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CRANEX D Digital Panoramic and Cephalometric

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1. Forehead 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 User s manual 8201083 17 3 Panoramic Exposures Cranex D 3 4 Temporomandibular Joint TMJ exposures 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 IMPORTANT NOTE You must take TWO separate exposures if you wish to have images of the TMJs with the mouth open and closed Lip support Slide the lip support on to the holder Place a disposable cover on to the lip support Prepare the patient in the same way as you would for a 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 midsagit tal plane light 18 User s manual 8201083 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 pus
2. s manual 8201083 31 4 Cephalometric exposures Cranex D 4 4 Taking an exposure 1 Check once more that the patient is positioned correctly for the exposure you plan to take and has not moved 2 Pressthe RETURN key to drive the rotating unit to the ceph start position The kV and exposure time will be automatically selected NOTE When the unit is in the start position and the ready light is on the unit cannot be driven up and down Check that the READY light is on If it is not refer to section 9 1 Error messages 3 If you wish to change the kV or Exposure time select different values from the User Interface 32 User s manual 8201083 Cranex D User s manual 8201083 4 Cephalometric exposures 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 During the exposure you hear the audible signal and the radiation warning light on the display 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 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
3. to section 9 1 Error messages The kV value based upon the size of the patient s head will appear on the unit display IMPORTANT NOTE ALWAYS press the RETURN key to drive the unit to the START position BEFORE you press the exposure button If you do not press the RETURN key first the kV value will NOT be automatically selected The kV value used will be the value on the control panel User s Interface User s manual 8201083 15 3 Panoramic Exposures 3 Cranex D If you wish to change the kV select a different value frm the User Interface Before taking a Panoramic exposure ask the patient to press their lips together and press their 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 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 The rotating unit will rotate around the patient s head and then stop When the rotating unit stops the exposure has been taken User s manual 8201083 Cranex D 3 Panoramic Exposures After taking a Panoramic exposure 1 Open the temple supports and press the button to release the forehead support
4. 1 Attaching the sensor cccccccseecccseeeeceeeeeceeeeeeeeeeseeeessseeseeeessaeeesaueeeseeessegs or 7 2 REMOVING the Sensor cccccescecesececeeeecceuceceuececsuseesueecseeessueeeseeeeeseneessass 38 9 EXDOSUNS SWITCH TOCK sussebass Eaa 39 8 1 Unlocking DOSEN Mccartney reese esseeauns sor eceuren lt aineesteeetennescunavincete 39 8 2 Locking the exposure switch EE NE 39 9 Troubleshooting and maintenance nnnrrnnnnuvnnnnnnnnnnnnnnnnnnnnnnnnnnnennnnnnennnnnvennnnnr 40 TETTE NNN 40 TETT geen ee ee nee eee 40 ONETO enters a d gece edn yee ce eee ee eng neces eed eee oe eee 43 Other operating problems EEE 45 TENNE 46 Cleaning and disinfecting the unit sciccoccscdescesasienvsdenwerdoccesaessetedescssddeeaetencen 46 Enamelied EE EE ETNE 46 Positioning mirror and light ICNSCS mand drenere aedekekdan 46 Surfaces that the patient touches ccccccccceeececeeeecseeeasesnasessenses 46 Corr ct operation of the UN S 46 Yearly maintenance ERE EE 47 ISO SAN EE E auecasasceecaeesenet aes eneeeaess 47 10 Warnings and precautions sisiccsccssedcsecsisesecensssnceususeesaseuedudestasnectexedccssnsenedecanswe 48 11 T cnnical informatio sosice ser secs oti cet cence csv eteeacceeveuteceevececcuuccts ccunercececseescaxpacence 50 VITEN SEE NN eee 50 2 ren 55 11 3 Symbols that appear ON the unit eee ccc cee eseececeeeeeeeeeceeeeeeeeseeaeeeeseaaeees 56 IV User s Manual 8201083 Cranex D 1 Introduction 1 Cranex
5. D digital X ray unit 1 1 Introduction The Cranex D is a digital panoramic dental x ray unit designed to take dental panoramic exposures It can take adult panoramic exposures child panoramic exposures reduced width and height partial panoramic exposures SINUS exposures and TMJ exposures An optional cephalometric device allows cephalomet ric 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 carefully before oper ating the unit Please read and observe the warnings and precau tions that appear in this manual See section 10 Warnings and Precautions User s Manual 8201083 1 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 imaging software with unit Forehead support Cables to PC H Jj y Rotating unit Rear of unit Control panel Horizontal light Emergency stop button Press to stop up down movement Turn clockwise T to release i Pow
