LAMBDA DATA SHEET. ANALOGIC mammography unit. ANALOGIC mammography unit. Rev. n.05 of 15/01/13

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2 NOTE The manufacturer reserves the right to make further improvements while keeping main features unchanged

3 MAIN CHARACTERISTICS Line voltage 220/230/240 VAC 50/60 Hz Power 6.6 kva (0.5 kva stand-by) Current absorption 30 A peak Number of phases 1 or 2 configurable Connection Permanently installed (IEC 601-1) Wall connection 20 A fuse or Thermal-magnetic circuit breaker Maximum apparent resistance 0.50 Ω H.V.GENERATOR Line voltage compensation Inverter Technology AUTOMATIC H.V. generator with kv closed loop and line Feed forward compensation Current fed, Mosfet bridge with output current limit capability and short circuit protection 50 khz Inverter Frequency Ripple Frequency/Amplitude 100 khz < 2% Generator Output Power 5 kw (@ 35 kv) Nominal electric power (IEC par ) 4.2 kw=140 ma*30 kv (3 s) kv range 20 / 35 kv kv resolution (Manual & Auto mode) 0.5 kv kv precision 1% kv repeatability 0.1% kv rise time 1.5 ms from 0 to 100% kv display Lowest Current Time Product (IEC par ) mas range XX,X kv (3 digits) 1 mas Small focus: 1/200 mas (from 20 to 30 kv) 1/180 mas (from 31 to 35 kv) Large focus: 1/640 mas (from 20 to 30 kv) 1/500 mas (from 31 to 35 kv) mas range (High Speed Starter option) Small focus: 1/200 mas (from 20 to 24 kv) 1/250 mas (from 25 to 30 kv) 1/200 mas (from 31 to 35 kv) Large focus: 1/640 mas (from 20 to 30 kv) 1/500 mas (from 31 to 35 kv) mas values according to series 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 resolution (Automatic) 0.1 mas mas display XXX.X mas (4 digits) Exposure Time Automatically selected in function of selected mas (max. 8s) Safety timer 10 sec

4 X-RAY TUBE ASSEMBLY Anode rotation speed Target material Maximum Anode Heat Content I.A.E. XM12i 3000 rpm 50 Hz rpm 150 Hz (optional) Molybdenum 225 kj (300 khu) Maximum Anode Cooling rate 750 W (60 khu/min) Maximum X-Ray Tube Assembly Heat Content 320 kj (425 khu) Housing continuous Heat Dissipation 80 W (108 HU/s) Cooling method free air convection Anode Disc Target Angle 12.5 Anode Disc Diameter 80 mm Focal spots 2 Focal spot size according to IEC small 0.3 large Power 1150 W small 4800 W large (3000 rpm) 2000 W small 9000 W large (10000 rpm) Nominal X-Ray Tube Voltage 35 kv Highest X-Ray Tube Current (at 30 kv) 22 ma small 90 ma large (3000 rpm) 35 ma small 135 ma large (10000 rpm) Combination of X-Ray Tube Voltage and X-Ray 35 kv*100 ma=3500 W Tube Current which results in the highest electric output power (IEC par ) X-RAY Window 0.5 mm Beryllium Inherent filtration 0.0 mm Al IEC 522/1976 HVL measured at 28 kv >0.3 mm Al equiv. Total filtration >0.5 mm Al FILTER PROPERTIES 30 m Molybdenum 0.38 mm 28 kv, measured with Mo target 25 m Rhodium (optional) 0.62 mm 28 kv, measured with Mo target TUBE ASSEMBLY THERMAL OVERLOAD PROTECTION With active temperature sensor under main CPU control Upper limit temperature 65 outside tube assembly. HU and C display available in technical menu.

