Kavo Pan eXam ® Plus User Manual
Contents
1. 48 PaloDEx Group 206918 rev 1 206918 rev 1 4 Using the unit 4 4 3 Taking the exposure 1 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 2 Press and hold down the exposure button During the exposure you hear an audible signal and the exposure warning symbol on the touch screen display appears 3 Release the ear rods and guide the patient out Remove disposable covers and disinfect the unit 4 PC The image can be examined using the CliniView software See CliniView users manual NOTE n all examinations the user of the x ray equipment should wear protective clothing The operator does not need to be close to the patient during normal use The protection against stray radiation can be achieved by using the hand switch not less than 2 m 7 ft from the focal spot and the xray beam Operator should maintain visible contact with the patient and technique factors This allows immediate termination of radiation by the release of the exposure button in the event of a malfunction or disturbance PaloDEx Group 49 4 Using the unit 4 5 3D exposures 4 5 1 Positioning devices Chin support 4 5 2 General instructions PC Click Image Capture 2 Select the 3D modality tab y 0 000 mm angle 0 deg 50 PaloDEx Group 206918 rev 1 Y NOOO 19 9 216 4 Using the unit Select the Field Of Vie2. A Forward towards the mirror B Reset C Backward away from the mirror 8 Ask the patient to press their tongue against the roof of their mouth swallow and remain still for the duration of the exposure 206918 rev 1 PaloDEx Group 37 4 Using the unit 4 3 3 3 Maxillary Sinus exposure 1 Insert the required positioning devices bite fork with the bite block on the sinus rest Place the disposable covers NOTE Use a new disposable cover for every patient 2 Adjust the unit height TO AK 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 bite on the bite block 4 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 y OOOO 010 9 JOJO 5 Check the position of the midsagittal light If it is not on the midsagittal plane of the patient adjust the patient s head 38 PaloDEx Group 206918 rev 1 4 Using the unit Y Ol So J K RS UO YU 6 Move the head support against the patient s forehead Adjust the height Close the temple supports 7 Adjust the position of the image layer as necessary The image layer is 18 mm posterior compared to standard panoramic procedure Y OOO ge B C Image layer adjustment buttons A 10mm anterior B Center C 10mm posterior 8 Ask the patient to press
3. Check the lead apron positioning Remedy Retake the image Remedy Check patient positioning Remedy Retake the image Remedy Select correct panoramic procedure 61 5 Troubleshooting Problem Possible cause Remedy light horizontal line on Bite block was left on Remove the bite block and QA image place retake QA image Problem Possible cause Remedy Horizontal lines on image Sensor problem Consult the dealer Problem Possible cause Remedy CEPH Lateral view has 2 1 Cephalostat lock not 1 Lock it ear holder pins locked ail Service 2 Ear holders misaligned 62 PaloDEx Group 206918 rev 1 9 4 Problem Back of the patient s head is touching the x ray tube during the exposure Problem Patient s shoulders are touching the x ray tube or sensor 206918 rev 1 Unit operation Possible cause 1 Patient s 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 PaloDEx Group 5 Troubleshooting Remedy If the image is not acceptable then 1 Check the head position and retake the image Check the patient positioning Make the exposure even though the head may touch the tube head Check the patient positioning Make the exposure even though the head may touch the tube head Remedy Reverse patient s hands on handles left to right side handle and
4. Remedy 1 Check patient positioning with laser light lines and occlusion correction buttons Check patient positioning with laser light lines and occlusion correction buttons Insert bite block Remedy 1 Check patient positioning with laser light lines and occlusion correction buttons Check patient positioning with laser light lines and occlusion correction buttons Insert bite block Remedy 1 Check patient s mid sagittal plane with laser light line Check that patient s head is centered and that the head support side clamps where closed to keep the head straight 57 5 Troubleshooting 58 Problem The shadow of hard palate is exposed over maxillary molars Row of teeth has a wavy appearance IM joints are exposed outward Image is not smiling Mandible is imaged sharper than maxilla Problem Rows of teeth curved upwards Mandibular incisors are unsharp TMJ joints exposed high and are often cut off from the image Image is smiling too much Problem Middle area of the image too bright and unsharp Spine shadow i a BE CR FA AN WW ANECK Possible cause Patient head tilted back Possible cause Patient head tilted forward Possible cause Patient s neck was not stretched PaloDEx Group Remedy Check FH plane Remedy Check FH plane Remedy Stretch patient s neck 206918 rev 1 Problem Black shadow
5. fluctuations establishments including domestic establishments and flicker emissions those directly connected to the public low voltage power supply network that supplies buildings used for IEC 61000 3 3 domestic purposes Table 7 1 Electromagnetic emissions IEC 60601 1 2 Ed2 206918 rev 1 PaloDEx Group 93 7 Technical data Kavo Pan eXam Plus is suitable for use in the specified electromagnetic environment The purchaser or user of Kavo Pan eXam Plus should assure that it is used in an electromagnetic environment as described below Immunity Test Electrostatic discharge ESD IEC 61000 4 2 Electrical fast transient burst IEC 61000 4 4 Surge IEC 61000 4 5 Voltage dips short interruptions and voltage variations on power supply input lines IEC 61000 4 1 1 Power frequency 50 60 Hz magnetic field IEC 61000 4 8 IEC 60601 1 2 Test Level 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 U gt 95 dip in U for 0 5 cycle 40 U 60 dip in U for 5 cycles 70 Ur 30 dip in U for 25 cycles lt 5 Ur gt 95 dip in U 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 U gt 95
6. blow 15A Cooper Bussman time delay MDA 15 2 3 kVA 230 VAC 1 65 kVA 110 VAC Maximum impedance of malin Positioning laser lights Panoramic TMJ amp Maxillary Sinus Programs Cephalostat FH laser light 3D imaging programs laser light CLASS 1 LASER PRODUCT max output 100uW Warning symbols are placed next to the laser lights and the label describing the laser light classification is placed inside the carriage side cabinet USA Canada models have different types of laser light stickers according to local requirements Caution use of controls or adjustments or performance of procedures other than those specified herein may result in hazardous radiation exposure SS IEC 60825 1 1993 A1 1997 A2 2001 PaloDEx Group 79 7 Technical data X ray generator Spine compensation Spine compensation Pre programmed mode Program and technique Touch screen panel removable factors selection exposure button with 10m cable exposure control Patient positioning Positioning panel integrated Connection cable CAT6 Ethernet cable the unit PC Panoramic programs amp technique factors amp magnification Standard Adult Panoramic 57 90 kV 4 16 mA 30 16 45 Pediatric Panoramic 57 90 kV 4 16 mA 14 4 S Exposure Control Pre programmed icons for all programs Automatic Spine Compensation 80 PaloDEx Group 206918 rev 1 7 Technical data Cephalometric programs amp technique factors
7. over maxillary teeth apex area Problem TMJ s exposed on different heights on image Bilateral distortion in molar and premolar 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 206918 rev 1 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 PaloDEx Group 5 Troubleshooting Remedy Ask patient to swallow and place tongue against the roof of palate during the exposure Remedy 1 Check midsagittal plane and center patient s head 2 Check midsagittal plane and center patient s head Remedy 1 Check patient positioning and type of bite fork rod 2 Check patient positioning and type of bite fork rod Remedy Install chin rest 59 5 Troubleshooting 60 Problem Images are too light Problem Images are too dark Problem Lack of image contrast 5 2 Image appearance Possible cause 1 CliniView Contrast and brightness not optimum 2 CliniView Gamma not set correctly Possible cause 1 CliniView Contrast and brightness not optimum 2 Manual technique factors used too high Possible cause 1 CliniView Contrast an
