Aulisa Guardian Angel Rx GA2000, Instructions For Use Manual

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The graph below shows the error (SpO
2
-SaO
2
) plots of each subject
measured by the Aulisa GA2000 with upper and lower 95% limits of
agreement. Each sample data point is from a clinical study in healthy
adult volunteers.
2
2
2
Equipment Delay (Seconds)
Data Averaging ≤ 4 seconds
Alarm Condition Delay ≤ 4 seconds
Alarm Signal Generation Delay 0 seconds
Data Update Period
1 second
Pulse Rate Accuracy
Pulse rate accuracy has been functionally tested against an electronic
pulse simulator at 30, 50, 80, 100, 150, 200, 250, and 290 bpm, with
combinations of Pulse Amplitude settings of 0.5, 1, 3, 5, 7, 10, 13, 15,
17 and 20, and SpO
2
settings of 100%, 90%, 80%, 70%, 60%, 50%,
40%, 30%, 20%, 10%, and 1%. All 880 combinations of testing points
(=8 x 10 x 11) of Pulse Rate passed the ± 3% acceptance criteria.
Equipment Response Time
Aulisa GA2000 Digital Vital Sign Monitoring System uses a moving
average to determine the Pulse Rate and SpO
2
. The following table
shows the equipment response time of Aulisa GA2000 Digital Vital
Sign Monitoring System.
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