CEFLA MyRay Hyperion X9 User manual

97050543
Rev. 17
2018-12
hyperion X9
EN

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OPERATOR'S MANUAL
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ITALIANO

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Contents
1. INTRODUCTION AND INDICATIONS FOR USE .....................................................................................................5
1.1. DESCRIPTION OF THE MANUAL.......................................................................................................................6
1.2. GENERAL WARNINGS........................................................................................................................................6
1.3. REQUIREMENTS (NOT PROVIDED WITH THE PRODUCT) ............................................................................7
1.4. STANDARDS AND REGULATIONS ....................................................................................................................7
1.5. CLASSIFICATIONS..............................................................................................................................................8
1.6. STYLISTIC CONVENTIONS ................................................................................................................................8
1.7. GENERAL SAFETY WARNINGS.........................................................................................................................9
1.7.1. INSTALLATION CONDITIONS .....................................................................................................................9
1.7.2. CONDITIONS OF USE ...............................................................................................................................10
1.7.3. WARRANTY................................................................................................................................................10
1.7.4. MAINTENANCE AND DISPOSAL ..............................................................................................................11
1.7.5. CLEANING AND DISINFECTION...............................................................................................................12
1.7.6. HYGIENE PROCEDURES FOR PATIENT PROTECTION ........................................................................13
1.8.SAFETY WARNINGS.........................................................................................................................................13
1.8.1. CONDITIONS OF USE ...............................................................................................................................13
1.8.2. GENERAL SAFETY ....................................................................................................................................13
1.8.3. SAFETY DURING X-RAY DEVICE MOVEMENTS ....................................................................................14
1.8.4. EMERGENCY BUTTON .............................................................................................................................15
1.8.5. CONDENSATE FORMATION.....................................................................................................................15
1.8.6. ELECTROSTATIC DISCHARGE ................................................................................................................15
1.8.7. EXPOSURE TO LASER RADIATION.........................................................................................................15
1.8.8. ELECTROMAGNETIC SAFETY .................................................................................................................16
1.8.9. PROTECTION AGAINST RADIATION .......................................................................................................19
1.8.10. APPLIED PARTS...................................................................................................................................19
1.8.11. STRAY RADIATIONS ............................................................................................................................20
2. DESCRIPTION OF OPERATION............................................................................................................................21
3. COMPONENTS .......................................................................................................................................................22
4. CONTROL PANEL ..................................................................................................................................................24
4.1. CONSOLE ONBOARD THE MACHINE.............................................................................................................24
4.2. PUSHBUTTON PANEL ON TELE-X-RAY ARM ................................................................................................24
4.3. X-RAY EMISSION REMOTE CONTROL ...........................................................................................................25
4.4. PERFORM A SIMULATION (DUMMY RUN) .....................................................................................................25
5. PERFORMING A 2D X-RAY EXAMINATION .........................................................................................................26
5.1. STARTING THE SYSTEM .................................................................................................................................26
5.2. SELECTING THE EXAMINATION FROM THE CONTROL CONSOLE............................................................26
5.2.1. 2D EXAMINATIONS AVAILABLE ...............................................................................................................26
5.2.2. SELECTING AN EXAMINATION ................................................................................................................29
5.2.3. SETTING AN EXAMINATION FOR CHILDREN.........................................................................................30
5.2.4. SETTING A CURRENT EXAMINATION AS FAVOURITE .........................................................................30
5.2.5. SETTING THE PROJECTION TYPE..........................................................................................................31
5.2.6. SELECTING A REDUCED ANATOMIC REGION ......................................................................................32
5.2.7. CONFIGURATION OF THE X-RAY TECHNIQUE FACTORS ...................................................................33
5.3. PREPARATION OF THE X-RAY EXAMINATION..............................................................................................34
5.3.1. DEVICES FOR PATIENT POSITIONING ...................................................................................................34
5.3.2. SENSOR POSITIONING.............................................................................................................................35
5.3.3. PATIENT ACCESS STATUS –MINIMUM WAIT STATUS.........................................................................36
5.3.4. EXAMINATION SUMMARY PAGE .............................................................................................................37
5.3.5. DEVICES FOR EDENTULOUS PATIENTS (OPTIONAL)..........................................................................37
5.4. PATIENT POSITIONING....................................................................................................................................38
5.4.1. LASER TRACES .........................................................................................................................................38
5.4.2. PATIENT POSITIONING DESCRIPTION (CRANIOSTAT) ........................................................................39
5.4.3. CRANIOSTAT MOTOR-DRIVEN SUPPORT .............................................................................................40
5.4.4. PAN, DENT AND SIN EXAMINATIONS .....................................................................................................40
5.4.5. TMJ EXAMINATION....................................................................................................................................42
5.4.5.1. LATERAL TMJ ...................................................................................................................................42
5.4.5.2. FRONTAL TMJ ..................................................................................................................................43
5.4.6. TELERADIOGRAPHIC (CEPH) EXAMINATIONS......................................................................................44
5.4.7. POSITIONING FOR DTS EXAMINATION ..................................................................................................45

