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1. 83 ELAM zAnn albidantetlaree oi mu nasaq u an Ban a e ed ene 83 Tela KADANG ISTI Sia sanan anan naba adana ga a aia ahaaa gada a aa aa BA gan ta a aaa 83 L2 CHANGING NG TUSCS sasa kana ag Aa suan KAE a Dua tere a a a a E a EN aa 84 7 3 Cleaning and decontaminating the unit 84 8 Calibration and adjustment 87 o Mbndeecienert e Re cS 87 9 2 Preparing TOr callDESUOF ssepe eie aga aa a anaa ba usha a a na a aaa a ang 88 23 gt PANDENG Call Fall ON 55 asana gang aa a Ega aa ga aa banal cove a nga Sm Oen Ka ag aa Sana ad pesa 89 8 3 1 Panoramic geometry calibration 89 8 3 2 Panoramic pixel calibration sasasi aaa a E a A na Ga aa aka 90 8 3 3 Panoramic Quality Check optional 91 D SPD GOIIDKr GIOI uuu u ua a aga pa a ak a E a aa a Ag ag ial dan aa Bana a cde did ajaa traded erri 93 9 4 1 3D geomelry CallDEaOF sasaka a aga NE a E BAB A a BENE iun 93 SAZ DING GANDA NON MEE 93 64 5 SD Quality Check progra Meseres AN eb nee 2 oco ev eic ie aa a s Hore be Due 95 8 5 Cephalometric CaliDration cccccccceccceecsseceeeceecseceeeeeeeseeeeeeesneeseeneeeeeeeeseeseees 96 Reviewed Koskela Markku 2014 07 14 15 02 D511392 7 Approved See PDM system to determine
2. 68 Instrumentarium Dental 210457 rev 7 Reviewed Koskela Markku 2014 07 14 15 02 D5ll392 7 Approved See PDM system to determine the status of this document Printed out 2014 09 03 12 37 30 Copyright O by PaloDEx Group Oy All rights reserved 5 Using the unit 7 Select the FOV size based on the indication SFOV 61 x41 mm 61 x 78mm MFOV 50 x 50mm MAXIO 61 x 78mm 78x 78mm 78 x 150 mm 130 x 150 mm 8 Select either the scout for FOV positioning or 3D reso lution for direct image capture SCOUT Scout image 3D SFOV A Standard resolution B High resolution C Endo resolution MFOV Maxio A Low Dose B Standard resolution 210457 rev 7 Instrumentarium Dental 69 Reviewed Koskela Markku 2014 07 14 15 02 D5l1392 7 Approved See PDM system to determine the status of this document Printed out 2014 09 03 12 37 30 Copyright O by PaloDEx Group Oy All rights reserved 5 Using the unit C High resolution D Endo resolution r3 5 5 4 Scout image Note When scout image has been selected follow these instructions Note For 130 x 150 FOV the scout image is showing only the first lower scan 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 dis play 3 Fine adjust scout position using the side arrow keys
3. 66 kV 3 2 mA 70 kV 3 2mA 73 kV 3 2 mA 73 kV 6 3 mA 8s 8s 8s x LE 24 Instrumentarium Dental 210457 rev 7 Reviewed Koskela Markku 2014 07 14 15 02 D511392 7 Approved See PDM system to determine the status of this document Printed out 2014 09 03 12 37 30 Copyright O by PaloDEx Group Oy All rights reserved 3 Imaging programs 3 3 3D SFOV programs 61 x 41 mm FOV High resolution 133um voxel size Standard resolution 200um voxel size Program for optimized endodontic imaging Endo program 85um voxel size 61 x 78 mm FOV High resolution 200um voxel size Standard resolution 300um voxel size Exposure settings for 3D SFOV kak LE values Resolution FOV Exposure h x w time EI Endo program 61x41mm x 41 mm 61x41mm 90 10 618 61s J S HuhRes Six4 mm 9 f8 js SdRes eixiimm 90 0 235 HuhRes ix78mm 90 63 8s SdRes fexem 9 po A8 210457 rev 7 Instrumentarium Dental 25 Reviewed Koskela Markku 2014 07 14 15 02 D511392 7 Approved See PDM system to determine the status of this document Printed out 2014 09 03 12 37 30 Copyright O by PaloDEx Group Oy All rights reserved 3 Imaging programs 3 4 3D MFOV Maxio programs 50 x 50 mm FOV High resolution 125um voxel size Standard resolution 200um voxel size Low Dose Scan 280um voxel size Program optimized for endodontic imaging 61 x 78 mm
4. NEL NEM KANANG NANANG NANANG JAAN LAA NGANGEN MEN NUM l 6 x 4 std res 6 x 4 high res 6 x 8 std res 6 x 8 high res Table 5 MFOV Masio UNIT 100 VAC 90 kV 120 VAC 90 kV 240 VAC 90 kV LIMEN j j O L t DURER NN dec exper oa cl 2 Y b 1 Lee SSE oe Se 5 5 RENE ee re t NE 3 EISE GNE NOE NAE CE ee E AE Ea ESSA ESE SE SEA SE SES DES qum o t NL 3 ise aes EE i U P a ee Ee x x x 5x5 6x8 6x8 6x8 8x8 8x8 8x8 8x15 8x15 8x15 low low std high low std high low std high dose dose res res dose res res dose res res 102 Instrumentarium Dental 210457 rev 7 Reviewed Koskela Markku 2014 07 14 15 02 DoSld1392 7 Approved See PDM system to determine the status of this document Printed out 2014 09 03 12 37 30 Copyright by PaloDEx Group Oy All rights reserved 9 Technical data 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 OD IEC 60825 1 1993 A1 1997 A2 2001 X ray
5. 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 ORTHOPANTOMOGRAPH OP300 requires continued operation during power mains interruptions it is recommended that ORTHOPAN TOMOGRAPH OP300 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 210457 rev 7 Reviewed Koskela Markku 2014 07 14 15 02 Approved Instrumentarium Dental 115 D511392 See PDM system to determine the status of this document Printed out 2014 09 03 12 37 30 Copyright by PaloDEx Group Oy All rights reserved 9 Technical data Table 1 7 RF immunity of non life support equipment or system IEC 60601 1 2 ORTHOPANTOMOGRAPH OP300 is suitable for use in the specified electromagnetic envi ronment The purchaser or user of ORTHOPANTOMOGRAPH OP300should assure that it is used in an electromagnetic environment as described below Immunity IEC Compliance Electromagnetic Test 60601 1 2 Level
6. 210457 rev 7 Reviewed Koskela Markku 2014 07 14 15 02 Approved 5 Using the unit 5 4 2 5 Carpus view Not available in USA and Canada Before taking Carpus image make sure this imaging meth od is approved by local authorities of your country Note If Carpus program button is not displayed in Cepha lometric imaging modality tab ask local distributor to acti vate the button Not in USA or Canada 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 Adjust the unit height if needed Ask the patient to remove rings and metal objects and to place hand on the carpus holder 5 4 2 6 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 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 Release the ear rods and guide the patient out Re move disposable covers and disinfect the unit PC The image can be examined using the CLINI VIEW software See CLINIVIEW 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 aga
7. 210457 rev 7 Instrumentarium Dental 21 Reviewed Koskela Markku 2014 07 14 15 02 D511392 7 Approved See PDM system to determine the status of this document Printed out 2014 09 03 12 37 30 Copyright by PaloDEx Group Oy All rights reserved 3 Imaging programs Bitewing Magnification 1 3 An orthogonal view of the dentition from the canine and posterior b Exposure settings for Bitewing program 100 100VAC 66 66kV 5bmA mA 66 66kV BmA mA 66 kV 10 mA 70 kV 13 mA 230 66 ul mA 66 JR mA 66 kV 10 mA 70 kV 13 mA x jem TT 22 Instrumentarium Dental 210457 rev 7 Reviewed Koskela Markku 2014 07 14 15 02 D511392 7 Approved See PDM system to determine the status of this document Printed out 2014 09 03 12 37 30 Copyright by PaloDEx Group Oy All rights reserved 3 Imaging programs a Pediatric Lateral Cephalostat has an optimized image height 180 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 3 2 Cephalometric programs Cephalometric pediatric lateral projection Exposure settings for cephalometric pediatric lateral program 100 100VAC 90 90 kV 8 mA 10 s mA 10 s 90 90 kV 8 mA 13 s mA 13 s
8. 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 OP300 is in conformity with the provisions of Council Di rective 93 42 EEC as amended by the Directive 2007 47 EC concerning medical devices Performance Standards and European Union Directive 93 42 EEC Medical Devices Directive Product type Digital dental imaging system with panoramic cephalometric and Cone Beam 3D imaging programs 210457 rev 7 Instrumentarium Dental 99 Reviewed Koskela Markku 2014 07 14 15 02 D54192 7 Approved See PDM system to determine the status of this document Printed out 2014 09 03 12 37 30 Copyright by PaloDEx Group Oy All rights reserved 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 flammable cleaning agents are present 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
9. Instruct the patient to stand as straight and tall as possible under the cepha lostat head Turn the head ventral as reference to the canthomeatal line about 30 below the horizontal plane Slide the ear rods towards patient s ears Ask the patient open mouth maximally 210457 rev 7 Instrumentarium Dental 61 Reviewed Koskela Markku 2014 07 14 15 02 D511392 7 Approved See PDM system to determine the status of this document Printed out 2014 09 03 12 37 30 Copyright by PaloDEx Group Oy All rights reserved 9 Using the unit 5 4 2 4 Waters view 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 disposable covers Note Use a new disposable cover for every patient 2 Adjust the unit height TS OS E G a v G 4C f A fo o Guide the patient to the unit Instruct the patient to stand as straight and tall as possible under the cepha lostat 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 Askthe patient open or close mouth 62 Instrumentarium Dental 210457 rev 7 Reviewed Koskela Markku 2014 07 14 15 02 D5ll392 7 Approved Copyright by PaloDEx Group Oy All rights reserved See PDM system to determine the status of this document Printed out 2014 09 03 12 37 30
10. Patient has slumped Problem Patients shoulders are touching the x ray tube or sensor 210457 rev 7 Reviewed Koskela Markku 2014 07 14 15 02 Approved Possible cause Patient is too big for the unit Wide and high shoulders Instrumentarium Dental 6 Troubleshooting Remedy If the image is not accept able then 1 Check the head position and retake the image 2 Check the patient posi tioning Make the expo sure even though the head may touch the tube head 3 Check 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 D511392 81 7 6 Troubleshooting 7 N D o I oO In 7 A P Me gt AO Cv C o e 5 Q c o 5 il 0 N D LO A lt A r lt A O N 5 M I Y 2i D IV v O NG O o e oo p Q O d 8 gt Q O0 Q MG lt 08 Z8 Zl 0 60 FL0Z 1no palung lu uuinoop Sly jo snle s 94 euiuuejep oj Wa shs WOd 99S pamasa siuDu ily o dnoly x3gojed Aq 1luBiu doo See PDM system to determine the status of this document Printed out 2014 09 03 12 37 30 Copyright by PaloDEx Group Oy All rights reserved 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 t
11. Q O EY gt O O0 Q MG lt 08 Z8 Zl 0 60 FL0Z 1no palung lu uuinoop Sly jo snle s 94 euiuuejep oj Wa shs WOd 99S pamasa siuDu ily o dnoly x3gojed Aq 1luBiu doo See PDM system to determine the status of this document Printed out 2014 09 03 12 37 30 Copyright by PaloDEx Group Oy All rights reserved 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 care as instructed in this manual Ihe 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 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 Pull the sensor downwards firmly until it stops and then slide the locking knob down on the side of the sensor to lock the sensor in position Note Make sure that the sensor is seated properly before sliding the locking knob down Forcing the lock ing knob down when the sensor is not in correct posi tion may damage the sensor connectors 210457 rev 7
12. 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 double cone calibration tool 2 Select the program 3 Press Patient Positioning 4 Take an exposure EEPan detector calibration Passed CTO 3 0 9 0 signal level 5461 10559 Dark level S819 291 90 Instrumentarium Dental 210457 rev 7 Reviewed Koskela Markku 2014 07 14 15 02 D5ll392 7 Approved See PDM system to determine the status of this document Printed out 2014 09 03 12 37 30 Copyright by PaloDEx Group Oy All rights reserved 8 Calibration and adjustment 8 3 3 Panoramic Quality Check optional Note Use the same tool for cephalostat Quality Check 1 Attach a panoramic Quality Check Tool optional to the chin support im 2 Select the Pan QC program Pan QC 3 Press Patient Positioning 4 Take an exposure 5 Visually evaluate the result using the installed imaging software 210457 rev 7 Instrumentarium Dental WAY 91 Reviewed Koskela Markku 2014 07 14 15 02 D511392 7 Approved See PDM system to determine the status of this document Printed out 2014 09 03 12 37 30 Copyright O by PaloDEx Group Oy All rights reserved 8 Calibration and adjustment 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 mu
