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USER MANUAL NXDCEN160A • 02/2020 • REV00 PRECISION AND SIMPLICITY DC INTRAORAL RADIOLOGY SYSTEM...
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Operator’s manual – Owandy-RX DC Language of the original document: ENGLISH Important: All new editions and revisions of the manuals supersede the previous ones Refer to complete manuals and For complete manuals Scan the QR code to access the instructions and instructions dedicated website www.owandy.com...
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Operator’s manual – Owandy-RX DC MANUFACTURER Owandy Radiology 2 rue des vieilles vignes 77183 Croissy-Beaubourg FRANCE Tel. +33 1 64 11 18 18 info@owandy.com www.owandy.com Page 3 of 61 OPERATOR’S MANUAL • Owandy-RX DC • 02/2020 • NXDCEN160A...
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AND ALL OTHER DOCUMENTS REFERRING TO OWANDY-RX DC IN ANY FORM WITHOUT PRIOR WRITTEN CONSENT BY OWANDY RADIOLOGY. THE MANUAL MUST ALWAYS BE KEPT NEAR THE MEDICAL DEVICE FOR FUTURE REFERENCE. OWANDY RADIOLOGY SHALL NOT BE LIABLE FOR AN INCORRECT USE OF THE INFORMATION CONTAINED IN THIS MANUAL. Page 4 of 61...
Operator’s manual – Owandy-RX DC CONTENTS 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.
Operator’s manual – Owandy-RX DC CONTROL PANEL OWANDY RX - HUMAN VERSION DISPLAY KEY TO DECREASE KEY TO INCREASE EXPOSURE TIME EXPOSURE TIME TUBEHEAD TUBEHEAD TYPE INDICATOR SELECTION RADIOGRAPHIC RADIOGRAPHIC CURRENT INDICATOR DISTANCE INDICATOR SELECTION OF RADIOGRAPHIC PATIENT TYPE VOLTAGE INDICATOR OCCLUSAL SAVE IN EXAM...
Dear Customer, thanks for having chosen the Owandy-RX DC 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.
Operator’s manual – Owandy-RX DC 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...
Otherwise basic safety and essential performances of the device will not be guaranteed. Owandy Radiology is 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 DC device.
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It is prohibited to modify any part of the Owandy-RX DCmedical 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.
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Operator’s manual – Owandy-RX DC 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 DC is a medical device that generates X-rays;...
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Operator’s manual – Owandy-RX DC 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...
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CAUTION SYSTEM MODIFICATIONS OR UPGRADES Modifi cations or upgrades of the system can be carried out only if advised by Owandy Radiology and performed by authorized and qualifi ed personnel, using ONLY genuine original spare parts of Owandy Radiology. Owandy Radiology proscribes 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.
Operator’s manual – Owandy-RX DC 2 2 2 RADIOGRAPHIC SYSTEM 2.1. RADIOGRAPHIC SYSTEM The Owandy-RX DC 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 and in compliance with the following American Standard: The following protective measures were adopted in the design and construction of the unit:...
Operator’s manual – Owandy-RX DC 2.2. SYSTEM COMPONENTS Fig. 1 Owandy-RX DC radiographic system (Fig. 1) consists of: 1. Owandy-RX DC 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.
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Operator’s manual – Owandy-RX DC 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). 2.2.1.
Operator’s manual – Owandy-RX DC 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 2.3.2.
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Operator’s manual – Owandy-RX DC PICTOGRAMS USED SYMBOL INDICATING THE MANUFACTURER 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...
Operator’s manual – Owandy-RX DC 3 3 3 HUMAN VERSION CONFIGURATION OWANDY RX - HUMAN VERSION 3.1. CONFIGURATION OWANDY RX - HUMAN VERSION The Owandy-RX DC radiographic system is provided in the “standard mode” confi guration. OWANDY RX - HUMAN VERSION OWANDY RX - HUMAN VERSION On the control panel the LED relevant to the following exposure parameters will light up: No.
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Operator’s manual – Owandy-RX DC 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 ►radiographic voltage (60kV/70kV) ►radiographic current (4mA/8mA)
Operator’s manual – Owandy-RX DC 4 4 4 INSTRUCTIONS FOR USE 4.1. INSTRUCTIONS FOR USE 1° - TURN ON Bring the main switch located on the upper part of the timer to the “I” position (ON) 1. the green light turns on, indicating that the system is powered 2.
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Operator’s manual – Owandy-RX DC STEP 2 : check the selected radiographic distance CONE The LED of the cone length (source-skin distance = SSD) in use should be turned on LED 8” ON indicates that the selected tubehead is equipped with 8” = 20cm (SSD) cone LED 12”...
