DRF 4343 Product Data en

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DRF 4343

Acquisition and processing system with Dynamic Flat Panel detector

Product Data

Detector features
Model Thales - Trixell Pixium RF 4343
Technology Dynamic Flat Panel Detector.
Amorphous Silicon photodiodes array with high absorption
and high resolution CsI scintillator screen with 6 μm needle
structure
Acquisition modes − radiography
− tomography
− pulsed fluoroscopy
− continuous fluoroscopy
Frame rate 1 to 30 img/s
Max spatial resolution 3.4 lp/mm (Nyquist frequency)
MTF (Modulation transfer 66% @ 1.0 lp/mm
function) 32% @ 2.0 lp/mm
DQE (Detection Quantic 65% @ 0 lp/mm
Efficiency) 52% @ 1.0 lp/mm
42% @ 2.0 lp/mm
19% @ 3.4 lp/mm
Exposure dose 0.1 – 10 μGy
Max linear response dose 50 μGy
Saturation dose 85 μGy
Total sensitive area 43 x 43 cm (17” x 17”)
Matrix 2880 x 2881 pixels
Pixel size 148 μm
A/D conversion 16 bits (65.536 grey levels)
Cooling Air, with automatic internal air circulation system

Product data DRF 4343 - Rev. 16 Page 1 of 8


System control and image processing
System control and image processing is based on a multi-processor subsystem which provides
real-time image acquisition, processing and integrated workflow management including: insertion
of patient demographic data, exam procedure selection, exposure factors setting, detector
control, processing algorithms and DICOM functionalities.
Master control processor
Functionalities − System diagnostics
− Interface with examination table
− Interface with generator
− Interface with AEC
Image processing, GUI and DICOM connectivity
Architecture PC
Processor Intel i7
Clock 4 GHz
RAM memory 8 GB
Mass storage System: 250 GB SSD (Solid State Drive)
Archive: 250 GB SSD (500 GB, 1 TB, 2 TB in option as SATA 2
HDD or SSD)
Operating System Windows 10 Enterprise LTSC 64 bit
Local storage capacity > 16000 images with 250 GB hard disk
> 32000 images with 500 GB hard disk (option)
> 65000 images with 1 TB hard disk (option)
> 130000 images with 2 TB hard disk (option)
Image display time Real time image display up to 30 frames/s (Dynamic acquisition
mode)
Image sequences storage Fluoro acquisition cine-loops can be stored in the hard disk
GUI language English, Spanish, Italian, French, German, Dutch, Russian,
Romanian
Backup hard disk The system is equipped with a backup hard disk for the
complete memorization of principal hard disk content. This
feature allows to restore the complete functionality of the
machine in case of crash of primary disk

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Acquisition modes
Useful area Matrix (pixel) Resolution Max frame rate
(bits) (img/s)
(img/s )
Continuous 43x43 cm (17”x17”) 960x961 16 18
fluoroscopy 30x30 cm (12”x12”) 1024x1025 16 15
20x20 cm (8”x8”) 673x673 16 30
15x15 cm (6”x6”) 1024x1024 16 15
Useful area Matrix (pixel) Resolution Selectable frame
(bits) rate (img/s
(img/s )
Pulsed 43x43 cm (17”x17”) 960x961 16 1, 2, 4, 7.5, 15
fluoroscopy 30x30 cm (12”x12”) 1024x1025 16 1, 2, 4, 7.5, 15
20x20 cm (8”x8”) 673x673 16 1, 2, 4, 7.5, 15
15x15 cm (6”x6”) 1024x1024 16 1, 2, 4, 7.5, 15
Useful area Matrix (pixel) Resolution Max frame
fr ame rate
(bits) (img/s)
(img/s)
Radiography
43x43 cm (17“x17“) 2880x2881 16 3
43x43 cm (17“x17“) 1440x1441 16 8

Tomography
Digital tomography Choice between 16 combinations of angles and speeds. Layer
position sent from Apollo remote controlled table. See “Apollo
DRF” product data for details

