Masimo Stork Vitals+ - Oxygen Level (SpO2) ARMS Performance Specifications

Stork Vitals+ Appendix
Masimo Corporation 46 www.masimo.com
Oxygen Level (SpO2) ARMS Performance Specifications
The tables below provide the A
RMS
(Accuracy Root Mean Square) values for the Stork as
compared to Masimo RD SET Adhesive sensors under no motion clinical testing. A total of 30
subjects, 14 dark skinned and 16 light skinned, were tested.
Measurement
ARMS
Values for Masimo Stork to RD SET Adhesive Sensor
SpO
2
Accuracy Range (%) A
RMS
(%)
90-100 0.75
80-90 1.04
70-80 1.75
70-100 1.24
The below Bland-Altman plot represents the distribution of points in the difference between
the Masimo Stork and the RD SET Adhesive reference (SpO
2
– SpO
2Ref
) versus the reference
(SpO
2Ref
) under no motion with an upper 95% and lower 95% limits of agreement.
Figure 1: Masimo Stork (70-100%)
The tables below provide the A
RMS
(Accuracy Root Mean Square) values for the Masimo RD
SET Adhesive sensors to Arterial Blood References (SaO
2
) under no motion clinical testing.
Measurement A
RMS
Values for RD SET Adhesive Sensors to Arterial Blood References (SaO
2
)
SpO
2
Accuracy Range (%) A
RMS
(%)
90-100 0.83
80-90 1.11
70-80 1.53
70-100 1.16