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Medix 90 Specification

The document provides detailed specifications for the Medix 90 bone densitometry device, including its X-ray generator, tube, and scanning capabilities. It outlines the examination sites, parameters, and acquisition methods, as well as radiation dose information and software features. The device is certified as a Class IIb medical device for bone densitometry evaluation in the European Union.

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Dren Bedra
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0% found this document useful (0 votes)
32 views

Medix 90 Specification

The document provides detailed specifications for the Medix 90 bone densitometry device, including its X-ray generator, tube, and scanning capabilities. It outlines the examination sites, parameters, and acquisition methods, as well as radiation dose information and software features. The device is certified as a Class IIb medical device for bone densitometry evaluation in the European Union.

Uploaded by

Dren Bedra
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
Available Formats
Download as PDF, TXT or read online on Scribd
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Technical data

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 Pencil beam
Focal point dimensions 0.5 mm x 0.5 mm
X-ray spectrum peaks 43 keV & 70 keV (Filtering: Samarium 200 µm + Aluminium 2 mm)
Anode capacity 40 kJ (54kHU)
Tube housing thermal capacity 500 kJ (675kHU)

SOURCE COLLIMATOR
Material Lead
Height 5 mm
Diameter 1 mm & 2 mm
Collimator-patient distance 50 mm
Tube-patient distance 160 mm
Shutter 5 mm Lead

DETECTOR COLLIMATOR
Material Brass
Height 38 mm
Diameter 30 mm

DETECTOR
Quantity 1 (Scintillator & Photomultiplier)
Type of detection High performance photomultiplier tube
Material Cerium Bromide (CeBr3)
Localization Above the patient
SCANNER
Scanning method Rectilinear scan
Maximum scan area 200 cm x 65 cm
//compact version// //160 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”
Resolution 1 mm

ACQUISITION METHOD
Method Dual Energy X-ray Absorptiometry (DEXA)
Type Digital fast beam technology

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
//not available for compact version//
Image Type Isotropic image without magnification

EXAMINATION SITES & PARAMETERS


AP Spine L1 – L4 (Including Scoliotic Analysis)
Bone Mineral Density (BMD), Bone Mineral Content (BMC), T-score, Z-
score, Area
Forearm Ultradistal, Mid-Radius & Distal 1/3
BMD, BMC, T-score, Z-score, Area
Femur Total Hip, Femoral Neck, Trochanter, Intertrochanter, Ward’s zone
BMD, BMC, T-score, Z-score, Area
Dual Femur Combined examination of the left & right Femur
BMD, BMC, T-score, Z-score, Area
In-row scan Combined examination of the lumbar spine & left/right Femur
BMD, BMC, T-score, Z-score, Area
Lateral Spine BMD Bone density measurement of lumbar vertebrae from a lateral angle
without spinal backbone
BMD, BMC, T-score, Z-score, Area
Paediatrics AP Spine, Femur, Whole Body and Body Composition
BMD, BMC, Area, Skeletal age comparison, Z-Score
Orthopaedics Enables a smart implant management. Available for hand, forearm, elbow,
shoulder, spine, femur, AP knee, lateral knee, feet. Automatic detection of
ROI (ex: Gruen Zone) for femur, knee and lateral knee examinations.
Bone Mineral Density (BMD), Bone Mineral Content (BMC), Area
Whole Body * Total with or without head, android, gynoid, left arm, right arm, left ribs,
(Body Composition) right ribs, t spine, l spine, pelvis, left leg, right leg, head
*not available on compact version
Total Bone Mineral Density (BMDt), Local Bone Mineral Density
(BMDl), Total T-score & Z-score

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**)

Visceral Adipose Tissue Area, Visceral Adipose Tissue Mass, Visceral


Adipose Tissue Volume, Subcutaneous Adipose Tissue Area

**BMR Reference equation:


Revised Harris-Benedict, Mifflin St Jeor, Katch-McArdle.

COMPLEMENTARY SITES & PARAMETERS


Digital Vertebral Assessment Provides a low dose, lateral image of the spine (to view all the vertebrae of
(DVA) 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.
Cobb angle measurement with AP- Provides a low dose, AP image of the spine (to view all the vertebrae of the
DVA 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.

