ZOLL AED 3 Administrator's Manual

Below you will find brief information for AED AED 3 AED 3, AED AED 3 AED 3 Automatic, AED AED 3 AED 3 BLS. The ZOLL AED 3 defibrillator is designed to be used for both adult and child victims of sudden cardiac arrest and is compatible with ZOLL CPR Uni-padz®, CPR-D-padz®, CPR Stat-padz®, Stat-padz II and Pedi-padz II defibrillation pads. The defibrillator incorporates a sequence of audio and visual prompts to help rescuers follow established current AHA/ERC/ILCOR Guidelines for use of AEDs. The ZOLL AED 3 defibrillator has a liquid crystal display (LCD) touch screen and includes a CPR audio metronome function designed to encourage the rescuer to perform chest compressions at the AHA/ERC/ILCOR recommended minimum rate of at least 100 compressions per minute (CPM).

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9650-000752-12 Rev. D

Administrator’s Guide

The issue date for the ZOLL AED 3 Administrator’s Guide (REF 9650-000752-12 Rev. D) is

March, 2016.

CPR-D-padz, Pedi-padz, Real CPR Help, Rectilinear Biphasic, RescueNet, Stat-padz, ZOLL, and

ZOLL AED 3 are trademarks or registered trademarks of ZOLL Medical Corporation in the United

States and/or other countries.

0123

ZOLL Medical Corporation

269 Mill Road

Chelmsford, MA USA

01824-4105

ZOLL International Holding B.V.

Newtonweg 18

6662 PV ELST

The Netherlands

Preface

Conventions.................................................................................... iv

ZOLL AED 3 Safety Considerations ..................................................... iv

Tracking Requirements ..................................................................... iv

Notification of Adverse Events ............................................................ v

Technical Service .......................................................................... v

International Customers ........................................................... vi

Software License Agreements............................................................ vi

Chapter 1 Overview

ZOLL AED 3 User Interface................................................................ 2

Child Mode...................................................................................... 2

Real CPR Help ................................................................................. 2

Using Defibrillation Pads ................................................................... 3

Data Recording and Storage.............................................................. 4

Post Event Analysis .......................................................................... 4

Transferring Files Using a USB Flash Drive .......................................... 4

Wi-Fi Communication ....................................................................... 4

ZOLL AED 3 Operation...................................................................... 5

Operating Controls and Indicators .................................................. 5

Graphical Display Area ................................................................. 6

AED Management Mode ............................................................ 6

Rescue Mode........................................................................... 7

Audio Prompts............................................................................. 9

Chapter 2 Data Transfer

Data Storage ................................................................................. 14

Data and Audio Recording............................................................ 14

Exporting Files From the AED ....................................................... 15

Exporting Files........................................................................ 15

Using RescueNet Code Review Software..................................... 16

Using Case Review Software..................................................... 16

Importing Files from a USB Flash Drive.......................................... 16

Importing Files ....................................................................... 17

Troubleshooting Communication Issues ......................................... 18

Chapter 3 Maintenance

Self Tests ...................................................................................... 21

Self Test Functions...................................................................... 22

Automatic Self-Test Transfer .................................................... 22

Optional Maintenance Tests.............................................................. 24

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Physical Inspection ..................................................................... 24

Cleaning the ZOLL AED 3 Defibrillator............................................ 24

Optional Maintenance Test for Technical Professionals...................... 25

Test Procedure (ZOLL AED 3 and ZOLL AED 3 BLS Models) ........... 25

Test Procedure (ZOLL AED 3 Automatic Models).......................... 26

Battery Maintenance ....................................................................... 27

Identifying Battery Conditions ...................................................... 27

Chapter 4 Troubleshooting

Troubleshooting the AED ................................................................. 29

Appendix A Specifications

Defibrillator Specifications................................................................ 33

Guidance and Manufacturer’s Declaration - Electromagnetic

Compatibility Guidance .................................................................. 36

Rectilinear Biphasic Waveform Characteristics..................................... 40

ECG Analysis Algorithm Accuracy ...................................................... 45

Clinical Performance Results......................................................... 46

Wireless Output Guidance and Manufacturer’s Declaration .................... 48

RF Transmission Emitted (IEC 60601-1-2)...................................... 48

FCC Notice................................................................................. 48

Canada, Industry Canada (IC) Notices ........................................... 48

Appendix B Accessories

Accessories .................................................................................... 49

Appendix C Configuration Settings

Overview ....................................................................................... 51

Setting Up Your Wireless Configuration .............................................. 57

For IT Setup Only ....................................................................... 57

Entering Supervisor Configuration Mode......................................... 58

Setting Up Clinical Archive Wi-Fi Configuration............................ 58

Quick Setup for Clinical Archives ............................................... 58

IT Setup for Clinical Archives .................................................... 59

Setting Up Device History Wi-Fi Configuration............................. 61

Quick Setup for Device History ................................................. 61

IT Setup for Device History ...................................................... 62 ii

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Preface

The ZOLL AED 3

defibrillator is an Automated External Defibrillator (AED) that is designed to be used for both adult and child victims of sudden cardiac arrest.

The defibrillator incorporates a sequence of audio and visual prompts to help rescuers follow established current AHA/ERC/ILCOR Guidelines for use of AEDs.

This guide provides information about the operation and care of the

ZOLL AED 3 defibrillator. The ZOLL AED 3 Administrator’s Guide is to be used by trained medical personnel in conjunction with the ZOLL AED 3 Operator’s

Manual.

This guide contains the following sections:

Chapter 1—Overview describes a general product overview of the

ZOLL AED 3 defibrillator.

Chapter 2—Data Transfer provides instructions on how to transfer data that is stored on the AED.

Chapter 3—Maintenance provides the recommended procedures for evaluating the condition and performance of the ZOLL AED 3 defibrillator.

Chapter 4—Troubleshooting describes possible problems and solutions and lists the error log messages that indicate the AED requires technical service.

Appendix A—Contains specification information and the ZOLL

Rectilinear

Biphasic

waveforms that are produced when the ZOLL AED 3 defibrillator is discharged into loads of 25, 50, 75, 100, 125, 150, and 175 ohms at each energy setting (200, 150, 120, 85, 70, and 50 joules).

Appendix B—Contains a list of accessories for the ZOLL AED 3 defibrillator.

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iii

Appendix C—Contains definitions of all configuration settings for the

ZOLL AED 3 defibrillator and provides instructions for setting up your wireless configuration.

Conventions

Throughout this document, text prompts and 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 defibrillator.

NOTE Notes contain important additional information on using the defibrillator.

