Owandy Radiology RX-PRO User manual

USER MANUAL
User manual • Owandy-RX PRO • 01/2023 • NORPEN010B

Page 2 User manual • Owandy-RX PRO • 01/2023 • NORPEN010B
User manual • Owandy-RX PRO
Refer to complete manuals and
instructions For complete manuals and instructions
www.owandy.com
Scan the QR code to access the
dedicated website
www.owandy.com
Language of the original document: ENGLISH
Important: All new editions and revisions of the manuals supersede the previous ones

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User manual • Owandy-RX PRO • 01/2023 • NORPEN010B
User manual • Owandy-RX PRO
MANUFACTURER
Owandy Radiology
2 rue des Vieilles Vignes
77183 Croissy-Beaubourg
FRANCE
Tel. + 33 1 64 11 18 18
[e-mail]
www.owandy.com

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User manual • Owandy-RX PRO
THE ELECTROMEDICAL EQUIPMENT DESCRIBED IN THIS MANUAL REFERS TO THE Owandy-RX PRO MEDICAL DEVICE.
“Owandy Radiology” RESERVES THE RIGHT TO MODIFY THE PRODUCT AND ALL THE MANUALS WITHOUT PRIOR
NOTICE.
IT IS PROHIBITED TO MODIFY, COPY, REPRODUCE, DISPLAY, SHARE, DISCLOSE AND PUBLISH THIS MANUAL AND
ALL OTHER DOCUMENTS REFERRING TO Owandy-RX PRO IN ANY FORM WITHOUT PRIOR WRITTEN CONSENT BY
Owandy Radiology
THIS MANUAL MUST ALWAYS BE KEPT NEAR THE MEDICAL DEVICE FOR FUTURE REFERENCE.
“Owandy Radiology”SHALL NOT BE HELD LIABLE FOR MISUSE OF THE INFORMATION PROVIDED BY THIS MANUAL.

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User manual • Owandy-RX PRO • 01/2023 • NORPEN010B
User manual • Owandy-RX PRO
CONTENTS
INTRODUCTION................................................................................................... 7
1.1 PRELIMINARY INFORMATIONS.............................................................................................................................7
1.2. INFORMATION FOR THE OPERATOR...................................................................................................................8
1.2.1. QUALITY DETERMINANTS IN X-RAY INTRAORAL RADIOGRAPHY.................................................................9
1.3. WARRANTY CONDITIONS.....................................................................................................................................9
1.4. TRANSPORT CONDITIONS..................................................................................................................................10
1.5. SAFETY WARNINGS..............................................................................................................................................10
X-RAY SYSTEM OVERVIEW........................................................................................................16
2.1. SYSTEM COMPONENTS.......................................................................................................................................17
2.2. OWANDY-RX PRO ACCESSORIES........................................................................................................................18
2.3. IDENTIFICATION TAGS........................................................................................................................................19
2.4. MEANING OF INFORMATION REPORTED ON THE LABEL...............................................................................19
2.5. SYMBOLS ..............................................................................................................................................................20
CONTROL PANEL OVERVIEW ................................................................................................... 22
3.1. STATUS LED ..........................................................................................................................................................23
3.2. INFORMATION DISPLAY .....................................................................................................................................23
3.3. SETTINGS..............................................................................................................................................................23
3.4. TYPE OF PATIENT.................................................................................................................................................24
3.5. TYPE OF EXAMS....................................................................................................................................................24
OPERATING INSTRUCTIONS ....................................................................................................25
CONFIGURATION AND TAKING AN X-RAY EXPOSURE ......................................................... 27
5.1. CHECK THE SELECTED TYPE OF CONE ..............................................................................................................28
5.2.CHECK THE SOURCE TO SKIN DISTANCE...........................................................................................................29
5.3. CHECK THE SELECTED X-RAY TUBE VOLTAGE ..................................................................................................29
5.4. CHECK THE SELECTED X-RAY TUBE CURRENT..................................................................................................29
5.5. CHECK THE SELECTED TYPE OF PATIENT..........................................................................................................30
5.6. CHECK THE SELECTED X-RAY DETECTOR SUPPORT (FILM/DIGITAL/PSP) .....................................................30
5.7. ECK THE SELECTED EXAM TYPE .........................................................................................................................31
5.7.1.PERIAPICAL EXAM........................................................................................................................................................ 31
5.7.2.OCCLUSAL EXAM.......................................................................................................................................................... 31
5.7.3. BITEWING EXAM ......................................................................................................................................................... 31
5.8. CHECK THE SELECTED IRRADIATION TIME ......................................................................................................31
5.9. CHECK THE DOSE AREA PRODUCT VALUES......................................................................................................32
5.10 POSITIONING THE PATIENT..............................................................................................................................33
5.11. POSITIONING FILM OR SENSOR .....................................................................................................................33
5.11.1. PARALLELING TECHNIQUE ...................................................................................................................................... 34
5.11.2. BISECTING ANGLE TECHNIQUE .............................................................................................................................. 34
5.12. POSITIONING THE X-RAY GENERATOR AND COLLIMATOR (BEAM LIMITING DEVICE)........................................................35
5.12.1. SUGGESTED INCLINATION ANGLES ....................................................................................................................... 36
5.13. MAKE THE EXPOSURE .......................................................................................................................................36
5.14. TRANSPORT AND POSITIONING OF THE MOBILE STAND............................................................................39
CHARTS OF DEFAULT EXPOSURE VALUES...............................................................................41
6.1. SHORT CONE: 8 INCHES – 20 CM SDD..............................................................................................................42
6.2. LONG CONE: 12 INCHES – 30 CM SDD..............................................................................................................43
CUSTOMIZE DEFAULT EXPOSURE VALUES.............................................................................. 44
7.1. RESTORING FACTORY VALUES ...........................................................................................................................45

