Owandy Radiology RX-AC User manual

PRECISION AND SIMPLICITY
AC INTRAORAL RADIOLOGY SYSTEM
USER MANUAL
NXACEN160A •02/2020 •REV00

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User Manual – Owandy-RX AC
Language of the original document: ENGLISH
Important: All new editions and revisions of the manuals supersede the previous ones
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

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User Manual – Owandy-RX AC
MANUFACTURER
Owandy Radiology
2 rue des vieilles vignes
77183 Croissy-Beaubourg
FRANCE
Tel. [phone]
[e-mail]
www.owandy.com

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User Manual – Owandy-RX AC
THE RADIOGRAPHIC SYSTEM DESCRIBED IN THIS MANUAL REFERS BOTH TO THE WALL
INSTALLATION AND THE MOBILE VERSION.
“OWANDY RADIOLOGY” RESERVES ITSELF THE RIGHT TO MODIFY THE PRODUCTION AND
THE MANUAL WITHOUT NOTICE.
IT IS PROHIBITED TO MODIFY, COPY, REPRODUCE, DISPLAY, SHARE, DISCLOSE AND
PUBLISH THIS MANUAL AND ALL OTHER DOCUMENTS REFERRING TO OWANDY-RX AC IN
ANY FORM WITHOUT PRIOR WRITTEN CONSENT BY OWANDY RADIOLOGY.
THE MANUAL MUST ALWAYS BE KEPT NEAR THE MEDICAL DEVICE FOR FUTURE
REFERENCE.
OWANDY RADIOLOGYSHALLNOT BE LIABLE FORAN INCORRECT USE OFTHE INFORMATION
CONTAINED IN THIS MANUAL.

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1. SOMMAIRE
CONTROL PANEL...........................................................................................................................6
PRELIMINARY INFORMATION.......................................................................................................7
1.1. PRELIMINARY INFORMATION ........................................................................................................................ 7
1.2. INFORMATION FOR THE OPERATOR............................................................................................................ 7
1.3. QUALITY DETERMINANTS IN X-RAY INTRAORAL RADIOGRAPHY ............................................................ 8
1.4. WARRANTY CODITIONS ................................................................................................................................. 9
1.5. TRANSPORT CONDITIONS............................................................................................................................. 9
1.6. SAFETY WARNINGS........................................................................................................................................ 9
RADIOGRAPHIC SYSTEM............................................................................................................14
2.1. RADIOGRAPHIC SYSTEM............................................................................................................................. 14
2.2. SYSTEM COMPONENTS............................................................................................................................... 15
2.2.1. ACCESSORIES............................................................................................................................................ 16
2.3. IDENTIFICATION TAGS.................................................................................................................................. 16
CONFIGURATION .........................................................................................................................19
3.1. CONFIGURATION .......................................................................................................................................... 19
INSTRUCTIONS FOR USE............................................................................................................21
4.1. INSTRUCTIONS FOR USE ............................................................................................................................ 21
4.2. CONE REPLACEMENT .................................................................................................................................. 26
EXPOSURE VALUES ....................................................................................................................27
5.1. CHART OF DEFAULT EXPOSURE VALUES ................................................................................................. 27
PROGRAMMING DEFAULT EXPOSURE VALUES......................................................................32
6.1. PROGRAMMING DEFAULT EXPOSURE VALUES........................................................................................ 32
6.2. RESTORING ORIGINAL VALUES .................................................................................................................. 34
DIAGNOSTIC.................................................................................................................................35
7.1. DIAGNOSTIC .................................................................................................................................................. 35
CHAPTER 8 ...................................................................................................................................36
8.1. ERROR MESSAGES ...................................................................................................................................... 36
VERIFICATION OF THE EXPOSURE FACTORS .........................................................................37
9.1. VERIFICATION OF THE EXPOSURE FACTORS .......................................................................................... 37
SUGGESTED MAINTENANCE .....................................................................................................39
10.1. SUGGESTED MAINTENANCE..................................................................................................................... 39
10.2. CLEANING THE OUTER SURFACES.......................................................................................................... 39
REPAIR ..........................................................................................................................................41
11.1. REPAIR.......................................................................................................................................................... 41
11.2. DISPOSAL..................................................................................................................................................... 41
ANNEX 1........................................................................................................................................42
A1. TECHNICAL SPECIFICATIONS ...................................................................................................................... 42
ANNEX 2........................................................................................................................................46
A2. INTENDED ENVIRONMENT ........................................................................................................................... 46
ANNEX 3........................................................................................................................................47
A3. LIST OF INTERNATIONAL STANDARDS AND DIRECTIVES ........................................................................ 47
ANNEX 4........................................................................................................................................48
A4. DOSIMETRIC INDICATIONS .......................................................................................................................... 48
ANNEX 5........................................................................................................................................49
A5. ELECTROMAGNETIC COMPATIBILITY ......................................................................................................... 49
ANNEX 6........................................................................................................................................53
A6. DRAWINGS AND DIMENSIONS ..................................................................................................................... 53
ANNEX 7........................................................................................................................................55
A7. INSTALLATION ELECTRICAL SCHEME ........................................................................................................ 55

