Technical data TECHNICAL DATA

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1 Technical data TECHNICAL DATA

2 ACQUISITION CHAIN PARAMETERS Dual Energy X ray Absorptiometry (DEXA) 2D Fan Beam with X and Y kinematics GENERATOR X-ray Continuous Generator Manufacturer Cooling system Maximum/Nominal High Voltage Maximum/Nominal Tube Current High Frequency Monoblock IMD Generators Immersion in oil + cooling fans 110kV/90kV 2.4mA/2mA X-RAY TUBE Type Tungsten Fixed Anode Localization Under the patient Anode angle 12 Anode-Cathode direction Horizontal X-ray Beam Fan Beam Focal Point Dimensions 0.6 mm x 0.6 mm X-ray Spectrum peaks 43 kev & 70 kev (Filtering: Samarium 200µm + Aluminium 2mm) Anode Capacity 40 kj (54kHU) Housing Tube Thermal Capacity 500 kj (675kHU) SOURCE COLLIMATOR Material Size Collimator-patient distance Tube-Patient distance Shutter Lead 18 mm x 2.5 mm 77 mm 270 mm 4 mm Lead DETECTOR COLLIMATOR Material Height Size Brass 30 mm 72 mm x 8 mm DETECTOR Quantity Multi Element 2D array, 256 Pixels (4 x 64) Type of Detection Material Specification Detector Pixel Pich (Resolution) Localization Direct Detection Solid State CdTe (Cadmium Telluride 1 mm) Photon Counting (Energy Sensitive) 1.1 mm x 1.6 mm Above the patient MEDILINK PAGE 2 OF 9

3 SCANNER Scanning Method Maximum scan area Scanning Type Table Type Rectilinear scan 200 cm x 65 cm Motorized arm with X & Y kinematics (Longitudinal & Transverse Scan) Fixed for all exams including the Whole Body Mode ACQUISITION METHOD Method Dual Energy X-ray Absorptiometry (DEXA) Type 2D Fan Beam Technology Fan Angle 5 ACQUISITION WINDOWS Scan Window Size Multisite (L x W) Whole Body (L x W) Adjustable to patient s morphology Customizable scan area 200 cm x 65 cm maximum Isotropic image without magnification CANNER COMPATIBLE WITH 3D-DXA BOX Site 3D Modelisation Hip Cortical Thickness, Volumetric BMD MEDILINK PAGE 3 OF 9

4 TECHNICAL DATA 2D-FAN BEAM WHOLE DENSITOMETER SOFTWARE - DIAGNOSTIC EXAMINATION SITES AP Spine Forearm L1 L4 (Including Scoliotic Analysis) Ultradistal, Mid-Radius & Distal 1/3 Femur Total Hip, Femoral Neck, Trochanter, Intertrochanter, Ward s zone Dual Femur Combined examination of the left & right Femur In-Row Scan Combined examination of the lumbar spine & left/right Femur Whole Body BMD Total T-score & Z-score Lateral Spine BMD Paediatrics Orthopaedics Digital Vertebral Assessment (DVA) Bone density measurement of lumbar vertebrae from a lateral angle without spinal backbone BMD and Z-Score measurement (AP Spine, Femur, Whole Body and Body Composition) To measure the BMD around the prosthesis. Enables a smart implant management. Available for hand, forearm, elbow, shoulder, spine, femur, AP knee, lateral knee, feet. Automatic detection of ROI for femur, knee and lateral knee examinations. Provides a low dose, lateral image of the spine (to view all the vertebrae of the spine). The deformation or compression is precisely diagnosed, measured and classified. This analysis can be either automatic using the Genant s semiquantitative classification, or manual using the Genant s visual classification. Operator can use dual (bone image) or single (attenuation) energy images. Cobb Angle Measurement with APDVA Provides a low dose, AP image of the spine (to view all the vertebrae of the spine). The Cobb Angle invented by Dr.John Cobb (1948) is used as a standard measurement to determine and track the progression of scoliosis. The angle of curvature can be measured and reported by drawing lines parallel to the upper border of the upper vertebral body and the lower border of the lowest vertebra of the structural curve, then erecting perpendiculars from these lines to cross each other, the angle between these perpendiculars is angle of curvature. Operator can use dual (bone image) or single (attenuation) energy images Whole Body Composition Fat & Lean Tissue Analysis (total with or without head, android, gynoid, left arm, right arm, left ribs, right ribs, t spine, l spine, pelvis, left leg, right leg, head) Dual Femur AP Spine (DVA) Single Energy Dual Energy In Row Scan DIAGNOSTIC TOOLS Calculation of Bone Mineral Density (BMD), Bone Mineral Content (BMC), Surface (area), T-score & Z-score, Advanced Morphometric tools (surface, distance & angle): Measurements can be done on every type of examination (spine, femur, forearm etc) Automated Hip Structural Analysis (HAS): Hip Axis Length (HAL), Femoral Neck Axis Length (FNAL), Intertrochanter to Femoral Head Center Distance (IH) and Femoral axis versus Neck axis Angle (FNA) Fracture risk information using Hip Structural Analysis (HSA) FRAX tool from WHO to evaluate the 10 years probability of osteoporotic fractures Body Composition: Calculation of Body Mass Index (BMI), Fat Mass Index (FMI), Android/Gynoid Ratio, Lean Mass Balance, Appendicular Lean Mass (Sarcopenia), Resting Metabolic Rate (RMR), Basal Metabolic Rate (BMR) MEDILINK PAGE 4 OF 9

