AEDPLUS Administrator’s Guide Rev R March 2010

Page 1

Administrator’s Guide

REF 9650-0301-01 Rev. R

Page 2

This issue date for the ZOLL AED Plus Administrator’s Guide, Revision P, is March 2010.

If more than three years have elapsed since the revision date, contact ZOLL Medical Corporation to

determine if additional product information updates are available.

ZOLL, AED Plus, AED Pro, M Series, CPR-D•padz, stat•padz, pedi•padz, RescueNet, and

Real CPR Help are registered trademarks of ZOLL Medical Corporation. Rectilinear Biphasic is a

trademark of ZOLL Medical Corporation. All other trademarks and registered trademarks are property of

their respective owners.

Copyright © 2010 ZOLL Medical Corporation. All rights reserved.

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Guidance and Manufacturer’s Declaration - Electromagnetic Emissions ................................................................................... 32

Rectilinear Biphasic Waveform Characteristics ............................................................................................................................... 36

Clinical Trial Results for the M Series Biphasic Waveform........................................................................................................... 40

Randomized Multi-Center Clinical Trial for Defibrillation of Ventricular Fibrillation (VF) and Ventricular Tachycardia (VT) .......... 40

ECG Analysis Algorithm Accuracy...................................................................................................................................................... 42

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Preface

The AED Plus® Administrator’s Guide is to be used by responsible medical authorities in conjunction

with the ZOLL AED Plus Operator’s Guide (REF 9650-0300-01).

The AED Plus is to be used by trained rescuers to provide emergency defibrillation. It incorporates a

sequence of visual and voice prompts to help rescuers follow established AHA/ERC Guidelines 2005

protocols for use of AEDs. It also incorporates recording/memory capabilities to allow medical

control authorities to review rescuer’s use of the device. Recording includes ECG rhythms, event data,

device identification, and optionally, voice recording of rescuer and ambient sounds. This information

is available via an upload capability to a personal computer for event review and archiving.

Both the American Heart Association (AHA) and the European Resuscitation Council (ERC) publish

extensive information regarding the use of automated external defibrillators and their relationship to

cardiopulmonary resuscitation. The following publications provide supplemental material to be used

in conjunction with the ZOLL AED Plus Administrator’s Guide and Operator’s Guide:

1. 2005 American Heart Association Guidelines for CPR and ECC; Supplement to Circulation,

Volume 112, Issue 24, December 13, 2005.

2. European Resuscitation Council Guidelines for Resuscitation 2005; Resuscitation (2005) 67S1,

S7-S23.

This guide provides information about the operation and care of the AED Plus unit. The administrator,

and user should read each section carefully. Make sure to read the Safety Summary section.

This guide is divided into six sections.

Preface - This page.

Safety Summary - Describes General Warnings and Cautions.

Introduction- Provides a general product overview of the AED Plus.

Section 1 - Operation - Describes the functions of all controls and indicator lights of the AED Plus.

Section 2 - Installation, Self Test, Maintenance and Troubleshooting- Describes configuration of the

unit, data communications, troubleshooting, maintenance and how to order accessories and supplies.

Appendices - Provides the specifications of the AED Plus, characteristics of the ZOLL Rectilinear

Biphasic™ waveform, and information on the ECG Analysis Algorithm Accuracy.

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Safety Summar y

The following section describes general warnings and safety considerations for administrators, rescuers,

and patients.

Warnings

• Use the AED Plus unit only as described in this manual. Improper use of the device can cause death

or injury.

• DO NOT use or place the AED Plus unit in service until you have read the AED Plus Operator’s and

Administrator’s Guides.

• DO NOT use or place the AED Plus unit in service if the unit’s status indicator window (located on

the left side of the handle) displays a red “X”.

• DO NOT use or place the AED Plus unit in service if the unit emits a beeping tone.

• Connect the electrode cable to the AED Plus unit after installing batteries.

• Keep the electrode cable connected to the AED Plus unit at all times.

• This device should only be used by properly trained individuals.

• Only use electrodes labeled “Infant/Child” on children less than 8 years old or weighing less than

55 lbs (25 kg). Use CPR-D•padz® if victim is older than 8 years or weighs more than 55 lbs (25 kg).

• Always stand clear of victim when delivering a shock. Defibrillation energy delivered to the victim

may be conducted through the victim’s body and cause a lethal shock to those touching the victim.

• DO NOT TOUCH the electrode surfaces, the victim, or any conductive material touching the victim

during ECG analysis or defibrillation.

• Move victim away from electrically conductive surfaces prior to use of equipment.

• DO NOT use this unit near or within puddles of water.

• Keep the victim as motionless as possible during ECG analysis.

• DO NOT use this unit near flammable agents, such as gasoline, oxygen-rich atmospheres or

flammable anesthetics.

• Avoid radio frequency interference from high-power sources that might cause the defibrillator to

interpret cardiac rhythms incorrectly by turning off cell phones and 2 way-radios.

• Disconnect non-defibrillation protected electronic devices or equipment from victim before

defibrillation.

• Dry victim’s chest, if wet, before attaching electrodes.

• Apply freshly opened and undamaged electrodes, within the electrode expiration date, to clean and

dry skin to minimize burning.

• DO NOT place the electrodes directly over the victim’s implanted pacemaker. Pacemaker stimuli

may degrade the accuracy of ECG rhythm analyses or the pacemaker may be damaged by

defibrillator discharges.

• Check labeling inside the AED Plus cover before using the cover as a Passive Airway Support

System (PASS) device. Ensure it is intended for this use.

• DO NOT use Passive Airway Support System (PASS) if there is a suspected head or neck injury.

Place victim on a firm surface before performing cardiopulmonary resuscitation.

• DO NOT recharge, disassemble, or dispose of batteries in fire. Batteries may explode, if mistreated.

• Do not use or stack the AED Plus unit with other equipment. If the unit is used or stacked with other

equipment, verify proper operation prior to use.

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Cautions

• Do not disassemble the unit. A shock hazard exists. Refer all servicing to qualified personnel.

• Use only commercially available type 123A lithium manganese dioxide batteries. Discard batteries

properly after removal from unit. Use only batteries from recommended manufacturers.

• If the device is stored outside the recommended environmental conditions, the electrode pads and/

or batteries may be damaged or their useful life reduced.

• Safety and effectiveness data submitted by ZOLL Medical Corporation to the Food and Drug

Administration (FDA) under section 510(K) of the Medical Device Act to obtain approval to

market are based upon the use of ZOLL accessories such as disposable electrodes. The use of

electrodes from sources other than ZOLL is not recommended. ZOLL makes no representations or

warranties regarding the performance or effectiveness of its products when used in conjunction

with electrodes from other sources. If unit failure is attributable to the use of accessories not

manufactured by ZOLL, this may void ZOLL's warranty.

• The CPR-D•padz electrode can be connected to other ZOLL Defibrillators with Multifunction

Cables. Defibrillation can be administered when connected to other ZOLL Defibrillators. The CPR

function does not operate with any device other than the AED Plus and AED Pro®.

Indications for Use

Use the AED Plus when a suspected cardiac arrest victim has an apparent LACK OF CIRCULATION

as indicated by:

• Unconsciousness; and

• Absence of normal breathing; and

• Absence of a pulse or signs of circulation.

When the victim is less than 8 years of age or weighs less than 55 lbs (25 kg), the AED Plus should be

used with AED Plus Pediatric Electrodes (pedi•padz®II). Therapy should not be delayed to determine

the victim’s exact age or weight.

Contraindications for Use

Do NOT use the AED Plus when the victim:

• Is conscious; or

• Is breathing; or

• Has a detectable pulse or other signs of circulation.

Intended Users of the Device

The AED Plus external defibrillator is intended to be used by personnel who are qualified by training in

the use of the AED Plus device, basic life support, advanced life support, or other physician-authorized

emergency medical response to defibrillate victims of cardiac arrest. The Real CPR Help® function

provides a metronome designed to encourage rescuers to perform chest compressions at the AHA/ERC

recommended rate of 100 compressions per minute. Voice and visual prompts encourage a compression

depth of 1½ - 2 inches for adult victims. The Real CPR Help function is not intended for use on victims

under 8 years of age.

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Tracking Requirements

U.S Federal Law (21 CFR 821) requires the tracking of defibrillators. As an owner of this device, you

have the responsibility under this law to notify ZOLL Medical Corporation if this product has been

received, lost, stolen or destroyed or has been donated, resold or otherwise distributed to a different

organization.

If any of the events described above occur, please contact ZOLL Medical Corporation in writing with the

following information:

1. Originator’s organization - Company Name, Address, Contact Name and Contact Phone Number.

2. Part Number/Model Number and Serial Number.

3. Disposition of Device (e.g. received, lost, stolen destroyed, distributed to another organization).

4. New Location and/or Organization (if different from #1 above) - Company Name, Address, Contact

Name and Contact Phone number.

5. Date change took effect.

Notification of Adverse Events

As a health care provider, you may have responsibilities under the Safe Medical Devices Act (SMDA)

for reporting to ZOLL and possibly to the FDA, the occurrence of certain events. These events, described

in 21 CFR Part 803, include device related death and serious injury or illness. In any event, as part of our

Quality Assurance Program, ZOLL should be notified of any device failures or malfunction. This

information is required to assure that ZOLL provides only the highest quality products.

Unpacking

• Carefully inspect each packing container for damage.

• Examine the unit for any signs of damage that may have occurred during shipping.

• If the contents are incomplete or damaged or if the unit fails to pass its self test as indicated by a Red

“X” in the status indicator window after battery installation, contact ZOLL Medical Corporation’s

Technical Service Department.

• Review the shipping list to insure that all items ordered were received.

Conventions

Throughout this document, voice prompts are indicated by capital italicized letters, such as

CALL FOR HELP.

WARNING! Warning statements describe conditions or actions that can result in personal

injury or death.

CAUTION! Caution statements describe conditions or actions that can result in damage to the

unit.

NOTE Notes contain additional information on using the defibrillator.

