CRANEX D - Dental Concepts
Contents
1. 7 3 1 PE TG TEPPE CC 7 3 2 Preparing thie fem rH 8 3 3 Taking a panoramic exposure 9 Selecting the panoramic program bte tu suona ind tur ta 9 Positioning the patient for a panoramic exposure 10 Takinga F RE eg 15 After taking panoramic exposure 3 e erre peo 17 3 4 Taking a temporomandibular joint 18 Selecting the TMY PEN S 18 Positioning the patient for TMJ exposures 18 Taking TMJ EPLE eee 19 After taking TMJ GXDOSUF BS used aou las ma ndn cU UE 22 3 5 Taking a 23 Selecting the sinus 23 Positioning the patient for a Sinus exposure 23 Takinga 15461010 25 26 4 Taking cephalometric exposures option 27 4 1 IIO PO 27 4 2 ct 27 4 3 Taking a cephalometric exposure mum 28 Selecting the cephalometric program2. D 10 Troubleshooting and Maintenance If you do not hear the exposure warning tone when an exposure is taken stop using the unit and contact your service technician for help Check weekly that the mains cable of the unit is in proper order and that all the unit operates Make sure that the unit does not move up down if the safety switch is pressed Yearly maintenance Disposal 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 akV mA test beam alignment test a ball pin test a check to see that the safety ground is connected a check to see that the positioning lights operate a check to see that the tube head is not leaking acheck to see 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 At the end of the useful working life of the unit and or its accessories make sure that you follow national and local regulations regarding the disposal of the unit its accessories parts and materials The unit includes some parts that are made of or include materials that are non environmentally friendly or hazardous User s manual 203371 51 11 Warnings and precautions Cranex D 11 Warnings and precautions The unit must only be used to take the dental
3. 28 Positioning ING DAMON 29 Taking EE 31 hugo 33 User s Manual 203371 iii D 5 Carpus exposures Not in USA rrnnnnnnnnnnnvvnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnvnnnnnnnnnnnnnen 34 6 Using the unit without 2 36 Attaching and removing the CCD sensor 111 37 TT Ol 37 7 2 E MNA 38 8 Exposure switch bek ERAN RR 39 8 1 Unlocking the exposure SMIT 39 8 2 Locking the exposure switch 39 70 EM aaia 40 EE 40 2 MADE PIG VIEW das 42 10 Troubleshooting and maintenance cessere 44 10 1 44 44 Unit EOTS NR RR 47 Other per PODIENS Em 49 10 2 Care MaitenanCE 50 Cleaning and disinfecting the 0 50 Enamelled SUMBCES iios or nnigiaanaaaasanaees 50 Positioning mirror and light 1 50 Surfaces that the patient touch
4. 30 User s manual 203371 D 4 Cephalometric exposures Taking an exposure kV 85 81 6 1 Check once more that the patient is positioned correctly for the exposure you plan to take and has not moved Press the RETURN key to drive the rotating unit to the ceph start position Make sure that the READY light is on If it is not refer to section 10 1 Error messages NOTE When the unit is in the ceph start position and the ready light is on the unit cannot be driven up and down The value exposure time based upon the size of the patient s head will be automatically selected IMPORTANT NOTE The unit must be in the ceph START position press the RETURN key for the KV value and exposure time to be automatically selected If the unit is not driven to the START position the kV value and exposure time will NOT be automatically selected and the values that were used for the previous ceph exposure will be selected User s manual 203371 31 4 Cephalometric exposures kV 85 6 81 D If you wish to change the kV or exposure time select different values Ask the patient to bite their teeth together nor mally Move at least two metres from the unit and protect yourself from radiation Make sure that you can see the patient during the exposure Press and hold down the exposure button for the duration of the exposure
5. Ceph reduced width Lat q _ AT X rays OFF key Partial panoramic keys READY indicator Exposure indicator Info key mA display Exposure values display 5 Exposure time D Dose L Focal trough position mm in PIO position Exposure time selection keys Info display Focal trough adjustment keys Y movement RETURN key Up Down adjustment keys Z movement 4 User s manual 203371 Cranex D 2 Unit description 2 4 User interface D Always on top key lt 5286661 vB 10 0ma o 10 8 s Error code display 1 3 mGycm Info key Scroll up down keys User s manual 203371 5 2 Unit description Cranex D 2 5 Accessories Chin rest 9802612 Disposable cover for chin rest 6801140 gt Bite block 6811860 Disposable cover for bite block 6801120 lt gt Lip support 6811880 a Disposable cover for lip support 68011 s 9 Lip holder 6811870 Disposable covers for cephalometric ear cones 6801150 gt 6 User s manual 203371 D 3 Panoramic Exposures 3 Taking Panoramic Exposures 3 1 Preparing the PC CRANEX D Gui 17 PC Switch the PC that is connected to the unit 2 PC Open the dental imaging software and then open anew or existing patien
6. The Image Preview window will reappear Click OK to apply adjustments to the current image and ALL subsequent images NOTE If you wish to have the factory default settings click the Factory defaults radio button 42 User s manual 203371 D 9 Unit setup The Marking field These tools allow you to add text and numbers to an image User s manual 203371 43 10 Troubleshooting and maintenance Cranex D 10 Troubleshooting and maintenance 10 1 Error messages If the READY light does not come on and an error message appears on the screen it indicates that there is a problem with the unit Correct the cause of the error and then press the E key to clear the error from the display If another error message appears after you have cleared the first it indicates that there is another problem with the unit PC On the user s interface the info key will turn red and the error message will appear The scroll up down keys allow you to scroll through errors User Errors PC1 NC only on the User s Interface PROBLEM X ray unit not switched on or there is no connection between the PC and the Unit SOLUTION Switch the unit on and or check that the cable between the PC and the UNIT is con nected properly CoL Pan Ceph units only PROBLEM The primary slot has not moved to the correct position Ceph primary slot has been selected for a panoramic program exposure SOLUT
