便携式肺功能仪原理、质控及临床应用的中国专家共识
Consensus of Chinese experts on product principles, quality control and clinical application of portable spirometer
摘要便携式肺功能仪相较于传统实验室肺功能仪具有小型、便携、操作简便和造价低廉的优势。它可作为实验室肺功能仪的补充,适用于社区、基层等卫生机构。目前,国内尚缺乏便携式肺功能仪相关的指导性文件,本专家共识将从设备硬件、设备质量要求,操作要领、操作质控、临床应用和人员培训等几方面进行阐述。便携式肺功能仪由肺量计和计算机系统组成。它的核心部件是流量传感器,其保留了实验室肺功能仪的核心功能即常规通气功能、舒张试验,但不具备测定肺容积、残气量和弥散功能的能力。便携式肺功能仪产品需通过国家和国际权威机构的质量检测,需达到ISO26782:2009的标准。便携式肺功能仪的质控包括设备质控、操作过程质控、报告质控等,其技术细节与实验室肺功能仪的质控要求一致。它可用于呼吸疾病早筛、流行病学调查、体检筛查、临床试验、呼吸慢病管理及行动不便者床旁检查等。便携式肺功能仪器的操作技术培训主要针对基层社区医务工作者,培训方式灵活多样,注重理论和实践操作相结合。便携式肺功能仪具备实验室肺功能仪没有的一些高科技技术,如数据智能传输、云数据库、大数据管理、生物传感器等,这些技术的应用将使肺功能仪更加智能化和多元化,也将极大提升呼吸慢病管理的水平。
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abstractsCompared with the traditional laboratory spirometer, the portable spirometer has obvious advantages, e.g., small size, portability, simple operation and low cost. The portable spirometer is a supplementary instrument in the primary health institutions when the laboratory spirometer is unavailable or inapplicable. However, there is still a lack of guidance in documents regarding the application of portable spirometer in China. This consensus elaborated the specific details of portable spirometer, such as the equipment hardware, the equipment quality requirement, the operation protocols, the quality control, the clinical application and the personnel training. The portable spirometer consists of a spirometer and a computer system. Its core component is the flow sensor, which retains the core functions of the traditional spirometer, i.e., regular pulmonary function and bronchodilation test, but does not have the ability to measure the total lung volume, residual volume and diffusion capacity. In addition, the portable spirometer needs to pass the quality inspection of the national and international authorities and needs to meet the standard of ISO26782 of 2009. The quality control for a portable spirometer includes equipment quality control, process quality control and report quality control, and its technical details are consistent with the quality control requirements of the laboratory spirometer. It can be widely used for screening of respiratory diseases, epidemiological investigation and regular physical check-up, clinical trials, management of chronic respiratory diseases, and examination on the disability. The training courses for the portable spirometer contain theory and practice curriculums, mostly for primary and community healthcare workers with various and flexible options. Furthermore, the portable spirometer has integrated many high-tech technologies that surpass the similar functions in the laboratory spirometer such as intelligent data transmission, cloud database, big data management, biosensors, etc. With the development of the high-tech, portable spirometer has become more and more intelligent and diversified, and is able to greatly improve the management model for chronic respiratory diseases in the future.
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