Owandy Radiology RX-AC User Manual

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USER MANUAL

NXACEN160A • 02/2020 • REV00

PRECISION AND SIMPLICITY

AC INTRAORAL RADIOLOGY SYSTEM

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Page 1 USER MANUAL NXACEN160A • 02/2020 • REV00 PRECISION AND SIMPLICITY AC INTRAORAL RADIOLOGY SYSTEM...
Page 2 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 For complete manuals Scan the QR code to access the instructions and instructions dedicated website www.owandy.com...
Page 3 User Manual – Owandy-RX AC 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 55 USER MANUAL • Owandy-RX AC • 2/2020 • NXACEN160A...
Page 4 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.
Page 5: Table Of Contents
User Manual – Owandy-RX AC 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.
Page 6: Control Panel
User Manual – Owandy-RX AC 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 RADIOGRAPHIC SELECTION OF VOLTAGE INDICATOR PATIENT TYPE SAVE IN OCCLUSAL MEMORY...
Page 7: Preliminary Information
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.
Page 8: Quality Determinants In X-Ray Intraoral Radiography
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 –...
Page 9: Warranty Coditions
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...
Page 10 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.
Page 11 User Manual – Owandy-RX AC 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;...
Page 12 User Manual – Owandy-RX AC 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...
Page 13 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.
Page 14: Radiographic System
User Manual – Owandy-RX AC 2 2 2 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;...
Page 15 User Manual – Owandy-RX AC Fig. 1 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°...
Page 16: Accessories
User Manual – Owandy-RX AC 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 Lights supplied for highlighting the XRay emission out- 100-240 V side the XRay room.
Page 17 User Manual – Owandy-RX AC Model 115 V 2.3.2. TIMER Model 230 V Model 220 V Model 115 V CONE GRADUATED SCALE Page 17 of 55 USER MANUAL • Owandy-RX AC • 2/2020 • NXACEN160A...
Page 18 User Manual – Owandy-RX AC 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 xxxx 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...
Page 19: Configuration
User Manual – Owandy-RX AC 3 3 3 HUMAN VERSION CONFIGURATION OWANDY RX - HUMAN VERSION 3.1. CONFIGURATION OWANDY RX - HUMAN VERSION The Owandy-RX AC 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.
Page 20 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...
Page 21: Instructions For Use
User Manual – Owandy-RX AC 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.
Page 22 User Manual – Owandy-RX AC 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”...
Page 23 User Manual – Owandy-RX AC MAN VERSION STEP 5 : check the selected radiographic current The LED of the radiographic current should be turned on OWANDY RX - HUMAN VERSION LED 8mA ON if LED is not lit call the “Assistance Service” OWANDY RX - HUMAN VERSION STEP 6 : check the selected type of patient The LED of the desired type of patient should be turned on...
Page 24 User Manual – Owandy-RX AC PLEASE NOTE After the modiﬁ cation, default exposure values will be automatically changed. DIGITAL TECHNIQUE (SENSOR) The LED should be turned on to change the selection press the button for 3 s: an acoustic signal (beep) will conﬁ rm the change PLEASE NOTE OWANDY RX - HUMAN VERSION After the modiﬁ...
