SCANORA® 3Dx - thetechgods.net
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1. 73 DT TO De observed 76 Appendix A Technical 1 1 Technical specifications 1 9 Electromagnetic declaration 10 yi User s Manual 207301 SCANORA 3Dx 1 Introduction 1 Introduction 1 1 The SCANORA 3Dx The SCANORA 3Dx is a cone beam computerized tomography x ray unit The SCANORA 3Dx unit the unit is part of the SCANORA 3Dx system the system that com prises the unit which is connected to a PC the PC in which suitable dental imaging software and 3D imaging software have been installed All software must conform to the MDD and the rel evant legal requirements in the USA The unit uses an amorphous silicon flat panel detec tor for acquiring 3D images and an optional CCD sensor for acquiring panoramic images 1 2 Intended use The unit must only be used and operated by quali fied healthcare professionals The unit must only be used to take 3D and op tional panoramic images of the dento maxillo facial complex and the head and neck areas including the ear nose and throat ENT areas of the human skull The unit must not be used to take images of any other part of the human Note that panoramic and 3D exposures should not be used if conventional i2. Tg Head strap Temple supports knob N support lever Head support 7 Q ID x Ly Head support adjusting knob Forehead support locking lever 6 User s Manual 207301 SCANORA 3Dx 2 The SCANORA 3Dx Seat Back rest Chair Arm rests Leg rests E SLY P lt Arm rests User s Manual 207301 7 2 The SCANORA 3Dx SCANORA 3Dx 2 2 The control panel 3D display a 167 761 7167 Smith John 1 Information window Mode buttons panoramic Is optional FOV Field of View buttons Scout resolution buttons mA buttons Settings button Test exposure button N 9o Om KF End study button 8 User s Manual 207301 SCANOR A 3Dx 2 The SCANORA 3Dx 3D optional display YO E 9 FOV and XL FOV buttons Panoramic optional display 10 Partial panoramic exposure buttons 11 Program buttons 12 kV buttons mA buttons User s Manual 207301 9 2 The SCANORA 3Dx SCANORA 3Dx 2 3 Remote control Rotating unit Position lights return key on off key f Backwards Field Of View Head support height adjusting keys Chair height adjusting keys LIS Y 10 User s Manual 207301 Down SCANORA 3Dx 2 The SCANORA 3Dx 2 4 Patient positioning lights 3D lights Lateral light Lateral front light Sagittal light Center of FOV Front of 165 FOV
3. 45 User s Manual 207301 V SCANORA 3Dx oystem Sell 46 S MN Badii ge NETT 46 Opening the Settings nnne 46 lupe EEPE E T PETEA T 46 Information DUTTON 47 EIR AGS EI EE E E A 47 9 2 47 6 Quali 48 6 1 The 3D QA procedure 49 Starting the QA OCG 49 Geometry calibra liOn 52 Pixel calibration RITTER 95 Pixel calibration TNE 56 E E EEE 57 6 2 The Panoramic QA procedure 61 7 Care maintenance and disposal 68 1 Cleaning and disinfecting the see 68 Unit surfaces and 61 68 F OGIMOMING NOME COVBIS 68 Surfaces that the patient touches eene 68 7 2 Checking that the unit operates 69 MET AOD SET AU ONS I pm EN 69 Quality assurance CHECK TRO TE 69 R 69 WS ALY MAMENANG O NR TU 69 fo BI DO T A E AE E AEA E 70 TA SYMDOIS that appear on 71 8 Warnings and precautions
4. pull the temple supports away from the seat 9 Rotate the head support adjusting knob to move the head support to its mid point You will feel slight click when you reach this position 4 10 Turn the head support lever to the left to release the head support and then rotate the head sup port away from the seat to the open position 11 Insert the chin cup into the chin rest NOTE Use a new disposable cover for every patient User s Manual 207301 21 3 Taking an exposure V 12 13 SCANORA 3Dx Press the chair down key to drive the chair down so that it is low enough for the patient to enter unit 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 or a child you can dem onstrate how the unit works to reassure them Touch the T Test button and then press and hold the exposure button The unit will complete an exposure cycle without generating x rays Press the key button to drive the rotating unit to the 3D ready position If necessary lift up the arm rests and then ask the patient to sit on the chair Make sure that the patient is sitting straight and in the middle of the chair with their back pushed against the backrest Also make sure that they are sitting in a position in which they
5. temple supports as far as they will go and then pull the temple supports away from the seat Rotate the head support adjusting knob to move the head support to its mid point You will feel slight click when you reach this position to release the head support and then rotate the head support away from the seat Insert the required positioning device bite block lip rest or lip support into the head support Place the appropriate disposable cover on posi tioning device NOTE Use a new disposable cover for every patient User s Manual 207301 SCANORA 3Dx User s Manual 207301 N 3 Taking an exposure 10 Press the seat height adjusting keys to drive the chair down so that it is low enough for the pa tient 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 or a child you can dem onstrate how the unit works to reassure them Touch the T Test button and then press and hold the exposure button The unit will complete an exposure cycle without generating x rays Press the Return button to drive the rotating unit to the ready position If necessary lift up the arm rests and then ask the patient to sit on the chair Make sure that the patient is sitting straight and in the middle of the chai
6. DUTY CYCLE Intermediate use 6 2596 255 ON 400s OFF Environmental data OPERATING ambient temperature from 10 to 30 relative humidity O 85 no condensation STORAGE TRANSPORTATION ambient temperature from 0 to 50 relative humidity O 85 no condensation atmospheric pressure 700 1060 mbar Appendix A Technical Data SCANORA 3Dx PC requirements Windows 7 Professional Ultimate Enterprise SP1 64 bit or Windows Vista Business Ultimate Enterprise SP2 64 bit 2 5 GHz Intel quad core processor or AMD equivalent 4 GB RAM or more 6 8 GB recommended 1000 GB 1 Terabyte 7200 RPM HDD or better RAID 1 strongly recommended DVD ROM drive Two 1000 Mb s Gigabit Ethernet ports One available PCI Express x16 bus slot for supplied GPU card full length dual slot 2 available USB ports hardware keylocks 20 LCD display 1600 x 1200 pixels 32 bit color 500 watt power supply with two 6 pin PCle supplementary power cables The PC must meet the IEC 60950 standard minimum requirements SCANORA 3Dx Appendix A Technical Data 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 6
7. OIL Inside tubehead CESIUM IODIDE Csl Amorphous silicon sensor CCD sensor User s Manual 207301 SCANORA 3Dx 7 Care maintenance and disposal 7 4 Symbols that appear on the unit AN Radiation warning Dangerous voltage On or enabled Off or disabled Gonnector remote control Exposure switch Connector for Ethernet RJ45 Connector for exposure switch gt Connector for external exposure light N Attention consult accompanying documents User s Manual 207301 1 7 Care maintenance and disposal SCANORA 3Dx L Ground Functional D Protective ground CLASS 1 LASER PRODUCT aser class label EN 60 825 1 2 2001 Patient positioning lights This symbol indicates that the waste of electrical and electronic equipment must not be disposed as unsorted municipal waste and must be collected separately Please contact an authorized representative of the manufacturer for information concerning the decommissioning of your equipment Type B equipment 72 User s Manual 207301 SCANORA 3Dx 8 Warnings and precautions 8 Warnings and precautions 8 1 To be observed during use User s Manual 207301 The unit must only be used to take x ray im ages of the dento maxillo facial complex and the head and neck areas including the ear nose and throat ENT areas of the human skull The unit must NOT be used to take any other x ray exposures It is not s
8. PASSED This indicates that the unit has passed the Quality Check test Passed If the word FAILED appears the image the unit has failed the test If required compare this image to the original QA image Recheck the position of the 3D phantom and reposition and relevel it if necessary 58 User s Manual 207301 SCANORA 3Dx r1 ES User s Manual 207301 6 Quality assurance NOTE You can check if the QC phantom is level by scrolling through the volume see step 9 next and checking if the cross at the top and dot at the bottom appear within the white circles If they do not the QC phantom is not level Repeat the test If it fails a second time call service PC Now check the position of the lights using the same image ocroll to the top of the quality check image A cross will appear The center of the cross should be within the white circle at the center of the crosshairs Now scroll to the bottom of the quality check image In the center of the image you will see a dot The dot should be within the white circle at the center of the crosshairs If both the center of the cross and the dot are within the white circle at the center of the cross hairs the lights are correctly positioned If the center of the cross and the dot are not within the white circle the lights are not po sitioned correctly and must be adjusted Call service 6 Quality assurance S
