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Technical Information
Testing Summary
SpO
2
accuracy, motion, and low perfusion testing were conducted by
Nonin Medical, Inc., as described below:
SpO
2
Accuracy Testing
SpO
2
accuracy testing is conducted during induced hypoxia studies on
healthy, non-smoking, light- to dark-skinned subjects during motion and
no-motion conditions in an independent research laboratory. The
measured arterial hemoglobin saturation value (SpO
2
) of the sensors is
compared to arterial hemoglobin oxygen (SaO
2
) value, determined from
blood samples with a laboratory co-oximeter. The accuracy of the sensors
in comparison to the co-oximeter samples measured over the SpO
2
range
of 70 - 100%. Accuracy data is calculated using the root-mean-squared
(A
rms
value) for all subjects, per ISO 9919:2005, Medical Electrical
Equipment—Particular requirements for the basic safety and essential
performance of pulse oximeter equipment for medical use.
Pulse Rate Motion Testing
This test measures pulse rate oximeter accuracy with motion artifact
simulation introduced by a pulse oximeter tester. This test determines
whether the oximeter meets the criteria of ISO 9919:2005 for pulse rate
during simulated movement, tremor, and spike motions.
Low Perfusion Testing
This test uses an SpO
2
Simulator to provide a simulated pulse rate, with
adjustable amplitude settings at various SpO
2
levels for the oximeter to
read. The oximeter must maintain accuracy in accordance with
ISO 9919:2005 for heart rate and SpO
2
at the lowest obtainable pulse
amplitude (0.3% modulation).