Milady DG
Digital Mammography Machine
PRODUCT Specifications
H.V. Generator
Generator output power: 5 kW @ 35 kV
Nominal electric power: 4,2 kW (140 mA - 30 kV @ 3 s)
According to IEC 60601-2-45: 201.7.9.2.1.d
Line voltage compensation: Automatic. H.V. Generator with kV closed loop and line feed forward compensation.
Inverter technology: Current fed, Mosfet bridge wit output current limit capability and short circuit protection.
Inverter frequency: 50 kHz
Frequency/Amplitude ripple: 100 kHz (< 2%)
kV range: 20 ÷ 35 kV (Option 20 ÷ 40kV)
kV resolution: (manual and automatic mode) 0,5 kV
kV precision: ± 1%
kV repeatability: ± 0,1%
kV rise time: ≤ 1,5 ms from 0 to 100%
kV display: XX,X kV (3 digits)
Lowest current time product: 1 mAs
According to IEC 60601-2-45:201.7.9.2.1.f
mAs maximum value: 640 mAs
mAs values: In accordance with R’ 20:
1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 13, 16, 20, 25, 32,40,
50, 63, 80, 100, 130, 160, 180, 200, 250,320, 400,
500, 640 mAs
Note: values rounded down on the base of
standards tolerance and series limited to 640 mAs
mAs resolution 0,1 mAs automatic
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 time 10 s
Filter Properties
50 μm Silver 0,55 mm Al eq @ 28 kV, measured with W target
50 μm Rhodium (option) 0,51 mm Al eq @ 28 kV, measured with W target
X-RAY TUBE ASSEMBLY
X-ray tube model: IAE XM 1016T
Anode rotation speed: 3.000 r.p.m @50 Hz
Optional: 10.000 r.p.m. @ 150 Hz
Anode material RT (Tungsten plus Rhenium) + TZM (Titanium plus
Zirconium plus Molybdenum)
Anode angle:
• Small focus: 10°
• Large focus: 16°
Anode disk diameter: 80 mm
Focal spot size according to IEC 336
• Small focus: 0,1 mm × 0,1 mm
• Large focus: 0,3 mm × 0,3 mm
Nominal anode input power according to
IEC 613
• With an anode rotation speed of 3.000 r.p.m.
Small focus 1.400 W / Large focus 5.600 W
• With an anode rotation speed of 10.000 r.p.m.
Small focus 2.400 W / Large focus 9.600 W
X-ray tube voltage when the AEC is enabled
IEC 60601-2-45: 201.7.9.2.1.i
20 ÷ 35 kV
Option: 20 ÷ 40 kV
mAs range • Small focus:
• 1 ÷ 80 mAs (from 20 to 21 kV)
• 1 ÷ 140 mAs (from 22 to 30 kV)
• 1 ÷ 100 mAs (from 31 to 34 kV)
• 1 ÷ 100 mAs (from 35 to 40 kV)
Large focus:
• 1 ÷ 320 mAs (from 20 to 24 kV)
• 1 ÷ 400 mAs (from 25 to 27 kV)
• 1 ÷ 640 mAs (from 28 to 30 kV)
• 1 ÷ 560 mAs (from 31 to 34 kV)
• 1 ÷ 320 mAs (35 kV)
• 1 ÷ 250 mAs (from 36 to 40 kV)
Maximum anode heat content: 225 kJ (≈ 300 kHU)
Maximum anode continuous heat dissipation: 700 W (≈ 60 kHU/min)
X-ray tube assembly heat storage capacity: 320 kJ (≈ 425 kHU)
X-ray tube assembly heat storage capacity: 80 W (≈ 108 HU/s)
X-ray window 0,5 mm Beryllium
Housing X-ray protection: ≥ 0,5 mm Pb equivalent
Inherent filtration 0,0 mm Al according to IEC 60522:1999-02
HVL measured at 28 kV > 0,5 mm Al equivalent
Total filtration: > 0,5 mm Al
Cooling modality: Free air convection
Overload protection: With active temperature sensor under main CPU control. Upper limit set at 65 °C outside the X-ray
tube assembly. HU and °C values are available on
the technical menu.
