ZOLL Fully Automatic AED Plus Administrator's Manual

Fully Automatic

ON

OFF

Automatic

REF 9650-0311-05 Rev. B

AED Plus
Administrator’s Guide

This issue date for the ZOLL Fully Automatic AED Plus Administrator’s Guide, REF

0123

ZOLL Medical Corporation

269 Mill Road
Chelmsford, MA USA
01824-4105

ZOLL International Holding B.V.

Newtonweg 18
6662 PV ELST
The Netherlands

9650-0311-05 Rev. B, is November, 2013.
If more than three years have elapsed since the revision date, contact ZOLL Medical Corporation to

determine if additional product information up d ate s ar e av aila ble .
© 2013 ZOLL Medical Corporation. All rights reserved. AED Plus, AED Pro, M Series, CPR-D-padz,

stat-padz, pedi-padz, RescueNet, Real CPR Help, Rectilinear Biphasic and ZOLL are trademarks or
registered trademarks of ZOLL Medical Corporation in the United States and/or other coun tries.

All other trademarks are the property of their respective owners.

Ta b l e o f C o n t e n t s

PREFACE................................................................................................................................................................................................... V

SAFETY SUMMARY.................................................................................................................................................................................. VI

Warnings.....................................................................................................................................................................................................vi

Cautions.....................................................................................................................................................................................................vii

Indications for Use................................................................................................................................................................................... vii

Contraindications for Use .....................................................................................................................................................................vii

Intended Users of the Device...............................................................................................................................................................vii

Tracking Requirements.......................................................................................................................................................................... viii

Notification of Adverse Events............................................................................................................................................................viii

Unpacking .................................................................................................................................................................................................viii

Conventions.............................................................................................................................................................................................viii

Symbols .......................................................................................................................................................................................................ix

INTRODUCTION ..................................................................................................................................................................................... 1

Using the Fully Automatic AED Plus.....................................................................................................................................................1

Using Real CPR Help

OPERATION............................................................................................................................................................................................. 3

Operating Controls and Indicators........................................................................................................................................................3

Using the Fully Automatic AED Plus Graphical User Interface ......................................................................................................5

Voice Prompts ............................................................................................................................................................................................6

Using the LCD Display .............................................................................................................................................................................9

Using the Passive Airway Support System (PASS) .......................................................................................................................... 10

Using Electrodes...................................................................................................................................................................................... 11

Applying CPR-D-padz ............................................................................................................................................................................ 12

Applying pedi-padz II (Infant/Child Electrodes)................................................................................................................................ 13

Using the CPR Monitoring Function — Real CPR Help................................................................................................................ 13

Using the Audio Recording Option.................................................................................................................................................... 14

®

..............................................................................................................................................................................2

INSTALLATION AND SELF TEST...........................................................................................................................................................15

Inspecting the Unit.................................................................................................................................................................................. 15

Preparing the Fully Automatic AED Plus for Use............................................................................................................................ 15

Using the Self Test Feature................................................................................................................................................................... 16

Battery Installation Self Test ...................................................................................................................................................................................... 16

Power On Self Test ..................................................................................................................................................................................................... 17

Manual Self Test............................................................................................................................................................................................................ 17

Automatic Self Test...................................................................................................................................................................................................... 18

Automatic Monthly Test............................................................................................................................................................................................. 18

Installing or Replacing Batteries........................................................................................................................................................... 18

Identifying Battery Condition............................................................................................................................................................... 20

MAINTENANCE AND TROUBLESHOOTING ....................................................................................................................................... 22

Maintaining the Fully Automatic AED Plus........................................................................................................................................ 22

Maintenance Checklist ................................................................................................................................................................................................ 22

Cleaning the Fully Automatic AED Plus ............................................................................................................................................ 22

Optional Maintenance for Technical Professionals......................................................................................................................... 23

Troubleshooting...................................................................................................................................................................................... 24

Contacting Technical Service............................................................................................................................................................... 25

International Customers............................................................................................................................................................................................. 25

ZOLL ADMINISTRATION SOFTWARE................................................................................................................................................ 26

Installing ZOLL Administration Software.......................................................................................................................................... 26

RescueNet Code Review Software .................................................................................................................................................... 26

Setting Up Data Communications....................................................................................................................................................... 26

ORDERING ACCESSORIES .................................................................................................................................................................... 27

A

PPENDIX A: SPECIFICATIONS............................................................................................................................................................29

Fully Automatic AED Plus Administrator’s Guide iii

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

iv Fully Automatic AED Plus Administrator’s Guide

Preface

The Fully Automatic AED Plus® Administrator’s Guide is to be used by responsible medical
authorities in conjunction with the Fully Automatic AED Plus Operator’ s Guide (

The Fully Automatic 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 2010 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 automatic external defibrillators and their relationship to
cardiopulmonary resuscitation. The following publications provide supplemental material to be used
in conjunction with the ZOLL Fully Automatic AED Plus Admin istrato r’s Guide and Operator’s
Guide:

1. 2010 American Heart Association Guidelines for CPR and ECC; Supplement to Circulation,

2. European Resuscitation Council Guidelines for Resuscitation 2010; Resuscitation (2010) Volume

This guide provides information about the operation and care of the Fully Automatic 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 Fully Automatic AED Plus.
Section 1 - Operation - Describes the functions of all controls and indicator lights of the Fully

Automatic 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 Fully Automatic AED Plus, characteristics of the

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

REF 9650-0310-01).

