Instrumentarium Dental OP-300 User Manual

ENGLISH

ORTHOPANTOMOGRAPH® OP300

3D Dental X-Ray System
User Manual
210457 rev. 7
ORTHOPANTOMOGRAPH® OP300
Copyright Code: 210457 rev 7 Date: July 7, 2014
Copyright © 7/7/14 by Instrumentarium Dental, PaloDEx Group Oy. All rights reserved.
ORTHOPANTOMOGRAPH®/ 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.
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
Table of Contents
1 Introduction..................................................................................................................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 .................................................................................... 3
1.6.1 Warnings to be observed during use .........................................................3
1.6.2 Warnings for cross infection....................................................................... 5
1.6.3 General warnings .......................................................................................5
1.7 Disclaimer ............................................................................................................. 8
1.8 Disposal ................................................................................................................ 8
2 Unit description ........................................................................................................... 9
2.1 Main parts and controls......................................................................................... 9
2.2 Patient positioning lights ..................................................................................... 11
2.3 Patient positioning panel .....................................................................................14
2.3.1 Cephalometric unit (optional) ................................................................... 14
2.4 Emergency stop switch ....................................................................................... 15
3 Imaging programs .....................................................................................................17
3.1 Panoramic programs........................................................................................... 17
3.2 Cephalometric programs..................................................................................... 23
3.3 3D SFOV programs............................................................................................. 25
3.4 3D MFOV (Maxio) programs ............................................................................... 26
3.5 Selecting resolution and FOV ............................................................................. 28
3.6 MAR, Metal Artifact Reduction ............................................................................ 29
3.7 Exposure settings for 3D imaging ....................................................................... 30
4 Touch screen display................................................................................................33
4.1 Main control panel............................................................................................... 33
4.2 Modality section .................................................................................................. 34
4.2.1 Exposure indicators and settings ............................................................. 34
4.3 Automatic dose control (ADC)............................................................................. 35
4.4 Status section...................................................................................................... 36
4.5 Other sections .....................................................................................................36
5 Using the unit.............................................................................................................39
5.1 Attaching and removing the sensor..................................................................... 39
5.1.1 Attaching the sensor ................................................................................ 39
5.1.2 Removing the sensor ...............................................................................40
5.2 Preparing the system ..........................................................................................40
5.3 Panoramic exposures ......................................................................................... 41
5.3.1 Positioning devices .................................................................................. 41
5.3.2 Sectional imaging..................................................................................... 42
5.3.3 General instructions .................................................................................42
5.3.4 Default exposure settings........................................................................ 43
5.3.5 User Configurable Default Program .........................................................44
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5.3.6 Patient positioning.................................................................................... 44
5.3.6.1 Panoramic exposure.................................................................. 44
5.3.6.2 TMJ exposure............................................................................ 48
5.3.6.3 Maxillary Sinus exposure........................................................... 51
5.3.7 Taking the exposure................................................................................. 53
5.3.8 Multilayer Selection ..................................................................................54
5.4 Cephalometric exposures ................................................................................... 56
5.4.1 General instructions .................................................................................56
5.4.2 Patient positioning.................................................................................... 58
5.4.2.1 Pediatric lateral and Lateral projection ...................................... 58
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 ......................................................................................................64
5.5.1 Positioning devices .................................................................................. 64
5.5.2 General instructions .................................................................................64
5.5.3 Patient positioning.................................................................................... 66
5.5.4 Scout image .............................................................................................70
5.5.5 3D image..................................................................................................71
5.5.5.1 Stone model and radiographic guide scan ................................72
5.6 Warnings and error messages ............................................................................ 73
5.6.1 Acknowledging errors............................................................................... 73
5.6.2 Image transfer errors................................................................................ 73
6 Troubleshooting ........................................................................................................ 75
6.1 Patient positioning............................................................................................... 75
6.2 Image appearance ..............................................................................................78
6.3 Artefacts ..............................................................................................................79
6.4 Unit operation...................................................................................................... 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 Check (optional)......................................................... 91
8.4 3D calibration ......................................................................................................93
8.4.1 3D geometry calibration ........................................................................... 93
8.4.2 3D pixel calibration................................................................................... 93
8.4.3 3D Quality Check program....................................................................... 95
8.5 Cephalometric calibration.................................................................................... 96
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8.5.1 Ceph pixel calibration............................................................................... 96
8.5.2 Ceph Quality check program (Optional)................................................... 96
9 Technical data............................................................................................................99
9.1 Technical specifications ......................................................................................99
9.2 Unit dimensions................................................................................................. 109
9.3 Symbols that appear in the unit......................................................................... 111
9.4 Labels on the unit.............................................................................................. 113
9.5 Electromagnetic Compatibility (EMC) tables..................................................... 114
9.6 X-ray tube assemblies....................................................................................... 119
10 PC requirements ......................................................................................................121
10.1 Minimum PC requirements................................................................................ 121
10.2 The dental imaging software ............................................................................. 124
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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)
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3D SFOV (optional) H x W
61x41 mm Field of View
61x78 mm Field of View
3D MFOV (Maxio) (optional) H x W
MFOV (Maxio) 50 x 50 mm Field of View
MFOV (Maxio) 61 x 78 mm Field of View
MFOV (Maxio) 78 x 78 mm Field of View
MFOV (Maxio) 78 x 150 mm Field of View
MFOV (Maxio) 130 x 150 mm Field of View (optional)