13. with an Ethernet cable Connection through the LAN network of the site is not allowed Two network ports are needed in the PC in order to connect also to the site network All service operations must be made by authorized service personnel only 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 Instrumentarium Dental 210457 rev 7 D511392 7 Copyright by PaloDEx Group Oy All rights reserved See PDM system to determine the status of this document Printed out 2014 09 03 12 37 30 210457 rev 7 Reviewed Koskela Markku 2014 07 14 15 02 Approved 1 Introduction 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 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 ti
14. 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 100 Instrumentarium Dental 210457 rev 7 Reviewed Koskela Markku 2014 07 14 15 02 DoSld1392 7 Approved See PDM system to determine the status of this document Printed out 2014 09 03 12 37 30 Copyright by PaloDEx Group Oy All rights reserved 9 Technical data 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 2D modalities The following charts represent technique factors that can be used with the selected line voltage and continuous radiation One of the three technique factors is always fixed WI D T L L L L L L L L 3 j LL LLLLCL AA E ed 210457 rev 7 Instrumentarium Dental 101 Reviewed Koskela Markku 2014 07 14 15 02 Dold392 7 Approved See PDM system to determine the status of this document Printed out 2014 09 03 12 37 30 Copyright by PaloDEx Group Oy All rights reserved 9 Technical data Table 3 240 VAC 3D modalities The following charts represent technique factors that can be used with the selected line voltage in 3D imaging mode 3D modality uses pulsed x rays with fixed kV and exposure time Table 4 100 VAC Q 90 kV 120 VAC 90 kV 240 VAC 90 kV
15. 3D SFOV touch panel MFOV touch panel With MFOV Maxio touch panel touch somewhere in the dentition Pop up screen appears Move the FOV cursor on the area of interest For precise adjustment use the arrow keys 210457 rev 7 Instrumentarium Dental 65 Reviewed Koskela Markku 2014 07 14 15 02 D5l1392 7 Approved See PDM system to determine the status of this document Printed out 2014 09 03 12 37 30 Copyright O by PaloDEx Group Oy All rights reserved 5 Using the unit 5 With 3D SFOV lock the position by pressing the lock key Use the same key for unlocking if the position needs to be changed Lock key is not in the MFOV Maxio touch panel 6 Press the patient positioning button to rotate the unit to patient in position Y o 7 Open the temple supports Remove head support in case FOV 130 x 150 mm is selected 8 Askthe patient to remove any spectacles hearing aids removable dentures jewellery and hair clips and pins 5 5 3 Patient positioning 1 Insert the chin support In case of FOV 130 x 150 mm insert lower head support and chin support ae 4 Fig 1 9 Chin rest Fig 1 9 Lower head support and chin support for FOV 13 x15 66 Instrumentarium Dental 210457 rev 7 Reviewed Koskela Markku 2014 07 14 15 02 D5ll392 7 Approved Copyright by PaloDEx Group Oy All rights reserved See PDM system to determine the status of this document Printed out 2014 09 03 12 37 30 5 Using the
16. 8 1 3 Haaa 1 8 1 3 Suomi 1 8 1 3 Portugu s 1 8 1 3 m Retrieve Last Image Use this to retrieve the last image from the device memory e g after a system error m Retrieve With MAR After taking a with MAR either on or off image can be re reconstructed with different setting by selecting either Retrieve last image or Retrieve With MAR from the general settings on the touch screen If reconstruction with MAR is unavailable for the last captured image e g last taken image is cephalometric Retrieve With MAR 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 36 Instrumentarium Dental 210457 rev 7 Reviewed Koskela Markku 2014 07 14 15 02 D5ll392 7 Approved See PDM system to determine the status of this document Printed out 2014 09 03 12 37 30 Copyright by PaloDEx Group Oy All rights reserved 4 Touch screen display m Languages Use this to select language on the touchscreen m Service Use this to reach the programs for periodical maintenance 210457 rev 7 Instrumentarium Dental 37 Reviewed Koskela Markku 2014 07 14 15 02 Dodd Rozen 7 Approved 4 Touch screen display 7 N D o I oO In 7 A P Me gt AO Cv C o e 5 Q c o 5 il 0 N D LO A lt A r lt A O N 5 M I Y 2i D IV v O NG O o eoo p
17. All rights reserved 10 PC requirements 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 Network Gigabit Ethernet 1000Base T Operating system Windows 7 Windows Vista or Windows 8 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 Note This is an abbreviated list of requirements Please refer to the software installation manual or contact your local dealer for detailed installation requirements 22 Instrumentarium Dental 210457 rev 7 Reviewed Koskela Markku 2014 07 14 15 02 DoSld1392 7 Approved See PDM system to determine the status of this document Printed out 2014 09 03 12 37 30 Copyright by PaloDEx Group Oy All rights reserved 10 PC requirements Minimum PC requirements for 2D 3D Viewing workstation Processor 2 0 GHz dual core or better Memory 3 Gigabytes RAM or more Graphics board 1GB 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 Windows Vista or Windows 8 32 or 64 bit Display 19 LCD
18. Copyright by PaloDEx Group Oy All rights reserved 9 Technical data Cephalostat patient positioning Positioning aids Ear holders Nasion support with vertical mm scale Frankfort horizontal plane laser light Contact plate Car pus program 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 20 s Panoramic image receptor Sensor unit Pan sensor or interchangeable Ceph sensor Technology Sensor type CMOS Image pixel size and depth 100 x 100 um and 14 bits Active area height 5 8 inches 148 mm 1480 pixels Resolution Pan 5 LP mm 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 Resolution 4 LP mm cephalometric 106 Instrumentarium Dental 210457 rev 7 Reviewed Koskela Markku 2014 07 14 15 02 D51492 7 Approved See PDM system to determine the status of this document Printed out 2014 09 03 12 37 30 Copyright by PaloDEx Group Oy All rights reserved 9 Technical data receptor 3D SFOV unit Technology CMOS Image pixel size and depth 200 x 200 um and 13 bits Photodiode area 100 x 68 2 mm receptor MFOV Maxio unit Image p
19. FOV Endo program 85um voxel size High resolution 200um voxel size Standard resolution 300um voxel size Low Dose Scan 320um voxel size 26 Instrumentarium Dental 210457 rev 7 Reviewed Koskela Markku 2014 07 14 15 02 D5ll392 7 Approved See PDM system to determine the status of this document Printed out 2014 09 03 12 37 30 Copyright O by PaloDEx Group Oy All rights reserved 3 Imaging programs 78 x 78 mm FOV High resolution 200um voxel size Standard resolution 300um voxel size Low Dose Scan 320um voxel size 78 x 150 mm FOV High resolution 250um voxel size Standard resolution 350um voxel size Low Dose Scan 400um voxel size 130 x 150 mm FOV High resolution 320um voxel size Standard resolution 380um voxel size Low Dose Scan 420um voxel size 210457 rev 7 Instrumentarium Dental 27 Reviewed Koskela Markku 2014 07 14 15 02 D511392 7 Approved See PDM system to determine the status of this document Printed out 2014 09 03 12 37 30 Copyright by PaloDEx Group Oy All rights reserved 3 Imaging programs 3 5 Selecting resolution and FOV The resolution selection has an effect to the image quality and to the patient dose For example High resolution will give better image quality than Standard resolution but on the other hand the patient dosage is also higher The unit offers a Low Dose resolution see Tables 1 1 amp
20. Instrumentarium Dental 39 Reviewed Koskela Markku 2014 07 14 15 02 D511392 7 Approved 9 Using the unit LOCKING 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 CLINIVIEW 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 40 Instrumentarium Dental 210457 rev 7 Reviewed Koskela Markku 2014 07 14 15 02 D5ll392 7 Approved See PDM system to determine the status of this document Printed out 2014 09 03 12 37 30 Copyright by PaloDEx Group Oy All rights reserved See PDM system to determine the status of this document Printed out 2014 09 03 12 37 30 Copyright by PaloDEx Group Oy All rights reserved 5 Using the unit 5 3 Panoramic exposures Standard Pediatric Ortho Zone Orthogonal Wide arch Bitewing Ortho TMJ axially corrected lateral projection TMJ PA projection Maxillary sinus view 5 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 ww w w eaa 210457 rev 7 Instrumentarium Dental 41 Reviewed Koskela Markku 2014 07 14 15 02 D511392 7 Ap
21. a Ma aa a aaa a a a aa qay aka 62 5 4 2 5 Carpus view Not available in USA and Canada 63 9420 aKING ING expoSUELe uu uu u ab ipa u u u s uuu ayu vate c maa 63 99 SDISXDOSU SS sa as Ly u ul iu au NEG ntu uit Sa Sa S UM c UR fep DUE 64 92021 HPOSHIOMIIG CC dem 64 59 2 GENElal INSWUCHONS emet Aa aa TA a a ag A EN a a NG a Aa ka 64 5 5 3 Patient positioning a nnns 66 DA SS COUN lli0g6 a state tetanic ak ana Da a bu Da Na AR gah DE aga anaa daa usasqa 70 DE OL MIGE aa 71 0 5 5 1 Stone model and radiographic guide scan 72 5 6 Warnings and error messages 13 5 6 1 Acknowledging errors a rr s s 13 5 0 2 Image transior GOLS ar aan aan ga aed eb pun ag A u ED RI Ya a as u asa 13 6 FROUDICSNOOUING asinan na u uu u niaaa ass Da EA NGA AANE NGANA KAEN 75 6 1 Fallent DOSIMOMING aaa akata aga bana aa pa aa aia SE E 15 6 2 Image appearance ase ececeeceeceeeseeceeceecaeeeeeeeecaeeseeseesaeeseeseesaeeseeseeeseeseeeas 16 Duo SPACE ACS ngaen ag aa a a E a ga naga Sa a aa a KI E eterna eee 79 0 J deeem TE Tm 81 T Maintenance eec 83 7 1 Maintenance procedure a a
22. generator Tube voltage 57 90 kV 5 kV Supply frequency 75 150 kHz Spine compensation kV mA compensated Spine compensation Pre programmed mode 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 UTP Ethernet cable OP300 PC Standard Adult Panoramic 210457 rev 7 Instrumentarium Dental 103 Reviewed Koskela Markku 2014 07 14 15 02 DSJ1392 7 Approved See PDM system to determine the status of this document Printed out 2014 09 03 12 37 30 Copyright by PaloDEx Group Oy All rights reserved 9 Technical data Panoramic programs amp technique factors amp magnification Exposure Control Automatic Dose Rate Control ADC P1 P5 Pre programmed icons for all programs Automatic Spine Compensation Cephalometric programs amp technique factors Pediatric lateral view 85 90 kV 8 12 6 mA 6 9 14 s PA AP facial and oblique views 85 90 kV 8 12 6 mA 10 20 s Carpus View 60 90 kV 3 2 12 6 mA 8 20 s Not available in USA and Canada Exposure Control Automatic Facial Contour AFC Pre programmed icons for all programs Magnification factor 1 15 1596 50 x 50 mm FOV standard resolution 50 x 50 mm FOV high resolution 50 x 50 mm FOV endo program 61 x 78 mm FOV standard resolution 61 x 78 mm FOV high resolution 78 x 78 m
23. 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 ex posure cycle without generating x rays d hold down the exposure button During the you hear an audible signal and the exposure warning symbol on the touch screen display appears The unit rotates around the patients head and stops When the rotating unit stops the exposure has been taken 3 After the exposure the rotating unit is in patient out po sition if the exposure switch has been pressed until all 210457 rev 7 Instrumentarium Dental 53 Reviewed Koskela Markku 2014 07 14 15 02 D511392 7 Approved See PDM system to determine the status of this document Printed out 2014 09 03 12 37 30 Copyright by PaloDEx Group Oy All rights reserved See PDM system to determine the status of this document Printed out 2014 09 03 12 37 30 Copyright by PaloDEx Group Oy All rights reserved 5 Using the unit movements have stopped Release temple supports Guide the patient out Remove disposable covers and disinfect the unit 5 3 8 Multilayer Selection For maximum image clarity and sharpness the position of the focal trough may be adjusted after exposure Five pre adjusted images are calculated and displayed on the touch screen In the midmost image no adjustment is applied i e the focal through is located exactly at the layer laser position To the left of thi