Page 25 User Manual – Owandy-RX AC LED MANDIBULA ON radiographic system is set for occlusal exam of the lower jaw LED MAXILLA ON radiographic system is set for occlusal exam of the upper jaw to change the selection press again the button BITE-WING EXAM The LED of the selected type of test should be turned on LED ANT ON...
Page 26: Cone Replacement
User Manual – Owandy-RX AC 7° - MAKE THE EXPOSURE 1. Take the control button of the timer relevant to the selected tubehead and keep a safety distance (at least 2 meters) from the tubehead, in order to be able to constantly check the radiographic exposure 2.
Page 27: Exposure Values
User Manual – Owandy-RX AC 5 5 5 EXPOSURE VALUES 5.1. CHART OF DEFAULT EXPOSURE VALUES The chart indicates the Owandy-RX AC 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...
Page 28 User Manual – Owandy-RX AC 12” LONG CONE (SSD = 31cm) CONVENTIONAL RADIOGRAPHIC TECHNIQUE (FILM) ADULT PROGRAMMED EXPOSURE TIMES (sec) MAXILLA FILM MANDIBLE MAXILLA FILM MANDIBLE MAXILLA FILM MANDIBLE CHILD PROGRAMMED EXPOSURE TIMES (sec) MAXILLA FILM MANDIBLE MAXILLA FILM MANDIBLE MAXILLA FILM MANDIBLE...
Page 29 User Manual – Owandy-RX AC DIGITAL RADIOGRAPHIC TECHNIQUE (SENSOR) ADULT PROGRAMMED EXPOSURE TIMES (sec) MAXILLA MANDIBLE CHILD PROGRAMMED EXPOSURE TIMES (sec) MAXILLA MANDIBLE Page 29 of 55 USER MANUAL • Owandy-RX AC • 2/2020 • NXACEN160A...
Page 30 User Manual – Owandy-RX AC 8” SHORT CONE (SSD = 20cm) CONVENTIONAL RADIOGRAPHIC TECHNIQUE (FILM) ADULT PROGRAMMED EXPOSURE TIMES (sec) MAXILLA FILM MANDIBLE MAXILLA FILM MANDIBLE MAXILLA FILM NON DISPONIBILE NOT AVAILABLE MANDIBLE CHILD PROGRAMMED EXPOSURE TIMES (sec) MAXILLA FILM MANDIBLE MAXILLA FILM...
Page 31 User Manual – Owandy-RX AC DIGITAL RADIOGRAPHIC TECHNIQUE (SENSOR) ADULT PROGRAMMED EXPOSURE TIMES (sec) MAXILLA MANDIBLE CHILD PROGRAMMED EXPOSURE TIMES (sec) MAXILLA MANDIBLE Page 31 of 55 USER MANUAL • Owandy-RX AC • 2/2020 • NXACEN160A...
Page 32: Programming Default Exposure Values
User Manual – Owandy-RX AC 6 6 6 PROGRAMMING DEFAULT EXPO- SURE VALUES 6.1. PROGRAMMING DEFAULT EXPOSURE VALUES WARNING The 17 programmed exposure times cannot be modiﬁ ed in the Owandy-RX AC radiographic system. Meanwhile it is possible to customize the default exposure values. WARNING OWANDY RX - HUMAN VERSION After customizing, the “Chart of default exposure values”...
Page 33 User Manual – Owandy-RX AC EXAMPLE 12” LONG CONE (SSD = 31cm) CONVENTIONAL RADIOGRAPHIC TECHNIQUE (FILM) PREDEFINED DEFAULT EXPOSURE VALUES ADULT PROGRAMMED EXPOSURE TIMES (sec) MAXILLA FILM MANDIBLE MAXILLA FILM MANDIBLE MAXILLA FILM MANDIBLE CUSTOMISED EXPOSURE VALUES THE RANGE OF EXPOSURE FIELD HAS BEEN REDUCED BY TWO STEPS ADULT PROGRAMMED EXPOSURE TIMES...
Page 34: Restoring Original Values
User Manual – Owandy-RX AC OWANDY RX - HUMAN VERSION 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 .
Page 35: Diagnostic
User Manual – Owandy-RX AC ANDY RX - HUMAN VERSION 7 7 7 DIAGNOSTIC 7.1. DIAGNOSTIC With Owandy-RX AC radiographic system it is possible to set and visualise certain functional parameters. To visualise them proceed as follows: 1. press simultaneously and keep pressed the keys OWANDY RX - HUMAN VERSION (17) MAXILLA MOLAR (47) MANDIBULARY MOLAR...
Page 36: Chapter 8
User Manual – Owandy-RX AC 8 8 8 CHAPTER 8 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.
Page 37: Verification Of The Exposure Factors
User Manual – Owandy-RX AC 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.
Page 38 User Manual – Owandy-RX AC Dose in air is: SOURCE-SKIN DISTANCE 31 cm = 12” 20 cm = 8” 70 kV – 8 mA = 5,5 mGy/s ± 30% 70 kV – 8 mA = 12 mGy/s ± 30% STEP 3 – Checking the exposure time (s) The exposure time is measured with a “non invasive”...
Page 39: Suggested Maintenance
• 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.
