34
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 were conducted by Nonin Medical, Inc., as described
below:
SpO
2
Accuracy Testing
During motion and no-motion conditions at an independent research laboratory, SpO
2
accuracy
testing is conducted during induced hypoxia studies on healthy, male and female, non-smoking,
light- to dark-skinned subjects that are 18 years of age and older. 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 - 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.
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
Tim e in seconds
Sp
O
2
SaO2 Reference
4 Beat Average