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The OP300 unit service manual

1. 36 4 2 1 Exposure indicators and settings 36 4 3 Status section 37 4 4 Other sections 37 5 Using the unit 39 5 1 Attaching and removing the sensor 39 5 1 1 Attaching the sensor 40 5 1 2 Removing the sensor 41 5 2 Preparing the system 41 5 3 Panoramic exposures 42 5 3 1 Positioning devices 42 5 3 2 General instructions 43 5 3 3 Patient positioning 45 5 3 3 1 Panora
2. 81 7 Maintenance 83 7 1 Maintenance procedure 83 7 1 1 Annual maintenance 83 7 1 2 Calibration intervals 83 7 2 Changing the fuses 84 7 3 Cleaning and decontaminating the unit 84 8 Calibration and adjustment 87 8 1 Introduction 87 8 2 Preparing for calibration 88 8 3 Panoramic calibration 89 8 3 1 Panoramic geometry calibration 89 8 3 2 Panoramic pixel calibration 90 8 3 3 Panoramic Quality Ch
3. 11 2 2 Patient positioning lights 13 2 3 Patient positioning panel 16 2 3 1 Cephalometric unit 17 2 4 Emergency stop switch 19 3 Imaging programs 21 3 1 Panoramic programs 21 3 1 1 Cephalometric programs 29 3 1 2 3D programs 31 3 1 3 MAR Metal Artifact Reduction 32 3 1 4 Exposure settings for 3D imaging 33 4 Touch screen display 35 4 1 Main control panel 35 4 2 Modality section
4. 64 5 5 1 Positioning devices 64 5 5 2 General instructions 64 5 5 3 Scout image 69 5 5 4 3D image 70 5 5 4 1 Stone model and radiographic guide scan 72 5 7 Warnings and error messages 74 5 7 1 Acknowledging errors 74 5 7 2 Image transfer errors 74 6 Troubleshooting 75 6 1 Patient positioning 75 6 2 Image appearance 78 6 3 Artefacts 79 6 4 Unit operation
5. 1 1 1 ORTHOPANTOMOGRAPH OP300 1 1 2 References 2 1 3 Intended use 2 1 4 Associated documentation 3 1 5 Abbreviations used in this manual 3 1 6 Warnings and precautions 4 1 6 1 Warnings to be observed during use 4 1 6 2 Warnings for cross infection 5 1 6 3 General warnings 7 1 7 Disclaimer 9 1 8 Disposal 9 2 Unit description 11 2 1 Main parts and controls
6. 1 2 References The following instructions are delivered with in the OP300 installation manual Firmware update instructions Calibration instructions Cephalostat upgrade instructions Cephalostat side changing instructions The following instructions are separate and can be ordered from customer service 3D upgrade instructions are delivered with the 3D upgrade kit 1 3 Intended use OP300 must only be used and operated by dentist 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 bitewing exposures would be sufficient Cone beam computed tomography images are not adequate for the analysis of soft tissue CAUTION USA only Federal law restricts this device to sale by or on the order of a dentist or other qualified professional 1 Introduction 203887 rev 5 Instrumentarium Dental 3 1 4 Associated documentation OP300 user manual OP300 installation manual The CLINIVIEW software user manual The CLINIVIEW software installation manual The user manual supplied with the dental imaging software The installation manual supplied with the dental imaging software The us
7. Note Use a new disposable cover for every patient 2 Adjust the unit height 3 Guide the patient to the unit and instruct to stand as straight and tall as possible Ask the patient to take grip on the handles and bite on the bite block 4 Adjust the height of the Frankfort Horizontal plane FH laser to get the laser light over the orbita porion Straighten the patient s head if needed 5 Check the position of the midsagittal light If it is not on the midsagittal plane of the patient adjust the patient s head 5 Using the unit 50 Instrumentarium Dental 203887 rev 5 6 Move the head support against the patient s forehead Adjust the height Close the temple supports 7 Adjust the position of the image layer as necessary The image layer is 18 mm posterior compared to stand ard panoramic procedure Image layer adjustment buttons A 10 mm anterior B Center C 10 mm posterior 8 Ask the patient to press their tongue against the roof of their mouth and remain still for the duration of the expo sure 5 Using the unit 203887 rev 5 Instrumentarium Dental 51 5 3 4 Taking the exposure 1 Press Start position Check the patient positioning Protect yourself from radiation by standing behind a suitable x ray radiation shield Make sure that you can see and hear the patient during the exposure Note In all examinations the user of the x ray equip ment should wear protective clothing The
8. Adjust the unit height 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 5 Using the unit 44 Instrumentarium Dental 203887 rev 5 5 Adjust the height of the Frankfort Horizontal plane FH laser to get the laser light over the orbita porion Straighten the patient s head if needed 6 Check the position of the midsagittal light If it is not on the midsagittal plane of the patient adjust the patient s head Make sure the patient s head is not turned or tilted 5 Using the unit 203887 rev 5 Instrumentarium Dental 45 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 B Normal occlusion default C Protrusion 9 Ask the patient to press their tongue against the roof of their mouth swallow and remain still for the duration of the exposure 5 Using the unit 46 Instrumenta
9. Exposure switch Connector for exposure switch CLASS II equipment Double insulated electrical appliance Ethernet connector Operating instruction More details in operation instructions Laser radiation Attention consult accompanying documents 9 Technical data 110 Instrumentarium Dental 203887 rev 5 Ground Functional Protective ground Laser class label Patient positioning lights This symbol indicates that the waste of electrical and electronic equipment must not be disposed as unsorted municipal waste and must be collect ed separately Please contact an authorized rep resentative of the manufacturer for information concerning the decommissioning of your equip ment Type B equipment CE 0537 symbol MDD 93 42 EEC ETL Classified conforms to UL STD 60601 1 Certified to CSA 9 Technical data 203887 rev 5 Instrumentarium Dental 111 9 4 Labels on the unit The main label of the unit is located on the vertical carriage next to the on off power switch The unit is class I type B and with IP20 protection Type OP300 1 Ser No Manufactured 10 A 220 240 V 50 60 Hz 1A continuous 15 A 100 120 V 50 60 Hz 1A continuous This product complies with DHHS 21 CFR Chapter I Subchapter J at the date of manufacture Rx only Warning This X ray unit may be dangerous to patient and operator unless safe exposure factors operating instructions and maintenance schedules are ob
10. 1 PC Click Image Capture 2 Select the 3D modality tab Chin support 2 3 4 5 Using the unit 64 Instrumentarium Dental 203887 rev 5 3 Select the Field Of View FOV 61 x 41 mm FOV Program 1 61 x 78 mm FOV Program 2 4 Move the FOV cursor on the area of interest For pre cise 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 5 Lock the position by pressing the lock key Use the same key for unlocking if the position needs to be changed 6 Press the patient positioning button to rotate the unit to patient in position 7 Adjust the unit height 8 Ask the patient to remove any spectacles hearing aids removable dentures jewellery and hair clips and pins 9 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 5 Using the unit 203887 rev 5 Instrumentarium Dental 65 10 Check the position of the midsagittal light If it is not on the midsagittal plane of the patient adjust the patient s head 11 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 oc
11. 170 mm minimum Image field width in PA view 7 9 inches 200 mm Resolution 4 LP mm cephalometric 3D image receptor Sensor unit 3D sensor Technology CMOS Image pixel size 200 x 200 m Photodiode area 100 x 68 2 mm Unit physical measures source image distance SID 500 mm Panoramic 570 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 lbs Panoramic 9 Technical data 203887 rev 5 Instrumentarium Dental 103 OP300 ceph physical measures source image distance SID 68 7 inches 1745 mm source object distance SOD 60 inches 1520 mm Installation Standard wall mount with 45 angled joint Optional base for free standing unit unit height is increased 25 mm Height x Width x Depth inches mm 2410 x 1931 x 1193 mm 94 9 x 76 x 47 inches Weight 240 kg 529 lbs Cephalometric Ambient temperatures Transportation and Storage 10 60 C Operation Temperature 10 35 C RH max 85 Minimum PC requirements for 3D acquisition workstation Processor 2 5 GHz dual core or better Memory 3 Gigabytes RAM or more Hard disk 500 GB or more Power supply 500 watt minimum Network Gigabit Ethernet 1000Base T Operating system Windows 7 or Windows Vi
