Covidien Nellcor Series, Руководство оператора

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A-1
A Clinical Studies
A.1
Overview
Prospective clinical studies were conducted in accordance with EN ISO 80601-2-
61:2011 using a Nellcor™ monitoring system containing identical algorithms and
SpO
2
circuitry to the Nellcor™ bedside SpO
2
patient monitoring system. These
studies demonstrated the accuracy of pulse oximetry for OxiMax™ sensors used with
the Nellcor™ bedside SpO
2
patient monitoring system during both motion and non-
motion conditions.
All referenced studies are internal Covidien clinical studies.
A.2
Methodology
A.2.1
Hypoxia Methodology (Accuracy, Low Saturation, and Motion
Studies)
The general purpose of invasive controlled desaturation study is to validate the
SpO
2
and pulse rate accuracy in comparison to reference-standard measurements
of blood SaO
2
by a CO-oximeter and ECG heart rate. This is achieved through paired
observations of SpO
2
and SaO
2
values over the SaO
2
accuracy range of 70% to 100%
on a group of healthy adult volunteers. The fraction of inspired oxygen (FiO
2
) deliv-
ered to test subjects is varied to achieve a series of targeted steady-state saturation
periods. Arterial blood samples are periodically taken from an indwelling arterial
catheter for use in the comparison.
In accordance to EN ISO80601-2-61:2011, desaturation to 70% is conducted in a
gradual continuous process targeting multiple saturation plateaus (e.g. 98, 90, 80
and 72%). In these studies, six arterial samples were taken, 20 seconds apart at each
plateau, resulting in a total of approximately 24 samples per subject. Each sample
was drawn while SpO
2
data were simultaneously collected and marked for direct
comparison to CO-oximetry. Similarly, pulse rate from SpO
2
was compared to ECG
heart rate.