Myray Hyperion X5 Series User manual

97050799
Rev. 05
16.09
EN
IT
FR
DE
ES
PT
RU
TR
ZH
NO
SV
FI
DA
PL
CS
HU
RO
UK

2
OPERATOR'S MANUAL
EN
ITALIANO

2
OPERATOR'S MANUAL
EN
ITALIANO
Contents
0. DEVICE IDENTIFICATION........................................................................................................................................4
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..............................................................................................................................................7
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 .........................................................................................................................................14
1.8.1. CONDITIONS OF USE ...............................................................................................................................14
1.8.2. GENERAL SAFETY ....................................................................................................................................14
1.8.3. SAFETY DURING X-RAY DEVICE MOVEMENTS ....................................................................................14
1.8.4. EMERGENCY BUTTON .............................................................................................................................15
1.8.5. EXPOSURE TO LASER RADIATION .........................................................................................................15
1.8.6. ELECTROMAGNETIC SAFETY .................................................................................................................16
1.8.7. PROTECTION AGAINST RADIATION .......................................................................................................18
1.8.8. APPLIED PARTS ........................................................................................................................................18
1.8.9. STRAY RADIATIONS..................................................................................................................................19
2. DESCRIPTION OF OPERATION ............................................................................................................................20
3. COMPONENTS .......................................................................................................................................................21
4. CONTROL PANEL ..................................................................................................................................................22
4.1. CONSOLE ONBOARD THE MACHINE .............................................................................................................22
4.2. X-RAY EMISSION REMOTE CONTROL ...........................................................................................................22
4.3. PERFORM A SIMULATION (DUMMY RUN) .....................................................................................................23
5. PERFORMING A 2D X-RAY EXAMINATION .........................................................................................................24
5.1. STARTING THE SYSTEM..................................................................................................................................24
5.2. SELECTING THE EXAMINATION FROM THE CONTROL CONSOLE ............................................................24
5.2.1. 2D EXAMINATIONS AVAILABLE ...............................................................................................................24
5.2.2. SELECTING AN EXAMINATION ................................................................................................................28
5.2.3. SETTING THE PROJECTION TYPE ..........................................................................................................31
5.3. PREPARATION OF THE X-RAY EXAMINATION..............................................................................................32
5.3.1. EDENTOLOUS PATIENTS DEVICES ........................................................................................................32
5.4. PATIENT POSITIONING ....................................................................................................................................32
5.4.1. LASER TRACES .........................................................................................................................................33
5.4.2. PATIENT POSITIONING DESCRIPTION (CRANIOSTAT) ........................................................................34
5.4.3. PAN, DENT AND SIN EXAMINATIONS .....................................................................................................35
5.4.4. TMJ EXAMINATION....................................................................................................................................36
5.4.4.1. LATERAL TMJ ...................................................................................................................................36
5.4.4.2. FRONTAL TMJ ..................................................................................................................................37
5.5. ACQUISITION OF THE EXAM ...........................................................................................................................37
5.6. TYPICAL IMAGES OF THE EXAMS..................................................................................................................38
5.6.1. ADULT PANORAMIC IMAGING .................................................................................................................38
5.6.2. CHILD PANORAMIC IMAGING ..................................................................................................................38
5.6.3. TMJ EXAMINATIONS (TEMPOROMANDIBULAR JOINT) ........................................................................38
5.6.4. SIN EXAMINATIONS ..................................................................................................................................39
5.6.5. DENTITION/BITEWING EXAMINATIONS..................................................................................................39

