X-VIEW 3D PAN

Technical Info

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Date: 21/10/2020
Language: English
Rev: 3
Code: IT01-3D-EN.r3-X-VIEW 3D PAN-Infotec
 Trident S.r.l.
X-VIEW 3D PAN
Technical Info

DESCRIPTION AND INTENDED USE

X-VIEW 3D PAN manufactured by Trident S.r.l., is a cone-beam computed tomography
system, or CBCT system that uses a cone-shaped X-Ray beam to take pictures of the skull and
teeth. The system uses those pictures, along with the digital processing software (Deep-View),
to reconstruct 3D images.

X-VIEW 3D PAN is essentially a digital X-Ray scanner mounted on a rotating arm. The machine
uses a rotating X-Ray source, which emits a cone-shaped beam of radiation through the
head, or alternative area of interest, onto an X-ray detector (a CMOS Flat panel sensor with
a 13 x 13 cm active area) on the opposite side. The X-ray source and detector rotate around
a support located directly above the patient, positioned so the head is at the center of the
system. The system takes a series of projection images over the course of a few seconds,
taking the images in either a complete or partial arc, depending on the focus.

The process of images acquisition includes the following steps:

Patient positioning: The patient’s head will be stabilized with a restraint mechanism, such as a
chin rest, to minimize movement during the scanning process.
Acquiring: The X-Ray source rotates around the head, while the flat panel sensor moves
opposite, both rotating around a fixed support oriented directly over the patient’s head. The
frame rate, speed of rotation, field of view and completeness of the trajectory arc are all set
to get the desired image. During this process, the machine emits radiation in short bursts,
meaning the exposure time of the patient is only a fraction of the total scan time. This scan
takes few seconds on average.
Detecting: The flat panel sensor picks up the radiation emitted from the X-Ray and collects it
as digital data. This data is then transmitted to and collected at a dedicated computer.
Reconstructing: Once the projected images have been acquired and collected, the images
are taken and used to construct a model of the skull. This is done with Deep-View software
that uses reconstruction algorithms to build up a three dimensional model of the skull, teeth
or other area of interest.
Displaying: X-VIEW 3D PAN provides a complete digital model at the end of the process.
Deep-View software also provides the doctors with a relatively large choice of display
formats, allowing for 2D and 3D images of the mouth and head, along with other viewing
options to help focus in on areas of interest.

The device allows an upgrade to CEPH.

GENERAL CHARACTERISTICS
Unit name X-VIEW 3D PAN
Trident Srl
Manufacturer
Via Artigiani 4, Castenedolo, 25014 (BS) Italy
Classification according to IEC 60601-2-
Medical Device
63:2012
Medical Device Class I with type B
Classification according to IEC 60601-1
applied parts
Classification according to Directive EC 93/42 Medical Device Class II b
Working way Continuous with adaptive duty cycle
Protection Rank IPX0

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 Trident S.r.l.
X-VIEW 3D PAN
Technical Info

SYSTEM SUPPLY
Characteristic Value
Line Voltage 230 V ± 10%
Frequency 50/60 Hz
Maximum line current during exposure 6.6 A @ 230V @ 50/60Hz
Absorbed power 1.5kVA @ 230V @ 50/60Hz
Apparent line resistance 0.5 Ω max
Main Power protection fuse (F1) 10 A T
Column actuator Protection fuse (F2) 5AT
Rectifier Board protection fuse XRPSR 6,3 AT
Inverter Board protection fuse XRPSI 6,3 AT
Switching power supply protection fuse 24 V 2 x 3, 15AT
Switching power supply protection fuse 12 V 2 x 2, 15AT
High tension 61 to 85 kVp, at steps of 3 kVp (9 steps)
5 to 10 mA, according to R’20 scale for
PAN
Anodic current
6.3 to 10 mA, according to R’20 scale
for CBCT
Flat panel sensor coverage additional filtration
≤ 1.2 mm Al eq. @ 70 kVp
(for 3D and PAN exams)
CEPH sensor coverage additional filtration < 1.0 mm Al eq.
Centering bite height 105 to 182 cm

X-RAY GENERATOR
Characteristic Value
Type High frequency generator, DC
Tube Voltage 85 kVp
Precision kVp ±8%
Maximum Anodic current 10 mA
Anode current accuracy ± 10%
Radiation Output linearity < 0.2 IEC 60601-2-63 paragraph 203.6.3.1.101
Adaptive Duty cycle according to the
Duty cycle
exposure and dielectric oil temp.
Transformer Isolation Oil bath
Nominal power 850 VA (85 kVp - 10 mA)
Total filtration 2.5 mm Al eq. @ 70 kVp
> 2.0 mm Al eq. @ 60 kVp
Half Value Layer (HVL) > 2.7 mm Al eq. @ 74 kVp
> 3.05 mm Al eq. @ 85 kVp
Cooling As per convection
Focal spot 0.5 mm (IEC 60336:2005)
< 0.5 mGy/h @ 86 kVp - 10 mA – 3s duty cycle
Leakage radiation at 1 m
1/16
Max thermal capacity of tube head 900 kJ
kVp From 61 to 85 kVp, steps of 3 kVp
PAN: 5 to 10 mA
Exposition parameters regulation
mA CBCT: 6.3 to 10
According to R’20 scale
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 Trident S.r.l.
X-VIEW 3D PAN
Technical Info