Software Screenshot in Annex “Attached document”


TOOLS
FRAX Fracture risk tool from The University of Sheffield, to evaluate the 10 years
probability of osteoporotic fractures (spine, forearm, hip or shoulder).
DVO recommendations (Certified by DachVerband Osteologie).
Reference Calculation of standardized BMD (comparison to NHANES III normative
data of the femur). 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 population (reference normality curve): Caucasian, Asian,
NHANES III, African, Turkish, Hispanic, Japanese and Korean.
Personalized multiple reference populations (normality curves editor)
Advanced Morphometric tools Automated Hip Structural Analysis (HSA): Hip Axis Length (HAL), Femoral
(distance, angle and area) Neck Axis Length (FNAL), Intertrochanter to Femoral Head Center Distance
(IH) and Femoral axis versus Neck axis Angle (FNA)
Personalized ROI & Image tools Manual analysis of BMD in any site, BMC, Area.
Contrast, Brightness and zoom for Image display. Density display in colour
scale.
Exclusion of non-bone region from calculation with advanced masking
(metal, calcification, etc...)
Multi-user Different profiles (operator, physician...etc) can be configured with security
access. Several workstations can be linked to an equipment
Export & Import Patient’s data follow-up: Data base importation from other devices +
previous data input.
Customizable automatic/semi-automatic database archiving
Print Multi-report for comparative purposes with personalization
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)
Trending Patient follow-up graphs, patient’s pictures & parameters evolution
Multi-language software Chinese simplified, Czech, German, English, Spanish, French, Italian,
Polish, Russian, Taiwanese Mandarin, Turkish, Norwegian, Hungarian,
Vietnamese (other languages can be translated)
Customizable user interface Colours, trend, results, print-out, etc.
Help menu
Telemaintenance and fault Network connection required)
detection software
3D-DXA 3D Femur modelization (Cortical/Trabecular) OPTION
RADIATION DOSE
(EFFECTIVE/DAP/INPUT DOSE DISPLAYED IN THE REPORT)
Staff dose at 1m Spine (90s): 0.0264 µSv
(Annual staff dose 0.678 mSv*) Proximal Femur (90s): 0.0301 µSv
* 6 patients/h, 1 spine & 1 femur, Whole Body (300s): 0.0009 µSv
2000h/year
Dose to patient NORMAL MODE PEDIATRIC MODE
Using ICRP60 weighting factors in
Femur < 0.28 µSv (0,028 mrem) -
Normal mode
Dual Femur < 0.6 µSv (0.06 mrem) -
Using ICRP103 weight factors in
AP Spine < 2 µSv (0.2 mrem) 1.1149 µSv
Paediatric mode
Forearm < 0.2 µSv (0.001 mrem) -
Whole Body < 0.02 µSv (0.002 mrem) 0.0323 µSv
Surface entrance dose NORMAL MODE PEDIATRIC MODE
Spine 40 µGy (2mA/90kV/2mm) 10 µGy
Femur < 10 µGy (2mA/90kV/2mm) -
Whole Body < 0.08 µGy 0.033 µGy
(0.1mA/90kV/12mm)

TIME & PIXEL SIZE

FEMUR Pixel Size Scan time DVA Pixel Size Scan time
Fast 3x1.5 mm² 60 s Fast 3x1.5 mm² 3 min
Normal 2x1 mm² 90 s Normal 2x1 mm² 5 min
Precision 1x1 mm² 3 min Precision 1x1 mm² 8 min

AP SPINE Pixel Size Scan time FOREARM Pixel Size Scan time
Fast 3x1.5 mm² 60 s Fast 3x1.5 mm² 60 s
Normal 2x1 mm² 90 s Normal 2x0.8 mm² 90 s
Precision 1x1 mm² 3 min Precision 1x0.8 mm² 3 min

LATERAL Pixel Size Scan time WHOLE Pixel Size Scan time*
SPINE BODY
Fast 3x1.5 mm² 60 s Fast 20x10 mm² 4 min
Normal 2x1 mm² 90 s Normal 12x6 mm² 7 min
Precision 1x1 mm² 3 min Precision 8x4 mm² 10 min
*depending on BMI
METHOD OF EXAMINATION
Preset exam modes Exam parameters adjusted automatically based on patient’s morphology
(Thin, Healthy and Overweight)
Customized options Customized options: Scan speed, scan area and resolution (up to 0.50 mm)
Automatic and manual selection of Image acquisition with Intelligent Scan
the Region Of Interest (ROI)
IntelliScan Smart reduction of the scan window and of the examination time