ZOLL AED 3 Safety Considerations

Only qualified personnel should service an ZOLL AED 3 defibrillator. Before using this defibrillator, read the ZOLL AED 3 Operator’s Manual. Before servicing any equipment, review these safety considerations and read this manual carefully.

WARNING! The ZOLL AED 3 defibrillator can generate as much as

2250 volts with sufficient current to cause lethal shocks.

Before discharging the defibrillator, warn everyone near the equipment to

STAND CLEAR.

Do not recharge, disassemble, or dispose of the battery in fire. The battery might explode if mishandled.

Tracking Requirements

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

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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 Food and Drug

Administration (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 failure or malfunction. This information is required to assure that

ZOLL provides only the highest quality products.

Technical Service

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

Department or the nearest ZOLL sales office or distributor:

Telephone: 1-978-421-9655

Toll free: 1-800-348-9011

Fax: 1-978-421-0010

Email: [email protected]

Have the following information available for the Technical Service representative:

•

Serial number

•

Description of the problem

If you need to send the ZOLL AED 3 defibrillator to ZOLL Medical Corporation, obtain a service order request number from the Technical Service representative.

NOTE Before sending the defibrillator and battery to ZOLL, check with your local shipping company to see if there are any restrictions on shipping lithium batteries.

Remove the battery pack from the defibrillator and return the AED and battery pack 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

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International Customers

Customers outside of the United States should remove the battery pack from the

AED and return the AED and battery pack in its original container (or equivalent packaging) to the nearest authorized ZOLL Medical Corporation Service Center.

To locate an authorized service center, contact the nearest ZOLL sales office or authorized distributor. For a list of ZOLL offices, please visit: http://www.zoll.com/contact/worldwide-locations/.

Software Licensing Statement

Certain software components (referred to herein as "Open Source Components") that are used in this product are licensed by ZOLL Medical Corporation (referred to herein as "ZOLL Medical") under various open source license agreements. As required by the terms of these open source license agreements, ZOLL Medical offers to make the source code corresponding to the Open Source Components, and any ZOLL Medical modifications thereof, available upon request.

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Chapter 1 Overview

The ZOLL AED 3 defibrillator is an Automated External Defibrillator (AED) that is designed to be used for both adult and child victims of sudden cardiac arrest.

The AED uses audio and visual prompts to guide the rescuer through a resuscitation sequence that may include defibrillation and/or cardiopulmonary resuscitation (CPR). The ZOLL AED 3 defibrillator has a liquid crystal display

(LCD) touch screen and uses detachable defibrillation pads. The defibrillation pads include an intelligent CPR sensor that allows the AED to monitor chest compressions and provide feedback during CPR.

This guide contains instructions for all ZOLL AED 3 models:

• ZOLL AED 3 — Operates in Semi-Automatic Mode. Includes lay rescuer prompts and graphics, and Real CPR Help

for CPR monitoring and feedback.

• ZOLL AED 3 Automatic — Operates in Fully Automatic Mode. Includes lay rescuer prompts and graphics, and Real CPR Help for CPR monitoring and feedback.

• ZOLL AED 3 BLS — Operates in Semi-Automatic Mode. Includes Real CPR Help for CPR monitoring and feedback, optional patient ECG display, CPR Dashboard, optional lay rescuer graphics, and optional audio recording.

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When the rescuer attaches defibrillation pads to a patient’s chest, the AED monitors and analyzes the electrocardiographic (ECG) rhythm of the patient’s heart to determine whether or not the ECG rhythm is shockable. If the AED detects a shockable rhythm, it either issues instructions to deliver the shock

(semi-automatic) or automatically delivers the shock (fully automatic). The

ZOLL AED 3 defibrillator then prompts the rescuer to perform CPR for a period of time (configured by the AED Administrator), after which the AED automatically initiates a new ECG analysis.

ZOLL AED 3 User Interface

The ZOLL AED 3 defibrillator has a Status Indicator that allows you to quickly see if it has passed its last self test and is ready for use. An LCD screen in the center of the front panel provides text prompts, rescue graphics, and incident information. The AED defibrillator provides audio prompts through a speaker located on the front of the AED. The front panel of the AED has an On/Off button on the top left side of the device and a Shock button beneath the LCD screen. It also has a Child selection button for patients that are less than 8 years old or weigh less than 55 pounds (25 kg).

The ZOLL AED 3 defibrillator has two operating modes: AED Management Mode and Rescue Mode. In AED Management Mode, the icons on the touch screen allow you to change configuration settings and upload clinical archives, device history, and configuration files. There is also a Supervisor menu for advanced users to make more complex changes to the AED, such as device configuration, shock settings, and CPR settings.

In Rescue Mode, the LCD screen displays graphics that are coordinated with audio prompts to guide the rescuer through the necessary steps to perform a rescue. The steps that include graphics and audio prompts are defined by local protocols for use of an AED.

Child Mode

The ZOLL AED 3 defibrillator has a Child mode that can be enabled in two ways: when the rescuer uses ZOLL CPR Uni-padz

defibrillation pads and presses the

Child selection button, or when the rescuer uses ZOLL Pedi-padz

II defibrillation pads. In this mode, the AED uses configured pediatric energy settings that are lower doses of energy than those used for adults. The

ZOLL AED 3 defibrillator also uses a pediatric AED analysis algorithm that is specifically designed for a child’s ECG. This algorithm accurately distinguishes shockable versus non-shockable rhythms in the pediatric patient.

Real CPR Help

The ZOLL AED 3 CPR Uni-padz defibrillation pads include a sensor that detects the rate and depth of chest compressions. This sensor is part of the defibrillation pads that the rescuer places on the patient’s chest, and must be located between

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your hands and the patient’s lower sternum. When the rescuer performs CPR compressions, the sensor detects the rate and depth and sends the information to the AED. The ZOLL AED 3 defibrillator includes a CPR audio metronome function designed to encourage the rescuer to perform chest compressions at the AHA/ERC/ILCOR recommended minimum rate of at least 100 compressions per minute (CPM). The AED performs CPR monitoring, prompts the rescuer, and records chest compressions in the clinical patient file.

WARNING! Real CPR Help audio prompts are not enabled in Child mode.

When performing CPR on adult patients, the ZOLL AED 3 defibrillator may issue one or more audible prompts based on the depth of chest compressions detected. If Real CPR Help determines that compression depth is consistently less than 5 centimeters, the AED issues a PUSH HARDER prompt. The AED issues a GOOD COMPRESSIONS prompt if the rescuer responds by increasing compression depth to 5 centimeters or more.

