AEDPLUS Administrator’s Guide Rev R March 2010

Page 1

Administrator’s Guide

REF 9650-0301-01 Rev. R

Page 2

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

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

determine if additional product information updates are available.

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

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

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

their respective owners.

Copyright © 2010 ZOLL Medical Corporation. All rights reserved.

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

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

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

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

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

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Preface

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

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

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

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

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

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

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

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

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

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

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

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

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

Volume 112, Issue 24, December 13, 2005.

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

S7-S23.

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

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

This guide is divided into six sections.

Preface - This page.

Safety Summary - Describes General Warnings and Cautions.

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

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

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

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

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

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

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Safety Summar y

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

and patients.

Warnings

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

or injury.

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

Administrator’s Guides.

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

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

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

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

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

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

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

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

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

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

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

during ECG analysis or defibrillation.

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

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

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

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

flammable anesthetics.

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

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

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

defibrillation.

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

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

dry skin to minimize burning.

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

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

defibrillator discharges.

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

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

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

Place victim on a firm surface before performing cardiopulmonary resuscitation.

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

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

equipment, verify proper operation prior to use.

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Cautions

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

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

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

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

or batteries may be damaged or their useful life reduced.

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

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

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

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

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

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

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

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

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

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

Indications for Use

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

as indicated by:

• Unconsciousness; and

• Absence of normal breathing; and

• Absence of a pulse or signs of circulation.

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

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

the victim’s exact age or weight.

Contraindications for Use

Do NOT use the AED Plus when the victim:

• Is conscious; or

• Is breathing; or

• Has a detectable pulse or other signs of circulation.

Intended Users of the Device

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

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

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

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

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

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

under 8 years of age.

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Tracking Requirements

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

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

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

organization.

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

following information:

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

2. Part Number/Model Number and Serial Number.

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

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

Name and Contact Phone number.

5. Date change took effect.

Notification of Adverse Events

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

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

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

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

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

Unpacking

• Carefully inspect each packing container for damage.

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

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

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

Technical Service Department.

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

Conventions

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

CALL FOR HELP.

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

injury or death.

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

unit.

NOTE Notes contain additional information on using the defibrillator.

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Symbols

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

Class II equipment

Defibrillation protected Type BF patient connection

ATTENTION: Refer to manual for more information

DANGEROUS VOLTAGE

Not new battery cells

New battery cells

Do Not push button

Push button

Do not use this manufacturer

Ok to use this manufacturer

Unit equipped to treat adult and pediatric victims

Manufacturer

Authorized representative in the European

Community

Serial Number

Catalogue number

Consult instructions for use

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Introduction

Using the ZOLL AED Plus

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

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

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

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

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

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

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

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

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

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

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

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

a new ECG analysis.

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

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

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

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

dioxide batteries.

The AED Plus can:

• Perform periodic self tests to ensure its continual readiness.

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

that is easy to apply to the victim.

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

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

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

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

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

CPR-D•padz).

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

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

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

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

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

• Use commercially available batteries.

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Using Real CPR Help ®

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

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

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

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

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

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

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

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

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

under 8 years of age.

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

60 CPM.

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

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

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

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

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Operation

This section describes the following functions:

• Operating Controls and Indicators

• Using the AED Plus Graphical User Interface

• Voice Prompts

• Using the LCD Display

• Using the Passive Airway Support System (PASS)

• Using Electrodes

• Applying CPR-D•padz

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

• Using the CPR Monitoring Function — Real CPR Help

• Using the Audio Recording Option

Operating Controls and Indicators

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

LCD Display (not supplied on

some units)

Electrode Connector

Graphics

IrDA Port (on side of unit)

Indicator Lights

Status

Indicator

Battery Compartment (bottom)

Carrying Handle

Microphone (hidden)

On/Off

Speaker (bottom)

Shock Button

Figure 1: Identifying Operating Controls and Indicators

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Table 1: Control Function

Control/Indicator

Description

ON/OFF Button

Turns power ON or OFF.

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

communications.

