Acteon XMIND TRIUM User manual

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Operator’s Manual
for U.S. and Canadian
Markets
Operator’s manual • X-Mind trium • V0G • (13) • 10/2017 • NTR0EN040G

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1. CONTENTS
INTRODUCTION..........................................................................................................................4
1.1 CAUTIONS ...............................................................................................................................................................4
1.2 IDENTIFICATION TAGS...........................................................................................................................................5
1.3 POSITION OF THE IDENTIFICATION LABELS ......................................................................................................8
DESCRIPTION..............................................................................................................................9
2.1 OPERATOR’S WORKSTATION ................................................................................................................................9
2.2 X-MIND TRIUM REMOTE CONTROL......................................................................................................................9
2.3 X-MIND TRIUM MEDICAL DEVICE.......................................................................................................................10
2.4 X-MIND TRIUM CONFIGURATIONS ....................................................................................................................12
2.5 EXAMS....................................................................................................................................................................12
2.6 CONTROL PANELS ...............................................................................................................................................14
2.7 KEYS DESCRIPTION ..............................................................................................................................................15
2.8 LIGHT INDICATORS ..............................................................................................................................................16
2.9 X-MIND TRIUM REMOTE CONTROL....................................................................................................................16
2.10 EMERGENCY SWITCHES.....................................................................................................................................17
2.11 X-RAY EXPOSURE SWITCH .................................................................................................................................17
2.12 HEAD SUPPORT FOR PAN/CBCT EXAMS ..........................................................................................................18
2.13 HEAD SUPPORT FOR CEPH EXAMS...................................................................................................................18
2.14 ACCESSORIES .....................................................................................................................................................19
SWITCHING ON / OFF THE SYSTEM ........................................................................................21
3.1 SWITCHING ON ....................................................................................................................................................21
3.2 SWITCHING OFF ...................................................................................................................................................22
PRE ACQUISITION ....................................................................................................................23
4.1 PREPARING THE SYSTEM.....................................................................................................................................23
4.2 CREATING OR SELECTING PATIENT DATA .........................................................................................................23
4.3 INSTRUCTING THE PATIENT ...............................................................................................................................23
4.4 POSITIONING THE PATIENT FOR PAN/CBCT EXAMS........................................................................................24
PAN ACQUISITION....................................................................................................................26
5.1 SELECTING THE EXAM TYPE ................................................................................................................................26
5.2 PATIENT POSITIONING........................................................................................................................................26
5.3 EXECUTION OF THE PAN EXAM ..........................................................................................................................28
CBCT ACQUISITION ..................................................................................................................30
6.1 SELECTING THE EXAM TYPE ................................................................................................................................30
6.2 PATIENT POSITIONING........................................................................................................................................32
6.3 EXECUTION OF THE CBCT EXAM.........................................................................................................................34
CEPH ACQUISITION..................................................................................................................36
7.1 SELECTING THE EXAM TYPE ................................................................................................................................36
7.2 PATIENT POSITIONING........................................................................................................................................36
7.3 EXECUTION OF THE CEPH EXAM ........................................................................................................................38
RELEASING THE PATIENT.........................................................................................................39
MAINTENANCE, CLEANING AND DISPOSAL ..........................................................................40
9.1 MAINTENANCE .....................................................................................................................................................40
9.2 CLEANING .............................................................................................................................................................40
9.3 DISPOSAL ..............................................................................................................................................................40
TROUBLESHOOTING.................................................................................................................41
10.1 ERROR CODES AND REQUIRED ACTIONS........................................................................................................41
10.2 TRIUM ERRORS ...................................................................................................................................................42