5 SOFTWARE TOOLS SOFTWARE TOOLS Patient follow-up graphs Advanced Morphometric tools (distance, angle and area) ex: Hip Axis Lenght (HAL) Calculation of standardized BMD (comparison to NHANES III normative data of the femur) Customizable user interface (colours, trend, results, print-out, etc.) PC controlled easy scan repositioning Multi-user (different profiles can be configured: operator, physician, etc.) Reference population (reference normality curve): Caucasian, Asian, NHANES III, African, Turkish, Hispanic, Japanese and Korean Personalized multiple reference populations (normality curves editor) Patient s data follow-up: Data base importation from other devices + previous data input Customizable automatic/semi-automatic database archiving Multi-report for comparative purposes Customizable reports (header, footer, predefined forms, letters, etc.) Detailed colour print out of reports (bone + reference curve + analysis report + operator comments + patient and physician letters + follow-up), configurable by the physician or fax reports sending Automatic and customizable letter (patient and physician) Image display tools: Contrast, brightness and zoom Density display in colour scale Exclusion of non-bone region from calculation with advanced masking (metal, calsification, etc.) Multi-language software: Chinese simplified, Czech, German, English, Spanish, French, Italian, Polish, Russian, Taiwan &Turkish (other languages can be translated) Help menu DVO recommendations (Certified by DachVerband Osteologie) Telemaintenance software: Maintenance and fault detection software (network connection required) STORAGE CD, DVD, External Hard-Drive or Network Share Nero Software (Min V5.5.10) required for CD & DVD CONNECTIVITY DICOM Compatibility (HIS, RIS, PACS) Push & Print: Storing, printing and transferring patient s data Optional Color printing (License to buy) Worklist: To manage the patient list (Query/Retrieve SCU) Format used to export image data:.jpeg or.pdf Workstation mode (option): Possibility to connect from multiple distant workstations and access to device data Multi-user mode (option): Login, logout and rights management MEDILINK PAGE 5 OF 9

6 SOFTWARE ANALYSIS PARAMETERS AVAILABLE ON FINAL MEDICAL REPORT Multisite Whole Body Orthopaedic Paediatric Reference curve Reference Equation Manual Analysis Morphometry Trending Bone Mineral Density (BMD) expressed in g/cm 2, stands for the mineral density of the bones Area expressed in cm 2, 2D projection of the bone T-Score: Difference between the patient s BMD value and the mean BMD value of a young adult population of healthy subjects of the same gender and from the same ethnic background as the patient, divided by the standard deviation of the young population of healthy subjects. Z-score: Difference between the patient s BMD value and the mean BMD value of a same age population of healthy subjects of the same gender and from the same ethnic background as the patient, divided by the standard deviation of the same age healthy population. Total Bone Mineral Density (BMDt), Local Bone Mineral Density (BMDl), Area Fat Mass, Lean Mass, Bone Mineral Mass, Segmentation Body Mass Index (BMI), Fat Mass Index (FMI), Android/Gynoid Ratio, Lean Mass Balance, Appendicular Lean Mass (Sarcopenia), Resting Metabolic Rate (RMR), Basal Metabolic Rate (BMR) Bone Mineral Density (BMD), Bone Mineral Content (BMC), Area, Automatic ROI selection (ex: Gruen zone): femur, knee and lateral knee Bone Mineral Density (BMD), Bone Mineral Content (BMC), Area, Skeletal age comparison Displays BMD according to the age for the examined regions and supplies T-score and Z-score values as diagnosis values. Body Composition according to NHANES (2009) Revised Harris-Benedict, Mifflin St Jeor, Katch-McArdle, BMD Measurement in any site Bone Mineral Content (BMC) Area Quantitative morphometry in any site (areas, lengths, angles). Ex: Automatic Hip Structural Analysis (HSA) Graphs, Patient s Pictures & Parameters Evolution SPECIFICATION OF THE CLINICAL DATA (PRECISION) Bone Mineral Density (BMD) ± 1.0% in vivo (± 0.5% in vitro) (Multi-Report) (Body Composition Report) MEDILINK PAGE 6 OF 9