Using Defibrillation Pads

The ZOLL AED 3 defibrillator is compatible with the following adult and child defibrillation pads:

•

CPR Uni-padz (for adults and children)

•

CPR-D-padz

(for adults only)

•

CPR Stat-padz

(for adults only)

•

Stat-padz II (for adults only)

•

Pedi-padz II (for children only)

Make sure that the defibrillation pads used are appropriate for the patient.

NOTE When using CPR Uni-padz with a child patient, the rescuer must press the Child Selection button.

NOTE When using Pedi-padz II, the Child Selection button automatically lights up.

The CPR Uni-padz package is connected to the AED by a cable. The package contains defibrillation pads that the rescuer attaches to the patient. The pad package includes scissors for cutting clothing or chest hair off the patient.

If the defibrillation pads cable is not attached properly, the AED issues the

PLUG IN PADS CABLE prompt. Make certain to connect the defibrillation pad cable to the ZOLL AED 3 defibrillator and attach the pads to the patient properly.

WARNING! Defibrillation pads must be pre-attached to the device.

Keep the defibrillation pad cable connected to the AED at all times.

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NOTE Defibrillation pads 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.

WARNING! DO NOT reuse defibrillation pads.

Data Recording and Storage

All ZOLL AED 3 models can record and store up to 120 minutes of continuous

ECG/audio and clinical event data during a rescue or patient case. See “Data and

Audio Recording” on page 14 for more detailed information about this function.

Post Event Analysis

All ZOLL AED 3 models automatically store patient clinical data and device history in long-term memory.

•

Patient clinical data (clinical archives) — Includes date and time notation that you can view and analyze using ZOLL RescueNet

Code Review software or view online with ZOLL RescueNet Case Review (requires ZOLL

Online account and ZOLL AED 3 device to transmit clinical event data over

Wi-Fi).

•

Device history — A log of device status information that you can view and analyze. You can transfer this file over Wi-Fi or upload it using a USB flash drive.

Transferring Files Using a USB

Flash Drive

All ZOLL AED 3 models have a USB port that allows you to export and save configuration settings, clinical archives, and device history to a USB flash drive.

This feature allows you to easily copy a configuration from one AED to other

AEDs. The USB port also allows you to import new system software to quickly upgrade the AED.

Wi-Fi Communication

All ZOLL AED 3 models have wireless communication that provides automatic upload of self-test reports and on-demand transfer of patient clinical archives and device history information through a wireless access point.

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ZOLL AED 3 Operation

Operating Controls and Indicators

This section describes the functions of the controls on the front of the

ZOLL AED 3 defibrillator.

ON/OFF Button

Defibrillation Pad Connector

Status Indicator

Window

Speaker

Liquid Crystal Display

(LCD) Screen

Shock Button

Child Selection

Button

Carrying Handle

USB Connector

Compartment

Battery

Compartment

Support Bar

AED Passed

Self Test

AED Failed

Self Test

ON/OFF Button — Turns power ON or OFF.

When pressed and held for at least 5 seconds, the AED initiates a self test and enters AED Management Mode.

Status Indicator Window — Green check indicates that the AED passed its last self test and is ready for use.

A blank window indicates that the AED has failed its self test and is not ready for use.

Speaker — Provides audio prompts and metronome beeps that direct rescuers on what to do during a rescue; also provides audio prompts to indicate if service is required.

Defibrillation Pad Connector — This connector is used to attach defibrillation pads to the AED.

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Liquid Crystal Display (LCD) Screen — A 5.3 x 9.5 centimeter touch screen for display and user input. During a rescue, it displays graphics and text messages to guide the rescuer.

Shock Button — Illuminates when the AED is charged and ready to deliver a shock to the patient.

When pressed, the charged and ready AED discharges its energy into the patient.

Child Selection Button — If using CPR Uni-padz, illuminates when pressed.

Illuminated button indicates the AED is in Child Mode to prepare a rescue for a pediatric patient. Automatically illuminates when using Pedi-padz II.

USB Connector Compartment — Contains a connection for a USB flash drive when importing or exporting files to or from the AED.

Battery Compartment — Holds the battery pack used to power the AED.

Carrying Handle — The strap designed for carrying the AED.

Support Bar — The brace that opens to hold the AED in an upright position.

Graphical Display Area

The ZOLL AED 3 defibrillator has a 5.3 x 9.5 centimeter LCD screen that displays the following information in the modes in this section: AED Management Mode and Rescue Mode.

AED Management Mode

Press icon to enter Rescue

Mode

Press icon to enter Rescue

Mode

Press icon to access configuration settings

Press information icon to show data such as defibrillation pad expiration date

Battery icon shows remaining battery life

USB icon displays when

USB device is connected

Display message

Unit device identifier

Current time

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Rescue Mode

The ZOLL AED 3 and ZOLL AED 3 Automatic models show the Lay Rescuer display, while the ZOLL AED 3 BLS model can be configured to show the Lay

Rescuer display, CPR only display, or CPR and ECG display.

Lay Rescuer Display

CPR countdown timer

CPR depth compression indicator

User prompt

Number of shocks

Elapsed event time

CPR Countdown Timer -- Indicates the amount of time remaining in the CPR interval.

CPR Depth of Compression Indicator -- A bar graph that displays the depth of chest compressions measured while the rescuer is performing CPR. Indicator lines are displayed in the bar graph at 5 and 6 centimeters of compression depth and provide reference points for rescuers performing CPR.

User Prompt -- Displays a visual message on the screen while simultaneously issuing an audio prompt.

Elapsed Event Time -- Indicates the amount of time that has elapsed since the start of the rescue.

Number of Shocks -- Indicates the total number of defibrillation shocks delivered during the rescue.

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CPR Only/CPR and ECG Displays (ZOLL AED 3 BLS models only)

Chest compression rate CPR countdown timer

Chest compression depth

Depth

(cm)

5.3

Rate

(cpm)

107

CPR Time

0:15

ECG rhythm

(optional)

ECG scale marker

Number of shocks

GOOD COMPRESSIONS

User prompt

0:02:15

Event elapsed time

Chest Compression Depth — Indicates the depth of the current CPR compressions.

Chest Compression Rate —Indicates the rate of the current CPR compressions.

CPR Countdown Timer — Indicates the amount of time remaining in the CPR interval.

ECG Rhythm (optional) — Displays the current ECG waveform.

User Prompt — Displays a visual message on the screen while simultaneously issuing an audio prompt.

Event Elapsed Time — Indicates the amount of time that has elapsed since the start of the rescue.

