49
Technical Information
Example - SpO
2
Exponential Averaging
SpO
2
decreases 0.75% per second (7.5% over 10 seconds)
Pulse Rate = 75 BPM
Specific to this example:
• The response of the 4-beat average is 1.5 seconds.
Testing Summary
SpO
2
accuracy, and low perfusion testing was conducted by Nonin Medical, Inc., as described below:
SpO
2
Accuracy Testing
SpO
2
accuracy testing is conducted during induced hypoxia studies on healthy, non-smoking, light- to
dark-skinned human subjects during motion and no-motion conditions in an independent research
laboratory. The measured arterial hemoglobin saturation value (SpO
2
) of the sensors is compared to
arterial hemoglobin oxygen (SaO
2
) value, determined from blood samples with a laboratory co-
oximeter. The accuracy of the sensors in comparison to the co-oximeter samples measured over the
SpO
2
range of 70 to 100%. Accuracy data is calculated using the root-mean-squared (A
rms
value) for
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
Simulator to provide a simulated pulse rate, with adjustable amplitude settings
at various SpO
2
levels for the oximeter to read. The oximeter must maintain accuracy in accordance
with ISO 80601-2-61 for heart rate and SpO
2
at the lowest obtainable pulse amplitude
(0.3% modulation).
60
65
70
75
80
85
90
95
100
0.
0
8.
0
16.
0
24.
0
32.
0
40.
0
48.
0
56.
0
64.
0
72.
0
80.
0
Time in seconds
Sp
O
2
SaO2 Reference
4 Beat Average