7. During the exposure you hear the audible signal and the radiation warning light on the display 32 User s manual 203371 D 4 Cephalometric exposures After exposure 1 Open the ear posts and the forehead support Guide the patient out of the unit The front head support can be turned to make it easier for the patient to get out PC The digital image can now be examined using Digora for Windows not in USA Press the return key and the unit is now ready to take another ceph exposure If you wish to take a panoramic exposure click the appropriate panoramic exposure key and then press the RETURN key The rotating unit will return to the panoramic PIO position User s manual 203371 33 5 Carpus exposures Cranex D 5 Carpus exposures Not in USA 1 Prepare the unit to take a PAcephalometric exposure 2 Slide the carpus holder on to the forehead support and then lock the carpus holder in position by turning the locking knob Carpus holder 3 Press the RETURN key to drive the rotating unit to r the ceph start position Check that the READY light is on If itis not refer to section 10 1 Error messages 34 User s manual 203371 D 60 5 Carpus exposures 4 Selecta kV value of 60 and an exposure time of 10 sec Place the patient s hand on the carpus holder Move at least two metres from the unit and protect
8. IMPORTANT NOTE You must take TWO separate exposures if you wish to have images of the TMJs with the mouth open and closed 1 Slide the lip support on to the holder Place a disposable cover on to the lip support 2 Prepare the patient in the same way as you would fora PANORAMIC exposure Holder Midsagittal light Open the mirror and position the patient as fol lows top lip pressed against the top of the lip support midsagittal plane coincides with the midsagit tal plane light Lip support 18 User s manual 203371 Cranex D 3 Panoramic Exposures focal trough light in the same position as for panoramic exposures between the upper 2nd tooth lateral incisor and the 3rd tooth canine Frankfort plane Horizontal light Focal trough light frankfort plane coincides or is parallel with the horizontal light 4 Close the temple supports by moving the temple support knob to the right and carefully push the forehead support in until it touches the patient s forehead or nasion 5 Close the mirror Taking TMJ exposures 1 Check once more that the patient has not moved and is positioned correctly fora TMJ exposure 2 Press the RETURN key to drive the rotating unit to 9 the START position User s manual 203371 19 3 Panoramic Exposures kV 85 D Make sure that the READY light is on If itis not refer to section 10 1 Error
9. Windows not in USA 26 User s manual 203371 D 4 Cephalometric exposures 4 Taking cephalometric exposures Ceph option 4 1 Preparing the PC Prepare the PC in the same way as described in Taking panoramic exposures 4 2 Preparing the unit 1 Attach the CCD sensor to the sensor holder on the ceph head see section 7 Attaching and removing the CCD sensor 2 Switch the unit on 3 Rotate the cephalometric head support so that it is in the correct position Lateral or PA for the cephalometric exposure you wish to take 4 Remove any chin rest support from the panoramic 2 2 User s manual 203371 27 4 Cephalometric exposures Cranex D 4 3 Taking a cephalometric exposure Selecting the cephalometric program 1 Select the required cephalometric program Full width Lateral or Posterior Anterior PA 9 Magnification 1 15 Field size full width lateral 22 cm heigh x 26 cm wide PA22 cm high x 20 cm wide NOTE The position of the ceph head support lateral or PA will automatically determine whether the lateral or PA program is selected Magnification 1 15 Field size 22cm high x 18 cm wide 4 Reduced width Lateral NOTE If the ceph head support is in the PA position the key is not active Turn the ceph head support to the lateral position to activate the key PC A picture will appear reminding you to remove the chin rest lip support be
10. the fast exposure time or the S key for the standard exposure time The selected exposure time will appear on the exposure values display NOTE When the unit is in the PIO position the exposure time will only appear briefly on the display when an S key is pressed Select the required panoramic program The programs are Adult panoramic magnification 1 34 Exposure time standard 17 6 s or fast 11 s Child panoramic magnification 1 34 Exposure time standard 13 8 s or fast 8 6 s Partial panoramic exposures magnification 1 34 Select the Adult panoramic program All the partial panoramic indicator lights will come on Select the first sector you wish to expose The indicator light for this sector will stay on and all the other sector lights will go out Select the other sectors you wish to expose Exposure times standard 3 1 4 7 6 4 3 1 or fast 1 9 2 5 4 8 2 5 1 9 User s manual 203371 3 Panoramic Exposures Cranex D Positioning the patient for a panoramic exposure NOTE If the patient appears nervous you may want reas sure the patient by demonstrating how the unit works To do this see section 6 Using the unit without x rays 1 Slide the chin rest on to the holder at the front of the patient handles A If the patient is DENTATE slide the bite block into the chinrest B If the patient is EDENTULOUS slide the lip holder into the chin rest Lip holder Bite Block C
11. unit has over heated because of extended continuous use SOLUTION Wait at least one hour for the tubehead to cool down Note that you will not be able to clear the error message until the tube head has cooled to the correct temperature If the error message appears even if the unit has not been used a lot switch the unit off and then on again If the error message reappears call service for help C2 the mains voltage is displayed The mains voltage out of allowed tolerances C3 gEn Tube fail signal activated Tubehead or generator defected C4 Inu Inverter defect The voltage of the tube does not increase during an exposure C5 FIL Filament defect mA does not increase during exposure C6 EEPROM defect User s manual 203371 47 10 Troubleshooting and maintenance Cranex D C7 Por R movement error C8 PoC Collimator movement error C9 PoL Linear Y movement error C10 PoU Z movement error C11 Poc Cephalo movement error C12 SEn CCD sensor base frequency failing C13 the wait time will appear in seconds Stepping motors over heated C14 Cba Cephalo beam misaligned C15nPC No connection to PC or PC does not acknowledge the image identification data SOLUTION Check that the cables between the PC and unit are connected C19LbL The PC acknowledges the image identification data but the data is corrupted SOLUTION Check that the cables between the PC and unit are c