Number of Shocks — Indicates the total number of defibrillation shocks during the rescue.

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Audio Prompts

During clinical use of the ZOLL AED 3 defibrillator, you may hear the following audio prompts:

Table 1. Clinical Audio Prompts

Audio Prompt

AUTOMATIC DEFIBRILLATOR

UNIT OK

UNIT FAILED

CHANGE BATTERY

BATTERY HAS BEEN

REPLACED

PLUG IN PADS CABLE

ATTACH CORRECT DEFIB

PADS

CHECK PADS

REPLACE PADS

ADULT PADS

PEDIATRIC PADS

STAY CALM

CHECK RESPONSIVENESS

CALL FOR HELP

OPEN AIRWAY

Definition/Action

The AED is the fully automatic model that has the capability to automatically shock the patient without the rescuer having to press the Shock button.

The AED has successfully passed its power up self tests.

The AED has failed its power up self tests and is not usable for patient care.

The ZOLL AED 3 self test has detected a low battery condition that is insufficient for the AED’s use for patient care. Replace battery pack with a new one as soon as possible.

The AED has detected that the battery has been changed.

Ensure that the defibrillation cable is properly connected to the ZOLL AED 3 defibrillation connector.

Pads that are connected to the AED are not compatible with the ZOLL AED 3 defibrillator.

Previously attached defibrillation pads are not making good contact with the patient’s skin or the pads are defective.

There is a problem with the pads connected to the

AED. Attach new pads to the AED.

Adult pads (CPR-D-padz, CPR Stat-padz, Statpadz II) are attached to the AED.

Pedi-padz II are attached to the AED.

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

Check patient for responsiveness/consciousness by gently shaking the patient and shouting “Are you all right?”

Call EMS for assistance or ask a bystander to do it for you.

Place patient in the supine position and perform

Head Tilt – Chin Lift or Jaw – Thrust maneuver to open patient’s airway.

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Audio Prompt

CHECK BREATHING

ADULT PATIENT SELECTED

IF PATIENT IS A CHILD,

PRESS CHILD BUTTON

CHILD PATIENT SELECTED

REMOVE PAD PACKAGE

Definition/Action

Look, listen, or feel for the presence of breathing and/or airflow from the patient’s lungs.

CPR Uni-padz are attached to the AED and the

Child button has not been pressed.

If patient is less than 8 years old or weighs less than 55 pounds (25 kg), press the Child Selection

Button.

The rescuer pressed the Child Button to indicate that the patient is a child.

Remove the defibrillation pad package from the back of the AED.

If needed, use scissors to completely remove the patient’s shirt.

CUT OR TEAR CLOTHING TO

EXPOSE PATIENT’S BARE

CHEST

COMPLETELY REMOVE

CHILD’S SHIRT, CUTTING OR

TEARING IF NEEDED

OPEN PAD PACKAGE

If needed, use scissors to completely remove child’s shirt.

ATTACH PADS TO PATIENT’S

BARE CHEST

ATTACH PADS TO CHILD’S

BACK AND CHEST

DON’T TOUCH PATIENT

ANALYZING

NO SHOCK ADVISED

SHOCK ADVISED

DON’T TOUCH PATIENT.

PRESS THE FLASHING SHOCK

BUTTON.

RELEASE SHOCK BUTTON

SHOCK WILL BE DELIVERED

IN THREE, TWO, ONE

SHOCK DELIVERED

Tear open the defibrillation pad package to access the defibrillation pads.

Attach defibrillation pads to the patient’s bare chest.

Attach defibrillation pads to child’s bare back and chest as shown.

Do not touch the patient; an ECG rhythm analysis is in progress or about to begin.

ECG rhythm analysis has detected a rhythm that is not treatable by defibrillation.

ECG rhythm analysis has detected the presence of ventricular fibrillation or shockable ventricular tachycardia.

Warn all persons in attendance to stand clear and stop touching the patient. Press the Shock Button to deliver defibrillation therapy.

The Shock Button was pressed before the defibrillator was ready to defibrillate. Release the

Shock Button and press again after the ready tone sounds.

(ZOLL AED 3 Automatic model only) The AED will automatically deliver shock after the countdown completes.

A defibrillation shock has just been delivered to the patient.

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Audio Prompt

NO SHOCK DELIVERED

START CPR

PUSH TO MATCH THE TONE

PUSH HARDER

GOOD COMPRESSIONS

CONTINUE CPR

ANALYSIS HALTED. KEEP

PATIENT STILL.

GIVE TWO BREATHS

STOP CPR

CPR ONLY MODE

Definition/Action

No shock was delivered to the patient because rescuer failed to press Shock Button or an error condition was detected.

Begin CPR.

Announced at the start of the CPR period.

CPR compressions are consistently less than 5 centimeters deep. (Adult patients only)

After prompting to Push Harder, rescuer has succeeded in delivering chest compressions at least 5 centimeters deep. (Adult patients only)

Continue providing CPR. This prompt may also be issued if Real CPR Help fails to detect chest compressions at least 2 centimeters deep.

ECG rhythm analysis has been halted due to excessive ECG signal artifact. Stop any ongoing

CPR and keep the patient as motionless as possible.

If patient is not breathing, give two rescue breaths.

Stop CPR. The AED is about to begin an ECG rhythm analysis.

Defibrillation is not working properly; AED will only provide CPR support.

Prompts that you may hear during non-clinical use of the ZOLL AED 3 defibrillator include:

Table 2. Non-Clinical Audio Prompts

Audio Prompt

REPLACE PADS

CHANGE BATTERY

UNIT POWERING OFF

Definition

The ZOLL AED 3 self test has detected that the defibrillation pads have passed their expiration date.

Replace the defibrillation pads immediately.

The ZOLL AED 3 self test has detected that the battery has passed its install by date. Replace the battery pack immediately.

The AED is shutting down.

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Chapter 2 Data Transfer

Device

Configuration

Icon

The ZOLL AED 3 defibrillator automatically stores patient clinical data and device history information. You can access this data and transfer it to a remote device

(such as a computer) using either a USB flash drive or a wireless access point.

The AED stores the patient clinical event data with the date and time notation.

You can view and analyze this information using ZOLL RescueNet Code Review software or ZOLL RescueNet Case Review software through ZOLL Online.

You can transfer information to the AED such as a software upgrade or configuration settings using a USB flash drive. This allows you to quickly and easily update software or copy a configuration to multiple AEDs.

