B40/B20 Patient Monitor11-14Arrhythmia detectionSafety precautionsWarnings• LOSS OR DETERIORATION OF ARRHYTHMIA DETECTION -Automated arrhythmia analysisprograms may incorrectly identify the presence or absence of an arrhythmia. A physicianmust therefore interpret the arrhythmia information in conjunction with other clinicalfindings. Please take special note of the following ECG waveform conditions:− Noisy waveforms. Noisy portions of ECG waveforms are typically excluded fromanalysis. The exclusions are necessary to reduce the occurrence of inaccurate beatinterpretations and/or rhythm alarms. If the excluded noisy portions of the ECGwaveform contain true arrhythmia events, those events may remain undetected bythe system.− Beat amplitude and duration. Accurate detection and interpretation of beatsbecomes increasingly difficult as the amplitude and/or duration of those beatsapproach the design limits of the analysis program. Thus, as beats becomeextremely wide or narrow, or especially as beats become small, arrhythmiainterpretation performance may degrade.− Other morphology considerations. Automated arrhythmia detection algorithms aredesigned fundamentally to detect significant changes in QRS morphology. If anarrhythmia event is present and does not exhibit a significant change from thepatientís predominant morphology, it is possible for those events remainundetected by the system.• SUSPENDED ANALYSIS - Certain conditions suspend arrhythmia analysis. Whensuspended, arrhythmia conditions are not detected and alarms associated witharrhythmias do not occur.The messages which alert you to the conditions causingsuspended arrhythmia analysis are: 'Arrhythmia Paused', ‘Leads off’ and ‘Patientdischarged’.• Always monitor ECG for arrhythmia detection purposes. HR calculated from pulsatileSpO 2 waveform may differ significantly from ECG HR measured values. Users should beaware that the “SpO2 probe off” and “No SpO2 pulse” technical alarms escalate no higherthan a Medium priority.• Artifact and arrhythmia paused alarm - The artifact and arrhythmia paused alarmindicates that the system is no longer monitoring ECG and there may be no Tachy orBrady alarms.NOTES:• Since the arrhythmia detection algorithm sensitivity and specificity is less than 100%,sometimes there may be some false arrhythmias detected and also some truearrhythmia events may not be detected. This is especially true when the signal is noisy.• If QRS amplitude is low, the monitor might not be able to calculate HR and false Asystolemay occur.• During the learning phase of the algorithm, arrhythmia detection may not be available. Asa result, the patient condition should be closely monitored during the learning phase and
