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The OP300 unit service manual

1. SOREDEX Metal Artifact Reduction U 24 4 CGontolling the Uhlf say ya xin tnodo zanya weyan aba war dak anode ddr meme wa wak Eee nee ated ust 25 4 1 Gleda Touch control Dane ssodceesmnbdulcey dd won mdp d bad CE Mk PM bap Rada 20 AZ INIOGANILY i es re m 26 dio DeCUOM AN IMAGING ERES SUMUS 26 4 4 Automatic Exposure setting AES eesseessesssseseeee nennen nnne nnne nnn nnns 2f 4 4 1 AES values for Panoramic imaging uu EE 2f 4 4 2 AES values for Cephalometric imaging eeeseeessesse 28 4 4 3 Exposure indicators and settings cccccccecseecseeeeeeeeeeceeeeeeeeeeseeeseeeaees 29 4 5 talus SC CHOI NNN este ca eain detaie cel acura dete nates Saleen oicf esa o Dd dpi s dd 29 BG Gage UMEN 30 Mp epar a an 31 5 1 Attaching and removing the sensor eeseeeseesseeeeeeennnnee nennen 31 oO T Attaching t ie SensOlL erena i Nero Re tone a tatus uice der ce amoenus 32 5 1 2 IREMOVING NG SSMS OM ucciso kk akele rayda b ke va e ek aia salya bl keyay as Kay da be dk 33 5 2 Preparing The systems dotium ora N 33 9 9 Panoramie exDOSUFOS sesvsseeietmitor oorr vavceo PUE P Lob tee mua A081 45530 a ee EP EREU ERE PRI 34 9 9 1 POSIMONING QeVIGBS uscite cuento ast duces ua tie N n Kund dede lay tie tuus ae Peas
2. 50 5 Using the unit 5 4 2 Patient positioning 9 9 9 Qr O 10 0 G Ready SOREDEX Full width and reduced width projection A Maija Mallinen WWW e 9 9 Q 2 77 G 10 0 G O 1 4 0 9 25 9 mGycm l f 206718 rev 5 o Using the unit 1 Unlock the lever and turn the ear rods to the lateral pro jection position Lock the position 2 Place the disposable covers Note Use a new disposable cover for every patient 3 Adjust the unit height 4 Guide the patient to the unit Instruct the patient to stand as straight and tall as possible under the cepha lostat head Slide the ear rods towards to patient s ears Tall patients can also sit on a chair 206718 rev 5 SOREDEX 51 52 5 Using the unit 5 Adjust the patient head so that the Frankfort Horizontal plane FH and laser light are in same horizontal plane Note The shown laser line is a horizontal reference line 6 Slide nasion support against patient s nasion SOREDEX 206718 rev 5 5 Using the unit 5 4 2 2 PA projection 206718 rev 5 SOREDEX 53 5 Using the unit 1 Unlock the lever and turn the ear rods to the PA projec tion position Lock the position Tilt the nasion support aside 4 S 1 2 Place the disposable covers Note Use a new disposable cover for every patient 3 Adjust the unit height 4
3. Always use available disposable protective covers with the patient positioning accessories Bite block cover Chin plane cover TMJ support cover Lip holder cover Chin cup cover SOREDEX 5 1 Introduction 1 6 3 General warnings Personnel operating the device must be adequately trained with respect to the technological principles of operation and radiation protection when using cone beam computed tomography CBCT imaging This unit complies with the EMC Electromagnetic Compatibility according to IEC 60601 1 2 Radio transmitting equipment cellular phones etc shall not be used in close proximity of the unit as they could influence the performance of the unit The correct software and settings in the workstation are essential to the performance of the unit Consult technical support to ensure correct setup Danger Explosion hazard do not use in the presence of flammable anesthetics gases or vapors The unit is factory set to operate using a 230 240 10 VAC power supply Never connect the unit to a power supply different to the voltage marked on the unit The site must fulfill the environmental requirements in the installation manual chapter technical specifications There should be free space around the unit for safe operation To maintain patient safety it is mandatory to use an unshielded CAT6 Ethernet cable between the unit and the network or workstation so that multiple chassis are not connected Non medi
4. 206718 rev 5 SOREDEX 17 3 Imaging programs Bitewing Magnification 1 3 u An orthogonal view of the dentition from the canine and posterior Lateral TMJ Magnification 1 23 Lateral TMJ program provides a wide layer axially corrected views for the patient s left and right temporomandibular joints PA TMJ Magnification 1 55 SOREDEX 206718 rev 5 3 Imaging programs Maxillary Sinus Magnification 1 3 fe nh 7 Mesial 10 mm Start Distal 10 mm Maxillary Sinus program produces a pan tomographic layer through the posterior maxillary sinus The layer is flatter than the standard panoramic programs and is moved 18 mm backward These images are helpful in visualizing the mid and posterior maxillary sinus 206718 rev 5 SOREDEX 19 3 Imaging programs 3 2 Cephalometric programs Cephalometric programs provide central projection images of patient skull and dental anatomy Images are utilized in ortodontics and general diagnostics Full size lateral Magnification 1 15 Field size 22 x 26 cm height x wide E A Lateral Cephalostat uses a full height image field Reduced size lateral Field size 22 x 18 cm height x wide A Reduced Width Lateral program has an optimized image width that is used e g for pediatric my patients but also adult patients to reduce the radiation Lh dose 20 SOREDEX 206718 rev 5 206718 rev 5 3 Imaging programs Cephalom
5. sssssssssssssssssese eene nne ener nne k KK KK KK KK kK KA f3 9 6 1 ACKNOWICOGING OL OL S xwan u oum nie Dl bakin kr e tu eoe KERO k n pais Sud H k u aA 73 56 2 Image transfer GIONS ss n c yay nen end Meye NO HENA e REN AMAN W K k e0 Decium u H d k ba 13 TFOUDIESNOOUNG PRESS TED DE 75 MB ueniet Imm 15 02 MAGES AD DCALANCS ela ett i pU Dad venden anc ntes pu tx I acepte dabe Kel D w nes 78 OS AIST ACIS sadi senna a r tune ase on ctio ect eared 19 OA XmboberalloD yl KAK n ind NN MEOS DUM K KE A Rete esM ae M e eo t 81 I AINE ANG ee TR 83 Zr Maintenance DIOCCOULC s yy kun ki lr a emu de este RENE AA biok bata d N A Hera A RAK 83 Tak ANu mall oll C teneis ert n er na eka y KARA b n D ep QE RAYE E e KB A K esu 83 1 1 2 CallbFationqntervals xiya y kel kel estat n K E Duet agn ebeke 83 ad Changing ANG TUSE Scese ied tuo od P pee 555 eset ANDA es es 84 7 3 Cleaning and decontaminating the UNnIt ec E 84 Calibration and adjustment 5 ak e op o Eee aa LE AA S kak ban a na ha AN An 87 oM MNMIMTOGUCHON ari sacs d To besek ayaa E 8 9 2 PFEParing for CallbEStlODni oninia atii icum aec muto oed ome edlen i du den iam rebos c bred ins 88 0 3 Panoramic Call a Ol y s 4 4 5 4s40 154355510555 a ada KANA RM k e HAN EXE A S6 n n b n KA NENA DM 89 8 3 1 Panoramic geometry calibration E u uu EEE 89 8 3 2 Panoramic pixel
6. 5 16 4 10 0 93 2 meyen wy idi Ready 2 Select panoramic imaging 3 Select the imaging program 4 Any section of the dental arc can be selected for the sec tional imaging to limit exposure area and reduce the ra diation dosage 5 Press the Return button to rotate the unit to patient in I position 206718 rev 5 SOREDEX 35 9 Using the unit 6 Open the temple supports 1 Temple support knob 2 Forehead support 3 Temple supports 7 Ask the patient to remove any spectacles hearing aids removable dentures jewellery and hair clips and pins Place a protective lead apron on the patient 36 SOREDEX 206718 rev5 5 Using the unit 5 3 3 Patient positioning 5 3 3 1 Panoramic exposure 1 Insert the chin rest and bite rod with the bite block Place the disposable covers Note Use a new disposable cover for every patient 2 Adjust the unit height 3 Guide the patient to the unit and instruct to stand as x straight and tall as possible Exposure can be taken also in sitting position Ask the patient to take grip on the han dles and bite on the bite block Use the lipholder or the chin support for an edentulous patient Figure 1 1 bite block and lip holder 4 Ask the patient to take one step forward to straighten the spinal column Patient is slightly leaning backwards dur ing the imaging 206718 rev 5 SOREDEX 37 5 Using the unit 5 Check the position of the
7. Close the temple supports by sliding the temple support knob to the right Adjust the position of the nasion sup port and push the forehead support in until it touches the patient s nasion SOREDEX 206718 rev5 5 Using the unit 7 Adjust the position of the image layer as necessary The focal trough light should be positioned in the middle of the 3rd tooth or if wanted slightly posterior Note 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 posi tioned correctly 8 If AES is enabled green light lit around A press the Return button and wait for the movement to finish Verify that the suggested exposure values are suitable for the patient If AES is disabled set the exposure values man ually and press Return to drive the unit into exposure start position optional 9 Ask the patient to press their tongue against the roof of their mouth and remain still for the duration of the expo sure 206718 rev 5 SOREDEX 45 9 Using the unit 46 5 3 3 4 Taking the exposure N WARNING Close the patient positioning mirror before taking any exposures 1 Ask the patient to remove any spectacles dentures jew ellery and hair clips and pins Place a protective lead apron around the patient s neck to protect the patient s thyroid gland from radiation 2 Press Return Check the patient positionin
8. assed eTom 1i 3 Kul set 010 mm Offset 0D mm potis ett IP mm 5 Take an exposure 6 Repeat the calibration until calibration result passed is achieved This calibration is only needed with 3D units 206718 rev 5 SOREDEX 93 8 Calibration and adjustment 8 4 2 3D pixel calibration 1 Remove the 3D calibration phantom 3D Pix 2 Select the program Y 3 Press Return i 4 Take an exposure The result image informs when the calibration is passed DJaridlevelf is CT detector calibration Passed ETa 3 10 0 Signal level 2730 60 5 94 SOREDEX 206718 rev5 8 Calibration and adjustment 8 4 3 3D Quality Check program 1 Attach the QC phantom to the unit Select the 3D QC program r 3 Press Return 4 Take an exposure 5 Review with 3D viewing software from the axial view by scrolling the slices the info about calibration result The resulting image contains information on whether the quality check was passed Repeat until quality check is passed 206718 rev 5 SOREDEX 95 8 Calibration and adjustment OnDemand SE Lite Module DNE Undc f Redo se dj Volume 9 ag DEN Axial 3 View ID 20110628085538933 Lite eA Ur 20110801 amp j ore s mir PMMA minimum val moe PMMA meaimum wua 159 5 2x na xume ma stl cay SO PTRE 691 sta aay Sil n a S9 Stalk Cleve ho j Valles Tr t
9. the patient SOREDEX 69 9 Using the unit 55 4 3D image 1 Select the Standard A high resolution B or endo pro gram C Endo program is only for 61 x 41 mm FOV E EA j i g A NE A B C 2 Select mA A 2 90 v Ma a 0 mA ur 300 E mGyem j 2 5 mm N WARNING Close the patient positioning mirror before taking any exposures 3 Press and hold down the exposure button During the ex posure you hear an audible signal and the exposure warning symbol on the ClearTouch control panel ap pears 4 Select SMAR ON or OFF based on your estimation of the need See chapter 3 4 1 SMAR SOREDEX Met al Artifact Reduction W 70 SOREDEX 206718 rev 5 206718 rev 5 5 Using the unit 5 5 5 Stone model and radiographic guide scan For scanning of stone models and radiographic guides a positioning plate is available for the system 1 Scan the patient with an open bite by securing the bite with cotton pads 2 Install positioning plate Position stone model 7 i Note It is recommended to use a sponge or a foam under radiographic guide during the scan SOREDEX 71 5 Using the unit 3 Take scout image with default values Correct position if needed Ready 4 Select same resolution and parameters as in patient scan Note More detailed instructions in the CRANEX 3D Quick Guide Stone model and radiographic guide scan protocol 72 SOREDEX 206718 r
