MEDIX90

( + C O M PA C T V E R S I O N )

TECHNICAL DATA
 Technical Data
5w (7z) - digital fast beam densitometer

Acquisition chain parameters

Dual Energy X-ray Absorptiometry - Pencil Beam with X and Y kinematics

Generator
X-ray Continuous
High Frequency Monoblock
Generator
Manufacturer IMD Generators
Cooling system Immersion in oil + cooling fans
Maximum/Nominal High
110kV/90kV
Voltage
Maximum/Nominal Tube
2.4mA/2mA
Current

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
500 kJ (675kHU)
Capacity

Source Collimator
Material Lead
height 5mm
Diameter 1 mm & 2 mm
Collimator-patient
50 mm
distance
Tube-Patient distance 160 mm
Shutter 5 mm Lead

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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//
Motorized arm with X & Y kinematics (Longitudinal & Transverse
Scanning Type
Scan)
Table Type Fixed for all exams including the “Whole Body Mode”
Resolution 1 mm

Acquisition Method
Method Dual Energy X-ray Absorptiometry (DXA)
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

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5w (7z) - digital fast beam densitometer

Software - Diagnostic
Intuitive solution for workflow improvement and optimized patient care

Examination Sites & Parameters

L1 – L4 (Including Scoliotic Analysis)
AP Spine Bone Mineral Density (BMD), Bone Mineral Content (BMC),
T-score, Z-score, Area
Ultradistal, Mid-Radius & Distal 1/3
Forearm
BMD, BMC, T-score, Z-score, Area
Total Hip, Femoral Neck, Trochanter, Intertrochanter, Ward’s zone
Femur
BMD, BMC, T-score, Z-score, Area
Combined examination of the left & right Femur
Dual Femur
BMD, BMC, T-score, Z-score, Area
Combined examination of the lumbar spine & left/right Femur
In-Row Scan
BMD, BMC, T-score, Z-score, Area
Bone density measurement of lumbar vertebrae from a lateral
Lateral Spine BMD angle without spinal backbone
BMD, BMC, T-score, Z-score, Area
AP Spine, Femur, Whole Body and Body Composition
Paediatrics
BMD, BMC, Area, Skeletal age comparison, Z-Score
Enables a smart implant management. Available for hand,
forearm, elbow, shoulder, spine, femur, AP knee, lateral knee, feet.
Automatic detection of ROI (ex: Green Zone) for femur, knee and
Orthopaedics
lateral knee examinations.
Bone Mineral Density (BMD), Bone Mineral Content (BMC),
Area
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

Total Bone Mineral Density (BMDt), Local Bone Mineral

Density (BMDl), Total T-score & Z-score

Fat Mass, Lean Mass, Bone Mineral Mass, Segmentation

Whole Body *
(Body Composition)
*not available on compact version
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.

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Complementary Sites & Parameters

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
Digital Vertebral
can be either automatic using the Genant’s semi-quantitative
Assessment (DVA)
classification, or manual using the Genant’s visual classification.
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 curvature
Cobb Angle Measurement can be measured and reported by drawing lines parallel to the
with AP-DVA 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”

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Tools
FRAX :
Fracture risk tool from The University of Sheffield, to evaluate the 10 years probability of
osteoporotic fractures. Fracture risk information using Hip Structural Analysis (HSA).
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 (distance, angle and area) :
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)
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
Exportation & Importation :
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)
Patient follow-up graphs, patient’s pictures & parameters evolution
Multi-language software: Chinese simplified, Czech, German, English, Spanish, French, Italian,
Polish, Russian, Taiwan & Turkish (other languages can be translated)
Customizable user interface (colours, trend, results, print-out, etc.)
Help menu
Telemaintenance and fault detection software (network connection required)

3D-DXA : 3D Femur modelization (Cortical/Trabecular) OPTION

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

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, 2000h/year Whole Body (300s) : 0.0009 µSv
Normal mode Paediatric mode
Dose to patient Femur < 0.28 µSv (0,028 mrem) -
Using ICRP60 weighting factors in Dual Femur < 0.6 µSv (0.06 mrem) -
AP Spine
Normal mode
Using ICRP103 weight factors in < 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
Normal mode Paediatric mode

Spine < 40 µGy (2mA/90kV/2mm)

10 µGy
Surface entrance dose
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
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Method of Examination
Preset exam modes: Exam parameters adjusted automatically based on patient’s
morphology (Thin, Healthy and Overweight)
Customized 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

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

Patient Positioning
Laser Light
PC controlled easy scan repositioning

Accessories
Cube, Mattress, DVA Cushion, Spine phantom, Calibration phantom
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)

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Computer configuration
Minimal Hardware Configuration
Windows 7, 64 bits, or more recent
Operating System
(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
2 LAN port for communication & DICOM
Connectivity LAN for DICOM can be supplied by USB to LAN converter +
1 LAN for 3D-DXA (Option Box 3D)

