Testing Summary; Spo 2 Accuracy Testing; Pulse Rate Motion Testing; Low Perfusion Testing - Nonin 9847 Operator's Manual

Technical Information
Example - SpO Exponential Averaging
2
SpO decreases 0.75% per second (7.5% over 10 seconds)
2
Pulse Rate = 75 BPM
Specific to this example:
• The response of the 4-beat average is 1.5 seconds.

Testing Summary

SpO accuracy, and low perfusion testing was conducted by Nonin Medical, Inc., as described below:
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SpO Accuracy Testing
2
SpO accuracy testing is conducted during induced hypoxia studies on healthy, non-smoking, light- to
2
dark-skinned subjects during motion and no-motion conditions in an independent research laboratory.
The measured arterial hemoglobin saturation value (SpO
hemoglobin oxygen (SaO
accuracy of the sensors in comparison to the co-oximeter samples measured over the SpO
70% to 100%. Accuracy data is calculated using the root-mean-squared (A
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
2
various SpO levels for the oximeter to read. The oximeter must maintain accuracy in accordance with
2
ISO 80601-2-61 for heart rate and SpO
SaO2 Reference
100
95
90
85
80
75
70
65
60
) value, determined from blood samples with a laboratory co-oximeter. The
2
Simulator to provide a simulated pulse rate, with adjustable amplitude settings at
at the lowest obtainable pulse amplitude (0.3% modulation).
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4 Beat Average
Tim e in seconds
) of the sensors is compared to arterial
2
range of
2
value) for all subjects, per
rms
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