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ORTHOPANTOMOGRAPH® OP30

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1. 1 Tod yeme or INN EU UU 2 UNU COS SUID Cl OWN ld EINE MSN Nu SUI 3 2 1 3 88 1119 5 RACC OSS ONO esi aM LEN ME AM GUERRE mm r r pp zzy 6 NE UNIT e c 7 3 1 FPO m r 3 2 EXPOSUTOS dann 10 Panoramic standard paediatric and 10 Temporomandibular Joint 4 19 4 Operating the unit without generating x rays 25 5 SIT UNS NR TT erer mm r r rm 26 5 1 Opening the Setup WINdOW PUn DUE ad K k KEK KK KAK KAK r 26 9 2 T DOVICO cee Tc 27 AS TG er E 27 Retrieve Last Image field u EA 27 Device Serial Number field uk 28 6 Troubleshooting and Maintenance 29 6 1 Error messages and 5 29 EEFFOT S VIMO Ol woom hr rrr HH H HH 30 RN 31 HHHH HHH EE E _ 31 6 2 Care and Maintenance 33 Cleaning and disinfecting the 33 Surfaces that the patient 33 Bela SIT ACS RR 33 Positioning mirror and light lenses
2. L EL ELAELCELEAEELLL 33 Touch screen control panel Lu u Lu sensns nnn nnn nnns 33 Correct operation of the unit 34 Yearly MIR ANNETTE 35 7 Warnings and precautions kk aka aka kk kk kk Ak KAK AA KAKA AA AA KAK KA AKAR WAA 36 no00 WV ALN J 36 gae wei De Rare MM 37 DO DIS DOS Ly AKAR AA 40 Appendix A Technical eere nnne A 1 User Manual 208677 V Contents VI ORTHOPANTOMOGRAPH OP30 User Manual 208677 ORTHOPANTOMOGRAPH OP30 1 Introduction 1 Introduction 1 1 ORTHOPANTOMOGRAPH OP30 X ray unit User Manual 208677 The ORTHOPANTOMOGRAPH OP30 the unit is a digital panoramic dental x ray unit designed to take standard panoramic exposures paediatric panoramic exposures reduced width bitewing exposures and TMJ exposures The unit uses a CCD sensor as the image recep tor and a PC with suitable MDD complient dental imaging software such as CLINIVIEW for image acquisition and handling The unit can be used in single or multiple user con figurations With the single user configuration the unit is con nected to a single PC With the multiple user configuration Easy Share activated the unit is connected to a network where up to eight PCs can be connected to the unit With the Easy Share configuration only one PC at a time can reserve and use the unit
3. IMPORTANT NOTE The last image can only be retrieved if the unit is left on after the last exposure was taken If the unit is switched off the image will be lost To retrieve the last image A Correct the problem that caused the network PC or software failure and then reopen the patient card User manual 208677 27 5 Unit Set up ORTHOPANTOMOGRAPH OP30 B The last image taken should be automatically transferred If it is not click the Retrieve now button to re trieve the last image taken by the unit C Click OK to close the OP30 Setup window The last image taken will appear on the patient card Device Serial Number field Device Seral Number Add serial number to new images 28 Click the Add serial number check box and the serial number of the unit will be added to all new images The serial number will appear in the top left hand corner and the bottom right hand corner of the image User manual 208677 ORTHOPANTOMOGRAPH OP30 6 Troubleshooting and Maintenance 6 Troubleshooting and Maintenance 6 1 Error messages and symbols If the unit is not used correctly or the unit malfunc tions an error message or symbol will appear on the unit display There are three groups of error message ERROR 1 CLEAR Error symbols The symbol will clear when the problem is cor rected H user errors E Error exposure errors these occur during exposure These all appear on the unit di
4. System errors E4 REASON Tubehead too hot or too cold SOLUTION When the error message automatically clears the tubehead has reached the cor rect operating temperature In normal conditions this will take about 30 minutes for the tubehead to reach the correct temperature If the error message does not disappear within a reasonable amount of time contact service E5 REASON Line voltage not within limits SOLUTION If the error message reappears it indicates that the voltage is not within limits The error message will automatically clear when the voltage returns to then correct level If the error message keeps on appearing or does not disappear within a rea sonable amount of time contact service User manual 208677 31 6 Troubleshooting and Maintenance ORTHOPANTOMOGRAPH OP30 E19 REASON Exposure switch stuck down during unit start SOLUTION Switch the unit off and check that the exposure switch is not stuck in the exposure position Switch the unit on again If the message reappears contact service Exx all other E errors except E4 E5 and E19 above SOLUTION Clear the error message and try to take an exposure without a patient If the error message reappears switch the unit off wait for half a minute and then switch the unit on again If the error message reappears contact service 32 User manual 208677 ORTHOPANTOMOGRAPH OP30 6 Troubleshooting and Maintenance 6 2 Care and Maintenance Cleaning
5. User manual 208677 ORTHOPANTOMOGRAPH OP30 3 Taking an Exposure 17 Move at least two metres away from the unit and protect yourself from radiation Make sure that you can see and hear the patient during the exposure Press and hold down the exposure button for the duration of the exposure The exposure starts when you hear the exposure warning sig nal and the exposure warning indicator control panel and light side of the unit come on The rotating unit will rotate around the patients head and take the exposure When the exposure warning signal and rotating unit stop the exposure has been taken Press the release button at the top of the fore head support A and then slide the forehead support away from the patient B Open the temple supports by sliding the temple support knob to the left C Guide the patient out of the unit User manual 208677 17 3 Taking an Exposure 18 Scanning the image ORTHOPANTOMOGRAPH OP30 20 Press the Return key to drive the unit to the PIO 21 position NOTE After the exposure a timer indicating the tube head cooling time will appear on the display A new exposure cannot be taken until the counter reaches zero the exposure time reappears on the display and the unit status indicator comes on PC After the exposure has been taken a pro gress bar will appear This indicates that the image is being transferred to the PC Open Preview Us
