Covidien Nellcor FLEXMAX, Instructions For Use Manual

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