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ANNEXES ...................................................................................................................................54
11.1 DEVICE POWER SUPPLY.....................................................................................................................................54
11.2 ELECTRICAL CLASSIFICATION (IEC 60601-1) ...................................................................................................54
11.3 X-RAY ASSEMBLY AND X-RAY TUBE ..................................................................................................................54
11.4 DEGREE OF PROTECTION PROVIDED BY ENCLOSURES ................................................................................56
11.5 DEVICE MECHANICAL DATA ..............................................................................................................................56
11.6 WORKSTATION FEATURES.................................................................................................................................57
11.7 DETECTORS .........................................................................................................................................................57
11.8 SCANNING PARAMETERS – PAN/CEPH ............................................................................................................58
11.9 SCANNING PARAMETERS – CBCT .....................................................................................................................58
11.10 LASER ................................................................................................................................................................58
11.11 CLIENT PC MINIMUM REQUIREMENTS .........................................................................................................59
11.12 INTENDED ENVIRONMENT .............................................................................................................................59
11.13 DIMENSIONS OF THE UNIT ............................................................................................................................60
11.14 LIST OF INTERNATIONAL STANDARDS AND DIRECTIVES............................................................................61
11.15 DOSIMETRIC INDICATIONS ............................................................................................................................61
11.16 ELECTROMAGNETIC COMPATIBILITY ............................................................................................................80

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INTRODUCTION
Thank you for choosing the X-MIND trium.
The electro medical equipment described in this manual refers to the X-Mind trium medical device.
X-MIND trium is a radiological device and must be used and handled only by specialised surgeons, dentists and authorised
and duly trained personnel, who meet the requirements provided by the national laws in force in the country of installation.
The training and preparation of personnel must be included in the tasks of the responsible organization.
Before using the X-MIND trium, the operator must read and understand all the instructions provided in the manual in order to
obtain the highest performance and ensure the safety of patients, of operators, of the medical device and the environment.
X-MIND trium is a digital panoramic, cephalometric and tomographic extra-oral X-ray system, indicated for use in:
- producing panoramic X-ray images for diagnostic examination of dentition (teeth), jaws and oral structures;
- producing radiographs of maxillofacial region and parts of the skull for cephalometric examination, if equipped with CEPH
arm;
- producing radiographs of hands and wrists for carpus examination, if equipped with CEPH arm;
- producing tomographic images of the oral and maxillofacial region, for diagnostic examination of dentition (teeth), jaws,
oral structures and some cranial bones, if equipped with CBCT option.
From a clinical point of view, the X-MIND trium can be applied for the following medical applications:
• Generic dentistry
• Dental implantology
• Dental surgery
• Maxillo-facial surgery
• Cephalometric analysis
• Carpus radiology
The target patient population includes adults and pediatric patients from 5 years old [~21 kg (46 lb); 113 cm (44.5 in) standing
height]; anyway the sustainability to X-ray exposure must be evaluated by surgeons, dentists and qualied and authorized
physicians.
The intended user prole is a qualied, trained and authorized physician or dentist who meets the requirements provided
by national laws in force in the country of installation; the operator must understand the language of the country where the
device is installed.
Contraindications:
● Viewing cartilaginous structures;
● The CBCT technique has a limited capability of detecting soft tissues.
1.1 CAUTIONS
CAUTION :
CAUTION messages refer to circumstances that can jeopardise the operator’s safety, cause injuries to operators and patients or
damage the medical device and the environment.
!
WARNING :
WARNING messages refer to circumstances that can compromise the performance of the X-MIND trium medical device.
NOTE :
NOTE messages provide indications for easier maintenance and highlight important information.

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Terminology used in the manual:
TERM MEANING
AOR Axis Of Rotation. Axis of rotation of the U-Arm.
CBCT Medical device that acquires radiological images, using a cone radiation beam and reconstructs the 3D volume
of the scan.
CEPH Is the common name for Cephalometry or Cephalostat.
DGI Proprietary le format used to save digital radiological projections.
DICOM Digital Imaging and Communications in Medicine. Medical imaging standard that denes the rules and criteria
to transfer, view, store and print information in medical imaging, in order to ensure communication between
medical devices and information systems.
FOV Field Of View. The volume scanned and reconstructed by the X-MIND trium medical device.
FPD Flat Panel Detector. 2-dimensional digital detector to acquire radiographic projections.
PAN Is the common name for panoramic image or Orthopantomogram.
ROI Region of Interest. Patient’s anatomical area to be examined and segmented in a tomographic image.
HU Hounseld Unit. Standard reference scale used to describe radiodensity in systems.
AIS Acteon imaging Suite software that manages all the functional aspects of the X-MIND trium system, including:
patient database, patient acquisition, calibrations, quality tests, maintenance, display that allows the operator
to make the diagnosis and treatment planning.
1.2 IDENTIFICATION TAGS
X-MIND TRIUM LABEL
X-RAY ASSEMBLY label