6. 0 5 mm IEC 60336 2005 Appendix A Technical Information ORTHOPANTOMOGRAPH OP30 FOCAL SPOT ACCURACY The accuracy is 10 mm from the marking on the tubehead cover TARGET ANGLE 5 TARGET MATERIAL Tungsten NOMINAL X RAY TUBE VOLTAGE WITH THE HIGHEST X RAY TUBE CUR RENT 100 V 81 kV at7 5mA 120 V 81 kV at9 6 mA 220 240 V 81 kV at 12 mA X RAY TUBE VOLTAGE tolerance is 4 kV HIGHEST X RAY TUBE CURRENT WITH THE HIGHEST X RAY TUBE VOLTAGE 100 V 7 5 mAat 81 kV 120 V 9 6 mA at 81 kV 220 240 V 12 mAat 81 kV X RAY TUBE CURRENT tolerance is 1 mA NOMINAL ANODE INPUT POWER AND NOMINAL ELECTRIC POWER 100 V 607 W at 81 kV 7 5 mA 10 120 V 778 W nominal at 81 kV 9 6 mA 10s 220 240 V 972 W nominal at 81 kV 12 mA 10 s X RAY TUBE VOLTAGE STEPS 100 V 63 66 70 73 77 and 81 kV 120 V 63 66 70 73 77 and 81 kV 220 240 V 63 66 70 73 77 and 81 kV X RAY TUBE VOLTAGE tolerance is 4 kV X RAY TUBE CURRENT STEPS 100 V 6 and 7 5 mA 120 V 6 7 5 and 9 6 mA 220 240 V 6 7 5 9 6 and 12 mA X RAY TUBE CURRENT tolerance is 1 mA ORTHOPANTOMOGRAPH OP30 Appendix A Technical Information FILTRATION inherent filtration minimum 0 6 mm AI at 50 kV IEC 60522 1999 additional filtration minimum 2 mm Al patient support attenuation equivalent less than 0 2 mm AI attenuation equavalent of plastic cover approximately 0 25 mm AI total filtration minimum 2 6 mm AI at 77 kV BEAM QUALITY HVL over 2 77 mm Al at 77
7. 4 3 2 5 GHz mended separation distance in metres m Field strengths from fixed RF transmitters as determined by an electromagnetic site survey should be less than the compliance level in each frequency range Interference may occur in the vicinity of equipment marked with the following symbol NOTE 1 At 80 MHz and 800 MHz the higher frequency range applies NOTE 2 These guidelines may not apply in all situations Electromagnetic propagation is affected by absorption and reflection from structures objects and people Field strengths from fixed transmitters such as base stations for radio cellular cordless telephones and land mobile radios amateur radio AM and FM radio broadcast and TV broadcast cannot be predicated theoretically with accuracy To assess the electromagnetic environment due to fixed RF transmitters an electromagnetic site survey should be considered If the measured field strength in the location in which the device is used exceeds the applicable RF compliance level above the device should be observed to verify normal operation If abnormal performance is observed additional measures may be necessary such as reorienting or relocating the device Over the frequency range 150 kHz to 80 MHz field strengths should be less than 3 V m A 14 ORTHOPANTOMOGRAPH OP30 Appendix A Technical Information OP30 2 Recommended separation distances between portable and mobile RF communications e
8. IMPORTANT NOTE Before using the unit for the first time make sure that it is set up to your requirements See section 5 Unit Settings USA only Caution Federal law restricts this device to sale by or on the order of a dentist or other qualified professional 1 Introduction ORTHOPANTOMOGRAPH OP30 1 2 About this manual This manual describes how to use and set up the unit Please read these instructions carefully before op erating the unit Before operating the unit please read and observe the warnings and precautions that appear in section 7 Warnings and Precautions 2 User Manual 208677 ORTHOPANTOMOGRAPH OP30 2 Unit description 2 Unit description 2 1 Main parts Column Upper shelf Rotating unit Emergency stop button Press to stop rotate to release On off switch rear of column PC with MDD compliant dental imaging software QI WN User manual 208677 3 2 Unit description ORTHOPANTOMOGRAPH OP30 Exposure warning light Midsagittal light Mirror Frankfort light and light positioning knob Focal trough positioning knob Patient support Focal trough light Patient support handles Head support N 9 QI gt 4 User manual 208677 ORTHOPANTOMOGRAPH OP30 2 Unit description 2 2 Unit controls AUN A Side control panel Lights key switches the positioning lights on and off Up key drives the unit up Down key drives the unit down
9. 052 SB Maximum Rating Charts Absolute maximum rating charts Focus Spot 0 5 mm TUBE CURRENT mA EXPOSURE TIME s HEAT STORAGE kJ Appendix A Technical Information Anode thermal characteristics Anode Thermal Characteristics Ter 7Z MA K YN AT _ 0 2 4 6 8 TIME min A 8 ORTHOPANTOMOGRAPH OP30 10 ORTHOPANTOMOGRAPH OP30 Appendix A Technical Information A 2 Unit dimensions 92 1 965 1740 38 68 5 175 215 6 9 8 5 980 38 6 830 32 7 Appendix A Technical Information ORTHOPANTOMOGRAPH OP30 A 3 Symbols that appear on the unit Radiation warning Dangerous voltage or enabled O Off or disabled Exposure switch Connector for Ethernet RJ45 Connector for exposure switch Connector for external exposure light Electrostatic discharge ESD warning symbol Attention consult accompanying documents ORTHOPANTOMOGRAPH OP30 Appendix A Technical Information L Ground functional Protective ground CLASS 1 LASERPRODUCT Laser class label APPAREIL A RAYONNEMENT Patient positioning lights LASER DE KLASSE 1 KLASS 1 LASERAPPARAT LUOKAN 1 LASERLAITE IEC 60825 1 2007 X 0537 ANTERTE W ec CHO01 This symbol indicates that the waste of electrical and electronic equipment must not be disposed of as unso
