Adult SafeBVM Flow Limiting Device

This Adult SafeBVM by Sotair was funded by grants and contracts from NIH, NSF, Military and Air Force. This BVM fits between a manual resuscitator and a patient mask/airway. The valve keeps flow rates of air from exceeding 55 LPM during manual ventilation. Regulation of air flow has been shown to reduce peak airway pressures, excessive tidal volumes and excessive breath delivery rates, minimizing the risk of over-pressurization, over-ventilation and hyperventilation.

Sotair’s design is easy to use and only requires 30 seconds for training. The device gives real-time, multi-sensory feedback (haptic, auditory, visual) to help providers, enhancing adaptability and consistency in patient care no matter the patient type or lung condition.

Features

• FDA 510(k) cleared for Adult, single patient use
• Valve prevents flow rates of air from exceeding 55 LPM during manual ventilation
• Acts as a ‘Forcing Function,’ constraining the provider to deliver safer manual ventilation with less variability. This is most effective in ensuring system-wide change
• Immediate real-time haptic auditory and visual feedback
• Decreases provider variability and improves consistency of ventilation
• 100% activation and flow limiting testing ensures reliability in performance
• 30 second basic training

Dynamic Pressure Delivery - While Sotair has a static flow limit of ~55 LPM, the output peak pressure delivered to the patient is dynamic depending on the patient's lung compliance and resistance. For example, for an average adult with healthy lungs, Sotair’s flow limit of 55 LPM corresponds to a maximum peak pressure delivered of approximately 20 cmH2O, when air starts to enter the stomach. In other disease states like COPD, Asthma or ARDS, the peak pressure generated by the user may be 20-30+ cmH2O depending on the degree of decreased lung compliance and/or increased airway resistance.  

Instructions  

Information Sheet

Device Literature