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X-RAY CALIBRATION PROCEDURE ..........................................................................................46
ERROR MESSAGES .....................................................................................................................47
SUGGESTED MAINTENANCE AND REPAIR .............................................................................. 50
10.1. NTENANCE AND CLEANING.............................................................................................................................50
10.2. DISPOSAL ...........................................................................................................................................................51
SSD - SOURCE TO SKIN DISTANCE AND FOCAL SPOT POSITION ..........................................52
ANNEX A : TECHNICAL DATA ...................................................................................................53
A.1 TECHNICAL SPECIFICATIONS..............................................................................................................................53
A.2 INTENDED ENVIRONMENT .................................................................................................................................57
A.3 DIMENSIONS OF THE UNIT ...............................................................................................................................58
A.4 LIST OF INTERNATIONAL STANDARDS AND DIRECTIVES................................................................................63
A.5 DOSIMETRIC INDICATIONS ................................................................................................................................64
A.6 EMC COMPATIBILITY ...........................................................................................................................................67

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User manual • Owandy-RX PRO
1. INTRODUCTION
1.1. PRELIMINARY INFORMATIONS
Before starting with the use of the “Owandy-RX PRO” x-ray system, it is mandatory to carefully read and follow the
instructions contained herein in order to obtain the best performance and assure the safety of the patient, operator,
device and the environment.
Always pay close attention to the messages when operating the system.
CAUTION
WARNING
PLEASE NOTE
PROHIBITION
LEGEND
CAUTION
The word CAUTION identies those occurrences which might compromise the operator’s personal safety or cause injuries to
people.
!
WARNING
The word WARNING identies those occurrences which might compromise the x-ray system’s performance.
PLEASE NOTE
PLEASE NOTE serves to give special indications to facilitate maintenance or make important information clearer.
PROHIBITION
PROHIBITION The word prohibition identies those actions that must be avoided because they might compromise the
operator’s personal safety or cause injuries to people.

