Tachatos Nikolaos, Steffen Nicola, Zander Mark, Stankovic Nikola, Meboldt Mirko, Erb Thomas O, Hammer Jürg, Schmid Daners Marianne
Product Development Group Zurich, Department of Mechanical and Process Engineering, ETH Zürich, Zurich, Switzerland.
Department of Anesthesiology, University Children's Hospital Basel, University of Basel, Basel, Switzerland.
Front Med Technol. 2022 Aug 16;4:899328. doi: 10.3389/fmedt.2022.899328. eCollection 2022.
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). 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.
为满足新型冠状病毒肺炎相关肺部疾病后的临床需求，多个研究团队和行业组织开展了密集研究以开发大流行呼吸机（PDV）。对所开发设备的特定性能进行严格评估测试是一项基本要求。本研究提出了一种测试方案，该方案促进了对此类PDV进行面向测试、迭代和敏捷的评估以及持续开发。它允许在各个测试特征中快速识别每个PDV的特定特性。该测试方案包括在参数变化时对控制系统和仪器的准确性、氧动力学以及对触发信号的响应进行评估。测试环境是一个机械肺，它能够再现各种肺力学并模拟主动呼吸周期。以一台Hamilton T1作为参考，对正在开发的总共三台PDV进行了迭代测试。对正在开发的PDV进行持续测试能够快速识别值得进一步改进的关键应用方面。基于当前的测试方案，这些呼吸机展现出了有前景的性能，证明值得继续开发。
