x5 - ceflasupport.comceflasupport.com/.../myray/x5_user_manual.pdf · hyperion x5 is a digital...

97050799 Rev. 09 2018-07

hype

rion

X5

EN

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 ........................................................................................................................................ 7 1.3. REQUIREMENTS (NOT PROVIDED WITH THE PRODUCT) ............................................................................ 8 1.4. STANDARDS AND REGULATIONS .................................................................................................................... 8 1.5. CLASSIFICATIONS .............................................................................................................................................. 8 1.6. STYLISTIC CONVENTIONS ................................................................................................................................ 9 1.7. GENERAL SAFETY WARNINGS ....................................................................................................................... 10

1.7.1. INSTALLATION CONDITIONS ................................................................................................................... 10 1.7.2. CONDITIONS OF USE ............................................................................................................................... 10 1.7.3. WARRANTY ................................................................................................................................................ 11 1.7.4. MAINTENANCE AND DISPOSAL ............................................................................................................... 12 1.7.5. CLEANING AND DISINFECTION ............................................................................................................... 13 1.7.6. HYGIENE PROCEDURES FOR PATIENT PROTECTION ........................................................................ 14

1.8. SAFETY WARNINGS ......................................................................................................................................... 15 1.8.1. CONDITIONS OF USE ............................................................................................................................... 15 1.8.2. GENERAL SAFETY .................................................................................................................................... 15 1.8.3. SAFETY DURING X-RAY DEVICE MOVEMENTS .................................................................................... 15 1.8.4. EMERGENCY BUTTON ............................................................................................................................. 16 1.8.5. EXPOSURE TO LASER RADIATION ......................................................................................................... 16 1.8.6. ELECTROMAGNETIC SAFETY ................................................................................................................. 17 1.8.7. PROTECTION AGAINST RADIATION ....................................................................................................... 19 1.8.8. APPLIED PARTS ........................................................................................................................................ 19 1.8.9. STRAY RADIATIONS.................................................................................................................................. 20

2. DESCRIPTION OF OPERATION ............................................................................................................................ 21 3. COMPONENTS ....................................................................................................................................................... 22 4. CONTROL PANEL .................................................................................................................................................. 23

4.1. CONSOLE ONBOARD THE MACHINE ............................................................................................................. 23 4.2. X-RAY EMISSION REMOTE CONTROL ........................................................................................................... 23 4.3. PERFORM A SIMULATION (DUMMY RUN) ..................................................................................................... 24

5. PERFORMING A 2D X-RAY EXAMINATION ......................................................................................................... 25 5.1. STARTING THE SYSTEM .................................................................................................................................. 25 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 THE PROJECTION TYPE .......................................................................................................... 33

5.3. PREPARATION OF THE X-RAY EXAMINATION .............................................................................................. 34 5.3.1. EDENTOLOUS PATIENTS DEVICES (OPTIONAL) .................................................................................. 34

5.4. PATIENT POSITIONING .................................................................................................................................... 34 5.4.1. LASER TRACES ......................................................................................................................................... 35 5.4.2. PATIENT POSITIONING DESCRIPTION (CRANIOSTAT) ........................................................................ 36 5.4.3. PAN, DENT EXAMINATIONS ..................................................................................................................... 37 5.4.4. TMJ EXAMINATION .................................................................................................................................... 38 5.4.4.1. LATERAL TMJ ................................................................................................................................... 38 5.4.4.2. FRONTAL TMJ .................................................................................................................................. 39 5.4.5. SIN EXAMINATION ..................................................................................................................................... 39

5.5. ACQUISITION OF THE EXAM ........................................................................................................................... 40 5.6. TYPICAL IMAGES OF THE EXAMS .................................................................................................................. 41

5.6.1. ADULT PANORAMIC IMAGING ................................................................................................................. 41 5.6.2. CHILD PANORAMIC IMAGING .................................................................................................................. 41 5.6.3. TMJ EXAMINATIONS (TEMPOROMANDIBULAR JOINT) ........................................................................ 41 5.6.4. SIN EXAMINATIONS .................................................................................................................................. 42 5.6.5. DENTITION/BITEWING EXAMINATIONS .................................................................................................. 42

6. 3D TOMOGRAPHIC EXAMINATION (CB3D) ......................................................................................................... 43 6.1. SELECTING THE EXAMINATION FROM THE CONTROL CONSOLE ............................................................ 43 6.2. POSITIONING THE PATIENT FOR 3D EXAMINATIONS ................................................................................. 49 6.3. PERFORMING THE EXAMINATION ................................................................................................................. 49

EN OPERATOR'S MANUAL 3

6.4. SPECIAL CONSIDERATIONS FOR CBCT EXAMINATIONS WITH CHILDREN OR SMALL PATIENTS ....... 50 7. VIEWING AND SAVING .......................................................................................................................................... 51 8. PERIODIC CHECKS AND MAINTENANCE ........................................................................................................... 52

8.1. PERIODIC INSPECTIONS TO CHECK THE IMAGE ........................................................................................ 52 8.1.1. X-RAY EMISSION QUALITY CONTROL .................................................................................................... 52 8.1.2. COLLIMATOR TEST ................................................................................................................................... 53 8.1.3. 2D IMAGE QUALITY CONTROLS BY MEANS OF PHANTOM ................................................................. 53 8.1.4. 3D IMAGE QUALITY CONTROLS .............................................................................................................. 54

8.2. QA PHANTOM ACQUISITION ........................................................................................................................... 55 8.2.1. QA PHANTOM TROUBLESHOOTING ....................................................................................................... 57

9. TECHNICAL DATA .................................................................................................................................................. 58 9.1. ELECTRICAL CHARACTERISTICS .................................................................................................................. 58 9.2. RADIOLOGICAL CHARACTERISTICS.............................................................................................................. 58 9.3. ISODOSE CURVES FOR 2D EXAMINATIONS ................................................................................................. 60 9.4. ISODOSE CURVES FOR CBCT EXAMINATIONS ........................................................................................... 60 9.5. PANORAMIC SENSOR CHARACTERISTICS(PAN) ......................................................................................... 61 9.6. 3D PANEL FEATURES ...................................................................................................................................... 61 9.7. LASER CHARACTERISTICS ............................................................................................................................. 61 9.8. DIMENSIONAL CHARACTERISTICS ................................................................................................................ 62 9.9. ENVIRONMENT CHARACTERISTICS .............................................................................................................. 65 9.10. PC REQUIREMENTS .................................................................................................................................... 66 9.11. MOBILE DEVICE REQUIREMENTS ............................................................................................................. 67 9.12. IDENTIFICATION LABEL POSITION ............................................................................................................ 68

10. ERROR MESSAGES .............................................................................................................................................. 69 11. USER’S LICENCE CONTRACT .............................................................................................................................. 70

11.1. GENERAL CONDITIONS OF THE IMAGE SOFTWARE LICENCE ............................................................. 70 11.1.1. USER’S LICENCE ................................................................................................................................. 70 11.1.2. COPYRIGHT .......................................................................................................................................... 70 11.1.3. USE OF THE SOFTWARE PRODUCT AND EXPRESS TERMINATION CLAUSE ............................. 71 11.1.4. GUARANTEE AND EXCLUSIONS FROM THE GUARANTEE ............................................................ 71 11.1.5. LIMITS OF RESPONSIBILITY ............................................................................................................... 71 11.1.6. APPLICABLE LAWS, JURISDICTION AND COURT OF JURISDICTION ........................................... 71 11.1.7. WRITTEN FORM ................................................................................................................................... 71 11.1.8. TRANSLATION ...................................................................................................................................... 72 11.1.9. SOFTWARE COMPLIANCE WITH THE REGULATIONS IN FORCE .................................................. 72

12. INSPECTION AND MAINTENANCE ....................................................................................................................... 73 12.1. USER INSPECTION ...................................................................................................................................... 73 12.2. TECHNICAL MAINTENANCE ........................................................................................................................ 74


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.


1. INTRODUCTION AND INDICATIONS FOR USE

For 2D machine only:

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.


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 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.

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.

Do not use on patients (children) 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.


Contraindications:

- visualisation of cartilaginous structures;

- the CBCT technique (for 3D machines only) 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”.

The manufacturer’s website contains a list of authorised agents.

Address for circulation of consumers within the Russian Federation:

Zenith R.S. LLC

Bldg 3, Property 15, Gorodok-17 Str., Bolshie Vyazemy Settlement, Odintsovo District

143051 Moscow Region, Russia

phone: +7 (495) 980-13-50

+7 (495) 787-68-36

e-mail: [email protected]

Website: www.zenith-rs.ru

For technical service, it is possible to contact the local distributor.

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. - 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, 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.

- 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.

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 machine 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

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.


1.6. STYLISTIC CONVENTIONS

The following symbols may be found on the X-ray device:

Equipment compliant with directive 93/42/EEC as amended.

Notified body: IMQ spa.

Applied part of type B, according to IEC 60601-1.

Product/equipment identification code.

Product serial number.

Manufacturer.

Date of manufacture (month / year).

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.

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.

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.

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: [email protected].

Users in the USA market are required to contact:

Cefla North America Inc.,

6125 Harris Technology Blvd., Charlotte, NC, 28269 United States

Phone: +1 704 598 0020, e-mail: [email protected]

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.


1.7.4. MAINTENANCE AND DISPOSAL

Never remove the device covers.

The device does not contain parts that can be repaired directly by the user. In the event of malfunctioning, do not

attempt to carry out any type of maintenance operation. If you find or suspect any kind of system malfunctioning, do

not attempt to carry out any type of maintenance operation and do not use the system on a patient, but directly

contact your local distributor.

The user may not carry out maintenance on any mechanical or electronic part of the x-ray system.

Opening the cases to access the internal circuits may cause device breakage and failure of the electrical safety

devices and will lead to forfeiture of the warranty.