Volume 192, Issue 18, November 12, 2010.

81, October 2010.

Fully Automatic AED Plus Administrator’s Guide v

Safety Summar y

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

Warn ing s

• Use the Fully Automatic 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 Fully Automatic AED Plus unit in service until you have read the Fully
Automatic AED Plus Operator’s and Administrator’s Guides.

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

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

• Keep the electrode cable connected to the Fully Automatic 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

• 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 Fully Automatic 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 Fully Automatic AED Plus unit with other equipment. If the unit is used or
stacked with other equipment, verify proper operation prior to use.

®

if victim is older than 8 years or weighs more than 55 lbs (25 kg).

vi Fully Automatic AED Plus Administrator’s Guide

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 connecte d to ot her ZOLL Defibrillators. CPR
monitoring will only work if the device is configured to work with CPR-D-padz.

Indications for Use

Use the Fully Automatic 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 Fully Automatic AED
Plus should be used with Fully Automatic AED Plus Pediatric Electrodes (pedi
should not be delayed to determine the victim’s exact age or weight.

-padz

®

II). Therapy

Contraindications for Use

Do NOT use the Fully Automatic 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 ZOLL AED Plus Fully Automatic external defibrillator is intended to be used by responders who
have been trained and certified in CPR and the use of an AED to defibrillate victims of cardiac arrest.
The CPR monitoring function provides a metronome designed to encourage rescuers to perform chest
compressions at the AHA recommended rate of 100 compressions per minute. Voice and visual prompts
encourage a compression depth of 5 - 6 cm for adult patients. The CPR monitoring function is not
intended for use on patients under 8 years of age.

Fully Automatic AED Plus Administrator’s Guide vii

Tracking Requirements

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

viii Fully Automatic AED Plus Administrator’s Guide

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

Fully Automatic AED Plus Administrator’s Guide ix

x Fully Automatic AED Plus Administrator’s Guide

Introduction

Using the Fully Automatic AED Plus

The Fully Automatic AED Plus is an automatic 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 Fully Automatic AED Plus supports both adult and pediatric defib rillation 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, defibrillat ion energy is delivered
automatically by the device without the user taking any action, through these same electrodes. When
the unit detects a shockable rhythm, it charges and issues the warning SHOCK WILL BE DELIVERED
IN THREE (TWO), (ONE), followed by a loud shock tone. A shock is then delivered automatically by
the unit. 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 Fully Automatic 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 Fully Automatic AED Plus is powered by ten commercially available
consumer brand lithium-manganes e dioxide batteries.

The Fully Automatic 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 (P ASS). (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.

Fully Automatic AED Plus Administrator’s Guide 1

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
Fully Automatic AED Plus unit. When used with CPR-D-padz, the Fully Automatic 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 5 - 6 cm 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 th e 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 (2 minutes
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 Fully Automatic AED Plus periodically re-issues the CONTINUE
CPR prompt.

The rate of beeps issued by the Fully Automatic 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 Fully Automatic 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 5 cm, a PUSH HARDER prompt will be issued. A GOOD COMPRESSION
prompt will be issued if the rescuer responds by increasing compression depth to 5 cm or more.

The Fully Automatic AED Plus unit can be configured to display the FULLY RELEASE text prompt to
remind the user to lift the hands off the chest during CPR. By default, this text prompt is not enabled.

®

2 Fully Automatic AED Plus Administrator’s Guide

Operation

ON

OFF

Automatic

LCD Display (not supplied on
some units)

Graphics Indicator Lights

Electrode Connector

Status
Indicator

Carrying Handle

IrDA Port (on side of unit)

Shock Indicator

Speaker (bottom)

Battery Compartment (bottom)

On/Off Button

This section describes the following functions:

• Operating Controls and Indicators

• Using the Fully Automatic 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.

Figure 1: Identifying Operating Controls and Indicators

Fully Automatic AED Plus Administrator’s Guide 3

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.
If it is necessary to abort a shock when the unit is charged, pressing this

button will discharge the unit.
Indicator lights Illuminates to indicate which step rescuer must take to treat a victim.
Shock Indicator Illuminates when the Fully Automatic AED Plus is charged and in the

process of delivering a shock to the victim.