OWANDY RX - HUMAN VERSION
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CONTROL PANEL
X-RAY OUPTUT
SIGNAL
PAUSE
INDICATOR
MALFUNCTION
INDICATOR
SAVE IN
MEMORY
BITE - WING
EXAM
MANDIBULARY
LOWER TEETH
DIGITAL X-RAY
CONVENTIONAL
X-RAY
OCCLUSAL
EXAM
DISPLAY
KEY TO INCREASE
EXPOSURE TIME
KEY TO DECREASE
EXPOSURE TIME
TUBEHEAD
SELECTION
RADIOGRAPHIC
DISTANCE INDICATOR
SELECTION OF
PATIENT TYPE
TUBEHEAD
TYPE INDICATOR
RADIOGRAPHIC
CURRENT INDICATOR
RADIOGRAPHIC
VOLTAGE INDICATOR
MAXILLARY
LOWER TEETH

111
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PRELIMINARY INFORMATION
1.1. PRELIMINARY INFORMATION
Before beginning to use the Owandy-RX AC radiographic system, it is mandatory to carefully read and follow the
instructions contained herein, so as to obtain the best possible performance and to assure the safety of the patient,
operator, device and environment.
Always pay close attention to the
CAUTION
WARNING
PLEASE NOTE
messages when operating the system.
LEGEND
CAUTION
The word CAUTION identifi es those occurrences which might compromise the operator’s personal safety or cause injuries to people.
!
WARNING
The word WARNING identifi es those occurrences which might compromise the radiographic system’s performance.
PLEASE NOTE
PLEASE NOTE serve to give special indications so as to facilitate maintenance or make important information clearer.
1.2. INFORMATION FOR THE OPERATOR
Dear Customer,
thanks for having chosen the Owandy-RX AC radiographic system.
It is designed and manufactured by Owandy Radiology and is the result of many years of experience in the fi eld of
radiology and in the application of advanced electronics.
This high performing system represents a further development of technological research at the service of dental
radiography.
The Owandy-RX AC is an X-ray generator for dental intra-oral X-ray imaging, particularly, Owandy-RX AC is an extra-
oral source of X-rays, intended to be used for producing diagnostic dental radiographs for treatment of disease of
teeth, jaw and oral structures.
From a clinical point of view, Owandy-RX AC can be applied in routine dental radiography examinations involving the
diagnosis, treatment, i.e. surgical or interventional, of disease of the teeth, jaw and oral cavity structures.
Its intended medical applications are:
• Generic dentistry
• Dental implantology
• Dental surgery
The intended population can be whatever, anyway the sustainability of the X-ray exposure must be evaluated by sur-
geons, dentists and qualifi ed and authorized physicians.
The Intended user profi 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

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User Manual – Owandy-RX AC
the country where the device is installed. The intended conditions of use are detailed in Annex A2 (“Intended Environ-
ment”).
PLEASE NOTE
This manual does not contain all the recommendations and the obligations relative to the possession of a source of ionising radiations – since
they do vary from Country to Country – but only the most common ones.
The user must consult his country’s legislation so as to fulfi l all local obligations.
!
WARNING
This manual describes how to set and use the Owandy-RX AC 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 fi rst time, it is essential to thoroughly and carefully read the instructions, CAUTION and WARNING messages
listed in the present chapter.
It is mandatory to comply with these instructions every time the device is used.
Owandy-RX AC is compatible with all kind of X-ray detectors which have been designed and certifi ed for dental intra-oral radiology; in detail, such
a compatibility is ensured by the compliance of the Owandy-RX AC device with the basic safety and essential performance requirements of the
IEC 60601-2-65: 2012.
1.3. 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 (i.e., 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 different components: quality performance of equipment, characteristics of the modules used which affect
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 specifi 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-fi 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 AC equipment itself, but the whole chain of components that bring to the fi 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
comply with the specifi ed tolerances, are stated by the respective manufacturers and by the requirements specifi ed by
the respective applicable standards.
Radiographic fi lms, fi 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 AC.