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X-RAY BEAM LIMITER label
CAUTION X-RAYS LABEL
CAUTION LASER BEAM LABEL
PAN DETECTOR LABEL

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REMOVABLE DETECTOR LABEL
3D DETECTOR LABEL
CEPH ARM LABEL
ETL MARKING
UDI LABEL

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1.3 POSITION OF THE IDENTIFICATION LABELS

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DESCRIPTION
The X-MIND trium medical device system consists of:
2.1 OPERATOR’S WORKSTATION
The operator’s workstation is provided optionally for the PAN only unit.
The workstation allows the operator to perform the following procedures:
• Calibrations of the medical device
• Acquisition parameters setting
• Radiological image acquisition
• Image visualization and post processing
• Database management
• Periodic quality Tests
The workstation must have installed the following modules:
• ACTEON IMAGING SUITE (AIS) equipment management software + 2D diagnostic analysis
• AIS 3D app (CBCT)
Communication with the medical device occurs by means of Ethernet protocol.
2.2 X-MIND TRIUM REMOTE CONTROL
The X-MIND trium remote control must be located in a safe place protected against radiations, in compliance with the local
standards in force concerning ionising radiation protection.
The X-MIND trium remote control allows the operator to activate or deactivate X-ray emission from the control room. This
consists of two switches, one for exposure and one for emergency, which control device operation.

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X-MIND trium Light
The X-MIND trium Light is an indicator light that warns that X-ray emission is in progress.
It indicates no entry into the room when the red light is on; it also has a triangular danger sign that warns of X-ray hazards.
2.3 X-MIND TRIUM MEDICAL DEVICE
The X-MIND trium medical device for PAN/CBCT models consists of the following parts:
1. Control panel. The control panel provides an intuitive overview of the system to move the mobile column, move the bite
block holder (only PAN/CBCT version), move the U-arm, turn the positioning lasers on and off and activate the X-MIND
trium medical device.
2. X-ray generator. The X-ray assembly is the source of the X-ray beam during the rotation of the U-Arm. An automatic
collimator shapes the X-Ray beam, whereas the electronic control ensures stability and accuracy of the selected loading
factors (exposure time, kVp and anodic current). A lter is used to harden the beam and remove low-energy ionising
radiations, thereby obtaining suitable radiation quality whilst reducing its dose absorbed by the patient. The lter’s
material is aluminium for PAN and CEPH exams, aluminium + copper for CBCT exams.
3. Sliding body. The sliding body is the mobile part of the column that supports U-arm.
4. U-arm. The U-Arm supports the PAN/CBCT Detector sliding group and the X-ray generator. This is the rotating part of
the medical device, which moves around the patient during the image acquisition phase ; it can as well be moved in two
horizontal directions (X and Y) by the operator during the setup of the exam, in order to obtain the best superimposition
between the patient’s head anatomy and the diameter of the Field of View (FOV).
5. Detector sliding group. It contains detectors that allow to acquire PAN and CBCT images.
6. CBCT detector. This at panel detector is indicated for use in generating radiographic images of the maxillo-facial region,
more specically it is dedicated for CBCT acquisitions.

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7. PAN detector. This at panel detector is indicated for use in generating radiographic images of the maxillo-facial region,
more specically it is dedicated for PAN acquisitions.
8. Patient support. The patient support allows stabilising and immobilising the patient. It can be moved vertically in order to
obtain the best superimposition between the patient’s head anatomy and the height of Field of View (FOV).
9. F group. It is the whole assembled mobile group of the device. It is the moving part of the medical device, which adapts
the acquisition geometry to the patient’s anatomy and stance (sitting or standing). It supports the U-Arm and head
support
10. Column. The xed column supports the entire structure of the medical device. This contains the motor that raises the F
Group.
Overview of the medical device: Cephalometric extension:
The Cephalometric version of X-MIND trium medical device consists of the parts listed above and of the following additional
parts:
11. CEPH arm extension. Can be positioned both on the right or left side of the vertical column.
12. CEPH control panel. Provides an intuitive overview of the system to move the mobile column and activate the X-MIND
trium medical device.
13. CEPH patient support. Allows stabilising and immobilising the patient during CEPH exams, by means of ears rest
and nasion rest.
14. CEPH detector sliding group. Enables to slide the detector to follow the X-Ray beam.
15. CEPH secondary collimator. Is positioned on U-arm; it translates during X-Rays (keeping aligned the X-Ray beam
emerging from the tube head with the CEPH detector).
16. CEPH detector. This at panel detector is indicated for use in generating radiographic images of the maxillo-facial region,
more specically it is dedicated for CEPH acquisitions. It gives 2D images of the whole patient head; this detector can
optionally be moved from the CEPH arm to the detector sliding group for PAN examinations.

