Welch Allyn AED 10 User Manual page 82

User Manual
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
Shockable: VF
Shockable: VT
Nonshockable: NSR
Nonshockable:
asystole
Nonshockable: all
other rhythms
ECG Test Performance Goal
Sample Size
90 >90% sensitivity
33 >75% sensitivity
349 >99% specificity
(AHA)
10 >95% specificity
242 >95% specificity
Specifications
90% one-sided Conclusion
lower confidence
level
97.2% Meets the AAMI DF39
requirement and AHA
recommendation
84.6% Meets the AAMI DF39
requirement and AHA
recommendation
100% Meets the AAMI DF39
requirement and AHA
recommendation
100% Meets the AAMI DF39
requirement and AHA
recommendation
97.8% Meets the AAMI DF39
requirement and AHA
recommendation
73