Testing Summary; Spo Accuracy Testing; Pulse Rate Motion Testing; Low Perfusion Testing - Nonin 9570 User Manual

Testing Summary

SpO accuracy and low perfusion testing were conducted by Nonin Medical, Inc., as described below:
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SpO Accuracy Testing
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SpO accuracy testing is conducted during induced hypoxia studies on healthy, non-smoking, light- to dark-
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skinned subjects during motion and no-motion conditions in an independent research laboratory. The measured
arterial hemoglobin saturation value (SpO
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
root-mean-squared (Arms 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 a SpO Simulator to provide a simulated pulse rate, with adjustable amplitude settings at various
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SpO levels for the oximeter to read. The oximeter must maintain accuracy in accordance with ISO 9919:2005
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for heart rate and SpO at the lowest obtainable pulse amplitude (0.3% modulation).
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) of the sensors is compared to arterial hemoglobin oxygen (SaO
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range of 70 - 100%. Accuracy data is calculated using the
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)
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