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2.4 X-MIND TRIUM CONFIGURATIONS
X-MIND trium can be sold in these congurations:
PAN only
• The equipment can carry out uniquely exams of the PAN group (PAN, TMJ, Sinus);
• The image detector is xed to the PAN bay;
• All the exams are carried out with the same extension in height (146 mm height on image receptor), primary collimator
being of xed dimension;
• The equipment can be upgraded in a later stage by replacing and adding several parts.
PAN and CBCT
• The equipment can carry out both exams of the PAN group (PAN, TMJ, Sinus) and of the CBCT group;
• There are two image detectors, one for PAN and one for CBCT exam; the equipment automatically exposes in front of X-Ray
source the right detector, depending on the selected exam;
• PAN exams can be carried out with different extension in height (up to 146 mm height on image receptor), since the
collimator height can be adjusted depending on the exam selected by the user;
• CBCT exams can be carried out at different FOV dimensions as specied in the technical data appendix;
• The equipment can be upgraded in the eld to CEPH conguration by simple procedure, adding CEPH arm with CEPH image
detector replacing the existing PAN image detector.
PAN / CEPH
• The equipment can carry out both exams of the PAN group (PAN, TMJ, Sinus) and of the CEPH group (AP/PA, LL, carpus);
• The image detector can optionally be unique, both for PAN and CEPH exams, and in this case it must be manually moved by
the operator from PAN bay to CEPH bay and viceversa, depending on the selected exam; otherwise two different detectors
can be dedicated: one for CEPH exams and the other one for PAN exams;
• The exams can be carried out with different extension in height (up to 146 mm height on image receptor for PAN, up to 220
mm height on image receptor for CEPH), since the primary collimator can be automatically adjusted in height depending on
exam selected by the user;
• The equipment can be upgraded in the eld to CBCT conguration by a simple procedure, adding CBCT image detector and
bite block holder with vertical movement.
PAN / CBCT / CEPH
• The equipment can carry out all feasible exams of the PAN group (PAN, TMJ, Sinus), of the CEPH group (AP/PA, LL, carpus)
and of the CBCT group;
• There are optionally two image detectors, one for PAN/CEPH and one for CBCT exam; in this case the PAN/CEPH image
detector must be manually moved by the operator from PAN bay to CEPH bay and viceversa; otherwise three image detectors,
one for PAN, one for CEPH and one for CBCT exams;
• To carry out PAN or CEPH or CBCT exam the equipment automatically exposes in front of X-Ray source the right detector,
depending on the selected exam;
• PAN and CEPH exams can be carried out with different extension in height (up to 146 mm height on image receptor for
PAN, up to 220 mm height on image receptor for CEPH), since the primary collimator can be automatically adjusted in height
depending on exam selected by the user;
• CBCT exams can be carried out at different FOV dimensions as specied in the technical data appendix.
2.5 EXAMS
In its different congurations X-MIND trium equipment carries out the following exams:
Panoramic group
The panoramic group includes all the 2D radiographs of the jaws, dentition, temporomandibular joints and maxillary sinuses.
1) Standard panoramic
· Full scan
· Right side only
· Left side only