X-RAY TUBE
Value
Characteristic
CEI Tube Kailong Tube
Manufacturer Skan-X-CEI Italy RADII Kailong
Model OPX 105 KL5A-0.5-105
Nominal Focus size 0.5 IEC 60336:2005 0.5 IEC 60336:2005
Inherent filtration 0.5 mm Al eq. 0.6 mm Al / 75 kV
Anode angle 5° 5°
Anode material Tungsten Tungsten
Maximum Nominal voltage 105 kVp 105 kV
Nominal reverse tension 136 kVp 135 kVp
Maximum filament current 4A 4.2 A
Maximum filament tension 8V 7.8 - 8.2 V
Anode’s thermal capacity 30 kJ 30 kJ (42 kHU)
Maximum anodic dissipation 250W 250 W

DINAMIC FLAT PANEL

Characteristic Value
Type of sensor CMOS
Sensitive area 15 x 15 cm
Scintillator CsI
Pixel dimensions (W=H) 100 µm
Number of Pixel (H x W) 1536 x 1536
Voxel dimensions (W=H) 141 µm
Dynamic range 16 bit (64000 grey levels)
Operating temperature 10 to +40° C
Storage temperature -20 to + 70° C
Image format, 2D 30 x 13
Image format, 3D FOV 11 x 11 cm
Image format, adult 2D 15 x 30 cm
Image format, child 2D 13 x 30 cm

DIGITAL CEPH SENSOR

Characteristic Value
One Shot, Digital CMOS Sensor
Type of sensor
technology
Pixel dimensions 125 µm
Active area 300 x 250 mm
Image format 30 x 25cm and 24 x 24cm
Image dimensions (pixel) 2448x2048 for 30 x 25 cm image format
Exposure time 200-500 ms
Reading time Immediate

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 Trident S.r.l.
X-VIEW 3D PAN
Technical Info

EXAMINATION PROCEDURES
Automatic selection for Adult and Child, 3 sizes, with preset
Technical factors values
selection for PAN Manual selection for kV and mA
Rotating collimator with automatic positioning
Automatic selection for Adult and Child, 3 sizes, with preset
values
Volumetric 3D Manual selection for kV and mA
Panoramic
Choice of 3 types of exams: dentition, left TMJ, right TMJ.
Image capture every 0.75 ° of rotation.
Adult/Child Standard Panoramic
Adult /Child Right Hemi Panoramic
Panoramic
Adult/Child Left Hemi Panoramic
Frontal Dentition
Adult/Child Reduced Dose Panoramic
Adult/Child Improved Orthogonality Panoramic
Optional PAN Right Bitewing
Left Bitewing
Right and Left Bitewing
TMJ closed mouth
TMJ
TMJ open mouth
Sinus Sinus P/A rotational projection
LL CEPH 30 x 24
Cephalometric AP CEPH
And Carpus
Carpus

EXPOSURE TIME
Exposure time is preceded by the heating time of the filament, equal to 3 s

Program Exposure Time

(in seconds)
Adult Standard Panoramic 15.5
Child Standard Panoramic 14.8
Adult Right/Left Hemi Panoramic 8.4
Child Right/Left Hemi Panoramic 8
Adult Reduced dose Panoramic 12.1
Child Reduced dose Panoramic 12.1
Adult Improved Orthogonality Dentition 12.8
Child Improved Orthogonality Dentition 12.1
Frontal dentition Adult/Child 4.0
1,7s for right/left side joint with open/ closed
TMJ open/close mouth
mouth; 6,8 s in total
SINUS 12.1
10 s for dentition and 3D sinus
Volumetric 3D Exams
9.7 s for right/left TMJ
Variable exposure time as a function of the
Cephalometric (CEPH) value of the current time * selected time.
Minimum 2 mAs, maximum 30 mAs
Exposure times accuracy ± 10 %

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 Trident S.r.l.
X-VIEW 3D PAN
Technical Info

ACQUISITION SOFTWARE
Name DEEP-VIEW
Type of license FULL FIRST LICENCE USB KEY MULTIUSER
The acquisition software DEEP-VIEW provides many image
manipulation functions, including:
• PAN and/or multi image visualization
• Enlarging images with dynamic zoom and scroll
• Flip and rotate images
• Change of brightness and contrast
• Application of median, logarithmic, noise reduction, dynamic and
spatial filters
Functions • Edit of LUT (look up table) and range (greyscale compression)
• Inversion of the gray scale (positive / negative)
• Application of special filters such as exclusive harmonizer that
optimizes the display of all the densities on the image
• Display of histograms and representation of densitometry profiles
• Insertion of anatomical references according to international
numbering
• Linear and angular dimensions measurement with the possibility of
dedicated calibration
• Printing of images with or without comments and measurements
• Database
Integration with
DEEP-VIEW is integrated with Xelis Basic implant surgery programming
implant planning
software, up to export and import of STL files for guided surgery.
software

