TECHNICAL DATA. GIOTTO IMAGE SDL/W is pre-arranged for Full Field Digital Biopsy examination with the patient in prone position.

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1 Ver. 01/06/07 TECHNICAL DATA GIOTTO IMAGE SDL/W LOW DOSE, FULL FIELD DIGITAL MAMMOGRAPHY UNIT USING AMORPHOUS SELENIUM (a-se) TECHNOLOGY DETECTOR (pre-arranged for stereotactic biopsy with the same digital detector) GIOTTO IMAGE SDL/W is a modern mammography system for diagnostic and screening examinations which utilises the latest technologies: the 2 nd Generation Amorphous Selenium (a-se) digital detector 24x30 cm and a Special Tungsten Anode X-Ray Tube for Patient Dose Reduction. Detector Technology: Direct Digital Mammography (image visualisation in real time) with direct energy conversion (direct conversion of the x-photons into electric charges). X-Ray Tube Technology: special Tungsten (W) anode with traditional mammography micro-focuses (0.1 & 0.3 mm focal spots). The use of the Tungsten decreases dramatically the mean radiation to the patient. GIOTTO IMAGE SDL/W is pre-arranged for Full Field Digital Biopsy examination with the patient in prone position. GIOTTO IMAGE SDL/W includes: 1. DIGITAL DETECTOR 24x30 CM 2. MAMMO STAND, MECHANICS AND ELECTRONICS 3. A.W.S.- ACQUISITION WORKSTATION 4. R.W.S.- REVIEW WORKSTATION 1. DIGITAL DETECTOR 24x30 CM The GIOTTO IMAGE SDL/W uses the last generation technology for the Digital Detector: 2 nd Generation AMORPHOUS SELENIUM (a-se) The energy conversion is direct (direct conversion of the x-photons into electric charges) and the system efficiency is very high. DETECTOR Detector dimensions: 24x30 cm (239x305 mm) Matrix: 2816 x 3584 pixel ( pixel) Pixel dimension: 85 µm Spatial resolution: 6 lp/mm Digital Image dimension: 19 Mbytes Conversion A/D: 13 bit Very large dynamic range Quantic Efficiency (DQE) at 2 lp/mm 55% Resolution (MTF) at 2 lp/mm 90% 1

2 2. MAMMO STAND, MECHANICS AND ELECTRONICS GENERATOR / INVERTER Single phase, High Frequency Very low ripple: 1% Microprocessor Controlled Max. Power: 8Kw Max absorbed Current: 20A High technology innovative transformer with extremely fast rising and descending time: 1 m sec kv: with 0.5 Kv steps mas: Max. anodic current: 42 ma (SMALL FOCUS), 145 ma (LARGE FOCUS) Exposure Time: sec VARIAN X-RAY TUBE Anode: Tungsten (W) with Rhenium (Re) Rotating up to 9000 rpm Anode Diameter: 77mm Anode Thermal Capacity: 300,000 HU (222 KJ) Cooling rate : HU/min Dual Anode Angle: 10 /16 Small Focus: 0.1 mm; up to 1.3 kw; 42 ma Large Focus: 0.3 mm; up to5 Kw;.145mA Inherent Filtration: 0.63 mm Be (equivalent 0.0 mm Al) Tube overload protection FILTERS Automatic and manual insertion Aluminum (Al) filter Rhodium (Rh) filter: 0.05 mm A.E.C. Fully Computer Controlled The same digital detector is utilized as AEC chamber It uses: a) pre-exposure (breast density) and b) difference between uncompressed and compressed thickness to determine kv, filter and starting grid speed A.E.C. parameters: kv, mas, Al/Rh filter, Techniques: 1) Fully automatic: all parameters (kv, mas, filters) automatically selected by the computer 2) Manual tech: all parameters (kv, mas, filter) manually selected Post exposure readings: kv, mas, filter (visible on the control panel and on the acquisition Workstation) 2