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User manual • Owandy-RX PRO
1.2. INFORMATION FOR THE OPERATOR
Dear customer,
thank you for choosing the Owandy-RX PRO x-ray system. This medical device has been designed and manufactured by
Owandy Radiology and is the result of many years of experience in the radiology and medical imaging industry and of
advanced electronic applications. This device is a further step forward in dental radiology.
The Owandy-RX PRO is an X-ray generator for dental intra-oral x-ray imaging, particularly, the Owandy-RX PRO is an
extra-oral source of X-rays, intended to be used for producing diagnostic dental radiographs for treatment of disease
of the teeth, jaw and oral structures. From a clinical application point of view, the Owandy-RX PRO can be applied in
routine, dental radiography examinations involving the diagnosis, treatment, i.e. surgical or interventional, of diseases
of the teeth, jaws and oral cavity structures.
Its intended medical indication are:
• generic dentistry;
• dental implantology;
• dental surgery.
The intended population can be whatever, anyway the sustainability to X-ray exposure must be evaluated by surgeons,
dentists and qualied and authorized physicians (refer also to section“SAFETY WARNINGS”)
The Intended user prole is an able-bodied specialized surgeon, dentist and authorized personnel, who meet the
requirements provided by the national laws in force in the country of installation; they must understand the language of
the country where the device is installed. The intended conditions of use are detailed in Annex A (“Intended Environment”)
This manual has been written and published under the supervision of Owandy Radiology. It contains all the latest
descriptions and features of the product. Although every eort is made to produce up-to-date and multi-language
documentation (since each accompanying document is translated in dierent languages), this publication should not
be regarded as an infallible guide to current specications. The information in this manual is periodically updated; any
amendment will be included in subsequent publications without prior notice by Owandy Radiology
Contact your dealer to request the latest version of the manual.
In the event of errors, please inform Owandy Radiology promptly.
CAUTION -
!
WARNING
This manual does not include all the recommendations and obligations concerning possession and use of
ioniszng radiation sources, since they dier from country to country. Therefore, only the most common are listed.
Operators must refer to the laws in force in their country to meet all legal requirements.
CAUTION -
!
WARNING
For the U.S. market: federal laws restrict these devices to sale by or on the order of a specialized surgeons, dentists and
authorized personnel, who meet the requirements provided by the national laws in force in the country of installation.
CAUTION -
!
WARNING
This manual describes how to set and use the Owandy-RX PRO x-ray system.
The operator must read and understand the manual before using the medical device.
This manual must be always kept as a reference document.
Before using this device for the rst time, it is essential to thoroughly and carefully read the instructions, CAUTION and
WARNING messages listed in the paragraph General warnings and precautions.
It is mandatory to comply with these instructions every time the device is used.
Owandy-RX PRO is compatible with all kind of X-ray detectors which have been designed and certied for dental intra-oral
radiology; in detail, such a compatibility is ensured by the compliance of the Owandy-RX PRO with the basic safety and
essential performance requirements of the IEC 60601-2-65:2012.

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User manual • Owandy-RX PRO
1.2.1. QUALITY DETERMINANTS IN XRAY INTRAORAL RADIOGRAPHY
Image quality is linked to the precise and accurate acquisition of information from the x-ray beam transmitted through
the patient (ito the x-ray detector). Most problems in dental radiography are not the result of x-ray equipment failure: the
production of consistent and high quality x-ray diagnostic images, concurrent with minimal patient exposure, depends
generally on dierent components: quality performance of equipment, characteristics of the modules used which aect
the imaging system resolution (i.e.: x-ray image detector type and relevant image processing chain, analogue or digital)
and optimal performance of the operator.
Among the physical factors for achieving optimum image quality, the following can be considered:
- optimum optical density and Wiener spectrum,
- detectors for radiography must meet the needs of the specic radiological procedure where they will be used and key
parameters are spatial resolution, uniformity of response, contrast sensitivity, dynamic range, acquisition speed and
frame rate
- minimization of motion blurring (using short exposure times),
- minimization of geometric blurring (reducing the focal spot size and/or of the object-lm distance),
- geometric distortions,
- correct positioning: errors in patient positioning when using uncoupled positioning devices during the various typologies
of x-ray examinations may lead to exposure errors, which require additional x-ray exposures, thereby increasing the
radiation dose adsorbed by the patient.
This means that it is absolutely essential and mandatory that the operator consider the performances not only of the
Owandy-RX PRO equipment itself, but the whole chain of components that bring to the nal x-ray diagnostic image.
The essential parameters and relevant metrics which describe the performance of dental X-ray system, with regard to
imaging properties and patient dose, methods of testing and whether measured quantities related to those parameters
complying with the specied tolerances, are stated by the respective manufacturers and by the requirements specied
by the respective applicable standards.
Radiographic lms, lm processing, digital x-ray image detectors, and imaging plates are vital parts in the imaging
chain. It is responsibility of the operator to ensure that these components perform in an acceptable way, with respect
to sensitivity, contrast and absence of artifacts. A test of the performance of these components shall precede any
acceptance test measurement involving the irradiation of the x-ray detectors using the Owandy-RX PRO1.
!
WARNING
It is full responsibility of the operator and RESPONSIBLE ORGANIZATIONS of the Owandy-RX PRO to check that any kind of
x-ray detectors used with the Owandy-RX PRO are in compliance with the requirements stated by their specic regulations in
force and to the specications stated by their respective manufacturers.
1 For example refer to IEC 61223-3-4 and similar standards.

