Philips M5066A owner manual ECG Analysis Performance

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

	meets AHA recommendationsb for adult defibrillation
ECG test	observed	90% one-sided
samplea 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

E-6