METHOD OF EXAMINATION
Quality control & reporting using external spine 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

PATIENT POSITIONING
Laser Light
PC controlled easy scan repositioning

ACCESSORIES
Cube, Mattress, DVA Cushion, Spine phantom, Calibration phantom (option)
PC data cable, Power cable, USB Adapter
Double foot support, Foot support strap

SPECIFICATIONS OF THE CLINICAL PARAMETERS


Age Grouping 20 – 90 years old (4-19 years old in paediatric mode)
Maximum Patient Weight <200kg (<440lbs)

MINIMAL HARDWARE CONFIGURATION


Operating system Windows 7, 64 bits, or more recent (Windows 10, 64 bits, recommended)
Processor Intel Core i5 or better
RAM 8 GB
Hard disc 300 GB (about 60.000 standard exams)
Archiving External Hard-Drive or Network Share
Monitor 15” or 17” SVGA or larger (1024x768 minimum)
Printer Color: Any printer compatible with windows 7 or higher
Connectivity 2 LAN port for communication & DICOM
LAN for DICOM can be supplied by USB to LAN converter + 1 LAN for 3D-
DXA (Option Box 3D)

CONNECTIVITY
(MEDIX 90 CONFORMANCE STATEMENT AVAILABLE UPON REQUEST)
DICOM Compatibility (HIS, RIS, PACS)
Push (C-store) & Print: Storing, printing and transferring patient’s data color printing (option)
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
HL7 equivalent: DICOM structured report

ENVIRONMENTAL DATA
Operating temperature 10 - 30°C (50-86°F)
Operating humidity 30% - 75% (without condensation)
Operating pressure 700 - 1060 hPa
Storage temperature 0 - 40°C (32-104°F)
Storage humidity 10% - 80% (without condensation)
Storage pressure 700 – 1060 hPa
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
Recommended UPS (Medix 90 Min 700 W, 1000 VA
without PC & Printer)
DIMENSIONS & WEIGHT (LENGHT, WIDTH, HEIGHT)
Dimensions L 240 x W 125 x H 146 cm (L 94” x W 49” x H 57”)
//compact version// //L 200 x W 125 x H 146 cm (L 79” x W 49” x H 57”)//
Examination table L 240 x W 110 cm (L 94” x W 43”)
//compact version// //L 200 x W 110 cm (L 79” x W 43”)//
Mattress L 208 x W 72.5 cm (L 82” x W 28”)
//Compact Version// //L 200 x W 72.5 cm (L 79” 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)

CHARACTERISTICS
Medix 90 Compact version

ROOM LAYOUT
DUAL FEMUR

DVA SPINE
AP DVA SPINE

IN-ROW SCAN
TRIPLE-EXAM REPORT

BODY COMPOSITION REPORT


HSA

EASY SCAN REPOSITIONING


3D-DXA

Medix 90 is a Class IIb medical device manufactured by Medilink. The conformity assessment has been carried out by SGS, n°0120 and bears the CE
marking. It is intended for bone densitometry evaluation. Read the operating instructions carefully. This product is certified as medical devices in the
European Union according to Directive 93/42/EEC on medical devices by SGS CE0120, exclusively for the indication of bone densitometry evaluation.
Other non-medical uses attributed to this device does not fall within the scope of CE certification, and users should be aware that the performance
and/or safety of the product has not been evaluated by SGS for these purposes. 3D-DXA: Class I medical device, manufactured by DMS. Photos are
non-contractual. TDA_5W(7H)_M_02 / 06.2019

BONE DENSITOMETRY - INNOVATION MADE IN FRANCE

HEADQUARTERS › 393 rue Charles Lindbergh - 34130 Mauguio — FRANCE


FACTORY › Parc Scientifique G. Besse — 175 Allée Von Neumann - 30035 Nîmes — FRANCE
Tel › +33 4 66 29 09 07 – Fax › +33 4 67 50 49 09 – www.dms-imaging.com

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