9. chair to avoid dam age to the unit or injury to people Press and hold the chair down key until the unit stops moving A message will then appear asking you to select a patient and then start image capture The system is now ready to take an exposure 3 Taking an exposure SCANORA 3Dx 3 2 Taking a 3D exposure 1 PC Open a new or existing patient or select a patient from the work list Refer to the user s guide supplied with the SCANORA Workstation software for information on how to do this NOTE The 3D viewing software must NOT be open when taking an exposure 2 PC Click the Image Capture button The image capture window will open a 3 Touch the 3D button to select the 3D program 4 Select the Field Of View FOV 50x50 50x100 80x100 PS 50 50 mm small FOV 8 50x 100 mm small plus FOV gt 80x 100 mm medium FOV ES 80x 165 mm medium plus FOV m 140x 100 mm large FOV wa k uM 140x165 mm large plus FOV 80x165 140x100 140x165 18 User s Manual 207301 SCANORA 3Dx 3 Taking an exposure Unit with optional extra large FOVs 50x50 50x100 80x100 80X165 50 y 50 mm small FOV ms N e 90 x 100 mm small plus FOV m 80 x 100 mm medium FOV QC 80 x 165 mm medium plus FOV 140 x 100 mm large FOV 140 x 165 mm large plus FOV scum 180 165 mm extra large FOV 140x100 140x165 180 165 240x165 240 x 165 mm extra large
10. for example drawers wheel chairs stools etc from around the chair to avoid dam age to the unit or injury to people Press the seat height adjusting key to drive the chair down as far as it will go 3 Press the Return key to drive the unit to the ready position 4 Touch the pixel calibration button to select the test 5 Protect yourself from radiation by standing be hind a suitable x ray radiation shield Press and hold down the exposure button until the exposure is complete this will take about 15 seconds User s Manual 207301 55 6 Quality assurance SCANORA 3Dx 6 After the exposure it will take approximately one and a half minutes for the image to be recon structed When reconstruction is complete the image will appear briefly on the unit display and then the PC The word PASSED should appear on the image This indicates that the unit has passed the pixel calibration test eG UE Gala If the word FAILED appears on the image the unit has failed the test If required compare the parameters of this im age to those of the original QA image Repeat the test If it fails a second time call service lt Touch the OK button to save the image and return to the QA window You must now carry out pixel calibration fine Pixel calibration fine Carry out the pixel calibration fine in the same way as the pixel calibration fast You must now car
11. height x width for verifying the positions of the optional 180 x 165 mm 3D XL FOV and the 240 x 165 mm 3D XL plus FOV The scout image or images are of the lower part of the 3D FOVs 14 User s Manual 207301 SCANORA 3Dx 2 The SCANORA 3Dx Panoramic programs Optional Adult panoramic or five freely selectable partial sections Magnification 1 25 Reduced width and height panoramic child or five freely selectable partial sections Magnification User s Manual 207301 15 2 The SCANORA 3Dx SCANORA 3Dx 2 6 Positioning devices Forehead support Chin cup Disposable cover Bite block Disposable cover Lip holder Disposable cover Lip support Disposable cover 16 User s Manual 207301 SCANORA 3Dx 3 Taking an exposure 3 Taking an exposure 3 1 Preparing the system 1 User s Manual 207301 PC Switch the PC on IMPORTANT NOTE Make sure that the hardware key dongle is connected to the PC If a hardware key has been removed the system will not work correctly Note that some systems have two hardware keys Switch the unit on The on off switch is on the under side of the electronics cabinet A message will appear on the control panel ask M ing you to press and hold the chair down button to complete unit start up CAUTION Crushing Danger Before pressing the chair down button remove all objects for example drawers wheel chairs stools etc from around the
12. im ages will be compromised The user must protect himself herself from x ray radiation when taking exposures by standing behind a suitable x ray radiation shield The user must be able to see and hear the pa tient during an exposure The user must see the radiation warning light and or hear the audio warning signal during the exposure If the unit is installed in such a place where the warning light cannot be seen a sepa rate warning light should be used Please con tact the local service for help 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 the local service If the unit will not be used for a long time switch the unit off and lock the exposure switch in order to prevent unauthorized people using the unit The annual maintenance as described in this manual is mandatory for the correct and safe operation of the unit 8 Warnings and precautions SCANORA 3Dx 8 2 General warnings There should be at least 10 cm clear space around the installation place of the unit The place where the unit is to be installed and the position from where the user will take expo sures must be correctly shielded from the radia tion that is generated when the unit is operated The unit or its parts must not be changed or modi
13. specified below The customer the user of the SBR3D 2 should assure that it is used in such an environment Emissions test Compliance Electromagnetic environment guidance RF emissions CISPR 11 The SBR3D 2 uses RF energy only for its internal function Therefore its RF emissions are very low and are not likely to cause any interference in nearby electronic equipment The SBR3D 2 is suitable for use in all ermine cies one Class A establishments including domestic 56 establishments and those directly connected to the public low voltage power supply network Voltage fluctuations flicker Complies that supplies buildings used for domestic emissions IEC 61000 3 3 purposes SCANOR A 3Dx Appendix Technical Data Guidance and manufacturer s declaration electromagnetic immunity The SBR3D 2 is intended for use in the electromagnetic environment specified below The customer or the user of the SBR3D 2 should assure that it is used in such an environment Immunity test IEC 60601 test level Compliance level Electromagnetic environment guidance Electrostatic discharge ESD IEC 61000 4 2 Electrical fast transients bursts IEC 61000 4 4 Surge IEC 61000 4 5 Voltage dips short interruptions and voltage variations on power supply lines IEC 61000 4 1 1 Power frequency 50 60 Hz magnetic field IEC 61000 4 8 6 kV contact 8 kV air 2 kV for power supply lines 1 kV for input outp
14. the vertical and horizontal lines on the phantom and the horizon tal light is at the bottom edge of the phantom Touch the geometric calibration button to select the test Protect yourself from radiation by standing be hind a suitable x ray radiation shield Press and hold down the exposure button until the exposure is complete this will take about 30 seconds After the exposure it will take approximately five minutes for the image to be reconstructed When reconstruction is complete the image will appear briefly on the unit display and then the PC 6 Quality assurance SCANORA 3Dx The word PASSED should appear on the im age This indicates that the unit has passed the geometry calibration test GhiGeometryycallbrsilon nis ass ae jm i9 If the word FAILED appears on the image the unit has failed the test If required compare the parameters of this im age to those of the original QA image Recheck the position of the 3D phantom and reposition and relevel it if necessary Repeat the test If it fails a second time call service ES Touch the OK button to save the image and OK return to the QA window You must now carry out the pixel calibration test 54 User s Manual 207301 SCANORA 3Dx 6 Quality assurance Pixel calibration fast 1 Remove the 3D phantom 2 CAUTION Crushing Danger Before pressing the chair down button remove all objects
