Physio Control LIFEPAK 15, Руководство по эксплуатации

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Nellcor Clinical Validation Data
260
LIFEPAK 15 Monitor/Defibrillator 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 SpO2 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.