Philips M5066A owner manual ECG analysis performance

E-6

ECG analysis performance

rhythm class

shockable rhythm — ventricular fibrillation

shockable rhythm — ventricular tachycardia

non-shockable rhythm — normal sinus rhythm

non-shockable rhythm — asystole

non-shockable rhythm — all other non-shockable rhythmsc

ECG test			meets AHA recommendationsb for adult defibrillation
			observed	90% one-sided
sample	a	size
			performance	lower confidence limit
300			sensitivity >90%	(87%)
			(meets AAMI DF80 requirement)
100			sensitivity >75%	(67%)
			(meets AAMI DF80 requirement)
300			specificity >99%	(97%)
			(meets AAMI DF80 requirement)
100			specificity >95%	(92%)
			(meets AAMI DF80 requirement)
450			specificity >95%	(88%)
			(meets AAMI DF80 requirement)

Philips

a.From Philips Medical Systems Heartstream ECG rhythm databases.

b.American Heart Association (AHA) AED Task Force, Subcommittee on AED Safety & Efficacy. Automatic External Defibrillators for Public Access Use: Recommendations for Specifying and Reporting Arrhythmia Analysis Algorithm Performance, Incorporation of New Waveforms, and Enhancing Safety. Circulation 1997;95:1677-1682.

c.Supraventricular tachycardia (SVT) is specifically included in the non-shockable rhythm class, in accordance with AHA recommendationsb and the AAMI standard DF80.

Medical Systems

HEARTSTART M5066A