What is being measured with Omnisense/MiniOmni?

Omnisense/MiniOmni measures Speed of Sound (SOS) expressed as meters Per second. SOS is a proven parameter to measure Bone density since multiple bone properties – microstructure, elasticity, cortical thickness, and bone density – are accounted for in the result.

What is Omnipath axial transmission technology?

BeamMed’s patented axial transmission technology, Omnipath™, is based on the measurement of the Speed of Sound (SOS) of ultrasonic waves propagating along the bone.
Omnipath™ enables measurement along the bone’s maximal strength axis, eliminating soft tissue effects.

How precise is Omnisense/MiniOmni?

Omnisense/MiniOmni precision is 0.4% at the radius, one of the highest Precision ratings in the industry. Precision is important Because it gives the system the ability to monitor bone Changes due to aging, treatment and other disorders. Based on Omnisense high precision levels, the FDA approved The Omnisense indication for use in monitoring bone changes in The relevant age groups (50-65).

Does Omnisense/MiniOmni comply with WHO diagnosis criteria?

Yes, Omnisense/MiniOmni is WHO compliant.
The Omnisense/MiniOmni reference database has the same osteoporosis prevalence as Spine and Forearm DXA crossing the -2.5 diagnosis line at approximately 75 years of age.

Can Omnisense/MiniOmni be used to monitor patients?

Yes, Omnisense/MiniOmni measurement at any of the approved skeletal sites can be used for monitoring bone changes resulting from treatment.
Omnisense/MiniOmni measurement results will show changes following positive intervention. While changes in the bone caused by aging can be observed only after two or three years, Omnisense/MiniOmni can measure changes resulting from treatment after shorter time spans.

Does Omnisense require connection to an external computer for user interface or any other purpose?

The Omnisense 7000/8000 is a self-contained unit which includes a computer, monitor, application software and probes. It does not require connection to an external computer for operation. The self-contained full-size monitor provides a full-color, user-friendly graphic user interface for the user’s convenience, with extended data management capabilities and full-color graphic display of results and patient history.

Does MiniOmni require connection to an external computer for user interface or any other purpose?

The MiniOmni Device is an external accessory measurement unit that requires a connection via USB to an external Computer to interface to the application software.

Does Omnisense/MiniOmni have imaging capabilities?

No, they are based on quantitative ultrasound measurement technology which does not use imaging technology.

Does an Omnisense/MiniOmni operator require any advanced training or Certification?

Omnisense/MiniOmni is easy to operate, a person with no prior experience can expect to master its use within a few hours of training and practice.

Is the measurement dependent upon room temperature?

The Omnisense/MiniOmni result is independent of temperature, within a range of 10°C-35°C. The true phantom SOS value is temperature dependent. For this reason, the measurement obtained during System Quality Verification depends upon the temperature in a well documented and known fashion. However, measurement of patients with Omnisense/MiniOmni is independent of room temperature. Unlike Omnisense/MiniOmni, other QUS devices are temperature dependent.

Does Omnisense/MiniOmni measure trabecular bone?

Metabolic changes occur in both the cortical and trabecular layers of bone. It is known that the bone remodeling process is less active in the cortical bone than in the trabecular bone. However, although changes in the cortical layer are much smaller in magnitude than those occurring at the trabecular layer, Omnisense/MiniOmni is sensitive to these changes.

Which reference databases are available for Omnisense/MiniOmni, and how many adults were measured to generate them?

Sunlight collected reference databases for different ethnic groups worldwide (Asian and Caucasian). These groups were subdivided into male, female and child and adult sub-groups. More than 5,000 subjects were measured to generate the different reference databases. Omnisense/MiniOmni includes unique databases formales and females, for the different ethnic groups, for each skeletal site.

What is the warranty period of the device?

The standard warranty period of the device is 12 months from date of delivery to the end-user. There is an option to either extend the warranty period at the end of the first year, or purchasea longer warranty period in advance.

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