ZOLL M Series User Manual

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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).

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ZOLL M Series User Manual

OPTION INSERT

Defibrillator Function

The M Series Rectilinear Biphasic Waveform Defibrillator Option is a DC defibrillator capable of delivering up to 200 joules of energy. It can be used for defibrillation or in a synchronized mode for Cardioversion using the R-wave of the patient’s ECG as a timing reference. The unit operates with external paddles, or disposable pre-gelled, MFE Pads for defibrillation and cardioversion.

Energy Selection and Displays

Multiple energy levels, and the ability to program initial and subsequent shock energies, allow users to set the M Series to either a non-progressive or progressive sequence of shocks.

The M Series supports the use of progressive shock sequences to provide an energy reserve, allowing the delivery of a higher energy shock if a lower energy shock fails to terminate the arrhythmia. A sequence of 120J Biphasic, 150J Biphasic and 200J Biphasic would most closely approximate the current AHA recommended escalating energy sequence of 200J, 300J, and 360J for adult defibrillation using a monophasic defibrillator.

When an M Series device is equipped with the Biphasic Option, all Energy Displays shown in Section 3, Section 4, and Section 5 (for Manual Defibrillation, Advisory Defibrillation and Automated Defibrillation) of this M Series Operator’s Guide are modified to add the word “BIPHASIC” to the energy display as shown below.

The M Series is capable of delivering energy up to 200 Joules with external paddles or Multi-Function Pads. The initial default energy setting for the M Series Biphasic option is 120J with external paddles or Multi-Function Pads. The energy settings available with the M Series Bi-Phasic device are 1,2, 3, 4, 5, 6, 7, 8, 9, 10, 15, 20, 30, 50, 75, 100, 120, 150 and 200 Joules. Energy settings are selected by using the controls located on the Sternum Paddle or on the front panel of the unit.

The maximum energy available from the M Series with Rectilinear Biphasic Waveform Option is 200 Joules. If the operator attempts to increase the energy level above 200 Joules the error message “200 Joules Max Biphasic” will be displayed.

Upon power-up M Series units equipped with the Rectilinear Biphasic Waveform Defibrillator Option automatically default to the 120 Joule setting. In units with automatic progressive energy selection enabled, Shock No. 1 is set at 120J; Shock No. 2 is set at 150J and Shock No. 3 is set at 200J. These are the default energy settings. They may be modified following the instructions in the M Series Configuration Guide.

Charge Time

Charge time: < 6 seconds with a new fully charged battery (first 15 charges to 200 Joules). Depleted batteries will result in a longer Defibrillator charge time.

All other operational aspects of the M Series Rectilinear Biphasic Waveform Defibrillator are identical to those described in the M Series Operator’s Guide.

Recorder Printer Annotations

In addition to the information normally printed on the M Series recorder and the M Series Summary Reports described in Section 2, units equipped with the Biphasic Option will also print Defibrillation Impedance (DEFIB IMPEDANCE), and Delivered Current (PATIENT CURRENT). This information will be included in the Summary Report for each defibrillation shock.

NAME

PRE SHOCK 15:18:45 10 MAY 93

BIPHASIC DEFIBRILLATION

ECG LEAD

PADS

ECG SIZE

3.0

JOULES SELECTED

30

JOULES DELIVERED

34

PATIENT CURRENT

34 A

DEFIB IMPEDANCE

71 Ohms

POST SHOCK 15:18:45

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RECTILINEAR BIPHASIC WAVEFORM

Energy Delivery Test

The energy delivery test for the Biphasic Option is performed at 30 J according to the instructions contained in Section 9 of the M Series Operators Guide.

When performing the energy delivery test at 30J the recorder strip should resemble that shown below.

12:46:30 02-SEP-99 PAD SIZE 1.0 HR = 30 30 JOULES TEST OK TEST_CUR = 11A DEFIB_IMPED = 1

Rectilinear Biphasic Waveform

Defibrillator Option Information

The Biphasic Option has been designed to produce a Rectilinear Biphasic Waveform whose shape remains essentially constant from patient to patient by the device.

The Rectilinear Biphasic Waveform consists of a 6 millisecond, essentially constant current first phase followed by a 4 millisecond, truncated exponential second phase. The first and second phases of the defibrillation waveform are of opposite polarity and their amplitudes vary based on the user selected therapeutic energy level. The initial amplitude of this waveform's second phase is approximately equal to the first phase's final amplitude. This waveform has an integrated patient impedance measurement sensing pulse at the beginning of the waveform. The positive and negative phases are separated by 100 µsec. The shape of the waveform’s first phase is controlled by electronics and software which compensate for different transthoracic impedances to maintain an essentially constant current throughout the first phase.

When the highest energy setting is selected and patient impedance exceeds 85 ohms, the first phase of the waveform will droop. All other waveform parameters (phase duration, inter-phase delay and integrated impedance measurement sensing pulse) remain the same. The following Rectilinear Biphasic Waveform is produced when the M Series with Biphasic option is discharged into a 50Ω load at the default energy setting of 120 Joules. The vertical axis is in amperes; the horizontal axis is in milliseconds. (For more detailed information regarding the parameters of the Rectilinear Biphasic Waveform when discharged into 25Ω, 50Ω, and 100Ω loads at a maximum energy setting of 200 Joules refer to the Specification section of this Operator’s Insert.

BIPHASIC DEFIBRILLATION PULSE 120 JOULES INTO 50 OHM LOAD

Current

(I Patient)

Duration (msec)

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