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!
WARNING
It is full responsibility of the operator and RESPONSIBLE ORGANIZATIONS of the Owandy-RX AC to check that any kind of X-ray detectors used
with the Owandy-RX AC are in compliance with the requirements stated by their specifi c regulations in force and to the specifi cations stated by
their respective manufacturers.
1.4. WARRANTY CODITIONS
Inappropriate use or any arbitrary tampering with the equipment exempt Owandy Radiology, as manufacturer of the
Owandy-RX AC radiographic system, from any service under warranty or from any other liability.
The warranty is valid only if the following precautions are taken:
- any repairs, modifi cations, adjustments, recalibrations must be performed only by Owandy Radiology
- the installation must be made by professionally qualifi ed technicians according to the regulations in force
- the system must be installed and used in compliance with the instructions given in this Manual and for the purposes
and applications for which it was designed
- the power supply must be adequate to supply the required power indicated in the radiographic system’s nameplate
data
- in order to safeguard one’s warranty rights, please fi ll in the enclosed Warranty Document, immediately after the
installation is completed, together with the technician
- The system must be checked completely at least each 12 months by professionally qualifi ed technicians according to
the regulation in force. Use the manuals provided with the device Owandy-RX AC for reference.
- In case of repair, please use only spare parts from the manufacturer of the Owandy-RX AC.
Otherwise basic safety and essential performances of the device will not be guaranteed.
Owandy Radiologyis not responsible for any damage caused by any person or thing as a consequence of non-
compliance of any of the guidelines contained in all the manuals provided with the Owandy-RX AC device.
CAUTION
No compliance of any of the above mentioned rules and all the indications provided by the manufacturer in the documentation, or successively
in written paper or electronic format, will result in losing 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.
1.5. TRANSPORT CONDITIONS
The Owandy-RX AC radiographic system travels at the receiver’s own risk.
All claims for damage or miscarriage regarding the shipment must be pointed out in the
presence of the shipping agent.
In case of miscarriages, or actual or suspected damage, the receiver shall indicate the proper reserves on the way-bill
or on the consignment note.
1.6. SAFETY WARNINGS
A few safety recommendations which should be followed when using the Owandy-RX AC radiographic system are listed
here below.

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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 AC radiographic
system.
Training and preparation of personnel is responsibility of THE RESPONSIBLE ORGANIZATION.
Owandy-RX AC radiographic system 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 medical equipment; this sche-
dule must be documented for every device and transmitted to the various operating levels (*). The preventive maintenance (that must be perfor-
med at least every 12 months), which includes functional, performance and safety tests of the device, must be carried out by qualifi ed, authorized
professional technicians. It is mandatory to ensure patients’ health and safety and proper Owandy-RX AC radiographic system operation (IEC
60601-1 etc.). These operations must be carried out according to the methods and frequency indicated in this manual and in the installation 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 will 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 modifi ed).
Operators must know the environmental and operating specifi cations of the device, as well as the procedures to follow in the event of hazards or
emergency stops.
Owandy-RX AC radiographic system has been designed to acquire radiography images for dental intraoral X-ray imaging. The Owandy-RX AC
medical device must not be used for X-ray imaging of other body parts.
Carefully follow the instructions of this manual to install, operate and maintain the Owandy-RX AC radiographic system. 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 AC radiographic system throughout the entire duration of
the X-ray examination.
It is prohibited to modify any part of the Owandy-RX ACmedical 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.
Before each examination, it is mandatory to apply to the collimator cone (Beam Limiting Device) a disposable protection sheath designed to cover
the end part of the X-ray unit, which is more susceptible of being directly contaminated during the X-ray exposure (class I Medical Device
Directive 93/42/EEC and subsequent amendments). 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 AC radiographic system you must assure that the device has no visible signs of damage.

