oscare esite DEF update29062015.indd 1 29.6.2015 10oscaresono.co.uk/brochure.pdf · oscare_esite_DEF_update29062015.indd 2 29.6.2015 10.31. 3 ... International Osteoporosis Foundation

oscare_esite_DEF_update29062015.indd 1 29.6.2015 10.31

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Top: Healthy Vertebrae Above: Osteoporotic bone


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Osteoporosis is a worldwide and growing problem. One out of three women and one out of five men over 50 years old will experience osteoporotic fractures in their remaining lifetime. In many cases, treatment delays are extended because osteoporosis is not detected in time. Osteoporosis accounts for more disability and life years lost than rheumatoid arthritis.

The most important risk factors for osteoporosis are advanced age (in both men and women) and female sex. For women, estrogen deficiency following menopause is correlated with a rapid reduction in bone mineral density, while in men, a decrease in testosterone levels has a comparable effect. While osteoporosis occurs in people from all ethnic groups, European or Asian ancestry predisposes to osteoporosis. Those with a family history of fracture or osteoporosis are at an increased risk; the heritability of osteoporosis and low bone mineral density is relatively high. Those who have already had a fracture are at least twice as likely to have another fracture, compared to someone of the same age and sex.

Other factors predisposing to osteoporosis are, for example, excessive alcohol use, vitamin D deficiency, smoking, malnutrition, high dietary protein and being underweight.

OsCare Sono™ is specifically developed for the early detection of osteoporosis, and for

the assessment of bone health. Together with other clinical risk factors, the OsCare Sono™ measurement results aid the physician in estimating osteoporotic fracture risk. The measurement is easily accessible, accurate, cost-effective and without radiation exposure, enabling the screening of large populations.

Calcium, exercise and vitamin D can help to prevent osteoporosis. Medical treatment and lifestyle changes can further prevent bone loss.

OSTEOPOROSIS IS A DISEASE OF THE BONES, WHICH LEADS TO AN INCREASED RISK OF FRACTURE. IN OSTEOPOROSIS, THE DENSITY AND QUALITY OF BONE ARE REDUCED. THE LOSS OF BONE OCCURS SILENTLY AND PROGRESSIVELY.

3250

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NORTHAMERICA

ASIALATIN

AMERICAEUROPE

The Breaking Spine, International Osteoporosis Foundation

INCREASED BURDEN OF OSTEOPOROTIC FRACTURES WORLDWIDE

1990 1.66M HIP FRACTURES WORLDWIDE

2050 6.62M HIP FRACTURES WORLDWIDE


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The properties of a bone affect the way it conducts sound - and also ultrasound. A healthy, elastic bone allows sound to travel fast. In osteoporosis, the bone’s mineral density is lower and the cortical layer is thinner. The bone is less elastic and the speed of sound will be lower than normal.

OsCare Sono works by emitting and receiving pulses of ultrasound along the radial bone. The low 200 kHz frequency used by OsCare Sono™ allows the signals to penetrate deep into the bone. This way the device can accurately measure the speed of sound in the bone and determine how healthy it is. The bidirectional measurement together with the patented calculation algorithm help eliminate the effects of soft tissue.

Based on clinical study data, OsCare Sono™ calculates the statistical T-score and Z-score. T-score compares the measured speed of ultrasound to the average speed of ultrasound measured from healthy young females. T-score is reported as a number of standard deviations from the average. A T-score of greater than -1 (green area in the OsCare report) tells that the measurement result is in the same range as the result in most healthy young females and the risk for osteoporosis is low.

For subjects with a T-score between -1 and -2.5(yellow area in the report), counseling on bonehealth should be given and further investigationconsidered - especially if there are other riskfactors present that may contribute to osteoporosis. All subjects with an OsCare T-score of less than -2.5 (red area in the report) should be further investigated as the relative risk for osteoporosis as detected by DXA is significant.

Z-score is used to compare the result with theaverage measurement from others of the sameage, ethnicity and gender, reported asa number of standard deviations from thisaverage. A low Z-score indicates the possibility ofother contriburing factors, in addition to ageing, to an osteoporotic diagnosis.

DESIGNED FOR:

Early detection of osteoporosis

Estimating fracture risk

Assessment of bone health


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OSCARE SONO ™ PARTS

Sensor: Handheld measurement probe

Hub: Data transfer unit and sensor rest. Connection to PC via USB plug

Handle: Hand support for the patient

Ruler: Measure for bone lenght for optimal sensor position


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The OsCare Sono™ osteoporosis detection devicemeasures ultrasound wave propagation lengthwisein the bone, featuring a sensor that has several transmitting and receiving ultrasonic heads enabling a bidirectional measurement. In comparison to most other ultrasound bone sonometers, the OsCare Sono™ has a lower ultrasound frequency, of about 200 kHz. The low frequency ultrasound travels deeper in to the bone tissue providing better correlation with cortical thickness, mineral density and elasticity of the bone. The device also houses a patented sensor head geometry and measurement algorithm, that help to eliminate the effect of soft tissue.

