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CRANEX 3D

1. TIME min Fig 7 2 Maximum Rating Charts Absolute maximum rating charts DC Center Grounded Focal Spot 0 5 mm 25 80kV 70kV 60kV 20 50kV TUBE CURRENT mA an no 3 5 7 10 NO eo EXPOSURE TIME s Fig 7 3 Te SOREDEXR 206718 rev4 206718 rev 4 7 Technical data TUBE HOUSING ASSEMBLY COOLING CHARACTERISTICS Fig 7 4 HEAT UNITS SOREDEX ARE PRCEEEELELE TSEC CAPES 0 120 150 180 TIME IN MINUTES 113
2. 206718 rev 4 SOREDEX 17 2 Unit description 2 5 2 Cephalometric programs Cephalometric programs provide central projection images of patient skull and dental anatomy Images are utilized in ortodontics and general diagnostics Full size lateral Magnification 1 15 Field size 22 x 26 cm height x wide Lateral Cephalostat uses a full height image field Reduced size lateral Field size 22 x 18 cm height x wide A Reduced Width Lateral program has an optimized image width that is used e g for pediatric patients but also adult patients to reduce the radiation dose SOREDEX 206718 rev 4 206718 rev 4 2 Unit description Cephalometric posterior anterior PA Magnification 1 15 PA 22 x 20 cm height x wide Carpus view Not in USA and Canada and Canada M SOREDEX 19 2 Unit description 2 5 3 3D programs F J Cone beam 3D imaging enables seeing dentomaxillofacial anatomy of selected Field of View FOV helping with diagnostics and treatment planning With 3D viewing software user is able to analyze FOV area from multiple directions and see cross sectional images from the area of interest XS FOV 61 x 41 mm height x diameter w LY High resolution t Standard resolution Midi size FOV 61 x 78 mm OPTIONAL Standard resolution or High resolution m High resolution z Standard resolution 2 5 4 Exposure settings for 3D imaging 20 SOREDEX
3. 4 5 3 Scout image WARNING Close the patient positioning mirror before taking any exposures 1 Press and hold down the exposure button During the exposure you hear an audible signal and the exposure warning symbol on the ClearTouch M control panel appears 2 Scout preview image appears to the ClearTouch control panel 3 Fine adjust scout position using the side arrow keys Press the left lower corner icon to continue C 206718 rev 4 SOREDEX 65 4 Using the unit 4 Take anew scout or save current and continue to 3D image 5 Previous FOV position is shown as gray circle and new position is showed as green circle NOTE Gray circles remain in control panel until you change the patient 66 SOREDEX 206718 rev 4 4 Using the unit 4 5 4 3D image 1 Select the Standard mw OF High resolution L 2 Select mA P el S Ree j o 0 mA 380 7 se yem b L 9 mm WARNING Close the patient positioning mirror before taking any exposures 3 Press and hold down the exposure button During the exposure you hear an audible signal and the exposure warning symbol on the ClearTouch M control panel appears 206718 rev 4 SOREDEX 67 4 Using the unit 68 4 6 Warnings and error messages The unit responds to error situations by showing a dialog box containing an error code and descriptive text on the touch screen When an error code appears on the
4. 101 7 Technical data 7 2 Unit dimensions iw ok TE H N LI NL ws LES _ T S D T TUE ug ul EU j Ud IH ola L ij d H oO e dean lo oO m ee Oo z LO t FEEL te u C hmm E t j f x A ies N me O0 hide eo oO eo 7 L u Lu t To co d E 2 8 ib amp 0 S E Ea ES ce OO o 2000 78 7 1518 59 7 483 19 T Hi 1385 54 5 1425 56 965 38 102 SOREDEX 206718 rev 4 7 Technical data 7 3 Symbols that appear in the unit AN Radiation warning h Dangerous voltage On or enabled Q Off or disabled Connector for remote control ail Exposure switch Connector for Ethernet RJ45 Connector for exposure switch gt Connector for external exposure light N Attention consult accompanying documents 206718 rev 4 SOREDEX 103 7 Technical data l Ground Functional Protective ground CLASS 1 LASER PRODUCT Laser class label EN 60 825 1 A2 2001 Patient positioning lights and must be collected separately Please contact an authorized representative of the manufacturer for information concerning th decommissioning of your equipment This symbol indicates that the waste of electrical and electronic equipment must not be disposed as unsorted municipal waste Type B equipment CE 0537 symbol MDD 93 42 EEC C Q they ETL
5. Resulting from the each calibration is an image containing calibration results telling the operator how to proceed with the calibration and adjustment procedure In addition to the calibration name e g Adjustment panCol the images contain image data sampled during the calibration SOREDEX 77 6 Maintenance adjustment instructions and a Passed Not Passed Failed calibration status Passed means that the calibration program is successfully done Move on to next calibration Not passed means that adjustment is still needed Follow the instructions contained in the image if any and take another exposure Some calibration programs are iterative and demand a few repetitions Failed means that the system could not decide what adjustment should be done in order for the calibration to succeed This calibration status is always the result of some error condition Contact service if the problem persists after restarting the unit and PC 6 1 2 Preparing for calibration 1 Close the head support and lock it in its upmost position 2 Switch the PC and unit on 3 PC Open the dental imaging sofware and then open a patient card and give it and identfiable name for example calibration refer to the users manual supplied with the dental imaging software for more information a 4 PC Click the image acquisition button to activate he w image capture e 5 Touch Settings on the Touch screen display Qua
6. TID ie QAIBUS qe CORN ABACK 206718 rev 4 trough set too far anterior 2 Image layer laser light not obeyed 3 Bite block was not used SOREDEX Remedy 1 Check patient positioning with laser light lines and occlusion correction buttons Check patient positioning with laser light lines and occlusion correction buttons Insert bite block Remedy 1 Check patient positioning with laser light lines and occlusion correction buttons Check patient positioning with laser light lines and occlusion correction buttons Insert bite block 69 5 Troubleshooting Problem opposite Ramus widths are different on opposite sides Problem exposed over maxillary molars Row of teeth has a wavy appearance TM joints are exposed outward Image is not smiling Mandible is imaged sharper than maxilla Problem upwards Mandibular incisors are unsharp TMJ joints exposed high and are often cut off from the image Image is smiling too much 70 Possible cause Teeth appear wider on one 1 Midsagittal line not obeyed side and narrower on theo Patient s head not in center Possible cause The shadow of hard palate is Patient head tilted back Possible cause Rows of teeth curved Patient head tilted forward Remedy 1 2 Check patient s mid sagittal plane with laser light line Check that patient s head is centered and that the head support side clamps where
7. Tube head assembly Tube head assembly THA 300 type Tube type Toshiba D 052SB D 054SB C Stationary anode Tube voltage 57 90 kV Max electric output 1 44 kW Focal spot 0 5 x 0 5 mm IEC 336 1982 Nominal anode input 1750 W Reference axis In the middle of the panoramic sensor s active area Max anode heat content 35 kJ Max X ray tube 385 kJ assembly heat content Max continuous heat 38 W dissipation of the X ray tube assembly 92 SOREDEX 206718 rev 4 7 Technical data Tube head assembly Total filtration gt 3 2 mm Al Leakage Technical 90 kV 4 mA Factors Nominal mains voltage Input power frequency Nominal current Fuses 230 Vac Littelfuse 326 slow blow 10A Cooper Bussman time delay MDA 10 110 Vac Littelfuse 326 slow blow 15A Cooper Bussman time delay MDA 15 Power consumption 2 3 KVA 230 VAC 1 65 kVA 110 VAC Maximum impedance of 0 2 Q main Positioning laser lights Panoramic TMJ amp laser light CLASS 1 LASER Maxillary Sinus Programs PRODUCT max output 100uW Cephalostat FH laser light Warning symbols are placed next to 3D imaging programs the laser lights and the label describing the laser light classification is placed inside the carriage side cabinet USA Canada models have different types of laser light stickers according to local requirements Caution use of controls or adjustments or performance of procedures other than those specified herein m
8. closed to keep the head straight Remedy Check FH plane Remedy Check FH plane 206718 rev 4 5 Troubleshooting Problem Possible cause Remedy Middle area of the image too Patient s neck was not otretch patient s neck bright and unsharp Spine stretched shadow Vm Pu e CE Y c Es 2 ANECK Problem Possible cause Remedy Black shadow over maxillary Tongue was not against the Ask patient to swallow and teeth apex area roof of palate place tongue against the roof of palate during the exposure Problem Possible cause Remedy TMJ s exposed on different 1 Patient tilted to one side 1 Check midsagittal plane and heights on image Bilateral center patient s head M 2 Midsagittal laser light line distortion in molar and premolar not obeyed 2 Check midsagittal plane and regions center patient s head Problem Possible cause Remedy Rows of teeth exposed too 1 Chin was not resting on chin 1 Check patient positioning high TMJ s cut off support and type of bite rod 2 Patient positioned too high 2 Check patient positioning and type of bite rod Problem Possible cause Remedy Rows of teeth exposed too low Chin rest was not used with bite Install chin rest Mandible not exposed rod completely to the image 206718 rev 4 SOREDEX 71 5 Troubleshooting 5 2 Image appearance Problem Possible cause Remedy Images are too light 1 SCANORA software 1 Adjust contrast and Contrast and brightness not b