Any maintenance, repairs and modifications of the device must be carried out only by personnel directly authorised

by the Manufacturer or by third parties expressly authorised by the Manufacturer and must be carried out according

to the laws in force and the generally accepted technical standards.

All the system components must be checked and replaced, if necessary, by qualified personnel.

For any maintenance operation, please contact the Manufacturer via the website indicated on the cover of this

manual by filling in the Information Request form.

Further information about the device regular inspection and maintenance is provided in the document “hyperion X5 -

Inspection and Maintenance”.

Should you for any reason need to return the device or its parts to the Manufacturer or a Technical Service centre,

disinfect all the external parts of the device using a specific product (see the paragraph “Cleaning and disinfection”)

and preferably return it in its original packaging.

At the end of its lifetime, dispose of the device in accordance with the regulations in force. It is also advisable to

disinfect all the external parts of the device before disposal and to separate the materials for differentiated waste

collection.

In compliance with Directives 2011/65/EU and 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 purchasing a new

device of an equivalent type, one for one, the device that has come to the end of its lifetime should be returned to the

distributor for disposal. As regards reuse, recycling and other forms of recovery of waste electrical and electronic

equipment, the Manufacturer carries out the functions defined by current local laws. Appropriate differentiated waste

collection for subsequent recycling treatment and environmentally friendly disposal contributes to preventing possible

negative effects on the environment and health and encourages recycling of the materials of which the device is

made up. The crossed-out bin symbol on the device indicates that the product must be collected separately from

other waste at the end of its useful life. Under local legislation, fines can be imposed if the equipment is disposed in

an illegal manner.


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.


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.


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

- Do not forget to turn off the main switch on the equipment before leaving the surgery.

- The device is not protected against liquid penetration (Class IPX0 – common protection).

- The equipment 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.

- This equipment must be stored properly so that it is kept in top working order at all times.

- The user must be present at all times when the equipment is turned on or ready for start-up. In particular, never

leave the equipment unattended in the presence of children or other unauthorised personnel in general.

- The Manufacturer shall not be held responsible (under civil and criminal law) for misuse, carelessness or

improper use of the equipment.

- If any person who is not an authorised technician changes the product in any way by replacing parts or

components with other ones not used by the Manufacturer, they shall assume responsibility for the product.

- Any computer, monitor, printer, mouse, keyboard and any other device connected to the X-ray device must be

compliant with ISO, IEC, EN or local standards.

- The Manufacturer is not responsible for problems or malfunction of parts and/or components not approved by

itself, not complying with the regulations and not installed by qualified technical personnel acknowledged by the

Manufacturer.

- Do not use electronic equipment not compliant 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 its 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.


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 .


1.8.6. ELECTROMAGNETIC SAFETY

Do not use electronic equipment not compliant 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, including the X-ray device.

Guidance and Manufacturer's declaration - Electromagnetic emissions

hyperion X5 is designed to operate in the specified electromagnetic environment. 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 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 must be used only by adequately trained

personnel (dentists and paramedics). hyperion X5

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 hyperion X5 or shielding the installation site.

Guidance and Manufacturer's declaration - Electromagnetic immunity

hyperion X5 is designed to operate in the specified electromagnetic environment. 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

Level of

conformity

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



environment.

Voltage drops,

short interruptions

and voltage

change on the IEC

61000-4-11 input

electric line

0% Un for 0.5 cycles

40% Un for 5 cycles

70% Un for 25 cycles

0 % Un for 5 s

IEC 60601-1-2

Test level



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.


Guidance and Manufacturer's declaration - Electromagnetic immunity

hyperion X5 is designed to operate in the specified electromagnetic environment. The customer or user of

hyperion X5 must ensure that it is used in such environment.

Immunity test IEC 60601-1-2

Test level

Level of

conformity

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 metres (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 intended for use in electromagnetic environment where RF irradiated disturbances are controlled.

The customer or the user of the hyperion X5 can prevent electromagnetic interferences by ensuring a minimum

distance between RF mobile and portable (transmitter) communication devices and hyperion X5 as shown below,

according to maximum power output of the communication devices.

Transmitter maximum nominal

output

(W)

Distance according the transmitter frequency

(m)

150KHz to 80MHz

d = 1.2 x √P 80KHz to 800MHz

d = 1.2 x √P 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 d in metres

(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.


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.


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.


(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).


(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.


(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.


2. DESCRIPTION OF OPERATION

For the execution of panoramic X-rays or tomographic exams, the radiographic device consists of a rotating arm

fitted on a column support. The rotating arm features motor-driven rotating shifting devices that allow moving the X-

ray emission system and the image detector around the patient according to complex orbits following the

morphological profile. The rotating arm is attached to a column support capable of moving vertically through a motor

drive. The position of the X-ray device shown in the pictures is the Patient Access Position.

1 - 3D/2D panel (only for 3D machines) 2 - 2D sensor for panoramic images (only for 2D

machines)

3 - Craniostat

4 - Console

5 - Aiming laser

6 - X-ray source

7 - Lifting telescopic column

8 - Support for chin and bite


3. COMPONENTS

Basic machine

2D sensor for panoramic images (only for 2D machines)

3D/2D panel for panoramic / tomographic images (only for 3D machines)

Craniostat

Craniostat (only for 3D machines)

Optional, standard stand

Remote ray button (optional)

USB Pen Drive containing the Instruction Manual, Driver and Software for image visualisation

Declaration of conformity

Certificate of warranty


4. CONTROL PANEL 4.1. CONSOLE ONBOARD THE MACHINE

Control panel area

Button Description and use

Confirm button

Column up movement

Column down movement

Vertical Laser Positioning -

canine or condyle cusp for

patient framing (+)

Vertical Laser Positioning -

canine or condyle cusp for

patient framing (-)

The control panel (console on-board the machine) allows controlling the X-ray device.

The control panel consists of 5 buttons with functions to move parts of the X-ray device (column, craniostat, laser

traces) used to position the Patient.

2 LEDs on the control panel indicate the system status:

RGB LED

If the X-ray device is ready, the green LED is on.

If the X-ray device is on and working, the LED is blue.

If the X-ray device is in standby, the LED is blue and flashing.

If the machine is in error, the LED is red.

The yellow LED on the right comes on when X-ray emission is in progress.

4.2. X-RAY EMISSION REMOTE CONTROL

The system can be equipped with a remote control to activate X-ray emission.

The remote control features:

1) A button to confirm the X-ray emission

2) Two LED lights

a. Green (machine ready for emission)

b. Yellow (X-ray emission in progress)

When the system is Ready (green LED steady-on), you can start X-ray emission by pressing the button on the

remote control and holding it down for the entire duration of the examination.

During the examination, the yellow LED on the remote control turns on and simultaneously an acoustic signal is

emitted.

Button pressed Button released

If the button is released before the examination is completed, the image acquisition will be interrupted.


If the acquisition is interrupted before its completion, the entire portion of analysed tissue will however be shown on

the PC together with an error message.

If the image is exhaustive, even if partial, the examination does not need to be repeated, thus avoiding subjecting the

patient to a further dose of radiation.

In order to comply with the operator safety regulations on ionizing radiation (for clarifications, see paragraph 1.8.7

"Protection against ionizing radiation"), the operator must stand at least 2 metres away from the X-ray device during

emission.

4.3. PERFORM A SIMULATION (DUMMY RUN)

The unit moves when the following operations are performed. The operator must:

- Closely monitor the patient and immediately let go of the button to stop movement if there is a risk of the

device hitting the patient.

- Prevent the patient from assuming incorrect positions (putting hands or other body parts in inappropriate

areas) or moving out of the examination area.

To perform a simulated cycle, a simulation of the projection mode or program selected, but without emission of

radiation (dummy run), hold down the button (CONFIRM).

This button must be held down for the entire cycle, otherwise the movement will stop.

This simulation can be useful for particularly emotional patients, especially children, showing them what the

examination consists of without having to leave them alone in the room.


5. PERFORMING A 2D X-RAY EXAMINATION

The steps to follow to properly perform an X-ray examination are:

1 – Switching on of system and PC where the acquisition driver is installed

2 – Selection of the X-ray examination from virtual control console (PC/iPAD)

3 – Preparation of the X-ray examination

4 – Positioning of the patient (with optional aid of control console on PC/iPAD or its limited version for other mobile

platforms)

5 – Examination execution

6 – Image display and processing

5.1. STARTING THE SYSTEM

Turn the X-ray device on by pressing power button (1) on

the top right-hand side: the console lights up and a beep

sound is emitted.

If the X-ray device is in standby (multicolour flashing LED) press the CONFIRM button to reset the functions.

Before starting exposure, wait for the DRIVER software to be ready (the driver icon on the bottom right-hand

side of the PC turns green)

Once the system and DRIVER are correctly started, the multicolour LED remains steady-on.

Excessive dose on pediatric patient: 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.


5.2. SELECTING THE EXAMINATION FROM THE CONTROL CONSOLE

5.2.1. 2D EXAMINATIONS AVAILABLE

Panoramic examinations (PAN) :

The panoramic standard examinations have the traditional path and angles of the X-ray beam. If the patient is a child,

or very small adult, we recommend to use the child setting for the exposure where the width of the exposed area and

the dose irradiated are reduced. The panoramic pediatric PAN CHILD projection is a subset of the panoramic

standard projection, with a reduced field projection to limit the patient exposure to radiation. To identify a PAN CHILD

projection, select CHILD as the Patient type.

If the patient is a child of less than approximately 104 cm in height and less than 19 Kg in weight that are the

height and weight measurements approximately correspondent to an average 4 year old child, he shall not

be exposed to hyperion X5.

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 radiographies 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”.

Preview Name Description

PAN STANDARD Projection that allows the view of the entire dental arch and of

the TMJ (temporomandibular joints)

PAN CHILD Panoramic projection for children (reduced dose)

PAN QUICK Very quick projection for the entire dental arch, including the

TMJ.

