Covidien Nellcor Series, Operator'S Manual

Page: 142 / 160

Clinical Studies
A-24 Operator’s Manual
Modified Bland-Altman plots for all the data are presented in Figure A-19 and Figure
A-20 for SpO
2
and pulse rate respectively.

Note:
Each individual subject is represented by a unique color on the plots. Subject identification
numbers are indicated in the legend to the left of each plot.
Figure A-19. Modified Bland-Altman for SpO
2
(All Data - Low Saturation): SaO
2
vs. (SpO
2
- SaO
2
)
MAXFAST No 281 0.81

3.0 Pass
ALL No 2309 0.76

3.0 Pass
Table A-6. Pulse Rate Accuracy Results (60 to 80% SaO
2
) (Continued)
Sensor Motion # of
Data
Points
A
RMS
(BPM)
Pulse Rate
Acceptance
Criteria
(BPM)
Pass/Fail
1 SpO
2
- SaO
2
(%) 3 Upper 95% LoA
2 SaO
2
(%) 4 Mean Bias
5 Lower 95% LoA