Oxitone 1000M - Accuracy Testing

Oxitone 1000M
User Manual Rev. 1.
2
Page 32 of 39
11.1 ACCURACY TESTING
1
The SpO
2
accuracy has been validated in human blood studies on healthy adult male and female
volunteers with normal levels of carboxyhemoglobin (COHb) and methemoglobin (Met Hb) and with
light to dark skin pigmentation, induced hypoxia studies in the range of 70-100% SpO
2
against a
laboratory Co-Oximeter per ISO 80601-2-61. The variation equals plus or minus one standard
deviation. Plus or minus one standard deviation encompasses 68% of the population.
Accuracy summary of Oxitone 1000M – comparison to reference CO-oximetry:
Oxitone1000M
Pulse Oximeter
70—100 90--100 80--<90 67--<80
A
RMS
Spec 3% for
range of 70%-
100%
Bias -0.6 -1.1 -0.9 0.1 Pass
A
RMS
1.9 1.7 2.0 2.1
Note: The range of 70% to 100% includes reference data down to 67%.
The following graph shows plots of error (SpO
2
-SaO
2
) using the Oxitone 1000M with a linear
regression fit and upper 95% and lower 95% limits of agreement, as described by the Bland and
Altman method. Each sample data point is identified by subject from a clinical study in non-motion
conditions.
-10
-8
-6
-4
-2
0
2
4
6
8
10
65 70 75 80 85 90 95 100
Oxitone 1000 - Ref CO-Oximeter
(SpO2 - SaO2)
Reference CO-Oximeter & Oxitone 1500 (SaO2+ SpO2 )/2
Bland-Altman Plot: Oxitone 1500 vs Ref CO-Oximeter
Non-Motion, 10 Subjects
1
2
3
4
5
6
7
8
10
12
Upper LOA
Lower LOA
Mean
Regression Line