TDA MEDIX DR 01 - forexmedical.hu › attachments › article › 112 › 03_TDA_MEDIX_DR_01.pdfTDA_MEDIX_DR_01 SOFTWARE - DIAGNOSTIC Dual Femur AP Spine In Row Scan DIAGNOSTIC TOOLS

Technical data

TECHNICAL DATA

TECHNICAL DATA – 2D-FAN BEAM WHOLE DENSITOMETER

MEDILINK PAGE 2 OF 9 TDA_MEDIX_DR_01

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

DETECTOR COLLIMATOR

Material Brass

Height 30 mm

Size 72 mm x 8 mm

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

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

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)



CANNER

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

COMPATIBLE WITH 3D-DXA BOX

Site Hip

3D Modelisation Cortical Thickness, Volumetric BMD



SOFTWARE - DIAGNOSTIC

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, Appendicular Lean Mass (Sarcopenia), Resting Metabolic Rate (RMR), Basal Metabolic Rate (BMR)

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

Lateral Spine BMD Bone density measurement of lumbar vertebrae from a lateral angle without spinal backbone

Paediatrics

BMD and Z-Score measurement (AP Spine, Femur, Whole Body and Body Composition)

Orthopaedics

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.

Digital Vertebral Assessment (DVA)

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 semi-quantitative classification, or manual using the Genant’s visual classification. Operator can use dual (bone image) or single (attenuation) energy images.

(DVA) Single Energy Dual Energy

Cobb Angle Measurement with AP-DVA

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)



SOFTWARE – TOOLS

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

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)



SOFTWARE – ANALYSIS

(Multi-Report) (Body Composition Report)

PARAMETERS AVAILABLE ON FINAL MEDICAL REPORT

Multisite

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 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.

Whole Body

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)

Orthopaedic Bone Mineral Density (BMD), Bone Mineral Content (BMC), Area, Automatic ROI selection (ex: Gruen zone): femur, knee and lateral knee

Paediatric Bone Mineral Density (BMD), Bone Mineral Content (BMC), Area, Skeletal age comparison

Reference curve 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)

Reference Equation Revised Harris-Benedict, Mifflin St Jeor, Katch-McArdle,

Manual Analysis BMD Measurement in any site 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)



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

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 0.276 mSv*) *6 patients/h, 1 spine & 1 femur, 2000h/year

Spine(30s): 0.0107 µSv Proximal Femur(30s): 0.0123 µSv Whole Body(300s): 0.0049 µSv

Dose to patient* (in standard mode) * Using ICRP60 weighting factors

Low dose adapted to patient morphology

Femur Dual Femur AP Spine Forearm Whole Body



ACCESSORIES

RECOMMENDED COMPUTER CONFIGURATION

* Computer specifications may be up-graded depending on the market and sales conditions.

ENVIRONMENTAL DATA

& ELECTRICAL SPECIFICATIONS

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

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)

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

Voltage / Current 110 VAC (±10%) 10A 220 - 240 VAC (±10%) 5A

Frequency 50 - 60 Hz

Power Consumption 560W

Required UPS (Stratos without PC & Printer) 800W/1000VA



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

Documents

TDA MEDIX DR 01 - forexmedical.hu › attachments › article › 112 › 03_TDA_MEDIX_DR_01.pdfTDA_MEDIX_DR_01 SOFTWARE - DIAGNOSTIC Dual Femur AP Spine In Row Scan DIAGNOSTIC TOOLS