5 AUTOMATIC EXPOSURE CONTROL (ULTRA) Controlled parameters Auto kv / Auto mas (Zero Point Mode) Manual kv / Auto mas (One Point Mode) Auto parameters selection criteria Selected in function of effective BREAST DENSITY evaluated by pre-exposure Nominal shortest Irradiation Time 10 ms limited to pre-exposure with associated alarms for (IEC par ) detector Saturation or Overexposed Auto kv range Function of the selected technique (standard- high contrast-low dose), the Anode/Filter combination Manual density control 11 steps 0 5 Programmable with PC independently for all the operative techniques available Film Screen combinations 16 film/screen fully programmable (3 dedicated to CR cassettes) O.D. linearity over 2 to 6 cm of Plexiglas Better than 0.1 of O.D. (after field calibration) Reference O.D. Programmable during installation CR dose limits Programmable during installation A.E.C. short time stability measured over 10 <3% exposures taken at 28 kv 50 mas Detector PHTM 9000 SOLID STATE (9 active sensors) Detector Positions 3 fields electronically selectable Erratic exposure protection Detector saturation Excessive breast density For both cases Dose Released < 1 mas Test Phantom 3x2 cm + 1 cm cm of Plexiglas for calibration and daily self test procedure A.E.C. Self Test Procedure Included in control panel functions Average glandular dose measured in ACR method: < 3 mgy 4.5 cm phantom of 50% glandular tissue and 50% adipose tissue exposure taken with 28 kv 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

6 C-ARM F.F.D. Manual rotation Motorized rotation (optional) Projection preset positions Vertical movement with respect to Breast support (C-ARM in vertical position) Protection of examination field ISOCENTRIC C-ARM F.F.D. Manual rotation Motorized rotation (optional) Rotation for biopsy projections Projection preset positions Vertical movement with respect to Breast support (C-ARM in vertical position) Protection of examination field 65 cm 180 with disc brake 180 (90 /5 s with acceleration and deceleration ramp for smooth operation) Fully programmable at any position with audible alert (Manual rotation) Programmable projections LAT, OBL, CC, OBL, LAT and CW, CCW continuous rotation to any position over +/- 180 (Motorized rotation) 428 mm to 1278 mm (motorized) Removable polycarbonate screen 65 cm 180 with disc brake 180 (90 /5 s with acceleration and deceleration ramp for smooth operation) Motorized 15 microprocessor controlled Fully programmable at any position with audible alert (Manual rotation) Programmable projections LAT, OBL, CC, OBL, LAT and CW, CCW continuous rotation to any position over +/- 180 (Motorized rotation) 747 mm to 1597 mm (motorized) Removable polycarbonate screen BYM 3D DEVICE - OPTION The BYM 3D is composed of the following parts : 1) Needle Placement Unit (NPU), comprising: - the needle placement support (different sizes of needles can be fitted) - the compression paddle with window for biopsy - the film holder. This unit is fitted to the c-arm at the rotation axis level, in order to give the c-arm the possibility of rotating ±15 2) Processing Unit (PU), performing: - introduction of horizontal coordinates measured through a precision joystick on the two radiograms taken +/- 15 degrees - calculation and display of the final x, y, z space coordinates for automatic positioning of the needle placement support - indication of compression thickness and selection range for needle length 3) Mechanical security device for compression release in case of power line and/or device failure

7 COLLIMATOR Light beam With automatic switch ON when operating compression and electronic timer Light intensity 150 lux Light beam collimation accuracy according to IEC Mirror with automatic out of field function Collimation plates (standard) 18X24 cm removable Collimation plates (optional) 24x30 cm removable, Ø 14 cm removable Automatic collimator (optional) 18x24 cm/24x30 cm MAGNIFICATION Top Cover Magnification support (optional) Carbon fiber 0.1 mm Al equivalent x1.5 and x2 variable with gridless cassette holder, cassette detector and automatic focal spot selection COMPRESSION SYSTEM Smart μpress Compression Plate movement Motor driven through foot pedals or manual with fine regulation of the compression force through double rotary control on both sides of C-arm Compression Plates (standard) 18x24 cm shifted Compression Plates (optional) Ø 7.5 cm spot, 24x30 cm shifted, 10x24 cm shifted, 9x21 cm straight, Ø 7.5 cm shifted, 18x24 cm shifted for bidimensional biopsy Maximum free space available between 325 mm with shifted Compression Plates Compression Plate and image receptor In Magnification Mode (straight compression plate) MAG. X 1.5 = 231 mm MAG. X 2 = 131 mm Compression Thickness Display Displayed in mm Compression Force Adjustment Adjustable from 40 to 150 N or 200 N according to breast density detected by microprocessor controlled sensor Compression Force Display Effective applied force with 1 N resolution Maximum Compression Force Safety Triple safety device: electronic, electro-mechanical, mechanical Compression Holder Fast mechanical unlock Compression plate release after exposure Selectable from control panel, automatic or manual for 2D biopsy Compression plate aluminium equiv. Less than 0.2 mm Al (0.135 mm Al 30 kv) Special function for 0 compression force for oncology procedures