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5.5. ACQUISITION OF THE EXAM ...........................................................................................................................46
6. 3D TOMOGRAPHIC EXAMINATION (CBCT).........................................................................................................47
6.1. SELECTING THE EXAMINATION FROM THE CONTROL CONSOLE ............................................................47
6.2. POSITIONING THE PATIENT FOR 3D EXAMINATIONS .................................................................................50
6.3. PERFORMING THE EXAMINATION .................................................................................................................50
7. VIEWING AND SAVING ..........................................................................................................................................51
7.1. VIEWING AND SAVING .....................................................................................................................................51
8. CONTROL CONSOLE.............................................................................................................................................52
8.1. LANGUAGE SELECTION ..................................................................................................................................52
8.2. TOUCH SCREEN DISPLAY ICON.....................................................................................................................53
9. PERIODIC CHECKS AND MAINTENANCE ...........................................................................................................56
9.1. PERIODIC INSPECTIONS TO CHECK THE IMAGE ........................................................................................56
10. TECHNICAL DATA..................................................................................................................................................56
10.1. ELECTRICAL CHARACTERISTICS ..............................................................................................................56
10.2. RADIOLOGICAL CHARACTERISTICS .........................................................................................................57
10.3. RADIOLOGICAL FEATURES IN CBCT MODE.............................................................................................58
10.4. ISODOSE CURVES FOR CBCT EXAMINATIONS .......................................................................................59
10.5. ISODOSE CURVES FOR 2D EXAMINATIONS ............................................................................................59
10.6. CTDI (COMPUTED TOMOGRAPHY DOSE INDEX) MEASUREMENTS .....................................................60
10.7. CBCT DETECTOR CHARACTERISTICS......................................................................................................62
10.8. PANORAMIC SENSOR CHARACTERISTICS(PAN) ....................................................................................62
10.9. TELERADIOGRAPHIC (CEPH) SENSOR CHARACTERISTICS (CEPH) ....................................................62
10.10. LASER CHARACTERISTICS.........................................................................................................................62
10.11. DIMENSIONAL CHARACTERISTICS............................................................................................................63
10.12. ENVIRONMENT CHARACTERISTICS..........................................................................................................63
10.13. PC REQUIREMENTS.....................................................................................................................................64
10.14. IDENTIFICATION LABEL POSITION ............................................................................................................67
11. ERROR MESSAGES...............................................................................................................................................68
12. USER’S LICENCE CONTRACT ..............................................................................................................................70
12.1. GENERAL CONDITIONS OF THE IMAGE SOFTWARE LICENCE .............................................................70
12.1.1. USER’S LICENCE .................................................................................................................................70
12.1.2. COPYRIGHT..........................................................................................................................................70
12.1.3. USE OF THE SOFTWARE PRODUCT AND EXPRESS TERMINATION CLAUSE .............................71
12.1.4. GUARANTEE AND EXCLUSIONS FROM THE GUARANTEE ............................................................71
12.1.5. LIMITS OF RESPONSIBILITY...............................................................................................................71
12.1.6. APPLICABLE LAWS, JURISDICTION AND COURT OF JURISDICTION............................................71
12.1.7. WRITTEN FORM ...................................................................................................................................72
12.1.8. TRANSLATION ......................................................................................................................................72
12.1.9. SOFTWARE COMPLIANCE WITH THE REGULATIONS IN FORCE ..................................................72
13. INSPECTION AND MAINTENANCE .......................................................................................................................73
13.1. USER INSPECTION.......................................................................................................................................73
13.2. TECHNICAL MAINTENANCE........................................................................................................................74