12. 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 expo sure that the unit is not designed to take The unit or its parts must not be changed or modi fied in any way without approval and instructions from Soredex 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 de scribed in this manual and or if the user does not know how to use the unit Always use the lowest suitable x ray dose to obtain the desired level of image quality Because the x ray limitations and safety regula tions change from time to time it is the responsi bility 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 Avoid taking x ray exposures of pregnant women Never press the up down height adjustment button Z movement when the patient is positioned in the cephalometric head holder 52 User s manual 203371 D 11 Warnings and precautions The user must protect him herself from radiation when taking exposures The user must stand at least two meters from the patient when taking exposures The user must be able to see and hear the patient at all times The user must see the radiation warning light and hear the au
13. yourself from radiation Make sure that you can see the patient during the exposure Press and hold down the exposure button for the duration of the exposure During the exposure you hear the audible signal and the radiation warning light on the display will come on B e User s manual 203371 35 6 Using the unit without x rays Cranex D 6 Using the unit without x rays In some situations for example with nervous patients or patients with unusual anatomy you may wish to operate the unit without x rays before taking a proper exposure To do this press the TEST T key the indicator light will come on The exposure switch can now be pressed to demonstrate how the unit operates without x rays being generated Press the TEST T key asecond time to return to the normal exposure mode 36 User s manual 203371 D 7 Attaching and removing the CCD sensor 7 Attaching and removing the CCD sensor IMPORTANT NOTE Handle the CCD sensor with care and do not drop it 7 1 Attaching the sensor 1 Insert the four hooks on the rear of the CCD sensor into the four slots in the sensor holder CCD Sensor Slide the CCD sensor down until it stops and then slide the locking knob on the front of the CCD sensor to the left to lock the CCD sensor in posi tion The GREEN light on the rear of the CCD sensor will come on This indicates that the CCD sensor is ready
14. AC breaker activation leakage current in accordance with local regulations Mechanical parameters PANORAMIC Source to Image layer Distance SID 520 mm 10 mm Magnification factor 1 34 CEPHALOMETRIC Source to Image layer Distance SID 1721 mm 20 mm Source to Object Distance SOD 1500mm Magnification factor 1 15 WEIGHT Panoramic unit 120 kg Panoramic cepahlometric unit 165 kg DIMENSIONS Panoramic unit H x W x D 2320 x 1200 x 1000 mm Panoramic cephalometric unit H x W x D 2320 x 1200 x 1900 mm VERTICAL HEIGHT OF CHIN REST 950 1750 mm 10 mm D Version 3 Appendix A Technical Information Digital image receptor Only the CCD sensors specifically designed for Cranex D unit can be used PIXEL SIZE 96 micrometres Timer PANORAMIC EXPOSURE TIMES Adult normal 17 6 s 15 fast 11 s 415 Child normal 13 8 15 fast 8 6 s 15 Partial normal 3 1 5 45 7 65 45 3 15 fast 1 9 s 2 5s 4 8s 2 5s 1 9s Can be freely selected and combined overlap approx 0 3 s TMJ 3 2 3 2 s 15 240 mAs CEPHALOMETRIC EXPOSURE TIMES 8 20 scanning times 5 steps according to R 10 series ISO BACK UP TIMER 23 5 5 1 5s Leakage technique factors PANORAMIC 85 kV 2400 mAs h 85 kV 10 mA duty cycle 1 15 CEPHALOMETRIC 85 kV 1800 mAs h 85 kV 10 mA duty cycle 1 20 Measurement bases kV and mA values can be verified with a specified digita
15. CRANEX D Digital Panoramic and Cephalometric X ray Unit Version 3 User s Manual Number 203371 rev 1 0812 D Digital Panoramic and Cephalometric X ray Unit Version 3 User s Manual Medical Device Directive 93 42 EEC Number 203371 rev 1 0812 Original approved English language version Manufactured by SOREDEX Nahkelantie 160 Tuusula P O BOX 148 04301 Tuusula Finland Tel 358 0 45 7882 2000 Fax 358 9 701 5261 D 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 current product specifi cations Soredex maintains the right to make changes and alterations without prior notice ii User s Manual 203371 D Contents Te Intf OCDUG sn 1 1 1 Cranex D digital X ray Ulloa tren nri re esempi tiones 1 1 2 About this manual eser trennt pape epe nuance uc tunt Een P peu UU 1 20 descrIBEIOD smidde 2 XE D RER EG 2 2 2 Optional cephalometric 3 2 3 COMING 4 24A User MEM ACE EE 5 SIO COS SONOS 6 Taking Panoramic
16. ION Contact your dealer 44 User s manual 203371 Cranex D 10 Troubleshooting and Maintenance E4 CoL Pan Ceph units only PROBLEM The primary slot has not moved to the correct position Panoramic primary slot has been selected for a ceph exposure SOLUTION Contact your dealer E7 rEL PROBLEM The exposure button was released during an exposure SOLUTION Check if the attempted exposure is sufficient for the diagnostic task If it is not take a new exposure If the exposure failed while the exposure button was still being pressed check the exposure switch by taking a test exposure without patient to see if the exposure button is defective or not If the same problem occurs again call service E8 MoE PROBLEM The exposure button was pressed when one of the Y Z keys was being pressed SOLUTION Do not press the exposure button while the Y Z buttons are being pressed E9 the WAIT time will appear in seconds PROBLEM The WAIT time cooling time between exposures has not yet elapsed SOLUTION Wait until the WAIT time elapses User s manual 203371 45 10 Troubleshooting and maintenance Cranex D E10 dor PROBLEM The patient positioning mirror is open SOLUTION Close the mirror E12 cCo PROBLEM The primary collimator has not changed to the child panoramic size SOLUTION Press the E key to clear the error message Then press the RETURN key to drive the unit to the
17. PIO position and then press the key again to drive it to the START posi tion If the error message reappears call service E16 PoS PROBLEM i The rotating unit is not in the PIO or START position ii The mirror is open SOLUTION i Press the E key to clear the error and then press the RETURN key to drive the rotating unit to the right position ii Close the mirror E18 dCh PROBLEM i There is no connection to the PC ii or DW not in USA or the dental imaging software you are using is not open iii orthe CCD sensor is not attached to the sensor holder iv orthe CCD sensor is attached to the wrong sensor holder pan ceph units only v orthe CCD sensor is not fully locked in position 46 User s manual 203371 Cranex D 10 Troubleshooting and Maintenance SOLUTION i Switch the PC on and start DfW not in USA or the dental imaging software you are using and start the User Interface program ii Start DfW not in USA or the dental imaging software you are using iii Attach the CCD sensor to the sensor holder iv Attach the CCD sensor to the correct pan or ceph sensor holder v sure that the CCD sensor locking lever is pushed fully to the left the locked position Unit Errors If any of the following errors appear switch the unit off and then on again If the error message reappears call service for help C1 HHo PROBLEM The thermal switch in the tubehead has been activated because the