10. 206718 rev 5 9 Technical data 10A 230 VAC 15A Q 110 VAC Fuses 230 Vac Littelfuse 326 slow blow 10A Cooper Bussman time delay MDA 10 110 Vac Littelfuse 326 slow blow 15A Cooper Bussman time delay MDA 15 Positioning laser lights Panoramic TMJ amp Maxillary Sinus laser light Programs CLASS 1 LASER PRODUCT max output 1000W Cephalostat FH laser light Warning symbols are placed next to the laser lights and 3D imaging programs the label describing the laser light classification is placed inside the carriage side cabinet USA Canada models have different types of laser light stickers according to lo cal requirements Caution use of controls or adjustments or performance of procedures other than those specified herein may re sult in hazardous radiation exposure IEC 60825 1 1993 A1 1997 A2 2001 High frequency DC generator Nominal power 1750 W nominal at 90 kV 12 mA Anode voltage 57 90 kV 5 kV Anode current 3 2 16 mA 1 mA Minimum total filtration 206718 rev 5 SOREDEX 103 9 Technical data User interface Program and technique factors selec Touch screen panel optional remote exposure switch tion exposure control Patient positioning Positioning panel integrated Connection cable CAT6 Ethernet cable CRANEX 3D PC Panoramic programs amp Technical factors amp magnification Standard Adult Panoramic vig EW Panoramic QC 57 90 kV 3 2 12 6 mA 16 4
11. FOV lights Posi tion the patient so that the occlusal plane is horizontal gt 1 Horizontal light top of FOV 2 Horizontal light bottom of FOV Note Target ROI is always in the middle plane of la ser lights 11 Select the image area from the dental arch 66 SOREDEX 206718 rev 5 o Using the unit 12 Close the temple supports by sliding the temple support knob to the right A Adjust the position of the nasion support B and push the forehead support in until it touches the patient s nasion C 13 Select A the Scout image Or B the Standard Or C High resolution 3D image Or D Endo program 9 O 8 A B C D 206718 rev 5 SOREDEX 67 5 Using the unit 5 5 3 Scout image AN WARNING Close the patient positioning mirror before taking any exposures Ai acces 1 Press and hold down the exposure button During the ex posure you hear an audible signal and the exposure warning symbol on the ClearTouch control panel ap pears 2 Scout preview image appears to the ClearTouch con trol panel 3 Fine adjust scout position using the side arrow keys Press the left lower corner icon to continue 68 SOREDEX 206718 rev 5 206718 rev 5 5 Using the unit 4 Take a new scout or save current and continue to 3D image 5 Previous FOV position is shown as gray circle and new position is showed as green circle Note Gray circles remain in control panel until you change
12. Guide the patient to the unit facing the sensor Instruct the patient to stand as straight and tall as possible un der the cephalostat head Slide the ear rods towards patient s ears Tall patients can also sit on a chair 54 SOREDEX 206718 rev 5 5 Using the unit 5 4 2 3 Reverse towne projection Maija Mallinen e Ready 1 Unlock the lever and turn the ear rods to the PA projec tion position Lock the position Tilt the nasion support aside 2 Place the disposable covers Note Use a new disposable cover for every patient 206718 rev 5 SOREDEX 55 5 Using the unit 3 Adjust the unit height 4 Guide the patient to the unit facing the sensor Instruct the patient to stand as straight and tall as possible un der the cephalostat head 5 Turn the head ventral as reference to the canthomeatal line about 30 below the horizontal plane 6 Slide the ear rods towards patient s ears T Ask the patient open mouth maximally 56 SOREDEX 206718 rev5 5 Using the unit 5 4 2 4 Waters view amp Maija Mallinen 4 L e m i e TT w D 10 0 44 20 0 O 37 0 meyor e Ready 1 Unlock the lever and turn the ear rods to the PA projec tion position Lock the position Tilt the nasion support aside 2 Place the disposable covers Note Use a new disposable cover for every patient 206718 rev 5 SOREDEX 57 5 Using the unit 3 Adjust the unit height 4 Guide the
13. TE 5 Ready 1 Modality selection Program selection Imaging values Imaging area Status of the unit Test mode Settings CON O Q FP O N Case end 206718 rev 5 SOREDEX 25 4 Controlling the unit 26 4 2 4 3 Modality section Select the modality button PAN CEPH or 3D When panoramic modality is selected a program specific dental arch is shown This can be used for partial panoramic imaging Cephalometric programs have their own program specific model heads and setting buttons for the start position of lateral scanning 3D programs two FOV sizes have buttons for selecting low resolution high resolution or scout image mode The FOV for 3D imaging can be positioned on the XY plane by selecting the center point of the FOV on the dental arch of the touch screen display The FOV is positioned in the Z direction by using the chin rest movement and positioning lights Sectional imaging Dental arch on the touch panel shows the enabled and disabled arch sections from the result point of view Select the image area from the dental arch SOREDEX 206718 rev5 4 Controlling the unit 4 4 Automatic Exposure setting AES AES automatically recommends the exposure values according to the size of the patients head in panoramic Aj and cephalometric imaging The AES is activated with active A button and by pushing Return button once The AES suggest exposure values based on patient si
14. calibration cc cc cccceecceeceeeceeceeeeeeeseceeeeeeeeeseeseeeeeetes 90 8 3 3 Panoramic Quality Check optional Lu EEE 91 on OLD CAMOE AION ce 93 04 1 33D geometry callDFallOTni ior eai A Zaza cuc dua eas 93 O 4 2 SW pixel caliDEatlOE losa ao EoE exl ia Qu N 94 8 4 3 3D Quality Check DrOgFIaIT Eu EKE KAK 95 9 5 Cephalometric calibrato i 2 oobis oi moli n Eat o ua AA PER Eb daka ak totins 97 65 1 CED pIxel callDBESUOTlacnasssdusovs YE 545455142523028 eo rtu WAD Aba S k WAAR k n Rond r n A Tus 97 8 5 2 Ceph Quality check program Optional seeeeseessese 98 BL all l lC SR NHHH HE HHHHERRR suena numus 101 Technieal SPECINCALONS zubissis erani dini a aha Ma fre nac E ERO VAT ERE Seh k niv ken n 101 LMI OMMEH SIONS sese teta d atate MA d p RR MEO IPM RI LIBE 112 oymbols that appear In the UL i c i 5yis 55y5y31 1445315545 3544503444054550 wet er AW demi 113 Labels on the UNIt ccc cecccecceeceeceeeceeteeeeeeesececeeeseeseeceesegeesesaeeseeseeeeeeeeeees 115 Electromagnetic Compatibility EMC tables seeeeeeeeeeesese 116 X Tay UDe dS ND ggmmggggmgmmemg 2 a zE 121 1 Introduction 1 1 CRANEX 3D CRANEX 3D is a dental x ray system for producing high quality digital images of dentition TM joints and skull In order to take images with CRANEX 3D you need a suitable PC hardware connect
15. enabled green light lit around A press the A D Return button and wait for the movement to finish Verify m that the suggested exposure values are suitable for the patient If AES is disabled set the exposure values man ually and press Return to drive the unit into exposure start position optional 10 Ask the patient to press their tongue against the roof of their mouth swallow and remain still for the duration of the exposure 40 SOREDEX 206718 rev 5 5 Using the unit 5 3 3 2 TMJ exposure 1 Insert the required positioning devices including the TMJ support Place the disposable covers Note Use a new disposable cover for every patient 2 Adjust the unit height 3 Guide the patient to the unit and instruct to stand as straight and tall as possible Ask the patient to take grip on the handles and set the mouth against the lip holder 4 TMJ lateral projection Adjust the height of the Frankfort Horizontal plane FH laser to get the laser light over the orbita porion Straighten the patient s head if needed 206718 rev 5 SOREDEX 41 5 Using the unit 5 TMJ PA AP projection Tilt the patients head forward 6 Check the position of the midsagittal light If it is not on the midsagittal plane of the patient adjust the patient s head 7 Close the temple supports by sliding the temple support knob to the right Adjust the position of the nasion sup port and push the forehead suppor
16. image VM SMAR Info System IP address and other system related data Languages Use this to select language on the touchscreen Service Use this to reach the programs for periodical maintenance Retrieve Last Image Use this to retrieve the last image from the device memory e g after a system crash Please make sure that the retrieved image is as sociated with the correct patient Retrieve With SMAR After taking a 3D image with SMAR either on or off image can be re reconstructed with different setting by selecting either Retrieve last image or Retrieve With SMAR from the general settings on the touch screen If reconstruction with SMAR is unavailable for the last captured image e g last taken image is cephalometric Retrieve With SMAR button will not be visible NOTE Only the last taken x ray image is saved in the unit until the power is switched off This image data is used in the retrieve procedure SOREDEX 206718 rev 5 5 Using the unit 5 1 Attaching and removing the sensor Note The pixel calibration results are sensor specific If the x ray unit is equipped with separate panoramic and cepha lometric sensors the cephalometric sensor cannot be used for panoramic imaging without re calibration and vice ver Sa Re do panoramic pixel calibration if cephalostat sensor is moved to panoramic side or the sensor is changed N WARNING Handle the sensor with c
17. midsagittal light If it is not on the midsagittal plane of the patient adjust the patient s head Make sure the patient s head is not turned or tilted 6 Adjust the height of the Frankfort Horizontal plane FH laser to get the laser light over the orbita porion Straight en the patient s head if needed 38 SOREDEX 206718 rev 5 5 Using the unit 7 Close the temple supports by sliding the temple support knob to the right A Adjust the position of the nasion Om lt support B and push the forehead support in until it touches the patient s nasion C 8 The focal trough light indicates the center of the focal trough which is 10 mm wide at the front The root apices of the patients central upper and lower front incisors must be within the focal trough Ask the patient to open their lips so that you can see their teeth The focal trough light should be positioned slightly in front of the root apices which for most patients will be in the middle of 3rd tooth canine 206718 rev 5 SOREDEX 39 9 Using the unit If the patient is edentulous the focal trough light should be approximately 5mm behind the lip holder when the focal trough position is 0 mm Note If the focal trough light is not positioned as de gt scribed above press the focal trough adjustment key s to move the focal trough light until it is posi tioned correctly Figure 1 2 Focal trough light position indicator 9 If AES is