9. 2 5 2 GepnaloiTielric progi aNG uu iioiest ete eit rhoset e iota N tese ia M roto NNa 18 ZPSEOMESIBNelfeol cR TT UU TS 20 2 5 4 Exposure settings for 3D imaging cccsccccseeecseeeeeeeeceeeeseeeseneeeseeesaees 20 3 Controlling the Unit ccc antec chess teo ae ewes reece eR bi oxucUau Riu tasas ees c tu et coe ta e deci curre iR WU ele a 23 3 1 Clear Louch control Dallebanesndased odes feti tapete N 23 32 Modalty Secho eee ara re nn ce nner Dn a Ne TR 24 33 sie iine Em 24 3 4 Automatic Exposure setting AES cccccsccccssecceeeeeceeeecsssesseseeseusesseeeesseneeees 25 3 4 1 AES values for Panoramic IMAQING cccseseeceeeecseeeeeseeeseeesseeeeseeeeeas 25 3 4 2 AES values for Cephalometric imaging eeeeseeeeeses 26 3 4 3 Exposure indicators and settings ceeeseeeerneeeeee 27 S oleis c M 27 SN MGE if HEN 28 MEE hebur i em M M 29 4 1 Attaching and removing the SENSOL cccccsceceeccceeeeceeeeceeeeceeeeeeeseueesseeeseneess 29 2 1 1 JAUacnirig te SellSOF xemeresvavsuedotasezecs evo vites upto asso oc veto did up a eda doge iu dd ep e Das 29 4 1 2 Removing ING SCNSOM sod erereso ctun Ede bi pap ea adeoque rre oic rufa ed edit in 30 4 2 TreDabi g iesyS IO Tli se adt ecards A eruta Varta dapes 30 T3 Panoramie CX DOSUNC Sei sr tnchay th eanas anne Dated a EM
10. 60 45 2 General MSC ONS costas rt En a Der Ple pt Um EC PI eed SERA frd Lite aas 61 A530 SCOUL IMAG C contenute teite dtd bbc dtd eds Ur MO odassutubntus 65 dud 39 DAdeeiascdpe deduc Edad M dM DRIN REMO reer er tenner er Spare NEM UN are 67 4 6 Warnings and error messages ssessssseeeeeee nennen nennen nennen nna nnne nnn 68 4 5 1 sACKMOWICGGING ENO S ara a eade a esr umdat uie etudes 68 4 6 2 Image trarisfer GITO S e ipea tcu iro aes Se io nua no Lev Dx deret td o vi o eb Du dua 68 A HORI IES MO OMI ERN TTE EST D 69 Si Vues mr 69 52 Image apDDegsl ANCES siio career tua Ceo dco tnr e UR m e bep enacted eee eaten 72 So dPidc ecMeec ted 73 IA MIE OMe cei RENTEN UU LM 15 Aurigiiispe teeee e et 77 6 1 Maintenance prOCegdUle uc eiie e ii e ener eene ix pnto dine sud tuae eer tepus 77 6 11 Performing calra NS socio rera du vay eee doa d doy caveant vea had pa ovata 7 6 1 2 Preparing for CalIDEATOELIS ciens ec p duda Chad bd dup e ebat oss esed er oa ocean 78 6 1 3 Panoramic calibration and quality CNECK ccccccecseecceeeseeeeneeeeseeeeneees 79 6 1 3 1 Panoramic geometry calibration ccccecccsseeeceeeeeeeeseeeeeeeeesees 7 9 6 1 9 2 Panoramic pixel CallbEatlQlT suede sidus a ep bei vetu 80 6 1 3 3 Panoramic Quality Check OPTIONAL 81 6 1 4 3D calibration and quality check cccccccccseceeseeeeeseeeseeeeeseeeeseeeesaaeees 81 6 1 4 1 3D geom
11. Also we recommend that a qualified serviceman to check the unit to be in its original condition regarding electrical radiation and mechanical safety according to our maintenance program described in more details in maintenance manual every year or after 2000 images For more information please contact your local dealer According to EN61223 3 4 and DIN 6868 151 If service on the unit is performed a work order describing the type and extent of repair must be provided by the service technician This must contain information of changes of nominal data or work range performed The work order must furthermore indicate the date of repair the name of the company concerned and a valid signature User should keep this work order for future references 6 SOREDEX 206718 rev 4 2 Unit description 2 1 Main parts and controls Column Carriage Main support Rotating unit On off switch rear of column and main fuses Tubehead assembly niM ClearTouch control panel O N O A A CQ N Positioning panel 9 Sensor head 10 Head support 11 Chin rest 12 Handles 13 Cephalometric unit 14 Cephalometric sensor 15 Secondary collimator 16 Positioning panel 206718 rev 4 SOREDEX 2 Unit description Fig 2 1 On off switch and main fuses PC with MDD approved dental imaging software and 3D viewing software All software must conform to the MDD and the relevant legal requirements in the USA 8 SORE
12. all laws and regulations that have jurisdiction of law within the jurisdiction on which the unit is Examples of cleaning agents that are allowed or prohibited when cleaning the unit Allowed Methanol metyl alcohol Soap lsopropyl alcohol distilled water Not allowed Bentzene Chlorine bentzene Acetone Acetic ether agents containing phenol paracetic acid SOREDEX 87 6 Maintenance 88 peroxide and other oxygen cleaving agents hypochlorite and iodine cleaving agents SOREDEX sodium 206718 rev 4 206718 rev 4 6 Maintenance 6 4 Disposal 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 disposed of in accordance with all local national and international regulations regarding the disposal of non environmentally friendly or hazardous materials The locations of all parts can be found in the chapter 2 1 Main parts and controls Unit has at least the following parts that should be regarded as nonenvironmental friendly waste products Tubehead Pb Collimator Pb All electronic circuits Sensor covers EMC painted SOREDEX 89 6 Maintenance 90 SOREDEX 206718 rev 4 7 Technical data 7 1 Technical specifications Manufacturer SOREDEX PaloDEx Group Nahkelantie 160 P O Box 20 FIN 04300 Tuusula FINLAND Quality system In acc
13. bea od dud VD Su EO eE d MM 31 A Sel POSIMOMINGACVICCS asmina tuebitur ide oben Beto Pert dd Lu Tuba ero d AEOE Us 31 49 2 General INSUWUCTIONS eed oct ease epe TutoDu ed vo vat vu eV Poo Feliu bes e peor iv ri Ep UE 32 2 9 9 Pallet DOSIUORIiO eos r eta ideiunub Salue eben duo tadis sEvea UC o int A tuse bu dua 34 4 3 3 1 Panoramic exDOSUFG ui iidem ES eno t kc ated x vata ias 34 29 992 VIVIHOXDOSLIFO sorra e tuae Cod tud deuote tu adus 38 4 3 3 3 Maxillary Sinus CXPOSULEC ccccceecccseeeceseeeceeeseceseeeeeeeessaneeeas 41 4 3 4 TAKING ine exDOSlllOsccssuneidcrxt ccnepa und und ebuau tui cu aed aede dide i aba died 43 44 Cephalometric exposure Siea tu Hem t o patie tes tee einbauen 45 AAT XerneralstfUclloliSsieestisesmd eve Ivctir ci did aetna 45 4 4 2 Palen DosltiODiTgsisnussass todas deser aU aa ege ded T 47 4 4 2 1 Full width and reduced width projection 47 206718 rev 4 SOREDEX i 7 44 2 2 PAQIOJGCIOL eee ee bete D Tn UID 50 4 4 2 3 Reverse towne projection cccccscccceeeecesseecseeeeceeeeeseeeesseeeees 52 4 4224 N AES VIEW tete tepap epa Event ertt libse ee dct dnb ae ren aadu 54 4 4 2 5 Carpus view Not in USA and Canada and Canada 57 4 4 3 TAKING ine exDOSUlQ coin ou His ev conponat nevdeienan OR d co peu dU D S uud 59 4S SD OX DOS USS asc M 60 45 1 Positioning GOVICES 15 9 9 0 e m wi CHO n m iow Gen abi oci
14. cycle 40 U 60 dip in U for 5 cycles 70 U 30 96 dip in U for 25 cycles lt 5 96 U gt 95 dip in U Floors are wood concrete or ceramic tile or floors are covered with synthetic material and the relative humidity is at least 30 percent Mains power quality is that of a typical commercial and or hospital environment Mains power quality is that of a typical commercial and or hospital environment Mains power quality is that of a typical commercial and or hospital environment If the user of CRANEX 3D requires continued operation during power mains interruptions it is recommended that CRANEX 3D be powered from an uninterruptible power supply or a battery Power frequency magnetic fields are at levels characteristic of a typical location in a typical commercial and or hospital environment NOTE U is the a c mains voltage prior to application of the test level Table 7 2 Electromagnetic immunity IEC 60601 1 2 Ed2 108 SOREDEX 206718 rev 4 7 Technical data CRANEX 3D is suitable for use in the specified electromagnetic environment The purchaser or user of CRANEX 3D should assure that it is used in an electromagnetic environment as described below Immunity IEC Compliance Electromagnetic Test 60601 1 2 Level Environment Test Level Portable and mobile RF communications equipment are used no closer to any part of CRANEX 3D including cables than the recommend
15. delay SOREDEX 206718 rev 4 206718 rev 4 6 Maintenance 6 3 Cleaning and disinfecting the unit CAUTION Switch the unit off or disconnect it from mains before cleaning the unit If you use a spray cleaner do not spray into any ventilation grills Do not allow water or other cleaning liquids to enter the unit interior since these may cause short circuits or corrosion The unit should be cleaned after every usage Unit surfaces All surfaces can be wiped clean with a soft cloth dampened with a mild detergent e g soapy water DO NOT use abrasive 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 detergent e g soapy water 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 instructions supplied with the disinfectant All items and surfaces should be dried before next usage NOTE Wear gloves and other protective equipment during decontamination process WARNING Do not use any disinfecting sprays since the vapor could ignite causing injury Disinfecting techniques for both the unit and the room must comply with
16. display the unit will stop working and cannot be operated while the error code is on the display In less severe cases a warning message will be displayed leaving the unit operable 4 6 1 Acknowledging errors Most errors may be acknowledged by closing the dialog box the error is reported in Some errors require the unit to be rebooted If such an error occurs or if the unit fails to operate as described in the user s manual switch the unit off wait a few seconds and switch the unit on again 4 6 2 Image transfer errors If an image is not transferred successfully to the PC close and then reopen the dental imaging software and or restart the PC DO NOT restart the unit as this will erase any image that is stored in the unit memory and this retrievable image will be lost SOREDEX 206718 rev 4 9 Troubleshooting High quality images with sharp contrast and good detail provide optimum diagnostic information Images with less quality are usually the result of one or more common problems 5 1 Patient positioning Problem Incisors and canines narrow and unsharp Overshadow in molar and premolar areas Rows of teeth are compressed Problem Possible cause 1 Occlusal correction of focal trough set too far posterior 2 Image layer laser light not obeyed 3 Bite block was not used Possible cause Incisors and canines wide 1 Occlusal correction of focal and unsharp Rows of teeth widened INR rn MA mii
