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PD HELIANTHUS DBT A Si U 012
PD HELIANTHUS DBT A Si U 012
The Helianthus DBT is a top-of-the-line system configured for any type of digital mammography
exam including tomosynthesis. It is easily upgradable with cutting edge biopsy techniques in tomo
and contrast mammography.
It is composed of:
• Mammography Unit with isocentric C-Arm, integrated high voltage generator, biangular X-ray tube
and full field digital detector;
• Integrated or separated Acquisition Work Station (AWS)
THIS DOCUMENT CONTAINS PROPRIETARY INFORMATION OF METALTRONICA Spa: ANY USE BY A THIRD PARTY WITHOUT PRIOR AUTHORIZATION BY THE COMPANY SHALL BE PURSUED ACCORDING TO LAW
CLASSIFICATION (IEC 60601-1/A1)
POWER SUPPLY
GENERAL SPECIFICATIONS
Line voltage 115/220/230/240 Vac ±10% 50/60 Hz
Power 115/220/230/240 Vac
Momentary: 85/45/43/41 A
Long time: 2,5/1,3/1,2/1,2 A
Number of phases 1 or 2 configurable
Connection Permanently installed (IEC 60601-1)
Wall connection 20 A Thermal-magnetic circuit breaker
(40 A Thermal-magnetic circuit breaker in 115 Vac
option)
Mains resistance <0.50 Ω
EMERGENCY STOPS
System contains in some of its parts and subassemblies, solid and liquid substances that must be disposed
only designated by companies according to local laws
Tube assembly Beryllium, glass, dielectric oil (PCB free), other metals
and plastic
H.V. transformer Dielectric oil (PCB free), plastic, copper and other
metals
Other subassemblies Plastic, other metals, electronic components, glass,
epoxy printed circuits, amorphous silicon
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PD HELIANTHUS DBT a-Si U-012 (Amorphous Silicon)
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ENVIRONMENTAL CONDITIONS (with a-Si Detector)
GENERAL SPECIFICATIONS
Note: detector packed in the original crate Barometric pressure: 540 hPa ÷ 1060 hPa
Operating conditions Temperature: +5 °C ÷ +40 °C
• Mammo unit switched on Relative humidity: 30% ÷ 85%
Barometric pressure: 540 hPa ÷ 1060 hPa
Detector maximum rate of temperature change 10° C in 20’
Heat dissipated in max load condition of 35 kV
316 kCal/h
500 mAs (1 shot every 5 minutes)
ISOCENTRIC C-ARM
CONTROL SWITCHES
MAMMOGRAPHY UNIT
kV risetime ≤1.5 ms from 0 to 100%
kV display XX,X kV (3 digits)
Lowest Current Time Product
1 mAs
(IEC 60601-2-45: 201.7.9.2.1.f)
mAs maximum value 640 mAs (allowed)
mAs resolution (Automatic) 0,1 mAs
mAs values in accordance with R’20 series (Note: values rounded
down on the base of
standards tolerance and series limited to 640 mAs)
mAs display XXX,X mAs (4 digits)
Exposure Time range 0.02÷4.7 s (640 mAs @135 mA)
(Automatically selected in function of selected mAs)
Safety timer 10 s
4/14
PD HELIANTHUS DBT a-Si U-012 (Amorphous Silicon)
THIS DOCUMENT CONTAINS PROPRIETARY INFORMATION OF METALTRONICA Spa: ANY USE BY A THIRD PARTY WITHOUT PRIOR AUTHORIZATION BY THE COMPANY SHALL BE PURSUED ACCORDING TO LAW
X-RAY TUBE (IAE XM1016 T)
MAMMOGRAPHY UNIT
Power (Nominal Anode Input Power) 2.400 W (Small)/9.600 W (Large)
Nominal X-Ray tube voltage and highest X-Ray Large focus: 49 kV and 80 mA
Tube current available at that voltage Small focus: 49 kV and 42 mA
(IEC 60601-2-45:201.7.9.2.1.a) In tomo mode:
Large focus: 49 kV and 140 mA
Highest X-Ray tube current and highest X-Ray tube Large focus: 135 mA and 35 kV
