Masimo Rad-67 Pulse CO-Oximeter, Руководство оператора

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Rad-67 Chapter 8: Specifications
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The below Bland-Altman plot represents the correlation of the (SpO
2
- SaO
2
) versus (SpO
2
+
SaO
2
)/2 under no motion with an upper 95% and lower 95% limits of agreement.
Figure 1: Reusable (rainbow DCI-mini) Sensors (ARMS 70-100%)
SpHb Accuracy Data
The data in this section describes the accuracy of SpHb measurements with Rad-67.
Accuracy testing for SpHb was performed on adult subjects.
The following table provides the 95% Limits of Agreement (LOA) based upon the clinical
validation of the SpHb performance. The 95% LOA was determined by the comparison of
SpHb measurements against the tHb values determined by a HiCN reference method over
the specification range of 8-17 g/dL. The lower 95% limit of agreement is the mean
difference minus 1.96 standard deviation and the upper 95% limit of agreement is the mean
difference plus 1.96 standard deviation.
Group Bias Precision Samples Upper LOA* Lower LOA*
Overall 0.1 1.0 660 2.07 -1.82
* See Bland and Altman. Agreement between methods of measurement with multiple
observations per individual. Journal of Biopharmaceutical Statistics (2007) vol. 17 pp. 571-
582.