When the Fully Automatic AED Plus is not charged the lighted indicator is

extinguished.
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

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 Fully Automatic 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 Fully Automatic AED Plus models (see

“Ordering Accessories” on page 27).
Battery

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

Electrode Connector Connector for attaching electrodes to the Fully Automatic 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.

4 Fully Automatic AED Plus Administrator’s Guide

Using the Fully Automatic AED Plus Graphical User
Interface

The Fully Automatic 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 Fully Automatic 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 Fully Automatic 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 Fully
Automatic 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 automatically inform the user that a shock is about to be delivered. When
no shock is advised, the Fully Automatic AED Plus issues the audio prompts, NO SHOCK ADVISED

Fully Automatic AED Plus Administrator’s Guide 5

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 Fully
Automatic AED Plus automatically re-initiates a new ECG rhythm analysis.

The Fully Automatic 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 automatically; the heart icon (and associated LED) located in the center of the
graphical user interface will light up, and the unit will emit a loud tone when a shock is delivered.

Consult the Fully Automatic 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 Fully Automatic AED Plus, you may hear the following voice prompts.

Table 2: Clinical Voice Prompts

Voice Prompt Definition

UNIT OK. Fully Automatic AED Plus has successfully passed its power up

self tests.

UNIT FAILED. Fully Automatic AED Plus has failed its power up self tests and

is not usable for victim care.

CHANGE BATTERIES. Fully Automatic 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. (This prompt is off by default.)

GIVE TWO BREATHS. If victim is not breathing, give two rescue breaths. (This prompt

is off by default.)

PLUG IN CABLE. Ensure that the electrode cable is properly connected to the Fully

Automatic AED Plus electrode connector.

ATTACH DEFIB PADS TO
PATIENT’S BARE CHEST.

6 Fully Automatic AED Plus Administrator’s Guide

Attach defibrillation pads to the victim’s bare chest.

Voice Prompt Definition

CHECK ELECTRODE PADS. Previously attached electrodes are not making good contact with

the victim’s skin or the electrodes are defective.

ADULT PADS. Fully Automatic AED Plus has detected adult electrode pads

connected to it and adjusted defibrillation energy settings to adult
levels.

PEDIATRIC PADS. Fully Automatic 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.

SHOCK WILL BE DELIVERED
IN THREE (TWO), (ONE)

A shock is about to be delivered to the victim. Warn all persons
attending the victim to stand clear and stop touching the victim.
If the unit must be discharged before a shock is delivered, press
the On/Off button.

SHOCK DELIVERED. A defibrillation shock has just been delivered to the vict im .
NO SHOCK DELIVERED. No shock was delivered to the vi ctim because an error condition

was detected.

n SHOCKS DELIVERED. A total of n shocks have been delivered since the Fully

Automatic AED Plus was turned on.

START CPR. Begin CPR.
CONTINUE CPR. Continue providing CPR. This prompt may also be issued if

PUSH HARDER. CPR compressions are consistently less than 5 cm deep.
GOOD COMPRESSIONS. After prompting to Push Harder, rescuer has succeeded in

STOP CPR. Stop CPR, the Fully Automatic AED Plus is about to begin an

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

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

delivering chest compressions at least 5 cm deep.

ECG rhythm analysis.

Fully Automatic AED Plus Administrator’s Guide 7

Table 2b Non-Clinical Voice Prompts

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. Fully Automatic AED Plus device has entered the diagnostics/data

communications mode.

COMMUNICATIONS
ESTABLISHED.

IrDA Communications between the Fully Automatic AED Plus and a
personal computer or modem have been established.

8 Fully Automatic AED Plus Administrator’s Guide

Using the LCD Display

05:25

SHOCKS: 05

CHECK

RESPONSIVENESS

05:25

SHOCKS: 05

CHECK

RESPONSIVENESS

With ECG

Without ECG

5cm
depth

6cm
depth

Elapsed Time

CPR Depth of
Compression Indicator

5cm
depth

6cm
depth

Shock Count

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

Figure 3: LCD Displays

NOTE Some special Fully Automatic 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 Fully Automatic AED Plus since it was last powered on. Shock count is saved through
brief power off periods (< 5 seconds). When the Fully Automatic 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 Fully Automatic AED Plus was last powered on. Elaps e d ti me continues to be
counted through brief power off periods (< 5 seconds). When the Fully Automatic 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 5 and 6 cm of compression depth to provide reference points for rescuers
performing CPR.

Visual User Prompts (Lower 1/3 of screen): Whenever the Fully Automatic 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 Fully Automatic 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.

Fully Automatic AED Plus Administrator’s Guide 9

Using 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.

The unit cover also functions as 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 P ASS 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).