6. a panoramic exposure click the appropriate panoramic exposure key on the User s Interface and then press the RETURN key The rotating unit will return to the panoramic PIO position 5 Carpus exposures Cranex D 5 Carpus exposures Not in USA 1 Prepare the unit to take a PA cephalometric exposure 2 Slide the carpus holder on to the forehead support and then lock the carpus holder in position by pushing the locking lever forward Carpus holder 3 Select a kV value of 60 and an exposure time of 10 sec Press the RETURN key to drive the rotating unit to the ceph start position Check that the READY light is on If itis not refer to section 9 1 Error messages 34 User s manual 8201083 Cranex D User s manual 8201083 5 Carpus exposures Place the patient s hand on the carpus holder 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 During the exposure you hear the audible signal and the radiation warning light on the display will come on 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 will come on The exposure switch can now be pressed to
7. sure warning light does not come on when an expo sure is taken stop using the unit and contact your service technician for help 46 User s manual 8201083 Cranex D 9 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 User s manual 8201083 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 a 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
8. 601 1 1 harmonized national standard only RS 232C interface cable and fibre cable provided by the manufacturer shall be used User s Manual 8201083 53 11 Technical Information Cranex D Tube housing assembly cooling characteristics TUBE HOUSING ASSEMBLY COOLING CHARACTERISTICS kHU HEAT UNITS 30 60 90 120 150 180 TIME IN MINUTES OPX 105 and KL5 H FIT T 1 41 kHU HL Corey kJoule 1 kJ 0 05 0 1 020305 No Q3 oy M D Q D 54 User s Manual 8201083 m Cranex D 11 Technical Information 11 2 Unit dimensions 2311 1825 User s Manual 8201083 55 11 Technical Information Cranex D 11 3 Symbols that appear on the unit O Exposure switch locked ul Exposure switch W Ready On or enabled O Off or disabled AN Radiation warning N Attention consult accompanying documents Exposure switch unlocked I LY ED Protective earth ground as X ray source assembly emitting Dangerous voltage Ground Functional C CE 0537 symbol MDD 93 42 EEC 0537 SSIF wen UL UL Classification and CSA classification GN e US 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 t
9. CRANEX D Digital Panoramic and Cephalometric X ray Unit User s Manual CE Vo Medical Device Directive 93 42 EEC Document number 8201083 rev 0510 Original approved English language version Manufactured by SOREDEX P O BOX 148 FIN 04301 TUUSULA FINLAND Tel 358 10 394 820 Fax 358 9 701 5261 Cranex D Soredex endeavours to produce product documentation that is accurate and up to date However our policy of continual product develooment 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 ji User s Manual 8201083 Cranex D Contents 1 Cranex D digital X ray unit seemed n eee 1 RT 1 1 2 About this manual een 1 2 Unt descri UON isan NE ENEE REENA RERE EAER Ea 2 aed FONE D eee eee ne EEE eee ee EE 2 2 2 Optional cephalometric device ccccccccseseeeceeeeeecseeeeeseeeeeeeeeaeeeeeeeeeeesaseeeeas 3 2 3 Unit operating Keys rrrnrnnnrvrnnnnrrrrnnnrvnnnnnrrnvnnnrnnnnnnrrnnnnnsnnnnnnsrnnnnnsnnnnnssennnnssnen 4 2 4 Unit displays and indicator lights ccccccccecsseeeeseeeeeeeseeseesseeseeeeeeeeessaeeeeeaas 5 2 5 Accessories EE EEE NE 6 3 Taking Panoramic EXposures nsnnvrnnnnvnnnnnnnnnnnnnnnnvennnnvnnnnuennnnvennnnvennnvennnnuennnner 7 PE NN NN 7 BZ FOAMING LG ES 8 3 3 Pano
10. Focal trough positon mm When in PIO position Exposure indicator READY indicator User s manual 8201083 5 2 Unit description Cranex D 2 5 Accessories Chin rest 9802612 Disposable cover for chin rest 6801140 Bite block 6811860 in Disposable cover for bite block 6801120 Lip support 6811880 Disposable cover for lip support 68011 0 DP Lip holder 6811870 Disposable covers for cephalometric ear cones 6801150 gt 6 User s manual 8201083 Cranex D 3 Panoramic Exposures 3 Taking Panoramic Exposures 3 1 Preparing the PC 1 Switch on the PC that is connected to the unit 2 Open Digora for Windows DfW software not in USA and then open a new or existing patient card for the patient For information on how to do this refer to the Digora for Windows user s manual not in USA Click the Image capture button not in USA on the patient card The button text will change to Abort capture which indicates that DfW not in USA is ready to receive an image 4 Click the User Interface icon to open the inter ng face 5 From the User Interface click the appropriate program key or keys for the exposure you wish to take The programs are Adult panoramic magnification 1 34 O Child panoramic magnification 1 34 Temporomandibular joint magnification 1 34 Goq User s manual 8201083 7 3 Panoramic Exposures Cranex D Partial panoramic exposures m