18. PP1 is intended for use the electromagnetic environment specified below The customer or the user of the PP1 should assure that it is used in such an environment Immunity test IEC 60601 test level Compliance level Electromagnetic environment guidance Electrostatic discharge ESD 6 kV contact 6 kV contact Floors should be wood concrete or ceramic tile 30 dip Ur for 25 cycles 30 dip in Ur for 25 cycles IEC 61000 4 2 8 kV air 8 kV air If floors are covered with synthetic material the relative humidity should be at least 30 Electrical fast 2 kV for power supply 2 kV for power Mains power quality transients bursts lines supply lines should be that of a IEC 61000 4 4 1 kV for input output 1 kV for typical commercial or ines input output lines hospital environment Surge 1 kV differential mode 1 kV differential Mains power quality IEC 61000 4 5 2 kV common mode mode should be that of a 2 kV common typical commercial or mode hospital environment Voltage dips lt 5 95 Ur lt 5 Ur Mains power quality short gt 95 dip in Ur gt 95 dip in Ur should be that of a interruptions and for 0 5 cycle for 0 5 cycle typical commercial or voltage variations hospital environment If on power supply 40 Ur 40 Ur user of the PP1 requires lines 60 dip in Ur 60 dip in Ur continued operation 61000 4 11 for 5 cycles for 5 cycles
19. Shows the statuses of the Pan device or Ceph device Pan Ceph device The statuses are Ok the device is ready for image capture Connected the device is connected to the PC Disconnected the unit is switched off or the there is no connection between the unit and the PC No Camera the CCD sensor is not connected to the unit Not Enabled device not enabled Not Enabled no gain file device not enabled because the gain file is missing The Versions field Shows the software and driver versions The Image Processing field The Show image preview check box see section 9 2 Image Preview The Automatic Density Adjust check box Select to automatically optimize the image density 40 User s manual 203371 D 9 Unit setup The Apply Enhancement check box Select to sharpen the image The enhancement value must be entered in the Matrix size edit box The recommended value is between 7 and 11 The maximum value is 25 maximum sharpening and 1 is the minimum minimum sharpening The Retrieve Last Image field If you wish to recover an image after a system failure or are dissatisfied with any automatic or manual changes made to the the image click the Must be retrieved check box to retrieve the original image The Device Serial Number field The Add serial number check box Select and then enter the serial number of the unit into the Serial number edit box to
20. User s manual 203371 37 7 Attaching and removing the CCD sensor Cranex D NOTE If the light is RED it indicates that the CCD sensor is not functioning correctly Switch the unit off and then on again If the light is still RED contact you dealer for assistance 7 2 Removing the sensor 1 Slide the locking knob on the front of the CCD sensor to the right to unlock the CCD sensor 2 Slide the CCD sensor up and remove it 38 User s manual 203371 Cranex D 8 Exposure switch lock 8 Exposure switch lock The exposure switch lock allows the exposure switch to be locked This prevents unauthorized people from taking exposures even if the unit is switched on The exposure switch lock is located on the side of the unit 8 1 Unlocking the exposure switch 5 Insert the key and turn it clockwise to the horizontal aN position to unlock the exposure switch 8 2 Locking the exposure switch Turn the key anticlockwise to the vertical position and O remove the key The exposure switch is locked User s manual 203371 39 9 Unit setup 9 Unit setup 9 1 Setup options Cranex D Various setup options allow the unit to be customized to your specific requirements PC Open DfW not in the USA or the dental imaging software you are using PC Select Options and then click CRANEX D Setup The CRANEX D Setup window will appear The Device Status field
21. add the serial to the images The serial number will appear in the top left hand corner and the bottom right hand corner of all new images NOTE If you select Enable image marking in DFW General Setup Image Image marking do NOT select the left top or right bottom options as the image marking text will appear on top of the serial number User s manual 203371 41 9 Unit setup 9 2 Image Preview Cranex D The Image Preview feature allows an image to be adjusted BEFORE it is saved The adjustments be applied to the open image only or to ALL subsequent images CAUTION Adjustments made to images CANNOT be undone after the adjustments have been saved If you wish to undo the adjustments retrieve the original image click Retrieve Last Image 1 PC In the D Setup window click the Show Image Preview check box Take an exposure PC The Image Preview window will automatically appear To activate image adjustment click the Density Adjustment and Sharpen filter check boxes The Image Quality Controls will become active and the image can be adjusted CURRENT IMAGE ONLY Click OK to apply the adjustments to the image in the Image Preview window ONLY CURRENT AND ALL SUBSEQUENT IMAGES Click the Edit Quality Presets button The Set Image Quality Presets window will appear The Get from Preview window radio button will be active Click OK to accept the image adjustments you have made
22. ansmitter in watts W according to the 4 3 transmitter manufacturer and d is the recommended separation distance in metres m Field strengths from fixed RF transmitters as determined by an electromagnetic site survey should be less than the compliance level in each frequency range Interference may occur in the vicinity of equipment marked with the following symbol t NOTE 1 At 80 MHz and 800 MHz the higher frequency range applies NOTE 2 These guidelines may not apply in all situations Electromagnetic propagation is affected by absorption and reflection from structures objects and people Field strengths from fixed transmitters such as base stations for radio cellular cordless telephones and land mobile radios amateur radio AM and FM radio broadcast and TV broadcast cannot be predicated theoretically with accuracy To assess the electromagnetic environment due to fixed RF transmitters an electromagnetic site survey should be considered If the measured field strength in the location in which the PP1 is used exceeds the applicable RF compliance level above the PP1 should be observed to verify normal operation If abnormal performance is observed additional measures may be necessary such as reorienting of relocating the PP1 gt Over the frequency range 150 kHz to 80 MHz field strengths should be less than 3 V m D Version 3 Appendix A Technical Information R
