Operator's Manual

Rad-97 Chapter 15: Specifications
www.masimo.com 180 Masimo
Measurement A
RMS
Values for Disposable (RD SET Series) Sensors
SpO
2
Accuracy Range (%) A
RMS
(%)
90-100 1.53
70-100 1.15
The table below provides the upper 95% and lower 95% limits of agreement. The differences
between measurements by the two methods are used to calculate the mean and standard
deviation. The lower 95% limit of agreement is the mean minus 1.96 standard deviation and
the upper 95% limit of agreement is the mean plus 1.96 standard deviation. These limits are
expected to contain 95% of the differences between measurements between the two methods
in controlled environments.
SpO
2
Upper and Lower Limits of Agreement (LoA)*
Upper 95% LoA 2.27%
Lower 95% LoA -2.29%
* See Bland and Altman. Agreement between methods of measurement with multiple
observations per individual. Journal of Biopharmaceutical Statistics (2007) vol. 17 pp.
571-582.
The below Bland-Altman plot represents the correlation of the (SpO
2
+ SaO
2
)/2 versus (SpO
2
-
SaO
2
) under no motion with an upper 95% and lower 95% limits of agreement.
Figure 1: Disposable (RD SET Series) Sensors (ARMS 70-100%)