17. though the head may touch the tube head Remedy Reverse patient s hands on handles left to right side handle and vice versa 75 5 Troubleshooting 76 SOREDEX 206718 rev 4 6 Maintenance 6 1 Maintenance procedure The maintenance procedure described below shall be seen as a minimum requirement and can be made more stringent to comply with regulations regarding the use and maintenance of dental x ray devices that are in force in the country in which the unit is installed Annual maintenance An annual maintenance procedure must be carried out at least once a year by qualified service personnel Contact your local distributor for details Calibration intervals To keep the image quality at best possible level calibrations and quality checks shall be carried out at regular intervals according to the table below Modal Two 2 times annually Four 4 times annually Panoramic Annually during normal Two 2 times annually maintenance Cephalometric Annually during normal Two 2 times annually maintenance NOTE 7he calibrations mentioned in this manual can be done by the user or qualified service personnel 206718 rev 4 6 1 1 Performing calibrations Calibrations and quality checks are performed by taking exposures of calibration tools The system does needed adjustments according to the image data captured For panoramic and cephalometric quality checks the quality is visually evaluated by the operator
18. 206718 rev 4 2 Unit description Exposure settings for 3D imaging NOTE Voltage settings is always 90kV with unit 3D modality em FOV Exposur Scanning Amount h x w e time time projectio ns Hes poem x 41 mm 6 3 i mm F 2 oo op ess m9 e se wren eae oe ta E M 145 181 227 High Res 61x 78mm 12 6s 1260 dee p k ien EQ Ut us ve Ge Sid Res 61 x 78mm n ib an a I lo lol eo wa wA DAP values vary from unit to unit in relation to the x ray tube output Thus above values indicate average DAP values In addition to these recommended values there is a possibility to use the whole mA range if the user prefers Available mA ranges for each field of view sizes and resolution settings Resolution FOV 4 mA 5mA 6 3mA 8mA 10mA 13 MA h x w DAP HighRes Hes eix4imm x 41 mm X B RE Hes e rtm x 41 mm High Res 61 x 78 mm Exposure settings for scout imaging default values Resolution FOV kV mA Scannin h x w time Scout eix4imm x 41 mm 0002s 02s som eremm 9 18 0 08 206718 rev 4 SOREDEX 21 2 Unit description 22 SOREDEX 206718 rev 4 3 Controlling the unit 3 1 ClearTouch control panel a Maija Mallinen p x 16 4 10 0 AV 93 2 mGycm X Nay Orin 6 1 Modality selection Program selection Imaging values Imaging area Status of the unit Test mode Settings O N O Ci FP CQ N Case end
19. 206718 rev 4 SOREDEX 23 3 Controlling the unit 24 3 2 3 3 Modality section Select the modality button PAN CEPH or 3D When panoramic modality is selected a program specific dental arch is shown This can be used for partial panoramic imaging Cephalometric programs have their own program specific image figures and setting buttons for the start position of lateral scanning 3D programs two FOV sizes have buttons for selecting low resolution High resolution or scout image mode The FOV for 3D imaging can be positioned on the XY plane by selecting the center point of the FOV on the dental arch of the ClearTouch control panel The FOV is positioned in the Z direction by using the chin rest movement and positioning lights Sectional imaging Dental arch on the touch panel shows the enabled and disabled arch sections from the result point of view Select the image area from the dental arch SOREDEX 206718 rev 4 206718 rev 4 3 Controlling the unit 3 4 Automatic Exposure setting AES AES automatically recommends the exposure values according to the size of the patients head in panoramic and cephalometric imaging The AES is activated with active A button and by pushing Return button once The AES suggest exposure values based on patient size The user can change the value before exposure if needed by pushing A button again and changing the values 3 4 1 AES values for Panoramic imaging NOTE Values can
20. A 6 1s Midi FOV optional High 90 kV 4 10mA 12 6s resolution XS FOV scout 90 kV 4 12 5 mA 0 025s Midi FOV optional scout 90 kV 4 12 5 mA 0 04 s Image storing and retrieving File formats PNG 16 bit JPG 12 bit File compression PNG lossless JPG 100 60 quality Typical panoramic About 2 4 MB PNG 16 bits file size Typical cephalometric 3 5 MB PNG 16 bits file size Typical 3D file size 150 250 MB DICOM 206718 rev 4 SOREDEX 95 7 Technical data Image storing and retrieving Patient database Standalone workstation Server on local area network LAN Panoramic patient positioning Operation Left Motorised carriage movement Positioning aids Chin rest bite block 3 point headrest Hinged mirror 3 positioning laser lights Y layer step less adjustment Cephalostat patient positioning Operation Arm mounts on left or right side of the unit Interlocked pan ceph sensor Motorised carriage buttons at cephalostat head assembly Positioning aids Ear holders Nasion support with vertical mm scale Frankfurt horizontal plane laser light Contact plate Carpus view 3D imaging patient positioning Operation Left Motorised carriage movement Positioning aids Chin rest chin support chin cup 3 point headrest hinged mirror 3 positioning laser lights Cephalostat scanning Scanning method Horizontal scan synchronized sensor and secondary slot motion Scanning time 10 20 s Pa
21. CLASSIFIED IJ CONFORMS TO UL STD 60601 1 N CERTIFIED TO CSA STD C22 2 NO 601 1 104 SOREDEX 206718 rev 4 206718 rev 4 7 Technical data 7 4 Labels on the unit The main label of the unit is located on the vertical carriage next to the on off power switch The unit is class I type B and with IP20 protection Type PP3 1 Ser No Manufactured 10A 220 240 V 50 60 Hz 1A continuous 15A 100 120 V 50 60 Hz 1A continuous INNAM A N IEC 60601 1 R 0537 This product complies with DHHS 21 CFR Chapter Subchapter J at the date of manufacture Rx only Warning This X ray unit may be dangerous to patient and operator unless safe exposure factors operating instructions and maintenance schedules are observed ETL CLASSIFIED CONFORMS TO UL STD 60601 1 US CERTIFIED TO CSA STD C22 2 NO 601 1 Intertek Manufactured by Soredex Nahkelantie 160 Fl 04300 TUUSULA Finland D502470 SOREDEX 105 7 Technical data 7 5 Unit identification labels J a Main label 10A amp 15A Fuse label next to the fuse holders Laser class 1 warning label IEC 60825 1 2007 Ethernet and remote exposure button label oa fF c N Warning label for line voltage connection on the power cord o Sensors on the sensor Primary collimator label on the collimator and on the tubehead cover 8 Tubehead label on the tubehead and on the tubehead cover 9 Warning label for deadly voltages ins
22. DEX 206718 rev 4 2 Unit description 1 Sensor holder PAN units only 2 Panoramic sensor 1 3D sensor units with 3D option 2 Panoramic sensor 206718 rev 4 SOREDEX 9 2 Unit description 2 2 Patient positioning lights oO O A Q N Midsagittal Frankfort horizontal Focal trough Cephalometric Frankfort horizontal Horizontal top of FOV 3D option only Horizontal bottom of FOV 3D option only SOREDEX 206718 rev 4 2 Unit description Panoramic lights 1 Midsagittal light 2 Frankfort horizontal plane 1 Focal trough light 206718 rev 4 SOREDEX 11 2 Unit description Cephalometric lights 1 Frankfort horizontal plane 3 D lights 1 Midsagittal light 2 Horizontal light top of FOV 3 Horizontal light bottom of FOV 12 SOREDEX 206718 rev 4 206718 rev 4 2 Unit description 2 3 Patient positioning panel uu Carriage UP DOWN Z movement Focal trough adjustment Y movement Positioning lasers ON OFF Return Chin support UP DOWN oa fF c N SOREDEX 13 2 Unit description 2 4 Emergency stop switch In case of malfunction of the exposure button or other protective devices of the unit an emergency stop switch is provided near the handles and on the roof of the cephalostat head so that the patient can reach it If the emergency stop switch is pressed during an exposure the exposure is terminated immediately and the x ray unit is completely sto
23. ENGLISH CRANEX 3D 3D Dental Imaging System User s Manual 206 18 rev 4 Copyright Manufactured by Code 206718 rev4 Date 20 June 2012 Document code D506689 rev 4 Copyright 06 2012 by PaloDEx Group Oy All rights reserved SOREDEX SCANORA and CRANEX are registered trademarks of SOREDEX PaloDEx Group Oy Other product names and trademarks are the property of their respective owners CE marked NB 0537 Windows is trademark of Microsoft Corporation in the United States of America and other countries Electric safety according to IEC 60601 1 Manufacturing complies with ISO 13485 2003 ISO 9001 2008 and ISO 14001 2004 DICOM is the registered trademark of the National Electrical Manufacturers Association for its standards publications relating to digital communications of medical information 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 SOREDEX The original language of this manual is English SOREDEX 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 SOREDEX representative for the most current information CE 0537 SOREDEX Pal