10. Press the T key Test the exposure values on the display will clear The exposure switch can now be pressed to demonstrate how the unit operates with out x rays being generated Press the T key a second time to return to the nor mal exposure mode NOTE After switching the unit off and then on again the unit returns to the normal exposure mode 5 Unit Set up ORTHOPANTOMOGRAPH OP30 5 Unit settings 5 1 Opening the Setup window 1 PC Open CLINIVIEW or the dental imaging software you are using 2 Select Tools and then click OP30 Settings File DICOM Patient Study Image View Diagnose Graphics Measure Tools Window Help Settings Default Image Settings Installed Devices Intra J OP3 Settings 3 The OP30 Setup window will appear OP30 Setup BH x Device Settings Driver Infa Cancel 26 User manual 208677 ORTHOPANTOMOGRAPH OP30 5 Unit Set up 5 2 The Device page Status field Device Settings Driver Info Status Device Disconnected Version Serial Device indicates whether the unit is connected to the PC Version shows the software version of the unit and Serial No the serial number of the unit Retrieve Last Image field Last Image Retrieve latest image from the device unit memory Retieve now If the last image taken is not transferred to the PC because of a network PC or software fail ure the image can be retrieved from the unit memory
11. the displayed exposure times 5 SINGLE LOAD RATING 100 V 81 kV 7 5 mA 10 s panoramic 120 V 81 kV 9 6 mA 10 s panoramic 220 240 V 81 kV 12 mA 10 s panoramic BACK UP TIMER 15 17 s 15 ORTHOPANTOMOGRAPH OP30 Appendix A Technical Information Leakage technique factors PANORAMIC 100V 4329 mAs h exposure with maximum values 81 kV 7 5 mA 10 s according to the 1 5 duty cycle 120V 4486 mAs h exposure with maximum values 81 kV 9 6 mA 10 s according to the 1 7 duty cycle 220 240V 4606 mAs h exposure with maximum values 81 kV 12 mA 10 s according to the 1 8 duty cycle Measurement bases The kV is measured by monitoring differentially the current flowing through 450 Mohm 1 feedback resistor connected between the tube anode and ground The mA is measured by monitoring current in the HT return line which equals the tube current Collimator TYPE BLD M 1 PRIMARY SLIT Adult panoramic slit only For child panoramic the exposure time is reduced to give a reduced length image PRIMARY SLIT SIZE 0 7 0 75 x 38 mm Z motor DUTY CYCLE Intermittent use 6 25 25s ON 400s OFF Environmental data OPERATING Ambient temperature from 10 C to 40 C Relative humidity 10 90 no condensation STORAGE TRANSPORTATION Ambient temperature from 20 C to 50 C Relative humidity 5 85 no condensation Atmospheric pressure 500 1080 mbar Appendix A Technical Information ORTHOPAN
12. ENGLISH ORTHOPANTOMOGRAPH OP30 Digital Panoramic X ray Unit User Manual Number 208677 ver 1 2012 06 Copyright Manufactured by Document code 208677 ver 1 2012 06 Copyright 2012 by PaloDEx Group Oy All rights reserved Documentation trademark and the software are copyrighted with all rights reserved Under the copyright laws the documentation may not be copied photocopied reproduced translated or reduced to any electronic medium or machine readable form in whole or part without the prior written permission of Instrumentarium Dental The original language of this manual is English Instrumentarium Dental reserves the right to make changes in specification and features shown herein or discontinue the product described at any time without notice or obligation Contact your Instrumentarium Dental representative for the most current information ORTHOPANTOMOGRAPH is a registered trademarks of Instrumentarium Dental CLINIVIEW is a common law trademark of Instrumen tarium Dental 0537 Instrumentarium Dental PaloDEx Group Oy Nahkelantie 160 P O Box 20 FI 04300 Tuusula FINLAND Tel 358 0 10 270 2000 Fax 358 9 851 4048 For service contact your local distributor Contents ORTHOPANTOMOGRAPH OP30 IV User Manual 208677 ORTHOPANTOMOGRAPH OP30 Contents Contents T MOGUC HON usi sete REN 1 1 1 ORTHOPANTOMOGRAPH OP30 X ray
13. OP30 7 Warnings and precautions 7 2 User patient warnings User manual 208677 The unit may be dangerous to the user and the patient if the safety regulations in this manual are ignored if the unit is not used in the way described in this manual and or if the user does not know how to use the unit Because the x ray limitations and safety regula tions change from time to time it is the respon sibility of the user to make sure that all the valid safety regulations are fulfilled It is the responsibility of the user to decide if the x ray exposure is necessary Always use the lowest suitable x ray dose to obtain the desired level of image quality Always use suitable hygienic barriers on parts of the unit that the patient has contact with Avoid taking x ray exposures of pregnant wom en If the patient is using a pacemaker consult the manufacturer of the pacemaker to confirm that the x ray unit will not interfere with the operation of the pacemaker before taking an exposure The user of the unit must stand at least two me ters away from the unit AND protect him herself from radiation when taking exposures It is recommended that a moveable radiation protection screen is used to protect the user The radiation protection screen should be lo cated so that the user is able to see the control panel and patient from behind the radiation protection screen the protected area or control zone 37 7 Warnings and pre
14. Return key drive the unit to the patient in out position PIO B Main control panel Program selection keys P1 standard pan P2 paediatric pan P3 TMJ BW bitewing Patient size selection keys Child Juvenile Adult Large adult Manual M mode selection key kV and mA selection keys manual mode only Test key operates the unit without x rays Exposure values Service key Dose Area Product DAP Unit status indicator User manual 208677 5 2 Unit description ORTHOPANTOMOGRAPH OP30 2 3 Accessories Chin rest Bite block Bite fork 71 mm Chin support Edentulous bite positioner Nose support long for children Nose support short for adults 6 User manual 208677 ORTHOPANTOMOGRAPH OP30 3 Taking an Exposure 3 Using the Unit IMPORTANT NOTE If the unit is being used for the first time or if you are using the unit for the first time check that it is set up to your requirements See section 5 Unit Settings 3 1 Preparing the Unit 55 mGycm User manual 208677 1 PC Switch on the PC that is connected to the unit 2 PC Open CLINIVIEW or the dental imaging software you are using and enable image cap ture Refer to the instructions supplied with the dental imaging software for information on how to do this 3 Switch the unit on The on off switch is at the rear of the column near the base The unit display will come on and the unit will carry out a self