AUTOMATIC COLLIMATOR
Light source LED: (Class I device | Power 320 μW power)
Light intensity: ≥ 150 Lux
Light beam: Automatic switch ON when operating compression
(selectable by service) with electronic time
Light beam collimator accuracy: According to IEC 60601-2-45:203.8.5.4 Mirror With automatic out of field function
Formats (with device for geometric magnification)
• 18 × 24 cm and 10 × 14 cm for magnification
using the detector 18 × 24 cm format.
• 24 × 30 cm and 10 × 14 cm for magnification
using the detector 24 × 30 cm format.
Protection of the examination: field Fast lock and extended protective screen to keep patient’s face out of the X-ray beam
GRID
Type Linear and vibrating
Interspatial material Carbon based polymer
Potter Bucky factor 2.1 (W/Rh) / 1,92 (W/Ag)
Ratio 6:1
Lines/cm 36
Contrast factor 1,54
Lateral Control Panel
Position On preferred side of mammographic equipment
(on request - to be required in advance)
Technology Microprocessor controlled with unique safety
features exceeding IEC 601-1-4, all functions under
active operator control
Display Graphic LCD Display 240 × 128 dots
Alarm messages In several languages selectable
Option: acoustic message
Special feature
• X-ray tube thermal unit display and active protection.
• Technical display for self-test and defective
block identification, firmware release, exposure
counter and last exposure time and date
Diagnostic functions Selectable service functions on LCD Display for
hardware testing of each specific board with input
status display, single status display and ON/OFF
function
Optional Device for maginification
Type Without grid, Interchangeable with Potter Bucky.
Top cover Format 18 × 24 cm: Carbon fiber 0,1 mm Al equivalent
Format 24 × 30 cm: Polycarbonate 0,2 mm Al
equivalent
Magnification ratio ×1,5 / ×2 (variable)
Small focus selection Automatic once fitted in
Image quality
Spatial resolution: Conformity with: “European Guidelines for quality assurance in mammography screening”, third edition,
and with ”Recommended specifications” for
Quality assurance in mammography of American
College of Radiology
Automatic exposure Control
The A.E.C. has full automatic kV/mAs, manual kV/auto mAs in function of effective breast density
evaluated by pre-exposure X-Ray pulse or breast thickness for fast operation and/or special cases
with silicone prosthesis. Dose limits according to European Protocol for Dosimetry and EUREF
protocol
Controlled parameters • Auto kV / Auto mAs (Zero Point Mode)
• Manual kV / Auto mAs (One Point Mode)
Auto parameters selection criteria • Dual mode:
• Pre: tissue composition based (parameters
evaluated by short X-ray exposures)
• Fast: compressed breast thickness based
Sensitive area (only for Pre mode)\ Mosaic of 96 areas of detector automatically selected
in function of breast size and projections
DOSE CALCULATOR
Calculation method Average Glandur Dose (A.G.D.) according to «D.R. distance et al»
mGy data visualization On display of control panel, on acquisition workstation
Recording methodology Dicom | Image holder
A.G.D. with 40 mm PMMA Phantom 1,216 mGy
Dose rate • 36,63 R/min without compression plate
• 29,80 R/min with compression plate
C-ARM
Focus Detector Distance (F.F.D.) / S.I.D
(Source to image receptor Distance): 660 mm
Manual rotation: ± 180° with disk brake
Motorized rotation (optional): ± 180°
90° in 8 s with acceleration and deceleration ramp for smooth operation
Motorized movements: Vertical
Range of vertical movement from the floor: From 430 mm to 1.280 mm (vertical travel of 850 mm)
C-Arm rotation angulations range: ± 180° (CW, CCW continuous to any position)
Projection preset position: Nr. 5 programmable projections : Lat, Obl, CC, Obl, Lat
Display for the angle rotation visualizing: On control panel and on auxiliary display (ACR)
ISOCENTRIC C-ARM
Focus Detector Distance (F.F.D.) / S.I.D
(Source to image receptor Distance)
660 mm
Manual rotation: ± 180° with disk brake
Motorized rotation (optional: ± 180°
90° in 8 s with acceleration and deceleration
ramp for smooth operation
Motorized movements: Vertical
Rotating range ± 15°, only with SBD FFDM
Range of vertical movement from the floor: From 750 mm to 1.600 mm
(vertical travel of 850 mm)
C-Arm rotation angulations range: ± 180° (CW, CCW continuous to any position) ± 135° with the C-arm in the lowest position
Projection preset position: Nr. 5 programmable projections : Lat, Obl, CC, Obl, Lat
Display for the angle rotation: visualizing On control panel and on auxiliary display (ACR)
Auxiliary display
Display type :• 3 rows
• 7 segments
• 18 LED
Tagging keyboard (ACR protocol) 10 pushbuttons: E/L laterality and prefixes/suffixes
Information shown
• Compression force
• C-arm rotation angle
• Compression thickness
• Laterality, projection, ACR prefixes and suffixes
EMERGENCY STOP
Two “red head” Emergency Stop push-buttons are located on both sides of the mammographic.