24. is too high Gamma value is not cor rect for the monitor being used Instrumentarium Dental Remedy Adjust contrast and brightness 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 210457 rev 7 Dolls92 See PDM system to determine the status of this document Printed out 2014 09 03 12 37 30 Copyright by PaloDEx Group Oy All rights reserved 6 3 Problem Irregular bright shadows or artefacts Ez Ue ae m UND By 3 Ten M j 4 i r WA a AJEWEL Problem An unexposed area is shown down in the lower middle sec tion of the image AAPRO Problem Partial lack 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 210457 rev 7 Reviewed Koskela Markku 2014 07 14 15 02 Approved 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 Patient s shoulder in touch with machine parts Possible cause Exposure
25. 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 too much 76 Reviewed Koskela Markku 2014 07 14 15 02 Approved 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 Instrumentarium Dental 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 210457 rev 7 D511392 See PDM system to determine the status of this document Printed out 2014 09 03 12 37 30 Copyright by PaloDEx Group Oy All rights reserved Problem Middle area of the image too bright and unsharp Spine shadow Ms TOR v CT eod E ES 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 210457 rev 7 Reviewed Koskela Markku 2014 07 14 15 02 Approved Possible cause Patient s neck was not stretched Possible ca
26. rights reserved 9 Using the unit 6 Move the head support against the patient s forehead Adjust the height Close the temple supports T Adjust the position of the image layer as necessary The image layer is 18 mm posterior compared to stand ard panoramic procedure A B C Image layer adjustment buttons A 10mm anterior B Center C 10mm posterior 8 Askthe patient to press their tongue against the roof of their mouth and remain still for the duration of the expo sure 52 Instrumentarium Dental 210457 rev 7 Reviewed Koskela Markku 2014 07 14 15 02 D5ll392 7 Approved 5 Using the unit 5 3 7 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 Y DOOM Note In 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 Note f the patient is nervous or a child you can demonstrate
27. the status of this document Printed out 2014 09 03 12 37 30 Copyright by PaloDEx Group Oy All rights reserved 9 544 CDM pixel Galibrali olu u u uu uu A aa uiti pe E REIR de Ra a RE 96 8 5 2 Ceph Quality check program Optional 96 9 Technical dala scs os wau ME FREUNDE CE GA o opc au E P cU IND NEU M EE 99 9 1 Technical specifications a aa aar rrrarsr aaa 99 DZ WAIL NT NG ns OD y stands nuusan Shim au a us e 109 9 3 Symbols that appear in the unit a r nean enere 111 93 obesum u a u u u VR redet uS Sansapa v DN M iu LANE 113 9 5 Electromagnetic Compatibility EMC tables 114 9 6 X ray tube assemlbll8S ceo eoi eroe ER rodado t e nere vest fu gaudes asusta uds 119 T0 PC requiremehnls 5255 u oo CO Ee To Or Ede fees e cvs e Cha dcm MM P DES I Ba a MD sansa 121 10 1 MIAME PO reg lremellts ue a Kana asian uta tua take Pad a unan saa s 121 10 2 The dental imaging software aane 124 Reviewed Koskela Markku 2014 07 14 15 02 dert 7 Approved 7 D511392 iV Reviewed Koskela Markku 2014 07 14 15 02 Approved 0 4 2L 0 60 7 10 1no palung JUBWNDOP siu JO snle s eui euiuJejep oj ulejs S NOd ees pamasa siuDu ily o dnoly x3goje
28. 014 07 14 15 02 D5ll392 7 Approved See PDM system to determine the status of this document Printed out 2014 09 03 12 37 30 Copyright O by PaloDEx Group Oy All rights reserved 5 Using the unit 5 4 Cephalometric exposures m Pediatric lateral projection Lateral projection PA projection Reverse towne projection Waters view Carpus view Not available in USA and Canada WARNING Remove all calibration tools Pan and 3D patient positioning accessories before taking any cephalomateric exposures 5 4 1 General instructions 1 Move the ceph sensor to the ceph sensor holder 2 PC Click Image Capture 3 Select CEPH tab 9 fiw g 5 10mA 5 6 5s xs mGycm D A580 5 9 56 Instrumentarium Dental 210457 rev 7 Reviewed Koskela Markku 2014 07 14 15 02 D5ll392 7 Approved See PDM system to determine the status of this document Printed out 2014 09 03 12 37 30 Copyright by PaloDEx Group Oy All rights reserved 5 Using the unit 4 Select the imaging program 5 Select the Manual mode Default oet 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 T Askthe patient to remove any spectacles hearing aids removable dentures jewellery and hair clips and pins Place a protective lead apron on the patient 210457 rev 7 Instrumentarium Dental 57 Reviewed K
29. 1 4 which can be used for example in treatment follow up cases The Low Dose resolution will result in images of reduced image quality in other words image quality is proportional to dose and it is up to the dental professional to decide when it is sufficient to use this mode As small as possible FOV size should be selected for the patient case in order to follow the ALARA As Low As Reasonably Achievable principle Table 1 1 General guidelines for selecting 3D resolution It is always up to the dental professional to select the appropriate mode Resolution setting General recommendations for the use Low Dose Resolution Treatment follow up children Standard Resolution Implants 3 molars TMJ impacted teeth resorptions Endo Resolution Endodontic cases periapical infections root canals fractures etc Table 1 2 General guidelines for selecting 3D FOV It is always up to the dental professional to select the appropriate mode Resolution setting General recommendations for the use SFOV 61 x 41 mm Optimized for single site implants or localized diagnostics for ex MFOV 50 x 50 mm ample 3rd molar extractions impacted teeth s single TMJ analy sis endodontics and children SFOV 61 x 78 mm Multiple implant placement using surgical guides covers complete MFOV dental arch optimized for one jaw MFOV 78 x 78 mm Entire dentition both mandibula and maxilla as well as a portion of OA manas TAN e E RT MFOV 78 x 150 mm Both ma
30. 2 Approved 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 x10 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 medical 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 The unit shall be connected directly to the acquisition PC
31. 3 Ortho TMJ program provides a wide layer axially corrected views for the patient s left and right temporomandibular joints Exposure settings for Ortho Lateral TMJ program 100 VAC 3 kV 6 3 mA 3 kV 10 mA 3 kV 13 mA 3 kV 16 mA 230 VAC 3 kV 6 3 mA 73 kV 10 mA 73 kV 13 mA 73 kV 16 mA EN x jelas PA TMJ Magnification 1 55 Exposure settings for PA TMJ program 100 VAC 3 kV 6 3 mA 3 kV 10 mA 73 kV 13 mA 3 kV 16 mA 230 VAC 3 kV 6 3 mA 3 kV 10 mA 73 kV 13 mA 73 kV 16 mA demi 20 Instrumentarium Dental 210457 rev 7 Reviewed Koskela Markku 2014 07 14 15 02 D511392 7 Approved See PDM system to determine the status of this document Printed out 2014 09 03 12 37 30 Copyright by PaloDEx Group Oy All rights reserved See PDM system to determine the status of this document Printed out 2014 09 03 12 37 30 Copyright by PaloDEx Group Oy All rights reserved 3 Imaging programs Maxillary Sinus Magnification 1 3 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 Exposure settings for Maxillary Sinus program 100 VAC 66 kV 6 3 mA 6 kV 10 mA 6 kV 13 mA 3 kV 13 mA 230 VAC 66 kV 6 3 mA 66kV 10 mA 66 kV 13 mA 73 kV 13 mA PS ea
32. 300 should assure that it is used in an electromagnetic environment as described below Emissions Test Electromagnetic Environment Radio Frequency Group 1 ORTHOPANTOMOGRAPH OP300 uses RF energy Emissions only for its internal function Therefore the RF emission CISPR11 is very low and not likely to cause any interference in nearby electronic equipment Radio Frequency Class B ORTHOPANTOMOGRAPH OP300 is suitable for use Emissions in all establishments including domestic establishments CISPR11 and those directly connected to the public low voltage power supply network that supplies buildings used for domestic purposes Harmonic emis IEC 61000 3 2 ORTHOPANTOMOGRAPH OP300 is suitable for use sions Class A in all establishments including domestic establishments and those directly connected to the public low voltage IEC 61000 3 2 power supply network that supplies buildings used for domestic purposes Voltage fluctua Complies ORTHOPANTOMOGRAPH OP300 is suitable for use tions in all establishments including domestic establishments flicker emissions and those directly connected to the public low voltage power supply network that supplies buildings used for IEC 61000 3 3 domestic purposes 114 Instrumentarium Dental 210457 rev 7 Reviewed Koskela Markku 2014 07 14 15 02 DoSld1392 7 Approved See PDM system to determine the status of this document Printed out 2014 09 03 12 37 30 Copyright by PaloDEx Group Oy All r
33. 7 30 9 4 210457 rev 7 Instrumentarium Dental Reviewed Koskela Markku 2014 07 14 15 02 Approved 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 10A 220 240 V 50 60Hz 1A continuous 15A 100 120 V 50 60 Hz 1 5A continuous IP20 gC N IEC 60601 1 0537 This product complies with DHHS 21 CFR Chapter Subchapter J at the date of manufacture Rx only Warning This X ray unit may be dangerous to patient and operator unless safe exposure factors operating instructions and maintenance schedules are CONFORMS TO UL STD 60601 1 us CERTIFIED TO CSA STD C22 2 NO 601 1 Intertek 3155128 Manufactured by PaloDEx Group Oy Nahkelantie 160 FI 04300 TUUSULA Finland Instrumentarium Dental 210412 r2 9 Technical data WAY 113 D511392 7 See PDM system to determine the status of this document Printed out 2014 09 03 12 37 30 Copyright by PaloDEx Group Oy All rights reserved 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 5 Electromagnetic emissions IEC 60601 1 2 Ed2 ORTHOPANTOMOGRAPH OP300 is suitable for use in the specified electromagnetic en vironment The purchaser or user of ORTHOPANTOMOGRAPH OP
34. 90 90 kV 8 mA 16 s mA 16 s 90 90 kV 8 mA 20 s mA 20 s 120 VAC 85 kV 10 mA 85 kV 10 mA 90 kV 8 mA 16 s 90 kV 8 mA 20 s pee e n 230 VAC 85 kV 10 mA 90 kV 10 mA 90 kV 13 mA 90 kV 13 mA ome oque Tome jas o pee Cephalometric lateral projection r E Lateral Cephalostat uses a full height image e x field 223 mm Exposure settings for cephalometric lateral program 100VAC 90 90 kV 8 mA 10 s mA 10 s 90 90 kV 8 mA 13 s mA 13 s 90 90 kV 8 mA 16 s mA 16 s 90 90 kV 8 mA 20s mA 20 s 120 avae mA 10 s GEALA mA 13 s s TTT mA 16 s BED mA 20 s 230 kus 85 kV 10 mA 13 s 90 kV 10 mA 13 s 90 kV 13 mA 16 s 90 kV 13 mA 20 s a I LN NN 210457 rev 7 Instrumentarium Dental 23 Reviewed Koskela Markku 2014 07 14 15 02 D511392 7 Approved See PDM system to determine the status of this document Printed out 2014 09 03 12 37 30 Copyright by PaloDEx Group Oy All rights reserved 3 Imaging programs Cephalo posterior anterior PA projection LJ Reverse towne projection Waters view Exposure settings for cephalometric PA program 100 VAC 90 kV 8 mA 10 s 90 kV 8 mA 13 s 90 kV 8 mA 16 s 90 kV 8 mA 20 s 120 VAC 85 kV 10 mA 85 kV 10 mA 90 kV 10 mA 90 kV 10 mA oe ae fes ga 0 230 VAC 85 kV 10 mA 90 kV 10 mA 90 kV 13 mA 90 kV 13 mA 13s 16s 20s React NAN Carpus view Not available in USA and Canada y Exposure settings for Carpus view program 8s
35. 92 7 Approved See PDM system to determine the status of this document Printed out 2014 09 03 12 37 30 Copyright by PaloDEx Group Oy All rights reserved 5 Using the unit 5 3 6 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 N x Lf gan f A e MEN AN AN m TMj A busca Jf Ji j L AUP Upc Ww N EIN z T pt a NUUS 1 7 P d 4 C di b Qu 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 otraighten the patient s head if needed TE A T Vs ire Y w NO i f cam V gar Y 7 7 1 Y b 4 4 M be b u k F 5 Check the position of the midsagittal light If it is not on the midsagittal plane of the patient adjust the patient s head NGGON A BM B ol i A AX d TAN W PF N p p y W d W Lv CENE T 210457 rev 7 Instrumentarium Dental Urn 51 Reviewed Koskela Markku 2014 07 14 15 02 D511392 7 Approved See PDM system to determine the status of this document Printed out 2014 09 03 12 37 30 Copyright by PaloDEx Group Oy All