PAN HALF R Similar to PAN STANDARD but regarding only the right side.

PAN HALF L Similar to PAN STANDARD but regarding only the left side.

PAN DENT Projection of the entire dental arch without the TMJ, with

improved orthogonality to reduce crown overlapping.

PAN DENT HALF R Similar to PAN DENT but regarding only the right side.

http://www.imagegently.org/


PAN DENT HALF L Similar to PAN DENT but regarding only the left side.

PAN FRONTAL Similar to PAN DENTITION but regarding only the front area.

PAN BITEWING Set of optimised images that represent the crowns of all teeth

(only for 3D machines).

PAN BITEWING R Set of optimised images that represent the crowns of the right-

hand teeth (only for 3D machines).

PAN BITEWING L Set of optimised images that represent the crowns of the left-

hand teeth (only for 3D machines).

Patient positioning is very important in order to obtain the best

focusing of the anterior teeth. Please follow the

recommendations of paragraph 5.4 “Patient Positioning”.

However, in order to obtain a properly focused image, for each

PAN diagnostic program you can select to download a set of

multiple panoramic images, each with slightly different focusing

of the anterior teeth. If you prefer to manage just a single image,

you may let the application software to choose the best focused

image for you, by enabling the “free focus” option in the

application settings (see paragraph 5.2.2. SELECTING AN

EXAMINATION, button 3).


Maxillary sinuses examinations (SIN) :


SIN MAXILLARY Linear projection of the cranium in posteroanterior view at the

level of the maxillary sinuses.

SIN MAXILLARY R Linear projection of the cranium in lateral view at the level of the

right-hand maxillary sinuses.

SIN MAXILLARY L Linear projection of the cranium in lateral view at the level of the

left-hand maxillary sinuses.

Temporomandibular joints examinations (TMJ) :


TMJ Both R-L Lateral and frontal exam of both the right and left joints; for a

total of four images.

TMJ Frontal R-L Posteroanterior projection of both joints.

TMJ Lateral R-L Lateral projection (along the longest axis of the mandibular

condyles) of both temporomandibular joints.

For each one of the TMJ diagnostic programs, it is possible to

carry out the exam with the mouth closed, in rest conditions and

with the mouth open.


5.2.2. SELECTING AN EXAMINATION

For 2D machine only

Once the configuration is completed, the application can

be started by using the relevant icon in the application list.

From now on, every choice made on the console is sent

directly to hyperion X5 and displayed on the control panel.

The application is divided into two main screens: home,

2D examination selection and 3D examination

selection (for 3D machine only) that can be accessed by

pressing the relevant button on the button bar placed at

the bottom of the screen.

The images on the left show the button bars in case of 2D

version (top) and 3D version (bottom) of the machine.

By way of example, the images used in the following

pages will show the button bar of the 3D version. Unless

otherwise specified, the console functions in case of 2D

version of the machine are completely equivalent.

For 3D machine only

Every screen features an upper tool bar; it is structured as shown in the figure on the left.

1- Connection button.

Press this button to connect / disconnect the device. During the connection procedure, this button flashes, and it

turns off when the device is in "Demo" mode or there is no connection.

2- Button to display the last image downloaded on your iPad (always saved, even after the tablet has been turned

off, until the next scan).

3- Button to access the application settings.

4- Type of exam selected; the parameters (kV, mA and SEC) are displayed only when the machine is in “Ready”

status for displaying.

5- Status icons of hyperion X5.

The main screen (Home) lists the last 3 examinations.

This helps in the quick selection of the scanning protocol.


This screen contains the selectable examinations divided

into families (PAN, SIN, TMJ) with all the specific exams

available (that can be selected with the scroll bar).

Select the icon to access the Settings screen

containing the exposure parameter settings.

The values are automatically adapted to the selected

exposure protocol.

From this screen it is possible to select combinations of

exposure parameters among the different types of

patients (man, woman, child) and the preselected options

of the relevant sizes (small, medium, big), each of them

with its own default kV, mA and time parameters.

The kiloVolt (kV) and milliAmpere (mA) values that appear

are the default Voltage and Current values for the

selected patient type, as configured in the device. The

table below shows the initial default values of the kV, mA

and time settings for a medium size:

Patient

type

Default Exposure Values

(For 2D machine only) Default Exposure Values

(For 3D machine only)

kV mA Second kV mA Second

PAN:

Child: 4-13 yrs 72 7 10.9 72 8 10.9

Standard: Adult-Man 78 7 12.2 78 8 12.2

Standard: Adult-Woman 77 7 12.2 77 8 12.2

Pan Dent 78 7 11.4 78 8 11.4

Sin Maxill 78 7 6.2 78 8 6.2

TMJ Both R+L 78 7 13.8 78 8 13.8


Moreover, by touching the padlock icon, it is possible to

directly work on exposure parameters, changing kV and

mA settings.

Press the confirmation button on the console of the

machine, or press the NEXT button on the control console

on PC or iPAD (enclosed in the red rectangle in the image

on the left).

Afterwards, let the patient in and position him/her as

described in paragraph 5.4 "Patient positioning".

In addition to the console present on the device, it is

possible to use the control console on PC/iPAD (or its

limited version for other mobile platforms) to improve the

column and the vertical focusing laser positioning.

By clicking on the arrows in the right-hand box, it is

possible to slightly move the column upwards or

downwards, or move the vertical focusing laser forward or

backward.

Once all the examination settings are adjusted, and the

patient is properly positioned, if desired, it is possible to

start exposure.


The image is downloaded on the PC and is displayed /

hidden by pressing the button on the upper tool bar of the console on iPAD, if used.

Open the menu on the bottom left-hand side to access the

image editing tools; brightness, contrast, range and X,

which restores the image to its original status. On the

right-hand side, instead, there are 2 icons, the first sends

the image via e-mail (if the relevant option is enabled) and

the second is used to save the image (which is in the

iPAD image database).

The image on iPAD is provided just for preview purpose and it must not be adopted for diagnostic purposes.

The quality of image preview depends on the display of the mobile platform used: refer to paragraph 9.11

“Mobile device requirements”.


5.2.3. SETTING THE PROJECTION TYPE

Inside the examination families, different projection types are available. Select one of three projections icon: PAN,

SIN and TMJ and then select the purple dots showing the name on the functional bar until the desired projection type

appears.

PAN

It is possible to choose among 9 types of panoramic X-rays. For a panoramic pediatric projection or panoramic

dentition, select PAN and then select the purple dots for PAN CHILD or PAN DENTITION. The figure appears as

blue and changes to white. Click on the dot as shown in the two examples below:

PAN STANDARD PAN HALF R

SIN

For SIN examinations, it is possible to choose among 3 types, clicking on a dot as shown in the two examples below:

SIN MAXILLARY SIN MAXILLARY R

TMJ

For TMJ exams, it is possible to choose among 3 types, clicking on a dot as shown in the two examples below:

TMJ BOTH R-L TMJ LATERAL R-L


5.3. PREPARATION OF THE X-RAY EXAMINATION

5.3.1. EDENTOLOUS PATIENTS DEVICES (OPTIONAL)

In case of edentulous patients, for the PAN, DENT, SIN or CBCT examinations requiring the use of the bite piece,

apply the single-use soft insert supplied, as follows:

1 - remove the soft bite from the mould (Fig. 1)

2 - apply the single-use protection on the bite piece (Fig. 2)

3 - insert the soft bite in the bite piece as shown in the figure (Fig. 3)

4 - push the bite until the material block is ejected (Fig. 4)

Always apply the single-use protection on the bite piece before inserting the soft bite.

Then proceed to the standard positioning for the examination, asking the patient to close the mucous membranes at

the centre of the soft insert.

Fig. 1 Fig. 2 Fig. 3 Fig. 4

5.4. PATIENT POSITIONING

Having the patient correctly positioned for a panoramic X-ray is extremely important for the quality of the image. The

size and shape of the most sharply defined area on the image depends on the correct positioning of the patient.

Set the X-ray device to Patient Access status before letting the patient in and starting any cranium positioning

operation.

If the X-ray device is not in Patient Access status, press the CONFIRM button , wait for the X-ray device to

complete its movements and for the laser beams to turn on.

When pressing the CONFIRM button, wait a few seconds for the X-ray device to complete its movements; in this

phase you will not be able to use the control console, the only exception being the CONFIRM button to interrupt the

process.

During patient access and, in any case, before starting the examination, ensure that the X-ray device is not

hit unintentionally: if this is the case, press the emergency button and position the X-ray device once again

with the button.


5.4.1. LASER TRACES

The X-ray device features three light traces which help positioning the patient:

1) Upper Horizontal Laser Trace used in all PAN, DENT, SIN, TMJ,

CBCT examinations

2) Sagittal Vertical Laser Trace used in all the examinations

3) Vertical Focusing Laser Trace used in PAN, DENT, SIN, TMJ

examinations

Upper horizontal trace (1)

it is generated by a laser projector placed on the X-ray generator side; it can be moved upward or downward to be

adapted to different dimensions, using the suitable lever beside the light opening. This trace is used in PAN and

DENT examinations to ensure that the patient’s Frankfurt plane is horizontal and, more generally, to ensure correct

positioning.

The Frankfurt plane is represented by an imaginary line running from the upper edge of the auditory meatus to the

lower edge of the orbit.

Sagittal vertical trace (2)

it ensures the symmetry of the patient head with respect to the sagittal midline. While observing this trace, it is

necessary to make sure that the patient looks straight ahead to prevent him/her from tilting the head to one side or

from rotating it slightly.

Vertical focusing trace (3)

it indicates the exact position of the focal point; to obtain a good focusing in PAN and DENT examinations, make this

trace coincide with the cusp of the upper canine. This trace is used also to point at the exact position of the condylar

head for TMJ examinations and between the first and second upper molar for SIN examinations.

