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

Page 3
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

Page 4 User manual • Owandy-RX PRO • 01/2023 • NORPEN010B
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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User manual • Owandy-RX PRO
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 • 01/2023 • NORPEN010B
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 • 01/2023 • NORPEN010B
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.

Page 10 User manual • Owandy-RX PRO • 01/2023 • NORPEN010B
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”.