18. of detail and mo tion artefacts Irregular verti cal bright lines on image Problem Vertical dark lines on image Problem Patient s right side tooth are not exposured Problem Right and left image sides are uncomplete TMJ s are not shown 206718 rev 5 Artefacts Possible cause Patient is wearing metal ob jects such as earrings neck lace etc Possible cause Lead apron misplaced Possible cause Patient has moved during the exposure Possible cause Patients shoulder in touch with machine parts Possible cause Exposure button released prematurely Possible cause TMJ areas in sectional imag es where deselected SOREDEX 6 Troubleshooting Remedy Ask patient to remove ob jects Remedy Check the lead apron po sitioning Remedy Retake the image Remedy Check patient position ing Remedy Retake the image Remedy Select all sections in pan oramic image 79 6 Troubleshooting Problem A light horizontal line on QA image Problem Horizontal lines on image Problem CEPH Lateral view has 2 ear holder pins 80 Possible cause Bite block was left on place Possible cause Sensor problem Possible cause 1 Cephalostat lock not locked 2 Ear holders misaligned SOREDEX Remedy Remove the bite block and retake QA image Remedy Consult the dealer Remedy 1 Lock it 2 Call service 206718 rev 5 6 4 Unit operation Problem Back of the patient s
19. or right side of the unit Interlocked pan ceph sensor Motorised carriage buttons at cephalostat head assem bly Positioning aids Ear holders Nasion support with vertical mm scale Frankfort horizontal plane laser light Contact plate Car pus program 206718 rev 5 SOREDEX 105 9 Technical data 3D imaging patient positioning Operation Left or right side of unit Motorised carriage movement Positioning aids Chin rest chin support chin cup 3 point headrest hinged mirror 3 positioning laser lights Cephalostat scanning Scanning method Horizontal scan synchronized sensor and secondary slot motion Panoramic image receptor Resolution Pan 5 LP mm 106 SOREDEX 206718 rev 5 9 Technical data Active area height 223 2 mm 2232 pixels Image field width in lateral view 10 2 inches 260 mm maximum 6 7 inches 170 mm minimum Image field width in PA view 7 9 inches 200 mm 3D image receptor Technology CMOS Flat panel Image pixel size and depth 200 um and 13 bits Active sensor surface 100 x 68 mm H x W Unit physical measures source image distance SID 500 mm Panoramic 5 0 mm 3D Installation Standard wall mount with 45 angled joint Optional base for free standing unit unit height is in creased 25 mm Height x Width x Depth inches mm 2414x965x1126mm standard column 94 9 x 38 x 44 3 inches Max Weight 200 kg 440 Ibs Panoramic 206718 rev 5 SOREDEX 107 9 Tec
20. presence or absence of clinical signs and symptoms 3D imaging examinations must be justified for each patient to demonstrate that the benefits outweigh the risks Where it is likely that evaluation of soft tissues will be required as part of the patient s radiological assessment the imaging should be done using conventional medical CT or MR rather than 3D imaging using Cone Beam technology Make sure that patient s thyroid glands are protected by a lead apron during the exposure The place where the unit is to be installed and the position from where the user will take exposures must be correctly shielded from the radiation that is generated when the unit is operated Ensure to fulfill or exceed the requirements of your local regulations The unit or its parts must not be changed or modified in any way without approval and instructions from the manufacturer When servicing use only approved replacement parts supplied by the manufacturer The use of accessories not complying with the equivalent safety requirements of this equipment may lead to a reduced level of safety of the resulting system If this device is used with 3rd party imaging application software not supplied by the manufacturer the 3rd party imaging application software must comply with all local SOREDEX 7 1 Introduction 1 7 1 8 laws on patient information software This includes the Medical Device Directive 93 42 EEC and or relevant legal requirement
21. s Exposure Control Automatic Exposure Setting AES based on patient head size Reduced width lateral view PA AP facial and oblique views Not in USA and Canada Exposure Control Automatic Exposure Setting AES based on patient head size Magnification factor 1 15 15 3D imaging programs XS FOV dimensions 61 x 41 mm HxD Midi FOV optional 61 x 78 mm HxD dimensions 104 SOREDEX 206718 rev 5 9 Technical data 3D imaging programs XS FOV standard 90 kV 6 3 12 5 maA 2 3 s resolution Midi FOV optional 90 kV 6 3 12 5 maA 4 9 s standard resolution XS FOV High resolution and 90 kV 4 12 5 maA 6 1 s Endo program Midi FOV optional High 90 kV 4 10mA 12 6 s resolution XS FOV scout 90 kV 4 12 5 mA 0 02 s Midi FOV optional scout 90 kV 4 12 5 mA 0 04 s Image storing and retrieving File formats PNG 16 bit JPG 12 bit File compression PNG lossless JPG 100 60 quality Typical panoramic file size About 2 4 MB PNG 16 bits Typical cephalometric file size 3 5 MB PNG 16 bits Typical 3D file size 150 250 MB DICOM Patient database Standalone workstation Server on local area network LAN Panoramic patient positioning Operation Left Motorised carriage movement Positioning aids Chin rest bite block 3 point headrest Hinged mirror 3 positioning laser lights Y layer step less adjustment Cephalostat patient positioning Operation Arm mounts on left
22. slot for GPU board 108 SOREDEX 206718 rev5 9 Technical data Minimum PC requirements for 3D acquisition workstation USB USB ports for HASP Dongle keys 1 for reconstruction system 1 for 3D viewing SW if needed Graphics board NVidia GeForce 6600 or ATI Radeon X700 or better 256MB or more memory integrated graphics are not supported Power supply 500 watt minimum Operating system Windows 7 or Windows Vista 32 or 64 bit Display 20 LCD display 1600 x 1200 or 22 LCD wide screen display 1680 x 1050 or better Standard The PC must meet the IEC 60950 standard minimum re quirements Mouse Mouse with scroll wheel OpenCL support OpenCL 1 1 supported by either processor or graphics adapter These requirements are valid only if driver update 11 4 or later is used For earlier versions see table Minimum PC requirements for 3D acquisition workstation Note This is an abbreviated list of requirements Please refer to the software installation manual or contact your local dealer for detailed installation requirements 206718 rev 5 SOREDEX 109 9 Technical data Minimum PC requirements for 2D 3D Viewing workstation Processor 2 0 GHz dual core or better Memory 2 Gigabytes RAM or more Graphics board NVIDIA GeForce 6600 or ATI Radeon X700 or better 256MB or more memory integrated graphics are not supported Hard disk 3 GB free space or more Network Gigabit Ethernet 1000Base T recommended
23. 1x 78mm STA r mA j mA ee eS ESS a wa d DAP values vary from unit to unit in relation to the x ray tube output Thus above values indicate average DAP values In addition to these recommended values there is a possibility to use the whole mA range if the user prefers Available mA ranges for each field of view sizes and resolution settings Resolution FOV 4mA 5mA 6 3mA 8mA 13 mA h x w High Res 7 x 41 mm Std Res 61 x 41 mm High Res x 78mm Exposure settings for scout imaging PE values Resolution FOV kV Scan h x w ning time Scout zw x 41 mm 13 0 02s _ 02 s Scout j61 x 78 mm 90190045 206718 rev 5 SOREDEX 23 3 Imaging programs 3 4 1 SMAR SOREDEX Metal Artifact Reduction SMAR SOREDEX Metal Artifact Reduction software can be used to reduce the effect of metals and other dense radiopaque objects on the 3D image These create artifacts that are seen typically as stripes and shadows from the above mentioned objects To utilize SMAR ona 3D image may have affect to image reconstruction time ZI 176716A1761 Antti ji li T li ar SMARTM button is ON SMARTM button becomes visible on the 3D modality amp 176716A176I Antti SMAR button is OFF 24 SOREDEX 206718 rev 5 4 Controlling the unit 4 1 ClearTouch control panel A Maija Mallinen OW 2 m O se A 16 4 Ua 1 0 0 1 A ji 93 2 mGyem ww De y
24. 34 9 9 2 Generalins UC OL lS ene TM 35 99 9 Pauen DOSIHODIHO emer ene ann nt eon ad te cee ene ern PTO 37 59 91 Panoramic expoSUFGusitteburtsse bunt upt W ba n w bend aka d et oU 1 D992 JM OXDOSUTG ies Ec Pu E RERO OR Dux uda der OU n as 41 5 3 3 3 Maxillary Sinus exposure eeeeeeeeeeeeneeenennnn nn 44 9 9 94 Taking ihe expoSuUEB gn 46 5 4 Cephalometric expOSUEGS 5 tired ro cre FESReP TY aU p2 D XE VI EC E 3i2 IH t h k VIE ERA 48 5 3 1 Xseneral IDSITUCLOFPIS uuesxcxeecciodam tta ap kerane a dede aka ean NARA ot Kele EKE 48 O42 Pauen DOSITIONIN TO xn o Dm 50 5 4 2 1 Full width and reduced width projection 50 D422 PA DOGC UOM SS oreste a ee 53 5 4 2 3 Reverse towne projection le 55 9A 2A WAAS VICW nrin a a N 57 5 42 5 Carpus program OPtlONAl esireast 59 5 4 2 6 Taking the exposure ccccccscccecceeceseceeeceecaeeseeecuesaueseeesaeesas 61 29 JD eXDOSUFPOSQudadduiscdatodibuhdsitdbasdoradetd E pudbau e crane tqd tta bd 63 SEE o enjeke V ICE S0451104 val 12ya ka E AES 63 992 Cice PR TET T T TT TT 64 D020 ASSODUEIITIBGIO cucine basa de la c ey Kine We instat ben uad e na n utut uates r 68 opor M DID 200 sn m n 70 5 5 5 Stone model and radiographic guide SCAN ccccceccceeceeeeeaeeeseeeeeeeeaes 71 5 6 Warnings and error MESSAGES
25. 3D requires continued operation during power mains interruptions it is rec ommended that CRANEX 3D be powered from an_ uninterruptible power supply or a battery Power frequency magnetic fields are at levels characteristic of a typical lo cation in a typical commercial and or hospital environment NOTE U is the a c mains voltage prior to application of the test level 206718 rev 5 SOREDEX 117 9 Technical data Table 1 3 RF immunity of non life support equipment or system IEC 60601 1 2 CRANEX 3D is suitable for use in the specified electromagnetic environment The pur chaser or user of CRANEX 3D should assure that it is used in an electromagnetic environ ment as described below Immunity IEC Compliance Electromagnetic Test 60601 1 2 Level Environment Test Level Portable and mobile RF communications equipment are used no closer to any part of CRANEX 3D in cluding cables than the recommended separation distance calculated from the equation appropriate for the frequency of the transmitter Recommended Separation Distance Conducted 3 V150kHz V1 3V 45 RF IEC to80 MHz d VP 61000 4 6 Vi 3 5 Radiated 3vV m80 E1 3 V m WP RFIEC MHz t02 5 Ei 80 MHz to 800 MHz 61000 4 3 GHz 7 d vP Ei 800 MHz to 2 5 GHz Where P is the maximum output power rating of the transmitter in watts W according to the transmitter manufacturer and d is the recommended separation distanc
