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Respiration Per Minute (RPM) Difference when Compared
to Control for Hospitalized Pediatric Subjects
Outliers in the data from the healthy adult subjects and the hospitalized pediatric subjects were associated with subjects experiencing a fast
change in breath rate, breath in/breath out cycles that were very close to each other, or external noise interfering with the sensor (e.g., subject
movement or scratching on the sensor). Spot check data of less than 45 seconds should not be considered accurate: it is recommended to evaluate
more than one minute of trend data to obtain an accurate respiratory rate.
The accuracy of this device has not been validated for monitoring of respiratory rate in patients with specific medical conditions, e.g., asthma,
COPD or cystic fibrosis. The accuracy of the sensor has not been validated in infants or neonates.
70
100 ≤ Number of Samples
10 ≤ Number of Samples < 100
0 < Number of Samples < 10
60
50
40
30
20
10
10
20
Hospitalized Pediatric Subjects: Capnograph vs. Control (manual count)
40
1000 ≤ Number of Samples
100 ≤ Number of Samples < 1000
10 ≤ Number of Samples < 100
30
0 < Number of Samples < 10
20
10
0
−10
−20
−30
10
20
)Capnograph + Control)/2 )Respiration per Minute)
Hospitalized Pediatric Subjects: Capnograph vs. Control (manual count)
+ 1 RPM
+ 2 RPM
+ 3 RPM
30
40
50
Control )Respiration per Minute)
Bias=0.23, STDEV=3.29
30
40
50
70.2%
83.4%
89.3%
75
60
70
60
70
Coverage
RAM
Capnograph
51.8%
73.4%
84.3%
8995B-eIFU-1115
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