11. 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 tube head has been activated because the unit has over heated because of extended continuous use SOLUTION Wait at least one hour for the tube head 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 time will appear in seconds The mains voltage out of allowed tolerances C3 gEn Tube fail signal activated Tube head or generator defected C4 Inu Inverter defect The voltage of the tube does not increase during an exposure User s manual 8201083 43 9 Troubleshooting and maintenance Cranex D C5 FIL Filament defect mA does not increase during exposure C6 EEP EEPROM defect C7 Por R movement error C8 PoC Receptor 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 th
12. 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 2 D2 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 mA MAXIMUM OUTPUT POWER 945 W nominal FILTRATION minimum filtration 2 7 mm Al 50 User s Manual 8201083 Cranex D 11 Technical Information BEAM QUALITY HVL over 2 5 mm Al 85 kV OUTER SHELL TEMPERATURE 50 C 122 F maximum DUTY CYCLE controlled by the software of the unit Power requirements INPUT VOLTAGE 230 or 115 VAC 410 50 60 Hz single phase grounded socket MAXIMUM LINE CURRENT 7 A 0285 kV 10mA 230 VAC mains MAXIMUM LINE RESISTANCE 1 ohm MAXIMUM LINE FUSING 10 A 20A 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 VAC breaker activatio
13. agnification 1 34 Select the Adult panoramic program All the partial exposure indicator lights will come on Click the indicator light s for the area s that you DO NOT wish to expose the indicator light s will go out The remaining on light s indicate the area s that will be exposed Sinus magnification 1 34 Select the Adult panoramic program All the partial exposure indicator lights will come on Click the uppermost left and right indicator lights so that the they go out The three remaining on light s indicate that the sinus area that will be exposed Cephalometric Units with the ceph option only O See section 4 Cephalometric exposures The program lights on both the unit control panel and the User Interface will come on NOTE If you wish the User Interface Window to always remain visible click the Always on top key 3 2 Preparing the Unit 8 User s manual 8201083 Cranex D 3 Panoramic Exposures 1 Ifthe CCD sensor is not attached to the sensor holder on the rotating unit attach it For information on how to attach and remove the CCD sensor see section 7 Attaching and removing the CCD sensor 2 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 3 Press the RETURN key to drive the rotating unit t
14. as you would fora PANORAMIC exposure Holden lt 3 Open the mirror and position the patient as fol lows Midsagittal light top lip pressed against the top of the lip support midsagittal plane coincides with the midsagit tal plane light User s manual 8201083 23 3 Panoramic Exposures Cranex D focal trough light as far backwards as possible 20 frankfort plane coincides with the horizontal plane light Frankfort plane Horizontal light Focal trough 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 a Sinus exposure 1 Check once more that the patient has not moved and is positioned correctly for a Sinus exposure 2 Press the RETURN key to drive the rotating unit to the START position 24 User s manual 8201083 Cranex D User s manual 8201083 3 Panoramic Exposures Check that the READY light is on If it is not refer to section 9 1 Error messages The kV value based upon the size of the patient s head will appear on the unit display IMPORTANT NOTE ALWAYS press the RETURN key to drive the unit to the START position BEFORE you press the exposure button If you do not press the RETURN key first the kV value will NOT be automatically selected The kV value used will be the value on the control panel U
15. at 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 connected C40 rAM RAM defect C41 roM EPROM defect C42 Lin Mains voltage selector in wrong position 44 User s manual 8201083 Cranex D 9 Troubleshooting and Maintenance C43 FIL Preheat circuit not functioning preheat not calibrated on the Filament Board C44 InP A key is held or stuck down 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 lf the GREEN led on the rear of the CCD sens
16. cations equi Rated maximum Separation distance according to frequency of EA m output power of Fi kHz to 80 MHz A MHz to 800 MHz 800 MHz to 2 5 GHz transmitter W 1 2 Ip 1 2 IP d 2 3 4 P For transmitters rated at a maximum output power not listed above the recommended separation distance din meters m can be estimated using the equation applicable to the frequency of the transmitter where P is the maximum output power rating of the transmitter in watts W according to the transmitter manufacturer NOTE 1 At 80 MHz and 800 MHz the separation distance for the higher frequency range applies NOTE 2 These guidelines may not apply in all situations Electromagnetic propagation is affected by absorption and reflection from structures objects and people User s Manual 8201083
