Adult SafeBVM Flow Limiting Device

Description: SafeBVM’s flagship innovation, the award-winning Sotair device, is primarily funded by grants and contracts from the NIH, NSF, and the Military. Sotair is a flow control valve that fits between the manual ventilator and the Adult patient’s mask or advanced airway device. It limits the maximum flow rate to 55 liters per minute, ensuring that air delivery stays within safe limits. Controlling flow reduces the risk of high peak pressures, excessive tidal volumes, and excessive breath delivery rates—all of which are important in order to avoid patient harm when delivering breaths with the manual ventilator. Research has shown that high peak pressures during manual ventilation can lead to complications such as vomiting, aspiration, acute lung injury, barotrauma, and ARDS. By controlling air flow, Sotair helps maintain peak pressures within safe levels specific to each patient.Sotair maintains a consistent max flow limit of 55 LPM and the peak pressure delivered is automatically adjusted based on the patient’s airway and lung compliance, making it suitable for any adult patient. For instance, in a patient with healthy lungs and normal airway, Sotair caps peak pressures around 20-22 cmH2O, just below the threshold where air could enter the stomach when manually ventilating. However, if a patient has a high resistance due to an an obstructive lung condition, like asthma or COPD, or a restrictive lung condition affecting the lungs’ ability to expand, such as pulmonary fibrosis or Obesity Hypoventilation Syndrome, the peak pressure limit will automatically be adjusted to meet their specific needs.By acting as a 'forcing function,' Sotair forces the right actions to deliver max air flows less than 55 LPM, avoiding rapid, forceful squeezes that lead to over-ventilation. By maintaining a squeeze of the bag to 1 second and under Sotair’s flow limit of 55 LPM, providers will avoid delivery of excessive tidal volumes. Because the device tends to slow a provider down, the provider is less likely to deliver a large number of breaths per minute. This decreases the risk of hyperventilation.If the bag is squeezed too quickly or forcefully, Sotair’s valve closes, creating a resistance in the bag producing alarms realized by the user. Alarms are tactile and/or auditory with visual cues. These alarms indicate when Sotair’s flow limit has been exceeded, prompting the provider to adjust their technique in real-time. This intuitive feedback makes training easy and reinforces best practices in real time.”FeaturesFDA 510(k) cleared for Adult, single patient usePrevents flow rates of air from exceeding 55 LPM during manual ventilation Peak Pressure limit during air delivery is automatically adjusted based on the patient's lung compliance and resistanceActs as a ‘Forcing Function,’ constraining the provider to deliver safer manual ventilation with less variability. This is most effective in ensuring system-wide changeImmediate real-time tactile and auditory alarms with visual cuesDecreases provider variability and improves consistency of ventilation100% activation and flow limiting testing ensures reliability in performance30 second basic trainingInstructions Information SheetDevice Literature

Price: 57.8 USD

Location: Leland, North Carolina

End Time: 2025-01-22T15:18:52.000Z

Shipping Cost: 4.99 USD