In order to transfer data, the ZOLL AED 3 defibrillator must be in AED

Management mode. To enter AED Management Mode, press and hold the On/Off button for at least 5 seconds, then press the Device Configuration icon on the main display screen. While in AED Management mode, you can export data at any time to a USB flash drive or a wireless access point.

NOTE The AED retains device history and clinical event data even when powered off or when the battery pack is removed. When the AED is powered on and defibrillation pads are attached to a new patient, the new clinical data replaces the old clinical data once the AED has stored data for one or two patients (default is two).

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Data Storage

The ZOLL AED 3 defibrillator stores the following patient clinical archive and device history data:

Clinical Archive Data (.crd)

(Clinical Event File)

•

Elapsed time (since power on)

•

Continuous ECG Data

•

Number of patient shocks

•

Energy delivered

•

Patient impedance

•

Audio prompts

•

Audio recording (if applicable)

•

Power on (date and time)

•

Indication of defibrillation pad attachment

•

Results of ECG analysis

•

CPR data

•

Errors

Device History Data (.dhf)

(Self-Test Report)

•

AED serial number

•

Battery status

•

Defibrillation pad information

•

Hardware revision number

•

Software revision number

•

Date/time and results of last self test

•

Error codes in most recent self test

The ZOLL AED 3 defibrillator generates device history data when it performs a self-test during power up or at a scheduled time during sleep state. When the

AED detects system issues it saves these issues in device log files.

Data and Audio Recording

The ZOLL AED 3 BLS model has an audio recording option that can be configured on or off. If the audio recording option is on, the ZOLL AED 3 BLS model can record and store 60 minutes of continuous audio, ECG, and clinical event data.

If the audio recording option is off, the ZOLL AED 3 BLS model can record and store 120 minutes of clinical event data and ECG data. The recorded audio data is synchronized to the clinical event data. The audio recording starts when defibrillation pads are attached and the AED completes its automatic self tests.

All ZOLL AED 3 models can be configured to store one or two patient cases containing ECG, audio (BLS model), and clinical event data. When the AED is configured to store two cases and a clinical event is detected in rescue mode, the AED deletes the oldest of the two previously stored cases from memory before recording data for the current rescue. If the AED is configured to store one case, it deletes the stored case from memory before recording data for the current rescue. Deleting of old ECG, audio, and event data occurs 15 seconds after the defibrillation pads are properly connected to the patient. If the

ZOLL AED 3 defibrillator is started in AED Management Mode, the recorded data of the last rescue is retained and may be transferred using a wireless connection or USB flash drive.

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Exporting Files From the AED

You can export the following data from a ZOLL AED 3 defibrillator:

•

Clinical Archives (using USB or Wi-Fi)

•

Device History (using USB or Wi-Fi)

•

Configuration (using USB)

NOTE When transferring files via USB, the USB flash drive must be USB 1.1 or 2.0 compliant.

NOTE You do not need Supervisor access to export data files to a USB flash drive or wireless access point.

Exporting Files

Use the following procedure to transfer files from the AED.

NOTE You cannot transfer configuration files through a wireless connection.

In order to transfer data via a wireless connection, you need to create a wireless profile. If you have not already done so, see “Setting Up Your Wireless

Configuration” on page 57.

WARNING! Do not connect the AED to a computer or other device

(via the USB port) while the AED’s defibrillation pads are still connected to the patient.

Device

Configuration icon

Press and hold the On/Off button for longer than 5 seconds, then press the Device Configuration icon to enter AED Management mode.

If you are transferring data:

•

Using a wireless connection, go to step 3.

•

Using a USB flash drive, insert the flash drive into the USB connector on the back of the AED. The USB device icon ( )appears in the status bar at the bottom of the display screen.

Export Files icon

Press the Export Files icon and select the following data option(s) to transfer:

•

Clinical Archives (all)

•

Clinical Archives (new)

•

Device History

•

Configuration (USB only)

A green check displays next to the option(s) you have selected.

Press Save (USB) or Send (Wi-Fi). When the AED has finished transferring data, it issues the prompt, DATA TRANSFER COMPLETE.

Press OK to return to the previous screen.

NOTE If you rename a configuration file with the intention of importing it into another ZOLL AED 3 defibrillator, do not include spaces in the file name.

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You can transfer clinical archives (patient data) for use with ZOLL RescueNet

Code Review software or Case Review software (over Wi-Fi using ZOLL Online).

Once you have transferred a configuration file to a USB flash drive you can copy it to other ZOLL AED 3 defibrillators. See “Importing Files from a USB Flash

Drive” on page 16 for more information.

Using RescueNet Code Review Software

RescueNet Code Review software allows you to analyze resuscitation incident information from the AED and perform the following functions:

•

Access and review patient event information.

•

Add or modify patient information.

•

View animated versions of ECG traces.

•

Annotate ECG traces.

•

Print ECG stripcharts and case reports.

Visit www.zolldata.com/c-r-downloads/ to download the latest version of

RescueNet Code Review Software and corresponding documentation.

Using Case Review Software

Case Review software is a cloud-based clinical data management and quality reporting system that is hosted in ZOLL Online. Using its Wi-Fi capability, the

ZOLL AED 3 can be configured to transmit clinical event data over Wi-Fi to ZOLL

Case Review. When using Case Review software to manage clinical event data, you can perform the following functions:

•

Collect clinical files to a single destination.

•

Make data easily available to a clinical quality team.

•

Review quality of CPR directly from the web.

•

View trends in CPR quality and data movement.

Visit www.zollonline.com for more information.

Importing Files from a USB Flash Drive

You can import a configuration file, a software upgrade, or a wireless configuration to an AED using a USB flash drive. You must have Supervisor access to import data files from a USB flash drive (see “Set Supervisor Passcode” on page 54 for more information).

NOTE When importing files via USB, the USB flash drive must be USB 1.1 or

2.0 compliant.

NOTE The AED does not allow you to perform a software upgrade when the battery is below 30% capacity.

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You can import the following file types:

•

Configuration— Allows to you import clinical or Wi-Fi configuration files.

Before importing a configuration file, make sure the file name (.ini) does not have spaces in it.

•

System Software— Allows you to upgrade to the latest software version.

•

Root Certificates— Allows you to import Wi-Fi configuration files to validate the identity of the server and different elements in the network.

Importing Files

Follow the steps below to import files from a USB flash drive to an AED.

WARNING! Do not connect the AED to a computer or other device

(via the USB port) while the AED’s defibrillation pads are still connected to the patient.

Insert the USB flash drive into the USB connector on the back of the AED.