17. demonstrate how the unit operates without x rays being generated To do this press the TEST T key the indicator light O Press the TEST T key a second time to return to the normal exposure mode 36 User s manual 8201083 Cranex 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 Insertthe four hooks on the rear of the CCD sensor into the four slots in the sensor holder 2 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 User s manual 8201083 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 8201083 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 un
18. en 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 audio 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 11 Technical Information Cranex D 11 Technical Information 11 1 Technical specifications Model PP1 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 Performance
19. ency range applies NOTE 2 These guidelines may not apply in all situations Electromagnetic propagation is affected by absorption and reflection from structures objects and 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 P Over the frequency range 150 kHz to 80 MHz field strengths should be less than 3 V m User s Manual 8201083 59 11 Technical Information Cranex D Recommended separation distances between portable and mobile RF communications equipment and the PP1 The PP1 is intended for use in 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 ee below according to the maximum output power of the communi
20. er switch Chin rests Midsagittal light 2 User s manual 8201083 FSS PN Cranex D 2 Unit description 2 2 Optional cephalometric device Up I Down keys ETEN i ll N me CCD sensor Ear posts ass Forehead support i Fin User s manual 8201083 3 2 Unit description Cranex D 2 3 Unit operating keys The keys on User Interface are for selecting the programs and exposure parameters The keys on the unit display and control panel are for adjusting the height of the unit positioning the focal trough and driving the rotating unit to the ready posi tion User Interface Always on top key a D E 5 o B1 iz o 73 o 79 i Va i es Program selection keys KV selection keys o 60 U n it A rays OFF key Tlo Control Panel dn Partial panoramic Keys X rays OFF key Cepn exposure fime selection keys Info key l p Focal trough adjustment keys Y movement Up Down adjustment keys Z movement RETURN key 4 User s manual 8201083 Cranex D 2 Unit description 2 4 Unit displays and indicator lights PC User Interface de x mA display Exposure values display Exposure lime sec Dunng exposure D Dose mGycm Affer exposure Exposure indicator READY indicator Unit Control Panel KV display mA display Exposure Values display 5 Exposure time sec D Dose mGycnm L
21. g keys to drive it to the 0 position If the 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 3 Panoramic Exposures Chin rest Cranex D If the patient is EDENTULOUS ask them to place their chin on the chin rest and press their top lip against the lip holder 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 User s manual 8201083 Cranex D 3 Panoramic Exposures 9 Look at the reflection of the patient in the mirror and position the midsagittal plane 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 Midsagittal plane Correct position Incorrect head tilted Incorrect head turned 10 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 User s ma
22. ge variations on power supply lines IEC 61000 4 11 Power frequency 50 60 Hz magnetic field IEC 61000 4 8 NOTE U is the a c mains voltage prior to application of the test level 6 kV contact 8 kV air 2 kV for power supply lines 1 kV for input output lines 1 kV differential mode 2 kV common mode lt 5 Ur gt 95 dip In Ur for 0 5 cycle 40 Ur 60 dip in Ur for 5 cycles 70 Ur 30 dip in Ur for 25 cycles lt 5 Ur gt 95 dip In Ur for 5 sec 6 kV contact 8 kV air 2 kV for power supply lines 1 kV for input output lines 1 kV differential mode 2 kV common mode lt 5 Ur gt 95 dip in Ur for 0 5 cycle 40 Ur 60 dip in Ur for 5 cycles 70 Ur 30 dip in Ur for 25 cycles lt 5 Ur gt 95 dip in Ur for 5 sec IEC 60601 test level Compliance level Electromagnetic environment guidance Floors should be wood concrete or ceramic tile If floors are covered with synthetic material the relative humidity should be at least 30 Mains power quality should be that of a typical commercial or hospital environment Mains power quality should be that of a typical commercial or hospital environment Mains power quality should be that of a typical commercial or hospital environment If user of the PP1 requires continued operation during power mains interruptions it is recommended that the PP1 be powered from an uninterruptible