8. positioning Operation Arm mounts on left or right side of the unit Interlocked pan ceph sensor Motorised carriage buttons at cephalostat head assembly Positioning aids Ear holders Nasion support with vertical mm scale Frankfurt horizontal plane laser light Contact plate Carpus view 3D imaging patient positioning Operation Left or right side of unit Motorised carriage movement Positioning aids Chin rest chin support 3 point headrest Curved mirror 3 positioning laser lights Cephalostat scanning Scanning method Horizontal scan synchronized sensor and secondary slot motion Scanning time 10 20s Panoramic image receptor Sensor unit Pan sensor or interchangeable Ceph sensor 82 PaloDEx Group 206918 rev 1 Technical data Image field height Image field height Image field width in lateral 10 2 inches 260 mm maximum view 6 7 inches 170 mm minimum Image field width in PA 7 9 inches 200 mm view unit physical measures SID 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 2410x830x1126mm standard column inches mm 94 9 x 32 7 x 44 3 inches Max 200 kg 441 Ibs Panoramic unit ceph physical measures source image distance 68 7 inches 1745 mm SID source object distance 60 inches 1520 mm SOD Installation Standard wall mount with 45 angled joint Optional base for f
9. the position Tilt the nasion support aside Place the disposable covers NOTE Use a new disposable cover for every patient 2 Adjust the unit height 190000 wO OOOO J O U YU 3 Guide the patient to the unit Instruct the patient to stand as straight and tall as possible under the cephalostat head Slide the ear rods towards to patien s ears 4 Adjust the unit height to get the Frankfort Horizontal plane FH laser light passing over the orbita porion y Ol So JOGDG J O U O 5 Tilt the nasion support down and slide it towards patient s nasion 44 PaloDEx Group 206918 rev 1 4 Using the unit 4 4 2 2 PA projection 1 Unlock the lever and turn the ear rods to the PA projection position Lock the position Tilt the nasion support aside Place the disposable covers NOTE Use a new disposable cover for every patient 2 Adjust the unit height 2 TOWO 3 Guide the patient to the unit facing the sensor Instruct the patient to stand as straight and tall as possible under the cephalostat head Slide the ear rods towards patien s ears 206918 rev 1 PaloDEx Group 45 4 Using the unit 4 4 2 3 Reverse towne projection 1 Unlock the lever and turn the ear rods to the PA projection position Lock the position Tilt the nasion support aside Place the disposable covers NOTE Use a new disposable cover for every patient 2 Adjust the unit height 9 O00 TO AK 3 Guide the patient to
10. to take images with unit you need a suitable PC hardware connected to the unit and CliniView software to handle images Unit performs the following procedures Standard panoramic Pediatric panoramic Ortho Zone enhanced panoramic Wide arch panoramic Bitewing Orthogonal panoramic Maxillary sinus Ortho TMJ axially corrected lateral projection TMJ PA projection Cephalo pediatric lateral projection Cephalo lateral projection Cephalo postero anterior PA projection Reverse Towne projection Waters view Carpus view Not in USA 3D imaging Intended use The unit must only be used and operated by dentist and other qualified professionals The unit must only be used to take panoramic cephalometric and 3D images of the dento maxillofacial complex of the human skull It must not be used to take images of any other part of the human body USA only CAUTION Federal law restricts this device to sale by or on the order of a dentist or other qualified professional PaloDEx Group 1 1 Introduction 1 3 1 4 1 5 About this manual This manual describes how to set up and use the unit Please read this user s manual before operating the unit for the first time CAUTION t is important to read the warnings and precautions listed in section 1 6 before operating the unit for the first time It is also important to observe these warnings and precautions whenever the unit is used Abbreviations used in this manual
11. vice versa 63 5 Troubleshooting 64 PaloDEx Group 206918 rev 1 6 Maintenance 6 1 Maintenance procedure The maintenance procedure described below shall be seen as a minimum requirement and can be made more stringent to comply with regulations regarding the use and maintenance of dental x ray devices that are in force in the country in which the unit is installed Annual maintenance An annual maintenance procedure must be carried out at least once a year by qualified service personnel Contact your local distributor for details Calibration intervals To keep the image quality at best possible level calibrations and quality checks shall be carried out at regular intervals according to the table below Modality Two 2 times annually Four 4 times annually Panoramic Annually during normal Two 2 times annually maintenance Cephalometric Annually during normal Two 2 times annually maintenance 206918 rev 1 PaloDEx Group 65 6 Maintenance 66 6 1 1 Performing calibrations Calibrations and quality checks are performed by taking exposures of calibration tools The system does needed adjustments according to the image data captured For panoramic and cephalometric quality checks the quality is visually evaluated by the operator Resulting from the each calibration is an image containing calibration results telling the operator how to proceed with the calibration and adjustment procedure In additio
12. 00 mm angle 0 deg 206918 rev 1 PaloDEx Group 53 4 Using the unit 4 5 3 Scout image 1 Press and hold down the exposure button During the exposure you hear an audible signal and the exposure warning symbol on the touch screen display appears 2 Scout preview image appears to the touch screen display 3 Fine adjust scout position using the side arrow keys Press the right upper corner icon to continue 4 Take a new scout or save current and continue to 3D image 54 PaloDEx Group 206918 rev 1 4 Using the unit 4 5 4 3D image 1 Select the Standard D or high resolution D 61 x 41 mm x 0 000 mm y 0 000 mm angle 0 deg 2 Select mA 3 Press and hold down the exposure button During the exposure you hear an audible signal and the exposure warning symbol on the touch screen display appears 206918 rev 1 PaloDEx Group 55 4 Using the unit 56 4 6 Warnings and error messages The unit responds to error situations by showing a dialog box containing an error code and descriptive text on the touch screen When an error code appears on the display the unit will stop working and cannot be operated while the error code is on the display In less severe cases a warning message will be displayed leaving the unit operable 4 6 1 Acknowledging errors Most errors may be acknowledged by closing the dialog box the error is reported in Some errors require the unit to be rebooted If such an error occ
13. 1 4 Abbreviations used in this manual Re 2 1 0 Associated documentation attente deteste 2 120 Wamnngs anda pPreCAUTIONS EE SN Rd tan a 3 1 7 Manufacturer s liability ker tk nere kerner kr kk 6 2 UNIT CSS SUE OUD sa Ea st eee at toc 7 ZAM MAIN parts and COMMONS ES a ar AAAA 7 222 Jalen DOSINOMIMG NOMS ESS RO dd ner 9 2 3 Patient positioning panel sise 12 24 Emergency SIOD SWINCIN ESS ne nement nus 13 229 MIMAdINO PDIOOTAMS ES an nn no in 14 29 11 Panoramie DO AMS EE RER NRA en ends 14 29 2 Gepnalometric programs ax orig eee enken oh herskende soens 19 25 95 BD DOr aNG 2 raa desire EAR ERE ARR ace niet es nn 21 3 Touchscreen display sure bade anelse bede al a dents teinte nest 23 ull Man CONOR EJE za anne E E treer meeen 23 322 Modally SCO Man ere nier den en its ed 24 9 9 EXPOSUTG SOTHO S srini nets se clean las toc en E iiaii 24 SB Patents ze SETTINGS rs ns et Na ce 24 3 3 2 Exposure indicators and settings ccccccceccsecceecceeceeseeeeeeseeesseeseeeees 25 JS AUS SEC HON SES ne Ne Sale DNS seats 25 3 5 Other SECIONS sisri aean N e easton 26 A USNO tHE UNI PRE aa ea i ia aR 27 4 1 Attaching and removing the sensor 27 AM AHACRINd N SCMSOM EE ne a Ne 27 41 2 REMOVING MNE SENSOR niiit en ae re a Mie 28 AE Preparmno Me Syste sani race ede ce cect age a T E R 28 43 Panoramie CxDOSUICS ee A E nie 29 4 IMPOSITION CO VICE S esas e ae a nee 29 43 2 Genera
