Testing Summary; Spo Accuracy Testing; Low Perfusion Testing - Nonin G02 ARCHIEVE 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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During no-motion conditions at an independent research laboratory, SpO
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
is compared to arterial hemoglobin oxygen (SaO
co-oximeter. The accuracy of the sensors in comparison to the co-oximeter samples measured over the
SpO range of 70 – 100%. Accuracy data is calculated using the root-mean-squared (Arms value) for all
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subjects, per ISO 80601-2-61 and ISO 9919, Medical Electrical Equipment–Particular requirements for the
basic safety and essential performance of pulse oximeter equipment for medical use.

Low Perfusion Testing

This test uses a SpO Simulator to provide a simulated pulse rate, with adjustable amplitude settings at
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various SpO levels for the oximeter to read. The oximeter must maintain accuracy in accordance with
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ISO 80601-2-61 and ISO 9919 for heart rate and SpO
modulation).
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) value, determined from blood samples with a laboratory
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at the lowest obtainable pulse amplitude (0.3%
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accuracy testing is conducted
) of the sensors
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