Manual DTX

ORTHOPANTOMOGRAPH™ OP 3D LX
User Manual
224311-PTU rev. 15
ENGLISH
Contents
1 Disclaimer.............................................................................................................................. 5
2 Introduction........................................................................................................................... 6
2.1 ORTHOPANTOMOGRAPH™ OP 3D™ LX.................................................................................. 6
2.2 Intended use and intended purpose..........................................................................................7
2.3 Intended user profile................................................................................................................. 7
2.4 Radiation guideline.................................................................................................................... 7
2.5 Contraindications.......................................................................................................................7
2.6 Associated documentation........................................................................................................ 8
2.7 Abbreviations.............................................................................................................................8
2.8 Signal words..............................................................................................................................9
2.9 Disposal and recycling.............................................................................................................. 9
2.10 Warnings and requirements.....................................................................................................9
2.10.1 Warnings and precautions for use............................................................................. 9
2.10.2 Connection requirements.........................................................................................10
2.10.3 Device modifications................................................................................................11
2.10.4 Protection Against Cybersecurity Threats................................................................ 11
3 Overview..............................................................................................................................12
3.1 Main parts............................................................................................................................... 12
3.2 Patient positioning lights..........................................................................................................13
3.2.1 Positioning light locations.......................................................................................... 13
3.2.2 Panoramic lights........................................................................................................ 13
3.2.3 Cephalometric lights.................................................................................................. 14
3.2.4 3D lights.................................................................................................................... 14
3.3 Accessories............................................................................................................................. 15
3.4 Other detachable parts........................................................................................................... 16
3.5 Emergency stop switch........................................................................................................... 17
3.6 Device label locations..............................................................................................................18
4 User interfaces...................................................................................................................20
4.1 Graphical User Interface (GUI)................................................................................................20
4.1.1 Overview................................................................................................................... 20
4.1.2 Panoramic imaging.................................................................................................... 23
4.1.3 Cephalometric imaging.............................................................................................. 25
4.1.4 3D imaging................................................................................................................ 28
4.1.5 Dental cast view........................................................................................................ 34
4.1.6 Device settings.......................................................................................................... 38
4.2 Control panel...........................................................................................................................42
4.3 Status indicator light................................................................................................................43
5 Imaging programs.............................................................................................................44
5.1 Panoramic programs............................................................................................................... 44
5.2 Cephalometric programs......................................................................................................... 46
5.3 3D programs........................................................................................................................... 48
5.3.1 FOV Sizes..................................................................................................................48
5.3.2 3D Resolutions.......................................................................................................... 51
5.4 Dental cast program............................................................................................................... 51
ORTHOPANTOMOGRAPH™ OP 3D LX iii
6 Using the device............................................................................................................... 52
6.1 General imaging workflow....................................................................................................... 52
6.2 Powering on/off the device...................................................................................................... 53
6.3 Preparing the device for imaging.............................................................................................54
6.4 Patient positioning................................................................................................................... 55
6.4.1 Patient positioning for Panoramic imaging................................................................. 55
6.4.2 Patient positioning for Cephalometric imaging........................................................... 59
6.4.3 Patient positioning for Carpus imaging...................................................................... 63
6.4.4 Patient positioning for 3D imaging............................................................................. 65
6.5 Taking an image......................................................................................................................68
6.5.1 Taking Panoramic and Cephalometric images........................................................... 68
6.5.2 Taking Scout and 3D images.................................................................................... 69
6.5.3 Taking Dental cast images........................................................................................ 70
7 Maintenance....................................................................................................................... 72
7.1 Cleaning and decontamination................................................................................................ 72
7.2 Calibrations for the user.......................................................................................................... 73
7.2.1 When to calibrate the device.....................................................................................73
7.2.2 Preparation for calibration......................................................................................... 73
7.2.3 Calibration procedure................................................................................................ 75
7.3 Quality control......................................................................................................................... 79
7.3.1 PAN QC.................................................................................................................... 79
7.3.2 3D QC.......................................................................................................................81
7.3.3 CEPH QC.................................................................................................................. 83
7.4 Annual maintenance................................................................................................................85
8 Troubleshooting.................................................................................................................86
9 Technical data....................................................................................................................87
9.1 Technical specifications...........................................................................................................87
9.2 Imaging program specifications............................................................................................... 91
9.2.1 Panoramic programs................................................................................................. 91
9.2.2 Cephalometric programs........................................................................................... 92
9.2.3 3D programs............................................................................................................. 92
9.2.4 Patient size setting default values..............................................................................94
9.3 Patient contacting parts.......................................................................................................... 95
9.4 Device dimensions.................................................................................................................. 96
9.4.1 Main device dimensions............................................................................................ 96
9.4.2 Cephalometric device dimensions............................................................................. 97
9.5 Symbols that may appear on the device or its parts................................................................98
9.6 Electromagnetic Compatibility (EMC) tables.......................................................................... 100
9.7 X-ray tube assemblies........................................................................................................... 106
9.8 Workstation minimum requirements.......................................................................................108
iv ORTHOPANTOMOGRAPH™ OP 3D LX
1 Disclaimer
1 Disclaimer
ORTHOPANTOMOGRAPH™ OP 3D LX User Manual, 224311-PTU r15.
Copyright © 08-2023 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.
DEXIS™ is a registered trademark or a trademark of Dental Imaging Technologies Corporation.
DTX Studio™ is a registered trademark or a trademark of Nobel Biocare Services AG.
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 PaloDEx Group Oy
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. +358 10 270 2000

www.dexis.com
Download this manual in digital format or order one in printed format for no additional cost from:
http://www.dexis.com
NOTICE! Make sure that you get the manual that applies to your device.
For service, contact your local distributor.
ORTHOPANTOMOGRAPH™ OP 3D LX 5
2 Introduction
2 Introduction
2.1 ORTHOPANTOMOGRAPH™ OP 3D™ LX

The ORTHOPANTOMOGRAPH OP 3D LX (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 device is used as part of digital dental workflow, providing image data to diagnosis and treatment
planning for the healthcare professionals. X-ray images reveal the targeted craniofacial anatomy, and
condition and the position of anatomical structures inside field-of-view, such as teeth, mandibular joints
and oral and nasal cavities. This helps dentists to prepare for various dental procedures such as implant
placement, orthodontics and dental prosthetics and make possible to diagnose issues early, which enables
early and less invasive treatment.
The device 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 (3D Volume Height x Diameter in centimeters)
◦ 5x5
◦ 6x9*
◦ 8x8
◦ 10 x 10 *
◦ 12 x 15 **
◦ 15 x 20 **
• Resolution
◦ Low (using 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
10 x 10 are replaced with FOV sizes 6 x 8 and 8 x 8.
** Optional FOV sizes available as separately purchasable features.
6 ORTHOPANTOMOGRAPH™ OP 3D LX
2 Introduction
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.
To function, the device requires a workstation with a dental imaging software. The device produces X-ray
images in the industry standard image formats (DICOM and JPEG).
Any software used to capture and view X-ray images with the device (e.g. DTX Studio Clinic or a third party
dental imaging software supporting TWAIN) must conform to the local regulatory standards, regulations and
approval required to place the device on the market. Any workstation used with the device must conform
to the connection and hardware requirements presented in chapters Connection requirements on page
10 and Workstation minimum requirements on page 108 as well as the dental imaging software system
requirements.
2.2 Intended use and intended purpose

ORTHOPANTOMOGRAPH OP 3D LX 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 cranio-
maxillofacial complex including the ear, nose and throat (ENT) and airway regions, and cervical spine. The
device can be configured to take carpus images.
The device is operated and used by qualified healthcare 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 Radiation guideline
The device produces X-ray beams to produce digital images. Reduce the risk of excessive radiation
exposure by following the As Low As Reasonably Achievable (ALARA) principle and try to reduce the
radiation dose to the level where obtained images are still clinically adequate.
The justification for X-ray exposure and the balance between intensity of radiation exposure and image
quality should always be considered.
The X-ray beam intensity is a product of beam quality (kVp), beam quantity (mAs) and the distance between
the X-ray tube and the exposed area. The radiation intensity is provided as Dose Area Product value
2
(mGycm ) on the GUI.
NOTICE! An approximate DAP value is shown during the imaging

program selection but the actual radiation dose amount is shown after
the exposure.
2.5 Contraindications
X-rays are known to be potentially harmful and the decision if the risk outweighs the benefit is always done
by the professional user. No contraindications are identified for this device.
2 Introduction
2.6 Associated documentation

• Device installation manual, supplied with the device (for authorized service technicians only).
• Dental imaging software documentation
• Quick Guide
2.7 Abbreviations
3D Three Dimensional
PAN Panoramic
CEPH Cephalometric
L Left
R Right
H Head
F Foot
P Posterior
A Anterior
PA Posterior-Anterior
FOV Field Of View. The cylindrical 3D volume that is reconstructed by the device. The FOV
sizes are presented as the Height x Diameter of the 3D volume in centimeters.
ROI Region Of Interest. The anatomical area or region that you are interested to examine.
TMJ Temporomandibular joint
FH Frankfort-Horizontal
GUI Graphical User Interface
DAP Dose Area Product
LDT Low Dose Technology™ for low resolution 3D imaging
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
MDR Medical Device Regulation (EU) 2017/745
2 Introduction
CBCT Cone Beam Computed Tomography
SSD Solid State Drive
2.8 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.
2.9 Disposal and recycling

The device and its components are lead-free, including its radiation protection components. The device
meets the RoHS directives 2011/65/EU and EU 2015/863 on the restriction of the use of certain hazardous
substances in electrical and electronic equipment. 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
2.10 Warnings and requirements

2.10.1 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.
• When taking an X-ray image, protect yourself from radiation or stand at least 3 meters (9.8 ft) away from
the device.
• Bite block and ear rods must always be used with new disposable covers and the patient contacting
parts decontaminated according to guidance in chapter Cleaning and decontamination on page 72 to
prevent cross contamination.
• Clean the patient positioning accessories before their first use.
• If patient positioning accessories show any signs of deterioration, replace them before use.
• Always ensure that you can see and hear the patient during the imaging process, while also maintaining
visibility to the GUI.
• 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.
• Use the pediatric programs always when taking X-ray images of pediatric patients and where feasible,
adjust the radiation field size.
2 Introduction
• 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.
• 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.
• Avoid taking X-ray images of pregnant women.
• Switch the device off after use.
• 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.
• 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 computed tomography or magnetic
resonance, rather than 3D imaging using Cone Beam technology.
• The device must not be used for screening examinations.
• 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.
• 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.
• USA only: Federal law restricts this device to sale by or on the order of a dentist or other qualified
professional.
2.10.2 Connection requirements

2.10.2.1 Electrical connection requirements
NOTICE! Always follow local and national requirements regarding the connection of medical
systems.
• 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.
• The workstation and any other external device(s) connected to the device must meet the IEC
62368-1 (previously IEC 60950) 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.
• Additional multiple socket-outlets or extension cords shall not be connected to the system.
2.10.2.2 Network connection requirements

NOTICE! The workstation firewall or anti-virus software may cause unexpected issues to IP traffic
and system performance.
• 1Gbit 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.
• If device is connected to the IT-network, it is the responsibility of the IT-network organization to evaluate
that 1Gbit Ethernet connection between device and acquisition workstation is adequate and no
disturbance or high traffic peaks exist from other applications during image transfer. Other methods in IT-
infrastructure like Virtual LAN (VLAN) configuration between acquisition workstation and device can be
also used to secure bandwidth for image transfer.
2 Introduction
• 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.
• 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.
• Network elements used in the IT-network must not use their default passwords and wireless connections
must be encrypted.
• The workstation connected to the device must use an anti-virus software and have individual password
protected user accounts to prevent unauthorized access to patient data.
2.10.3 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 re-manufacture 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.
• Connect only items that have been specified as part of the ME system or specified as being compatible
with ME system by the manufacturer of the device.
2.10.4 Protection Against Cybersecurity Threats

