TDA MEDIX DR 01 - forexmedical.hu › attachments › article › 112 ›...
Transcript of TDA MEDIX DR 01 - forexmedical.hu › attachments › article › 112 ›...
-
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)
-
TECHNICAL DATA – 2D-FAN BEAM WHOLE DENSITOMETER
MEDILINK PAGE 3 OF 9 TDA_MEDIX_DR_01
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
-
TECHNICAL DATA – 2D-FAN BEAM WHOLE DENSITOMETER
MEDILINK PAGE 4 OF 9 TDA_MEDIX_DR_01
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)
-
TECHNICAL DATA – 2D-FAN BEAM WHOLE DENSITOMETER
MEDILINK PAGE 5 OF 9 TDA_MEDIX_DR_01
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)
-
TECHNICAL DATA – 2D-FAN BEAM WHOLE DENSITOMETER
MEDILINK PAGE 6 OF 9 TDA_MEDIX_DR_01
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)
-
TECHNICAL DATA – 2D-FAN BEAM WHOLE DENSITOMETER
MEDILINK PAGE 7 OF 9 TDA_MEDIX_DR_01
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
-
TECHNICAL DATA – 2D-FAN BEAM WHOLE DENSITOMETER
MEDILINK PAGE 8 OF 9 TDA_MEDIX_DR_01
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
-
TECHNICAL DATA – 2D-FAN BEAM WHOLE DENSITOMETER
MEDILINK PAGE 9 OF 9 TDA_MEDIX_DR_01
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