8 POTTER BUCKY Bucky factor (grid) 1.96 Ratio 5:1 Lines/cm 36 Contrast factor 1.47 Cassette size 18x24 cm (standard) 24x30 cm (optional) Cassette compatibility All the most common models with window as: Agfa, Dupont, Fuji,Kodak,3M Cassette detector switch With alarm in different languages to avoid double exposure or exposure without cassette Top Cover Carbon fiber Film marker Integrated with two labels wheels Test with NORMI Phantom Other features Aluminum equivalence DOSE CALCULATOR Calculated dose Data visualization Dose Label Printer (optional) CONTROL PANEL Technology Typical 3.5 balls Easily interchangeable with other accessories without tools Grid movement synchronized with X-RAY beam Same weight of different formats to maintain C-Arm balancing Table: 0.1 mmaleq (carbon fiber) Potter-Bucky: 0.3 mmaleq (carbon fiber and grid) Average Glandular Dose (AGD) mgy on display, label printer and data memory with average dose value on 1300 exposition to evaluate released dose Adhesive labels Microprocessor controlled with unique safety features exceeding IEC , all functions under active operator control GRAPHIC LCD Display 240x128 dots In several languages selectable Display Alarm messages Serial port for Film ID Flasher or Dose Label Printer Dedicated for Film Labelling device Easylabel (200 characters printed on film) or Adhesive Labels with Dose Calibration and service Serial port For service laptop with dedicated software Last 1300 exposure memory. Tube Thermal Unit display and active protection. Special features Technical display for self-test and defective block identification, firmware release, exposure counter and last exposure time/date. Statistics function Position Diagnostic functions Average dose, amount of exposures for every kv value, amount of exposure in every test technique Reversible covers to place control panel on preferred side Selectable service functions on LCD Display for hardware testing of each specific board with input status display, single status display and ON/OFF function

9 AUXILIARY DISPLAY Display Information FOOT PEDALS For compression 3 rows 7 segments display Compression force C-arm rotation angle Compression thickness One pair (standard) Two pair (optional) Multifunctional for compression and C-arm vertical movement control (optional) EMERGENCY STOP/SHUTDOWN SWITCHES Red push-buttons PROTECTIVE SHIELD Protective glass shield (optional) ENVIRONMENTAL CONDITIONS Storage and delivery conditions (while packed) On both sides to switch the unit totally off Stand Alone: > 0.34 mm Pb kv temperature -20 C / + 70 C relative humidity 10% / 90% barometric pressure 500 hpa/1060 hpa Operating conditions temperature +10 C / + 40 C relative humidity 30% / 75% barometric pressure 700 hpa/1060 hpa Protection degree according to standard IEC 529 IP 10 Heat dissipated in max load condition of 35 kv 500 mas (1 shot every 5 minutes) 264 kcal/h

10 ENVIRONMENT PROTECTION AND WASTE DISPOSAL Device contains in some of its parts and subassemblies, solid and liquid substances that must be disposed only by designated companies according to local laws. More specifically, device contains: Tube assembly H.V. transformer Other subassemblies Beryllium, lead, glass, dielectric oil (PCB free), other metals and plastic. Dielectric oil (PCB free), plastic, copper other metals Plastic, other metals, electronic components glassepoxy printed circuits. CLASSIFICATION (IEC 601-1) Protection against electric shock: Protection against harmful ingress of water: Degree of safety in the presence of flammable anesthetics mixture with. air or with oxygen or with nitrous oxide: Mode of operation: Class I, with type B applied parts IPX0 Not suitable for use in the presence of Flammable Anesthetics Mixture with air or with oxygen or with nitrous oxide. Continuous operation with intermittent loading.

11 OVERALL DIMENSIONS MAMMOGRAPHY UNIT Weight: 275 kg

12 OVERALL DIMENSIONS ANTI-X PROTECTION GLASS Weight: 77 kg Weight: 105 kg