Figure 4: Using the PASS Cover

10 Fully Automatic AED Plus Administrator’s Guide

Using Electrodes

WARNING! DO NOT reuse electrodes.

The Fully Automatic 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 Fully Automatic 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 Fully Automatic 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 Fully Automatic 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 Fully Automatic 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.

Fully Automatic AED Plus Administrator’s Guide 11

Applying CPR-D-padz

ZOLL Medical Corporation 269 Mill Road
Chelmsford, MA 01824-4105 USA 978-421-9655

®

®

0123

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.

Figure 5: Placement of CPR-D-padz

12 Fully Automatic AED Plus Administrator’s Guide

Applying pedi-padz II (Infant/Child Electrodes)

IIII

9305-0627-01 Rev. 1

ZOLL Medical Corporation 269 Mill Road
Chelmsford, MA 01824-4105 USA 978-421-9655

Infant/Child Defibrillation Electrodes

0-8 Years <55lbs / 25kg

2

3

®

®

Prepare the victim before attaching the electrodes.
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. T ear 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 Fully Automatic 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).

Figure 6: Placement of pedi-padz II

Fully Automatic AED Plus Administrator’s Guide 13

Using the CPR Monitoring Function — Real CPR Help

When used with ZOLL CPR-D-padz, the Fully Automatic AED Plus monitors the rate and depth of
CPR chest compressions. The Fully Automatic 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 a compression depth of 5 - 6 cm
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 Fully Automatic 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 Fully Automatic 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 Fully Automatic 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 Fully Automatic AED Plus prompts you to PUSH HARDER, your compressions are less than 5 cm

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 Fully Automatic 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 Fully
Automatic AED Plus issues the STAY CALM prompt.

NOTE The Fully Automatic 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 Fully Automatic 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 Fully Automatic 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.

14 Fully Automatic AED Plus Administrator’s Guide

Installation and Self Test

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

• Inspecting the Unit

• Preparing the Fully Automatic 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 Fully Automatic AED Plus for Use

To ensure that the Fully Automatic 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
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 Fully Automatic AED Plus cover.

®

II or pedi-padz II to be used with the Fully Automatic

NOTE If the electrodes are not connected to the Fully Automatic 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 Fully Automatic AED Plus unit and initiate a self test by pressing the
Power Button. Verify that the uni t issues the UNIT OK voi ce prom pt. This prompt indicates that
the new batteries and electrodes are properly installed and that the unit is ready for service.

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

8. Turn the Fully Automatic AED Plus unit off.

9. Wait 2 minutes. Verify that the green check symbol (
and that the unit does not emit a beeping tone.

10. Place the Fully Automatic AED Plus unit in service.

11. Check the Fully Automatic 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 followin g completion of the above test, the Fully Automatic AED

Plus is not ready for use and may be defective. Remove th e Full y Automat ic AED Plus f rom servi ce
and consult the Troubleshooting section on page 23 of this guide to help determine the problem.

) appears in the status indicator window

)

Fully Automatic AED Plus Administrator’s Guide 15

Using the Self Test Feature

The Fully Automatic 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

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

If the status indicator displays a red X following completion of any self test, the Fully Automatic AED
Plus is not ready for use and may be defective. Remove the Fully Automatic AED Plus from service
and consult the Troubleshooting section of this guide to help determine the problem.

Battery Installation Self Test

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

1. Defibrillation Electrodes Connection: Verifies that the defibrillation electrod e s 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: V erifies 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 Fully Automatic 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: Veri fi es that voice prompts are functional.

At the end of this self test, the Fully Automatic 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.

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

CAUTION! 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.

16 Fully Automatic AED Plus Administrator’s Guide

Power On Self Test

Elapsed TimeShock Count

Language File Version

Boot File Version

Application Software Version

Firmware Version

Hardware Version

The Fully Automatic 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 Fully Automatic 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: Ve rifies that voi ce prompts are functional.

Manual Self Test

Y ou can initiate a manual self test on the Fully Automatic AED Plus by pressing and holding the unit’s
On/Off button for 5 seconds. The Fully Automatic 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.

SHOCKS: 00

00:12

B:03.31 P:05.10
L:05.00 C:02.00
H:10.00

This self test verifies the following Fully Automatic 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 Fully Automatic 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: Ve rifies that voi ce prompts are functional.

8. Display: Verifies that visual indicators are functional.

Fully Automatic AED Plus Administrator’s Guide 17

Automatic Self Test

By default, the Fully Automatic 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 Fully Automatic 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 electrod e s 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: V erifies 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 Fully Automatic 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

By default, the Fully Automatic 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 Fully Automatic 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 electrod e s 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: V erifies 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 Fully Automatic 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

T o power the Fully Automatic 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.

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.