15. 0 VAC breaker activation leakage current in accordance with local regulations Mains fuses in the device F1 special 8 amp 250 V slow 6 3 x 32mm F2 special 8 amp 250 V slow 6 3 x 32mm External warning light fuse F3 special 2 amp 250 V slow 6 3 x 32mm Appendix A Technical Data SCANORA 3Dx Mechanical parameters SOURCE TO IMAGE LAYER DISTANCE SID 3D 650 mm 10 mm Panoramic Optional 550 mm 10 MAGNIFICATION FACTOR 3D 1 5 Panoramic Optional 1 3 WEIGHT 308 6 kg 313 kg with Panoramic Optional DIMENSIONS H x W x D 1963 x 1541 x 1100 mm PATIENT HEIGHT 140 205 cm PATIENT WEIGHT maximum 150 kg 3D image receptor TYPE Amorphous silicon Flat Panel Panoramic Optional image receptor TYPE CCD PIXEL SIZE 48 microns X ray field size 3D 140 x 165 mm Maximum 50 x 50 mm Minimum PANORAMIC Optional Adult panoramic maximum size 15 cm x 30 cm SCANORA 3Dx Appendix A Technical Data Timer EXPOSURE TIMES 3D 6 s maximum Panoramic Optional 15 s maximum SINGLE LOAD RATING 81 kV 8 mA 15 s panoramic BACK UP TIMER 30 s 415 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 PRIMARY SLIT Motorized variable Chair motor
16. 0601 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 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 230 VAC 230 VAC Appendix A Technical Data SCANORA 3Dx Tube housing assembly cooling heating characteristics TUBE HOUSING ASSEMBLY COOLING CHARACTERISTICS kHU HEAT UNITS Ep T L tA _ 90 120 150 180 TIME IN MINUTES Tube rating chart mA 20 18 RT 26 14 N Wn 12 1077 TES S T 1 1 SCANORA 3Dx Appendix A Technical Data A 2 Unit dimensions 1973 mm 1984 mm 1400 mm 1600 mm Appendix A Technical Data SCANORA 3Dx A 3 Electromagnetic declaration Guidance and manufacturer s declaration electromagnetic emissions The SBR3D 2 is intended for use in the electromagnetic environment
17. 2 Panoramic programs Optional sess 3 lt 3 1 5 Abbreviations used in this 4 1 6 Associated documentation vssessscesusik dua itti 4 1 7 About cone beam 3D 4 2 Ihe SCANORA M ATE UNAM 5 2 Man pans and CONOIS serene ens 9 Zee NE COMMOL TTE ITO DOTT 8 Sen E 8 OISDIGU 9 Panoramic optional display RR 9 gt 10 2 4 Patent POSITIONING MONTS EEEE TEENE 11 11 Panoramic lights Optional 11 2 9 WIIG FOO GAINS m 12 TOLD OO 12 8 EA EEE E 13 14 Panoramic programs Optional 15 AS VIC EE 16 3 Taking FUE 17 DN 17 18 3 3 Taking a Panoramic exposure 32 AART 42 4 Messages and error codes 43 A TMCS SE 43 da ENO COOS
18. 2 34 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
19. 301 SCANORA 3Dx 1 Introduction Panoramic programs Optional With the OPTIONAL panoramic sensor the following panoramic images can be taken Adult panoramic Child panoramic reduced width and height Temporomandibular joint TMJ Five freely selectable partial segments 1 4 About this manual This manual describes how to set up and use both the 3D and the 3D pan versions of the SCANORA 3Dx x ray unit Please read this 5 manual before operating the unit for the first time CAUTION It is important to read the warnings and precau tions listed in section 8 before operating the unit for the first time It is also important to observe these warnings and precautions whenever the unit is used NOTE Instructions in this user s manual starting with PC for example 1 PC Open a new or existing patient indicate that the task is carried out from the PC Instructions NOT starting with PC for example 3 Close the head supports indicate that the task 1 carried out from the UNIT NOTE Before you use the imaging system for the first time set the system to your requirements See section 5 System Settings User s Manual 207301 3 1 Introduction SCANORA 3Dx 1 5 Abbreviations used in this manual FOV Field Of View The cylindrical 3D volume that the unit will take an exposure of ROI Region Of Interest The anatomical area or region of the patient that you wish to ex
20. CANORA 3Dx 10 Touch the OK button to save the image and return to the QA window 11 The QA test for 3D imaging is now complete Touch the arrow button to exit the QA mode and return to the main program window User s Manual 207301 SCANORA 3Dx 6 Quality assurance 6 2 The Panoramic QA procedure OPTIONAL 1 Start the system as described in section 3 1 Preparing the system 2 Close the head support rotate it towards the chair and lock it in position with the head sup port locking lever 3 PC Open a patient card in which the QA images can be or are stored 4 PC Calibrate the contrast and brightness of the monitor to optimise its image quality Refer to SCANORA Workstation software user manual for information on how to do this 5 PC Click the Image Capture button 6 Touch the Panoramic button to select the Pano ramic program mode 7 Select the adult panoramic program User s Manual 207301 61 6 Quality assurance 60 kV e SCANORA 3Dx 8 Select exposure factors 60 kV and 4 mA 9 Push the temple supports towards the chair so that the panoramic sensor will not hit them dur ing the exposure 10 Attach the copper filter to the front of the tube head assembly in front of the collimator 11 Place the adjustable phantom holder on the chin rest and then level the holder using the levelling screws on the under side There is a spirit level on top of the h
21. Center of FOV Upper light Top of FOV 240 or 180 or 140 or 80 or 50 mm height Lower light Bottom of FOV Panoramic lights Optional Midsagittal light Focal trough light Center of focal trough Horizontal light Bottom of panoramic field User s Manual 207301 11 2 The SCANORA 3Dx SCANORA 3Dx 2 5 Imaging programs 3D programs 50 x 50 mm height x diameter small FOV S Resolution voxel size standard 0 150 mm or high 0 100 mm Use single implants wisdom teeth localized dental problems single TMJ ear etc 50 x 100 mm height x diameter small plus FOV 5 Resolution voxel size standard 0 400 mm high 0 200 mm Use maxilla or mandible implants for one jaw etc 80 x 100 mm height x diameter medium FOV M Resolution voxel size standard 0 250 mm or high 0 150 mm Use maxilla and mandible implants for both jaws etc 80 x 165 mm height x diameter medium plus FOV M Resolution voxel size standard 0 350 mm or high 0 150 mm Use TMJs and ears 12 User s Manual 207301 SCANORA 3Dx 2 The SCANORA 3Dx 140 x 100 mm height x diameter large FOV L Resolution voxel size standard 0 350 mm or high 0 250 mm Use sinuses 140 x 165 mm height x diameter large plus FOV L Resolution voxel size standard 0 300 mm or high 0 200 mm Use sinuses both TMJs both temporal bones ENT etc Optional 3D programs 180 x 165 mm height x
22. ENGLISH SCANORA 3Dx Cone Beam 3D Imaging System User s Manual 207301 rev 03 2012 04 SCANORA 3Dx Cone Beam 3D Imaging System User s Manual 0537 Medical Device Directive 93 42 EEC Number 207301 rev 03 2012 04 Original approved English language version Manufactured by SOREDEX Nahkelantie 160 Tuusula P O BOX 148 1 04301 Tuusula Finland Tel 358 10 270 2000 Fax 358 9 701 5261 SCANORA 3Dx SOREDEX are registered trademark a common law trade mark of SOREDEX SOREDEX endeavours to produce product documentation that is accurate and up to date However our policy of continual product development may result in changes to products that are not reflected in the product documentation Therefore this document should not be regarded as an infallible guide to cur rent product specifications SOREDEX maintains the right to make changes and alterations without prior notice DICOM is the registered trademark of the National Electrical Manufacturers Association for its standards publication relating to digital communications of medical information User s Manual 207301 SCANORA 3Dx Contents BIN 1 REF E NUES 1 194 RIGO FIN ORAS OO 1 Na ISG 1 I RN 2 OLD 2 ree ORO
23. MAXIMUM TUBE CURRENT 3D imaging 10 mA 0 01 s Panoramic Optional imaging 8 mA MAXIMUM ANODE OUTPUT POWER 900 W nominal at 90 kV 10 mA MAXIMUM GENERATOR OUTPUT POWER 3D maximum 900 W at 90 kVp 10 mA 3D maximum nominal 210 W at 90 kVp 10 mA Panoramic Optional maximum 0 65 kW at 81 kVp 8 mA Panoramic Optional maximum nominal 0 65 kW at 81 kVp 8 mA REFERENCE CURRENT TIME PRODUCT 8 mAs at 81 kV 8 mA 1 0 5 FILTRATION Collimator BLD SBR3D 3 Total filtration 3D 6 6 mm equivalent 0 2 mm Cu Panoramic Optional 3 3 mm equivalent 0 1 mm Cu SCANORA 3Dx Appendix A Technical Data BEAM QUALITY HVL over 3 2 mm Al at 85 kV RADIATION LINEARITY lt 20 PRIMARY PROTECTIVE SHIELDING minimum 0 5 mm Pb or equivalent OUTER SHELL TEMPERATURE 50 C 122 F maximum DUTY CYCLE Controlled by the software of the unit 3D 28 pictures per hour Panoramic Optional 19 pictures per hour LEAKAGE TECHNIQUE FACTORS 3D 1680 mAs h at 90 kV FOV 50 x 50 mm high resolution Panoramic Optional 81 kV 2300 mAs h 81 kV 8 mA Power requirements INPUT VOLTAGE 230 240 VAC 410 50 60 Hz single phase grounded socket LINE CURRENT long term 1 cont 230 240 VAC mains momentary 8 A 230 240 VAC mains MAXIMUM LINE RESISTANCE 1 ohm MINIMUM LINE FUSE 10 A slow at 230 240 VAC LINE SAFETY SWITCH when required Approved type min 10 A 250 VAC EARTH LEAKAGE CIRCUIT BREAKER when required Approved type min 16 25