24. at the patient s thyroid glands are protected by a lead apron during exposure 2 Press Return Check the patient positioning Protect yourself from radiation by standing behind a suitable x ray radiation shield Make sure that you can see and hear the patient during the exposure NOTE n all examinations the user of the x ray equipment should wear protective clothing The operator does not need to be close to the patient during normal use The protection against stray radiation can be achieved by using the hand switch not less than 2 m 7 ft from the focal spot and the xray beam Operator should maintain visible contact with the patient and Technical factors This allows immediate termination of radiation by the release of the exposure button in the event of a malfunction or disturbance NOTE f the patient is nervous or a child you can demonstrate how the unit works to reassure them Press the T Test mode button and then press and hold the exposure button The unit will complete an exposure cycle without generating x rays SOREDEX 43 4 Using the unit 44 Press and hold down the exposure button During the exposure you hear an audible signal and the exposure warning symbol on the ClearTouch M control panel appears The unit rotates around the patient s head and stops When the rotating unit stops the exposure has been taken After the exposure the rotating unit is in patient out position if the exposure swit
25. ay result in hazardous radiation exposure MEN IEC 60825 1 1993 A1 1997 A2 2001 206718 rev 4 SOREDEX 93 7 Technical data Minimum total filtration Spine compensation User interface Program and technical Touch screen panel removable factors selection exposure button with 10m cable exposure control Patient positioning Positioning panel integrated Connection cable CAT6 Ethernet cable the unit PC Panoramic programs amp Technical factors amp magnification Standard Adult Panoramic 57 90 kV 4 16 mA 30 16 4 S Child Panoramic 57 90 kV 4 16 mA 14 4 S Panoramic QC 57 90 kV 4 16 mA 16 4 s 30 Exposure Control Automatic Exposure Setting AES based on patient head size 94 SOREDEX 206718 rev 4 7 Technical data Cephalometric programs amp Technical factors Reduced width lateral 60 90 kV 4 16 mA 6 14s view Full width lateral 60 90 kV 4 16 mA 10 20 s PA AP facial and oblique 60 90 kV 4 16 mA 10 20 s views Carpus View 60 90 kV 4 16 mA 10 20 s Not in USA and Canada and Canada Exposure Control Automatic Exposure Setting AES based on patient head size Magnification factor 1 14 1496 3D imaging programs XS FOV dimensions 61 x41 mm HxD Midi FOV optional 61 x 78 mm HxD dimensions Technical factors XS FOV standard 90 kV 6 3 12 5mA 2 3S resolution Midi FOV optional 90 kV 6 3 12 5 mA 4 9s standard resolution XS FOV High resolution 90 kV 4 12 5m
26. be re scaled by SOREDEX authorized service personnel Adult child panoramic Bitewing Sinus Head width min V mA AES values for TMJ Lat PA i 73 73 73 73 73 SOREDEX 5E 3 Controlling the unit 3 4 2 AES values for Cephalometric imaging Lat PA 100 V Head width min kV PEST 1 8 nem 90 eem 90 nem 90 085m 90 88emMm 95 Head width win W ma 7m Waxy 30 10 n m 90 10 esm 91 19 45m 90 o es osm 90 o o esm 5 8 w Ceph Lat PA 240 V Fead wian min KW mk s sem Waxy 90 128 36 IS C Is 17 45 om 885emWMm 85 8 30 26 SOREDEX 206718 rev 4 3 Controlling the unit 3 4 3 Exposure indicators and settings P d 6 3m FJ mA value 1 6 4 s Exposure time s 93 2 mGycm Dose value mGycm 0 mm Focal through light mm lt Focal through light y layer position TJ Test mode A Automatic Exposure setting ua AES 3 5 Status section Status field shows when the unit is ready for capturing or any trouble occurs Green and yellow colour indicate the status in question amp Status ready Ready for imaging 206718 rev 4 SOREDEX 27 3 Controlling the unit 3 6 Other sections General settings 7 User programs Info Info Languages Languages Quality assurance Quality assurance Retrieve last image Retrieve last image Exposure settings Expo
27. ce ZEE Sharpen fier TS ID A01 DOG FOSS oS Calif i ROIL resus PMMA minimum veus 104 PMMA mese veus 158 PMMA meimum sil v gn ITE GO si dev 8i buco Vtrum EMMA RON vels 70 Medru PMMA ACE ROI Sio ev 7S Mtr PFE yeus 60 maximum std dey 413 Mestinunn AR we SOD Meun AR eid cay 40 em g AOLI 10 Icky Ih lamas 2015 20 1968 405 12 i D Atit qe met franca Taal Options Ho Cp Andina 10 mA EX KI WL 1156 WW 5121 tht ETE z AFA TT 89 kVp Toom x2 3 0 087 mim CT ID 20110628085538033 Calib testi 20110501 eV CRAINEXSD SEil 00046 Thu Ost 13 10 12 46 21033 Tool Options Ha Opaon aie ela 10 mA B9 kvp Zoom x2 3 0 087 nM M WL 1156 Ls LX Fig 6 2 Quality Check Passed 206718 rev 4 SOREDEX 85 6 Maintenance 86 6 2 Changing the fuses Main fuses are located next to the on off power switch Push inward on the fuse base and twist it counterclockwise with a screwdriwer The fuse with the base comes out Remove the fuse from the base and replace it with the new one Repeat this with each blown fuse Fasten both fuses by pushing the base in and twisting it clockwise with a screwdriver Use only appropriate fuses Line voltage 220 240 Vac 326 Littelfuse 10A slow blow or Cooper Bussman MDA 10 time delay Line voltage 100 120 Vac 326 Littelfuse 15A slow blow or Cooper Bussman MDA 15 time
28. ch has been pressed until al movements have stopped Release temple supports Guide the patient out Remove disposable covers and disinfect the unit PC The image can be examined using the SCANORA software See SCANORA software user s manual SOREDEX 206718 rev 4 4 Using the unit 4 4 Cephalometric exposures B Reduced Width lateral projection B Lateral projection B PA AP projection B Reverse towne projection B Waters view B Carpus view Not in USA and Canada and Canada 4 4 1 General instructions 1 Move the ceph sensor to the ceph sensor holder in a case of single sensor configuration 2 PC Click Image Capture 3 Select CEPH Maija Mallinen w A 5 34 37 0 mGycm Ready 4 Select the imaging program 206718 rev 4 SOREDEX 45 4 Using the unit 5 If AES is enabled green light lit around A press the A r Return button and wait for the movement to finish M Verify that the suggested exposure values are suitable for the patient If AES is disabled set the exposure values manually and press Return to drive the unit into exposure start position optional Press the Return button to drive the unit to patient in 6 J position 7 Ask the patient to remove any spectacles hearing aids removable dentures jewellery and hair clips and pins Place a protective lead apron on the patient 46 SOREDEX 206718 rev 4 4 Using the unit 4 4 2 Patient posi
29. close mouth 56 SOREDEX 206718 rev 4 4 Using the unit 4 4 2 5 Carpus view Not in USA and Canada and Canada Ready 206718 rev 4 SOREDEX 57 4 Using the unit CAUTION Before taking Carpus image make sure this imaging method is approved by local authorities of your country 1 Unlock the lever and turn the ear rods to the PA projection position Lock the position Tilt the nasion Support aside Place the carpus holder to the nasion support holder 2 Adjust the unit height if needed 3 Ask the patient to remove rings and metal objects and to place hand on the carpus holder 58 SOREDEX 206718 rev 4 206718 rev 4 4 Using the unit 4 4 3 Taking the exposure WARNING Close the patient positioning mirror before taking any exposures 1 Ask the patient to remove any spectacles dentures jewellery and hair clips and pins Place a protective lead apron around the patients neck to protect the patient s thyroid gland from radiation 2 Protect yourself from radiation by standing behind 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 During the exposure you hear an audible signal and the exposure warning symbol on the ClearTouch M control panel appears Helease the ear rods and guide the patient out Hemove disposable covers and disinfect the unit PC Ihe image can be examined using th
30. core or better Hard disk 500 GB or more Expansion slot PCI Express bus for supplied GPU full length Power supply 500 watt minimum Gigabit Ethernet 1000Base T Operating system Windows 7 or Windows Vista 32 or 64 bit Display 20 LCD display 1600 x 1200 or 22 LCD widescreen display 1680 x 1050 or better Standard The PC must meet the IEC 60950 standard minimum requirements Graphics card GTX 460 Nvidia Quadro GPU FX 3800 Nvidia Quadro NVidia Quadro 4000 NVidia driver version 259 57 PCI board connection Full length PCle x16 slot for GPU board USB USB ports for HASP Dongle keys 1 for reconstruction system Dongle supplied with Mercury GPU Kit e 1 for OnDemand3D Dongle supplied with CD Kit Color monitor size 20 2MP LCD display 1600 x 1200 19 1 3MP LCD 1280 x 1024 minimum Mouse Mouse with scroll wheel NOTE This is an abbreviated list of requirements Please refer to the software installation manual or contact your local dealer for detailed installation requirements 206718 rev 4 SOREDEX 99 7 Technical data Minimum PC requirements for Viewing workstation for 2D 3D images 2 0 GHz dual core or better Graphics NVIDIA GeForce 6600 or ATI Radeon X700 or better 256MB or more memory integrated graphics are not supported Hard disk 3 GB free space or more Network Gigabit Ethernet 1000Base T recommended or Fast Ethernet 100Base TX Operating system Windows 7 or Windows Vi
31. ding domestic establishments and those directly flicker emissions connected to the public low voltage power supply network that supplies buildings used for domestic IEC 61000 3 3 AA Table 7 1 Electromagnetic emissions IEC 60601 1 2 Ed2 206718 rev 4 SOREDEX 107 7 Technical data CRANEX 3D is suitable for use in the specified electromagnetic environment The purchaser or user of CRANEX 3D should assure that it is used in an electromagnetic environment as described below Immunity Test IEC 60601 1 2 Compliance Electromagnetic Environment Test Level Level Electrostatic discharge ESD IEC 61000 4 2 2 4 6 kV for contact discharge 2 4 8 kV for air discharge Electrical fast transient burst IEC 61000 4 4 2 kV for power supply lines 1 kV for input output lines 1 kV differential mode 2 kV common mode lt 5 96 U gt 95 dip in U for 0 5 cycle 40 U 60 dip in U for 5 cycles 70 U 30 96 dip in U for 25 cycles lt 5 96 U 95 96 dip in U Surge IEC 61000 4 5 Voltage dips short interruptions and voltage variations on power supply input lines IEC 61000 4 11 Power frequency 50 60 Hz magnetic field IEC 61000 4 8 2 4 6 kV for contact discharge 2 4 8 kV for air discharge 2 kV for power supply lines 1 kV for input output lines 1 kV differential mode 2 kV common mode lt 596 U gt 95 dip in U for 0 5
