ORTHOPANTOMOGRAPH™ OP 3D

User and Installation manual

ENGLISH

212972 rev. 6
0.805.4913

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 Contents

1 Disclaimer................................................................... 6

2 Introduction................................................................ 7
2.1 ORTHOPANTOMOGRAPH™ OP 3D.............................................................. 7
2.2 Intended use......................................................................................... 7
2.3 Intended user profile.............................................................................. 7
2.4 Associated documentation....................................................................... 7
2.5 Abbreviations......................................................................................... 8
2.6 Signal words.......................................................................................... 8
2.7 Disposal and recycling............................................................................ 8
2.8 Warnings and requirements..................................................................... 9
2.8.1 Warnings and precautions for use..................................................9
2.8.2 Warnings and precautions for installation........................................9
2.8.3 Connection requirements............................................................ 10
2.8.4 Device modifications.................................................................. 10

3 Overview................................................................... 11
3.1 Main parts........................................................................................... 11
3.2 Patient positioning lights........................................................................12
3.2.1 Positioning light locations............................................................12
3.2.2 Panoramic lights........................................................................ 12
3.2.3 3D lights.................................................................................. 13
3.3 Accessories.......................................................................................... 13
3.4 Other detachable parts..........................................................................14
3.5 Emergency stop switch..........................................................................15

4 User Interfaces......................................................... 16
4.1 Graphical User Interface (GUI)............................................................... 16
4.1.1 GUI Overview............................................................................16
4.1.2 Panoramic view......................................................................... 18
4.1.3 3D view....................................................................................20
4.1.4 Settings menu...........................................................................25
4.2 Positioning panel.................................................................................. 28
4.3 Status indicator light.............................................................................28

5 Imaging programs.................................................... 29
5.1 Panoramic programs............................................................................. 29
5.2 3D programs........................................................................................31
5.2.1 FOV Sizes (H x D)..................................................................... 31
5.2.2 3D Resolutions.......................................................................... 32

6 Using the device....................................................... 33

6.1 General imaging workflow......................................................................33
6.2 Powering on the device......................................................................... 34
6.3 Preparing the device for imaging............................................................ 34
6.4 Patient positioning................................................................................ 35
6.5 Taking an image................................................................................... 40
6.5.1 Taking a Panoramic, Bitewing or TMJ image.................................. 40

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 6.5.2 Taking Scout and 3D images....................................................... 41

7 Maintenance.............................................................. 43
7.1 Cleaning and decontamination................................................................43
7.2 Quality Control..................................................................................... 44
7.2.1 PAN QC.................................................................................... 44
7.2.2 3D QC...................................................................................... 45
7.3 Calibrations for the user........................................................................ 48
7.3.1 When to calibrate the device.......................................................48
7.3.2 Preparation for Calibration.......................................................... 48
7.3.3 Calibration procedure................................................................. 50
7.4 Annual maintenance..............................................................................52

8 Troubleshooting........................................................ 53

9 Installation................................................................54
9.1 Device package.................................................................................... 54
9.2 Pre-installation requirements.................................................................. 54
9.2.1 Installation location requirements................................................ 54
9.2.2 Space requirements................................................................... 55
9.2.3 Fixing hardware and tools...........................................................56
9.3 Back panel connectors...........................................................................57
9.4 Installing the device..............................................................................57
9.5 Attaching the covers............................................................................. 65
9.6 Configuring the communication link to the workstation.............................. 70
9.6.1 Connection options.................................................................... 70
9.7 Finishing the installation........................................................................ 72
9.8 Complete device calibration................................................................... 73
9.8.1 Accessing the calibrations........................................................... 73
9.8.2 Device Movement Calibration...................................................... 74
9.8.3 Z-Movement Limits.................................................................... 74
9.8.4 X-Ray Generator Calibration........................................................ 75
9.8.5 3D Pixel Calibration....................................................................75
9.8.6 Device Geometry Calibration....................................................... 76
9.8.7 Collimator Calibration................................................................. 77
9.8.8 PAN Pixel Calibration.................................................................. 77
9.8.9 3D Geometry Calibrations........................................................... 78
9.8.10 PAN QC (optional)....................................................................79
9.8.11 3D QC.................................................................................... 81
9.8.12 Panoramic beam size verification (optional)................................. 83
9.9 Additional installation procedures............................................................84
9.9.1 Remote exposure switch installation............................................. 84
9.9.2 Mains power configuration.......................................................... 85
9.9.3 Changing the fuses.................................................................... 86
9.9.4 Additional wall bracket installation............................................... 86
9.9.5 Exhibition stand installation.........................................................88
9.9.6 Collimator adjustment................................................................ 88
9.9.7 Sensor adjustment.....................................................................90
9.9.8 Patient positioning light adjustment............................................. 91
9.9.9 Device configuration...................................................................93
9.9.10 Verification.............................................................................. 96
9.9.11 Repacking the device................................................................96

10 Technical data......................................................... 98
10.1 Technical specifications........................................................................ 98

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 10.2 Imaging program specifications...........................................................102
10.3 Patient contacting parts..................................................................... 104
10.4 Device dimensions.............................................................................105
10.5 Symbols that may appear on the device or its parts.............................. 108
10.6 Electromagnetic Compatibility (EMC) tables.......................................... 110
10.7 X-ray tube assemblies....................................................................... 114
10.8 Minimum workstation requirements..................................................... 116

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 1 Disclaimer

1 Disclaimer
ORTHOPANTOMOGRAPH™ OP 3D User and Installation manual, 212972 r6.
Copyright © 2017 by PaloDEx Group Oy. All rights reserved.
ORTHOPANTOMOGRAPH™, OP™, ORTHOselect™, QUICKcompose™, SMARTview™,
ORTHOfocus™ and Low Dose Technology™ are either registered trademarks or
trademarks of KaVo Kerr Group Finland in the United States and/or other countries.
KaVo™ is either registered trademark or trademark of Kaltenbach & Voigt GmbH in the
United States and/or other countries.
All other trademarks are property of their respective owners.
Documentation, trademark and the software are copyrighted with all rights reserved.
Under the copyright laws the documentation may not be copied, photocopied,
reproduced, translated, or reduced to any electronic medium or machine-readable form
in whole or part, without the prior written permission of PaloDEx Group Oy.
The original language of this manual is English.
PaloDEx Group Oy reserves the right to make changes in specification and features
shown herein, or discontinue the product described at any time without notice or
obligation. Contact your 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.kavokerrgroup.com

Download this manual in digital format:

www.kavo.com/downloads

For service, contact your local distributor.

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 2 Introduction

2 Introduction

2.1 ORTHOPANTOMOGRAPH™ OP 3D
The ORTHOPANTOMOGRAPH™ OP 3D (later called device) is a dental X-ray device
producing high quality digital images of dentition, TM-joints and skull. To take images,
you need a suitable workstation connected to the device and a dental imaging software
to capture and manage the images.

The ORTHOPANTOMOGRAPH™ OP 3D can be used for the following procedures:

Panoramic Imaging
• Standard Panoramic
• Segmented Panoramic
• Pediatric Panoramic
• Bitewing
• TMJ, lateral projection

3D CBCT Imaging
Volume Height x Diameter (H x D)
• 5 x 5 cm; implant and other single tooth imaging
• 6 x 9 cm; single jaw imaging
• 9 x 11 cm; whole dental area imaging (both jaws)
• 9 x 14 cm (optional); both jaws including TMJ
• FOV position and height fine-tuning is possible according to scout images

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

2.2 Intended use

ORTHOPANTOMOGRAPH™ OP 3D is an X-ray device that is configured to take panoramic
and 3D images of the cranio-maxillofacial complex for use in diagnostic support.
ORTHOPANTOMOGRAPH™ OP 3D must only be used and operated by dentist and other
qualified professionals.

2.3 Intended user profile

Only for professionally qualified dental/medical personnel.
Typical user is a dental assistant with specific training for using dental X-ray devices.

2.4 Associated documentation

• Dental imaging software documentation
• ORTHOPANTOMOGRAPH™ OP 3D Quick Guide

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 2 Introduction

2.5 Abbreviations
3D Three dimensional
ALARA As Low As Reasonably Achievable
CBCT Cone Beam Computed Tomography
D Diameter
DAP Dose Area Product
FH Frankfort-Horizontal
FOV Field Of View. The cylindrical 3D volume that is reconstructed by the
device.
GUI Graphical User Interface
H Height
LDT Low Dose Technology™
MAR Metal Artifact Reduction. Reduces the effect of metal and other dense
radiopaque objects, that typically create artifacts which are seen as
stripes and shadows.
MDD Medical Device Directive 93/42/EEC
PAN Panoramic
QC Quality Control
ROI Region Of Interest. The anatomical area or region that you are interested
to examine.
TMJ Temporomandibular joint

2.6 Signal words

The following signal words and labels are used in this document:
WARNING! Indicates a hazardous situation which, if not avoided, could result in
death or serious injury.
CAUTION! Indicates a hazardous situation which, if not avoided, could result in
minor or moderate injury.
NOTICE! Highlights suggestions which will result in enhanced installation,
reliability, or operation. Not used for safety related hazards.

2.7 Disposal and recycling

The device and its components are lead-free, including its radiation protection
components. The device meets the RoHS Directive 2011/65/EU, WITHOUT any
exemptions mentioned in Annex IV.

At least the following parts of the device should be re-cycled according to local and
national regulations regarding disposal of non-environmentally friendly materials:
• Tubehead (oil)

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 2 Introduction

• All electronic circuits and electronic boards

• Plastic parts

2.8 Warnings and requirements

2.8.1 Warnings and precautions for use
• Before using the device for the first time, familiarize yourself with this manual to
ensure the safe use of the device.
• Before using the device for the first time, ensure that it has been set up according to
your requirements.
• This device complies with the EMC (Electromagnetic Compatibility) according to IEC
60601-1-2. Radio transmitting equipment, cellular phones etc. shall not be used in
proximity of the device as they could influence the performance of the device.
• 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.
• 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.
• Always ensure the patient positioning before taking X-ray images to diminish the need
for retakes.
• When taking an X-ray image, protect yourself from radiation or stand at least 3
meters (9.8 ft) away from the device.
• When taking an X-ray image of a patient who is feeling insecure or has exceptional
anatomy (typically very tall or large patient) use the Test-mode first to demonstrate
the device movements and to make sure that the rotating device doesn't collide with
the patient during the imaging process.
• Avoid taking X-ray images of pregnant women.
• Always ensure that you can see and hear the patient during the imaging process,
while also maintaining visibility to the GUI.
• Always place new disposable covers on patient positioning parts and decontaminate
the patient contacting parts according to guidance in chapter Cleaning and
decontamination.
• Close the patient positioning mirror before taking images.
• Switch the device off after use.
• The device must not be used for screening examinations.

2.8.2 Warnings and precautions for installation

• Only authorized service technicians are allowed to perform the device installation or
service.
• The column telescope assembly is not a serviceable part and it should not be opened
or altered in any circumstances.
• Always ensure that the device is isolated from mains during any installation or service
procedures to avoid a risk of electric shock. Live parts are marked with high voltage
symbols.
• Familiarize yourself with this manual before device installation and follow the
installation instructions to ensure the safe use of the device.

