Covidien Nellcor FLEXMAX Instructions For Use Manual page 8

Refer to the Bland-Altman plots at the end of this booklet.
Figure Bland-Altman Plot: Nellcor™ N-600x/FLEXMAX
1
1
Call out:
2
3
4
5
6
Figure Bland-Altman Plot: Nellcor™ N-395/FLEXMAX
2
1
Call out:
2
3
4
5
6
Figure Bland-Altman Plot: Covidien Nellcor™ PM1000N Platform/FLEXMAX
3
1
Call out:
2
3
4
5
6
Figure Bland-Altman Plot: Covidien Nellcor™ N-560/FLEXMAX
4
Call out: 1
2
3
4
5
6
4) Clinical accuracy study, 11 test subjects
Y-axis N-600x FLEXMAX - Ref CO-Oximeter (SpO
X-axis Reference CO-Oximeter (SaO
Upper 95% Limit of Agreement
Mean
Lower 95% Limit of Agreement
Clinically Obtained Accuracy (A
Y-axis N-395 FLEXMAX - Ref CO-Oximeter (SpO
X-axis Reference CO-Oximeter (SaO
Upper 95% Limit of Agreement
Mean
Lower 95% Limit of Agreement
Clinically Obtained Accuracy (A
Y-axis PM1000N FLEXMAX - Ref CO-Oximeter (SpO
X-axis Reference CO-Oximeter (SaO
Upper 95% Limit of Agreement
Mean
Lower 95% Limit of Agreement
Clinically Obtained Accuracy (A
Y-axis N-560 FLEXMAX - Ref CO-Oximeter (SpO
X-axis Reference CO-Oximeter (SaO
Upper 95% Limit of Agreement
Mean
Lower 95% Limit of Agreement
Clinically Obtained Accuracy (A
4
)
2
for each stated SaO
RMS
4
)
2
for each stated SaO
RMS
)
2
for each stated SaO
RMS
)
2
for each stated SaO
RMS
8
- SaO )
2 2
Range)
2
- SaO )
2 2
Range)
2
4
- SaO )
2 2
Range)
2
4
- SaO )
2 2
Range)
2