KaVo ORTHOPANTOMOGRAPH OP 3D User manual

Dental Excellence
OP 3D
ORTHOPANTOMOGRAPH™ OP 3D
User Manual
212972 rev. 30|0.805.4913
ENGLISH

Contents
1Disclaimer............................................................................................................................5
2Introduction....................................................................................................................... 6
2.1ORTHOPANTOMOGRAPH™ OP 3D.............................................................................................................. 6
2.2Intended use....................................................................................................................................................7
2.3Intended user profile.................................................................................................................................... 7
2.4Associated documentation.........................................................................................................................7
2.5Abbreviations.................................................................................................................................................. 7
2.6Signal words................................................................................................................................................... 8
2.7Disposal and recycling..................................................................................................................................8
2.8Warnings and requirements.......................................................................................................................9
2.8.1Warnings and precautions for use............................................................................................9
2.8.2Connection requirements......................................................................................................... 10
2.8.3Device modifications..................................................................................................................10
3Overview........................................................................................................................... 11
3.1Main parts....................................................................................................................................................... 11
3.2Patient positioning lights.......................................................................................................................... 12
3.2.1Positioning light locations......................................................................................................... 12
3.2.2Panoramic lights.......................................................................................................................... 12
3.2.3Cephalometric lights.................................................................................................................. 13
3.2.43D lights......................................................................................................................................... 13
3.3Accessories....................................................................................................................................................14
3.4Other detachable parts..............................................................................................................................15
3.5Emergency stop switch.............................................................................................................................16
3.6Device connectors.......................................................................................................................................17
4User interfaces.................................................................................................................18
4.1Graphical User Interface (GUI).................................................................................................................. 18
4.1.1GUI Overview.................................................................................................................................18
4.1.2Panoramic view........................................................................................................................... 20
4.1.3Cephalometric view....................................................................................................................22
4.1.4 3D view.......................................................................................................................................... 25
4.1.5Dental cast view.......................................................................................................................... 31
4.1.6Device settings............................................................................................................................ 35
4.2Patient positioning panel......................................................................................................................... 39
4.3Status indicator light.................................................................................................................................40
5Imaging programs........................................................................................................... 41
5.1Panoramic programs...................................................................................................................................41
5.2Cephalometric programs..........................................................................................................................43
5.33D programs.................................................................................................................................................45
5.3.1FOV Sizes........................................................................................................................................45
5.3.23D Resolutions............................................................................................................................. 47
5.4Dental cast program..................................................................................................................................48
6Using the device............................................................................................................. 49
6.1General imaging workflow.......................................................................................................................49
6.2Powering on the device............................................................................................................................50
ORTHOPANTOMOGRAPH™ OP 3D iii

6.3Preparing the device for imaging...........................................................................................................50
6.4Patient positioning..................................................................................................................................... 52
6.4.1Patient positioning for Panoramic imaging......................................................................... 52
6.4.2Patient positioning for Cephalometric imaging................................................................. 57
6.4.3Patient positioning for Carpus imaging................................................................................ 61
6.4.4Patient positioning for 3D imaging....................................................................................... 63
6.5Taking an image...........................................................................................................................................67
6.5.1Taking Panoramic and Cephalometric images.....................................................................67
6.5.2Taking Scout and 3D images....................................................................................................68
6.5.3Taking Dental cast images....................................................................................................... 69
7Maintenance..................................................................................................................... 70
7.1Cleaning and decontamination................................................................................................................ 70
7.2Calibrations for the user............................................................................................................................ 71
7.2.1When to calibrate the device.................................................................................................... 71
7.2.2Preparation for calibration........................................................................................................ 71
7.2.3Calibration procedure.................................................................................................................73
7.3Quality control..............................................................................................................................................77
7.3.1PAN QC............................................................................................................................................ 77
7.3.2CEPH QC........................................................................................................................................ 80
7.3.33D QC.............................................................................................................................................. 82
7.4Annual maintenance.................................................................................................................................. 84
8Troubleshooting.............................................................................................................. 85
9Technical data..................................................................................................................87
9.1Technical specifications.............................................................................................................................87
9.2Imaging program specifications............................................................................................................. 93
9.2.1Panoramic programs.................................................................................................................. 93
9.2.2Cephalometric programs..........................................................................................................93
9.2.33D programs................................................................................................................................ 94
9.2.4Patient size setting default values........................................................................................ 95
9.3Patient contacting parts.......................................................................................................................... 96
9.4Device dimensions......................................................................................................................................97
9.4.1Main device dimensions.............................................................................................................97
9.4.2Cephalometric device dimensions.........................................................................................98
9.5Symbols that may appear on the device or its parts........................................................................99
9.6Electromagnetic Compatibility (EMC) tables.....................................................................................101
9.7X-ray tube assemblies............................................................................................................................. 105
9.8Workstation minimum requirements.................................................................................................. 107
iv ORTHOPANTOMOGRAPH™ OP 3D