32. e SCANORA software See SCANORA software user s manual NOTE n all examinations the user of the x ray equipment should wear protective clothing The operator does not need to be close to the patient during normal use The protection against stray radiation can be achieved by using the hand switch not less than 2 m 7 ft from the focal spot and the xray beam Operator should maintain visible contact with the patient and Technical factors This allows immediate termination of radiation by the release of the exposure button in the event of a malfunction or disturbance SOREDEX 59 4 Using the unit 4 5 3D exposures 4 5 1 Positioning devices Chin cup Bite block and chin plane 60 SOREDEX 206718 rev 4 4 Using the unit 4 5 2 General instructions 1 PC Click Image Capture 2 Select the 3D modality A Maija Mallinen WVW The teeth locations on the 3D dental arch are approximate and are based on average dentition The exact teeth locations will depend on the patient s individual anatomy The EasyScout function helps locate the correct dental location of the Field of view e Ready 206718 rev 4 SOREDEX 61 4 Using the unit 62 select the Field Of View FOV XS FOV 61 x 41 mm Program 1 Midi FOV 61 x 78 mm Program 2 OPTIONAL Select the area of interest on the dental arch The 3D FOV is positioned more accurately by using the scout image mode The area of interest can be adjusted on
33. e press the focal trough adjustment key s to move the focal trough light until it is positioned correctly Fig 4 2 Focal trough light position indicator 9 If AES is enabled green light lit around A press the r Return button and wait for the movement to finish Verify that the suggested exposure values are suitable for the patient If AES is disabled set the exposure values manually and press Return to drive the unit into exposure start position optional 10 Ask the patient to press their tongue against the roof of their mouth swallow and remain still for the duration of the exposure 206718 rev 4 SOREDEX 37 4 Using the unit 4 3 3 2 TMJ exposure 1 Insert the required positioning devices including the TMJ support Place the disposable covers NOTE Use a new disposable cover for every patient Adjust the unit height 3 Guide the patient to the unit and instruct to stand as straight and tall as possible Ask the patient to take grip on the handles and set the mouth against the lip WV holder 4 TMJ lateral projection Adjust the height of the Frankfort Horizontal plane FH laser to get the laser light over the orbita porion Straighten the patient s head if needed 38 SOREDEX 206718 rev 4 4 Using the unit 5 TMJ PA AP projection Tilt the patient s head forward 6 Check the position of the midsagittal light If it is not on the midsagittal plane of the patient adjust the patient
34. e 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 Electromagnetic 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 regulations change from time to time it is the responsibility of the user to make sure that all the valid safety regulations are fulfilled In all examinations the user of the x ray equipment should wear protective clothing The operator does not need to be close to the patient during normal use The protection against stray radiation can also be achieved by using the hand switch not less than 2 m 7 ft from the focal spot and the xray beam Operator should maintain visible contact with the patient and Technical factors This allows immediate termination of radiation by the release of the exposure button in the event of a malfunction or disturbance It is the responsibility of the doctor to decide if the x ray exposure is necessary SOREDEX 3 1 Introduction The minimum height of patient that can be imaged is 120 cm 3 9 ft 47 2 and the maximum is 200 cm eft 78in These heights only apply to patients with normal anatomy When taking an x ray exposure o
35. ed separation distance calculated from the equation appropriate for the frequency of the transmitter Recommended Separation Distance Conducted 3 V150 kHz 3 5 RF IEC to80 MHz d WP 61000 4 6 Vi Radiated 3 V m80 3 5 RFIEC MHz t02 5 d WP 61000 4 3 GHz Ei 80 MHz to 800 MHz 7 d WP Ei 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 meters m Field strengths from fixed RF transmitters as determined by an electromagnetic site survey are less than the compliance level in each frequency range Interference may occur in the vicinity of equipment marked with the following symbol i Field strengths from fixed transmitters such as base stations for cellular telephones and land mobile radios amateur radio AM and FM radio broadcast and TV broadcast cannot be estimated accurately To assess the electromagnetic environment due to fixed RF transmitters an electromagnetic site survey should be performed If the measured field strength exceeds the RF compliance level above observe CRANEX 3D to verify normal operation in each use location If abnormal performance is observed additional measures may be necessary such as re orienting or relocating CRANEX 3D Over the frequency range 150 kHz to 80 MHz field strengths are less than V V m The Recommended Separation Distance
36. ents shall apply Cables shielding amp grounding All interconnect cables to peripheral devices must be shielded and properly grounded Use of cables not properly shielded and grounded may result in the equipment causing radio frequency interference Electrostatic discharges environment amp recommendations In order to reduce electrostatic discharge interference a charge dissipative floor should be installed to prevent charge accumulation B The dissipative floor material must be connected to the system reference ground if applicable B Relative humidity must be maintained above 30 percent Stacked components amp equipment The unit should not be used adjacent to or stacked with other equipment if adjacent or stacked use is necessary the unit should be observed to verify normal operation in the configuration in which it will be used Interference may occur in the vicinity of equipment marked with the following symbol o No portable or mobile RF communications equipment may be used closer to any part of the unit including cables than the recommended separation distance calculated from the equation appropriate to the frequency of the transmitter See Table 4 SOREDEX 111 7 Technical data T X ray tube assemblies Duty cycle 1 8 Rectification type Constant potential x ray generator Generator rating Generator nominal power 1750W Anode Thermal Characteristics HEAT STORAGE kJ
37. entulous patients 206718 rev 4 J SOREDEX 51 4 Using the unit 4 3 2 General instructions 1 PC Click Image Capture Maija Mallinen P m 16 4 1 0 0 93 2 mGycm 0 mm Q a3 2 Select panoramic imaging 3 Select the imaging program 4 Any section of the dental arc can be selected for the sectional imaging to limit exposure area and reduce the radiation dosage 32 SOREDEX 206718 rev 4 4 Using the unit 5 Press the Return button to rotate the unit to patient in r position 6 Open the temple supports 1 Temple support knob 2 Forehead support 3 Temple supports 7 Ask the patient to remove any spectacles hearing aids removable dentures jewellery and hair clips and pins Place a protective lead apron on the patient 206718 rev 4 SOREDEX 33 4 Using the unit 4 3 3 Patient positioning 4 3 3 1 Panoramic exposure 1 Insert the chin rest and bite rod with the bite block Place the disposable covers NOTE Use a new disposable cover for every patient 2 Adjust the unit height 3 Guide the patient to the unit and instruct to stand as straight and tall as possible Exposure can be taken also in sitting position Ask the patient to take grip on the handles and bite on the bite block Use the lipholder or the chin support for an edentulous patient Fig 4 1 bite 34 L ANA lin halAanr lt gt 4 Ask the patient to take one s
38. etry calibration eeeeseeeeseeeeseeeee 81 O14 2 SD OIXC CANORA Me sisetects steele retorts esca e etui ciet dte mre codi 82 6 143 lt 3 D Qualify CHECK ais cene er ER Poe on toii estote 83 62 CMANGIAG INE TUSES 5 9 92 6 0I r dre armies ho Ee oed dep uud duoi eios dpa soe 86 6 3 Cleaning and disinfecting the unit cccccceecccssececsseeecesecceeeesceeesseeessseessaaees 87 O4 WISDOS Al ossetuquduidsedtucdtas Dad ttikpoedintum ty Guiendienentatesieniy dels deed va E qud 89 OE CTNAIG AMC AN A inteets reed seats potas aveesest E iE 91 7 1 T chnical SDeclllGallOFiS tucesaxtsvsnetuceauseinanniouupanseansemavesnteevansssasateininierlantssnaseeeideuved 91 7 2 BhibolmensloliS sueiemcsteetut educ du dtes sectas cas ces usu le eri emi d ME Ee D ODD EuE 102 7 3 Symbols that appear in the unit eseeeeesseeeeeseeeenneeennnnnn 103 TA Cape OMNE UA neea E T TE Nh 105 Fo Ut dentiicaton aDeSe RE em Eb Gb Hu aedes 106 7 6 Electromagnetic Compatibility EMC tables ssesesseeeessesessese 107 rc KWAY UDC ASS SIMON SS ERE T TT 112 SOREDEX 206718 rev 4 1 Introduction 206718 rev 4 1 1 1 2 CRANEX 3D SOREDEX CRANEX 3D hereafter called the unit is a high quality dental imaging system designed to take images of the dento maxillo facial complies of the human skull In order to take images with the unit you need a suitable PC hardware connected t
