Testing Summary; Spo 2 Accuracy Testing; Pulse Rate Accuracy Testing; Low Perfusion Accuracy Testing - Nonin LS1 Operator's Manual

Specific to this example, the response of the 4 beat-average is 1.5 seconds.
CAUTION: A functional tester cannot be used to assess the accuracy of a pulse
!
oximeter monitor or sensor.

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-
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to-dark-skinned subjects during motion and no-motion conditions in an independent research
laboratory. The measured arterial hemoglobin saturation value (SpO
arterial hemoglobin oxygen (SaO
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 (A
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all subjects, per ISO 80601-2-61, Standard Specification for Pulse Oximeters for Accuracy.

Pulse Rate Accuracy Testing

This test measured pulse rate oximeter accuracy with and without 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 Accuracy Testing

This test uses an SpO
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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 pulse rate and SpO
(0.3% modulation).
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) value, determined from blood samples with a laboratory co-
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Simulator to provide a simulated pulse rate, with adjustable amplitude settings
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at the lowest obtainable pulse amplitude
Technical Information
) of the sensors is compared to
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rms
value) for