NONIN PureSAT® Oximetry Technology Provides Superior Accuracy in the Most Challenging Environments
The Effects of Dark Skin Pigmentation and Low Saturation in Oximetry
In a controlled laboratory study of 36 subjects, leading researchers at the University of California San Francisco found that dark skin can result in decreased accuracy of pulse oximeters, especially in combination with low oxygen saturations. In the study, the NONIN PureSAT oximetry with clip sensor was not affected by skin pigmentation compared to competitive products tested. The NONIN PureSAT oximeter with clip sensor had excellent accuracy and the lowest bias throughout the oxygen saturation levels and for all skin pigmentations. Of particular note, the authors state "clinically important bias should be considered when monitoring patients with saturation below 80%, especially those with darkly pigmented skin". In this most challenging environment of low saturation (SaO2 70% to 80%) and dark skin pigmentation, the bias for NONIN PureSAT oximetry with the clip sensor was minimal at -0.6 ± 1.2 and the accuracy was excellent. This is in contrast to the competitor's results with a mean bias of 2.6 ± 2.6 and 2.6 ± 3.0 in the same subgroup.
Thirty-six normal subjects underwent a standard breath down protocol to achieve arterial oxygen saturation between 70% and 100%. The pulse oximeters tested included: NONIN Avant® 9700, Masimo Radical®, and Nellcor OxiMax® N-595. Seventeen subjects were categorized as "dark skinned" and are included in this report.
The mean and precision (SD) of the bias compared to arterial oxygen saturation, were computed. Accuracy is reported as Arms, a computed value based on mean and SD of bias per FDA standards for pulse oximetry accuracy (Arms = √ Bias2 + SD2)
At 70% to 80% oxygen saturation, the mean bias (± S.D.) in dark skin pigmentation was minimal for NONIN's oximeter with the clip sensors at -0.6% ± 1.4, compared to the mean bias for Masimo (2.6% ± 3.0) and Nellcor (2.6% ± 2.6) oximeters with clip sensors. (Table 1)
Accuracy – a combined measure of error and variability – was excellent with the NONIN oximeter and clip sensor in dark skin subjects throughout the most challenging environments. NONIN's oximeter with the clip sensor maintained acceptable variability (per FDA Standards: Arms <3.0) in the most challenging environment of dark skin pigmentation and SaO2 less than 80%. (Figure 1)
1. Nonin Technical Bulletin M-5407, based on "Dark skin decreases the accuracy of pulse oximeters at low oxygen saturations: effects of oximeter probe type and gender," John Feiner, et al. Anesthesia & Analgesia, December, 2007.