在早期和敏捷开发下测试大流行呼吸机。

Frontiers in Medical Technology Pub Date : 2022-08-16 eCollection Date: 2022-01-01 DOI:10.3389/fmedt.2022.899328
Nikolaos Tachatos, Nicola Steffen, Mark Zander, Nikola Stankovic, Mirko Meboldt, Thomas O Erb, Jürg Hammer, Marianne Schmid Daners
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摘要

针对sars - cov -2相关肺部疾病的临床需求,多个研究小组和行业团体开展了大量研究,以开发大流行呼吸机(pdv)。体外测试以批判性地评估所开发仪器的具体性能是一项基本要求。本研究提出了一种测试协议,该协议促进了面向测试、迭代和敏捷的评估以及此类pdv的连续开发。它允许在单个测试特征中快速识别每个PDV的特定特征。测试方案包括控制系统和仪器在改变参数时的准确性评估,氧动力学和对触发信号的响应。测试环境是一个机械肺,它允许复制各种肺力学和模拟主动呼吸循环。总共有三个正在开发的pdv进行了迭代测试,以Hamilton T1作为参考。对开发中的pdv进行持续测试可以快速识别需要进一步改进的关键应用程序方面。根据目前的测试方案,呼吸机表现出良好的性能,值得继续开发。
本文章由计算机程序翻译,如有差异,请以英文原文为准。

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Testing of pandemic ventilators under early and agile development.

Aiming to address clinical requirements subsequent to SARS-CoV-2-related pulmonary disease, multiple research groups and industry groups carried out intensive studies to develop pandemic ventilators (PDVs). In vitro testing to critically evaluate the specific performance of the developed apparatuses is an essential requirement. This study presents a test protocol which promotes a test-oriented, iterative, and agile assessment and consecutive development of such PDVs. It allows for fast identification of specific characteristics of each PDV in the individual test features. The test protocol includes an evaluation of the accuracy of control systems and instruments at changing parameters, the oxygen dynamics, and the response to trigger signals. The test environment is a mechanical lung, which allows reproducing various lung mechanics and to simulate active breathing cycles. A total of three PDVs that are under development were iteratively tested, with a Hamilton T1 as a reference. Continuous testing of the PDVs under development enables quick identification of critical application aspects that deserve further improved. Based on the present test protocol, the ventilators demonstrate a promising performance justifying continued development.

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