14. 6 1 3 1 Panoramic geometry calibration Select the program Press the patient positioning button Install the double cone calibration tool h N Take an exposure Repeat the calibration until calibration result passed is achieved Adjustment panGeom Passed X offset lt 0 5 0 3mm offset lt 0 5 0 1 mm N offset lt 0 5 0 04 mm J offset 15 9 mm 68 PaloDEx Group 206918 rev 1 206918 rev 1 6 Maintenance 6 1 3 2 Panoramic pixel calibration 4 Remove the double cone calibration tool select the program Press the patient positioning button i 3 eee 4 Take an exposure FFFan detector calibration Passed CVO gt 3 0 9 0 signal level 5461 9935 Dark level lt 819 273 PaloDEx Group 69 6 Maintenance 70 6 1 3 3 Panoramic Quality check ry YS Attach a line pair calibration tool to the chin support Select the Pan QC program Take an exposure Visually evaluate the result using the installed imaging software PaloDEx Group 206918 rev 1 6 Maintenance 6 1 4 3D calibration and quality check 6 1 4 1 3D geometry calibration Attach the base of the phantom to the lower shelf Level it with the bubble Select the program There is a calibration procedure for both 3D imaging modes standard and high resolution Standard geometry calibration has to be done first Press the patient positioning button Install the 3D calibration phantom
15. ENGLISH Kavo Pan eXam Plus User Manual 206918 rev 1 Copyright Manufactured by Code 206918 rev 1 Date 17 February 2011 Document code D506901 rev 1 Copyright 02 2011 by PaloDEx Group Oy All rights reserved Pan eXam Plus is a registered trademark of Kaltenbach amp Voigt GmbH Windows is trademark of Microsoft Corporation in the United States of America and other countries Documentation 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 PaloDEx Group The original language of this manual is English PaloDEx Group 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 PaloDEx Group representative for the most current information CE 0537 PaloDEx Group Oy Nahkelantie 160 P O Box 20 FI 04300 Tuusula FINLAND Tel 358 10 270 2000 Fax 358 9 851 4048 For service contact your local distributor Table of Contents T INITOQUCUHON ESS RBR DERE NERE SES ETS ENES nus annees nca sense seen teen n nach attenant enaie das 1 Ci Karo Pare ne POS RED SEE 1 T WIT CIVO USE ne crane ce in on nicole ie ere ele nete 1 eo ADOUTINIS MINUA SSSR nine ct aloo sect pos 2
16. Ex Group 31 4 Using the unit 4 3 3 Patient positioning 4 3 3 1 Panoramic exposure 4 Insert the sinus rest chin rest and bite fork with the bite block Place the disposable covers NOTE Use a new disposable cover for every patient 2 Adjust the unit height 49 Q0O O OOOO J O U YU 3 Guide the patient to the unit and instruct to stand as straight and tall as possible Exposure can be taken also in sitting position Ask the patient to take grip on the handles and bite on the bite block Use the edentulous bite positioner or the chin support for an edentulous patient 4 Ask the patient to take one step forward to straighten the spinal column Patient is slightly leaning backwards during the imaging 32 PaloDEx Group 206918 rev 1 4 Using the unit 5 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 6 Check the position of the 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 206918 rev 1 PaloDEx Group 33 4 Using the unit 7 Move the head support against the patient s forehead Adjust the height Close the temple supports 8 Check the position of the image layer light If it is not on the buccal of the maxillary canine or base of the nose if edentulous adjust the image layer Im
17. 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 FH Frankfort Horizontal H Horizontal Associated documentation The CliniView software user s manual or the users manual for the dental imaging software you are using The users instructions supplied with the 3D imaging software you are using PaloDEx Group 206918 rev 1 206918 rev 1 1 Introduction 1 6 Warnings and precautions To be observed during use The unit must only be used to take the dental x ray exposures described in this manual The unit must NOT be used to take any other x ray exposures It is not safe to use the unit to take an x ray exposures that it is not designed for Only professionally qualified dental and or medical personnel are allowed to operate the unit and carry out any diagnoses based on output from the unit The unit may be dangerous to the user and the patient if the safety regulations in this manual are ignored if the unit is not used in the way described in this manual and or if the user does not know how to use the unit This unit complies with the EMC Electromagnetic Compatibility according to IEC 60601 1 2 Radio transmitting equipment cellular phones etc shall not be used in close proximity of the unit as they could influence the performance of the unit Because the x ray limitations
18. OR ee ere titane 63 LES TT LEE 5 LILI 01 PAPAS PR eee RER RER SPORE ee PR 65 Gl Mantenance DOU sn G ere 65 GT ANAUAll MAINS NAINICE gece nn eee ann ten 65 0 1 2 Calibration MeV maleren dn rer learned eneret 65 6 1 3 Performing Calibrations usssssssssneuueueeee keen ktr keen ket sense k ken nnee 66 6 14 Preparing for c libraHo NR 2235 menes ne deet 66 6 1 5 Panoramic calibration and quality check 67 STS PAN DIXEl CAIIDTAUON aar ere din ns 68 6 1 5 2 Panoramic Quality Check 2253 roser msn uen antec esos 69 6 1 6 CT calibration and quality check 70 OLOT CT Keel Rio RAR ne oo 71 6 1162 CU OUI CIC GIR suerte a era een 72 0 2 Chanding Ihe MUSES Le al DM ele dt bene rene eee nel ne 73 6 3 Cleaning and disinfecting the unit 74 0A TSI SAN statist eerste Remick a ots vaccine a ale en nti nin clue sc not so ead 16 NOCH G AUC Ala vactecy tect wicareceneect M du s nca 77 fl VECHAMICANSDSCIIGAN ONS enen estate Ans tent dite 7 122 UNIL AM NSIONS no en a ee ne bone 87 ko SYMDOIS hat appear In the UIA caucus na natal 89 TA Lape ON TMS UAW 2820 E a ee 91 7 5 Electromagnetic Compatibility EMC tables 92 PaloDEx Group 206918 rev 1 1 Introduction 206918 rev 1 1 1 1 2 Kavo Pan eXam Plus Pan eXam Plus x ray unit hereafter called the unit is a software controlled diagnostic dental X ray equipment for producing high quality digital images of dentition TM joints and skull In order
19. Pediatric lateral view 60 90 kV 4 16 mA 10 20 s Lateral view 60 90 KV 4 16 mA 10 20 s PA AP facial and oblique 60 90 kV 4 16 mA 10 20 s views Carpus View Not in USA 60 90 kV 4 16 mA 10 20 s Exposure Control Automatic Facial Contour AFC Pre programmed icons for all programs Magnification factor 1 14 14 3D imaging programs Small FOV dimensions 61 x 41 mm HxD Large FOV dimensions 61 x 78 mm HxD Technique factors Small FOV standard 90 kV 6 3 12 5mA 2 3s resolution Large FOV standard 90 KV 6 3 12 5mA 49s resolution Small FOV high resolution 90 kV 4 12 5mA 6 1s Large FOV high 90 kV 4 10mA 12 6s resolution Small FOV scout 90 kV 4 12 5 mA 0 02s Large FOV 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 t Typical panoramic About 2 4 MB PNG 16 bits file size Typical cephalometric 3 5 MB PNG 16 bits file size Typical 3D file size 150 250 MB DICOM 206918 rev 1 PaloDEx Group 81 7 Technical data Image storing and retrieving Patient database Standalone workstation Server on local area network LAN Panoramic patient positioning Operation Left or right side of unit Motorised carriage movement Positioning aids Chin rest bite block 3 point headrest Curved mirror 3 positioning laser lights Occlusion correction buttons Cephalostat patient
20. STEM 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 m Relative humidity must be maintained above 30 percent Stacked components amp equipment The Kavo Pan eXam Plus should not be used adjacent to or stacked with other equipment if adjacent or stacked use is necessary the Kavo Pan eXam Plus 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 No portable or mobile RF communications equipment may be used closer to any part of the Kavo Pan eXam Plus including cables than the recommended separation distance calculated from the equation appropriate to the frequency of the transmitter See Table 4 PaloDEx Group 97