24. NEVER use abrasive cleaning agents or polishes to clean the covers 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 instruc tions supplied with the disinfectant User s Manual 207301 SCANORA 3Dx 7 Care maintenance and disposal 7 2 Checking that the unit operates correctly User s Manual 207301 General observations 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 still does not operate correctly contact your authorized serv ice technician for help If you hear the exposure warning tone but expo sure warning light on the display does not come on when an exposure is taken stop using the unit and contact your authorized 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 authorized service technician for help Quality assurance check The quality assurance QA check must be carried out at regular intervals to check the image quality oee section 6 Emergency stop knob When the emergency stop button has been pressed down make sure
25. ORA 3Dx 16 Carefully rotate the head support towards the patient until it stops Turn the head support lock ing lever to the right to lock the head support in gt position 17 Rotate the head support positioning knob to position the head support so that the patient can place their chin on the chin cup or bite the bite block 6 18 Press the light key to switch the patient position ing lights on 5 If the patient positioning lights do not come on the rotating unit is not in the 3D ready position To switch the lights on press the return key to drive the unit to the 3D ready position and then press the light key to switch the patient position ing lights on 19 Press the head support up down keys to level or adjust the angle of the patient s head 24 User s Manual 207301 SCANORA 3Dx 3 Taking an exposure 20 Push the temple supports towards the patient so that they are positioned on both sides of the patient s head Carefully rotate the temple sup port knob to close the temple supports so that they grip the patient s head 21 Press the seat height adjusting keys to position N the ROI within FOV you have selected The up per light beam indicates top of the FOV and the lower light beam the bottom of the FOV If you are taking an XL XL FOV image posi tion the lower light level with the bottom of the patient s chin For an adult patient with average size
26. a patient card in which the QA images are or can be stored NOTE Do not open the 3D viewing software PC Calibrate the contrast and brightness of the monitor to optimise its image quality Refer to the SCANORA Workstation software user manual for information on how to do this User s Manual 207301 SCANOR A 3Dx Quality assurance User s Manual 207301 6 Quality assurance PC Click the Image Capture button Touch the setting button at the bottom of the main window The settings window will appear Touch the Quality assurance button The QA window will appear 6 Quality assurance SCANORA 3Dx Geometry calibration 1 Place the adjustable phantom holder on the chin rest and then level the holder using the levelling screws on the under side There is a spirit level on the holder Place the 3D phantom on the adjustable phan tom holder Note that it can only be placed in one position because of the different size pins in the base 3 Press the Return key to drive the unit to the ready position tioning lights on 4 Press the Lights key to switch the patient posi 52 User s Manual 207301 SCANORA 3Dx lt User s Manual 207301 6 Quality assurance 5 Use the seat height adjusting keys and the field of view positioning keys on the remote control to adjust the position of the 3D phantom Position the phantom so that the vertical and horizontal lights coincide with
27. afe to use the unit to take an x ray ex posure that the unit is not designed to take Only professionally qualified dental and or medi cal personnel are allowed to operate the unit and carry out any diagnoses based on output from the unit 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 This unit complies with the EMC Electromag netic Compatibility according to IEC 60601 1 2 Radio transmitting equipment cellular phones etc shall not be used in close proximity of the unit as they could influence the performance of 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 doctor to decide if the x ray exposure is necessary The minimum height of patient that can be x rayed without the optional cushion is 140 cm 4 ft 7in and the maximum is 205 cm 6 ft 9 in These heights only apply to patients with normal anatomy 8 Warnings and precautions SCANORA 3Dx The unit chair can support a patient with a maxi mum weight of 150 kg When taking an x ray exposure of a patient with exceptional anatomy typically very tall or large use the test program no x rays first to make su
28. amine 1 6 Associated documentation The SCANORA Workstation Software user s man ual The user documentation supplied with the 3D view ing software you are using Any applicable optional local or national require ments or specifications related to the operation testing and maintenance of dental x ray imaging devices and systems 1 7 About cone beam 3D imaging During a 3D exposure the tubehead rotates around the patient s head taking a series of 2D images of the selected ROI 150 to 600 depending upon the 3D program and resolution selected The 3D imag ing software then reconstructs the separate 2D im ages to form a 3D model a volume of the ROI 4 User s Manual 207301 SCANORA 3Dx 2 The SCANORA 3Dx 2 The SCANORA 3Dx 2 1 Main parts and controls Tubehead assembly Rotating unit Detector head r A 1d JE L Electronics cabinet H On off switch Underside of electronics Tubehead api enc binet ems cabinet assembly Wi Pan OPTIONAL Remote control PC with SCANORA Workstation software and 3D viewing sofware All software must conform to the MDD and the relevant legal requirements in the USA User s Manual 207301 2 The SCANORA 3Dx SCANORA 3Dx Emergency stop knob Press to stop the unit Rotate to release Forehead support gt
29. ded you that you take a test exposure to check whether or not the sensor will touch the patients head and whether the pa 5 head will have to be tilted Slide forehead support up or down until it is po sitioned in front of the patient s forehead Wrap the forehead support strap around the patient s head slide the strap through the buckle and then gently pull the strap to tighten it around the patient s head Fold the strap backwards and then secure it in position 3 Taking an exposure m A j 90 a oe E i i M wd gt lt SCANORA 3Dx 25 Tell the patient not to move for the duration of the exposure If you are taking an XL or XL 3D image tell the patient that TWO images will be taken and that after the first image has been taken the chair will automatically descend and the unit will take a second exposure 26 Protect yourself from radiation by standing be hind a suitable x ray radiation shield 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 appears on the control panel The rotating unit will rotate around the patients head and take the expo sure When the exposure warning signal and rotating unit stop the exposure has been taken If you are taking a scou
30. diameter extra large FOV XL Resolution voxel size standard 0 500 mm or high 0 300 mm Use both jaws sinuses both TMJs both temporal bones ENT etc 240 x 165 mm height x diameter extra large plus Resolution voxel size standard 0 500 mm high 0 300 mm Use facial surgery planning and control traumatol ogy ortho etc User s Manual 207301 13 2 The SCANORA 3Dx SCANORA 3Dx Scout programs The scout programs are used to verify the position of the 3D FOVs Each scout program takes a lateral image or a anterior posterior image or both lateral and anterior posterior images of the corresponding 3D FOV NOTE The lateral exposure is taken from the right hand side of the patient and the anterior posterior image from the rear 50 x 50 mm height x width scout images For verifying the position of the 50 x 50 mm 3D small FOV 50 x 100 mm height x width scout images For verifying the position of the 50 x 100 mm 3D small plus FOV 80 x 100 mm height x width scout images For verifying the position of the 80 x 100 mm 3D medium FOV 80 x 165 mm height x width scout images For verifying the position of the 80 x 165 mm 3D medium plus FOV 140 x 100 mm height x width scout images For verifying the position of the 140 x 100 mm 3D large FOV 140 x 165 mm height x width scout images For verifying the position of the 140 x 165 mm 3D large plus FOV 140 x 165
