ZOLL M Series Defibrillator Rev E BiPhasic - Manual

9650-0209-01 Biphasic - 1 Rev. E
RECTILINEAR BIPHASIC WAVEFORM
DEFIBRILLATOR OPTION
General Information
Introduction
M Series™ products are available with an advanced electrical design that provides a unique rectilinear biphasic waveform for
defibrillation and cardioversion. With this option, the electrical energy of the defibrillator is delivered in two successive current
(voltage) phases of opposite polarity. This type of defibrillation waveform is commonly called “biphasic”, as opposed to the
earlier “monophasic” damped sine wave common to most commercially available defibrillators.
The ZOLL M Series Rectilinear Biphasic Waveform Defibrillator Option produces a proprietary waveform designed for optimal
clinical performance and tested extensively in multi-center clinical trials. These clinical trials have demonstrated that the
waveform is clinically effective for both defibrillation and synchronized cardioversion.
This insert explains how the M Series Rectilinear Biphasic Waveform Defibrillator Option differs from the monophasic damped
sine wave output of other M Series units. It is to be used in conjunction with the M Series Operator’s Guide. Important safety
information relating to general use of the M Series is located in the “Safety Considerations” section of the
M Series Operator’s Guide.
M Series with Rectilinear Biphasic Waveform Defibrillator Option Indications for Use
The ZOLL M Series Biphasic Option is to be used only by qualified medical personnel for converting Ventricular Fibrillation
(VF), a cardiac rhythm incompatible with life, and/or Ventricular Tachycardias (VT) to sinus rhythm or other cardiac rhythms
capable of producing hemodynamically stable heart beats.
In addition, this product is to be used in the synchronized mode only by qualified medical personnel to terminate Atrial
Fibrillation (AF) at lower energies and currents than monophasic defibrillators. A qualified physician must decide when
synchronized cardioversion is appropriate.
This product is also to be used in the synchronized mode only by qualified medical personnel to terminate Ventricular
Tachycardias (VT). A qualified physician must decide when synchronized cardioversion is appropriate.
The Rectilinear Biphasic Waveform (RBW) has been successfully tested in multi-center, prospective, randomized,
transthoracic defibrillator VT/VF and AF clinical trials, and proven to defibrillate and cardiovert adult patients at lower energies
and currents than existing monophasic devices. The M Series Biphasic Option incorporates a broad range of user selectable
energy settings some of which are lower than those used during those clinical trials.
The AED or advisory function should only be used to confirm ventricular fibrillation in patients meeting the following clinical
criteria:
the patient should be unconscious and unresponsive.
the patient should be apneic (not breathing).
the patient should be pulseless.
WARNING
Do not use the unit’s AED function on patients under 8 years of age.
(Per AHA Guidelines for Adult Cardiopulmonary Resuscitation and AED,
3-5, 1998).