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Symbols

Symbols used in this manual or on the equipment include the following:

Class II equipment

Defibrillation protected Type BF patient connection

ATTENTION: Refer to manual for more information

DANGEROUS VOLTAGE

Not new battery cells

New battery cells

Do Not push button

Push button

Do not use this manufacturer

Ok to use this manufacturer

Unit equipped to treat adult and pediatric victims

Manufacturer

Authorized representative in the European

Community

Serial Number

Catalogue number

Consult instructions for use

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Introduction

Using the ZOLL AED Plus

The AED Plus is an automated external defibrillator (AED) that uses voice prompts and visual

indicators to guide the rescuer through a resuscitation sequence that may include defibrillation and/or

cardiopulmonary resuscitation (CPR). The unit incorporates the ZOLL Rectilinear Biphasic

Defibrillation waveform, and operates in either adult or pediatric mode.

The AED Plus supports both adult and pediatric defibrillation electrode pads, and automatically

adjusts the defibrillation energy based on the type of electrode pads connected to it. Following

attachment of electrodes to a victim’s chest, the defibrillator monitors the electrocardiographic (ECG)

rhythm of the victim’s heart, analyzes that rhythm, and determines whether the rhythm is shockable

or non-shockable. When needed, defibrillation energy is delivered through these same electrodes.

When the unit detects a shockable rhythm, it charges and issues the warning PRESS FLASHING

SHOCK BUTTON. The rescuer presses the Shock Button to deliver the shock. The rescuer will then

be prompted to perform CPR for a period of two minutes, after which the unit automatically initiates

a new ECG analysis.

Some versions of the AED Plus include a cover that can also be used as a PASS (Passive Airway

Support System) to support the victim’s neck and shoulders in a position that assists in maintaining an

open airway. Some versions also contain disposable accessories (razor, barrier mask, scissors, and a

towel). The AED Plus is powered by ten commercially available consumer brand lithium-manganese

dioxide batteries.

The AED Plus can:

• Perform periodic self tests to ensure its continual readiness.

• Use a one-piece electrode assembly (CPR•D-padz) that facilitates proper electrode placement and

that is easy to apply to the victim.

• Analyze heart rhythm and inform the rescuer if the rhythm is shockable or non-shockable.

• Deliver defibrillation treatment to victims of cardiac arrest who exhibit shockable ECG rhythms.

• Provide voice prompts and graphics to guide the rescuer regarding what to do and when to do it

during a cardiac emergency, such as calling for help or giving CPR to the victim.

• Provide audible beeps to encourage rescuers to provide CPR compressions at 100 CPM (requires

CPR-D•padz).

• Monitor the depth of chest compressions during CPR and provide voice prompts, if compression

depth is inadequate (requires CPR-D•padz).

• Provide a unit cover that functions as a Passive Airway Support System (PASS). (Note the PASS

feature is standard with some versions of the product and optional with others.)

• Upload data from the defibrillator to a computer to store events or print event reports.

• Use commercially available batteries.

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Using Real CPR Help ®

The CPR-D•padz include a sensor that detects the rate and depth of CPR chest compressions. This

sensor is placed (as part of the electrodes application) on the victim’s chest so that it is located between

the rescuer’s hands and the victim’s lower sternum during chest compressions. When the rescuer

performs CPR compressions, the sensor detects their rate and depth and sends the information to the

AED Plus unit. When used with CPR-D•padz, the AED Plus monitors the depth and rate of CPR chest

compressions. It provides a CPR metronome function designed to encourage rescuers to perform chest

compressions at the AHA/ERC recommended rate of 100 compressions per minute (CPM) as well as

voice and visual prompts to encourage a compression depth of 1½ - 2 inches for adult victims.

WARNING! Real CPR Help is intended for use on adult victims only; do not use on victims

under 8 years of age.

The adaptive metronome function is disabled during periods when CPR should not be performed (for

example, during ECG analyses and defibrillation shock sequences). During periods when CPR may be

indicated, the metronome begins issuing audible beeps following detection of the rescuer’s first few

compressions. The beeps continue automatically (at rates described below) until a few seconds after

chest compressions are halted by the rescuer or until the recommended “CPR period” ends (1 minute

for AHA and ERC protocols). If the rescuer ceases chest compressions during the CPR period,

metronome beeps stop within a few seconds after compressions are halted. Audible beeps resume

during the CPR period following any re-initiation of CPR compressions. If no CPR compressions are

detected during “CPR periods”, the AED Plus periodically re-issues the CONTINUE CPR prompt.

The rate of beeps issued by the AED Plus adaptive metronome function adapts to the rescuer’s actual

chest compression rate. The metronome will beep at 100 CPM when chest compressions are delivered

at greater than 80 compressions per minute (CPM). Should the rescuer fail to deliver compressions at

80 CPM or greater, the metronome will beep at a rate that is approximately 15 CPM higher than the

rescuer’s actual rate. This increased metronome rate is intended to encourage the rescuer to increase

his/her chest compression rate until the recommended 100 CPM rate is achieved. The metronome beeps

at a minimum rate of 60 CPM in cases where the rescuer’s compression rate is substantially below

60 CPM.

During CPR, the AED Plus may issue one or more audible prompts based on the depth of chest

compressions detected. When Real CPR Help determines that compression depth is consistently less

than 1½ inches, a PUSH HARDER prompt will be issued. A GOOD COMPRESSION prompt will be

issued if the rescuer responds by increasing compression depth to 1½ inches or more.

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Operation

This section describes the following functions:

• Operating Controls and Indicators

• Using the AED Plus Graphical User Interface

• Voice Prompts

• Using the LCD Display

• Using the Passive Airway Support System (PASS)

• Using Electrodes

• Applying CPR-D•padz

• Applying pedi•padz II (Infant/Child Electrodes)

• Using the CPR Monitoring Function — Real CPR Help

• Using the Audio Recording Option

Operating Controls and Indicators

See Table 1: Control Functions for an explanation of each of these controls.

LCD Display (not supplied on

some units)

Electrode Connector

Graphics

IrDA Port (on side of unit)

Indicator Lights

Status

Indicator

Battery Compartment (bottom)

Carrying Handle

Microphone (hidden)

On/Off

Speaker (bottom)

Shock Button

Figure 1: Identifying Operating Controls and Indicators

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Table 1: Control Function

Control/Indicator

Description

ON/OFF Button

Turns power ON or OFF.

When held depressed for > 5 seconds initiates self test or data

communications.

Indicator lights

Illuminates to indicate which step rescuer must take to treat a victim.

Shock Button

Illuminates when the AED Plus is charged and ready to deliver a shock to the

victim.

When pressed, causes the charged and ready AED Plus to discharge its

energy into the victim.

When the AED Plus is not charged the lighted button is extinguished.

Pressing this button initiates a voice prompt that indicates the number of

defibrillator shocks delivered since the unit was powered on.

Pictograms

Icons that explain the series of steps needed for resuscitation and

defibrillation.

Status Indicator

Illuminated check mark indicates the unit passed its last self test and is ready

for use.

Illuminated “X” indicates unit has failed its self test and is not ready for use

4

LCD Display

Displays elapsed time, shock count, user prompts, CPR compression depths

and ECG waveforms.

IrDA Port

Provides a communications link between the defibrillator and a personal

computer or another IrDA equipped device.

PASS Cover

(optional)

Some AED Plus models include a cover that may be used as a shoulder

support to aid victim airway management. The PASS can be ordered

separately for other AED Plus models (see “Ordering Accessories” on

page 27).

Battery

Compartment

Holds 10 123A lithium manganese dioxide batteries used to power the unit.

Electrode Connector

Connector for attaching electrodes to the AED Plus.

Speaker

Provides audio prompts and metronome beeps that direct rescuers on what to

do during a rescue; also provides voice prompts to indicate if service is

required.

Microphone

(optional)

When voice recording option is installed, this microphone picks up and

records ambient sounds, including rescuer’s voice.

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Using the AED Plus Graphical User Interface

The AED Plus graphical user interface (see Figure 2) is visible on the top of the unit when the cover

is removed. The pictograms are reminders of the steps to follow when performing a rescue and

reinforce instructions provided through voice prompts and optional display messages.

Each pictogram on the device is associated with an indicator light (LED) and voice prompts. This

combination draws attention to the graphics in a sequence defined by current protocols for use of an

Automated External Defibrillator (AED) by the AHA and ERC.

Figure 2: Graphical User Interface

The AED Plus unit contains an LCD display (some special models do not have an LCD) that displays

elapsed time, number of shocks delivered, text messages corresponding to the voice prompts, and

depth of CPR compressions. The LCD can also be configured to display the acquired ECG signals.

When the AED Plus is turned on, the unit automatically initiates the sequence of voice prompts and

graphic illuminations for a rescue event. The sequence continues until the AED Plus is turned off or

the electrodes are disconnected from the victim for an extended period of time. As soon as electrodes

are attached to the victim and impedance of the connection is verified, the unit stops cycling through

the above-mentioned voice and graphic illumination sequence and automatically begins analysis of

the ECG rhythm.

Following the results of this ECG analysis, voice prompts tell the rescuer whether a shockable or

non-shockable rhythm has been detected. If a shockable ECG rhythm is present, the graphics

illuminate and voice prompts guide the rescuer through the defibrillation sequence. When no shock is

advised, the AED Plus issues the audio prompts, NO SHOCK ADVISED and START CPR, and

illuminates the CPR-related graphics. A period of 2 minutes (depending upon device configuration)

is then allowed for rescuer CPR. Following this “CPR period”, the AED Plus automatically re-initiates

a new ECG rhythm analysis.

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The AED Plus automatically adjusts defibrillation energy to adult or pediatric levels based on the type

of electrodes attached to the unit. In its factory default configuration, the unit delivers the first three

shocks at 120J, 150J, and 200J respectively in adult mode, and at 50J, 70J, and 85J in pediatric mode.

However, the device can be configured to deliver shocks at other energy levels, as long as the setting

for each successive shock is the same or greater than the setting for the preceding shock. Shocks are

delivered by depressing the Shock Button (indicated by the heart icon and associated LED) located in

the center of the graphical user interface.

Consult the AED Plus Operator’s Guide for more details on the graphics included in the unit’s graphic

interface, the audio prompts issued at each step in the treatment protocol and the rescuer action

associated with these audio and visual prompts.

Loss of contact between the electrodes and the victim interrupts ECG analysis and/or shock delivery

until the electrodes are re-attached and results in a CHECK ELECTRODE PADS prompt to the operator.

