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Bindex measures apparent cortical bone thickness at the proximal tibia and can be used in conjunction with other clinical risk factors or patient characteristics as an aid to the physician in the diagnosis and other medical conditions leading to reduced bone strength and in the determination of fracture risk.

The Bindex Bl-2 system consists of handheld ultrasound transducer and software. Bindex Bl-2 is connected to the USB port of a computer and controlled with computer software. Bindex Bl-2 is used for measurement of cortical bone thickness and it provides Density Index (DI), a parameter which estimates bone mineral density at the hip as measured with DXA. For measurements, gel is applied on skin and ultrasound transducer is manually placed on the measurement location. Standardized measurement location is at proximal tibia (1/3 length of tibia). Transducer is manually oriented perpendicularly to the surface of the cortical bone to achieve accepted measurement. Measurement is repeated five times at each measurement location. Finally, transducer is disinfected by wiping gel off with isopropyl alcohol moistened cloth. The associated accessories include: - . Measurement stick - Ultrasound gel (optional)

1) EchoS Family is a non-invasive ultrasound (US) bone sonometer. EchoS Family works together with EchoStudio software. EchoStudio analyzes the ultrasound signals in order to compute the diagnostic parameters (BMDus, T-score, and Z-score). The BMDus Index is a clinical measure based on ultrasound variables of the lumbar spine or femoral neck which is highly correlated with the value of BMD of the same anatomical location as provided by DXA (BMDDXA), with a standard error of the estimate of 0.044grams/cm^2 for lumbar spine and 0.038 grams/cm^2 for femoral neck measurements. BMDus Index is expressed in grams/cm^2 and as a T- and Z-score, derived from comparison to a normative x-ray absorptiometry reference database. BMDus Index has a precision comparable to that of x-ray absorptiometry, which makes it suitable for monitoring bone changes in women and men. 2) The EchoStudio software includes an optional tool called Fragility Score, which is intended to provide an assessment of 5-year fracture risk. The optional tool Fragility Score provides an estimate of 5-year probability of hip fracture and 5-year probability of a major osteoporotic fracture (clinical spine, forearm, hip or shoulder fracture). This estimate takes into account the patient's age, sex, ethnicity, height, and the vertebraffemur neck ultrasound spectra and is computed using a proprietary algorithm. The tool has been validated for men and women between 30 and 90 years old. The output is provided in a separate screen display and report that can be viewed or exported to an optional physician report generator tool. The results can be used by a physician, in conjunction with other clinical risk factors, as an aid in the diagnosis of osteoporosis and medical conditions leading to increased bone fragility, and ultimately in the assessment of fracture risk. 3) EchoS Family, when used with the optional Body Composition module of EchoStudio software, is indicated to estimate total body fat percentage (%BF). EchoS Family, together with Body Composition software module, is intended to be used only on generally healthy adults and is not for disease or condition. Body Composition software is indicated for the calculation of the Body Mass Index (BMI) and the Basal Metabolic Rate (BMR). Body Composition software module generates a report which displays the calculated values of Body FAT, BMR, and Body Mass Index (BMI).

The EchoS Family is an ultrasound device intended primarily for the diagnosis of osteoporosis. EchoS, through the ultrasound scan of the lumbar or femoral site of interest, picks up the ultrasound signal (RF) and performs an estimate of the bone mineral density (BMD). The device therefore allows not only the visualization of ultrasound images, but also the real-time sampling of the RF signal and its appropriate treatment to make it usable for diagnostic algorithms. The EchoS Family consists in two different configurations: EchoS (portable version) and the EchoStation (cart version). Each version consists of two main parts: the equipment device (EchoS and EchoStation) with its own probe and the software EchoStudio. EchoStudio is a biomedical software that, used in combination with EchoS Family, allows the evaluation of bone mineral density (BMD) by means of the proprietary method REMS (Radiofrequency Echographic Multi Spectrometry) densitometry. By using EchoStudio, it is possible to assess the key diagnostic parameters directly on the anatomical sites with increased fracture risk, such as lumbar spine and proximal femur. EchoStudio analyzes the ultrasound signals and echographic images in order to compute the diagnostic parameters (BMD, T-score, and Z-score) and to estimate the fracture risk by means of the Echolight diagnostic algorithms and non-ionizing technique.