1Disclaimer
1Disclaimer
ORTHOPANTOMOGRAPH™ OP 3D User Manual, 212972 r30.
Copyright © 01-2022 by PaloDEx Group Oy. All rights reserved.
ORTHOPANTOMOGRAPH™, OP™, OP 3D™, ORTHOceph™, ORTHOselect™, QUICKcompose™, SMARTVIEW™,
ORTHOfocus™ and Low Dose Technology™ are either registered trademarks or trademarks of PaloDEx
Group Oy in the United States and/or other countries.
KaVo™ is either registered trademark or trademark of Kaltenbach & Voigt GmbH in the United States
and/or other countries.
All other trademarks are property of their respective owners.
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 PaloDEx Group Oy.
The original language of this manual is English.
PaloDEx Group Oy 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 KaVo Kerr
representative for the most current information.
The manufacturer has no liability for consequential damage, personal injury, loss, damage or expense
directly or indirectly caused by the use of the product. No agent, distributor or other party is authorized
to give warranty or other liability on behalf of the manufacturer with respect to its products.
Manufacturer:
PaloDEx Group Oy
Nahkelantie 160
FI-04300 Tuusula
FINLAND
Tel. [phone]
www.kavokerr.com
Download this manual in digital format or order in printed format for no additional cost:
https://elabeling.kavokerr.com
Make sure that you get the manual that applies to your device.
For service, contact your local distributor.
ORTHOPANTOMOGRAPH™ OP 3D 5

2Introduction
2Introduction
2.1ORTHOPANTOMOGRAPH™ OP 3D
The ORTHOPANTOMOGRAPH™ OP 3D (later called device) is a dental X-ray device producing high quality
digital images of dentition, TM-joints, head and neck area and carpus. To take images, you need a
suitable workstation connected to the device and a dental imaging software to capture and manage
the images.
The ORTHOPANTOMOGRAPH™ OP 3D can be used for the following procedures depending on the
device configuration and country-specific regulatory approvals:
Panoramic Imaging
• Standard panoramic
• Segmented panoramic
• Pediatric panoramic
• Bitewing
• TMJ, lateral projection
Cephalometric Imaging
• Cephalometric lateral projection
• Cephalometric pediatric lateral projection
• Cephalometric Posterior-Anterior (PA) projection
• Carpus view
3D CBCT Imaging
• FOV (Volume Height x Diameter)
◦ 5 x 5
◦ 6 x 8 *
◦ 6 x 9
◦ 8 x 8 *
◦ 9 x 11
◦ 9 x 14
• Resolution
◦ LDT - Low Dose Technology™
◦ Standard
◦ High
◦ Endo (5 x 5 only)
• Scout images for FOV position and height verification
• Dental cast imaging
* In some countries/areas where 3D volume dimensions are limited by local regulations FOV sizes 6 x 9
and 9 x 11 are replaced by FOV sizes 6 x 8 and 8 x 8.
NOTICE! This manual describes the use of a device with all available functions and so may
contain instructions to more functions than what are available with your device configuration.
CAUTION! USA only: Federal law restricts this device to sale by or on the order of a dentist or
other qualified professional.
To function, the device requires an additional workstation with MDD approved dental imaging
software. Every software used with the device must conform to the MDD and the relevant legal
6ORTHOPANTOMOGRAPH™ OP 3D

2Introduction
requirements in the USA. The workstation must conform to all the device and dental imaging software
requirements.
2.2Intended use
ORTHOPANTOMOGRAPH™ OP 3D is an X-ray device that is intended to be used for imaging of adult and
pediatric patients. The device can be configured to take panoramic, cephalometric, or 3D images of the
cranio-maxillofacial complex for use in diagnostic support. The device can also be configured to take
carpus images.
ORTHOPANTOMOGRAPH™ OP 3D must only be used and operated by dentist and other qualified
professionals.
2.3Intended user profile
Only for professionally qualified dental/medical personnel.
Typical user is a dental assistant with specific training for using dental X-ray devices.
2.4Associated documentation
• Dental imaging software documentation.
• ORTHOPANTOMOGRAPH™ OP 3D Quick Guide.
2.5Abbreviations
3D Three Dimensional
PAN Panoramic
CEPH Cephalometric
LLeft
RRight
HHead
FFoot
PPosterior
AAnterior
PA Posterior-Anterior
FOV Field Of View. The cylindrical 3D volume that is reconstructed by the device.
ROI Region Of Interest. The anatomical area or region that you are interested to examine.
TMJ Temporomandibular joint
ORTHOPANTOMOGRAPH™ OP 3D 7