Protecting your practice against cybersecurity threats is a shared responsibility between the device and
software manufacturers and you, as the healthcare provider. The device and software manufacturers
have taken precautions to ensure that your imaging system is protected against such threats. However,
the protection of the network system is always the responsibility of the healthcare provider. It is highly
recommended to have a qualified IT security professional check and maintain the office network system for
proper protection against viruses, malware, and intrusions (e.g. anti-virus software, and/or use of firewall).
CAUTION! Failure to maintain cybersecurity can result in compromised device functionality, loss
of data (medical or personal) availability or integrity, or exposure of other connected devices or
networks to security threats.
• Workstation should have anti-virus software running on it.
• Access to the workstation should be protected by strong passwords.
• Passwords should not be shared or reused.
3 Overview
3 Overview
3.1 Main parts
MAIN DEVICE
1. Column 2. Carriage 3. Lower shelf
4. Rotator 5. Upper shelf 6. PAN/3D Tubehead
7. X-ray sensor 8. Exposure switch 9. Patient handles
10. Emergency stop switch 11. Control panel 12. Head support
13. Mirror 14. Status indication light
CEPHALOMETRIC UNIT
15. CEPH tubehead 16. CEPH arm 17. CEPH head support
18. Nasion support 19. Ear rods
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
1.Tilt light (PAN imaging)

2. Midsagittal light
3. Horizontal light; top of FOV / FH light
4. Horizontal light; bottom of FOV
5. Cephalometric FH light
3.2.2 Panoramic lights
1 - Tilt light
2 - Midsagittal light
3 - FH (Frankfort-Horizontal) light
NOTICE! The position of FH light is automatically adjusted according to the selected imaging
program.
3 Overview
3.2.3 Cephalometric lights
5 - FH (Frankfort-Horizontal) light
NOTICE! Used only in lateral imaging programs.
3.2.4 3D lights
2 - Midsagittal light
3 - Horizontal light, top of FOV
4 - Horizontal light, bottom of FOV
NOTICE! The position of the top of FOV light is automatically adjusted according to the selected
FOV.
3 Overview
3.3 Accessories
Chin rest Bite block Lip support
Head support Carpus holder

(available separately)
Disposable covers for patient positioning accessories:

• Disposable covers for bite block
• Disposable covers for lip support
• Disposable covers for chin rest
• Disposable covers for nasion support (CEPH only)
• Disposable covers for ear rods (CEPH only)
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 (AVAILABLE SEPARATELY):
2D QC test phantom Copper filter - 0.8 mm/1.8 mm
PAN QC phantom holder CEPH QC phantom holder
DENTAL CAST IMAGING TOOLS (AVAILABLE SEPARATELY):
Dental cast holder
3 Overview
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.
3 Overview
3.6 Device label locations

MAIN DEVICE LABELS
1. Type label 2. Sensor label 3. THA label

4. PAN/3D collimator label 5. Filtration label 6. Warning label
CEPHALOMETRIC UNIT LABELS
1. Cephalometric arm label 2. THA label 3. CEPH primary collimator label

4. Filtration label 5. CEPH secondary collimator
label
3 Overview
Example illustrations of the device labels:

Device type label Serial number labels
NOTICE! These labels are for illustrative purposes only. Texts and images may vary.
4 User interfaces
4 User interfaces
4.1 Graphical User Interface (GUI)

4.1.1 Overview
1. Patient name and identification.

2. Selection of imaging modality, PAN, CEPH, 3D or CAST.
NOTICE! The available imaging modalities vary depending on the device configuration.
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; kV and mA. These can be manually adjusted according to the patient
size and skull anatomy if needed.
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.
BASIC USE OF THE GUI:

Press on an icon to activate/inactivate imaging program or setting. Active selections are indicated with
GREEN colour. Inactive selections are indicated with GRAY colour.
4 User interfaces
COMMON IMAGING PROGRAM SETTINGS:
Test mode
Indicates if Test mode is active. Test mode disables device radiation
production.
Test mode can be used for example to demonstrate the device movements.
You can also use the control 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.
Imaging parameters
Indicates the currently selected kV and mA values. By default the selection is
based on the imaging program and patient size selections.
• Press the Imaging parameters to open an adjustment menu.
• If needed, adjust the kV and mA values manually with the + and - buttons
4 User interfaces
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 generating X-rays.
• BLUE: Device is in error state or pending user action. Details are shown
on the status message bar.
4 User interfaces
4.1.2 Panoramic imaging

4.1.2.1 Panoramic imaging program settings
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 Pediatric Bitewing TMJ, lateral
Panoramic Panoramic
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
4 User interfaces
4.1.2.2 Panoramic image preview

QUICKcompose™ low resolution image preview is shown on the GUI after the image has been taken.
NOTICE! Adjustments done in the preview are not saved to the image.
Zoom slider
You can zoom the preview image in/out using the zoom slider.
While zoomed in, you can click and drag to scroll the image.
Brightness slider
You can adjust the brightness of the shown preview image using the brightness
slider.
Contrast slider
You can adjust the contrast of the shown preview image using the contrast
slider.
OK button
Press OK button to close the image preview.
4 User interfaces
4.1.3 Cephalometric imaging

4.1.3.1 Cephalometric imaging program settings
ORTHOselect™ cephalometric view
The cephalometric view shows which parts of the skull are imaged with the
selected imaging program.
In lateral imaging, the image field width can be manually adjusted by dragging
the slider control. The available adjustment range is indicated with a scale.
4 User interfaces
Cephalometric imaging programs

Indicates which imaging program is selected.
Press the imaging program icons to change the active imaging program;
Lateral Pediatric lateral PA projection Carpus view

projection projection
NOTICE! The carpus view program requires an optional carpus holder.
A sample image for the selected imaging program is shown on the bottom of
the GUI. The grayed out area shown in the sample image is an approximation of
the unexposed region.
Lateral projection Pediatric lateral projection
4 User interfaces
4.1.3.2 Cephalometric image preview

Zoom slider
You can zoom the preview image in/out using the zoom slider.
While zoomed in, you can click and drag to scroll the image.
Brightness slider
You can adjust the brightness of the shown preview image using the brightness
slider.
Contrast slider
You can adjust the contrast of the shown preview image using the contrast
slider.
OK button
4 User interfaces
4.1.4 3D imaging
4.1.4.1 3D imaging program settings
ORTHOselect™ dental chart
Dental chart is used to select the Region of Interest (ROI) for the 3D scan. The FOV changes automatically
according to the selections made in the dental chart.
• To individually select the studied parts of dentition, press teeth, jaw and TMJ icons:
◦ A single tooth (1)
◦ Range of teeth (2)
◦ Jaw with all teeth (3)
◦ TMJ (4)
◦ Maxillary Sinus (5)
◦ Frontal Sinus (6)
◦ Whole dentition
NOTICE! Both TMJs are selectable only with 12 x 15 and 15 x 20 FOV sizes.
• To select all parts of the dentition, double-click on any part of the dentition.
• To clear all selections, click on the gray area (7) on the lower corners of the dental chart.
• To undo the latest action and return to previous selection, double-click on any part of the dentition.
4 User interfaces
FOV size
Indicates the currently selected FOV size (H x D).
The FOV changes automatically according to the selections made in the dental
chart but can be changed manually also:
• Press the FOV size icon to open a list of the available 3D FOV sizes.
• Press on the listed FOV size icon to activate it.

The GUI illustrates an approximate coverage of the selected FOV.
NOTICE! Use the ORTHOselect™ dental chart as primary method for FOV
size selection.
NOTICE! The list of available FOV sizes depend on the device configuration
and country specification.
Image resolution
Indicates the currently selected resolution. The resolution affects the image
quality and radiation dose to the patient.
• Press the image resolution selection icon to open a list of available image
resolutions;
Low Standard High Endo
• Press on the listed resolution icon to activate it.

For recommendations on resolution selection, see chapter 3D Resolutions on
page 51.
NOTICE! Endo resolution is available only for 5 x 5 FOV.
4 User interfaces
Scout image program
A Scout image is taken to verify and perform adjustment to the FOV position
and height before initiating a full 3D scan. By default, the Scout image is always
active when taking 3D images.
When the Scout image program is active, the FOV coverage illustration turns
green.
Implant contrast enhancement
Implant contrast enhancement improves the visibility of the internal structures

of metal implants. This helps in investigation of bone integration, abutment and
crown seating.
NOTICE! This feature is designed and should only be used to examine
existing implanted metal structures such as dental implants. It is not
recommended for any other diagnostic purposes.
NOTICE! Implant contrast enhancement compresses the gray value
ranges in the whole image data to enhance visibility and distinction of
metal structures. The image data processing is irreversible.
NOTICE! Implant contrast enhancement is an optional feature,
available only for DTX Studio software users.
Example image without Example image with

enhancement: enhancement:
4 User interfaces
4.1.4.2 3D scout image

SMARTVIEW™ 2.0 scout image is shown on the GUI after the scout image has been taken. In this view you
can fine-tune the FOV (green area) size and position for the actual 3D image.
FOV height adjustment

You can adjust the height of the FOV, according the scout image, by sliding the
height adjustment icon up or down.
It's recommended to adjust the FOV size so that the ROI is in the middle of the
volume.
FOV position adjustment

You can adjust the position of the FOV, according to the scout image, by sliding
the adjustment icons left or right on the scale. The left slider adjusts the FOV
position in Posterior (P) - Anterior (A) direction and the right slider in Left (L) -
Right (R) direction.
You can also click and drag sideways on the image to adjust the FOV position.
It's recommended to adjust the FOV location so that the ROI is in the middle of
the volume.
Brightness slider
You can adjust the brightness of the shown image preview using the brightness
slider.
NOTICE! Adjustment is not saved to the image.
Contrast slider
You can adjust the contrast of the shown image preview using the contrast
slider.
4 User interfaces
OK button
Press OK button to approve the changes made to the FOV location and size
using the Scout image and to proceed to the 3D exposure.
4.1.4.3 3D image preview

NOTICE! The image has indications from which direction the image is shown; A/P (Anterior/
Posterior), L/R (Left/Right) and H/F (Head/Foot).
Slice preview projection

Indicates which preview projection is selected.
3D preview image is shown as a slice preview (left) and a rendered volume
(right) on the GUI.
Press the preview projection icons to change the projection of the shown
preview.
Coronal Sagittal Axial
Slice preview
Shows a preview of 3D slices. You can scroll through the preview using the
slider on the right side of the image.
4 User interfaces
Volume preview
Shows a preview of the 3D volume. You can rotate the preview using the slider
on the right side of the image.
Brightness slider
slider.
Contrast slider
slider.
OK button
4 User interfaces
4.1.5 Dental cast view

NOTICE! This is an optional, separately activated imaging modality.
4.1.5.1 Dental cast program selection
Image resolution
Indicates the currently selected resolution. The resolution affects the image
quality and the amount of image layers.
• Press the image resolution selection icon to open a list of available image
resolutions;
Low Standard High
Press on the listed resolution icon to activate it.
Scout image program

Indicates if the Scout image program is active.
A Scout image is taken to verify and perform adjustment to the FOV position
and height before initiating a full 3D scan.
Press the Scout image icon to deactivate/activate it.
4 User interfaces
4.1.5.2 Dental cast scout image view
FOV height adjustment

You can adjust the height of the FOV, according the scout image, by sliding the
height adjustment icon up or down.
It's recommended to adjust the FOV size so that the ROI is in the middle of the
volume.
FOV position adjustment

You can adjust the position of the FOV, according to the scout image, by sliding
the adjustment icons left or right on the scale. The left slider adjusts the FOV
position in Posterior (P) - Anterior (A) direction and the right slider in Left (L) -
Right (R) direction.
You can also click and drag sideways on the image to adjust the FOV position.
It's recommended to adjust the FOV location so that the ROI is in the middle of
the volume.
Brightness slider
slider.
Contrast slider
slider.
4 User interfaces
OK button
Press OK button to approve the changes made to the FOV location and size
using the Scout image and to proceed to the 3D exposure.
4.1.5.3 QUICKcompose™ dental cast image preview
NOTICE! Image previews are not shown in full resolution on GUI.
NOTICE! The image has indications from which direction the image is shown; A/P (Anterior/
Posterior), L/R (Left/Right) and H/F (Head/Foot).
Slice preview projection

