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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.