Connectivity
(Medix90 Conformance Statement available on request)

DICOM Compatibility (HIS, RIS, PACS)

Push (C-store) & Print: Storing, printing and transferring patient’s data
Color printing (Optional)
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

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Environmental Data
& Electrical Specifications

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

110 VAC (±10%) 10A

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

Frequency 50 - 60 Hz
Power Consumption 560W
Recommended UPS
(Medix90 without PC &
Min 700 W, 1000 VA
Printer)

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Physical Description

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
60 cm (24”)
height
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

Room Layout

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Attached Documents

Dual Femur

DVA Spine

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AP DVA Spine

In ROW Scan

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Triple-Exam
SCM DES SALYENSReport 1/3

333 Bd Ledru Rollin

13300 SALON DE PROVENCE
Phone number : 90 53 02 02 E-mail : Fax : 04 90450964

Patient : DUAL Scans Height : 165 cm Weight : 55 kg Operator :

Patient's ID : Ethnic : Caucasian Sex : Female Prescriber :
Birth Date : 01-13-1960 Current Age : 58 Years Menopause age : Physician :
*Effective/DAP/Input dose: 2.9 µSv/0.169 mGy.cm²/54.2 µGy BMI: 20.20 kg/m² Health [18.5 - 24.9]

1 - Right Femur Left Femur

Reference curve Dual Femur
BMD (g/cm²) Right Femur T-Score
Left Femur
1.50
1.30 2.0
1.0
1.10 0.0
0.90 -1.0
0.70 -2.0
-3.0
0.50 -4.0
0.30 -5.0
0.10 -6.0
20 30 40 50 60 70 80 90
Year
Caucasian F Right Femur
10-19-2011 16:38 165 cm 55 kg 10-19-2011 16:38 165 cm 55 kg
2 - Spine Reference curve Spine
Total : 0.962 (g/cm²)
BMD (g/cm²) T-Score
Young Ref.(%) 91.8
1.20 1.0 T-score -0.8
1.00 -1.0 Age Match (%) 98.6
0.80 Z-score -0.1
-3.0
0.60
-5.0 Date BMD T-score Z-score
0.40
-7.0
0.20
20 30 40 50 60 70 80 90
Year
Caucasian F Spine
04-26-2011 14:12 177 cm 71 kg
3 - Right Forearm Reference curve Right Forearm
Total : 0.564 (g/cm²)
BMD (g/cm²) T-Score
0.70 Young Ref.(%) 99.5
1.0 T-score -0.1
0.50 -1.0 Age Match (%) 107.9
-3.0 Z-score 0.9
0.30 -5.0
-7.0 Date BMD T-score Z-score
0.10 -9.0
20 30 40 50 60 70 80 90
Year
Caucasian F Right Forearm
12-09-2014 12:02 165 cm 66 kg
ROI BMD(g/cm²) BMC(g) Area(cm²) T-score Z-score
1 - Right Femur - Total Hip 0.851 28.79 33.83 -1.4 (-20%) -1.1 (-16%)

Left Femur - Total Hip 0.866 28.90 33.39 -1.3 (-19%) -1.0 (-14%)

2 - Spine - L1-L4 0.962 59.08 61.42 -0.8 ( -8%) -0.1 ( -1%)

L1 0.900 12.72 14.13 -0.8 ( -9%) -0.2 ( -2%)

L2 0.947 13.25 14.00 -1.1 (-12%) -0.4 ( -5%)

L3 0.976 15.89 16.27 -0.9 ( -9%) -0.2 ( -2%)

L4 1.013 17.22 17.01 -0.4 ( -4%) 0.3 ( 3%)

3 - Right Forearm - Total 0.564 11.33 20.09 -0.1 ( -1%) 0.9 ( 8%)

2D Fan Beam DEXA Printing date/hour 06-14-2018 14:44:42 High Energy: 70 keV, Low Energy: 43 keV Ver.V4.1.9.0 demo 06-14-2018 / H0 0 - SN: 900 OT 100
Normality Curve : Caucasian F RightFemur from DMS normality curves, 2003/2004.
* Effective and input doses are measured for rachis and femur
in normal mode with normal patient (18<BMI<25). dosimetry (February 2009).

