Evaluation of analytic and motion-resistant performance of the Mindray 9006 pulse oximeter.

BACKGROUND 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. RESULTS 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). CONCLUSIONS The overall performance of the Mindray 9006 for SpO(2) and PR analysis is excellent and compares favorably with the Masimo MS-3.