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 2 Introduction

• To avoid the risk of electric shock, the device must only be connected to a mains
power outlet with protective earth.
• The device shall not be connected to an extension cord.
• Ensure the proper tightness and attachment of all of the screws and bolts when
installing the device.
• All device covers must be properly installed before handing the device to the user.
• Ensure the electrical safety of the device by inspecting the proper grounding of user
touchable metallic parts before handing the device to the user.

2.8.3 Connection requirements

NOTICE! Always follow local and national requirements regarding the connection
of medical systems.
• The workstation and any other external device(s) connected to the device must meet
the IEC 60950 standard (minimum requirements). Devices that do not meet the IEC
60950 standard must not be connected to the device as they may pose a threat to
operational safety. After installation, ensure that the IEC 60601-1 leakage current
levels are not exceeded.
• The workstation and any other external devices must be connected in accordance with
IEC 60601-1.
• Electronic equipment (workstation, network connecting devices etc.) that does not
fulfill medical safety standards (IEC 60601-1) must be located outside of the patient
environment, at least 1.5m from the device.
• The X-ray 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 X-ray device.
• Additional multiple socket-outlets or extension cords shall not be connected to the
system.
• The device must be connected to a private, firewall protected LAN network.
• Connecting the device to an IT-network that includes other equipment or changing the
IT-network can cause unidentified 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.

2.8.4 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 spareparts supplied by the manufacturer are allowed
to be used in device service.
• Never make unauthorized changes or modifications to the device or any of its parts.
• Never remove or remanufacture any part of the tubehead assembly or beam limiting
device.
• Never adjust any part of the beam limiting device 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.

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 3 Overview

3 Overview

3.1 Main parts

1. Column
2. Carriage
3. Upper shelf
4. Rotating unit
5. Sensor
6. Tubehead
7. Power switch (Back of
the device)
8. Exposure switch
9. Positioning panel
10. Emergency stop switch
11. Patient handles
12. Mirror
13. Status indicator light
14. Chin rest
15. Head support
16. Head support locking
lever
17. Lower shelf tray

Additionally, a workstation with MDD approved dental imaging software is needed.

All software must conform to the MDD and the relevant legal requirements in the USA.
The workstation must conform to all the device and dental imaging software
requirements.

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 3 Overview

3.2 Patient positioning lights

NOTICE! Appropriate lights are turned on automatically, based on the selected
modality, program and FOV.

3.2.1 Positioning light locations

A. Tilt light (Panoramic image layer)
B. Midsagittal light
C. Horizontal light, top of FOV / FH light
D. Horizontal light, bottom of FOV

3.2.2 Panoramic lights

A. Tilt light (Image layer)

B. Midsagittal light
C. Frankfort-Horizontal (FH) light
NOTICE! The position of Frankfort-Horizontal light is automatically adjusted
according to the selected imaging program.

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 3 Overview

3.2.3 3D lights

B. Midsagittal light
C. Horizontal light, top of FOV
D. Horizontal light, bottom of FOV

3.3 Accessories
Chin Rest Bite Block Lip Support (3D,
TMJ and edentulous
patients)

Head Support with a detachable

strap

Disposable covers for patient positioning devices:

• Disposable covers for Bite Block
• Disposable covers for Lip Support
• Disposable cover sheets for Chin Rest and Head Support

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 3 Overview

3.4 Other detachable parts

CALIBRATION TOOLS:

3D Geometry Calibration Phantom 3D QC Phantom & 3D

QC phantom holder

QUALITY CONTROL TOOLS (OPTIONAL):

2D QC Test Phantom & Copper filter - 0.8 mm/1.8 mm

PAN QC phantom holder

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 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.

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 4 User Interfaces

4 User Interfaces

4.1 Graphical User Interface (GUI)

4.1.1 GUI Overview

1. Selected patient name and Patient Identification (ID).

2. Selection of imaging modality, PAN or 3D.
3. Imaging program settings.
4. Main view area. Shows a dental chart for the selected modality and previews of the
taken images.
5. Status message bar shows the device status and provides messages and instructions
to the user. Click on the bar to show messages if there are more than the ones
shown.
6. Imaging parameters. Imaging parameters, kV (PAN only) and mA, can be manually
adjusted according to the patient size and skull anatomy using the - & + icons.
7. Sample image of the selected Panoramic program or 3D FOV size and location
illustration.
8. Scan time and DAP display. Shows the duration of X-ray radiation and the dose
production with the selected imaging program and parameters.
9. Settings. Settings menu is used to access the device settings, calibration programs
and to show the device information, like serial number and software version.

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 4 User Interfaces

IMAGING PROGRAM SETTINGS:

Test mode
Indicates if Test mode is active.
Press Test mode icon to disable/enable device radiation production.
This mode can be used for example to demonstrate the device
movements.
You can also use the positioning panel to activate 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 listed patient size icon to activate it.

Selecting a patient size, according to the scanned patient, adjusts
the kV and mA to preset levels.
NOTICE! Patient size presets can be adjusted from settings
menu.

End Study
Press End Study icon to finalize the imaging procedure and return to
the main view.

STATUS MESSAGE BAR:

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: Imaging process ongoing.
• Blue: Device in error state or pending user action.

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 4 User Interfaces

4.1.2 Panoramic view

Panoramic imaging program selection

ORTHOselect™ panoramic dental chart

Dental chart shows which segments of the dentition are imaged with
the selected imaging program.
You can also manually select which segments of the dentition are
imaged. Press the segments to select (blue) and deselect (white)
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 produced by the selected imaging program is shown

on the bottom of the GUI. If you take a segmented image, the
unselected segments are grayed out in the sample image.

Standard Panoramic Segmented Panoramic

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 4 User Interfaces

QUICKcompose™ panoramic image preview

NOTICE! Panoramic image previews are not shown in full resolution on GUI.

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.

NOTICE! None of the adjustments done to the preview image are saved to the
image.

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 4 User Interfaces

4.1.3 3D view
3D imaging program selection

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.
Press teeth, jaw and TMJ icons to select which parts of the dentition
are studied:
• Single tooth (1)
• Range of teeth (2)
• One jaw and all teeth in it (3 or 4)
• Both jaws and all teeth in them (3 and 4)
• TMJ (5 or 6)
• Both TMJ's (5 and 6)
• Whole dentition (3, 4, 5 and 6)
NOTICE! Both TMJs are selectable only if 9x14 FOV size is
available.
You can select the whole dentition by double-clicking any single
selection (tooth, jaw or TMJ). Undo the "select all" by double-clicking
the selection to return to the previous state.
Clear all selections by double clicking the gray area on the lower
corners of the dental chart. Undo the "clear all" by double-clicking
the gray area to return to the previous state.

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 4 User Interfaces

FOV size
Indicates the currently selected FOV size (H x D).
Press the FOV size icon to open a list of the available 3D FOV sizes;
5 x 5, 6 x 9, 9 x 11 and 9 x 14 (optional).

Press on the listed FOV size icon to activate it. The skull on the
bottom of the GUI also illustrates an approximate coverage of the
selected FOV.

NOTICE! Use the ORTHOselect™ dental chart as primary

method for FOV size selection.

Image resolution
Indicates the currently selected resolution.
Press the image resolution selection icon to open a list of available
image resolutions;

Low Dose Standard High ENDO

Technology™ resolution resolution resolution
resolution

Press on the listed resolution icon to activate it.

For recommendations on resolution selection, see chapter 3D
Resolutions.

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. By default, the
Scout image is always active when taking 3D images.
Press the Scout image icon to deactivate/activate it.
When the Scout image program is active, the FOV coverage
illustration turns green.

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 4 User Interfaces

SMARTVIEW™ 2.0 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.
NOTICE! FOV diameter can be also changed using the FOV
size icon.

Brightness slider
You can adjust the brightness of the shown Scout image using the
brightness slider.
NOTICE! Adjustment is not saved to the image.

Contrast slider
You can adjust the contrast of the shown Scout image using the
contrast slider.
NOTICE! Adjustment is not saved to the image.

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 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.

QUICKcompose™ 3D image preview

NOTICE! 3D 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).

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 slider
You can scroll through the previewed 3D slices using the slice slider.
The previewed 3D volume also changes according to the currently
shown slice.

Volume rotation slider

You can rotate the previewed 3D volume using the volume rotation
slider.

Brightness slider
You can adjust the brightness of the shown preview image using the
brightness slider.
NOTICE! Adjustment is not saved to the image.

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 4 User Interfaces

Contrast slider
You can adjust the contrast of the shown preview image using the
contrast slider.
NOTICE! Adjustment is not saved to the image.

OK button
Press OK button to close the image preview.

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 4 User Interfaces

4.1.4 Settings menu

1. CALIBRATIONS
Shows a list of user performable device calibrations, their completion status and last
completion date. The calibrations are performed through this menu.
See chapters Calibrations for the user and Complete device calibration for more
detailed information on calibration programs and how to perform them.
2. QUALITY CONTROL
Shows a list of Quality Control (QC) programs, their completion status and last
completion date. See chapter Quality Control for more information on how to take
Quality Control images.

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 4 User Interfaces

3. SYSTEM INFO

Software Show the device serial number and firmware versions.

versions
Notices Legal information and terms and conditions for use.

Exposure Show amount of exposures taken with the device.

counters

4. PREFERENCES

Configurations Friendly name Set a name for the device, which is shown
next to the settings icon and on the
imaging software.

3D Metal Artefact Enable or disable MAR, Metal Artefact

Reduction Reduction. MAR is used to reduce
the effect of metals and other dense
radiopaque objects on the 3D image.
It is recommended to keep MAR activated.

Force device Change the language of the GUI if needed.

language
It is recommended not to force the
language of the GUI but change the
language profile of the workstation.

Default to Scout Enable or disable automatic Scout image

before 3D 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
"enabled", a Scout image mode can
still be activated manually in the 3D
imaging program selection view.

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 4 User Interfaces

Patient Size Adjust the default mA and kV values for imaging programs.
Configuration

5. SERVICE MENU
NOTICE! This menu is intended for authorized service personnel only.

The Service menu can be accessed only with a PIN code.

The Service menu contains:
• 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

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4.2 Positioning panel

1. Carriage up/down slider. The carriage can be driven up and down by sliding a finger
on the carriage up/down slider. The speed of the carriage movement depends on the
distance the finger is moved.
2. Test mode button. Disables radiation production of the device. You can also use the
GUI to activate the Test mode.
3. Patient positioning lights button. Turns the patient positioning lights on/off.
4. HOME button. Drives the rotating unit to HOME (Patient-In) and scan start positions.
5. Exposure indicator (YELLOW). Illuminates when the device is radiating.
6. Status indicator (BLUE). Illuminates when the device is in Error state. The error
details are shown on the GUI.
7. Ready indicator (GREEN). Illuminates when the device is ready for imaging.
NOTICE! If carriage up/down slider backlight is not illuminated, the carriage up/
down slider is in safe mode and cannot be used. Wait until the light comes back on
or wipe the panel clean if it is dirty.

4.3 Status indicator light

Device status indicator light, located on the top of the carriage, illuminates according the
device status:
• YELLOW: Device is radiating.
• BLUE: Device is in error state or pending user action. Check the GUI for details.
• GREEN: Device is ready for imaging.

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5 Imaging programs

5.1 Panoramic programs

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
select and deselect them.

NOTICE! The segment widths and height differences shown here are for
illustrative purposes only.