Each pressure of the CONFIRMATION button will move all the device mobile parts. Make sure NOT to

press the button during the patient positioning and that the device can be safely moved.


5.4.2. PATIENT POSITIONING DESCRIPTION (CRANIOSTAT)

Craniostat components:

1 – Anatomic arches

2 – Bite

3 – Chinrest

The craniostat is equipped, in its upper side, with

anatomic arches that, once the patient is positioned, can

be adjusted and automatically locked by simply pressing

point (A) with your fingers. The arches perform

synchronous movements with each other. To unlock

them, always press area (A).

The craniostat lower area consists of chinrest (3) and bite (2) that can be disassembled as shown in the figure next.


5.4.3. PAN, DENT EXAMINATIONS

1) Adjust the height of the unit to facilitate patient access using the column

up or down movement buttons. The telescopic column moves slowly at

first and then picks up speed. Adjust the height until the bite piece is

slightly higher than the occlusal plane of the patient. As a result, the

patient will have to stretch to reach the bite, thus extending and

straightening his/her neck.

2) Make sure that the bite piece is turned sideways to leave room for the patient. Make sure the bite disposable

protection is fitted.

3) Accompany the patient to the unit so that he/she is in front of the bite and can grasp the large handles. Ask the

patient to rest his or her chin on the chinrest.

4) Ask the patient to take one step forward, while still gripping the handles,

until he/she reaches the position shown in the figure.

5) Adjust the height of the bite piece and turn it inside the mouth, letting the

patient bite on it as shown in the figure. The tip of the upper and lower

incisors must sit in the groove of the bite piece. The interproximal space

of the incisors must be on the median line of the bite piece.

6) The support post can slide up and down, facilitating the proper

positioning of the bite piece.

7) Check the symmetry of the patient’s head using the sagittal vertical trace

as a guide (dotted line) by looking at the mirror.


8) Check the proper positioning of the Frankfurt plane superimposing the

upper horizontal light beam (dotted line). To adjust the patient’s head

inclination, work the column up and down movement buttons. Make sure

that the patient keeps his or her back straight and extended.

9) Ask the patient to smile to uncover the upper teeth. The vertical light beam usually falls between the canine cusp

*.

In case of patient dysmorphia, move the light beam forward or backward towards the canine, by using the

console buttons , in order to optimise teeth focusing.

* the canine can be used as a useful reference to fine-tune the patient alignment, but this is not strictly necessary.

10) Press the CONFIRM button and, just before leaving the room to press the X-ray emission button, ask the patient

to close his or her eyes, swallow and place the tongue against the palate.

5.4.4. TMJ EXAMINATION

5.4.4.1. LATERAL TMJ

1) Remove the chin rest and the bite, and insert the under-nose support.

2) Adjust the unit height, in order to facilitate the patient’s access, using the keys to move the column

upward or downward until the under-nose support reaches the height of the nose base. The telescopic column

will move slowly at first, then it will speed up.

TMJ examinations can be carried out with open mouth or closed mouth by selecting the proper icon on the

control console.

3) Guide the patient toward the unit so that he/she faces

the under-nose support and can grab the wide

handles. The patient will rest the nose base on the

under-nose support, as in the figure.

4) Check the symmetry of the patient’s head using the

sagittal vertical trace as a guide; check the correct

positioning of the Frankfurt plane by overlapping the

upper horizontal light trace, as shown in the previous

figure. If required for the examination and if

necessary, slightly tilt the patient’s head forward to

ease the maximum mouth opening.

5) Once the correct orientation has been found, lock the

craniostat as explained in paragraph 5.4.2.


6) Make sure that the examination required is selected

correctly.

Use keys to position the vertical

focusing light trace exactly on the condyle head, as

shown in the figure.

7) Press the CONFIRMATION button and, immediately before leaving the room to press the X-ray emission button,

ask the patient to close his/her eyes and remain still.

5.4.4.2. FRONTAL TMJ

Follow the same steps of the Lateral TMJ examination.

In order to adjust the head inclination, just raise or lower

the unit using the height adjustment buttons.

5.4.5. SIN EXAMINATION

1) Remove the chin rest and the bite, and insert the under-nose special support for sinuses.

2) Adjust the unit height, in order to facilitate the patient’s access, using the keys to move the column

upward or downward until the special support for sinuses reaches the height of the nose base. The telescopic

column will move slowly at first, then it will speed up.

3) Guide the patient toward the unit so that he/she faces

the under-nose support and can grab the wide

handles. The patient will rest the nose base on the

special support for sinuses, as in the figure.


4) Check the symmetry of the patient’s head using the

sagittal vertical trace as a guide; check the correct

positioning of the Frankfurt plane by overlapping the

upper horizontal light trace, as shown in the previous

figure.

5) Once the correct orientation has been found, lock the

craniostat as explained in paragraph 5.4.2.

6) Make sure that the examination required is selected

correctly.

Use the keys to position the vertical

focusing light trace between the first and the second

upper premolar.

7) Press the CONFIRMATION button and, immediately before leaving the room to press the X-ray emission button,

ask the patient to close his/her eyes and remain still.

5.5. ACQUISITION OF THE EXAM

- Visually check that the patient is correctly positioned and that the central green LED on the X-ray remote control

is steady on.

- Ask the patient not to move during the examination and to breathe slowly and regularly. For panoramic (PAN)

projections, ask the patient to swallow just before X-ray radiation exposure (so that the tongue is up against

palate).

- Have anyone not necessary move away from the area exposed to radiation and, where required, stand behind

the special protection.

- Press the X-ray button on the remote control and

hold it down for the entire duration of the

examination. The examination time is determined by

the intermittent yellow LED on the X-ray remote

control device. X-ray emission is signalled by an

acoustic signal.

The X-ray device emits rays to acquire the images only if its status is Ready, i.e. when the green LED on the

control console and on the remote control is on. It may occur that, as a result of the user or of the X-ray

device error, the device does not indicate that it is ready and X-rays can hence not be emitted. Correct the

error (see the chapter Error Messages) and press the CONFIRM button.


5.6. TYPICAL IMAGES OF THE EXAMS

5.6.1. ADULT PANORAMIC IMAGING

The program of standard panoramic exposure enables a

thorough or partial analysis of the patient’s state by

selecting the area of diagnostic relevance. The image on

the left shows a typical image with PAN standard

exposure.

5.6.2. CHILD PANORAMIC IMAGING

The program of standard panoramic child (PAN CHILD)

produce an automatically reduced and optimized

exposure that with a reduction in trajectory / time / dose

still allows the evaluation of the overall oral health of the

patient.

The image on the left shows a typical image with PAN

CHILD exposure.

5.6.3. TMJ EXAMINATIONS (TEMPOROMANDIBULAR JOINT)

The program for the X-ray of temporomandibular joints

(TMJ) allows a study of the temporomandibular status in

a simpler way showing four (latero-lateral and

posteroanterior) X-ray images in a single scan.

The image on the left shows a typical image with TMJ

exposure.


5.6.4. SIN EXAMINATIONS

The program for the X-ray of maxillary sinuses (SIN)

allows a study of the state of this anatomical region with

one latero-lateral or postero-anterior X-ray image.

The image on the left shows a typical image with SIN

exposure.

5.6.5. DENTITION/BITEWING EXAMINATIONS

The program of dentition panoramic exposure enables an

analysis with optimised orthogonal projection by selecting

the area of diagnostic relevance. The image on the left

shows a typical image with PAN/DENT-BITEWING (*)

standard exposure.

(*) reduced collimation, only 3D version


6. 3D TOMOGRAPHIC EXAMINATION (CB3D)


The CBCT exam consists in the three-dimensional reconstruction of an X-rayed anatomical region, which produces

both two-dimensional views and three-dimensional representations that are generated by a software on a workstation

(PC).

Instructions about image processing can be found in the iRYS software user manual.

Remember to change the disposable protective covers before positioning a new patient.

Before positioning the patient, make sure all metal items worn have been taken off such as eyeglasses,

movable prosthesis, earrings and any other removable metal items present at head level. If an apron is used

for protection against radiation, make sure the patient’s neck is not covered. If it is, an area will not be X-

rayed.

6.1. SELECTING THE EXAMINATION FROM THE CONTROL CONSOLE

The 3D exam can only be performed if the X-ray device is connected to a PC where the iRYS software is

installed.

1) Turn the PC on and run the iRYS program .

2) Upon the first start of each day, the daily control procedure (Daily Check) has to be completed before any 3D

exam can be started. This daily check is a service procedure with X-ray emission that has to be performed

WITHOUT THE PATIENT.

3) For instructions, please consult the "Acquisition Operations" section of the iRYS manual.

The patient must not access the X-ray device during the exam selection and the device reset operations.

Position the patient only after the device reset has been carried out according to the procedure described in

this paragraph.


In order to display the FAVOURITES starting page, press the icon.

If the 3D exam is among the favourites, it will be

possible to select it by touching its icon, otherwise the

3D section can be accessed by pressing the

icon.

In both cases, the screen shown on the left will be

displayed, containing the correctly selected CBCT

program.

1) Selection of the field of view (FOV)

In order to display the list of the available fields of view,

select the icon.

In the menu, set the diameter of the desired field of

view. The following fields of view are available:

[10 x 10] (volume diameter 10cm, height 10cm)

[10 x 7]

[10 x 6]

[8 x 10]

[8 x 7]

[8 x 6]

[6 x 7]

[6 x 6]


2) Protocol setting

Select the exam protocol by pressing the

icon.

The protocol selection menu will appear;

depending on the kind of machine and on the

diameter of the selected field of view, the

following options will be available:

Lower arch protocol

Upper arch protocol

Two arches protocol

Maxillary sinuses protocol

3) Mode selection

Select the exam mode:

Standard resolution:

reconstruction with minimum

voxel dimension 160µm;

High resolution: reconstruction

with minimum voxel dimension

80µm.


