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OPERATOR’S MANUAL • Owandy-RX DC • 02/2020 • NXDCEN160A

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

• CEI EN 61000-4-2: 2011

• CEI EN 61000-4-3: 2007 + A1: 2008

• CEI EN 61000-4-4: 2013

• CEI EN 61000-4-5: 2007

• CEI EN 61000-4-6: 2011

• CEI EN 61000-4-8: 2013

• CEI EN 61000-4-11:2006

Guidance and manufacturer’s declaration – electromagnetic emissions

Owandy-RX DC

is intended to be used in the electromagnetic environment speciﬁ ed below. The customer or the

operator of

Owandy-RX DC

must ensure that the device is used in this type of environment.

Emission test

Conformity

Electromagnetic

environment guidance

RF emissions

CISPR 11

Group 1

Owandy-RX DC uses RF energy only for internal

operation. RF emissions are extremely and

attenuated are not likely to generate interference

with electronic equipment in the vicinity.

RF emissions

CISPR 11

Class B

Owandy-RX DC is suitable for use in all establishments,

including domestic establishments and those

directly connected to the public low-voltage power

supply network that supplies buildings used for

domestic purposes.

Harmonic emissions

CEI EN 61000-3-2

Class A

Voltage ﬂ uctuations/ﬂ icker

emissions

CEI EN 61000-3-3

Complies

NOTE:

Ensure that the device is not stack and location close to other EQUIPMENT please refer to the «

Recommended

separation distances between portable and mobile RF communication equipment and Owandy-RX DC medical

device»

Содержание RX-DC

Страница 1: ...PRECISION AND SIMPLICITY DC INTRAORAL RADIOLOGY SYSTEM USER MANUAL NXDCEN160A 02 2020 REV00...

Страница 2: ...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 instructions For complete manuals and in...

Страница 3: ...RATOR S MANUAL Owandy RX DC 02 2020 NXDCEN160A 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 co...

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 DC...

Страница 5: ...28 5 1 CHART OF DEFAULT EXPOSURE VALUES 28 PROGRAMMING DEFAULT 35 EXPOSURE VALUES 35 6 1 PROGRAMMING DEFAULT EXPOSURE VALUES 35 6 2 RESTORING ORIGINAL VALUES 37 DIAGNOSTIC 38 7 1 DIAGNOSTIC 38 ERROR...

Страница 6: ...UNCTION 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 SELE...

Страница 7: ...perience in the 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 radiogra...

Страница 8: ...t 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 dens...

Страница 9: ...ed technicians according to the regulation in force Use the manuals provided with the device Owandy RX DC for reference In case of repair please use only spare parts from the manufacturer of the Owand...

Страница 10: ...quently 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 DC...

Страница 11: ...iance with the local standards in force to protect the operator patient and other people against X rays The Owandy RX DC device is intended to be used solely by surgeons dentists and quali ed and auth...

Страница 12: ...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 cleanin...

Страница 13: ...he 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: ...ient 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 freq...

Страница 15: ...TUBEHEAD The intra oral Owandy RX DC is a tubehead type and its light alloy housing is divided into two compartments The high voltage transformer the X ray tube and the expansion chamber are submerged...

Страница 16: ...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...

Страница 17: ...Owandy RX DC 2 3 IDENTIFICATION TAGS The identi 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 char...

Страница 18: ...RDING 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 IONISI...

Страница 19: ...posure 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 DC DIRECT CURRENT radiographic voltage LED 70kV radiographic curr...

Страница 20: ...ASE 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 ra...

Страница 21: ...ime and 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...

Страница 22: ...cally changed STEP 3 check the selected type of tubehead The LED of the type of selected tubehead should be turned on LED AC ON indicates that the selected tubehead works in alternate current technolo...

Страница 23: ...diographic technique LED 8mA ON indicates that the radiographic system is set with nominal dose It is advisable the use of conventional radiographic technique to change the selection press again the b...