Page 40 User Manual – Owandy-RX AC 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. •...
Page 41: Repair
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 Tel. +33 1 64 11 18 18 info@owandy.com...
Page 42: Annex 1
User Manual – Owandy-RX AC ANNEX 1 A1. TECHNICAL SPECIFICATIONS X-ray SOURCE ASSEMBLY Half Value Layer (HVL) at 70 kV 2 mm Al Total ﬁ ltration at 70 kV 2,3 mm Al Tube inherent ﬁ ltration at 70 kV > 1 mm Al X-ray tube tension accuracy ±10% X-ray tube current accuracy...
Page 43 User Manual – Owandy-RX AC HEATING AND COOLING CURVES X-ray TUBE X-ray tube model CEI OX70-G7 TOSHIBA DG-073-AC 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-AC CEI OX70-G7 Page 43 of 55 USER MANUAL •...
Page 44 User Manual – Owandy-RX AC DEVICE POWER SUPPLY Type of power supply single phase, alternate Supply nominal voltage 115 V / 220V / 230V Maximum voltage variation ±10% 3,5 A @ 220V / 230V Nominal current 5,7 A @ 115V Supply voltage frequency 50/60 Hz Maximum line current (measured @ 70 kV, 8 mA, 3,2 s)
Page 45 User Manual – Owandy-RX AC 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 45 of 55...
Page 46: Annex 2
User Manual – Owandy-RX AC ANNEX 2 A2. INTENDED ENVIRONMENT CAUTION Owandy-RX AC is for INDOOR USE ONLY. If the Owandy-RX AC 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.
Page 47: Annex 3
User Manual – Owandy-RX AC ANNEX 3 A3. LIST OF INTERNATIONAL STANDARDS AND DIRECTIVES Owandy-RX AC: X-ray equipment for dental intraoral radiography is classiﬁ ed as: Directive MDD 93/42 EEC TG(MD) Regulations 2002 Schedule 2 part 4.3 Annex IX, article 10 Class IEC/EN 60601-1:2005 + A1:2012 (3.1 edition) IEC/EN 60601-1-3:2008 + A1:2013 (2.1 edition)
Page 48: Annex 4
User Manual – Owandy-RX AC 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.
Page 49: Annex 5
User Manual – Owandy-RX AC 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 •...
Page 50 User Manual – Owandy-RX AC Guidance and manufacturer’s declaration – electromagnetic immunity Owandy-RX AC is intended to be used in the electromagnetic environment speciﬁ ed below. The customer or Owandy-RX AC operator must ensure that the device is used in this type of environment. Electromagnetic Immunity test CEI EN 60601 test level...
Page 51 User Manual – Owandy-RX AC Owandy-RX AC is intended to be used in the electromagnetic environment speciﬁ ed below. The customer or Owandy-RX AC operator must ensure that the device is used in this type of environment. CEI EN 60601 Compliance Electromagnetic Immunity test...
Page 52 User Manual – Owandy-RX AC These devices are intended to be used in environments where radiated RF interference is controlled. The customer or Owandy-RX AC operator can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communication equipment (transmitters) and Owandy-RX AC, as indicated below, according to the maximum output power of the communication equipment.
Page 53: Annex 6
User Manual – Owandy-RX AC 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 53 of 55 USER MANUAL •...
Page 54 User Manual – Owandy-RX AC 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 AC exists also in the mobile version and it is sustained by the stand shown in the following ﬁ...
Page 55: Annex 7
User Manual – Owandy-RX AC ANNEX 7 A7. INSTALLATION ELECTRICAL SCHEME Page 55 of 55 USER MANUAL • Owandy-RX AC • 2/2020 • NXACEN160A...
Page 56 DIGITAL WORKFLOW OWANDY RADIOLOGY A COMPREHENSIVE RANGE TO MEET ALL YOUR REQUIREMENTS CEPHALOMETRIC UNITS 2D/3D UNITS HF INTRA-ORAL GENERATOR FACE SCAN .PLY IMPORT INTRAORAL PLATE SCANNER DENTAL IMPRESSIONS .STL IMPORT DIRECT USB SURGICAL DIGITAL USB EXPORT TO SENSORS GUIDE INTRAORAL CAMERA...

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