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User manual • Owandy-RX PRO
1.3. WARRANTY CONDITIONS
Inappropriate use or any arbitrary tampering with this equipment exempts, “Owandy Radiology”, as manufacturer of the
“Owandy-RX PRO” x-ray system, from any service under warranty or from any other liability
This warranty is valid only if the following precautions are taken. Please refer to the following warranty conditions:
• Any repair, modication, adjustment, or any kind of technical intervention must be performed only by Owandy
Radiology or by a qualied authorized representative
• The installation must be made by professionally qualied technicians according to the regulations in force.
• The system must be installed and used in compliance with the instructions given in this operator’s manual and in its
associated documentation.
• The device shall be used in compliance with the purposes and applications for which it is designed.
• The power supply must be adequate to supply the required power indicated in the data contained in the labels of the
device.
• In order to activate your warranty protection carefully read, ll and sign the Warranty Document provided by the
seller, immediately after the installation is completed, together with the installer.
• The system must be checked completely at least each 12 months by professionally qualied technicians according to
the regulations in force. Use the manuals provided with the device Owandy-RX PRO for reference.
• In case of repair, please only use OEM spare partsfrom the manufacturer of the Owandy-RX PRO Otherwise basic
safety and essential performances of the device will be not guaranteed.
•
Owandy Radiology is not responsible for any damages caused by any person or thing as a consequence of non com-
pliance of any or all guidelines contained in all the manuals provided with the Owandy-RX PRO device.
CAUTION
Noncomplianceofanyofthe abovementionedrulesandall theindicationsprovidedbythemanufacturerinthedocumentation,
or successively in written paper or electronic format, will result in voiding the warranty of the product and the manufacturer will
be discharged from any obligation, including consequential damages, direct or indirect that may derive to people, things or
environment. Furthermore, the facility representative, customer or employees of the facility, will be liable for any damage and/
or incident and/or degeneration of the health status of a patient, operator, involved people and the surrounding environment.
This will also result in service charges for non-warranty technical assistance.
1.4. TRANSPORT CONDITIONS
The“Owandy-RX PRO”x-ray system travels at the receiver’s own risk.
All claims for damages or mishaps regarding the shipment must be pointed out in the presence of the shipping agent.
In case of actual or suspected damages, the receiver shall indicate the proper reserves on the way-bill or on the
consignment note.
1.5. SAFETY WARNINGS
A few safety recommendations are listed here below which must be followed when using the“Owandy-RX PRO x-ray
system”.