VIEWER SOFTWARE
Name XELIS
Type of license FULL FIRST LICENCE USB KEY MONO-USER
Xelis Dental combined with Deep-View software, is an essential
tool for implant planning and post-procedure follow-up. Xelis
Description shows high precision 3D images and provides advanced features
such as Implant Simulation, Canal Draw, and Bone Density
assessment. Available in two versions, Advanced and Basic
• DBM Xelis Dental Database
• Basic 3D Toolbar including Measurement Tools, MPR, Cross
Basic version Functions Section
• Advanced Toolbar. Canal Draw, Implant Simulation, Utilities
• Single User. Optional Up to 10 users
• DBM Xelis Dental Database
• Basic 3D Toolbar including Measurement Tools, MPR, Cross
Section
• Advanced Toolbar.
• Canal Draw, Implant Simulation, Utilities
• STL export. Save surface Image export to external storage.
Advanced version CD/DVD/USB export
Functions (Optional) • Batch Print. One click Image Batch
• Print (Axial, Panoramic, Cross Section)
• DLB – Dynamic Lightbox
• Image stitching
• Report – Captured Image
• Management and Report Generation
• DICOM Print and CD burning

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 Trident S.r.l.
X-VIEW 3D PAN
Technical Info

IMAGES ENLARGEMENT
Program Value
Adult/Child Standard Panoramic 1 : 1.28
TMJ open/close mouth, 4 images 1 : 1.25 (nominal)
Sinus 1 : 1.27 (nominal)
1: 1.10 on the median sagittal plane projection in
LL (Latero-lateral)
CEPH
Not quantifiable in Projection AP (Antero-
Posterior)
Carpus Not quantifiable enlargement.

PC SPECIFICATIONS
Model Personal Computer HP Z240 SFF
Intel Core i7-6700 3.4 8M 4C
RAM 16GB DDR4-2133 NECC (2x8GB)
HDD 1 TB
OS Windows 8.1 Professional 64bit
Windows 10
1 DVDRW
Ethernet 2 LAN 10/100/1000
USB ports 2 internal + 4 external
GRAPHIC CARD NVIDIA Quadro K420 2GB
Monitor Monitor HP Z24NQ

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 Trident S.r.l.
X-VIEW 3D PAN
Technical Info

LABEL ID
3D PAN
This label shows the following data:
Unit type: X-VIEW 3D PAN
REF: alphanumeric code to identify the
type of unit – upgradeable to CEPH
Year of Manufacture
Serial Number: Alphanumeric code, the
letters identify the unit and the numbers
stand for the YOM and consecutive
number of production.
Technical data
Barcode
Manufacturer Address

3DPAN CEPH DR

This label shows the following data:

Unit type: X-VIEW 3D PAN
REF: alphanumeric code to identify the
type of unit – with CEPH DR
Year of Manufacture
Serial Number: Alphanumeric code, the
letters identify the unit and the numbers
stand for the YOM and consecutive
number of production.
Technical data
Barcode
Manufacturer Address

3D PAN CEPH CR
This label shows the following data:
Unit type: X-VIEW 3D PAN
REF: alphanumeric code to identify the
type of unit – with CEPH CR
Year of Manufacture
Serial Number: Alphanumeric code, the
letters identify the unit and the numbers
stand for the YOM and consecutive
number of production.
Technical data
Barcode
Manufacturer Address

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 Trident S.r.l.
X-VIEW 3D PAN
Technical Info

APPLICABLE STANDARD AND CLASSIFICATION

Classification CE directive 93/42: Medical device class IIB
• EN 60601-1
• EN 60601-2
• EN 60601-1-3
• IEC 60601-2-63
• IEC 60336
Applicable Standard
• EN 60601-1-2
• IEC 60825-1
• IEC 60601-1-6
• EN ISO 15223-1
• EN ISO 780
• IEC 60417-1

PACKAGING
W Size
Box Contents
(Kg) (cm)

• Carriage
• Optional base, when required
• PC 160 Kg with
• Ceph panel, when required standard
base
The base is fixed to the floor of
the pallet and the carriage is
180 Kg with
supported above a layer of
big base 120 x 80 x 120
polyethylene foam cushioning
material.
Ceph: 15
The display group, the front Kg
cover, and the accessories bag
(chin support, bite, small parts, PC: 10 Kg
etc.), are housed in a special
packaging.

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 Trident S.r.l.
X-VIEW 3D PAN
Technical Info

DIMENSIONS
X-View without Ceph Arm

X-View with Ceph Arm

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