Indicator lights

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

Shock Button

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

victim.

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

energy into the victim.

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

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

defibrillator shocks delivered since the unit was powered on.

Pictograms

Icons that explain the series of steps needed for resuscitation and

defibrillation.

Status Indicator

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

for use.

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

4

LCD Display

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

and ECG waveforms.

IrDA Port

Provides a communications link between the defibrillator and a personal

computer or another IrDA equipped device.

PASS Cover

(optional)

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

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

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

page 27).

Battery

Compartment

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

Electrode Connector

Connector for attaching electrodes to the AED Plus.

Speaker

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

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

required.

Microphone

(optional)

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

records ambient sounds, including rescuer’s voice.

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Using the AED Plus Graphical User Interface

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

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

reinforce instructions provided through voice prompts and optional display messages.

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

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

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

Figure 2: Graphical User Interface

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

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

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

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

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

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

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

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

the ECG rhythm.

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

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

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

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

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

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

a new ECG rhythm analysis.

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

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

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

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

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

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

the center of the graphical user interface.

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

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

associated with these audio and visual prompts.

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

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

Voice Prompts

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

Table 2: Clinical Voice Prompts

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Voice Prompt

Definition

UNIT OK.

AED Plus has successfully passed its power up self tests.

UNIT FAILED.

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

victim care.

CHANGE BATTERIES.

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

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

immediately.

STAY CALM.

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

CHECK RESPONSIVENESS.

Check victim for responsiveness/consciousness by gently

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

CALL FOR HELP.

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

OPEN AIRWAY.

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

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

CHECK BREATHING.

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

from the victim’s lungs.

GIVE TWO BREATHS.

If victim is not breathing, give two rescue breaths.

PLUG IN CABLE.

Ensure that the electrode cable is properly connected to the AED

Plus electrode connector.

ATTACH DEFIB PADS TO

PATIENT’S BARE CHEST.

Attach defibrillation pads to the victim’s bare chest.

CHECK ELECTRODE PADS.

Previously attached electrodes are not making good contact with

the victim’s skin or the electrodes are defective.

ADULT PADS.

AED Plus has detected adult electrode pads connected to it and

adjusted defibrillation energy settings to adult levels.

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Voice Prompt

Definition

PEDIATRIC PADS.

AED Plus has detected pediatric electrode pads connected to it

and adjusted defibrillation energy settings to pediatric levels.

DON’T TOUCH PATIENT,

ANALYZING.

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

about to begin.

SHOCK ADVISED.

ECG rhythm analysis has detected the presence of ventricular

fibrillation or shockable ventricular tachycardia.

NO SHOCK ADVISED.

ECG rhythm analysis has detected a rhythm that is not treatable

by defibrillation.

ANALYSIS HALTED. KEEP

PATIENT STILL.

ECG rhythm analysis has been halted due to excessive ECG

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

motionless as possible.

DON’T TOUCH PATIENT.

PRESS FLASHING SHOCK

BUTTON.

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

stop touching the victim. Press the Shock Button to deliver

defibrillation therapy.

RELEASE SHOCK BUTTON.

Shock Button was depressed before the defibrillator was ready to

defibrillate. Release the Shock Button and press again after the

ready tone sounds.

SHOCK DELIVERED.

A defibrillation shock has just been delivered to the victim.

NO SHOCK DELIVERED.

No shock was delivered to the victim because rescuer failed to

press Shock Button or an error condition was detected.

n SHOCKS DELIVERED.

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

turned on.

START CPR.

Begin CPR.

CONTINUE CPR.

Continue providing CPR. This prompt may also be issued if

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

inch deep.

PUSH HARDER.

CPR compressions are consistently less than 1 ½ inches deep.

GOOD COMPRESSIONS.

After prompting to Push Harder, rescuer has succeeded in

delivering chest compressions at least 1 ½ inches deep.

STOP CPR.

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

analysis.

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

Table 2b Non-Clinical Voice Prompts

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Voice Prompt

Definition

IF NEW BATTERIES,

PRESS BUTTON.