2Introduction
FH Frankfort-Horizontal
GUI Graphical User Interface
DAP Dose Area Product
LDT Low Dose Technology™
MAR Metal Artifact Reduction. Reduces the effect of metal and other dense radiopaque
objects, that typically create artifacts which are seen as stripes and shadows.
QC Quality Control
ALARA As Low As Reasonably Achievable
MDD Medical Device Directive 93/42/EEC
CBCT Cone Beam Computed Tomography
SSD Solid State Drive
2.6Signal words
The following signal words and labels are used in this document:
WARNING! Indicates a hazardous situation which, if not avoided, could result in death or serious
injury.
CAUTION! Indicates a hazardous situation which, if not avoided, could result in minor or
moderate injury.
NOTICE! Highlights suggestions which will result in enhanced installation, reliability, or
operation. Not used for safety related hazards.
2.7Disposal and recycling
The device and its components are lead-free, including its radiation protection components. The device
meets the RoHS Directive 2011/65/EU, WITHOUT any exemptions mentioned in Annex IV. Dispose of the
device, accessories and consumables according to local requirements.
At least the following parts of the device should be recycled according to local and national regulations
regarding disposal of non-environmentally friendly materials:
• Tubehead (oil)
• All electronic circuits and electronic boards
• Plastic parts
8ORTHOPANTOMOGRAPH™ OP 3D

2Introduction
2.8Warnings and requirements
2.8.1Warnings and precautions for use
• Before using the device for the first time, familiarize yourself with this manual to ensure the safe
use of the device.
• Before using the device for the first time, ensure that it has been set up according to your
requirements.
• This device complies with the EMC (Electromagnetic Compatibility) according to IEC 60601-1-2.
Radio transmitting equipment, cellular phones etc. shall not be used in proximity of the device as
they could influence the performance of the device.
• Always use new disposable covers on patient positioning accessories and decontaminate the
patient contacting parts according to guidance in chapter Cleaning and decontamination on page
70 to prevent cross contamination.
• If patient positioning accessories show any signs of deterioration, replace them before use.
• Clean the patient positioning accessories before their first use.
• Avoid taking X-ray images of pregnant women.
• If the patient is using a pacemaker, consult the manufacturer of the pacemaker before taking an X-
ray image to confirm that the device will not interfere with the operation of the pacemaker.
• Follow the ALARA (As Low As Reasonably Achievable) principle and always seek to reduce the
radiation dose.
• Use the pediatric programs always when taking X-ray images of pediatric patients and where
feasible, adjust the radiation field size.
• 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.
• The device must not be used for screening examinations.
• Always ensure the patient positioning before taking X-ray images to diminish the need for retakes.
• Always ask the patient to remain still for the duration of the exposure to diminish the need for
retakes.
• When taking an X-ray image, protect yourself from radiation or stand at least 3 meters (9.8 ft) away
from the device.
• When taking an X-ray image of a patient who is feeling insecure or has exceptional anatomy
(typically very tall or large patient) use the Test-mode first to demonstrate the device movements
and to make sure that the rotating device doesn't collide with the patient during the imaging
process.
• Always ensure that you can see and hear the patient during the imaging process, while also
maintaining visibility to the GUI.
• Do not move the upper shelf of the device by hand as it may hit a wall or cause the device to go to
an error state.
• Close the patient positioning mirror before taking images.
• Switch the device off after use.
• Report any incident, related to use of this device, having a serious effect on the health of a patient,
user or other person to the manufacturer and to the local competent authority.
ORTHOPANTOMOGRAPH™ OP 3D 9

