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Technical Information
Testing Summary
SpO
2
accuracy, and low perfusion testing were conducted by Nonin Medical, Inc., as described
below:
SpO
2
Accuracy Testing
During motion and no-motion conditions in an independent research laboratory, SpO
2
accuracy
testing is conducted during induced hypoxia studies on healthy, male and female, non-smoking,
light- to dark-skinned subjects that are 18 years of age and older. 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 80601-2-61, 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 80601-2-61 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 80601-2-61 for heart rate and SpO
2
at the lowest obtainable pulse
amplitude (0.3% modulation).
Principles of Operation
Pulse oximetry is a non-invasive method that passes red and infrared light through perfused
tissue and detects the fluctuating signals caused by arterial pulses. Well-oxygenated blood is
bright red, while poorly oxygenated blood is dark red. The pulse oximeter determines functional
oxygen saturation of arterial hemoglobin (SpO
2
) from this color difference by measuring the ratio
of absorbed red and infrared light as volume fluctuates with each pulse.