39. f a patient with exceptional anatomy typically very tall or large use the test mode no x rays first to make sure that patient can be positioned correctly to 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 women When taking an x ray exposure of a child always use the lowest possible x ray dose the smallest possible image area and the lowest possible resolution that allows you to perform the required diagnostic task If the patient is using a pacemaker consult the manufacturer of the pacemaker before taking an exposure to confirm that the x ray unit will not interfere with the operation of the pacemaker Always use available disposable protective covers with the patient positioning accessories Bite block cover Chin rest cover Ear holder cover Disinfect all the surfaces that the patient is in contact with after every patient Panoramic and 3D should not be used for routine or screening examinations in which a radiograph is taken regardless of the presence or absence of clinical signs and symptoms 3D imaging examinations must be justified for each patient to demonstrate that the benefits outweigh the risks Where it is likely that evaluation of soft tissues will be required as part of the patients radiological assessment the imaging should be done using conventional medical CT or MH rather than 3D imaging using Cone Beam technolog
40. g the unit 4 4 2 3 Reverse towne projection Maija Mallinen s Ready 52 SOREDEX 206718 rev 4 4 Using the unit 1 Unlock the lever and turn the ear rods to the PA projection position Lock the position Tilt the nasion support aside 2 Place the disposable covers NOTE Use a new disposable cover for every patient 3 Adjust the unit height AN Guide the patient to the unit Instruct the patient to stand as straight and tall as possible under the cephalostat head Turn the head ventral as reference to the canthomeatal line about 30 below the horizontal plane Slide the ear rods towards patient s ears Ask the patient open mouth maximally 206718 rev 4 SOREDEX 53 4 Using the unit 4 4 2 4 Waters view Az Maija Mallinen a Ready 54 SOREDEX 206718 rev 4 206718 rev 4 4 Using the unit 1 Unlock the lever and turn the ear rods to the PA projection position Lock the position Tilt the nasion support aside AN NY 2 Place the disposable covers NOTE Use a new disposable cover for every patient 3 Adjust the unit height 4 Guide the patient to the unit Instruct the patient to stand as straight and tall as possible under the cephalostat head 5 Turn the head dorsal as reference to the canthomeatal line about 35 40 above the horizontal plane 6 Slide the ear rods towards patient s ears SOREDEX 55 4 Using the unit 7 Askthe patient open or
41. ght side tooth are not Exposure button released Retake the image exposured prematurely Problem Possible cause Remedy Right and left image sides are Orthogonal procedure was Select correct panoramic uncomplete TMJ s are not mistakenly used procedure shown 206718 rev 4 SOREDEX 73 5 Troubleshooting Problem A light horizontal line on QC image Problem Horizontal lines on image Problem CEPH Lateral view has 2 ear holder pins 74 Possible cause Bite block was left on place Possible cause Sensor problem Possible cause Remedy Remove the bite block and retake QC image Remedy Consult the dealer Remedy 1 Cephalostat lock not locked 1 Lock it 2 Ear holders misaligned SOREDEX 2 Call service 206718 rev 4 Problem Back of the patient s head is touching the x ray tube during the exposure Problem Patient s shoulders are touching the x ray tube or Sensor 206718 rev 4 5 4 Unit operation Possible cause 1 Patient s head inclination not If the image is not acceptable then 1 2 Patient is too big for the unit 3 Patient has slumped Possible cause Patient is too big for the unit Wide and high shoulders SOREDEX 5 Troubleshooting Remedy Check the head position and retake the image Check the patient positioning Make the exposure even though the head may touch the tube head Check the patient positioning Make the exposure even
42. he chin rest holder Level it with the bubble Select the program There is a calibration procedure for both 3D imaging modes standard and High 206718 rev 4 SOREDEX 81 6 Maintenance resolution Standard geometry calibration has to be done first 3 Press the return button 4 Install the 3D calibration phantom 5 Take an exposure Repeat the calibration until calibration result passed is achieved This calibration is only needed with 3D units BGcometnicalibrationmgpassed Cla PEM She Noffseu s 2E ED 5imm Scan difff Ni5 1000 5tdeq enffse BUE TE Bro ffe amm affse ale oem N 6 1 4 2 3D pixel calibration 1 Remove calibration tools and base of the phantom 2 Select the program 3 Press the return button 4 Takean exposure 82 SOREDEX 206718 rev 4 6 Maintenance Denk imal KSl 1A CT detector calibration Passed CTQ 3 9 7 signal level 2730 5759 6 1 4 3 3D Quality Check 1 Attach base of the phantom and the QC phantom to the unit f 3D X 2 Select the 3D QC program a 3 Press the return button 4 Take an exposure 206718 rev 4 SOREDEX 83 6 Maintenance 5 Review with 3D viewing software from the axial view by scrolling the slices the info about calibration result The resulting image contains information on whether the quality check was passed Repeat until quality check is passed 84 SOREDEX 206718 rev 4 6 Maintenan
43. head Adjust the height of the Frankfort Horizontal plane FH laser to get the laser light over the orbita porion otraighten the patient s head if needed Close the temple supports by sliding the temple support knob to the right Adjust the position of the nasion support and push the forehead support in until it touches the patient s nasion Adjust the position of the image layer as necessary The focal trough light should be positioned in the middle of the 3rd tooth or if wanted slightly posterior NOTE f the focal trough light is not positioned as described above press the focal trough adjustment key s to move the focal trough light until it is positioned correctly SOREDEX 41 4 Using the unit 8 If AES is enabled green light lit around A press the A r Return button and wait for the movement to finish M Verify that the suggested exposure values are suitable for the patient If AES is disabled set the exposure values manually and press Return to drive the unit into exposure start position optional 9 Askthe patient to press their tongue against the roof of their mouth and remain still for the duration of the exposure 42 SOREDEX 206718 rev 4 206718 rev 4 I T 4 Using the unit 4 3 4 Taking the exposure WARNING Close the patient positioning mirror before taking any exposures 1 Ask the patient to remove any spectacles dentures jewellery and hair clips and pins Ensure th
44. ide the tubehead cover 10 Cephalostat outside on the cover 11 Secondary collimator on the secondary collimator and on the collimator cover 106 SOREDEX 206718 rev 4 7 Technical data 7 6 Electromagnetic Compatibility EMC tables NOTE Medical electrical equipment needs special precautions regarding EMC and needs to be installed according to EMC information CRANEX 3D is suitable for use in the specified electromagnetic environment The purchaser or user of CRANEX 3D should assure that it is used in an electromagnetic environment as described below Emissions Test Electromagnetic Environment Radio Frequency Group 1 CRANEX 3D uses RF energy only for its internal Emissions function Therefore the RF emission is very low and not CISPR11 likely to cause any interference in nearby electronic equipment Radio Frequency Class B CRANEX 3D is suitable for use in all establishments Emissions including domestic establishments and those directly CISPHR1 1 connected to the public low voltage power supply network that supplies buildings used for domestic purposes Harmonic IEC 61000 3 2 CRANEX 3D is suitable for use in all establishments emissions Class A including domestic establishments and those directly connected to the public low voltage power supply IEC 61000 3 2 network that supplies buildings used for domestic purposes Voltage Complies CRANEX 3D is suitable for use in all establishments fluctuations inclu
45. lity assurance j Select Quality assurance The calibration display appears 78 SOREDEX 206718 rev 4 6 Maintenance a 167761 716Z Smith John Quality assurance j gt a a V Ready 6 1 3 Panoramic calibration and quality check 6 1 3 1 Panoramic geometry calibration l 1 Select the program 2 Pressthe return button 3 Install the double cone calibration tool 4 Take an exposure Repeat the calibration until calibration result passed is achieved 206718 rev 4 SOREDEX 79 6 Maintenance Adjustment panGeom Passed offset 0 5 0 3 mm Y offset lt 0 5 0mm N offset 0 5 2 0 04 mm J offset 15 9 mm 6 1 3 2 Panoramic pixel calibration 1 Remove calibration tools select the program 2 3 Press the return button 4 Take an exposure EEPan detector calibration Passed CTOQ 3 0 9 0 Signal level 5451 9935 Dark level S819 273 80 SOREDEX 206718 rev 4 6 Maintenance 6 1 3 3 Panoramic Quality Check OPTIONAL 1 Attach a line pair calibration tool on the ball pin p mW phantom to the chin support Select the Pan QC program Press the return button Take an exposure 5 Visually evaluate the result using the installed imaging software According to DIN 6868 151 5 Test Tool Digital and EN 61223 3 4 6 1 4 3D calibration and quality check 6 1 4 1 3D geometry calibration 1 Attach the base of the phantom to t
46. nician This product itself complies IEC 60601 1 medical safety standard but in order to the system incorporating also a PC to comply the standard EITHER the PC has to be a medical PC OR the PC has to be located over 1 5 meters apart from the unit The installer and the user of the system shall confirm that at least one of the above requirements is fulfilled A PC is a medical one if it complies IEC 60601 1 standard and that is indicated in the accompanying documents of the PC All service operations are performed by SOREDEX authorized service personnel SOREDEX 5 1 Introduction 1 7 Manufacturer s liability As a manufacturer we can only assume liability of safe and reliable operation of this unit when he unit installation was performed according to the unit Installation amp Adjustments Manual by qualified CRANEX dealer and The unit is used according to the unit User Manual SCANORA PC software was installed according to the Installation Manual for SCANORA software SCANORA software is used according to User Manual for SCANORA software Maintenance and repairs are performed by a qualified CRANEX Dealer Original or authorized spare parts are used In order to guarantee maximal image quality for the entire life time of this high performance imaging system we suggest that a special image quality assurance procedure and test object designed for image quality assurance purposes is used