18 Fully Automatic AED Plus Administrator’s Guide

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

1) Depress latch
here

2) Lift cover here

Battery
Compartment
Door

life when not installed in an Fully Automatic AED Plus unit.
The following examples demonstrate how to read date codes on Duracell, Sanyo and Varta batteries.

Duracell:
The date code is YYYY/MM.

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 date code is MMYY.
To install the batteries:

1. Ensure that the Fully Automatic AED Plus is turned off. Open the battery compartment by
removing the battery cover from the back of the unit.

T o remove the battery cover, insert a small tool (e.g., flat blade screw driv er) 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).

Figure 7: Removing the Battery Compartment Door

Fully Automatic AED Plus Administrator’s Guide 19

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

Battery Reset Button

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.

Figure 8: Battery Compartment

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 Fully

Automatic AED Plus cannot detect whether all batteries or only a few batteries have been
replaced. Do not place used batteries into the Fully Automatic 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 Fully Automatic
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 Fully Automatic 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 Fully Automatic AED Plus monitors energy remaining in the installed batteries. When battery
capacity is low or depleted, the Fully Automatic AED Plus will not function to specification. When a
low battery condition occurs, the Fully Automatic AED Plus:

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

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

20 Fully Automatic AED Plus Administrator’s Guide

• displays a red “X” in the status indicator window, indicating that the batteries are at low capacity
or that the Fully Automatic AED Plus has failed other self tests.

Table 3: Battery Condition

Battery Condition Indications Correction

Low Battery with Fully
Automatic AED Plus off.

Audible beep from Fully
Automatic AED Plus once every
minute.

Low Battery during power
up self test.

CHANGE BATTERIES prompt
(when Fully Automatic AED
Plus is powered on)

Low Battery or other self
test failure with Fully
Automatic AED Plus

Status Indicator has red “X”
indicating failure to operate

(when off).
powered off or during self
test.

Low Battery with Fully
Automatic AED Plus

CHANGE BATTERIES prompt

(unit powered on).
powered on.

Dead Battery Status Indicator has red “X”

indicating failure to operate

(when off).

Replace batteries.

Replace batteries.

Replace batteries. Check or
replace electrodes. If red “X”
remains, return to ZOLL
Technical Support for service.

Replace batteries as soon as
possible.

Replace batteries. If red “X”
remains, return to ZOLL
Technical Support for service.

Fully Automatic AED Plus Administrator’s Guide 21

Maintenance and Troubleshooting

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

• Maintaining the Fully Automatic AED Plus

• Cleaning the Fully Automatic AED Plus

• Optional Maintenance for Technical Professionals

• Troubleshooting

Maintaining the Fully Automatic AED Plus

• Inspect frequently, as necessary.

• Check for the green check (

• 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 Fully Automatic AED Plus.

Table 4: Maintenance Checklist

Check the following Pass Fail

) showing that the Fully Automatic AED Plus is ready to use.

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 Fully Automatic AED Plus and

sealed in their package. Replace if expired.
Are all cables free of cracks, cuts and exposed or broken wires?

Turn the Fully Automatic 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 Fully Automatic AED Plus

• After each use, clean and disinfect the Fully Automatic 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 Fully Automatic AED Plus in water.

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

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

• Do not sterilize the Fully Automatic AED Plus.

22 Fully Automatic AED Plus Administrator’s Guide

Optional Maintenance for Technical Professionals

The Fully Automatic AED Plus automatically performs maintenance testing during periodic self tests.
However, if a qualified technical professional wishes to test the Fully Automatic AED Plus further,
the following checkout procedure can be followed:

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

2. Power on the simulator and Fully Automatic 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 (
turned on.

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

• The Fully Automatic 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 Fully Automatic 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 Fully Automatic AED Plus. Verify that after the
Fully Automatic 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, ANALYZING and SHOCK WILL BE DELIVERED IN

THREE (TWO), (ONE) voice prompts

4. Verify that the shock tone is heard and that the Shock Indicator illuminates when the shock is
automatically delivered.

5. Verify that the message “Sh ocks: 1” disp lays 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 Fully
Automatic AED Plus simulator/tester to verify the accuracy of the delivered energy.

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

7. Activate the simulator’s CPR function. V erify 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 th at a NO SHOCK ADVISED prom pt is issued.

10. Turn the Fully Automatic AED Plus and Simulator off.

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

) within 4 to 5 seconds after the Fully Automatic AED Plus is

Fully Automatic AED Plus Administrator’s Guide 23

Troubleshooting

The following table summarizes common error indications on the Fully Automatic AED Plus, and their
associated corrective action. Return the Fully Automatic AED Plus to ZOLL’s Technical Service
Department if the Fully Automatic AED Plus is not working properly.

