Shockable Rhythm Criteria
When placed on a patient meeting the indications for use criteria, the DDU-2000 Series AED is designed to recommend
a defibrillation shock when it detects proper pad impedance and one of the following:
Ventricular Fibrillation:
Peak-to-peak amplitude at least 200 µVolts.
Some very low amplitude or low frequency VF rhythms may not be interpreted as shockable.
Ventricular Tachycardia
(Including ventricular flutter and polymorphic VT):
Cardiac rhythm rate of at least 180 bpm and peak-to-peak amplitude at least 200 µVolts.
Some very low amplitude or low frequency VT rhythms may not be interpreted as shockable.
The DDU-2000 Series AED is designed to recommend
no
shock for all other rhythms, including Normal Sinus
Rhythms, fine Ventricular Fibrillation (<200 µVolts), and some slow Ventricular Tachycardia and Asystole.
Patient Analysis System Performance
Rhythm Class
ECG Test
Sample
1
Size
Algorithm Performance
3
Specifications
Performance
2
90% Lower
Confidence Limit
2
Shockable Rhythm –
Ventricular Fibrillation
227
>97%
>95%
Meets the AAMI
DF80 requirement
and AHA
recommendation
2
of
Sensitivity > 90%
Shockable Rhythm –
Ventricular Tachycardia
101
99%
>97%
Meets the AAMI
DF80 requirement
and AHA
recommendation
2
of
Sensitivity > 75%
Non-Shockable
Rhythm – Normal
Sinus Rhythm
213
100%
100%
Meets the AAMI
DF80 requirement
of Specificity
>95% and the AHA
recommendation
2
of
Specificity > 99%
Non-Shockable
Rhythm – Asystole
113
100%
100%
Meets the AAMI
DF80 requirement
and the AHA
recommendation
2
of
Specificity > 95%
Non-Shockable
Rhythm – All other
non-shockable
rhythms
248
>99%
>98%
Meets the AAMI
DF80 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.
3. Schneider T, Martens PR, Paschen H, et al. Multicenter, randomized, controlled trial of 150 J 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.
Note
: Additional information available upon request.
WARNING
WARNING
11
.
Tec
hnical Specifications
Defibtech DDU-2000 Series AED (continued)
57
DAC-E2510EN-BA