Voice Prompts

During clinical use of the AED Plus, you may hear the following voice prompts.

Table 2: Clinical Voice Prompts

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Voice Prompt

Definition

UNIT OK.

AED Plus has successfully passed its power up self tests.

UNIT FAILED.

AED Plus has failed its power up self tests and is not usable for

victim care.

CHANGE BATTERIES.

AED Plus self test has detected a low battery condition that is

insufficient for the device’s use for victim care. Replace batteries

immediately.

STAY CALM.

Relax as much as possible and focus on the rescue effort.

CHECK RESPONSIVENESS.

Check victim for responsiveness/consciousness by gently

shaking the victim and shouting “Are you all right?”.

CALL FOR HELP.

Activate the EMS system or ask a bystander to do it for you.

OPEN AIRWAY.

Place victim in the supine position and perform Head Tilt – Chin

Lift or Jaw – Thrust maneuver to open victim’s airway.

CHECK BREATHING.

Look, listen or feel for the presence of breathing and/or airflow

from the victim’s lungs.

GIVE TWO BREATHS.

If victim is not breathing, give two rescue breaths.

PLUG IN CABLE.

Ensure that the electrode cable is properly connected to the AED

Plus electrode connector.

ATTACH DEFIB PADS TO

PATIENT’S BARE CHEST.

Attach defibrillation pads to the victim’s bare chest.

CHECK ELECTRODE PADS.

Previously attached electrodes are not making good contact with

the victim’s skin or the electrodes are defective.

ADULT PADS.

AED Plus has detected adult electrode pads connected to it and

adjusted defibrillation energy settings to adult levels.

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Voice Prompt

Definition

PEDIATRIC PADS.

AED Plus has detected pediatric electrode pads connected to it

and adjusted defibrillation energy settings to pediatric levels.

DON’T TOUCH PATIENT,

ANALYZING.

Do not touch victim, an ECG rhythm analysis is in progress or

about to begin.

SHOCK ADVISED.

ECG rhythm analysis has detected the presence of ventricular

fibrillation or shockable ventricular tachycardia.

NO SHOCK ADVISED.

ECG rhythm analysis has detected a rhythm that is not treatable

by defibrillation.

ANALYSIS HALTED. KEEP

PATIENT STILL.

ECG rhythm analysis has been halted due to excessive ECG

signal artifact. Stop any ongoing CPR and keep the victim as

motionless as possible.

DON’T TOUCH PATIENT.

PRESS FLASHING SHOCK

BUTTON.

Warn all persons in attendance of the victim to stand clear and

stop touching the victim. Press the Shock Button to deliver

defibrillation therapy.

RELEASE SHOCK BUTTON.

Shock Button was depressed before the defibrillator was ready to

defibrillate. Release the Shock Button and press again after the

ready tone sounds.

SHOCK DELIVERED.

A defibrillation shock has just been delivered to the victim.

NO SHOCK DELIVERED.

No shock was delivered to the victim because rescuer failed to

press Shock Button or an error condition was detected.

n SHOCKS DELIVERED.

A total of n shocks have been delivered since the AED Plus was

turned on.

START CPR.

Begin CPR.

CONTINUE CPR.

Continue providing CPR. This prompt may also be issued if

Real CPR Help fails to detect chest compressions at least ¾ of an

inch deep.

PUSH HARDER.

CPR compressions are consistently less than 1 ½ inches deep.

GOOD COMPRESSIONS.

After prompting to Push Harder, rescuer has succeeded in

delivering chest compressions at least 1 ½ inches deep.

STOP CPR.

Stop CPR, the AED Plus is about to begin an ECG rhythm

analysis.

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Prompts that may be heard during non-clinical use of the AED Plus unit include:

Table 2b Non-Clinical Voice Prompts

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Voice Prompt

Definition

IF NEW BATTERIES,

PRESS BUTTON.

Press the Battery Reset Button located in the battery compartment

after replacing ALL batteries in the device with new batteries.

NON-RESCUE MODE.

AED Plus device has entered the diagnostics/data communications

mode.

COMMUNICATIONS

ESTABLISHED.

IrDA Communications between the AED Plus and a personal

computer or modem have been established.

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Using the LCD Display

The AED Plus is equipped with a 1.3 x 2.6 inch LCD screen (see Figure 3) that displays the following

information:

Shock Count

Elapsed Time

CPR Depth of

Compression Indicator

05:25

SHOCKS: 05

CHECK

RESPONSIVENESS

SHOCKS: 05

1.5” (3.8 cm)

depth

CHECK

RESPONSIVENESS

2.0” (5.1 cm)

depth

With ECG

05:25

1.5” (3.8 cm)

depth

2.0” (5.1 cm)

depth

Without ECG

Figure 3: LCD Displays

NOTE Some special AED Plus models do not have an LCD.

Shock Count (Upper left corner of screen): Indicates the total number of defibrillation shocks

delivered by the AED Plus since it was last powered on. Shock count is saved through brief power off

periods (< 5 seconds). When the AED Plus is turned off for more than 5 seconds, the shock count is

reset to 0.

Elapsed Time (Upper right corner of screen): Indicates the total time in minutes and seconds that has

elapsed since the AED Plus was last powered on. Elapsed time continues to be counted through brief

power off periods (< 5 seconds). When the AED Plus is turned off for more than 5 seconds, elapsed

time is reset to 00:00. When elapsed time exceeds 99 minutes and 59 seconds, the timer wraps around

to 00:00 and continues counting.

CPR Depth of Compression Indicator (Right side of screen): A bar graph is displayed that shows

the depth of chest compressions measured during the delivery of CPR. Indicator lines are displayed in

the bar graph area at 1 ½ and 2 inches of compression depth to provide reference points for rescuers

performing CPR.

Visual User Prompts (Lower 1/3 of screen): Whenever the AED Plus issues a voice prompt, the text

of the voice prompt is simultaneously displayed on the LCD display.

ECG Waveform (Center portion of screen): Although AED Plus units do not display ECG waveforms

in their factory default configuration, the device can be specifically set up to continuously display

ECG signals as they are acquired.

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Using the Passive Airway Support System (PASS)

If there is no evidence of head or neck trauma, the head tilt chin lift method is the recommended

maneuver for opening the airway. The PASS may be placed under the victim’s shoulders to help

maintain head tilt.

WARNING! DO NOT use PASS if suspected head or neck injury. Place victim on a firm

surface before performing CPR.

If the victim requires airway support and there is no evidence of head or neck trauma, roll the victim on

his/her side and then roll him/her back over so that the PASS is under the victim’s shoulders causing the

head to tilt backwards.

For PASS COVERS only: The shape of the PASS, when placed under the shoulders of the victim, can

be used to help maintain an open airway (see Figure 4).

The unit cover also functions as the Passive Airway

Support System (PASS).

Place the PASS under the victim to lift his/her shoulders.

Do not use the PASS if there is a suspected head or neck

injury.

Figure 4: Using the PASS Cover

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Using Electrodes

WARNING!

DO NOT reuse electrodes.

The AED Plus supports both adult and pediatric electrode pads. The device automatically adjusts

defibrillation energy to adult or pediatric levels depending on the type of electrodes connected to it.

Make sure that the electrode pads used are appropriate for the victim.

WARNING! DO NOT use adult electrode pads or CPR-D•padz on victims under 8 years

of age.

The AED Plus uses electrode packs that are connected to the unit by a cable. The package contains

electrodes that you attach to the victim.

• Make sure to install a new package of electrodes and connect the electrode cable to the unit after

each use, to prepare for future emergencies.

• Check the electrode expiration date regularly to ensure that electrodes are fresh and ready to use

in an emergency situation.

• Replace electrodes, if expired

• After the AED Plus is powered on and completes its self-test, the unit will issue an “Adult Pads”

voice prompt or a “Pediatric Pads” voice prompt to indicate the type of electrodes connected to the

unit. Verify that the connected electrode pads are appropriate for the victim being treated. Connect

alternate electrode pads if necessary.

If the electrodes are not attached properly, the unit issues the CHECK ELECTRODE PADS or the

ATTACH ELECTRODE PADS voice prompt during operation. If the electrode cable is not properly

attached to the unit, the unit issues the PLUG IN CABLE prompt. Make certain to connect the electrode

cable to the AED Plus unit and attach the electrodes to the victim properly.

WARNING! Electrodes must be pre-attached to the device. Keep the electrode cable

connected to the AED Plus unit at all times.

The electrode package may include:

• Scissors to cut clothing or chest hair.

• Razor to remove excessive hair at the electrode application site, if necessary.

• Small towel to make sure that the victim’s skin is dry.

• Gloves.

• Barrier Mask.

NOTE Electrodes contain no hazardous materials and may be disposed of in general trash unless contaminated

with pathogens. If contaminated, appropriate precautions should be used in their disposal.

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Applying CPR-D •padz

Prepare the victim before attaching the electrodes.

WARNING! CPR-D•padz are intended for use on adult victims only; do not use on victims

under 8 years of age.

To prepare the victim:

1. Remove all clothing covering the victim’s chest.

2. Ensure the victim’s chest is dry.

3. If the victim has excessive chest hair, clip or shave the hair to help ensure proper adhesion of the

electrodes.

To apply the electrodes:

1. Tear open the electrode package and unfold the electrodes. Place the electrodes on the victim

according to the graphics on the package (see Figure 5).

2. Hold the CPR sensor and place the sensor between the nipples and on the middle of the victim’s

breastbone, using the sensor’s cross hairs to guide you.

3. Press the CPR sensor with your right hand and pull the number 2 tab to peel the protective backing

from the electrode. Press the electrode from the center out to make sure it adheres properly to the

victim’s skin.

4. Press the CPR sensor with your left hand and pull the number 3 tab to peel the protective backing

from the electrode. Press the electrode from the center out to make sure it adheres properly to the

victim’s skin.

NOTE If the victim is large or there is a need to place the electrode under a breast, you may need to tear away

the lower pad at the perforated line (see Figure 5) and extend the pad. Place the pad slightly to the victim’s

left and below the victim’s left breast.

NOTE If the victim has an implanted pacemaker or defibrillator in the upper right chest, angle the electrodes

slightly to avoid placing the electrodes over either device. Make certain that the CPR sensor maintains a

position over the lower half of the breastbone.