Tomosynthesis (option)
Tomosynthesis function Through a scan performed at a fixed angular range of 40°
(±20°), the systems acquires a series of projection at different
angles which are reconstructed by software in a sequence of
slices parallel to the exam plane
Acquisition speed 8 frame/s
Acquisition time 7.5 s
Image matrix 1440 x 1441 pixel
Number of acquired images 60
Layer height (geometric 0 ÷ 350 mm, step 1 mm
position of central slice of
reconstructed volume respect
to table)
Distance between two adjacent Selectable at 1 mm steps
slices
Image display functions Cine-loop with selectable speed, frame-by-frame image view
Reconstructed tomosynthesis The software allows to define the first and final slice of the
images reconstructed sequence of tomosynthesis images, as well as
the distance between adjacent slices. Different processings can
be obtained and stored by using the same tomosynthesis
acquisition
Product data DRF 4343 - Rev. 16 Page 3 of 8
Reconstruction profiles Selection among three suggested reconstruction profiles to get
the best presentation of the images. Other profiles can be
created during the installation phase according to the user’s
needs

Stitching (option)
Stitching function The stitching function allows the acquisition of a series of
images of a wide anatomic part, which are then joined together
in a single image in a completely automatic process.
This function is typically used for spine and extremity exams
Manual correction Is possible to manually correct the overlapping zone between
two images both vertically and horizontally.
Memorization The full stitched image and the original segmented images are
stored in a single patient record.

Digital Subtraction Angiography (option)


Multiple phase angio Each Angio procedure can be made of up 6 phases with different
procedures frame. It is possible to define the start of the injection and the start of
the subtraction.
Maximum opacification To track the flow of contrast media in subtraction mode
function (maxop)
Lock-In This function can be selected to lock the dose level between the
different steps of the angio procedure
Injector control With automatic synchronization of the mask image acquisition
Road mapping Continuous fluoroscopy with image subtraction for tracking the
progress of the catheter insertion
Reference image For image comparison, the live image is shown on one monitor while a
stored image can be displayed on the reference monitor
Cine loop Possibility to select the speed of the playback and to define the start
and stop of the sequence to be played
Sub-on, Sub-off It is possible to review images with and without the image subtraction
Remasking Manual choice of the mask image
Maxop It’s possible to activate the maxop function on exams acquired without
it
Pixel shift Mask image repositioning with sub-pixel increments
Landmarking It’s possible to modify the weight of the mask image. It allows to
adjust the level of the background anatomy display
Image summation Images can be summed to enhance the visibility of the contrast media

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Exam preparation and image acquisition
Patient demographics Patient data can be entered with the following modalities:
− DICOM Worklist
− Local database query
− Manual insertion via keyboard
− “Emergency” mode
Exam settings User selection of anatomic examination procedures from a pre-
defined library (customizable), with automatic setting of:
− Exposure technique (3 points, 2 points, AEC)
− 4 patient sizes (pediatric, small, medium, large)
− Focal Spot
− Exposure factors
− Look-Up Table for grey scale optimization
− Region Of Interest for automatic parameters optimization
− Image processing algorithm
− Zoom factor
− Windowing
Possibility of manual override for modification of the preset
parameters
Exam table pre-setting According to the predefined examination procedure, the table
automatically sets:
− Table Tilt
− Column tilt
− Longitudinal detector position
− Transversal tabletop position
− Source-Detector distance
− Collimated area
− Grid type
− Additional filtration (if present)
Last Image Hold (LIH) After X-ray emission, the last image will be held on the monitor
Virtual collimation The function allows to adjust the collimator opening area without X-
ray emission adjusting a digital rectangle on the last image (LIH)
Virtual scan The function displays the displacement of the collimator on the last
image hold (LIH) during the table movements (longitudinal scan and
transversal tabletop movement), allowing the centering of the region
of interest without X-ray emission
RIS mapping If the PACS supports this function, when a patient record is
downloaded from the Worklist, the system automatically recognizes
the requested anatomic procedure and sets itself according to it