31. ears call service for help User s Manual 207301 45 5 System Settings SCANORA 3Dx 5 System Settings 5 1 Unit Settings Opening the Settings window Touch the settings button at the bottom of the main a window The settings window will appear 7 j Display patient s Retrieve last i T Display DAP value Quality assu The Settings Display patient s name Allows you to select whether or not the name of the Display patient s narne Patient appears on the unit control panel Display DAP Allows you to select whether or not the DAP Dose Display DAP value Area Product appears on the unit control panel 46 User s Manual 207301 SCANORA 3Dx Retrieve last mage Quality assurance 5 System Settings Retrieve last image If the image is not transferred to the PC or there is a problem with the PC or the PC unit connection this function can be used to retrieve the last image from the unit memory CAUTION If the unit is switched off the last image taken will be lost WARNING Before retrieving the last image MAKE SURE that the patient where the image must be stored is open If a different patient is open the retrieved im age will be stored with this the wrong patient Quality assurance oee section 6 Quality assurance Information button Displays the unit IP address and software versions id Language butto
32. ed 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 SBR3D 2 is used exceeds the applicable RF compliance level above the SBR3D 2 should be observed to verify normal operation If abnormal performance is observed additional measures may be necessary such as reorienting of relocating the SBR3D 2 Over the frequency range 150 kHz to 80 MHz field strengths should be less than V m SCANORA 3Dx Appendix A Technical Data Recommended separation distances between portable and mobile RF communications equipment and the SBR3D 2 The SBR3D 2 is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled The customer or the user of the SBR3D 2 can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment transmitters and the SBR3D 2 as recommended below according to the maximum output power of the communications equipment Rated maximum Separation distance according to frequency of transmitter m MOM ol 150kHzto80 MHz 80MHzto800MHz 800 MHz to 2 5 GHz transmitter W d 12XP d 2124P
33. f the patient s head until the roots of the upper and lower front inci sors are within the focal trough Note that you may have to reposition the focal trough slightly IMPORTANT NOTE When you press the exposure button to take a panoramic exposure the panoramic sensor will automatically rotate to the exposure position If before taking an exposure you want to check that the sensor will not touch the patient during the exposure sequence press the Return key to drive the sensor to the exposure position and check its position in relation to the patient For safety reasons the height of the chair can not be adjusted when the panoramic sensor is in the exposure position If you wish to adjust the height of the chair you must press the Return key to drive the panoramic sensor back to the non exposure position User s Manual 207301 SCANORA 3Dx 25 26 27 28 al 29 User s Manual 207301 3 Taking an exposure Ask the patient to press their tongue against the roof of their mouth and remain still for the dura tion of the exposure 15 seconds If you are taking a temporomandibular joint exposure ask the patient to open or close their mouth depending on which exposure you wish to take Protect yourself from radiation by standing be hind a suitable x ray radiation shield Make sure that you can see and hear the patient during the exposure Press and hold down the exposure button for
34. feel comfortable With small patients and children you may have to use cushions to position the patient at the right height User s Manual 207301 SCANORA 3Dx User s Manual 207301 3 Taking an exposure If the patient is very large and cannot sit com pletely on the seat or is small and cannot sit back far enough adjust the forward backward position of the backrest with the knob at the rear of the chair Wheelchair patients Adjust the height of the unit chair so that the seat is level with the wheelchair seat or as near as possible at the same level Position the patient in the wheelchair as close as possible to the left hand side of the unit chair with the patient facing forwards Ask the patient to put the wheelchair s brake on so that wheelchair cannot move Make sure that the left hand arm rest of the unit chair is in the raised position Manually rotate the rotating unit so that the detector head is at the front This will make it easier for the patient to enter the unit Ask the patient to remove or lower the armrest on the right hand side of the wheelchair Ask the patient to slide from the wheelchair onto the unit chair When the patient is in the unit chair lower the left hand chair armrest Remove the wheelchair from the unit environ ment NOTE After taking the exposure repeat the above procedure in the reverse order to get the patient back into the wheelchair 3 Taking an exposure SCAN
35. fied in any way without approval and in structions from Soredex To maintain low EMC emissions that conform with the MDD it is mandatory to use a shielded CAT6 Ethernet cable between the unit and the network If this device will be used with 3rd party imaging application software not supplied by SOREDEX the 3rd party imaging application software must comply with all local laws on patient information software This includes the Medical Device Di rective 93 42 EEC and or relevant legal require ments in the USA Do not connect any equipment to the unit that has not been supplied with the unit or that is not recommended by SOREDEX The use of accessory equipment not complying with the equivalent safety requirements of this equipment may lead to a reduced level of safety of the resulting system The aperture plate and tubehead housing are made of lead Pb which is a toxic material Do not touch these parts with your bare hands User s Manual 207301 SCANORA 3Dx 8 Warnings and precautions User s Manual 207301 77 SCANORA 3Dx Appendix A Technical Data Appendix A Technical Data A 1 Technical specifications Type SBR3D 2 Classification IEC 60601 1 1988 and A1 A2 IEC 60601 1 4 1996 and A1 IEC 60601 2 7 1998 IEC 60601 2 28 1993 IEC 60601 2 32 1994 IEC 60601 2 44 2001 and A1 IEC 60601 1 3 1994 IEC EN 60601 1 2 2001 and A1 UL 60601 1 2003 CAN CSA C22 2 No 601 1 M90 and 51 2 standards Com
36. fy image qual ity These original QA images together with image parameters and viewing information are stored ina patient card opened specifically for these images The QA images taken during the following QA pro cedure can be compared with these original QA images to check image quality and monitor changes in image quality User s Manual 207301 SCANORA 3Dx 6 Quality assurance 6 1 The 3D QA procedure Starting the QA procedure 1 Push the forehead support locking lever up and remove the forehead support Close the head support rotate it towards the chair and lock it in position with the head sup port locking lever 3 Rotate the head support adjusting knob until the head support is in the mid point of its travel There is a slight resistance when you reach this point o User s Manual 207301 49 6 Quality assurance SCANORA 3Dx 4 Restart the system as described in section 3 1 Preparing the system IMPORTANT NOTE When the system is ready the head support will be in the mid point of its vertical travel During the QA test procedure DO NOT use the head support height adjusting keys on the remote control nor the head support adjusting knob to adjust the position of the QA phantoms cC BAN To adjust the position of the phantoms ONLY use the Seat Height adjusting keys and the Field of View positioning keys on the remote control to adjust the position of the QA phan toms PC Open
37. head this will place the boundary between the two large FOV images in an area away from the crowns St M M L XL XL User s Manual 207301 25 3 Taking an exposure 23 22 SCANORA 3Dx The sagittal light vertical front light indicates the center of the FOV in the sagittal direction Press the left right field of view positioning keys to position the sagittal light so that it is in the center of the ROI you wish to examine lt gt The lateral light vertical side light indicates the center of the FOV in the lateral direction Press the forwards backwards field of view positioning keys to position the patient so that the lateral light in the center of the ROI you wish to examine If you are taking a scout view the sagittal light and the lateral light indicate the center of the scout view viewed from the front and from the right hand side of the patient respectively User s Manual 207301 SCANORA 3Dx EAD Aa User s Manual 207301 24 3 Taking an exposure CAUTION Small FOV exposures If you are going to take an exposure of the ante rior tip of the chin using the small FOV the pa tient must be positioned as far back as possible If you are NOT using the forehead support you may have to tilt the patients head down slightly so that the sensor will not touch the back of the patient s head during the exposure It is recommen
