Data_Sheet_1_Construction and Performance Testing of a Fast-Assembly COVID-19 (FALCON) Emergency Ventilator in a Model of Normal and Low-Pulmonary Compliance Conditions.PDF

IntroductionThe COVID-19 pandemic has revealed an immense, unmet and international need for available ventilators. Both clinical and engineering groups around the globe have responded through the development of “homemade” or do-it-yourself (DIY) ventilators. Several designs have been prototyped, tested, and shared over the internet. However, many open source DIY ventilators require extensive familiarity with microcontroller programming and electronics assembly, which many healthcare providers may lack. In light of this, we designed and bench tested a low-cost, pressure-controlled mechanical ventilator that is “plug and play” by design, where no end-user microcontroller programming is required. This Fast-AssembLy COVID-Nineteen (FALCON) emergency prototype ventilator can be rapidly assembled and could be readily modified and improved upon to potentially provide a ventilatory option when no other is present, especially in low- and middle-income countries.HypothesisWe anticipated that a minimal component prototype ventilator could be easily assembled that could reproduce pressure/flow waveforms and tidal volumes similar to a hospital grade ventilator (Engström CarestationTM).Materials and MethodsWe benched-tested our prototype ventilator using an artificial test lung under 36 test conditions with varying respiratory rates, peak inspiratory pressures (PIP), positive end expiratory pressures (PEEP), and artificial lung compliances. Pressure and flow waveforms were recorded, and tidal volumes calculated with prototype ventilator performance compared to a hospital-grade ventilator (Engström CarestationTM) under identical test conditions.ResultsPressure and flow waveforms produced by the prototype ventilator were highly similar to the CarestationTM. The ventilator generated consistent PIP/PEEP, with tidal volume ranges similar to the CarestationTM. The FALCON prototype was tested continuously for a 5-day period without failure or significant changes in delivered PIP/PEEP.ConclusionThe FALCON prototype ventilator is an inexpensive and easily-assembled “plug and play” emergency ventilator design. The FALCON ventilator is currently a non-certified prototype that, following further appropriate validation and testing, might eventually be used as a life-saving emergency device in extraordinary circumstances when more sophisticated forms of ventilation are unavailable.

引言：COVID-19大流行揭示了全球范围内对可供使用的呼吸机存在的巨大、未满足且国际性的需求。全球范围内的临床和工程团队通过开发“自制”或自行组装（DIY）呼吸机进行了响应。已有多款设计被原型化、测试并在互联网上共享。然而，许多开源的DIY呼吸机需要广泛的微控制器编程和电子组装知识，而这些知识许多医疗保健提供者可能缺乏。鉴于这一情况，我们设计并进行了台式测试一款低成本、压力控制式机械呼吸机，其设计理念为“即插即用”，无需终端用户进行微控制器编程。这款快速组装的COVID-Nineteen（FALCON）应急原型呼吸机可以迅速组装，并可以轻松修改和改进，以便在无其他选择的情况下提供呼吸支持，尤其是在低收入和中等收入国家。假设：我们预期可以轻松组装一个最小组件原型呼吸机，其能够产生与医院级呼吸机（Engström CarestationTM）相似的压/流波形和潮气量。材料与方法：我们使用人工肺在36种测试条件下对原型呼吸机进行了台式测试，这些测试条件包括不同的呼吸频率、峰值吸气压力（PIP）、正压通气末压（PEEP）和人工肺顺应性。记录了压力和流波形，并计算了潮气量，将原型呼吸机的性能与在相同测试条件下医院级呼吸机（Engström CarestationTM）的性能进行了比较。结果：原型呼吸机产生的压力和流波形与CarestationTM高度相似。呼吸机产生了稳定的PIP/PEEP，潮气量范围与CarestationTM相似。FALCON原型呼吸机连续测试了5天，没有出现故障或显著的PIP/PEEP变化。结论：FALCON原型呼吸机是一种低成本、易于组装的“即插即用”应急呼吸机设计。目前，FALCON呼吸机是一个未经认证的原型，经过进一步的适当验证和测试后，可能会在更复杂的呼吸支持形式不可用的情况下，作为救命应急设备在特殊情况下使用。