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USER MANUAL • Owandy-RX AC • 2/2020 • NXACEN160A

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

Annex IX, article 10

TG(MD) Regulations 2002

Schedule 2 part 4.3

Class

IIb

IEC/EN 60601-1:2005 + A1:2012 (3.1 edition)

IEC/EN 60601-1-3:2008 + A1:2013 (2.1 edition)

IEC/EN 60601-1-6:2010 + A1:2013 (3.1 edition)

IEC 62366: 2007

IEC 60601-2-65:2012 A1:2017 (1.1 edition)

IEC/EN 60601-1-2: 2014 (4 edition)

IEC 62304:2006 + A1:2015

Содержание RX-AC

Страница 1: ...PRECISION AND SIMPLICITY AC INTRAORAL RADIOLOGY SYSTEM USER MANUAL NXACEN160A 02 2020 REV00...

Страница 2: ...nguage 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 instruct...

Страница 3: ...55 USER MANUAL Owandy RX AC 2 2020 NXACEN160A 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 o...

Страница 4: ...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...

Страница 5: ...URE 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...

Страница 6: ...N 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...

Страница 7: ...Owandy Radiology and is the result of many years of experience in the eld of radiology and in the application of advanced electronics This high performing system represents a further development of te...

Страница 8: ...m 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 qualit...

Страница 9: ...hnicians 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 A...

Страница 10: ...y amended and modi ed Operators must know the environmental and operating speci cations of the device as well as the procedures to follow in the event of hazards or emergency stops Owandy RX AC radiog...

Страница 11: ...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 quali ed and authorized...

Страница 12: ...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...

Страница 13: ...e presence of disinfectant ammable or potentially explosive gases or vapours that might catch re and cause damage In case these disinfectants have to be used let the vapour completely disperse before...

Страница 14: ...y 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 volt...

Страница 15: ...ely 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...

Страница 16: ...uipment MOBILE STAND AC DC MOBILE STAND UK PLUG COL RAL9003 Mobile con guration of Owandy RX AC is the third pos sible con guration besides the two standards wall mounting top or bottom The mobile sta...

Страница 17: ...Page 17 of 55 USER MANUAL Owandy RX AC 2 2020 NXACEN160A User Manual Owandy RX AC Model 115 V 2 3 2 TIMER Model 230 V Model 220 V Model 115 V CONE GRADUATED SCALE...

Страница 18: ...NG 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...

Страница 19: ...llowing 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 radi...

Страница 20: ...est 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 CHIL...

Страница 21: ...parameters which appear on the display are the last that were set before the timer was turned off If the timer remains inactive for a few minutes it switches to the stand by mode Press any key on the...

Страница 22: ...he Assistance Service PLEASE NOTE After the modi cation default exposure values will be automatically changed STEP 3 check the selected type of tubehead The LED of the type of selected tubehead should...

Страница 23: ...a patient with a small physique LED ADULT ON indicates that the radiographic system is set for a patient with a large physique to change the selection press again the button PLEASE NOTE After the modi...

Страница 24: ...uld be turned on to change the selection press the button for 3 s an acoustic signal beep will con rm the change PLEASE NOTE After the modi cation default exposure values will be automatically changed...

Страница 25: ...e selection press the key relative to the desired exam 3 POSITIONING THE PATIENT Position the patient following the standard intraoral procedures 4 POSITIONING FILM or SENSOR Position either the lm or...

Страница 26: ...D PAUSE intermittently turns on 5 The display indicates the actual exposure time 6 All the timer functions are inhibited PLEASE NOTE The pause time is necessary to allow the X ray tube to cool down Th...

Страница 27: ...Therefore the operator must establish for each of support used and for each patient the correct technique factors kV mA s setting needed The operator has the full responsibility to determine and impl...

Страница 28: ...000 2 500 3 200 FILM D MAXILLA I C P Bp M Op MANDIBLE I C P M Ba Oa FILM E MAXILLA I C P Bp M Op MANDIBLE I C P M Ba Oa FILM F MAXILLA I C P Bp M Op MANDIBLE I C P M Ba Oa CHILD PROGRAMMED EXPOSURE T...

Страница 29: ...RE TIMES sec 0 080 0 100 0 125 0 160 0 200 0 250 0 320 0 400 0 500 0 630 0 800 1 000 1 250 1 600 2 000 2 500 3 200 MAXILLA I C P Bp M Op MANDIBLE I C P M Ba Oa CHILD PROGRAMMED EXPOSURE TIMES sec 0 08...

Страница 30: ...00 1 250 1 600 FILM D MAXILLA I C P Bp M Op MANDIBLE I C P M Ba Oa FILM E MAXILLA I C P Bp M Op MANDIBLE I C P M Ba Oa FILM F MAXILLA NON DISPONIBILE NOT AVAILABLE MANDIBLE CHILD PROGRAMMED EXPOSURE T...

Страница 31: ...PROGRAMMED EXPOSURE TIMES sec 0 080 0 100 0 125 0 160 0 200 0 250 0 320 0 400 0 500 0 630 0 800 1 000 1 250 1 600 MAXILLA I C P Bp M Op MANDIBLE I C P M Ba Oa CHILD PROGRAMMED EXPOSURE TIMES sec 0 08...

Страница 32: ...any more To program the new exposure values press the following keys PLEASE NOTE The repeat function automatically sets in when the key is kept pressed so the time shown on the display scrolls faster...

