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
SpO2
SaO2 Reference 4 Beat Average
41
Technical Information
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 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 - 100%. Accuracy data is calculated using the root-mean-squared (A
rms
value) for all
subjects, per ISO 9919:2005, Medical Electrical Equipment—Particular requireme
nts 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 9919:2005 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 9919:2005 for heart rate and SpO
2
at the lowest
obtainable pulse amplitude (0.3% modulation).
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