38. lane is parallel to the horizontal light 19 Now position the patient for the exposure you wish to take If you are taking a panoramic PAN exposure press the seat height adjusting keys and posi tion the patient so that the horizontal light is under the patient s chin If you are taking a tem poromandibular joint TMJ exposure position the patient so that the light is under the lower lip User s Manual 207301 SCANORA 3Dx I User s Manual 207301 20 21 22 3 Taking an exposure Check the position of the midsagittal light If it is not on the midsagittal plane of the patient press the left right field of view positioning keys to position the light correctly Make sure that the patient s head is not turned or tilted to one side Push the temple supports towards the patient so that they are positioned on both sides of the patient s head Carefully rotate the temple sup port knob to close the temple supports so that they grip the patients head The focal trough light indicates the center of the focal trough which is approximately 10 mm wide at the front Press the forwards backwards positioning keys and position the focal trough light in the middle of the patient s upper canine IN 3 Taking an exposure 23 24 SCANORA 3Dx This position is used for both panoramic and temporomandibular joint exposures If necessary readjust the tilt o
39. may not be working Either the Ethernet cable between the unit and the PC is not connected or the PC has not been switched on Reconnect the Ethernet cable or switch the PC on to clear the message Check the image to see if it is sufficient for the diag nostic task If not take another image User s Manual 207301 43 4 Messages and error codes SCANORA 3Dx See if the image can be retrieved using the Retrieve last image option If not take another image NOTE This message will also appear if the hardware key dongle used for software protection has been re moved from the PC s USB slot owitch the system off and then on again If the mes sage reappears call service for help The exit button was pressed before the images could be processed The preview image s can be retrieved from the imaging software owitch the system off and then on again If the mes sage reappears call service for help User s Manual 207301 SCANORA 3Dx 4 Messages and error codes The movement of the rotating unit was interrupted during the exposure Determine and remove the reason for the interrup tion and then take another image The panoramic detector was moved during an expo sure Check the image to see if it is sufficient for the diagnostic task If not take another image 4 2 Error codes lf an error code appears switch the unit and PC off and then restart the unit and PC If the error message reapp
40. n Displays the GUI language options _ IB Touch the language button to select the language _ you require 5 2 Software settings User s Manual 207301 Refer to the User s manuals supplied with the ware 6 Quality assurance SCANORA 3Dx 6 Quality assurance The quality assurance QA procedures for checking 3D and panoramic optional image quality must be carried out at regular intervals in accordance with local and national regulations related to the use of 3D and panoramic x ray equipment Also follow local and national regulations concerning the evaluation of image quality of 3D and panoramic x ray equipment Also follow any regulations on how to take examine interpret and store test images Store the 3D and panoramic images produced during the QA procedures in a patient card opened specifically for QA images There are three steps in the 3D quality assurance procedure Geometry calibration checks the rotation geom etry Pixel calibration checks the sensor and Quality check checks the density values and also allows you to check the positioning lights All the QA steps must be carried out and they must be carried out in the order in which they are listed above For the optional panoramic quality assurance a sin gle image is used to check the image quality IMPORTANT NOTE When the unit was installed a series of 3D and pan oramic QA images were taken to veri
41. nd pin and the left hand pin to the ball must be the same within 0 5mm Unexposed edge around the image Without using the magnification tool you must be able to see an unexposed white border around the image User s Manual 207301 SCANORA 3Dx User s Manual 207301 min 6 Quality assurance Homogeneity of the image 19 The whole image should be homogenous and artifact free no lines bands or speckling PASS If the quality of new QA image matches the qual ity of the original QA image the unit has passed the panoramic image quality check FAIL If the quality of the new QA image does not match the quality of the original QA image the unit has failed the test Repeat the test If it fails a second time call service Save the new QA image in the patient card specifically opened for it and then touch the Exit button to exit the test 7 Care maintenance and disposal SCANORA 3Dx 7 Care maintenance and disposal 7 1 Cleaning and disinfecting the unit Warning Switch the unit off before cleaning it If you use a spray cleaner do not spray into any ventilation grills Unit surfaces and upholstery All surfaces can be wiped clean with a soft cloth dampened with a mild detergent DO NOT use abra sive cleaning agents or polishes on this equipment Positioning light covers The positioning light covers are made of clear plastic Use a soft cloth dampened with a mild de tergent
42. ntraoral radiographic im ages bitewing exposures would suffice Note that cone beam computerized tomography im ages are not adequate for the analysis of soft tissue USA only Caution Federal law restricts this device to sale by or on the order of a dentist or other qualified profes sional User s Manual 207301 1 1 Introduction SCANORA 3Dx 1 3 Imaging programs 3D programs The following 3D images can be taken using either standard or high resolution 50 50 mm height x diameter small 5 FOV Field Of View 50 100 mm small plus S FOV 80 100 mm medium FOV 80x 165 mm medium plus M FOV 140 x 100 mm large L FOV 140 x 165 mm large plus L FOV Optional 3D programs 180 x 165 mm extra large XL FOV 240 165 mm extra large plus XL FOV For the optional XL and XL images two 3D im ages are taken and then combined stitched to form a XL or XL image Scout programs Scout programs take single exposure image s that can be used to verify the position of the 3D image before it is taken The scout programs can take a lateral image Lat or a anterior posterior AP image or both a lateral and anterior posterior image The sizes of the scout images height and width correspond to the sizes of the 3D image height and diameter except for the optional XL and XL FOVs where the scout images are of the lower part of the 3D image only 2 User s Manual 207
43. older User s Manual 207301 SCANORA 3Dx 6 Quality assurance 12 Place the panoramic ball and pin phantom on to the adjustable phantom holder and then place the test tool line pair phantom on top of pano ramic ball and pin phantom 13 Press the Return key to drive the unit to the ready position 14 Press the lights key to switch the patient posi tioning lights on User s Manual 207301 63 6 Quality assurance SCANORA 3Dx 15 Use the Field of View positioning keys on the remote control to position the test tool so that the focal trough light strikes the middle of the clear plastic layer sandwiched between the two aluminium layers Use the Seat height adjusting keys ONLY to position the horizontal light so that it strikes the lower edge of the ball and pin phantom The midsagittal light beam should strike the mid dle of the test tool the x axis position displayed on the control panel should be 0 NOTE If the midsagittal light beam does not strike the middle of the test tool carry out the 3D geomet ric calibration procedure to realign the unit Protect yourself from radiation by standing be hind a suitable x ray radiation shield Press and hold down the exposure button The exposure will last about 15 seconds e 17 Click the Abort Capture button User s Manual 207301 SCANORA 3Dx 6 Quality assurance An image of the test tool and the panoramic ball pin