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CAUTION
PROTECTION AGAINST RADIATIONS
“The general principles regarding safety and protection of workers and people” must always be applied when using the unit:
1. Justifi cation of the practice
2. Protection Optimisation
3. Reduction of the limits of individual dose and risks
The Owandy-RX AC is a medical device that generates X-rays; therefore, both the patients and the operator are exposed to risks due to ionizing
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.) and out of the path of the X-ray beam, in order to avoid the exposi-
tion to the stray radiation.
The Owandy-RX AC medical device must be used in compliance with the local standards in force and with the international directives concerning
radiation protection.
The device must comply with the guidelines and indications provided by an accredited specialist in radiation protection, who will recommend, if
necessary, additional shields or precautions for every specifi 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 AC device is intended to be used solely by surgeons, dentists and qualifi ed and authorized physicians. The operator must:
- determine, when appropriate, the possible need for sedation and the related operating methods and appropriate precautions 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 only for diagnostic purposes by qualifi ed and authorized dentists and/or physicians.
The operator and other personnel must 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 AC do not
interfere with its functionality.
Owandy-RX AC 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 hazard.

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CAUTION
MECHANICAL RISK
Before removing the tubehead from the positioning arm, RELEASE THE SPRING.
The sudden opening of the joint may cause damage to people and/or things.
Check that the installation of the unit complies with the mechanical specifi 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 qualifi ed and authorized service personnel.
The Owandy-RX AC must not be used in environments or close to environments subjected to mechanical vibrations or mechanical shocks.
CAUTION
ELECTRIC SAFETY
The radiographic system contains high voltage. It is prohibited to inspect internal parts of the system.
Never attempt to open the X-ray tubehead.
The covers on the Owandy-RX AC radiographic system must only be removed by qualifi ed and authorized service personnel.
The unit must be used only in environments that are in compliance with all electrical safety standards set forth for medical environments.
To avoid the risk of electric shock, this device must only be connected to a supply mains with protective earth.
The unit is NOT equipped with protections against penetration of liquids; it will therefore be necessary to make sure that no water or other liquids
penetrate inside in order to avoid short circuits or corrosion.
Always disconnect the radiographic system from the power supply and wait for 2 minutes before beginning cleaning and disinfecting operations.
Do not connect the X-ray system to a multiple portable socket outlet (MPSO) nor to 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 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.
It is mandatory to use an isolation device (Separation Device) to isolate the equipment located outside the patient environment from the equip-
ment 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 defi ned in IEC 60601-1, edition 3, clause 16.
For the wall version of Owandy-RX AC:
based on the IEC 60601-1, the installation is a permanent type (fi xed). IT IS NOT ALLOWED TO connect the equipment to the main supply using
a plug.
The cone (beam limiting device) is an APPLIED PART of the system and it is classifi ed as type B.

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CAUTION
EMC COMPATIBILITY
EMC requirements must be considered and the Owandy-RX AC must be installed and used accordingly with the specifi c EMC information provi-
ded in the accompanying documents.
The device complies with the EMC (Electromagnetic Compatibility) requirements, 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 infl uence the performance of the system.
Carefully read the indications relevant to the EMC in the dedicated appendix A5. EMC compatibility of this manual.
Repairs and replacements of any component included cables, must be carried out solely by authorized and highly qualifi ed personnel and only
using genuine spare parts supplied by de Götzen® S.r.l. using other cables may negatively affect EMC performance.
CAUTION
PROTECTION AGAINST EXPLOSIONS
The radiographic system MUST NOT be used in the presence of disinfectant, fl ammable or potentially explosive gases or vapours that might
catch fi re and cause damage.
In case these disinfectants have to be used, let the vapour completely disperse before turning on the radiographic system.
CAUTION
SYSTEM MODIFICATIONS OR UPGRADES
Modifi cations or upgrades of the system can be carried out only if advised by Owandy Radiologyand performed by authorized and qualifi ed per-
sonnel, using ONLY genuine original spare parts of Owandy Radiology.
Owandy Radiologyproscribes improper, unauthorized modifi cations or upgrades of the device, in order to avoid malfunctions
resulting in breakdowns and/or accident for patient, operator and equipment. Owandy Radiologyassumes 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 to attempt to repair electronic or mechanical parts by yourself.
Disregarding this warning can result in irreversibly compromising the overall safety of the system and can be dangerous for operators, patients
and environment.

