B40/B20 Patient Monitor13-10• Electromagnetic interference (EMI)• Ventilator-induced pressure changesSpO2 functional testersSome models of commercially available bench-top functional testers and patient simulatorscan 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 thesystem’s SpO2 measurements.Many functional testers and patient simulators have been designed to interface with the pulseoximeter’s expected calibration curves, and may be suitable for use with the pulse oximetermonitor and sensors. Not all devices, however, are adapted for use with all digital calibrationsystems. While this will not affect use of the simulator for verifying system functionality,displayed SpO2 measurement values may differ from the setting of the device. For a properlyfunctioning monitor, this difference will be reproducible over time and from monitor to monitorwithin the performance specifications of the test device.GE Trusignal technology clinical studies on neonatalGE Oxy-AF and GE Oxy-SE sensors have been validated for neonatal accuracy. The subjectdemographics included 28 neonates and 1 infant (15 females and 14 males). The subjectsranged in age from newborn to 37 days old. The weights ranged from 560 to 3060 g. The skintones included in the study were light to dark. For neonatal study, the Arms of the collectedconvenience samples are 2.7, Oxy-AF sensor in the SaO2 range of 87-100% collected 52 datapoints, Oxy-SE sensor in the SaO2 range of 81-100% collected 53 data points.Bland-Altman graphical plot analysis on blood test resultsLinear regression graphical plot of TruSignal V2 SpO 2 Test DataBland-Altman graphs with a linear regression fit and the upper 95% and lower 95% limits ofagreement (Mean ± 1.96 * standard deviation) are given below.For each graph, the subjects are differentiated with different color and style. Figure 1 to Figure8 represent different sensors under test.
