Foreword; Description Of The Equipment; Description Of The Manual; Standards And Regulations - Myray Hyperion Instrucciones De Uso

1. FOREWORD

1.1. DESCRIPTION OF THE EQUIPMENT

hyperion MRT / hyperion is the digital orthopanoramic system designed by myray to simplify the entire X-ray
acquisition procedure. Suited for trained dental professionals, it allows low dose highly detailed and accurate dental
images to be obtained easily and automatically.
The hyperion MRT / hyperion device digitally acquires every image - using an X-ray generator operating at high
frequency and constant power and a CCD sensor – and transfers it to a connected computer in real-time or at a later
stage on choice of the operator.
The standard system configuration is capable of obtaining:
- standard or paediatric panoramic views;
- complete or partial views, selected by the user;
- frontal or lateral views of maxillary sinus; - lateral views from multiple angles or posterior-anterior views of temporomandibular joints (TMJ);
- the device is available in two models: hyperion MRT - hyperion. For the hyperion model, a series of options,
called "X7 options" are available. In the hyperion MRT version, the sensor is fixed and the X7 options cannot be
applied.
The hyperion model allows the following projections, if the remote X-ray arm is mounted:
- standard or paediatric cephalography in latero-lateral view;
- cephalography in anterior-posterior and posterior-anterior view;
- X-ray of the hand (carpus) – Not available for Singapore market.

1.2. DESCRIPTION OF THE MANUAL

This manual is an essential consultation tool and contains important information and instructions for use of
the X-ray system and the relative controls.
These instructions describe how to properly and safely use the digital X-ray system.
Carefully read and familiarise yourself with the entire contents of the manual before attempting to use the
system.
For use of the software, refer to the specific manual.
The manual is only provided in electronic format on a DVD and can be consulted directly on the PC screen
during use.
It is advisable to keep a copy of this manual within reach with the aim of training the operators and as guide
for consultation during use of the device. This manual also contains all the essential information for safety of
the patient, the operator and the device.
It is therefore advisable to particularly carefully read the paragraphs on the safety rules.
The original text of this manual is in Italian.

1.3. STANDARDS AND REGULATIONS

The system has been designed to meet the following standards:
- Directive 93/42/EEC and s.c.
(dir. 2007/47/EC) - Medical Device Directive;
- Directive 2006/42/EEC - Machinery Directive.
Technical Standards:
IEC 60601-1:2005
IEC 60601-1-2:2007
IEC 60601-1-3:2008
IEC 60601-2-63:2012
IEC 60601-1-6:2010
IEC 62366:2007
IEC 60825-1:1993
The CE marking certifies compliance of the product as described herein with Medical Device Directive
93/42/EEC and subsequent amendments.
EN OPERATOR'S MANUAL
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