用于应对新冠疫情的新型米兰机械呼吸机。
The novel Mechanical Ventilator Milano for the COVID-19 pandemic.
作者信息
Abba A, Accorsi C, Agnes P, Alessi E, Amaudruz P, Annovi A, Desages F Ardellier, Back S, Badia C, Bagger J, Basile V, Batignani G, Bayo A, Bell B, Beschi M, Biagini D, Bianchi G, Bicelli S, Bishop D, Boccali T, Bombarda A, Bonfanti S, Bonivento W M, Bouchard M, Breviario M, Brice S, Brown R, Calvo-Mozota J M, Camozzi L, Camozzi M, Capra A, Caravati M, Carlini M, Ceccanti A, Celano B, Cela Ruiz J M, Charette C, Cogliati G, Constable M, Crippa C, Croci G, Cudmore S, Dahl C E, Dal Molin A, Daley M, Di Guardo C, D'Avenio G, Davignon O, Del Tutto M, De Ruiter J, Devoto A, Diaz Gomez Maqueo P, Di Francesco F, Dossi M, Druszkiewicz E, Duma C, Elliott E, Farina D, Fernandes C, Ferroni F, Finocchiaro G, Fiorillo G, Ford R, Foti G, Fournier R D, Franco D, Fricbergs C, Gabriele F, Galbiati C, Garcia Abia P, Gargantini A, Giacomelli L, Giacomini F, Giacomini F, Giarratana L S, Gillespie S, Giorgi D, Girma T, Gobui R, Goeldi D, Golf F, Gorel P, Gorini G, Gramellini E, Grosso G, Guescini F, Guetre E, Hackman G, Hadden T, Hawkins W, Hayashi K, Heavey A, Hersak G, Hessey N, Hockin G, Hudson K, Ianni A, Ienzi C, Ippolito V, James C C, Jillings C, Kendziora C, Khan S, Kim E, King M, King S, Kittmer A, Kochanek I, Kowalkowski J, Krücken R, Kushoro M, Kuula S, Laclaustra M, Leblond G, Lee L, Lennarz A, Leyton M, Li X, Liimatainen P, Lim C, Lindner T, Lomonaco T, Lu P, Lubna R, Lukhanin G A, Luzón G, MacDonald M, Magni G, Maharaj R, Manni S, Mapelli C, Margetak P, Martin L, Martin S, Martínez M, Massacret N, McClurg P, McDonald A B, Meazzi E, Migalla R, Mohayai T, Tosatti L M, Monzani G, Moretti C, Morrison B, Mountaniol M, Muraro A, Napoli P, Nati F, Natzke C R, Noble A J, Norrick A, Olchanski K, Ortiz de Solorzano A, Padula F, Pallavicini M, Palumbo I, Panontin E, Papini N, Parmeggiano L, Parmeggiano S, Patel K, Patel A, Paterno M, Pellegrino C, Pelliccione P, Pesudo V, Pocar A, Pope A, Pordes S, Prelz F, Putignano O, Raaf J L, Ratti C, Razeti M, Razeto A, Reed D, Refsgaard J, Reilly T, Renshaw A, Retriere F, Riccobene E, Rigamonti D, Rizzi A, Rode J, Romualdez J, Russel L, Sablone D, Sala S, Salomoni D, Salvo P, Sandoval A, Sansoucy E, Santorelli R, Savarese C, Scapparone E, Schaubel T, Scorza S, Settimo M, Shaw B, Shawyer S, Sher A, Shi A, Skensved P, Slutsky A, Smith B, Smith N J T, Stenzler A, Straubel C, Stringari P, Suchenek M, Sur B, Tacchino S, Takeuchi L, Tardocchi M, Tartaglia R, Thomas E, Trask D, Tseng J, Tseng L, VanPagee L, Vedia V, Velghe B, Viel S, Visioli A, Viviani L, Vonica D, Wada M, Walter D, Wang H, Wang M H L S, Westerdale S, Wood D, Yates D, Yue S, Zambrano V
机构信息
Nuclear Instruments S.R.L., Como 22045, Italy.
Elemaster Group S.p.A., Lomagna (LC) 23871, Italy.
出版信息
Phys Fluids (1994). 2021 Mar;33(3):037122. doi: 10.1063/5.0044445. Epub 2021 Mar 23.
This paper presents the Mechanical Ventilator Milano (MVM), a novel intensive therapy mechanical ventilator designed for rapid, large-scale, low-cost production for the COVID-19 pandemic. Free of moving mechanical parts and requiring only a source of compressed oxygen and medical air to operate, the MVM is designed to support the long-term invasive ventilation often required for COVID-19 patients and operates in pressure-regulated ventilation modes, which minimize the risk of furthering lung trauma. The MVM was extensively tested against ISO standards in the laboratory using a breathing simulator, with good agreement between input and measured breathing parameters and performing correctly in response to fault conditions and stability tests. The MVM has obtained Emergency Use Authorization by U.S. Food and Drug Administration (FDA) for use in healthcare settings during the COVID-19 pandemic and Health Canada Medical Device Authorization for Importation or Sale, under Interim Order for Use in Relation to COVID-19. Following these certifications, mass production is ongoing and distribution is under way in several countries. The MVM was designed, tested, prepared for certification, and mass produced in the space of a few months by a unique collaboration of respiratory healthcare professionals and experimental physicists, working with industrial partners, and is an excellent ventilator candidate for this pandemic anywhere in the world.
本文介绍了米兰机械呼吸机（MVM），这是一款专为应对新冠疫情而设计的新型重症治疗机械呼吸机，旨在实现快速、大规模、低成本生产。MVM没有活动机械部件，仅需压缩氧气和医用空气源即可运行，旨在支持新冠患者常需的长期有创通气，并以压力调节通气模式运行，可将加重肺损伤的风险降至最低。在实验室中，使用呼吸模拟器依据国际标准化组织（ISO）标准对MVM进行了广泛测试，输入与测量的呼吸参数之间吻合良好，且在故障条件和稳定性测试中表现正常。MVM已获得美国食品药品监督管理局（FDA）的紧急使用授权，可在新冠疫情期间用于医疗机构；同时也获得了加拿大卫生部的医疗器械进口或销售授权，依据的是与新冠疫情相关的临时使用令。获得这些认证后，大规模生产正在进行中，并且在多个国家开展了分发工作。MVM由呼吸医疗专业人员和实验物理学家与工业合作伙伴独特合作，在短短几个月内完成了设计、测试、认证准备和大规模生产，是全球应对此次疫情的理想呼吸机选择。
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