Covidien Nellcor - Clinical Studies; Study Population; Study Results; Table A-1. Demographic Data

Clinical Studies
104 Operator’s Manual
A.3 Study Population
A.4 Study Results
Accuracy was calculated using the root mean square difference (RMSD).
TableA-1.Demographic Data
Type Class Total
Gender
Male 5
Female 6
Race
Caucasian 8
Hispanic 2
African American 1
Asian 0
Age -- 19-48
Weight -- 108-250
Skin pigment
Very light 2
Olive 5
Dark olive/Medium black 3
Extremely dark/Blue black 1
TableA-2.SpO2 Accuracy for Nellcor™ Sensors vs. CO-oximeters
SpO
2
Decade
MAX-A MAX-N MAX-FAST
Data
Points
Arms Data
Points
Arms Data
Points
Arms
60-70 71 3.05 71 2.89 71 2.22
70-80 55 2.35 55 2.32 55 1.28
80-90 48 1.84 48 1.73 48 1.48
90-100 117 1.23 117 1.68 117 0.98