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.
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
select and deselect them.

NOTICE! The segment widths and height differences shown here are for
illustrative purposes only.

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Bitewing program

A bitewing view of the patient's Premolar-Molar region dentition.

NOTICE! The segment widths and height differences shown here are for
illustrative purposes only.

TMJ, lateral projection

Lateral TMJ program provides a lateral view of the patient's left and right
temporomandibular joints.

NOTICE! The segment widths and height differences shown here are for
illustrative purposes only.

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5.2 3D programs
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.

5.2.1 FOV Sizes (H x D)

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.

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:

High resolution

Standard resolution

LDT (Low Dose Technology™) resolution

Program for optimized endodontic imaging:

Endo program

FOV 6 x 9
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.

Available resolutions:

High resolution

Standard resolution

LDT resolution

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FOV 9 x 11
Optimized for imaging the entire dentition, both mandibula and maxilla,
maxillary sinuses, jaws with bilateral joints and jaws with airways.

Available resolutions:

High resolution

Standard resolution

LDT resolution

FOV 9 x 14 (optional)
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.

Available resolutions:

High resolution

Standard resolution

LDT resolution

5.2.2 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 Low Dose Technology™ (LDT) 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

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.

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6 Using the device

6.1 General imaging workflow

Prepare the Select imaging

Power device on workstation program
and initialize

Place positioning Select patient size to

accessories and position set imaging parameters
patient to the device

95 kV
_ 8.00 mA +

Release patient and

Take Scout image Take PAN/3D image end study

Adjust FOV

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6.2 Powering on the device

1. Power the device on. Power switch is located at the rear of the carriage.

2. The device starts initialization.

3. Complete the device initialization by pressing the HOME button on the positioning
panel when 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
positioning panel lights are lit. The device wakes up from the power save
mode when connection to it is established or when the positioning panel is
used.

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.

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6. GUI: Select or ensure the correct settings; imaging modality, imaging program
and patient size. If the preset selections are not suitable for the patient, adjust the
imaging parameters manually.

Imaging
Modality

PAN 3D

Imaging
Program

Patient size

Imaging
parameters

6.4 Patient positioning

NOTICE! The device can be used to take images of both standing and seated
patients. It's recommended to have very tall patients seated for easier positioning.

1. Press HOME button on the patient positioning panel. The device moves to HOME
(Patient-In) position.

NOTICE! Ensure from the GUI that the device has been set up according to
the required examination.

2. Ask the patient to remove their glasses, hearing aids, removable dentures, jewellery,
hair clips and all other things that may cause artifacts to the image.

3. Protect the patient from radiation according to the local regulations, for example
using a lead apron.

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4. 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.

Panoramic Imaging:
Standard and Pediatric Standard and Pediatric TMJ imaging
panoramic and panoramic and
Bitewing imaging Bitewing imaging for
for dentate patients edentulous patients

Bite Block + Chin Rest Lip Support + Chin Rest Lip Support + Chin Rest

3D Imaging:
Lower jaw or both jaws Upper jaw

Lip Support + Chin Rest Lip Support + Chin Rest

NOTICE! The Chin Rest has magnets to keep it in place.

NOTICE! The chin rest needs to be positioned correctly to the device for the
selected imaging program before the device allows images to be taken.

5. Place disposable covers on the positioning accessories.

6. Adjust the device's height to approximately match the patient's height.

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7. Open the head support locking lever on the lower shelf and push the head support
towards the mirror.

8. Guide the patient to the device and instruct to stand as straight and as tall as
possible.

9. Ask the patient to grab the patient handles and place their chin on the Chin Rest and
press their lip against the Lip Support or if using the Bite Block, to bite the notches.
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 soulders.

10. Ask the patient to take a step forward to straighten their spine.

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11. Fine adjust the device's 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 tilt light is approximately on the incisors and the root
tips of lower and upper incisors are parallel to the tilt light. The ORTHOfocus™
feature automatically determines the optimum panoramic image layer, enabling
forgiving patient positioning.
NOTICE! The patient’s Frankfort-Horizontal plane should be close to
parallel to the FH light.

BITEWING IMAGING:
• The patient’s occlusal plane should be horizontal and parallel to the FH light.

TMJ IMAGING:
• The patient’s Frankfort-Horizontal plane should be close to parallel to the
horizontal light. The horizontal light indicates the center of the field. You can take
a TMJ image with the patient's mouth closed or open.

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3D 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.

12. Check that the patient’s head is straight and not rotated and the patient’s midline
coincides with the midsagittal light.

13. Turn the head support against the patient's forehead.

14. Lock the head support in place by closing the temple supports and close the locking
lever.

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15. If you take a 3D image, place the head support strap behind patient's head and
tighten it to minimize the patient movement.

6.5 Taking an image

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 positioning panel and then press and hold the exposure
button. The unit will complete the imaging movements without
generating X-rays.

6.5.1 Taking a Panoramic, Bitewing or TMJ image

1. Ensure the correct patient positioning, imaging program selection, imaging
parameters and ask the patient to stay still during the imaging process.

2. Ask the patient to close their lips and press their tongue against the palate if
possible.

3. Protect yourself from radiation.

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. Release the patient from the device.

8. A preview image appears on the GUI for a quick review (no visible artifacts etc.).

9. Acknowledge the preview by pressing the OK button.

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10. Continue to take the next image, if multiple images need to be taken.

11. Press "End Study" to end the study or return to imaging program.

12. 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 and ask the patient to stay still during the
Scout imaging process.

2. Protect yourself from radiation.

3. Press and hold the exposure button down.

4. The device starts to move and an audible exposure warning signal is played.

5. 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.

6. The Scout image appears on the GUI.

7. GUI: Adjust the FOV height, diameter and location using the Scout image, if needed.
NOTICE! If you wish to verify the adjustments, you can take another scout
image by pressing the exposure button.

8. GUI: Approve the scout image and proceed to the 3D imaging phase by pressing OK
button.

9. Ask the patient to stay still during the 3D imaging process.

10. Protect yourself from radiation.

11. Press and hold the exposure button down.

12. The device starts to move and an audible exposure warning signal is played.

13. 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.

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14. Release the patient from the device.

15. Image preview appears on the GUI for a quick review (no visible artifacts etc.).

16. Acknowledge the preview by pressing the OK button.

17. Continue to take the next image, if multiple images need to be taken.

18. Press "End Study" to end the study or return to imaging program.

19. Remove all disposable covers and decontaminate the device and the patient
positioning accessories.

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7 Maintenance
The maintenance and calibration procedure intervals described here are minimum
requirements and 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

The device should be cleaned after every use.
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.
NOTICE! Decontamination techniques for the device, its accessories and the
room must comply with all laws and regulations within the local jurisdiction.
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.

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.
NOTICE! Wear gloves and other protective equipment during the
decontamination process.
WARNING! Do not use any disinfecting aerosols, since the vapors coud ignite
causing injuries.

Allowed cleaning agents for cleaning and decontamination of the device:

• Distilled water
• Ethanol 96%
• Isopropyl alcohol
• Soapy water
• CaviCide™ disinfectant
• Metasys™ disinfectant

Autoclave
Lip Supports and Bite Blocks may be autoclaved in 121°C (250F) temperature for max. 3
minutes. Other parts are not autoclavable.
NOTICE! Autoclaving is not recommended as cleaning method, and the parts are
not intended to be sterilized.

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 7 Maintenance

7.2 Quality Control

The Quality Control (QC) programs in the Quality Control menu are used to ensure that
the image quality remains constant.
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.

7.2.1 PAN QC
NOTICE! The PAN QC is an optional, yet recommendable, procedure and is
mandatory to be performed where local regulations require it.

1. GUI: Go to Settings menu.

2. GUI: Select Quality Control menu.

3. GUI: Select PAN QC program from the list.

4. Attach the Panoramic QC phantom holder and 2D QC phantom to the device.

5. Attach the copper filter in front of the radiation window on the tube head. The filter
attaches in place with magnets.

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6. Protect yourself from radiation.

7. Press and hold down the exposure switch to take the QC image.

8. The QC image preview appears on the GUI.

9. Acknowledge the result by pressing the OK button on the GUI.

10. 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, four holes if using 0.8 mm filter and two
holes if using 1.8 mm 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.

11. If the image fails on any of the previously listed criteria, redo the QC program. If it
fails again, recalibrate the device or contact service.

7.2.2 3D QC
1. GUI: Go to Settings menu.

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2. GUI: Select Quality Control menu.

3. GUI: Select 3D QC program from the list.

4. Attach the 3D QC phantom holder and the 3D QC phantom to the device.

5. Protect yourself from radiation.

6. Press and hold down the exposure switch to take the QC image.

7. The QC image preview appears on the GUI.

8. Acknowledge the result by pressing the OK button on the GUI.

9. The QC image appears on the workstation, showing the result of the check.

10. Workstation: Visually evaluate the image using the dental imaging software for
visual defects such as artifacts.
NOTICE! The device determines if the QC image is PASSED or FAILED
according to measured data, not based on the visible image quality.
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.

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11. If the image fails or any visual defects are apparent, redo the QC program. If it fails
again, recalibrate the device or contact service.

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7.3 Calibrations for the user

7.3.1 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.

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 the change the frequency of the re-calibration reminders, contact service
for assistance.
The device must be re-calibrated completely at least once a year, by a service
technician according to chapter Complete device calibration. The last calibration date for
each program is listed in the calibration menu.

The device must be calibrated after the first installation, see chapter Complete device
calibration, or when parts are replaced, as described in the device service manual.
QC images have to be taken always after calibration.

7.3.2 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.

1. Access the Calibrations menu by pressing Settings icon on the GUI.

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2. A list of available device calibrations is shown with the status of the calibration.

Calibration status indications:

Calibration not performed Recalibration is required. Calibration performed

or failed. successfully.
3. Start a calibration program by pressing the calibration name 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. All adjustment instructions in the calibration images also refer to this
perspective.

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7.3.3 Calibration procedure

Perform the calibrations in the exact order instructed in here.

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.

1. Select 3D Pixel calibration from the Calibrations menu.

2. Protect yourself from radiation.

3. Press and hold down the exposure button 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.

PAN Pixel Calibration

This program calibrates the sensor for Panoramic imaging.
No calibration tools are required when performing this calibration.
NOTICE! This calibration produces X-rays. Protect yourself from radiation.

1. Select PAN Pixel Calibration from the Calibrations menu.

2. Protect yourself from radiation.

3. Press and hold down the exposure button to take the calibration image.

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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.

3D Geometry Calibrations
These programs create the calibration data for reconstructing 3D images.
NOTICE! This calibration produces X-rays. Protect yourself from radiation.

Perform the calibrations in this order:

• 3D Geometry Calibration, 5x5 FOV
• 3D Geometry Calibration, 6x9 FOV
• 3D Geometry Calibration, 9x11 FOV
• 3D Geometry Calibration, 9x14 FOV
3D Geometry Calibration Phantom is required when performing these calibrations.

1. Attach the 3D Geometry Calibration Phantom to the device.

2. Select a 3D Geometry Calibration from the Calibrations menu.

3. Protect yourself from radiation.

4. Press and hold down the exposure button to take the calibration image.

5. The calibration results appear on the GUI.

NOTICE! This will take several minutes.

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6. Acknowledge the calibration by pressing the OK button.