®

®

ZOLL Medical Corporation 269 Mill Road

Chelmsford, MA 01824-4105 USA 978-421-9655

Figure 5: Placement of CPR-D•padz

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Applying pedi•padz II (Infant/Child Electrodes)

Prepare the victim before attaching the electrodes.

Important! This symbol indicates that an AED Plus unit is equipped for treating adult and pediatric victims.

An AED Plus unit without this symbol is not equipped to treat pediatric victims and will NOT

work with the pedi•padz II pediatric electrodes. To upgrade an AED Plus unit for use with

ZOLL pedi•padz II pediatric electrodes, contact ZOLL Medical Corporation or an authorized

ZOLL distributor for information on the ZOLL AED Plus Pediatric Upgrade Kit.

To prepare the victim:

1. Remove all clothing covering the victim’s chest.

2. Ensure the victim’s chest is dry.

To apply the electrodes:

1. Tear open the electrode package and unfold the inner package to expose the electrodes. Place the

electrodes on the victim according to the graphics on the package (see Figure 6).

2. Remove the round electrode from its backing material and place it on the victim’s chest (as shown

in Figure 6).

3. Place your hand on the electrode edge and, using the other hand, gently roll the electrode onto the

victim’s chest, pushing any air out from beneath the electrode as you go.

4. Roll the victim onto his/her chest, remove the square electrode from its backing and place it on

the victim’s back (as shown in Figure 6).

5. Place your hand on the electrode’s edge and, using your other hand, roll the electrode onto the

victim’s skin, pushing any air out from beneath the electrode as you go.

6. Roll the victim onto his/her back and follow the AED Plus prompts.

NOTE The pedi•padz II (infant/child electrodes) can also be used with ZOLL pacemaker products for up to

one hour of pacing (see the M Series Operator’s Guide for information about pacing).

®

II

Infant/Child Defibrillation Electrodes

0-8 Years

<55lbs / 25kg

3

2

®

0197

ZOLL Medical Corporation 269 Mill Road

Chelmsford, MA 01824-4105 USA 978-421-9655

9305-0627-01 Rev. 1

Figure 6: Placement of pedi•padz II

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Using the CPR Monitoring Function — Real CPR Help

When used with ZOLL CPR-D•padz, the AED Plus monitors the rate and depth of CPR chest

compressions. The AED Plus provides a CPR adaptive metronome function designed to encourage

rescuers to perform chest compressions at the AHA/ERC recommended rate of 100 compressions per

minute. Voice and visual prompts encourage a compression depth of 1 ½ - 2 inches for adult victims.

Real CPR Help operates only when CPR-D•padz are used, and is intended for use on adult victims only.

To use Real CPR Help you must do the following:

1. Connect CPR-D•padz to the AED Plus unit.

2. Apply the CPR-D•padz to the victim as described in the previous section

Ensure that the CPR sensor is centered on the lower half of the victim’s sternum.

3. If no signs of circulation are present when the AED Plus issues the START CPR prompt, place your

hands on top of the CPR sensor and push on the sensor to deliver chest compressions to the victim.

After your first few compressions, the AED Plus adaptive metronome will begin issuing timing

beeps. Try to maintain synchronization between these beeps and your chest compressions. Shortly

after you stop chest compressions to deliver rescue breaths the metronome will stop beeping.

NOTE If the AED Plus prompts you to PUSH HARDER, your compressions are less than 1½ inches deep. Increase

your compression depth to improve CPR performance.

4. Deliver the appropriate number of rescue breaths then resume chest compressions. The metronome

will begin to beep again after your first few compressions have been delivered.

Using the Audio Recording Option

If installed and configured, the AED Plus contains an audio recording option that records and stores

20 minutes of continuous audio and clinical event data during a rescue. (The unit records and stores at

least 7 hours of clinical event data if the audio recording option is disabled.) The recorded audio data is

synchronized to the clinical event data. The audio recording starts when the AED Plus issues the

STAY CALM prompt.

NOTE The AED Plus allows for up to 3 minutes of audio recording prior to electrode attachment. When you

turn the unit off, the first indicator light (LED) on the graphical user interface illuminates and the second

indicator light (LED) flashes intermittently while the unit stores the data in memory.

Whenever the device detects a clinical event in rescue mode, the AED Plus deletes previously stored

data (ECG, Audio and Event) from memory before data for the current rescue is recorded. Overwriting

of old ECG, audio and event data begins 10 seconds after the electrodes are properly connected to the

victim. However, if the AED Plus is started in Non-rescue Mode, the recorded data of the last rescue is

retained and may be uploaded to a data storage or archiving system.

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Installation and Self Test

This section describes the following functions to prepare the AED Plus for use:

• Inspecting the Unit

• Preparing the AED Plus for Use

• Using the Self Test Feature

• Installing or Replacing Batteries

• Identifying Battery Condition

Inspecting the Unit

Once unpacked, inspect the device for any signs of damage due to shipping. Check for accessories and

any other parts ordered.

Preparing the AED Plus for Use

To ensure that the AED Plus is functioning properly and is ready for use in an emergency situation,

the following set-up and checkout procedures should be performed before placing the device into

service and after each clinical use.

1. Inspect all external surfaces of the unit to ensure that they are clean and free of structural damage

such as cracks, broken or missing parts.

2. Inspect the electrode connector to ensure that there are no broken or missing connector pins.

3. Verify that new CPR-D•padz, stat•padz® II or pedi•padz II to be used with the AED Plus are well

within their expiration date.

4. Follow instructions provided with the new electrodes to pre-connect them to the electrode

connector on the device and pack them within the AED Plus cover.

NOTE If the electrodes are not connected to the AED Plus unit, the device will fail the self test and display

a red “X” in the status indicator window.

5. If the status indicator displays a red X, install new batteries. (See “Installing or Replacing

Batteries” on page 18.)

6. Close the top cover of the AED Plus unit and initiate a self test by pressing the Power Button.

Verify that the unit issues the UNIT OK voice prompt. This prompt indicates that the new batteries

and electrodes are properly installed and that the unit is ready for service.

7. Verify that the AED Plus unit issues the appropriate “Adult Pads” or “Pediatric Pads” voice

prompt.

8. Turn the AED Plus unit off.

9. Wait 2 minutes. Verify that the green check symbol () appears in the status indicator window

and that the unit does not emit a beeping tone.

10. Place the AED Plus unit in service.

11. Check the AED Plus unit periodically to ensure that the green check symbol () appears in the

status indicator window.

NOTE If the status indicator displays a red X following completion of the above test, the AED Plus is not

ready for use and may be defective. Remove the AED Plus from service and consult the

Troubleshooting section on page 23 of this guide to help determine the problem.

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Using the Self Test Feature

The AED Plus performs the following self tests to verify unit integrity and its readiness for emergency

use:

• Battery Installation Self Test

• Power On Self Test

• Manual Self Test

• Automatic Self Test

• Automatic Monthly Test (software version 5.32 or higher only)

Following successful completion of all self tests, the AED Plus’s status indicator displays a green check

() to show that all tests passed and that the unit is ready to use.

If the status indicator displays a red X following completion of any self test, the AED Plus is not ready

for use and may be defective. Remove the AED Plus from service and consult the Troubleshooting

section of this guide to help determine the problem.

Battery Installation Self Test

The AED Plus performs a self test whenever batteries are installed and verifies the following functions:

1. Defibrillation Electrodes Connection: Verifies that the defibrillation electrodes are properly preconnected to the device.

2. ECG Circuitry: Verifies that the ECG signal acquisition and processing electronics are functional.

3. Defibrillator Charge and Discharge Circuitry: Verifies that the device’s defibrillator electronics are

functional and can charge and discharge at 200 joules.

4. Microprocessor Hardware/Software: Verifies proper function of the AED Plus microprocessor

electronics and the integrity of its software.

5. CPR Circuitry and Sensor: Verifies that CPR monitoring and compression depth detection are

functional.

6. Audio Circuitry: Verifies that voice prompts are functional.

At the end of this self test, the AED Plus prompts the user to press the Battery Reset Button, located

inside the battery compartment. Pressing this button resets the unit’s battery usage indicator to full

charge.

CAUTION!

16

DO NOT press the Battery Reset Button unless all batteries are new. Pressing the Battery Reset

Button when used batteries are installed may result in a false high reading of battery capacity. See

the “Installing or Replacing Batteries” on page 18 for more information.

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Power On Self Test

The AED Plus performs a self test whenever the unit is turned on and verifies the following functions:

1. Battery Capacity: Verifies that the battery usage indicator shows adequate battery capacity

remaining.

2. Defibrillation Electrodes Connection: Verifies that the defibrillation electrodes are properly preconnected to the device.

3. ECG Circuitry: Verifies that the ECG signal acquisition and processing electronics are functional.

4. Defibrillator Charge and Discharge Circuitry: Verifies that the device’s defibrillator electronics

are functional and can charge and discharge at 2 joules.

5. Microprocessor Hardware/Software: Verifies proper function of the AED Plus microprocessor

electronics and the integrity of its software.

6. CPR Circuitry and Sensor: Verifies that CPR monitoring and compression depth detection are

functional.

7. Audio Circuitry: Verifies that voice prompts are functional.

Manual Self Test

You can initiate a manual self test on the AED Plus by pressing and holding the unit’s On/Off button

for 5 seconds. The AED Plus illuminates all graphic indicators and issues voice and LCD display

messages to allow user verification of the device’s visual and auditory output functionality. In

addition, the LCD shows the application software version currently running on the unit.

Shock Count

Elapsed Time

SHOCKS: 00

Boot File Version

Language File Version

00:12

B:03.31 P:05.10

L:05.00 C:02.00

H:10.00

Application Software Version

Firmware Version

Hardware Version

This self test verifies the following AED Plus functions:

1. Battery Capacity: Verifies that the battery usage indicator shows adequate battery capacity

remaining.

NOTE For units with software below version 5.32, batteries must be replaced every 3 years regardless of test

results.

2. Defibrillation Electrodes Connection: Verifies that the defibrillation electrodes are properly preconnected to the device.

3. ECG Circuitry: Verifies that the ECG signal acquisition and processing electronics are functional.

4. Defibrillator Charge and Discharge Circuitry: Verifies that the device’s defibrillator electronics

are functional and can charge and discharge at 200 joules.

