Defibtech DDU-120 Series - Manual (Page 57)

49
DAC-530E-EN-BH
8.1.5.2 Patient Analysis System Performance
Rhythm Class
ECG Test
Sample 1
Size
Algorithm Performance 1
Specifications
Performance 2
90% Lower
Confidence Limit 2
Shockable Rhythm –
Ventricular Fibrillation
227 >98% >97%
Meets the AAMI DF39
requirement and AHA
recommendation 2 of
Sensitivity > 90%
Shockable Rhythm
– Ventricular
Tachycardia
100 99% >97%
Meets the AAMI DF39
requirement and AHA
recommendation 2 of
Sensitivity > 75%
Non-Shockable
Rhythm – Normal
Sinus Rhythm
213 100% 100%
Meets the AAMI DF39
requirement of Specificity
>95% and the AHA
recommendation 2 of
Specificity > 99%
Non-Shockable
Rhythm – Asystole
113 100% 100%
Meets the AAMI DF39
requirement and the AHA
recommendation 2 of
Specificity > 95%
Non-Shockable
Rhythm – All other
non-shockable
rhythms
248 >99% >98%
Meets the AAMI DF39
requirement and the AHA
recommendation 2 of
Specificity > 95%
1. From Defibtech ECG Rhythm Databases.
2. Automatic External Defibrillators for Public Access Defibrillation: Recommendations for
Specifying and Reporting Arrhythmia Analysis Algorithm Performance, Incorporating New
Waveforms, and Enhancing Safety. American Heart Association (AHA) Task Force on
Automatic External Defibrillation, Subcommittee on AED Safety and Efficacy. Circulation,
1997;95:1677-1682.
Note: Additional information available upon request.
8.1.6 Clinical Summary
The DDU-120 AED uses a Biphasic Truncated Exponential waveform with specifications that are
substantially equivalent to the waveform specifications of the device used in the study
* cited
below. The DDU-120 AED has not been the subject of a published clinical study.
8.1.6.1 Background
The objective of this study was to compare AEDs that delivered 150-J biphasic shocks with AEDs
that delivered high-energy (200- to 360-J) monophasic shocks.
* Schneider T, Martens PR, Paschen H, et al. Multicenter, randomized, controlled trial of 150J biphasic
shocks compared with 200- to 360-J monophasic shocks in the resuscitation of out-of-hospital cardiac
arrest victims. Circulation 2000;102:1780-1787.