Masimo Rainbow - Respiration Rate Accuracy

72
8995B-eIFU-1115
Resperation Rate Accuracy
Accuracy data was obtained from a comparison of a manual count of respiratory rate in healthy adult subjects and in hospitalized pediatric
subjects for whom post-operative monitoring of respiratory rate was indicated.
Respiration rate accuracy for the rainbow Acoustic Monitoring sensor and instrument has been validated for the range of 4 to 70 breaths per
minute in bench top testing. Clinical validation was performed with the RAS-125 and RAS-125c sensors and instrument for up to 30 breaths per
minute in adult subjects >30 kg, and up to 50 breaths per minute in hospitalized pediatric subjects, age 2 years or older and >10 kg.
RAS-125 RAS-125c
NON
STERILE
LATEX
Title: Graphics, Sensor/Cable symbols, 03/06
GR-14231
DRO-13914
-40 C
+70 C
+1060 hPa - +500 hPa
795 mmHg - 375 mmHg
5%-95% RH
5%
95%
%
Body Weight
Adult > 30 kg Adult, Pediatric > 10 kg
Application Site Neck Neck
Breaths per Minute, Accuracy Range 4 to 70 ± 1 breath per minute 4 to 70 ± 1 breath per minute
The following plots graph the results for the healthy adult subjects vs. the control method:
5 10 15 20 25 30 35 40
5
10
15
20
25
30
35
40
0 < Number of Samples < 10
10 ≤ Number of Samples < 100
100 ≤ Number of Samples
Control (Respiration per Minute)
RAM (Respiration per Minute)
Healthy Adult Subjects: RAS-125 vs. Control (manual count)
5 10 15 20 25
−30
−20
−10
0
10
20
30
40
Bias=0.18, STDEV=1.31
(RAM + Control)/2 (Respiration per Minute)
RAM − Control (Respiration per Minute)
0 < Number of Samples < 10
10 ≤ Number of Samples < 100
100 ≤ Number of Samples < 1000
1000 ≤ Number of Samples
Healthy Adult Subjects: RAS-125 vs. Control (manual count)