Peng Liming, Yan Cunliang, Lu Hong, Xia Yong
Department of Laboratory Medicine, Peking University Shenzhen Hospital, Shenzhen, People's Republic of China.
Med Sci Monit. 2007 Aug;13(8):MT19-27.
The Mindray 9006 is a newly developed pulse oximeter. The performance of noninvasive monitoring of arterial oxygen saturation by pulse oximetry (SpO(2)) and pulse rate (PR) with the Mindray 9006 was evaluated.
MATERIAL/METHODS: Twenty healthy volunteers participated in this study. The Mindray 9006 was evaluated according to guidelines including HS3-A, EP5-A, and EP9-A2 published by the CLSI, and ISO 9919. A blinded side-by-side comparison of the Mindray 9006 and the Masimo MS-3 oximeter was also performed.
The results demonstrated that the coefficients of variation (CV) of imprecision were less than 1% for SpO(2) and less than 5% for PR analyzed by the Mindray 9006. Comparisons of methods showed there was no significant difference in SpO(2)/PR analysis between the Mindray 9006 with Rapidlab 855 CO-oxymeter or 812 Electrocardiogram (ECG) monitor (p>0.05) and between the Mindray 9006 and Masimo MS-3 (p>0.05). There was good correlation for SpO(2) between the Mindray 9006 and CO-oxymetry or the Masimo MS-3 (r>0.96) and for PR between the Mindray 9006 and ECG or the Masimo MS-3 (r>0.98). The accuracy as the root-mean-square (A(rms)) was less than 3% for both SpO(2) and PR between the Mindray 9006 and CO-oxymetry or between the Mindray 9006 and ECG. Also, there was no significant difference for SpO(2)/PR between the motion and rest conditions (p>0.05).
The overall performance of the Mindray 9006 for SpO(2) and PR analysis is excellent and compares favorably with the Masimo MS-3.
迈瑞9006是一款新研发的脉搏血氧仪。对迈瑞9006进行无创监测动脉血氧饱和度（SpO₂）和脉率（PR）的性能进行了评估。
材料/方法：20名健康志愿者参与了本研究。根据临床和实验室标准协会（CLSI）发布的HS3 - A、EP5 - A和EP9 - A2指南以及ISO 9919对迈瑞9006进行评估。还对迈瑞9006和Masimo MS - 3血氧仪进行了双盲并列比较。
结果表明，迈瑞9006分析的SpO₂不精密度变异系数（CV）小于1%，PR的CV小于5%。方法比较显示，迈瑞9006与Rapidlab 855 血气分析仪或812心电图（ECG）监护仪之间在SpO₂/PR分析上无显著差异（p>0.05），迈瑞9006与Masimo MS - 3之间也无显著差异（p>0.05）。迈瑞9006与血气分析或Masimo MS - 3之间的SpO₂具有良好相关性（r>0.96），迈瑞9006与心电图或Masimo MS - 3之间的PR具有良好相关性（r>0.98）。迈瑞9006与血气分析之间以及迈瑞9006与心电图之间的SpO₂和PR的均方根误差（A(rms)）均小于3%。此外，运动和静息状态下的SpO₂/PR无显著差异（p>0.05）。
迈瑞9006在SpO₂和PR分析方面的整体性能出色，与Masimo MS - 3相比具有优势。