21. Take an exposure Repeat the calibration until calibration result passed is achieved This calibration is only needed with 3D units BecemetiJealibrationmaieass ed CAPAMea r Noris enico taen Scen dit 0 16 MIE deg ete Li on bioffse RO EN m offset BEGIN M 206918 rev 1 JE JE E JE E JE De ME HEL JEL ee EE IL FEL FE FE EE PaloDEx Group 71 6 Maintenance 6 1 4 2 3D pixel calibration Remove the 3D calibration phantom Select the program Press the patient positioning button h N Take an exposure Dark la TD 129 CT detector calibration Passed CTQ gt 3 9 7 signal level 2750 5759 72 PaloDEx Group 206918 rev 1 6 Maintenance 6 1 4 3 3D Quality check or SY SS 206918 rev 1 Attach the QC phantom to the unit select the 3D QC program Press the patient positioning button Take an exposure The resulting image contains information on whether the quality check was passed PaloDEx Group 73 6 Maintenance 6 2 Changing the fuses Main fuses are located next to the on off power switch Push inward on the fuse base and twist it counterclockwise with a screwdriwer The fuse with the base comes out Remove the fuse from the base and replace it with the new one Repeat this with each blown fuse Fasten both fuses by pushing the base in and twisting it clockwise with a screwdriver Use only appropriate fuses Line voltage 220 240 Va
22. Xam Plus Over the frequency range 150 kHz to 80 MHz field strengths are less than V V m The Recommended 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 Table 7 3 RF immunity of non life support equipment or system IEC 60601 1 2 206918 rev 1 PaloDEx Group 95 7 Technical data NOTE RF communications equipment can effect medical electrical equipment NOTE This equipment generates uses and can radiate radio frequency energy If not installed and used in accordance with this manual it may cause harmful interference to radio communications Portable and mobile RF communications equipment can also affect the performance of the unit Recommended Separation Distances for Portable and Mobile RF Communications Equipment IEC 60601 1 2 Frequency of 150KHz to 80 MHz to 800 MHz to Transmitter 80 MHz 800 MHz 2 5 GHz Equation d WP d LWP E by Rated Maximum Separation Separation Separation Output Distance Distance Distance Power of meters meters meters Transmitter watts Fig 7 1 Table 4 96 PaloDEx Group 206918 rev 1 206918 rev 1 Technical data USE LIMITATION External components The use of accessories transducers and cables other than those specified may result in degraded ELECTROMAGNETIC COMPATIBILITY of the EQUIPMENT and or SY
23. age layer adjustment buttons A Retrusion B Normal occlusion default C Protrusion 9 Ask the patient to press their tongue against the roof of their mouth swallow and remain still for the duration of the exposure 34 PaloDEx Group 206918 rev 1 4 Using the unit 4 3 3 2 TMJ exposure Nose support r J iyi iy 1 Insert the required positioning devices including the TMJ nose support Place the disposable covers NOTE Use a new disposable cover for every patient 2 Adjust the unit height QOOO WOOO 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 nose against the TMJ nose support 4 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 206918 rev 1 PaloDEx Group 35 4 Using the unit 5 Check the position of the midsagittal light If it is not on the midsagittal plane of the patient adjust the patient s head 6 Move the head support against the patient s forehead Adjust the height Close the temple supports 7 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 y 36 PaloDEx Group 206918 rev 1 4 Using the unit a 6990 MO HOC A B C TMJ light adjustment buttons
24. and maintenance schedules are observed Manufactured by PaloDEx Group Oy Nahkelantie 160 Fl 04300 TUUSULA Finland D502470 PaloDEx Group 206918 rev 1 Technical data 7 5 Electromagnetic Compatibility EMC tables NOTE Medical electrical equipment needs special precautions regarding EMC and needs to be installed according to EMC information Kavo Pan eXam Plus is suitable for use in the specified electromagnetic environment The purchaser or user of Kavo Pan eXam Plus should assure that it is used in an electromagnetic environment as described below Emissions Test Electromagnetic Environment Radio Frequency Group 1 Kavo Pan eXam Plus uses RF energy only for its Emissions internal function Therefore the RF emission is very low CISPR11 and not likely to cause any interference in nearby electronic equipment Radio Frequency Class B Kavo Pan eXam Plus is suitable for use in all Emissions establishments including domestic establishments and CISPR11 those directly connected to the public low voltage power supply network that supplies buildings used for domestic purposes Harmonic IEC 61000 3 2 Kavo Pan eXam Plus is suitable for use in all emissions Class A establishments including domestic establishments and those directly connected to the public low voltage power IEC 61000 3 2 supply network that supplies buildings used for domestic purposes Voltage Complies Kavo Pan eXam Plus is suitable for use in all
25. and safety regulations change from time to time it is the responsibility of the user to make sure that all the valid safety regulations are fulfilled In all examinations the user of the x ray equipment should wear protective clothing The operator does not need to be close to the patient during normal use The protection against stray radiation can also be achieved by using the hand switch not less than 2 m 7 ft from the focal spot and the xray beam Operator should maintain visible contact with the patient and 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 if the x ray exposure is necessary The minimum height of patient that can be xrayed is 120 cm 3 9 ft 47 2 in and the maximum is 200 cm 6ft 78in These heights only apply to patients with normal anatomy PaloDEx Group 3 1 Introduction 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 Always use the lowest suitable x ray dose to obtain the desired level of image quality Avoid taking x ray exposures of pregnant women When taking an x ray exposure of a child always use the lowest possible x ray dose the smallest possible image area and the lowest possible resolutio
26. c 326 Littelfuse 10A slow blow or Cooper Bussman MDA 10 time delay Line voltage 100 120 Vac 326 Littelfuse 15A slow blow or Cooper Bussman MDA 15 time delay 74 PaloDEx Group 206918 rev 1 206918 rev 1 6 Maintenance 6 3 Cleaning and disinfecting the unit CAUTIONT Switch the unit off or disconnect it from mains before cleaning the unit If you use a spray cleaner do not spray into any ventilation grills Do not allow water or other cleaning liquids to enter the unit interior since these may cause Short circuits or corrosion The unit should be cleaned after every usage Unit surfaces All surfaces can be wiped clean with a soft cloth dampened with a mild detergent e g soapy water DO NOT use abrasive cleaning agents or polishes on this equipment Positioning light covers The positioning light covers are made of clear plastic Use a soft cloth dampened with a mild detergent e g soapy water NEVER use abrasive cleaning agents or polishes to clean the covers Surfaces that the patient touches All surfaces and parts that the patient touches or comes into contact with must be disinfected after each patient Use a disinfectant that is formulated specifically for disinfecting dental equipment and use the disinfectant in accordance with the instructions supplied with the disinfectant All items and surfaces should be dried before next usage NOTE Wear gloves and other protective equipment during decontaminatio
27. ce while being x rayed The PC and any other external devices shall not be connected to an extension cable Multiple extension cables shall not be used Do not position the PC where it could be splashed with liquids Clean the PC in accordance with the manufacturer s instructions Ceph ready option Ordered separately SE Interchangeable Ceph Unit has the same sensor as ceph unit sensor with the pan unit Cost saving with future digital ceph upgrade Field upgrades for model unit Digital Cephalostat Kit Add digital ceph imaging to the digital pan unit PaloDEx Group 87 7 Technical data 7 2 Unit dimensions 453 min 550 recommended T mn 550 recommended D gt _ 321 80 1126 1385 1425 mm CA PRE TE ci 1610 2410 1300 88 PaloDEx Group 206918 rev 1 7 Technical data 1300 mm 51 1 in 1405 mm 1144 mm 55 3 in 45 in 206918 rev 1 PaloDEx Group 89 min 550 mm recommended 453 mm 17 8 in ay ET nr h ad 1376 2176 mm 54 2 85 7 in 1610 2410 mm Chin support up 63 4 94 9 in 958 1758 mm 37 7 in 69 2 in Chin support down 898 1698 mm 35 3 in 66 8 in iT 2005 mm 965 mm al in 78 9 in 7 Technical data 7 3 Symbols that appear in the unit PN Radiation warning 4 Dangerous voltage On or enabled O Off or disabl