222
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RADIOGRAPHIC SYSTEM
2.1. RADIOGRAPHIC SYSTEM
The Owandy-RX AC radiographic system guarantees the maximum safety both for the operator and the patient.
It is built in compliance with the following European Directives:
►93/42/EEC and subsequent amendments MEDICAL DEVICES
►EURATOM 96/29 IONISING RADIATIONS
The following protective measures were adopted in the design and construction of the unit:
- protection against the risk of electric injuries, ensured by a grounded protection conductor;
- protection against leakage radiation, made negligible by the shielded casing;
- protection against excessive radiations, thanks to the immediate activation of the safety device;
- protection against continuous service, since the system is designed, according to standards, not to allow use in
radioscopy;
- protection for the patient against dangerous radiations, obtained by means of the high frequency technology capable
of producing a constant and hard radiation;
- protection against exposure mistakes obtained with the high frequency technology which is unaffected by voltage
fl uctuation and consequently capable to guarantee extremely accurate exposure parameters;
- protection for the operator against irradiation ensured by the extensible cable of the hand control which allows for a
safety distance of more than 2 meters (6 ft.);
- protection against involuntarily selection of radiographic technique (FILM or DIGIT) obtained, according to standards,
by means of confi rmation on the selection key.
“ELECTRO-MEDICAL” CLASSIFICATION
According to paragraph §6 of the general safety regulations CEI EN 60601-1: 2007 on safety of medical equipment, the
system is classifi ed as: Class I - Type B
“MEDICAL DEVICES” CLASSIFICATION
According to the classifi cation rules indicated in attachment IX of the EEC Directive 93/42 on medical devices and
subsequent amendments the system is classifi ed as: Class IIb
“E.M.C.” CLASSIFICATION
According to paragraph §4 of the CEI EN 55011, the system is classifi ed as: Group 1 – Class B
2.2. SYSTEM COMPONENTS

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Owandy-RX AC radiographic system (Fig. 1) consists of:
1. Owandy-RX AC TIMER
The timer is the control panel used to manage the exposure times and to safely use the tubehead.
To make the exposure, the control button with safety key is available.
The timer can be connected to n° 2 ac tubeheads.
In case of alternate current tubeheads the technology of the timer is “self - compensating”:
depending on the line voltage fl uctuation, the microprocessor automatically modifi es the predetermined exposure time
ensuring a constant dose to the patient.
This technological expedient avoids the repetition of the exposure because of over/under exposure errors.
2. BRACKET
The horizontal bracket is available in 3 different lengths (110 cm, 80 cm, 40 cm) and represents the support for the
pantograph arm. Its shaft is fi xed in a dedicated section of the timer (top or bottom) and allows for 180° movement.
3. PANTOGRAPH ARM
Thanks to the new shape and new mechanisms of the positioning arm, it can be adjusted in height and depth in order
to precisely explore any spot in its reach.
It is made of light alloy with an ABS coating.
4. Owandy-RX AC TUBEHEAD
The intra-oral tubehead Owandy-RX AC is a monoblock type and its light alloy housing contains an airtight compartment.
The high voltage transformer, the X-ray tube and the expansion chamber are submerged in highly dielectric insulating
oil inside a light alloy container.
The expansion chamber guarantees an adequate compensation to oil expansion for the entire temperature range.
The X-ray tube is located in the back part of the container, allowing a source-skin distance 50% higher than traditional
structures.
5. CONE
The collimator cone or Beam Limiting Device represents the applied part of the device. Made of transparent polycarbonate,
or alternatively of lead-coated polycarbonate, it ensures:
- the correct distance between focal spot and skin
- dimension, direction and centering of X-ray beam
- the realization of different radiographic technique (biting and parallel technique).
During X-ray exposition, the collimator cone comes in contact with the skin of the patient.
Before each exam, it is necessary to apply to the cone a disposable protective cover designed to cover the end part of
the X-ray generator.
Such protection is useful to avoid crosscontamination (from patient to patient).
Fig. 1