Страница 24: ...ic system is set for use with E speed lm LED F ON radiographic system is set for use with F speed lm to change the selection press the button for 3 s an acoustic signal beep will con rm the change PLE...

Страница 25: ...the selected radiographic technique PERIAPICAL EXAM The LED of the selected teeth should be turned on to change the selection press the key relative to the desired tooth OCCLUSAL EXAM The LED of the s...

Страница 26: ...standard intra oral procedures to position the cone 6 CHECK ON THE DISPLAY THE SELECTED TIME Before proceeding with the exposure check on the display the selected time to change the selection press th...

Страница 27: ...o cool down This time is calculated by the microprocessor depending on the exposure time with a ratio of 1 32 32 s of pause are required for each second of exposure A NEW EXPOSURE WILL BE POSSIBLE AFT...

Страница 28: ...ue factors kV mA s setting needed The operator has the full responsibility to determine and implement the correct technique factors required in accordance with the type of X ray examination being perf...

Страница 29: ...0 2 500 3 200 70kV 8mA FILM D MAXILLA I C P Bp M Op MANDIBLE I C P Ba M Oa FILM E MAXILLA I C P Bp M Op MANDIBLE I C P Ba M Oa FILM F MAXILLA I C P Bp M Op MANDIBLE I C P Ba M Oa ADULT PROGRAMMED E X...

Страница 30: ...AXILLA I C P Bp M Op MANDIBLE I C P Ba M Oa FILM E MAXILLA I C P Bp M Op MANDIBLE I C P Ba M Oa FILM F MAXILLA I C P Bp M Op MANDIBLE I C P Ba M Oa CHILD PROGRAMMED E X P O S U R E TIMES sec 0 020 0 0...

Страница 31: ...063 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 60kV 4mA FILM D MAXILLA I C P Bp M Op MANDIBLE I C P Ba M Oa CHILD PROGRAMMED E X P O S U R E...

Страница 32: ...0 2 500 3 200 70kV 8mA FILM D MAXILLA I C P Bp M Op MANDIBLE I C P Ba M Oa FILM E MAXILLA I C P Bp M Op MANDIBLE I C P Ba M Oa FILM F MAXILLA I C P Bp M Op MANDIBLE I C P Ba M Oa ADULT PROGRAMMED E X...

Страница 33: ...AXILLA I C P Bp M Op MANDIBLE I C P Ba M Oa FILM E MAXILLA I C P Bp M Op MANDIBLE I C P Ba M Oa FILM F MAXILLA I C P Bp M Op MANDIBLE I C P Ba M Oa CHILD PROGRAMMED E X P O S U R E TIMES sec 0 020 0 0...

Страница 34: ...063 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 60kV 4mA FILM D MAXILLA I C P Bp M Op MANDIBLE I C P Ba M Oa CHILD PROGRAMMED E X P O S U R E...

Страница 35: ...Chart of default exposure values refer to Chapter 5 are not valid any more To program the new exposure values press the following keys PLEASE NOTE The repeat function automatically sets in when the k...

Страница 36: ...LA I C P Bp M Op MANDIBLE I C P Ba M Oa FILM E MAXILLA I C P Bp M Op MANDIBLE I C P Ba M Oa FILM F MAXILLA I C P Bp M Op MANDIBLE I C P Ba M Oa CUSTOMISED EXPOSURE VALUES THE RANGE OF EXPOSURE FIELD H...

Страница 37: ...MANUAL Owandy RX DC 02 2020 NXDCEN160A Operator s manual Owandy RX DC 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...

Страница 38: ...TIC 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 MOL...

Страница 39: ...DER CALL THE ASSISTANCE SERVICE E01 RX2 TUBEHEAD IS NOT CONNECTED OR IS OUT OF ORDER CALL THE ASSISTANCE SERVICE E02 CORRUPTED EEPROM DATA CALL THE ASSISTANCE SERVICE E03 EEPROM DATA NOT SAVED PROPERL...