23. atient appears nervous you may want to reas sure the patient by demonstrating how the unit works Holder 1 To do this see section 6 Using the unit without x rays Slide the lip support on to the holder Place a disposable cover on to the lip support User s manual 203371 23 3 Panoramic Exposures Midsagittal light Lip support Cranex D Prepare the patient in the same way as you would fora PANORAMIC exposure Open the mirror and position the patient as fol lows top lip pressed against the top of the lip support midsagittal plane coincides with the midsagittal plane light focal trough light as far backwards as possible 20 frankfort plane coincides with the horizontal plane light Frankfort plane Horizontal light Focal trough light Close the temple supports by moving the temple support knob to the right and carefully push the forehead support in until it touches the patient s forehead or nasion Close the mirror 24 User s manual 203371 D 3 Panoramic Exposures Taking a Sinus exposure 2 85 kV 85 6 81 Check once more that the patient has not moved and is positioned correctly for a Sinus exposure 2 Pressthe RETURN key to drive the rotating unit to the START position Make sure that the READY light is on If it is not refer to section 10 1 Error messages The KV value based upon
24. d the Warnings and Precautions in section 11 Warnings and Precautions before operating the unit NOTE Instructions starting with PC for example 1 PC Open a patient card indicate that the task is carried out from the PC Instructions NOT starting with PC for example 8 Close the head supports indicate that the task is carried out from the UNIT User s Manual 203371 2 Unit description Cranex D 2 Unit description 2 1 Cranex D Head support PC with User Interface Software and Digora for Windows dental Temple support knob ig gt i ESN 5 supports PC not included with unit Forehead support Cables to PC f Rotating unit Focal trough light CCD sensor Rear of unit Control panel Horizontal light Emergency stop button 6 Press to stop up down movement Turn clockwise to release Chin rests T Midsagittal light 2 User s manual 203371 Cranex D 2 Unit description 2 2 Optional cephalometric device Up I Down keys CCD sensor Ear posts Forehead support User s manual 203371 3 2 Unit description Cranex D 2 3 Control panel Either the control panel or the user interface 2 4 can be used to select the imaging programs and exposure factors Program selection keys Adult panoramic WY 85 KV selection keys Child panoramic 81 ew Temporomandibular joint di OVN 73 Cephalometric Lat PA aa
25. dio warning signal during the expo sure If the unit is installed in such a place where the warning light cannot be seen a separate warning light must be used Please contact the local service for help If the unit does not appear to be working correctly 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 whether 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 key switch in order to prevent unauthorized exposures Disinfect all the surface that the patient has con tact with after every patient 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 for example the Medical Device Directive 93 42 EEC and or FDA if appli cable User s manual 203371 53 11 Warnings and precautions Cranex D 54 User s manual 203371 D Version 3 Appendix A Technical Information Appendix A Technical Information A 1 Technical specifications Model 1 Classification IEC class I type B IP20 Conforms with the standards EN 60601 1 EN60601 1 3 EN 60601 2 7 and EN 60601 1 2 Group 1 class B Conforms with the regulations of DHHS Radiation Perfor
26. during power mains interruptions it is 70 Ur 70 Ur recommended that the PP1 be powered from an uninterruptible power supply or a battery 50 60 Hz magnetic field IEC 61000 4 8 NOTE Ui is the mains voltage prior to application of the test level 5 96 Ur lt 5 Ur gt 95 dip in Ur gt 95 dip in Ur for 5 sec for 5 sec Power frequency 3 A m 3 A m Power frequency magnetic field should be at levels characteristic of a typical location in a typical commercial or hospital environment Appendix A Technical Information Cranex D Version 3 Guidance and manufacturer s declaration electromagnetic immunity The PP1 is intended for use the electromagnetic environment specified below The customer or the user of the PP1 should assure that it is used in such an environment Immunity IEC 60601 test Compliance Electromagnetic environment guidance test level level Portable and mobile RF communications equipment should be used no closer to any part of the PP1 including cables than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter Recommended separation distance Conducted 3 Vrms d 124P RF 150 kHz to 61000 80 MHz 12 80 MHz to 800 MHz d 2 34P 800 MHz to 2 5 GHz Radiated 3 V m 3 V m where P is the maximum output power rating RF 80 MHz to IEC 61000 25GHz of the tr
27. ecommended separation distances between portable and mobile RF communications equipment and the PP1 The PP1 is intended for use an electromagnetic environment in which radiated RF disturbances are controlled The customer or the user of the PP1 can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment transmitters and the PP1 as recommended below according to the maximum output power of the communications equipment Rated maximum Separation distance according to frequency of transmitter output power of 150 kHz to 80 MHz 80 MHz to 800 MHz 800 MHz to 2 5 GHz transmitter W d 1 2 P d 1 2 P d 2 3 P 0 01 0 12 0 12 0 23 0 1 0 38 0 38 0 73 1 1 2 1 2 2 3 10 3 8 3 8 7 3 100 12 12 23 For transmitters rated at a maximum output power not listed above the recommended separation distance d in meters 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
