PRODUCT DATA

Helianthus
nthus is a co
comp
complete
m lete digital mammograph
mammography
hy syste
system
tem
m op
opti
optimized
timized
i d for 2D image acquisition, fufully
upgradable to any digital method: tomosynthesis and dual energy (predisposed for a future
implementation).
It can be completed with a wide range of accessories including the device for stereotactic and
tomoguided biopsies.
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 separate Acquisition Work Station (AWS)

PD HELIANTHUS a-Si U-011 (Amorphous Silicon)

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CLASSIFICATION (IEC 60601-1/A1)

Protection against electric shock Class I, with type B applied parts

Applied parts •
Potter-Bucky/Biopsy device carbon fiber
• Compression paddles
• Magnification device
Protection degree according to IEC 529 IP X0 (Mammo Unit)
IP X2 (Foot-controls)
Degree of safety in the presence of flammable Not suitable for use in the presence of Flammable
anesthetics mixture with air or with oxygen or with Anesthetics Mixture with air or with oxygen or with
nitrous oxide nitrous oxide
Mode of operation Continuous operation with intermittent loading

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

Number and type Two red push buttons on both sides of

mammography unit
One red push button on optional separate AWS
Function To switch off totally the power of mammo unit
except PC and logic interfaces
(Safety to close/save studies and switch off the unit)

ENVIRONMENT PROTECTION AND WASTE DISPOSAL

System contains in some of its parts and subassemblies, solid and liquid substances that must be dispo-
sed only designated 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 selenium

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ENVIRONMENTAL CONDITIONS (with a-Si Detector)

Mammography Unit Temperature: -20° C ÷ +70° C

Transit/Delivery and Storage Conditions Relative humidity: 10% ÷ 90%
Barometric pressure: 500 hPa ÷ 1060 hPa
Detector conditions during: Temperature: -15° C ÷ +65° C
• Transfer to transport terminal Relative humidity: 10% ÷ 85%
• Destination terminal Custom Clearance period Barometric pressure: 540 hPa÷ 1060 hPa
• Door delivery
• Storage conditions
• Mammo unit switched off
Detector conditions during: Temperature: -18° C ÷ +70° C (under 36 h)
• International air transport Relative humidity: 10% ÷ 85%
Note: detector packed in the original crate Barometric pressure: 540 hPa ÷ 1060 hPa
Operating conditions Temperature: +5° C ÷ +40° C

MAMMOGRAPHY UNIT
• 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

F.D.D. (Focus Detector Distance)/S.I.D. 66 cm

Motorized Movements Rotation and vertical translation
+/- 15° Rotation (only with Bym 3D DMD)
C- Arm rotation range ±180°
(CW, CCW continuous to any position)
Rotation speed 20°/s with acceleration and deceleration ramp for
smooth operation
C-Arm vertical range (Floor-Potter Bucky table) From 54 to 145 cm (travel of 91 cm)
Vertical movement speed 5 cm/s
Projection Preset positions N° 5 Programmable projections
(LAT, OBL, CC, OBL, LAT)
Tomosynthesis scan angles ± 7,5° (15°)
(activated only with tomosynthesis upgrade kit) ± 12° (24°)
± 25° (50°)

CONTROL SWITCHES

Number and Type Three multiswitches (five push-buttons)

Two on both sides of C-Arm and
one on top of X-Ray tube cover
Control Actions Vertical movement of C-Arm
Continous rotation of C-Arm
Switch-on of collimation light
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X-RAY HIGH-VOLTAGE GENERATOR

Line voltage compensation AUTOMATIC

H.V. generator with kV closed loop and line feed
forward compensation
Inverter Technology Current fed, Mosfet bridge with output current limit
capability and short circuit protection
Inverter Frequency 50 kHz
Ripple Frequency/Amplitude 100 kHz < 2%
Generator output power 7,4 kW (@ 37 kV)
kV range 20÷35 kV
20÷49 kV (optional)
kV resolution (all modalities) 0,5 kV
kV precision ± 1%

MAMMOGRAPHY UNIT
kV repeatability ± 0,1%
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

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X-RAY TUBE (IAE XM1016 T)