4) Selection of the volumetric reconstruction

centre

Select the centre of the CBCT reconstruction

in the EXAM screen by touching the region

to be reconstructed. A red circle will highlight

the selected area.

The choice of the reconstruction centre is only preliminary: at the end of the patient positioning, the final selection of

the anatomical region for the 3D exam will be realised via a guided procedure on the PC workstation.

Changing the factors of the X-ray exposure technique (kV, mA, s) is not required nor permitted, because the

system will automatically fine-tune them during the exam.

5) Device reset

After selecting the CBCT reconstruction centre and

the required resolution, press the NEXT button

(enclosed in the red rectangle in the image on the left)

to continue.


The following screen requires you to reset the device

to the default position. In order to start the reset, press

the NEXT button once again.

After pressing NEXT, wait for the device to complete

the automatic reset procedure.

6) Support selection and patient positioning

Once the reset is completed, follow the instructions

displayed in the left-hand box and, if necessary,

mount the specific patient support on the unit.

It is now possible to let the patient in and position him/her as described in paragraph 6.2 "Positioning the

patient for 3D exams".


Afterwards, let the patient in and position him/her as

described in paragraph 6.2 "Positioning the patient for

3D exams".

By clicking on the arrows in the right-hand box it is

possible to improve the column positioning, moving it

upwards or downwards.

Once the patient has been correctly positioned, click

on the NEXT button.

6) Starting the scan

Choose between the PATIENT SCAN or DENTURE

SCAN option to pass the control to the iRYS software.

7) Scanning mode selection

In the following screen, select the Eco Scan or the

Regular Scan option in order to start the CBCT

acquisition process.

Follow the instructions for the acquisition operations

described in the iRYS manual to complete image

acquisition.

Compared to the Regular Scan mode, the Eco Scan option has a lower dose and a smaller number of

acquired images for all modes, alongside a reduced scanning time for the Hi-Res modes and for the fields of

view with a diameter of 8 cm and 10 cm in standard mode.

Thanks to these characteristics, the Eco Scan option is especially recommended in place of the Regular

Scan mode for pediatric patients.


6.2. POSITIONING THE PATIENT FOR 3D EXAMINATIONS


1) After preparing the X-ray device, let the patient in.

2) Adjust the height of the motorised column with the buttons to facilitate patient access. The column

must reach the height of the patient.

3) The patient must grip the handles with both hands and

stand straight.

4) During 3D examinations, the patient's head must be

positioned in one of these 3 positions: right-hand,

central or left-hand. The right-hand or left-hand

position is fundamental to centre the field of view in

the lateral anatomical districts. Such positioning is

reached by manually moving chinrest and craniostat

in the desired direction.

A position detector on the chinrest will indicate whether the chosen position is correct for the selected

examination. If it is incorrect, the software will not allow to continue the examination until a correct position is

reached.

5) Use the lateral laser guides to obtain the desired

patient alignment.

6) Place the patient's head using the frontal laser beam as

a guide since it identifies the sagittal plane passing

through the centre of the selected FOV.

7) Go to the PC workstation.

6.3. PERFORMING THE EXAMINATION

Follow the instructions for the acquisition operations described in the iRYS manual to complete image acquisition.

Refer to “Extended View” mode for the acquisition with fields of the Extended View type.


Follow the instructions for the acquisition operations described in the iRYS manual to complete image acquisition.


6.4. SPECIAL CONSIDERATIONS FOR CBCT EXAMINATIONS WITH CHILDREN OR SMALL PATIENTS

The hyperion X5 device has been specifically designed for patients that are more than 104 cm in height and more

than 19 Kg in weight. These height and weight measurements approximately correspond to that of an average 4 year

old.

Before performing CBCT examinations on pediatric patients, it is necessary to consider their increased sensitivity to

ionizing radiation. It is due to many factors, such as: a longer life expectancy compared to adult patients, a higher

cancer risk per dose unit of ionizing radiation and the impact that such radiation could have on organs which are still

developing.

A CBCT exam has only to be performed if it is strictly necessary to solve a medical problem, using protocols that

include the minimum effective dose to obtain an adequate image quality (according to the ALARA principle, "As Low

As Reasonably Achievable"). We recommend not to perform repeated CT studies on children, unless they are

essential to reach a diagnosis. Before carrying out an X-ray examination, all indications and the medical history of the

patient must be carefully examined.

It is possible to use hyperion X5 on children and small patients, within the limitations described in the indications for

use. To that end, the available functions are:

fields of view with reduced dimensions, e.g.: 6x6 (volume diameter 6 cm, height 6 cm), 6x7, 8x6, 8x7;

Eco Scan mode, a low-dose protocol having a scanning time shorter than or equal to the default mode (6.4s-9.6s

in standard mode, 11.2s in Hi-Res mode);

automatic calculation of the minimum effective X-ray parameters for the examination, based on the size and

density of the examined volume (MRT technology);

before the scan, indication of the dose values selected by the software;

possibility of performing the exam with the patient in a seated position, in order to limit movement risks;

adjustable craniostat to secure the patient's head.

Furthermore, we recommend to take all the necessary steps to reassure the child before starting the acquisition

procedure. The immobility of the patient is crucial to obtain an adequate image quality.


7. VIEWING AND SAVING

In order to view and save an examination, a PC is required.

The X-ray system is supplied with the iRYS program for viewing and saving the examinations. Please refer to the

iRYS user manual.

The use of iRYS is essential for the acquisition of tomographic examinations, because it includes the volumetric

image reconstruction technology (only for 3D machines).

If you need to send the X-ray examination to the patient or another operator, iRYS automatically guides you in

creating a DVD that will include a redistributable copy of iRYS for image viewing (iRYS Viewer).

Alternatively, you can export only the X-ray images in a standard format (DICOM 3.0) so that they can be viewed with

third-party programs.


8. PERIODIC CHECKS AND MAINTENANCE

In the interest of safety and health of patients, the staff or third parties, inspections and maintenance need to be

carried out at scheduled intervals.

Period Operator Object Description

Yearly Specialised technician of

the dealer that initially

installed the device or

another technician

authorised by the

Manufacturer

The X-ray device as a

whole

In order to ensure the

operating safety of the

device, it is advisable to

inspect the X-ray device in

all its parts, in order to

prevent or repair any faults

For installations in the U.S.: please refer to chapter “Inspection and Maintenance”.

8.1. PERIODIC INSPECTIONS TO CHECK THE IMAGE

8.1.1. X-RAY EMISSION QUALITY CONTROL

In order to assure adequate X-ray emission efficiency, the following parameters should be measured and checked at

least on a yearly basis by a qualified technician with proper instruments:

Parameter Maximum deviation

from nominal value

MEASUREMENT CRITERIA

Tube peak voltage

(kV)

±5% It should be measured with a calibrated, non-invasive kVp-meter.

Exposure time (s) ±10% The beginning and end points of exposure time are defined at 70%

of peak radiation. They should be measured with a calibrated, non-

invasive multimeter.

Half Value Layer

[HVL] (mm)

>2.9mm @80kV Set 80kV and measure the Air Kerma rate with additional 2.9mm

Al. filter. Repeat the measure without additional filter.

Then:

(Dose rate with +2.9mm Al filtration) / (Dose rate without added

filtration) > 0.5.


8.1.2. COLLIMATOR TEST

In order to verify correct X-ray beam alignment, the following check should be performed at least yearly:

a) From the main bar of the iRYS software, select “Tools” → “Scanner Test”.

b) From the service window bar, select “Tools” and “service window bar”. Select the desired FOV.

c) Set the appropriate X-ray load parameters according

to the FOV used (standard: 4 mA, 10 ms, 90 kV;

Hires: 6 mA, 10 ms, 90 kV).

d) Start an acquisition.

e) Check that the collimation is limited within the

indicated margins:

- the green rectangle must be completely inside the

acquired grey area.

- the grey rectangle sides must pass through the red

line pairs where these are drawn.

8.1.3. 2D IMAGE QUALITY CONTROLS BY MEANS OF PHANTOM

In order to verify 2D images quality, the use of a dental phantom compliant with standard IEC 61223-3-4:2000 is

recommended.

Acceptance criteria are listed below:

Image resolution (line pairs/mm) 2.5 lp/mm

Low contrast resolution At least 2 low contrast points can be distinguished

Artifacts In the image, there must be no artifacts such as visible

horizontal lines or halftones

Frequency of the check Yearly

A phantom with required features is available upon request, with the relevant instructions for use.


8.1.4. 3D IMAGE QUALITY CONTROLS

- Acquisition of Blank image

The Blank acquisition allows optimising the scanning performance. This short procedure is compulsory and the iRYS

software requires it every two weeks.

Please find below the sequence of instructions to be carried out for a correct acquisition.

Make sure the scan area is empty.

After a few seconds the acquired blank image will

appear.

Once the blank has been acquired, check the image

does not present halos or black spots.

If the above-mentioned spots are present, check that

the scan area is actually empty, then click again on “X-

ray Flash” and repeat the acquisition procedure. If the

image is correct, click the “Stop” button.

- 3D image quality controls by means of phantom

The quality control consists in the execution of the standard examination on a suitable QA phantom, through an

automatic procedure.

This periodic monitoring, to be performed at least once a year, ensures the verification of the proper functioning of

the device and the validity of the results obtained.

Refer to paragraph 8.2 “QA phantom acquisition”.


8.2. QA PHANTOM ACQUISITION

QA Phantom for Quality Control.

Before carrying out the quality control, fill QA phantom

with water.

Please find below a description of the operations

required to position the QA phantom and perform the

quality control.

From the software main menu, select “Scan” and “QA

Phantom scan”.

Remove the chinrest and replace it with the octagonal

support.