7. Repeat the calibration for the remaining FOV sizes.

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 power 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 tube head.
• 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 button.
• Check the Z-movement limits.
• Check that the exposure warning indicators work correctly.
• Check device movements and functionality of exposure switch.
During the annual maintenance, all calibrations and QC programs must be performed
according to chapter Complete device calibration.
A full description of the maintenance procedure is described in the device Service
Manual.

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 8 Troubleshooting

8 Troubleshooting
Problem Possible cause Solution
Taken image is not Local network connection The device stores the latest
transferred to the modality is disrupted, which causes image until a confirmation
workstation. loss of data. of a succesfull transfer to
the workstation has been
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.
Device cannot be driven 1. Up/down slider is on 1. Clean the positioning
upwards or downwards. safe mode. panel and wait for the
2. Mechanical safety safe mode to clear out.
device on the driving 2. Contact service.
motor has activated.
3. Positioning panel not
working.

No connection to the device. 1. The device is not 1. Power the device on.
powered on. 2. Check the Ethernet
2. Problem with the local cable connections on
area network (LAN). the workstation and the
3. Check the device device.
configuration. 3. Restart the device and
the workstation.

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9 Installation
NOTICE! This section of the manual is only for authorized service technicians.

9.1 Device package

Package contents

1. Carriage and rotating unit.

2. Column and wall bracket.
3. Device covers.
4. Installation accessories, manuals and
parts for device installation.
5. Patient positioning accessories.
6. Calibration tools.

NOTICE! It is recommended not to discard the device package and the packaging
supports as they can be used if the device needs to be repacked.

9.2 Pre-installation requirements

9.2.1 Installation location requirements
WARNING! Ensure that each of the wall mount fixing screws and the wall can
withstand pull-out force of at least 1500 N.
• The place where the device is to be installed and the position from where the user
takes images must be correctly shielded from the radiation that is generated when the
device is operated. Follow the local radiation and safety requirements.
• The device must be fixed to the wall and the floor. If floor attachment is not possible,
use either an additional wall support (ordered separately) or an optional exhibition
stand together with one wall mount bracket.
• The wall material should be suitable for fixing the device. If the wall is made of a
weak material, you may have to use a reinforcing plate on the rear side of the wall to
hold the fixing hardware.
• Make sure that the floor, where the device is to be installed, can support its weight.
To avoid the device from tipping over, fix the device with floor bolts appropriate to the
floor material. The bolts and the floor material must endure pull-out force of 1500 N
on the base plate.

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• Do not install the device in environments where corrosive or explosive vapours or

flammable anaesthics are present.
• Special steps regarding EMC need to be taken when installing the device. For more
information, refer to the chapter Electromagnetic Compatibility (EMC) tables.
• The device is supplied with a 3m (10ft) long power cord. Ensure that when connected
to a power outlet, the power cord is long enough, taking in consideration the device's
up/down movements.
• It's recommended to use a max. 30 A circuit breaker with the device.
• Maximum allowed mains line impedance is 0.2 Ω.
• For permanent installation, a separate lockable mains switch (not supplied) is required
to be installed to the mains feed.
• Maximum mains over-current releases:
100-120V: 20A
220-240V: 16A

9.2.2 Space requirements

When you install the device, ensure that:
• There is enough space at the front and sides of the device to allow patients to enter
and exit the device easily. Patients in wheelchairs will require more space than
standing patients.
• There is enough space for the operator to position the patient correctly.
• The device is positioned at least 1.5m (59") away from any non-medical electrical or
electromechanical equipment.
• The device is positioned so that the operator who is protected from radiation can see
and hear the patient during the imaging, while maintaining visibility to the GUI.
• If the device is installed in an angle of 15 or more, the plywood supports may come
in the way of the installation and need to be removed. See more details in chapter
Device dimensions.

Absolute minimum installation space requirements

One man installation Two man installation
Depth 1800 mm / 70.9 in 1500 mm / 59 in
Width 1240 mm / 48.8 in 1500 mm /59 in
Height 2080 mm / 81.9 in

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Minimum operating space requirements

Depth Minimum:
min. 715 mm / 28.1 in min. 660 mm / 26 in
1385 mm / 54.5 in rec. 950 mm / 37.4 in

Recommended
minimum:
1630 mm / 64.2 in

Width Minimum:
1375 mm / 54 in
Recommended
minimum:
1610 mm / 63.4 in

Height Minimum:
2080 mm / 81.9 in
Recommended
minimum:
2467 mm / 97.1 in

9.2.3 Fixing hardware and tools

The following tools and hardware are required to install and set up the device. These are
not included in the delivery, unless otherwise stated.

Fixing hardware
NOTICE! Mounting bolts for floor and wall fastening are not included in the
delivery. The fixing hardware used to fix the device to the wall must be of correct
type for the wall.
The type and length of hardware to be used depend on the wall material and floor
material where the device is to be fixed. The fixing hardware must be selected so that
they withstand at least 1500 N pull-out force.
WARNING! Ensure that the mounting bolts, the wall and the floor the device is
attached to, can withstand at least 1500 N pull-out force.
Installation tools
• Electric drill
• Spanners size 13 & 17 mm
• Allen keys 3, 5 & 6 mm
• Flat head screwdriver
• Spirit level
• Pliers and wire cutter
• Scissors/knife
• Torque wrench

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9.3 Back panel connectors

1. Power cord
2. Ethernet cable for workstation connection
3. Exposure button connector
4. Remote exposure switch connector (optional)
5. External warning light connector (optional)
6. Main fuses F1+F2 (10A fuses installed as default)
7. External warning light (optional) fuse F3
8. Control interface
NOTICE! All cables, except the power cord, must be routed through a strain relief
attached to the back panel plate.
The Control interface can be used to connect optional device controls such as external
exposure switch and door switch.
PIN 1 2 3 4 5 6 7 8

SIGNAL EXPSW READY GND +5V WARNING DOORSW

USE Exposure switch LOW signal when LOW signal when Door switch
connection device is ready exposure is ON connection

NOTICE! If a door switch is installed it has to be activated on the GUI. See

chapter Device configuration for more information.

9.4 Installing the device

NOTICE! If the device cannot be fixed to the floor or the device is to be installed
on an exhibition stand, see chapter Additional installation procedures for more
details.

1. Transport the packing pallet to the installation location.

2. Remove the packing straps.

3. Remove the package lid and sides.

4. Move the boxes with accessories and device covers aside.

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5. Open the lowest box to find the device column and the wall bracket.

6. Lift and set the column standing to the installation location.

NOTICE! Use spirit level to ensure that the wall and floor of the chosen
installation location are straight enough to allow the device to be installed
vertically straight.

7. Detach the preinstalled installation bolts, washers and locking nuts from the column
side bracket.

8. Take the wall side bracket of the wall mount from the column box.

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9. Attach the wall side bracket to the column side bracket using the same bolts,
washers and locking nuts that were previously detached. Do not tighten the bolts
fully yet.

10. Adjust the angle and the depth of the wall bracket and tighten the angle adjustment
screws (2 pcs) to lock the wall bracket into the desired position. Screw the depth
adjustment screw in to hand tightness.

11. Mark the installation screw locations to the wall (2 pcs) and to the floor (4 pcs) using
the holes in the wall bracket and the column base plate as a template.
NOTICE! The top surface of the wall side bracket should be approximately
790 mm (31.1") from the floor when attached to the wall.
CAUTION! If the device cannot be bolted to the floor, an additional wall
bracket or exhibition stand is required. See chapter Additional wall bracket
installation and Exhibition stand installation for more instructions.

12. Lift the column aside and drill appropriate holes for the used fixing hardware.

13. Attach the column to the wall with the wall bracket using appropriate bolts and
washers. Use a spirit level on the top of the column to ensure the column is vertically
aligned in both directions. The wall bracket allows the device to be tilted in all
directions, if needed.
NOTICE! The wall bracket cannot be used in adjustment if the device is
bolted to the floor.
NOTICE! If the angle/position of the wall bracket was required to be
changed, re-tighten the wall bracket angle and depth adjustment screws.

14. Install the wall bracket cover plate with two (2) screws.

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15. Attach the column to the floor using appropriate screws and washers.

NOTICE! Ensure that the column is vertically straight before fully tightening
the floor screws.

16. Remove the bubble wrap between the outer and inner column covers. Ensure that
the outer column cover plate is properly in place and doesn't scratch the inner
column cover.

17. Attach the floor screw covers on the screw heads.

18. Pull the carriage to the edge of the pallet so that the diagonal sections of the
plywood supports are outside of the pallet.

19. Flip the carriage 90° to the floor so that it stands in upright position using the
cutouts in the plywood as handles.

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20. Pull the protective plastic aside from the carriage to reveal the base plate and back
panel connectors.

21. Check that the device's mains power configuration is applicable to the installation
location.
NOTICE! The device is delivered with 10A fuses installed. If installing to other
than 230V mains voltage the fuses need to be changed. See chapters Mains
power configuration and Changing the fuses for more information.
NOTICE! If mains connection type needs to be changed, see chapter Mains
power configuration for more information.

22. Move the carriage against the column.

NOTICE! If the device is installed in an angle (e.g. corner installation) the

plywood supports may come in the way of the installation and need to be
removed at this point. See more details in chapter Device dimensions.

23. Loosen the three carriage locking bolts on top of the column and ensure that they
are facing outwards.

24. Push the carriage installation rail into the slot on the column. The rail locks itself into
the slot.

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25. Lift the carriage onto the column using the installation rail as a hinge and by lifting
from the cutouts in the plywood support.

NOTICE! The liftable weight corresponds to approximately 55 kg and lifting it

on the column may require two persons.
NOTICE! Ensure that nothing gets caught between the carriage and the
column.
NOTICE! A latch locks the carriage in place when it is lifted on to the column.

26. Lift the carriage locking bolts (3 pcs) up and tighten them to 25 Nm torque to secure
the carriage.

CAUTION! The carriage may fall down during use, if the carriage locking
bolts are not properly installed and tightened.

27. Detach the plywood cover from one side first by detaching all the seven (7) indicated
screws and pulling it off.

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28. Detach the upper and rear screws (4 pcs) of the plywood cover on the other side and
carefully pull it off with the metal supports attached.

NOTICE! Hold the plywood cover in place when detaching the last screw to
prevent it from falling down.
NOTICE! Be careful not to scratch the unit with the metal supports attached
to the plywood cover.

29. Detach the plywood top cover and the metal supports on top of the carriage (4
screws).

30. Remove the metal support from the rear of the carriage (4 screws).

31. Remove the protective plastic from the carriage carefully so that it doesn't catch and
break any circuit boards.

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32. Detach the two screws holding the front support bar in place, push it inside the
upper shelf frame and reattach it.

33. Detach the linear movement support from the top shelf (2 screws).

34. Detach the rotating unit support from the carriage (4 screws), push the rotating unit
outwards a bit and lift the support off from the rotating unit .

NOTICE! The rotating unit can now move freely, ensure that it does not hit
the lower shelf.

35. Connect the Column control and Emergency switch connector to the connectors in
the column.

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36. Connect the Mains cable (1), Ethernet cable (2) and Exposure button cable (3) to
the rear of the carriage.