SCM DES SALYENS

Body Composition 1/2 SCM DES SALYENS
333 Bd Ledru Rollin 333 Bd Ledru Rollin
13300 SALON DE PROVENCE 13300 SALON DE PROVENCE
Phone number : 90 53 02 02 E-mail : Fax : 04 90450964 Phone number : 90 53 02 02 E-mail : Fax : 04 90450964

Patient : WHOLE BODY Xxxx12 Height : 179 cm Weight : 74 kg Prescriber : Self ref Patient : WHOLE BODY Xxxx12 Height : 179 cm Weight : 74 kg Operator : Default
Patient's ID : Ethnic : Caucasian Sex : Male Scan date: 09-03-2014 12:52:36 Patient's ID : Ethnic : Caucasian Sex : Male Prescriber : Self ref
Birth Date : 05-24-1976 Current Age : 42 Years Analysis date : 09-03-2014 12:52:36 Birth Date : 05-24-1976 Current Age : 42 Years Physician : Rachael
*Effective/DAP/Input dose: 0.1 µSv/3.28 mGy.cm²/0.27 µGy BMI: 23.10 kg/m² Health [18.5 - 24.9]
Composition indices

Whole Body 100 % Fat 100 % Fat

Measure Results
Total body weight (kg) 72.253
Total body % Bone 5.4
Total body % Lean 89.7
Total body % Fat 4.9
BMC/Height² (g/m²) 1.2
Fat mass/height² (kg/m²) (FMI) 1.1
Android/Gynoid %fat ratio 0.85
Trunk/legs %fat ratio 1.18
Trunk/limb fat mass ratio 0.97
Lean mass/height² (kg/m²) 20.2
Skeletal lean mass index (kg/m²) 11.4
Basal metabolic rate (kcal/Day) 1695.3
Body mass index (kg/m²) (BMI) 23.10

05-07-2014 11:27:19 07-09-2014 11:43:50 09-03-2014 12:52:36 0 %

Total

Age Total mass Change/previous Change/ref. Change/ref.

Scan date
(years) (g) (%) (%) (%/year)
09-03-2014 38.3 72183 -0.7 -8.0 -24.6
07-09-2014 38.1 72659 -7.4 -7.4 -42.9
05-07-2014 38.0 78466 0.0 reference reference

Total

0 % Fat Age Change/previous Change/ref. Change/ref.

Tissue Composition Scan date Fat free (g)
(years) (%) (%) (%/year)
Body Mass Index (BMI) = 23.10 09-03-2014 38.3 68053 4.5 9.6 29.4
13 18.5 25 30 (BMI) 40 07-09-2014 38.1 65122 4.9 4.9 28.2
Underweight Normal Overweight Obesity 05-07-2014 38.0 62104 0.0 reference reference
42 59 80 96 (kg) 128
Body composition

ROI Tissues Tissues Tissues Area Fat Lean BMC BMC Area Total mass
(%Fat) (g) (cm²) (g) (g) (g) (cm²) (kg) Total

Left Arm 2.4 4662 1737.0 113 4549 351.8 293.4 5.0 Age Fat Change/previous Change/ref. Change/ref.
Right Arm 3.2 4409 1452.5 140 4269 345.3 287.0 4.8 Scan date
(years) (g) (%) (%) (%/year)
Left Ribs 5.1 12748 797.7 651 12097 361.3 121.4 13.1 09-03-2014 38.3 4130 -45.2 -74.8 -229.5
Right Ribs 5.0 3519 322.8 175 3343 149.4 61.0 3.7 07-09-2014 38.1 7536 -53.9 -53.9 -312.7
T Spine 5.3 2284 148.6 120 2164 115.4 77.2 2.4 05-07-2014 38.0 16362 0.0 reference reference
L Spine 2.9 565 67.8 16 549 20.2 6.4 0.6
Pelvis 5.1 7471 429.4 378 7094 257.6 108.3 7.7
Left Leg 3.8 13923 2806.9 535 13388 886.7 510.0 14.8
Right Leg 4.0 14861 2806.4 600 14261 952.8 505.2 15.8
SubTotal 4.2 64441 10569.2 2728 61713 3440.4 1969.9 67.9
Head 20.0 3913 1480.2 783 3131 458.6 242.2 4.4 Body Mass Index (BMI) = 23.10
Total 5.1 68354 12049.3 3511 64843 3899.0 2212.2 72.3 13 18.5 25 30 (BMI) 40
Android 5.3 5198 317.0 277 4921 107.7 29.1 5.3 Underweight Normal Overweight Obesity
Gynoid 6.3 9302 740.1 586 8715 383.4 135.8 9.7 42 59 80 96 (kg) 128
2D Fan Beam DEXA Printing date/hour 06-14-2018 14:49:29 High Energy: 70 keV, Low Energy: 43 keV Ver.V4.1.9.0 demo 06-14-2018 / H0 0 - SN: 900 OT 100
Body composition references values from NHANES, 2009,BMR according to Harris-Benedict 2D Fan Beam DEXA Printing date/hour 06-14-2018 14:46:59 High Energy: 70 keV, Low Energy: 43 keV Ver.V4.1.9.0 demo 06-14-2018 / H0 0 - SN: 900 OT 100
Body composition references values from NHANES, 2009,BMR according to Harris-Benedict

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HSA

Easy Scan Repositioning

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3D-DXA

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 Photos non-contractual | TDA_5W(7Z)_M_02

Medix90 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.

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