Technical data

TECHNICAL DATA
 TECHNICAL DATA – 2D-FAN BEAM WHOLE DENSITOMETER

ACQUISITION CHAIN PARAMETERS

Dual Energy X-ray Absorptiometry (DEXA)
2D Fan Beam with X and Y kinematics

GENERATOR

X-ray Continuous Generator High Frequency Monoblock

Manufacturer IMD Generators
Cooling system Immersion in oil + cooling fans
Maximum/Nominal High Voltage 110kV/90kV
Maximum/Nominal Tube Current 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 Lead
Size 18 mm x 2.5 mm
Collimator-patient distance 77 mm
Tube-Patient distance 270 mm
Shutter 4 mm Lead

DETECTOR COLLIMATOR

Material Brass
Height 30 mm
Size 72 mm x 8 mm

DETECTOR

Quantity Multi Element – 2D array, 256 Pixels (4 x 64)

Type of Detection Direct Detection
Material Solid State CdTe (Cadmium Telluride 1 mm)
Specification Photon Counting (Energy Sensitive)
Detector Pixel Pich (Resolution) 1.1 mm x 1.6 mm
Localization Above the patient

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SCANNER

Scanning Method Rectilinear scan

Maximum scan area 200 cm x 65 cm
Scanning Type Motorized arm with X & Y kinematics (Longitudinal & Transverse Scan)
Table Type 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 Adjustable to patient’s morphology

Multisite (L x W) Customizable scan area
Whole Body (L x W) 200 cm x 65 cm maximum

Isotropic image without magnification

CANNER

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SOFTWARE - DIAGNOSTIC
EXAMINATION SITES

AP Spine L1 – L4 (Including Scoliotic Analysis)

Forearm 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

Bone density measurement of lumbar vertebrae from a lateral angle without spinal
Lateral Spine BMD
backbone
Paediatrics BMD and Z-Score measurement (AP Spine, Femur, Whole Body and Body
Composition)

To measure the BMD around the prosthesis.

Orthopaedics 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
Digital Vertebral spine). The deformation or compression is precisely diagnosed, measured and
Assessment (DVA) classified. This analysis can be either automatic using the Genant’s semi- (DVA)
quantitative classification, or manual using the Genant’s visual classification. Single Energy Dual Energy

Operator can use dual (bone image) or single (attenuation) energy images.

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
Cobb Angle
curvature can be measured and reported by drawing lines parallel to the upper
Measurement with AP-
border of the upper vertebral body and the lower border of the lowest vertebra of
DVA
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 Fat & Lean Tissue Analysis (total with or without head, android, gynoid, left arm,
Composition right arm, left ribs, right ribs, t spine, l spine, pelvis, left leg, right leg, head)

Dual Femur AP Spine 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, Skeletal Lean Mass
Index (Sarcopenia), Resting Metabolic Rate (RMR), Basal Metabolic Rate (BMR)

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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
Email 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

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SOFTWARE – ANALYSIS
PARAMETERS AVAIBLE ON FINAL MEDICAL REPORT

Bone Mineral Density (BMD) expressed in g/cm2, stands for the mineral density of the bones
Area expressed in cm2, 2D projection of the bone
T-Score: Difference between the patient’s BMD value and the mean BMD value of a young adult
Multisite 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
Whole Body
Body Mass Index (BMI), Fat Mass Index (FMI), Android/Gynoid Ratio, Lean Mass Balance, Skeletal Lean Mass
Index (Sarcopenia), Resting Metabolic Rate (RMR), Basal Metabolic Rate (BMR)
Bone Mineral Density (BMD), Bone Mineral Content (BMC), Area,
Orthopaedic
Automatic ROI selection (ex: Gruen zone): femur, knee and lateral knee
Paediatric 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
Reference curve diagnosis values.
Body Composition according to NHANES (2009)
Reference Equation Revised Harris-Benedict, Mifflin St Jeor, Katch-McArdle,
BMD Measurement in any site
Manual Analysis Bone Mineral Content (BMC)
Area
Morphometry Quantitative morphometry in any site (areas, lengths, angles). Ex: Automatic Hip Structural Analysis (HSA)
Trending 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)

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EXAMINATION PARAMETERS
Automatic & Manual selection of the Region Of Interest (ROI)
Low Dose adapted to patient Morphology

RADIATION DOSE

Staff Dose at 1m
Spine(30s): 0.0107 µSv Proximal Femur(25s): 0.0102 µSv Whole Body(300s): 0.0053 µSv
(Annual Staff Dose 0.276 mSv)
Low dose adapted to patient morphology
Femur <0.5µSv (0,05 mrem)
Dose to patient* (in standard mode) Dual Femur < 1 µSv (0.1 mrem)
AP Spine < 2 µSv (0.2 mrem)
Forearm <0.01 µSv (0.001 mrem)
Whole Body <0.1µSv (0.01 mrem)
Proximal Femur <13.2 µGy (1mA/90kV)
Surface entrance dose (in standard mode) Spine <24.5 µGy (2mA/90kV)
Whole Body <0.3 µGy (0.1mA/90kV)
* Using ICRP60 weighting factors

EXAMINATION TIME & PIXEL SIZE

Femur Pixel Size Scan time DVA Pixel Size Scan time
Fast 1 mm 15 s Fast 1 mm 45 s
Normal 1 mm 25 s Normal 1 mm 95 s
Precision 0.75 mm 45 s Precision 0.75 mm 170 s

AP Spine Pixel Size Scan time Forearm Pixel Size Scan time
Fast 1 mm 15 s Fast 0.75 mm 10 s
Normal 1 mm 30 s Normal 0.75 mm 18 s
Precision 0.75 mm 60 s Precision 0.75 mm 30 s

Lateral Spine Pixel Size Scan time Whole Body Pixel Size Scan time*
Fast 1 mm 15 s Fast 3 mm 3-5 min
Normal 1 mm 30 s Normal 2 mm 4-5 min
Precision 0.75 mm 60 s Precision 1 mm 3-6 min
*Depending on patient’s height

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 20 – 90 years old (4-19 years old in paediatric mode)

Maximum Patient Weight <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.

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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 Newer

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
2LAN port for communication & DICOM (LAN for DICOM can be supplied by USB to LAN converter
Connectivity
+1 LAN for Box3DXA (Option)
* Computer specifications may be up-graded depending on the market and sales conditions.

ENVIRONMENTAL DATA
& ELECTRICAL SPECIFICATIONS
ENVIRONMENTAL DATA

Operating Temperature 20 -28°C (68-82.4°F)

Operating Humidity 20% - 80% (without condensation)
Pressure 0.8 – 1.2 Bar
Storage Temperature 10 -40°C (50-104°F)
Storage Humidity 20% - 80% (without condensation)
Radioprotection No external shielding required

ELECTRICAL SPECIFICATIONS
110 VAC (±10%) 10A
Voltage / Current
220 - 240 VAC (±10%) 5A
Frequency 50 - 60 Hz
Power Consumption 560W
Required UPS
800W/1000VA
(Stratos without PC & Printer)

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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

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