2Introduction
2.8.2Connection requirements
NOTICE! Always follow local and national requirements regarding the connection of medical
systems.
NOTICE! The workstation firewall or antivirus software may cause unexpected issues to IP traffic
and system performance.
• A network connection between the device and the acquisition workstation is required for the device
to be used. If the network is interrupted during the imaging process, the image data is saved to the
device memory and is transferred to the acquisition workstation automatically after the connection
is re-established.
• The device must be connected to a private, firewall protected local area network to ensure proper
data security. All connections from outside of the local area network to the device must be blocked.
Connections between the device and the workstation in the local area network must be allowed.
• Connecting the device to an IT-network that includes other equipment or changing the IT-network
can cause unidentified safety or security risks to patients or operators. It is the responsibility of the
organization controlling the IT-network to identify, analyze, evaluate and control these possible
risks.
• Network elements used in the IT-network must not use their default passwords.
• The workstation and any other external device(s) connected to the device must meet the IEC 60950
(62368-1) standard (minimum requirements). Devices that do not meet these requirements must
not be connected to the device as they may pose a threat to the operational safety.
• Electronic equipment (workstation, network connecting devices etc.) that do not fulfill medical
safety standard IEC 60601-1 must be located outside of the patient environment, at least 1.5 m
from the device.
• The workstation and any other external devices must be connected to the device in accordance
with IEC 60601-1.
• The workstation connected to the device must use an antivirus software and have individual
password protected user accounts to prevent unauthorized access to patient data.
• The device must be connected to a dedicated mains power outlet with protective earth. The
workstation and any other external devices must NOT be connected to the same outlet as the
device.
• Additional multiple socket-outlets or extension cords shall not be connected to the system.
2.8.3Device modifications
CAUTION! The device does not contain user serviceable parts. Only authorized service
technicians are allowed to service, install and replace parts of the device.
CAUTION! Only approved spare parts supplied by the manufacturer are allowed to be used in
device service.
• Never make unauthorized changes or modifications to the device or any of its parts.
• Never remove or remanufacture any part of the tubehead assembly or beam limiting devices.
• Never adjust any part of the beam limiting devices unless under the direction of the manufacturer.
• All required information on the device service and part replacement is found in the Service Manual,
which is available for authorized service technicians.
10 ORTHOPANTOMOGRAPH™ OP 3D

3Overview
3Overview
3.1Main parts
MAIN DEVICE
1. Column 2. Carriage 3. Upper shelf
4. Rotating unit 5. Sensor (2D/3D)* 6. Sensor (2D)*
7. PAN/3D Tubehead 8. Patient positioning panel 9. Status indicator light
10. Power switch (Back of the
device)
11. Emergency stop switch 12. Exposure switch
13. Mirror 14. Lower shelf tray 15. Patient handles
16. Head support 17. Head support locking lever 18. Chin rest
CEPHALOMETRIC UNIT
19. CEPH head support 20. CEPH tubehead 21. CEPH arm
22. Nasion support 23. Ear rod
* The sensor configuration and appearance may vary depending on the device configuration.
ORTHOPANTOMOGRAPH™ OP 3D 11

3Overview
3.2Patient positioning lights
NOTICE! Appropriate lights are turned on automatically, based on the selected modality,
program and FOV.
3.2.1Positioning light locations
A. Tilt light (PAN imaging)
B. Midsagittal light
C. Horizontal light; top of FOV / FH light
D. Horizontal light; bottom of FOV
E. Cephalometric FH light (CEPH devices)
3.2.2Panoramic lights
B
C
A
A. Tilt light
B. Midsagittal light
C. FH (Frankfort-Horizontal) light
NOTICE! The position of FH light is automatically adjusted according to the selected imaging
program.
12 ORTHOPANTOMOGRAPH™ OP 3D

3Overview
3.2.3Cephalometric lights
E
E. FH (Frankfort-Horizontal) light
NOTICE! Lateral programs only.
3.2.43D lights
B
C
D
B. Midsagittal light
C. Horizontal light, top of FOV
D. Horizontal light, bottom of FOV
NOTICE! The position of the top of FOV light is automatically adjusted according to the selected
FOV.
ORTHOPANTOMOGRAPH™ OP 3D 13

3Overview
3.3Accessories
Chin Rest Bite Block Lip Support
Head Support with a detachable strap Carpus holder (optional)
Disposable covers for patient positioning accessories:
• Disposable covers for Bite Block
• Disposable covers for Lip Support
• Disposable cover sheets for Chin Rest and Head Support
• Disposable covers for Nasion Support (CEPH only)
• Disposable covers for Ear Rods (CEPH only)
14 ORTHOPANTOMOGRAPH™ OP 3D

3Overview
3.4Other detachable parts
CALIBRATION TOOLS:
Geometry calibration phantom CEPH calibration rod (CEPH only)
3D QUALITY CONTROL TOOLS:
3D QC phantom 3D QC phantom holder
2D QUALITY CONTROL TOOLS (OPTIONAL):
2D QC test phantom Copper filter - 0.8 mm/1.8 mm
PAN QC phantom holder CEPH QC phantom holder
ORTHOPANTOMOGRAPH™ OP 3D 15