12. Note Patient size adult third from the left is the default exposure setting 3 Imaging programs 22 Instrumentarium Dental 203887 rev 5 Orthogonal Magnification 1 3 An optimized view of the dentition only with 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 off s must be made The ascending rami may be lost and in adult patients and redundant shadows will be increased Y 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 Note Patient size adult third from the left is the default exposure setting 3 Imaging programs 203887 rev 5 Instrumentarium Dental 23 Wide arch Magnification 1 3 Used when the patient has a wider than normal dental arch Ortho Lateral TMJ Magnification 1 23 Ortho TMJ program provides a wide layer axially corrected views for the patient s left and right temporomandibular joints Exposure settings for Wide arch 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 Note Patient size adult third from the left is the default exposure setting a b Exposure settings for Ortho Lat
13. 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 1 Sensor holder units without 3D option 2 Panoramic sensor Fig 1 2 2 Unit description 203887 rev 5 Instrumentarium Dental 11 1 3D sensor units with 3D option 2 Panoramic sensor Fig 1 3 2 Unit description 12 Instrumentarium Dental 203887 rev 5 2 2 Patient positioning lights 1 Midsagittal light 2 Frankfort horizontal FH light 3 Image layer light 4 Cephalometric FH light 5 TMJ light 6 Horizontal light top of FOV 3D option only 7 Horizontal light bottom of FOV 3D option only Fig 1 4 2 Unit description 203887 rev 5 Instrumentarium Dental 13 Panoramic lights 1 Midsagittal light 2 FH light 1 Image layer light 2 TMJ light Fig 1 5 Fig 1 6 2 Unit description 14 Instrumentarium Dental 203887 rev 5 Cephalometric lights 1 FH light 3D lights 1 Midsagittal light 2 Horizontal light top of FOV 3 Horizontal light bottom of FOV Fig 1 7 Fig 1 8 2 Unit description 203887 rev 5 Instrumentarium Dental 15 2 3 Patient positioning panel 1 Carriage UP 2 Carriage DOWN 3 Positioning lights ON OFF 4 Patient positioning 5 Start positioning 6 Chin support UP 7 Chin support DOWN 8 Move the image
14. 1 3 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 MAR button is ON MAR button becomes visible on the 3D modality MAR button is OFF 3 Imaging programs 203887 rev 5 Instrumentarium Dental 31 3 1 4 Exposure settings for 3D imaging DAP values vary from unit to unit in relation to the x ray tube output Thus above values indicate average DAP values In addition to these recommended values there is a possibility to use the whole mA range if the user prefers Exposure settings for 3D imaging Note Voltage settings is always 90kV with the unit 3D modality Resolution FOV h x w Exposure time Scanning time Amount of projections mA Low dose DAP mGycm2 mA High quality DAP mGycm2 mA High quality DAP mGycm2 High Res 61 x 41 mm 6 1 s 10 s 608 6 3 mA 298 8 mA 379 13 mA 593 Std Res 61 x 41 mm 2 3 s 10 s 230 8 mA 145 10 mA 181 13 mA 227 High Res 61 x 78 mm 12 6 s 20 s 1260 5 mA 491 6 3 mA 619 10 mA 983 Std Res 61 x 78 mm 4 9 s 20 s 460 8 mA 302 10 mA 372 13 mA 472 Available mA ranges for each field of view sizes and resolution settings Resolution FOV
15. 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 9 Technical data 203887 rev 5 Instrumentarium Dental 101 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 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 CMOS Image pixel size 100 x 100 m Active area height 5 8 inches 148 mm 1480 pixels Resolution Pan 5 LP mm 9 Technical data 102 Instrumentarium Dental 203887 rev 5 Cephalometric image receptor Sensor unit interchangeable Ceph sensor Technology CMOS Image pixel size 100 x 100 m Active area height 223 2 mm 2232 pixels Image field width in lateral view 10 2 inches 260 mm maximum 6 7 inches
16. 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 WARNING Handle the sensor with care as instructed in this manual The sensor must not be dropped or exposed to impacts A shock indicator inside the sensor shows if the sensor has been exposed to excess impact 5 Using the unit 38 Instrumentarium Dental 203887 rev 5 5 1 1 Attaching the sensor 1 Insert the four slots on the rear of the sensor into the four hooks in the sensor holder 2 Slide the sensor downwards until it stops and then slide the locking knob down on the side of the sensor to lock the sensor in position 5 Using the unit 203887 rev 5 Instrumentarium Dental 39 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 5 Using the unit 40 Instrumentarium De
17. 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 1 8 Disposal The device its spare parts its replacement parts and its accessories may include parts that are made of or include materials that are non environmentally friendly or hazardous These parts must be disposed of in accordance with all local national and international regulations regarding the disposal of non environmentally friendly or hazardous materials Unit has at least the following parts that should be regarded as nonenvironmental friendly waste products Tubehead Pb oil Collimator Pb All electronic circuits electronic boards inside Sensor covers EMC painted 203887 rev 5 Instrumentarium Dental 9 2 Unit description 2 1 Main parts and controls 1 Column 2 Carriage 3 Main support 4 Rotating unit 5 On off switch rear of carriage and main fuses 6 Tubehead assembly 7 Touch screen display 8 Positioning panel 9 Sensor head 10 Head support 11 Chin rest 12 Handles 13 Cephalostat unit 14 Cephalostat sensor 15 Secondary collimator 16 Positioning panel Fig 1 1 Fig 1 1 On off switch and main fuses 2 Unit description 10 Instrumentarium Dental 203887 rev 5 PC with MDD approved dental imaging software and 3D
18. 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 The dissipative floor material must be connected to the system reference ground if applicable 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 to verify normal operation in the configuration in which it will be used Interference may occur in the vicinity of equipment marked with the following symbol No portable or mobile RF communications equipment may be used closer to any part of the ORTHOPANTOMOGRAPH OP300 including cables than the recommended separation distance calculated from the equation appropriate to the frequency of the transmitter See Table 4 9 Technical data 203887 rev 5 Instrumentarium Dental 117 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 4 Figure 1 5 0 5 10 15 20 25 30 35 0 2 4 6 8 10 HEAT STORAGE kJ TIME min 225W 175W
19. h x w 4 mA 5 mA 6 3 mA 8 mA 10 mA 13 mA Endo program 61 x 41 mm x x x x x x High Res 61 x 41 mm x x x x x x Std Res 61 x 41 mm x x x x High Res 61 x 78 mm x x x x x Std Res 61 x 78 mm x x x x Exposure settings for scout imaging default values Resolution FOV h x w kV mA Scanning time Scout 61 x 41 mm 90 13 0 02 s Scout 61 x 78 mm 90 13 0 04 s 3 Imaging programs 32 Instrumentarium Dental 203887 rev 5 203887 rev 5 Instrumentarium Dental 33 4 Touch screen display 4 1 Main control panel 1 Modality imaging program section 2 Status of the unit 3 Settings 4 End examination 5 Exposure settings 4 Touch screen display 34 Instrumentarium Dental 203887 rev 5 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 panoramic imaging Cephalometric programs have their own program specific model heads and setting buttons for the start position of lateral scanning 3D programs two FOV sizes have buttons for selecting low resolution high resolution or scout image mode The FOV for 3D imaging can be positioned on the XY plane by selecting the center point of the FOV on the dental arch of the touch screen display The FOV is positioned in the Z direction by using the chin rest movement and positioning lights 4 2 1 Exposure indicat
20. mA 230 VAC 66 kV 5 mA 66 kV 8 mA 66 kV 10 mA 70 kV 13 mA Note Patient size adult third from the left is the default exposure setting 3 Imaging programs 203887 rev 5 Instrumentarium Dental 27 3 1 1 Cephalometric programs Cephalometric pediatric lateral projection 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 Cephalometric lateral projection Lateral Cephalostat uses a full height image field 223 mm Exposure settings for cephalometric pediatric lateral program 100 VAC 81 kV 8 mA 10 s 85 kV 8 mA 12 s 90 kV 8 mA 16 s 90 kV 8 mA 20 s 230 VAC 85 kV 8 mA 10 s 90 kV 8 mA 12 s 90 kV 10 mA 16 s 90 kV 13 mA 20 s Note Patient size adult third from the left is the default exposure setting Exposure settings for cephalometric lateral program 100 VAC 81 kV 8 mA 10 s 85 kV 8 mA 12 s 90 kV 8 mA 16 s 90 kV 8 mA 20 s 230 VAC 85 kV 8 mA 10 s 90 kV 8 mA 12 s 90 kV 10 mA 16 s 90 kV 13 mA 20 s Note Patient size adult third from the left is the default exposure setting 3 Imaging programs 28 Instrumentarium Dental 203887 rev 5 Cephalo posterior anterior PA proje
