有创诱导降血氧法评估可孚指夹式脉搏血氧仪的准确度

Invasive Controlled Desaturation Study of Accuracy of the Cofoe Pulse Oximeter

目的:根据ISO 80601-2-61:2017的要求,验证可孚指夹式脉搏血氧仪的准确度。方法:纳入12例志愿者,同时用受试设备和质控设备进行脉搏血氧饱和度(SpO_(2))监测,通过调节志愿者吸入空气和氮气的比例逐步降低其SpO_(2),分别在5个SpO_(2)区间内,记录受试设备数据并采集对应时间的动脉血样本测得SaO_(2)。比较受试设备SpO_(2)和动脉血SaO_(2)并进行统计。结果:以血气分析SaO_(2)为对照,受试设备SpO_(2)准确度为1.98%,符合SpO_(2)准确度在非运动条件下均方根差为≤3.0%的要求。其脉率检测结果与质控设备的心率对比,偏差为(1.19±1.33)次/min。试验过程无不良事件发生。结论:可孚指夹式脉搏血氧仪的准确度符合ISO 80601-2-61:2017以及中国YY 0784-2010的要求。

Objective:To validate the accuracy of Cofoe pulse oximeter according to ISO 80601-2-61:2017.Methods:A total of 12 volunteers were included the trail.The volunteers were connected with investigational device and quality control device,the quality control device pulse oxygen saturation(SpO_(2))of volunteers was gradually declined by regulating the inhalational air and nitrogen ratio in order to step down and maintain in the specific section.The data of investigational device was recorded and the corresponded blood sample were collected.The SpO_(2) data from investigational device and the arterial oxygen saturation(SaO_(2))data from arterial blood gas analysis were used for further analysis.Results:Contrast with the SaO_(2),the accuracy of SpO_(2) of the investigational device was 1.98%,which met the requirement that the accuracy of SpO_(2) being≤3.0%under non-exercise conditions.Contrast with the heart rate of quality control device,the pulse rate of experimental device deviation was(1.19±1.33)beats per minute.Conclusions:The SpO_(2) accuracy of Cofoe pulse oximeter meets the requirement according to ISO 80601-2-61:2017 and YY 0784-2010.