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 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.
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CAUTION! USA only: Federal law restricts this device to sale by or on the order of a dentist or other qualified professional.

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 user manual supplied with the 3D imaging software
1 Introduction
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

1.6 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.
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Only professionally qualified dental and/or medical personnel are allowed to operate the unit and carry out any diagnoses based on output from the unit.
Because the x-ray limitations and safety regulations change from time to time, it is the responsibility of the user to make sure that all the valid safety regulations are fulfilled.
When taking an x-ray exposure of a patient with exceptional anatomy (typically very tall or large) use the Test-mode (no x-rays) first to make sure that patient can be positioned correctly to the unit and for checking that the unit doesn't hit the patient.
Operator should maintain visible contact with the patient and technique factors. This allows immediate termination of radiation by the release of the exposure button in the event of a malfunction or disturbance.
It is the responsibility of the doctor to decide whether x-ray exposure or any additional exposures are justified and necessary.
The minimum height of patient that can be x-rayed is 120 cm (3.9ft / 47.2in) and the maximum is 200 cm (6ft /78in). These heights only apply to patients with normal anatomy.
Always use the lowest suitable x-ray dose to obtain the desired level of image quality.
Avoid taking x-ray exposures of pregnant women.
When taking an x-ray exposure of a child 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 unit’s enclosures. No user serviceable parts inside.
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1 Introduction
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.
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.
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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 Requirements, in user manual.
The unit shall be connected directly to the acquisition PC with an Ethernet cable. Connection through the LAN­network 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.
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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 & 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 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
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1 Introduction
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.

1.7 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.

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 non-environmental friendly waste products:
Tubehead (Pb, oil)
Collimator (Pb)
All electronic circuits, electronic boards inside
Sensor covers (EMC painted)
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2 Unit description

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. On/off switch and main fuses

2.1 Main parts and controls

PC with MDD approved dental imaging software and 3D viewing software (not included).
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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.
2 Unit description
1. Sensor holder (units without 3D option)
2. Panoramic sensor
1. 3D sensor (units with 3D option)
2. Panoramic sensor
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2.2 Patient positioning lights

2 Unit description
1. Midsagittal light
2. Frankfort horizontal (FH) light / Horizontal light, top of 130 mm high FOV (3D MFOV (Maxio) option only)
3. Image layer light
4. Cephalometric FH light
5. TMJ light
6. 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)
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2 Unit description
Fig 1.1.
Fig 1.2.
Panoramic lights
1. Midsagittal light
2. FH light
1. Image layer light
2. TMJ light
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Cephalometric lights
Fig 1.3.
Fig 1.4.
1. FH light
2 Unit description
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 is indicated with Frankfort horizontal (FH) light. Move FH light to 130 mm position (locked in up-position).
3. Horizontal light, bottom of FOV
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2 Unit description

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 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
3. Carriage UP
4. Carriage DOWN
5. Positioning lights ON/OFF
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2.4 Emergency stop switch

Fig 1.6.
Fig 1.7.
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.
2 Unit description
Press to stop the unit, rotate to release.
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2 Unit description
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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
< default >
Pediatric: Magnification 1.3
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
< default >
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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 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
< default >
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Orthogonal: Magnification 1.3
Y
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.
Exposure settings for Orthogonal program
3 Imaging programs
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
< default >
Wide arch: Magnification 1.3
Used when the patient has a wider than normal dental arch.
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
< default >
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3 Imaging programs
a
b
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 Ortho Lateral 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
< default >
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
< default >
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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 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
< default >
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3 Imaging programs
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 mA 230 VAC 66 kV/5 mA 66 kV/8 mA 66 kV/10 mA 70 kV/13 mA
< default >
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