5. Microprocessor Hardware/Software: Verifies proper function of the AED Plus microprocessor

electronics and the integrity of its software.

6. CPR Circuitry and Sensor: Verifies that CPR monitoring and compression depth detection are

functional.

7. Audio Circuitry: Verifies that voice prompts are functional.

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8. Display: Verifies that visual indicators are functional.

Automatic Self Test

By default, the AED Plus unit performs an automatic self test once every 7 days (this interval can be

configured to 1, 2, 3, 4, 5, 6, or 7 days) when the unit is stored with batteries installed. This self test

verifies the following AED Plus functions:

1. Battery Capacity: Verifies that the battery usage indicator shows adequate battery capacity

remaining.

NOTE For units with softeware below version 5.32, batteries must be replaced every 3 years regardless of test

results.

2. Defibrillation Electrodes Connection: Verifies that the defibrillation electrodes are properly preconnected to the device.

3. ECG Circuitry: Verifies that the ECG signal acquisition and processing electronics are functional.

4. Defibrillator Charge and Discharge Circuitry: Verifies that the device’s defibrillator electronics are

functional and can charge and discharge at 2 joules.

5. Microprocessor Hardware/Software: Verifies proper function of the AED Plus microprocessor

electronics and the integrity of its software.

6. CPR Circuitry and Sensor: Verifies that CPR monitoring and compression depth detection are

functional.

Automatic Monthly Test (software version 5.32 or higher only)

By default, the AED Plus unit performs an automatic self test once per month when the unit is stored

with batteries installed. This self test verifies the following AED Plus functions:

1. Battery Capacity: Verifies that the battery usage indicator shows adequate battery capacity

remaining.

2. Defibrillation Electrodes Connection: Verifies that the defibrillation electrodes are properly preconnected to the device.

3. ECG Circuitry: Verifies that the ECG signal acquisition and processing electronics are functional.

4. Defibrillator Charge and Discharge Circuitry: Verifies that the device’s defibrillator electronics are

functional and can charge and discharge at 200 joules.

5. Microprocessor Hardware/Software: Verifies proper function of the AED Plus microprocessor

electronics and the integrity of its software.

6. CPR Circuitry and Sensor: Verifies that CPR monitoring and compression depth detection are

functional.

Installing or Replacing Batteries

To power the AED Plus, use 10 consumer type 123A Photo Flash lithium manganese dioxide batteries.

You can purchase these batteries at many department, camera or electronics stores.

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ZOLL AED PLUS Administrator’s Guide

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For AED Plus units running software version 5.32 or higher, replace batteries every 5 years or if unit

prompts. For earlier software versions, replace batteries every 3 years. A dated AED Plus battery

replacement reminder label can be placed next to the On/Off button (available from ZOLL Customer

Service).

CAUTION! Use Duracell, Sanyo or Varta batteries only. Do not use Panasonic or Rayovac

batteries. Use of Panasonic or Rayovac batteries may result in significantly longer

defibrillator charging times than those required during emergency situations.

These batteries:

• Should be used well before their labeled expiration date.

• Should be checked periodically for the expiration date.

Batteries produced by all recommended manufacturers have a 10 year from date of manufacture shelf

life when not installed in an AED Plus unit.

The following examples demonstrate how to read date codes on Duracell, Sanyo and Varta batteries.

Duracell:

The first digit indicates the year of manufacture (Example: 7=1997, 6=1996 etc.).

The second character is a letter from A-L that indicates the month of manufacture (Example:

A=January, B=February and so on to L for December.)

Sanyo:

The first letter indicates the year of manufacture (Example: A=1996, B=1997, etc.).

The second letter indicates the month of manufacture (Example: A=January, B=February, etc.).

Varta:

The BRAUNSCHWEIG - Code (always two letters) is printed on the side of the can in axial direction

to cell height.

The first letter indicates the month of manufacture (Example: B=January, R=February, A=March,

etc.).

The second letter indicates the year of manufacture (Example: B=2001, R=2002, A=2003, etc.).

To install the batteries:

1. Ensure that the AED Plus is turned off. Open the battery compartment by removing the battery

cover from the back of the unit.

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To remove the battery cover, insert a small tool (e.g., flat blade screw driver) into the two slots on

the rear of the unit to depress the latches, then insert the tool into the groove on the bottom to lift

the cover (see Figure 7).

2) Lift cover here

Battery

Compartment

Door

1) Depress latch

here

Figure 7: Removing the Battery Compartment Door

2. Remove all batteries at once and dispose of batteries properly. Place new batteries into the battery

bank, observing battery polarity markings and making sure that all batteries are securely seated and

properly oriented. After placing the first 5 to 9 batteries in the battery well, the

INSTALL BATTERIES audio prompt reminds you to install the remaining batteries in the battery

compartment.

Battery Reset Button

Figure 8: Battery Compartment

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3. After installing new batteries, press the Battery Reset Button inside the battery compartment when

prompted (see Figure 8). Pressing the button resets the battery usage indicator to full charge.

CAUTION! You MUST replace all 10 batteries at once. Do not replace individual batteries. The AED

Plus cannot detect whether all batteries or only a few batteries have been replaced. Do

not place used batteries into the AED Plus. Using less than fully charged batteries

can affect the unit when performing a rescue. DO NOT press the Battery Reset

Button if all the batteries are not new. The AED Plus then assumes that they are the same

batteries that were just removed.

NOTE If you do not press the Battery Reset Button in the battery well within 15 seconds after installing all

batteries, the AED Plus assumes that the batteries installed in the device were temporarily removed,

and are not fully charged.

NOTE Because Lithium Manganese Dioxide battery cells do not contain toxic materials, they may be disposed

of in general trash after discharge or when properly protected against shorting between terminals.

Identifying Battery Condition

Battery capacity depletes during standby operation of the unit, while the unit is operating, and as a

result of each defibrillation. Battery capacity also gradually diminishes over a shelf life of years

without use. The AED Plus monitors energy remaining in the installed batteries. When battery

capacity is low or depleted, the AED Plus will not function to specification. When a low battery

condition occurs, the AED Plus:

• emits an audible alarm or “beep” once every minute, if the AED Plus is off

• issues the CHANGE BATTERIES audio prompt, if the AED Plus is on

• displays a red “X” in the status indicator window, indicating that the batteries are at low capacity

or that the AED Plus has failed other self tests.

Table 3: Battery Condition

Battery Condition

Indications

Correction

Low Battery with AED

Plus off.

Audible beep from AED Plus

once every minute.

Replace batteries.

Low Battery during power

up self test.

CHANGE BATTERIES prompt

(when AED Plus is powered on)

Replace batteries.

Low Battery or other self

test failure with AED Plus

powered off or during self

test.

Status Indicator has red “X”

indicating failure to operate

(when off).

Replace batteries. Check or

replace electrodes. If red “X”

remains, return to ZOLL

Technical Support for service.

Low Battery with AED

Plus powered on.

CHANGE BATTERIES prompt

(unit powered on).

Replace batteries as soon as

possible.

Dead Battery

Status Indicator has red “X”

indicating failure to operate

(when off).

Replace batteries. If red “X”

remains, return to ZOLL

Technical Support for service.

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Maintenance and Troubleshooting

This section describes the following functions to maintain the AED Plus:

• Maintaining the AED Plus

• Cleaning the AED Plus

• Optional Maintenance for Technical Professionals

• Troubleshooting

Maintaining the AED Plus

•

•

•

•

•

•

Inspect frequently, as necessary.

Check for the green check () showing that the AED Plus is ready to use.

Verify that electrodes are within their expiration date.

Verify that batteries are within their expiration date.

Verify that electrodes are pre-connected to the input connector.

Verify that supplies are available for use (razor, mask, gloves, extra batteries.)

Maintenance Checklist

Use the following maintenance checklist when you periodically check your AED Plus.

Table 4: Maintenance Checklist

Check the following

Pass

Fail

Is the unit clean, undamaged, free of excessive wear?





Are there any cracks or loose parts in the housing?





Verify electrodes are connected to the AED Plus and sealed in their

package. Replace if expired.





Are all cables free of cracks, cuts and exposed or broken wires?





Turn the AED Plus on and off and verify the green check indicates ready

for use.





Batteries within expiration date. Replace if expired.





Check for adequate supplies.





Cleaning the AED Plus

• After each use, clean and disinfect the AED Plus with a soft, damp cloth using 90% isopropyl

alcohol, or soap and water, or chlorine bleach and water mixture (30 ml/liter water).

• Do not immerse any part of the AED Plus in water.

• Do not use ketones (MEK, acetone, etc.) to clean the AED Plus.

• Avoid using abrasives (e.g., paper towel) on the display window or IrDa port.

• Do not sterilize the AED Plus.

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Optional Maintenance for Technical Professionals

The AED Plus automatically performs maintenance testing during periodic self tests. However, if a

qualified technical professional wishes to test the AED Plus further, the following checkout procedure

can be followed:

1. Connect an AED Plus Simulator/Tester (or equivalent) to the AED Plus electrode connector.

2. Power on the simulator and AED Plus. Verify that all of the following occur:

• The status indicator (located on the left side of the handle) initially displays a red “X” which

changes to a green check () within 4 to 5 seconds after the AED Plus is turned on.

• All top panel user interface lights (LEDs) illuminate sequentially.

• The AED Plus issues the UNIT OK voice prompt within 5 seconds after power-up (and displays

the message if equipped with an LCD).

• If the AED Plus has an LCD, the message “SHOCKS: 0” appears in the upper left corner and

the elapsed time (since power-up) appears in the upper right corner of the screen.

3. Using the simulator, input a VF rhythm to the AED Plus. Verify that after the AED Plus proceeds

through its sequence of victim assessment prompts, it:

• analyzes the ECG rhythm

• issues the SHOCK ADVISED voice prompt

• charges the defibrillator

• issues the DON’T TOUCH PATIENT, PRESS FLASHING SHOCK BUTTON voice prompt

4. Verify that the charge ready tone is heard and that the Shock Button illuminates.

5. Press the Shock Button and verify that the simulator shows that a shock was delivered. Verify that

the message “Shocks: 1” displays on LCD screen.

NOTE This test checks the device’s ability to defibrillate. It does not, however, verify that the correct

defibrillation energy was delivered. A defibrillator analyzer should be used in place of the AED Plus

simulator/tester to verify the accuracy of the delivered energy.