NOTICE! Route the Ethernet cable and exposure button cable through the
strain relief.
NOTICE! You can also connect other additional cables to the carriage at this
point. See chapter Back panel connectors.
NOTICE! The cables will move when the unit is driven upwards. Ensure that
the cables connected to the device are long enough so that the unit can be
driven to upmost position without causing any strain to the cables.

9.5 Attaching the covers

NOTICE! The screws used to attach the covers are located in the screw bag.

1. Attach upper shelf covers. Place the right cover onto the upper shelf and then push
the left cover against it.

2. Secure the covers with two screws on the top of the covers and then one on the
bottom.

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3. Attach the right carriage side cover. Insert the claws on the cover into the slots on
the rear of the column and turn the cover to correct position. Secure the cover in
place with one screw under the status indicator light.

4. Press the side covers together and ensure that they sit properly.

5. Secure the side covers in place with the remaining four (4) screws.

NOTICE! When securing the left cover, ensure that the horizontal lasers sit in
the middle of the groove so that the cover does not block the positioning light
beam.

6. Attach the lower shelf tray by pressing the upper edges down and turning the lower
part against the side covers until it snaps in place.

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7. Attach the mirror by guiding the pins on the carriage plate (4pcs) through the
keyholes on the mirror plate and sliding the mirror down to lock it in place.

8. Route the mains cord, exposure button cable, Ethernet cable and other optional
cables through the cable clamp on the rear of the device.

9. Attach the back panel cover by sliding it to its place and secure it with one screw,
located on the left side of the unit.

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10. Attach the carriage back plate by pressing the hooks on the lower side of the plate to
the gaps in the column and turning the upper side in place.

11. Attach the filler strips over the gaps under the carriage back plate.

12. Attach the patient handles with four screws. Tighten the screws to 10 Nm torque.

13. Attach the tube head plate in place by pressing it in one side at a time.

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14. Install the head support to the lower shelf by screwing the rods in. Slide the head
support into the rods.

15. Attach the exposure button holder to the column or other metallic surface using its
built in magnets or screw it to a non-magnetic surface.

16. Remove all remaining protective film from the device covers and the positioning
panel.

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9.6 Configuring the communication link to the

workstation
1. Install the Dental Imaging software to the workstation.

2. Connect the device to the local area network (LAN) or directly to the workstation
with an Ethernet cable. See chapter Connection options for more detailed
information.
NOTICE! The unit requires 1Gb Ethernet connection between the unit and the
reconstruction workstation. The workstation must be connected to the unit in
accordance with IEC 60601-1-1.

3. Configure the imaging software to connect to the device. See software instructions
for more information.

4. When communication link has been established, the device GUI appears on the
screen.

9.6.1 Connection options

Network Configuration
In network configuration, the unit is connected to the workstation via a 1Gb network
switch. With this configuration, the PC is connected to the unit and to other devices
in the network with a single network card. The unit is also accessible from other
workstations in the same network (same subnet).
By default, the device is configured to retrieve its IP address automatically from the
DHCP server in the network.
For the network configuration with static IP address, you may need a dedicated IP-
address for the unit to be reserved by your local system administrator.
When configuring the IP address or DHCP server, the device can have any IP-address,
but it and the reconstruction workstation must be in the same subnet. Subnet mask is
recommended to be set as 255.255.255.0.
NOTICE! The device does not support connection to IPv6 or L3 (routable)
networks. Only IPv4 is supported.

Standalone Configuration
In standalone configuration, the unit is connected directly to a workstation and the unit
then reserves the whole network interface card. The unit and the workstation function
as a single standalone system with no access to other networks. If it is necessary to be
connected to another network or to a server, the workstation will require two network
interface cards.
In standalone configuration, both the ETHERNET interface of the workstation and
the device IP address need to be set to have IP addresses from the same subnet, for

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example 192.168.1.1 for the PC and 192.168.1.2 for the device. The recommended
Subnet mask is 255.255.255.0.
A static IP address can be configured to the device through the device driver. See
software documentation for more information on how to configure the imaging software
for device connection required for the static IP address configuration.
NOTICE! When configuring a static IP address it must be set for both the device
and the PC. The device may have initial local host IP Address (169.xxx.xxx.xxx)
but this is not static unless set. It is not recommended to use addresses from the
local host address range as static IP addresses.

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9.7 Finishing the installation

After the device has been installed, perform these checks and tasks, before handing it to
the user.

1. Check the wall mount screw tightness.

2. Check the floor screw tightness.

3. Ensure that the wall mount screws match the wall material.

4. Ensure that the wall mount and floor screws withstand 1500N pull-out force.

5. Check that the power cord and the Ethernet cable, along with all the other cables
connected, are installed so that the up/down movement of the device doesn't cause
stress to them.

6. Check that the power cord is not damaged in any way

7. Check that all covers are attached correctly.

8. Check the electrical safety of the device by inspecting the proper grounding of user
touchable metallic parts.

9. Check that the IEC 60601-1 leakage current levels are not exceeded.

10. Check the functionality of the power switch.

11. Check that the patient positioning lights work properly and are aligned correctly. The
positioning light can be checked during the Device Geometry Calibration.

12. Check that the device has been configured correctly for the installation location. See
chapter Device configuration for more information.

13. Carry out the device calibrations described in chapter Complete device calibration.

14. Check that the exposure warning indicators work correctly.

15. Check the functionality of the Emergency Stop button.

NOTICE! Activating the Emergency Stop causes the device to restart.

16. Check the Z-movement limits.

17. Gather the screws left over from the installation for storage.

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9.8 Complete device calibration

After the installation of the device and during the annual maintenance, a complete
calibration procedure must be performed. See chapter Preparation for Calibration for
information on the unit calibration.
Perform the calibrations in the order as described in this chapter.
After the calibrations have been completed, the QC images need to be taken and stored
for the user as reference.

9.8.1 Accessing the calibrations

A complete list of calibration programs, required to be performed after the unit
installation, can be found in the PIN code protected Service menu.
NOTICE! The calibrations programs in the Service menu are intended for service
technicians only, and not to be performed by the end user of the unit.
NOTICE! The device's country selection needs to be configured correctly before
performing the calibrations. See chapter Device configuration.

1. Turn the device on and establish a connection to the workstation. See chapters
Powering on the device and Preparing the device for imaging for more information.

2. Select Settings menu on the GUI.

3. Select Service menu and enter PIN code 0612.

4. The GUI informs that additional options have been added under the Service menu.

5. Select Calibrations under the Service menu to see the list of all calibration
programs.

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9.8.2 Device Movement Calibration

This program is used to calibrate the movements of the upper shelf and the rotating unit.
No calibration tools are required when performing this calibration.

1. Select Device Movement Calibration from the Calibrations menu.

2. Turn the device to HOME (Patient-in) position by hand.

3. Press and hold the exposure button. The device starts to move.

4. Keep the exposure button pressed down during the whole calibration.

5. When the device's movements stop and the program end tone is played, the
program is complete.

9.8.3 Z-Movement Limits

This program is used to determine the maximum height of the device, required especially
for low room installations.
No calibration tools are required when performing this calibration.
NOTICE! The maximum height of the device must be at least 2080 mm / 81.9".

NOTICE! Z-movement limits do not need to be re-determined during annual

calibration, checking the limits will suffice.

1. Select Z-Movement Limits from the Calibrations menu.

2. Press and hold down the exposure button. The carriage starts to move upwards.

3. Keep the exposure button pressed down until the device is in the maximum allowed
height and release the button.

4. Wait a minimum of 2 seconds and then Press and hold the exposure button down to
drive the device downwards.

5. When the device's movements stop and the program end tone is played, the
program is complete.

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9.8.4 X-Ray Generator Calibration

NOTICE! This calibration is pre-performed at the factory, but should be
performed nonetheless.
NOTICE! This calibration produces X-rays. Protect yourself from radiation.

1. Select X-Ray Generator Calibration from the Calibrations menu.

2. Protect yourself from radiation.

3. Press and hold down the exposure button to take the calibration image.

4. When the exposure warning stops and the program end tone is played, the program
is complete.

9.8.5 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.

1. Select 3D Pixel calibration from the Calibrations menu.

2. Protect yourself from radiation.

3. Press and hold down the exposure button 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.

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6. Acknowledge the calibration result by pressing the OK button.

9.8.6 Device Geometry Calibration

NOTICE! This calibration produces X-rays. Protect yourself from radiation.

NOTICE! This calibration is iterative and may need to be run a couple of times
before it passes.
3D Geometry Calibration Phantom is required when performing this calibration.

1. Attach the 3D Geometry Calibration Phantom to the device.

2. Select Device Geometry Calibration from Calibrations menu.

3. All patient positioning lights come on. Check that the lights hit the grooves on the
phantom to ensure that the positioning lights are correctly aligned. If the lights do
not hit the grooves, they need to be re-aligned. See chapter Patient positioning light
adjustment.

4. Protect yourself from radiation

5. Press and hold down the exposure button to take the calibration image.

6. When the exposure warning stops and the program end tone is played, the program
is complete.

7. The calibration results appear on the GUI.

NOTICE! This may take several minutes.

8. Acknowledge the calibration by pressing the OK button.

NOTICE! If the device geometry calibration fails and the GUI informs you
to adjust the height of the sensor. See chapter Sensor adjustment for more
information.
NOTICE! Repeat the 3D Pixel Calibration if any mechanical adjustment was
needed.

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9.8.7 Collimator Calibration

No calibration tools are required when performing this calibration.
NOTICE! This calibration produces X-rays. Protect yourself from radiation.

NOTICE! The X-ray beam size is verified during this calibration.

1. Select Collimator Calibration from the Calibrations menu.

2. Protect yourself from radiation.

3. Press and hold down the exposure button 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.

NOTICE! If the collimator calibration fails and the GUI informs you to adjust
the height or tilt of the collimator, adjust the collimator according to chapter
Collimator adjustment.

6. Acknowledge the calibration result by pressing the OK button.

NOTICE! Repeat the 3D Pixel Calibration and Device Geometry Calibration if any
mechanical adjustment was required.

9.8.8 PAN Pixel Calibration

This program calibrates the sensor for Panoramic imaging.
No calibration tools are required when performing this calibration.
NOTICE! This calibration produces X-rays. Protect yourself from radiation.

1. Select PAN Pixel Calibration from the Calibrations menu.

2. Protect yourself from radiation.

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3. Press and hold down the exposure button 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.

9.8.9 3D Geometry Calibrations

These programs create the calibration data for reconstructing 3D images.
NOTICE! This calibration produces X-rays. Protect yourself from radiation.

Perform the calibrations in this order:

• 3D Geometry Calibration, 5x5 FOV
• 3D Geometry Calibration, 6x9 FOV
• 3D Geometry Calibration, 9x11 FOV
• 3D Geometry Calibration, 9x14 FOV
3D Geometry Calibration Phantom is required when performing these calibrations.

1. Attach the 3D Geometry Calibration Phantom to the device.

2. Select a 3D Geometry Calibration from the Calibrations menu.

3. Protect yourself from radiation.

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4. Press and hold down the exposure button to take the calibration image.

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.

9.8.10 PAN QC (optional)

NOTICE! The PAN QC is an optional, yet recommendable, procedure and is
mandatory to be performed where local regulations require it.
NOTICE! The device's country selection needs to be configured per local
requirements before performing the QC programs. See chapter Device
configuration.