Press and hold the On/Off button for more than 5 seconds. Once the USB flash drive has been detected, the USB device icon ( status bar at the bottom of the display screen.

) appears in the

Press the Device Configuration icon to enter AED Management mode.

Configuration

Device icon

Press the Supervisor Access icon, enter your supervisor passcode, and press OK.

Supervisor

Access icon

Import Files icon

Press the Import Files icon and select one the following options to import:

•

Configuration

•

System Software

•

Root Certificates

A green check displays next to the option you have selected.

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See the table below to determine your next step based on the option you have selected:

Option

Configuration

Do the following

Select the following option(s):

•

Clinical Configuration

Wi-Fi Configuration

Then

Press OK. When the

ZOLL AED 3 has finished transferring data, it issues the prompt, FILES TRANS-

FERRED SUCCESSFULLY.

System Software Press OK. The AED issues the prompt:

UPON COMPLETION OF THE SOFTWARE UPGRADE THE SYSTEM

WILL RESTART. THE SCREEN WILL GO BLANK DURING THIS

PROCESS. THIS MAY TAKE UP TO 5 MINUTES. DO NOT POWER

OFF DURING THIS TIME.

Root Certificates Select a root certificate(s).

Press OK. When the AED has finished transferring data, it issues the prompt,

SELECTED CERTIFICATES

SUCCESSFULLY STORED.

Press OK to return to the previous screen.

Troubleshooting Communication Issues

The following table summarizes communication messages that the

ZOLL AED 3 defibrillator may issue, and their associated description and/or recommended action. If the AED is not working properly, contact ZOLL’s

Technical Service Department for assistance. See “Technical Service” on page v for more information.

Table 3. ZOLL AED 3 Communication Error Messages

Message

DATA TRANSFER COMPLETE

UNABLE TO SAVE FILES. PLEASE

ENSURE THAT AN EMPTY USB

FLASH DRIVE IS SECURELY

INSERTED INTO THE DEVICE.

UNABLE TO SAVE FILE TO

DEVICE.

FILES TRANSFERRED

SUCCESSFULLY.

UNABLE TO EXPORT REQUESTED

FILE. INTERNAL ERROR.

NO CERTIFICATES FOUND.

Description/Recommended Action

The data transfer through Wi-Fi is complete.

The AED cannot save the files to the USB flash drive. Verify that there is sufficient space to export the file(s) to the USB flash drive, and that the flash drive is inserted properly into the unit.

The file import was not successful.

Make sure there is a configuration file (.ini) on the USB flash drive and try the file import operation again.

The file(s) has been successfully imported from the USB flash drive.

The file export was not successful.

Verify the Wi-Fi configuration and try the export operation again.

There are no root certificates on the USB flash drive available to import.

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Message

SELECTED CERTIFICATES

SUCCESSFULLY STORED.

YOU HAVEN’T SELECTED ANY

FILES.

CLINICAL ARCHIVE

UNAVAILABLE.

DEVICE HISTORY UNAVAILABLE.

CONFIGURATION FILES

UNAVAILABLE.

THE REQUESTED FILE IS OUT OF

DATE. UNABLE TO IMPORT.

THE REQUESTED FILE CONTAINS

INVALID DATA. UNABLE TO

IMPORT.

THE REQUESTED FILE IS

CORRUPTED. UNABLE TO

IMPORT.

THE REQUESTED FILE CANNOT

BE FOUND. VERIFY THAT THE

USB FLASH DRIVE CONTAINS

THE NECESSARY FILE AND THAT

THE USB FLASH DRIVE IS

PROPERLY INSERTED IN THE

DEVICE.

CONFIGURATION FILES ARE

ONLY SAVED TO USB. THEY ARE

NOT TRANSMITTED VIA WI-FI.

WI-FI CONNECTION NOT

ESTABLISHED. CANNOT

TRANSMIT REQUESTED DATA.

SOFTWARE UPGRADE FAILED.

PLEASE ENSURE THAT THE USB

FLASH DRIVE IS PROPERLY

INSERTED AND CONTAINS A

SOFTWARE UPGRADE FILE.

THE SYSTEM IS UNABLE TO

INSTALL THE SELECTED

CERTIFICATES. PLEASE ENSURE

THAT THE USB FLASH DRIVE IS

PROPERLY INSERTED.

UNABLE TO TRANSMIT

REQUESTED FILE.

Description/Recommended Action

The root certificates have been imported to the AED.

You have not selected any files to be imported.

Select the file(s) and try the import operation again.

There are no clinical archive files (.crd) available to export.

There are no device history files (.dhf) available to export.

There are no configuration files (.ini) available to export.

The AED cannot import the configuration file

(.ini) from the USB flash drive. Verify that the file is a compatible version and try the import operation again.

The AED cannot import the file from the USB flash drive. Verify that the file is valid and try the import operation again.

The AED cannot read the USB flash drive.

Verify that the USB flash drive is inserted properly into the unit.

The AED cannot transmit configuration files through Wi-Fi.

The AED cannot transmit the data through the Wi-Fi connection. If you have not already done so, see “Setting Up Your Wireless

Configuration” on page 57.

The software upgrade was unsuccessful. Try the upgrade operation again.

The AED cannot save the files to the USB flash drive. Verify that the USB flash drive is inserted properly into the device.

The attempt to export the file to the USB flash drive was unsuccessful.

Try the file transfer again.

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Message

UPON COMPLETION OF THE

SOFTWARE UPGRADE THE

SYSTEM WILL RESTART. THE

SCREEN WILL GO BLANK DURING

THIS PROCESS. THIS MAY TAKE

UP TO 5 MINUTES. DO NOT

POWER OFF DURING THIS

TIME.

Description/Recommended Action

AED is performing a software upgrade. Wait until the upgrade is complete and the unit restarts.

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Chapter 3 Maintenance

The ZOLL AED 3 defibrillator automatically performs functional testing during periodic self tests. There are also some basic maintenance tests that can be performed on the AED. This section of the guide contains information about functions that are performed with each self test as well as procedures for maintaining the ZOLL AED 3 device.

Self Tests

The ZOLL AED 3 defibrillator performs the following self tests to verify AED integrity and its readiness for emergency use:

•

Battery Installation

•

Power On

•

Manual

•

Automatic (daily or weekly, based on configuration)

•

Automatic Monthly

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AED Passed

Self Test

AED Failed

Self Test

Following successful completion of all self tests, the status indicator displays a green check (

)

to show that all tests passed and that the AED is ready to use.

If the status indicator is blank following completion of any self test, the

ZOLL AED 3 defibrillator is not ready for use and may be defective. Remove the

AED from service and consult the section, “Chapter 4 Troubleshooting” on page 29, to help determine the problem.