6. Following shock delivery, verify that the AED Plus issues the START CPR messages.

7. Activate the simulator’s CPR function. Verify that the adaptive metronome begins to beep and

that the following voice prompts/messages are issued within 60 seconds: PUSH HARDER

followed by GOOD COMPRESSIONS.

8. After approximately two minutes of CPR, verify that the STOP CPR prompt is issued. Set the

simulator to Normal Sinus Rhythm (NSR) and verify that a new ECG analysis begins.

9. Verify that a NO SHOCK ADVISED prompt is issued.

10. Turn the AED Plus and Simulator off.

See “Preparing the AED Plus for Use” on page 15 for instructions on placing the AED Plus back into

service.

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Troubleshooting

The following table summarizes common error indications on the AED Plus, and their associated

corrective action. Return the AED Plus to ZOLL’s Technical Service Department if the AED Plus is

not working properly.

Table 5: Troubleshooting

24

Technical Problem

Recommended Action

Self test failed.

Initiate manual self test by pressing and holding the

ON/OFF Button for more than 5 seconds. Attempt to

repair the device by replacing the batteries or

electrodes. If the AED Plus fails test again, remove the

AED Plus from service and contact ZOLL Technical

Service.

CHANGE BATTERIES prompt.

Replace all batteries with new batteries at the same

time. Press the Battery Reset Button when prompted.

Red “X” in status indicator window.

Initiate manual self test by pressing and holding the

ON/OFF Button for more than 5 seconds.

Check to see if cable is attached properly to the AED

Plus or replace the electrodes.

Cycle power on the AED Plus by turning the unit off,

then on again.

Replace all batteries at the same time with new

batteries that are less than 1 year old. Press the Battery

Reset Button when prompted.

If the AED Plus still does not operate correctly, remove

unit from service and contact ZOLL Technical Service.

Beeping noise when AED Plus is off.

Remove AED Plus from service and replace batteries.

Replace all batteries at the same time with new

batteries. Press the Battery Reset Button when

prompted.

If beeping continues, contact ZOLL Technical Service.

PLUG IN CABLE prompt.

Check cable connection between electrodes and the

AED Plus.

ANALYSIS HALTED. KEEP VICTIM

STILL prompt.

Excessive artifact detected during ECG analysis.

Victim must be motionless during ECG analysis. Do

not touch the victim during analysis. Keep the victim

still. If the rescuer is using the AED Plus in an

emergency vehicle, bring the vehicle to a halt before

performing ECG analysis.

RELEASE SHOCK BUTTON prompt.

Release Shock Button, then press and hold Shock

Button until discharge occurs. If voice prompt

continues, contact ZOLL Technical Service.

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Contacting Technical Service

If a ZOLL product requires service, contact the ZOLL Technical Service Department:

Telephone:

Toll free:

Fax:

1-978-421-9655

1-800-348-9011

1-978-421-0010

Have the following information available for the Technical Service representative:

• Unit serial number.

• Description of the problem.

• Purchase Order or credit card number to allow tracking of loan equipment.

• Purchase Order or credit card number for a unit with an expired warranty.

If you need to send the AED Plus to ZOLL Medical Corporation, obtain a service order request

number from the Technical Service representative. AED Plus units are available on loan at an

additional cost while your AED Plus is being repaired.

Remove all batteries from the AED Plus and return the unit and batteries in its original container (or

equivalent packaging) with the service order request number on it to the following address:

ZOLL Medical Corporation

269 Mill Road

Chelmsford, MA 01824-4105

Attn: Technical Service Department

International Customers

Customers outside of the United States should remove all batteries from the unit and return the unit

and batteries in its original container (or equivalent packaging) to the nearest authorized ZOLL

Medical Corporation Service Center. To locate an authorized service center, contact the nearest ZOLL

Sales office or authorized distributor.

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ZOLL Administration Software

ZOLL Administration Software (ZAS) helps you perform software maintenance tasks when your

defibrillator is connected to your personal computer (PC). ZAS lets you upload data from a defibrillator

to a PC, then transmit that data to your main network, or print the data locally from your PC to your

printer.

See the online Help for instructions on how to use ZAS.

Installing ZOLL Administration Software

To install ZAS, insert the ZAS CD into the CD-ROM drive on your PC. The installation program starts

automatically.

If the installation program does not start automatically:

• Select RUN from the Start menu.

• In the Open field, enter X:Setup.exe, where X is the correct letter of your CD-ROM drive.

• Click OK.

• Follow the instructions that appear on the screen to complete the installation.

RescueNet Code Review Software

RescueNet® Code Review software allows you to analyze resuscitation incident information uploaded

from the AED Plus to a PC. Using RescueNet Code Review software, you can:

• access and review victim event information

• add or modify victim information

• view animated versions of ECG traces

• annotate ECG traces

• print ECG stripcharts and case reports

See the RescueNet Code Review User’s Guide for more information.

Setting Up Data Communications

You can exchange data between a AED Plus unit and a personal computer without any cable connection

by transferring data using two IrDA (infrared interface standard) ports. One IrDA port is located on

the side of the AED Plus. The second IrDA port may be on your personal computer. In some cases, you

will be sending data from the IrDA port on your AED Plus to an IrDA port on a modem which then

transmits the data to a remote computer.

For best transmission results, IrDA ports must be facing each other and the path between the two

devices must be clear of obstacles. Beaming distances between devices may vary but should be at least

10 inches and not more than 18 inches. Power up the PC and have the ZAS and/or RescueNet Code

Review software running. Press and hold the ON/OFF Button on the AED Plus for at least 5 seconds to

establish contact with the computer or modem. Once connected properly, you hear the

COMMUNICATIONS ESTABLISHED audio prompt and see a message on your computer screen that

the connection was successful.

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Ordering Accessories

You can order the following accessories from the ZOLL Customer Service Department.

Table 6: Ordering Accessories

Item

REF

CPR-D•padz electrode including accessory kit

8900-0800-01

Adult stat•padz II electrode (single)

8900-0801-01

Adult stat•padz II electrode (case)

8900-0802-01

pedi•padz II electrode (single)

8900-0810-01

Set of 10 Batteries (Type 123L Lithium Batteries)

8000-0807-01

Administrator’s Guide

9650-0301-01

Operator’s Guide

9650-0300-01

Simulator/Tester

8000-0800-01

AED Cover (PASS)

8000-0812-01

Graphical Cover (PASS)

8000-0808-01

Low Profile Cover

8000-0803-01

Soft Case

8000-0802-01

Battery expiration labels

9305-0395-01

Upgrade Kit, Battery Replacement W/Label & Addendum

7771-0100-01

Universal Adapter Cable

8000-0804-01

Administration Guide with ZOLL Administration Software CD

9659-0302-01

Mounting Bracket

8000-0809-01

Flush Mount Wall Box

8000-0811

Recess Mount Wall Box

8000-0814

Surface Mount Wall Box

8000-0817

Standard Metal Wall Cabinet

8000-0855

Clear AED Plus Wall Cabinet

8000-0856

Brushed Stainless Steel Wall Cabinet

8000-0855-02

USB IrDA PC Adapter

8000-0815

RS-232 IrDA PC Adapter

8000-0816

RescueNet Code Review Software

8000-0813-01

AED Plus Trainer

8008-0104-01

AED Plus Trainer2

8008-0050-01

Replacement Trainer

1008-0115-01

Replacement Trainer Control

1008-0113-01

ZOLL AED PLUS Administrator’s Guide

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REF

Item

Trainer AC Adapter

US

EURO

UK

Switzerland

Australia

Trainer Cord

28

9355-0802

9355-0803

9355-0804

9355-0805

9355-0806

9355-0801

ZOLL AED PLUS Administrator’s Guide

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Appendix A: Specifications

Table 7: General Specifications

DEVICE

Size (H x W x D)

5.25" x 9.50" x 11.50"; 13.3 cm x 24. 1 cm x 29.2 cm

Weight

6.7 lbs.; 3.1 kg

Power

User Replaceable Batteries. 10 Type 123A Photo Flash lithium

manganese dioxide batteries

Device Classification

Class II and internally powered per EN60601-1

Design Standards

Meets applicable requirements of UL 60601-1, AAMI DF-39,

IEC 601-2-4, EN 60601-1, IEC 60601-1-2

ENVIRONMENT

Operating Temperature

PS Model: 32° to 122° F; 0° to 50° C

Storage Temperature

PS Model: -22° to 158° F; -30° to 60° C

Humidity

10 to 95% relative humidity, non-condensing

Vibration

MIL Std. 810F, Min Helicopter Test

Shock

PS Model: IEC 68-2-27; 100G

Altitude

PS Model: -300 to 15,000 ft.; -91m to 4573m

Aircraft

Method RTCA/DO-160D: 1997

Section 21, Category M – all operating modes.

Particle and Water Ingress

IP-55

DEFIBRILLATOR

Waveform

Rectilinear Biphasic™

Defibrillator Charge Hold

Time

30 seconds

Energy Selection

Automatic pre-programmed selection

(Adult mode: 120J, 150J, 200J; Pediatric mode: 50J, 70J, 85J)

Patient Safety

All patient connections are electrically isolated.

Charge Time

Less than 10 seconds with new batteries.

Maximum time from first rhythm

analysis to unit charged and ready

to shock

With new batteries: 14 seconds

With batteries depleted by 15 200J discharges: 15 seconds

ZOLL AED PLUS Administrator’s Guide

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DEFIBRILLATOR (cont’d)

Maximum time from power on to

unit charged and ready to shock at

200J

22.6 seconds

Electrodes

ZOLL stat•padz II, CPR-D•padz or pedi•padz II

Built in Defibrillator Self Test

Included

CPR

*Metronome Rate: Variable 60 to 100 CPM

Depth: ¾" to 3"; 1.9 to 7.6 cm

Defibrillation Advisory

Evaluates electrode connection and patient ECG to determine if

defibrillation is required.

Shockable Rhythms: Ventricular fibrillation with average

amplitude>100 microvolts and wide complex ventricular

tachycardia with rates greater than 150 BPM (adult mode) and

200 BPM (pediatric mode). Refer to ECG Analysis Algorithm

Accuracy Section for sensitivity and specificity performance.