28. d brightness not optimum 2 kV used is too high 3 Gamma value is not correct for the monitor being used PaloDEx Group Remedy 1 Adjust contrast and brightness 2 Select a more fitting histogram type and check gamma setting Remedy 1 Adjust contrast and density 2 Decrease technique factors Remedy 1 Adjust contrast and brightness 2 Lower the kV setting 3 Adjust Gamma value 206918 rev 1 5 3 Problem Irregular bright shadows or artefacts ag ma mat ane g SA R i T We AJEWEL Problem An unexposed area Is shown down in the lower middle section of the image ANA VG ATEN ina YOON 50e Problem Partial lack of detail and motion artefacts Irregular vertical 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 206918 rev 1 Artefacts Possible cause Patient is wearing metal objects such as earrings necklace etc Possible cause Lead apron misplaced Possible cause Patient has moved during the exposure Possible cause Patient s shoulder in touch with machine parts Possible cause Exposure button released prematurely Possible cause Orthogonal procedure was mistakenly used PaloDEx Group 5 Troubleshooting Remedy Ask patient to remove objects Remedy
29. dip in U for 0 5 cycle 40 U 60 dip in U for 5 cycles 70 U 30 dip in U for 25 cycles lt 5 U gt 95 dip in U Compliance Electromagnetic Environment Level Floors are wood concrete or ceramic tile or floors are covered with synthetic material and the relative humidity is at least 30 percent Mains power quality is that of a typical commercial and or hospital environment Mains power quality is that of a typical commercial and or hospital environment Mains power quality is that of a typical commercial and or hospital environment If the user of Kavo Pan eXam Plus requires continued operation during power mains interruptions it is recommended that Kavo Pan eXam Plus be powered from an uninterruptible power supply or a battery Power frequency magnetic fields are at levels characteristic of a typical location in a typical commercial and or hospital environment NOTE U is the a c mains voltage prior to application of the test level Table 7 2 Electromagnetic immunity IEC 60601 1 2 Ed2 94 PaloDEx Group 206918 rev 1 7 Technical data Kavo Pan eXam Plus is suitable for use in the specified electromagnetic environment The purchaser or user of Kavo Pan eXam Plus should assure that it is used in an electromagnetic environment as described below Immunity IEC Compliance Electromagnetic Test 60601 1 2 Level Environment Test Level Portable and mobile RF c
30. ed Connector for remote control all Exposure switch LC Connector for Ethernet RJ45 Connector for exposure switch gt Connector for external exposure light Attention consult accompanying documents 90 PaloDEx Group 206918 rev 1 7 Technical data L Ground Functional D Protective ground CLASS 1 LASER PRODUCT I aser class label EN 60 825 1 A2 2001 Patient positioning lights and must be collected separately Please contact an authorized representative of the manufacturer for information concerning th This symbol indicates that the waste of electrical and electronic equipment must not be disposed as unsorted municipal waste decommissioning of your equipment Type B equipment CE 0537 symbol MDD 93 42 EEC ETL CLASSIFIED El CONFORMS TO UL STD 60601 1 NS CERTIFIED TO CSA 206918 rev 1 PaloDEx Group 91 7 Technical data 92 7 4 Labels on the unit The main label of the unit is located on the vertical carriage next to the on off power switch The unit is class type B and with IP20 protection Type eXam 1 Ser No Manufactured 10 A 220 240 V 50 60 Hz 1A continuous 15 100 120 V 50 60 HZ 1A continuous KANE coors CE KR IN IEC 60601 1 053 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
31. eparing the system 4 Switch on the unit and the PC 2 PC Start CliniView software or 3rd party application 3 PC Open a new or existing patient or select a patient from the worklist See the user manual supplied with the dental imaging program 28 PaloDEx Group 206918 rev 1 4 Using the unit 4 3 Panoramic exposures Standard Pediatric Ortho Zone Orthogonal Wide arch Bitewing Ortho TMJ axially corrected lateral projection TMJ PA projection Maxillary sinus view 4 3 1 Positioning devices Bite fork with Bite fork with Chin support the bite block the edentulous bite for edentulous positioner patients gt Sinus rest Chin rest TMJ nose support 206918 rev 1 PaloDEx Group 29 4 Using the unit 4 3 2 General instructions 1 PC Click Image Capture 2 Select PAN tab 3 Select the imaging program 4 Any section of the tooth arch can be selected for the partial panoramic imaging to reduce the radiation 5 Select the Manual mode Set the kV and mA or select the patient size child juvenile adult large adult 30 PaloDEx Group 206918 rev 1 Y OS So J O U UO WU 206918 rev 1 4 Using the unit Press the patient positioning button to rotate the unit to patient in position Open the temple supports 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 PaloD
32. evice its spare parts its replacement parts and its accessories may include parts that are made of or include materials that are non environmentally friendly or hazardous These parts must be disposed of in accordance with all local national and international regulations regarding the disposal of non environmentally friendly or hazardous materials The locations of all parts can be found in the chapter 2 1 Main parts and controls Unit has at least the following parts that should be regarded as nonenvironmental friendly waste products Tubehead Pb Collimator Pb All electronic circuits Sensor covers EMC painted PaloDEx Group 77 7 Technical data 7 1 Technical specifications Manufacturer PaloDEx Group Oy Nahkelantie 160 P O Box 20 FIN 04300 Tuusula FINLAND Quality system In accordance with 15013485 and 1309001 standard Environmental In accordance with 15014001 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 The unit is in conformity with the provisions of Council Directive 93 42 EEC as amended by the Directive 2007 47 EC concerning medical de
33. f requirements Please refer to the software installation manual or contact your local dealer for detailed installation requirements 206918 rev 1 PaloDEx Group 85 7 Technical data 86 Minimum PC requirements for Viewing workstation for 2D 3D images 2 0 GHZ dual core or better Graphics NVIDIA GeForce 6600 or ATI Radeon X700 or better 256MB or more memory integrated graphics are not supported Hard disk 3 GB free space or more Network Gigabit Ethernet 1000Base T recommended or Fast Ethernet 100Base TX Operating system Windows 7 or Windows Vista 32 or 64 bit or Windows XP 32 bit only Display 19 LCD display 1280 x 1024 or better PaloDEx Group 206918 rev 1 206918 rev 1 Technical data System requirements and connections The PC and any other external device s connected to the system must meet the IEC 60950 standard minimum requirements Devices that do not meet the IEC 60950 standard must not be connected to the system as they may pose a threat to operational safety The PC and any other external devices must be connected in accordance with IEC 60601 1 1 The x ray unit must be connected to its own separate power supply The PC and any other external devices must NOT be connected to the same power supply as the x ray unit Position the PC and any other external device at least 1 5 m 60 from the xray unit so that the patient cannot touch the PC or any other external devi
34. k Standard resolution 206918 rev 1 PaloDEx Group 21 2 Unit description 22 PaloDEx Group 206918 rev 1 3 Touch screen display 3 1 Main control panel PAN 3D Baa BBB p k i A i f 5 Modality imaging program section Status of the unit Settings End examination Se Ps Exposure settings 206918 rev 1 PaloDEx Group 23 3 Touch screen display 24 3 2 3 3 Modality section Select the modality tab 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 Exposure settings 3 3 1 Patient size settings Select the patient size in manual exposure control mode Optional patient sizes with preprogrammed technique factors are child juvenile adult and large adult The dose is decreased towards left and increased towards right Z o PaloDEx Group 206918 rev 1 3 Touch screen display 3 3 2 Ex