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CAUTION
GENERAL REQUIREMENTS
• RESPONSIBLE ORGANIZATION is the authority that has the responsibility for the USE and MAINTENANCE of the Owandy-
RX PRO system. The training and preparation of personnel is the responsability of THE RESPONSIBLE ORGANIZATION.
• Owandy-RX PRO is an x-ray generator and must be used and handled only by specialised surgeons, dentists and authorized
personnel, who meet the requirements provided by the national laws in force in the country of installation.
• It is mandatory for the RESPONSIBLE ORGANIZATION to provide a routine and special maintenance schedule for biomedical
equipment; this schedule must be documented for every device and transmitted to the various operating levels (*).The
preventive maintenance (that must be performed at least every twelve months), which includes functional, performance
and safety tests of the device, must be carried out by qualied, authorized professional technicians.It is mandatory to
ensure patients’ health and safety and proper Owandy-RX PRO operation (IEC 60601-1 etc.).These operations must be
carried out according to the methods and frequency indicated in this manual, the installation and maintenance manual
and maintenance manual. Failure to comply with this requirement or with the messages concerning anomalies will
release the manufacturer from any liability for direct and indirect injuries to persons and/or damage to property or the
environment. Furthermore, the managers of the facility, customers or collaborators shall be held liable for any damage and/
or accidents and/or degeneration of patients’ or operators’ health or of the surrounding environment. The RESPONSIBLE
ORGANIZATION must also provide for the safe and proper use of the equipment. (*) For Italy refer to Presidential Decree
14/01/1997, Legislative Decree No. 81/2008 (as subsequently amended and modied).
• Operators must know the environmental and operating specications of the device, as well as the procedures to follow in
the event of hazards or emergency stops.
• The Owandy-RX PRO has been designed to acquire radiography images for dental intraoral x-ray imaging. The Owandy-RX
PRO medical device must not be used for x-ray imaging of other body parts.
• Carefully follow the instructions in this manual to install, operate and maintain the Owandy-RX PRO device. In the event
that local laws and standards are more restrictive than the manufacturer’s indications, the former supersede the latter.
• The RESPONSIBLE ORGANIZATION must comply with the standards and regulations in force concerning the installation of
the medical device in consideration of the place of installation.
• The operator is cautioned to monitor the patient and the parameters of the Owandy-RX PRO throughout the entire
duration of the x-ray examination.
• It is prohibited to modify any part of the Owandy-RX PRO medical device.
• Owandy Radiology and its authorized technicians are not required to verify compliance of the installation site with local
standards concerning electrical safety and X-ray protection and with any other directive concerning safety in force in the
country of installation.
• The RESPONSIBLE ORGANIZATIONS of the facility must ensure compliance of the installation site with the local laws in
force.
• The Installation of the Owandy-RX PRO system and all its accessories must be executed only by trained, qualied and
authorized service personnel.
• Before each examination, it is mandatory to apply a disposable protection sheath to the collimator cone (Beam Limiting
Device) which is designed to cover the end part of the X-ray unit, which is more susceptible of being directly contaminated
during the X-ray exposure. It can come into contact with the patient’s skin: verify biocompatibility according to the
principles given in the ISO 10993 series of standards, refer for details to the disposable use protection’s instructions for use.
• Before operating the Owandy-RX PRO you must assure that the device has no visible signs of damage.