Indicates which preview projection is selected.
3D preview image is shown as a slice preview (left) and a rendered volume
(right) on the GUI.
Press the preview projection icons to change the projection of the shown
preview.
Coronal Sagittal Axial
Slice preview
Shows a preview of 3D slices. You can scroll through the preview using the
slider on the right side of the image.
4 User interfaces
Volume preview
Shows a preview of the 3D volume. You can rotate the preview using the slider
on the right side of the image.
Brightness slider
slider.
Contrast slider
slider.
OK button
4 User interfaces
4.1.6 Device settings
1. QUALITY CONTROL
Shows a list of Quality Control (QC) programs, their completion status and last completion date.
The Quality Control (QC) programs are used to ensure that the technical performance and the image
quality of the device remains constant and valid for clinical use. Quality Control should be performed at
regular intervals, preferably at least once a month and always after calibration.
See chapter Quality control on page 79 for more information on how to take quality control images.
2. CALIBRATIONS
Shows a list of user performable device calibrations, their completion status and last completion date.
The calibrations are carried out through this menu.
See chapter Calibrations for the user on page 73 for more detailed information on calibration
programs and how to perform them.
NOTICE! The available calibration programs depend on the device configuration.
4 User interfaces
3. SETTINGS
Device settings:
Friendly name Set a name for the device, which is shown next to the device
settings icon and on the imaging software.
3D Metal Artefact Enable or disable MAR, Metal Artefact Reduction. MAR is used to
Reduction reduce the effect of metals and other dense radiopaque objects on
the 3D image.
It is recommended to keep MAR activated.
Force device language Change the language of the device GUI if needed.
It is recommended not to force the language of the GUI but change
the language profile of the workstation.
Default to Scout before 3D Enable or disable automatic Scout image activation when a 3D
imaging modality is selected. It is recommended to have the Scout
image taking enabled.
NOTICE! If the selection is set to "disabled", a Scout image
mode can still be activated manually in the 3D imaging
program selection view.
Volume level Adjust the volume level of the audible signals played by the device.
NOTICE! Does not affect exposure warning signal.
The default volume level setting is 8.
Button volume level Adjust the volume level of the audible signal played when a button
on the control panel is pressed.
The default volume level setting is 8.
Button sound Select the sound that is played when HOME, Test mode or
Patient positioning lights buttons are pressed.
4 User interfaces
Time zone Set the timezone to match the installation location. To change the
time zone, start to write the continent, capitol or state (US) and
select the correct selection from the drop down list.
Patient size settings:
Adjust the default mA and kV values for medium size patient preset. Other patient size selections are
changed relatively to the adjustment made.
Adjustments made to the 3D imaging program with standard resolution are applied relatively to other
resolution selections as well.
The default values for each program are listed in chapter Patient size setting default values on page
94.
NOTICE! The available programs and patient size presets depend on the device configuration.
4 User interfaces
4. ABOUT
Software versions Shows the serial numbers of:

• The main device
• Sensors
• Tubehead assemblies
Shows also the versions of the installed firmware and hardware.
Notices Legal information and terms and conditions for use.
Exposure counters Shows the amount of exposures taken with the device.
Network configuration Shows the current network configuration of the device:

• IP address
• Subnet mask
• Default gateway
• IP address allocation
• MAC address
• NTP server
5. SERVICE MODE
NOTICE! This menu is intended for authorized service personnel only.
This menu is used to unlock Installation and Service specific functions on the GUI.
• Additional device settings
• Calibrations for installation and service of the device
• Optional imaging programs activation
• Demonstration mode activation for exhibition use
• Verification programs for radiation related testing
To access these functions, a PIN code is required.
NOTICE! The functions unlocked by the PIN code are highlighted with coloured indicators.
4 User interfaces
4.2 Control panel
1. Device height controller. Move the device up/down by pressing on the device height controller. The
device can move in two speeds, slow and fast.
MOVE DEVICE UP
1. Press the underside of the controller to move 2. Press also the top of the controller to move
slowly. faster.
MOVE DEVICE DOWN
1. Press the top of the controller to move slowly. 2. Press also the underside of the controller to
move faster.
2. Patient positioning lights button. Turn the patient positioning lights on/off.
3. Test mode button. Disable radiation production of the device. You can also use the GUI to activate the
Test mode.
4 User interfaces
4. Device status indicators. Device status indicators light up according to the device status.
Ready
Device is ready for imaging.
Error state
Device is in error state or pending user action. Check the GUI for details.
Exposure
Device is generating X-rays.
5. HOME button. Move the device to HOME (Patient-In) and scan start positions.
CONTROL PANEL STATUSES

Status Explanation
Device power off Control panel lights are off.
All button lights are "breathing"

slowly.
Device in power save mode
Press any button or the height
controller to wake up the device.
HOME button light is flashing.

Device requesting user input Press the HOME button to
complete action.
Button light is dim but visible.

Button/Function is enabled Press the button to activate the
function.
Button light is on.

Button/Function is active The function is active as long as
the light is on.
4.3 Status indicator light

Device status indicator light, located on the top of the carriage, illuminates according the device status:
• GREEN: Device is ready for imaging.

• YELLOW: Device is generating X-rays.
• BLUE: Device is in error state or pending user action.
Check the GUI for details.
5 Imaging programs
5 Imaging programs
5.1 Panoramic programs

NOTICE! The image field dimensions and segment widths and height differences shown here are for
illustrative purposes only.
Standard Panoramic imaging program
The Standard Panoramic imaging program provides general view of dental and facial anatomy
based on panoramic imaging technique.
You can choose which segments of the dentition are imaged if imaging of the whole dentition is
not required. Press the segments on the dental chart to deselect and select them.
Pediatric Panoramic imaging program
The Pediatric Panoramic imaging program provides a general view of the dental and facial
anatomy based on panoramic imaging technique for pediatric patients while using smaller
radiation dose and smaller imaging area.
Adult patients with exceptionally narrow jaw can also be imaged with this program but note
that the image height is limited.
You can choose which segments of the dentition are imaged if imaging of the whole dentition is
not required. Press the segments on the dental chart to deselect and select them.
5 Imaging programs
Bitewing program
A bitewing view of the patient's Premolar-Molar region dentition.

You can choose to image both or only other segment in single scan. Press the segments on
the dental chart to deselect and select them.
TMJ, lateral projection
Lateral TMJ program provides a lateral view of the patient's left and right temporomandibular
joints.
You can choose to image both or only other segment in single scan. Press the segments on
the dental chart to deselect and select them.
5 Imaging programs
5.2 Cephalometric programs

NOTICE! These programs are available only for cephalometric devices.
Cephalometric programs provide projection images of patient skull and dental anatomy. Images are utilized
in orthodontics and general diagnostics.
NOTICE! The image field dimensions shown here are for illustrative purposes only.
Cephalometric lateral projection
The lateral projection uses a full height image field that provides a nearly full skull image.
You can adjust the width of the image field by dragging the slider control on the cephalometric
view. The available image field widths, represented at the image plane, are 16-26 cm. The
image field starts at the center of the ear rods with the smallest image width selection.
The exposure time depends on the width of the selected image field.
Cephalometric pediatric lateral projection
The pediatric lateral projection is a lateral projection with a reduced image height, optimized
for pediatric patients.
The program can also be used for adult patients to reduce the radiation dose when imaging
of the upper part of the skull is not necessary. The pediatric lateral projection covers all typical
cephalometric landmarks from the glabella to the spine.
You can adjust the width of the image field by dragging the slider control on the cephalometric
view. The available image field widths, represented at the image plane, are 16-26 cm. The
image field starts at the center of the ear rods with the smallest image width selection.
The exposure time depends on the width of the selected image field.
5 Imaging programs
Cephalometric Posterior-Anterior (PA) projection
PA projection imaging can be used, for example, to identify any facial asymmetries,
dentoalveolar asymmetries, dental cross-bite and mandibular displacement.
In PA projections, the patient faces away from the tubehead to keep the radiation dose to
patient's eyes in minimal level.
PA projection uses a full height image field.
Carpus view (optional)

The carpus view can be used, for example, to determine the patient's bone age for orthodontic
treatment planning.
The carpus view program requires a separate optional carpus holder to be attached to the
device.
5 Imaging programs
5.3 3D programs
NOTICE! These programs are available only for 3D devices.
Always select the smallest feasible FOV size, resolution and imaging parameters for the 3D image in order to
follow the ALARA (As Low As Reasonably Achievable) principle.
NOTICE! It is always up to the dental professional to select the appropriate FOV, resolution and
imaging parameters.
5.3.1 FOV Sizes

The FOV sizes are presented as the Height x Diameter of the 3D volume in centimeters. For example FOV
5 x 5 corresponds to a cylindrical volume with diameter of 5 cm and height of 5 cm.
NOTICE! Fine adjustment of the FOV location and FOV height can be done using the scout images.
The location of the FOV is determined by the selected ROI.
NOTICE! Available FOV sizes depend on the device configuration and country specification.
NOTICE! FOV sizes 12x15 and 15x20 are optional programs and available only with a separately
purchased license.
FOV 5 x 5
Optimized for single site implants or localized diagnostics, for example, 3rd molar
extractions, impacted teeth, periodontal cases, root fractures, single TMJ analysis,
endodontics and for pediatric imaging.
Available resolutions:
Low (LDT)
Standard
High
Resolution optimized for endodontic

imaging:
Endo
5 Imaging programs
FOV 6 x 9 / 6 x 8
Optimized for multiple implant placement using surgical guides, imaging
the whole dental arc of one jaw, 3rd molar visualization, pathology (bilateral
analysis) and periodontal cases.
Low (LDT)
Standard
High
FOV 10 x 10 / 8 x 8
Optimized for imaging the entire dentition, both mandibula and maxilla with
portion of maxillary sinuses.
Low (LDT)
Standard
High
5 Imaging programs
FOV 12 x 15
Optimized for imaging the entire dentition, both mandibula and maxilla, including airway
and upper cervical spine or the sinus, maxillary sinuses, jaws with bilateral joints, jaws with
airways, analyses of both TMJs and for maxillofacial surgeries.
Low (LDT)
Standard
High
FOV 15 x 20
Optimized for imaging the maxillofacial complex, both mandibula and maxilla, including
airway and upper cervical spine or the sinus, maxillary sinuses, jaws with bilateral joints,
jaws with airways, analyses of both TMJs, maxillofacial surgeries and orthodontic analyses.
Low (LDT)
Standard
High
5 Imaging programs
5.3.2 3D Resolutions
The resolution affects the image quality and radiation dose to the patient. For example, high resolution will
produce more details than standard resolution, but the radiation dose is also higher. The unit offers a LDT
(Low Dose Technology™) resolution which can be used for example in treatment follow-up cases. The LDT
resolution will result in images proportional to the low dose and it is up to the healthcare professional to
decide when it is sufficient to be utilized.
Resolution setting General recommendations for the use

Low (LDT) resolution Implants, treatment follow up, children
Standard resolution Implants, 3rd molars, TMJ, impacted teeth, resorptions
High resolution Pathologies, alveolar bone defects, root fractures
Endo resolution Endodontic cases (periapical infections, root canals,

fractures, etc.). Available only for 5x5 FOV.
5.4 Dental cast program

The dental cast program is initially taken with FOV 10 x 10. The height of the FOV can be adjusted after
scout image.
NOTICE! The resolution selection affects the amount of
image layers produced. Dose production is not affected.
Low resolution
Standard resolution
High resolution
6 Using the device
6 Using the device
6.1 General imaging workflow
Power on and Prepare Select imaging program

initialize the device imaging software
DTX
STUDIO
20.3 cm
Attach patient positioning accessories Select patient size or

and position patient to device set imaging parameters
66 kV 66 kV
10.0 mA
10 mA
3D 2D
Release patient
Take Scout Take X-ray and end study
image image
Adjust FOV
6 Using the device
6.2 Powering on/off the device

POWERING ON THE DEVICE
1. Push the power switch to ON (I) position. Power switch is located at the rear of the carriage.
2. The device starts the initialization process.