3 BUCKY Dimensions: 24 x 30 cm Grid: ratio 6:1, 36 lines/cm, focused at 65 cm, carbon fibre interspaced The grid movement is a fast alternate movement (PSC technology) constantly controlled by the computer. result: the grid is invisible both for thin and translucent breasts as for thick and opaque breasts X-RAY CONTROL PANEL Alphanumeric display (LCD) showing kv, mas, filter, focal spot, A.E.C. technique, HU accumulated in %, released dose in mgy Controls: ON/OFF, A.E.C. technique, kv, mas, focal spot, Al/Rh filter, reset, no breast release after exposure, x-ray exposure S.C.S. - SENSITIVE COMPRESSION SYSTEM Fully computer controlled power driven and manual mechanism Double power driven speed: fast up to the breast and very slow when compression starts; footpedal control Motor-assisted manual fine compression according with FDA regulations Total run: 180 mm Max Force 200 N (20 kg) Precise digital force display: Max error ±1 Kg Compressed breast thickness display in cm Automatic breast release after exposure and override push button Automatic release in case of power off Compression paddles with dual plastic thickness: thinner the compression surface (to decrease the patient dose), thicker the vertical borders (to strengthen the plastic paddle) Vertical movement and electromagnetic brakes are automatically locked during breast compression All movements and electromagnetic brakes are automatically locked in case of power off All movements are stopped during the biopsy exam SAFETY Automatic breast release in case of power off Alarms and error messages are displayed in all cases of equipment fault or operator misuse x-ray inhibited in automatic modes if no compression applied POSITIONING / MOVEMENTS S.I.D.: 65 cm Unit conceived for the Giotto Positioning Method : face-to-face, inclined positioning and side by side lateral positioning too Vertical motorised movement. Total run 750 mm (with 30 tilted gantry) (from 65 cm to 140 cm) Foot pedal control and push buttons control on four (4) panels: two on the stand and two on the circular gantry Rotation movement : ±180 manual considering also the tilting movement that allows rotation from CC to reverse CC, both sides. Electromagnetic brakes with foot pedal control and push buttons control on four (4) panels: two on the stand and two on the circular gantry Tilting movement: +180 / -30 manual with electromagnetic brakes with foot pedal control and push buttons control on four (4) panels: two on the stand and two on the circular gantry Digital display of rotation and tilting angles 3

4 PROTECTION GLASS Dimensions: 1930 x 600 mm Radiation protection: following the rules EN A.W.S.- ACQUISITION WORKSTATION Images Acquisition Workstation dedicated to the mammography technologist. The Workstation receives the data directly from the digital detector and shows them on the high definition flat monitor. The AWS is provided with an ergonomic trolley supporting the monitor and containing the pc and other electronics. Image visualisation time: approx. 5 sec after the end of the exposure Automatic optimal visualization with the selected contrast/brightness level Tissue Equalization Software: automatic algorithm for the optimum visualization of all the breasts Areas at the same time (more or less dense) The visualised images on the monitor could be treated and transmitted to the RWS and to other receivers. Workstation with user-friendly interface: RAFFAELLO AWS CPU with last generation processor P IV Monitor LCD 21, flat type - very high brightness and resolution for medical use. Professional Hard disk type SCSI 2 min 250 GB (sufficient capacity for storing more than 13,000 images 24x30 cm and 20,000 mixed size) in RAID RAM 2 GB DDR ETHERNET 100T CARD Floppy Disk Drive Keyboard / Mouse Professional DVD/CD burner & floppy disk drive Both row an processed images are automatically stored on the Hard disk UPS continuity group for the digital detector and for Workstation Interface towards DICOM peripheral units compatible: RIS, PACS, validated laser printers -MODALITY PUSH -MODALITY PULL - DICOM STORAGE SCU/SCP - DICOM QUERY/RETRIVE SCU - DICOM MODALITY WORKLIST SCU - DICOM STORAGE COMMITMENT SCU - DICOM BASIC GRAYSCALE PRINT SCU - DICOM COMPLIANT CD-R DATA INTERCHANGE - PACS PUSH - DICOM VERIFICATION SCU/SCP - DICOM MODALITY PERF. PROCEDURE STEP 4