21. manufacturer and d is the recommended separation distance in meters m Field strengths from fixed RF transmitters as determined by an electromagnetic site survey are less than the compliance level in each frequency range Interference may occur in the vicinity of equipment marked with the following symbol 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 OP300 to verify normal operation in each use location If abnormal performance is observed additional measures 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 P V d 5 3 1 P E d 5 3 1 P E d 7 1 9 Technical data 203887 rev 5 Instrumentarium Dental 115 Note RF communications equipment can effect medical electrical equip
22. not opti mum 2 Manual technique factors used too high 1 Adjust contrast and den sity 2 Decrease technique fac tors Problem Possible cause Remedy Lack of image contrast 1 CLINIVIEW Contrast and brightness not opti mum 2 kV used is too high 3 Gamma value is not cor rect for the monitor being used 1 Adjust contrast and brightness 2 Lower the kV setting 3 Adjust Gamma value 6 Troubleshooting 203887 rev 5 Instrumentarium Dental 75 6 3 Artefacts Problem Possible cause Remedy Irregular bright shadows or artefacts Patient is wearing metal ob jects such as earrings neck lace etc Ask patient to remove ob jects AJEWEL Problem Possible cause Remedy An unexposed area is shown down in the lower middle sec tion of the image Lead apron misplaced Check the lead apron po sitioning AAPRO Problem Possible cause Remedy Partial lack of detail and mo tion artefacts Irregular verti cal bright lines on image Patient has moved during the exposure Retake the image Problem Possible cause Remedy Vertical dark lines on image Patient s shoulder in touch with machine parts Check patient position ing Problem Possible cause Remedy Patient s right side tooth are not exposured Exposure button released prematurely Retake the image Problem Possible cause Remedy Right and left image sides are uncomplete TMJ s are not shown Orthogonal procedu
23. 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 If the patient is nervous or a child you can demonstrate how the unit works to reassure them Press the T Test mode button and then press and hold the exposure button The unit will complete an ex posure cycle without generating x rays 2 Press and hold down the exposure button During the exposure you hear an audible signal and the exposure warning symbol on the touch screen display appears The unit rotates around the patient s head and stops When the rotating unit stops the exposure has been taken 5 Using the unit 52 Instrumentarium Dental 203887 rev 5 3 After the exposure the rotating unit is in patient out po sition if the exposure switch has been pressed until all movements have stopped Release temple supports Guide the patient out Remove disposable covers and disinfect the unit 5 3 5 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 to
24. Dental 57 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 The shown laser line is a horizontal reference line 5 Tilt the nasion support down and slide it towards patient s nasion 5 Using the unit 58 Instrumentarium Dental 203887 rev 5 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 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 patient s ears Tall patients can also sit on a chair Figure 1 2 Unlock first the lever turn the ear rods and lock the lever again Figure 1 3 Locking lever 1 ear holder brake 2 Note Use a new disposable cover for every patient 5 Using the unit 203887 rev 5 Instrumentarium Dental 59 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 dis
25. ENGLISH Digital Panoramic X Ray System User Manual 203887 rev 5 ORTHOPANTOMOGRAPH OP300 ORTHOPANTOMOGRAPH OP300 Copyright Code 203887 rev 5 Date March 28 2013 Copyright 3 28 13 by Instrumentarium Dental PaloDEx Group Oy All rights reserved ORTHOPANTOMOGRAPH is a registered 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 Instrumentarium 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 Manufacturer Instrumentarium Dental PaloDEx Group Oy Nahkelantie 160 P O Box 20 FI 04300 Tuusula FINLAND Tel 358 10 270 2000 Fax 358 10 270 2230 For service contact your local distributor ORTHOPANTOMOGRAPH OP300 rev i Table of Contents 1 Introduction
26. HEATING COOLING Anode Thermal Characteristics 0 5 10 15 20 25 30 35 0 2 4 6 8 10 HEAT STORAGE kJ TIME min 225W 175W HEATING COOLING Anode Thermal Characteristics 5 10 15 20 25 1 10 TUBE CURRENT mA EXPOSURE TIME s 2 3 5 7 20 80kV 90kV 100kV 50kV 60kV 70kV Maximum Rating Charts Absolute maximum rating charts DC Center Grounded Focal Spot 0 5 mm 5 10 15 20 25 1 10 TUBE CURRENT mA EXPOSURE TIME s 2 3 5 7 20 80kV 90kV 100kV 50kV 60kV 70kV Maximum Rating Charts Absolute maximum rating charts DC Center Grounded Focal Spot 0 5 mm 9 Technical data 118 Instrumentarium Dental 203887 rev 5 Figure 1 6
27. arium Dental 79 7 Maintenance 7 1 Maintenance procedure The maintenance procedure described below shall be seen as a minimum requirement and can be made more stringent to comply with regulations regarding the use and maintenance of dental x ray devices that are in force in the country in which the unit is installed 7 1 1 Annual maintenance An annual maintenance procedure must be carried out at least once a year by qualified service personnel Contact your local distributor for details 7 1 2 Calibration intervals To keep the image quality at best possible level calibrations and quality checks shall be carried out at regular intervals according to the table below Note The calibrations mentioned in this manual can be done by the user or qualified service personnel Modality Minimum requirement Recommendation 3D Two 2 times annually Four 4 times annually Panoramic Annually during normal mainte nance Two 2 times annually Cephalometric Annually during normal mainte nance Two 2 times annually 7 Maintenance 80 Instrumentarium Dental 203887 rev 5 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 clo
28. arpus holder to the nasion support holder 2 Adjust the unit height if needed 3 Ask the patient to remove rings and metal objects and to place hand on the carpus holder 5 Using the unit 62 Instrumentarium Dental 203887 rev 5 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 2 Press and hold down the exposure button During the exposure you hear an audible signal and the exposure warning symbol on the touch screen display appears 3 Release the ear rods and guide the patient out Re move disposable covers and disinfect the unit 4 PC The image can be examined using the CLINI VIEW software See CLINIVIEW user manual 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 5 Using the unit 203887 rev 5 Instrumentarium Dental 63 5 5 3D exposures 5 5 1 Positioning devices 5 5 2 General instructions
29. ations Manufacturer Instrumentarium Dental Nahkelantie 160 P O Box 20 FIN 04300 Tuusula FINLAND Quality system In accordance with ISO13485 and ISO9001 standard Environmental management system In accordance with ISO14001 standard Conformity to standards IEC 60601 1 1988 and A1 A2 IEC 60601 1 1 2000 IEC 60601 1 4 1996 and A1 IEC 60601 2 7 1998 IEC 60601 2 28 1993 IEC 60601 2 32 1994 IEC 60601 1 2 2001 and A1 IEC 60601 1 3 1994 UL 60601 1 2003 CAN CSA C22 2 No 601 1 M90 and S1 A2 standards This product complies with DHHS 21 CFR Chapter I 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 name ORTHOPANTOMOGRAPH OP300 Model OP300 Product type Digital dental imaging system with panoramic cephalometric and Cone Beam 3D imaging programs 9 Technical data 96 Instrumentarium Dental 203887 rev 5 Unit data Protection against electric shock Class I Degree of protection Type B applied with no conductive connection to the pa tient Protection against the ingress of liq uids IP20 Disinfection methods mild soapy water non abrasive non alcohol based disinfectant for the chin rest disposable plastic covers for bite block chin rest and chin support For
30. between the two pins 5 Other pin is longer than the other 1 2 3 4 5 8 Calibration and adjustment 203887 rev 5 Instrumentarium Dental 89 8 4 3D calibration 8 4 1 3D geometry calibration 1 Attach the base of the phantom to the lower shelf Level it with the bubble 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 4 Install the 3D calibration phantom 5 Take an exposure 6 Repeat the calibration until calibration result passed is achieved This calibration is only needed with 3D units 8 Calibration and adjustment 90 Instrumentarium Dental 203887 rev 5 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 8 Calibration and adjustment 203887 rev 5 Instrumentarium Dental 91 8 4 3 3D Quality Check program 1 Attach the QC phantom to the unit 2 Select the 3D QC program 3 Press Patient Positioning 4 Take an exposure 5 The resulting image contains information on whether the quality check was passed 8 Calibration and adjustment 92 Instrumentarium Dental 203887 rev 5 8 5 Cephalometric calibration 8 5 1 Ceph pixel calibration Note The pixel calibration result