EchoS is a non-invasive ultrasound (US) bone sonometer. EchoS works together with EchoStudio software. EchoStudio analyzes the ultrasound signals in order to compute the diagnostic parameters (BMD13, T-sore, and Z-sore) and to assess fracture risk through the integrated FRAX® software. The BMDgs Index is a clinical measure based on ultrasound variables of the lumbar spine or femoral neck which is highly correlated with the value of BMD as provided by DXA at the same anatomical location (BMDnxA), with a standard error of the estimate of 0.044 grams/cm² for lumbar spine and 0.038 grams/cm² for femoral neck measurements. BMDris Index is expressed in grams/cm² and it is based on a proprietary internal database, obtained from clinical data on adult white females and males, while T- and Z-score are derived from comparison to a normative X-ray absorptiometry reference database (NHANES). BMDus Index has a precision comparable to that of x-ray absorptiometry, which makes it suitable for monitoring bone changes in women.

The subject device, EchoS, consists of two main parts: the equipment EchoS device with its own probe and the software EchoStudio. - The EchoS device consists of EchoS device together with its probe, - . The software EchoStudio: user interface and algorithmic calculation software provided in installation disc. The EchoS device is connected to the computer via the USB port, and it is controlled by the EchoStudio to send the transmitting parameters to the EchoS device and to acquire the ultrasound (US) signals from EchoS device in order to calculate the BMDus and the other diagnosis parameters. The EchoS System is a PC-based device that employs an ultrasound probe to collect ultrasound (RF) signals for echographic applications. During the measurement, the ultrasound convex probe, connected by a standard connector to the EchoS device, is applied directly to the skin in correspondence of the lumbar vertebrae or proximal femur, applying a thin layer of ultrasound gel between the probe surface and the skin to facilitate acoustic coupling. The ultrasound waves emitted by the probe are reflected by the bone, and then detected by the same probe. During the scan, the algorithm automatically detects the bone interfaces and calculates the region of interest (ROIs) for data analysis. The automatic data processing is performed through the following steps: a custom developed signal pre-processing chain performs filtering, amplification and A/D conversion operations on the RF signals that are then passed to the EchoStudio software. EchoStudio includes RF signal analysis and spectral comparison with reference models for the calculation of diagnostic parameters (BMDus, T-score, Z-score), and generation of the final medical report. The relevant scan depth, focus position, and visualization parameter settings can be adjusted and set by the interface of the software - EchoStudio. EchoStudio software provides BMDus (in g/cm²), T-score and Z-score. It also estimates the 10-year osteoporotic fracture risk calculated with the original FRAX® algorithm that is integrated in the device.

UltraScan 650 can be used to determine BMDus Index in adult men and women and to assess appendicular fracture risk in postmenopausal women. The BMDus Index is a clinical measure based on ultrasound variables of the forearm which is highly correlated with the value of BMD of the 1/3 radius as provided by DXA, with a standard error of the estimate of 0.041 grams/cm2. BMDus Index is expressed in grams/cm² and as a T- and z-score, derived from comparison to a normative x-ray absorptiometry reference database. BMD 15 Index has a precision comparable to that of x-ray absorptiometry, which makes it suitable for monitoring bone changes in postmenopausal women.