Table 5: Troubleshooting

Technical Problem Recommended Action

Self test failed. Initiate manual self test by pressing and holding the

CHANGE BATTERIES prompt. Replace all batteries with new batteries at the same

Red “X” in status indicator window. 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 Fully Automatic AED Plus fails
test again, remove the Fully Automatic AED Plus
from service and contact ZOLL Technical Service.

time. Press the Battery Reset Button when
prompted.

ON/OFF Button for more than 5 seconds.
Check to see if cable is attached properly to the
Fully Automatic AED Plus or replace the
electrodes.
Cycle power on the Fully Automatic 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 Fully Automatic AED Plus still does not
operate correctly, remove unit from service and
contact ZOLL Technical Service.

Beeping noise when Fully Automatic
AED Plus is off.

PLUG IN CABLE prompt. Check cable connection between electrodes and the

ANALYSIS HALTED. KEEP VICTIM
STILL prompt.

24 Fully Automatic AED Plus Administrator’s Guide

Remove Fully Automatic 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.

Fully Automatic AED Plus.
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 Fully
Automatic AED Plus in an emergency vehicle,
bring the vehicle to a halt before performing ECG
analysis.

Contacting Technical Service

If a ZOLL product requires service, contact the ZOLL Technical Service Department:
Telephone: [phone]

Toll free: 1-800-3 48-9011
Fax: [phone]

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 Fully Automatic AED Plus to ZOLL Medical Corporation, obtain a service
order request number from the Technical Service representative. Fully Automatic AED Plus units are
available on loan at an additional cost while your Fully Automatic AED Plus is being repaired.

Remove all batteries from the Fully Automatic 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 . T o locate an authorized service center , contact the nearest ZOLL
Sales office or authorized distributor.

Fully Automatic AED Plus Administrator’s Guide 25

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

T o 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:AEDPlusSoftwareUpgradeSetup.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 Fully Automatic 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 in formation.

Setting Up Data Communications

Y ou can exchange data between a Fully Automatic 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 Fully Automatic 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 Fully Automatic
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/o r RescueNet Cod e
Review software running. Press and hold the ON/OFF Button on the Fully Automatic 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.

26 Fully Automatic AED Plus Administrator’s Guide



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
Adult

stat-padz II
stat-padz II

electrode (single) 8900-0801-01
electrode (case) 8900-0802-01

pedi-padz II
Set of 10 Batteries (Type 123L Lithium Batteries) 8000-0807-01
Administrator’s Guide 9650-0311-01
Operator’s G u ide 9650-0310-01
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
Universal Adapter Cable 8000-0804-01
Administration Guide with
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 Fully Automatic AED Plus Wall Cabinet 8000-0856

electrode (single) 8900-0810-01

ZOLL Administration Software

CD 9659-0302-01

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

Fully Automatic AED Plus Administrator’s Guide 27

Item REF

Trainer AC Adapter

US

9355-0802

EURO

Switzerland

Australia

UK

9355-0803
9355-0804
9355-0805
9355-0806

Trainer Cord

9355-0801

28 Fully Automatic AED Plus Administrator’s Guide

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 2601, 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; 10 0G
Altitude PS Model: -300 to 15,000 ft.; -91m to 4573m
Aircraft Method RTCA/DO-160D: 1997

Section 21, Category M – all operating mo d e s.
Particle and Water Ingress IP-55

DEFIBRILLATOR

Waveform Rectilinear Biphasic™
Defibrillator Charge Hold

Time
Energy Selection

Patient Safety
Charge Time
Maximum time from first rhythm

analysis to unit charged and ready
to shock

30 seconds

Automatic pre-programmed selection

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

All patient connections are electrically isolated.

Less than 10 seconds with new batteries.

With new batteries: 12 seconds

With batteries depleted by 15 200J discharges: 13 seconds

Fully Automatic AED Plus Administrator’s Guide 29

DEFIBRILLATOR (cont’d)

Maximum time from power on to

22.6 seconds
unit charged and ready to shock at
200J

Electrodes
Built in Defibrillator Self Test
CPR

ZOLL stat-padz II, CPR-D-padz or pedi-padz II
Included
*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

0 to 300 ohms

Measurement Range
Defibrillator Electrode ECG

Protected

Circuitry
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
Data Recording and Storage

25 mm/sec

50 minutes of ECG and CPR data.

If audio recording option is installed and enabled:

20 minutes of audio recording, ECG, and CPR data.

If audio recording is disabled: 7 hours of ECG and CPR data.
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 Fully Automatic AED Plus Cover to Aid in Airway Patency

• Depth and Compression Rate Response of Real CPR Help

• Fully Automatic AED Plus Real CPR Help Test Results.

30 Fully Automatic AED Plus Administrator’s Guide

Guidance and Manufacturer’s Declaration - Electromagnetic
Emissions

Table 8: EMC Specifications

The Fully Automatic AED Plus is intended for use in the electromagnetic environment specified
below. The customer or the user of the Fully Automatic AED Plus should assure that it is used in
such an environment.