3Overview
DENTAL CAST IMAGING TOOLS (OPTIONAL):
Dental cast holder
3.5Emergency stop switch
An emergency stop switch is located on the left side of the carriage.
Pressing the emergency stop switch immediately terminates the imaging and all device movements.
NOTICE! An interrupted imaging process cannot be resumed. A new image needs to be taken.
To release the emergency stop switch, rotate it clockwise.
NOTICE! Make sure that the emergency stop switch is not pressed down when you start the
imaging process.
The Graphical User Interface (GUI) has indication if the emergency stop is active and the device status
indication lights are blue.
NOTICE! Activating the emergency stop causes the device to restart.
16 ORTHOPANTOMOGRAPH™ OP 3D

3Overview
3.6Device connectors
The device connectors are located at the rear of the device, under the back panel cover.
1. Power cord
2. Ethernet cable for workstation connection
3. Exposure button connector
4. Remote exposure switch connector (optional)
5. External warning light connector (optional)
6. Main fuses F1+F2 (10 A fuses pre-installed)
7. External warning light fuse F3 (2 A fuse pre-installed)
8. Control interface
NOTICE! All cables, except the power cord, must be routed through a strain relief attached to the
back panel plate.
The Control interface can be used to connect optional device controls such as external exposure switch
and door switch.
ORTHOPANTOMOGRAPH™ OP 3D 17

4User interfaces
4User interfaces
4.1Graphical User Interface (GUI)
4.1.1GUI Overview
1. Patient name and identification.
2. Selection of imaging modality, PAN, CEPH, 3D or CAST.
3. Selection of imaging program and imaging program settings.
4. Main view area. Shows a dental chart for the selected modality and previews of the taken images.
5. Selection of imaging parameters. Imaging parameters, kV and mA, can be manually adjusted
according to the patient size and skull anatomy.
6. Exposure time and DAP estimation. Shows the estimated duration of X-ray radiation and the
radiation dose with the selected imaging program and parameters. The actual imaging parameters
and DAP are shown after imaging.
7. Sample image of the selected program or 3D FOV size and location illustration.
8. Status message bar and device status indicator.
9. Device settings and friendly name of the device. Pressing the cogwheel symbol opens a menu
which is used to access the device settings, quality control and calibration programs and to show
the device information, like serial number and software versions.
NOTICE! The available imaging modalities vary depending on the device configuration.
18 ORTHOPANTOMOGRAPH™ OP 3D

4User interfaces
IMAGING PROGRAM SETTINGS:
Test mode
Indicates if Test mode is active.
Press Test mode icon to enable/disable device radiation production.
Test mode can be used for example to demonstrate the device movements.
You can also use the patient positioning panel to enable/disable the Test
mode.
Patient size
Indicates the currently selected patient size preset.
Press the Patient size selection icon to open a list of patient sizes; Small,
Medium & Large.
Press on the patient size icon to activate the preset.
Select the patient size preset according to the patient to adjust the kV and
mA to preset levels.
NOTICE! Patient size presets can be adjusted from device settings.
STATUS MESSAGE BAR:
Message bar
The message bar provides messages and guidance to the user. Press on the
bar to show messages if there are more than the ones shown.
Device status indicator
Status message bar shows the device status with a colored Device status
indicator.
•GREEN: Device is ready for imaging.
•GRAY: Device is not ready for imaging, follow the instructions on the
status message bar.
•YELLOW: Device is radiating.
•BLUE: Device is in error state or pending user action. Details are shown
on the status message bar.
ORTHOPANTOMOGRAPH™ OP 3D 19

4User interfaces
4.1.2Panoramic view
4.1.2.1Panoramic imaging program selection
ORTHOselect™ panoramic dental chart
Dental chart shows which segments of the dentition are imaged with the
selected imaging program.
You can also manually select which segments of the dentition are imaged.
Press the segments to select (green) and deselect (gray) them.
Panoramic imaging programs
Indicates which imaging program is selected.
Press the imaging program icons to change the active imaging program;
Standard
Panoramic
Pediatric
Panoramic
Bitewing TMJ, lateral
A sample image for the selected imaging program is shown on the GUI. If
you take a segmented image, the unselected segments are grayed out in the
sample image.
Standard Panoramic Segmented Panoramic
20 ORTHOPANTOMOGRAPH™ OP 3D