ZOLL E Series, Operator'S Manual, Page: 120 / 133

9650-1210-01 Rev. T A-21
Figure A-19. Rectilinear Biphasic Waveforms at 2 Joules
Figure A-20. Rectilinear Biphasic Waveforms at 1 Joules
Clinical Trial Results for the Biphasic Waveform
The efficacy of ZOLL’s Rectilinear Biphasic waveform has been clinically verified during a study of defibrillation of
Ventricular Fibrillation (VF)/Ventricular Tachycardia (VT). A feasibility study was performed initially for defibrillation of
VF/VT (n=20) on two separate groups of patients to ensure waveform safety and energy selection. Subsequently, a
separate, multi-center, randomized clinical trial was performed to verify the waveform’s efficacy. A description of this
study is provided below. The study was performed using ZOLL defibrillation systems consisting of ZOLL defibrillators,
the ZOLL Rectilinear Biphasic Waveform and ZOLL Multi-Function pads.
Randomized Multi-Center Clinical Trial for Defibrillation of

Ventricular Fibrillation (VF) and Ventricular Tachycardia (VT)
Overview: The defibrillation efficacy of ZOLL’s Rectilinear Biphasic waveform was compared to a monophasic damped
sine waveform in a prospective, randomized, multi-center study of patients undergoing ventricular defibrillation for VF/
VT during electro-physiological studies, ICD implants and tests. A total of 194 patients were enrolled in the study. Ten
(10) patients who did not satisfy all protocol criteria were excluded from the analysis.
Objectives: The primary goal of this study was to compare the first shock efficacy of the 120 J rectilinear biphasic
waveform with a 200 J monophasic waveform. The secondary goal was to compare all shock (three consecutive 120,
150, 170 J) efficacy of the rectilinear biphasic waveform with that of a monophasic waveform (three consecutive 200,
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