47. noramic image receptor Sensor unit Pan sensor or interchangeable Ceph sensor Technology CMOS 96 SOREDEX 206718 rev 4 7 Technical data Active area height Active area height Image field width in lateral 10 2 inches 260 mm maximum view 6 7 inches 170 mm minimum Image field width in PA 7 9 inches 200 mm view Hesolution 4 LP mm Active sensor surface 100 x 68 mm H x W Unit physical measures Source image distance 500 mm Panoramic SID 570 mm 3D Installation Standard wall mount with x45 angled joint Optional base for free standing unit unit height is increased 25 mm Height x Width x Depth 2414x965x1126mm standard column inches mm 94 9 x 38 x 44 3 inches Max Weight 200 kg 440 Ibs Panoramic 206718 rev 4 SOREDEX 97 7 Technical data Unit ceph physical measures Source image distance 68 7 inches 1745 mm SID Source object distance 60 inches 1520 mm SOD Installation Standard wall mount with 45 angled joint Optional base for free standing unit unit height is increased 25 mm Height x Width x Depth 2414 x 1872 x 1126 mm inches mm 94 9 x 73 7 x 44 3 inches Weight 250 kg 551 Ibs Cephalometric Ambient temperatures Transportation and 10 60 C Storage Operation Temperature 10 435 C RH max 85 98 SOREDEX 206718 rev 4 7 Technical data Minimum PC requirements for Modality workstation 3D acquisition workstation 2 5 GHz dual
48. o the unit and SCANORA software to manage images The unit performs the following procedures Pan Adult panoramic Child panoramic Reduced width and height Bitewing TMJ PA projection TMJ lateral projection axially corrected Maxillary sinus Ceph optional Cephalometric Full size Lateral Cephalometric Reduced size lateral Cephalometric posterior anterior projection PA AP Reverse Towne projection Waters view Carpus Not in USA and Canada and Canada 3D optional B XS 61x41 mm Field of View B Midi 61x78 mm Field of view Intended use The unit must only be used and operated by dentist and other qualified professionals The unit must only be used to take panoramic cephalometric and 3D images of the dento maxillofacial complex of the human skull It must not be used to take images of any other part of the human body Note that panoramic and 3D exposures should not be used if conventional intraoral radiographic images bitewing exposures would suffice Note that cone beam computerized tomography images are not adequate for the analysis of soft tissue SOREDEX 1 1 Introduction 1 3 1 4 1 5 USA only CAUTION Federal law restricts this device to sale by or on the order of a dentist or other qualified professional About this manual This manual describes how to set up and use the unit Please read this user s manual before operating the unit for the first time CAUTION t is important to
49. oDEx Group Oy Nahkelantie 160 P O Box 148 Fl 04300 Tuusula FINLAND Tel 4358 10 270 2000 Fax 358 9 701 5261 For service contact your local distributor Table of Contents 1 Introduction 1 Tel XOBAINEX JQ9Dusuuccn daion ine nte adatto atu eie OO e e ete Debate een du eM Caves dE 1 t2 WATCMOC Gl USC aati dut dti used ee le sth Sete he cet age re ae ee reed ees 1 TS ADUS MaMa eee UE 2 1 4 Abbreviations used in this manual eeseeeeeeeeeeeeeennen nnns 2 to Associated doculmelitallofis eere vods n eed sre doen caren seated eet eye eae LE 2 16 Warnings ard DrECAUTIONS isses rennan eren RaO auae ae ER eren Yerba deberes r reet 3 Tey Manufracturer s MaDi ceses e tet et temet eut ox bre teta a cedens oees 6 MES QErcledeueime m 7 2 Mampan and collEolS e euo heit bt n erba et DER bran ad QUEUE be ru UC D uu 7 2 2 Patent positionirig NOMS sceneries asada eve vua eta Pea vente duro sus oa PEE Pede Fecerat Ou 10 2 9 allen poslitionlrig Dalielszsesssosatveotecte co sa E Rio vata a d mper 13 2 4 EmernencystoDpSWIIGEI s iat ci er n amid ute Beeridurt x qM Kar PL er e CLE D ME SU ida UT Ld Ra 14 Zor didgld progi a MS sarea Ek cand edens toS ddr vadc dccem E Har cud Rau 15 2 5 L i adoramic DIOGFL allis iate osteeon ua codon qe IN m dapes tem Monde Nec sn RU CORE 15
50. ordance with ISO13485 and ISO9001 standard Environmental In accordance with ISO14001 standard management system Conformity to standards IEC 60601 1 1988 and A1 A2 IEC 60601 1 1 2000 IEC 60601 1 4 1996 and A1 IEC 60601 2 7 1998 IEC 60601 2 28 1993 IEC 60601 2 32 1994 IEC 60601 1 2 2001 and A1 IEC 60601 1 3 1994 UL 60601 1 2003 CAN CSA C22 2 No 601 1 M90 and 1 A2 standards This product complies with DHHS 21 CFR Chapter Subchapter J at the date of manufacture CRANEX 3D is in conformity with the provisions of Council Directive 93 42 EEC as amended by the Directive 2007 47 EC concerning medical devices Performance Standards and European Union Directive 93 42 EEC Medical Devices Directive ais G Product type Digital dental imaging system with panoramic cephalometric and Cone Beam 3D imaging programs 206718 rev 4 SOREDEX 91 7 Technical data Protection against electric Class shock Degree of protection Type B applied with no conductive connection to the patient Protection against the IP20 ingress of liquids Disinfection methods mild soapy water non abrasive non alcohol based disinfectant for the chin rest disposable plastic covers for bite block chin rest and chin support For use In environments where no flammable anaesthics nor flammable cleaning agents are present Mode of operation continuous operation intermittent loading EMC Classification Class B
51. pped An interrupted exposure cannot be continued later but has to be retaken from the beginning Press to stop the unit rotate to release 14 SOREDEX 206718 rev 4 2 Unit description 2 5 Imaging programs 2 5 1 Panoramic programs Adult Magnification 1 3 Panoramic imaging provides general view of dental and facial anatomy based on panoramic imaging technic Adult panoramic 20 5 cm width x 11 cm height Child Magnification 1 3 Child panoramic 11 5 cm width x 8 5 height Child panoramic has reduced width and height Children can be imaged with less radiation dosage and shorter exposure time Patients with jaw more narrow than average jaw can be exposed with this too 206718 rev 4 SOREDEX 15 2 Unit description Bitewing Magnification 1 3 TT An orthogonal view of the dentition from the canine and posterior Lateral TMJ Magnification 1 23 Lateral TMJ program provides a wide layer axially corrected views for the patient s left and right temporomandibular joints PA TMJ Magnification 1 55 SOREDEX 206718 rev 4 2 Unit description Maxillary Sinus Magnification 1 3 gt uc Mesial 10 mm Start Distal 10 mm Maxillary Sinus program produces a pan tomographic layer through the posterior maxillary sinus The layer is flatter than the standard panoramic programs and is moved 18 mm backward These images are helpful in visualizing the mid and posterior maxillary sinus
52. read the warnings and precautions listed in section 1 6 before operating the unit for the first time It is also important to observe these warnings and precautions whenever the unit is used Abbreviations used in this manual FOV Field Of View The cylindrical 3D volume that is reconstructed by the system ROI Region Of Interest The anatomical area or region of the patient that you are interested to examine ACS z Automatic Collimator Selector AES Automatic Exposure Setting Associated documentation The SCANORA software users manual or the user s manual for the dental imaging software you are using The users instructions supplied with the 3D imaging software you are using SOREDEX 206718 rev 4 206718 rev 4 1 Introduction 1 6 Warnings and precautions To be observed during use There should be free space around the unit for safe operation 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 exposures that it is not designed for Only professionally qualified dental and or medical personnel are allowed to operate the unit and carry out any diagnoses based on output from the unit The personnel operating the device must be adequately trained in CBCT technology with respect to principles of operation and radiation protection The unit may be dangerous to th
53. rightness optimum 2 Select a more fitting histogram type and check 2 SCANORA software gamma setting Gamma not set correctly Problem Possible cause Remedy Images are too dark 1 SCANORA software 1 Adjust contrast and density Contrast and brightness not 2 Decrease Technical factors optimum 2 Manual Technical factors used too high Problem Possible cause Remedy Lack of image contrast 1 SCANORA software 1 Agjust contrast and Contrast and brightness not brightness optimum 2 Lower the kV setting 2 kV used is too high 3 Adjust Gamma value 3 Gamma value is not correct for the monitor being used 72 SOREDEX 206718 rev 4 5 Troubleshooting 5 3 Artefacts Problem Possible cause Remedy Irregular bright shadows or Patient is wearing metal Ask patient to remove objects artefacts objects such as earrings necklace etc ww V9 JJ ke uh yit All NEC MIR AE Du Problem Possible cause Remedy An unexposed area is shown Lead apron misplaced Check the lead apron down in the lower middle positioning section of the image gt Problem Possible cause Remedy Partial lack of detail and motion Patient has moved during the Retake the image artefacts Irregular vertical exposure bright lines on image Problem Possible cause Remedy Vertical dark lines on image Patient s shoulder in touch with Check patient positioning machine parts Problem Possible cause Remedy Patient s ri
