General Safety Warnings; Intended Use; Installation Conditions - Myray Hyperion Instrucciones De Uso

2. GENERAL SAFETY WARNINGS

These instructions describe how to use the system correctly. Please carefully read this manual before using
the device.
The owner or the installation site manager is obliged to verify compliance with the local regulations in force and/or
ask a Qualified Expert for advice. Pay particular attention to fulfilling the obligations of the law regarding the
protection of workers, the population and patients against radiation.
The main REFERENCE STANDARDS are listed in this manual (1.4 - Standards and Regulations).
Do not use the system for uses different from those described in the indications for use (Introduction) and do not use
it if you do not have the necessary knowledge in the dentistry and radiological field.
The law restricts and reserves the sale and use of this device exclusively to physicians, dentists or radiology
specialists.

2.1. INTENDED USE

hyperion MRT / hyperion is a next generation medical device intended for dental assessments and radiological
diagnosis by acquiring images in real time thanks to the support of a computer and memory card.

2.1.1. 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.
EN OPERATOR'S MANUAL
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