Physio Control LIFEPAK 20, Manual

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Ap
pendix F
SpO2 Clinical Validation Summaries
LIFEPAK 20e Defibrillator/Monitor Operating Instructions F-1
©2006-2015 Physio-Control, Inc.
MASIMO CLINICAL VALIDATION DATA
Masimo Corporation conducted clinical studies and tests to assess the accuracy of the SpO
2
measurement function. The following paragraphs provide a summary of that data.
Test Methods for Accuracy
SpO
2
accuracy was determined by testing on healthy adult volunteers in the range of 60-100%
against a laboratory CO-oximeter. SpO
2
accuracy was determined on 16 neonatal intensive care
patients ranging in age from 7-135 days old and weighing between 0.5-4.25 kg. Seventy-nine
(79) data samples were collected over a range of 70-100% SaO
2
with a resultant accuracy of
2.9% SpO
2
.
The Masimo sensors have been validated for no motion accuracy in human blood studies on
healthy adult male and female volunteers with light to dark skin pigmentation in induced hypoxia
studies in the range of 70-100% SpO
2
against a laboratory CO-oximeter and ECG monitor. This
variation equals plus or minus one standard deviation. Plus or minus one standard deviation
encompasses 68% of the population weight.
The Masimo sensors have been validated for motion accuracy in human blood studies on
healthy adult male and female volunteers with light to dark skin pigmentation in induced hypoxia
studies while performing rubbing and tapping motions at 2 to 4 Hz at an amplitude of 1 to 2 cm,
and a non-repetitive motion between 1 to 5 Hz at an amplitude of 2 to 3 cm in induced hypoxia
studies in the range of 70-100% SpO
2
against a laboratory CO-oximeter and ECG monitor. This
variation equals plus or minus one standard deviation which encompasses 68% of the
population.
The Masimo sensors have been validated for pulse rate accuracy for the range of 25-240 bpm in
bench top testing against a Biotek Index 2 simulator. This variation equals plus or minus one
standard deviation which encompasses 68% of the population.