SONAS® Design Concept
Not for sale in the United States. For investigational use only.
The concept of SONAS® is a portable, battery-powered ultrasound device for non-invasive brain perfusion assessment. SONAS® is used in combination with commercially available, approved microbubble contrast agents. Ultrasound transducers on each side of the head are installed in a headset. Following ultrasound microbubble injection via a peripheral vein brain perfusion is assessed in comparable fashion (right vs. left hemisphere) using proprietary signal detection algorithms and based on bolus kinetic modeling.
Key features
- Portable, battery-powered
- Utilizes commercially available, CE Marked ultrasound compatible microbubbles
- SONAS® consumables (including custom gel pads) are provided for each SONAS® test
- Simple user interface
- Results report generated in PDF file format
- Favorable safety (low output power)
- Cost effective
Technical Specifications
Intended Use of SONAS®
SONAS is a
medical device intended to aid in the unilateral and bilateral assessment of cerebral blood perfusion.
SONAS® uses transcranial ultrasound to detect acoustic signals that relate to cerebral blood perfusion, and if differences in the signals are detected, this can indicate differences in blood perfusion. Information from the SONAS® assessment is to be used adjunctively in combination with other available information, including patient history, symptoms, and other appropriate clinical assessments and diagnostic testing to aid and support clinical decision making.
SONAS® - Intended Users
SONAS® is intended for use by professional medically trained personnel including emergency medical technicians, medical imaging technicians, nurses, and physicians. A user qualified to perform an intravenous administration of the recommended microbubble contrast agent (SonoVue™) must be available when a test is performed. The SONAS® Results Report is intended for use by physicians responsible for the assessment of patients.
SONAS® - Indications for Use
SONAS® is intended for evaluation of patients who have presented symptoms consistent with possible impaired perfusion in the brain. SONAS® provides indications of unilateral and bi-lateral cerebral blood perfusion, to be used in combination with other clinical information.
DOWNLOAD FACT SHEET
“Diagnosis and Monitoring”
SONAS includes minimal GPL-licensed source code available on GitHub.