5 RAFFAELLO AWS, MANAGEMENT AND PROCESSING SOFTWARE RAFFAELLO, software is the user interface dedicated to the mammography which allows the largest and most complete processing images and database management. Window level: very large possibility to adjust the contrast and the brightness Electronic zoom on the whole image Moving the zoomed image on the monitor Ruler with multiple application Automatic and/or manual extension of the window level to all images of the same pat Image inversion Magnifying glass with adjustable magnification factor and lens dimensions Possibility to restore only the original dimension or window level and dimension Possibility to visualize so that every pixel corresponds to a pixel of the monitor Key function to hide/display all labels with patient data (as to enable a best visualization of the displayed of the displayed image) Possibility to visualise one, two or four image on the same monitor Possibility to go to next page contents other image Possibility to send the image to other DICOM station 4. R.W.S.- REVIEW WORKSTATION Review Workstation for images reading and diagnosis dedicated to the radiologist. The Workstation receives the data directly from the Acquisition Workstation and shows them on the two very high resolution monitors (5 mpixel). Automatic optimal visualization with the selected contrast/brightness level Tissues Equalisation software : automatic algorithm for the optimum visualisation of all the breasts areas at the same time (more or less dense) Possibility of large and complete images treatment, printing and transmission to different receivers. Workstation with user-friendly software interface : RAFFAELLO RWS CPU with last generation processor P IV Couple of 21 mono-chrome monitors Portrait Format with very high resolution (2k x 2,5k pixel) and brightness dedicated to digital mammography. Professional Hard Disk SCSI 2 with min 250 GB (sufficient capacity for storing more than 13,000 images24x30 cm and 20,000 mixed size) RAID MEMORY RAM 2 GB DDR ETHERNET 100T card Professional DVD/CD burner & floppy disk drive Keyboard / Mouse Interface towards dicom peripheral unitscompatible: RIS, PACS, validated laser printer -MODALITY PUSH -MODALITY PULL - DICOM STORAGE SCU/SCP - DICOM QUERY/RETRIVE SCU - DICOM MODALITY WORKLIST SCU - DICOM STORAGE COMMITMENT SCU - DICOM BASIC GRAYSCALE PRINT SCU - DICOM COMPLIANT CD-R DATA INTERCHANGE - PACS PUSH - DICOM VERIFICATION SCU/SCP - DICOM MODALITY PERF. PROCEDURE STEP 5

6 RAFFAELLO RWS, TREATMENT AND MANAGEMENT SOFTWARE RAFFAELLO, software is the user interface dedicated to the mammography which allows the largest and most complete images elaboration and database management. Window level: very large possibility to adjust the contrast and the brightness. Automatic and/or manual extension of the window level to all images of the same patient Electronic zoom on the entire image Magnifying glass with adjustable magnification factor and lens dimensions Possibility of automatic magnification so that each image covers the whole useful surface of the monitor Possibility to visualise one, two or four images on the same video Image inversion Rapid sequential visualisation of the selected examinations (in particular useful for the screening) Marker of the cases already examined Ruler with multiple application Key function to hide/display all luminous labels with patient data (as to enable a best visualitation of the displayed image) Possibility to go to next or previous page contents other image Possibility to go to directly to next or previous study Possibility to restore only the original dimension or window level and dimension Possibility to visualize so that every pixel corresponds to a pixel of the monitor Re-call of the patient name in the database ordered for all information about patients, study and image 6

7 MAIN UNIT CONTROL PANEL 7

8 ACQUISITION WORKSTATION REVIEW WORKSTATION 8