1. GUI: Go to Settings menu.

2. GUI: Select Quality Control menu.

3. GUI: Select PAN QC program from the list.

4. Attach the Panoramic QC phantom holder and 2D QC phantom to the device.

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5. Attach the copper filter in front of the radiation window on the tube head. The filter
attaches in place with magnets.

6. Protect yourself from radiation.

7. Press and hold down the exposure switch to take the QC image.

8. The QC image preview appears on the GUI.

9. Acknowledge the result by pressing the OK button on the GUI.

10. 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, four holes if using 0.8 mm filter and two
holes if using 1.8 mm filter.
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.

11. If the image fails on any of the previously listed criteria, redo the QC program. If it
fails again, recalibrate the device or contact service.

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12. Save the passed QC image as a reference image for the user and let the user know
the reference image location.

9.8.11 3D QC
NOTICE! The device's country selection needs to be configured per local
requirements before performing the QC programs. See chapter Device
configuration.

1. GUI: Go to Settings menu.

2. GUI: Select Quality Control menu.

3. GUI: Select 3D QC program from the list.

4. Attach the 3D QC phantom holder and the 3D QC phantom to the device.

5. Protect yourself from radiation.

6. Press and hold down the exposure switch to take the QC image.

7. The QC image preview appears on the GUI.

8. Acknowledge the result by pressing the OK button on the GUI.

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9. The QC image appears on the workstation, showing the result of the check.

10. Workstation: Visually evaluate the image using the dental imaging software for
visual defects such as artifacts.
NOTICE! The device determines if the QC image is PASSED or FAILED
according to measured data, not based on the visible image quality.
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.

11. If the image fails or any visual defects are apparent, redo the QC program. If it fails
again, recalibrate the device or contact service.

12. Save the passed QC image as a reference image for the user and let the user know
the reference image location.

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9.8.12 Panoramic beam size verification (optional)

This program runs an automatic test to verify, that the X-ray beam hits the active area of
the sensor with the required accuracy.
NOTICE! The Panoramic Beam Size Verification is an optional, yet
recommendable, procedure and is mandatory to be performed where local
regulations require it.

1. GUI: Go to Settings menu.

2. GUI: Select Quality Control menu.

3. GUI: Select Panoramic Beam Size Verification program from the list.
NOTICE! The Panoramic Beam Size Verification program appears under
Quality Control menu only when the Service menu has been unlocked.

4. Protect yourself from radiation.

5. Press and hold down the exposure switch to take the calibration.

6. The test result appears on the GUI.

7. Acknowledge the result by pressing the OK button on the GUI.

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9.9 Additional installation procedures

9.9.1 Remote exposure switch installation

A wall-mountable remote exposure switch, with integrated exposure warning light, is
available as an option for the device.

1. Exposure switch
2. Exposure warning light
3. Exposure button connector

If a remote exposure switch needs to be used, install it as follows:

1. Connect one end of the remote exposure switch cable to the connector J2 inside the
remote exposure switch.

2. Attach the remote exposure switch to the wall with two screws.
NOTICE! Guide the remote exposure switch cable through the small cut-
out in the bottom of the remote exposure switch housing and ensure that the
cable does not press against the circuit board.

3. Guide the remote exposure switch cable to the back panel of the device, see chapter
Back panel connectors.

4. If the user wants, the exposure button can be attached also to the remote exposure
switch instead of attaching it directly to the device.

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9.9.2 Mains power configuration

Detach the indicated screw on the back panel cover and lift it off to access the device
back panel.

Mains connection type configuration

IEC 60601-2-63 standard requires extraoral X-ray devices to be installed permanently.
The device can, however, be installed with plug connection if the local regulations allow
this. In these cases, order a mains cord with plug from the manufacturer.
The i4100 Back Panel Board contains a switch (SW1), which needs to be configured if the
type of installation is changed from permanent to plug connection.
NOTICE! If device has been delivered from the factory with plug connection, it
has already been configured accordingly.
To access the switch, you must detach the Back panel plate by removing the two
indicated screws.

Mains power configurations:

Permanent connection - Switch (SW1) shall be in F1 position.
Plug connection - Switch (SW1) shall be in F2 position and both fuses (F1+F2) must
be installed.

See chapter Changing the fuses for information on how to install the fuses.

Mains voltage configuration

The device can be used in 220-240 VAC or 100-120 VAC mains voltage. The installed
main fuses (F1+F2) need to be configured according to the mains voltage:
• 10A suited for 220-240 VAC mains voltage
• 15A suited for 100-120 VAC mains voltage

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If the device mains voltage needs to be changed, change the fuses accordingly. See
chapter Changing the fuses for information on how to install the fuses.

9.9.3 Changing the fuses

Main fuses are located at the rear of the carriage, under the back panel cover. To reach
the fuses, remove the cover first.

The device is supplied with pre-installed 10A fuses. The fuses may need to be replaced
as part of the installation depending on the mains voltage:
• 10A suited for 220-240 VAC mains voltage
• 15A suited for 100-120 VAC mains voltage

To release a fuse cap, push it inwards and rotate counterclockwise with a flat head
screwdriver.
Remove the fuse from the socket and replace it with a new one. Install the fuse by
pushing the fuse cap in and rotating it clockwise with a screwdriver.
The 10A and 15A fuses are physically of different sizes and have their own fuse caps. If
you need to change the fuse rating, also the fuse cap needs to be changed. The fuses
are supplied with the corresponding fuse caps.

CAUTION! Use only specified fuses. See the list of fuses from chapter Technical
specifications.

9.9.4 Additional wall bracket installation

If the device cannot be bolted to the floor and the exhibition stand is not used, an
additional wall bracket is required (ordered separately). This part of the installation can
be done after the column has been unpacked.
NOTICE! The existing wall bracket holder doesn't need to be removed when
installing an additional holder.

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1. Detach two screws holding the cable router on the rear of the column.

2. Detach two screws holding the wall bracket rail cover in place.

3. Pull the rail cover off of the column.

4. Guide the bottom part of the rail cover through the additional wall bracket holder.

5. Lift the wall bracket holder up to the position where the rail has openings on both
sides to fit the holder in.

6. Slide the holder in the rail to the required height.

NOTICE! The lower wall bracket installation screws have to be fixed to the
wall 57-87 mm (2.2-3.4") from the floor. See chapter Device dimensions.

7. Secure the wall bracket holder in place with four screws.

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8. Re-install the wall bracket rail cover back in place.

9. Re-install the cable clamp to its place.

10. Continue to install the column normally according to chapter Installing the device.

9.9.5 Exhibition stand installation

If the device cannot be bolted to the floor, it may be installed on a special exhibition
stand (ordered separately).
NOTICE! The device has to be fixed to the wall even when the exhibition stand is
used.

1. Transport the exhibition stand to the location, where the device is to be installed.

2. Attach the device column on the exhibition stand. See the installation instructions
supplied with the exhibition stand for more details.

3. Complete the installation according to the normal installation instructions in chapter

Installing the device.

9.9.6 Collimator adjustment

If the collimator calibration has failed due to the collimator being too high/low or tilted,
adjustment is needed.
NOTICE! This adjustment is required only in special cases. After the adjustment,
all calibrations related to radiation must be performed again.

1. Remove the tubehead rear cover by detaching the 3 indicated screws and pull the
cover outwards. The screw on the middle of the cover has a screw cover cap over it.

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2. Remove the tubehead front cover by detaching 4 screws holding the cover on the
tubehead frame and pull it outwards.

3. To move the collimator in UP/DOWN direction, turn the collimator height

adjustment screw:
a) Clockwise to move the collimator downwards.
b) Counter clockwise to move the collimator upwards.

NOTICE! The GUI informs you how much the collimator needs to be adjusted
and in which direction. One full turn of the screw (360°) equals about 0.7 mm.

4. To rotate the collimator LEFT/RIGHT, loosen the two upper locking screws (1), the
lower locking screw (2) and turn the adjustment screw (3):
a) Clockwise to turn the collimator left.
b) Counter clockwise to turn the collimator right.

NOTICE! You may also loosen the screws 2 and 3, turn the collimator to the
required position by hand and then tighten the screws.

5. After the adjustments, tighten the locking screws and redo the collimator calibration
to verify the adjustment.

6. Install the tubehead covers back on.

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9.9.7 Sensor adjustment

If the device geometry calibration has failed due to the sensor being too high/low the
height adjustment is needed.
NOTICE! This adjustment is required only in special cases.

1. Pull the left and right sensor collar cover halves downwards.

2. Pull the inner collar cover half downwards to unlock the teeth holding the covers
together.

3. Pull the collar cover halves apart.

4. Remove the screw that holds the sensor front and back cover halves.

5. Pull the sensor covers apart to detach them.

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6. Loosen the two (2) vertical screws.

7. Turn the adjustment screw to adjust the height of the sensor. One turn is equivalent
of 0.7 mm.

8. Re-tighten the vertical screws after the adjustment.

9. Re-attach all covers in reverse order.

9.9.8 Patient positioning light adjustment

If the positioning lights are aligned improperly, adjustment is needed to ensure correct
patient positioning.
Correct alignment of the lights can be ensured by checking that the lights hit and are
parallel to the grooves in the 3D Geometry Calibration Phantom when Device Geometry
Calibration is selected.

Horizontal and midsagittal lights

1. Detach the carriage back plate, back panel cover, mirror, lower shelf tray and the
carriage side covers. See chapter Attaching the covers for more information.

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2. The positioning lights are held in place in a fixture with one screw. Loosen the screw
to release the light.
Horizontal lights Midsagittal light

3. Re-align the light by rotating it and tilting it up/down.

4. Tighten the screw.

5. Re-attach the covers.

NOTICE! When reattaching the left side cover, ensure that the horizontal
lasers sit in the middle of the groove so that the cover does not block the
positioning light beam

6. Attach the 3D Geometry Calibration Phantom to the device and verify the correct
alignment of the lights with Device Geometry calibration program selected.

7. Repeat the process if lights are still not aligned correctly.

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Tilt light
1. Detach the Layer laser cover from the lower shelf by detaching a screw on the
underside and pulling it out.

2. If you need to rotate the light, loosen the screw A. If you need to reposition the light
assembly, loosen the screw B and move the assembly sideways by turning the screw
C.

3. Tighten the screws A and B.

4. Re-attach the cover.

5. Attach the 3D Geometry Calibration Phantom to the device and verify the correct
alignment of the lights with Device Geometry calibration program selected.

6. Repeat the process if light is still not aligned correctly.

9.9.9 Device configuration

The device configurations can be changed if required during the installation or service.
The user has few device configurations that can be accessed through the Preferences
menu, but the device may be configured more through the Service menu.
1. Go to Settings menu.

2. Select Service menu and enter PIN code 0612.

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3. Select Preferences menu that appears under the Service menu.

User configurable options:

Configurations Friendly name Set a name for the device, which is shown
next to the settings icon and on the imaging
software.

3D Metal Artefact Enable or disable MAR, Metal Artefact

Reduction Reduction. MAR is used to reduce the effect
of metals and other dense radiopaque
objects on the 3D image.
It is recommended to keep MAR activated.

Force device Change the language of the GUI if needed.

language
It is recommended not to force the language
of the GUI but change the language profile of
the workstation.

Default to Scout Enable or disable automatic Scout image

before 3D 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
"enabled", a Scout image mode can
still be activated manually in the 3D
imaging program selection view.

