Ecg Analysis Performance - Philips HeartStart M5066A Owner's Manual

E-6
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
rhythms
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 recommendations
and the AAMI standard DF80.
HEARTSTART M5066A

ECG analysis performance

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