36. A mA 66 66 kV 10 mA 10 mA 70 70KV13 mA 13 mA 230 66 BEING mA 66 cl LE mA 66 dL mA 70 eae mA x j gt TT 18 Instrumentarium Dental 210457 rev 7 Reviewed Koskela Markku 2014 07 14 15 02 D5ll392 7 Approved See PDM system to determine the status of this document Printed out 2014 09 03 12 37 30 Copyright by PaloDEx Group Oy All rights reserved 3 Imaging programs Orthogonal Magnification 1 3 4 An optimized view of the dentition only with f 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 Exposure settings for Orthogonal program 100 VAC 66 kV 5 mA 66 kV 8 mA 66 kV 10 mA 70 kV 13 mA 230 VAC 66 kV 5 mA 66 kV 8 mA 66 kV 10 mA 70 kV 13 mA x j gt TT Wide arch Magnification 1 3 5 Used when the patient has a wider than normal fN dental arch Exposure settings for Wide arch program 100 VAC 66 kV 5 mA 66 kV 8 mA 70 kV 13 mA 230 VAC 66 kV 5 mA 66 kV 8 mA 70 kV 13 mA 210457 rev 7 Instrumentarium Dental 19 Reviewed Koskela Markku 2014 07 14 15 02 D5l1392 7 Approved 3 Imaging programs Ortho Lateral TMJ Magnification 1 2
37. Environment Test Level Portable and mobile RF communications equipment are used no closer to any part of ORTHOPANTO MOGRAPH OP300 including cables than the rec ommended separation distance calculated from the equation appropriate for the frequency of the trans mitter Recommended Separation Distance Conducted 3 V150 kHz V1 3V RF IEC to80 MHz 35 61000 4 6 d WP Vi Radiated 3 V m80 E1 3 V m 3 5 RFIEC MHZ to2 5 P 61000 4 3 GHz Ei 80 MHz to 800 MHz d WP 7 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 o 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 ORTHOPANTOMOGRAPH OP300to verify normal operation in each use location If abnormal performance is observed additional m
38. Press the right upper corner icon to continue 4 Take a new scout or save current and continue to 3D image TO Instrumentarium Dental 210457 rev 7 Reviewed Koskela Markku 2014 07 14 15 02 D5ll392 7 Approved See PDM system to determine the status of this document Printed out 2014 09 03 12 37 30 Copyright O by PaloDEx Group Oy All rights reserved 5 Using the unit 55 5 3D image Note After selecting FOV size and taking the scout image 1 Select the Low Dose A standard B high resolution C or endo program D Endo program is only for 61 x 41 mm 3D SFOV and 50 x 50 mm MFOV Maxio Low Dose resolution is only available for MFOV Maxio i B 0 D 61 x 41 mm 13 x 15 cm X 22mm Y 47 mm Z 0 0 mm x 44 3 mm y 23 1 mm angle 180 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 4 Select MAR ON or OFF based on your estimation of the need See chapter 3 4 1 Instructions for using MAR 210457 rev 7 Instrumentarium Dental T1 Reviewed Koskela Markku 2014 07 14 15 02 D511392 7 Approved See PDM system to determine the status of this document Printed out 2014 09 03 12 37 30 Copyright by PaloDEx Group Oy All rights reserved 9 Using the unit 5 5 5 1 Stone model and radiographic guide scan For scanning of stone models and radiographic guides a positi
39. Reviewed Koskela Markku 2014 07 14 15 02 D5ll392 7 Approved 5 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 middle of the maxillary canine or base of the nose if edentulous adjust the image layer Image layer adjustment buttons A Retrusion 10 mm anterior B Normal occlusion default center C Protrusion 10 mm posterior 9 Askthe patient to press their tongue against the roof of their mouth swallow and remain still for the duration of the exposure 210457 rev 7 Instrumentarium Dental WAY 47 Reviewed Koskela Markku 2014 07 14 15 02 D511392 7 Approved See PDM system to determine the status of this document Printed out 2014 09 03 12 37 30 Copyright by PaloDEx Group Oy All rights reserved See PDM system to determine the status of this document Printed out 2014 09 03 12 37 30 Copyright by PaloDEx Group Oy All rights reserved 9 Using the unit 5 3 6 2 TMJ exposure Nose support J iyi 1 Remove the chin rest Insert the required positioning devices including the TMJ nose support Place the dis posable covers Note Use a new disposable cover for every patient N Adjust the unit height EAG XC 4 k 4 L m Nay nds N gan F CATER CA MT Nea z os 2 Nas lt AYU 3 Guide the patient to the unit and instruct to st
40. S uuu u A aa aia NA Aa e bae beo Cas ukasa qS h mas tun 42 5 3 4 Default exposure settings 43 5 3 5 User Configurable Default Program 44 Reviewed Koskela Markku 2014 07 14 15 02 D511392 7 Approved See PDM system to determine the status of this document Printed out 2014 09 03 12 37 30 Copyright by PaloDEx Group Oy All rights reserved 996G Patent POSITIONING ep N Ba AE ANG 44 5 3 6 1 Panoramic exposure 44 9 9 0 2 Md GK DOS GA aaa uU Gd Dur an aa aa a iam a gah aa 46 5 3 6 3 Maxillary Sin s eXDOSU 8 uu uu u AGE NG EE aai 51 5 23 TAKING NGSX DOS UNC iive cadentes stata t ver Laa cat dete pent ed odues TE 53 5 59 Mulla ver Selecion ssiri k unusapa a an ag apupa tan 54 5 4 Cephalometric exposures a a arraaarrrss s 56 0 2 1 General INSUUCIONS uuu u u uuu uuu un suu Sh aec Foe bita tss 56 94 2 T allenbDOSIHOPlD ze ultu unas yu SSS naspas 58 0 4 2 1 Pediatric lateral and Lateral projection 58 9422 PADIOJ GUON kasatan aaa aa anna kaka a a ajaa aaa aaa ga aa naa a aaa aga 60 0 4 2 3 Reverse towne projection 61 942b WACS VICW ui sacucduid ei pd iaciunt n dec a
41. SING ASSEMBLY COOLING CHARACTERISTICS kHU HEAT UNITS 0 66 350 120 150 180 TIME IN MINUTES 120 Instrumentarium Dental 210457 rev 7 Reviewed Koskela Markku 2014 07 14 15 02 DoSld1392 7 Approved See PDM system to determine the status of this document Printed out 2014 09 03 12 37 30 Copyright by PaloDEx Group Oy All rights reserved 10 PC requirements 10 1 Minimum PC requirements 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 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 660 The compatible graphics driver versions are found on the driver update DVD For MFOV Maxio 2 GB dedicated display memory is re quired PCI board connection Full length PCle x16 slot for GPU board USB ports for HASP Dongle keys e 1 for reconstruction system e 1 for 3D viewing SW if needed Mouse Mouse with scroll wheel C UJ 210457 rev 7 Instrumentarium Dental 121 Reviewed Koskela Markku 2014 07 14 15 02 DO Ze 7 Approved See PDM system to determine the status of this document Printed out 2014 09 03 12 37 30 Copyright by PaloDEx Group Oy
42. See PDM system to determine the status of this document Printed out 2014 09 03 12 37 30 Copyright by PaloDEx Group Oy All rights reserved ENGLISH ORTHOPANTOMOGRAPH OP300 3D Dental X Ray System User Manual 332 210457 rev 77 Reviewed Koskela Markku 2014 07 14 15 02 Doll1392 7 Approved 7 D511392 Reviewed Koskela Markku 2014 07 14 15 02 Approved 0 4 ZL 0 60 P OZ 1no palung 1ueuinoop Sly jo sniejs 94 euiuuejep oj Wa shs WOd 99S pamasa siuDu ily o dnoJo x3gojed Aq 1uDu doo See PDM system to determine the status of this document Printed out 2014 09 03 12 37 30 Copyright by PaloDEx Group Oy All rights reserved ORTHOPANTOMOGRAPH OP300 Copyright Code 210457 rev 7 Date July 7 2014 Copyright 7 7 14 by Instrumentarium Dental PaloDEx Group Oy All rights reserved ORTHOPANTOMOGRAPHS INSTRUMENTARIUM DENTAL CLINIVIEW is a registered trademark a common law trademark of Instrumentarium Dental 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 Instrumentarium Dental The original language of this manual is English Inst
43. aaa anae eee 29 3 Exposure settings for 3D imaging aas aa aa a E aa aa Ka KE a NA a KNA Ka a a nnn 30 4 To uch screen CISDIAY sa aan au uuu uuu a a a ajaka aaa a ys sasay a 33 AM MAIN COMO patlelissstus sabe buts a ER DANT u QI u iu una sss 32 eZ Modal Se CUO aapa sa uuu a a a aaa ad ken aa ab nd a aa Kaga ngana aga ak aan Naga kaa ia 34 4 2 1 Exposure indicators and settings 34 4 3 Automatic dose control TADE iesei soda a agan ai aaa aaa kanan a aaa abang ka aa aia a aan gah agi 35 A A Status SECTION ccccccccccscccseecseecaeeceececesenecseesseesseeeseesaeesseesaueeeeesausenseesagesses 36 a OMM ciem TU UE UM 36 9 CUSIBG TIO HD uu aaa iesu aa ukt verres mut Ea E Na NA d vo Due demi wee ANANA NE 39 5 1 Attaching and removing the sensor 39 5 1 1 Attaching the sensor 39 9 1 2 REMOVING NG SEN SOM anaa n aun a aD u aS Gn es iga ga 40 92 Propano TING SY SLOT naa aana uu aaa Dajah gana a aa aaa aab ana aa abi a aja gag aa ea agal 40 S49 Panoramie exDOSLHEIGS uu u n a Ta ETE a BA A KANA eta Aa EMI IMMUNE IMS 41 9 9 1 Positioning deVviG8S saa saanane a La gaga aa a a angina ga aaa aaa a a aa a A ga Aa iua 41 5 9 2 SCCUOMAl MMACIING uuu uyu uu BA aga a aa ANG cuente au a p va qa Mud setae 42 9 9 9 ENE Fal J6iSII QGIIO
44. and as straight and tall as possible Ask the patient to take grip on the handles and set the nose against the TMJ nose support 48 Instrumentarium Dental 210457 rev 7 Reviewed Koskela Markku 2014 07 14 15 02 D5ll392 7 Approved 5 Using the unit 4 Adjust the height of the Frankfort Horizontal plane FH laser to get the laser light over the orbita porion otraighten the patient s head if needed 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 210457 rev 7 Instrumentarium Dental WAY 49 Reviewed Koskela Markku 2014 07 14 15 02 D5l1392 7 Approved See PDM system to determine the status of this document Printed out 2014 09 03 12 37 30 Copyright by PaloDEx Group Oy All rights reserved See PDM system to determine the status of this document Printed out 2014 09 03 12 37 30 Copyright by PaloDEx Group Oy All rights reserved 5 Using the unit T 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 V w Y NG TMJ light adjustment buttons A Forward towards the mirror B Reset C Backward away from the mirror 50 Instrumentarium Dental 210457 rev 7 Reviewed Koskela Markku 2014 07 14 15 02 D5ll3
45. anoramic imaging Cephalometric programs have their own program specific model heads and setting buttons for the start position of lateral scanning OP300 3D SFOV two FOV sizes has buttons for selecting standard resolution high resolution and scout image mode OP300 MFOV Maxio five FOV sizes has buttons for selecting Low DoseMinidose standard or high resolution and 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 4 2 1 Exposure indicators and settings 66 kv ery kV value cJ 11 mA Tj mA value 14 1 c Exposure time 0 mGycm Dose value Patient size settings Child juvenile small adult large adult 34 Instrumentarium Dental 210457 rev7 Reviewed Koskela Markku 2014 07 14 15 02 D511392 Approved See PDM system to determine the status of this document Printed out 2014 09 03 12 37 30 Copyright by PaloDEx Group Oy All rights reserved 7 See PDM system to determine the status of this document Printed out 2014 09 03 12 37 30 Copyright O by PaloDEx Group Oy All rights reserved 4 Touch screen display ADC Automatic Dose rate Control Manual dose rate control Test mode Exposure Indicator 4 3 Automatic dose control ADC With ORTHOPANTOMOGRAPH OP300 it is pos
46. bration 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 Instrumentarium Dental 87 D51192 7 See PDM system to determine the status of this document Printed out 2014 09 03 12 37 30 Copyright O by PaloDEx Group Oy All rights reserved 8 Calibration and adjustment 8 2 Preparing for calibration 1 Close the head support and lock it in its upmost position 2 Switch the PC and unit on 3 PC Open the dental imaging software and then open a patient card and give it an identifiable name for exam ple calibration refer to the user s manual supplied with the dental imaging software for mo
47. button released prematurely Possible cause TMJ areas in sectional imag es where deselected Instrumentarium Dental 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 D511392 See PDM system to determine the status of this document Printed out 2014 09 03 12 37 30 Copyright by PaloDEx Group Oy All rights reserved 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 Reviewed Koskela Markku 2014 07 14 15 02 Approved Possible cause Bite block was left on place Possible cause Sensor problem Possible cause 1 Cephalostat lock not locked 2 Ear holders misaligned Instrumentarium Dental Remedy Remove the bite block and retake QA image Remedy Consult the dealer Remedy 1 Lock it 2 Call service 210457 rev 7 D511392 Copyright by PaloDEx Group Oy All rights reserved See PDM system to determine the status of this document Printed out 2014 09 03 12 37 30 6 4 Unit operation Problem Back of the patient s head is touching the x ray tube during the exposure Possible cause 1 Patients head inclination not correct 2 Patient is too big for the 3
