19
The graph below shows the error (SpO
2
– SaO
2
) plots of each subject measured by
this device
with upper and lower 95% limits of agreement. Each sample data point is
from a clinical study in healthy volunteers.
Pulse Rate Accuracy
Pulse rate accuracy has been functionally tested against an electronic pulse simulator
from 30 to 300 bpm in 10bpm intervals, with combinations of Pulse Amplitude
settings of 0.5, 1, 3, 5, 7, 10, 12, 15, 17 and 20, and SpO
2
settings of 100%, 95%, 90%,
85%, 80%, 75% and 70%. All 1960 combinations of testing points (=7 x 28 x 10) of
Pulse Rate passed the ± 3 digits acceptance criteria.
Equipment Response Time
This device
uses a moving average to determine the pulse rate and SpO
2
. The
following table shows the equipment response time of
this device
.
Equipment Delays (second)
Data Averaging
≤ 4 seconds
Alarm Condition Delay
≤ 4 seconds
Alarm Signal Generation Delay
0 second
Data Update Period
1 second
