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A Clinical Studies
A.1 Overview
This appendix contains data from clinical studies conducted for the Nellcor™
sensors used with the Nellcor™ Bedside SpO
2 Patient Monitoring System.
One (1) prospective, controlled hypoxia clinical study was conducted to demon-
strate the accuracy of Nellcor™
sensors
when used in conjunction with the
Nellcor™ Bedside Respiratory Patient Monitoring System. The study was per-
formed with healthy volunteers at a single clinical laboratory. Accuracy was estab-
lished by comparison to CO-oximetry.
A.2 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 approx-
imately 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 sub-
ject. Each arterial sample was drawn over two (2) respiratory cycles (approxi-
mately 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 mon-
itored throughout the study.
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