48. cuits electronic boards inside m Sensor covers EMC painted Instrumentarium Dental 210457 rev 7 D511392 7 2 Unit description 2 1 Main parts and controls Column Carriage Main support Rotating unit on O N On off switch rear of carriage and main fuses Tubehead assembly Touch screen display 6 7 8 Positioning panel 9 Sensor head 10 Head support 11 Chin rest 12 Handles 13 Cephalostat unit 14 Cephalostat sensor 15 Secondary collimator L3 16 Positioning panel 3 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 The PC must conform to all the unit and dental imaging software requirements 210457 rev 7 Instrumentarium Dental 9 Reviewed Koskela Markku 2014 07 14 15 02 D511392 7 Approved See PDM system to determine the status of this document Printed out 2014 09 03 12 37 30 Copyright by PaloDEx Group Oy All rights reserved 2 Unit description 1 Sensor holder units without 3D option P 2 Panoramic sensor 1 3D sensor units with 3D option 2 Panoramic sensor 10 Instrumentarium Dental 210457 rev 7 Reviewed Koskela Markku 2014 07 14 15 02 D5ll392 7 Approved See PDM system to determine the status of this document Printed out 2014 09 03 12 37 30 Copyright O by PaloDEx Group Oy All rights re
49. d Aq 1uDu do2 See PDM system to determine the status of this document Printed out 2014 09 03 12 37 30 Copyright by PaloDEx Group Oy All rights reserved 1 Introduction 1 1 ORTHOPANTOMOGRAPH OP300 INSTRUMENTARIUM DENTAL ORTHOPANTOMOGRAPH OP300 x ray unit hereafter called OP300 is a dental x ray system for producing high quality digital images of dentition TM joints and skull In order to take images with OP300 you need a suitable PC hardware connected to the OP300 unit and CLINIVIEW software or suitable third party software via TWAIN driver to capture and manage images OP300 performs the following procedures Panoramic e Standard panoramic e Pediatric panoramic e Wide arch panoramic e Bitewing e TMJ PA projection e Ortho TMJ axial corrected lateral projection e Maxillary sinus e Ortho Zone enhanced panoramic Orthogonal panoramic Cephalometric optional e Cephalometric lateral projection e Cephalometric pediatric lateral projection e Cephalometric postero anterior PA projection e Reverse Towne projection e Waters view e Carpus program optional Not available in USA and Canada 210457 rev 7 Instrumentarium Dental 1 Reviewed Koskela Markku 2014 07 14 15 02 D54192 7 Approved Copyright by PaloDEx Group Oy All rights reserved See PDM system to determine the status of this document Printed out 2014 09 03 12 37 30 1 Introduction 1 2 1 3 2 Reviewed Kos
50. 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 The unit shall be connected directly to the acquisi tion PC with an Ethernet cable Connection through the LAN network of the site is not allowed Two network ports are needed in the PC in order to connect also to the site network Position the PC and any other external device at least 1 5 m 607 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 210457 rev 7 Instrumentarium Dental 123 Reviewed Koskela Markku 2014 07 14 15 02 DollT1392 7 Approved Copyright by PaloDEx Group Oy All rights
51. e 6 Repeat the calibration until calibration result passed is achieved This calibration is only needed with 3D units Instrumentarium Dental Reviewed Koskela Markku 2014 07 14 15 02 Approved 93 D511392 7 See PDM system to determine the status of this document Printed out 2014 09 03 12 37 30 Copyright by PaloDEx Group Oy All rights reserved 8 Calibration and adjustment 8 4 2 3D pixel calibration 1 Remove the 3D calibration phantom 2 Select the program 3 Press Patient Positioning 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 Instrumentarium Dental 210457 rev 7 Reviewed Koskela Markku 2014 07 14 15 02 D5ll392 7 Approved See PDM system to determine the status of this document Printed out 2014 09 03 12 37 30 Copyright O by PaloDEx Group Oy All rights reserved 8 Calibration and adjustment 8 4 3 3D Quality Check program 1 Attach the QC phantom to the unit Ensure that QC phantom is aligned with libel Select the 3D QC program Press Patient Positioning 5 Take an exposure 6 The resulting image contains information on whether the quality check was passed 210457 rev 7 Instrumentarium Dental 95 Reviewed Koskela Markku 2014 07 14 15 02 D511392 7 Approved See PDM system to determine the status of this doc
52. e unit to take x ray exposures that it is not designed for Instrumentarium Dental 3 D54141 592 7 See PDM system to determine the status of this document Printed out 2014 09 03 12 37 30 Copyright by PaloDEx Group Oy All rights reserved 1 Introduction 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
53. easures may be necessary such as re orienting or relocating ORTHOPANTOMOGRAPH OP300 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 116 Instrumentarium Dental 210457 rev 7 Reviewed Koskela Markku 2014 07 14 15 02 D54192 7 Approved See PDM system to determine the status of this document Printed out 2014 09 03 12 37 30 Copyright by PaloDEx Group Oy All rights reserved 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 interference to radio communications Portable and mobile RF communi cations equipment can also affect the performance of OP300 Table 1 8 Table 4 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 dp gene gek E Vi Fi Fi Separation Separation Separation Rated Distance Distance Distance Maximum meters meters meters Equation Output Power of Transmitter watts USE LIMITATION Externa
54. ents 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 Allowed 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 Instrumentarium Dental 85 DSLL392 7 See PDM system to determine the status of this document Prin
55. f this document Printed out 2014 09 03 12 37 30 Copyright by PaloDEx Group Oy All rights reserved 9 Using the unit 5 4 2 2 PA projection 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 disposable covers Note Use a new disposable cover for every patient 2 Adjust the unit height gt OOO o Q C C3 3 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 patients ears Tall patients can also sit on a chair Figure 1 3 Unlock first the lever turn the ear rods and lock the lever again Note Use a new disposable cover for every patient 60 Instrumentarium Dental 210457 rev 7 Reviewed Koskela Markku 2014 07 14 15 02 D5ll392 7 Approved See PDM system to determine the status of this document Printed out 2014 09 03 12 37 30 Copyright by PaloDEx Group Oy All rights reserved 5 Using the unit 5 4 2 3 Reverse towne projection 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 disposable covers Note Use a new disposable cover for every patient 2 Adjust the unit height aN cr 4 TER F f AS x GOO O wW M a sa gt p Fu W wW gt j ue Guide the patient to the unit
56. he installed imaging software 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 210457 rev 7 Instrumentarium Dental 97 Reviewed Koskela Markku 2014 07 14 15 02 D511392 7 Approved 8 Calibration and adjustment 7 N D o I oO In 7 A P Me gt AO Cv C o e 5 Q c o 5 il 0 N D LO A lt A r lt A O N 5 M I Y 2i D IV v O NG O o eoo p Q O EY gt O O0 Q MG lt 08 Z8 Zl 0 60 FL0Z 1no palung lu uuinoop Sly jo snle s 94 euiuuejep oj Wa shs WOd 99S pamasa siuDu ily o dnoly x3gojed Aq 1luBiu doo See PDM system to determine the status of this document Printed out 2014 09 03 12 37 30 Copyright by PaloDEx Group Oy All rights reserved 9 Technical data 9 1 Technical specifications Manufacturer Instrumentarium Dental Nahkelantie 160 P O Box 20 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
57. he 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 regular intervals according to the table below Modality Minimum requirement Recommendation Two 2 times annually Four 4 times annually O 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 210457 rev 7 Instrumentarium Dental 83 Reviewed Koskela Markku 2014 07 14 15 02 D51492 7 Approved Copyright by PaloDEx Group Oy All rights reserved See PDM system to determine the status of this document Printed out 2014 09 03 12 37 30 7 Maintenance 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 w
58. ights reserved 9 Technical data Table 1 6 Electromagnetic immunity IEC 60601 1 2 Ed2 ORTHOPANTOMOGRAPH OP300 is suitable for use in the specified electromagnetic en vironment The purchaser or user of ORTHOPANTOMOGRAPH OP300 should assure that it is used in an electromagnetic environment as described below Immunity Test IEC 60601 1 2 Compliance Electromagnetic Environment Test Level Level Electrostatic 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 9o dip in UT for 5 cycles 70 UT 30 9o dip in UT for 25 cycles lt 596 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 9o UT 60 Yo dip in UT for 5 cycles 70 9o UT 30 Yo dip in UT for 25 cycles 596 UT gt 95 dip in UT Floors are wood concrete or ce
59. inst 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 Instrumentarium Dental 63 D511392 7 See PDM system to determine the status of this document Printed out 2014 09 03 12 37 30 Copyright O by PaloDEx Group Oy All rights reserved 5 Using the unit 5 5 3D exposures 5 5 1 Positioning devices Chin support 5 5 2 General instructions Workflow 4 PC Click Image Capture 2 Select the 3D modality tab 3 Select the Field Of View FOV 4 With 3D SFOV unit move the FOV cursor on the area of interest For precise adjustment the arrow keys can be used 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 64 Instrumentarium Dental 210457 rev 7 Reviewed Koskela Markku 2014 07 14 15 02 D5ll392 7 Approved See PDM system to determine the status of this document Printed out 2014 09 03 12 37 30 Copyright O by PaloDEx Group Oy All rights reserved 5 Using the unit 61 x 41 mm x 44 3 mm y 23 1 mm angle 180 deg 13x 15 cm X 22 mm Y 17 mm 2 00mm 90 0 0 mA 2 3s 0 mGycm C 88868 eH
60. itch 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 210457 rev 7 Instrumentarium Dental 73 Reviewed Koskela Markku 2014 07 14 15 02 Dold3924 7 Approved 9 Using the unit 7 N D o I oO In 7 A P Me gt AO Cv C o e 5 Q c o 5 il 0 N D LO A lt A r lt A O N 5 M I Y 2i D IV v O NG O o H o0 gt Q O d 5 gt Q O0 Q MG lt 08 Z8 Zl 0 60 FL0Z 1no palung lu uuinoop Sly jo snle s 94 euiuuejep oj Wa shs WOd 99S pamasa siuDu ily o dnoly x3gojed Aq 1luBiu doo 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 See PDM system to determine the status of this document Printed out 2014 09 03 12 37 30 Copyright by PaloDEx Group Oy All rights reserved 6 1 Patient positioning Problem Incisors and canines narrow and unsharp Overshadow in molar and premolar areas Rows
61. ith a screwdriver Use only appropriate fuses e Line voltage 220 240 Vac 326 Littelfuse 10A slow blow or Cooper Bussman MDA 10 time delay Line voltage 100 120 Vac 326 Littelfuse 15A slow blow or Cooper Bussman MDA 15 time 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 off 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 84 Instrumentarium Dental 210457 rev 7 Reviewed Koskela Markku 2014 07 14 15 02 D5l13925 Approved 7 Copyright by PaloDEx Group Oy All rights reserved See PDM system to determine the status of this document Printed out 2014 09 03 12 37 30 210457 rev 7 Reviewed Koskela Markku 2014 07 14 15 02 Approved 7 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 ag
62. ixel size and depth 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 2410x830x1126mm standard column 94 9 x 32 7 x 44 3 inches Max Weight 200 kg 441 Ibs Panoramic OP300 ceph physical measures source image distance SID 1745 mm 68 7 inches source object distance SOD 1520 mm 60 inches 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 2410 x 1931 x 1193 mm 94 9 x 76 x 47 inches Weight 240 kg 529 Ibs Cephalometric Ambient temperatures Transportation and Storage 10 60 C Operation Temperature 10 35 C RH max 85 210457 rev 7 Instrumentarium Dental 107 Reviewed Koskela Markku 2014 07 14 15 02 BS5SLISY2 z 7 Approved See PDM system to determine the status of this document Printed out 2014 09 03 12 37 30 Copyright by PaloDEx Group Oy All rights reserved 9 Technical data Ceph ready option Ordered separately ee BANA l Ceph Upgrade to OP300 pan Unit has the same sensor as ceph unit Cost saving with future digital ceph upgrade Configuration options for model OP300 Cephalostat Upgrade Add ceph imaging to OP300 pan Left right Change handedness to OP300