31. cannot be used for panoramic imaging without re calibration and vice ver sa Note Re do panoramic pixel calibration if cephalostat sensor is moved to panoramic side or the sensor is changed 1 Remove the double cone calibration tool 2 Select the program 3 Press Patient Positioning 4 Take an exposure 8 Calibration and adjustment 203887 rev 5 Instrumentarium Dental 87 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 2 Select the Pan QC program 3 Press Patient Positioning 4 Take an exposure 5 Visually evaluate the result using the installed imaging software 8 Calibration and adjustment 88 Instrumentarium Dental 203887 rev 5 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 Subjects to be evaluated 1 Smoothness of the exposed area Non exposed area surrounds the whole image 2 High contrast resolution minimum 3 1LP mm must be distinguishable 3 All four low contrast holes must be visible 4 Roundness of the ball The ball should be placed symmetrically
32. ced inside the carriage side cabinet USA Canada models have different types of laser light stickers according to lo cal requirements Caution use of controls or adjustments or performance of procedures other than those specified herein may re sult in hazardous radiation exposure IEC 60825 1 1993 A1 1997 A2 2001 9 Technical data 203887 rev 5 Instrumentarium Dental 99 X ray generator Nominal power 1750 W nominal at 90 kV 12 mA Tube voltage 57 90 kV 5 kV Tube current 3 2 16 mA 1 mA Supply frequency 75 150 kHz Spine compensation kV mA compensated Spine compensation mode Pre programmed User interface Program and technique factors selec tion exposure control Touch screen panel optional remote exposure switch Patient positioning Positioning panel integrated Connection cable OP300 PC CAT6 Ethernet cable Panoramic programs amp technique factors amp magnification Standard Adult Panoramic 57 90 kV 3 2 16 mA 16 4 s 30 Pediatric Panoramic 57 90 kV 3 2 16 mA 14 4 s 30 Ortho Zone 57 90 kV 3 2 16 mA 17 9 s 25 Orthogonal Panoramic 57 90 kV 3 2 16 mA 12 9 s 30 Wide Arch Panoramic 57 90 kV 3 2 16 mA 16 2 s 30 Ortho TMJ 57 90 kV 3 2 16 mA 10 6 s 23 PA TMJ View 57 90 kV 3 2 16 mA 10 6 s 55 Maxillary Sinus 57 90 kV 3 2 16 mA 12 5 s 30 Bitewing 57 90 kV 3 2 16 mA 11 9 s 30 Panoramic QC 57 90 kV 3 2 12 6 mA 16 4 s 30 Exp
33. ckwise with a screwdriver Use only appropriate fuses 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 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 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 7 Maintenance 203887 rev 5 Instrumentarium Dental 81 Positioning light covers The positioning light covers are made of clear plastic Use a soft cloth dampened with a mild detergent e g soapy water NEVER use abrasive cleaning agents or polishes to clean the covers Surfaces that the patient touches All surfaces and parts that the patient touches or comes into contact with must be decontaminated after each patient Use a disinfectant that is formulated specifically for decontaminating dental equipme
34. clusal plane is hori zontal 1 H light top of FOV 2 H light bottom of FOV 5 Using the unit 66 Instrumentarium Dental 203887 rev 5 12 Move the head support against the patient s forehead Adjust the height Close the temple supports 13 Select A the Scout image or B the Standard or high resolution 3D image 14 Move the FOV cursor on the area of interest For precise adjustment the arrow keys can be used Lock the position by pressing the lock key Use the same key for unlocking if the position needs to be changed A B 5 Using the unit 203887 rev 5 Instrumentarium Dental 67 5 5 3 Scout image 1 Press and hold down the exposure button During the exposure you hear an audible signal and the exposure warning symbol on the touch screen display appears 2 Scout preview image appears to the touch screen dis play 3 Fine adjust scout position using the side arrow keys Press the right upper corner icon to continue 4 Take a new scout or save current and continue to 3D image 5 Using the unit 68 Instrumentarium Dental 203887 rev 5 5 5 4 3D image 1 Select the Standard A high resolution B or endo program C Endo program is only for 61 x 41 mm FOV 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 estimatio
35. ction Carpus view Not available in USA and Canada Reverse towne projection Waters view Exposure settings for cephalometric PA program 100 VAC 81 kV 8 mA 10 s 85 kV 8 mA 12 s 90 kV 8 mA 16 s 90 kV 8 mA 20 s 230 VAC 85 kV 8 mA 10 s 90 kV 8 mA 12 s 90 kV 10 mA 16 s 90 kV 13 mA 20 s Note Patient size adult third from the left is the default exposure setting Exposure settings for Carpus view program 100 VAC 66 kV 3 2 mA 8 s 70 kV 3 2 mA 8 s 73 kV 3 2 mA 8 s 73 kV 6 3 mA 8 s 230 VAC 66 kV 3 2 mA 8 s 70 kV 3 2 mA 8 s 73 kV 3 2 mA 8 s 73 kV 6 3 mA 8 s Note Patient size adult third from the left is the default exposure setting 3 Imaging programs 203887 rev 5 Instrumentarium Dental 29 3 1 2 3D programs 61 x 41 mm FOV High resolution 133 m voxel size Standard resolution 200 m voxel size Endo FOV 61 x 41 mm height x diameter Program for optimized endodontic imaging Endo program 85 m voxel size 61 x 78 mm FOV Standard resolution or high resolution High resolution 200 m voxel size Standard resolution 300 m voxel size Exposure settings for 3D imaging default values Resolution FOV h x w kV mA Exposure time Endo program 61 x 41 mm 90 10 6 1 s High Res 61 x 41 mm 90 8 6 1 s Std Res 61 x 41 mm 90 10 2 3 s High Res 61 x 78 mm 90 6 3 13 s Std Res 61 x 78 mm 90 10 4 9 3 Imaging programs 30 Instrumentarium Dental 203887 rev 5 3
36. eck optional 91 8 4 3D calibration 92 8 4 1 3D geometry calibration 92 8 4 2 3D pixel calibration 93 8 4 3 3D Quality Check program 94 8 5 Cephalometric calibration 95 8 5 1 Ceph pixel calibration 95 8 5 2 Ceph Quality check program Optional 95 9 Technical data 97 9 1 Technical specifications 97 9 2 Unit dimensions 109 9 3 Symbols that appear in the unit 111 rev iii 9 4 Labels on the unit 113 9 5 Electro
37. emory integrated graphics are not supported Power supply 500 watt minimum Network Gigabit Ethernet 1000Base T Operating system Windows 7 or Windows Vista 32 or 64 bit Display 20 LCD display 1600 x 1200 or 22 LCD wide screen display 1680 x 1050 or better Standard The PC must meet the IEC 60950 standard minimum re quirements Mouse Mouse with scroll wheel OpenCL support OpenCL 1 1 supported by either processor or graphics adapter 9 Technical data 203887 rev 5 Instrumentarium Dental 105 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 The x ray unit must be connected to it s own sepa rate power supply The PC and any other external devices must NOT be connected to the same pow er supply as the x ray unit Position the PC and any other external device at least 1 5 m 60 from the xray unit so that the pa tient cannot touch the PC or any other external de vice while being x rayed The PC and any other external devices shall not be connected to an extensi
38. ents in user manual All service operations must be made by authorized service personnel only 1 Introduction 203887 rev 5 Instrumentarium Dental 7 The annual service as described in manual is mandatory for the correct and safe operation of the unit When taking exposures operators and service personnel must protect themselves from radiation and remain at least two meters six feet away from the unit during exposure Protect the patient from scattered radiation by placing a protective lead apron over the patient The unit must be installed and serviced according to the unit Installation amp adjustments manual by a qualified technician Only personnel trained and approved by the manufacturer of the unit are allowed to service the unit 3D should not be used for routine or screening examinations in which a radiograph is taken regardless of the presence or absence of clinical signs and symptoms 3D imaging examinations must be justified for each patient to demonstrate that the benefits outweigh the risks Where it is likely that evaluation of soft tissues will be required as part of the patient s radiological assessment the imaging should be done using conventional medical CT or MR rather than 3D imaging using Cone Beam technology Make sure that patient s thyroid glands are protected by a lead apron during the exposure The place where the unit is to be installed and the position from where the user will take exp