3. Press HOME button on the control panel when the indicator light starts blinking in blue. The device GUI
also indicates when HOME button can be pressed.
NOTICE! The device moves up or down when HOME button is pressed.
NOTICE! The device enters a power save mode after 30 minutes of inactivity. While in the
power save mode, the device cooling fan is not active, but the control panel lights are lit. The
device wakes up from the power save mode when connection to it is established or when the
HOME button is pressed.
POWERING OFF THE DEVICE

1. Push the power switch to OFF (O) position. The device should be powered off when not in use.
2. Device can be isolated from the mains by detaching the mains cable plug from the rear of the device
(under a cover, below the power switch) or cutting off the power supply from an external mains isolation
switch (not supplied with the device).
NOTICE! Press the yellow locking piece in to release the mains cable plug.
6 Using the device
6.3 Preparing the device for imaging

1. Power up the workstation.
2. Launch the dental imaging software.
3. Imaging SW: Select the patient for examination.
4. Imaging SW: Select the device to establish a connection.
NOTICE! Refer to the dental imaging software documentation for more details.
5. The device GUI opens on the workstation when the connection to the device is established.
NOTICE! The device must be powered on and initialized before the connection is established.
6. GUI: Select the imaging modality, imaging program and patient size to set up the device. If the
preset selections are not suitable for the patient in question, adjust the imaging parameters manually.
Imaging modality
Imaging program
Patient size
Imaging parameters
NOTICE! Exercise special care when imaging patients outside the typical adult size range,
especially smaller pediatric patients. When imaging pediatric patients follow the ALARA (As
Low As Reasonably Achievable) principle and seek to reduce the radiation dose to the amount
necessary to acquire images that are clinically adequate. This can be achieved for example
through utilizing the pediatric imaging programs and adjusting the imaging parameters for the
patient in question.
6 Using the device
6.4 Patient positioning

6.4.1 Patient positioning for Panoramic imaging
NOTICE! The device can be used to take images of both standing and seated patients. It is
recommended to have very tall patients seated for easier positioning.
1. Press HOME button. The device moves to HOME (Patient-In) position.
NOTICE! Make sure that the device is set up correctly for the intended examination.
2. The device goes to ready state and the status indicator light turns green.
NOTICE! If the status indicator light does not turn green, look for more information on the GUI.
3. Select the patient positioning accessory according to the image to be taken, attach it to the chin rest
and place them on the lower shelf of the device, as shown below.
Standard and Pediatric Standard and Pediatric TMJ imaging

panoramic and Bitewing panoramic and
imaging for dentate patients Bitewing imaging for
edentulous patients
Bite Block + Chin Rest Lip Support + Chin Rest Lip Support + Chin Rest
NOTICE! The Chin Rest needs to be attached to the device in the correct orientation for the
selected imaging program before the device allows images to be taken.
6 Using the device
4. Place disposable covers on the patient positioning accessories.
5. Adjust the device's height to approximately match the patient's height.
6. Open the head support.
7. Tell the patient to remove their glasses, hearing aids, removable dentures, jewellery, hair clips and all
other things that can cause artifacts to the image.
8. Protect the patient from radiation according to the local regulations, for example with a lead apron or a
thyroid shield.
9. Guide the patient to the device and instruct to stand as straight and as tall as possible.
10. Tell the patient to hold the patient handles, place their chin on the chin rest and to bite the notches on
the bite block or to push their lip against the lip support if it is used.
CAUTION! Evaluate the condition of the patient’s dentition before using the Bite Block. If the
patient's teeth are more fragile than a normal healthy patient's, use the Lip Support and a cotton
roll between the front teeth instead.
NOTICE! If the patient has wide shoulders that could collide with the rotating unit, ask the
patient to cross their arms when holding the handles in order to contract the shoulders.
11. Ask the patient to take a step forward to straighten their spine.
6 Using the device
12. Fine adjust the device height and adjust patient's head position/orientation using the patient positioning
lights as guides.
NOTICE! To ensure optimal image quality, pay attention to the correct patient positioning.
NOTICE! You can open the mirror and use it to help in positioning the patient. Close the mirror
before you start the imaging.
STANDARD AND PEDIATRIC PANORAMIC IMAGING:
• Align the patient so that the root tips of lower and upper incisors are vertically aligned and parallel
to the Tilt light. The ORTHOfocus™ feature automatically finds the optimum panoramic image layer,
enabling forgiving patient positioning.
NOTICE! When you align the incisors to the same vertical level, the patient's Frankfort-
Horizontal plane is also in the necessary orientation and close to parallel to the FH light.
NOTICE! In rare cases, typically caused by abnormal anatomy, if the ORTHOfocus™
feature cannot find the optimal image layer, the device provides 5 different image layers to
use in diagnosis.
BITEWING IMAGING:
• The patient’s occlusal plane should be horizontal and parallel to the FH light.
6 Using the device
TMJ IMAGING:
• The patient’s Frankfort-Horizontal plane should be close to parallel to the horizontal light. The FH
light indicates the center of the field. You can take a TMJ image with the patient's mouth closed or
open.
13. Check that the patient’s head is straight and not rotated and the patient’s mid-line coincides with the
midsagittal light.
14. Close the head support.
15. Adjust the forehead support against the patient's forehead.
16. Ask the patient to close their lips and press their tongue against the palate if possible.
6 Using the device
6.4.2 Patient positioning for Cephalometric imaging

NOTICE! The device can be used to take images of both standing and seated patients. It is
recommended to have very tall patients seated for easier positioning.
1. Press HOME button. The device moves to CEPH HOME (Patient-In) position.
NOTICE! Ensure that the device has been set up correctly for the required examination.
3. Turn the CEPH head support to Lateral or PA position, according to the required examination.
Lateral projection Posterior-Anterior (PA) projection
4. To ease the patient entry you may turn the nasion support an the ear rods aside and pull them to their
out-most position.
5. Place disposable covers on the ear rods and nasion support.
6 Using the device
thyroid shield.
10. Turn the ear rods down if they were previously turned aside.
11. Fine adjust the device height so that the ear rods are on the level of the patient's ear canals.
12. Slide the ear rods gently to the patient's ears so that the tips hit the patient's external auditory canals.
6 Using the device
13. Adjust the patient's head position/orientation.

LATERAL PROJECTION:
• The patient's Frankfort-Horizontal plane should be horizontal. Use the FH light as a guide.
PA PROJECTION:
The patient's Frankfort-Horizontal plane should be horizontal.
NOTICE! The horizontal light is not lit for PA projections.
PA REVERSE TOWNE PROJECTION:
• Turn the patient's head downwards until the angle between the patient’s Frankfort-Horizontal plane
and the horizontal light is around 30°.
• The patient's mouth should be opened fully and pressed against the neck/upper chest.
6 Using the device
PA WATERS PROJECTION:
• Turn the patient's head upwards until the angle between the patient’s Frankfort-Horizontal plane
and the horizontal plane is around 35-40°.
14. Turn the nasion support down and slide it against the patient's nasion when taking Lateral projections.
patient to cross their arms in front of them in order to contract the shoulders.
15. Ask the patient to gently bite their molars together, if possible.
16. When taking a Lateral projection, ask the patient to close their lips.
6 Using the device
6.4.3 Patient positioning for Carpus imaging

The Carpus imaging program requires a special carpus holder (optional) to be used.
CAUTION! Before taking a Carpus image, make sure the imaging method is approved by local
authorities.
1. Press HOME button. The device moves to CEPH HOME (Patient-In) position.
NOTICE! Ensure that the device has been set up correctly for the required examination.
3. Turn the cephalometric unit's head support to PA position.
4. Move the nasion support to its out-most position and turn it aside, to the direction shown in the image.
You may also turn the ear rods aside for easier positioning.
5. Attach the carpus holder by sliding it to the base of the nasion support.
6 Using the device
6. Adjust the device height if needed.

7. Ask the patient to remove any jewellery and all other things that may cause artifacts to the image.
8. Protect the patient from radiation according to the local regulations, for example using a lead apron.
9. Ask the patient to place their palm against the carpus holder with their fingers spread apart and wrist
straightened. The palm of the hand should face the sensor.
NOTICE! Only the center area of the carpus holder is exposed. Ensure that the patient's hand
is positioned so that the imaged parts are on the center area of the carpus holder (white area in
the image above).
NOTICE! You may place the patient's hand diagonally on the carpus holder if it doesn't fit
properly otherwise.
6 Using the device
6.4.4 Patient positioning for 3D imaging

NOTICE! The device can be used to take images of both standing and seated patients. In 3D
imaging, having patient seated can decrease unwanted patient movement.
1. Press HOME button. The device moves to HOME (Patient-In) position.
NOTICE! Make sure that the device is set up correctly for the intended examination.
3. Select the patient positioning accessory according to the image to be taken, attach it to the chin rest
and attach them on the lower shelf of the device, as shown below.
Lower jaw or both jaws Upper jaw

Lip Support + Chin Rest Lip Support + Chin Rest
NOTICE! It is possible to take 3D images with FOV 15 x 20 without chin rest if diagnostic need
requires it and reduced patient support is justified.
4. Place disposable covers on the patient positioning accessories.
6 Using the device
6. Open the head support.
thyroid shield.
10. Ask the patient to grab the patient handles and place their chin on the Chin Rest and press their lip
against the Lip Support.
patient to cross their arms when holding the handles in order to contract the shoulders.
NOTICE! If you are taking FOV 15 x 20 image without a chin rest, use the horizontal lights to
determine the correct height for the head support and patient head.
11. Ask the patient to take a step forward to straighten their spine.
6 Using the device
12. Fine adjust the device height and adjust patient's head position/orientation using the patient positioning
lights as guides.
NOTICE! You can open the mirror and use it to help in positioning the patient. Close the mirror
before you start the imaging.
• The patient's occlusal plane should be horizontal and the ROI is between the top and bottom FOV
lights.
NOTICE! You may place a cotton roll or similar between the patient's front teeth to separate the
jaws.
13. Check that the patient’s head is straight and not rotated and the patient’s mid-line coincides with the
midsagittal light.
14. Close the head support.
6 Using the device
15. Adjust the forehead support against the patient's forehead.
6.5 Taking an image

The exposure button is used to operate the device movements and X-ray generation
during the imaging process.
The exposure button must be pressed down for the whole duration of the imaging
process.
If device movements and exposure must be stopped prematurely, release the exposure
button or activate the emergency stop switch.
NOTICE! If the patient is feeling insecure or has an exceptional anatomy, use the Test mode to
demonstrate the unit movements and to make sure that the rotating unit does not collide with the
patient during the imaging process. Activate the Test mode from the GUI or the control panel and
then press and hold the exposure button. The unit will complete the imaging movements without
generating X-rays.
6.5.1 Taking Panoramic and Cephalometric images

1. Ensure the correct patient positioning, imaging program selection, imaging parameters and that the
device is in Ready state with the indicator light turned green.
2. Press HOME button. The device moves to IMAGING START position and locks the device in place to
prevent unwanted movement.
NOTICE! This is an optional step but decreases the imaging process time and the time that the
patient must stay still.
NOTICE! The device stays in the IMAGING START position for 1 minute.
3. Ask the patient to stay still during the whole imaging process.
4. Protect yourself from radiation.
5. Press and hold the exposure button down to take the image. The device starts to move and plays an
audible exposure warning signal.
6 Using the device
6. Release the exposure button after all device movements stop and the device plays an audible program
end signal.
7. A preview image appears on the GUI for a quick review (no visible artifacts etc.).
8. Acknowledge the preview by pressing the OK button.
9. Continue to take the next image, if multiple images need to be taken.

10. Release the patient from the device.
11. Remove all disposable covers and decontaminate the device and the patient positioning accessories.
6.5.2 Taking Scout and 3D images
NOTICE! It's recommended to have Scout mode enabled by default. If you do not
wish to take a Scout image, deactivate the selection from the GUI.
1. Ensure the correct patient positioning, imaging program selection and that the device is in Ready state
with the indicator light turned green.
2. Ask the patient to stay still during the whole imaging process.
4. Press and hold the exposure button down.
5. The device starts to move and an audible exposure warning signal is played.
6. Hold the exposure button down until all movements have stopped.
NOTICE! The device also plays a program end tone when the imaging process is complete.
7. The Scout image appears on the GUI.

8. GUI: Adjust the FOV height, diameter and location using the Scout image, if needed.
NOTICE! You can verify the adjustments by pressing the exposure button to take another scout
image. Scout images produce only a small radiation dose so taking additional scout images
won't produce excessive radiation dose to the patient.
9. GUI: Approve the scout image and proceed to the 3D imaging phase by pressing OK button.
6 Using the device
10. Press HOME button. The device moves to IMAGING START position and locks the device in place to
prevent unwanted movement.
NOTICE! This is an optional step but decreases the imaging process time and the time that the
patient must stay still.
NOTICE! The device stays in the IMAGING START position for 1 minute.
11. Ask the patient to stay still until the 3D image has been taken.
13. Press and hold the exposure button down to take the image. The device starts to move and plays an
audible exposure warning signal.
14. Release the exposure button after all device movements stop and the device plays an audible program
end signal.
15. Image preview appears on the GUI for a quick review (no visible artifacts etc.).
17. Continue to take the next image, if multiple images need to be taken.
18. Release the patient from the device.
19. Remove all disposable covers and decontaminate the device and the patient positioning accessories.
6.5.3 Taking Dental cast images
NOTICE! You can take a Scout image of the dental cast before the actual 3D image
by activating the Scout selection from the GUI.
1. Attach Chin rest to the lower shelf of the device.
6 Using the device
2. Attach the Dental cast holder over the Chin rest.
3. Place the dental cast on the holder as shown on the GUI.