35. l MS MUCHIONS sen an dm dE en due 30 49 39 PAHBNLDOSIIONIFIQ Eee esse nana anna ne note eme 32 4 3 3 1 Panoramic exposure 32 493 93 2 IMJ XDOSUr aine Nm ne he 39 4 3 3 3 Maxillary Sinus exposure 38 Ad Faking NE EXHOSUFER EL SE nn lade 40 4 4 Cephalometric exposures ccccecceeccseeceeeeeeteeeteeeceeceueeeeeeueesueteeetseseeteneteeenaes 42 ZACK GencralMNStTUCUONS SSSR Re SN Ni ne 42 44 2 PATENT DOSINONMING teesien dernede E tienne nee 44 4 4 2 1 Pediatric lateral and Lateral projection ssssssneeree 44 AZ me 2 DOC CHOMES E eee Geet Sentence deanna eee 45 4 4 2 3 Reverse towne projection 46 AA 2A NN ALE FS VOW SR ne Do ete 47 206918 rev 1 PaloDEx Group i 7 4 4 2 5 Carpus view Not in USA 48 AAS Taking N OXDOS UMC 2 nee de poesie manettes 49 D SD KOS ISS ER Se nasa ae eT aa nase 50 4 521 POSIMONING GOVICES icicscrsdsceisunireninauitensvebdapevedueviuehigetivainevivandssdebsdeedanive 50 4o22 GENET lie OR SS no ne cn eee ne 50 ADS BOONE GES EE a nn en ne 54 BOA 2D MAC Le Er E 59 4 6 Warnings and error MESSAGES ccecceceeeccecceeeeeeceeceeeseecueeeecseeseeseeeseeseeeeeeaeetaes 56 AGT ACKNOWISAOINA lTOrS nn a 56 406 2 Mage transir SKF OS EE RE Rd E Roma onda 56 TCOUDIESNOOUNO EEE ES RER ee ns cn or 57 Ol Paent DOSIIOMIAOR it ao eee 57 Diz IMAC ADD AANCS mien naar neue 60 D SA RE gt ee eee ne eee eee eee 61 94A CUNIT OD rANON EE Se ANR ieee inden
36. lary 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 Bitewing Magnification 1 3 5 An orthogonal view of the dentition from the SER canine and posterior 18 PaloDEx Group 206918 rev 1 206918 rev 1 2 Unit description 2 5 2 Cephalometric programs Cephalo pediatric lateral projection Pediatric Lateral Cephalostat has an optimized image height 184 mm that is used e g for pediatric patients but also adult patients to reduce the radiation dose The pediatric lateral projection covers all the typical cephalostat landmarks from Nasion down to the spine and the starting point of the lateral scan is adjustable with both Standard and pediatric lateral cephalostat programs Cephalo lateral projection 2 Lateral Cephalostat uses a full height image field 221 mm PaloDEx Group 19 2 Unit description 20 Cephalo posterior anterior PA projection Reverse towne projection Waters view oo g g A AS peermes gor Carpus view Not in USA PaloDEx Group 35 40 206918 rev 1 2 Unit description 2 5 3 3D programs 61 x 41 mm FOV High resolution k Standard resolution 61 x 78 mm FOV Standard resolution or high resolution Ly High resolution
37. n process WARNING Do not use any disinfecting sprays since the vapor could ignite causing injury Disinfecting techniques for both the unit and the room must comply with all laws and regulations that have jurisdiction of law within the jurisdiction on which the unit is PaloDEx Group 15 6 Maintenance 76 Examples of cleaning agents that are allowed or prohibited when cleaning the unit Allowed Methanol metyl alcohol Soap Isopropyl 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 touch with the patient are Sterilizable in autoclave Such parts are bite forks and bite block lf autoclaving is performed for these items disinfection by immersing in disinfectant solution for 10 minutes is not needed Steam sterilization Recommended parameters for sterilizable parts are H Gravity displacement steam sterilization Flash sterilization Temperature 270 F 132 C Exposure time 3 minutes E Prevacuum steam sterilization Flash sterilization Temperature 270 F 132 C Exposure time 3 minutes m Steam flush pressure pulse steam sterilization Temperature 270 F to 275 F 132 C to 135 C Exposure time 3 to 4 minutes PaloDEx Group 206918 rev 1 206918 rev 1 6 Maintenance 6 4 Disposal The d
38. n that allows you to perform the required diagnostic task 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 interfer with the operation of the pacemaker Always use available disposable protective covers with the patient positioning accessories Bite fork coat Chin support coat Head support coat Nose support cover Ear holder cover Disinfect all the surfaces that the patient is in contact with after every patient Sterilize all device accessories that contact the patient during a radiographic examination Danger Explosion hazard do not use in the presence of flammable anesthetics PaloDEx Group 206918 rev 1 206918 rev 1 1 Introduction General warnings There should be enough space around the installation place of the unit The place where the unit is to be installed and the position from where the user will take exposures must be correctly shielded from the radiation that is generated when the unit is operated The unit or its parts must not be changed or modified in any way without approval and instructions from PaloDEx Group When servicing use only approved replacement parts supplied by PaloDEx Group The Ethernet cable shall be unshielded CAT6 so that multiple chassis are not connected If this device is used with 3rd party imaging application software not supplied by PaloDEx Group the 3rd party imaging a
39. n 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 successfully done Move on to next calibration Not passed means that adjustment is still needed Follow the instructions contained in the image if any and take another exposure Some calibration programs are iterative and demand a few repetitions Failed means that the system could not decide what adjustment should be done in order for the calibration to succeed This calibration status is always the result of some error condition Contact service if the problem persists after restarting the unit and PC PaloDEx Group 206918 rev 1 206918 rev 1 6 Maintenance 6 1 2 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 sofware and then open a patient card and give it and identfiable name for example calibration refer to the users manual supplied with the dental imaging software for more information 4 PC Click the image acquisition button to activate image capture Touch the settings button on the touch screen display Select the Quality assurance button The calibration display appears PaloDEx Group 67 6 Maintenance 6 1 3 Panoramic calibration and quality check
40. of FOV 206918 rev 1 PaloDEx Group 11 2 Unit description 2 3 Patient positioning panel Et JQ oO Carriage UP Carriage DOWN Positioning lasers ON OFF Patient positioning Start positioning Chin support UP Chin support DOWN move the image layer anterior before exposure 3 mm with sinus program 10 mm er ewe PS 9 normal occlusion reset position 10 move the image layer posterior before exposure 3 mm with sinus program 10 mm 12 PaloDEx Group 206918 rev 1 2 Unit description 2 4 Emergency stop switch In case of malfunction of the exposure button or other protective devices of the unit an emergency stop switch is provided near the handles and on the roof of the cephalostat head so that the patient can reach it If the emergency stop switch is pressed during an exposure the exposure is terminated immediately and the x ray unit is completely stopped An interrupted exposure cannot be continued later but has to be retaken from the beginning 206918 rev 1 PaloDEx Group 13 2 Unit description 2 5 Imaging programs 2 5 1 Panoramic programs Standard Magnification 1 3 Pediatric Magnification 1 3 Pediatric patients can be imaged with less radiation dosage and shorter exposure time Patients with jaw more narrow than average jaw can be exposed with this procedure too 14 PaloDEx Group 206918 rev 1 2 Unit description Ortho Zone Magnification 1 25 The Ortho Zone prog