equipment. One “red head” Emergency Stop push-button is located on the acquisition workstation.
They are intended for switching OFF the mammographic equipment in case of malfunctioning,
expect the Digital Flat Panel detector.
Flat Panel Detector
Detector Technology • Standard: Amorphous Selenium (a-Se
• Option: A Si TFT array with PIN Photodiode
Selenium thickness: 200 μm
Case dimensions: • 27,8x26,8 cm (18x24 cm format)
• 35,9x34,6 cm (24x30 cm format )
Top cover: Carbon fiber 0,1 mm Al equivalent
Cooling method: Air + Fan (integrated)
NOTE: The detector blowers will typically create a
difference of around 4-5 degrees with respect to
the ambient temperature.
Digitalization type: Logarithmic
Pixel pitch: 85×85 μm
Active area: • 17.2x23.9 cm (18x24 cm format)
• 23.9x30.5 cm (24x30 cm format)
Image matrix: • 2016x2816 (18x24 cm format)
• 2816x3584 (24x30 cm format)
Image depth: 16 bit
Fill factor: • 88 % geometric (for a-Se Detector)
• 80% geometric (for a-Si Detector)
MTF (Modulation Transfer Function):
• For a-Se Detector:
>90% @ 1 lp/mm
>40% @ 5,8 lp/mm
• For a-Si Detector:
>75% @ 1 lp/mm (typical 85%)
>10% @ 5 lp/mm for a-Si Detector (typical 20%)
DQE (Detector Quantum Efficiency)
(for exposure of 28 kV)
• For a-Se Detector:
• > 50% (@ 1 lp/mm)
• > 20% (@ 5,8 lp/mm)
• For a-Si Detector:
• > 45% @ 1 lp/mm (typical 50%)
• > 10% @ 5 lp/mm (typical 20%)
Maximum spatial resolution: 7 lp/mm
Nyquist frequency: 5,88 lp/mm
Signal to Noise Ratio: (SNR)
(with 45mm PMMA Phantom
15,19 (28,5 kV 10 mAs)
Ghost image factor
(Point n°2b.2.4.5 of “European Guidelines”)
• For a a-Se Detector: 0,02
• For a a-Si Detector: 0,05
Detector read time:
• < 1.4 s (18×24 cm)
• < 1.1 s (24×30 cm)
Image display time on acquisition
workstation: < 15 s
Time between two images acquisition: < 20 s
SMART μPRESS
COMPRESSION SYSTEM
Compression paddle movement: Motor driven or manual with fine adjustment by double rotating controller
Compression plates (standard): 18×24 cm shifted
Standard compression paddles suitable for
18×24 cm format:18×24 cm shifted for normal breasts
Standard compression paddles suitable for
24×30 cm format:
• 24×30 cm shifted for large breasts
• 18×24 cm with lateral shifting for normal
breasts
Compression paddle (option): 9×21 cm straight for magnification
Compression paddle holder: Fast mechanical unlock
Maximum free space available between
compression paddle and image receptor:
325 mm with shifted compression plates in
magnification mode (straight compression plate)
• Magnification × 1,5 = 231 mm
• Magnification × 2 = 131 mm
Compression thickness display: Displayed in mm
Compression force: Adjustable from 70 to 200 N
Compression force display: Effective force applied with 1 N resolution
Compression paddle descent speed: Proportionally decreasing compressing the breast
Maximum compression force safety: Triple safety device: electronic, electro-mechanical and mechanical
Soft compression paddle release: Selectable from the control panel, after exposure
Compression paddle aluminium equivalence: Less than 0,2 mm Al (0,135 mm Al ≈30 kV)
Special function: for 0 compression force for oncology procedures
Classifications
Protection against electrical shocks: Class I with type B applied parts
Applied parts :
• Potter Bucky/Biopsy device carbon fiber
• Compression paddle
• Magnification device
