18
Device Performance
SpO
2
Accuracy
SpO
2
accuracy testing is performed by in vivo accuracy testing under laboratory
conditions on healthy subjects with varying skin pigmentation in an independent
research laboratory through induced hypoxia studies. Analysis of bias* was
performed vs. Hemoximeter data. The limits of agreement shown are calculated per:
Bland JM, Altman D. (2007) Agreement between methods of measurement with
multiple observations per individual. Journal of Biopharmaceutical Statistics 17, 571
– 582.
Root mean square error (RMS error) is calculated as follows:
*Bias is defined as the monitor under test reading minus the hemoximeter reading.
NOTE:
Because pulse oximeter equipment measurements are statistically distributed,
only about two-thirds of this device measurements can be expected to fall within
±Arms of the value measured by a co-oximeter.