15. TOMOGRAPH OP30 System requirements and connections The PC and any other external device s connected to the system must meet the IEC 60950 standard minimum requirements Devices that do not meet the IEC 60950 standard must not be connected to the system as they may pose a threat to operational safety The PC and any other external devices must be connected in accordance with IEC 60601 1 1 The x ray unit must be connected to it s own separate power supply The PC and any other external devices must NOT be connected to the same power supply as the x ray unit Position the PC and any other external device at least 1 85 m 73 from the x ray unit so that the patient cannot touch the PC or any other external device while being x rayed The PC and any other external devices shall not be connected to an extension cable Multiple extension cables shall not be used Do not position the PC where it could be splashed with liquids Clean the PC in accordance with the manufacturer s instructions X ray system to 60601 1 1 IEC 60950 1 85m 73 won e efe ae 9 A 6 ORTHOPANTOMOGRAPH OP30 Appendix A Technical Information Tube housing assembly cooling heating characteristics TUBEHEAD THERMAL CHARASTERISTICS 140 000 T 120 000 pa 100 000 o 80 000 ian D 60 000 7 20000 0 0 100 200 300 400 500 600 700 Time min Tube rating chart Toshiba D
16. and disinfecting the unit Warning Switch the unit off before cleaning it Surfaces that the patient touches All surfaces and parts that the patient touches or comes into contact with must be disinfected after each patient Use a disinfectant that is formulated specifically for disinfecting dental equipment and use the disinfectant in accordance with the manu facturer s instructions Unit surfaces Use a soft cloth dampened with a mild detergent disinfectant to clean unit surface DO NOT use abrasive cleaning agents or polishes on the unit Positioning mirror and light lenses The positioning mirror is made of glass and the fo cal trough positioning light cover is made of plastic Use a soft cloth dampened with a mild detergent NOT use abrasive cleaning agents or polishes on these parts Touch screen control panel If the surface of the control panel becomes soiled clean it with absorbent cotton or other soft cloth Remove any drops of liquid from the control panel surface immediately Prolonged contact with liquid may cause the surface of the control panel to dis color or spots to appear User manual 208677 33 6 Troubleshooting and Maintenance ORTHOPANTOMOGRAPH OP30 34 Correct operation of the unit If any of the unit s controls displays or functions fail to operate or do not operate in the way described in this manual switch the unit off wait 30 seconds and then switch the unit on again If the unit sti
17. cautions ORTHOPANTOMOGRAPH OP30 The radiation protection screen must be large enough to fully protect the user from radiation The radiation protection area must be at least 60 cm wide 60 cm deep and 200 cm high The radiation protection screen must include lead shielding with a minimum thickness 0 5 mm and the screen must conform to all national regulations concerning radiation shielding of dental medical devices 38 The user must be able to see and hear the pa tient at all times during an exposure The user must be positioned so that he she can see the exposure warning light indicator and hear the audio exposure warning signal during the exposure If the unit is installed in such a place where the exposure warning light indicator cannot be seen or the audio exposure warning signal cannot be heard then a separate expo sure warning light indicator device should be used Please contact your local service for help User manual 208677 ORTHOPANTOMOGRAPH OP30 7 Warnings and precautions User manual 208677 Disinfect all the surfaces that the patient is in contact with after every patient If the unit does not appear to be working cor rectly switch the unit off and release the patient Make sure that the unit operates correctly before you continue using it If you are not sure wheth er the unit is operating correctly please contact your local service for help If the unit will not be used for a long time switc
18. er manual 208677 ORTHOPANTOMOGRAPH OP30 3 Taking an Exposure Temporomandibular Joint TMJ 1 Slide the nose support into the support holder Use the short version for adults and the long version for children 2 Place a disposable cover on to the nose sup port P3 3 Press the TMJ key P3 to select TMJ program AN The magnification is 1 25 4 Select the patient size Child Juvenile or small adult r Adult or Large adult Default kV and mA values for the selected pa tient size will appear on the display The appropriate DAP value will appear on the 55 display you consider that the default kV and mA val ues are not correct for the patient being exam ined select different values based on the pa tient s size age and estimated bone density User manual 208677 19 3 Taking an Exposure Oo 3kv S 9 6 mA 10 s ORTHOPANTOMOGRAPH OP30 To select different kV and mA values press the M key Plus and minus keys will appear These allow you to change the kV and mA values to suit the patient being examined The recommended values are Child 66 kV Juvenile or small adult 70 kV Adult 73 kV Large Adult 77 kV Use the focal trough knob and position the sup port holder so that it is 5 for an adult and O for a child 20 6 Askthe patient to remove any spectacles den tures jewellery and hair clips and pins Place a protect