44. phantom will appear on the unit display and then the PC lt 2014200226 A 33033 Gyan 18 Open the original QA image that was taken when the unit was installed S seni BAO Use the Image Control tools to adjust the brightness contrast and gamma correction lev els of the image just taken so that they are the same as the levels recorded on the original QA image Select the linear histogram before mak ing adjustments When the levels are the same compare the im age quality of the new QA image with the origi nal QA image taken during installation User s Manual 207301 65 6 Quality assurance SCANORA 3Dx The new QA image must meet the following requirements Minimum high contrast requirement A 2 5 LP mm all 3 lines must be visible Minimum low contrast requirement B 2 holes minimum must be visible Grayscale value C Position the cursor on the largest hole and then read the I Original pixel value bottom right hand corner of the display Now compare it to the same value recorded on the original QA im age taken during installation The value should be the same 20 Ball pin phantom dimensions Use the measuring tools to check the new QA image and compare it to the original QA image The ball in the center must be round and the dis tances from the right ha
45. plies with DHHS 21 CFR Chapter Subchapter J at the date of manufacture Performance Standards and European Union Directive 93 42 EEC Medical De vices Directive Class 12 Safety according to IEC 60601 1 Protection against electric shock Class 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 cone beam 3D x ray unit that generates 3D images and Panoramic Optional images The image receptors are an amorphous silicon flat panel sensor for cone beam 3D images and an Optional CCD sensor for panoramic images Appendix A Technical Data SCANORA 3Dx X ray generator wee 3D image Fixed anode eeror FOCAL SPOT 0 5 mm 90 TARGET ANGLE 4 15 TARGET MATERIAL Tube cea optional OPERATING TUBE POTENTIAL 3D imaging 90 kV 5 kV Panoramic Optional imaging 60 81 kV 5 kV OPERATING TUBE CURRENT AVERAGE 3D imaging 0 9 2 3 mA 40 5 Panoramic Optional imaging 4 8 mA 1 mA NOMINAL ANODE INPUT POWER 648 W nominal at 81 kV 8 mA
46. plus FOV NOTE For the optional extra large FOVs the unit will take two large FOV images and then combine stitch them to form a single extra large FOV image 5 Select the 3D image resolution Standard resolution 1 High resolution 3D BEEN or the Scout image s Press the scout button repeatedly to scroll X through the three scout image options lateral M Lat anterior posterior AP or lateral plus anterior posterior Lat AP The option and size of the selected scout image will appear on the information window NOTE It is recommended that a scout image or im ages are taken before the 3D image is taken to ensure that the region of interest ROI you wish to examine is correctly positioned within the 3D field of view FOV User s Manual 207301 19 3 Taking an exposure SCANORA 3Dx 10 mA 6 Select the mA BE T CAUTION When taking an exposure of a child use the lowest possible mA that will allow you to take an image of sufficient quality for you to perform the required diagnostic examination 7 Slide the forehead support into the two holes in the chin rest and then push the locking lever down to lock the forehead support in position om e 7 A fim T Release the head strap 20 User s Manual 207301 SCANORA 3Dx 3 Taking an exposure 8 Rotate the temple supports knob to open the temple supports as far as they will go and then
47. r with their back pushed against the backrest Also make sure that they are sitting in a position in which they feel comfortable With small patients and children use cushions to position the patient at the right height 3 Taking an exposure SCANORA 3Dx If the patient is very large and cannot sit com pletely on the seat or is small and cannot sit back far enough adjust the forward backward position of the backrest with the knob at the rear of the seat Wheelchair patients Adjust the height of the unit chair so that the seat is level with the wheelchair seat or as near as possible at the same level Position the patient in the wheelchair as close as possible to the left hand side of the unit chair with the patient facing forwards Ask the patient to put the wheelchair s brake on so that wheelchair cannot move Make sure that the left hand arm rest of the unit chair is in the raised position Manually rotate the rotating unit so that the detector head is at the front This will make it easier for the patient to enter the unit Ask the patient to remove or lower the armrest on the right hand side of the wheelchair Ask the patient to slide from the wheelchair onto the unit chair When the patient 1 in the unit chair lower the left hand chair armrest Remove the wheelchair from the unit environ ment NOTE After taking the exposure repeat the above procedure in the reverse order to get the patient back into
48. re Optional 1 PC Open a new or existing patient or select a patient from the work list Refer to the SCANO RA Workstation software users guide for infor mation on how to do this 2 PC Click the Image Capture button S 3 Touch the Panoramic button to select the Pano ramic program mode The button will change color 4 Select the panoramic program you wish to use adult panoramic child panoramic _ temporomandibular joints TMJ Partial adult or child panoramic exposure Touch the partial panoramic segments to disable those that you do not wish to expose the seg ments will change color 32 User s Manual 207301 SCANORA 3Dx User s Manual 207301 3 Taking an exposure NOTE The images produced by selecting the rear two segments from the partial panoramic program are not the same as those produced by the dedi cated TMJ program The TMJ program images have a different pro jection and are wider than the partial panoramic images Select the kV and mA CAUTION When taking an exposure of a child use the low est possible kV 67kV recommended and mA 4 5 3mA recommended that will allow you to perform the required diagnostic task Pull the forehead support locking lever up and remove the forehead support 3 Taking an exposure 1 8 Turn the head support locking lever to the left SCANORA 3Dx Rotate the temple supports knob to open the
49. re that patient can be positioned correctly in the unit Always use the lowest suitable x ray dose to obtain the desired level of image quality Avoid taking x ray exposures of pregnant wom en When taking an x ray exposure of a child always use the lowest possible x ray dose the small est possible image area and the lowest possi ble resolution that will allow you to perform the required diagnostic task 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 Always use disposable protective covers with the chin supports chin rests and bite pieces Disinfect all the surfaces that the patient is in contact with after every patient Crushing Danger The up down chair movement is only safe if the area around the chair is clear of foreign objects that could become trapped un der the edges of the chair Before using the unit remove all foreign objects for example drawers wheel chairs stools etc from around the chair to avoid damage to the unit or injury to people User s Manual 207301 SCANORA 3Dx User s Manual 207301 8 Warnings and precautions If the patient moves during the exposure and or the imaging procedure is incorrect or incorrectly set up for the required examination and or the unit is not correctly maintained the accuracy of and measurement taken from the resulting
50. ry out the quality check 56 User s Manual 207301 SCANORA 3Dx 6 Quality assurance Quality Check 1 Place the QC phantom on the adjustable phan tom holder Make sure that the pin in the base of the quality assurance phantom goes into the middle hole in the adjustable phantom holder 2 Press the Return key to drive the unit to the ready position 3 Press the lights key to switch the patient posi tioning lights 4 Aswith the geometry calibration test use the seat height adjusting keys and the field of view positioning keys on the remote control to adjust the position of the QC phantom Position the patient positioning lights so that they coincide with the vertical and horizontal lines marked on the phantom User s Manual 207301 57 6 Quality assurance SCANORA 3Dx 5 Touch the Quality Check button to select the test 6 Protect yourself from radiation by standing be hind a suitable x ray radiation shield Press and hold down the exposure button until the exposure is complete this will take about 15 seconds 7 After the exposure it will take approximately three minutes for the image to be reconstructed When reconstruction is complete the image will appear briefly on the unit display and then the PC Open the 3D viewing software and then Dual passed open the quality check image Scroll through the quality check image the cylindrical 3D volume until you see the word