39. er manual supplied with the 3D imaging software The installation manual supplied with the 3D imaging software 1 5 Abbreviations used in this manual FOV Field Of View The cylindrical 3D volume that is reconstructed by the system ROI Region Of Interest The anatomical area or region of the patient that you are interested to examine FH Frankfort Horizontal H Horizontal 1 Introduction 4 Instrumentarium Dental 203887 rev 5 1 6 Warnings and precautions 1 6 1 Warnings to be observed during use The unit may be dangerous to the user and the patient if the safety regulations in this manual are ignored if the unit is not used in the way described in this manual and or if the user does not know how to use the unit The unit must only be used to take the dental x ray exposures described in this manual The unit must NOT be used to take any other x ray exposures It is not safe to use the unit to take x ray exposures that it is not designed for Only professionally qualified dental and or medical personnel are allowed to operate the unit and carry out any diagnoses based on output from the unit Because the x ray limitations and safety regulations change from time to time it is the responsibility of the user to make sure that all the valid safety regulations are fulfilled When taking an x ray exposure of a patient with exceptional anatomy typically very tall or large use the Test mode no x rays firs
40. eral TMJ program 100 VAC 73 kV 6 3 mA 73 kV 10 mA 73 kV 13 mA 73 kV 16 mA 230 VAC 73 kV 6 3 mA 73 kV 10 mA 73 kV 13 mA 73 kV 16 mA Note Patient size adult third from the left is the default exposure setting 3 Imaging programs 24 Instrumentarium Dental 203887 rev 5 PA TMJ Magnification 1 55 Exposure settings for PA TMJ program 100 VAC 73 kV 6 3 mA 73 kV 10 mA 73 kV 13 mA 73 kV 16 mA 230 VAC 73 kV 6 3 mA 73 kV 10 mA 73 kV 13 mA 73 kV 16 mA Note Patient size adult third from the left is the default exposure setting 3 Imaging programs 203887 rev 5 Instrumentarium Dental 25 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 66 kV 10 mA 66 kV 13 mA 73 kV 13 mA 230 VAC 66 kV 6 3 mA 66 kV 10 mA 66 kV 13 mA 73 kV 13 mA Note Patient size adult third from the left is the default exposure setting 3 Imaging programs 26 Instrumentarium Dental 203887 rev 5 Bitewing Magnification 1 3 An orthogonal view of the dentition from the canine and posterior Exposure settings for Bitewing program 100 VAC 66 kV 5 mA 66 kV 8 mA 66 kV 10 mA 70 kV 13
41. es RF energy only for its internal function Therefore the RF emission is very low and not likely to cause any interference in nearby electronic equipment Radio Frequency Emissions CISPR11 Class B ORTHOPANTOMOGRAPH OP300 is suitable for use in all establishments including domestic establishments and those directly connected to the public low voltage power supply network that supplies buildings used for domestic purposes Harmonic emis sions IEC 61000 3 2 IEC 61000 3 2 Class A ORTHOPANTOMOGRAPH OP300 is suitable for use in all establishments including domestic establishments and those directly connected to the public low voltage power supply network that supplies buildings used for domestic purposes Voltage fluctua tions flicker emissions IEC 61000 3 3 Complies ORTHOPANTOMOGRAPH OP300 is suitable for use in all establishments including domestic establishments and those directly connected to the public low voltage power supply network that supplies buildings used for domestic purposes 9 Technical data 203887 rev 5 Instrumentarium Dental 113 Table 1 2 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 Test Level Compliance Level Electromagnetic Env
42. f main 0 2 Table 1 100 VAC mA 16 13 x x x 10 x x x x x x x 8 x x x x x x x x x x 6 x x x x x x x x x x 4 x x x x x x x x x x 57 60 63 66 70 73 77 81 85 90 kV Table 2 120 VAC mA 16 x x x 13 x x x x x x x x 10 x x x x x x x x x x 8 x x x x x x x x x x 6 x x x x x x x x x x 4 x x x x x x x x x x 57 60 63 66 70 73 77 81 85 90 kV 9 Technical data 98 Instrumentarium Dental 203887 rev 5 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 3 240 VAC mA 16 x x x x x x x 13 x x x x x x x x x x 10 x x x x x x x x x x 8 x x x x x x x x x x 6 x x x x x x x x x x 4 x x x x x x x x x x 57 60 63 66 70 73 77 81 85 90 kV Table 4 100 VAC 90 kV 120 VAC 90 kV 240 VAC 90 kV mA 13 x x x 10 x x x x 8 x x x x 6 x x x x 4 x x 6 x 4 std res 6 x 4 high res 6 x 8 std res 6 x 8 high res Positioning laser lights Panoramic TMJ amp Maxillary Sinus Programs Cephalostat FH laser light 3D imaging programs laser light CLASS 1 LASER PRODUCT max output 100 W Warning symbols are placed next to the laser lights and the label describing the laser light classification is pla
43. he 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 8 Calibration and adjustment 84 Instrumentarium Dental 203887 rev 5 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 and identifiable name for exam ple calibration refer to the user s manual supplied with the dental imaging software for more 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 8 Calibration and adjustment 203887 rev 5 Instrumentarium Dental 85 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 8 Calibration and adjustment 86 Instrumentarium Dental 203887 rev 5 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
44. ight not obeyed 3 Bite block was not used 1 Check patient positioning with laser light lines and occlusion correction buttons 2 Check patient positioning with laser light lines and occlusion correction buttons 3 Insert bite block ABACK 6 Troubleshooting 72 Instrumentarium Dental 203887 rev 5 Problem Possible cause Remedy Teeth appear wider on one side and narrower on the opposite Ramus widths are different on opposite sides 1 Midsagittal line not obeyed 2 Patient s head not in center position 1 Check patient s mid sag ittal plane with laser light line 2 Check that patient s head is centered and that the head support side clamps where closed to keep the head straight Problem Possible cause Remedy The shadow of hard palate is exposed over maxillary mo lars Row of teeth has a wavy appearance TM joints are exposed outward Image is not smiling Mandible is imaged sharper than maxil la Patient head tilted back Check FH plane AUP Problem Possible cause Remedy 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 Patient head tilted forward Check FH plane 6 Troubleshooting 203887 rev 5 Instrumentarium Dental 73 Problem Possible cause Remedy Middle area of the image too bright and unsharp Spine shadow Patient s neck was not stretched Stretch pa
45. ion Flash sterilization Temperature 270 F 132 C Exposure time 3 minutes Steam flush pressure pulse steam sterilization Temperature 270 F to 275 F 132 C to 135 C Exposure time 3 to 4 minutes 203887 rev 5 Instrumentarium Dental 83 8 Calibration and adjustment 8 1 Introduction Calibrations and quality checks are performed by taking exposures of calibration tools The system does needed adjustments according to the image data captured For panoramic and cephalometric quality checks the quality is visually evaluated by the operator Resulting from the each calibration is an image containing calibration results telling the operator how to proceed with the calibration and adjustment procedure In addition to the calibration name e g Adjustment panCol the images contain image data sampled during the calibration adjustment instructions and a Passed Not Passed Failed calibration status Passed means that the calibration program is suc cessfully done Move on to next calibration Not passed means that adjustment is still needed Follow the instructions the image if any and take another exposure Some calibration programs are iterative and demand a few repetitions Failed means that the system could not decide what adjustment should be done in order for the calibration to succeed This calibration status is al ways the result of some error condition Taking an other exposure will not help T
46. ironment Electrostatic dis charge ESD IEC 61000 4 2 2 4 6 kV for contact discharge 2 4 8 kV for air discharge 2 4 6 kV for contact discharge 2 4 8 kV for air discharge Floors are wood concrete or ce ramic tile or floors are covered with synthetic material and the relative humidity is at least 30 percent Electrical fast transient burst IEC 61000 4 4 2 kV for power supply lines 1 kV for input output lines 2 kV for power supply lines 1 kV for input output lines Mains power quality is that of a typi cal commercial and or hospital envi ronment Surge IEC 61000 4 5 1 kV differential mode 2 kV common mode 1 kV differential mode 2 kV common mode Mains power quality is that of a typi cal commercial and or hospital envi ronment Voltage dips short interrup tions and volt age variations on power supply input lines IEC 61000 4 11 lt 5 UT gt 95 dip in UT for 0 5 cycle 40 UT 60 dip in UT for 5 cycles 70 UT 30 dip in UT for 25 cycles lt 5 UT gt 95 dip in UT lt 5 UT gt 95 dip in UT for 0 5 cycle 40 UT 60 dip in UT for 5 cycles 70 UT 30 dip in UT for 25 cycles lt 5 UT gt 95 dip in UT 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 i