23. h 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 for a TMJ exposure 2 Press the RETURN key to drive the rotating unit to the START position User s manual 8201083 19 3 Panoramic Exposures Cranex D Check that the READY light is on If it is not refer to section 9 1 Error messages The kV value based upon the size of the patient s head will appear on the unit display IMPORTANT NOTE ALWAYS press the RETURN key to drive the unit to the START position BEFORE you press the exposure button If you do not press the RETURN key first the kV value will NOT be automatically selected The kV value used will be the value on the control panel User Interface If you wish to change the kV select a different value from the User Interface Before taking a TMJ exposure ask the patient to open their mouth mouth open TMJ 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 the reflection of their nose in the mirror and to remain still for the duration of the exposure User s manual 8201083 Cranex D User s manual 8201083 3 Panoramic Exposures Move at least two metres from the unit and protect yourself from radiation Make sure that y
24. he decommissioning of your equipment User s Manual 8201083 Cranex D 11 Technical Information Guidance and manufacturer s declaration electromagnetic emissions The PP1 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 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 IEC 61000 3 2 purposes Voltage Complies fluctuations flicker emissions IEC 61000 3 3 User s Manual 8201083 57 11 Technical Information Cranex D Guidance and manufacturer s declaration electromagnetic immunity The PP1 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 Immunity test Electrostatic discharge ESD IEC 61000 4 2 Electrical fast transients bursts IEC 61000 4 4 Surge IEC 61000 4 5 Voltage dips short interruptions and volta
25. hich lateral program is selected full width or reduced width Click the right key to change the lateral program from full to reduced or from reduced to full If you plan to take a P exposure one cephalomet ric key will appear The magnification of Cephalometric images is 1 15 The field sizes are Lateral full width 22cm high x 26cm wide Lateral reduced width 22cm high x 18cm wide PA 22cm high x 20 cm wide 4 Cephalometric exposures Cranex D 4 3 Positioning the patient 1 Press the RETURN key to drive the rotating unit to the ceph PIO position The CCD sensor will also move to the PIO position 2 Place the protective disposable covers onto the ear cones 30 User s manual 8201083 Cranex D 4 Cephalometric exposures 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 5 Ifyou 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 User
26. in the primary radiation beam Exposed field size in cephalometry 22 x 26 cm for lateral projections 22 x 22 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 52 User s Manual 8201083 Cranex D 11 Technical Information 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 COM 1 and COM 2 available 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 evidence that the safety certification of the ACCESSORY has been performed in accordance to the appropriate IEC 601 1 and or IEC
27. ish to take 4 REMOVE the CHIN REST LIP SUPPORT from the panoramic holder User s manual 8201083 27 4 Cephalometric exposures Cranex D 4 2 Preparing the PC user interface 1 Switch on the PC that is connected to the unit 2 Open Digora for Windows DfW software not in USA and then open a new or existing patient card for the patient For information on how to do this refer to the Digora for Windows user s manual not in USA Click the Image capture button not in USA on the patient card The button text will change to Abort capture which indicates that DfW not in USA is ready to receive an image 4 Click the PC User Interface icon to open the ng interface 5 Click the Cephalometric program key A window with picture will appear reminding you to REMOVE the chin rest lip support before 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 28 User s manual 8201083 Cranex D Oo f D Full Reduced 0 Q D User s manual 8201083 4 Cephalometric exposures 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 If you plan to take a Lateral exposure two cepha lometric keys will appear The left key indicates w
28. it is switched on The exposure switch lock is located on the side of the unit 8 1 Unlocking the exposure switch He Insert the key and turn it clockwise to the horizontal position to unlock the exposure switch 8 2 Locking the exposure switch Turn the key anticlockwise to the vertical position and D OD remove the key The exposure switch is locked User s manual 8201083 39 9 Troubleshooting and maintenance Cranex D 9 Troubleshooting and maintenance 9 1 Error messages lf the READY light does not come on and the INFO key appears on the User s Interface it indicates that there is an error Press the RETURN key or the Exposure button An error code or codes will appear on Unit Control Panel On the User s Interface press the INFO key to display the error code If there is more that one error code an a arrow keys will appear that allow you to display the Info key other error codes Correct the cause of the error and then press the E key on the Unit Control Panel to clear the error from the display 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 E3 CoL Pan Ceph units only PROBLEM The primary slot has not moved to the correct position Ceph primary slot has bee