Emissions test Compliance Electromagnetic environment -

guidance

RF emissions CISPR11 Gro up 1 The Fully Automatic 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
Voltage Fluctuations/Flicker

Emission
IEC 61000 3-3

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 Fully Automatic AED Plus is intended for use in the electromagnetic environment specified
below. The customer or the user of the Fully Automatic AED Plus should assure that it is used
in such an environment.

Immunity test IEC 60601 test

level

Electrostatic
discharge (ESD)
IEC 61000-4-2

Electrical fast
transient/burst
IEC 61000-4-4

± 6 kV contact
± 8 kV air

± 2 kV for power
supply lines
± 1 kV for input/
output lines

Not applicable

Not applicable

Compliance
level

± 6 kV contact
± 8 kV air

Not applicable

± 1 kV I/O

Electromagnetic environment ­guidance

Floors should be wood, concrete or
ceramic tile. If floors are covered with
synthetic material, the relative
humidity should be at least 30%.

Surge
IEC 61000-4-5

± 1 kV differential
mode
+/- 2 kV common
mode

Fully Automatic AED Plus Administrator’s Guide 31

Not applicable

Not applicable

Immunity test IEC 60601 test

P

P

level

Compliance
level

Electromagnetic environment ­guidance

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

Not applicable

Not applicable

Not applicable

Not applicable

in Ut) for 5 sec

Power frequency
(50/60 Hz)
magnetic field
IEC 61000-4-8

3 A/m 3 A/m Power frequency magnetic fiel ds

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 Fully Automatic AED Plus is intended for use in the electromagnetic environment specified
below. The customer or the user of the Fully Automatic AED Plus should assure that it is used
in such an environment.

Immunity test IEC 60601 test

level

Compliance
level

Electromagnetic environment ­guidance

Conducted RF
IEC 61000-4-6

3 Vrms
150 kHz to 80 MHz

outside ISM bands
10 Vrms

150 kHz to 80 MHz
in ISM bands

a

a

3 Vrms

10 Vrms

Portable and mobile RF
communications equipment should be
used no closer to any part of the Fully
Automatic AED Plus, including
cables, than the recommended
separation distance calculated from
the equation applicable to the
frequency of the transmitter.

Recommended separation distance

d = 1.17

d = 1.20

32 Fully Automatic AED Plus Administrator’s Guide

Immunity test

P

P

(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 80 MHz to 800 MHz

d = 2.30 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.

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 m obile/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 recommende d 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 Fully Automatic AED Plus is used exceeds the applicable RF compliance
level above, the Fully Automatic 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 Fully Automatic AED Plus.

d

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

Fully Automatic AED Plus Administrator’s Guide 33

Recommended separation distances between portable and mobile RF communications

d =

P

3.5
3

[

]

d =

P

12
10

[

]

d =

P

12
10

[

]

d =

P

23
10

[

]

equipment and the Fully Automatic AED Plus

The Fully Automatic AED Plus is intended for use in an environment in which radiated RF disturbances are
controlled. The customer or the user of the Fully Automatic AED Plus

can help prevent electromagnetic
interference by maintaining a minimum distance between portable and mobile RF communications equipment
(transmitters) and the Fully Automatic 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

150 kHz to 80

MHz outside

ISM bands

150 kHz to 80

MHz in ISM

bands

80 MHz to 800

MHz

800MHz to 2.5

GHz

W

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

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.

34 Fully Automatic AED Plus Administrator’s Guide

Rectilinear Biphasic Waveform Characteristics

The following table shows the Rectilinear Biphasic waveform’s characteristics when dischar ged into
25 ohm, 50 ohm, 100 ohm, and 125 ohm loads at a maximum energy setting of 200 joules.

Table 9: Biphasic Waveform

First Phase

Discharged
into 25 ohm
load

32 A 26 A 21 A 17 A

Discharged
into 50 ohm
load

Discharged
into 100 ohm
load

Discharged
into 125 ohm
load

Maximum Initial
Current

First Phase

28 A 22A 16 A 13 A

Average Current
First Phase Duration 6 ms 6 ms 6 ms 6 ms

Interphase duration
between first and second

150 sec 150 sec 150 sec

150 sec

phases
Second Phase Maximum

33 A 19 A 12 A 11 A

Initial Current
Second Phase Average

21 A 14 A 11 A 10 A

Current
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

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

Accuracy ±15% ±15% ±15% ±15% ±15% ±15%

50 J 70 J 85 J 120 J 150 J 200 J

The efficacy of ZOLL’s Rectilinear Biphasic Waveform has been clinically verified during a
V entricular 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
Fully Automatic 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 Fully Automatic AED Plus defibrillation

waveforms are considered substantially equivalent.