The device compares the measurement result to the available reference population data and calculates the T- and Z-score values, indicating if the patient has an increased risk of osteoporosis and future fractures. A qualified doctor can now use this data, in combination with other data available on the patient, and prescribe further examinations, when needed. The doctor may also provide advice on diet and a healthy lifestyle.

• Easy to install software

• Basic user training leads to quick patient measurement of 5 min on average

• OsCare Sono™ calculates the T- and Z-Score values based on reference population data

• OsCare Sono™ delivers valuable information about the risk of osteoporosis

SCIENTIFIC ARTICLES

1. M. Määttä, P. Moilanen, J. Timonen, P. Pulkkinen, R. Korpelainen, T. Jämsä, Association between low-frequency ultrasound and hip fractures – comparison with DXA-based BMD, BMC Musculoskelet Disord, 15:208, 2014 2. P. Moilanen, M. Määttä, V. Kilappa, L. Xu, P.H. Nicholson, M. Alén, J. Timonen, T. Jämsä, S. Cheng, Discrimination of fractures by low-frequency axial transmission ultrasound in postmenopausal females, Osteoporos Int, 24(2):723-730, 2013. 3. V. Kilappa, P. Moilanen, L. Xu, P.H. Nicholson, J. Timonen, S. Cheng, Low-frequency axial ultrasound velocity correlates with bone mineral density and cortical thickness in the radius and tibia in pre- and postmenopausal women, Osteoporos Int 22(4):1103-13, 2011. 4. M Muller, D Mitton, P Moilanen, V Bousson, M Talmant, P Laugier. Prediction of bone mechanical properties using QUS and pQCT: study of the human distal radius, Med Eng Phys. 2008 Jul;30(6):761-7 5. P. Moilanen, Ultrasonic guided waves in bone, IEEE Trans. Ultrason. Ferroelect. Freq. Contr., 55(6): 1277-1286, 2008. 6. P. Moilanen, M. Talmant, V. Kilappa, P.H.F. Nicholson, S. Cheng, J. Timonen, P. Laugier, Modeling the impact of soft tissue on axial transmission measurements of ultrasonic guided waves in long bones, J. Acoust. Soc. Am., 124(4): 2364-2373, 2008. 7. P. Moilanen, P. H. Nicholson, V. Kilappa, S. Cheng, and J. Timonen, Assessment of the cortical bone thickness using ultrasonic guided waves: modelling and in vitro study, Ultrasound Med Biol, 33: 254-262, 2007. 8. P. Moilanen, M. Talmant, V. Bousson, P. H. F. Nicholson, S. Cheng, J. Timonen, and P. Laugier, Ultrasonically determined thickness of long cortical bones: Two-dimensional simulations of in vitro experiments, J. Acoust. Soc. Am, 122: 1818-1826, 2007. 9. P. Moilanen, V. Kilappa, P.H.F. Nicholson, J. Timonen, S. Cheng, Thickness sensitivity of ultrasound velocity in long bone phantoms. Ultrasound Med Biol, 30: 1517-1521, 2004.


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Top: UI view; measurement Above: UI view; measurement results


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• Compact in size

• Mobile

• Low-frequency (200 kHz) axial ultrasound velocity correlates well with bone mineral density (BMD) and cortical thickness, giving valuable information on bone strength

• Detection of cortical bone with patented soft tissue disturbance effect elimination

• No ionizing radiation — measurement can be repeated when needed

• OsCare Sono™ is cost-effective and enables large scale screening

• No specialized nurse qualified for taking X-rays needed

• User interface software runs in standard Windows operating system

• No dedicated PC needed

• Reliable and quick procedure


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Type: OUD-01-C-01-01 The device meets applicable CE requirements.

Dimensions: Sensor head: 105 x 37 x 87 mm (LxWxH)Table top unit: 78 x 37 x 22 mm (LxWxH)

Weight: 0,4 kg

Power input: 5 V 500 mA (2,5 W) from USB Continuous Measuring sound propagation speed range: 3200 – 4300 m/s

Accuracy of measurement: +/- 50 m/sUltrasound Sensor (line sensor 4 elements, ~200 kHz)Serial number is on the underside of the table top unit.There are no electrical contacts to patient.Protection against electrical shock is class II BF-type

Transportation and storage: Temperature 0–70 ° C Relative humidity of 30–75 % Pressure 500–1060 mbar

Operating conditions: Temperature 10 – 36 ° C Relative humidity 30–75 % Pressure 800–1060 mbar


OSCARE MEDICAL OYÄyritie 22 FI-01510 VantaaFinland

www.oscaremedical.com [email protected]


UK Distributor:

The Old MalthouseWillow Street OswestryShropshire SY11 1AJ T: 01691 [email protected]

Documents

oscare esite DEF update29062015.indd 1 29.6.2015 10oscaresono.co.uk/brochure.pdf · oscare_esite_DEF_update29062015.indd 2 29.6.2015 10.31. 3 ... International Osteoporosis Foundation