63. kela Markku 2014 07 14 15 02 Approved 3D SFOV optional H x W 61x41 mm Field of View e 61x78 mm Field of View 3D MFOV Maxio optional H x W e MFOV Masio 50 x 50 mm Field of View e MFOV Masio 61 x 78 mm Field of View e MFOV Masio 78 x 78 mm Field of View e MFOV Masio 78 x 150 mm Field of View e MFOV Masio 130 x 150 mm Field of View optional References The following instructions are delivered with in the OP300 installation manual e Firmware update instructions e Calibration instructions e Cephalostat upgrade instructions 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 OP300 must only be used and operated by healthcare professionals and other qualified professionals OP300 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 should not be used if conventional intraoral radiographic images like bitewing exposures would be sufficient Cone beam computed tomography images are not adequate for the analysis of soft tissue Instrumentarium Dental 210457 rev 7 D511392 7 Copyright by PaloDEx Group Oy All rights reserved See PDM system to determine
64. l components he use of accessories transducers and cables other than those specified may result in degraded ELECTROMAGNETIC COMPATIBILITY of the EQUIPMENT and or SYSTEM 210457 rev 7 Instrumentarium Dental 117 Reviewed Koskela Markku 2014 07 14 15 02 Dol 992 4 Approved Copyright by PaloDEx Group Oy All rights reserved See PDM system to determine the status of this document Printed out 2014 09 03 12 37 30 9 Technical data 118 Reviewed Koskela Markku 2014 07 14 15 02 Approved 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 ORTHOPANTOMOGRAPH OP300 should not be used adjacent to or stacked with other equipment if adjacent or stacked use is necessary the ORTHOPANTOMOGRAPH OP300 should be observed
65. lace the disposable covers Note Use a new disposable cover for every patient 2 Adjust the unit height Instrumentarium Dental 210457 rev7 D511392 7 See PDM system to determine the status of this document Printed out 2014 09 03 12 37 30 Copyright by PaloDEx Group Oy All rights reserved 5 Using the unit C305 X QUO 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 edentu lous bite positioner or the chin support for an edentu lous patient 4 Ask the patient to take one step forward to straighten the spinal column Patient is slightly leaning backwards during the imaging L W 5 Adjust the height of the Frankfort Horizontal plane FH laser to get the laser light over the orbita porion otraighten the patient s head if needed 210457 rev 7 Instrumentarium Dental WAY 45 Reviewed Koskela Markku 2014 07 14 15 02 D5ll392 7 Approved See PDM system to determine the status of this document Printed out 2014 09 03 12 37 30 Copyright O by PaloDEx Group Oy All rights reserved 5 Using the unit 6 Checkthe 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 46 Instrumentarium Dental 210457 rev 7
66. m FOV standard resolution 78 x 78 mm FOV high resolution 104 Instrumentarium Dental 210457 rev 7 Reviewed Koskela Markku 2014 07 14 15 02 DSllT392 7 Approved See PDM system to determine the status of this document Printed out 2014 09 03 12 37 30 Copyright by PaloDEx Group Oy All rights reserved 9 Technical data 78 x 150 mm FOV standard resolution 78 x 150 mm FOV high resolution 130 x 150 mm FOV Low Dose 130 x 150 mm FOV standard resolu 90 kV 3 2 10mA 9s tion 130 x 150 mm FOV high resolution 90 kV 4 10 mA 9s Image storing and retrieving File formats PNG 16 bit JPG 12 bit File compression PNG lossless JPG 100 60 quality Panoramic file size 2 4 MB Cephalometric file size 3 5 MB 3D file size 12 400 MB DICOM 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 positioning Operation Arm mounts on left or right side of the unit Interlocked pan ceph sensor Motorised carriage buttons at cephalostat head assem bly 210457 rev 7 Instrumentarium Dental 105 Reviewed Koskela Markku 2014 07 14 15 02 Dodd Roz 7 Approved See PDM system to determine the status of this document Printed out 2014 09 03 12 37 30
67. ndibula and maxilla including airway and upper cervical x inger sus boh TM jos gt i et ME MFOV 130 x 150 mm Covers entire maxillofacial region from maxilla to frontal ENN nus or tom manabu omadlar snus o 28 Instrumentarium Dental 210457 rev 7 Reviewed Koskela Markku 2014 07 14 15 02 DoSld1392 7 Approved See PDM system to determine the status of this document Printed out 2014 09 03 12 37 30 Copyright O by PaloDEx Group Oy All rights reserved 3 Imaging programs 3 6 MAR Metal Artifact Reduction MAR 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 MAR on a 3D image may have affect to image reconstruction time g 0 000 mm w 0 000 mm angle 180 deg 90 nv 3D SFOV touch screen MAR button is ON MAR button becomes visible on the 3D modality 5x5cm X 194 mm Y 31 5 mm Z 12 5 mm MFOV Maxio touch screen MAR button is ON MAR button becomes visible on the 3D modality 210457 rev 7 Instrumentarium Dental 29 Reviewed Koskela Markku 2014 07 14 15 02 D511392 7 Approved See PDM system to determine the status of this document Printed out 2014 09 03 12 37 30 Copyright by PaloDEx Group Oy All rights reserved 3 Imaging programs 3 Exposure settings for 3D imaging Table 1 3 Exposure setti
68. ngs for 3D SFOV imaging Note Voltage settings is always 90kV with the unit 3D modality Resolution FOV Exposure Scanning Amount of h x w time time projections Low dose default High quality DAP DAP DAP mGycm2 mGycm2 mGycm2 High Res 61x 41mm 6 15 10s 6 3 mA 8 mA 13 mA 240 385 601 Std Res 61x41 mm nM Py E P E E rmm e O T7 e aep Endo Res 61 x 41 mm 4 mA mA A m t O PU Ge wm too High Res 61x 8mm 12 6s 1262 STA SITA 1 mA RD O ae Ge Std Res 61x 78 mm m mA mA as ewe OSES 0 G2 ary Table 1 4 Exposure settings for 3D imaging MFOV Maxio Note Voltage settings is always 90kV with the unit 3D modality A 5 aay Ue MM CU eee a 1 3D program FOV Exposure Project Scanning Default mAs DAP Voxel Low Dose 90x 50 mm M s 1096s 2mA 3 oss w High Res 50x50mm 609s 609 174s amp 3mA 384 32 425 85 320 10 963 High Res 61x 78mm 609s 609 174s 63mA 384 591 200 10 963 High Res T8x78mm 609s 609 174s 63mA 384 735 200 i955 72 400 350 850 814 250 Low Dose 130 x 150 mm 45s 900 40s 63mA 144 StdRes 30x 150mm 90s 900 40s 4mA 360 690 380 High Res 130x 150 mm 90s 900 40s 63mA 567 1086 320 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 possibilit
69. ntal 7 Dolls92 7 Copyright by PaloDEx Group Oy All rights reserved See PDM system to determine the status of this document Printed out 2014 09 03 12 37 30 1 Introduction 1 7 1 8 8 Reviewed Koskela Markku 2014 07 14 15 02 Approved equipment may lead to a reduced level of safety of the resulting system All protective covers must be properly installed before handing unit to the user or when operating the unit Correct sharp layer should be chosen when using multilayer PAN images See user manual chapter Multilayer PAN images for correct procedure 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 non environmental friendly waste products m lubehead Pb oil m Collimator Pb m All electronic cir
70. o be observed during use 3 1 6 2 Warnings for cross infection 9 tE S ECIAM TER 5 Mad NIS GELANG uu TIT k a KG a sa a ss anus aaa thua aaa 8 128 DISDOSAll saga anaa EN a a NAN a want aa Gaga A a ak a ANG ede sate ae ees 8 2 UHIDL eSOCrpiigh k u u a BA ANA u u uuu Su u wa Sasa 9 2 1 Man DANES aNd COMMONS assist naa aga aana T 9 2 2 Paent DOSIDOPIHG HONS ossi td eden es utut Ense Mao A NGA KA Ga a DEN A aa AN aaa 11 2 9 Patient positioning Ba uuu uu idet omo pe vetera oro EL oid paia akan in a Waga 14 2 3 1 Cephalometric unit optional 14 24 JEImergerncy SIOD SWINGIN uec udo tud desta deseen tal deus a eed orci atte tuba ed aaa aaa 15 3 Imaging programs 17 3k Panoramic pFOGFalITIS usuy uuu naa eaaa Nan a a a aa Ue aa GN eee 17 32 GepDhalomeltmo Progra encena ANNA nad ad Ka KA E 23 29 OLS OV pi ograliSuuu yu aa a E a a AAN a a A a TG a aaa ee 25 o SD MFEFOV Maxio DIOGFAITIS sisiran kana aba etae u a aa a nada gka ai ea ng aa apaa daa ea aba aa aaa 26 3 9 Selecting resolution and FOV aaa agak aga i pa Ng gg Baga I vele Kaga KN a Na tvi died 26 3 6 MAR Metal Artifact Reduction see ido qu eso e pene eaaa aa d I PM aaa e
71. of teeth are compressed Problem Incisors and canines wide and unsharp Rows of teeth widened 210457 rev 7 Reviewed Koskela Markku 2014 07 14 15 02 Approved Possible cause 1 Occlusal correction of fo cal trough set too far pos terior Image layer laser light not obeyed Bite block was not used Possible cause Occlusal correction of fo cal trough set too far ante rior Image layer laser light not obeyed Bite block was not used Instrumentarium Dental 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 kA 75 D511392 See PDM system to determine the status of this document Printed out 2014 09 03 12 37 30 Copyright by PaloDEx Group Oy All rights reserved 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
72. oning 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 Note It is recommended to use a sponge or a foam under radiographic guide during the scan 3 Take scout image with default values Correct position if needed 4 Select same resolution and parameters as in patient scan Note More detailed instructions in OP300 Quick Guide Stone model and radiographic guide scan protocol 72 Instrumentarium Dental 210457 rev7 Reviewed Koskela Markku 2014 07 14 15 02 D5ll392 7 Approved See PDM system to determine the status of this document Printed out 2014 09 03 12 37 30 Copyright by PaloDEx Group Oy All rights reserved 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 sw
73. oskela Markku 2014 07 14 15 02 D511392 7 Approved See PDM system to determine the status of this document Printed out 2014 09 03 12 37 30 Copyright by PaloDEx Group Oy All rights reserved 9 Using the unit 5 4 2 Patient positioning 5 4 2 1 Pediatric lateral and Lateral projection 1 Unlock the lever and turn the ear rods to the lateral pro jection position Lock the position Tilt the nasion sup port aside Place the disposable covers Figure 1 1 Unlock first the lever turn the ear rods and lock the lever again Note Use a new disposable cover for every patient 2 Adjust the unit height 58 Instrumentarium Dental 210457 rev7 Reviewed Koskela Markku 2014 07 14 15 02 D5ll392 7 Approved 5 Using the unit 3 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 4 Adjust the unit height to get the Frankfort Horizontal plane FH laser light passing over the orbita porion Note 5 Tilt the nasion support down and slide it towards patient s nasion Reviewed Koskela Markku 2014 07 14 15 02 D511392 Approved See PDM system to determine the status of this document Printed out 2014 09 03 12 37 30 Copyright by PaloDEx Group Oy All rights reserved 210457 rev 7 Instrumentarium Dental 59 7 See PDM system to determine the status o
74. osure settings for pediatric program 100 VAC 66 kV 4 mA 66 kV 6 3 mA 166 kV 8 mA 0 kV 10 mA 230 VAC 66 kV 4 mA 66 kV 6 3 mA 166 kV 8 mA 70 kV 10 mA x LEN NN 210457 rev 7 Instrumentarium Dental 47 Reviewed Koskela Markku 2014 07 14 15 02 D511392 7 Approved See PDM system to determine the status of this document Printed out 2014 09 03 12 37 30 Copyright by PaloDEx Group Oy All rights reserved 3 Imaging programs 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 Ortho Zone Magnification 1 25 The Ortho Zone program 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 result of this scanning location will allow for views of the TM joint and molar area without redundant shadows from the opposite side ramus obscuring the image Patients with prosthetic condyles or other posterior radio opaque objects can have the opposite side successfully imaged 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 lll malocclusion and uncooperative patients Exposure settings for Ortho Zone program 100VAC 66 66kV 5bmA mA 66 66kV Bm