19. focal trough and be on the same vertical plane If the roots of the upper and lower front incisors are not on the same vertical plane adjust the tilt A of the patient s head until they are For bitewing BW panoramic exposures posi tion the chinrest on the BW line User manual 208677 15 3 Taking an Exposure ORTHOPANTOMOGRAPH OP30 13 Close the temple supports by sliding the temple support knob to the right A Make sure that patient s neck is stretched and straight Adjust the position of the nasion support B and then carefully push the forehead support in until it touches the patient s nasion C Ask the patient to press their lips together and press their tongue against the roof of their mouth Then ask the patient to look at a fixed point in the mirror and to remain still for the duration of the exposure The exposure takes approximately ten seconds 15 Ask the patient to step forward slightly so that 16 O Ready they out of balance and hanging onto the sup port handles This will force the patient to stretch their neck as far a possible Check that the patient has not moved and is still in the correct position Make sure that the unit status indicator is still GREEN indicating that the unit is ready to take an exposure If the indicator is not GREEN the unit reservation time may have expired Reserve the unit again see section 3 1 Prepar ing the unit
20. h the unit off in order to prevent unauthorized peo ple using the unit Do not use the unit if any of its covers or parts are damaged loose or have been removed Contact a service person approved by Instrumentarium Dental and get them to repair or replace any damaged loose or removed cov ers or parts before reusing the unit When touching the patient do not touch any electrical or Ethernet connectors at the same time Do not touch or operate the unit if the unit is be ing serviced or if the covers have been removed for any reason 39 8 Disposal 8 Disposal 40 ORTHOPANTOMOGRAPH OP30 At the end of useful service life of the device its spare parts its replacement parts and its acces sories make sure that you follow all local national and international regulations regarding the correct and safe disposal and or recycling of the device its spare parts its replacement parts and its accesso ries The device its spare parts its replacement parts and its accessories may include parts that are made of or include materials that are non environmentally friendly or hazardous These parts must be dis posed of in accordance with all local national and international regulations regarding the disposal of non environmentally friendly or hazardous materi als Hazardous materials and parts that are made of or contain these materials LEAD Tubehead housing collimator CCD sensor circuit boards TUBEHEAD OIL I
21. ive lead apron around the pa tients neck to protect the patient s thyroid gland from radiation User manual 208677 ORTHOPANTOMOGRAPH OP30 3 Taking an Exposure User manual 208677 10 NOTE If the patient is nervous you can reassure him her by demonstrating how the unit works before taking the exposure See section 4 Operating the unit without x rays Press the Up Down keys to adjust the height of the nose support so that the top is level with the patient s upper lip Ask the patient to step into the unit grasp the patient handles and press their top lip against the top of the nose support Press the Lights key to switch the patient po sitioning lights on They will remain on for two minutes NOTE The patient positioning lights will automatically come on when either the Up or Down key is pressed Look at the reflection of the patient in the mir ror and position the midsagittal plane of the patient so that it coincides with the midsagittal plane light Make sure that the patient is looking straight ahead and that the patient s head is not tilted or turned to one side 21 3 Taking an Exposure 22 ORTHOPANTOMOGRAPH OP30 11 Press either Up Down key to adjust the tilt of the patient s head until the patient s Frankfort plane coincides with or is parallel to the hori zontal light CAUTION When pressing the Up Down keys to adjust the tilt of the patients head make small adjus
22. k at the reflection of the patient in the mir ror and position the midsagittal plane of the patient so that it coincides with the midsagittal plane light Make sure that the patient is looking straight ahead and that the patient s head is not tilted or turned to one side 13 3 Taking an Exposure 2 14 11 12 ORTHOPANTOMOGRAPH OP30 Press either Up Down key to adjust the tilt of the patient s head For a standard or paediatric panoramic expo sure position the patient so that the Frankfort plane coincides with or is parallel to the hori zontal light For a bitewing exposures position the patient so that the Occlusal plane coincides with or is parallel to the horizontal light CAUTION When pressing the Up Down keys to adjust the tilt of the patients head make small adjustments only so as not to cause the patient any distress or discomfort The focal trough light indicates the center of the focal trough which is 10 mm wide at the front Ask the patient to open their lips so that you can see the patient s teeth For standard panoramic P1 and paediatric panoramic P2 panoramic exposures use the focal trough knob to position the patient so that the focal trough light is in the center of the pa tients upper and lower third teeth canines User manual 208677 ORTHOPANTOMOGRAPH OP30 3 Taking an Exposure The roots of the upper and lower front incisors must be located within the
23. kV DAP Dose Area Product accuracy of displayed value better than 25 PRIMARY PROTECTIVE SHIELDING minimum 0 5 mm Pb or equivalent OUTER SHELL TEMPERATURE 50 C 122 F maximum DUTY CYCLE 1 8 at maximum technique factors Example an 81 kV 12 mA 10 s exposure will have 85 s cool down period Power requirements OPERATING LINE VOLTAGE 100 120 V or 220 240 V 50 60Hz INPUT POWER Standby 26 W maximum 1300 W MAXIMUM LINE IMPEDANCE Apparent resistance of supply mains 0 5 ohm MAXIMUM LINE FUSING 100 120 V 16A 220 240 V 10A MAIN FUSE T 10A H 250V LINE SAFETY SWITCH when required 100 120 V Approved type min 16 A250 V 220 240 V Approved type min 10 A 250 V Appendix A Technical Information ORTHOPANTOMOGRAPH OP30 EARTH LEAKAGE CIRCUIT BREAKER when required 100 120 V Approved type min 16 A250 V 220 240 V Approved type min 10 A 250 V breaker activation leakage current in accordance with local regulations Mechanical parameters PANORAMIC Source to Image layer Distance SID 500 mm 10 mm Magnification factor 1 25 Focus to skin distance minimum 154 mm WEIGHT 120 kg DIMENSIONS H x W x D 2340 x 835 x 715 mm VERTICAL HEIGHT OF CHIN REST 950 1750 mm 10 mm Digital image receptor CCD PIXEL SIZE 96 microns ACTIVE SENSOR SURFACE 147 5 x 6 1mm Timer EXPOSURE TIMES Normal 10 0s Child 8 8 s Bitewing 2 5 Z 5 s TMJ 3 1 3 1 s Accuracy for
