Testing Summary - Nonin 7500FO Manual Del Operador

Testing Summary

SpO accuracy, and low perfusion testing were conducted by NONIN
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Medical, Inc., as described below:
SpO Accuracy Testing
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SpO accuracy testing is conducted during induced hypoxia studies on
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healthy, non-smoking, light- to dark-skinned subjects during motion and
no-motion conditions in an independent research laboratory. The
measured arterial hemoglobin saturation value (SpO
compared to arterial hemoglobin oxygen (SaO
blood samples with a laboratory co-oximeter. The accuracy of the sensors
in comparison to the co-oximeter samples measured over the SpO
of 70 - 100%. Accuracy data is calculated using the root-mean-squared
(A value) for all subjects, per ISO 9919:2005, Medical Electrical
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Equipment—Particular requirements for the basic safety and essential
performance of pulse oximeter equipment for medical use.
Low Perfusion Testing
This test uses an SpO
adjustable amplitude settings at various SpO
read. The oximeter must maintain accuracy in accordance with
ISO 9919:2005 for heart rate and SpO
amplitude (0.3% modulation).
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Simulator to provide a simulated pulse rate, with
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2
) of the sensors is
2
) value, determined from
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levels for the oximeter to
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at the lowest obtainable pulse
Technical Information
range
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