Страница 33: ...P Bp M Op MANDIBLE I C P M Ba Oa FILM E MAXILLA I C P Bp M Op MANDIBLE I C P M Ba Oa FILM F MAXILLA I C P Bp M Op MANDIBLE I C P M Ba Oa CUSTOMISED EXPOSURE VALUES THE RANGE OF EXPOSURE FIELD HAS BEE...

Страница 34: ...MANUAL Owandy RX AC 02 2020 NXACEN160A User Manual Owandy RX AC 6 2 RESTORING ORIGINAL VALUES 1 Turn off the timer 2 Turn the timer on keeping the key pressed OFF 3 OFF appears on the display 4 Releas...

Страница 35: ...raphic 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 17 MAXILLA MOLAR 47 MANDIBULARY MO...

Страница 36: ...e version ERROR MESSAGES CAUSE SOLUTION E00 RX1 TUBEHEAD IS NOT CONNECTED OR IS OUT OF ORDER CALL THE ASSISTANCE SERVICE E01 RX2 TUBEHEAD IS NOT CONNECTED OR IS OUT OF ORDER CALL THE ASSISTANCE SERVIC...

Страница 37: ...X rays will be emitted Please take every necessary precautions in order to avoid accidental exposure to ionizing radia tions STEP 1 Checking the radiographic voltage kVp The radiographic voltage is me...

Страница 38: ...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 instrument SET TECHNICAL FACTORS Vn 10 NOMINAL VOLTAGE 3 MAXIMUM VOLTAGE...

Страница 39: ...o make read justments WARNING If the parts should become hard to move or should squeak call the Assistance Service 10 2 CLEANING THE OUTER SURFACES Clean the external surface using a damp cloth and no...

Страница 40: ...The RESPONSIBLE ORGANIZATION must always carry out routine maintenance on a daily basis to ensure optimal device performance These checks must be performed to complete the installation of the Owandy R...

Страница 41: ...indicates that at the end of its lifespan this product may not be treated as house hold waste but must be treated separately in conformity to the Directive 2012 19 EC EU Council Directive 2012 19 EC W...

Страница 42: ...t 3 2 s Reproducibility 0 05 Generator Single phase X ray generator X ray tube nominal current 8 mA X ray tube nominal voltage 70 kV Exposure times 0 080 s 3 2 s 17 steps Reference current time produ...

Страница 43: ...0A 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...

Страница 44: ...es F5 n 1 630 mA 125 V F6 n 1 500 mA 125 V ELECTRICAL CLASSIFICATION IEC 60601 1 Protection against electrical shock insulation class Class I Degree of protection against electrical Shock applied part...

Страница 45: ...2020 NXACEN160A User Manual Owandy RX AC COLLIMATOR CONE TECHNICAL DATA Source skin distance SSD short cone long cone rectangular cone 20 cm 8 31 cm 12 31 cm 12 X ray beam dimension short cone long co...

Страница 46: ...perature before reconnecting it to the mains voltage and applying power CLINICAL ENVIRONMENT CONDITIONS OPERATING CONDITIONS Temperature 10 C 50 F 40 C 104 F Relative humidity 25 75 Atmospheric pressu...

Страница 47: ...dental intraoral radiography is classi ed as Directive MDD 93 42 EEC Annex IX article 10 TG MD Regulations 2002 Schedule 2 part 4 3 Class IIb IIb IEC EN 60601 1 2005 A1 2012 3 1 edition IEC EN 60601...

Страница 48: ...ayer HVL kV HVL mm Al Total Filtration mm Al 70 2 0 2 3 In the following tables the radiation exposure is indicated in terms of DAP mGy cm2 for each setting of kV beam limiting device length SSD and B...

Страница 49: ...sure that the device is used in this type of environment Emission test Conformity Electromagnetic environment guidance RF emissions CISPR 11 Group 1 Owandy RX AC uses RF energy only for internal opera...

Страница 50: ...al or hospital applications Surge CEI EN 61000 4 5 1 kV differential mode 2 kV common mode CEI EN 60601 1 2 Test level Mains power quality should conform to that of typical commercial or hospital appl...

Страница 51: ...transmitters as determined by an electromagnetic site surveya must be below the compliance level corresponding to each frequency range b Interference can occur in the proximity of equipment marked wit...

Страница 52: ...1 0 38 0 38 0 73 1 1 2 1 2 2 3 10 3 8 3 8 7 3 100 12 12 23 In the event of transmitters whose maximum nominal output power coef cient does not fall within the indicated parameters the recommended sep...

Страница 53: ...ANUAL Owandy RX AC 2 2020 NXACEN160A User Manual Owandy RX AC ANNEX 6 A6 DRAWINGS AND DIMENSIONS WALL INSTALLATION Lateral view rest position Bottom mount A 40 cm 16 bracket 63 cm 80 cm 31 bracket 104...

Страница 54: ...mobile version and it is sustained by the stand shown in the following gure Only for the mobile version of Owandy RX AC It is allowed to connect the equipment to the main supply using a plug supplied...

Страница 55: ...A7 A7 A7 Page 55 of 55 USER MANUAL Owandy RX AC 2 2020 NXACEN160A User Manual Owandy RX AC ANNEX 7 A7 INSTALLATION ELECTRICAL SCHEME...

Страница 56: ...NNER EXPORT TO 3D PRINTER DIGITAL USB INTRAORAL CAMERA DIRECT USB SENSORS 2D 3D UNITS CEPHALOMETRIC UNITS HF INTRA ORAL GENERATOR SURGICAL GUIDE FACE SCAN PLY IMPORT DENTAL IMPRESSIONS STL IMPORT 2 ru...

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