EN
OPERATOR'S MANUAL
3
6. 3D TOMOGRAPHY (CBCT)....................................................................................................................................40
6.1. SELECTING THE EXAMINATION FROM THE CONTROL CONSOLE............................................................40
6.2. POSITIONING THE PATIENT FOR 3D EXAMINATIONS .................................................................................46
6.3. PERFORMING THE EXAMINATION .................................................................................................................46
6.4. SPECIAL CONSIDERATIONS FOR CBCT EXAMINATIONS WITH CHILDREN OR SMALL PATIENTS .......47
7. VIEWING AND SAVING..........................................................................................................................................48
8. PERIODIC CHECKS AND MAINTENANCE ...........................................................................................................49
8.1. PERIODIC INSPECTIONS TO CHECK THE IMAGE ........................................................................................49
9. TECHNICAL DATA..................................................................................................................................................50
9.1. ELECTRICAL CHARACTERISTICS ..................................................................................................................50
9.2. RADIOLOGICAL CHARACTERISTICS..............................................................................................................50
9.3. ISODOSE CURVES FOR 2D EXAMINATIONS.................................................................................................52
9.4. ISODOSE CURVES FOR CBCT EXAMINATIONS ...........................................................................................52
9.5. PANORAMIC SENSOR CHARACTERISTICS(PAN).........................................................................................53
9.6. 3D PANEL FEATURES ......................................................................................................................................53
9.7. LASER CHARACTERISTICS.............................................................................................................................53
9.8. DIMENSIONAL CHARACTERISTICS................................................................................................................54
9.9. ENVIRONMENT CHARACTERISTICS ..............................................................................................................57
9.10. PC REQUIREMENTS ....................................................................................................................................58
9.11. IDENTIFICATION LABEL POSITION ............................................................................................................60
10. ERROR MESSAGES ..............................................................................................................................................61
11. USER’S LICENCE CONTRACT..............................................................................................................................62
11.1. GENERAL CONDITIONS OF THE IMAGE SOFTWARE LICENCE .............................................................62
11.1.1. USER’S LICENCE .................................................................................................................................62
11.1.2. COPYRIGHT..........................................................................................................................................62
11.1.3. USE OF THE SOFTWARE PRODUCT AND EXPRESS TERMINATION CLAUSE.............................62
11.1.4. GUARANTEE AND EXCLUSIONS FROM THE GUARANTEE ............................................................63
11.1.5. LIMITS OF RESPONSIBILITY...............................................................................................................63
11.1.6. APPLICABLE LAWS, JURISDICTION AND COURT OF JURISDICTION ...........................................63
11.1.7. WRITTEN FORM ...................................................................................................................................63
11.1.8. TRANSLATION......................................................................................................................................63
11.1.9. SOFTWARE COMPLIANCE WITH THE REGULATIONS IN FORCE..................................................63
12. INSPECTION AND MAINTENANCE.......................................................................................................................64
12.1. USER INSPECTION ......................................................................................................................................64
12.2. TECHNICAL MAINTENANCE........................................................................................................................65

4
OPERATOR'S MANUAL
EN
0. DEVICE IDENTIFICATION
This manual applies to the following models of the hyperion X5 family:
-hyperion X5 REF. 708G (hyperion X5 2D version);
-hyperion X5 REF. 708H (hyperion X5 3D version).
Unless otherwise indicated, the instructions included in this manual apply to all models of the hyperion X5 family
(hereinafter referred to as "hyperion X5").
In the following part of this manual, instructions that only apply to the device model hyperion X5 REF. 708G are
identified by the description “ Only for 2D machines ”.
Instructions that only apply to the device model hyperion X5 REF. 708H are identified by the icon, by the
description “ Only for 3D machines ” or by both.

EN
OPERATOR'S MANUAL
5
1. INTRODUCTION AND INDICATIONS FOR USE
Only for 2D machines :
hyperion X5 is an extraoral X-ray system for digital panoramic exams. It is intended to produce orthopanoramic
images of the maxillofacial region and to carry out diagnostic examination on teeth, dental arches and other
structures in the oral cavity.
Only for 3D machines :
hyperion X5 is an extraoral X-ray system for digital panoramic exams 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 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.
The system performs tomographic exams with the acquisition of X-ray images through a 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 X5 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. The image is then transmitted to a computer in real time.
USA federal law restricts this device to sale by or on the order of a licensed healthcare practitioner.
hyperion X5 allows the following 2D projections:
- standard or panoramic views for pediatric patients (PAN);
- complete or partial views of the teeth, selected by the user (DENT);
- frontal or lateral views of the maxillary sinuses (SIN);
- lateral and posteroanterior views of the temporomandibular joints (TMJ), from different angles.
Furthermore, the 3D version machine also allows to acquire tomographic images.
hyperion X5 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.
Not for use on patients (child) less than approximately 104 cm in height and less than 19 Kg in weight. These
height and weight measurements approximately correspond to that of an average 4 year old
Use of equipment and exposure settings designed for adults of average size can result in excessive radiation
exposure for a smaller patient. Studies have shown that pediatric patients may be more radiosensitive than
adults (i.e., the cancer risk per unit dose of ionizing radiation is higher), and so unnecessary radiation exposure
is of particular concern for pediatric patients.
Not for use with patients not vigilant and cooperative, since the patient must be able to understand and follow
the operator's instructions for a correct positioning.

