Safety Guidelines; Operating Conditions; General Safety Rules; Safety Guidelines To Be Followed While Equipment Is In Motion - Myray hyperion Manual Del Usuario

2.2 Safety guidelines

2.2.1 Operating conditions

The operating conditions required for safe use of the device are given in the next paragraphs in this manual. Refer to
General standard EN-IEC 60601-1 and specific applied standards.

2.2.2 General safety rules

● Shut off the main switch of the equipment before leaving the office.
● The apparatus is not protected against penetration of liquids (risk of electric shock).
● The apparatus is not designed for use in the presence of flammable anesthetic mixture with air or with oxygen or
nitrous oxide.
● Portable wireless communication devices (RF) may cause interference to the equipment; therefore they should not
be used near the equipment.
● The apparatus must be stored and kept in perfect condition.
● The apparatus must always be attended when turned on or set up to be started. In particular it must never be left
unattended in the presence of minors or, in general, persons not authorized to operate it.
● The manufacturer shall not be held liable (civil or penal) for any consequential damage caused by misuse, neglect or
unintended, inappropriate or erroneous use of the equipment.
● An unauthorized technician who modifies the product replacing parts or components with ones different from those
used by the manufacturer shall assume the same responsibility as the manufacturer.
● Computers, monitors, printers, mouses, keyboards and any other device connected to the machine must comply with
standards ISO, IEC, EN along with local regulations.
● The manufacturer is not responsible for any faults or malfunctions of parts or components not approved by the manu-
facturer and which do not comply to standards installed by a qualified technician authorized by the manufacturer.
● Do not eat or drink near the device.

2.2.3 Safety guidelines to be followed while equipment is in motion

hyperion moves near the patient and operator.
These movements are always controlled by the dentist or operator by pressing the dedicated keys.
While the unit is moving, the operator must:
● closely monitor the patient and immediately let go of the button to stop movement if there is a risk of the device hitting
the patient;
● prevent the patient from assuming incorrect positions (putting hands or other body parts in inappropriate areas) or
moving out of the examination area.
The operator must be careful not to interfere with the sensor movement during its servo-controlled activation.

2.2.4 Protection against radiation

hyperion is a radiological apparatus. As a result, the patient and clinicians are exposed to the risks deriving from radia-
tion. It must be used in accordance with the safety standards set forth by radioprotection regulations in force in the user's
country. Some requirements are listed below:
● Start x-ray emission only from the control room. The radiation room must be adequately shielded (if required by regu-
lations currently in force).
● Make sure the radiation room's doors are closed before starting the examination.
● Only the patient should be present in the radiation room during x-ray emission. If the presence of a person is neces-
sary during the examination (for example to help patients who are not self-sufficient), personal equipment must be
used to protect the individual against scattered radiation. In any case, no body parts should be exposed directly to
the X-rays. Patients may not be assisted by pregnant women or minors.
● During the system initialization procedure, no one may stay in the radiation room and the doors must be closed. The
room should be guarded from the outside by authorized personnel until the initialization procedure has been com-
pleted.

2.2.5 Emergency pushbutton

hyperion features an emergency pushbutton, positioned underneath the control panel; pressing it shuts down the appa-
ratus. If used it must be reset manually.
ATTENZIONE NOTA BENE BLOCCO IMMAGINI TABELLE A-Mastro OGGETTO REFERENZIATO

2.2.6 Exposure to laser radiation

hyperion contains three class 1 LASER diodes in compliance to IEC 60825-1. Two of them are placed on the x-ray gen-
erator, one at the base of the bite (as illustrated in the figure in paragraph 3).
Do not look directly into laser beams as it may cause permanent eye damage.

2.2.7 Electromagnetic safety

● Use of accessories and cables different from those supplied by the manufacturer may cause an increase in electro-
magnetic emissions by hyperion and a decrease in immunity to disturbances;
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hyperion
- OPERATING INSTRUCTION