Testing Summary; Spo 2 Accuracy Testing; Pulse Rate Motion Testing; Low Perfusion Testing - Nonin 8500 Operator's Manual

Technical Information

Testing Summary

SpO accuracy, and low perfusion testing was conducted by Nonin Medical, Inc., as described below:
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SpO Accuracy Testing
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During motion and no-motion conditions at an independent research laboratory, SpO accuracy
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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 ) of the sensors is compared to arterial hemoglobin oxygen (SaO ) value,
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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 range of 70 - 100%. Accuracy data
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is calculated using the root-mean-squared (Arms 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 Simulator to provide a simulated pulse rate, with adjustable amplitude settings
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at various SpO levels for the oximeter to read. The oximeter must maintain accuracy in accordance
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with ISO 80601-2-61 for heart rate and SpO at the lowest obtainable pulse amplitude
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(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 ) from this color difference by measuring the ratio of absorbed
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red and infrared light as volume fluctuates with each pulse.
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