title: Bench study of the accuracy of a commercial AED arrhythmia analysis algorithm in the presence of electromagnetic interferences.
abstract: This paper presents a bench study on a commercial automated external defibrillator (AED). The objective was to evaluate the performance of the defibrillation advisory system and its robustness against electromagnetic interferences (EMI) with central frequencies of 16.7, 50 and 60 Hz. The shock advisory system uses two 50 and 60 Hz band-pass filters, an adaptive filter to identify and suppress 16.7 Hz interference, and a software technique for arrhythmia analysis based on morphology and frequency ECG parameters. The testing process includes noise-free ECG strips from the internationally recognized MIT-VFDB ECG database that were superimposed with simulated EMI artifacts and supplied to the shock advisory system embedded in a real AED. Measurements under special consideration of the allowed variation of EMI frequency (15.7-17.4, 47-52, 58-62 Hz) and amplitude (1 and 8 mV) were performed to optimize external validity. The accuracy was reported using the American Heart Association (AHA) recommendations for arrhythmia analysis performance. In the case of artifact-free signals, the AHA performance goals were exceeded for both sensitivity and specificity: 99% for ventricular fibrillation (VF), 98% for rapid ventricular tachycardia (VT), 90% for slow VT, 100% for normal sinus rhythm, 100% for asystole and 99% for other non-shockable rhythms. In the presence of EMI, the specificity for some non-shockable rhythms (NSR, N) may be affected in some specific cases of a low signal-to-noise ratio and extreme frequencies, leading to a drop in the specificity with no more than 7% point. The specificity for asystole and the sensitivity for VF and rapid VT in the presence of any kind of 16.7, 50 or 60 Hz EMI simulated artifact were shown to reach the equivalence of sensitivity required for non-noisy signals. In conclusion, we proved that the shock advisory system working in a real AED operates accurately according to the AHA recommendations without artifacts and in the presence of EMI. The results may be affected for specificity in the case of a low signal-to-noise ratio or in some extreme frequency setting.
authors.affiliation: Centre of Biomedical Engineering, Bulgarian Academy of Sciences, Acad. G. Bonchev Str. Bl 105, 1113 Sofia, Bulgaria. irena@clbme.bas.bg
authors.forename: Irena
authors.initials: I
authors.lastname: Jekova
authors.forename: Vessela
authors.initials: V
authors.lastname: Krasteva
authors.forename: Sarah
authors.initials: S
authors.lastname: Ménétré
authors.forename: Todor
authors.initials: T
authors.lastname: Stoyanov
authors.forename: Ivaylo
authors.initials: I
authors.lastname: Christov
authors.forename: Roman
authors.initials: R
authors.lastname: Fleischhackl
authors.forename: Johann-Jakob
authors.initials: JJ
authors.lastname: Schmid
authors.forename: Jean-Philippe
authors.initials: JP
authors.lastname: Didon
mesh_terms: D000465:Algorithms; D001145:Arrhythmias, Cardiac / Q000175:diagnosis*; D047548:Defibrillators / Q000592:standards*; D004562:Electrocardiography; D004574:Electromagnetic Fields; D006801:Humans