Covidien Nellcor GR101704-RR, Operator'S Manual

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Clinical Studies
Operator’s Manual Addendum ADD-29
1.11.3
Study Results
Results for Respiration Rate Version 2.0 are shown in Table 1-9 . The observed
respiration rate range in the studies was 4 to 32 breaths per minute. Accuracy
was calculated using both root mean square difference (RMSD) and mean
error. The results demonstrate that Respiration Rate Version 2.0 calculates res-
piration rate with a mean error of less than 1 breath per minute when com-
pared to respiration rate derived from the capnography-based reference.
The clinical studies yielded 68,112 paired observations between Respiration Rate,
Version 2.0 and the capnography-based reference method.
Figure 1-18 , p. ADD-
30, presents a modified Bland-Altman plot of these paired observations to provide
another method of comparison between the two methods of measuring respira-
tion rate.

Note:
Each individual subject is represented by a unique marker on the plot. Subject
identification numbers are indicated in the legend next to the plot.
Table 1-9. Accuracy and Precision for Respiration Rate, Version 2.0
vs. Capnography-Based Reference
Population N Accuracy:
Mean Error
(Breaths Per
Minute)
Precision:
Standard Deviation
(Breaths Per Minute)
Accuracy:
RMSD
(Breaths Per
Minute)
Healthy Volunteers 30 -0.05 ± 1.04 1.04
Hospital Patients 75 -0.53 ± 2.53 2.58
All Subjects 105 -0.22 ± 1.77 1.74