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2) Sectorial panoramic with improved orthogonality
· Full scan
· Right side only
· Left side only
3) Frontal panoramic
4) Bitewings
5) Frontal temporomandibular joint with closed or open mouth
· Both sides
· Left TMJ only
· Right TMJ only
6) Lateral temporomandibular joint with closed or open mouth
· Both sides
· Left TMJ only
· Right TMJ only
7) Frontal maxillary sinuses
8) Lateral maxillary sinuses
· Left sinus only
· Right sinus only
CBCT group
The CBCT group includes all the 3D CBCT examinations of the dental and maxillofacial regions.
Here below the size of the reconstructed volumes expressed as diameter x height.
1) Dental FOV
· 40mm x 40mm
· 60mm x 60mm
· 80mm x 80mm
· 110mm x 80mm
NOTE :
A specic version of AIS software disables FOV 110mm X 80mm
2) ENT FOV – Nose
· 110mm x 80mm
NOTE :
A specic version of AIS software disables FOV 110mm X 80mm
3) ENT FOV – Ear
· Left ear only, 60mm x 60mm
· Right ear only, 60mm x 60mm
Cephalometric group
• Frontal (AP/PA)
• Lateral (LL)
• Hand acquisition (Carpus - special support needed)
For all examination groups, the operator set the predened loading factors, in terms of X-ray anodic current and X-ray tube
voltage, by selecting the patient type between the following options:
· MAN
- small

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- medium
- large
· WOMAN
- small
- medium
- large
· CHILD
- small
- medium
- large
For the panoramic group and the cephalometric group, the operator can still modify the loading factors by means of dedicated
sliders.
!
WARNING :
Only physicians or dentists properly trained can modify the loading factors from the predened values for the panoramic and
cephalometric groups taking into account the effects on the image quality, increase/decrease of radiation dose and the needs of the
clinical task.
On the contrary, for the CBCT group, the operator cannot modify the anodic current and tube voltage, but can just select the
quality of the 3D reconstruction between three protocols:
· Standard quality
· Medium quality
· High quality
The X-ray exposure time of the scan increases from the standard quality to the high quality involving both the improvement
of the image quality and the increase of the radiation dose to the patient.
!
WARNING :
Only physicians or dentists properly trained can select the quality protocol for the CBCT groups taking into account the effects on the
image quality, increase / decrease of radiation dose and the needs of the clinical task.
2.6 CONTROL PANELS
Equipment control panels are used during patient positioning phase.
Available keys allow to move the equipment to Initial position before patient access, turn on positioning LASERs, adjust the
U-arm position to align the patient to X-ray beam and set the “ready to X-ray” status.
Some keys are duplicated on the CEPH control panel, for use during patient positioning for CEPH exams.
Equipment control panel CEPH control panel

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CAUTION :
Some of the keys give the operator the possibility to move parts of the equipment. When pressing them the operator must check
carefully the patient and, in case of possible collision between equipment and patient, stop immediately the movement by releasing
the key.
2.7 KEYS DESCRIPTION
0 position key
After setting the exam parameters from operator’s workstation, by a single pressure of this key, the equipment moves to
the initial position.
When the U-arm reaches its initial position, the green status indicator will blink and the patient can be placed inside the
equipment.
Once the patient is correctly positioned on the equipment, a dummy run without X-Ray emission can be done by continuously
pressing this key.
This key is also present on CEPH control panel and has the same functionality.
LASERs key
Turns on/off the positioning lasers.
Only when the green status indicator is blinking, by a single pressure of this key, the patient positioning lasers turn on and
remain on until the key is pressed again.
CAUTION : Ask the patient to close his/her eyes before activating the patient positioning lasers.
Column up or down
Press the following keys:
UP or DOWN
These keys are also present on CEPH control panel and have the same functionality.
Bite block up or down
Press the following keys:
UP or DOWN
By single pressure of these keys the selected part of the equipment is moved by 1 mm.

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Horizontal movements keys
These keys move the U arm in the arrows direction, in order to place the LASER in the required position on patient face.
By single pressure of one of these keys the rotating U-arm is moved by 1 mm in the arrow direction.
These keys are enabled only for a sub-set of exams; for all remaining exams the pressure on these keys does not have any
effect.
2.8 LIGHT INDICATORS
Green Status indicator
• Blinking. The equipment is in the initial position. Patient can be placed under the equipment and positioning LASERs can be
turned ON.
• ON. The acquisition can start.
This indicator is also present on CEPH control panel.
Yellow X-Ray indicator
• OFF. No X-Ray emission.
• ON. X-Ray emission on going.
Red Error indicator
• ON. The equipment is in error status.
2.9 X-MIND TRIUM REMOTE CONTROL
The X-MIND trium remote control must be kept in a safe place protected against radiations, in compliance with local standards
in force concerning radiation protection. The X-MIND trium remote control allows the operator to activate or deactivate X-ray
emissions from the control room.
The components are listed below with a brief description of the parts.
1. Safety key selector switch. Deactivates the X-ray emission switch to prevent accidental exposure.