Press the Battery Reset Button located in the battery compartment

after replacing ALL batteries in the device with new batteries.

NON-RESCUE MODE.

AED Plus device has entered the diagnostics/data communications

mode.

COMMUNICATIONS

ESTABLISHED.

IrDA Communications between the AED Plus and a personal

computer or modem have been established.

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Using the LCD Display

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

information:

Shock Count

Elapsed Time

CPR Depth of

Compression Indicator

05:25

SHOCKS: 05

CHECK

RESPONSIVENESS

SHOCKS: 05

1.5” (3.8 cm)

depth

CHECK

RESPONSIVENESS

2.0” (5.1 cm)

depth

With ECG

05:25

1.5” (3.8 cm)

depth

2.0” (5.1 cm)

depth

Without ECG

Figure 3: LCD Displays

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

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

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

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

reset to 0.

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

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

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

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

to 00:00 and continues counting.

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

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

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

performing CPR.

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

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

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

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

ECG signals as they are acquired.

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Using the Passive Airway Support System (PASS)

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

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

maintain head tilt.

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

surface before performing CPR.

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

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

head to tilt backwards.

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

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

The unit cover also functions as the Passive Airway

Support System (PASS).

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

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

injury.

Figure 4: Using the PASS Cover

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Using Electrodes

WARNING!

DO NOT reuse electrodes.

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

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

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

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

of age.

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

electrodes that you attach to the victim.

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

each use, to prepare for future emergencies.

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

in an emergency situation.

• Replace electrodes, if expired

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

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

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

alternate electrode pads if necessary.

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

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

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

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

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

connected to the AED Plus unit at all times.

The electrode package may include:

• Scissors to cut clothing or chest hair.

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

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

• Gloves.

• Barrier Mask.

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

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

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Applying CPR-D •padz

Prepare the victim before attaching the electrodes.

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

under 8 years of age.

To prepare the victim:

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

2. Ensure the victim’s chest is dry.

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

electrodes.

To apply the electrodes:

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

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

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

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

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

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

victim’s skin.

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

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

victim’s skin.

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

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

left and below the victim’s left breast.

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

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

position over the lower half of the breastbone.

®

®

ZOLL Medical Corporation 269 Mill Road

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

Figure 5: Placement of CPR-D•padz

12

ZOLL AED PLUS Administrator’s Guide

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Applying pedi•padz II (Infant/Child Electrodes)

Prepare the victim before attaching the electrodes.

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

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

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

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

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

To prepare the victim:

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

2. Ensure the victim’s chest is dry.

To apply the electrodes:

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

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

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

in Figure 6).

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

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

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

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

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

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

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

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

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

®

II

Infant/Child Defibrillation Electrodes

0-8 Years

<55lbs / 25kg

3

2

®

0197

ZOLL Medical Corporation 269 Mill Road

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

9305-0627-01 Rev. 1

Figure 6: Placement of pedi•padz II

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Using the CPR Monitoring Function — Real CPR Help

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

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

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

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

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

To use Real CPR Help you must do the following:

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

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

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

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

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

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

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

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

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

your compression depth to improve CPR performance.

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

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

Using the Audio Recording Option

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

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

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

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

STAY CALM prompt.

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

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

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

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

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

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

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

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

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ZOLL AED PLUS Administrator’s Guide

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Installation and Self Test

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

• Inspecting the Unit

• Preparing the AED Plus for Use

• Using the Self Test Feature

• Installing or Replacing Batteries

• Identifying Battery Condition

Inspecting the Unit

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

any other parts ordered.

Preparing the AED Plus for Use

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

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

service and after each clinical use.

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

such as cracks, broken or missing parts.

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

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

within their expiration date.

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

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

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

a red “X” in the status indicator window.

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

Batteries” on page 18.)

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

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

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

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

prompt.

8. Turn the AED Plus unit off.

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

and that the unit does not emit a beeping tone.

10. Place the AED Plus unit in service.

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

status indicator window.

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

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

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

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