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User manual • Owandy-RX PRO
CAUTION
PROTECTION AGAINST RADIATIONS
• The «General principles for safeguarding and protecting the personnel and patients» must always be applied during the
use of the X-ray unit.
1. Justication of the practice
2. Optimization of protection principle (ALARA principle)
3. Individual risk and dose limits
• The Owandy-RX PRO is a medical device that generates X-rays; therefore, both the patients and the operator are exposed
to risks due to ionizingionizing radiation. The physician must assess the actual need for X-ray exposure.
• All personnel present during an x-ray examination must comply with safety regulations concerning protection against
radiation. For their own safety, the operator must always keep a distance of more than 2 meters (6 ft.) from the x-ray beam.
• TheOwandy-RX PRO medical devicemustbeused in compliance with the local standardsin forceand with the international
directives concerning radiation protection.
• Compliance with the guidelines and indications provided by an accredited specialist in radiation protection, who will
recommend, if necessary, the additional shields or precautions for every specic case.
• The device installation site must be shielded in compliance with the local standards in force to protect the operator,
patient and other people against X-rays.
• The Owandy-RX PRO device is intended to be used solely by surgeons, dentists and qualied and authorized physicians.
The operator must:
- determine, when appropriate, the possible need for sedation and the related operating methods and precautions best
suited appropriate for the patient
- supervise the entire x-ray examination procedure, paying attention to the indications and information from the unit.
• The device must be used for diagnostic purposes solely by qualied and authorized dentists and/or physicians.
• The operator and other personnelmust keep clear from the patient during the scan. The personnel involved in the
radiographic examination must take all the safety measures concerning radiation protection.
• It is the operator’s responsibility to protect the patient against unnecessary or excessive radiation doses.
• Additional protection devices (aprons, collars, etc) are required to protect the patient from radiation.
• Before exposing patients with pacemakers, contact the manufacturer of the latter to ensure that the X-rays generated by
Owandy-RX PRO do not interfere with its functionality
• Owandy-RX PRO generates x-rays: Before using this x-ray system please refer to the regulation in force in your area
concerning paediatric patients, pregnant women and anyone with health issues that contraindicate the use of x-rays.
Investigate and make sure of this condition before starting the exposure.
This symbol indicates X-ray hazards

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CAUTION
MECHANICAL RISK
• Pay extreme attention to the tension of the internal spring of the scissor arm in order to avoid the arm opening outward
and causing injury.
• Check that the installation of the unit complies with the mechanical specications of the support (walls, ceiling, etc..)
where it is installed
• Adjustments or any kind of attempt of repairing or disassembling must only be performed by qualied and authorized
service personnel.
• The Owandy-RX PRO must not be used in environments or close to environments subjected to mechanical vibrations or
mechanical shocks.
• Do not cause overbalancing of the MobileVersion due to improper pushing or leaning the device using other parts respect
to the handle, or with the brakes activated, or with the scissor arm opened.

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User manual • Owandy-RX PRO
CAUTION
ELECTRICAL SAFETY
• The x-ray system contains high voltage. It’s prohibited to inspect internal parts of the system.
• Never attempt to open the x-ray tube head.
• The covers on the Owandy-RX PRO equipment must only be removed by qualied and authorized service personnel.
• The unit must be used only in environments that are in compliance with all the electrical safety standards set forth for
medical environments.
• The unit is NOT waterproof; it will therefore be necessary to make sure that no water or other liquids penetrate inside the
equipment so as to avoid short circuits or corrosion.
• Always disconnect the x-ray system from the power supply and wait for 2 minutes before commencing to clean or disinfect
orperform any maintenance operations.
• Do not connect the x-ray system to a multiple portable socket outlet (MPSO) or any type of extension cord.
• External equipment intended for connection to signal input, signal output or other connectors shall comply with the
relevant product standard e.g. IEC 60950-1 for IT equipment and the IEC 60601-series for medical electrical equipment. In
addition, all such combinations – systems – shall comply with the safety requirements stated in the collateral standard
IEC 60601-1-1 or the general standard IEC 60601-1, edition 3, clause 16. Any equipment not complying with the leakage
current requirements in IEC 60601-1 shall be kept outside the patient environment i.e. at least 1.5 m from the patient
support.
• Any person who connects external equipment to signal input, signal output or other connectors has formed a system and
is therefore responsible for the system to comply with the requirements. If in doubt, contact qualied medical technician
or your local representative.
• It is mandatory to use an isolation device (Separation Device) to isolate the equipment located outside the patient
environment from the equipment located inside the patient environment. In particular such a Separation Device is required
when a network or data connection is made.The requirements on the Separation Device is dened in IEC 60601-1-1 and in
IEC 60601-1, edition 3, clause 16.
• Based on the IEC 60601-1, the installation of the Owandy-RX PRO wall version is a permanent type (xed). IT IS NOT
ALLOWED TO connect the equipment to the main supply using a plug.
• NEVER use the device without the presence of the lateral enclosure of the fork (example shown in the picture below) or
without the proper xing of the enclosure on the fork.