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Configurations for service personnel:

Configurations Calibration Change the required calibration and QC

intervals interval for the User and for Service
(full calibration) according to the local
regulations. The device will remind the user
when re-calibration and new PAN QC and 3D
QC retakes are required according to this
setting.
The default values are:
• User interval - Biannually
• Service interval - Annually
• PAN QC interval - Quarterly
• 3D QC interval - Quarterly

License If the user has purchased a licensable

upgrade for optional imaging programs, for
example 9x14 3D FOV, they can be activated
through this field.
Type the purchased license key to the field
and press Save to activate the option.

Select country Select the installation country of the device.

The selection configures the device according
to country specific regulations, for example
change the maximum selectable mA for
imaging.
NOTICE! For PAN QC to be used with
1.8mm Cu filter, select Germany.

Door Switch If an optional Door Switch has been installed

to the device according to chapter Back
panel connectors, it has to be activated here.

Demo mode Used for setting the device into

demonstration mode where the radiation
production of the device is disabled while
maintaining all other functionalities.
NOTICE! Demo mode is intended for
exhibition use only.

DAP correction Change the DAP correction factor which is

used to calculate the shown DAP value for
the currently selected imaging program. This
setting is preset at the factory and should
not be altered in normal conditions.
NOTICE! The DAP correction factor
has no impact on the device radiation
output, it is used for DAP display
calibration purposes only.

PAN QC spinal Enable/Disable spinal compensation for PAN

compensation QC program.

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9.9.10 Verification
The device offers Panoramic and 3D verification test programs with the device
movements disabled. These programs can be used for radiation related measurements,
for example, during device installation and acceptance tests.
A separate radiation measuring device/equipment is required for taking the radiation
measurements.

To access the verification tests:

1. Go to Settings menu.

2. Select Service menu and enter PIN code 0612.

3. Select Verification menu that appears under the Service menu.

4. Select the PAN testing tab for Panoramic verification test or 3D testing tab for 3D
verification test.

The PAN Testing program allows adjustment of the exposure values kV and mA for the
tests.

The 3D Testing program allows selection of different radiaton modes High/ENDO

Resolution (Constant), Standard Resolution (Pulse 10ms) or LDT resolution (Pulse 5ms)
and adjusting the related mA.
NOTICE! When using the PAN testing program, the X-Ray beam is adjusted
wider (over 2 cm) than in normal imaging programs to allow easier positioning of
the measurement device.

9.9.11 Repacking the device

If the device needs to be re-located it must be dismantled and is advisable to be
repacked for safer and easier transportation.

1. GUI: Go to Settings menu.

2. GUI: Select Service menu and enter PIN code 0612.

3. GUI: Select Service menu that appears under the Service menu.

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4. Select Drive to packing position.

NOTICE! The device supports driving to Packing position in cases of Z-

movement failure.

5. Press and hold down the exposure switch to drive the unit to the correct height.

6. Power the device off.

7. Detach the device from mains power and detach any external cables.

8. Detach the covers in reverse order to what is described in chapter Attaching the
covers.
NOTICE! It's recommended to wrap protective material around the covers
and place them in boxes to protect them against scratches.

9. Detach the column interconnection cables, install the packaging supports back to
their original place and install the plywood supports in reverse order to what is
described in chapter Installing the device.

10. Loosen the three locking screws holding the carriage on the column and turn them
outwards.

11. Carefully push the latch inside the carriage with a flat tool to release the carriage and
carefully lower it to the floor.
NOTICE! This step requires at least two persons.

NOTICE! It is recommended to place packing foam or such on the floor to

prevent any damage to the carriage.

12. Detach the carriage from the column, detach the column from the wall and floor and
move the carriage and the column onto the transportation pallet.

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10 Technical data

10.1 Technical specifications

General information
Manufacturer: PaloDEx Group Oy, Nahkelantie 160, FI–
04300 Tuusula, FINLAND
Quality system In accordance with ISO13485 standard
Environmental management system In accordance with ISO14001 standard
Conformity to standards: IEC60601–1 (ed.3)+Am1
IEC60601–1–3: (ed.2)+Am1
IEC60601–1–6 (ed.3.1)
IEC60601–1–9 (ed.1)
IEC60601–2–28 (ed.2)
IEC60601–2–63 (ed.1)
IEC60601–1–2 (ed.4)

ANSI/AAMI ES60601–1: 2005+A1

CAN/CSA–C22.2 No. 60601–1:2014
standards
This product complies with DHHS 21 CFR
Chapter I, Subchapter J at the date of
manufacture.
The device is in conformity with the
provisions of Council Directive93/42/EEC
as amended by the Directive 2007/47/EC
concerning medical devices.
RoHS Directive 2011/65/EU

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Device data
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 methods • Distilled water
• Ethanol 96%
• Isopropyl alcohol
• Soapy water
• Cavicide™ disinfectant
• Metasys™ disinfectant
• Disposable plastic covers for bite block,
chin rest, lip support and head support

Use environment In environments where no flammable

anesthetics nor flammable cleaning agents
are present
Mode of operation Continuous operation/intermittent loading
Safety IEC60601–1
Source of power Mains connection
EMC Classification Class B

Tube head assembly

Tube head assembly THA/HVGEN PCX
Tube type Toshiba D–054S or equivalent
Stationary anode

Tube voltage 60 – 95 kV
Max. tube current 16 mA
Target angle 5°
Focal spot 0,5 (IEC 60336/2005)
Total filtration min. 3,2mm Al @ 95kV
Leakage technical factors 2717 mAs/h @ 95kV/4mA

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Electrical connections
Nominal mains voltage 100–240 Vac
Input power frequency 50 / 60 Hz
Nominal current 10A @ 220–240 VAC, 15A @ 100 – 120
VAC
Main fuses (F1 & F2) 220–240Vac:
Littelfuse 215 (Time–Lag) 10A
Cooper Bussman (Time Delay) S505H–10–
R

100–120Vac:
Littelfuse 326 (SlowBlow) 15A
Cooper Bussman (Time Delay) MDA–15
External warning light fuse (F3) Cooper Bussmann (Time Delay) S506–2–R
Power consumption 2,3 kVA @ 220–240 VAC, 1,65 kVA @
100–120 VAC
Maximum impedance of mains 0,2 Ω
Recommended circuit breaker max. 30 mA
Mains cord EU: 16 A / 250 VAC; 50/60 Hz H05VV–
F3G1.5
US: 15 A / 125 VAC 50/60 Hz SJT 3 x AWG
14

Exposure controller cable Exposure switch: Li12Y11Y 2 x AWG 26,

3m
Remote exposure switch: DINFLEX–YY 4 x
AWG 26, max. 15m

Data communication cable CAT6 UTP Ethernet cable

Positioning laser lights

Panoramic laser lights (3) Laser light

(CLASS 1 LASER PRODUCT)
3D laser lights (3)
IEC 60825–1/2001
The device contains warning symbol of the
laser lights.

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X–ray generator
Generator High frequency DC generator
Nominal power 1520 W nominal @ 95 kV, 16 mA
Max. electric output 1,7 kW
Anode voltage 60 – 95 kV (+/– 5 kV)
Anode current 2 – 16 mA (+/– 20%)
Exposure time accuracy +/– 5%
DAP display accuracy +/– 25%
Supply frequency 50 – 100 kHz
Spine compensation kV / mA compensated
Accuracy of radiation output > 95%

Panoramic / 3D image detector

Technology / Sensor type CMOS
Image receptor area 147 x 112 mm / 5.78" x 4.4"

User interface
Program and technical factors selection, GUI, optional remote exposure switch,
exposure control exposure button with 3m cable.
Patient positioning Positioning panel, integrated

Device physical measures

Source–Image distance (SID) 580 mm / 22.83"
Dimensions (H x W x D) 1670–2467 x 765 x 1300 mm
65.7–97.1" x 30.1" x 51.1"

Weight 113 kg / 249 lbs

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Device package
Package dimensions (L x W x H) 1200 x 770 x 1100 mm
47.2" x 30.3" x 43.3"

Package weight 160 kg / 353 lbs

Package material weight Pallet: 17 kg / 37.5 lbs
Plywood: 14 kg / 30.9 lbs
Cardboard: 12 kg / 26.5 lbs

Ambient temperatures
Transportation and storage -25°…+55°C
Operation Temperature +10°...+35°C
RH 30–80%
Atmospheric pressure 70 – 106 kPa

10.2 Imaging program specifications

NOTICE! The values given in this chapter 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.

Panoramic programs & technical factors

Program kV range mA range Exposure time
Standard Panoramic 9.0 s
Segmented Standard 1.38-9.0 s
Panoramic 60 - 70 kV 2.0 - 16.0 mA
Pediatric Panoramic 9.0 s
73 - 81 kV 2.0 - 14.0 mA
Segmented Pediatric 1.39-9.0 s
Panoramic 85 - 90 kV 2.0 - 12.5 mA
Bitewing 5.20 s (2.6s + 2.6s)
TMJ, Lateral 4.0 s (2.0s + 2.0s)

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Scout programs & technical factors

NOTICE! Tube voltage is fixed to 95 kV

FOV size Resolution Pixel size mA range Exposure DAP range

time
2
5x5 Scout 200 μm 4.0 - 12.5 0.04 - 0.03 s 4 - 9 mGycm
mA
2
6x9 Scout 200 μm 4.0 - 12.5 0.08 - 0.07 s 7 - 20 mGycm
mA
2
9 x 11 Scout 200 μm 4.0 - 12.5 0.08 - 0.07 s 7 -20 mGycm
mA
2
9 x 14 Scout 200 μm 4.0 - 12.5 0.08 - 0.07 s 7 - 20 mGycm
(optional) mA

3D imaging programs & technical factors

NOTICE! Tube voltage is fixed to 95 kV

FOV size Resolution Voxel size mA range Exposure DAP range

time
2
5x5 LDT 280 μm 2.0 - 4.0 mA 1.49 - 1.40 s 33 - 63 mGycm
Standard 200 μm 4.0 - 12.5 3.06 - 2.87 s 137 - 402
2
mA mGycm
High 125 μm 2.0 - 4.0 mA 9.99 s 224 - 448
2
mGycm
ENDO 80 μm 2.0 - 4.0 mA 20.0 s 448 - 895
2
mGycm
6x9 LDT 320 μm 2.0 - 4.0 mA 4.48 - 4.19 s 121 - 227
2
mGycm
Standard 300 μm 4.0 - 12.5 4.19 - 3.61 s 227 - 610
2
mA mGycm
High 200 μm 2.0 - 4.0 mA 20.0 s 541 - 1081
2
mGycm
9 x 11 LDT 320 μm 2.0 - 4.0 mA 4.48 - 4.19 s 211 - 394
2
mGycm
Standard 300 μm 4.0 - 12.5 4.19 - 3.61 s 394 - 1060
2
mA mGycm
High 200 μm 2.0 - 4.0 mA 20.0 s 940 - 1879
2
mGycm
9 x 14 LDT 400 μm 2.0 - 4.0 mA 4.48 - 4.19 s 224 - 417
2
(optional) mGycm
Standard 350 μm 4.0 - 12.5 4.19 - 3.61 s 419 - 1128
2
mA mGycm
High 250 μm 2.0 - 4.0 mA 20.0 s 1000 - 2000
2
mGycm

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NOTICE! Device's radiation dose production vary 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 described in chapter Device configuration. Air KERMA
production can be calculated by dividing the provided DAP value with the active
sensor area.