24. ll does not operate correctly contact your service technician for help lf you hear the exposure warning tone but the expo sure warning light on the display does not come on when an exposure is taken stop using the unit and contact your service technician for help If you do not hear the exposure warning tone when an exposure is taken stop using the unit and con tact your service technician for help Every week check that the power supply cable is in good order not damaged in any way and that the unit operates correctly in accordance with the in structions in this manual Make sure that the unit cannot be driven up down when the emergency stop button has been pressed down User manual 208677 ORTHOPANTOMOGRAPH OP30 6 Troubleshooting and Maintenance Yearly maintenance Once a year an authorized service technician must carry out a full inspection of the unit The following tests and checks must be carried out User manual 208677 a kV mA test a beam alignment test check that the safety ground is connected check that the positioning lights operate check that no oil is leaking from the tube head check that the power lead is not damaged in any Way check that all covers and mechanical parts are correctly secured and have not come loose check that any vents in the covers are not blocked with dust and that no dust has accumu lated inside the unit A full description of all the tests and checks is de scribed i
25. m for 25 cycles for 25 cycles an uninterruptible power supply or a battery lt 5 lt 5 U1 gt 95 dip gt 95 dip in for 5 sec for 5 sec Power frequency 3 A m 3 A m Power frequency 50 60 Hz magnetic field should be magnetic field at levels characteristic of a typical location in a typical commercial or hospital environment NOTE Ur is the a c mains voltage prior to application of the test level IEC 61000 4 8 A 13 Appendix A Technical Information ORTHOPANTOMOGRAPH OP30 OP30 2 Guidance and manufacturer s declaration electromagnetic immunity The device is intended for use in the electromagnetic environment specified below The customer or the user of the device should assure that it is used in such an environment Immunity IEC 60601 test Compliance Electromagnetic environment guidance test level level Portable and mobile RF communications equipment should be used no closer to any part of the device including cables than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter Recommended separation distance Conducted 3 Vrms _ 150 kHz to d 1 2 VP IEC 61000 80 MHz 4 6 d 1 24P 80 MHz to 800 MHz d 2 384P 800 MHz to 2 5 GHz Radiated where P is the maximum output power rating RF 3 V m of the transmitter in watts W according to the IEC 61000 80 MHz to transmitter manufacturer and d is the recom
26. n the Service Manual 35 7 Warnings and precautions ORTHOPANTOMOGRAPH OP30 7 Warnings and precautions 7 1 General warnings 36 The unit must only be used to take the dental x ray exposures described in this manual The unit must NOT be used to take any other x ray exposures It is not safe to use the unit to take an x ray ex posure that the unit is not designed to take The unit must only be used by personnel quali fied and experienced in the use and operation of digital panoramic dental x ray devices If this device will be used with 3rd party imaging application software not supplied by Instrumentarium Dental the 3rd party imaging application software must comply with all local laws on patient information software This in cludes for example the Medical Device Direc tive 93 42 EEC and or FDA if applicable Do not connect any device to the unit that has not been supplied with the unit or that is not rec ommended by Instrumentarium Dental The unit or its parts must not be changed or modified in any way without approval and in structions from Instrumentarium Dental The unit should not be used adjacent to or stacked with other equipment This unit can interfere with other devices due to its EMC characteristics and other devices can interfere with this unit due to their EMC charac teristics Refer to the EMC Declaration A4 in Appendix A for more information User manual 208677 ORTHOPANTOMOGRAPH
27. nside tubehead CAESIUM IODIDE Csl CCD sensor For more information on these parts contact your dealer User manual 208677 ORTHOPANTOMOGRAPH OP30 8 Disposal User manual 208677 41 ORTHOPANTOMOGRAPH OP30 Appendix A Technical Information Appendix A Technical Information A 1 Technical specifications Type OP30 2 Classification Complies with IEC 60601 1 IEC 60601 1 2 IEC 60601 1 3 IEC 60601 1 4 IEC 60601 2 7 IEC 60601 2 28 IEC 60601 2 32 UL 60601 1 Conforms with the regulations of DHHS Radiation Performance Standard 21CFR Subchapter J Safety according to IEC 60601 1 Protection against electric shock Class 1 Degree of protection Type B applied with no conductive connection to the patient Protection against the ingress of liquids IP20 Disinfection methods mild soapy water non abrasive non alcohol based disinfectant for the chin rest disposable plastic covers for bite piece chin rest and lip support For use in environments where no flammable anaesthetics nor flammable cleaning agents are present Mode of operation continuous operation intermittent loading Unit description A dental panoramic x ray unit with a high frequency switching mode x ray generator The unit takes panoramic exposures The unit uses a CCD sensor as an image receptor Generator TUBE Toshiba D 052 SB or D 054 SB or CEI 105 5 TUBEHEAD HOUSING ASSEMBLY THA M X where X is the version number FOCAL SPOT