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Operator’s manual – Owandy-RX DC OWANDY RX - HUMAN VERSION PLEASE NOTE 60kV mode can be selected with the Owandy-RX DC radiographic system only. PLEASE NOTE After the modifi cation, default exposure values will be automatically changed. STEP 5 : check the selected radiographic current The LED of the radiographic current should be turned on LED 4mA ON indicates that the radiographic system is set with reduced dose.
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Operator’s manual – Owandy-RX DC PLEASE NOTE After the modifi cation, default exposure values will be automatically changed. STEP 7 : check the selected radiographic technique OWANDY RX - HUMAN VERSION CONVENTIONAL TECHNIQUE (FILM) The LED of the desired speed fi lm should be turned on LED D ON radiographic system is set for use with D speed fi...
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Operator’s manual – Owandy-RX DC PLEASE NOTE OWANDY RX - HUMAN VERSION After the modifi cation, default exposure values will be automatically changed. STEP 8 : check the selected radiographic technique PERIAPICAL EXAM The LED of the selected teeth should be turned on OWANDY RX - HUMAN VERSION to change the selection press the key relative to the desired tooth OCCLUSAL EXAM...
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Operator’s manual – Owandy-RX DC BITE-WING EXAM The LED of the selected type of test should be turned on LED ANT ON radiographic system is set for anterior bite-wing exam LED POST ON radiographic system is set for posterior bite-wing exam to change the selection press the key relative to the desired exam 3°...
Operator’s manual – Owandy-RX DC PLEASE NOTE If the “X-ray” key is released earlier than the selected exposition time, the exposure is immediately interrupted and the E12 error message appears on the display. 4. At the end of the exposure, the green LED PAUSE intermittently turns on 5.
Operator’s manual – Owandy-RX DC 5 5 5 EXPOSURE VALUES 5.1. CHART OF DEFAULT EXPOSURE VALUES The chart indicates the Owandy-RX DC radiographic system predefi ned exposure values. (refer to Chapter 3) INCISOR CANINE PREMOLAR MOLAR ANTERIOR BITE-WING POSTERIOR BITE-WING OCCLUSAL ANTERIOR OCCLUSAL POSTERIOR PLEASE NOTE...
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Operator’s manual – Owandy-RX DC 12” LONG CONE (SSD = 31cm) CONVENTIONAL RADIOGRAPHIC TECHNIQUE (FILM) ADULT PROGRAMMED E X P O S U R E TIMES (sec) 70kV - 8mA MAXILLA FILM MANDIBLE MAXILLA FILM MANDIBLE MAXILLA FILM MANDIBLE ADULT PROGRAMMED E X P O S U R E TIMES (sec)
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Operator’s manual – Owandy-RX DC CHILD PROGRAMMED E X P O S U R E TIMES (sec) 70kV - 8mA MAXILLA FILM MANDIBLE MAXILLA FILM MANDIBLE MAXILLA FILM MANDIBLE CHILD PROGRAMMED E X P O S U R E TIMES (sec) 60kV - 8mA MAXILLA FILM...
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Operator’s manual – Owandy-RX DC DIGITAL RADIOGRAPHIC TECHNIQUE (SENSOR) ADULT PROGRAMMED E X P O S U R E TIMES (sec) 70kV - 4mA MAXILLA FILM MANDIBLE ADULT PROGRAMMED E X P O S U R E TIMES (sec) 60kV - 4mA MAXILLA FILM MANDIBLE...
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Operator’s manual – Owandy-RX DC 8” SHORT CONE (SSD = 20cm) CONVENTIONAL RADIOGRAPHIC TECHNIQUE (FILM) ADULT PROGRAMMED E X P O S U R E TIMES (sec) 70kV - 8mA MAXILLA FILM MANDIBLE MAXILLA FILM MANDIBLE MAXILLA FILM MANDIBLE ADULT PROGRAMMED E X P O S U R E TIMES (sec)
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Operator’s manual – Owandy-RX DC CHILD PROGRAMMED E X P O S U R E TIMES (sec) 70kV - 8mA MAXILLA FILM MANDIBLE MAXILLA FILM MANDIBLE MAXILLA FILM MANDIBLE CHILD PROGRAMMED E X P O S U R E TIMES (sec) 60kV - 8mA MAXILLA FILM...
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Operator’s manual – Owandy-RX DC DIGITAL RADIOGRAPHIC TECHNIQUE (SENSOR) ADULT PROGRAMMED E X P O S U R E TIMES (sec) 70kV - 4mA MAXILLA FILM MANDIBLE ADULT PROGRAMMED E X P O S U R E TIMES (sec) 60kV - 4mA MAXILLA FILM MANDIBLE...