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2.2.1. 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 out-
side the XRay room.
(Also not using this accessory, the same function can be
achieved by the fi nal user with a different light connected
to the equipment)
MOBILE STAND
AC/DC MOBILE STAND,
UK PLUG,COL RAL9003
Mobile confi guration of Owandy-RX AC is the third pos-
sible confi guration (besides the two standards wall
mounting, top or bottom). The mobile stand provides
the possibility to move Owandy-RX AC quickly and easily
to different position of the room. The stand consists
of supporting structure, handle and four castors.
This accessory is porovided with the UK plug.
CAUTION
Using other accessories may negatively affect EMC performance
2.3. IDENTIFICATION TAGS
The identifi cation tags on the tubehead, on the timer and on the cone indicate the model number, the serial number, the
manufacturing date and the main technical characteristics.
2.3.1. TUBEHEAD
Model 230 V Model 220 V

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Model 115 V
2.3.2. TIMER
Model 230 V
Model 220 V
Model 115 V
CONE
GRADUATED SCALE

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User Manual – Owandy-RX AC
PICTOGRAMS USED
SYMBOL INDICATING THE MANUFACTURER
xxxx
THIS SYMBOL GUARANTEES THAT THE RADIOGRAPHIC SYSTEM COMPLIES WITH THE
REGULATIONS CONTAINED IN THE EUROPEAN DIRECTIVE EEC 93/42 REGARDING
MEDICAL DEVICES
SIZE OF THE FOCAL SPOT
THE DEGREE OF PROTECTION AGAINST DIRECT AND INDIRECT ELECTRIC CONTACTS
IS B TYPE
SYMBOL INDICATING THE SERIAL NUMBER
SYMBOL INDICATING DANGER DUE TO IONISING RADIATIONS
X-ray EMISSION (IEC 60417)
PAUSE (IEC 60417)
ATTENTION, REFER TO THE ATTACHED DOCUMENTS
INSTRUCTIONS IN ELECTRONIC FORMAT
REFER TO MANUAL’S INSTRUCTIONS
WEEE (Waste Electrical and Electronic Equipment) SYMBOL, IN CONFORMITY WITH 2012/19/
CE DIRECTIVE AND EN 50419 STANDARD.

OWANDY RX - HUMAN VERSION
333
OWANDY RX - HUMAN VERSION
OWANDY RX - HUMAN VERSION
OWANDY RX - HUMAN VERSION
OWANDY RX - HUMAN VERSION
OWANDY RX - HUMAN VERSION
OWANDY RX - HUMAN VERSION
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USER MANUAL • Owandy-RX AC • 2/2020 • NXACEN160A
User Manual – Owandy-RX AC
CONFIGURATION
3.1. CONFIGURATION
The Owandy-RX AC radiographic system is provided in the “standard mode” confi guration.
On the control panel the LED relevant to the following exposure parameters will light up:
No. of the selected tubehead
LED 1
supplied cone
LED 8” = SHORT CONE
LED 12” = LONG CONE
Type of tubehead
LED AC = ALTERNATE CURRENT
radiographic voltage
LED 70kV
radiographic current
LED 8mA
type of patient
LED ADULT
radiographic technique
CONVENTIONAL LED D
The following exposure times (s) have been stored:
0,080 – 0,100 –0,125 – 0,160 – 0,200 – 0,250 – 0,320 – 0,400 – 0,500 – 0,630 – 0,800 – 1,00 – 1,250 – 1,600 – 2,000
– 2,500 – 3,200
PLEASE NOTE
These times are in compliance with current CEI EN 60601-1: 2007 standard and with the ISO 497 series R’10 recommendations.
THEY CANNOT BE MODIFIED

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User Manual – Owandy-RX AC
Certain exposure values which depend on the selection of the operating parameters have been predefi ned:
►cone (8”/12”)
►type of patient (ADULT/CHILD)
►radiographic tecnique
►intra-oral test
PLEASE NOTE
These values have to be considered as “recommended”: it is possible to change these values if necessary. (refer to Charter 5 and 6)
To modify these exposure values
►Type of patient (ADULT/CHILD)
►Radiographic technique
(refer to Chapter 4)
To modify these exposure values
►N° of tubehead (1/2)
►Type of tubehead (AC/DC)
►N° control button
►Type of cone (8” /12”)
change the dip-switch position, inside the timer
THIS OPERATION MUST BE CARRIED OUT BY THE INSTALLER ONLY