5. Press and hold the exposure button down.
6. The device starts to move and an audible exposure warning signal is played.
7. Hold the exposure button down until all movements have stopped.
NOTICE! The device also plays a program end tone when the imaging process is complete.
8. A preview image appears on the GUI for a quick review (no visible artifacts etc.).
7 Maintenance
7 Maintenance
The maintenance and calibration procedure intervals described here are minimum requirements and
recommendations. The maintenance and calibration procedures can be made more frequent and stringent
to comply with local regulations regarding the use and maintenance of dental X-ray devices.
7.1 Cleaning and decontamination

NOTICE! Decontamination techniques for the device, its accessories and the room must comply
with all laws and regulations within the local jurisdiction.
NOTICE! Clean the patient positioning accessories before their first use.
NOTICE! Bite block and ear rods must always be used with new disposable covers.
CLEANING THE 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 decontaminant that is formulated specifically for decontaminating dental equipment
and use it in accordance with the instructions supplied with it. Wipe all items and surfaces dry after the
decontamination.
WARNING! Do not use any disinfecting aerosols, since the vapors could ignite causing injuries.
NOTICE! Wear gloves and other protective equipment during the decontamination process.
CLEANING THE DEVICE:

The device should be cleaned regularly.
CAUTION! Switch the device off or isolate it from mains before cleaning the device.
CAUTION! Do not allow water or other cleaning liquids to enter the device's interior since it might
cause short-circuits or corrosion. If you use a spray cleaner do not spray into any ventilation grills.
CAUTION! Clean the dust off the device regularly. The device might overheat if excess dust is
gathered on the ventilation grills.
Device surfaces
All device surfaces can be wiped clean with a soft cloth dampened with a mild detergent, for example soapy
water. DO NOT use abrasive cleaning agents or polishes.
Control panel
Wait for the control panel to dry or wipe it dry before use. Moisture can affect the usability of the panel.
Allowed cleaning agents for cleaning and decontamination of the device:

• Distilled water
• Ethanol 96%
• Isopropyl alcohol
• Soapy water
• CaviCide™, CaviWipes™ or Metasys™ disinfectant
7 Maintenance
7.2 Calibrations for the user

7.2.1 When to calibrate the device
The device must be calibrated and, if necessary, adjusted at regular intervals in accordance with the
national regulations regarding the use, maintenance and service of dental X-ray devices.
NOTICE! The device has multiple calibration programs, but only the ones listed in this chapter are
meant to be performed by the user.
NOTICE! Some of the calibrations presented in this chapter are not applicable to all device
configurations. Only the applicable and required calibration programs are listed on the GUI.
Minimum calibration frequency Recommended calibration frequency

2 times / year 4 times / year
NOTICE! The device will automatically remind of the re-calibrations (2 times a year for User
calibrations and once a year for service calibrations by default). If you want to change the frequency
of the recalibration reminders, contact service for assistance.
DEVICE CALIBRATION BASIC GUIDELINE

1. The device must be recalibrated completely at least once a year, by a service technician according
to the device installation manual. The last calibration date for each program is listed in the calibration
menu.
2. The device must be fully calibrated after the first installation.
3. The device must be recalibrated when parts are replaced, as described in the device service manual.
4. Take QC images always after calibration to ensure good and consistent image quality.
7.2.2 Preparation for calibration

The calibration programs help you to maintain the image quality and correct operation of the device.
Calibration data is stored in the device memory and is used for later calibrations and image processing.
NOTICE! Perform the calibrations in the exact order as described in this chapter and as they are
listed on the GUI.
1. GUI: Go to device settings.
2. GUI: Select Calibrations menu.
7 Maintenance
3. A list of available device calibrations is shown with the status of the calibration.
NOTICE! The calibration programs listed on the GUI depend on the device configuration.
Calibration status indications:
Calibration not performed or Recalibration is required. Calibration performed

failed. successfully.
4. Select a calibration program and follow the instructions on the GUI.
NOTICE! Performed calibrations are indicated with green colour and the completion date of the
calibration. All calibrations need to be successfully performed before using the device.
NOTICE! Calibration images are shown on the GUI as viewed from the sensor.
7 Maintenance
7.2.3 Calibration procedure

NOTICE! Some calibrations in this chapter are not available with all device configurations. Perform
the calibrations in the exact order as shown on the GUI.
After you have run all available calibrations successfully, take quality control images as instructed in chapter
Quality control on page 79.
NOTICE! Calibration result images may show some artefacts without them having an effect on the
image quality. Always verify the image quality from the QC images.
7.2.3.1 3D pixel calibration

This program calibrates the sensor for 3D imaging.
No calibration tools are required when performing this calibration.

NOTICE! This calibration produces X-rays. Protect yourself from radiation.
NOTICE! Make sure that PAN/3D tubehead front cover and sensor covers are installed. Calibrating
without the covers may have an effect on the image quality.
1. Select 3D pixel calibration from the Calibrations menu.

3. Press and hold the exposure button down to take the calibration image.
4. When the exposure warning stops and the program end tone is played, the program is complete.
5. The calibration image appears on the GUI.
6. Acknowledge the calibration result by pressing the OK button.
7 Maintenance
7.2.3.2 PAN pixel calibration

This program calibrates the sensor for Panoramic imaging.

NOTICE! Make sure that PAN/3D tubehead front cover and sensor covers are installed. Calibrating
without the covers may have an effect on the image quality.
1. Select PAN pixel calibration from the Calibrations menu.

7 Maintenance
7.2.3.3 3D geometry calibrations

These programs create the calibration data for reconstructing 3D images.
NOTICE! The list of available calibrations depend on the device configuration and country
specification.
Perform the calibrations in this order, the instructions are the same for all programs:
• 3D geometry calibration, 10x10 FOV LS
• 3D geometry calibration, 10x10 FOV H
• 3D geometry calibration, 12x15 FOV
• 3D geometry calibration, 15x20 FOV
Geometry Calibration Phantom is required when performing these calibrations.
1. Attach the Geometry Calibration Phantom to the device.
2. Select a 3D geometry calibration from the Calibrations menu.

5. The calibration results appear on the GUI.
NOTICE! This will take several minutes.
6. Acknowledge the calibration by pressing the OK button.
7. Repeat the calibration for the remaining FOV sizes.
7 Maintenance
7.2.3.4 CEPH pixel calibration

This program calibrates the sensor for Cephalometric imaging.

1. Turn the CEPH head support to LAT position.

2. Move the nasion support to its outmost position an turn it down.
3. Select CEPH pixel calibration from the Calibrations menu.
7 Maintenance
7.3 Quality control

The Quality Control (QC) programs are used to ensure that the technical performance and the image quality
of the device remains constant and valid for clinical use. Quality Control should be performed at regular
intervals, preferably at least once a month and always after calibration.
NOTICE! The device will automatically remind of retaking the QC images. If you want the change the
frequency of the reminders, contact your service for assistance.
NOTICE! QC programs produce X-rays. Protect yourself from radiation.
7.3.1 PAN QC
NOTICE! The PAN QC is a recommended procedure but some local regulations/authorities may
require it to be performed.
NOTICE! The PAN QC requires separately purchasable 2D Quality Control tools.
2. GUI: Select PAN QC program from the Quality control menu.
3. Attach the PAN QC phantom holder and 2D QC test phantom to the lower shelf.
4. Attach the copper filter in front of the radiation window on the PAN/3D tubehead. The filter attaches in
place with magnets.
7 Maintenance
6. Press and hold the exposure button down to take the QC image.
7. The QC image preview appears on the GUI.

8. Acknowledge the preview by pressing the OK button on the GUI.
9. Workstation: Visually evaluate the image using the dental imaging software:
A: Smoothness of the exposed area.

B: Non-exposed area surrounds the whole image.
C: High contrast resolution; the distinguishable line pair resolution should be:
• 3.1 LP/mm or better when using 0.8mm Copper filter
• 2.5 LP/mm or better when using 1.8mm Copper filter
D: Low contrast holes must be visible:
• 4 holes when using 0.8mm Copper filter
• 2 holes when using 1.8mm Copper filter
NOTICE! You should also compare the new QC image to the reference image taken during the
installation or the latest service. Doing this helps you ensure that the image quality has remained
constant.
NOTICE! The line pair resolution depends also on the other factors than the device itself, for
example the imaging Software configurations. According to the standards, the distinguishable
line pair resolution must be 2.5 LP/mm or better.
10. If the image fails on any of the previously listed criteria, redo the QC program. If it fails again, recalibrate
the device according to Calibration procedure on page 75 or contact service.
11. Detach the PAN QC phantom holder and 2D QC test phantom from the device.
12. Detach the copper filter from the PAN/3D tubehead.
7 Maintenance
7.3.2 3D QC
2. GUI: Select 3D QC program from the Quality control menu.
3. Attach the 3D QC phantom holder and the 3D QC phantom to the lower shelf.

6. The QC image preview appears on the GUI, showing the result of the check.
7 Maintenance
8. Workstation: Visually evaluate and inspect the 3D image for visual defects such as artifacts using the
3D imaging software.
NOTICE! The device determines if the QC image is PASSED or FAILED according to measured
data, not based on the visible image quality.
constant.
9. If the image fails or any visual defects are apparent, redo the QC program. If it fails again, recalibrate
the device according to Calibration procedure on page 75 or contact service.
10. Detach the 3D QC phantom and the 3D QC phantom holder from the device.
7 Maintenance
7.3.3 CEPH QC
NOTICE! This program is available only for devices with cephalometric (CEPH) modality.
NOTICE! The CEPH QC is a recommended procedure but some local regulations/authorities may
require it to be performed.
NOTICE! The CEPH QC requires separately purchasable 2D Quality Control tools.
2. GUI: Select CEPH QC program from the Quality control menu.
3. Turn the CEPH head support to PA position.

4. Turn the nasion support aside.
5. Attach the CEPH QC phantom holder to the ear rods so that the indicator on the holder faces the CEPH
tubehead.
6. Attach the 2D QC test phantom to the CEPH QC phantom holder.
7 Maintenance
7. If required by the local regulations, attach the copper filter in front of the radiation window on the CEPH
tubehead. The filter attaches in place with magnets.