Anode rotation speed 3.000 rpm @50 Hz (10.000 rpm @50 Hz optional)
Target material Tungsten
Focal track: RT (Tungsten+Rhenium)
Bulk: TZM (Molibdenum+Titanium+Zirconium)
Anode Heat Storage Capacity 300 kHU (225 kJ)
Maximum Anode Heat Dissipation Rate 60 kHU/min (750 W)
X-Ray Tube Assembly Heat Storage Capacity 500 kHU (375 kJ)
X-Ray Tube Assembly Heat Dissipation Rate 108 HU/s (80 W)
Cooling method Free air convection
Anode Disc Target Angle 10° (Small Focus)/16° (Large Focus)
Anode Disc Diameter 80 mm
Focal spots 2

MAMMOGRAPHY UNIT
Focal spot size according to IEC 336 0,1x0,1 mm (Small Focus)/0,3x0,3 mm (Large Focus)
Power (Nominal Anode Input Power) 1.400 W (Small)/5.900 W (Large) (3.000 rpm)
2.400 W (Small)/9.600 W (Large) (10.000 rpm opt.)
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 (optional):
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 (optional):
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 (optional):
(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 8 mAs (using 20 mm PMMA phantom)
with automatic Exposure Control controlling Loa-
ding Time, shortest Loading Time and/or the lowest
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

TUBE ASSEMBLY THERMAL OVERLOAD PROTECTION

With active temperature sensor under main CPU Upper limit temperature 65° outside tube assembly.
control HU and °C display available in technical menu.
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FILTERS

50 μm Rhodium (Rh) 0,51 mm Al eq. 28 kV

(measured with Tungsten target)
50 μm Silver (Ag) 0,54 mm Al eq. 28 kV
(measured with Tungsten target)
500 μm Aluminium (Al) (active only in tomo mode) 0,4 mm Al eq. 28 kV
(measured with Tungsten target)
700 μm Aluminium (Al) (optional and active only in 0,51 mm Al eq. 28 kV
tomo mode) (measured with Tungsten target)
300 μm Copper (Cu) (optional, predisposition for 3,85 mm Al eq. 28 kV
future Dual Energy implementation) (measured with Tungsten target)

AUTOMATIC COLLIMATION DEVICE

MAMMOGRAPHY UNIT
Type Automatic recognition of compression paddle
format and position
Light source LED (Risk Group 1 - 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 - 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
- Trapezoidal dynamic for tomo exam (optional)
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 face
out of X-ray beam during tomo exam (optional)

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DIGITAL FLAT PANEL DETECTOR

Detector technology (a-Si) TFT Array + Pin photodiode Amorphous Silicon

Case dimensions 35,9x34,6 cm
Top cover Carbon fiber 0.1 mm Al equivalent
Chest gap 3,9 mm
Cooling method Air + Fan (integrated)
Digitalization type Logarithmic
Pixel dimension 85x85 μm
Pixel dimension in tomo reconstructed slices 85x85 μm (with any scan angle)
(with optional tomo upgrade kit)
Pixel dimension in syntethic 2D images 85x85 μm
(with optional tomo upgrade kit and “M-VIEW/VI”
software)
Active area 23,9x30,5 cm (24x30 cm format)

MAMMOGRAPHY UNIT
Image matrix 2.816x3.584=10.092.544 pixel
Image depth 16 bit
Fill factor 80 % geometric
MTF (Modulation Transfer Function) >75% @ 1 lp/mm
>10% @ 5,8 lp/mm
DQE (Detector Quantum Efficiency) >45% @ 1 lp/mm
for an exposure of 28 kV >10% @ 5,8 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)
(activated with optional tomo upgrade kit) 6 s (with 24° scan angle)
11.5 s (with 50° scan angle)
Reconstruction time from last exposure <15 s (in 2D mode)
(breast thickness of 50 mm)
TOMO mode (all slices) (optional)
36 s (with 15° scan angle)
38 s (with 24° scan angle)
49 s (with 50° scan angle)

TOMO mode (slab of 10 mm) (optional)

13.5 s (with 15° scan angle)
15.5 s (with 24° scan angle)
26.5 s (with 50° scan angle)
Time between two images acquired successively <15 s (in 2D mode)
(breast thickness of 50 mm)
TOMO mode (optional)
36 s (with 15° scan angle)
38 s (with 24° scan angle)
49 s (with 50° scan angle)

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“SensROI” AUTOMATIC EXPOSURE CONTROL

Controlled parameters Auto kV / Auto mAs (Zero Point Mode)