Protection degree according to standard
IEC 529 (solid materials and liquids):
• IPX0
• IPX1 Foot-pedal controls
Degree of safety in presence of flammable
anaesthetics mixture with air or oxygen or
nitrous oxide": Not suitable for the using in presence of flammable anaesthetics mixture with air or with oxygen or
nitrous oxide
Operational modality: Continuous operation with intermittent loading
POWER SUPPLY REQUIREMENT
Line voltage: 220 Vac ÷ 240 Vac
Automatic line compensation: ± 10%
Number or phase: 1 or 2 configurable
Line frequency: 50 Hz / 60 Hz
Stand-by power absorption: 500 VA
Maximum power absorption: 6.600 VA
Momentary current: 30 A peak
Total line resistance: < 0,50 Ω
Installations notes: This equipment must be installed as a permanent installation according to the directive IEC 60601-1. The main lines should be protected by a dedicated automatic circuit breaker with 2 poles.
Wokrstation
Typical configuration (consult Factory for additional technical information)
Operating system: Windows 7 Professional 64 bit
CPU: Intel Core i7 2.600 3,4 GHz
RAM: 8 GByte | Option 16 GByte
H.D.D. • 1 TByte Sata for the Operating System and
diagnostic software
• 1 TByte for studies storage (≈ 25.000 images)
DVD Recorder: 48× SATA DVD +/- RW DL
Power requirement :230Vac single phase 50/60 Hz 400W
UPS (Uninterruptable Power Supply) 230Vac single phase 50/60 Hz 650 VA
2 MP COLOUR MONITOR
(Standard)
Technology: TFT colour LCD
Screen size (diagonal): 21,3” (≈541 mm)
Display resolution: 1.600×1.200 pixel
Pixel pitch: 270 μm
Viewing angle: 178° Horizontal and Vertical
Response time 20 ms
Brightness: 440 Cd/m² maximum (250 Cd/m² Dicom calibrated)
Contrast ratio: 1.500:1 Typical
Optional: 3MP Monitor
PRODUCT Specifications
Typical configuration (consult Factory for addition technical information)
Dicom Interface • 3 MG modality
• IHE conformity for the PIR
• SWF and mammography profiles
Functions
• Remote mammographic equipment control panel
• Off-line images display and viewing
• Local fully functional operational mode
• Patient information local database
• Mammo tools to set the exposure parameters and the ACR view
• PC tools to make operations on the local PC of the acquisition station:
• Local opening of new studies (i.e. not from the work list)
• Local studies storing (i.e. in the internal memory of the acquisition station)
• Local studies reloading (i.e. in the internal memory of the acquisition station)
• Local database managing
• Graphic tools to manipulate images:
• Selection and positioning of images to display
• Display protocol with ACR predefined views
• Current session loaded images
• GOP® images enhanced (GOP® is a post-processing algorithm specific for mammography
that enhance the quality of the acquired images)
• Fit to window, Zoom, Pan, Magnification lens
• 1:1, Effective size
• AOI operations
• DICOM W/L, High/Very High/Skin contrast
• Histograms
• Override ACR settings
• Mirroring operations on ACR standard views (CC, MLO)
• DICOM tools:
• Work list studies opening and closing
• Sending of locally stored studies to the appropriate RIS server
• Studies printing
• Studies recording on CD/DVD
• HOS-RIS-Pacs
Protocol conformities
• Dicom 3.0 MG
• Dicom store SCU
• Dicom print SCU
• Dicom worklist management SCU
• IHE (PIR-Patient Information Reconciliation, SWF-Scheduled Workflow,
MI-Mammography Image)