10. The QC image preview appears on the GUI.

12. Workstation: Visually evaluate the image using the dental imaging software:
a) Smoothness of the exposed area.

b) Non-exposed area surrounds the whole image.
c) High contrast resolution; the distinguishable line pair resolution should be:
• 3.1 LP/mm or better if copper filter was not used
• 2.5 LP/mm or better if 0.8 mm copper filter was used
d) Low contrast holes must be visible:
• 4 holes if copper filter was not used
• 2 holes if 0.8 mm copper filter was used
constant.
NOTICE! The line pair resolution depends also on the other factors than the device itself, for
example the imaging Software configurations. According to the standards, the distinguishable line
pair resolution must be 2.5 LP/mm or better.
13. If the image fails on any of the previously listed criteria, redo the QC program. If it fails again, redo the
CEPH calibrations according to Calibration procedure on page 75 or contact service.
7 Maintenance
14. Detach the CEPH QC phantom holder and 2D QC test phantom from the device.
15. Detach the copper filter from the CEPH tubehead if it was used.
7.4 Annual maintenance

An authorized service technician must carry out a full inspection of the device once a year.
The following checks must be carried out during the inspection:
• Check that the mains cord is not damaged in any way.
• Check that the protective earth is connected.
• Check that all fixing screws are tight.
• Check that the positioning lights operate correctly and are aligned correctly.
• Check that no oil is leaking from the tubehead.
• Check that all covers and mechanical parts are correctly secured and have not come loose.
• Check that any vents in the covers are not blocked with dust and that no dust has accumulated inside
the device.
• Check the functionality of the power switch.
• Check the functionality of the Emergency stop switch.
• Check the Z-movement limits.
• Check that the exposure warning indicators work correctly.
• Check device movements and functionality of exposure button.
During the annual maintenance, all calibrations and QC programs must be performed according to the
device installation manual.
The full maintenance procedure is described in detail in the device service manual.
8 Troubleshooting
8 Troubleshooting
Problem Possible cause Solution

Image is not transferred to the Local network connection is The device stores the latest image
workstation. disrupted, which causes loss of until a confirmation of a successful
data. transfer to the workstation
is received. Re-establish the
local network connection and
the image data is transferred
automatically. Do not power the
device off or the image will be
erased.
Message "Release control panel • A button is pressed down 1. Make sure that you are not
buttons" shows on the GUI. during the during the device pressing any button. The
initialization. message should clear and
• Button mechanics in the the initialization continue.
control panel is stuck or 2. Contact service if the
broken. problem persists.
No connection to the device. • The device is not powered on. 1. Power the device on.
• Problem with the local area 2. Check the Ethernet
network. cable connections on the
• Check the device workstation and the device.
configuration. 3. Restart the device and the
workstation.
Device shows error message Device has detected an issue Contact service. The device can
about disabled modalities. with one or more of its functions be used normally with the enabled
and has disabled their use. After functions in the meantime.
the next device boot the faulty
functions are removed from the
GUI.
Calibration and QC program date- The device receives the system 1. Restart the device and redo a
and timestamps are incorrect. time from the network it is calibration or QC program to
connected to during start-up. check if the device receives
If the time stamps in the the time correctly.
Calibration and Quality control 2. Check that the system time
menus are incorrect, the system is correct on the acquisition
time has not been received workstation, or any other
correctly. computer that may operate
as network time server in the
local network.
3. Check that the acquisition
workstation has UDP port
123 opened in the firewall
and the NetTime service
installed and running.
GUI shows a message "Detach Issue in CEPH head support Recalibrate the CEPH head
carpus holder" even though the calibration. support (service technician only).
carpus holder is not attached.
9 Technical data
9 Technical data
9.1 Technical specifications
General device information

Manufacturer: PaloDEx Group Oy
Nahkelantie 160, FI–04300 Tuusula, FINLAND
Model: PCX–1
Protection against electric shock Class I
Degree of protection Type B applied with no conductive connection to the patient
Protection against the ingress of liquids IP20
Cleaning agents and protection against • Distilled water
cross contamination • Ethanol 96%
• Isopropyl alcohol
• Soapy water
• Cavicide™ disinfectant
• CaviWipes™ disinfectant
• Metasys™ disinfectant
• Disposable plastic covers for bite block, chin rest, lip
support
• Disposable plastic covers for ear rods and nasion support
(CEPH only)
Use environment In environments where no flammable anesthetics nor

flammable cleaning agents are present
Mode of operation Continuous operation/intermittent loading
Source of power Mains connection
EMC Classification Class B
Conformity This product complies with DHHS 21 CFR Chapter I,
Subchapter J at the date of manufacture.
The device is in conformity with the Regulation (EU) 2017/745
of the European Parliament and of the Council on medical
devices.
RoHS directives 2011/65/EU and EU 2015/863 on the
restriction of the use of certain hazardous substances in
electrical and electronic equipment.
9 Technical data
Tubehead assembly
Tubehead assembly THA/HVGEN PCX
Tube type D–054S or equivalent
Stationary anode
Tube voltage 60 – 95 kV
Max. tube current 16 mA
Target angle 5°
Focal spot 0.5 (IEC 60336/2020)
Total filtration min. 3.4 mm Al @ 95 kV
Additional filtration of cover materials max. 1.6 mm Al @ 95 kV
(CEPH only)
Leakage technique factors PAN: 4613 mAs/h @ 90 kV/12.5 mA
3D: 2880 mAs/h @ 95 kV/4 mA
CEPH: 4736 mAs/h @ 95 kV/11 mA
NOTICE! Leakage technique factors may be impacted by ambient temperature or used workstation.
Electrical connections
Nominal mains voltage 100 - 240 VAC
Tolerance: ± 10%
Over-current release in the supply mains 220–240 VAC: 16A T 250V

100–120 VAC: 20A T 250V
Input power frequency 50 / 60 Hz
Nominal current 10 A @ 220–240 VAC, 15 A @ 100 – 120 VAC
Main fuses (F1 & F2) 220–240 VAC:
Littelfuse 215 (Time–Lag) 10 A
Cooper Bussman (Time Delay) S505H–10–R
100–120 VAC:
Littelfuse 326 (SlowBlow) 15 A
Cooper Bussman (Time Delay) MDA–15
External warning light fuse (F3) Cooper Bussmann (Time Delay) S506–2–R 2 A
Power consumption 2.3 kVA @ 220–240 VAC, 1.65 kVA @ 100–120 VAC
Maximum impedance of mains 0.2 Ω
Mains cord EU 230V: 16 A / 250 VAC; 50/60 Hz H05VV–F3G1.5
US 115V: 15 A / 125 VAC 50/60 Hz SJT 3 x AWG 14
US 230V: 15 A / 250 VAC 50/60 Hz SJT 3 x AWG 14
Exposure controller cable Remote exposure switch: DINFLEX–YY 4 x AWG 26, max. 15
m
Data communication cable CAT6 UTP Ethernet cable
9 Technical data
Positioning laser lights
Panoramic laser lights (3) IEC 60825–1/2014 (CLASS 1 LASER PRODUCT)
Cephalostat laser lights (1)
3D laser lights (3)
X–ray generator
Generator High frequency DC generator
Anode voltage 60 – 95 kV (± 5 kV)
Anode current 2 – 16 mA (± 20%)
Exposure time accuracy ± 5%
DAP display accuracy ± 25%
Spine compensation kV / mA compensated
Accuracy of radiation output > 95%
X-ray image detector

Technology / Sensor type IGZO TFT
Effective detector area 240,35 x 168,34 mm / 9.5 x 6.6 in
2530 x 1772 px
max. 240 mm
max. 147 mm centra
l beam
central beam
Device physical measures

Source–Image distance (SID) PAN/3D 630 mm / 24.8 in
imaging
CEPH imaging 1770 mm / 69.7 in
Dimensions (H x W x D) 2D/3D device 1688–2443 x 770 x 1095 mm
66.5–96.2 x 30.3 x 43.1 in
CEPH device 1688–2443 x 1674 x 1240–1490 mm

66.5–96.2 x 65.9 x 48.8–58.7 in
Weight 2D/3D device 120 kg / 265 lbs

CEPH device 155 kg / 342 lbs
9 Technical data
Main device package

Package dimensions (L x W x H) 1220 x 770 x 1100 mm
48 x 30.3 x 43.3 in
Package weight 179 kg / 395 lbs

Package material weight Wood: 17 kg / 37 lbs
Plywood: 10 kg / 22 lbs
Cardboard: 10 kg / 22 lbs
Plastic: 3.8 kg / 8.4 lbs
Metal: 9.5 kg / 21 lbs
Cephalometric unit package

Package dimensions (L x W x H) 1220 x 770 x 538 mm
48 x 30.3 x 21.2 in
Package weight 63 kg / 139 lbs

Package material weight Wood: 17 kg / 37 lbs
Cardboard: 3.4 kg / 7.5 lbs
Plastic: 2.7 kg / 6 lbs
Metal: 1.4 kg / 3 lbs
NOTICE! The device package and packaging material weights may vary depending on the device
configuration.
Ambient temperatures
Transportation and storage -25 – +55°C
RH 0 – 90%
Atmospheric pressure 70 – 108 kPa
Operation Temperature +10 – +35°C

RH 30 – 80%
Atmospheric pressure 70 – 106 kPa
9 Technical data
9.2 Imaging program specifications

NOTICE! The values given in this chapter are nominal values and apply to 220-240 VAC devices.
The technical factors and their ranges are limited and may differ from the given values when using a
device configured to 100 - 120 VAC.
NOTICE! Device's radiation dose production (DAP) varies from unit to unit. Radiation dose
production, shown on the GUI, is calculated by scaling a measured reference dose production value
with the selected imaging program technical factors and DAP correction factor.
NOTICE! Air KERMA production can be calculated by dividing the DAP value with the beam size at
the sensor. The tables in this chapter contain approximate beam size at sensor level for determining
the Air KERMA production.
9.2.1 Panoramic programs
Panoramic programs & technical factors
Magnification factor: 1.6

2 2
X-ray beam size at sensor: 8.1 cm / 6.2 cm (Pediatric)
Exposure time Image height kV range mA range
Standard Panoramic 9.0 s

187 mm / 7.3 in
Segmented Standard 1.4 - 9.0 s 1968 px
Panoramic
Pediatric Panoramic 9.0 s 144 mm / 5.6 in

60 - 70 kV 2.0 - 16.0 mA
Segmented Pediatric 1.4 - 9.0 s 1516 px
Panoramic 73 - 81 kV 2.0 - 14.0 mA
Bitewing 6.4 s 128.4 mm / 5 in 85 - 90 kV 2.0 - 12.5 mA

(3.2 + 3.2 s) 1352 px
TMJ, Lateral 4.0 s 187 mm / 7.3 in

(2.0 + 2.0 s) 1968 px
9 Technical data
9.2.2 Cephalometric programs
Cephalometric programs & technical factors

2 2
X-ray beam size at sensor: 17.8 cm / 13.9 cm (Pediatric)
Image width Image height kV range mA range Exposure time
Lateral projection 162 - 264 mm 235.9 mm 77 - 81 kV 4.0 - 14.0 mA 6.9 - 11.3 s

6.4 - 10.4 in 9.3 in
85 - 90 kV 4.0 - 12.5 mA
Pediatric lateral 180 - 190 mm
projection 95 kV 4.0 - 11.0 mA
7.1 - 7.5 in
PA projection 200 mm 235.9 mm 77 - 81 kV 4.0 - 14.0 mA 8.7 s

7.9 in 9.3 in
85 - 90 kV 4.0 - 12.5 mA
95 kV 4.0 - 11.0 mA
Carpus program & technical factors
Image width Image height kV range mA range Exposure time
Carpus view 200 mm 235.9 mm 60 - 73 kV 2.0 - 12.5 mA 8.7 s

7.9 in 9.3 in
9.2.3 3D programs
NOTICE! Available imaging programs and 3D FOV sizes depend on the device configuration and
country specification.
NOTICE! Voltage is fixed to 95 kV
Scout programs & technical factors
FOV Resolution mA range Exposure time
5x5 Scout 2.0 - 12.5 mA 0.04 s
6x8 Scout 0.04 s
6x9 Scout 0.04 s
8x8 Scout 0.04 s
10 x 10 Scout 0.04 s
12 x 15 Scout 0.07 s
15 x 20 Scout 0.07 s
9 Technical data
3D imaging programs & technical factors
FOV Resolution Voxel size Beam size at mA range Exposure Exposure Duty cycle
sensor time * pulse
2
5x5 Low 280 μm 65 cm 2.0 - 12.5 mA 0.9 s 5 ms 5:24
Standard 200 μm 2.7 s 10 ms 10:40
High 125 μm 2.0 - 11.0 mA 11.5 s Continuous 1:1
Endo 80 μm 2.0 - 8.0 mA 19.4 s Continuous 1:1

2
6x8 Low 320 μm 125 cm 2.0 - 12.5 mA 1.0 s 5 ms 5:24
Standard 300 μm 2.9 s 10 ms 10:40

2
6x9 Low 320 μm 141 cm 2.0 - 12.5 mA 1.0 s 5 ms 5:24
Standard 300 μm 2.9 s 10 ms 10:40

2
8x8 Low 320 μm 167 cm 2.0 - 12.5 mA 1.0 s 5 ms 5:24
Standard 300 μm 2.9 s 10 ms 10:40

2
10 x 10 Low 320 μm 261 cm 2.0 - 12.5 mA 1.0 s 5 ms 5:24
Standard 300 μm 2.9 s 10 ms 10:40

2
12 x 15 Low 400 μm 244 cm 2.0 - 12.5 mA 1.3 s 5 ms 5:50
Standard 350 μm 2.4 s 5 ms 5:25
High 250 μm 5.5 s 10 ms 10:25