28. es 2 1 2 0 1000000000 3000000000044 50 Correct operation of the UE cuui caeno n a en Eee enden 50 Yearly maintenance NN 51 Bollo PERERA an E AE E 51 11 Warhings arid 52 Appendix Technical Information 1 AT Technical SPENNE 1 EA ol EE A 6 Symbols that appear on the A 7 iv User s Manual 203371 D 1 Introduction 1 Introduction 1 1 Cranex D digital X ray unit The Cranex D is a digital dental x ray unit designed to take images of the dento maxillo facial complex of the human skull It can be used to take adult panoramic exposures child panoramic exposures reduced width and height partial panoramic exposures Sinus exposures andTMyJ exposures An optional cephalometric device allows ceph and carpus not USA exposures to be taken Both the unit and the cephalometric device use CCD sensors as the image receptor and a PC with the User Interface and suitable dental imaging software such as Digora for Windows not in USA to handle the digital dental images 1 2 About this manual This manual describes how to use the Cranex D digital dental x ray unit and the optional cephalometric device Please read these instructions an
29. fore taking a cephalometric exposure Remove the chin rest lip support if you have not already done so and then click the tick button on the reminder picture The picture window will disappear NOTE If you do not want the picture window to appear every time you click a cephalometric key click the check box in the bottom left hand corner of the picture window 28 User s manual 203371 Cranex D 4 Cephalometric exposures Positioning the patient 1 Press the RETURN key to drive the rotating unit to gt the ceph PIO position The CCD sensor will also move to the PIO position 2 Place the protective disposable covers onto the ear cones User s manual 203371 29 4 Cephalometric exposures Cranex D Ask the patient to stand between the open ear posts Adjust the height of the unit so that the ear posts are level with the patients ears Position patient s head so that the Frankfort plane is horizontal Close the ear posts by sliding the ear post knob to the left WARNING NEVER move the unit up or down when the ear posts are in the patient s ears If you are taking a lateral exposure push the frontal support in carefully until it touches the patient s nasion The frontal support will automatically select the correct amount of soft tissue filtering If you are taking a PA exposure turn the frontal support sideways to the horizontal position
30. heir tongue against the roof of their mouth Also ask the patient to look at a fixed point in the mirror and to remain still for the duration of the exposure 5 Moveatleast two metres from the unit and protect yourself from radiation Make sure that you can see and hear the patient during the exposure 6 Press and hold down the exposure button for the duration of the exposure During the exposure you hear the audible signal and the radiation warning light on the display will come on The rotating unit will rotate around the patient s head and then stop When the rotating unit stops the exposure has been taken 16 User s manual 203371 Cranex D 3 Panoramic Exposures After taking a panoramic exposure 1 Open the temple supports and press the button to release the forehead support 2 Guide the patient out of the unit 3 Press the RETURN key to drive the unit to the PIO P position 4 PC The digital image can now be examined using Digora for Windows not in USA User s manual 203371 17 3 Panoramic Exposures Cranex D 3 4 Taking a temporomandibular joint exposure Selecting the TMJ program 1 Select the Temporomandibular joint program WU magnification 1 34 Positioning the patient for TMJ exposures NOTE If the patient appears nervous you may want to reas sure the patient by demonstrating how the unit works To do this see section 6 Using the unit without x rays
31. hin rest Chin rest ni 2 Placethe appropriate disposable covers on the chin support you are using E 10 User s manual 203371 Cranex D 3 Panoramic Exposures Ask the patient to remove any spectacles and false teeth and any jewellery or metal objects from their face ears or neck Also ask them to remove any hair clips or pins 4 Place a protective lead apron over the patient s shoulders 5 Press the height adjusting keys to adjust the height of the chin support until it is slightly higher than the patient s chin 6 Ifthe patient is DENTATE ask them to grasp the patient handles place their chin on the chin rest and bite the bite block The biting edges of the patient s upper and lower incisors must be positioned in the respective notches in the top and bottom of the bite block Chin rest If the patient is EDENTULOUS ask them to place their chin on the chin rest and press their top lip against the lip holder User s manual 203371 11 3 Panoramic Exposures Midsagittal plane Correct position Cranex D Open the mirror so that you can see a reflection of the patient in the mirror The patient positioning lights will come on NOTE The lights will remain on for 30 seconds If you need more time briefly press one of the focal trough light adjusting keys oM Look at the reflection of the patient in the mirror and position the midsagittal pla
32. it back to the PIO position Reposition the patient for the second pair of images mouth open or closed 9 Press the RETURN key to drive the rotating unit to the START position and then take the second pair of TMJ images User s manual 203371 21 3 Panoramic Exposures Cranex D After taking TMJ exposures 1 Open the ear posts and press the button to re lease the forehead support 2 Guide the patient out of the unit 3 Press the RETURN key to drive the unit to the PIO position 4 The digital image can now be examined using Digora for Windows not in USA 22 User s manual 203371 D 3 Panoramic Exposures 3 5 Taking a sinus exposure Selecting the sinus program Select the exposure time you require Press the S key for the fast exposure time or the S key for the standard exposure time The selected exposure time will appear on the exposure values display NOTE When the unit is in the PIO position the exposure time will only appear briefly on the display when an S key is pressed Select the Adult panoramic program All the partial exposure indicator lights will come on Select the lower three areas After you select the first area the other indicator lights will go out Select the other two areas The magnification is 1 34 Exposure times standard 15 6s fast9 8s Positioning the patient for Sinus exposure NOTE If the p