28. quipment and the device The device is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled The customer or the user of the device can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment transmitters and the device as recommended below according to the maximum output power of the communications equipment Rated maximum Separation distance according to frequency of transmitter m power OL 150 kHz to 80 MHz 80MHzto800MHz 800 MHz to 2 5 GHz transmitter W d 1 2 P d 2124P d 2 3 P For transmitters rated at a maximum output power not listed above the recommended separation distance d in meters m can be estimated using the equation applicable to the frequency of the transmitter where P is the maximum output power rating of the transmitter in watts W according to the transmitter manufacturer NOTE 1 At 80 MHz and 800 MHz the separation distance for the higher frequency range applies NOTE 2 These guidelines may not apply in all situations Electromagnetic propagation is affected by absorption and reflection from structures objects and people A 15
29. romagnetic environment specified below The customer or the user of the device should assure that it is used in such an environment Immunity test IEC 60601 test level Compliance level Electromagnetic environment guidance Electrostatic 6 kV contact 6 kV contact Floors should be wood discharge ESD concrete or ceramic tile IEC 61000 4 2 8 kV air 8 kV air If floors are covered with synthetic material the relative humidity should be at least 30 96 Electrical fast 2 kV for power 2 kV for power supply Mains power quality transients bursts supply lines lines should be that of a IEC 61000 4 4 1 kV for input output 1 kV for input output typical commercial or lines lines hospital environment Surge 1 kV differential 1 kV differential mode Mains power quality IEC 61000 4 5 mode 2 kV common mode should be that of a 2 kV common mode typical commercial or hospital environment Voltage dips lt 5 Ur 5 Mains power quality short gt 95 dip in gt 95 dip in should be that of a interruptions for 0 5 cycle for 0 5 cycle typical commercial or voltage variations hospital environment If on power supply 40 40 user of the device lines 60 9o dip in UT 60 dip in requires continued IEC 61000 4 11 for 5 cycles for 5 cycles operation during power mains interruptions it is TO 96 Ur 70 96 Ur recommended that the 30 dip in Ur 30 dip in Ur device be powered fro
30. rted municipal waste and must be collected separately Please contact an authorized represen tative of the manufacturer for information concern ing the decommissioning of your equipment Type B equipment CE 0537 symbol MDD 93 42 EEC ETL symbol GOST R symbol Appendix A Technical Information ORTHOPANTOMOGRAPH OP30 A 4 EMC declaration for the OP30 2 OP30 2 Guidance and manufacturer s declaration electromagnetic emissions The device is intended for use in the electromagnetic environment specified below The customer or the user of the device should assure that it is used in such an environment Emissions test Compliance Electromagnetic environment guidance RF emissions The device uses RF energy only for its internal CISPR 11 function Therefore its RF emissions are very low and are not likely to cause any interference in nearby electronic equipment RF emissions Class B The device is suitable for use in all establishments CISPR 11 including domestic establishments and those directly connected to the public low voltage power supply Class network that supplies buildings used for domestic emissions purposes IEC 61000 3 2 Voltage Complies fluctuations flicker emissions IEC 61000 3 3 A 12 ORTHOPANTOMOGRAPH OP30 Appendix A Technical Information OP30 2 Guidance and manufacturer s declaration electromagnetic immunity The device is intended for use in the elect
31. splay Touch the CLEAR button to clear the error mes sage and return to the main display NOTE If the CLEAR button does not appear on the er ror message display you will have to wait for the error to clear automatically User manual 208677 29 6 Troubleshooting and Maintenance ORTHOPANTOMOGRAPH OP30 Error symbols REASON The PC connected to the unit is not ii The dental imaging software in the PC is not open lil The cable connecting the unit to the PC is disconnected or damaged IV The IP address is not set correctly SOLUTION Switch the PC on ii Open the dental imaging software and select a patient lil Reconnect the cable If damaged contact service IV Reconfigure the IP address REASON The emergency stop button is pressed down in the STOP position SOLUTION Rotate and release the emergency stop button The error symbol will clear 30 User manual 208677 ORTHOPANTOMOGRAPH OP30 6 Troubleshooting and Maintenance User errors H1 REASON The exposure button was released during an exposure SOLUTION Clear the error message and check if the attempted exposure is sufficient for the diagnostic task If it is not take a new exposure If the exposure failed while the exposure button was still being pressed check the exposure switch by taking a test exposure without patient to see if the exposure button is defective or not If the same problem occurs again contact service
32. t being examined The recommended values are Child 66 kV Juvenile or small adult 70 kV Adult 73 kV Large Adult 77 kV 11 3 Taking an Exposure 12 ORTHOPANTOMOGRAPH OP30 Ask the patient to remove any spectacles den tures jewellery and hair clips and pins Place a protective lead apron around the pa tients neck to protect the patient s thyroid gland from radiation NOTE If the patient is nervous you can reassure him her by demonstrating how the unit works before taking the exposure See section 4 Operating the unit without x rays Press the Up Down keys to adjust the height of the chin rest so it is slightly higher than the pa tients chin so that the patient will have to stretch up to place their chin on the chin rest If the patient is dentate ask the patient to step into the unit grasp the patient handles place his her chin on the chin rest and bite the notches in the bite block If the patient is partially edentulous ask the pa tient to bite the edentulous bite positioner User manual 208677 ORTHOPANTOMOGRAPH OP30 3 Taking an Exposure User manual 208677 10 If the patient is edentulous ask the patient press chin against the chin support Press the Lights key to switch the patient po sitioning lights on They will remain on for two minutes NOTE The patient positioning lights will automatically come on when either the Up or Down key is pressed Loo