75. p 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 Press to stop the unit rotate to release 210457 rev 7 Instrumentarium Dental WAY 15 Reviewed Koskela Markku 2014 07 14 15 02 D5ll392 7 Approved 2 Unit description 7 N oo I mM In 7 A P Me gt AO Cv C o Q 5 Q E o 2 0 N D LO A lt A O lt A O N 5 M I 4 4 0 Iv 2 O NG O o oo gt Q O e 9 gt Q 0 Q m lt 08 Z8 Zl 0 60 FL0Z 1no palung lu uuinoop Sly jo snle s 94 euiuuejep oj Wa shs WOd 99S pamasa siuDu ily o dnoly x3gojed Aq 1luBiu doo See PDM system to determine the status of this document Printed out 2014 09 03 12 37 30 Copyright by PaloDEx Group Oy All rights reserved 3 Imaging programs 3 1 Panoramic programs Standard Magnification 1 3 Exposure settings for panoramic program 100 VAC 66 kV 5 mA 66 kV 8 mA 6 kV 10 mA 70 kV 13 mA 230 VAC 66 kV 5 mA 66 kV 8 mA 6 kV 10 mA 70 kV 13 mA x je TT Pediatric Magnification 1 3 Exp
76. pan ceph 108 Instrumentarium Dental 210457 rev 7 Reviewed Koskela Markku 2014 07 14 15 02 DoSld1392 7 Approved Copyright by PaloDEx Group Oy All rights reserved See PDM system to determine the status of this document Printed out 2014 09 03 12 37 30 9 2 Unit dimensions 1610 2410 9 Technical data 210457 rev 7 Instrumentarium Dental Reviewed Koskela Markku 2014 07 14 15 02 Approved 109 D511392 7 See PDM system to determine the status of this document Printed out 2014 09 03 12 37 30 Copyright O by PaloDEx Group Oy All rights reserved 9 Technical data min 550 mm recommended 463 mm 18 2 in 1376 2176 mm 54 2 85 7 in 1610 2410 mm 63 4 94 9 in 958 1758 mm Chin support up 37 7 in 69 2 in H Chin support down 898 1698 mm 35 3 in 66 8 in 210 mm 8 2 in 1300 mm 51 1 in 1405 mm 1144 mm 55 3 in 45 in 2007 mm 965 mm in 79 0 in 110 Instrumentarium Dental 210457 rev 7 Reviewed Koskela Markku 2014 07 14 15 02 D5ll392 7 Approved Copyright by PaloDEx Group Oy All rights reserved See PDM system to determine the status of this document Printed out 2014 09 03 12 37 30 210457 rev 7 9 Technical data 9 3 Symbols that appear in the unit AN O N l CA gt B gt k F E Radiation warning Dangerous voltage On or enabled Off or disabled Exposure switch Connector for expo
77. proved See PDM system to determine the status of this document Printed out 2014 09 03 12 37 30 Copyright O by PaloDEx Group Oy All rights reserved 5 Using the unit 5 3 2 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 5 3 3 General instructions 2 Select PAN tab 3 Select the imaging program 4 Any section of the tooth arch can be selected for the par tial panoramic imaging to reduce the radiation 5 Select the Manual mode oet the kV and mA or select the patient size child juvenile adult large adult 42 Instrumentarium Dental 210457 rev 7 Reviewed Koskela Markku 2014 07 14 15 02 D5ll392 7 Approved See PDM system to determine the status of this document Printed out 2014 09 03 12 37 30 Copyright by PaloDEx Group Oy All rights reserved 9 Using the unit 6 Press the patient positioning button to rotate the unit to patient in position Y 5 lt 4 lt LJ LJ WO LJ WO 7 Open the temple supports 8 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 Note Local country regulations may set different stand ard for lead apron usage needs 5 3 4 Default exposure settings User Configurable Panoramic mA Level Default mA level for panoramic p
78. quality Avoid taking x ray exposures of pregnant women When taking an x ray exposure of a child always use the lowest possible x ray dose the smallest possible image area and the lowest possible resolution that allows you to perform the required diagnostic task If the patient is using a pacemaker consult the manufacturer of the pacemaker before taking an exposure to confirm that the x ray unit will not interfere with the operation of the pacemaker 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 4 Instrumentarium Dental 210457 rev 7 Reviewed Koskela Markku 2014 07 14 15 02 DSld392 7 Approved See PDM system to determine the status of this document Printed out 2014 09 03 12 37 30 Copyright by PaloDEx Group Oy All rights reserved 1 Introduction The customer must ensure that the siting environment fulfills the requirements listed in the Installation manual opecial 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 Re
79. re information 4 PC Click the image acquisition button to activate image capture 5 Touch the settings button on the touch screen display 6 Select the Quality assurance button The calibration display appears 88 Instrumentarium Dental 210457 rev 7 Reviewed Koskela Markku 2014 07 14 15 02 D5ll392 7 Approved See PDM system to determine the status of this document Printed out 2014 09 03 12 37 30 Copyright O by PaloDEx Group Oy All rights reserved 8 Calibration and adjustment 8 3 Panoramic calibration 8 3 1 Panoramic geometry calibration 1 Select the program 2 Press Patient Positioning 3 Install the double cone calibration tool 4 Take an exposure 5 Repeat the calibration until calibration result passed is achieved Adjustment panGeom Passed los en lt 5 02mm offset lt 05 02mm Niotiset lt 05 0103 mm Jotiset AA 2 mm 210457 rev 7 Instrumentarium Dental 89 Reviewed Koskela Markku 2014 07 14 15 02 D5l1392 7 Approved See PDM system to determine the status of this document Printed out 2014 09 03 12 37 30 Copyright O by PaloDEx Group Oy All rights reserved 8 Calibration and adjustment 8 3 2 Panoramic 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
80. reserved See PDM system to determine the status of this document Printed out 2014 09 03 12 37 30 10 PC requirements 10 2 124 Reviewed Koskela Markku 2014 07 14 15 02 Approved with liquids Clean the PC in accordance with the manufactur er s instructions The PC to be used with the unit must be installed in a location that meets all local and national safety requirements with regards the connection of a PC to an x ray device The connection of the unit to the PC must meet IEC 60601 1 requirements 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 Consideration relating to the choice shall include Use of the accessory in the PATIENT VICINITY The safety certification of the accessory has been performed in accordance to the appropriate IEC 601 1 and or IEC 601 1 1 harmonized national standard The dental imaging software The dental imaging software installed in the PC that is used with the unit must be MDD approved for example CLINIVIEW Instrumentarium Dental 210457 rev 7 D511392 7
81. rograms can be set using the touch screen display To change the setting 1 Start an exam and select a panoramic program ww w w eaa 210457 rev 7 Instrumentarium Dental 43 Reviewed Koskela Markku 2014 07 14 15 02 D511392 7 Approved Copyright by PaloDEx Group Oy All rights reserved See PDM system to determine the status of this document Printed out 2014 09 03 12 37 30 9 Using the unit Imaging program defaults Set current PAN mA as default 44 Reviewed Koskela Markku 2014 07 14 15 02 Approved 2 Press Settings on the touch screen 3 Select maging program defaults 4 Select Set current PAN mA level as default The selected mA value is used as default value for the current program The default mA level is adjusted by an equal amount also for other panoramic programs 5 3 5 User Configurable Default Program Default imaging program pan ceph 3D can be set using the touch screen display To change default program 1 Start an exam and select the desired program 2 Press the Settings button on the touch screen a d 3 Select Imaging program defaults Imaging program defaults 4 Select Set current program as default Set current program as default The selected program is automatically activated when an exam is started for a new patient and at startup 5 3 6 Patient positioning 5 3 6 1 Panoramic exposure 1 Insert the sinus rest chin rest and bite fork with the bite block P
82. rumentarium Dental 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 Instrumentarium Dental representative for the most current information CC 0537 Manufacturer Instrumentarium Dental PaloDEx Group Oy Nahkelantie 160 P O Box 20 Fl 04300 Tuusula FINLAND Tel 358 10 270 2000 Fax 358 10 270 2230 For service contact your local distributor Reviewed Koskela Markku 2014 07 14 15 02 D511392 7 Approved ORTHOPANTOMOGRAPH OP300 7 D511392 Reviewed Koskela Markku 2014 07 14 15 02 Approved 0 4 ZL 0 60 Y OZ 1no palung 1ueuinoop Sly jo snjejs 94 euiuuejep oj Wa shs WOd 99S pamasa siuDu ily o dnoly x3gojed Aq 1uDu doo See PDM system to determine the status of this document Printed out 2014 09 03 12 37 30 Copyright by PaloDEx Group Oy All rights reserved Table of Contents 1 IBITOQUCGU01I Lu u u 1 1 1 ORTHOPANTOMOGRAPH OP300 eaaa eaaa eaaa nennt 1 PAM iae T Dans SD sapa u sss 2 ko IBIeniqeqqls PL 2 tA JAsSOGlaled dOCUFeribad obla lu uuu u cu det a a EN sung Sas 3 1 5 Abbreviations used in this manual 3 1 6 VV arninGS and precallli niS uuuuuuu aia a ag a ab aja a a aana aga aa aaa a evi eu mi ionieni 3 1 6 1 Warnings t
83. s indicated with Frankfort horizontal FH light Move FH light to 130 mm position locked in up position 3 Horizontal light bottom of FOV 210457 rev 7 Instrumentarium Dental WAY 43 Reviewed Koskela Markku 2014 07 14 15 02 D511392 7 Approved See PDM system to determine the status of this document Printed out 2014 09 03 12 37 30 Copyright by PaloDEx Group Oy All rights reserved See PDM system to determine the status of this document Printed out 2014 09 03 12 37 30 Copyright by PaloDEx Group Oy All rights reserved 2 Unit description 2 3 Patient positioning panel e IG OG 1 Carriage UP Carriage DOWN Positioning lights ON OFF Patient positioning Start positioning Chin support UP Chin support DOWN O N O QO O N Move the image layer anterior before exposure 3 mm with sinus program 10 mm 9 Normal occlusion reset position 10 Move the image layer posterior before exposure 3 mm with sinus program 10 mm 2 3 1 Cephalometric unit optional 1 Carriage UP 2 Carriage DOWN 1 a A 3 Carriage UP r v v 4 4 Carriage DOWN 5 Positioning lights ON OFF 5 14 Instrumentarium Dental 210457 rev 7 Reviewed Koskela Markku 2014 07 14 15 02 D5ll392 7 Approved See PDM system to determine the status of this document Printed out 2014 09 03 12 37 30 Copyright by PaloDEx Group Oy All rights reserved 2 Unit description 2 4 Emergency sto
84. s are images where the focal through is adjusted towards the patients neck posterior To the right are images where the focal through is adjusted towards the patients lips anterior The difference in adjustment between the images is 3 mm 1 The touch screen shows one of the thumbnail images as magnified To select which image is shown press the corresponding thumbnail image in the lower part of the screen Once shown as magnified an image may be marked for saving by again pressing the thumbnail An save indication icon is shown in the upper right of the thumbnail image Repeat this process for all images of interest 2 Press the save button in the upper right of the screen The image s marked for saving will be sent to the workstation 3 PC The image s can be examined using the Cliview software See CLINIVIEW user manual for details Note The X ray unit may be configured to automatical ly select either the unadjusted midmost image or send all images to the workstation In such cases the selec tion process described above is bypassed 54 Instrumentarium Dental 210457 rev 7 Reviewed Koskela Markku 2014 07 14 15 02 DoSld1392 7 Approved See PDM system to determine the status of this document Printed out 2014 09 03 12 37 30 Copyright O by PaloDEx Group Oy All rights reserved 5 Using the unit PREVIEW 2 1 Preview selection 2 Save button 210457 rev 7 Instrumentarium Dental 55 Reviewed Koskela Markku 2
85. served See PDM system to determine the status of this document Printed out 2014 09 03 12 37 30 Copyright O by PaloDEx Group Oy All rights reserved 2 Unit description 2 2 Patient positioning lights O ON OD 1 Midsagittal light 2 Frankfort horizontal FH light Horizontal light top of 130 mm high FOV 3D MFOV Maxio option only Image layer light Cephalometric FH light TMJ light Horizontal light top of 78 mm high FOV 3D MFOV Maxio option only 7 Horizontal light top of 61 mm high FOV 3D option only 8 Horizontal light top of 50 mm FOV 3D MFOV Maxio option only 9 Horizontal light bottom of FOV 3D option only o O A C 210457 rev 7 Instrumentarium Dental 11 Reviewed Koskela Markku 2014 07 14 15 02 D5ll392 7 Approved See PDM system to determine the status of this document Printed out 2014 09 03 12 37 30 Copyright by PaloDEx Group Oy All rights reserved 2 Unit description Panoramic lights 1 Midsagittal light 2 FH light Fig 1 2 1 Image layer light 2 TMJ light 12 Instrumentarium Dental 210457 rev 7 Reviewed Koskela Markku 2014 07 14 15 02 D5ll392 7 Approved 2 Unit description Cephalometric lights Fig 1 3 1 FH light 3D lights optional Note Appropriate lasers are turned automatically on based on selected FOV 1 Midsagittal light 2 Horizontal light top of FOV Note With 3D MFOV Maxio option height 130 mm i