6
OPERATOR'S MANUAL
EN
Contraindications:
- visualisation of cartilaginous structures;
- the CBCT technique ( only for 3D machines ) has a limited ability to detect soft tissues.
In order to ensure a safe use of the device, specifically in the radiography of children, it is suggested to consult
the general indications described in the guidelines for dental radiographs as i.e. the ones referred on the
website Image Gently (www.imagegently.org), for dental Rx, or even in the FDA website for “Pediatric X-Ray
imaging”.
1.1. DESCRIPTION OF THE MANUAL
This manual is an essential consultation tool and contains important information and instructions for the use
of the X-ray system and the relevant 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.
To use the software, refer to the specific manual.
The manual is only provided in electronic format 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 the use of the device. This manual also contains all the essential information for the
safety of patient, operator and device.
It is therefore advisable to read carefully the paragraphs on the safety rules.
The original text 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. - Imola
(Italy), hereinafter referred to as the Manufacturer, which is manufacturer and distributor according to the European
Community Directive for medical devices.
In order to use the system, 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. Carefully read this
Manual and the Computer and Software manuals before using the equipment.
- No part of this publication may be reproduced, stored or transmitted in any form or by any means (electronic,
mechanical, photocopying, translation or otherwise) without prior written permission of the Manufacturer.
- The Manufacturer has a company policy of continual development. Although every effort is made to keep technical
documentation up-to-date at all times, some of the instructions, specifications and figures given in this manual may
slightly differ from the purchased product.
- The Manufacturer reserves the right to make changes without prior notice.
- Any information, technical specifications and illustrations contained in this manual are not binding on the
Manufacturer. The Manufacturer reserves the right to introduce changes and technical improvements without
having to modify these instructions.
- All registered trade marks and product names mentioned in this manual are the property of their respective owners.
- Carefully read the USER LICENSE AGREEMENT before using the product. Before installing the program, the user
will be explicitly asked to accept the agreement, otherwise no installation will be allowed.
Pay special attention to the sections of the manual in which the indicated symbols appear:
Patient or operator safety-related warnings.
Important information concerning the product use.

EN
OPERATOR'S MANUAL
7
Only for 3D machines.
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 the prevailing regulations require it, the practitioner must protect
such information by means of a password; please refer to the Microsoft® Windows operating system manual
to know the methods for a password-protected access to the information.
We recommend to create backup copies of the files at regular intervals (at least once a week). In this way,
you will keep all information even in case of damage to the PC's HDD or to the files 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
This system has been designed in accordance with the following standards:
- Directive 93/42/EEC and subsequent amendments and integrations
(Dir. 2007/47/EC) - Medical Device Directive;
- Directive 2006/42/EC - 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 62304:2006
IEC 60825-1:1993
The CE mark certifies the compliance of the product described below with the European Community Medical
Device Directive 93/42/EEC and subsequent amendments.
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.

8
OPERATOR'S MANUAL
EN
1.6. STYLISTIC CONVENTIONS
The following symbols may be found on the X-ray device:
Equipment in compliance with the essential requirements of directive 93/42/EEC and subsequent
amendments.
Type B applied part according to IEC 60601-1 standard.
Product/equipment identification code.
Product serial number.
Manufacturer.
Date of manufacture (Month / Year).
Consult the enclosed documentation before using the equipment relevant part.
It is necessary to read the user manual before using the equipment.
POWER
Power switch.
I
Unit ON.
O
Unit OFF.
Ionizing radiation warning symbol.
Class 1 LASER radiation warning symbol.
Crushing hazard.
Disposal symbol in accordance with directive 2012/19/EU.

