Testing Summary; Spo 2 Accuracy Testing; Pulse Rate Motion Testing; Low Perfusion Testing - Nonin WristOx2 3150 Operator's Manual

Technical Information

Testing Summary

SpO accuracy and low perfusion testing was conducted by Nonin Medical, Inc., as described
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below.
SpO Accuracy Testing
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During motion and no-motion conditions at an independent research laboratory, SpO accuracy
2
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
2
(SaO ) value, determined from blood samples with a laboratory co-oximeter. The accuracy of
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the sensors in comparison to the co-oximeter samples measured over the SpO range of 70 –
2
100%. Accuracy data is calculated using the root-mean-squared (A value) for all subjects,
rms
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
2
settings at various SpO levels for the oximeter to read. The oximeter must maintain accuracy
2
in accordance with ISO 80601-2-61 for heart rate and SpO at the lowest obtainable pulse
2
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 ) from this color difference by measuring the
2
ratio of absorbed red and infrared light as volume fluctuates with each pulse.
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