2
15 x 20 Low 400 μm 403 cm 2.0 - 12.5 mA 1.5 s 5 ms 5:54
Standard 350 μm 2.8 s 5 ms 5:27
High 270 μm 4.0 s 7 ms 7:27
Voxel size tolerance: ±2%

* Exposure time with Medium size patient.
Dental cast program & technical factors
FOV Resolution Voxel size Exposure time
10 x 10 Low 320 μm 12.0 s
Standard 300 μm
High 200 μm
NOTICE! Current is fixed to 4 mA
9 Technical data
9.2.4 Patient size setting default values
Panoramic programs
Patient size
Small Medium Large
PAN 66 kV / 7.1 mA 66 kV / 10.0 mA 73 kV / 12.5 mA
Pediatric PAN 63 kV / 5.0 mA 66 kV / 6.3 mA 66 kV / 8.0 mA
Bitewing 66 kV / 7.1 mA 66 kV / 10.0 mA 73 kV / 12.5 mA
TMJ 73 kV / 8.0 mA 73 kV / 10.0 mA 73 kV / 12.5 mA
Cephalometric programs
Patient size
Small Medium Large
Lateral 81 kV / 8.0 mA 85 kV / 8.0 mA 95 kV / 8.0 mA
Pediatric lateral 77 kV / 6.3 mA 81 kV / 8.0 mA 85 kV / 8.0 mA
PA 85 kV / 8.0 mA 90 kV / 8.0 mA 95 kV / 8.0 mA
Carpus 60 kV / 3.2 mA 63 kV / 3.2 mA 63 kV / 4.0 mA
9 Technical data
3D programs
Patient size
FOV Resolution Small Medium Large
5x5 Low 4 mA 6.3 mA 8 mA
Standard
High 5 mA
Endo 6.3 mA
6x8 Low 2.8 mA 4 mA 6.3 mA
Standard
High 3.2 mA
6x9 Low 2.8 mA 4 mA 6.3 mA
Standard
High 3.2 mA
8x8 Low 2.8 mA 4 mA 6.3 mA
Standard
High 3.2 mA
10 x 10 Low 2.8 mA 4 mA 6.3 mA
Standard
High 3.2 mA
12 x 15 Low 4 mA 5 mA 8 mA
Standard 6.3 mA 7 mA 10 mA
High 8 mA
15 x 20 Low 2.8 mA 4 mA 6.3 mA
Standard 4 mA 6.3 mA 8 mA
High 6.3 mA 8 mA 10 mA
NOTICE! Voltage is fixed to 95 kV
9.3 Patient contacting parts

Part type Type of contact Contact duration
Head Support Skin <5 min
Chin Rest with a disposable cover Skin <5 min
Bite Block with a disposable cover Mucosal membrane <5 min
Lip Support with a disposable cover Skin <5 min
Patient Handles Skin <5 min
Ear rod with a disposable cover Skin <5 min
Nasion support with a disposable cover Skin <5 min
Carpus holder Skin <5 min
9 Technical data
9.4 Device dimensions

9.4.1 Main device dimensions
773 mm / 30.4 in
1095 mm / 43.1 in
340 mm / 13.4 in
1690 - 2455 mm / 66.5 - 96.6 in
400 ± 20 mm
15.7 ± 0.8 in
953 - 1718 mm / 37.5 - 67.6 in
320 ± 20 mm
12.6 ± 0.7 in
902 - 1667 (nominal 940) mm
35.5 - 65.6 (nominal 37) in
59.5 ± 15 mm / 2.3 ± 0.6 in

759.5 mm / 29.9 in
100 mm
3.9 in
A= 0.05m2
198 mm
7.8 in
NOTICE! The maximum height of the device is adjustable during the installation calibration.
9 Technical data
9.4.2 Cephalometric device dimensions

810 mm / 31.9 in 864 mm / 34 in
773 mm / 30.4 in
1228 -1500 mm / 48.3 - 58.7 in
340 mm / 13.4 in
1690 - 2455 mm / 66.5 - 96.6 in
400 ± 20 mm
15.7 ± 0.8 in
953 - 1718 mm / 37.5 - 67.6 in
320 ± 20 mm
12.6 ± 0.8 in
902 - 1667 (nominal 940) mm
35.5 - 65.6 (nominal 37) in
95.5 ± 15 mm / 3.8 ± 0.5 in

765.5 mm / 30.1 in
*** 250 ± 12 mm
*** 9.8 ± 0.4 in
** 300 ± 12 mm
** 11.8 ± 0.4 in
A= 0.05m2
198 mm
7.8 in
* 500 ± 10 mm
* 19.7 - 0.3 in
* Main device perpendicular to the wall

** CEPH arm parallel to the wall
*** CEPH arm in 7° angle to the wall
NOTICE! The maximum height of the device is adjustable during the installation calibration.
9 Technical data
9.5 Symbols that may appear on the device or its parts
Manufacturer
Date of manufacture
Medical device
Serial number
Catalog or model number
Lot number
Unique Device Identification
Caution
General warning
Radiation warning
Laser Class 1 warning
Radiation emitting device
Type B Applied part
Dangerous voltage
On or enabled
Off or disabled
External warning light
Exposure switch
Remote exposure switch
Ethernet
9 Technical data
Protective earth (ground)
Focal spot
Total X-ray filtration
Do not reuse
Recyclable
Instructions for use

Refer to the instructions for use for more information. The instructions can
be supplied electronically or in paper format.
Refer to instruction manual
Caution: Federal law restricts this device to sale by or on the order of a

licensed healthcare practitioner.
This symbol indicates that the waste of electrical and electronic equipment
must not be disposed as unsorted municipal waste and must be
collected separately. Please contact an authorized representative of the
manufacturer for information concerning the decommissioning of your
equipment.
CE Mark
Marking for devices to be sold in European Economic Area with Notified
Body number
UKCA (UK Conformity Assessed) marking
Swiss authorised representative
NRTL Mark
Conforms to U.S. and Canada national safety standards
Importer
Fragile, Handle with Care (Packaging)
This way up (Packaging)
Keep dry (Packaging)
Maximum number of boxes that can be stacked on the bottom box

n
(Packaging)
9 Technical data
9.6 Electromagnetic Compatibility (EMC) tables

NOTICE! Medical electrical equipment needs special precautions regarding EMC and needs to be
installed according to EMC information.
IEC 60601-1-2 ed4.1 testing has verified that electromagnetic interference stimulus has no effect on safety
critical functionality of the device. This includes the device lifting movement, accuracy of loading factors and
reproducibility of the radiation output.
If abnormal performance is observed, such as degradation of essential performance in form of changes
in loading factors, additional measures may be necessary, such as reorienting or relocating the device.
Suggested actions according to RF immunity of non-life-support equipment or system IEC 60601-1-2 ed4.1
on page 102.
The device is suitable for use in both professional healthcare (hospitals/large clinics) facility environment and
home healthcare (clinics in domestic establishments and those directly connected to the public low-voltage
power supply) environment.
Exceptions for professional healthcare facility environment: Not to be used or installed near active HF
SURGICAL EQUIPMENT and the RF shielded room of an ME SYSTEM for magnetic resonance imaging,
where the intensity of EM DISTURBANCES is high.
Electromagnetic emissions IEC 60601-1-2 ed4.1
PCX-1 is suitable for use in the specified electromagnetic environment. The purchaser or user of PCX-1 should assure
that it is used in an electromagnetic environment as described below:
Emissions Test Compliance Electromagnetic Environment
Radio-Frequency Emissions Group 1 PCX-1 uses RF energy only for its internal function. Therefore,
CISPR11 the RF emission is very low and not likely to cause any
interference in nearby electronic equipment.
Radio-Frequency Emissions Class B PCX-1 is suitable for use in both at professional healthcare
CISPR11 (hospitals/large clinics) facility environment and home healthcare
(clinics in domestic establishments and those directly connected
Harmonic emissions IEC61000-3-2 to the public low-voltage power supply) environment.
IEC61000-3-2 Class A Exceptions for professional healthcare facility environment : Not
to be used or installed near active HF SURGICAL EQUIPMENT
Voltage fluctuations/ flicker Complies
and the RF shielded room of an ME SYSTEM for magnetic
emissions resonance imaging, where the intensity of EM DISTURBANCES is
IEC61000-3-3 high.
9 Technical data
Electromagnetic immunity IEC 60601-1-2 ed4.1
Immunity Test IEC60601-1-2 Test Level Compliance Level Electromagnetic

Environment
Electrostatic discharge (ESD) ± 8 kV for contact discharge ± 8 kV for contact discharge Floors are wood, concrete,
IEC61000-4-2 or ceramic tile, or floors are
±2, 4, 8, 15 kV for air discharge ±2, 4, 8,15 kV for air discharge covered with synthetic material
and the relative humidity is at
least 30 percent.
Electrical fast transient/burst ±2 kV for power supply lines ±2 kV for power supply lines Mains power quality is that of
IEC 61000-4-4 (100 kHz) a typical commercial and/or
±1 kV for input/output lines hospital environment
±1 kV for input/output lines
(100kHz)
Surge ± 0.5, 1 kV Line-to-line ± 0.5, 1 kV Line-to-line Mains power quality is that of

a typical commercial and/or
IEC61000-4-5 hospital environment.
± 0.5, 1, 2 kV Line-to-ground ± 0.5, 1, 2 kV Line-to-ground
Voltage dips, short 0 % UT; 0,5 cycle 0 % UT; 0,5 cycle Mains power quality is that
interruptions and voltage of a typical commercial and/
At 0°, 45°, 90°, 135°, 180°, At 0°, 45°, 90°, 135°, 180°, or hospital environment. If
variations on power supply
225°, 270° and 315° 225°, 270° and 315° the user of PCX-1 requires
input lines
continued operation during
IEC61000-4-11 0 % UT; 1 cycle 0 % UT; 1 cycle power mains interruptions,
At 0° At 0° it is recommended that
PCX-1 be powered from an
70 % UT; 25/30 cycles 70 % UT; 25/30 cycles uninterruptible power supply.
At 0° At 0°
0 % UT; 250/300 cycle 0 % UT; 250/300 cycle
Power frequency (50/60Hz) 30A/m 30 A/m Power frequency magnetic

magnetic field IEC 61000-4-8 fields are at levels
characteristic of a typical
location in a typical commercial
and/ or hospital environment.
The device shall not be used
closer than 15cm to sources of
50/60Hz magnetic field.
NOTICE! UT is the a.c. mains voltage prior to application of the test level.
9 Technical data
RF immunity of non-life-support equipment or system IEC 60601-1-2 ed4.1
Immunity Test IEC 60601-1-2 Test Level Compliance Level Electromagnetic Environment
Conducted RF IEC 61000-4-6 3V 3V Portable and mobile RF

communications equipment are
0.15 MHz - 80 MHz 0.15 MHz - 80 MHz
used no closer to any part of
6 V in ISM and amateur radio 6 V in ISM and amateur radio PCX-1 including cables, than
bands between 0.15 MHz and bands between 0,15 MHz and the recommended separation
80 MHz 80 MHz distance calculated from the
equation appropriate for the
Radiated RF IEC 61000-4-3 10 V/m 80 MHz to 2,7 GHz 10 V/m 80 MHz to 2,7 GHz frequency of the transmitter.
Immunity to proximity Immunity to proximity Recommended Separation
fields from RF wireless fields from RF wireless Distance:
communication equipment, communication equipment,
levels according to table levels according to table 150kHz-80MHz
60601-1-2 ed4 table 9. 60601-1-2 ed4 table 9:
80MHz to 800 MHz
Proximity magnetic fields IEC • 30 kHz: 8 A/m • 30 kHz: 8 A/m 800 MHz to 2,7
61000-4-39 • 134.2 kHz: 65 A/m • 134.2 kHz: 65 A/m GHz
• 13.56 MHz: 7.5 A/m • 13.56 MHz: 7.5 A/m
Where P is the maximum output
power rating of the transmitter
in watts (W) according to the
transmitter manufacturer and d
is the recommended separation
distance in meters (m). Field
strengths from fixed RF
transmitters, as determined by
an electromagnetic site survey,*
are less than the compliance
level in each frequency range.**
Interference may occur in the
vicinity of equipment marked
with the following symbol:
*Field strengths from fixed transmitters, such as base stations for cellular telephones and land mobile radios, amateur radio, AM and
FM radio broadcast, and TV broadcast cannot be estimated accurately. To assess the electromagnetic environment due to fixed RF
transmitters, an electromagnetic site survey should be performed. If the measured field strength exceeds the RF compliance level
above, observe PCX-1 to verify normal operation in each use location. If abnormal performance is observed, additional measures
may be necessary, such as reorienting or relocating PCX-1.
Guidance for actions taken can be found from AAMI TIR 18:2010, Guidance on electromagnetic compatibility of medical devices in
healthcare facilities.
NOTICE! Precautions to take if the use location is near (e.g. less than 1,5 km from) AM, FM or TV broadcast antennas.
**Over the frequency range 150 kHz to 80 MHz, field strengths are less than 3 V/m. The Recommended Separation Distances
are listed in the next table.
NOTICE! These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and
reflection from structures, objects, and people.
NOTICE! RF communications equipment can affect medical electrical equipment.
NOTICE! If the network connection is disrupted momentarily because of electromagnetic

disturbances, re-establish the local network connection. The latest image is stored in the device and
transferred automatically to the workstation. Do not power off the device as the image will be erased.
9 Technical data
Test specifications for enclosure port immunity to RF wireless communications equipment IEC
60601-1-2 ed4.1 table 9
Test frequency Band * Service * Modulation Immunity test level