EN
OPERATOR'S MANUAL
9
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 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.

10
OPERATOR'S MANUAL
EN
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: [e-mail]
1.7.3. WARRANTY
The manufacturer guarantees the safety, reliability and performance of the device.
The warranty is conditional on compliance with the following rules:
-the conditions indicated in the warranty certificate must strictly be observed;
-the device must be used exclusively according to the instructions contained in this manual;
-installation, technical service and updating of the devices must be carried out by persons authorised by
the manufacturer;
-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 device must be installed exclusively in environments that comply with the restrictions given in this
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.

EN
OPERATOR'S MANUAL
11
1.7.4. MAINTENANCE AND DISPOSAL
Never take the covers off the equipment.
The equipment does not contain any parts that can be repaired directly by the user. In the event of a malfunction, do
not attempt to carry out any type of maintenance operations. If a system malfunction is found or suspected, do not try
to carry out any maintenance operation and do not use the system on a patient, but directly contact the local distributor.
There are no mechanical or electronic part of this X-ray system that can be subject to maintenance by the user.
Devices may be broken, the protective means for electric safety be violated and the warranty will be void if the casings
are opened to reach the circuits inside.
The device must be maintained, repaired and modified only by personnel authorised directly by the Manufacturer or by
third parties authorised explicitly by the Manufacturer, and such operations must be performed in accordance with the
laws in force and with the generally accepted technical standards.
All system components must be checked and replaced, if necessary, by qualified personnel.
For any maintenance operations, please contact the Manufacturer on the website indicated on the cover of this manual
and fill in the Information Request form.
Further information about the device regular inspection and maintenance is provided in the document “hyperion X5 -
Inspection and Maintenance”.
If the equipment or its parts have to be returned to the Manufacturer or Service Centre for any reason, completely
disinfect the outside of the equipment with a specific product (see paragraph “Cleaning and disinfecting”) and send it
back preferably in its original packing.
At the end of the equipment working life, dispose of in accordance with the applicable regulations in force. We
recommend to disinfect all the equipment external parts before disposal and to sort out the stripped materials for
separate waste collection.
In compliance with Directives 2011/65/EU –2012/19/EU regarding restriction of the use of certain hazardous
substances in electrical and electronic equipment along with waste electrical and electronic equipment, it is forbidden
to dispose of this equipment in the municipal waste stream as unsorted municipal waste. When new equipment of
equivalent type is purchased, on a one-to-one basis, the old equipment must be returned to the dealer for disposal. As
regards reuse, recycling and other forms of recovery of waste electrical and electronic equipment, the producer carries
out the functions set forth by laws and regulations currently in force in the individual countries. A high level of separate
collection of waste electrical and electronic equipment is indispensable to efficiently recycle, treat and dispose of the
equipment. Recycling and treatment operations should comply with minimum standards to assure human health and
high environmental protection as well as favour recycling of the materials included in the equipment. The symbol
indicating separate collection for electrical and electronic equipment is the crossed out bin marked on the equipment.
Illegal waste clearance and disposal shall be punished as established by laws and regulations currently in force in the
individual countries.