Manual kV / Auto mAs (One Point Mode)
Auto parameters selection criteria Dual mode: PRE and FAST
PRE: tissue composition based
(parameters evaluated by short X-Ray exposure)
FAST: compressed breast thickness based
Sensitive area (only for PRE mode) Automatically selected in function of employed
compression paddle

“POEt” POST-PROCESSING ALGORITHM

Type Specific for mammography to optimize

the quality of acquired images

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 specimens
and surgical anatomical parts
Images compression format JPEG LOSSLESS (JL)
JPEG 2000 LOSSLESS (J2L)
Images saving/export format DICOM FOR PROCESSING FFDM
DICOM FOR PROCESSING (only in tomo mode)

TOMOSYNTHESIS ACQUISITION (optional)

Number of X-ray exposures 11 (with 15° scan angle)

(projections with constant angle span) 13 (with 24° scan angle)
19 (with 50° scan angle)
Reconstruction method Back-projection technique with incorporated
iterative technique to improve image quality and
remove artifacts
COMBO procedure Function that allows a 2D + tomosynthesis
acquisition with a single breast compression
Distance between reconstructed slices 1 mm
Tomo acquisition control Push-button with spiral cable
Push-buttons on AWS (with AWS upgrade kit)
Foot-control (optional)

RECONSTRUCTION SOFTWARE OF SYNTHETIC VIEW FROM TOMO EXAM (optional)

Name “M-VIEW/VI”

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GRID

Type Linear, vibrating

Interspace Material Carbon Based Polymer
Ratio 6:1
Lines/cm 36
Contrast factor 1,54

GRID (supplied with optional tomo upgrade kit)

Type Linear, vibrating

Interspace Material Graphite
Ratio 5:1

MAMMOGRAPHY UNIT
Lines/cm 102
Contrast factor 1,3

DEVICE FOR GEOMETRIC MAGNIFICATION (optional)

Type Gridless, interchangeable with Potter-Bucky

Magnification Ratio x1,5/x1,8/x2
Small Focus Selection Automatic once fitted

IMAGE QUALITY

Spatial resolution Conformity with:

“European Guidelines for Quality Assurance in
mammography screening”, Fourth edition
and with
“Recommended specifications” for Quality
Assurance in mammography
of American College of Radiology

DOSE CALCULATOR

Method of Calculation Average Glandular Dose (AGD) according to:

“D.R. Dance et al.”
Data visualization (mGy) On Acquisition Work Station (AWS)
Method of recording Image Header (DICOM)
AGD with a 4 cm PMMA phantom (2D) 1,40 mGy
AGD with a 4 cm PMMA phantom (TOMO) 1,50 mGy (15°)
(with optional tomo upgrade kit) 2,20 mGy (24°)
2,30 mGy (50°)
Dose limits According to European Protocol for Dosimetry and
EUREF protocol
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“Smart μPress” COMPRESSION SYSTEM

Compression paddle movement Motor driven or manual with fine adjustment

Standard compression paddles 24x30 cm for normal breasts
18x24 cm with lateral shifting for small breasts
Optional compression paddles 24x30 cm for tomo exams (with tomo upgrade kit)
9x21 cm for magnification
Φ7,5 cm spot for magnification
18x24 cm with Φ7,5 cm spot for contact examination
10x24 cm for axillary examination
18x24 cm with holes for 2D biopsy
Compression paddle holder Fast mechanical unlock by rotating knob
Right lock warning LED
Maximum free space available between 182 mm with shifted compression paddles
compression plate and top cover of In magnification mode with specific compression paddle:

MAMMOGRAPHY UNIT
Potter Bucky or magnification device 183 mm @ 1,5x/123 mm @ 1,8x/83 mm @ 2x
Compression force range 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)

ROTATING CONTROLLERS FOR COMPRESSION WITH FINE ADJUSTMENT

Number and type Two rotating wheels with central push-button

on both sides of C-Arm

TOUCHSCREEN COLOR DISPLAYS

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

FOOT-CONTROLS

Number and type One with four pedals and one push-button
Two with four pedals and one push-button (optional)
Control actions Vertical movement of C-Arm
Vertical movement of compression Paddle
Motor driven compression unlock
Protection degree according to IEC 529 IP X2
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PERSONAL COMPUTER

Operating System Windows 10 IoT Enterprise

CPU Intel Core i5-6500 (Quad Core) 3.2 GHz
RAM 8 GB (16 GB with optional tomo upgrade kit)

INTEGRATED ACQUISITION WORK STATION (AWS)