33. l multimeter according to separate measurement instructions The exposure times can be measured as the duration of radiation in the primary radiation beam Exposed field size in cephalometry 22 x 26 cm for lateral projections 22 x 20 cm for PA and AP projections Automatic filtration of soft tissues for lateral projections controlled by software Operating ambient conditions Operating temperature 10 40 C Relative humidity 0 85 RH Appendix Technical Information Cranex D Version 3 Storage ambient conditions Storage temperature 0 40 C Relative humidity 0 85 RH Minimum computer requirements The values in brackets are recommended values OPERATING SYSTEM Windows XP Professional Home SP1 or SP2 Windows 2000 Professional SP4 CPU Pentium 4 or Athlon XP or equivalent 1 5 GHz or better recommended RAM 256 MB 512 MB recommended HDD 20 GB single user VIDEO RAM 16 MB or more NETWORK CONNECTION 10 100 Mbit s Ethernet NIC DISPLAY 1280 x 1024 x 24 bit Tru Color 85Hz display 19 CRT or 17 TFT LCD recommended PCI slot 1 free Connection to the PC must meet EN60601 1 requirements The use of ACCESSORY equipment not complying with the equivalent safety re quirements of this equipment may lead to a reduced level of safety of the resulting system Consideration relating to the choice shall include use of the accessory in the PATIENT VICINITY evide
34. lder when the focal trough position is 0 mm NOTE If the focal trough light is not positioned as de lt gt scribed above press the focal trough adjustment key s to move the focal trough light until it is positioned correctly 12 Carefully push the forehead support in until it Forehead touches the patient s forehead or nasion support 13 Close the mirror 14 User s manual 203371 D 3 Panoramic Exposures Taking a panoramic exposure qi kV 85 81 9 Check once more that the patient has not moved and is positioned correctly for a panoramic exposure 2 Press the RETURN key to drive the rotating unit to the START position Make sure that the READY light is on If itis not refer to section 10 1 Error messages The kV value based upon the size of the patient s head will be automatically selected IMPORTANT NOTE The rotating unit must be in the START position press the RETURN key for the kV value to be automatically selected If the rotating unit is not driven to the START position the kV value will NOT be automatically selected and the kV value that was used for the previous exposure will be selected User s manual 203371 15 3 Panoramic Exposures Cranex D kV Ifyou wish to change the kV select a different 85 value 81 4 Beforetaking a panoramic exposure ask the patient to press their lips together and press t
35. mance Standard 21CFR Subchapter J The unit must be installed within a protected clinical area Unit description Dental panoramic and panoramic cephalometric x ray units with a high frequency switching mode x ray generator The panoramic version takes panoramic exposures The panoramic cephalometric version takes panoramic and cephalometric exposures The unit uses a CCD sensor as image receptor X ray generator TUBE OPX 105 or equivalent FOCAL SPOT 0 5 mm IEC 336 TARGET ANGLE TARGET MATERIAL Tungsten OPERATING TUBE POTENTIAL Panoramic imaging 57 85 kV 4 kV Cephalometric imaging 60 85 kV 4 kV OPERATING TUBE CURRENT 10 mA 1 mA at 0 5 FS MAXIMUM TUBE CURRENT 11 MAXIMUM OUTPUT POWER 945 W nominal FILTRATION minimum filtration 2 7 mm Al Appendix Technical Information Cranex D Version 3 BEAM QUALITY HVL over 2 5 Al 85 kV OUTER SHELL TEMPERATURE 50 122 F maximum DUTYGYGLE controlled by the software of the unit Power requirements INPUT VOLTAGE 230 or 115 VAG 10 50 60 Hz single phase grounded socket MAXIMUM LINE CURRENT 0285 kV 10mA 230 VAC mains MAXIMUM LINE RESISTANCE 1 ohm MAXIMUM LINE FUSING 10 20 slow 230 115 VAC main fuse 8A 16A slow in the device LINE SAFETY SWITCH when required Approved type min 10 A 250 VAC EARTH LEAKAGE CIRCUIT BREAKER when required Approved type min 16 A 250 V
36. messages The kV value based upon the size of the patient s head will be automatically selected IMPORTANT NOTE The rotating unit must be in the START position press the RETURN key for the kV value to be automatically selected If the rotating unit is not driven to the START position the kV value will NOT be automatically selected and the kV value that was used for the previous exposure will be selected If you wish to change the select a different value Before taking a TMJ exposure ask the patient to open their mouth mouth open or close their mouth and clench their back teeth together mouth closed TMJ depending on which TMJ exposure you wish to take first Also ask the patient to look at a fixed point in the mirror and to remain still for the duration of the exposure Move at least two metres from the unit and protect yourself from radiation Make sure that you can see and hear the patient during the exposure User s manual 203371 D 3 Panoramic Exposures Press and hold down the exposure button for the duration of the exposure During the exposure you hear the audible signal and the radiation warning light on the display will come on The rotating unit will rotate around the patient s head and then stop When the rotating unit stops the exposure has been taken Press the RETURN key after you have taken the first pair of TMJ images to drive the rotating un
37. nce that the safety certification of the ACCESSORY has been performed in accordance to the appropriate IEC 601 1 and or IEC 601 1 1 harmonized national standard the fibre optic cable provided by the manufacturer shall be used D Version 3 Appendix A Technical Information Tube housing assembly cooling characteristics TUBE HOUSING ASSEMBLY COOLING CHARACTERISTICS HEAT UNITS 8 T a 30 60 90 120 150 180 TIME MINUTES OPX 105 and KL5 a mA 20 18 1 16 4 2 201 Sat 14 I 12 700 HH 10 710 kJoule 1 kJ 05 01 020305 1 23 5 10 2030 Appendix Technical Information Cranex D Version 3 A 2 Unit dimensions 1825 Cranex D Version 3 Appendix A Technical Information A 3 Symbols that appear on the unit O Exposure switch locked ail Exposure switch or enabled Off or disabled N Radiation warning N Attention consult accompanying documents Exposure switch unlocked Protective earth ground 45 X ray source assembly emitting Dangerous voltage l Ground Functional C CE 0537 symbol gt 93 42 SSIF D Classification a
38. nd CSA classification Type B equipment 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 A 7 Appendix A Technical Information Cranex D Version 3 Guidance and manufacturer s declaration electromagnetic emissions The 1 is intended for use in the electromagnetic environment specified below The customer or the user of the PP1 should assure that it is used in such an environment Emissions test Compliance Electromagnetic environment guidance RF emissions Group 1 The PP1 uses RF energy only for its internal function CISPR 11 Therefore its RF emissions are very low and are not likely to cause any interference in nearby electronic equipment RF emissions Class B The PP1 is suitable for use in all establishments CISPR 11 including domestic establishments and those directly Harmonic Class A connected to the public low voltage power supply emissions network that supplies buildings used for domestic 61000 3 2 purposes Voltage Complies fluctuations flicker emissions IEC 61000 3 3 D Version 3 Appendix A Technical Information Guidance and manufacturer s declaration electromagnetic immunity The
