Physio Control LIFEPAK 20, Manual

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SpO2 Clinical Validation Summaries
F-2 LIFEPAK 20e Defibrillator/Monitor Operating Instructions
NELLCOR CLINICAL VALIDATION DATA
Nellcor conducted clinical studies and tests to assess the accuracy of the SpO
2
measurement
function of the Nellcor SpO
2
sensors. The following paragraphs provide a summary of that data.
Test Methods for Accuracy
SpO
2
accuracy specifications for Nellcor sensors are based on controlled hypoxia studies with
healthy nonsmoking adult volunteers over the specified saturation SpO
2
range. Pulse oximeter
SpO
2
readings were compared to SaO
2
values of drawn blood samples measured by
hemoximetry.
Subjects used to validate SpO
2
measurement accuracies were healthy and recruited from the
local population. The study group comprised both men and women; subjects spanned a range of
skin pigmentations and ranged in age from 18-50 years old. When sensors are used on neonatal
subjects as recommended, the specified accuracy is decreased by ±1%, as compared to adult
usage, to account for the theoretical effect on oximeter measurements of fetal hemoglobin in
neonatal blood.