(MHz) (MHz) (V/m)
385 380 to 390 TETRA 400 Pulse modulation ** 27

18 Hz
450 430 to 470 GMRS 460, FRS 460 FM *** 28

± 5 kHz deviation
1 kHz sine
710 704 to 787 LTE Band 13, 17 Pulse modulation ** 9
745 217 Hz
780
810 800 to 960 GSM 800/900, TETRA Pulse modulation ** 28

800, iDEN 820, CDMA
870 18 Hz
850, LTE Band 5
930
1720 1700 to 1990 GSM 1800; CDMA Pulse modulation ** 28

1900; GSM 1900;
1845 217 Hz
DECT; LTE Band 1, 3, 4,
25; UMTS
1970
2450 2400 to 2570 Bluetooth, WLAN Pulse modulation ** 28

802.11 b/g/n, RFID
217 Hz
2450, LTE Band 7
5240 5100 to 5800 WLAN 802.11 a/n Pulse modulation ** 9
5500 217 Hz
5785
If necessary to achieve the immunity test level, the distance between the transmitting antenna and the ME equipment or ME system
may be reduced to 1 m. The 1 m test distance is permitted by IEC 61000-4-3.
* For some services, only the uplink frequencies are included.
** The carrier shall be modulated using a 50% duty cycle square wave signal.
*** As an alternative to FM modulation, the carrier may be pulse modulated using a 50% duty cycle wave signal at 18 Hz. While it
does not represent actual modulation, it would be worst case.
9 Technical data
Separation distances
Recommended Separation Distances for Portable and Mobile RF Communications Equipment IEC 60601-1-2
The PCX-1 is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The user
of PCX-1 can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF
communications equipment (transmitters) and the PCX-1 as recommended below, according to the maximum output power of the
communications equipment.
Frequency of Transmitter 150 kHz to 80 MHz 80 MHz to 800 MHz 800 MHz to 2.7 GHz
Equation
Rated Maximum Output Power Separation Distance (meters) Separation Distance (meters) Separation Distance(meters)
of Transmitter (watts)
0,01 0,20*** 0,06*** 0,06***
0,1 0,63 0,19*** 0,19***
1 2 0,6 0,6
10 6,32 1,90 1,90
100 20 6 6
For transmitters rated at maximum output power not listed above, the recommended separation distance d in meters (m) can be
estimated using the equation applicable to the frequency of the transmitter, where P is the maximum output power rating of the
transmitter in watts (W) according to the transmitter manufacturer.
WARNING! *** Portable RF communications equipment (including peripherals such as antenna cables and external
antennas) should be used no closer than 30 cm (12") to any part of the device, including cables specified by the
manufacturer. Otherwise, degradation of the performance of this equipment could result. See Separation distances on
page 104.
NOTICE! At 80 MHz, the separation distance for the higher frequency range applies.
NOTICE! These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and
reflection from structures, objects, and people.
USE LIMITATION:
External components
WARNING! Use of accessories, transducers and cables other than those specified or provided
by the manufacturer of this equipment could result in increased electromagnetic emissions or
decreased electromagnetic immunity of this device and result in improper operation.
9 Technical data
INSTALLATION REQUIREMENTS & ENVIRONMENT CONTROL:

In order to minimize interference risks, the following requirements shall apply.
Cables shielding & grounding

All interconnect cables to peripheral devices must meet the requirements given in Technical specifications
on page 87. Use of incorrect cables may result in the device causing radio frequency interference.
Electrostatic discharges environment & 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 & equipment

WARNING! The PCX-1 should not be used adjacent to or stacked with other equipment; if adjacent
or stacked use is necessary, the PCX-1 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:
9 Technical data
9.7 X-ray tube assemblies
9 Technical data
9 Technical data
9.8 Workstation minimum requirements

NOTICE! A workstation used in a medical system must always meet the requirements in IEC
62368-1 (previously IEC 60950) standard.
NOTICE! Workstation that does not fulfill medical safety standard IEC 60601-1 must be located
outside of the patient environment, at least 1.5 m from the device.
NOTICE! Refer to the dental imaging software installation manual or contact your local dealer for
more specific workstation requirements.
Image acquisition workstation with database and image data
DTX Studio™ Core

DTX Studio™ Driver
DTX Studio™ Clinic
Processor Intel Core i5, i7 or Xeon, 4-cores or more

Memory 32 GB, ECC (error correcting) recommended
GPU Supported GPU's:

• NVIDIA Quadro T1000 8GB
• NVIDIA GeForce RTX 3050 8GB
Only validated GPU’s and WHQL certified driver versions may be used.
GPU requirements and driver versions are dependent on the DTX Studio
Driver version installed.
NOTICE! Always refer to the DTX Studio Driver documentation for
details on the supported GPU and driver versions. GPU requirements
may change at any time when a new DTX Studio Driver is released.
Storage space • 1 TB or more for image data.

• 256 GB SSD for the operating system and the imaging software is
recommended.
Image sizes:
• PAN: 5 - 10 MB
• CEPH: 9 - 12 MB
• 3D: 10 - 800 MB
Operating system • Windows 11 Pro or Enterprise 64-bit

• Windows 10 Pro or Enterprise 64-bit
NOTICE! 32-bit Windows installations are not supported.
9 Technical data
Image acquisition workstation with database and image data

Device Driver DTX Studio Driver 23.1 or newer (latest version is always preferred)
Network • Supported interface chipsets: Intel i210, i219, Intel i225 or Broadcom
• Gigabit Ethernet 1000Base-T
• 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.
Display 1920 x 1080 (Full HD) resolution or higher

Backup A suitable backup system is required to safeguard user-created data. Backup
of user-created data is solely the responsibility of the user. The manufacturer
disclaims responsibility for backup of user-created data. Contact your IT
provider regarding selection of a suitable backup system according to your
data storage needs.
UPS UPS (uninterruptible power supply) is recommended to prevent data
corruption or loss in the event of a power failure.
9 Technical data
Image acquisition workstation
DTX Studio™ Core DTX Studio™ Driver

DTX Studio™ Clinic
Processor Intel Core i5, i7 or Xeon, 4-cores or more

Memory 16 GB, ECC (error correcting) recommended
GPU Supported GPU's:

• NVIDIA Quadro T1000 8GB
• NVIDIA GeForce RTX 3050 8GB
Only validated GPU’s and WHQL certified driver versions may be used.
GPU requirements and driver versions are dependent on the DTX Studio
Driver version installed.
NOTICE! Always refer to the DTX Studio Driver documentation for
details on the supported GPU and driver versions. GPU requirements
may change at any time when a new DTX Studio Driver is released.
Storage space • 100 GB or more on the acquisition workstation

• 1 TB or more for image data on the separate database workstation.
• 256 GB SSD for the operating system and the imaging software is
recommended.
Image sizes:
• PAN: 5 - 10 MB
• CEPH: 9 - 12 MB
• 3D: 10 - 800 MB
Operating system • Windows 11 Pro or Enterprise 64-bit

• Windows 10 Pro or Enterprise 64-bit
NOTICE! 32-bit Windows installations are not supported.
Device Driver DTX Studio Driver 23.1 or newer (latest version is always preferred)
Network • Supported interface chipsets: Intel i210, i219, Intel i225 or Broadcom
• Gigabit Ethernet 1000Base-T
• 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.
Display 1920 x 1080 (Full HD) resolution or higher
Minimum requirements for 2D/3D Viewing workstation

Refer to dental imaging software requirements
9 Technical data
Minimum requirements for database server

Refer to dental imaging software requirements
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 PaloDEx Group Oy representative for the most current information.
Copyright © by PaloDEx Group Oy. All rights reserved.
DEXIS™ is a registered trademark or a trademark of Dental Imaging Technologies Corporation.
Headquarters
PaloDEx Group Oy
Nahkelantie 160 | FI-04300 Tuusula | FINLAND
Tel. +358 10 270 2000
https://dexis.com/contact-us
Find your local representative at

www.dexis.com

Manual DTX

Uploaded by

Manual DTX

Uploaded by

ORTHOPANTOMOGRAPH™ OP 3D LX

Copyright © 08-2023 by PaloDEx Group Oy. All rights reserved.

Tel. +358 10 270 2000

For service, contact your local distributor.

2.1 ORTHOPANTOMOGRAPH™ OP 3D™ LX

2.2 Intended use and intended purpose

2.3 Intended user profile

2.4 Radiation guideline

NOTICE! An approximate DAP value is shown during the imaging

2.6 Associated documentation

TMJ Temporomandibular joint

GUI Graphical User Interface

DAP Dose Area Product

LDT Low Dose Technology™ for low resolution 3D imaging

ALARA As Low As Reasonably Achievable

MDR Medical Device Regulation (EU) 2017/745

CBCT Cone Beam Computed Tomography

SSD Solid State Drive

2.8 Signal words

2.9 Disposal and recycling

2.10 Warnings and requirements

2.10.2 Connection requirements

2.10.2.2 Network connection requirements

2.10.3 Device modifications

2.10.4 Protection Against Cybersecurity Threats

3.1 Main parts

3.2 Patient positioning lights

3.2.1 Positioning light locations

1.Tilt light (PAN imaging)

3.2.2 Panoramic lights

3.2.3 Cephalometric lights

Head support Carpus holder

Disposable covers for patient positioning accessories:

3.4 Other detachable parts

Geometry calibration phantom CEPH calibration rod (CEPH only)

3D QUALITY CONTROL TOOLS:

3D QC phantom 3D QC phantom holder

2D QUALITY CONTROL TOOLS (AVAILABLE SEPARATELY):

2D QC test phantom Copper filter - 0.8 mm/1.8 mm

PAN QC phantom holder CEPH QC phantom holder

DENTAL CAST IMAGING TOOLS (AVAILABLE SEPARATELY):

Dental cast holder

3.5 Emergency stop switch

To release the emergency stop switch, rotate it clockwise.

3.6 Device label locations

1. Type label 2. Sensor label 3. THA label

CEPHALOMETRIC UNIT LABELS

1. Cephalometric arm label 2. THA label 3. CEPH primary collimator label

Example illustrations of the device labels:

4.1 Graphical User Interface (GUI)

1. Patient name and identification.

3. Selection of imaging program and imaging program settings.

BASIC USE OF THE GUI:

COMMON IMAGING PROGRAM SETTINGS:

Small Medium Large

• Press on the patient size icon to activate the preset.

STATUS MESSAGE BAR:

Device status indicator

4.1.2 Panoramic imaging

ORTHOselect™ panoramic dental chart

Panoramic imaging programs

Standard Panoramic Segmented Panoramic

4.1.2.2 Panoramic image preview

4.1.3 Cephalometric imaging

ORTHOselect™ cephalometric view

Cephalometric imaging programs

Lateral Pediatric lateral PA projection Carpus view

NOTICE! The carpus view program requires an optional carpus holder.

Lateral projection Pediatric lateral projection

4.1.3.2 Cephalometric image preview

ORTHOselect™ dental chart

• Press on the listed FOV size icon to activate it.

Low Standard High Endo

• Press on the listed resolution icon to activate it.

Scout image program

Implant contrast enhancement