Operator’s manual – Owandy-RX DC 6 6 6 PROGRAMMING DEFAULT EXPOSURE VALUES 6.1. PROGRAMMING DEFAULT EXPOSURE VALUES WARNING The 23 programmed exposure times cannot be modifi ed in the Owandy-RX DC radiographic system, since they are defi ned in conformity with the regulation in force concerning X-ray intra-oral equipment. Meanwhile it is possible to customize the default exposure values.
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Operator’s manual – Owandy-RX DC EXAMPLE 12” LONG CONE (SSD = 31cm) - CONVENTIONAL RADIOGRAPHIC TECHNIQUE (FILM) PREDEFINED DEFAULT EXPOSURE VALUES ADULT PROGRAMMED E X P O S U R E TIMES (sec) 70kV - 8mA MAXILLA FILM MANDIBLE MAXILLA FILM MANDIBLE MAXILLA...
OWANDY RX - HUMAN VERSION Operator’s manual – Owandy-RX DC OWANDY RX - HUMAN VERSION OWANDY RX - HUMAN VERSION 6.2. RESTORING ORIGINAL VALUES 1 . Turn off the timer 2. Turn the timer on keeping the key pressed OFF 3 .
Operator’s manual – Owandy-RX DC ANDY RX - HUMAN VERSION 7 7 7 DIAGNOSTIC 7.1. DIAGNOSTIC With Owandy-RX DC radiographic system it is possible to visualise certain functional parameters. To visualise them proceed as follows: 1. press simultaneously and keep pressed the keys (17) MAXILLA MOLAR (47) MANDIBULARY MOLAR OWANDY RX - HUMAN VERSION...
Operator’s manual – Owandy-RX DC 8 8 8 ERROR MESSAGES 8.1. ERROR MESSAGES An anomaly is indicated as follows: - emission of an intermittent acoustic signal (beep) - MALFUNCTIONING INDICATOR LED intermittently turns on - the error code (E ….) appears on the display) - all control panel functions are inhibited In this case turn off the timer and then turn it back on.
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Operator’s manual – Owandy-RX DC THE TUBEHEAD CALL THE “ASSISTANCE SERVICE” IS NOT CALIBRATED EEPROM DATA NOT SAVED PROPERLY CALL THE “ASSISTANCE SERVICE” CORRUPTED EEPROM DATA CALL THE “ASSISTANCE SERVICE” OVERVOLTAGE ERROR CALL THE “ASSISTANCE SERVICE” ANODE VOLTAGE OUT OF TOLERANCE CALL THE “ASSISTANCE SERVICE”...
Operator’s manual – Owandy-RX DC 9 9 9 VERIFICATION OF THE EXPOSURE FACTORS 9.1. VERIFICATION OF THE EXPOSURE FACTORS In order to guarantee safety of the radiographic system, it is necessary to set up a periodic control schedule of the exposure factors.
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Operator’s manual – Owandy-RX DC Dose in air is: SOURCE-SKIN DISTANCE 31 cm = 12” 20 cm = 8” 60 kV – 4 mA = 2,2 mGy/s ± 30% 60 kV – 4 mA = 4,5 mGy/s ± 30% 70 kV – 4 mA = 3 mGy/s ± 30% 70 kV –...
• Do not use UV systems to disinfect the equipment, as exposed parts of the device can turn yellow or discolour. • To avoid any potential hazard or danger to operators and patients, contact your authorized Owandy Radiology Technical Representative imme- diately if you experience any unusual operation, mechanical issues, or equipment malfunction.
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Operator’s manual – Owandy-RX DC CAUTION • To ensure both the patient’s and operator’s safety as well as preserving a high image quality, the device must always be well maintained as described in the accompanying documents. For other maintenance operations, refer to the installation and maintenance manual. •...
REPAIR 11.1. REPAIR In case of a malfunction, send the defective part following specifi c instructions provided by the technical support or using the original packaging to: Owandy Radiology 2 rue des vieilles vignes 77183 Croissy-Beaubourg FRANCE Tél. +33 1 64 11 18 18 info@owandy.com...
Operator’s manual – Owandy-RX DC ANNEX 1 A1. TECHNICAL SPECIFICATIONS X-ray SOURCE ASSEMBLY Half Value Layer (HVL) at 70 kV 2,2 mm Al Total fi ltration at 70 kV 2,4 mm Al Tube inherent fi ltration at 70 kV > 1 mm Al X-ray tube tension accuracy ±10% X-ray tube current accuracy...