Place the phantom on the octagonal support, as shown

in the figure.

Click on “X-ray Flash” and press the rays button when

prompted.

A side scout image is acquired to check positioning.

Assess phantom position; if necessary, correct it in

order to reach a position similar to the one shown in

the figure:

the aluminium cylinder should be between the vertical

red broken lines, whereas the internal balls must pass

through by the horizontal red broken lines.

In order to acquire a second scout, click again on “X-

ray Flash” and press the rays button when prompted.


Once the correct position is reached, press “Next”.

Then, in order to acquire a front positioning scout, click

on “X-ray Flash” and press the rays button when

prompted.

The front scout is acquired.

Assess phantom position and correct it as you did for

the side scout.

Click “Next” to confirm correct positioning, then “Start”.

Press the X-rays button when prompted.

The system performs a complete scan of the QA

phantom.

Once finished, when the system prompts to continue

the analysis, chick on “Yes”.

The calculations are made automatically; once

finished, a report like the one shown on the left will be

displayed.

If no value has asterisks, close the window; should this

not be the case, see paragraph 8.2.1 “QA phantom

troubleshooting” and repeat the procedure.


The following table provides a brief description of the values calculated during the phantom analysis.

Abbreviation Name Description

AAP Phantom’s angle in the

first scout view

Inclination angle of the symmetry axis of the

phantom in the first scout view

AAL Phantom’s angle in the

second scout view

Inclination angle of the symmetry axis of the

phantom in the second scout view

ScanTime Scan duration Scan duration in seconds

RNS%

Noise percentage Noise percentage on the phantom’s central axis

expressed as the standard deviation of the value

density with respect to their average value in a

defined area in the middle of the image (near the

water).

HDE External horizontal

diameter

External diameter of the aluminium cylinder along

the horizontal axis in the central axial image.

HDI Internal horizontal

diameter

Internal diameter of the aluminium cylinder along

the horizontal axis in the central axial image.

VDE External vertical

diameter

External diameter of the aluminium cylinder along

the vertical axis in the central axial image.

VDI Internal vertical

diameter

Internal diameter of the aluminium cylinder along

the vertical axis in the central axial image.

H FWHM

Horizontal Full Width

Half Maximum

Spatial resolution (millimetres) on the aluminium

cylinder's horizontal diameter in the central axial

image.

V FWHM

Vertical Full Width Half

Maximum

Spatial resolution (millimetres) on the aluminium

cylinder's vertical diameter in the central axial

image.

HFD Horizontal distance

between holes

Average horizontal distance between the cylinder

holes in the panoramic image.

VFD Vertical distance

between holes

Average vertical distance between the cylinder

holes in the panoramic image.

8.2.1. QA PHANTOM TROUBLESHOOTING

Below is a description of some countermeasures to take if there are errors in the phantom analysis results. Each

error is highlighted with the symbol “***”.

Parameter What to do…

AAP Verify the phantom acquisition during the first scout view.

If tilted, adjust the phantom position.

ALL Verify the phantom acquisition during the second scout view.

If tilted, lift or lower the support.

RNS Make sure that the phantom has been filled up with water.

Perform an acquisition of Blank image with reference to

paragraph 8.1.4 “3D image quality controls”.

H FWHM & V FWHM Contact the technical support.


9. TECHNICAL DATA 9.1. ELECTRICAL CHARACTERISTICS

Supply voltage Single-phase 115 – 240 VAC (allowed fluctuation +/-

10%)

Power supply frequency 50 / 60 Hz

Current absorbed in rest conditions 1A @ 115V; 0.5A @ 240V

Maximum current absorbed in operating conditions 20A @ 115V; 12A @ 240V

Column movement operating cycle 25 s ON, 400 s OFF

Maximum apparent line resistance 0.5 Ω @ 240 V - 0.25 Ω @ 115 V

Overvoltage class II

Power supply system protection With limiter at maximum current of 20 A and differential

current of 30 mA

Current/voltage combination for the maximum output

power

72 kV, 15 mA

9.2. RADIOLOGICAL CHARACTERISTICS

Generator voltage 2D: 60 – 85 kV (automatically or manually selectable in

steps of 1 kV)

3D: 90 kV pulsed mode (max 12mA)

Anode current 4-15 mA (automatically or manually selectable in steps

of 1 mA)

Maximum continuous input anode power 42 W

Leakage Technique Factor (LTF) 90kV; 0.47mA

Maximum peak input anode power 1080W (e.g. 72kV/15mA)

Maximum deviations from declared values kV: < 5% (10% IEC)

mA: < 10% (20% IEC)

ms: < 3% (5% + 50 ms IEC)

mAs: < 10 % + 0.2 mAs

Linearity error < 0.2

Coefficient of variation < 0.05

X-ray tube For 2D machine only:

CEI OPX/105

TOSHIBA D-054SB

KAILONG KL5


TOSHIBA D-067SB

Focal spot size 0.5 mm according to IEC 336

0.6 mm (for TOSHIBA D-067SB only)

Anode material Tungsten (W)

Anode inclination 5°

12° (for TOSHIBA D-067SB only)

Anode thermal capacity 30 kJ (CEI- KAILONG) – 35 kJ (TOSHIBA)

Supplementary filtration on the collimator 3D mode: 3.5 mm Al @ 85kV

Inherent filtration (including supplementary filtration) 2D mode: >2.5 mm Al @ 85kV

3D mode: 6 mm Al @ 85kV

Half value layer (HVL) 2D: >2.9mm @ 80kV

Stray radiation <0.88mGy / h at 1 metre from focal spot at 90KV


Exposure time (PAN/CB3D) 2D mode: 1s - 15s continuous radiation (depending on

the 2D examination type selected)

3D mode: 6.4s-16.8s pulsed mode

Source distance - primary collimator 100mm

Output radiation intensity (Output dose) 0.20 mG/mAs @ 70 kV, 500 mm/

0.30 mG/mAs @ 90 kV, 500 mm/

tolerance ±30%

Source - detector distance (SID) - PAN 500 ±5 mm

Source - detector distance (SID) - CBCT 500 ±5 mm

Generator reference axis:


9.3. ISODOSE CURVES FOR 2D EXAMINATIONS

9.4. ISODOSE CURVES FOR CBCT EXAMINATIONS



9.5. PANORAMIC SENSOR CHARACTERISTICS(PAN)


Sensitive area dimensions 6 x 151 mm

Resolution 5 lp/mm (PAN projection)

Primary screen > 0.5 mm Pb

Pixel size 100μm

Sensor technology CMOS

Scintillator material & type Direct deposition CsI

MTF 58% @ 1 lp/mm

DQE 70% @ 0 lp/mm

Sensor matrix dimensions 1.512 x 60

Gray level 14 bit

Magnification (PAN) 1.25 ±5%

Connection Gigabit Ethernet

For 3D machine only (in 2D mode):


Resolution 5 lp/mm (PAN projection)

Pixel size 127 µm


Sensor technology Amorphous silicon


MTF 55% @ 1 lp/mm

DQE 70% @ 0 lp/mm

Sensor matrix dimensions 1152 x 48 pixels

Gray level 16 bit

Magnification (PAN) 1.25 ±5%


9.6. 3D PANEL FEATURES


Sensitive area dimensions 146x146 mm

Resolution 3.94 LP/mm

Pixel size 127 x 127 µm

Sensor technology Amorphous silicon


MTF 57% @ 1lp/mm (1x1)

DQE 70% @ 0lp/mm (1x1)

Image pixels 1152 x 1152 pixels

Pixel depth 16 bit

Max Full Field 1x1 Frame Rate 28 fps


Voxel size Standard Resolution: 80-115-150 µm

HiRes: 160-230-300 µm

9.7. LASER CHARACTERISTICS

Optical power Class 1 according to IEC 60825-1: 2003

Laser power Max 3mW

Diffractive optics Aspheric lens; linear shape; 58° opening

Wave length 635-650 nm

Activation time Continuous wave; Timing limited to 30”


9.8. DIMENSIONAL CHARACTERISTICS

Suspended version

Weight (basic machine) For 2D machine only: 70 kg

For 3D machine only: 76 kg

Maximum overall dimensions in diagram (basic

machine)

972 x 872 mm

Height Min 1626 mm Max 2226 mm

Use the installation template for wall mounting.


Version with floor column and wall mount




machine)

1027 x 872 mm




Version with floor column and 45° wall mount




machine)

1030 x 1213 mm




Version with floor column and stand




machine)

1030 x 872 mm


9.9. ENVIRONMENT CHARACTERISTICS

Operating conditions Temperature + 10 - +35 °C

Relative humidity 10 – 90%

Pressure 710 – 1060 hPa

Altitude a.s.l. < = 3000 m

Pollution degree: 2

CTI class: IIIb

Transport and storage conditions Temperature -10 - +70 °C

Relative humidity 10 – 90%

Pressure 710 – 1060 hPa


9.10. PC REQUIREMENTS

Requirements for the PC workstation directly connected to the X-ray acquisition device.