51. t image or scout images the rotating unit will either take a single image from the side lateral or a single image from the rear anterior posterior or two images one from the side and one from the rear If you are taking a S S M Lor L 3D im age the rotating unit will rotate around the pa tients head once and then stop User s Manual 207301 SCANORA 3Dx v 194 gt lt E a m 8 Lj bw e i f A a User s Manual 207301 27 3 Taking an exposure If you are taking an XL or XL 3D image the ro tating unit will rotate around the patient s head take the first half of the image the bottom half and then stop The chair will then automatically descend and the rotating unit will then rotate around the patient s head in the opposite direc tion and take the second half of the image the top half When the audible signal stops and the exposure warning symbol disappears from the touch con trol panel the exposure has been taken It will take 1 to 5 minutes to process and transfer the 3D image to the PC After transfer open the image window and double click the 3D image to open it IMPORTANT NOTE XL and XL FOVs If the patient moved between the first and sec ond exposure or if the boundary between the two large FOV images is not clearly defined e g too many metal artifacts the software may not be able
52. that the unit movements do not operate Yearly maintenance Once a year an authorized service technician must carry out a full inspection of the unit During the inspection the following tests will be carried out a kV mA test a check that the safety ground is connected a check that the positioning lights operate a check that oil is not leaking from the tube head a check that all covers and mechanical parts are correctly secured and have not come loose A full description of all the tests and checks is de scribed in the Service Manual 7 Care maintenance and disposal SCANORA 3Dx 7 3 Disposal 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 circuit boards TUBEHEAD
53. the duration of the exposure The exposure starts when you hear the expo sure warning signal and the exposure warning indicator appears on the control panel The rotating unit will rotate around the patients head and take the exposure When the exposure warning signal and rotating unit stop the expo sure has been taken A preview image will appear on the unit control panel Touch the OK key After the image appears on the PC display press the Return key to drive the rotating unit to the ready position Drive the chair to its lowest position open the head support and guide the patient out of the unit 3 Taking an exposure SCANORA 3Dx 30 PC The panoramic image can be examined us ing the SCANORA workstation software Refer to SCANORA workstation software user s manual 31 PC Click the Abort Capture button when you 7 have taken the necessary images or Touch the End study button to finish the exami nation 3 4 After use When the unit is not being used rotate the head support to the closed position and lock it in position with the head support locking lever 42 User s Manual 207301 SCANORA 3Dx 4 Messages and error codes 4 Messages and error codes 4 1 Messages The SCANORA Workstation software in the PC has not been opened Open the program to clear the message NOTE If the unit is connected to the PC through a router this message indicates that the router is working but the PC
54. the wheelchair User s Manual 207301 SCANORA 3Dx 3 Taking an exposure 14 Carefully rotate the head support towards the 15 ee User s Manual 207301 patient until it stops Turn the head support lock ing lever to the right to lock the head support in position Rotate the head support positioning knob to position the head support so that the patient can place their chin on the chin rest and bite the bite block or press their lips against the lip holder or lip support o If you are using the lip holder or lip support ask the patient to position their front teeth so that the front edges are touching Press the light key to switch the patient position ing lights on NOTE If the patient positioning lights do not come on the rotating unit is not in the panoramic ready position To switch the lights on press the return key to drive the unit to the panoramic ready position and then press the light key to switch the patient positioning lights on again 3 Taking an exposure Y SCANORA 3Dx 17 The horizontal light indicates the bottom of the panoramic and TMJ fields However the light can also be used to position the Frankfort plane Press the down seat height adjusting key and position the patient so that the horizontal light is approximately level with the Frankfort plane 18 Press the head support up down keys to adjust the tilt of the patient s head until the Frankfort p
55. to properly combine the two images into a single XL or XL 3D image If this is the case two separate XL or XL 3D images will be produced 3 Taking an exposure S SCANORA 3Dx If the boundary between the XL and XL 3D images is not clearly defined but the software is able to combine the two 3D images the dimen sional accuracy across the boundary area may be reduced NOTE If you took a scout image it will take 10 20 sec onds for the image or images to appear on the unit control panel If the FOV is NOT positioned correctly touch the OK key on the image display reposition the patient and take another scout image If the patient is positioned correctly touch the OK key and then select the resolution you re quire and take the 3D image press the Return key to drive the rotating unit to 28 After the 3D image appears on the PC display the ready position Drive the chair to its lowest position open the head support and guide the patient out of the unit User s Manual 207301 SCANORA 3Dx User s Manual 207301 3 Taking an exposure 30 PC The 3D image can be examined using the 3D imaging software Refer to the documentation supplied with the 3D imaging software PC Click the Abort Capture button when you have taken all the required images Touch the End study button to finish the exami nation 3 Taking an exposure SCANORA 3Dx 3 3 Taking a Panoramic exposu
56. urer s declaration electromagnetic immunity The SBR3D 2 is intended for use in the electromagnetic environment specified below The customer or the user of the SBR3D 2 should assure that it is used in such an environment Immunity test IEC 60601 test level Conducted RF IEC 61000 4 6 Radiated RF IEC 61000 4 3 3 80 MHz to 2 5 GHz Compliance Electromagnetic environment guidance Portable and mobile RF communications equipment should be used no closer to any part of the SBR3D 2 including cables than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter Recommended separation distance d 212XP d 1 24P 80MHz to 800 MHz d 2 34P 800 MHz to 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 Field strengths from fixed RF transmitters as determined by an electromagnetic site should be less than the compliance level in each frequency range Interference may occur in the vicinity of equipment marked with the following symbol gt NOTE 1 At 80 MHz 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 fix
57. ut lines 1 kV differential mode 2 kV common mode 5 gt 95 dip in for 0 5 cycle 40 Ur 60 dip for 5 cycles 70 30 dip in for 25 cycles 5 gt 95 dip in for 5 sec 6 kV contact 8 kV air 2 kV for power supply lines 1 kV for input output lines 1 kV differential mode 2 kV common mode 5 gt 95 dip for 0 5 cycle 40 Ur 60 dip in UT for 5 cycles 70 9o 30 dip in for 25 cycles 5 gt 95 dip for 5 sec Floors should be wood concrete or ceramic tile If floors are covered with synthetic material the relative humidity should be at least 30 Mains power quality should be that of a typical commercial or hospital environment Mains power quality should be that of a typical commercial or hospital environment Mains power quality should be that of a typical commercial or hospital environment If user of the SBR3D 2 requires continued operation during power mains interruptions it is recommended that the SBR3D 2 be powered from an uninterruptible power supply or a battery Power frequency magnetic field should be at levels characteristic of a typical location in a typical commercial or hospital environment NOTE Ur is the AC mains voltage prior to application of the test level A 11 Appendix A Technical Data SCANORA 3Dx Guidance and manufact
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