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1. INTRODUCTION AND INDICATIONS FOR USE
hyperion X9 is an extraoral X-ray system for digital panoramic exams, tele-X-rays and tomographies, intended to:
(I) produce orthopanoramic images of the maxillofacial region and carry out diagnostic examination on teeth, dental
arches and other structures in the oral cavity;
(II) produce X-ray images of dental arches, cranium parts, carpus, and cephalometric examinations, if equipped with
tele-X-ray arm (CEPH);
(III) produce tomographic images of the oral cavity and maxillofacial structures and carry out diagnostic examination
on teeth, dental arches, structures of the oral cavity and some cranial bones, if equipped with CBCT option.
The system performs tomographic exams with the acquisition of X-ray images through a 360-degree rotating
sequence and the reconstruction of a three-dimensional matrix of the examined volume, thus producing two- and
three-dimensional views of the volume itself. This technique is known as CBCT.
hyperion X9 is a digital X-ray device, suitable for expert professionals, which allows to obtain dental images in a
simple and automatic way. The image is acquired by means of an X-ray detector and a constant potential X-ray
source, powered by a high-voltage and high-frequency generator. Then the image is sent to a computer, in real time
(2D or 3D) or subsequently (2D) according to the needs and choice of the operator.
hyperion X9 allows the following projections:
- standard or panoramic views for paediatric patients (PAN);
- complete or partial views of the teeth, selected by the user (DENT);
- front and side views of maxillary sinuses (SIN);
- side and posteroanterior views of the temporomandibular joints (TMJ), from different angles.
If equipped with tele-X-ray arm (CEPH), hyperion X9 allows the following projections:
- standard or paediatric cephalographies in latero-lateral view;
- cephalographies in anteroposterior and posteroanterior view;
- hand (carpus) X-ray.
If equipped with CBCT option, hyperion X9 also allows to acquire tomographic images.
hyperion X9 is intended for use in dentistry, in the following fields:
- endodontics;
- periodontology;
- dental prosthesis;
- functional diagnosis and therapy of craniomandibular dysfunctions;
- dental surgery;
- dental implants;
- maxillofacial surgery;
- orthodontics.
Contraindications:
- visualisation of cartilaginous structures;
- the CBCT technique has a limited ability to detect soft tissues.
The manufacturer’s website contains a list of authorised agents.

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1.1. 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.
1.2. GENERAL WARNINGS
The digital X-ray system with its drivers and software have been developed and manufactured by CEFLA s.c. - Via
Selice Prov.le 23/A 40026 Imola (Italia), hereinafter referred to as the Manufacturer, which is the manufacturer and
distributor in compliance with the EC Medical Device Directive.
In order to use the system, when it includes also the optional tomography function, the user must have a Personal
Computer with a suitable software for capturing and saving images; further information about its installation and use
is included in the Software user manual. If the system is used for the acquisition of X-ray and cephalometric images
only, a Personal Computer can be used but is not essential. Carefully read this Manual and the Computer and
Software manuals before using the equipment.
- The contents of this publication are valuable trade secrets and must not be given to third parties, stored, copied,
reproduced, disclosed or transferred in any manner (via computer, photocopies, translations or other means)
without the prior written consent of the Manufacturer.
- The Manufacturer pursues a policy of continual improvement of its products; therefore, some specific instructions
and images contained in this manual may differ from the product purchased.
- The Manufacturer reserves the right to make changes without prior notice.
- The information, technical specifications and illustrations contained in this publication are not binding. The
Manufacturer reserves the right to make technical modifications and improvements without modifying these
instructions.
- All the registered trademarks and the product names mentioned are the property of the respective owners.
- Carefully read the USER LICENSE AGREEMENT before using the product. When installing the program, you will
explicitly be asked to accept the agreement; if you do not accept, the program cannot be installed.