41. ommunications equipment are used no closer to any part of Kavo Pan eXam Plus including cables than the recommended separation distance calculated from the equation appropriate for the frequency of the transmitter Recommended Separation Distance Conducted 3 V150 kHz RF IEC to80 MHz I NE 61000 4 6 Vi Radiated 3 V m80 E 3 V m 3 5 RFIEC MHz to2 5 de NP 61000 4 3 GHz Ei 80 MHz to 800 MHz 7 d WP Ei 800 MHz to 2 5 GHz Where P is the maximum output power rating of the transmitter in watts W according to the transmitter manufacturer and d is the recommended separation distance in meters m Field strengths from fixed RF transmitters as determined by an electromagnetic site survey are less than the compliance level in each frequency range Interference may occur in the vicinity of equipment marked with the following symbol C Field strengths from fixed transmitters such as base stations for cellular telephones and land mobile radios amateur radio AM and FM radio broadcast and TV broadcast cannot be estimated accurately To assess the electromagnetic environment due to fixed RF transmitters an electromagnetic site survey should be performed If the measured field strength exceeds the RF compliance level above observe Kavo Pan eXam Plus to verify normal operation in each use location If abnormal performance is observed additional measures may be necessary such as re orienting or relocating Kavo Pan e
42. posure indicators and settings Zj 66 KV Gs kV value SJ 11 ma mA value 14 1 Exposure time in 0 mGycm Dose value EJ Er Patient size settings mm Manual dose rate control T Test mode 0 B Exposure Indicator 3 4 Status section Status field shows when the unit is ready for capturing or any trouble occurs Green yellow and blue colour indicate the status in question 3 5 Other sections Pr General settings w Retrieve last image Quality assurance Version numbers Software version GUI software version IP address Serial number Language versions 206918 rev 1 PaloDEx Group 25 3 Touch screen display 26 PaloDEx Group 206918 rev 1 4 Using the unit 4 1 Attaching and removing the sensor WARNING Handle the sensor with care as instructed in this manual The sensor must not be dropped or exposed to impacts shock indicator inside the sensor shows if the sensor has been exposed to excess impact 4 1 1 Attaching the sensor 4 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 206918 rev 1 PaloDEx Group 27 4 Using the unit 4 1 2 Removing the sensor 1 Slide the locking knob upwards on the side of the sensor to unlock the sensor 2 Slide the sensor up and remove tt 4 2 Pr
43. pplication software must comply with all local laws on patient information software This includes the Medical Device Directive 93 42 EEC and or relevant legal requirements in the USA Do not connect any equipment to the unit that has not been supplied with the unit or that is not recommended by PaloDEx Group The use of accessory equipment not complying with the equivalent safety requirements of this equipment may lead to a reduced level of safety of the resulting system The aperture plate and tubehead housing are made of lead Pb which is a toxic material Do not touch these parts with your bare hands The unit must be installed according to the the unit installation amp Adjustments manual by a qualified technician This product itself complies IEC 60601 1 medical safety standard but in order to the system incorporating also a PC to comply the standard EITHER the PC has to be a medical PC OR the PC has to be located over 1 5 meters apart from the unit The installer and the user of the system shall confirm that at least one of the above requirements is fulfilled A PC is a medical one if it complies IEC 60601 1 standard and that is indicated in the accompanying documents of the PC All service operations are performed by Instrumentarium Dental authorized service personnel PaloDEx Group 5 1 Introduction 1 7 Manufacturer s liability s a manufacturer we can only assume liability of safe and reliable operation of this
44. ram produces two different scanning geometries combined in the same image The first geometry 1 and 3 in the figure gives a standard panoramic view of the molar region The second view 2 in the figure produces an image of the anterior region with a very wide layer of focus approx 35 mm This view may be helpful when diagnosing trauma wired shut severe class II malocclusion and uncooperative patients 206918 rev 1 PaloDEx Group 15 2 Unit description Orthogonal Magnification 1 3 An optimized view of the dentition only with AN optimized angulation and reduced radiation Orthogonal program produces a panoramic view with modified projection geometry The Y axis of the rotation path is changed to improved the beam angle to be closer to 90 to the interproximal surfaces With this improvement other trade offs must be made The ascending rami may be lost and in adult patients and redundant shadows will be increased Wide arch Magnification 1 3 5 Used when the patient has a wider than normal HV dental arch PaloDEx Group 206918 rev 1 206918 rev 1 2 Unit description Ortho Lateral TMJ Magnification 1 23 Ortho TMJ program provides a wide layer axially corrected views for the patient s left and right temporomandibular joints PA TMJ Magnification 1 55 PaloDEx Group 17 2 Unit description Maxillary Sinus Magnification 1 3 Mesial 10 mm Start Distal 10 mm Maxil
45. ree standing unit unit height is increased 25 mm Height x Width x Depth 2410 x 1931 x 1193 mm inches mm 94 9 x 76 x 47 inches 206918 rev 1 PaloDEx Group 83 7 Technical data unit ceph physical measures Weight 240 kg 529 Ibs Cephalometric Ambient temperatures Transportation and 10 60 C Storage Operation Temperature 10 35 C RH max 85 84 PaloDEx Group 206918 rev 1 7 Technical data Minimum PC requirements for Modality workstation 3D acquisition workstation 2 5 GHZ dual core or better Hard disk 500 GB or more Expansion slot PCI Express bus for supplied GPU full length Power supply 500 watt minimum Gigabit Ethernet 1000Base T Operating system Windows 7 or Windows Vista 32 or 64 bit or Windows XP 32 bit only Display 20 LCD display 1600 x 1200 or 22 LCD widescreen display 1680 x 1050 or better Standard The PC must meet the IEC 60950 standard minimum requirements Graphics card GTX 460 Nvidia Quadro GPU FX 3800 Nvidia Quadro NVidia Quadro 4000 NVidia driver version 259 57 PCI board connection Full length PCle x16 slot for GPU board USB USB ports for HASP Dongle keys e 1 for reconstruction system Dongle supplied with Mercury GPU Kit e 1 for OnDemand3D Dongle supplied with CD Kit Color monitor size 20 2MP LCD display 1600 x 1200 19 1 3MP LCD 1280 x 1024 minimum Mouse Mouse with scroll wheel NOTE This is an abbreviated list o
46. s When the rotating unit stops the exposure has been taken 3 After the exposure the rotating unit is in patient out position if the exposure switch has been pressed until all movements have stopped Release temple supports Guide the patient out Remove disposable covers and disinfect the unit 4 PC The image can be examined using the CliniView software See CliniView users manual PaloDEx Group 41 4 Using the unit 4 4 Cephalometric exposures M Pediatric lateral projection MH Lateral projection E PA projection m Reverse towne projection m Waters view H Carpus view Not in USA 4 4 1 General instructions 1 Move the ceph sensor to the Ceph sensor holder 2 PC Click Image Capture 3 Select CEPH tab O mGycm 80 AA 42 PaloDEx Group 206918 rev 1 4 Using the unit 4 Select the imaging program 5 Select the Manual mode Set the kV and mA or select the patient size child juvenile adult large adult 6 Press the patient positioning button to drive the unit to patient in position Y 019 9010 19 9 216 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 206918 rev 1 PaloDEx Group 43 4 Using the unit 4 4 2 Patient positioning 4 4 2 1 Pediatric lateral and Lateral projection 1 Unlock the lever and turn the ear rods to the lateral projection position Lock
47. the company concerned and a valid signature User should keep this work order for future references 6 PaloDEx Group 206918 rev 1 2 Unit description 206918 rev 1 2 1 Main parts and controls O a a o E ME aE a N F l N Column Carriage Main support Rotating unit On off switch rear of column and main fuses Tubehead assembly Touch screen display Positioning panel Sensor head Head support Chin rest Handles PaloDEx Group 2 Unit description On off switch and main fuses PC with MDD approved dental imaging software and 3D viewing software All software must conform to the MDD and the relevant legal requirements in the USA 1 Sensor holder units without 3D option 2 Panoramic sensor 8 PaloDEx Group 206918 rev 1 206918 rev 1 2 Unit description 2 2 Patient positioning lights fe Z F we eT 1 Midsagittal light FH light Image layer light Cephalometric FH light TMJ light H light top of FOV 3D option only H light bottom of FOV 3D option only NERE SYS PaloDEx Group 9 2 Unit description Panoramic lights 1 Midsagittal light 2 FH light 1 Image layer light 2 TMJ light 10 PaloDEx Group 206918 rev 1 2 Unit description Cephalometric lights 1 FH light 3 D lights 1 Midsagittal light 2 Horizontal H light top of FOV 3 Horizontal H light bottom