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User manual • Owandy-RX PRO
CAUTION
• The cone (Beam Limiting Device) is an APPLIED PART of the system and is classied type B.
EMC COMPATIBILITY
• EMC requirements must be considered, and the Owandy-RX PRO must be installed and used accordingly with the specic
EMC information provided in the accompanying documents.
• The device complies with the EMC (Electromagnetic Compatibility) according to IEC 60601-1-2. Radio transmitting
equipment, cellular phones etc. shall not be used in close proximity of the unit as they could inuence the performance
of the system.
• Carefully read the indications relevant to the EMC in the dedicated appendix EMC compatibility of this manual.
• Repairs and replacements of any component included cables, must be carried out solely by authorized and highly qualied
personnel and only using genuine spare parts supplied by Owandy Radiology using other spare parts and cables may
negatively aect EMC performance.
CAUTION
PROTECTION AGAINST EXPLOSIONS
The x-ray system MUST NOT be used in the presence of disinfectants, ammable or potentially explosive gases or vapors that
might igniteand cause damage.
If these disinfectants must be used let the vapors completely disperse before turning on the x-ray system.
CAUTION
SYSTEM MODIFICATIONS OR UPGRADES
• Modications or upgrades of the system can be carried out only if advised by Owandy Radiology and performed by
authorized and qualied personnel, using ONLY genuine original spare parts of Owandy Radiology
• Owandy Radiology proscribes improper, unauthorized modications or upgrades of the device, in order to avoid
malfunctioning resulting in breakdowns and/or accident for patient, operator and equipment. Owandy Radiology assumes
no responsibility and, consequently, declines all responsibility with respect to direct or indirect damages to people, the
device or environment due to these reasons.
• Do not remove or attempt to remove the plastic covers of the device.
• It is strictly forbidden attempt to repair electronic or mechanical parts by yourself.
• Disregardingthis warning can result in irreversibly compromising the overall safety of the system and can be dangerous
for operators, patients and environment.

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User manual • Owandy-RX PRO
2. XRAY SYSTEM OVERVIEW
The“Owandy-RX PRO”is manufactured in compliance with the following American Standard:
• American Radiation Performance Standard 21 CFR, Subchapter J
Many protective measures have been adopted in the design and construction of the unit, such as:
protection against the risk of electric injuries, ensured by a grounded protection conductor and in accordance with the 2nd and
3ed of the IEC 60601-1, together with the applicable worldwide international deviations.
protection against leakage radiation, made negligible by the shielded casing;
protection against continuous service, since the system is designed, according to standards, to not be used in radioscopy;
protection for the operator against irradiation due to the extendable hand control and cable which allows for a safety distance
of more than 2 meters (6 ft.)
protection against accidental selection of the x-ray technique button selected (FILM or DIGIT) obtained, according to standards,
by means of the conrming of the key of selection.
“ELECTRO-MEDICAL”CLASSIFICATION
According to the general safety regulations EC EN 60601-1 on safety of medical equipment, the system is classied as: Class
I - Type B
“EMC” CLASSIFICATION
According to paragraph §4 of the EN 55011, this system is classied as: Group 1 - Class B

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2.1. SYSTEM COMPONENTS
The Owandy-RX PRO x-ray system (Fig.1) consists of the following components:
1 - X-RAY CONTROL UNIT (TIMER)
With it’s clear and highly visible display this component allows for easy and clear selection, of the exposure settings, the creation
of personal settings while alerting you with a visual display and an audible alert in case of incorrect operation or eventual
failures.
This is possible due to the control panel which represents the operator interface between device and operator.
The timer also contains the x-ray exposure switch, which triggers the x-ray when the button is depressed.
The internal sub-mechanical architecture of the X-ray control unit provides the necessary wall framework for
xating the control unit to a wall.
2 - HORIZONTAL BRACKET
The horizontal bracket is available in 3 dierent lengths and represents the support for the scissor arm. Its shaft is xed in a
dedicated section in the middle of the timer (top or bottom) and allows for 180° movement.
3 - PANTOGRAPH TYPE ARM (SCISSOR)
Due to the new shape and mechanism of the articulating arm, it can be ajusted in height and depth for easy and precise
movement to any position. It is equipped with internal balancing springs and made of extruded aluminum arms covered by
PC-ABS material enclosures.
4 - X-RAY SOURCE ASSEMBLY (TUBEHEAD)
The tubehead of the Owandy-RX PRO contains the x-ray tube, the high voltage board and the high frequency generator. The
high voltage board, the x-ray tube and the expansion chamber are submerged in a sealed aluminum chamber containing highly
dielectric insulating oil.
The expansion chamber guarantees the expansion of oil over the whole range of operating temperatures according to the
technical specications of the device.
The emission of the x-rays is electronically controlled which guarantee a great accuracy of the loading factors.