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Post Processing
Patient database query Possibility to query with different filters: performed exams, completed
exams, documented exams (print, store, etc)
Image review Single image review. Playback of dynamic sequences at acquisition or
arbitrary speed. Forward and backward manual image browse.
Cine loop with editing functions.
Multi-Image mosaic User selection of the number of images among 4 / 9 / 16 / 1+5 (1
view large image + 5 small images) / 1+7 (1 large image + 7 small images)
Zoom 1:1 / 2:1 / 3:1 /Magnifying glass
Image deletion From multi-image display or standard image review
Processing functions − Vertical and horizontal flip
− Rotation with 90° steps
− Automatic and manual (mouse driven) windowing (brightness and
contrast)
− Gamma correction
− Grey scale inversion (positive/negative)
− Spatial filters (weak/strong, kernel 3x3 - 11x11, weight 0 - 5)
− Harmonization
− Text notes with free text and pre-defined library
− Measurements of distance, angles and stenosis (for DSA)
− Calibration measurements
− Orthopaedic measurements (option)
− Pre-defined symbols
− Manual and automatic electronic collimation
ATH (Anatomical Tissue ATH is an advanced image processing function that automatically
Harmonization) improves the image quality by:
− Applying dedicated processing algorithms and parameters for every
anatomic district under examination
− Recovering the image visualization in under- or over-exposed areas
− Increasing the image latitude without loss of contrast
− Automatically optimizing the grey scale and reducing the need for
manual windowing
− Improving the visibility of details without adding noise or artifacts
− Balancing the visibility of high and low density structures in the
same image
FTH (Fluoroscopy FTH is an advanced image processing function for fluoroscopy images
Tissue Harmonization) in real time, able to optimize the image presentation, independently of
the radiographic features of examined organs and tissues. FTH
produces an high enhancement of the latitude of dynamic image,
without loss of contrast and definition
Hardcopy Interactive print layout editor. True-Size print capability.
Predefined layouts according to anatomic procedures from RIS

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Connectivity
DICOM classes - Print (SCU)
- Store (SCU)
- Worklist (SCU)
- Storage Commitment (SCU) (option)
- Query/Retrieve (SCU) (option)
- MPPS (SCU) (option)
- CD-DVD Media Creation (option). Every CD includes an image review
program that can be used to review images on any Windows
compatible PC
- Dose Structured Report (SCU) (option)
Network connection Ethernet 10/100/1000
Multiple destinations Images can be sent to multiple DICOM destinations
Auto Send Images can be automatically sent to DICOM destinations upon closing
the study
Remote Access Possibility of remote access for Technical service (option)
Note All features previously described are subject to verification of hardware
and software compatibility of the devices to be connected.

Dose measurement
Technology Ionization chamber on the collimator
Chamber type Rectangular, transparent ionization chamber
Reproducibility <1% under constant pressure and temperature
Energy dependence Better than ±8% related to 100 kV
Dose resolution 1 mGy cm2
Active area 146 x 146 mm
Optical transparency of ≥ 75%
ionization chamber
Installation Into the collimator rails
Dose recording The dose of each exposure is recorded with the relevant image. The
total accumulated dose (fluoro + exposures) is recorded with each
exam. Dose information is sent to the PACS network through DICOM
header

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Standards and regulations
CE symbol grants the product compliance to the European Directive
for Medical Devices 93/42/EEC and its revised versions as a class IIB
0051
device
c-CSA-us approval means that the product meets the
requirements of the applicable US and Canadian standards

FDA approval grants the product compliance to US Code of Federal


Regulation title 21 subchapter j
Health Canada Licence grants the product compliance to the Canadian
Medical Device Regulations SOR/98-282

Cabinet Mechanical Dimensions (in millimeters)

Weight: 126 kg

Note: Products are continuously under review in the light of technical advancement. The actual specification may
therefore be subject to improvement or modification without notice.

Company with Quality System certified by


VILLA SISTEMI MEDICALI s.p.a.
20090 BUCCINASCO (MI) – ITALY,
Via delle Azalee, 3
Tel. +39-02-488591, Fax +39-02-4881844
ISO 9001:2015 ISO 13485:2016

Product data DRF 4343 - Rev. 16 Page 8 of 8

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