a safe distance, protect him/herself with an adequate shielding and remain close
to the patient in the exam room only if the patient needs assistance. If the operator has to remain in the exam
room, he/she must wear a leaded apron with thyroid collar.
(f) Inform the patient about the risks associated with the exam, acquire his/her informed consent and archive
the document.
In case of claims or need of technical assistance, users in Brazil are required to contact the following email
address: servico.odontologico@cefla.it.
Users in the USA market are required to contact:
Cefla North America Inc.,
6125 Harris Technology Blvd., Charlotte, NC, 28269 United States
Phone: +1 704 598 0020, e-mail: info@ceflaamerica.com