Electrode Patient Impedance

Measurement Range

0 to 300 ohms

Defibrillator Electrode ECG

Circuitry

Protected

ECG Bandwidth

2-30Hz

Display Format

Optional LCD with Moving Bar

Size: 2.6" x 1.3"; 6.6 cm x 3.3 cm

Viewing Time: 2.6 seconds

Display Sweep Speed

25 mm/sec

Battery Capacity

Typical new battery (20° C):

• stand-by life with batteries installed: 5 years, or

• 300 ±5 continuous shocks: 250 ±5 shocks before “change

battery” indicator and 50 ±5 shocks after “change battery”

indicator; or

• at least 13 hours of continuous Monitoring time

*

Testing reports validating performance and accuracy of CPR depth measurement capability,

adaptive metronome feature function and rescuer performance, and the PASS (Passive Airway

Support System) cover function are on file with ZOLL Medical Corporation and are available for

review. Contact ZOLL Technical Support to request a copy of the following report(s) if desired:

• Using the AED Plus Cover to Aid in Airway Patency

• Depth and Compression Rate Response of Real CPR Help

• AED Plus Real CPR Help Test Results.

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DEFIBRILLATOR (cont’d)

PC Minimum Requirements

Windows® 98, Windows® 2000 Windows®NT, Windows® XP

IBM-compatible PII with 16550 UART (or higher) computer

64MB RAM.

VGA monitor or better

CD-ROM drive

IrDAport

20MB disk space

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Guidance and Manufacturer’s Declaration - Electromagnetic

Emissions

Table 8: EMC Specifications

The AED Plus is intended for use in the electromagnetic environment specified below. The

customer or the user of the AED Plus should assure that it is used in such an environment.

Emissions test

Compliance

Electromagnetic environment guidance

RF emissions CISPR11

Group 1

The AED Plus uses RF energy only

for its internal function. Therefore,

its RF emissions are very low and

are not likely to cause any

interference in nearby electronic

equipment.

RF emissions CISPR 11

Class B

Harmonic Emission

IEC 61000 3-2

Not applicable

Voltage Fluctuations/Flicker

Emission

IEC 61000 3-3

Not applicable

Medical Electrical Equipment needs special precautions regarding EMC and needs to be installed and

put into service according to EMC information provided in this document.

The AED Plus is intended for use in the electromagnetic environment specified below. The

customer or the user of the AED Plus should assure that it is used in such an environment.

32

Immunity test

IEC 60601 test

level

Compliance

level

Electromagnetic environment guidance

Electrostatic

discharge (ESD)

IEC 61000-4-2

± 6 kV contact

± 8 kV air

± 6 kV contact

± 8 kV air

Floors should be wood, concrete or

ceramic tile. If floors are covered with

synthetic material, the relative

humidity should be at least 30%.

Electrical fast

transient/burst

IEC 61000-4-4

± 2 kV for power

supply lines

± 1 kV for input/

output lines

Not applicable

Surge

IEC 61000-4-5

± 1 kV differential

mode

+/- 2 kV common

mode

Not applicable

± 1 kV I/O

Not applicable

ZOLL AED PLUS Administrator’s Guide

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Immunity test

IEC 60601 test

level

Compliance

level

Voltage dips,

short

interruptions and

voltage variations

on power supply

input lines.

IEC 61000-4-11

<5% Ut (>95% dip

in Ut) for 0.5 cycle

40% Ut (60% dip in

Ut) for 5 cycles

70% Ut (30% dip in

Ut) for 25 cycles

<5% Ut (>95%dip

in Ut) for 5 sec

Not applicable

Power frequency

(50/60 Hz)

magnetic field

IEC 61000-4-8

3 A/m

3 A/m

Electromagnetic environment guidance

Not applicable

Not applicable

Not applicable

Power frequency magnetic fields

should be at levels characteristic of a

typical location in a typical

commercial or hospital environment

NOTE Ut is the a.c. mains voltage prior to application of the test level.

The AED Plus is intended for use in the electromagnetic environment specified below. The

customer or the user of the AED Plus should assure that it is used in such an environment.

Immunity test

IEC 60601 test

level

Compliance

level

Electromagnetic environment guidance

Portable and mobile RF

communications equipment should be

used no closer to any part of the AED

Plus, including cables, than the

recommended separation distance

calculated from the equation

applicable to the frequency of the

transmitter.

Recommended separation distance

Conducted RF

IEC 61000-4-6

3 Vrms

150 kHz to 80 MHz

3 Vrms

d = 1.17 P

10 Vrms

d = 1.20 P

outside ISM bandsa

10 Vrms

150 kHz to 80 MHz

in ISM bandsa

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Immunity test

(cont’d)

IEC 60601 test

level (cont’d)

Compliance

level (cont’d)

Electromagnetic environment guidance (cont’d)

Recommended separation distance

Radiated RF

IEC 61000-4-3

10 V/m

80 MHz to 2.5 GHz

10 V/m

d = 1.20 P 80 MHz to 800 MHz

d = 2.30 P 800 MHz to 2.5 GHz

where P is the maximum output

power rating of the transmitter in

watts (W) according to the transmitter

manufacturer and d is the

recommended separation distance in

metres (m).b

Field strengths from fixed RF

transmitters, as determined by an

electromagnetic site survey,c should

be less than the compliance level in

each frequency range.d

Interference may occur in the vicinity

of equipment marked with the

following symbol:

NOTE 1 At 80 MHz, the higher frequency range applies.

NOTE 2 These guidelines may not apply in all situations. Electromagnetic propagation is affected by

absorption and reflection from structures, objects and people.

34

a

The ISM (industrial, scientific and medical) bands between 150 KHz and 80 MHz are 6.765 MHz to

6.795 MHz; 13.553 MHz to 13.567 MHz; 26.957 MHz to 27.283 MHz; and 40.66 MHz to 40.70

MHz.

b

The compliance levels in the ISM frequency bands between 150 kHz and 80 MHz and in the

frequency range 80 MHz to 2.5 GHz are intended to decrease the likelihood that mobile/portable

communications equipment could cause interference if it is inadvertently brought into patient areas.

For this reason, an additional factor of 10/3 is used in calculating the recommended separation

distance for transmitters in these frequency ranges.

c

Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless) telephones

and land mobile radios, amateur radio, AM and FM radio broadcast and TV broadcast cannot be

predicted theoretically with accuracy. To assess the electromagnetic environment due to fixed RF

transmitters, an electromagnetic site survey should be considered. If the measured field strength in

the location in which the AED Plus is used exceeds the applicable RF compliance level above, the

AED Plus should be observed to verify normal operation. If abnormal performance is observed,

additional measures may be necessary, such as reorienting or relocating the AED Plus.

d

Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 10 V/m.

ZOLL AED PLUS Administrator’s Guide

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Recommended separation distances between portable and mobile RF communications

equipment and the AED Plus

The AED Plus is intended for use in an environment in which radiated RF disturbances are controlled. The

customer or the user of the AED Plus can help prevent electromagnetic interference by maintaining a minimum

distance between portable and mobile RF communications equipment (transmitters) and the AED Plus as

recommended below, according to the maximum output power of the communications equipment.

Separation distance according to frequency of transmitter

m

Rated maximum

output power of

transmitter

W

150 kHz to 80

MHz outside

ISM bands

] P

d =[ 3.5

3

150 kHz to 80

MHz in ISM

bands

]

d = [ 12

10 P

80 MHz to 800

MHz

0.01

0.17

0.12

0.12

0.23

0.1

0.37

0.38

0.38

0.73

1

1.17

1.20

1.20

2.3

10

3.69

3.79

3.79

7.27

100

11.70

12.00

12.00

23.00

]

d = [ 12

10 P

800MHz to 2.5

GHz

d =[

23 ]

10

P

For transmitters rated at a maximum output power not listed above, the recommended separation

distance d in metres (m) can be determined using the equation applicable to the frequency of the

transmitter, where P is the maximum output power rating of the transmitter in watts (W) according to

the transmitter manufacturer.

NOTE 1 At 80 MHz and 800 MHz, the separation distance for the higher frequency range applies.

NOTE 2 The ISM (industrial, scientific and medical) bands between 150 kHz and 80 MHz are 6.765

MHz to 6.795 MHz; 13.553 MHz to 13.567 MHz; 26.957 MHz to 27.283 MHz; and 40.66 MHz to

40.70 MHz.

NOTE 3 An additional factor of 10/3 is used in calculating the recommended separation distance for

transmitters in the ISM frequency bands between 150 kHz and 80 MHz and in the frequency range

80 MHz to 2.5 GHz to decrease the likelihood that mobile/portable communications equipment

could cause interference if it is inadvertently brought into patient areas.

NOTE 4 These guidelines may not apply in all situations. Electromagnetic propagation is affected by

absorption and reflection from structures, objects and people.

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Rectilinear Biphasic Waveform Characteristics

The following table shows the Rectilinear Biphasic waveform’s characteristics when discharged into

25 ohm, 50 ohm, 100 ohm, and 125 ohm loads at a maximum energy setting of 200 joules.

Table 9: Biphasic Waveform

Discharged

into 25 ohm

load

Discharged

into 50 ohm

load

Discharged

into 100 ohm

load

Discharged

into 125 ohm

load

First Phase

Maximum Initial

Current

32 A

26 A

21 A

17 A

First Phase

Average Current

28 A

22A

16 A

13 A

First Phase Duration

6 ms

6 ms

6 ms

6 ms

Interphase duration

between first and second

phases

150 sec

150 sec

150 sec

150 sec

Second Phase Maximum

Initial Current

33 A

19 A

12 A

11 A

Second Phase Average

Current

21 A

14 A

11 A

10 A

Second Phase Duration

4 ms

4 ms

4 ms

4 ms

Table 10: Delivered Energy at Each Defibrillator Setting into a Range of Loads

Selected Energy

Load

50 J

70 J

85 J

120 J

150 J

200 J

25

40 J

61 J

66 J

95 J

111 J

146 J

50

51 J

80 J

85 J

124 J

144 J

183 J

75

64 J

89 J

111 J

148 J

172 J

204 J

100

62 J

86 J

108 J

147 J

171 J

201 J

125

63 J

89 J

110 J

137 J

160 J

184 J

150

67 J

93 J

116 J

127 J

148 J

168 J

175

61 J

86 J

107 J

119 J

138 J

155 J

±15%

±15%

±15%

±15%

±15%

±15%

Accuracy

The efficacy of ZOLL’s Rectilinear Biphasic Waveform has been clinically verified during a

Ventricular Fibrillation (VF) and Ventricular Tachycardia (VT) defibrillation study. This study (which

was conducted using ZOLL M Series defibrillators) and the findings are described below. Since the

AED Plus’s Rectilinear Biphasic Waveform employs the same first and second phase timing, similar

first and second phase currents/voltages and essentially the same mechanisms for controlling

defibrillation waveshape, the M Series® and AED Plus defibrillation waveforms are considered

substantially equivalent.