12
OPERATOR'S MANUAL
EN
1.7.5. CLEANING AND DISINFECTION
Cleaning is the first step necessary in any disinfection process. The physical action of rubbing a surface with
detergents and surface-active agents and rinsing with water removes a large number of microorganisms. If a
surface is not cleaned first, the disinfection process cannot be successful.
When a surface cannot be adequately cleaned, it should be protected with barriers.
The external parts of the device must be cleaned and disinfected using a product for hospital use with indications for
HIV, HBV and tuberculosis (medium-level disinfectant) specifically for small surfaces.
The various drugs and chemical products used in dentist’s surgeries may damage the painted surfaces and the plastic
parts. The tests and research conducted have demonstrated that the surfaces cannot be fully protected against attack
of all the products found on the market. It is therefore recommended to use barrier protections whenever possible.
The aggressive effects of chemical products also depend on the time they stay in contact with the surfaces. It is
therefore important not to leave the product on the surfaces of the device for longer than the time indicated by the
manufacturer.
It is recommended to use the specific medium-level disinfectant, STER 1 PLUS (CEFLA S.C.), which is compatible
with the painted surfaces, plastic parts and unpainted metal surfaces. Alternatively, it is recommended to use products
that contain:
-96% ethanol Concentration: maximum 30 g for every 100 g of disinfectant.
-1-propanol (N-propanol, propyl alcohol, N-propyl alcohol). Concentration: maximum 20 g for every 100 g of
disinfectant.
-Combination of ethanol and propanol. Concentration: the combination of the two must be at maximum 40 g for
every 100 g of disinfectant.
-Painted surfaces and plastic parts.
- Incidin Spezial (Henkel Ecolab);
- Omnizid (Omnident);
- Plastisept (Alpro) (not tuberculocide as not an alcohol-based disinfectant);
- RelyOn Virkosept (DuPont);
- Green & Clean SK (Metasys) (not tuberculocide as not an alcohol-based disinfectant).
-Do not use products containing isopropyl alcohol (2-propanol, isopropanol).
-Do not use products containing sodium hypochlorite (bleach).
-Do not use products containing phenols.
-Whatever product you use, follow the instructions given by the manufacturer.
-Do not mix the STER 1 PLUS disinfectant with other products.
-Do not spray the product directly on the device surfaces.
For cleaning and disinfection use disposable, soft, non-abrasive
paper (do not use recycled paper) or sterile gauze.
- It is recommended to turn off the device before cleaning and
disinfecting the external parts.
- Everything used for cleaning and disinfection must be thrown
away after use.

EN
OPERATOR'S MANUAL
13
1.7.6. HYGIENE PROCEDURES FOR PATIENT PROTECTION
Single-use hygienic protections are the main means of protection against transmission of cross-infections
between patients. In order to prevent transmission of infectious diseases from patient to patient, it is essential
to always use the single-use protections. The single-use protections are classified as Class I medical device
and may not be replaced with others in a lower class.
The single-use protections must be in compliance with the ISO 10993-1 standards on biocompatibility and
approved by the control bodies where required (e.g. FDA, CE).
Always change the disposable protective cover for the bite before using it for a new patient.
The disposable protective covers must be stored in a clean dry place away from direct sunlight and UV rays.
The bite piece and the chinrest can be disinfected by immersing them in a cold sterilising liquid. For
sterilisation of these parts, follow the instructions of the supplier of the sterilising product.
Cover all the components that will come into contact with the hands of the dental staff with disposable single-
use protections, as they might be contaminated by indirect contact with the patient’s mouth. In particular, be
careful how you handle the control console of the device, the mouse and keyboard of the PC.
Prior to positioning patients for any X-ray exposure, always cover the bite block with a new clean non-sterile
plastic barrier, to avoid cross contamination.
Note for users in Canada: ask your trusted dental material distributor for any plastic barrier that is suitable in
size and is marketed in Canada according to the local regulations in force.
According to Health Canada, bite block covers are Class I devices and are distributed by authorised
establishments only, as listed in the MDEL database.