Fully Automatic AED Plus Administrator’s Guide 35

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

-30

-25

-20

-15

-10

-5

0

5

10

15

20

25

30

35

0 2 4 6 8 10 12 14 16 18 20

Patient
Impedance
25ohms
50ohms
75ohms
100oh ms
125oh ms
150oh ms
175oh ms

-25

-20

-15

-10

-5

0

5

10

15

20

25

30

0 2 4 6 8 10 12 14 16 18 20

Patient

Impedance
25ohms
50ohms
75ohms
100oh ms
125oh ms
150oh ms
175oh ms

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).

Curren t (A)

Time (ms)

Figure 9: Rectilinear Biphasic Waveforms at 200 joul es

Curren t (A)

Figure 10: Rectilinear Biphasic Waveforms at 150 joules

36 Fully Automatic AED Plus Administrator’s Guide

Time (ms)

-20

-15

-10

-5

0

5

10

15

20

25

30

0 2 4 6 8 10 12 14 16 18 20

Curren t (A)

Patient

Impedance
25ohms
50ohms
75ohms
100oh ms
125oh ms
150oh ms
175oh ms

-20

-15

-10

-5

0

5

10

15

20

25

0 2 4 6 8 10 12 14 16 18 20

Patient

Impedance
25ohms
50ohms
75ohms
100oh ms
125oh ms
150oh ms
175oh ms

-20

-15

-10

-5

0

5

10

15

20

25

0 2 4 6 8 10 12 14 16 18 20

Patient

Impedance
25ohms
50ohms
75ohms
100oh ms
125oh ms
150oh ms
175oh ms

Time (ms)

Figure 11: Rectilinear Biphasic Waveforms at 120 joules

Curren t (A)

Time (ms)

Figure 12: Rectilinear Biphasic Waveforms at 85 joules

Curren t (A)

Time (ms)

Fully Automatic AED Plus Administrator’s Guide 37

Figure 13: Rectilinear Biphasic Waveforms at 70 joules

-15

-10

-5

0

5

10

15

20

0 2 4 6 8 10 12 14 16 18 20

Patient

Impedance
25ohms
50ohms
75ohms
100oh ms
125oh ms
150oh ms
175oh ms

Curren t (A)

Time (ms)

Figure 14: Rectilinear Biphasic Waveforms at 50 joules

38 Fully Automatic AED Plus Administrator’s Guide

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-p hysiological 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
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%).

±14 years. 143 patients were

1st Shock Efficacy 93% 99%
p-value 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

Monophasic Biphasic

±1 vs. 33 ±7 A, p=0.0001).

Fully Automatic AED Plus Administrator’s Guide 39

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%).

Monophasic Biphasic

1st Shock Efficacy (High

63% 100%

Impedance Patients)
p-value 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).”

40 Fully Automatic AED Plus Administrator’s Guide

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 the AED Plus unit is charged
and automatically delivers a shock.

Table 11: Clinical Performance Results (Adult Patients)

Rhythms Sample

Shockable (250 Total min.) 618

Coarse VF
Rapid VT

Non-shockable (300 Total min.) 3039

NSR
AF, SB, SVT, Heart block,
idioventricular, PVCs
Asystole

Intermediate

Fine VF
Other VT

Size

53583>90% sensitivity

2205
770

64

88

64
24

Performance
Goals

>75% sensitivity

>99% specificity
>95% specificity

>95% specificity

Report only
Report only

Observed
Performance

97.38%

91.57%

99.86%
100%

100%

93.75% sensitivity

91.67% sensitivity

90% One-sided
Lower
Confidence
Limit

95.65%

83.39%

99.60%

99.52%

99.40%

84.76%

73.00%

Fully Automatic AED Plus Administrator’s Guide 41

Table 12: Clinical Performance Results (Pediatric Patients)

Rhythms Sample

Size
(9 second

Performance
Goals

Observed
Performance

90%
One-sided Lower
Confidence Limit

records)

Shockable (23 Patients)

Coarse VF (1)
Rapid VT (2)

42
51

>90% sensitivity
>75% sensitivity

100% (42/42)

92.2% (47/51)

93.1%

82.9%

Non-shockable (121 Patients)

NSR (3)
AF, SB, SVT*, Heart block,

229
415

>99% specificity
>95% specificity

100% (229/229)
100% (415/415)

98.7%

99.3%
idioventricular, PVCs (4)
Asystole (5)

14

>95% specificity

100% (14/14)

80.7%

Intermediate (15 Patients)

Fine VF (6)
Other VT (7)

22

0

Report only
Report only

NA

77.3% (17/22)

---

58.0%

*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, 1677-1681

References:

Y oung 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 28

th

Edition”, William H. Beyer, Ph.D., CRC Press, Inc, Boca

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

42 Fully Automatic AED Plus Administrator’s Guide