Self Test Functions

The following functions are verified during self tests. Table 4 on page 23 lists the functions that are included in each self test.

•

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

•

Defibrillation Pads Connection: Verifies that the defibrillation pads are properly preconnected to the device.

•

Defibrillation Pads/Battery Expiration: Verifies that the defibrillation pads are within their expiration date and the battery is within its install by date.

•

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

•

Defibrillator Charge and Discharge Circuitry: Verifies that the device’s defibrillator electronics are functional and can charge and discharge at

2 joules. The following tests also include a separate 200 joule charge/ discharge test: Battery Installation Self Test, Manual Self Test, Automatic

Monthly Test.

•

Microprocessor Hardware/Software: Verifies proper function of the

AED microprocessor electronics and the integrity of its software.

•

CPR Circuitry and Sensor: Determines that CPR monitoring and compression depth detection are functional (if defibrillation pads with CPR functionality are connected).

•

Audio Circuitry: Verifies that voice prompts are working.

Automatic Self-Test Transfer

All ZOLL AED 3 defibrillators come standard with Program Management

Onboard

intelligent monitoring technology to transfer self-test data. If configured, the AED can automatically transfer self-test information over Wi-Fi to the ZOLL PlusTrac

AED program management system or to another AED program management provider.

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Table 4. Self Test Functions

Battery Capacity

Battery

Installation

Self Test



 Defibrillation Pads

Connection

Defibrillation Pads/

Battery Expiration

ECG Circuitry



 Defibrillator Charge and Discharge Circuitry

(2 Joule Charge/

Discharge Test)

Microprocessor

Hardware/Software

CPR Circuitry and

Sensor (if defibrillation pads with CPR functionality are connected)

Audio Circuitry



200 Joule Charge/

Discharge Test



Power On

Self Test



Manual

Self Test



Automatic

Self Test



Automatic

Monthly

Test



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Optional Maintenance Tests

This section includes a physical inspection of the ZOLL AED 3 defibrillator that you should perform periodically. There is also an optional maintenance test for

ZOLL AED 3 models to verify that the AED is working properly and is ready for use. Note that there are two separate optional maintenance tests in this chapter:

One for ZOLL AED 3 and ZOLL AED 3 BLS models, and one for the ZOLL AED 3

Automatic model.

Physical Inspection

Check the following:

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

Verify that the defibrillation pads are connected to the AED and sealed in their package. Replace defibrillation pads if expired.

Are there any cracks or loose parts in the housing?

Turn on the AED and verify the green check (

) indicates ready for use; then turn it off.

Battery pack is within install by date. Replace if the install by date has passed.

Cleaning the ZOLL AED 3 Defibrillator

After each use, clean and disinfect the defibrillator with a soft, damp cloth using either 90% isopropyl alcohol, or soap and water. You can also use a chlorine bleach and water mixture (30 ml/liter water) to clean the defibrillator (except on the contacts and connectors).

NOTE Wipe down the defibrillator with water after using any cleaning solution.

Chlorine residue that remains on the LCD screen may damage it.

DO NOT:

•

Immerse any part of the defibrillator in water.

•

Use chlorine mixture on contacts or connectors; this will degrade the contacts over time.

•

Use ketones (MEK, acetone, etc.) to clean the defibrillator.

•

Use abrasives (e.g., paper towel) on the display window or graphic screen.

•

Sterilize the defibrillator.

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Optional Maintenance Test for Technical

Professionals

Although the ZOLL AED 3 automatically performs maintenance testing during periodic self tests, you can periodically perform the following manual test to verify that the ZOLL AED 3 is working properly and is ready for use.

This section has two tests: one for ZOLL AED 3 and ZOLL AED 3 BLS models, and one for ZOLL AED 3 Automatic models.

Test Procedure (ZOLL AED 3 and ZOLL AED 3 BLS

Models)

NOTE You must use the ZOLL AED Simulator with this test.

1. Connect the ZOLL AED Simulator to the ZOLL AED 3 defibrillation pads connector.

2. Power on the simulator and the ZOLL AED 3 defibrillator. Verify that all of the following occur:

•

The status indicator (located on the top left of the AED) initially changes from blank to a green check (

) within 4 to 5 seconds after the AED is turned on.

•

The AED issues the UNIT OK voice prompt and displays the message within

5 seconds after power-up.

•

The AED displays the number of shocks in the bottom left of the screen and the event elapsed time (since power-up) in the bottom right of the LCD screen.

3. Using the simulator, input a VF rhythm to the AED. Verify that after the AED proceeds through its sequence of victim assessment prompts, it does the following:

•

Analyzes the ECG rhythm.

•

Issues the SHOCK ADVISED voice prompt.

•

Charges the defibrillator.

•

Issues the DON’T TOUCH THE PATIENT; PRESS THE FLASHING SHOCK

BUTTON voice prompt.

4. Verify that the AED emits the charge ready tone and that the Shock button illuminates.

5. Press the Shock button and verify that the simulator shows that a shock was delivered. Verify that the number 1 displays next to the shock icon on the bottom left of the LCD screen.

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

7. Activate the simulator’s CPR function. Verify that the metronome begins to beep and that the following voice prompts/messages are issued within 60 seconds: PUSH HARDER followed by GOOD COMPRESSIONS.

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8. After approximately two minutes of CPR, verify that the STOP CPR prompt is issued. Set the simulator to Normal Sinus Rhythm (NSR) and verify that a new ECG analysis begins.

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

10. Turn off the ZOLL AED 3 defibrillator and the simulator.

**Test Procedure (ZOLL AED 3 Automatic Models)**

NOTE You must use the ZOLL AED Simulator with this test.

1. Connect the ZOLL AED Simulator to the ZOLL AED 3 defibrillation pads connector.

2. Power on the simulator and the ZOLL AED 3 defibrillator. Verify that all of the following occur:

•

The status indicator (located on the top left of the AED) initially changes from blank to a green check (

) within 4 to 5 seconds after the AED is turned on.

•

The AED issues the UNIT OK voice prompt and displays the message within

5 seconds after power-up.

•

The AED displays the number of shocks in the bottom left of the screen and the event elapsed time (since power-up) in the bottom right of the LCD screen.

3. Using the simulator, input a VF rhythm to the AED. Verify that after the AED proceeds through its sequence of victim assessment prompts, it does the following:

•

Analyzes the ECG rhythm.

•

Issues the SHOCK ADVISED voice prompt.