26. ENGLISH CRANEX 3D Digital Panoramic X Ray System User Manual 206718 rev 5 Copyright Manufacturer CRANEX 3D Code 206718 rev 5 Date April 17 2013 Copyright 4 17 13 by SOREDEX All rights reserved SOREDEX SCANORA CRANEX are registered trademarks of SOREDEX PaloDEx Group Oy U S patents US6731717 US6829326 and USRE41197 Finnish patents 114383 Documentation trademark and the software are copyrighted with all rights reserved Under the copyright laws the documentation may not be copied photocopied reproduced translated or reduced to any electronic medium or machine readable form in whole or part without the prior written permission of SOREDEX The original language of this manual is English SOREDEX reserves the right to make changes in specification and features shown herein or discontinue the product described at any time without notice or obligation Contact your SOREDEX representative for the most current information CE 0537 SOREDEX PaloDEx Group Oy Nahkelantie 160 P O Box 148 Fl 04300 Tuusula FINLAND Tel 358 10 270 2000 Fax 358 9 701 5261 For service contact your local distributor CRANEX 3D Table of Contents 1 NEFOGUCTION iy a Leka 1 e pc 1 eZ LIH CCS MU UU 2 To MMLC MOCO US dem DTE 2 TA AASSOCIAICG doCHUieritellOPisesio ian nek n N EN beyA Ka Pe d A ehe coe a au
27. S or MIDI FOV Upgrades 206718 rev 5 SOREDEX 111 9 Technical data 9 2 Unit dimensions EE dHLLiki r T TL raum TL am m LL Ja l J E lli iy 1364 53 7 2164 85 1614 63 5 2414 95 Chin support up 958 37 7 1758 69 Chin support down 898 35 1698 66 8 2023 79 6 1540 60 6 483 19 1384 54 5 1424 56 965 38 T Note The cephalostat arm and the touchscreen can be on either side L R 112 SOREDEX 206718 rev 5 9 Technical data 9 3 Symbols that appear in the unit D O N Ii Pr gt pud 206718 rev 5 Radiation warning Dangerous voltage On or enabled Off or disabled Exposure switch Connector for exposure switch CLASS II equipment Double insulated electrical appliance Ethernet connector Operating instruction More details in operation instructions Laser radiation Attention consult accompanying documents SOREDEX 113 9 Technical data 114 _ Ground Functional Protective ground CLASS 1 LASER PRODUCT EN 60 825 1 A2 2001 Laser class label Patient positioning lights This symbol indicates that the waste of electrical and electronic equipment must not be disposed as unsorted municipal waste and must be collect ed separately Please contact an authorized rep resentative of the man
28. alibration and adjustment procedure In addition to the calibration name e g Adjustment panCol the images contain image data sampled during the calibration adjustment instructions and a Passed Not Passed Failed calibration status Passed means that the calibration program is suc cessfully done Move on to next calibration Not passed means that adjustment is still needed Follow the instructions the image if any and take another exposure Some calibration programs are iterative and demand a few repetitions Failed means that the system could not decide what adjustment should be done in order for the calibration to succeed This calibration status is al ways the result of some error condition Taking an other exposure will not help The image may give a hint on what the problem is e g no radiation colli mator severely tilted image data corrupted Contact service if the problem persists after restart ing the unit and PC SOREDEX 87 8 Calibration and adjustment 88 8 2 9 Quality assurance Preparing for calibration 1 Close the head support and lock it in its upmost position Switch the PC and unit on PC Open the dental imaging software and then open a patient card and give it and identifiable name for exam ple calibration refer to the user s manual supplied with the dental imaging software for more information PC Click the image acquisition button to activa
29. are as instructed in this manual The sensor must not be dropped or exposed to impacts A shock indicator inside the sensor shows if the sensor has been exposed to excess impact 206718 rev 5 SOREDEX 31 5 Using the unit 5 1 1 Attaching the sensor 1 Insert the four slots on the rear of the sensor into the four hooks in the sensor holder 2 Slide the sensor downwards until it stops and then slide the locking knob down on the side of the sensor to lock the sensor in position 32 SOREDEX 206718 rev5 5 Using the unit 5 1 2 Removing the sensor 1 Slide the locking knob upwards on the side of the sensor to unlock the sensor 2 Slide the sensor up and remove it 5 2 Preparing the system 1 Switch on the unit and the PC 2 PC Start SCANORA software or 3rd party applica tion 3 PC Open a new or existing patient or select a patient from the worklist See the user s guide supplied with the dental imaging program 206718 rev 5 SOREDEX 33 5 Using the unit 5 3 Panoramic exposures Adult panoramic Child panoramic Reduced width and height Bitewing Maxillary sinus TMJ PA AP projection TMJ lateral projection axially corrected 5 3 1 Positioning devices Bite block TMJ support Chin rest holder Lip holder for Chin cup edentulous patients 34 SOREDEX 206718 rev5 5 Using the unit 5 3 2 General instructions 1 PC Click Image Capture A Maija Mallinen QW 2 m
30. ays use the lowest possible x ray dose the smallest possible image area and the lowest possible resolution that allows you to perform the required diagnostic task SOREDEX 206718 rev5 206718 rev 5 1 Introduction lf the patient is using a pacemaker consult the manufacturer of the pacemaker before taking an exposure to confirm that the x ray unit will not interfere with the operation of the pacemaker Decontaminate all the surfaces that the patient is in contact with after every patient to prevent cross infection Decontaminate all device accessories that contact the patient during a radiographic examination Do not open or remove any of the units enclosures No user serviceable parts inside The customer must ensure that the siting environment fulfills the requirements listed in the Installation manual Special attention must be paid to the strength of the floor and wall materials electrical mains and radiation protection It is the responsibility of the customer to ensure that the site is large enough for the patients The unit contains toxic materials that need to be handled properly when disposing the unit Return the unit to the dealer in the end of its life cycle Excessive dust should be cleaned from the unit for free airflow and cooling Switch of the unit before cleaning Always follow the instructions for patient positioning and imaging procedures instructed in the User Manual 1 6 2 Warnings for cross infection
31. cal grade PC should not be used in patient environment This product itself complies with IEC 60601 1 medical safety standard but in order to the system incorporating also a PC to comply the standard EITHER the PC has to be a medical PC OR the PC has to be located over 1 5 meters apart from the unit The installer and the user of the system shall confirm that at least one of the above requirements is fulfilled A PC is a medical one if it complies IEC 60601 1 standard and that is indicated in the accompanying documents of the PC See chapter Technical specifications Minimum PC Requirements in user manual All service operations must be made by authorized service personnel only SOREDEX 206718 rev 5 206718 rev 5 1 Introduction The annual service as described in manual is mandatory for the correct and safe operation of the unit When taking exposures operators and service personnel must protect themselves from radiation and remain at least two meters six feet away from the unit during exposure Protect the patient from scattered radiation by placing a protective lead apron over the patient The unit must be installed and serviced according to the unit Installation amp adjustments manual by a qualified technician Only personnel trained and approved by the manufacturer of the unit are allowed to service the unit 3D should not be used for routine or screening examinations in which a radiograph is taken regardless of the
32. d not be used if conventional intraoral radiographic images bitewing exposures would be sufficient Cone beam computed tomography images are not adequate for the analysis of soft tissue CAUTION USA only Federal law restricts this device to sale by or on the order of a dentist or other qualified professional SOREDEX 206718 rev 5 206718 rev 5 1 Introduction 1 4 Associated documentation CRANEX 3D user manual CRANEX 3D installation manual The SCANORA software user manual The SCANORA software installation manual The user manual supplied with the dental imaging software The installation manual supplied with the dental imaging software The user manual supplied with the 3D imaging software The installation manual supplied with the 3D imaging software 1 5 Abbreviations used in this manual FOV Field Of View The cylindrical 3D volume that is reconstructed by the system ROI Region Of Interest The anatomical area or region of the patient that you are interested to examine AES Automatic Exposure Setting SOREDEX 3 1 Introduction 1 6 Warnings and precautions 1 6 1 Warnings to be observed during use The unit may be dangerous to the user and the patient if the safety regulations in this manual are ignored if the unit is not used in the way described in this manual and or if the user does not know how to use the unit The unit must only be used to take the dental x ray exposures desc
33. dsagittal plane and center pa tient s head 2 Check midsagittal plane and center pa tient s head Remedy 1 Check patient posi tioning and type of bite fork rod 2 Check patient posi tioning and type of bite fork rod Remedy Install chin rest Tr 6 Troubleshooting Problem Images are too light Problem Images are too dark Problem Lack of image contrast 78 6 2 1 1 Image appearance Possible cause SCANORAS Contrast and brightness not optimum SCANORA Gamma not set correctly Possible cause SCANORA Contrast and brightness not optimum Manual technique factors used too high Possible cause SCANORA Contrast and brightness not optimum kV used is too high Gamma value is not cor rect for the monitor being used SOREDEX Adjust Remedy contrast brightness and Select a more fitting his togram type and check gamma setting Remedy Adjust contrast and den sity Decrease technique fac tors Remedy Adjust contrast and brightness Lower the kV setting Adjust Gamma value 206718 rev 5 6 3 Problem Irregular bright shadows or artefacts A SUE I E ow VES A i dM AST AJ ANE j A Ld k A AJEWEL Problem An unexposed area is shown down in the lower middle sec tion of the image 2 Was Wt a Ee M nm 2 i AAPRO _ ar eee a a Problem Partial lack
34. e in meters m Field strengths from fixed RF transmitters as determined by an electromagnetic site survey are less than the compliance level in each frequency range Interference may occur in the vicinity of equipment marked with the following Field strengths from fixed transmitters such as base stations for cellular telephones and land mo bile radios amateur radio AM and FM radio broadcast and TV broadcast cannot be estimated accurately To assess the electromagnetic environment due to fixed RF transmitters an electro magnetic site survey should be performed If the measured field strength exceeds the RF compli ance level above observe CRANEX 3D to verify normal operation in each use location If abnormal performance is observed additional measures may be necessary such as re orienting or relocating CRANEX 3D Over the frequency range 150 kHz to 80 MHz field strengths are less than V1 V m The Rec ommended Separation Distances are listed in the next table Note These guidelines may not apply in all situations Electromagnetic propagation is affected by absorption and reflection from structures objects and people 118 SOREDEX 206718 rev 5 206718 rev 5 9 Technical data Note RF communications equipment can effect medical electrical equipment Note This equipment generates uses and can radiate ra dio frequency energy If not installed and used in accord ance with this manual it may cause harmful int
