Welch Allyn AED 10 - Rhythm Recognition Performance

User Manual Specifications 73
Rhythm Recognition Performance
Standards
The Welch Allyn AED 10 algorithm exceeds the requirements of ANSI/AAMI DF39-1993
section 3.3.18 and the sensitivity and specificity levels recommended by the AHA
Automatic External Defibrillators for Public Access Use: Recommendations for Specifying
and Reporting Arrhythmia Analysis Algorithm Performance. The test database includes
shockable rhythms consisting of ventricular fibrillation rhythms (> 99 υV) and wide-
complex ventricular tachycardia at a rate greater than 160 BPM. Non-shockable rhythms
include various sinus rhythms including supraventricular tachycardia, atrial fibrillation, atrial
flutter, sinus rhythm with PVC’s, asystole, pacemaker rhythms, and ventricular tachycardia
with a rate less than 160 BPM and/or narrow complexes.
Performance
Rhythm Class ECG Test
Sample Size
Performance Goal 90% one-sided
lower confidence
level
Conclusion
Shockable: VF 90 >90% sensitivity 97.2% Meets the AAMI DF39
requirement and AHA
recommendation
Shockable: VT 33 >75% sensitivity 84.6% Meets the AAMI DF39
requirement and AHA
recommendation
Nonshockable: NSR 349 >99% specificity
(AHA)
100% Meets the AAMI DF39
requirement and AHA
recommendation
Nonshockable:
asystole
10 >95% specificity 100% Meets the AAMI DF39
requirement and AHA
recommendation
Nonshockable: all
other rhythms
242 >95% specificity 97.8% Meets the AAMI DF39
requirement and AHA
recommendation