AED HeartPlus NT-180 - Characteristic of Ecg Analysis

Section IV - Appendix
52
Characteristic of ECG Analysis
ECG analysis accuracy
ECG Rhythm Class
AAMI DF39
requirment¹
Observed
performance
Validation
results²
90% one-sided
Lower confidence
limit¹
Shockable
VF
Sensitivity>90%
95% (n=200)
87%
VT
Sensitivity>75%
78% (n=50)
67%
Non-
shockable
Normal
sinus
rhythm
Specificity>99%
100% (n=150)
97%
Asystole
Specificity>95%
100% (n=100)
92%
Others
Specificity>95%
96% (n=50)
88%
1. American heart Association (AHA) AED Task Force, Subcommittee on
AED Safety & Efficacy. Automatic External Defibrillators for Public
Access Us: Recommendations for Specifying and Reporting Arrhythmia
Analysis Algorithm Performance, Incorporation of New Waveforms, and
Enhancing Safety. Circulation March 18, 1997 vol. 95 no. 6 1677-1682.
2. From MIT-BIH ECG arrhythmia database. (http://ecg.mit.edu/)