35. e the patient out Remove disposable covers and disinfect the unit PC The image can be examined using the SCANORA software See SCANORAS software user s manual SOREDEX 47 9 Using the unit 5 4 Cephalometric exposures Reduced Width lateral projection Lateral projections PA AP projection Reverse towne projection Waters view Carpus program optional Not available in USA and Canada N WARNING 9 4 1 Remove all calibration tools Pan and 3D patient positioning accessories before taking any cephalomateric exposures General instructions 1 Move the ceph sensor to the ceph sensor holder in a case of single sensor configuration 2 PC Click Image Capture 3 Select CEPH Maija Mallinen y hr u J o G Q c EET gg E TI wit 5 Ready 48 SOREDEX 206718 rev 5 206718 rev 5 5 Using the unit Select the imaging program If AES is enabled green light lit around A press the Return button and wait for the movement to finish Ver ify that the suggested exposure values are suitable for the patient If AES is disabled set the exposure values manually and press Return to drive the unit into expo sure start position optional Press Return to drive the unit to patient in position Ask the patient to remove any spectacles hearing aids removable dentures jewelry and hair clips and pins Place a protective lead apron on the patient SOREDEX 49
36. ed Methanol metyl alcohol Soap lsopropyl alcohol distilled water Not allowed Bentzene Chlorine bentzene Acetone Acetic ether agents containing phenol paracetic acid peroxide and other oxygen cleaving agents sodium hypochlorite and iodine cleaving agents Autoclave Some removable parts in contact with the patient may be autoclaved These parts are bite rods bite guides and chin supports SOREDEX 85 7 Maintenance lf autoclaving is performed for these items disinfection by alternate methods is not needed Steam sterilization Recommended parameters for sterilizable parts are B Gravity displacement steam sterilization Flash sterilization Temperature 270 F 132 C Exposure time 3 minutes B Prevacuum steam sterilization Flash sterilization Temperature 270 F 132 C Exposure time 3 minutes B Steam flush pressure pulse steam sterilization Temperature 270 F to 275 F 132 C to 135 C Exposure time 3 to 4 minutes 86 SOREDEX 206718 rev 5 8 Calibration and adjustment 206718 rev 5 8 1 Introduction Calibrations and quality checks are performed by taking exposures of calibration tools The system does needed adjustments according to the image data captured For panoramic and cephalometric quality checks the quality is visually evaluated by the operator Resulting from the each calibration is an image containing calibration results telling the operator how to proceed with the c
37. ed to the CRANEX 3D unit and SCANORA software to capture and manage images CRANEX 3D performs the following procedures Panoramic e Adult panoramic e Child panoramic Reduced width and height e Bitewing e TMJ PA projection e TMJ lateral projection axially corrected e Maxillary sinus Cephalometric optional e Cephalometric Full size Lateral e Cephalometric Reduced size lateral e Cephalometric posterior anterior projection PA AP e Reverse Towne projection e Waters view e Carpus program optional Not available in USA and Canada 3D optional e XS 61x41 mm Field of View e Midi 61x78 mm Field of View Endo 61 x 41 mm Field of View 206718 rev 5 SOREDEX 1 1 Introduction 1 2 1 3 References The following instructions are delivered with in the CRANEX 3D installation manual e Firmware update instructions e Calibration instructions e Cephalostat upgrade instructions e Cephalostat side changing instructions The following instructions are separate and can be ordered from customer service e 3D upgrade instructions are delivered with the 3D upgrade kit Intended use CRANEX 3D must only be used and operated by dentist and other qualified professionals CRANEX 3D must only be used to take panoramic cephalometric and 3D images of the dento maxillofacial complex of the human skull It must not be used to take images of any other part of the human body Panoramic and 3D exposures shoul
38. erference to radio communications Portable and mobile HF communi cations equipment can also affect the performance of CRANEX 3D Table 1 4 Table 4 Recommended Separation Distances for Portable and Mobile RF Communications Equipment IEC 60601 1 2 Frequency of 150KHz to Transmitter 80 MHz isj KE Vi Separation Rated Distance Maximum meters Equation Output Power of Transmitter watts 80 MHz to 800 MHz to 800 MHz 2 5 GHz asi e Jaye Ei Ei Separation Separation Distance Distance meters meters USE LIMITATION External components The use of accessories transducers and cables other than those specified may result in degraded ELECTROMAGNETIC COMPATIBILITY of the EQUIPMENT and or SYSTEM SOREDEX 119 9 Technical data 120 INSTALLATIONS REQUIREMENTS amp ENVIRONMENT CONTROL In order to minimize interference risks the following requirements shall apply Cables shielding amp grounding All interconnect cables to peripheral devices must be shielded and properly grounded Use of cables not properly shielded and grounded may result in the equipment causing radio frequency interference Electrostatic discharges environment amp recommendations In order to reduce electrostatic discharge interference a charge dissipative floor should be installed to prevent charge accumulation m The dissipative floor material must be connected to the system reference ground if applicable
39. etric posterior anterior PA Magnification 1 15 Ka PA 22 x 20 cm height x wide lt Carpus program optional Not available in USA and Canada Requires separate holder not part of standard delivery m N SOREDEX 21 3 Imaging programs 3 3 3D programs F J Cone beam 3D imaging enables seeing dentomaxillofacial anatomy of selected Field of View FOV helping with diagnostics and treatment planning With 3D viewing software user is able to analyze FOV area from multiple directions and see cross sectional images from the area of interest XS FOV 61 x 41 mm height x diameter High resolution 133um voxel size Standard resolution 200um voxel size Endo FOV 61 x 41 mm height x diameter Program for optimized endodontic imaging e Endo program 85um voxel size Midi size FOV 61 x 78 mm OPTIONAL Standard resolution or High resolution High resolution 200um voxel size Standard resolution 300um voxel size 22 SOREDEX 206718 rev 5 3 Imaging programs 3 4 Exposure settings for 3D imaging Exposure settings for 3D imaging Note Voltage settings is always 90kV with unit 3D modality Resolu FOV Expo Scanning Amount mA tion h x w sure of projec Low dose time tions DAP mGycm2 High Res 61x 41 mm 6 3 en 2 an ee en ee Std Res 61x41 mm E r an A 145 181 227 High Res 61x78 mm 12 6s 1260 dive pra P it t UU T wey e Ge Std Res 6
40. ev5 206718 rev 5 5 Using the unit 5 6 Warnings and error messages The unit responds to error situations by showing a dialog box containing an error code and descriptive text on the touch screen When an error code appears on the display the unit will stop working and cannot be operated while the error code is on the display In less severe cases a warning message will be displayed leaving the unit operable 5 6 1 Acknowledging errors Most errors may be acknowledged by closing the dialog box the error is reported in Some errors require the unit to be rebooted If such an error occurs or if the unit fails to operate as described in the user s manual switch the unit off wait a few seconds and switch the unit on again 5 6 2 Image transfer errors If an image is not transferred successfully to the PC close and then reopen the dental imaging software and or restart the PC DO NOT restart the unit as this will erase any image that is stored in the unit memory and this retrievable image will be lost If restarting the PC and or restarting the dental imaging software does not allow you to retrieve the images contact technical support without restarting the unit SOREDEX 73 9 Using the unit 74 SOREDEX 206718 rev 5 6 Troubleshooting High quality images with sharp contrast and good detail provide optimum diagnostic information Images with less quality are usually the result of one or more common problems 6 1 Patie
41. f the unit regularly The unit might overheat if excess dust is gathered on the cooling grilles Unit surfaces All surfaces can be wiped clean with a soft cloth dampened with a mild detergent e g soapy water DO NOT use abrasive cleaning agents or polishes on this equipment SOREDEX 206718 rev 5 206718 rev 5 Maintenance Positioning light covers The positioning light covers are made of clear plastic Use a soft cloth dampened with a mild detergent e g soapy water NEVER use abrasive cleaning agents or polishes to clean the covers Surfaces that the patient touches All surfaces and parts that the patient touches or comes into contact with must be decontaminated after each patient Use a disinfectant that is formulated specifically for decontaminating dental equipment and use the disinfectant in accordance with the instructions supplied with the disinfectant All items and surfaces should be dried before next usage Note Wear gloves and other protective equipment during decontamination process In accordance with the instruc tions supplied with the cleaner N WARNING Do not use any disinfecting sprays since the vapor could ignite causing injury Decontamination techniques for both the unit and the room must comply with all laws and regulations within the local jurisdiction Examples of cleaning agents that can be found in disinfectant products which are allowed or prohibited when cleaning the unit Allow
42. g Protect yourself from radiation by standing behind a suit able x ray radiation shield Make sure that you can see and hear the patient during the exposure Note In all examinations the user of the x ray equipment should wear protective clothing The operator does not need to be close to the patient during normal use The pro tection against stray radiation can be achieved by using the hand switch not less than 2 m 7 ft from the focal spot and the xray beam Operator should maintain visible contact with the patient and Technical factors This allows immedi ate termination of radiation by the release of the exposure button in the event of a malfunction or disturbance Note If the patient is nervous or a child you can demon strate how the unit works to reassure them Press the T Test mode button and then press and hold the exposure button The unit will complete an exposure cycle without generating x rays SOREDEX 206718 rev 5 206718 rev 5 5 Using the unit 3 Press and hold down the exposure button During the ex posure you hear an audible signal and the exposure warning symbol on the ClearTouch control panel ap pears The unit rotates around the patients head and stops When the rotating unit stops the exposure has been tak en After the exposure the rotating unit is in patient out po sition if the exposure switch has been pressed until all movements have stopped Release temple supports Guid
