GE HEALTHCARE B20, User'S Reference Manual

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B40/B20 Patient Monitor
13-10
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Electromagnetic interference (EMI)
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Ventilator-induced pressure changes
SpO2 functional testers
Some models of commercially available bench-top functional testers and patient simulators
can be used to verify proper functionality of pulse oximeter sensors, cables and monitors.
While such devices may be useful for verifying that the pulse oximetry system is functional,
they are incapable of providing the data required to properly evaluate the accuracy of the
system’s SpO
2
measurements.
Many functional testers and patient simulators have been designed to interface with the pulse
oximeter’s expected calibration curves, and may be suitable for use with the pulse oximeter
monitor and sensors. Not all devices, however, are adapted for use with all digital calibration
systems. While this will not affect use of the simulator for verifying system functionality,
displayed SpO
2
measurement values may differ from the setting of the device. For a properly
functioning monitor, this difference will be reproducible over time and from monitor to monitor
within the performance specifications of the test device.
GE Trusignal technology clinical studies on neonatal
GE Oxy-AF and GE Oxy-SE sensors have been validated for neonatal accuracy. The subject
demographics included 28 neonates and 1 infant (15 females and 14 males). The subjects
ranged in age from newborn to 37 days old. The weights ranged from 560 to 3060 g. The skin
tones included in the study were light to dark. For neonatal study, the Arms of the collected
convenience samples are 2.7, Oxy-AF sensor in the SaO2 range of 87-100% collected 52 data
points, Oxy-SE sensor in the SaO2 range of 81-100% collected 53 data points.
Bland-Altman graphical plot analysis on blood test results
Linear regression graphical plot of TruSignal V2 SpO
2
Test Data
Bland-Altman graphs with a linear regression fit and the upper 95% and lower 95% limits of
agreement (Mean ± 1.96 * standard deviation) are given below.
For each graph, the subjects are differentiated with different color and style. Figure 1 to Figure
8 represent different sensors under test.