54. s head 7 Close the temple supports by sliding the temple support knob to the right Adjust the position of the nasion support and push the forehead support in until it touches the patient s nasion 206718 rev 4 SOREDEX 39 4 Using the unit 8 Adjust the position of the TMJ light until it aligns in the middle of condyle NOTE The condyle moves forward by approximately 10 mm when the mouth is opened 9 If AES is enabled green light lit around A press the Return button and wait for the movement to finish Verify that the suggested exposure values are suitable for the patient If AES is disabled set the exposure values manually and press Return to drive the unit into exposure start position optional 10 Ask the patient to press their tongue against the roof of their mouth swallow and remain still for the duration of the exposure 40 SOREDEX 206718 rev 4 lt 206718 rev 4 gt var A tes 4 Using the unit 4 3 3 3 Maxillary Sinus exposure 1 Insert the the lip holder for sinus imaging Place the disposable covers NOTE Use a new disposable cover for every patient 2 Adjust the unit height Guide the patient to the unit and instruct to stand as straight and tall as possible Ask the patient to take grip on the handles and set the mouth against lip holder Check the position of the midsagittal light If it is not on the midsagittal plane of the patient adjust the patient s
55. s are listed in the next table Note These guidelines may not apply in all situations Electromagnetic propagation is affected by absorption and reflection from structures objects and people Table 7 3 RF immunity of non life support equipment or system IEC 60601 1 2 206718 rev 4 SOREDEX 109 7 Technical data NOTE RF communications equipment can effect medical electrical equipment NOTE This equipment generates uses and can radiate radio frequency energy If not installed and used in accordance with this manual it may cause harmful interference to radio communications Portable and mobile HF communications equipment can also affect the performance of CRANEX 3D Recommended Separation Distances for Portable and Mobile RF Communications Equipment IEC 60601 1 2 Frequency of 150KHz to 80 MHz to 800 MHz to Transmitter 80 MHz 800 MHz 2 5 GHz Equation d 2 1 P d MP d WP Vi Fi Fi Rated Maximum Separation Separation Separation Output Distance Distance Distance Power of meters meters meters Transmitter watts Fig 7 1 Table4 110 SOREDEX 206718 rev 4 206718 rev 4 7 Technical data USE LIMITATION External components The use of accessories transducers and cables other than those specified may result in degraded ELECTROMAGNETIC COMPATIBILITY of the EQUIPMENT and or SYSTEM INSTALLATIONS REQUIREMENTS amp ENVIRONMENT CONTROL In order to minimize interference risks the following requirem
56. sta 32 or 64 bit Display 19 LCD display 1280 x 1024 or better 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 he PC and any other external devices must be connected in accordance with IEC 60601 1 1 The x ray unit must be connected to its 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 5 m 60 from the xray unit so that the patient cannot touch the PC or any other external device while being x rayed he 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 100 SOREDEX 206718 rev 4 Ceph ready option Ordered separately mw ae 4 Interchangeable Ceph Unit has the same sensor as ceph unit sensor with the pan unit Cost saving with future digital ceph upgrade Field upgrades for the unit Digital Cephalostat Kit Add digital ceph imaging to the digital pan unit 206718 rev 4 SOREDEX 7 Technical data
57. sure settings 28 SOREDEX 206718 rev 4 4 Using the unit 4 1 Attaching and removing the sensor WARNING Handle the sensor with care as instructed in this manual The sensor must not be dropped or exposed to impacts A shock indicator inside the sensor shows if the sensor has been exposed to excess impact 4 1 1 Attaching the sensor 1 Insert the four slots on the rear of the sensor into the four hooks in the sensor holder y ah D UO S ui UVI9d ff j iif f 2 Slide the sensor downwards until it stops and then slide the locking knob down on the side of the sensor to lock the sensor in position 206718 rev 4 SOREDEX 29 4 Using the unit 4 1 2 Removing the sensor 1 Slide the locking knob upwards on the side of the sensor to unlock the sensor 2 Slide the sensor up and remove it 4 2 Preparing the system 1 Switch on the unit and the PC 2 PC Start SCANORA software or 3rd party application 3 PC Open a new or existing patient or select a patient from the worklist See the user s guide supplied with the dental imaging program 30 SOREDEX 206718 rev 4 4 Using the unit 4 3 Panoramic exposures B Adult panoramic B Child panoramic Reduced width and height B Bitewing B Maxillary sinus B TMJ PA AP projection B TMJ lateral projection axially corrected 4 3 1 Positioning devices Bite block Chin plane TMJ support St Chin rest holder Lip holder for Chin cup ed
58. tep forward to straighten the spinal column Patient is slightly leaning backwards during the imaging 5 Check the position of the midsagittal light If it is not on the midsagittal plane of the patient adjust the patient s head SOREDEX 206718 rev 4 4 Using the unit Make sure the patient s head is not turned or tilted 6 Adjust the height of the Frankfort Horizontal plane FH laser to get the laser light over the orbita porion otraighten the patient s head if needed i var Ae 206718 rev 4 SOREDEX 35 4 Using the unit 7 Close the temple supports by sliding the temple support knob to the right A Adjust the position of the nasion support B and push the forehead support in until it touches the patient s nasion C 8 The focal trough light indicates the center of the focal trough which is 10 mm wide at the front The root apices of the patient s central upper and lower front incisors must be within the focal trough Ask the patient to open their lips so that you can see their teeth The focal trough light should be positioned slightly in front of the root apices which for most patients will be in the middle of 3rd tooth canine If the patient is edentulous the focal trough light should be approximately 5mm behind the lip holder when the focal trough position is 0 mm 36 SOREDEX 206718 rev 4 4 Using the unit NOTE f the focal trough light is not positioned as gt described abov
59. the ClearTouch control panel after the scout image has been taken Press the Return button to rotate the unit to patient in position Adjust the unit height Ask the patient to remove any spectacles hearing aids removable dentures jewellery and hair clips and pins Guide patient to the unit Instruct patient to stand as Straight and tall as possible next to the unit Patient can also be imaged in sitting position Ask the patient to take grip on the handles and place chin on the chin cup SOREDEX 206718 rev 4 4 Using the unit 9 Check the position of the midsagittal light If it is not on the midsagittal plane of the patient adjust the patient s head Nm et 10 Adjust the unit height and chin rest height to get the SN amp area of interest between the top and bottom FOV i lights Position the patient so that the occlusal plane is horizontal 1 Horizontal light top of FOV 2 Horizontal light bottom of FOV NOTE Target ROI is always in the middle plane of laser lights 206718 rev 4 SOREDEX 63 4 Using the unit 11 Select the image area from the dental arch 12 Close the temple supports by sliding the temple support knob to the right A Adjust the position of the nasion support B and push the forehead support in until it touches the patient s nasion C 13 Select A the Scout image Or B the Standard or High resolution 3D image 64 SOREDEX 206718 rev 4 4 Using the unit
60. tioning 4 4 2 1 Full width and reduced width projection A Maija Mallinen DT DD 9000 GO 77 9 210 0 3 Quee XE Cas 206718 rev 4 SOREDEX 47 4 Using the unit 1 Unlock the lever and turn the ear rods to the lateral projection position Lock the position 2 Place the disposable covers NOTE Use a new disposable cover for every patient 3 Adjust the unit height 4 Guide the patient to the unit Instruct the patient to stand as straight and tall as possible under the cephalostat head Slide the ear rods towards to patient s ears 48 SOREDEX 206718 rev 4 4 Using the unit 5 Adjust the patient head so that the Frankfort Horizontal plane FH and laser light are in same horizontal plane 6 Slide nasion support against patient s nasion 206718 rev 4 SOREDEX 49 4 Using the unit 4 4 2 2 PA projection Maija Mallinen 10 0 4 20 0 dre 50 SOREDEX 206718 rev 4 4 Using the unit 1 Unlock the lever and turn the ear rods to the PA projection position Lock the position Tilt the nasion support aside 2 Place the disposable covers NOTE Use a new disposable cover for every patient 3 Adjust the unit height AN 4 Guide the patient to the unit facing the sensor Instruct the patient to stand as straight and tall as possible under the cephalostat head Slide the ear rods towards patient s ears 206718 rev 4 SOREDEX 51 4 Usin
61. y SOREDEX 206718 rev 4 206718 rev 4 1 Introduction General warnings There should be enough 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 exposures must be correctly shielded from the radiation that is generated when the unit is operated The unit or its parts must not be changed or modified in any way without approval and instructions from SOREDEX When servicing use only approved replacement parts supplied by SOREDEX The Ethernet cable shall be unshielded CAT6 so that multiple chassis are not connected If this device is 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 Directive 93 42 EEC and or relevant legal requirements 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 The unit must be installed according to the unit installation amp Adjustments manual by a qualified tech

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