39. ne of the patient so that it coincides with the midsagittal plane light The patient s head must be positioned symmetri cally and the patient must be looking straight ahead The patient s head must NOT be tilted or turned to one side Incorrect head tilted Incorrect head turned 12 User s manual 203371 D 5 Temple support knob 3 Panoramic Exposures Press either height adjusting key to adjust the tilt of the patient s head until the patient s Frankfort plane coincides with or is parallel to the horizon tal light _ Frankfort plane Horizontal light 10 Close the temple supports by moving the temple support knob to the right Make sure that patient s neck is stretched and straight The focal trough light indicates the center of the focal trough which is 15 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 between the upper 2nd tooth lateral incisor and upper 3rd tooth canine when the focal trough position is 0 mm User s manual 203371 13 3 Panoramic Exposures Cranex D If the patient is edentulous the focal trough light should be approximately 5mm behind the lip omm ho
40. onnected C40 rAM RAM defect C41 roM EPROM defect C42 Lin Mains voltage selector in wrong position C43 FIL Preheat circuit not functioning preheat not calibrated on the Filament Board C44 InP A key is held or stuck down 48 User s manual 203371 Cranex D 10 Troubleshooting and Maintenance C46 cPu CPU defect C51 Ulb Only PC user s interface X ray unit is in the service mode Reset error codes from control panel Other operating problems The unit does not become READY for an exposure CAUSE Wrong collimator CCD sensor not installed or no connection to the PC SOLUTION Press the exposure or info button On the kV and mA displays there appears an error code which indicates the reason why the unit is not ready for exposure Clear the error code by pressing the E key Rectify the reason If the error appears although the detail is in order please call service The unit does not move to the start position START CAUSE The unit is not ready for exposure READY SOLUTION Find out why the unit is not ready for exposure by pressing the exposure button Rec tify the problem and try again Red error Indicator light on the CCD sensor comes on CAUSE If the GREEN led on the rear of the CCD sensor turns RED it indicates that there is a problem with the CCD sensor imaging chain SOLUTION Switch the power off from the Cranex D unit for few seconds and switch it on again U
41. ser s manual 203371 49 10 Troubleshooting and maintenance Cranex D 10 2 Care and Maintenance Cleaning and disinfecting the unit Warning Switch the unit off before cleaning it Enamelled surfaces All enamelled surfaces can be wiped clean with a soft cloth dampened with a mild detergent NEVER use abrasive cleaning agents or polishes on this equip ment Positioning mirror and light lenses The positioning mirror and positioning light lenses are made of glass Use a soft cloth dampened with a mild detergent NEVER use abrasive cleaning agents or polishes on this equipment 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 manufacturer s instructions Correct operation of the unit If any of the unit s controls displays or functions fail to operate or do not operate in the way described in this manual switch the unit off wait 30 seconds and then switch the unit on again If the unit still does not oper ate correctly contact your service technician for help If you hear the exposure warning tone but the expo sure warning light does not come on when an expo sure is taken stop using the unit and contact your service technician for help 50 User s manual 203371
42. t card for the patient For information on how to do this refer to the user s guide supplied with the dental imaging software NOTE PC If you wish to use the User Interface to select the program and exposure factors click the CRANEX D Gui icon to open the User Interface PC If you want the User Interface Window to remain visible and always on top of other windows click the Always on top key User s manual 203371 3 Panoramic Exposures Cranex D 3 2 Preparing the Unit 1 ON OFF switch 2 Attach the CCD sensor to the sensor holder on the rotating unit if it is not already attached For information on how to attach and remove the CCD sensor see section 7 Attaching and removing the CCD sensor Press the ON OFF switch on the rear right hand side of the unit to the on position 1 to switch the unit on The unit will carry out a self test during which the display lights will come on Press the RETURN key to drive the rotating unit to the patient in out PIO position The READY light will come on and rotating unit will automatically move to the 0 mm focal trough position If the READY light does not come on refer to section 10 1 Error messages User s manual 203371 D 3 Panoramic Exposures 3 3 Taking a panoramic exposure Selecting the panoramic program Select the exposure time you require Press the S key for
43. the size of the patient s head will be automatically selected IMPORTANT NOTE The rotating unit must be in the START position press the RETURN key for the kV value to be automatically selected If the rotating unit is not driven to the START position the value will NOT be automatically selected and the KV value that was used for the previous exposure will be selected If you wish to change the kV select a different value User s manual 203371 25 3 Panoramic Exposures Cranex D Before taking a Sinus exposure ask the patient to press their lips together Also ask the patient to look at a fixed point in the mirror and to remain still for the duration of the exposure Move at least two metres from the unit and protect yourself from radiation Make sure that you can see and hear the patient during the exposure Press and hold down the exposure button for the duration of the exposure During the exposure you hear the audible signal and the radiation warning light on the display will come on The rotating unit will rotate around the patient s head and then stop When the rotating unit stops the exposure has been taken After taking a Sinus exposure Open the temple supports and press the button to release the forehead support Guide the patient out of the unit Press the RETURN key to drive the unit to the PIO position PC The digital image can now be examined using Digora for
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