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.
Summary of Primary Clinical Studies
The final order, Effective Date of Requirement for Premarket Approval for Automated External Defibrillator Systems,
published on January 29, 2015 and republished on February 3, 2015, states that clinical study information can be
leveraged for AEDs from both published studies and clinical data previously submitted to FDA under the 510(k)
process. Defibtech, LLC submitted a comparison of the Defibtech adult and pediatric defibrillation waveforms
for the DDU-100 and DDU-2000 series AEDs and the Philips defibrillation waveforms that were also used for the
original clearance of the Defibtech AEDs. The waveform delivered by the Defibtech and Philip AEDs is a biphasic
truncated, impedance-compensating exponential waveform. The comparison consisted of oscilloscope captures
of the defibrillation waveforms, as shown in the examples below. The waveforms were collected from 25 ohms to
200 ohms in 25 ohms steps. The following electrical parameter measurements and calculations were also included:
• Peak voltage of the leading edge of the first phase
• Peak voltage of the trailing edge of the first phase
• Peak voltage of the trailing edge of second phase
• Peak current of the leading edge of the first phase
• Peak current of the trailing edge of the first phase
• Phase 1 duration
• Phase 2 duration
Examples: Adult waveform at 75 omhs
Defibtech Adult waveform at 75 ohms
Philips Adult waveform at 75 ohms
The waveform data provided by Defibtech demonstrates that the waveforms from Defibtech and Philips are almost
identical. Consequently, the clinical data included in this submission was leveraged from published clinical data
1,2,3
for adult and pediatric uses of the Philips waveforms.
WARNING
WARNING
9.
Tec
hnical Specifications
Defibtech DDU-2000 Series AED (continued)
54
DAC-U2510EN-BF rev H