29. n selected for a panoramic program exposure SOLUTION Contact you dealer 40 User s manual 8201083 Cranex D 9 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 you 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 lf 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 8201083 41 9 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 ke
30. n 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 User s Manual 8201083 51 11 Technical Information Cranex D Digital image receptor Only the CCD sensors specifically designed for Cranex D unit can be used PIXEL SIZE 96 micrometres Timer PANORAMIC EXPOSURE TIMES Normal 17 6 s 415 Child 16 s 15 Partial 1 98 38 9 2s 38 1 9s Can be freely selected and combined overlapping approx 0 3 s TMJ 3 3 3 3 s 15 Max 240 mAs CEPHALOMETRIC EXPOSURE TIMES 8 20 s scanning times 5 steps according to R 10 series ISO BACK UP TIMER 23 5 s 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 digital multimeter according to separate measurement instructions The exposure times can be measured as the duration of radiation
31. nual 8201083 13 3 Panoramic Exposures Cranex D Temple support knob 11 Close the temple supports by moving the temple support knob to the right Make sure that patient s neck is stretched and straight 12 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 lf the focal trough light is not positioned as de scribed above press the focal trough adjustment key to move the focal trough light until it is posi tioned correctly lf the patient is edentulous press the focal trough adjustment key to position the focal trough light until it is approximately 5mm behind the lip holder 13 Carefully push the forehead support in until it touches the patient s forehead or nasion Forehead Support 14 User s manual 8201083 Cranex D 3 Panoramic Exposures Taking a Panoramic exposure 1 Check once more that the patient has not moved and is positioned correctly for a panoramic expo sure 2 Press the RETURN key to drive the rotating unit to the START position Check that the READY light is on If itis not refer
32. o the patient in out PIO position The READY light will come If the READY light does not come on refer to section 9 1 Error messages User s manual 8201083 9 3 Panoramic Exposures Cranex D 3 3 Panoramic exposures adult child and partial Patient positioning for Panoramic 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 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 A Lip holder Bite Block Chin rest ger ee DE j r h Chin rest al 2 Place the appropriate disposable covers on the chin support you are using 10 User s manual 8201083 Cranex D Upper incisors NNotch Lower incisors Chin rest User s manual 8201083 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 Place a protective lead apron over the patient s shoulders Press the height adjusting keys to adjust the height of the chin support until it is slightly higher than the patient s chin If the focal trough is not 0 press either focal trough light adjustin
33. or hazardous 10 Warnings and precautions Cranex D 10 Warnings and precautions e 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 expo sure that the unit is not designed to take e The unit or its parts must not be changed or modi fied in any way without approval and instructions from Soredex e 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 e Always use the lowest suitable x ray dose to obtain the desired level of image quality e 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 e Itis the responsibility of the doctor to decide if the x ray exposure is necessary e Avoid taking x ray exposures of pregnant women e Never press the up down height adjustment button Z movement when the patient is positioned in the cephalometric head holder 48 User s manual 8201083 Cranex D User s manual 8201083 10 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 wh
34. or 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 User s manual 8201083 45 9 Troubleshooting and maintenance Cranex D 9 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
