Clinical Study; Overview; Methods - Covidien Nellcor OxiMax N-600x Operator's Manual

Clinical Study

Overview

Methods

N-600x Operator's Manual
This section contains data from the clinical study conducted for
the Nellcor™ sensors used with the Nellcor™ N-600X Pulse
Oximeter.
One (1) prospective, controlled hypoxia clinical study was
conducted to demonstrate the accuracy of Nellcor™ sensors
when used in conjunction with the Nellcor™ N-600X Pulse
Oximeter. The study was performed with healthy volunteers at a
single clinical laboratory. Accuracy was established by comparison
to CO-oximetry.
Data from 11 healthy volunteers were included in the analysis.
Sensors were rotated on digits and brow to provide a balanced
study design. SpO values were continuously recorded from each
2
instrument while inspired oxygen was controlled to produce five
steady state plateaus at target saturations of approximately 98,
90, 80, 70 and 60%. Six arterial samples were taken 20 seconds
apart at each plateau resulting in a total of approximately 30
samples per subject. Each arterial sample was drawn over two (2)
respiratory cycles (approximately 10 seconds) while SpO
were simultaneously collected and marked for direct comparison
to CO . Each arterial sample was analyzed by at least two of the
2
three IL CO-oximeters and a mean SaO
sample. End tidal CO , respiratory rate, and respiratory pattern
2
were continuously monitored throughout the study.
Clinical Study
data
2
was calculated for each
2
187