13.07.2015 Views

AED 10 User Manual - Welch Allyn

AED 10 User Manual - Welch Allyn

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<strong>User</strong> <strong>Manual</strong> Specifications 81Rhythm recognition performanceStandardsPerformanceThe <strong>Welch</strong> <strong>Allyn</strong> <strong>AED</strong> <strong>10</strong> algorithm exceeds the requirements of ANSI/AAMI DF39-1993section 3.3.18 and the sensitivity and specificity levels recommended by the AHAAutomated External Defibrillators for Public Access Use: Recommendations forSpecifying and Reporting Arrhythmia Analysis Algorithm Performance. The test databaseincludes shockable rhythms consisting of ventricular fibrillation rhythms (> 99 V) andwide-complex ventricular tachycardia at a rate greater than 160 BPM. Non-shockablerhythms include various sinus rhythms including supraventricular tachycardia, atrialfibrillation, atrial flutter, sinus rhythm with PVC’s, asystole, pacemaker rhythms, andventricular tachycardia with a rate less than 160 BPM and/or narrow complexes.Rhythm ClassECG TestSample SizePerformance Goal90% one-sidedlower confidencelevelConclusionShockable: VF 90 >90% sensitivity 97.2% Meets the AAMI DF39requirement and AHArecommendationShockable: VT 33 >75% sensitivity 84.6% Meets the AAMI DF39requirement and AHArecommendationNonshockable: NSR 349 >99% specificity(AHA)Nonshockable:asystoleNonshockable: allother rhythms<strong>10</strong>0% Meets the AAMI DF39requirement and AHArecommendation<strong>10</strong> >95% specificity <strong>10</strong>0% Meets the AAMI DF39requirement and AHArecommendation242 >95% specificity 97.8% Meets the AAMI DF39requirement and AHArecommendation

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