HDD 128 GB SSD for Operating System, DMD Acquisition Software
and DMD Toolkit Software (256 GB SSD optional)
1 TB SATA for images storage (~ 25.000 images)
(2 TB SATA optional)
Pointing and selection device Keyboard with integrated touchpad
CD/DVD Recorder 24x
USB port 1 (3.1)
Power pack 250 W

2 MP (standard), 3 or 5 MP (optional) COLOR MONITOR

Technology TFT color LCD

Screen size (aspect ratio) and resolution 24” (2 MP), 21,3” (3 MP), 21,3” (5 MP)
1.920 x 1.200 (2 MP), 2.048x1.536 (3 MP), 2.800x2.100 (5 MP)
Viewing angle 178° (horizontal and vertical)
Response time 7 ms (2 MP), 20 ms (3 MP), 12.5 ms (5 MP)
Brightness 600 cd/m² max - 350 cd/m² DICOM calibrated (2 MP)
900 cd/m² max - 500 cd/m² DICOM calibrated (3 MP)
1.000 cd/m² max - 500 cd/m² DICOM calibrated (5 MP)
Contrast ratio 1.000:1 typical (2 MP), 1.400:1 typical (3 and 5 MP)

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PERSONAL COMPUTER (integrated in mammo unit)

Operating System Windows 10 IoT Enterprise

CPU Intel Core i5-6500 (Quad Core) 3.2 GHz
RAM 8 GB (16 GB with optional tomo upgrade kit)
HDD 128 GB SSD for Operating System, DMD Acquisition Software

SEPARATE ACQUISITION WORK STATION (AWS)

and DMD Toolkit Software (256 GB SSD optional)
1 TB SATA for images storage (~ 25.000 images)
(2 TB SATA optional)
Power pack 250 W

CONSOLLE WITH TRANSPARENT ANTI-X PROTECTION BARRIER

Pb equivalence > 0,34 mm @ 35 kV/0,26 mm @ 49 kV (IEC 60601-2-45)

(thickness of 20 mm)
> 0,5 mm up to 150 kV (optional)
(thickness of 11 mm)
Pointing and selection device Keyboard and mouse or
Touchscreen on 15” color display
CD/DVD Recorder 24x
USB port 1 (3.1)
Dimensions 857x2003x640 mm
Weight 90 kg (0,34 mm Pb eq)
56 kg (0,50 mm Pb eq)

COLOR DISPLAY (optionally available in touchscreen version)

Technology Active matrix TFT LCD

Screen size (aspect ratio) and resolution 15” (4:3) - 1024x768
Viewing angle 160° horizontal/150° vertical
Brightness 300 nits
Contrast ratio 800:1

2 MP (standard), 3 or 5 MP (optional) COLOR MONITOR

Technology TFT color LCD

Screen size (aspect ratio) and resolution 24” (2 MP), 21,3” (3 MP), 21,3” (5 MP)
1.920 x 1.200 (2 MP), 2.048x1.536 (3 MP), 2.800x2.100 (5 MP)
Viewing angle 178° (horizontal and vertical)
Response time 7 ms (2 MP), 20 ms (3 MP), 12.5 ms (5 MP)
Brightness 600 cd/m² max - 350 cd/m² DICOM calibrated (2 MP)
900 cd/m² max - 500 cd/m² DICOM calibrated (3 MP)
1.000 cd/m² max - 500 cd/m² DICOM calibrated (5 MP)
Contrast ratio 1.000:1 typical (2 MP), 1.400:1 typical (3 and 5 MP)

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 PD HELIANTHUS a-Si U-011 (Amorphous Silicon)

Founded in 1977, Metaltronica rapidly became known as a dynamic

an innovative company who with more than 9.000 diagnostic units
installed around the world could change the landscape in the field of
mammography. For over 40 years, Metaltronica units have been
supporting physicians in their work on breast cancer prevention,
offering extremely high quality mammographic images while
at the same time significantly reducing the dose of radiation.
METALTRONICA S.p.A.
An unwavering desire to achieve precise and consistent results is at the
Via delle Monachelle, 66
heart of the Metaltronica project. This is what we ask of our diagnostic
00071 Pomezia (Roma) - Italy
systems. We rely on a team of caring professionals that combines Tel +39 06 66160206
Fax +39 06 66160357
expertise, energy, creativity and intelligence to guarantee patients
www.metaltronica.com
the greatest possible comfort, and the most accurate diagnosis.