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2. X-ray emission LED. Remains on during the entire acquisition.
3. Remote emergency switch. Allows stopping the device in the event of emergency.
4. X-ray emission switch. Activates acquisition.
2.10 EMERGENCY SWITCHES
This device is equipped with two emergency switches that allow to stop the movement of parts and X-ray emission in the
event of an emergency.
Patient emergency switch
The patient emergency switch is installed on the head support and is within the patient’s reach, to allow both the patient and
the operator to stop the device in the event of panic or hazards, sudden column motion or any anomaly. The operator must
inform and instruct the patient on the emergency procedures and on the use of the emergency switches of the device, as
indicated in this chapter.
Remote emergency switch
1= Remote emergency switch
The Remote emergency switch is located on the X-MIND trium remote control.
How to use the emergency switches
In case of an emergency, stop any movement of the device and X-ray emission by pressing either the patient emergency
switch or the remote emergency switch. This action puts the device in the emergency status.
To reset the emergency status, rst solve the emergency condition and then release the emergency switch by turning it
clockwise until it reaches its initial position.

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2.11 X-RAY EXPOSURE SWITCH
To activate the exposure, the operator must press and hold the X-ray exposure switch for the entire acquisition. Meanwhile,
the yellow X-ray exposure LED stays ON to indicate X-ray emission.
If the operator removes his/her nger from the exposure button before acquisition is complete, X-ray emission and U-Arm
rotation will be interrupted and the X-ray exposure LED will turn off. At this point, an error message appears in the AIS
software. This message must be deleted before using the medical device again.
2.12 HEAD SUPPORT FOR PAN/CBCT EXAMS
The head support positions and immobilises the patient before the scan. It is equipped with a chin rest and forehead support
to ensure maximum stability.
1. Temple rest
2. Patient mirror
3. Patient emergency switch
4. Courtesy tray
5. Handlebar
6. Temple knob
7. Chin rest
8. Bite block
2.13 HEAD SUPPORT FOR CEPH EXAMS
The head support in CEPH arm positions and immobilises the patient before the scan. It is equipped with a couple of ear rests
and a nose support to ensure maximum stability.

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1. Ear rest
2. Ear rest knob
3. Nose support
To adapt to the patient’s anatomy, the CEPH head support is equipped with:
• Ear rest knob for horizontal ear rest movement.
• Nose support, that can be manually moved in horizontal and in vertical.
2.14 ACCESSORIES
Temple rest
The temple rest supports provide support, frontal and lateral stability to the patient’s head for all types of examination.
Chin rest
The chin rest allows immobilizing the patient’s mouth during the 3D CBCT and the 2D maxillary sinus exams; it should also be
used for 2D panoramic exams in case of edentulous patients.
Sliding bite block and chin rest assembly
The combined use of the bite block and the chin rest improves the stability of the jaws, allows separating the teeth during the
acquisition and places in the same vertical plane the superior and the inferior incisors.
The bite block and chin rest assembly must be used for immobilizing the patient in panoramic exams except in case of
edentulous patients; in addition, it can be used in CBCT scans when an improved 3D reconstruction of the dental crown
surface is required.

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TMJ nose support
This support must be used for TMJ examinations since it is specically designed to stabilize the patient’s head in both open
mouth and closed mouth conditions.
Calibration tray and geometric calibration phantom
The Calibration tray is used to position the geometric calibration phantom during the calibration procedure of the CBCT
apparatus.
The calibration procedure consists of a scan of the calibration phantom and the estimation of a set of parameters that des-
cribe the conguration of the system.
Quality phantom support for Germany
This accessory is intended to position the QUART DVT test phantoms for QA/QC of CBCT functionality for X-MIND trium
installed in Germany.
Self standing base