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User manual • Owandy-RX PRO
The tubehead is equipped with an angle scale indicator and is designed for easy handling and positioning of the tubehead
during the x-ray examination.
5 - COLLIMATOR CONE (Beam Limiting Device)
Made of transparent polycarbonate or PC-ABS, it allows for:
- correct focal spot to skin distance
- dimension, direction and centering of the x-ray beam
- implementation of dierent x-ray techniques (bisecting and parallel technique)
2.2. OWANDYRX PRO ACCESSORIES
ECB: remote exposure switch The intraoral accessories ECB (External Command Button)
allows to mount the timer close to the arm+head (inside the
room), having the External Command Button outside the
room.
External Lights
100-240 V
Lights supplied for highlighting the XRay emission outside
the XRay room.
(Also not using this accessory, the same function can be
achieved by the nal user with a dierent light connected to
the equipment)
Mobile stand Mobile conguration of Owandy-RX PRO is the third possible
conguration (besides the two standards wall mounting, top
or bottom). The mobile stand provides the possibility to move
Owandy-RX PRO quickly and easily to dierent position of the
room. The stand consists of supporting structure, handle and
four castors.
Wall plate interface The interface wallplate for Owandy-RX PRO is aimed to allow
the installation of the apparatus on drywalls. The part allows
to safely x the unity to drywalls with standard spacing
between the wooden structural pillars thanks to spaced
mounting holes of 16’’ (40,64cm). It’s made of two parts: (A)
the actual metal wallplate to which the unit will be xed and
(B) an aesthetical cover made of white plastic for continuity
with the design of Owandy-RX PRO.
CAUTION
Using other accessories may negatively aect EMC performance.

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User manual • Owandy-RX PRO • 01/2023 • NORPEN010B
User manual • Owandy-RX PRO
2.3. IDENTIFICATION TAGS
The identication tags on the tube head, timer and cone indicate the model number, serial number, the manufacturing
date and the symbols of the main technical characteristics.
2.4. MEANING OF INFORMATION REPORTED ON THE LABEL
Rated line voltage
Rated line voltage
Absorbed Power
Absorbed Power
Nominal voltage
Nominal voltage
Output max.
Output max.
Total ltration
Total ltration

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User manual • Owandy-RX PRO
2.5. SYMBOLS
En: Power ON (IEC 60417)
En: Power OFF (IEC 60417)
En: Protective earth (IEC 60417)
En: Applied Part: Type B (IEC 60601-1)
Attention, refer to the attached documents
Ionizing radiation hazard
Emitting X-ray equipment (IEC 60417)
Comply with the implementation standards in your country.
European Council Directive 2012/19/EC (WEE) imposes the disposal or recycling of electric and
electronic equipment. The product is marked with the following icon. This product must not be dis-
posed of as domestic waste. The crossed-out wheelie bin identies a product placed on the market
after the 13th of August 2005 (see IEC EN 50419:2005). This product is subjected to Council Directive
2012/19/EC (WEEE) and implementation standards in force in your country. The product must be
disposed of or recycled to protect the environment. Contact your supplier
Size of the focal spot (small)
Hazardous Voltage
Electrostatic discharge sensitive device
Pause (IEC 60417)
X-ray command (IEC 60417)
This symbol remind that is mandatory read carefully the whole documentation and manuals provi-
ded with the medical device before perform whatever operation.