Search Results

The VIP Bird Gold and VIP Sterling are ventilators intended to treat respiratory failure or respiratory insufficiency, in neonatal, infant and pediatric patients. The ventilators are intended for institutional use only, and not for emergency medical transport or home use.

The V.I.P Bird ventilator is a self-contained unit, combining an advanced pneumatic system with microprocessor -based technology. The result is a state-of-the-art ventilator system capable of providing excellent patient monitoring. Packaged in a compact lightweight unit, the V.I.P. Bird Gold/Sterling will incorporate all previous function of the V.I.P. Bird and the addition of Pressure Control mode of ventilation with Variable Rise Time, Volume Assured Pressure Support, Flow Triggering in Volume modes and a decelerating waveform. Other enhancements include expanded control setting range for Tidal Volume, improved resolution for the Inspiratory Time and Peak Flow controls. These specifications also include the volume monitoring functions of the Partner IIi.

I am sorry, but based on the provided text, there is no information about acceptance criteria, device performance, experimental studies, sample sizes, expert involvement, or ground truth establishment. The document is a 510(k) summary and an FDA clearance letter for a medical device (ventilator), primarily focused on declaring substantial equivalence to predicate devices and outlining regulatory compliance. It does not contain the kind of detailed technical study information that your request asks for.

Ask a specific question about this device