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目的按照脉搏血氧计相关标准,对两类脉搏血氧计实施人体实验评估,对其准确性进行评价并验证所建立的评估方法的有效性。方法以10名健康志愿者为被试者,在逐步降低其血氧饱和度的过程中,利用脉搏血氧计和血气分析仪测量被试者的血氧饱和度,并对二者的测量结果进行相关性分析,得出脉搏血氧计的准确度。结果血气分析结果按标准要求呈平台期均匀分布;脉搏血氧计的测量结果与血气分析值高度相关,确定系数为0.95;市场成熟产品Masimo血氧计的准确度评价结果与厂商说明一致。结论所建立的脉搏血氧计的人体实验评估方案符合标准要求,可用于脉搏血氧计的实验评估。
OBJECTIVE To evaluate the accuracy of two types of pulse oximeters in human body according to the relevant standard of pulse oximeter and verify the validity of the established evaluation method. Methods Totally 10 healthy volunteers were enrolled. During the gradual decrease of oxygen saturation, the blood oxygen saturation of the subjects was measured by pulse oximeter and blood gas analyzer, and the results of the two measurements Correlation analysis, the pulse oximeter accuracy. Results The results of blood gas analysis were evenly distributed according to the standard requirements. The results of pulse oximeter were highly correlated with the blood gas analysis values, and the coefficient of determination was 0.95. The accuracy of Masimo oximeter in the market was evaluated in accordance with the manufacturer’s instructions. Conclusion The built-in pulse oximeter human experimental evaluation program meets the standard requirements, can be used for experimental evaluation of pulse oximeter.