14
OPERATOR'S MANUAL
EN
1.8. SAFETY WARNINGS
1.8.1. CONDITIONS OF USE
In order to use the device in safe conditions, refer to the following paragraphs in the manual.
1.8.2. GENERAL SAFETY
-Before leaving the surgery, deactivate the main switch of the device.
-The device is not protected against liquid penetration (Class IPX0 –common protection).
-The device is not suitable for use in the presence of a mixture of flammable anaesthetic gas with oxygen or nitrous
oxide.
-Portable telecommunications devices (RF) may interfere with the X-ray device; use in the vicinity of the X-ray
device should therefore be prohibited.
-The device must be looked after and kept in perfect efficiency.
-The device must never be left unattended when it is on or ready to start, in particular in the presence of minors or
in general persons not authorised for its use.
-The manufacturer declines all responsibility (civil and penal) for any abuse, negligence or improper use of the
device.
-Unauthorised technicians that modify the device replacing parts or components with others different from those
used by the manufacturer assume the same responsibility as the manufacturer.
-Computers, monitors, printers, mice, keyboards and other devices connected to the X-ray device must be in
compliance with the ISO, IEC and EN standards or the respective local regulations.
-The manufacturer is not responsible for problems or malfunctions of parts or components not approved by the
manufacturer and not in compliance with the standards installed by qualified technicians acknowledged by the
manufacturer.
-Do not use electronic devices that do not comply with IEC 60601-1-2:2007 in proximity of life-support equipment
(e.g. pacemakers or heart stimulators) and hearing aids. Before using any electronic device in health facilities,
always check that it is compatible with the other equipment present.
-The X-ray tube contains insulating mineral oil. This oil is potentially hazardous if ingested or if it comes into contact
with the skin or mucous membranes. In the event of a defect or fault, the oil may leak out. Avoid direct contact with
the oil and do not inhale the vapours.
-Do not eat, drink or smoke near the device.
1.8.3. SAFETY DURING X-RAY DEVICE MOVEMENTS
The X-ray device carries out movements in the vicinity of the patient and the operator.
During the execution of the X-rays, the operator controls the movements by holding down dedicated buttons.
The reset procedure must be carried out before the patient accesses the device.
The operator must stand at a suitable distance from the moving parts. Movements can be stopped at any time
by pressing the emergency button.
During all the movements of the X-ray device, the operator must:
-closely watch over the patient, and if there is a risk of collision between the X-ray device and the patient,
immediately interrupt the movement by releasing the control button;
-not allow the patient to assume incorrect positions (resting the hands or other parts of the body in inappropriate
areas) or to move away from the examination area.
The operator must be careful not to interfere with the sensor movement during its servo-controlled activation.

EN
OPERATOR'S MANUAL
15
1.8.4. EMERGENCY BUTTON
The system is equipped with an emergency button to stop X-ray device operation, located under the patient support
arm in proximity of the telescopic column. A remote emergency button is connected using the dedicated connector on
the board located at the feet of the lifting column.
1 - Emergency button
These buttons must be activated in the event of danger and emergency, for example, failed interruption of radiation
from the source, in situations of evident danger to persons or when an emergency is signalled.
If the emergency button is pressed, radiation emission is immediately interrupted and all the movements of the patient
support and the rotary arm are stopped, all the linear motors run a distance of less than 10 mm and the rotary
movements a distance of less than 2 degrees, and the button remains locked in safe conditions.
After the emergency, turn the button in the direction indicated by the arrow to resume normal operation.
1.8.5. EXPOSURE TO LASER RADIATION
The system contains some class 1 LASER diodes, in compliance with IEC 60825-1.
Both the patient and the operator may be dazzled by laser traces.
-Do not look directly into the laser beam. Pay attention to avoid that the laser beam hits the patient’s eye.
-Keep a distance of at least 10 cm between the eye and the laser.
The position of the laser sources is indicated with the following symbol .

