15.5 Alarm Signal Generation Delay (Time from alarm condition to alarm signal) 74
15.6 SpO2 and Pulse Rate Display Ranges and Performance 74
15.7 Equipment Classification 75
15.8 Power 76
16. Theory of Operation 77
16.1 Pulse Oximeter Theory 77
16.2 Calibration Not Required 78
16.3 Functional Oxygen Saturation 78
16.4 Use of Functional Testers 79
16.5 Clinical SpO2 Accuracy Study Report Summary 79
16.6 In-Home Performance Study Report Summary 82
17. Cybersecurity Information 82
17.1 Ensuring Secure Access 82
17.2 Service Unavailability 83
17.3 Detecting Cybersecurity Events 83
17.4 Keeping Your Device Up To Date 83
17.4.1 Owlet Dream App Updates 83
17.4.2 Firmware Updates 84
18. Biocompatibility 85
19. Symbols Glossary 85