COMPONENT

BASIC

CONFIGURATION

(For 2D machine

only)

CONFIGURATION 1 CONF. 2 CONF. 3 CONF. 4

PROCESSOR

Intel Core i3 4150

(3.5GHz, 3MB L3

Cache, 1600MHz)

1 CPU INTEL I7

3770 - 3.4 GHZ – 4

CORE

1 CPU INTEL

XEON E5-2630

- 2.3GHZ - 6

CORE

1 CPU INTEL

XEON E3-1270

V3 – 3.50 GHZ

– 4 CORE

or

1 CPU INTEL

XEON E3-1270

V5 – 3.60 GHZ

– 4 CORE

CPU XEON E5-

1620 - 3.60

GHz - 4 CORE

Intel Core i3 4160

3.6GHz

Intel Core i3 4170

3.7GHz

Intel Core i3 6100

3.7GHz

SPACE ON HARD

DISK (1)

500 GB SATA

HARD

DISK - 7.2K RPM

or higher

1 x 500 GB SATA

DISK - 10K RPM

2 x 300 GB

SATA DISKS -

10K RPM –

SET TO RAID 0

1 x 500 GB SATA DISK - 10K RPM

RAM 1 x 4 GB 8 GB DDR3 1600

MHZ, OR HIGHER 4 GB DDR3

8GB DDR3 1600 MHZ ECC, OR

HIGHER

POWER SUPPLY

UNIT (2) ≥ 180 W ≥ 550 W ≥ 800 W ≥ 400 W ≥ 600 W

VIDEO CARD (3)

AMD Radeon HD

7450

PCI Express 2.0

128 Bit,

1024 MB, DDR3,

706 MHz

DirectX: 11

AMD RADEON HD 7770 OC GHZ EDIT.

VAPORX 1GB GDDR5

AMD RADEON

R7 250 1GB

GDDR5

AMD RADEON

HD 7770 OC

GHZ EDIT.

VAPORX 1GB

GDDR5 AMD Radeon HD

R5 230, 1024 MB,

DDR3

OPERATING

SYSTEM

WINDOWS 7 PROFESSIONAL 64 BIT SP1

WINDOWS 8.1 PROFESSIONAL 64 BIT

WINDOWS 10 - ANNIVERSARY EDITION - 64 BIT

NETWORK CARD 2 ETHERNET INTERFACES (OF WHICH AT LEAST ONE INTEL PRO -1000)

OTHER

PERIPHERALS

MONITOR MINIMUM RESOLUTION 1280X1024, 64 MILLION COLOURS (OR HIGHER), DVD

BURNER

Notes:

(1) The use of a 7200 RPM hard disk implies considerably reduced performance.

(2) In order to use video cards tested according to the specifications, a power supply unit also complying with the

power supply requirements of the chosen video card is required.

(3) In addition to the mentioned video card, see the complete list of tested video cards.


Validation tests have been carried out with the following video cards:

VIDEO CARD POWER SUPPLY UNIT

ATI RADEON HD 4850 / 5770 – 1GB ≥ 450 W

ATI RADEON HD 4870 / 4890 / 5850 / 5870 – 1GB ≥ 500 W

SAPPHIRE RADEON HD 6750 / 6770 – VAPORX – 1GB – RAM GDDR5 ≥ 450 W

SAPPHIRE RADEON HD 6850 / 6870 / 6950 / 7870 – VAPORX – 1GB – RAM GDDR5 ≥ 500 W

SAPPHIRE RADEON HD 7770 – GHZ ED. - OC - VAPORX – 1GB – RAM GDDR5 ≥ 500 W

SAPPHIRE RADEON HD 6970 – VAPORX – 2GB – RAM GDDR5 ≥ 550 W

SAPPHIRE RADEON HD 7850 - 1GB / 2GB - RAM GDDR5 ≥ 500 W

SAPPHIRE RADEON HD 7870 - 2GB - RAM GDDR5 ≥ 500 W

SAPPHIRE RADEON HD 7750 - OC - 1GB – RAM GDDR5 ≥ 400 W

AMD FIREPRO W7000 – 4GB GDDR5 ≥ 400 W

AMD/SAPPHIRE RADEON R7 250 1GB – RAM GDDR5 ≥ 400 W

AMD/SAPPHIRE RADEON R7 260X - RAM 1GB DDR5 ≥ 500 W

AMD/SAPPHIRE RADEON R9 270 - RAM 2GB DDR5 ≥ 500 W

Additional workstations

For the minimum requirements of the workstations not directly connected to the X-ray acquisition device and where

iRYS Station or iRYS Viewer will be installed, consult the iRYS manual.

9.11. MOBILE DEVICE REQUIREMENTS

Requirements for the mobile device running the control console or its limited version.

APP NAME OPERATING SYSTEM DISPLAY SIZE

hyperion X5 Remote Panel

(control console) Apple IOS 7 or higher 7.9-inch (minimum diagonal)

iRYS mobile

(control console - limited version)

Apple IOS 7 or higher

Android 4.0 (Ice Cream Sandwich)

or higher

4-inch (minimum diagonal)

7.8-inch (minimum diagonal)


9.12. IDENTIFICATION LABEL POSITION

1 Warnings and laser hazard plates

2 Generator plate

3 WARNING and DHHS plate

4 Main plates and brand plates

5 Column plate

These figures show the plates on all models of the hyperion X5 family, and they are for illustrative purposes

only; please refer to the plate on your machine.


10. ERROR MESSAGES

Code Message Description/Solution

WARNING

W 0.1 X-ray button released during

exposure.

Hold down the X-ray emission button

until the end of the procedure.

W 0.2 X-ray button not released at the end

of the examination.

1) X-ray button pressed for too

long, after the end of the

exposure (>15s).

2) Reset command output when X-

ray button was pressed.

3) The device remained in standby

mode when X-ray button was

pressed.

W 0.3 Emergency button pressed. Release the emergency button.

W 0.5 POWER electronic card can not

communicate with Logic card.

Turn off the device, wait for 30

seconds and turn it on again. If the

error persists, check the error code

documentation.

W 0.7 Active interlock. The door has been

opened with the examination in

progress.

Close the door and, if necessary,

repeat the examination.

W 0.8 Demo mode: examination not

loaded.

Demo started without loading the

examination: check connection with

the PC. Repeat the operation.

W 0.9 The unit is not set up. If the error persists, check the error

code documentation.

W 0.10 The unit is not calibrated. If the error persists, check the error

code documentation.

W 0.13 Button pressed on the keyboard

upon turning on or wake-up after

standby.

Check the keyboard. If the error

persists, check the error code

documentation.

W 0.14 Unit temperature too high. Temperature of converter card too

high, it is not possible to start a new

examination. Wait for cooling.

W 0.15 X-ray generator temperature too

high.

Temperature of X-ray generator too

high, it is not possible to start a new

examination. Wait for cooling.

Code Message Description/Solution

LOGIC PANEL ERRORS

E X.X Internal error If the error persists, check the error

code documentation.


11. USER’S LICENCE CONTRACT

IMPORTANT: READ CAREFULLY

11.1. GENERAL CONDITIONS OF THE IMAGE SOFTWARE LICENCE

This licence exclusively applies to the software, understood as specific drivers and libraries for connection to and

control of the digital X-ray system, and to the image display and storage software altogether identified as “iRYS” and

“iRYS viewer” (hereinafter referred to as “Software”) designed by CEFLA s.c. - Via Selice Prov.le 23/A 40026 Imola

(Italia) (hereinafter referred to as ”Author”) and handed to the customer (hereinafter referred to as “User”). These

conditions are understood fully recognised and accepted at the time of program installation.

Proper installation and subsequent use of the program therefore implies unconditional acceptance of all the

conditions.

11.1.1. USER’ S LICENCE

Use of the software, which is and remains the property of the author to every effect, is granted to the user under a

non-exclusive, free-of-charge user’s licence for an indeterminate period of time.

The user’s licence does not include the right to obtain the software in its source format or to make use of the related

design or logic system documentation. The user therefore acknowledges that the author is and remains the sole,

exclusive and legitimate holder of all rights of property, copyright and economic use of the software as well as related

documentation. The user is aware and expressly acknowledges that it is impossible, in general, to develop software

products to be entirely error-free as regards all possible applications and uses and that upgraded versions of the

Software may introduce new errors which were not present in the previous version. The User therefore expressly

accepts that the Software may contain errors. To this end, the User agrees, in his own interest, to make back-up

copies of the files (data and images) regularly and diligently in order to be prepared for any possible malfunctioning of

the Software product or of the systems the software is installed in.

Acceptance that the Software may contain errors is a condition that must be met in order for the Author to grant the

User the Licence to use the Software Product.

This licence grants the Software end-user the sole right to use it in the ways described below and according to the

additional conditions and warnings given in the “on-line” documentation.

11.1.2. COPYRIGHT

This Software is protected by all applicable laws, decrees, regulations and any other national provision and, in

particular, by laws regarding rights of authorship and intellectual property rights as well as European Union directives

and applicable international conventions.

The Software product, every single copy of it and every part or section of it (including – as mere examples and not

comprehensively – every image, icon, photograph, video, text), any text or image and the electronic and “on-line”

documentation regarding the Software product are the exclusive property of the Author or its suppliers and cannot be

reproduced by the User in any form or by any means whatsoever. All rights regarding use of trademarks, product

names and any other distinctive sign are reserved by the Author or respective legitimate owners.

In particular, the user agrees not to copy or reproduce, entirely or in part, the software he has been granted the right

to use in printed form or in any form which can be read by a processor. This also applies to any other documentation

regarding the software unless for safety reasons or to ensure proper functioning and then only with the express

authorisation of the author.


11.1.3. USE OF THE SOFTWARE PRODUCT AND EXPRESS TERMINATION CLAUSE

a. Software. The User can install the Software and can use it under the conditions and within the limits established

in this licence.

The User is not authorised to distribute the Software, whether free-of-charge or upon payment, and cannot

provide services or develop products or software applications based on the Image Software or which make use of

it in any way whatsoever.

It is expressly forbidden to make any changes to the software or incorporate it partially or fully in other programs.

In the same way, no trademarks/brand names/numbers or any other item included in the software or its storage

mediums may be removed, altered or copied.

b. Restrictions regarding decoding, decompilation and disassembly. The User cannot decode, decompile,

disassemble, modify or translate the Software product except when expressly laid down by the law.

c. Prohibition of transfer / sub-licence / leasing. The User cannot transfer, grant under a sub-licence, whether free-

of-charge or upon payment, or let out under a leasing or any other arrangement, this Software to third parties.

Unless otherwise agreed, the user cannot allow third parties the use of the software even for promotional,

demonstration or educational purposes.