43. head is touching the x ray tube during the exposure Problem Patient s shoulders are touching the x ray tube or sensor 206718 rev 5 Possible cause 1 Patients head inclination not correct 2 Patient is too big for the unit 3 Patient has slumped Possible cause Patient is too big for the unit Wide and high shoulders SOREDEX 6 Troubleshooting Remedy If the image is not accept able then 1 2 Gheck the head position and retake the image Gheck the patient posi tioning Make the expo sure even though the head may touch the tube head Gheck the patient posi tioning Make the expo sure even though the head may touch the tube head Remedy Reverse patient s hands on handles left to right side handle and vice versa 81 6 Troubleshooting 82 SOREDEX 206718 rev 5 7 Maintenance 7 1 Maintenance procedure The maintenance procedure described below shall be seen as a minimum requirement and can be made more stringent to comply with regulations regarding the use and maintenance of dental x ray devices that are in force in the country in which the unit is installed 7 1 1 Annual maintenance An annual maintenance procedure must be carried out at least once a year by qualified service personnel Contact your local distributor for details 7 1 2 Calibration intervals To keep the image quality at best possible level calibrations and quality checks shall be carried out at
44. hnical data CRANEX 3D ceph physical measures source image distance SID 68 7 inches 1745 mm source object distance SOD 60 inches 1520 mm Installation Standard wall mount with 45 angled joint Optional base for free standing unit unit height is increased 25 mm Height x Width x Depth inches mm 2414 x 1872 x 1126 mm 94 9 x 73 7 x 44 3 inches Weight 250 kg 551 Ibs Cephalometric Ambient temperatures Transportation and Storage 10 60 C Operation Temperature 10 35 C RH max 85 Minimum PC requirements for 3D acquisition workstation Processor 2 5 GHz dual core or better Memory 3 Gigabytes RAM or more Hard disk 500 GB or more Expansion slot PCI Express bus for supplied GPU full length Power supply 500 watt minimum Network Gigabit Ethernet 1000Base T W Operating system indows 7 or Windows Vista 32 or 64 bit 2 Display 0 LCD display 1600 x 1200 or 22 LCD widescreen display 1680 x 1050 or better Standard The PC must meet the IEC 60950 standard minimum re quirements Graphics board The system is highly dependent on the used graphics board and graphics driver of the reconstruction worksta tion Consult technical support for information on the sup ported boards and drivers Examples of supported boards NVidia Quadro 4000 NVidia GeForce GTX 560 The compatible graphics driver versions are found on the driver update DVD PCI board connection Full length PCle x16
45. m Relative humidity must be maintained above 30 percent Stacked components amp equipment The CRANEX 3D should not be used adjacent to or stacked with other equipment if adjacent or stacked use is necessary the CRANEX 3D should be observed to verify normal operation in the configuration in which it will be used Interference may occur in the vicinity of equipment marked with the following symbol c No portable or mobile RF communications equipment may be used closer to any part of the CRANEX 3D including cables than the recommended separation distance calculated from the equation appropriate to the frequency of the transmitter See Table 4 SOREDEX 206718 rev 5 9 Technical data 9 6 X ray tube assemblies Duty cycle 1 8 Rectification type Constant pot ential x ray generator Generator rating Generator nominal power 1750W Figure 1 3 Anode Thermal Characteristics HEAT STORAGE kJ TIME min Figure 1 4 Maximum Rating Charts Absolute maximum rating charts DC Center Grounded Focal Spot 0 5 mm 25 60kV 20 SOkV TUBE CURRENT mA an zx NO 3 5 7 10 N O EXPOSURE TIME s 206718 rev 5 SOREDEX 121 9 Technical data Figure 1 5 TUBE HOUSING ASSEMBLY COOLING CHARACTERISTICS kHU HEAT UNITS 60 50 120 150 180 TIME IN MINUTES 122 SOREDEX 206718 rev 5
46. mA TJ 57414 m W S mn 85 um L The teeth locations on the 3D dental arch are approximate and are based on NV average dentition The exact teeth we locations will depend on the patient s R L l individual anatomy Ready The EasyScout function helps locate the correct dental location of the Field of view 3 Select the Field Of View FOV XS FOV 61 x 41 mm Program 1 Endo program FOV 61 x 51 mm Midi FOV 61 x 78 mm Program 2 OPTIONAL 4 Select the area of interest on the dental arch The 3D FOV is positioned more accurately by using the scout im age mode The area of interest can be adjusted on the ClearTouch control panel after the scout image has been taken 5 Press Return to rotate the unit to patient in position 64 SOREDEX 206718 rev5 9 Using the unit 6 Adjust the unit height 7 Ask the patient to remove any spectacles hearing aids removable dentures jewellery and hair clips and pins 8 Guide patient to the unit Instruct patient to stand as straight and tall as possible next to the unit Patient can also be imaged in sitting position Ask the patient to take grip on the handles and place chin on the chin cup 9 Check the position of the midsagittal light If it is not on the midsagittal plane of the patient adjust the patient s head 206718 rev 5 SOREDEX 65 5 Using the unit 10 Adjust the unit height and chin rest height to get the area of interest between the top and bottom
47. n SOREDEX 97 8 Calibration and adjustment 8 5 2 Ceph Quality check program Optional 1 Attach the QC phantom to the ceph unit and ensure that it s leveled from the spirit level Y 2 Select the Ceph QC program 3 Press Return 4 Take an exposure 5 Visually evaluate the result using the installed imaging software 98 SOREDEX 206718 rev 5 8 Calibration and adjustment Beto alia An CIO ha a RA 4 y 7125 zi 4 ME x J a Subjects to be evaluated 1 Smoothness of the exposed area Non exposed area surrounds the whole image 2 High contrast resolution minimum 3 1LP mm must be distinguishable 3 All four low contrast holes must be visible 206718 rev 5 SOREDEX 99 8 Calibration and adjustment 100 SOREDEX 206718 rev 5 9 Technical data 9 1 Technical specifications Manufacturer SOREDEX PaloDEx Group Oy Nahkelantie 160 P O Box 148 FIN 04300 Tuusula FINLAND Quality system In accordance with 8013485 and 1809001 standard Environmental In accordance with ISO14001 standard management system Conformity to standards IEC 60601 1 1988 and A1 A2 IEC 60601 1 1 2000 IEC 60601 1 4 1996 and A1 IEC 60601 2 7 1998 IEC 60601 2 28 1993 IEC 60601 2 32 1994 IEC 60601 1 2 2001 and A1 IEC 60601 1 3 1994 UL 60601 1 2003 CAN CSA C22 2 No 601 1 M90 and S1 A2 standards This product complies with DHHS 21 CFR Chapter Subchapter J at the date of manufacture CRANEX 3D is in co
48. n fuses Column Carriage Main support Rotating unit On off switch rear of carriage and main fuses Tubehead assembly ClearTouch control panel Positioning panel Oo N O oa A W N Sensor head 10 Head support 11 Chin rest 12 Handles 13 Cephalometric unit 14 Cephalometric sensor 15 Secondary collimator 16 Positioning panel SOREDEX 206718 rev5 2 Unit description PC with MDD approved dental imaging software and 3D viewing software not included All software must conform to the MDD and the relevant legal requirements in the USA ECCE ESSE N The PC must conform to all the unit and dental imaging Dos eeoS lt a So software requirements 1 Sensor holder PAN units only 2 Panoramic sensor 1 3D sensor units with 3D option 2 Panoramic sensor 206718 rev 5 SOREDEX 11 2 Unit description 2 2 Patient positioning lights o oa A C N Midsagittal Frankfort horizontal Focal trough Cephalometric Frankfort horizontal Horizontal top of FOV 3D option only Horizontal bottom of FOV 3D option only SOREDEX 206718 rev 5 206718 rev 5 Panoramic lights 1 Midsagittal light 2 Frankfort horizontal plane 1 Focal through light SOREDEX 2 Unit description 2 Unit description Cephalometric lights 1 Frankfort horizontal plane 3D lights 1 Midsagittal light 2 Horizontal light top of FOV 3 Horizo
49. nformity with the provisions of Council Directive 93 42 EEC as amended by the Direc tive 2007 47 EC concerning medical devices Performance Standards and European Union Directive 93 42 EEC Medical Devices Directive Model PP3 1 CRANEX 3D Product type Digital dental imaging system with panoramic cephalometric and Cone Beam 3D imaging programs 206718 rev 5 SOREDEX 101 9 Technical data Protection against electric shock Degree of protection Type B applied with no conductive connection to the pa tient Protection against the ingress of liq IP20 uids Disinfection methods mild soapy water non abrasive non alcohol based disinfectant for the chin rest disposable plastic covers for bite block chin rest and chin support For use In environments where no flammable anaesthics nor flammable cleaning agents are present Mode of operation continuous operation intermittent loading Safety IEC 60601 1 Tube head assembly Tube head assembly type THA 300 Tube type Toshiba D 052SB D 054SB C Stationary anode Tube voltage 57 90 kV Max electric output 1 44 kW Focal spot 0 5 x 0 5 mm IEC 336 1982 Nominal anode input 1750 W In the middle of the panoramic sensor s active area Max anode heat content 35 kJ Max X ray tube assembly heat con 385 kJ tent Max continuous heat dissipation of 38 W the X ray tube assembly Total filtration 23 2 mm Al Leakage Technique Factors 90 kV 4 mA 102 SOREDEX
50. nt positioning Problem Incisors and canines narrow and unsharp Overshadow in molar and premolar areas Rows of teeth are compressed Problem Incisors and canines wide and unsharp Rows of teeth widened Possible cause 1 Focal trough light set too far posterior 2 Image layer laser light not obeyed 3 Bite block was not used Possible cause 1 Focal trough light set too far anterior 2 Image layer laser light not obeyed 3 Bite block was not used Remedy Check patient positioning with laser light lines and occlusion correction buttons Check patient positioning with laser light lines and occlusion correction buttons Insert bite block Remedy Check patient positioning with laser light lines and occlusion correction buttons Check patient positioning with laser light lines and occlusion correction buttons Insert bite block 206718 rev 5 SOREDEX 15 6 Troubleshooting Problem Teeth appear wider on one side and narrower on the opposite Ramus widths are different on opposite sides Problem The shadow of hard palate is exposed over maxillary mo lars Row of teeth has a wavy appearance TM joints are exposed outward Image is not smiling Mandible is imaged sharper than maxil la Problem Rows of teeth curved up wards Mandibular incisors are unsharp TMJ joints ex posed high and are often cut off from the image Image is smiling to
