Study on Accuracy Test Method of Blood Oxygen Saturation and Pulse Rate of Pulse Oximeter
DENG Zhenjin1, HUANG Haiping1, WU Bitao1, LIU Xiangrong1, XIE Lifeng1, LIU Pengju1, CHEN Xinping1, ZHOU Yang1, LIU Yang2
1. Hunan Institute of Drug Inspection and Testing, Changsha Hunan 410011, China;
2. Hunan Kefu Core Chi Medical Technology Co., Ltd., Changsha Hunan 410000, China
Abstract：Objective To verify the accuracy of pulse oximetry blood oxygen saturation (SpO2) and pulse rate, to ensure the safety
and effectiveness of users. Methods Measurements were performed under different light and weak perfusion conditions to verify
changes in SpO2 levels, pulse rate and pulse amplitude. Results The ring pulse oximeter was superimposed on the blood pressure
waveform of 60 Hz or 1-10 kHZ noise pulse or weak perfusion, SpO2 and pulse rate display reading error beyond the accuracy range
declared by the manufacturer (SpO2 70%-100% range, absolute tolerance ±3%; pulse rate in the range of 25-250 times/min, tolerance
±3 times /min). The SpO2 and pulse rate of finger clip pulse oximeter under different illumination were basically not affected.
Conclusion Under different light conditions, the data display of ring pulse oximeter is not accurate under strong light conditions,
but the blood oxygen saturation and pulse rate of finger clip pulse oximeter are basically not affected under different light conditions.
Under the condition of weak perfusion, when the pulse filling degree of ring type and finger clip pulse oximeter is less than 1%, the
blood oxygen saturation and pulse rate display readings are unstable and beat in a certain range, exceeding the accuracy requirements
claimed by manufacturers. The study results provide a reference for guiding and standardizing the accuracy test methods of pulse
oximeter SpO2 and pulse rate.
邓振进1，黄海萍1，吴碧涛1，刘向荣1，谢莉凤1，刘鹏举1，陈新平1，周阳1，刘阳2. 脉搏血氧仪血氧饱和度和脉搏率准确性试验方法的研究[J]. 中国医疗设备, 2023, 38(9): 46-52.
DENG Zhenjin1, HUANG Haiping1, WU Bitao1, LIU Xiangrong1, XIE Lifeng1, LIU Pengju1, CHEN Xinping1, ZHOU Yang1, LIU Yang2. Study on Accuracy Test Method of Blood Oxygen Saturation and Pulse Rate of Pulse Oximeter. China Medical Devices, 2023, 38(9): 46-52.
