Philips HeartStart OnSite M5066A - rhythm class; ECG test sample size; meets AHA recommendations for adult defibrillation; observed performance

PHILIPS MEDICAL SYSTEMS
E-6
ECG ANALYSIS PERFORMANCE
rhythm class
ECG test
sample
a
size
meets AHA recommendations
b
for adult defibrillation
observed performance
90% one-sided
lower confidence
limit
shockable rhythm —
ventricular fibrillation
300 sensitivity >90%
(meets AAMI DF80
requirement)
(87%)
shockable rhythm —
ventricular tachycardia
100 sensitivity >75%
(meets AAMI DF80
requirement)
(67%)
non-shockable rhythm —
normal sinus rhythm
300 specificity >99%
(meets AAMI DF80
requirement)
(97%)
non-shockable rhythm —
asystole
100 specificity >95%
(meets AAMI DF80
requirement)
(92%)
non-shockable rhythm — all
other non-shockable
rhythms
c
450 specificity >95%
(meets AAMI DF80
requirement)
(88%)
a. From Philips Medical Systems 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
recommendations
b
and the AAMI standard DF80.