If the User does not adhere to the conditions of use of the Software and, therefore, in the event of failure to

observe, or violation of, the terms laid out in this paragraph at points a, b and c the licence shall be withdrawn. If

this should happen, the Author has the right to request that the User destroys all copies of the Software and all

component parts in its possession.

Under these circumstances the author shall have the right to claim for damages.

11.1.4. GUARANTEE AND EXCLUSIONS FROM THE GUARANTEE

The Software is supplied in its original state and the Author does not offer and shall not acknowledge any guarantee

for original defects or defects which might subsequently arise and shall not make any guarantee of quality or trouble-

free functioning as regards the Software. Furthermore the Author shall not offer or acknowledge any guarantee

regarding compliance of the Software with that described in the electronic documentation made available “on-line” or

in any other manner, except for the guarantee for the actual storage medium (USB PEN DRIVE) if this should be

damaged or unusable.

Any other guarantee is excluded even if the Software is installed in or is part of other software applications developed

by third parties. In addition, in relation to these applications, the Author expressly states that no checks of any kind

have or will be made as regards the functioning of this product.

11.1.5. LIMITS OF RESPONSIBILITY

Under no circumstances shall the Author or its suppliers be held responsible for direct or indirect damage (including

damage resulting from lost earnings, lack of earnings or savings, interruption of business, loss of information or data

and other economic loss) caused to the User or third parties by the use or improper use of the Software product even

if the author has been informed of the possibility of such damage. This limit of responsibility is not only applicable

when the Software is used improperly and not as instructed in the Author’s indications but also when the Software is

used properly and in compliance with the Author’s directions.

11.1.6. APPLICABLE LAWS, JURISDICTION AND COURT OF JURISDICTION

The conditions of this licence are subject to Italian law. Notwithstanding other standards bringing together individual

laws or International Conventions, any disputes which might arise between the parts regarding the interpretation or

execution of this agreement shall come under the exclusive jurisdiction of Italian law and the exclusive court of

jurisdiction shall be the Law Court of Bologna.

11.1.7. WRITTEN FORM

Any modifications should be made in written form. Failure to observe the above shall result in the agreement being

made null and void. The parties agree not to recognise the validity in law of any verbal agreements made by any

person previously, at the same time or subsequently to the written contract and state that at no time from this

moment on shall any attempt be made to validate any verbal agreement which might alter that laid down in the

present general conditions. The author reserves the right to modify the present general conditions at any time and

unilaterally and to communicate any such changes by the most suitable means.


11.1.8. TRANSLATION

As regards the translation of this licence into other languages it remains understood that, should any inconsistencies

arise regarding interpretation, the Italian version shall prevail.

11.1.9. SOFTWARE COMPLIANCE WITH THE REGULATIONS IN FORCE

If the Author declares compliance of the Software with specific laws or regulatory standards, such compliance shall

be deemed valid on the date the Author places the product on the market.

It being evident that legislative or regulatory modifications are always possible as are changes in the interpretation of

regulations, and also considering that any modifications and changes would make the Software in possession of the

User no longer compliant to such regulations, the User is obliged to from time to time ascertain whether the use he

intends to make of the Software is legitimate (or in any case still legitimate) and abstain from using the Software in

case of doubt about compliance with the law for the use he intends to make of the Software, promptly notifying the

Author of the circumstances.


12. INSPECTION AND MAINTENANCE 12.1. USER INSPECTION

These instructions describe the maintenance procedures for the extraoral X-ray system.

These instructions apply to all versions of said equipment, as well as all the accessories that may have been provided, therefore the description of some parts may not correspond to your equipment.

Inspection and preventive maintenance must be performed at scheduled intervals to protect the health and safety of patients, users and other persons in accordance with national regulations regarding the use and maintenance of dental x-ray

units that are in force in the country where the device is installed.

In order to ensure the operational safety and functional reliability of your product, the system owner should check the equipment at regular intervals (at least once a year) or commission an authorised technician to do so.

If one or more checks to be performed are not satisfactory, please contact your dealer for technical support.

Answer questions with yes (√) or not (−)

Inspection DATE

Step Description Reference in the manual __/__/20__ __/__/20__ __/__/20__ __/__/20__ __/__/20__

1

Check that all labels located

- on the side of the device

- at the base of the column,

- on the X-ray tube housing,

are intact, well attached and legible.

User Manual, Section Identification plate position

2 Check there are no external damages to the equipment, which may reduce protection

against radiation. User Manual, Section Description of operation

3 Check the remote emission button cable is not broken or scratched. User Manual, Section X-ray emission remote control

4 Check the power switch verifying that the switch is working properly and the green light

on the switch, check if the keyboard illuminates when the switch is in the on position. User Manual, Section Starting the system

5 Verify that exposure is immediately interrupted when x-ray button is released User Manual, Section X-ray emission remote control

6 Check the control keyboard functionality: functions must respond to interrogation. User Manual, Section Console onboard the machine

7 Check proper functioning of X-ray exposure LED and exposure buzzer User Manual, Section X-ray emission remote control

8 Check proper functioning of patient centring laser traces User Manual, Section Laser traces

9

Perform a movement test running the Dummy panoramic procedure, making sure the

axis movement (rotation and translation simultaneously) is smoothly and without noise.

See figure 1, next page.

User Manual, Section Perform a simulation (Dummy Run)

10 Perform column movements, up and down on the Z axis and check proper functioning.

See figure 2, next page. User Manual, Section Console onboard the machine

11 Check the emergency stop button functionality. Emergency stop button is used to stop X-

ray device operation, it is located at the top near mains switch button. User Manual, Section Emergency stop button

12

Check the x-ray generator functionality performing a complete trial exposure. Select any

panoramic exam and reset the unit. Hold down the emission button throughout the entire

exam procedure. Absence of error messages assures proper generator functionality.

User Manual, Section Performing a 2D X-Ray examination

If Quality Phantoms are not available at installation site, then contact your dealer tech support to have the Quality Assurance procedure performed at your premises

13 Perform an exam on the 2D Quality Phantom and evaluate the quality of the outcome

radiographic image. Section 3D image quality controls

14 (For 3D machines only) Perform an exam on the 3D Quality Phantom and assess the

quality of the outcome image Section 3D image quality controls

Operator Name

Signature

The undersigned confirms that the equipment was checked for the above criteria and that, in case of any malfunction, an authorised technician of the local dealer was informed.

All inspection and maintenance work performed by the system owner and/or service engineer must be recorded in this document and kept near the unit!


12.2. TECHNICAL MAINTENANCE

These instructions describe the maintenance procedures for the extraoral X-ray system. These instructions apply to all versions of said equipment.

In order to ensure the operational safety and functional reliability of the equipment installed, at least once a year an authorized service technician must perform a full inspection of the device.

When taking measurements that require a multimeter, always use a calibrated digital multimeter.

All the following tests will be carried out. Customer should be notified prior to replacing any parts.

Answer questions with yes (√) or not (−)

Inspection DATE

Step Description Reference in the manual __/__/20__ __/__/20__ __/__/20__

1

Check that all labels located

- on side of the device

- at the base of the column,

- on the X-ray tube housing,

are intact, well attached and legible.

User Manual, Section Identification plate position

2 Check there are no external damages to the equipment, which may reduce protection against radiation. User Manual, Section Description of operation

3 Check the remote emission button cable is not broken or scratched. User Manual, Section X-ray emission remote control

4 Check the power switch verifying that the switch is working properly and the green light on the switch, check if the keyboard

illuminates when the switch is in the on position. User Manual, Section Starting the system

5 Verify that exposure is immediately interrupted when x-ray button is released User Manual, Section X-ray emission remote control

6 Check the control keyboard functionality: functions must respond to interrogation. User Manual, Section Console onboard the machine

7 Check proper functioning of X-ray exposure LED and exposure buzzer User Manual, Section X-ray emission remote control

8 Check proper functioning of patient centring laser traces User Manual, Section Laser traces

9 Perform a movement test running the Dummy panoramic procedure, making sure the axis movement (rotation and translation

simultaneously) is smoothly and without noise. See figure 1, next page. User Manual, Section Perform a simulation (Dummy Run)

10 Perform column movements, up and down on the Z axis and check proper functioning. See figure 2, next page. User Manual, Section Console onboard the machine

11 Check the emergency stop button functionality. Emergency stop button is used to stop X-ray device operation, it is located at the

top near mains switch button. User Manual, Section Emergency stop button

12

Check the x-ray generator functionality performing a complete trial exposure. Select any panoramic exam and reset the unit. Hold

down the emission button throughout the entire exam procedure. Absence of error messages assures proper generator

functionality.

User Manual, Section Performing a 2D X-Ray examination

13 Perform a complete 2D calibration of the unit: column calibration, PAN x-ray alignment, PAN detector calibration, PAN mechanical

alignment, Laser test. See specific “2D/3D CALIBRATION MANUAL – OPT E.L.” code

97071221

14 At the end make a 2D calibration backup Technical Manual, section Calibration backup See specific “2D/3D

CALIBRATION MANUAL – OPT E.L.” code 97071221

15 (For 3D machines only) Perform a complete 3D calibration of the unit: Beam limiter test, Daily check, Cylindrical test phantom

acquisition.

Technical Manual, section 3D calibration See specific “2D/3D


16 (For 3D machines only) At the end make a 3D calibration backup Technical Manual, section 3D calibration backup See specific “2D/3D


17 (For 3D machines only) Perform an exam on the 3D Quality Phantom and assess the quality of the resulting volumetric study. Section 3D image quality controls

Operator Name

Signature

The undersigned confirms that the equipment was checked for the above criteria and that it was provided in optimal operating conditions.

All inspection and maintenance work performed by the system owner and/or service engineer must be recorded in this document and kept near the unit!!


Figure 1

Figure 2

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