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ZOLL AED PLUS Administrator’s Guide

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Figures 9 through 14 show the Rectilinear Biphasic waveforms that the AED Plus defibrillator

produces when it discharges into loads of 25, 50, 75, 100, 125, 150, and 175 ohms at each energy

setting (200, 150, 120, 85, 70, and 50 joules).

The vertical axis shows the current in amperes (A); the horizontal axis shows the duration in

milliseconds (ms).

35

Patient

Impedance

25ohms

50ohms

75ohms

100ohms

125ohms

150ohms

175ohms

30

25

20

15

Current (A)

10

5

0

-5

-10

-15

-20

-25

-30

0

2

4

6

8

10

Time (ms)

12

14

16

18

20

Figure 9: Rectilinear Biphasic Waveforms at 200 joules

30

Patient

Impedance

25ohms

50ohms

75ohms

100ohms

125ohms

150ohms

175ohms

25

20

15

Current (A)

10

5

0

-5

-10

-15

-20

-25

0

2

4

6

8

10

Time (ms)

12

14

16

18

20

Figure 10: Rectilinear Biphasic Waveforms at 150 joules

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30

Patient

Impedance

25ohms

50ohms

75ohms

100ohms

125ohms

150ohms

175ohms

25

20

Current (A)

15

10

5

0

-5

-10

-15

-20

0

2

4

6

8

10

Time (ms)

12

14

16

18

20

Figure 11: Rectilinear Biphasic Waveforms at 120 joules

25

Patient

Impedance

25ohms

50ohms

75ohms

100ohms

125ohms

150ohms

175ohms

20

15

Current (A)

10

5

0

-5

-10

-15

-20

0

2

4

6

8

10

Time (ms)

12

14

16

18

20

Figure 12: Rectilinear Biphasic Waveforms at 85 joules

25

Patient

Impedance

25ohms

50ohms

75ohms

100ohms

125ohms

150ohms

175ohms

20

15

Current (A)

10

5

0

-5

-10

-15

-20

0

38

2

4

6

8

10

Time (ms)

12

14

16

18

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Figure 13: Rectilinear Biphasic Waveforms at 70 joules

20

Patient

Impedance

25ohms

50ohms

75ohms

100ohms

125ohms

150ohms

175ohms

15

Current (A)

10

5

0

-5

-10

-15

0

2

4

6

8

10

Time (ms)

12

14

16

18

20

Figure 14: Rectilinear Biphasic Waveforms at 50 joules

ZOLL AED PLUS Administrator’s Guide

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Clinical Trial Results for the M Series 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

test. A total of 194 patients were enrolled in the study. 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 120J

Rectilinear Biphasic Waveform with a 200J monophasic waveform. The secondary goal was to

compare all shock (three consecutive 120, 150, 170J) efficacy of the Rectilinear Biphasic Waveform

with that of a monophasic waveform (three consecutive 200, 300, 360J). A significance level of p=0.05

or less was considered statistically significant using Fischer’s Exact test. Also, differences between the

two waveforms were considered statistically significant when the customary 95% or AHA

recommended 90%* confidence interval between the two waveforms was greater than 0%.

Results: The study population of 184 patients had a mean age of 63 ±14 years. 143 patients were males.

98 patients were in the biphasic group (ventricular fibrillation/flutter, n=80, ventricular tachycardia,

n=18) and 86 patients were in the monophasic group (ventricular fibrillation/flutter, n=76, ventricular

tachycardia, n=10). There were no adverse events or injuries related to the study.

The first shock, first induction efficacy of biphasic shocks at 120J was 99% versus 93% for monophasic

shocks at 200J (p=0.0517, 95% confidence interval of the difference of -2.7% to 16.5% and 90%

confidence interval of the difference of -1.01% to 15.3%).

1st Shock Efficacy

p-value

Monophasic

Biphasic

93%

99%

0.0517

95% Confidence Interval

-2.7% to 16.5%

90% Confidence Interval

-1.01% to 15.3%

Successful defibrillation with rectilinear biphasic shocks was achieved with 58% less delivered

current than with monophasic shocks (14 ±1 vs. 33 ±7 A, p=0.0001).

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ZOLL AED PLUS Administrator’s Guide

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The difference in efficacy between the rectilinear biphasic and the monophasic shocks was greater in

patients with high transthoracic impedance (greater than 90 ohms). The first shock, first induction

efficacy of biphasic shocks was 100% versus 63% for monophasic shocks for patients with high

impedance (p=0.02, 95% confidence interval of the difference of -0.021% to 0.759% and 90%

confidence interval of the difference of 0.037% to 0.706%).

1st Shock Efficacy (High

Impedance Patients)

p-value

Monophasic

Biphasic

63%

100%

0.02

95% Confidence Interval

-0.021% to 0.759%

90% Confidence Interval

0.037% to 0.706%

A single patient required a second biphasic shock at 150J to achieve 100% efficacy versus six patients

for whom monophasic shocks of up to 360J were required for 100% total defibrillation efficacy.

Conclusion: The data demonstrate the equivalent efficacy of low energy rectilinear biphasic shocks

compared to standard high energy monophasic shocks for transthoracic defibrillation for all patients

at the 95% confidence level. The data also demonstrate the superior efficacy of low energy rectilinear

biphasic shocks compared to standard high energy monophasic shocks in patients with high

transthoracic impedance at the 90% confidence level. There were no unsafe outcomes or adverse

events due to the use of the rectilinear biphasic waveform.

* Kerber, R., et. al., AHA Scientific Statement, Circulation, 1997; 95: 1677-1682:

“... the task force suggests that to demonstrate superiority of an alternative waveform over standard

waveforms, the upper boundary of the 90% confidence interval of the difference between standard and

alternative waveforms must be < 0% (i.e., alternative is greater than standard).”

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ECG Analysis Algorithm Accuracy

Sensitivity and specificity are expressions of ECG analysis algorithm performance when compared to

ECG interpretation by a clinician or expert. Sensitivity refers to the algorithm’s ability to correctly

identify shockable rhythms (as a percentage of the total number of shockable rhythms); specificity

refers to the algorithm’s ability to correctly identify non-shockable rhythms (as a percentage of the total

number of non-shockable rhythms). The data in Table 11 and Table 12 summarizes the accuracy of the

ECG analysis algorithm as tested against ZOLL’s ECG Rhythm Database.

The algorithm sequence takes approximately 9 seconds and proceeds as follows:

• Divides the ECG rhythm into three-second segments.

• Filters and measures noise, artifact, and baseline wander.

• Measures baseline content (“waviness” at the correct frequencies — frequency domain analysis) of

signal.

• Measures QRS rate, width, and variability.

• Measures amplitude and temporal regularity (“auto-correlation”) of peaks and troughs.

• Determines if multiple 3 second segments are shockable then prompts the user to treat patient.

• Stops analyzing the ECG after detecting a shockable rhythm and theAED Plus unit is charged and

ready to deliver a shock.

Table 11: Clinical Performance Results (Adult Patients)

Rhythms

Sample

Size

Shockable (250 Total min.)

618

Coarse VF

Rapid VT

535

83

Non-shockable (300 Total

min.)

NSR

AF, SB, SVT, Heart block,

idioventricular, PVCs

Asystole

Intermediate

Fine VF

Other VT

42

Performance

Goals

Observed

Performance

90% One-sided

Lower

Confidence

Limit

>90% sensitivity 97.38%

>75% sensitivity 91.57%

95.65%

83.39%

2205

770

>99% specificity 99.86%

>95% specificity 100%

99.60%

99.52%

64

>95% specificity 100%

99.40%

3039

88

64

24

Report only

Report only

ZOLL AED PLUS Administrator’s Guide

93.75% sensitivity 84.76%

91.67% sensitivity 73.00%

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Table 12: Clinical Performance Results (Pediatric Patients)

Rhythms

Sample

Size

(9 second

records)

Performance

Goals

Observed

Performance

90%

One-sided Lower

Confidence Limit

42

51

>90% sensitivity

>75% sensitivity

100% (42/42)

92.2% (47/51)

93.1%

82.9%

229

415

>99% specificity

>95% specificity

100% (229/229) 98.7%

100% (415/415) 99.3%

14

>95% specificity

100% (14/14)

80.7%

0

22

Report only

Report only

NA

77.3% (17/22)

--58.0%

Shockable (23 Patients)

Coarse VF (1)

Rapid VT (2)

Non-shockable (121 Patients)

NSR (3)

AF, SB, SVT*, Heart block,

idioventricular, PVCs (4)

Asystole (5)

Intermediate (15 Patients)

Fine VF (6)

Other VT (7)

*155 of the 415 abnormal rhythm records were SVT (39 patients).

1. Arrhythmia Performance is reported according to the article, RE Kerber, LB Becker, JD Bourland,

RO Cummins, AP Hallstrom, MB Michos, G Nichol, JP Ornato, WH Thies, RD White, BD

Zuckerman, “Automated External Defibrillators for Public Access Defibrillation:

Recommendations for Specifying and Reporting Arrhythmia Analysis Algorithm Performance,

Incorporation New Waveforms, and Enhancing Safety”, Circulation 1997, Vol 95, No 6, 16771681

References:

Young KD, Lewis RJ: “What is confidence? Part 2: Detailed definition and determination of

confidence intervals”. Annals of Emergency Medicine, September 1997; 30; 311-218

“CRC Standard Mathematical Tables 28th Edition”, William H. Beyer, Ph.D., CRC Press, Inc, Boca

Raton, FL., 1981, Percentage Points, F-Distribution Table, pg 573.

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