The UltraScan 650 is an ultrasound device that is designed to non-invasively and quantitatively assess the amount of bone at the 1/3 location of the radius in the forearm of an individual. The UltraScan 650, with a user-supplied laptop, is designed for the estimation of bone mineral density (BMD in g/cm²) of the radius at the 1/3 location. The UltraScan 650 outputs a BMD is Index an estimate of the BMD that would be measured by dual-energy X-ray absorptiometry (DXA) at the same anatomical location, that is, an estimate of BMDDXA, at the 1/3 radius. The UltraScan 650 also outputs the T-score in standard deviations (SD) and Z-score in SD as well. The precision of the measurement is 2.1%, when expressed as a coefficient of variation. The range of the output of the UltraScan 650, depends on the subjects that are measured. However, based on the normative (reference) data, we can calculate the range that will include 99.85% of all subjects.

Bindex measures apparent cortical bone thickness at the proximal tibia and can be used in conjunction with other clinical risk factors or patient characteristics as an aid to the physician in the diagnosis and other medical conditions leading to reduced bone strength and in the determination of fracture risk.

The Bindex Bl-2 system consists of handheld ultrasound transducer and software. Bindex Bl-2 is connected to the USB port of a computer and controlled with computer software. Bindex Bl-2 is used for measurement of cortical bone thickness and it provides Density Index (DI), a parameter which estimates bensity at the hip as measured with DXA. For measurements, gel is applied on skin and ultrasound transducer is manually placed on the measurement location. Standardized measurement location is at proximal tibia (1/3 length of tibia). Transducer is manually oriented perpendicularly to the cortical bone to achieve accepted measurement. Measurement is repeated five times at each measurement location. Finally, transducer is disinfected by wiping gel off with isopropyl alcohol moistened cloth.

Bindex measures apparent cortical bone thickness at the proximal tibia and can be used in conjunction with other clinical risk factors or patient characteristics as an aid to the physician in the diagnosis of osteoporosis and other medical conditions leading to reduced bone strength and in the determination of fracture risk.

The Bindex system includes ultrasound pulser, transducer and software. Bindex is connected to the USB port of a computer and controlled with computer software. Bindex is used for measurement of cortical bone thickness and it provides Density Index (DI), a parameter which estimates bone mineral density at the hip as measured with DXA. For measurements, gel is applied on skin and ultrasound transducer is manually placed on the measurement location. Standardized measurement location is at proximal (1/3 length) of tibia. Transducer is manually oriented perpendicularly to the surface of the cortical bone to achieve accepted measurement. Measurement is repeated five times at each measurement location. Finally, transducer is disinfected by wiping gel off with disinfective solution moistened cloth or tissue.

Achilles OsteoReportN is software used with the Achilles family of ultrasonometers to provide a patient database, customized reporting, and communication with Health Information Systems. Achilles OsteoReportN together with the Achilles ultrasonometers measures ultrasound variables of the os calcis to provide a clinical measure called Stiffness Index. The Stiffness Index indicates risk of osteoporotic fracture in postmenopausal women comparable to bone mineral density (BMD) as measured by X-ray absorptiometry at the spine or hip. Stiffness index results expressed as t-scores are used to assist the physicians in the diagnosis of osteoporosis in the same way as are t-scores or obtained by x-ray absorptiometry. Either the stiffness index t-score or x-ray absorptiometry t-score can be utilized by a physician. in conjunction with other clinical risk factors, to provide a comprehensive skeletal assessment. The stiffness index has a precision error in older women comparable to that of x-ray absorptiometry, which makes it suitable for monitoring bone changes.