Страница 40: ...CE E43 CORRUPTED EEPROM DATA CALL THE ASSISTANCE SERVICE E44 OVERVOLTAGE ERROR CALL THE ASSISTANCE SERVICE E45 ANODE VOLTAGE OUT OF TOLERANCE CALL THE ASSISTANCE SERVICE E46 ANODE CURRENT OUT OF TOLER...

Страница 41: ...ays will be emitted Please take every necessary precautions in order to avoid accidental exposure to ionizing radiations STEP 1 Checking the radiographic voltage kVp The radiographic voltage is measur...

Страница 42: ...kV 8 mA 5 5 mGy s 30 60 kV 4 mA 4 5 mGy s 30 70 kV 4 mA 6 mGy s 30 60 kV 8 mA 9 mGy s 30 60 kV 4 mA 12 mGy s 30 STEP 3 Checking the exposure time s The exposure time is measured with a non invasive i...

Страница 43: ...could become necessary to 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 u...

Страница 44: ...pment 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 Ow...

Страница 45: ...ymbol 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 1...

Страница 46: ...0 kV Exposure times 0 020 s 3 2 s 23 steps Reference current time product 0 8 mAs 8 mA 0 1 s 0 4 mAs 4 mA 0 1 s Intensity of radiation in the air 30 Gy h at 1 m from focal spot Leakage radiation measu...

Страница 47: ...0A 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 tu...

Страница 48: ...CTRICAL CLASSIFICATION IEC 60601 1 Protection against electrical shock insulation class Class I Degree of protection against electrical Shock applied part Type B collimator cone Protection against har...

Страница 49: ...2020 NXDCEN160A Operator s manual Owandy RX DC 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...

Страница 50: ...e room temperature 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 Atmosphe...

Страница 51: ...for 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 60...

Страница 52: ...f kV beam limiting device length SSD and Beam Limiting Device type circular or rectangular As per paragraph 203 6 4 5 of the IEC 60601 2 65 the overall deviation from the estimated air kerma is within...

Страница 53: ...46 65348 0 2 22 81096 45 62192 29 15842 58 31685 0 25 28 5137 57 0274 36 44803 72 89606 0 32 36 49753 72 99507 46 65348 93 30695 0 4 45 62192 91 24383 58 31685 116 6337 0 5 57 0274 114 0548 72 89606 1...

Страница 54: ...14 83957 0 25 7 255727 14 51145 9 274733 18 54947 0 32 9 287331 18 57466 11 87166 23 74332 0 4 11 60916 23 21833 14 83957 29 67915 0 5 14 51145 29 02291 18 54947 37 09893 0 63 18 28443 36 56886 23 37...

Страница 55: ...DC must ensure that the device is used in this type of environment Emission test Conformity Electromagnetic environment guidance RF emissions CISPR 11 Group 1 Owandy RX DC uses RF energy only for int...

Страница 56: ...ld conform to that of typical commercial 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...

Страница 57: ...d 2 3 P 800 MHz 2 5 GHz where P is the maximum output power rating of the transmitter in watts W according to the transmitter manufacturer and d is the recommended separation distance in metres m Fie...

Страница 58: ...MHz 800 MHz d 1 2 P 800 MHz 2 5 GHz d 2 3 P 0 01 0 12 0 12 0 24 0 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...

Страница 59: ...S MANUAL Owandy RX DC 02 2020 NXDCEN160A Operator s manual Owandy RX DC ANNEX 6 A6 DRAWINGS AND DIMENSIONS WALL INSTALLATION Lateral view rest position Bottom mount A 40 cm 16 bracket 63 cm 80 cm 31...

Страница 60: ...in the mobile version and it is sustained by the stand shown in the following gure Only for the mobile version of Owandy RX DC It is allowed to connect the equipment to the main supply using a plug su...

Страница 61: ...A7 A7 A7 A7 A7 A7 Page 61 of 61 OPERATOR S MANUAL Owandy RX DC 02 2020 NXDCEN160A Operator s manual Owandy RX DC ANNEX 7 A7 INSTALLATION ELECTRICAL DIAGRAM...

Страница 62: ...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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