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Operator’s manual – Owandy-RX DC HEATING AND COOLING CURVES X-ray TUBE X-ray tube model CEI OX70-G7 TOSHIBA DG-073-DC Focal spot size (IEC 336) 0,7 mm 0,7 mm Anode angle 16° 20° Anod material tungsten tungsten Heating/cooling curves TOSHIBA DG-073B-DC CEI OX70-G7 Page 47 of 61 OPERATOR’S MANUAL •...
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Operator’s manual – Owandy-RX DC DEVICE POWER SUPPLY Type of power supply single phase, alternate Supply nominal voltage 230 V Maximum voltage variation ±10% Nominal current 5,2 A @ 230 V Supply voltage frequency 50/60 Hz Maximum line current (measured @ 70 kV, 8 mA, 3,2 s) 5,2 A @ 230 V Absorbed power 1,2 kVA @ 230V...
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Operator’s manual – Owandy-RX DC COLLIMATOR CONE TECHNICAL DATA short cone 20 cm (8’’) Source-skin distance (SSD) long cone 31 cm (12’’) rectangular cone 31 cm (12’’) short cone ≤ 60 mm X-ray beam dimension long cone ≤ 60 mm rectangular cone 44x35 mm Page 49 of 61...
Operator’s manual – Owandy-RX DC ANNEX 2 A2. INTENDED ENVIRONMENT CAUTION Owandy-RX DC is for INDOOR USE ONLY. If the Owandy-RX DC has been stored at a temperature below +10°C (+50° F) for more than a few hours, enough time must be allowed for the device to reach the room temperature before reconnecting it to the mains voltage and applying power.
Operator’s manual – Owandy-RX DC ANNEX 4 A4. DOSIMETRIC INDICATIONS The radiation exposure is reported in terms of Dose Area Product (DAP), which takes into account the entire area of the X-ray beam and the total amount of X-ray radiation incident on the patient. The DAP is obtained by multiplying the Air Kerma by the corresponding X-ray beam area, which is dependent by the typology of beam limiting device installed.
Operator’s manual – Owandy-RX DC ANNEX 5 A5. ELECTROMAGNETIC COMPATIBILITY Electromagnetic compatibility (EMC) is assessed with reference to the following standards: IEC/EN 60601-1-2: 2014 (4 edition) EMISSION • CEI EN 55011: 2013 • CEI EN 61000-3-2: 2015 • CEI EN 61000-3-3: 2014 IMMUNITY •...
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Operator’s manual – Owandy-RX DC Guidance and manufacturer’s declaration – electromagnetic immunity Owandy-RX DC is intended to be used in the electromagnetic environment specifi ed below. The customer or Owandy-RX DC operator must ensure that the device is used in this type of environment. Electromagnetic Immunity test CEI EN 60601 test level...
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Operator’s manual – Owandy-RX DC Guidance and manufacturer’s declaration – electromagnetic immunity Owandy-RX DC is intended to be used in the electromagnetic environment specifi ed below. The customer or Owandy-RX DC operator must ensure that the device is used in this type of environment. CAUTION Portable and mobile RF communication equipment should be used no closer than 30 cm (12 inches) to any part of the Owandy-RX DC, including cables than the recommended separation distance, calculated according to the equation...
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Operator’s manual – Owandy-RX DC Recommended separation distances between portable and mobile RF communication equipment and Owandy-RX DC medical device These devices are intended to be used in environments where radiated RF interference is controlled. The customer or Owandy-RX DC operator can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communication equipment (transmitters) and Owandy-RX DC, as indicated below, according to the maximum output power of the communication equipment.
Operator’s manual – Owandy-RX DC ANNEX 6 A6. DRAWINGS AND DIMENSIONS WALL INSTALLATION Lateral view (rest position) Bottom mount 40 cm (16’’) bracket 63 cm 80 cm (31’’) bracket 104 cm 110 cm (43’’) bracket 132 cm Page 59 of 61 OPERATOR’S MANUAL •...
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Operator’s manual – Owandy-RX DC Lateral view (open) Bottom mount 40 cm (16’’) bracket 178 cm 80 cm (31’’) bracket 220 cm 110 cm (43’’) bracket 247 cm The system can also be mounted with the timer on the top. For details, refer to the Installation and Maintenance Manual. MOBILE INSTALLATION Owandy-RX DC exists also in the mobile version and it is sustained by the stand shown in the following fi...
Operator’s manual – Owandy-RX DC ANNEX 7 A7. INSTALLATION ELECTRICAL DIAGRAM Page 61 of 61 OPERATOR’S MANUAL • Owandy-RX DC • 02/2020 • NXDCEN160A...
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