33. test When the self test is complete a question mark will appear next to the unit status indicator This indicates that you need to reserve the unit before you can take an exposure oingle user Ac Multiple users 3 Taking an Exposure ORTHOPANTOMOGRAPH OP30 NOTE If the no connection symbol X appears next to ESL the unit status indictor it indicates that there is no connection between the unit and the PC See gt section Troubleshooting and Maintenance for more information 4 PC Press the device icon to reserve the unit and enable image capture If a message appears stating that the unit is in use it indicates that the unit has been reserved by another user INFORMATION The status of the unit available ready or busy can be seen in the status field at the bottom of the PC display 7 a Vi e stat j 5 5 When the unit status indictor turns GREEN and the text Ready appears the unit is ready to take an exposure Single user Multiple users 8 User manual 208677 ORTHOPANTOMOGRAPH OP30 3 Taking an Exposure 6 Press the Return key to drive the rotating unit to O the Patient In Out PIO position User manual 208677 9 3 Taking an Exposure ORTHOPANTOMOGRAPH OP30 3 2 Taking Exposures Panoramic standard paediatric and bitewing 1 Slide the chin rest on to the support holder Dentate patients A
34. tion of the exposure The exposure starts when you hear the exposure warning sig nal and the exposure warning indicator control panel and light side of the unit come on The rotating unit will rotate around the patients head and take the exposure When the exposure warning signal and rotating unit stop the exposure has been taken 29 3 Taking an Exposure ORTHOPANTOMOGRAPH OP30 18 PC After the exposure has been taken a pro gress bar will appear This indicates that the image is being transferred to the PC Scanning the image Open Preview 19 If you wish to take a second TMJ exposure press the Return key to drive the unit back to the PIO position enable image capture PC and then reposition the patient and take the sec ond exposure steps 13 15 20 Press the release button at the top of the fore head support A and then slide the forehead support away from the patient B Open the temple supports by sliding the temple support knob to the left C Guide the patient out of the unit 21 Press the Return key to drive the unit to the PIO position 24 User manual 208677 ORTHOPANTOMOGRAPH OP30 4 Operating the unit without x rays 4 Operating the unit without generating x rays User manual 208677 In some situations for example with nervous pa tients or patients with unusual anatomy you may wish to operate the unit without generating x rays before taking an exposure
35. tments only so as not to cause the patient any distress or discomfort Close the temple supports by sliding the temple support knob to the right A Make sure that patient s neck is stretched and straight Adjust the position of the nasion support B and then carefully push the forehead support in until it touches the patient s nasion C Check once more that the patient is positioned correctly and has not moved If you are taking a TMJ exposure with the pa tients mouth closed ask the patient to clench their back teeth together look at a fixed point in the mirror and to remain still for the duration of the exposure User manual 208677 ORTHOPANTOMOGRAPH OP30 3 Taking an Exposure User manual 208677 15 16 17 If you are taking a TMJ exposure with the pa tients mouth open ask the patient to open their mouth look at a fixed point in the mirror and to remain still for the duration of the exposure The exposure takes approximately ten seconds Make sure that the unit status indicator is still GREEN indicating that the unit is ready to take an exposure If the indicator is not GREEN the unit reservation time may have expired Reserve the unit again see section 3 1 Prepar ing the unit Move at least two metres from the unit and pro tect yourself from radiation Make sure that you can see and hear the patient during the expo sure Press and hold down the exposure button for the dura
36. ttach the bite block to the bite fork and then insert the bite fork and bite block into the hole in the chin rest Edentulous patients panoramic standard and paediatric only Attach the chin support to the chin rest If the patient is partially edentu lous attach the edentulous bite positioner to a bite fork and then insert the bite fork and eden tulous bite positioner into the hole in the chin rest 3 Place the appropriate disposable covers to the patient Support you are using 10 User manual 208677 ORTHOPANTOMOGRAPH OP30 3 Taking an Exposure T m G8 4 Select the panoramic program you require standard panoramic P1 paediatric pano ramic P2 or bitewing BW The magnification for these programs is 1 25 Select the patient size Child Juvenile or small adult Adult a ala er heres adult 55 mGycm e 73 kv GO 9 6 MA 10 s User manual 208677 Default kV and mA values for the selected pa tient size will appear on the display The DAP value for the selected program and patient size will appear on the display If you consider that the default kV and mA val ues are not correct for the patient being exam ined select different values based on the pa tient s size age and estimated bone density To select different kV and mA values press the M key Plus and minus keys will appear These allow you to change the kV and mA values to suit the patien

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