10.3 Patient contacting parts

Part type Type of contact Contact duration
Head Support Skin <5 min
Chin Rest Skin <5 min
Disposable cover for Chin Skin <5 min
Rest and Head Support
Bite Block Mucosal membrane <5 min
Disposable cover for Bite Mucosal membrane <5 min
Block
Lip Support Skin <5 min
Disposable cover for Lip Skin <5 min
Support
Patient Handles Skin <5 min

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10.4 Device dimensions

765 mm / 30.1 in
1095 mm / 43.1 in
1688 - 2443 mm / 66.5 - 96.2 in 340 mm / 13.4 in

400 ± 20 mm
15.7 ± 0.8 in
951 - 1706 mm / 37.4 - 67.2 in

320 ± 20 mm
12.6 ± 0.8 in
900 - 1655 (nominal 940) mm

20 mm 16 mm
35.4 - 65.2 (nominal 37) in

0.8 in 0.6 in 60 ± 15 mm / 2.4 ± 0.6 in

759.5 mm / 29.9 in

A= 0.05m2

188 mm 198 mm
7.4 in 93 - 128 mm 7.8 in
219 mm 3.7 - 5 in 229 mm
8.6 in 9 in
450 mm
17.7 in

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PERPENDICULAR INSTALLATION
** 566 mm / 22.3 in

** 1385 mm / 54.5 in
* 1330 mm / 52.4 in
340 mm
13.4 in * 550 mm / 21.7 in
* 1100 mm / 43.3 in

** 660 mm / 26 in

** 1375 mm / 54 in

* Absolute minimum dimensions

** Recommended minimum dimensions

INSTALLATION IN MAX 15° ANGLE (LEFT/RIGHT)

** 765 mm / 30 in ** 550 mm / 22 in

99 mm / 4 in 99 mm / 4 in max. 15
max. 15° °
1377 mm / 54 in

** 1375 mm / 54 in ** 1358 mm / 53 in

* Absolute minimum dimensions

** Recommended minimum dimensions

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INSTALLATION IN 15-40° ANGLE (RIGHT)

** 1032 mm / 41 in

54 mm / 2 in
0°
x. 4
ma

** 1309 mm / 52 in

** 1292 mm / 51 in

NOTICE! This installation setup may require the carriage plywood supports to be
removed before lifting the carriage on the column, as they might hit the wall.

* Absolute minimum dimensions

** Recommended minimum dimensions

WALL BRACKET DIMENSIONS

450 mm / 18 in

192 mm / 7.6 in
128 mm / 5 in

30 mm 17.5 mm / 0.7 in
1.2 in
16 mm / 0.6 in

260 mm / 10.2 in
300 mm / 11.8 in

340 mm / 13.4 in

380 mm / 15.0 in

420 mm / 16.5 in

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10.5 Symbols that may appear on the device or its

parts
Manufacturer

Date of manufacture

Serial number

Catalog or model number

Caution

Radiation warning

Laser 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

Protective earth (ground)

Focal spot

Total X-ray filtration

Do not reuse

Recyclable

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Operating instructions
Refer to operating instructions for more information. The
operating instructions can be supplied electronically or in
paper format.

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 (0537) symbol

NRTL Mark
Conforms to AAMI ES60601-1:2006. Certified to CSA.

Fragile, Handle with Care (Packaging)

This way up (Packaging)

Keep dry (Packaging)

Maximum number of boxes that can be stacked on the

bottom box (Packaging)

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10.6 Electromagnetic Compatibility (EMC) tables

NOTICE! Medical electrical equipment needs special precautions regarding EMC
and needs to be installed according to EMC information.
IEC60601-1-2 ed4 testing has verified that electromagnetic interference stimulus has no
effect to safety critical functionality of the device. This includes the patient positioning
and other imaging pre-conditions, imaging program value selection from the GUI,
imaging process, image transfer to the workstation and the image quality.
If abnormal performance is observed, such as degradation of essential performance in
form of reduction of line pair resolution, additional measures may be necessary, such
as re-orienting or relocating the device. Suggested actions according to Table 3: RF
immunity of non-life-support equipment or system IEC 60601-1-2 ed.4.

The device is suitablefor use in both at 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.

Table 1: Electromagnetic emissions IEC 60601-1-2 Ed4

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 Group 1 PCX-1 uses RF energy only for its internal function. Therefore,
Emissions CISPR11 the RF emission is very low and not likely to cause any
interference in nearby electronic equipment.

Radio-Frequency Class B PCX-1 is suitablefor use in both at professional healthcare

Emissions CISPR11 (hospitals/large clinics) facility environment and home
healthcare (clinics in domestic establishments and those
Harmonic emissions IEC61000-3-2 directly connected to the public low-voltage power supply)
IEC61000-3-2 Class A environment.
Exceptions for professional healthcare facility environment :
Voltage fluctuations/ Complies
Not to be used or installed near active HF SURGICAL
flicker emissions EQUIPMENT and the RF shielded room of an ME SYSTEM
IEC61000-3-3 for magnetic resonance imaging, where the intensity of EM
DISTURBANCES is high.

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Table 2: Electromagnetic immunity IEC 60601-1-2 Ed4

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:

Immunity Test IEC60601-1-2 Compliance Level Electromagnetic Environment

Test Level

Electrostatic ± 8 kV for contact ± 8 kV for contact Floors are wood, concrete, or ceramic
discharge (ESD) discharge discharge tile, or floors are covered with synthetic
IEC61000-4-2 material and the relative humidity is at
±2, 4, 8, 15 kV for ±2, 4, 8,15 kV for least 30 percent.
air discharge air discharge

Electrical fast ±2 kV for power ±2 kV for power Mains power quality is that of a typical
transient/burst IEC supply lines (100 supply lines commercial and/or hospital environment
61000-4-4 kHz)
±1 kV for input/
±1 kV for input/
output lines
output lines
(100kHz)

Surge ± 0.5, 1 kV ± 0.5, 1 kV Mains power quality is that of a typical

differential mode differential mode commercial and/or hospital environment.
IEC61000-4-5
± 0.5, 1, 2 kV ± 0.5, 1, 2 kV
common mode common mode

Voltage dips, short -0 % U mains; 0,5 -0 % U mains; 0,5 Mains power quality is that of a
interruptions and cycle At 0°, 45°, cycle At 0°, 45°, typical commercial and/or hospital
voltage variations 90°, 135°, 180°, 90°, 135°, 180°, environment. If the user of PCX-1
on power supply 225°, 270° and 225°, 270° and requires continued operation during power
input lines 315° 315° mains interruptions, it is recommended
that PCX-1 be powered from an
IEC61000-4-11 -0 % U mains; 1 -0 % U mains; 1 uninterruptible power supply.
cycle, At 0° cycle, At 0°
-70 % U mains; -70 % U mains;
25/30 cycles At 0° 25/30 cycles At 0°
-0 % U mains; -0 % U mains;
250/300 cycle At 0° 250/300 cycle At 0°

Power frequency 30A/m 30 A/m Power frequency magnetic fields are at

(50/60Hz) magnetic levels characteristic of a typical location
field IEC 61000-4-8 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.

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Table 3: RF immunity of non-life-support equipment or system IEC 60601-1-2

ed.4

PCX-1 issuitable 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:

Immunity Test IEC 60601-1-2 Compliance Electromagnetic Environment

Test Level Level

Conducted RF 3V 150kHz to 80 3V 150kHz to 80 Portable and mobile RF communications equipment

IEC 61000-4-6 MHz, 6 V in ISM MHz, 6 V in ISM are used no closer to any part of PCX-1 including
and amateur and amateur cables, than the recommended separation distance
radio bands radio bands calculated from the equation appropriate for the
between 0,15 between 0,15 frequency of the transmitter.
MHz and 80 MHz and 80
Recommended Separation Distance:
MHz according MHz according
to table to table 150kHz-80MHz
60601-1-2. Ed4. 60601-1-2. Ed4.
Table 5/8. Table 5/8. 80MHz to 800 MHz

Radiated RF IEC 10 V/m 80 MHz 10 V/m 80 MHz 800 MHz to 2,7 GHz
61000-4-3 to 2,7 GHz to 2,7 GHz Where P is the maximum output power rating of the
Immunity to Immunity to transmitter in watts (W) according to the transmitter
proximity fields proximity fields manufacturer and d is the recommended separation
from RF wireless from RF wireless distance in meters (m). Field strengths from fixed RF
communication communication transmitters, as determined by an electromagnetic
equipment, equipment, site survey,* are less than the compliance level in
levels according levels according each frequency range.**
to table to table Interference may occur in the vicinity of equipment
60601-1-2 ed4 60601-1-2 ed4 marked with the following symbol:
table 9. table 9.

*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 re-orienting 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 effect medical electrical equipment.

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Table 4: 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 customer of 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 Separation Distance Separation Distance Separation

Power of Transmitter (meters) (meters) Distance(meters)
(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.
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.

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. 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.

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Interference may occur in the vicinity of equipment marked with the following symbol:

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
Table 4: Separation distances.

10.7 X-ray tube assemblies

Duty cycle without reconstruction: 1:4.3
Rectification type: Constant potential X-ray generator
Generator rating: Generator nominal power 1520W

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10.8 Minimum workstation requirements

NOTICE! A workstation used in a medical system must always meet the
requirements in IEC 60950 standard.
NOTICE! Refer to the dental imaging software installation manual or contact your
local dealer for more specific workstation requirements.

Minimum requirements for 3D acquisition workstation

Processor Intel Core i5, i7 or Xeon, 4-cores or more
Memory 8 GB
GPU Only validated GPU’s and WHQL certified
driver versions may be used.
GPU requirements and driver versions are
dependent on the KaVo Driver version
installed.
Example of supported GPU's:
• NVIDIA GTX 1050 Ti with 4GB memory
• NVIDIA Quadro M2000 with 4GB
memory
NOTICE! Always refer to the KaVo
Driver documentation for details
on the supported GPU and driver
versions. GPU requirements may
change at any time when a new
KaVo Driver is released.

Free storage space 1 TB

Operating system • Windows 10 Pro or Enterprise, 64-bit
• Windows 8.1 Pro or Enterprise, 64-bit
• Windows 7 Professional, Ultimate or
Enterprise, 64-bit, with SP1

Network Gigabit Ethernet 1000Base-T

The device has to be connected to a
private, firewall protected LAN network. All
outbound connections to the unit shall be
blocked.

Display 1280 x 1024 resolution

Minimum requirements for 2D/3D Viewing workstation

Refer to dental imaging software requirements

Minimum requirements for database server

Refer to dental imaging software requirements

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 PaloDEx Group Oy reserves the right to make changes in specification and features shown
herein, or discotinue the product decribed 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.

216453-2

Headquarters
PaloDEx Group Oy | Nahkelantie 160 | P.O. Box 20
FI-04301 Tuusula | FINLAND | Tel. +358 10 270 2000
http://www.kavo.com/en/contact
www.kavokerr.com

USA
Instrumentarium Dental | 11727 Fruehauf Drive | Charlotte, NC
28273 | U.S.A
Tel. 800-558-6120 | Fax. 877-292-6050
Email: [email protected]

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