47. itch the unit off wait a few seconds and switch the unit on again 5 6 2 Image transfer errors If an image is not transferred successfully to the PC close and then reopen the dental imaging software and or restart the PC DO NOT restart the unit as this will erase any image that is stored in the unit memory and this retrievable image will be lost If restarting the PC and or restarting the dental imaging software does not allow you to retrieve the images contact technical support without restarting the unit 203887 rev 5 Instrumentarium Dental 71 6 Troubleshooting High quality images with sharp contrast and good detail provide optimum diagnostic information Images with less quality are usually the result of one or more common problems 6 1 Patient positioning Problem Possible cause Remedy Incisors and canines narrow and unsharp Overshadow in molar and premolar areas Rows of teeth are compressed 1 Occlusal correction of fo cal trough set too far pos terior 2 Image layer laser light not obeyed 3 Bite block was not used 1 Check patient positioning with laser light lines and occlusion correction buttons 2 Check patient positioning with laser light lines and occlusion correction buttons 3 Insert bite block AUP Problem Possible cause Remedy Incisors and canines wide and unsharp Rows of teeth widened 1 Occlusal correction of fo cal trough set too far ante rior 2 Image layer laser l
48. 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 Fig 1 9 2 Unit description 16 Instrumentarium Dental 203887 rev 5 2 3 1 Cephalometric unit 1 Carriage UP 2 Carriage DOWN 3 Carriage UP 4 Carriage DOWN 5 Positioning lights ON OFF 2 Unit description 203887 rev 5 Instrumentarium Dental 17 2 4 Emergency stop switch In case of malfunction of the exposure button or other protective devices of the unit an emergency stop switch is provided near the handles and on the roof of the cephalostat head so that the patient can reach it If the emergency stop switch is pressed during an exposure the exposure is terminated immediately and the x ray unit is completely stopped An interrupted exposure cannot be continued later but has to be retaken from the beginning Press to stop the unit rotate to release Fig 1 10 Fig 1 11 2 Unit description 18 Instrumentarium Dental 203887 rev 5 203887 rev 5 Instrumentarium Dental 19 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 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 Note Patient size adult third from the left is the default exposure setting 3 Imaging programs 20 Inst
49. magnetic Compatibility EMC tables 113 9 6 X ray tube assemblies 119 iv rev 203887 rev 5 Instrumentarium Dental 1 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 Standard panoramic Pediatric panoramic Wide arch panoramic Bitewing TMJ PA projection Ortho TMJ axial corrected lateral projection Maxillary sinus Ortho Zone enhanced panoramic Orthogonal panoramic Cephalometric optional Cephalometric lateral projection Cephalometric pediatric lateral projection Cephalometric postero anterior PA projection Reverse Towne projection Waters view Carpus program optional Not available in USA and Canada 3D optional 61x41 mm Field of View 61x78 mm Field of View Endo 61 x 41 mm Field of View 1 Introduction 2 Instrumentarium Dental 203887 rev 5
50. ment 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 4 Table 4 USE LIMITATION External components The use of accessories transducers and cables other than those specified may result in degraded ELECTROMAGNETIC COMPATIBILITY of the EQUIPMENT and or SYSTEM Recommended Separation Distances for Portable and Mobile RF Communications Equipment IEC 60601 1 2 Frequency of Transmitter Equation Rated Maximum Output Power of Transmitter watts 150KHz to 80 MHz Separation Distance meters 80 MHz to 800 MHz Separation Distance meters 800 MHz to 2 5 GHz Separation Distance meters 0 01 0 12 0 12 0 23 0 1 0 37 0 37 0 74 1 1 17 1 17 2 34 10 3 69 3 69 7 38 100 11 67 11 67 23 34 P V d 5 3 1 P E d 5 3 1 P E d 7 1 9 Technical data 116 Instrumentarium Dental 203887 rev 5 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
51. mic exposure 45 5 3 3 2 TMJ exposure 48 5 3 3 3 Maxillary Sinus exposure 51 5 3 4 Taking the exposure 52 5 3 5 Multilayer Selection 55 ii rev 5 4 Cephalometric exposures 56 5 4 1 General instructions 57 5 4 2 Patient positioning 59 5 4 2 1 Pediatric lateral and Lateral projection 59 5 4 2 2 PA projection 60 5 4 2 3 Reverse towne projection 61 5 4 2 4 Waters view 62 5 4 2 5 Carpus view Not available in USA and Canada 63 5 4 2 6 Taking the exposure 63 5 5 3D exposures
52. n of the need See chapter 3 4 1 Instructions for using MAR A B C 1 2 5 Using the unit 203887 rev 5 Instrumentarium Dental 69 5 5 4 1 Stone model and radiographic guide scan For scanning of stone models and radiographic guides a positioning plate is available for the system 1 Scan the patient with an open bite by securing the bite with cotton pads 2 Install positioning plate Position stone model 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 5 Using the unit 70 Instrumentarium Dental 203887 rev 5 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 sw
53. not open or remove any of the unit s enclosures No user serviceable parts inside The customer must ensure that the siting environment fulfills the requirements listed in the Installation manual Special attention must be paid to the strength of the floor and wall materials electrical mains and radiation protection It is the responsibility of the customer to ensure that the site is large enough for the patients The unit contains toxic materials that need to be handled properly when disposing the unit Return the unit to the dealer in the end of its life cycle Excessive dust should be cleaned from the unit for free airflow and cooling Switch of the unit before cleaning Always follow the instructions for patient positioning and imaging procedures instructed in the User Manual 1 6 2 Warnings for cross infection 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 Introduction 6 Instrumentarium Dental 203887 rev 5 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 no
54. nt 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 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 Isopropyl alcohol distilled water Not allowed Bentzene Chlorine bentzene Acetone Acetic ether agents containing phenol paracetic acid peroxide and other oxygen cleaving agents sodium hypochlorite and iodine cleaving agents Autoclave Some removable parts in contact with the patient may be autoclaved These parts are bite rods bite guides and chin supports 7 Maintenance 82 Instrumentarium Dental 203887 rev 5 If autoclaving is performed for these items disinfection by alternate methods is not needed Steam sterilization Recommended parameters for sterilizable parts are Gravity displacement steam sterilization Flash sterilization Temperature 270 F 132 C Exposure time 3 minutes Prevacuum steam sterilizat
55. ntal 203887 rev 5 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 the bite block Bite fork with the edentulous bite positioner Chin support for edentulous patients Sinus rest Chin rest TMJ nose support 5 Using the unit 203887 rev 5 Instrumentarium Dental 41 5 3 2 General instructions 1 PC Click Image Capture 2 Select PAN tab 3 Select the imaging program 4 Any section of the tooth arch can be selected for the par tial panoramic imaging to reduce the radiation 5 Select the Manual mode Set the kV and mA or select the patient size child juvenile adult large adult 5 Using the unit 42 Instrumentarium Dental 203887 rev 5 6 Press the patient positioning button to rotate the unit to patient in position 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 5 Using the unit 203887 rev 5 Instrumentarium Dental 43 5 3 3 Patient positioning 5 3 3 1 Panoramic exposure 1 Insert the sinus rest chin rest and bite fork with the bite block Place the disposable covers Note Use a new disposable cover for every patient 2