7 EXAMINATION PARAMETERS Automatic & Manual selection of the Region Of Interest (ROI) Low Dose adapted to patient Morphology RADIATION DOSE Staff Dose at 1m (Annual Staff Dose msv*) *6 patients/h, 1 spine & 1 femur, 2000h/year Spine(30s): µsv Proximal Femur(30s): µsv Whole Body(300s): µsv Low dose adapted to patient morphology Dose to patient* (in standard mode) * Using ICRP60 weighting factors Surface entrance dose (in standard mode) Femur Dual Femur AP Spine Forearm Whole Body Proximal Femur Spine Whole Body <0.5µSv (0,05 mrem) < 1 µsv (0.1 mrem) < 2 µsv (0.2 mrem) <0.01 µsv (0.001 mrem) <0.1µSv (0.01 mrem) <14 µgy (1mA/90kV) <25 µgy (2mA/90kV) <0.3 µgy (0.1mA/90kV) EXAMINATION TIME & PIXEL SIZE Femur Pixel Size Scan time Fast 1 mm 15 s Normal 1 mm 25 s Precision 0.75 mm 45 s AP Spine Pixel Size Scan time Fast 1 mm 15 s Normal 1 mm 30 s Precision 0.75 mm 60 s Lateral Spine Pixel Size Scan time Fast 1 mm 15 s Normal 1 mm 30 s Precision 0.75 mm 60 s *Depending on patient s height DVA Pixel Size Scan time Fast 1 mm 45 s Normal 1 mm 95 s Precision 0.75 mm 170 s Forearm Pixel Size Scan time Fast 0.75 mm 10 s Normal 0.75 mm 18 s Precision 0.75 mm 30 s Whole Body Pixel Size Scan time* Fast 3 mm 3 5 min Normal 2 mm 4 5 min Precision 1 mm 3 6 min PATIENT POSITIONING Laser Light PC controlled easy scan repositioning METHOD OF EXAMINATION Pre-regulated exam modes: Exam parameters adjusted automatically based on patient s morphology (Thin, Healthy and Overweight) Personalized options: Scan speed, scan area and resolution (up to 0.50 mm) Automatic and manual selection of the Region Of Interest (ROI) = Image acquisition with Intelligent Scan IntelliScan: Smart reduction of the scan window and of the examination time SPECIFICATIONS OF THE CLINICAL PARAMETERS Age Grouping Maximum Patient Weight years old (4-19 years old in paediatric mode) <200kg (<440lbs) CALIBRATION & QUALITY CONTROL Quality control & reporting using external phantom Quality control trend plotting & reporting integrated to the software Control by internal reference between each scan Integrated Auto-Calibration: Reduce electronic drift & improve accuracy Double Beam Collimator: Improve image quality and patient dose for each exam site. MEDILINK PAGE 7 OF 9

8 ACCESSORIES SUPPLY ACCESSORIES Quality Control Spine Phantom ( L 150 x W 140 x H 175 cm) Made up of PMMA granules and an aluminium plate (Alu 2017A) with three different thickness (having 3 different densities) In compliance with the ANSM (French medicine and healthcare products regulatory national agency) rules Fit for the performance evaluation of DXA bone densitometers Spine Position Cushion Femur & Dual Femur foot support Digital Vertebral Assessment (DVA) positioning cushions RECOMMENDED COMPUTER CONFIGURATION MINIMAL COMPUTER CONFIGURATION* Operating System Windows 7 or more recent Processor Intel Pentium IV, Core Duo 1GHz or higher RAM 2GB Hard Disc 300 GB CD/DVD Rom Drive For updating software & archiving Archiving CD, DVD burner or external hard drive Monitor 15 or 17 SVGA or larger (1024x768 minimum) Printer Color: Any printer compatible with windows 7 or higher Connectivity 2LAN port for communication & DICOM (LAN for DICOM can be supplied by USB to LAN converter +1 LAN for 3D-DXA (Option) * Computer specifications may be up-graded depending on the market and sales conditions. ENVIRONMENTAL DATA & ELECTRICAL SPECIFICATIONS ENVIRONMENTAL DATA Operating Temperature Operating Humidity Pressure Storage Temperature Storage Humidity Radioprotection C ( F) 20% - 80% (without condensation) Bar C ( F) 20% - 80% (without condensation) No external shielding required ELECTRICAL SPECIFICATIONS Voltage / Current Frequency Power Consumption Required UPS (Stratos without PC & Printer) 110 VAC (±10%) 10A VAC (±10%) 5A Hz 560W 800W/1000VA MEDILINK PAGE 8 OF 9

9 PHYSICAL DESCRIPTION DIMENSION & WEIGHT (L:LENGTH, W:WIDTH, H:HEIGHT) Dimensions L 240 x W 125 x H 130 cm (L 94 x W 49 x H 51 ) Examination table L 240 x W 110 cm (L 94 x W 43 ) Mattress L 208 x W 72.5 cm (L 82 x W 28 ) Patient table lowest height 60 cm (24 ) Weight 280 kg (617 lbs) Packing dimensions L 257 x W 132 x H 114 cm (L 101 x W 52 x H 45 ) Packing Gross Weight 550 kg (1212 lbs) PHYSICAL CHARACTERISTICS ROOM LAYOUT MEDILINK PAGE 9 OF 9