Covidien Nellcor OxiMax N-600x, Руководство оператора

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Operator’s Manual
131
A Clinical Study
Overview
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.
Methods
Data from 11 healthy volunteers were included in the analysis. Sensors were rotated
on digits and brow to provide a balanced study design. SpO
2
values were
continuously recorded from each 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
2
data
were simultaneously collected and marked for direct comparison to CO
2
. Each
arterial sample was analyzed by at least two of the three IL CO-oximeters and a mean
SaO
2
was calculated for each sample. End tidal CO
2
, respiratory rate, and respiratory
pattern were continuously monitored throughout the study.