Testing Summary; Spo 2 Accuracy Testing; Pulse Rate Motion Testing; Low Perfusion Testing - Nonin 9847V 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
100
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:
2
SpO Accuracy Testing
2
SpO accuracy testing is conducted during induced hypoxia studies on healthy, non-smoking, light- to
2
dark-skinned human 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 to 100%. Accuracy data is calculated using the root-mean-squared (A
2
all subjects, per 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
at various SpO levels for the oximeter to read. The oximeter must maintain accuracy in accordance
2
with ISO 80601-2-61 for heart rate and SpO
(0.3% modulation).
SaO2 Reference
95
90
85
80
75
70
65
60
) value, determined from blood samples with a laboratory co-
2
Simulator to provide a simulated pulse rate, with adjustable amplitude settings
2
4 Beat Average
Tim e in seconds
at the lowest obtainable pulse amplitude
) of the sensors is compared to
2
rms
value) for
49