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Please pay particular attention to the sections in the manual where the following symbols appear:
Patient or operator safety-related warnings.
Important information on product use.
For 3D machines only.
In accordance with the privacy laws in force in several countries, all sensitive personal information must be
adequately protected. In addition, patients must sign a consent form before any personal information or
images are transmitted across networks. If required by the laws in force, dentists are obliged to protect data
using a protection password. Refer to the Microsoft® Windows operating system manual for data access
protection methods by means of password.
It is recommended to regularly (at least once a week) make a backup copy of the databases. This will allow
restoring the data in the event of damage to the hard disc of the PC or the databases themselves.
1.3. REQUIREMENTS (NOT PROVIDED WITH THE PRODUCT)
For proper functioning, the device requires connection to a personal computer (PC) and the relative software. For the
minimum requirements of the PC, refer to the paragraph TECHNICAL DATA.
The PC is not included with the device. It is recommended to only use a PC compliant to the IEC 60950-
1:2007 standards for information technology devices.
1.4. STANDARDS AND REGULATIONS
The system has been designed to meet the following standards:
- Directive 93/42/EEC and subsequent amendments and additions
(dir. 2007/47/EC) - Medical Devices Directive;
- Directive 2006/42/EEC - Machinery Directive.
Technical Standards:
IEC 60601-1:2005
IEC 60601-1-2:2014
IEC 60601-1-3:2008
IEC 60601-2-63:2012
IEC 60601-1-6:2010
IEC 62366-1:2015
IEC 62304:2006
The CE marking certifies compliance of the product as described herein with Medical Device Directive
93/42/EEC and subsequent amendments.

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1.5. CLASSIFICATIONS
The system is classified as Class I and Type B as regards safety according to IEC 60601-1.
The system is classified as a Class IIB medical electrical X-ray device in accordance with Medical Device Directive
93/42/EEC and subsequent amendments.
1.6. STYLISTIC CONVENTIONS
The following symbols may be found on the X-ray device and in the Manual:
CEFLA s.c.–
via Selice
Provinciale
23/A - 40026
Imola (BO)
Italia
Name of the Manufacturer and place of production.
SN
Product serial number.
Date of manufacture (month / year).
Manufacturer.
Symbol “Possible hazard: Read the user manual”.
Patient or operator safety-related warnings.
Consult the enclosed documentation before using the relevant part of the equipment.
It is necessary to read the user's manual before using the device.
This symbol in the Manual identifies the paragraphs containing important information on the use of
the product.
Applied part of type B, according to IEC 60601-1.
Equipment compliant with directive 93/42/EEC as amended.
Notified body: IMQ spa.
Ionizing radiation warning symbol.
Class 1 LASER radiation warning symbol.
Crushing hazard.
Disposal symbol in accordance with Directive 2012/19/EU.

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POWER
Power switch.
Product/equipment identification code.
I
Unit ON.
O
Unit OFF.
Ukraine compliance mark.
1.7. 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.
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 comply 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 installed must be taken into consideration to avoid
banging into any objects present in the room. Refer to the dimensional diagram in the service manual.
- Make sure that the operator can communicate verbally and visually with the patient during 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.

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For further details, refer to the installation template and the detailed instructions given in the service manual.
1.7.2. CONDITIONS OF USE
The equipment may only be used by authorised and adequately trained staff (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: [e-mail].
Users in the USA market are required to contact:
Cefla North America Inc.,
6125 Harris Technology Blvd., Charlotte, NC, 28269 United States
Phone: [phone], e-mail: [email protected]om
1.7.3. WARRANTY
The Manufacturer guarantees the safety, reliability and performance of the device.
The warranty is valid only under the following terms:
-closely observe the conditions specified in the warranty certificate itself;
-the equipment is only to be used as instructed in this manual;
-equipment installation, upgrade and technical support must be performed exclusively by personnel
authorised by the Manufacturer to carry out these operations;
-do not open the device covers: installation, repairs and in general all the operations that require opening
the device must be carried out exclusively by technicians authorised by the Manufacturer;
-the equipment is to be installed in rooms that satisfy the requirements specified in the manual;
-the room where the X-ray unit is installed must be in compliance with the official directives that govern
radiation protection in the country of use.