35. ou 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 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 RE TURN key after you have taken the first pair of TMJ images to drive the rotating unit back to the PIO position Reposition the patient for the second pair of images mouth open or closed Press the RETURN key to drive the rotating unit to the START position and then take the second pair of TMJ images 3 Panoramic Exposures Cranex D After taking TMJ exposures 1 Openthe temple supports and press the button to release the forehead support Forehead 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 will be transferred to the PC 22 User s manual 8201083 Cranex D 3 Panoramic Exposures 3 5 Sinus exposure Positioning the patient for a Sinus exposure NOTE lf 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 1 Slide the lip support on to the holder Place a disposable cover on to the lip support Lip Support 2 Prepare the patient in the same way
36. power supply or a battery Power frequency magnetic field should be at levels characteristic of a typical location ina typical commercial or hospital environment User s Manual 8201083 Cranex D 11 Technical Information Guidance and manufacturer s declaration electromagnetic immunity The PP1 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 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 1 2 P RF 150 kHz to es STOUT RO d 1 2 P 80 MHz to 800 MHz d 2 3vP 800 MHz to 2 5 GHz ee where Pis the maximum output power rating of the transmitter in watts W according to the IEC 61000 i transmitter manufacturer and dis the 4 3 l i i 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 NOTE 1 At 80 MHz and 800 MHz the higher frequ
37. ramic exposures adult child and partial rrrrnnnrnrnnrrnnnnrrnnnnenrnnnennnnre 10 Patient positioning for Panoramic EXPOSUIES cccccsseeeceeeeceeeeeseeeeeseees 10 Taking a Panoramic exposure Larver 15 After taking a Panoramic exposure sstussceaderneserdssaavdnreienesevtannsdeceavanceanedons 17 3 4 Temporomandibular Joint TMJ exposures rrrrnnrrrrrrannrnrnnnnrnvrannrnnnnnnrnnnnnner 18 Positioning the patient for TMJ exposures rrverranververvennnrrersvnnnrvennnnnenne 18 Taking TMJ exposures EE 19 After taking TMJ exposures JE 22 3 5 SINUS EXPOSUTE gt 23 Positioning the patient for a Sinus exposure rrrrrrrnnnnrerrrnnnnrernrnnrrrnnnnnnnnee 23 Taking a Sinus exposure EE 24 After taking a Sinus exposure cc ccsseccecsceeeeeessceeeeeescceseeeescceeeesecceeees 26 4 Cephalometric exposures Ceph option srrnrrrrrnnnnnnnnnnennnnnnnnnnnnnnnnnnnnnnenenn 27 PENN ov 4 2 Preparing the PC user interface acne cee fecaceetettiegse teen es czaenc teenie tense 28 AS I OSMO NING ING NN 30 EST Ga 6 AU OX OSU O a nes 32 A ED 0 SE EE NN EE a 93 5 Carpus exposures Not in USA rrnnnnvennnnnnnnnnnnnnnnnnnnnnnnnnennnnnnennnnnnennnnnnennnnnne 34 User s Manual 8201083 iii Cranex D 6 Using the unit without x rays ennnnnnnnnnnnnrnnnnnvnnnnnnnnnnnnnnnnnnnnennnnnvennnnnnennnnnvennnnnr 36 7 Attaching and removing the CCD Sensor revsnnnnnvnvvnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnerr 37 7
38. ser Interface If you wish to change the kV select a different value from the User Interface Before taking a Sinus exposure ask the patient to press their lips together Also ask the patient to look at the reflection of their nose 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 3 Panoramic Exposures Cranex D 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 The rotating unit will rotate around the patient s head and then stop When the rotating unit stops the exposure has been taken 1 Open the temple supports and press the button to release the forehead support Forehead 2 Guide the patient out of the unit 3 Pressthe RETURN key to drive the unit to the PIO position 4 The digital image will be transferred to the PC 26 User s manual 8201083 Cranex D 4 Cephalometric exposures 4 Cephalometric exposures Ceph option 4 1 Preparing the unit Attach the CCD sensor to the sensor holder on the ceph head see section 7 Attaching and removing the CCD sensor Switch the unit on Rotate the cephalometric head support so that it is in the correct position Lateral or PA for the cephalometric exposure you w
39. y to drive the unit to the PIO position and then press the key again to drive it to the START posi tion If the error message reappears Call service NOTE Exposures of children can be taken with the adult panoramic program Note how ever that the height and width of the exposed area is not reduced E16 PoS PROBLEM i The rotating unit is not in the PIO or START position li 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 DfW not in USA or the dental imaging software you are using or the User Interface are not on iii orthe CCD sensor is not attached to the sensor holder 42 User s manual 8201083 Cranex D 9 Troubleshooting and Maintenance 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 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 li Start DfW and press the capture image button not in USA and the User Inter face iii Attach the CCD sensor to the sensor holder iv Attach the CCD sensor to the correct pan or ceph sensor holder v Make sure that the CCD sensor locking lever is pushed fully to the left the locked position Unit Errors

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