16
OPERATOR'S MANUAL
EN
1.8.6. ELECTROMAGNETIC SAFETY
Do not use electronic equipment not complying with IEC 60601-1-2:2007 in proximity to life support equipment (e.g.
pacemakers or heart stimulators) and hearing aids.
Before using any electronic device in health facilities, always check that it is compatible with the other equipment
present, including X-ray device.
Guidance and manufacturer's declaration - Electromagnetic emissions
hyperion X5 is designed to operate in the electromagnetic environment specified below. The customer or the user
of hyperion X5 must ensure its use in an electromagnetic environment with the following features:
Emission test
Conformity
Electromagnetic Environment
RF emissions
CISPR 11
Group 1
hyperion X5 device uses RF energy only for its internal
operation.
For this, the RF emissions are very low and do not
interfere with the electronic devices nearby.
RF emissions
CISPR 11
Class A
hyperion X5 device must be used only by adequately
trained personnel (dentists and paramedics). hyperion
X5 device may cause radio interferences or disturb the
operation of the nearby equipment. It may be
necessary to adopt countermeasures, such as re-
orienting or moving the hyperion X5 device or
shielding the installation site.
Guidance and manufacturer's declaration - Electromagnetic immunity
hyperion X5 is designed to operate in the electromagnetic environment specified below. The customer or the user
of hyperion X5 must ensure its use in an electromagnetic environment with the following features:
Immunity test
IEC 60601-1-2
Test level
Conformity
degree
Electromagnetic Environment
Electrostatic
discharge (ESD)
IEC 61000-4-2
6 kV contact
8 kV air
IEC 60601-1-2
Test level
Floors must be made of wood, concrete or
ceramic tiles. If floors are covered with
synthetic material, the relative humidity
should be at least 30%.
IEC 61000-4-4
fast/burst electric
transients
2 kV for electrical lines
1 kV for input/output
lines > 3 m
IEC 60601-1-2
Test level
The power supply line quality should be that
of a typical commercial or hospital
environment.
Overvoltage
IEC 61000-4-5
1 kV differential
mode
2 kV standard mode
IEC 60601-1-2
Test level
The power supply line quality should be that
of a typical commercial or hospital
environment.
Voltage drops,
short interruptions
and voltage
change on the IEC
61000-4-11 input
electric line
0% Unfor 0.5 cycles
40 % Unfor 5 cycles
70 % Unfor 25 cycles
0 % Unfor 5 s
IEC 60601-1-2
Test level
The power supply line quality should be that
of a typical commercial or hospital
environment. If the hyperion X5 user
requires a continuous operation also in
case of blackout, it is recommended to
power the hyperion X5 with uninterruptible
power supply or batteries.
Magnetic field at
network frequency
(50/60 Hz)
IEC 61000-4-8
3 A/m
IEC 60601-1-2
Test level
The magnetic fields at network frequency
should feature levels typical of a standard
commercial or hospital environment.

EN
OPERATOR'S MANUAL
17
Guidance and manufacturer's declaration - Electromagnetic immunity
hyperion X5 is designed to operate in the electromagnetic environment specified below. The customer or user of
hyperion X5 must ensure that is used in such environment.
Immunity test
IEC 60601-1-2
Test level
Conformity
degree
Electromagnetic Environment
The RF communication devices (portable
and mobile) must not be used at a distance
from hyperion X5 and its components,
including cables, lower than the
recommended distance using the
corresponding equation applicable to the
transmitter frequency.
Recommended distance.
Radiated RF
EN 61000-4-3
3 V/m
From 80 MHz to 2.5
GHz
3 V/m
d = 1.2 x √P 80 MHz to 800MHz
d = 2.3 x √P 800 MHz to 2.5GHz
Conducted RF
EN 61000-4-6
3 V
From 150 kHz to 80
MHz
3 V
d = 1.2 x √P
Where P is the maximum output power of
the transmitter in Watt (W) according to the
transmitter manufacturer, and d is the
recommended distance in meters (m).
The field intensity of the fixed RF
transmitters, determined based on an
electromagnetic site, could be lower than
the conformity level in each frequency
interval.
Near the equipment with the following
symbol interferences can be caused:
Recommended distance between the RF portable and mobile communication devices and hyperion X5.
hyperion X5 is designed to operate in the electromagnetic environment where the RF irradiated disturbances are
controlled. The customer or the user of the hyperion X5 could help preventing electromagnetic interferences
ensuring a minimum distance between the RF mobile and portable (transmitter) communication devices and
hyperion X5 as shown herebelow, according to maximum power output of the communication devices.
Transmitter maximum nominal
output
(W)
Distance according the transmitter frequency
(m)
From 150KHz to 80MHz
d = 1.2 x √P
From 80KHz to
800MHz
d = 1.2 x √P
From 800KHz to
2.5MHz
d = 2.3 x √P
0.01
0.12
0.12
0.23
0.1
0.38
0.38
0.73
1
1.2
1.2
2.3
10
3.8
3.8
7.3
100
12
12
23
For transmitters having a maximum nominal output power not listed above, the recommended distance in meters
(m) can be determined using the corresponding equation applicable to the transmitter frequency where P is the
maximum output power of the transmitter in Watt (W) according to the transmitter manufacturer.
Note:
(1) At 80MHz and 800MHz it is necessary to apply the distance defined for the highest frequency interval.
(2) These guidelines cannot be applicable to all situations. The electromagnetic propagation is influenced by the
absorption and reflection of structures, objects and people.