86. sible to take panoramic exposure with Automatic Dose Control P1 through P5 The software will monitor the amount of radiation the CMOS sensor is receiving and automatically set the exposure factors for proper dose After the exposure the adjusted values are shown on the display The ADC will stay engaged with all the panoramic procedures P1 through P5 unless set to manual mode Any of sectional panoramic programs cannot utilize ADC The signal to noise ratio can be adjusted while keeping ADC engaged Adjustment is done from the GUI PAN iD W m ES 1 A 66 kv 10 mA 16 gt 87 mGycm DEE Fig 1 8 ADC signal to noise ratio scale 210457 rev 7 Instrumentarium Dental 35 Reviewed Koskela Markku 2014 07 14 15 02 D5ll392 7 Approved See PDM system to determine the status of this document Printed out 2014 09 03 12 37 30 Copyright O by PaloDEx Group Oy All rights reserved 4 Touch screen display 4 4 Status section otatus field shows when the unit is ready for capturing or when any trouble occurs Green yellow and blue color indicate the status in question 4 5 Other sections General settings USER PROGRAM SETTINGS Retrieve last image Retrieve With MAR Languages Service Software version R1 17 GUI software version 1 7 5930 0 IP address 10 208 6 101 Serial number NO SERIAL NUMBER Language versions Deutsch 1 8 1 3 Francais 1 8 1 3 English 1 8 1 3 Italiano 1 8 1 3 Espa ol 1
87. ssues 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 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 the manufacturer The use of accessory equipment not complying with the equivalent safety requirements of this Instrumentarium De
88. st 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 92 Instrumentarium Dental 210457 rev 7 Reviewed Koskela Markku 2014 07 14 15 02 DoSld1392 7 Approved Copyright O by PaloDEx Group Oy All rights reserved See PDM system to determine the status of this document Printed out 2014 09 03 12 37 30 glGcometryIcalibration CVA PEL G8 Noffseq 02 E Jo 9 mm 8 Calibration and adjustment 8 4 3D calibration 8 4 1 1 Attach the base of the phantom to the lower shelf Level it with the bubble 3D geometry calibration 2 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 3 Press Patient Positioning IN 4 Install the 3D calibration phantom SCanidifili enti nto ficu offset E 03Imm MoffsetIOSiemm offset Bi gImm 210457 rev 7 5 Take an exposur
89. sure switch CLASS Il equipment Double insulated electrical appliance Ethernet connector Operating instruction More details in operation instructions Laser radiation Attention consult accompanying documents Instrumentarium Dental 111 Reviewed Koskela Markku 2014 07 14 15 02 Approved D511392 7 See PDM system to determine the status of this document Printed out 2014 09 03 12 37 30 Copyright by PaloDEx Group Oy All rights reserved 9 Technical data Ground Functional Protective ground CLASS 1 LASER PRODUCT EN 60 825 1 A2 2001 Laser class label Patient positioning lights Caution Federal law restricts this device to sale Rx only by or on the order of a licensed healthcare practi tioner 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 manufacturer for information concerning the decommissioning of your equip ment Type B equipment C 4 CE 0537 symbol 0537 MDD 93 42 EEC AVERTE D ETL Classified conforms to UL STD 60601 1 CNTs Certified to CSA 1412 nstrumentarium Dental 240457 rev 7 Reviewed Koskela Markku 2014 07 14 15 02 D5ll392 7 Approved Copyright by PaloDEx Group Oy All rights reserved See PDM system to determine the status of this document Printed out 2014 09 03 12 3
90. ted out 2014 09 03 12 37 30 Copyright by PaloDEx Group Oy All rights reserved 7 Maintenance If 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 Instrumentarium Dental 210457 rev 7 Reviewed Koskela Markku 2014 07 14 15 02 DoSld1392 7 Approved Copyright by PaloDEx Group Oy All rights reserved See PDM system to determine the status of this document Printed out 2014 09 03 12 37 30 8 Calibration 6 1 210457 rev 7 Reviewed Koskela Markku 2014 07 14 15 02 Approved and adjustment 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 calibration and adjustment procedure In addition to the cali
91. the status of this document Printed out 2014 09 03 12 37 30 1 4 1 5 1 6 210457 rev 7 Reviewed Koskela Markku 2014 07 14 15 02 Approved 1 Introduction CAUTION USA only Federal law restricts this device to sale by or on the order of a dentist or other qualified professional Associated documentation OP300 user manual e OP300 installation manual e The CLINIVIEW software user manual The CLINIVIEW software installation manual e The user manual supplied with the dental imaging software e The installation manual supplied with the dental imaging software The user manual supplied with the 3D imaging software e The installation manual supplied with the 3D imaging software 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 FH Frankfort Horizontal H Horizontal 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 described in this manual The unit must NOT be used to take any other x ray exposures It is not safe to use th
92. 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 ORTHOPANTOMOGRAPH OP300 including cables than the recommended separation distance calculated from the equation appropriate to the frequency of the transmitter See Table 4 Instrumentarium Dental 210457 rev 7 D511392 7 See PDM system to determine the status of this document Printed out 2014 09 03 12 37 30 Copyright by PaloDEx Group Oy All rights reserved 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 5 Anode Thermal Characteristics HEAT STORAGE kJ TIME min Figure 1 6 Maximum Rating Charts Absolute maximum rating charts DC Center Grounded Focal Spot 0 5 mm 25 60kV 20 50kV E Z Y ne 15 2 O LLI m 10 5 1 2 3 5 7 10 20 EXPOSURE TIME s 210457 rev 7 Instrumentarium Dental LAS 119 Reviewed Koskela Markku 2014 07 14 15 02 D511392 7 Approved See PDM system to determine the status of this document Printed out 2014 09 03 12 37 30 Copyright by PaloDEx Group Oy All rights reserved 9 Technical data Figure 1 7 TUBE HOU
93. turn 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 In case of water damage water dropping over the product call for service technician to ensure the product is fully operational according to specification 1 6 2 Warnings for cross infection Always use available disposable protective covers with the patient positioning accessories Bite fork cover Chin support cover Head support cover Nose support cover Ear holder cover 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 210457 rev 7 Instrumentarium Dental 5 Reviewed Koskela Markku 2014 07 14 15 02 DolT3924 7 Approved Copyright by PaloDEx Group Oy All rights reserved See PDM system to determine the status of this document Printed out 2014 09 03 12 37 30 1 Introduction 6 Reviewed Koskela Markku 2014 07 14 15 0
94. ument Printed out 2014 09 03 12 37 30 Copyright O by PaloDEx Group Oy All rights reserved 8 Calibration and adjustment 8 5 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 Select Ceph Pix program Press Patient Positioning Take an exposure 5 This calibration should always be a pass 8 5 2 Ceph Quality check program Optional Note Rotate the ear holders into PA view position Turn nasion support up out of the way 1 Attach the QC phantom to the ceph unit and ensure that it s leveled from the spirit level 96 Instrumentarium Dental 210457 rev 7 Reviewed Koskela Markku 2014 07 14 15 02 D5ll392 7 Approved See PDM system to determine the status of this document Printed out 2014 09 03 12 37 30 Copyright O by PaloDEx Group Oy All rights reserved 8 Calibration and adjustment 2 Select the Ceph QC program 3 Press Patient Positioning 4 Take an exposure 5 Visually evaluate the result using t
95. unit 2 Adjust the unit height FQ QU O 3 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 4 Check the position of the midsagittal light If it is not on the midsagittal plane of the patient adjust the patient s head 2 009Q GGG 5 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 hori zontal 39909 A ce e LE A c OOOO Or AD OQOOO 210457 rev 7 Instrumentarium Dental WAY 67 Reviewed Koskela Markku 2014 07 14 15 02 D511592 Approved 7 See PDM system to determine the status of this document Printed out 2014 09 03 12 37 30 Copyright by PaloDEx Group Oy All rights reserved 9 Using the unit 1 H light top of FOV 2 H light bottom of FOV Note In case of 130 x 150 mm Field of View chin rest movement cannot be used for FOV height adjustment To adjust FOV higher remove the chin support The FOV height 130 mm is indicated with FH light Move FH light to 130 mm position up 6 Move the head support against the patient s forehead Adjust the height Close the temple supports In case of FOV 13 x 15 adjust height of the temple sup port to correct level and close head support strap
96. ure settings for scout imaging b Maxio default values Resolution FOV mA Scanning h x w time Scr SUxS0mm 30 T 0023 Sew Si1x8mm 90 13 002s Scout 78x78mm 90 13 0025 Scout 78x 150mm 90 13 004s Scout 730x780 mm 90 13 008s 210457 rev 7 Instrumentarium Dental 31 Reviewed Koskela Markku 2014 07 14 15 02 D54141292 7 Approved 3 Imaging programs 7 N D o I oO In 7 A P Me gt AO Cv C o e 5 Q c o 5 il 0 N D LO A lt A r lt A O N 5 M I Y 2i D IV v O NG O O eS XD P Q O EY gt O O0 Q MG lt 08 Z8 Zl 0 60 FL0Z 1no palung lu uuinoop Sly jo snle s 94 euiuuejep oj Wa shs WOd 99S pamasa siuDu ily o dnoly x3gojed Aq 1luBiu doo See PDM system to determine the status of this document Printed out 2014 09 03 12 37 30 Copyright O by PaloDEx Group Oy All rights reserved 4 Touch screen display 4 1 Main control panel 1 PAN Dow OBB 3D 1 Modality imaging program section 2 Status of the unit 3 Settings 4 End examination 5 Exposure settings 210457 rev 7 Instrumentarium Dental 33 Reviewed Koskela Markku 2014 07 14 15 02 D511392 7 Approved 4 Touch screen display 4 2 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 p
97. use 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 Instrumentarium Dental 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 midsagittal 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 77 D511392 See PDM system to determine the status of this document Printed out 2014 09 03 12 37 30 Copyright by PaloDEx Group Oy All rights reserved 6 Troubleshooting Problem Images are too light Problem Images are too dark Problem Lack of image contrast 78 Reviewed Koskela Markku 2014 07 14 15 02 Approved Image appearance Possible cause CLINIVIEW Contrast and brightness not opti mum CLINIVIEW Gamma not set correctly Possible cause CLINIVIEW Contrast and brightness not opti mum Manual technique factors used too high Possible cause CLINIVIEW Contrast and brightness not opti mum kV used
98. y to use the whole mA range if the user prefers 30 Instrumentarium Dental 210457 rev 7 Reviewed Koskela Markku 2014 07 14 15 02 DoSld1392 7 Approved See PDM system to determine the status of this document Printed out 2014 09 03 12 37 30 Copyright by PaloDEx Group Oy All rights reserved 3 Imaging programs Available mA ranges for each field of view sizes and resolution settings 3D SFOV h x w i CCELI D ONMEGEUE PA 5 U U UU T SENE WB rne Jo M rie xo i NE E EGEONOGE EDGE EE High Res 61 x 78mm sars engem X X X X AUD mA ranges for each field of view sizes and resolution settings MFOV h x w LowDose Dose S0xS0mm x 50 mm x m L m sm s m ni s HighRes 50x50mm x x x x x xX E ORE i SS E Low Dose 61 x 78 mm x sars o L HgnRe 6txr8mm x x x x x LowDosee 78x78mm x StdRes f xfmn x x x x x HghRe 78x78mm x x x x x 9 LowDosee 78x150mm x q StdRes 7 8x150mm x x x x x HghRes 8x150mm x x x x x LowDose 130x f 0omm x P o StdRes 130x 0mm x x x x x HghRes 130x150mm x x x x x Exposure settings for scout imaging 3D SFOV default values Resolution FOV kV mA Scanning h x w time GTxdTmm 90 135 0Us 61x78mm 90 18 004s Expos

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