Intended Use or Indications

 

The intended use of the Sahara Clinical Bone Sonometer is to perform a quantitative ultrasound measurement of the calcaneus (heel bone), the results of which can be used in conjunction with other clinical risk factors as an aid to the physician in the diagnosis of osteoporosis and medical conditions leading to reduced bone density, and ultimately in the determination of fracture risk.

Sahara measures the speed of sound (SOS, in m/s) and broadband ultrasonic attenuation (BUA, in dB/MHz) of an ultrasound beam passed through the heel, and combines these results to obtain the Quantitative Ultrasound Index (QUI). The output is also expressed as a T-score and as an estimate of the Bone Mineral Density (BMD, in g/cm2) of the heel.

 

Caution: Federal (U.S.A.) Law restricts this device to sale by or on the order of a physician (or properly licensed practitioner). Sahara should not be used to assess patients whose skin is abraded and/or have an open sore in the area that comes into contact with the system. Sahara ultrasound coupling gel should be used in accordance with the directions for use specified in the User's Guide. Other coupling gels should not be substituted.

The Sahara User's Guide provides detailed information regarding the relationship between heel BMD estimates obtained by Sahara and by Dual Energy X-Ray Absorptiometry (DXA) technique.

 

mainnav mainnav mainnav mainnav