Myray hyperion - 1 Introduction; Product Description; Description of the Manual; Standards and Directives

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hyperion - OPERATING INSTRUCTION
1 INTRODUCTION
1.1 Product description
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 myray 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 conguration is capable of obtaining:
● standard or pediatric 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;
● the device is available in two models: hyperion and hyperion MRT. For the hyperion model, a series of options,
called “X7 options” are available. In the hyperion MRT version, the sensor is xed and the X7 options cannot be
applied.
The hyperion model allows the following projections, if the remote X-ray arm is mounted:
● Cephalography in latero-lateral view of standard or pediatric;
● Cephalography in view of the anterior-posterior and posterior-anterior;
● X-ray of the hand (carpus).
1.2 Description of the manual
This is a fundamental tool and must be consulted as it contains important information and instructions on how to use
hyperion and the relative software.
Carefully read and become familiar with the entire content of the manual before attempting to use the hyperion.
A copy of this manual should be kept within easy reach to train personnel and allow the operator to rapidly consult it
while the apparatus is being used. In addition, this manual contains all the information fundamental for safety of the
patient, operator and device.
Special attention must therefore be given to the chapters that deal with safety guidelines, rules and standards.
The original text of this manual was written in Italian.
Translation from the original in Italian.
1.3 Standards and Directives
The hyperion unit has been designed in compliance with the following standards:
● IEC 60601-1 (1988 + A1 1995 + A2 1997);
● IEC 60601-1-4 (1996 + A1 1999);
● IEC 60601-2-7 (1998);
● IEC 60601-2-28 (1993);
● IEC 60601-2-32 (1994);
● IEC 60825-1 (1993 + A1 1997 + A2 2001);
● UL 60601-1 1st edition;
● CAN/CSA C22.2 No 601.1-M90 + A1 + A2.
Protection against radiation
● IEC 60601-1-3 (1994).
Electromagnetic interference
● IEC 60601-1-2 (2001).
0051
The CE marks ascertains conformity of the product described herein and constructed as of the year 2008,
to Council Directive 93/42 CEE regarding Medical Devices and subsequent changes (in particular Directive
2007/47/EC).
Cea Dental Group, Imola Italy, is the manufacturer and seller in compliance with the Council Directive concerning
Medical Devices.
Classications
hyperion is an electromedical x-ray apparatus Class I, Type B according to IEC 60601-1 classication.
hyperion is classied as class IIB as set forth by the Council Directive for medical devices 93/42/CEE and subsequent
changes.