voltage available at that current Small focus: 65 mA and 35 kV
(IEC 60601-2-45:201.7.9.2.1.b) In tomo mode:
Large focus: 200 mA and 35 kV
Corresponding combination of X-Ray tube voltage Large focus: 35 kV*135 mA=4.725 W
and X-Ray tube current which results in the highest Small focus: 42 kV*55 mA=2.310 W
electric output power In tomo mode:
(IEC 60601-2-45:201.7.9.2.1.c)
Large focus: 35 kV*200 mA=7.000 W
Lowest current time product
1 mAs for both operation modes
(IEC 60601-2-45:201.7.9.2.1.f)
For Mammographic X-Ray Equipment provided
with automatic Exposure Control controlling Loa-
ding Time, shortest Loading Time and/or the lowest 8 mAs (using 20 mm PMMA phantom)
resulting Current Time Product
(IEC 60601-2-45: 201.7.9.2.1.h)
X-Ray Window 0,5 mm Beryllium
Housing X-Ray protection ≥0,5 mm Pb equivalent
Inherent filtration 0,0 mm Al IEC 60522:1999-02
HVL measured at 28 kV >0,5 mm Al equivalent
Total filtration at 28 kV >0,5 mm Al
With active temperature sensor under main CPU Upper limit temperature 65° outside tube assembly.
control HU and °C display available in technical menu.
5/14
PD HELIANTHUS DBT a-Si U-012 (Amorphous Silicon)
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FILTERS
MAMMOGRAPHY UNIT
Type Automatic recognition of compression paddle format
and position.
The operator can switch from automatic to manual
collimation mode (not for tomo and biopsy exam).
Light source LED (Risk Group 1 at 50 cm - Low Risk -according to
IEC 62471)
Light beam Switch ON by push-button or automatic when
operating compression (selectable by service)
Electronic timer
Light intensity ≥150 lux
Light beam collimation accuracy according to IEC 60601-2-45: 203.8.5.4
Mirror with automatic out of field function
Image formats - Trapezoidal dynamic for TOMO exam
- 24x30 cm
- 18x24 cm
- 14x30 cm
- 12x30 cm
- 11x30 cm
- 10x24 cm
- 11x14 cm
- 9x13 cm
- 8x11 cm
- 7x7 cm
- 8x5/7x5 cm for biopsy
Protection of examination field Protective screen to keep patient’s face out of X-ray
beam during 2D exam
Extended protective screen to keep patient’s faceout
of X-ray beam during TOMO exam
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PD HELIANTHUS DBT a-Si U-012 (Amorphous Silicon)
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DIGITAL FLAT PANEL DETECTOR
MAMMOGRAPHY UNIT
Image depth 16 bit
Fill factor 80 % geometric
MTF (Modulation Transfer Function) >85% @ 1 lp/mm
>20% @ 5,8 lp/mm
DQE (Detector Quantum Efficiency) >50% @ 1 lp/mm
for an exposure of 28 kV >20% @ 5 lp/mm
Resolution 5,9 lp/mm (Nyquist)
Signal to Noise Ratio (SNR)
15,19 (28,5 kV-10 mAs)
(with 45 mm PMMA Phantom)
Ghost image factor (point n° 2b.2.4.5 of “EUREF”) 0,05
Tomosynthesis acquisition time 5 s (with 15° scan angle)
6 s (with 24° scan angle)
11.5 s (with 50° scan angle)
Reconstruction time from last exposure <4 s (in 2D mode)
(breast thickness of 50 mm)
TOMO mode (all slices)
15 s (with 15° scan angle)
16 s (with 24° scan angle)
19 s (with 50° scan angle)
Time to display the image on the AWS from last <5 s (in 2D mode)
exposure (breast thickness of 50 mm)
TOMO mode
30 s (with 15° scan angle)
32 s (with 24° scan angle)
50 s (with 50° scan angle)
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PD HELIANTHUS DBT a-Si U-012 (Amorphous Silicon)
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“SensROI” AUTOMATIC EXPOSURE CONTROL