18
OPERATOR'S MANUAL
EN
1.8.7. PROTECTION AGAINST RADIATION
This system is an X-ray equipment. As such, it exposes patients and operators to risks from radiation. It must
be used in compliance with the safety standards set forth by the radiological protection regulation in force in
the country of use. Following are some of the provisions:
-Control the emission of X-rays exclusively from the control workstation, the exam room must be suitably
shielded (if required by the local regulations in force).
-Make sure that the doors of the X-ray room are closed before starting the exam.
-During the emission, only the patient should stay in the exam room. If it is necessary for the operator to
remain during the exam (e.g. when the patient is not self-sufficient and requires assistance), he/she must
wear protective equipment against scattered radiation and, in any case, no parts of his/her body should
ever be exposed to direct X-ray emission. Patients may not be assisted by pregnant women or minors.
-During the system's initialisation procedure, nobody is allowed in the exam room and its doors must
remain closed. Authorised personnel must always be present outside the room until the projection is
completed.
-Pay attention not to release the emission button too soon. Please note that during an exposure cycle,
radiation can be emitted several times. Wait for the exposure cycle to be completed.
-Always observe the following points:
-Stay at least 2 metres away from the X-ray source during exposure. For installations in Canada, the
minimum distance is 3 metres.
-All persons that are not directly involved with the patient should stay outside the exam room, or behind
a lead or lead glass shielding during exposure.
-Make sure that the operator is able to communicate with the patient both verbally and visually.
-If required, use a dosimeter for personal monitoring.
-Full use must be made of all radiation protection devices, accessories, and procedures available to protect
the patient and operator from X-ray radiation, especially for child.
1.8.8. APPLIED PARTS
The parts that, during standard use, necessarily come into contact with the patient, so that the device may carry out its
functions correctly, are: chinrest, bite piece and hygienic protections, craniostat and handles.
The non-applied parts that may come into contact with patient are the external covers and the patient arm.

EN
OPERATOR'S MANUAL
19
1.8.9. STRAY RADIATIONS
Stray radiation measurement is highly influenced by ambient conditions, such as wall composition and positioning,
therefore, under certain circumstances, the detected values can be significantly different.
The measurement points used are at 0.5 m, 1.0 m and 2.0 m, respectively, from a central rotation axis.
The circular measurement points are determined based on the patient bite position on the machine.
1) Standard panoramic exam: stray radiation measured at the maximum usage percentage allowed by the X-ray
generator (corresponding to an average anode power of 42 W).
Distance between rotation axis and measurement point
(Circular measurement points)
Stray radiation *
0.5 m
80 µGy / h
1.0 m
26 µGy / h
2.0 m
6 µGy / h
3.0 m
3 µGy / h
2) Standard panoramic examination: stray radiation measured at the current average usage percentage or based on 4
examinations per hour.
Distance between rotation axis and measurement point
(Circular measurement points)
Stray radiation *
0.5 m
12 µGy / h
1.0 m
3 µGy / h
2.0 m
1 µGy / h
3.0 m
0.4 µGy / h
Only for 3D machines
3) 3D standard resolution 10x10: stray radiation measured at the maximum usage percentage allowed by the X-ray
generator (corresponding to an average anode power of 42 W).
Distance between rotation axis and measurement point
(Circular measurement points)
Leakage radiation *
0.5 m
890 µGy / h
1.0 m
225 µGy / h
2.0 m
60 µGy / h
3.0 m
30 µGy / h
4) 3D standard resolution 10x10: stray radiation measured at the current average usage percentage or based on 4
examinations per hour.
Distance between rotation axis and measurement point
(Circular measurement points)
Leakage radiation *
0.5 m
65 µGy / h
1.0 m
20 µGy / h
2.0 m
5 µGy / h
3.0 m
2 µGy / h
*It is the maximum value at 15 cm above the horizontal plane of intersection with the patient bite. Other values on
the vertical axis are lower than these values.