51. ntal H light bottom of FOV 14 SOREDEX 206718 rev5 2 Unit description 2 3 Patient positioning panel 9 1 Carriage UP DOWN Z movement 2 Focal through adjustment Y movement 3 Positioning lasers ON OFF 4 Return 5 Chin support UP DOWN 2 3 1 Cephalometric unit 1 Carriage down 2 Carriage up 3 Positioning lights ON OFF 206718 rev 5 SOREDEX 15 2 Unit description 2 4 Emergency stop switch In case of malfunction of the exposure button or other protective devices of the unit an emergency stop switch is provided near the handles and on the roof of the cephalostat head so that the patient can reach it lf the emergency stop switch is pressed during an exposure the exposure is terminated immediately and the x ray unit is completely stopped An interrupted exposure cannot be continued later but has to be retaken from the beginning Press to stop the unit rotate to release 16 SOREDEX 206718 rev 5 3 Imaging programs 3 1 Panoramic programs Adult Magnification 1 3 WY Panoramic imaging provides general view of dental and facial anatomy based on panoramic imaging technic Adult panoramic 20 5 cm width x 11 cm height Child Magnification 1 3 Child panoramic 11 5 cm width x 8 5 height Child panoramic has reduced width and height Children can be imaged with less radiation dosage and shorter exposure time Patients with jaw more narrow than average jaw can be exposed with this too
52. o much 76 Possible cause 1 Midsagittal line not obeyed 2 Patients head not in center position Possible cause Patient head tilted back Possible cause Patient head tilted forward SOREDEX Check that Remedy Check patient s mid sag ittal plane with laser light line patient s head is centered and that the head support side clamps where closed to keep the head straight Remedy Check FH plane Remedy Check FH plane 206718 rev 5 Problem Middle area of the image too bright and unsharp Spine shadow uc e CU WA ANECK Problem Black shadow over maxillary teeth apex area Problem TMJ s exposed on different heights on image Bilateral distortion in molar and pre molar regions Problem Rows of teeth exposed too high TMJ s cut off Problem Rows of teeth exposed too low Mandible not exposed completely to the image 206718 rev 5 Possible cause Patient s neck was not stretched Possible cause Tongue was not against the roof of palate Possible cause 1 Patient tilted to one side 2 Midsagittal laser light line not obeyed Possible cause 1 Chin was not resting on chin support 2 Patient positioned too high Possible cause Chin rest was not used with bite fork SOREDEX 6 Troubleshooting Remedy Stretch patient s neck Remedy Ask patient to swallow and place tongue against the roof of palate during the exposure Remedy 1 Check mi
53. or Fast Ethernet 100Base TX Operating system Windows 7 or Windows Vista 32 or 64 bit Display 19 LCD display 1280 x 1024 or better For the PC requirements of the 3D viewing software consult the 3D software manuals System requirements and connections The PC and any other external device s connect ed to the system must meet the IEC 60950 stand ard minimum requirements Devices that do not meet the IEC 60950 standard must not be connect ed to the system as they may pose a threat to op erational safety The PC and any other external devices must be connected in accordance with IEC 60601 1 1 he x ray unit must be connected to it s own sepa rate power supply The PC and any other external devices must NOT be connected to the same pow er supply as the x ray unit Position the PC and any other external device at least 1 5 m 60 from the xray unit so that the pa tient cannot touch the PC or any other external de vice while being x rayed The PC and any other external devices shall not be connected to an extension cable Multiple extension cables shall not be used Do not position the PC where it could be splashed with liquids Clean the PC in accordance with the manufactur er s instructions 110 SOREDEX 206718 rev 5 9 Technical data Ceph ready option Ordered separately aon y Ceph Upgrade to CRANEX 3D pan Upgrade CRANEX 3D panoramic with Cephalometric imaging 3D X
54. ote Use the same tool for cephalostat Quality Check 1 Attach a panoramic Quality Check Tool optional to the chin support a i 2 Select the Pan QC program 3 Press Return 4 Take an exposure 5 Visually evaluate the result using the installed imaging software 206718 rev 5 SOREDEX 91 8 Calibration and adjustment 92 Subjects to be evaluated 1 Smoothness of the exposed area Non exposed area surrounds the whole image 2 High contrast resolution minimum 3 1LP mm must be distinguishable 3 All four low contrast holes must be visible 4 Roundness of the ball 5 The ball should be placed symmetrically between the two pins The distance from both pins to center should be equal length Note The panoramic QC collimator is equipped with a 0 8 mm copper filter If more filtration is required additional fil tration may be attached to the tubehead cover The unit may be configured to use higher exposure values to com pensate for an additional 1 mm copper filter Ask Technical Support to adjust the copperthickness setting as required SOREDEX 206718 rev 5 8 Calibration and adjustment 8 4 3D calibration 8 4 1 3D geometry calibration 1 Attach the base of the phantom to the lower shelf Level it with the bubble both 3D imaging modes standard and high resolution otandard geometry calibration has to be done first r 3 Press Return 4 Install the 3D calibration phantom
55. patient s thyroid gland from radiation 2 Protect yourself from radiation by standing behind a suitable x ray radiation shield Make sure that you can see and hear the patient during the exposure Press and hold down the exposure button During the exposure you hear an audible signal and the exposure warning symbol on the ClearTouch control panel ap pears Release the ear rods and guide the patient out Remove disposable covers and decontaminate the unit 206718 rev 5 SOREDEX 61 5 Using the unit 62 PC The image can be examined using the SCANO RA software See SCANORA user manual Note n all examinations the user of the x ray equip ment should wear protective clothing The operator does not need to be close to the patient during normal use The protection against stray radiation can be achieved by using the hand switch not less than 2 m 7 ft from the focal spot and the xray beam Operator should maintain visible contact with the patient and technique factors This allows immediate termination of radiation by the release of the exposure button in the event of a malfunction or disturbance SOREDEX 206718 rev 5 5 Using the unit 5 5 3D exposures 5 5 1 Positioning devices Chin cup Bite block and chin plane 206718 rev 5 SOREDEX 63 9 Using the unit 5 5 2 General instructions 1 PC Click Image Capture 2 Select the 3D modality a Test R1 12 QJ A Ww Le W d J 1 0 O
56. patient to the unit facing the sensor Instruct the patient to stand as straight and tall as possible un der the cephalostat head 5 Turn the head torsal as reference to the canthomeatal line about 35 40 above the horizontal plane 6 Slide the ear rods towards patient s ears T Askthe patient open or close mouth 58 SOREDEX 206718 rev 5 5 Using the unit 5 4 2 5 Carpus program optional Not available in USA and Canada A Maija Mallinen WWW Qn 9 Q 3 2 m Qe CT Ready 206718 rev 5 SOREDEX 59 9 Using the unit N CAUTION Before taking Carpus image make sure this imaging method is approved by local authorities of your country 1 Unlock the lever and turn the ear rods to the PA projec tion position Lock the position Tilt the nasion support aside Place the carpus holder to the nasion support holder 2 Adjust the unit height if needed 3 Ask the patient to remove rings and metal objects and to place hand on the carpus holder Note Carpus holder is a separate accessory Order from local distributor 60 SOREDEX 206718 rev5 5 Using the unit 5 4 2 6 Taking the exposure N WARNING Close the patient positioning mirror before taking any exposures 1 Askthe patient to remove any spectacles hearing aids removable dentures jewellery and hair clips and pins Place a protective lead apron around the patient s neck to protect the
57. regular intervals according to the table below Modality Minimum requirement Recommendation Two 2 times annually Four 4 times annually Panoramic Annually during normal mainte Two 2 times annually nance Cephalometric Annually during normal mainte Two 2 times annually nance Note The calibrations mentioned in this manual can be done by the user or qualified service personnel 206718 rev 5 SOREDEX 83 7 Maintenance 84 7 2 Changing the fuses Main fuses are located next to the on off power switch Push inward on the fuse base and twist it counterclockwise with a screwdriver The fuse with the base comes out Remove the fuse from the base and replace it with the new one Repeat this with each blown fuse Fasten both fuses by pushing the base in and twisting it clockwise with a screwdriver Use only appropriate fuses e Line voltage 220 240 Vac 326 Littelfuse 10A slow blow or Cooper Bussman MDA 10 time delay e Line voltage 100 120 Vac 326 Littelfuse 15A slow blow or Cooper Bussman MDA 15 time delay 7 3 Cleaning and decontaminating the unit N CAUTION Switch the unit off or disconnect it from mains before cleaning the unit If you use a spray cleaner do not spray into any ventilation grills Do not allow water or other cleaning liquids to enter the unit interior since these may cause short circuits or corrosion The unit should be cleaned after every usage N CAUTION Clean the dust of
58. ribed 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 x ray exposures that it is not designed for Only professionally qualified dental and or medical personnel are allowed to operate the unit and carry out any diagnoses based on output from the unit Because the x ray limitations and safety regulations change from time to time it is the responsibility of the user to make sure that all the valid safety regulations are fulfilled When taking an x ray exposure of a patient with exceptional anatomy typically very tall or large use the Test mode no x rays first to make sure that patient can be positioned correctly to the unit and for checking that the unit doesn t hit the patient Operator should maintain visible contact with the patient and technique factors This allows immediate termination of radiation by the release of the exposure button in the event of a malfunction or disturbance It is the responsibility of the doctor to decide whether x ray exposure or any additional exposures are justified and necessary The minimum height of patient that can be x rayed is 120 cm 3 9ft 47 2in and the maximum is 200 cm 6ft 78in These heights only apply to patients with normal anatomy Always use the lowest suitable x ray dose to obtain the desired level of image quality Avoid taking x ray exposures of pregnant women When taking an x ray exposure of a child alw
59. ron ment as described below Radio Frequency Emissions CISPR11 Radio Frequency Emissions CISPR11 Harmonic emis sions IEC 61000 3 2 Voltage fluctua tions flicker emissions IEC 61000 3 3 116 IEC 61000 3 2 Class A CRANEX 3D uses RF energy only for its internal func tion Therefore the RF emission is very low and not likely to cause any interference in nearby electronic equip ment CRANEX 3D is suitable for use in all establishments in cluding domestic establishments and those directly con nected to the public low voltage power supply network that supplies buildings used for domestic purposes CRANEX 3D is suitable for use in all establishments in cluding domestic establishments and those directly con nected to the public low voltage power supply network that supplies buildings used for domestic purposes CRANEX 3D is suitable for use in all establishments in cluding domestic establishments and those directly con nected to the public low voltage power supply network that supplies buildings used for domestic purposes SOREDEX 206718 rev 5 9 Technical data Table 1 2 Electromagnetic immunity IEC 60601 1 2 Ed2 CRANEX 3D is suitable for use in the specified electromagnetic environment The pur chaser or user of CRANEX 3D should assure that it is used in an electromagnetic environ ment as described below Immunity Test IEC 60601 1 2 Compliance Electromagnetic Environment Tes