48. the unit Instruct the patient to stand as straight and tall as possible under the cephalostat head 4 Turn the head ventral as reference to the canthomeatal line about 30 below the horizontal plane Slide the ear rods towards patients ears Ask the patient open mouth maximally 46 PaloDEx Group 206918 rev 1 4 Using the unit 4 4 2 4 Waters view 1 Unlock the lever and turn the ear rods to the PA projection position Lock the position Tilt the nasion support aside Place the disposable covers NOTE Use a new disposable cover for every patient 2 Adjust the unit height 9 O00 WOOOVCE 3 Guide the patient to the unit Instruct the patient to stand as straight and tall as possible under the cephalostat head 4 Turn the head dorsal as reference to the canthomeatal line about 35 40 above the horizontal plane 5 Slide the ear rods towards patient s ears 6 Ask the patient open or close mouth 206918 rev 1 PaloDEx Group 47 4 Using the unit 4 4 2 5 Carpus view Not in USA CAUTION Before taking Carpus image make sure this imaging method is approved by local authorities of your country 1 Unlock the lever and turn the ear rods to the PA projection position Lock the position Tilt the nasion support aside Place the carpus holder to the nasion support holder 2 Adjust the unit height if needed 3 Ask the patient to remove rings and metal objects and to place hand on the carpus holder
49. their tongue against the roof of their mouth and remain still for the duration of the exposure 206918 rev 1 PaloDEx Group 39 4 Using the unit 4 3 4 Taking the exposure 1 Press Start position Check the patient positioning Protect yourself from radiation by standing behind a suitable x ray radiation shield Make sure that you can see and hear the patient during the exposure DO20Q 10 02 10 NOTE n all examinations the user of the x ray equipment should wear protective clothing The operator does not need to be close to the patient during normal use The protection against stray radiation can be achieved by using the hand switch not less than 2 m 7 ft from the focal spot and the xray beam Operator should maintain visible contact with the patient and technique factors This allows immediate termination of radiation by the release of the exposure button in the event of a malfunction or disturbance 40 PaloDEx Group 206918 rev 1 4 Using the unit NOTE f the patient is nervous or a child you can demonstrate how the unit works to reassure them Press the T Test mode button and then press and hold the exposure button The unit will complete an exposure cycle without generating x rays 206918 rev 1 2 Press and hold down the exposure button During the exposure you hear an audible signal and the exposure warning symbol on the touch screen display appears The unit rotates around the patient s head and stop
50. unit when the unit unit installation was performed according to the the unit Installation amp Adjustments Manual by qualified Kavo Pan eXam Plus dealer and the unit Unit is used according to the unit User Manual CliniView PC software was installed according to the Installation Manual for CliniView software CliniView software is used according to User Manual for CliniView software Maintenance and repairs are performed by a qualified Kavo Pan eXam Plus Dealer and Original or authorized spare parts are used In order to guarantee maximal image quality for the entire life time of this high performance imaging system we suggest that a special image quality assurance procedure and test object designed for image quality assurance purposes is used code 68795 Also we recommend that a qualified serviceman to check the unit to be in its original condition regarding electrical radiation and mechanical safety according to our maintenance program described in more details in maintenance manual every year or after 2000 images For more information please contact your local dealer According to EN61223 3 4 and DIN 6868 151 If service on the unit is performed a work order describing the type and extent of repair must be provided by the service technician This must contain information of changes of nominal data or work range performed The work order must furthermore indicate the date of repair the name of
51. urs or if the unit fails to operate as described in the user s manual switch the unit off wait a few seconds and switch the unit on again 4 6 2 Image transfer errors If an image is not transferred successfully to the PC close and then reopen the dental imaging software and or restart the PC DO NOT restart the unit as this will erase any image that is stored in the unit memory and this retrievable image will be lost PaloDEx Group 206918 rev 1 5 Troubleshooting 5 1 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 ABACK Problem Teeth appear wider on one side and narrower on the opposite Ramus widths are different on opposite sides 206918 rev 1 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 Patient positioning Possible cause 1 Occlusal correction of focal trough set too far posterior N Image layer laser light not obeyed 3 Bite block was not used Possible cause 1 Occlusal correction of focal trough set too far anterior 2 Image layer laser light not obeyed 3 Bite block was not used Possible cause 1 Midsagittal line not obeyed 2 Patient s head not in center position PaloDEx Group
52. vices Performance Standards and European Union Directive 93 42 EEC Medical Devices Directive nai en i stilt Product type Digital Panoramic X ray Unit Digital Panoramic X ray Unit with Cephalostat 206918 rev 1 PaloDEx Group 17 7 Technical data Protection against electric Class shock Degree of protection Type B applied with no conductive connection to the patient Protection against the IP20 ingress of liquids Disinfection methods mild soapy water non abrasive non alcohol based disinfectant for the chin rest disposable plastic covers for bite block chin rest and chin support For use In environments where no flammable anaesthics nor flammable cleaning agents are present Mode of operation continuous operation intermittent loading Safety IEC 60601 1 Tube head assembly type Stationary anode Max tube current Max electric output Focal spot 0 5 x 0 5 mm IEC 336 1982 Nominal anode input 1750 W Reference axis In the middle of the panoramic sensor s active area Max anode heat content 35 kJ Max X ray tube 385 kJ assembly heat content 38 W Max continuous heat dissipation of the X ray tube assembly 78 PaloDEx Group 206918 rev 1 206918 rev 1 7 Technical data Tube head assembly Total filtration Leakage Technique Factors gt 3 2 mm Al 90 kV 4 mA Fuses 230 Vac Littelfuse 326 slow blow 10A Cooper Bussman time delay MDA 10 110 Vac Littelfuse 326 slow
53. w FOV 61 x 41 mm FOV Program 1 61 x 78 mm FOV Program 2 Select the area of interest on the toothed arch The 3D FOV is positioned more accurately by using the scout image mode The area of interest can be adjusted on the touch screen display after the scout image has been taken Press the patient positioning button to rotate the unit to patient in position 6 Adjust the unit height A0000 WOOOO 206918 rev 1 Ask the patient to remove any spectacles hearing aids removable dentures jewellery and hair clips and pins Guide patient to the unit Instruct patient to stand as straight and tall as possible next to the unit Patient can also be imaged in sitting position Ask the patient to take grip on the handles and place chin on the chin rest PaloDEx Group 51 4 Using the unit 9 Check the position of the midsagittal light If it is not on the midsagittal plane of the patient adjust the patient s head 10 Adjust the unit height and chin rest height to get the area of interest between the top and bottom FOV lights Position the patient so that the occlusal plane is horizontal 1 H light top of FOV 2 H light bottom of FOV 52 PaloDEx Group 206918 rev 1 4 Using the unit 11 Move the head support against the patient s forehead Adjust the height Close the temple supports 12 Select A the Scout image or B the Standard or high resolution 3D image 61 x 41 mm x 0 000 mm y 0 0
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