Achilles OsteoReportN is a software program running on PC to enter patient information, remote control and retrieve measurement results of GE ultrasonometer to help physicians to analysis the osteoporotic fracture risk and communicate with hospital information system. Achilles ultrasonometers measures ultrasound variables of the os calcis to provide a clinical measure called Stiffness Index. The Stiffness Index indicates risk of osteoporotic fracture in postmenopausal women comparable to bone mineral density (BMD) as measured by X-ray absorptiometry at the spine or hip. Stiffness index results expressed as t-scores are used to assist the physicians in the diagnosis of osteoporosis in the same way as are t-scores or obtained by x-ray absorpiometry. Either the stiffness index t-score or x-ray absorpiometry t-score can be utilized by a physician, in conjunction with other clinical risk factors, to provide a comprehensive skeletal assessment. The stiffness index has a precision error in older women comparable to that of x-ray absorpiometry, which makes it suitable for monitoring bone changes. Achilles OsteoReportN is a windows based application running on PC and will provide the following capabilities for Achilles series device: - 1) A patient database - 2) Customizable reporting - 3) Operation of the Achilles unit from the PC to provide ergonomic relief to the operator - 4) Communication to the hospital/clinic information system The objectives of this program including: - Support Windows 7 (64 bit)/Windows XP(32bit) . operating system - . Support merging the database with older version of Achilles product with the database used with the newer Achilles ultrasonometers, which is stored on the device. - . Support remote control of EXPII's measurement and retrieve measurement results - Support customized report printing . - . Support DICOM

The Sunlight MiniOmni Ultrasound Bone Sonometer is a non-invasive device that is designed for the quantitative measurement of the signal velocity of ultrasound waves ("Speed of Sound" or "SOS" in m/sec) propagating at multiple skeletal sites (i.e., the distal one-third of the radius, the proximal third phalanx and the fifth metatarsal). SOS provides an estimate of skeletal fragility. The output is also expressed as a T-score and a Z-score, and can be used in conjunction with other clinical risk factors as an aid to the physician in the diagnosis of osteoporosis and other medical conditions leading to reduced bone strength and, ultimately, in the determination of fracture risk. Multiple skeletal site testing provided clinicians with alternatives if one site is not accessible and with additional skeletal information (i.e., from bones with different combinations of cortical and cancellous material and from weight bearing and non-weight bearing sites) that assists in diagnosing osteoporosis and risk fracture. The SOS measured by MiniOmni has a precision error low enough in comparison with the expected annual change in a patient's measurement to make it suitable for monitoring bone changes which occur in the early years following menopause (i.e., age range approximately 50-65 years).

The Sunlight MiniOmni Ultrasound Bone Sonometer is a noninvasive device that consists of: - Main unit, which contains an ultrasound transmission / reception printed circuit board (1) (ultrasound PCB) and mechanical and electric elements for connecting the ultrasound probes - (2) User interface and algorithmic calculation software provided in installation disc - (3) Hand-held probes (choice from 3 ultrasonic probe types already PMA-approved, plus one new probe) - Medical grade AC to DC power adaptor and cable (4) - (5) USB Connection cable - System quality verification (SQV) phantom; (6) - Spring-loaded positioning gauge; (7) - (8) Cushioned hand rest - (a) User Guide - Ultrasound gel (optional accessory) - Skin marker pencil (optional accessory) - Foot pedal (optional accessory) 12) - Sterile disinfection towelettes (optional accessory) (13) - Carrying case for easy mobility (optional accessory) (14) The MiniOmni requires connection to a stand-alone computer and visual display unit provided by the user in order to operate as intended.

The Achilles ultrasonometer measures ultrasound variables of the os calcis to provide a clinical measure called Stiffness Index. The Stiffness Index indicates risk of osteoporotic fracture in postmenopausal women comparable to bone mineral density (BMD) as measured by X-ray absorptiometry at the spine or hip. Stiffness index results expressed as t-scores are used to assist the physicians in the diagnosis of osteoporosis in the same way as are t-scores or obtained by x-ray absorpiometry. Either the stiffness index t-score or x-ray absorpiometry t-score can be utilized by a physician, in conjunction with other clinical risk factors, to provide a comprehensive skeletal assessment. The stiffness index has a precision error in older women comparable to that of x-ray absorpiometry, which makes it suitable for monitoring bone changes.

Achilles EXPII measures ultrasound variables of the os calcis to provide a clinical measure called Stiffness Index. The Stiffness Index indicates risk of osteoporotic fracture in postmenopausal women comparable to bone mineral density (BMD) as measured by X-ray absorptometry at the spine or hip.