60. s in the USA Do not connect any equipment to the unit that has not been supplied with the unit or that is not recommended by the manufacturer The use of accessory equipment not complying with the equivalent safety requirements of this equipment may lead to a reduced level of safety of the resulting system Mirror shall be closed before taking exposures Disclaimer The manufacturer shall have no liability for consequential damages personal injury loss damage or expense directly or indirectly arising from the use of its products No agent distributor or other party is authorized to make any warranty or other liability on behalf of the manufacturer with respect to its products Disposal The device its spare parts its replacement parts and its accessories may include parts that are made of or include materials that are non environmentally friendly or hazardous These parts must be disposed of in accordance with all local national and international regulations regarding the disposal of non environmentally friendly or hazardous materials Unit has at least the following parts that should be regarded as nonenvironmental friendly waste products Tubehead Pb oil Collimator Pb All electronic circuits electronic boards inside Sensor covers EMC painted SOREDEX 206718 rev 5 2 Unit description 2 1 Main parts and controls 206718 rev 5 SOREDEX co 2 Unit description Fig 1 1 On off switch and mai
61. t Level Level Electrostatic dis charge ESD IEC 61000 4 2 Electrical fast transient burst IEC 61000 4 4 Surge IEC 61000 4 5 Voltage dips short interrup tions and volt age variations on power supply input lines IEC 61000 4 1 1 Power frequen Cy 50 60 Hz magnetic field IEC 61000 4 8 2 4 6 kV for contact discharge 2 4 8 kV for air discharge 2 kV for power supply lines 1 kV for input output lines 1 kV differential mode 2 kV common mode lt 5 UT gt 95 dip in UT for 0 5 cycle 40 UT 60 dip in UT for 5 cycles 70 UT 30 dip in UT for 25 cycles lt 5 UT gt 95 dip in UT 2 4 6 kV for contact discharge 2 4 8 KV for air discharge 2 kV for power supply lines 1 kV for input output lines 1 kV differential mode 2 kV common mode lt 5 UT gt 95 dip in UT for 0 5 cycle 40 UT 60 dip in UT for 5 cycles 70 9o UT 30 dip in UT for 25 cycles lt 5 UT gt 95 dip in UT Floors are wood concrete or ce ramic tile or floors are covered with synthetic material and the relative humidity is at least 30 percent Mains power quality is that of a typi cal commercial and or hospital envi ronment Mains power quality is that of a typi cal commercial and or hospital envi ronment Mains power quality is that of a typi cal commercial and or hospital envi ronment If the user of CRANEX
62. t e Sets OA N DONNE 3 1 5 Abbreviations used in this manual L EYA 3 1 6 Warnings and precautlors deese ideo vaina tie y s Lom me ti tie etaed rint eto wes iue we Web e adu v EW N 4 1 6 1 Warnings to be observed during use cc kk ke 4 1 6 2 Warnings Tor cross infection suede LE eene rots ee e een edens 5 tO S oeneral WwarnhigS eerie acess ceo ce ob Mars Ee E Opp coto ptu ka Sed a E RR 6 VCI TREE 8 128 DIPSA oo rrr r 8 2 UI G SOL D ON Au sy DL EE 9 2al Wall DarlS and COL OS yy su An yeren dabana behay la ite ipo A nar n k nn Aw anl ar de qut each 9 2 2 Paent DOSTO NT TO HONS san xin y ke kel n e Lube tio an data apo ruse ante k l e e SAD 12 Z9 Patient DOSITONING Dal l k gt sen raped ovv enr Ped qut battle ai 15 2 3 1 Cephalometric DEL A s yyy sise ovni ramps edet bd ORA a Da tu t UR AA 15 ZA Emergency SIOD SWINGIN us klan ke h Dea dus Ansett cue didn Sar n n en cma 16 3 Im ging lase ll LC N De DE 17 ol Panoramic DiOQT AT S e c nice eriya d ka voci te akre ker bese sk kada rek l be b e a dee 0 ODE 17 9 2 GeDhalomeltme Di OO AI 9i 4 i yay eienaiabutumatdeu x z kr kin QBUS CURIE Ceo SXT OO ud 20 9 25 SSD DIOGFAITIS Susannae ciun KONANE eda y kaya e Ke kk os ki elek D Ue Mabeta Wala ease tse eae 22 3 4 Exposure settings for 3D imaging ccccseccseecceeeceeeceeeeseecanseceeeseeeseesseeeaeeess 23 3 4 4 SMAR
63. t in until it touches the patient s nasion 42 SOREDEX 206718 rev 5 206718 rev 5 5 Using the unit 8 Adjust the position of the TMJ light until it aligns in the middle of condyle Note The condyle moves forward by approximately 10 mm when the mouth is opened 9 If AES is enabled green light lit around A press the Return button and wait for the movement to finish Verify that the suggested exposure values are suitable for the patient If AES is disabled set the exposure values man ually and press Return to drive the unit into exposure start position optional Aj 10 Ask the patient to press their tongue against the roof of their mouth swallow and remain still for the duration of the exposure SOREDEX 43 9 Using the unit 44 var Bi l 5 3 3 3 Maxillary Sinus exposure 1 Insert the the lip holder for sinus imaging Place the disposable covers Note Use a new disposable cover for every patient 2 Adjust the unit height Guide the patient to the unit and instruct to stand as straight and tall as possible Ask the patient to take grip on the handles and set the mouth against lip holder Check the position of the midsagittal light If it is not on the midsagittal plane of the patient adjust the patient s head Adjust the height of the Frankfort Horizontal plane FH laser to get the laser light over the orbita porion Straight en the patient s head if needed A
64. te image capture Touch the settings button on the touch screen display Select the Quality assurance button The calibration display appears az 167761 716Z Smith John Quality assurance j SOREDEX 206718 rev 5 8 Calibration and adjustment 8 3 Panoramic calibration 8 3 1 Panoramic geometry calibration 1 Select the program r 2 Press Return 3 Install the double cone calibration tool 4 Take an exposure 5 Repeat the calibration until calibration result passed is achieved Adjustment panGeom Passed X offset lt 0 5 0 31mm offset lt 0 5 0 1 mm N offset lt 05 0 04 mm J offset 15 9 mm 206718 rev 5 SOREDEX 89 8 Calibration and adjustment 8 3 2 Panoramic pixel calibration 90 Note The pixel calibration results are sensor specific If the x ray unit is equipped with separate panoramic and cepha lometric sensors the cephalometric sensor cannot be used for panoramic imaging without re calibration and vice ver sa Note Re do panoramic pixel calibration if cephalostat sensor is moved to panoramic side or the sensor is changed 1 Remove the calibration tools 2 Select the program 3 Press Return 4 Take an exposure EEPan detector calibration Passed CTOQ 3 0 9 0 signal level 54b1 9935 Dark level S819 273 SOREDEX 206718 rev5 8 Calibration and adjustment 8 3 3 Panoramic Quality Check optional N
65. u EMMA RON vala D iini REBALUN tcl cay FS Minturn vale lS So Mna x m l m etg ele 38 QO 201 MOS day fh 120 488 SICIROTL 6S pee go a 01 J0 J23a2ay Jf0n rm A ete are Seu Sr Se 2 Preference Calib testi Tool Options No Option Avalable UAI WL 1156 WW 5121 89 kVp Zoom x2 3 0 087 mm CI ET sharpen Fer JE REI unco ness TER n 220m TI HPR Dental THI re g iD 20110028085538933 D Calib testi 01 LOB e Win RANE S b KS slbi 5 Thu 13 10 12 46 2011 1 J Axs amp Rtesken SHA preference Tool Options Po Delon Aabe x mA WL 1156 WW 5121 BO kvp Zoom CT 96 SOREDEX 206718 rev 5 206718 rev 5 8 5 8 Calibration and adjustment Cephalometric calibration 8 5 1 Ceph pixel calibration Note The pixel calibration results are sensor specific If the x ray unit is equipped with separate panoramic and cepha lometric sensors the cephalometric sensor cannot be used for panoramic imaging without re calibration and vice ver Sa Note Re do panoramic pixel calibration if cephalostat sensor is moved to panoramic side or the sensor is changed 1 Rotate the ear holders into PA view position and move them completely apart Turn nasion support up out of the way 2 Select Ceph Pix program 3 Press Return 4 Take an exposure 5 This calibration should always be a pass Ceph detectonealibtatiot evels sm Passeg Signalllevel Eon oae
66. ufacturer for information concerning the decommissioning of your equip ment Type B equipment CE 0537 symbol MDD 93 42 EEC ETL Classified conforms to UL STD 60601 1 Certified to CSA SOREDEX 206718 rev 5 206718 rev 5 9 Technical data 9 4 Labels on the unit The main label of the unit is located on the vertical carriage next to the on off power switch The unit is class I type B and with IP20 protection Type PP3 1 Ser No Manufactured 10A 220 240 V 50 60 Hz 1A continuous 15A 100 120 V 50 60 t 1A continuous AA ass ACE This product complies with DHHS 21 CFR Chapter I Subchapter J at the date of manufacture Rx only Warning This X ray unit may be dangerous to patient and operator unless safe exposure factors operating instructions and maintenance schedules are observed J ETL CLASSIFIED CONFORMS TO UL STD 60601 1 US CERTIFIED TO CSA STD C22 2 NO 601 1 Intertek Manufactured by Soredex Nahkelantie 160 Fl 04300 TUUSULA Finland D502470 SOREDEX 115 9 Technical data 9 5 Electromagnetic Compatibility EMC tables Note Medical electrical equipment needs special precau tions regarding EMC and needs to be installed according to EMC information Table 1 1 Electromagnetic emissions IEC 60601 1 2 Ed2 CRANEX 3D is suitable for use in the specified electromagnetic environment The pur chaser or user of CRANEX 3D should assure that it is used in an electromagnetic envi
67. ze The user can change the value before exposure if needed by pushing A button again and changing the values 4 4 1 AES values for Panoramic imaging Note Values can be re scaled by SOHEDEX authorized service personnel Adult child panoramic Bitewing Sinus Head width min KV mA 12 925 cm Head width min 206718 rev 5 SOREDEX 27 4 Controlling the unit 4 4 2 AES values for Cephalometric imaging kV 9 cm Min Head width min kV 7 3 cm Max kV l N N N O O o OO OO Qol CO CO Ol QIJ O1 Of O1 28 SOREDEX 206718 rev 5 4 Controlling the unit 4 4 3 Exposure indicators and settings 70 w er 16 4 93 2 mGycme mm XAR gt A 4 5 Status section kV value mA value Exposure time s Dose value mGycm2 Focal through light mm Focal through light y layer position Test mode Automatic Exposure setting AES Status field shows when the unit is ready for capturing or any trouble occurs Green or red color indicate the status in question Green means ready to capture and red means not ready During actual exposure a large radiation warning symbol will fill the display area Status ready 206718 rev 5 SOREDEX Ready for imaging 29 4 Controlling the unit 30 4 6 Other sections General settings if x j Fi 4 Languages d Service jl 1 A Fi Qu i ET f Retrieve last f Retrieve With D

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