56. nterruptions it is recommended that ORTHOPAN TOMOGRAPH OP300 be powered from an uninterruptible power supply or a battery Power frequen cy 50 60 Hz magnetic field IEC 61000 4 8 3 A m 3 A m Power frequency magnetic fields are at levels characteristic of a typical lo cation in a typical commercial and or hospital environment NOTE UT is the a c mains voltage prior to application of the test level 9 Technical data 114 Instrumentarium Dental 203887 rev 5 Table 1 3 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 OP300 should assure that it is used in an electromagnetic environment as described below Immunity Test IEC 60601 1 2 Test Level Compliance Level Electromagnetic Environment Conducted RF IEC 61000 4 6 Radiated RFIEC 61000 4 3 3 V150 kHz to80 MHz 3 V m80 MHz to2 5 GHz V1 3 V E1 3 V m 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 80 MHz to 800 MHz 800 MHz to 2 5 GHz Where P is the maximum output power rating of the transmitter in watts W according to the transmitter
57. on cable Multiple extension cables shall not be used Do not position the PC where it could be splashed with liquids Clean the PC in accordance with the manufactur er s instructions Minimum PC requirements for 2D 3D Viewing workstation Processor 2 0 GHz dual core or better Memory 2 Gigabytes RAM or more Graphics board NVIDIA GeForce 6600 or ATI Radeon X700 or better 256MB or more memory integrated graphics are not supported Hard disk 3 GB free space or more Network Gigabit Ethernet 1000Base T recommended or Fast Ethernet 100Base TX Operating system Windows 7 or Windows Vista 32 or 64 bit Display 19 LCD display 1280 x 1024 or better 9 Technical data 106 Instrumentarium Dental 203887 rev 5 Ceph ready option Ordered separately Options Description Interchangeable Ceph sensor with OP300 pan unit Unit has the same sensor as ceph unit Cost saving with future digital ceph upgrade Field upgrades for model OP300 Upgrade Description Digital Cephalostat Kit Add digital ceph imaging to OP300 digital pan 3D Upgrade Kit Add 3D option to OP300 9 Technical data 203887 rev 5 Instrumentarium Dental 107 9 2 Unit dimensions 9 Technical data 108 Instrumentarium Dental 203887 rev 5 9 Technical data 203887 rev 5 Instrumentarium Dental 109 9 3 Symbols that appear in the unit Radiation warning Dangerous voltage On or enabled Off or disabled
58. ors and settings Manual dose rate control Test mode Exposure Indicator kV value mA value Exposure time Dose value Patient size settings Child juvenile small adult large adult 4 Touch screen display 203887 rev 5 Instrumentarium Dental 35 4 3 Status section Status field shows when the unit is ready for capturing or any trouble occurs Green yellow and blue color indicate the status in question 4 4 Other sections General settings Retrieve Last Image Use this to retrieve the last image from the device memory e g after a system crash Ready for imaging 4 Touch screen display 36 Instrumentarium Dental 203887 rev 5 Retrieve With MAR After taking a 3D image with MAR either on or off image can be re reconstructed with different set ting 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 Languages Use this to select language on the touchscreen Service Use this to reach the programs for periodical maintenance 203887 rev 5 Instrumentarium Dental 37 5 Using the unit 5 1 Attaching
59. osure Control 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 Lateral view 85 90 kV 8 12 6 mA 10 20 s 9 Technical data 100 Instrumentarium Dental 203887 rev 5 PA AP facial and oblique views 85 90 kV 8 12 6 mA 10 20 s Carpus View Not available in USA and Canada 60 90 kV 3 2 12 6 mA 8 20 s Exposure Control Automatic Facial Contour AFC Pre programmed icons for all programs Magnification factor 1 15 15 Cephalometric programs amp technique factors 3D imaging programs Small FOV dimensions 61 x 41 mm HxD Large FOV dimensions 61 x 78 mm HxD Small FOV standard resolution 90 kV 6 3 12 5 mA 2 3 s Large FOV standard resolution 90 kV 6 3 12 5 mA 4 9 s Small FOV high resolution 90 kV 4 12 5 mA 6 1 s Large FOV high resolution 90 kV 4 10 mA 12 6 s Small FOV scout 90 kV 4 12 5 mA 0 02 s Large FOV scout 90 kV 4 12 5 mA 0 04 s Image storing and retrieving File formats PNG 16 bit JPG 12 bit File compression PNG lossless JPG 100 60 quality Typical panoramic file size About 2 4 MB PNG 16 bits Typical cephalometric file size 3 5 MB PNG 16 bits Typical 3D file size 150 250 MB DICOM Patient database Standalone workstation Server on local area network LAN Panoramic patient positioning
60. osures 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 1 Introduction 8 Instrumentarium Dental 203887 rev 5 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 equipment may lead to a reduced level of safety of the resulting system Correct sharp layer should be chosen when using multilayer PAN images See user manual chapter Multilayer PAN images for correct procedure 1 7 Disclaimer The manufacturer shall have no liability for consequential damages personal injury loss damage or
61. posable covers Note Use a new disposable cover for every patient 2 Adjust the unit height 3 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 ventral as reference to the canthomeatal line about 30 below the horizontal plane 5 Slide the ear rods towards patient s ears 6 Ask the patient open mouth maximally 5 Using the unit 60 Instrumentarium Dental 203887 rev 5 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 3 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 Ask the patient open or close mouth 5 Using the unit 203887 rev 5 Instrumentarium Dental 61 5 4 2 5 Carpus view Not available in USA and Canada CAUTION Before taking Carpus image make sure this imaging method is approved by local authorities of your country 1 Unlock the lever and turn the ear rods to the PA projec tion position Lock the position Tilt the nasion support aside Place the c
62. re was mistakenly used Select correct panoramic procedure 6 Troubleshooting 76 Instrumentarium Dental 203887 rev 5 Problem Possible cause Remedy A light horizontal line on QA image Bite block was left on place Remove the bite block and retake QA image Problem Possible cause Remedy Horizontal lines on image Sensor problem Consult the dealer Problem Possible cause Remedy CEPH Lateral view has 2 ear holder pins 1 Cephalostat lock not locked 2 Ear holders misaligned 1 Lock it 2 Call service 6 Troubleshooting 203887 rev 5 Instrumentarium Dental 77 6 4 Unit operation Problem Possible cause Remedy Back of the patient s head is touching the x ray tube during the exposure 1 Patient s head inclination not correct 2 Patient is too big for the unit 3 Patient has slumped 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 Problem Possible cause Remedy Patient s shoulders are touching the x ray tube or sensor Patient is too big for the unit Wide and high shoulders Reverse patient s hands on handles left to right side handle and vice versa 6 Troubleshooting 78 Instrumentarium Dental 203887 rev 5 203887 rev 5 Instrument
63. rium Dental 203887 rev 5 5 3 3 2 TMJ exposure 1 Insert the required positioning devices including the TMJ nose support Place the disposable covers Note Use a new disposable cover for every patient 2 Adjust the unit height 3 Guide the patient to the unit and instruct to stand as straight and tall as possible Ask the patient to take grip on the handles and set the nose against the TMJ nose support Nose support 5 Using the unit 203887 rev 5 Instrumentarium Dental 47 4 Adjust the height of the Frankfort Horizontal plane FH laser to get the laser light over the orbita porion Straighten the patient s head if needed 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 5 Using the unit 48 Instrumentarium Dental 203887 rev 5 7 Adjust the position of the TMJ light until it aligns in the middle of condyle Note The condyle moves forward by approximately 10 mm when the mouth is opened TMJ light adjustment buttons A Forward towards the mirror B Reset C Backward away from the mirror 5 Using the unit 203887 rev 5 Instrumentarium Dental 49 5 3 3 3 Maxillary Sinus exposure 1 Insert the required positioning devices bite fork with the bite block on the sinus rest Place the disposable covers
64. rojection 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 5 Using the unit 203887 rev 5 Instrumentarium Dental 55 4 Select the imaging program 5 Select the Manual mode Default Set the kV and mA or select the patient size child juvenile adult large adult 6 Press the patient positioning button to drive the unit to patient in position 7 Ask the patient to remove any spectacles hearing aids removable dentures jewellery and hair clips and pins Place a protective lead apron on the patient 5 Using the unit 56 Instrumentarium Dental 203887 rev 5 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 Unlock first the lever turn the ear rods and lock the lever again Figure 1 1 Locking lever 1 ear holder brake 2 Note Use a new disposable cover for every patient 2 Adjust the unit height 5 Using the unit 203887 rev 5 Instrumentarium