MAMMOGRAPHY UNIT
Description Processing of acquired RAW images and display in
“For Presentation” format to enhance breast tissue
structures and reduce the noise
Dedicated Filters For geometric magnification and in case of
prosthesis, metallic clips, surgical markers, clusters of
microcalcifications, breast specimensand surgical
anatomical parts
Images compression format
JPEG LOSSLESS (JL), JPEG 2000 LOSSLESS (J2L)
Images saving/export format DICOM FOR PROCESSING FFDM
DICOM FOR PROCESSING (TOMO projection)
TOMOSYNTHESIS ACQUISITION
Name “M-VIEW/VI”
8/14
PD HELIANTHUS DBT a-Si U-012 (Amorphous Silicon)
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GRID
MAMMOGRAPHY UNIT
IMAGE QUALITY
DOSE CALCULATOR
9/14
PD HELIANTHUS DBT a-Si U-012 (Amorphous Silicon)
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“Smart μPress” COMPRESSION SYSTEM
UNIT
MAMMOGRAPHYUNIT
warning LED
Maximum free space available between 182 mm with shifted compression paddles
compression paddle and top cover of In magnification mode with specific compression paddle:
Potter Bucky or magnification device 183 mm @ 1,5x/123 mm @ 1,8x/83 mm @ 2x
Compression force range
MAMMOGRAPHY
Adjustable from 70 to 200 N
Compression force displayed Effective applied force with 1 N resolution
Compression thickness accuracy ±1 mm
Compression paddle descent speed 4 cm/s at the start
Proportionally decreasing compressing the breast
Maximum compression force safety device Triple: electronic, electro-mechanical, mechanical
Soft compression release after exposure Selectable from control panel
Compression paddle aluminium equivalence < 0.2 mm Al (0.135 mm Al≈30 kV)
Number and type Two rotating wheels with central push-buttonon both
sides of C-Arm
Number and type Two LED backlight touchscreens on both sides of C-Arm
Screen size (aspect ratio) and resolution 7” (4:3) - 640x480
Displayed parameters Compression force, compressed breast thickness, patient
name, projection angle, breast laterality,
ACR code, collimation format, magnification factor
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PD HELIANTHUS DBT a-Si U-012 (Amorphous Silicon)
THIS DOCUMENT CONTAINS PROPRIETARY INFORMATION OF METALTRONICA Spa: ANY USE BY A THIRD PARTY WITHOUT PRIOR AUTHORIZATION BY THE COMPANY SHALL BE PURSUED ACCORDING TO LAW
FOOT-CONTROLS
Number and type Two with four pedals and one push-button
Control actions Vertical movement of C-Arm Vertical movement of
compression Paddle
Motor driven compression unlock
Protection degree according to IEC 529 IP X2
MAMMOGRAPHY UNIT
> 0,5 mm up to 150 kV (optional)
(thickness of 11 mm)
Dimensions 773x2100x505 mm
11/14
PD HELIANTHUS DBT a-Si U-012 (Amorphous Silicon)
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CALCULATOR (Integrated in Mammo Unit)
12/14
PD HELIANTHUS DBT a-Si U-012 (Amorphous Silicon)
THIS DOCUMENT CONTAINS PROPRIETARY INFORMATION OF METALTRONICA Spa: ANY USE BY A THIRD PARTY WITHOUT PRIOR AUTHORIZATION BY THE COMPANY SHALL BE PURSUED ACCORDING TO LAW
CALCULATOR (Integrated in Mammo Unit)
13/14
PD HELIANTHUS DBT a-Si U-012 (Amorphous Silicon)
THIS DOCUMENT CONTAINS PROPRIETARY INFORMATION OF METALTRONICA Spa: ANY USE BY A THIRD PARTY WITHOUT PRIOR AUTHORIZATION BY THE COMPANY SHALL BE PURSUED ACCORDING TO LAW
PD HELIANTHUS DBT a-Si U-012 (Amorphous Silicon)