[Consensus of Chinese experts on product principles, quality control and clinical application of portable spirometer].

Compared 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.