65. rumentarium Dental 203887 rev 5 Pediatric Magnification 1 3 Pediatric patients can be imaged with less radiation dosage and shorter exposure time Patients with jaw more narrow than average jaw can be exposed with this procedure too Exposure settings for pediatric program 100 VAC 66 kV 4 mA 66 kV 6 3 mA 66 kV 8 mA 70 kV 10 mA 230 VAC 66 kV 4 mA 66 kV 6 3 mA 66 kV 8 mA 70 kV 10 mA Note Patient size adult third from the left is the default exposure setting 3 Imaging programs 203887 rev 5 Instrumentarium Dental 21 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 III malocclusion and uncooperative patients Exposure settings for Ortho Zone 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
66. s are sensor specific If the x ray unit is equipped with separate panoramic and cepha lometric sensors the cephalometric sensor cannot be used for panoramic imaging without re calibration and vice ver sa Note Re do panoramic pixel calibration if cephalostat sensor is moved to panoramic side or the sensor is changed 1 Rotate the ear holders into PA view position and move them completely apart Turn nasion support up out of the way 2 Select Ceph Pix program 3 Press Patient Positioning 4 Take an exposure 5 This calibration should always be a pass 8 Calibration and adjustment 203887 rev 5 Instrumentarium Dental 93 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 2 Select the Ceph QC program 3 Press Patient Positioning 4 Take an exposure 5 Visually evaluate the result using the installed imaging software 8 Calibration and adjustment 94 Instrumentarium Dental 203887 rev 5 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 1 2 3 203887 rev 5 Instrumentarium Dental 95 9 Technical data 9 1 Technical specific
67. served 3174420 ETL CLASSIFIED CONFORMS TO UL STD 60601 1 CERTIFIED TO CSA STD C22 2 NO 601 1 Manufactured by Instrumentarium Dental Nahkelantie 160 FI 04300 TUUSULA Finland D502470 13 Type OP300 1 Ser No Manufactured 10 A 220 240 V 50 60 Hz 1A continuous 15 A 100 120 V 50 60 Hz 1A continuous This product complies with DHHS 21 CFR Chapter I Subchapter J at the date of manufacture Rx only Warning This X ray unit may be dangerous to patient and operator unless safe exposure factors operating instructions and maintenance schedules are observed 3174420 ETL CLASSIFIED CONFORMS TO UL STD 60601 1 CERTIFIED TO CSA STD C22 2 NO 601 1 Manufactured by Instrumentarium Dental Nahkelantie 160 FI 04300 TUUSULA Finland D502470 13 9 Technical data 112 Instrumentarium Dental 203887 rev 5 9 5 Electromagnetic Compatibility EMC tables Note Medical electrical equipment needs special precau tions regarding EMC and needs to be installed according to EMC information Table 1 1 Electromagnetic emissions IEC 60601 1 2 Ed2 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 Emissions Test Compliance Electromagnetic Environment Radio Frequency Emissions CISPR11 Group 1 ORTHOPANTOMOGRAPH OP300 us
68. sta 32 or 64 bit 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 560 The compatible graphics driver versions are found on the driver update DVD PCI board connection Full length PCIe x16 slot for GPU board 9 Technical data 104 Instrumentarium Dental 203887 rev 5 These requirements are valid only if driver update 11 4 or later is used For earlier versions see table Minimum PC requirements for 3D acquisition workstation Note This is an abbreviated list of requirements Please refer to the software installation manual or contact your local dealer for detailed installation requirements USB USB ports for HASP Dongle keys 1 for reconstruction system 1 for 3D viewing SW if needed Mouse Mouse with scroll wheel Minimum PC requirements for 3D acquisition workstation Minimum PC requirements for 2D acquisition workstation Processor 2 5 GHz dual core or better Memory 3 Gigabytes RAM or more Hard disk 500 GB or more Graphics board NVidia GeForce 6600 or ATI Radeon X700 or better 256MB or more m
69. t be used in close proximity of the unit as they could influence the performance of the unit The correct software and settings in the workstation are essential to the performance of the unit Consult technical support to ensure correct setup Danger Explosion hazard do not use in the presence of flammable anesthetics gases or vapors The unit is factory set to operate using a 230 240 10 VAC power supply Never connect the unit to a power supply different to the voltage marked on the unit The site must fulfill the environmental requirements in the installation manual chapter technical specifications There should be free space around the unit for safe operation To maintain patient safety it is mandatory to use an unshielded CAT6 Ethernet cable between the unit and the network or workstation so that multiple chassis are not connected Non 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 Requirem
70. t to make sure that patient can be positioned correctly to the unit and for checking that the unit doesn t hit the patient Operator should maintain visible contact with the patient and technique factors This allows immediate termination of radiation by the release of the exposure button in the event of a malfunction or disturbance It is the responsibility of the doctor to decide whether x ray exposure or any additional exposures are justified and necessary The minimum height of patient that can be x rayed is 120 cm 3 9ft 47 2in and the maximum is 200 cm 6ft 78in These heights only apply to patients with normal anatomy Always use the lowest suitable x ray dose to obtain the desired level of image quality Avoid taking x ray exposures of pregnant women When taking an x ray exposure of a child 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 1 Introduction 203887 rev 5 Instrumentarium Dental 5 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
71. tient s neck ANECK Problem Possible cause Remedy Black shadow over maxillary teeth apex area Tongue was not against the roof of palate Ask patient to swallow and place tongue against the roof of palate during the exposure Problem Possible cause Remedy TMJ s exposed on different heights on image Bilateral distortion in molar and pre molar regions 1 Patient tilted to one side 2 Midsagittal laser light line not obeyed 1 Check midsagittal plane and center pa tient s head 2 Check midsagittal plane and center pa tient s head Problem Possible cause Remedy Rows of teeth exposed too high TMJ s cut off 1 Chin was not resting on chin support 2 Patient positioned too high 1 Check patient posi tioning and type of bite fork rod 2 Check patient posi tioning and type of bite fork rod Problem Possible cause Remedy Rows of teeth exposed too low Mandible not exposed completely to the image Chin rest was not used with bite fork Install chin rest 6 Troubleshooting 74 Instrumentarium Dental 203887 rev 5 6 2 Image appearance Problem Possible cause Remedy Images are too light 1 CLINIVIEW Contrast and brightness not opti mum 2 CLINIVIEW Gamma not set correctly 1 Adjust contrast and brightness 2 Select a more fitting his togram type and check gamma setting Problem Possible cause Remedy Images are too dark 1 CLINIVIEW Contrast and brightness
72. uch 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 this 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 5 Using the unit 203887 rev 5 Instrumentarium Dental 53 1 Preview selection 2 Save button 1 2 5 Using the unit 54 Instrumentarium Dental 203887 rev 5 5 4 Cephalometric exposures Pediatric lateral p
73. use In environments where no flammable anaesthics nor flammable cleaning agents are present Mode of operation continuous operation intermittent loading Safety IEC 60601 1 EMC Classification Class B 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 tube current 16 mA Max electric output 1 44 kW Target angle 5 degrees Focal spot 0 5 x 0 5 mm IEC 336 1982 Nominal anode input 1750 W Reference axis In the middle of the panoramic sensor s active area Max anode heat content 35 kJ Max X ray tube assembly heat con tent 385 kJ Max continuous heat dissipation of the X ray tube assembly 38 W Total filtration gt 3 2 mm Al Leakage Technique Factors 90 kV 4 mA 9 Technical data 203887 rev 5 Instrumentarium Dental 97 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 Electrical connections Nominal mains voltage 100 240 Vac Selectable Input power frequency 50 60 Hz Nominal current 10A 230 VAC 15A 110 VAC Fuses 230 Vac Littelfuse 326 slow blow 10A Cooper Bussman time delay MDA 10 110 Vac Littelfuse 326 slow blow 15A Cooper Bussman time delay MDA 15 Power consumption 2 3 kVA 230 VAC 1 65 kVA 110 VAC Maximum impedance o

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