•

Charges the defibrillator.

•

Issues the DON’T TOUCH THE PATIENT; SHOCK WILL BE DELIVERED IN

THREE, TWO, ONE voice prompt.

4. Verify that the AED emits the charge ready tone and the AED automatically delivers a shock.

5. Following shock delivery, verify the following:

•

The AED issues the SHOCK DELIVERED message.

•

The simulator shows that a shock was delivered.

•

The number 1 displays next to the shock icon on the bottom left of the AED

LCD screen.

•

The AED issues the START CPR messages.

6. Activate the simulator’s CPR function. Verify that the metronome begins to beep and that the following voice prompts/messages are issued within 60 seconds: PUSH HARDER followed by GOOD COMPRESSIONS.

7. 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.

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

9. Turn off the ZOLL AED 3 defibrillator and the simulator.

Battery Maintenance

Identifying Battery Conditions

Battery capacity depletes during standby operation of the ZOLL AED 3 defibrillator, while the AED is operating, and as a result of each defibrillation.

Battery capacity also gradually diminishes over a shelf life of years without use.

The AED monitors energy remaining in the installed battery pack. When battery capacity is low or depleted, the ZOLL AED 3 defibrillator will not function to specification. When a low battery condition occurs, the AED does one of the following things:

•

Emits an audible alarm or “beep” once every minute (if the AED is off).

•

Issues the CHANGE BATTERY voice prompt (if the AED is on).

•

Displays a blank status indicator window (no green check), indicating that the battery is at low capacity or that the ZOLL AED 3 defibrillator has failed other self tests.

Table 5. Battery Conditions

Battery Icon/

Condition

Low Battery with AED off.

Low Battery during power up self test.

Low Battery or other self test failure with

AED powered off or during self test.

Indications

Audible beep from AED once every minute.

CHANGE BATTERY prompt

(when AED is powered on)

Status Indicator window is blank (no green check) indicating failure to operate

(when off).

Correction

Replace battery pack.

Low Battery with AED powered on.

Dead Battery.

CHANGE BATTERY prompt

(AED powered on).

Status indicator window is blank (no green check) indicating failure to operate when AED is off.

Replace battery pack.

Check or replace defibrillation pads. If blank status indicator window remains, contact

ZOLL Technical Service

Department for service.

Replace battery pack as soon as possible.

Replace battery pack. If blank status indicator window remains, contact

ZOLL Technical Service

Department for service.

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Chapter 4 Troubleshooting

This chapter describes technical issues that you may encounter during routine maintenance or after a malfunction of the ZOLL AED 3 defibrillator.

If this chapter does not help you resolve the problem, call the ZOLL Technical

Service Department for assistance. For contact information, refer to page v.

Troubleshooting the AED

The following table lists issues that may occur and their solutions. First, try the recommendations listed under “Operator Action.” If these steps do not remedy the problem, follow the suggestions under “Technical Action.”

For information on contacting ZOLL Technical Service, refer to page v.

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Table 6. ZOLL AED 3 Troubleshooting

Problem

Green check does not appear in status indicator window.

UNIT FAILED

Beeping noise when AED is off.

CHANGE BATTERY

Operator Action

Press and hold the On/Off button for at least 5 seconds to perform a self-test.

Verify that the defibrillation pads cable is properly plugged into the patient cable connector. Replace the defibrillation pads.

Turn the AED off and then press and hold the On/Off button for at least 5 seconds to perform a self-test.

Verify that the defibrillation pads cable is properly plugged into the patient cable connector. Replace the defibrillation pads.

Verify that the defibrillation pads cable is properly plugged into the patient cable connector.

Hold the On/Off button for at least 5 seconds to perform a self-test. Verify that a green check appears in the status indicator window.

Replace the battery pack.

PLUG IN PADS CABLE

CHECK PADS

ANALYSIS HALTED;

KEEP PATIENT STILL

NO SHOCK DELIVERED

Technical Action

If the AED continues to fail, remove it from service and contact ZOLL

Technical Service.

If the AED continues to fail, remove it from service and contact ZOLL

Technical Service.

If the AED continues to beep, remove it from service and contact ZOLL

Technical Service.

Ensure that the defibrillation pads

cable is properly plugged into the patient cable connector.

Reattach pads.

If the message persists, remove the AED from service and contact ZOLL

Technical Service.

If the message persists, remove the AED from service and contact ZOLL

Technical Service.

If the message persists, attach new pads.

If the message persists, remove the AED from service and contact ZOLL

Technical Service.

Keep the patient still during ECG analysis. If transporting the patient by stretcher or vehicle, stop all patient movement during analysis.

The Shock button was not pressed or an internal error occurred.

When prompted to press the button, do so within 30 seconds.

If an internal error occurred (no shock was delivered when the Shock button was pressed properly), remove the

AED from service and contact ZOLL Technical

Service.

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Table 6. ZOLL AED 3 Troubleshooting (Continued)

Problem

RELEASE SHOCK

BUTTON

ATTACH CORRECT

DEFIB PADS

REPLACE PADS

Operator Action

(ZOLL AED 3 and ZOLL AED 3

BLS models) Release the Shock button. Do not press the button until the charge-ready tone sounds and the button begins flashing.

Attach one of the following compatible defibrillation pads to the AED:

•

CPR Uni-padz

•

CPR-D padz

•

CPR Stat padz

•

Pedi-Padz II (child pads)

•

Stat-padz II

Attach new defibrillation pads to the AED.

Technical Action

If the message persists, remove the AED from service and contact ZOLL

Technical Service.

If the message persists, remove the AED from service and contact ZOLL

Technical Service.

If the message persists, remove the AED from service and contact ZOLL

Technical Service.

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Appendix A

Specifications

Defibrillator Specifications

This section describes product specifications for the ZOLL AED 3 defibrillator:

Device

Size (H x W x D)

Weight

Power

Device Classification

Design Standards

5.0" x 9.3" x 9.7" (12.7 cm x 23.6 cm x 24.7 cm)

5.5 lbs.; 2.5 kg

Battery pack

Internally powered per EN60601-1

Meets applicable requirements of EN 60601-1,

IEC 60601-1-11, EN 60601-2-4

Environment

Operating Temperature

Storage Temperature

Humidity

Vibration

Shock

Altitude

Particle and Water Ingress

Drop

32° to 122° F; 0° to 50° C

-22° to 158° F; -30° to 70° C

10 to 95% relative humidity, non-condensing

IEC 60068-2-64, Random, Spectrum A.4, Table A.8,

Cat. 3b; RTCA/DO-160G, Fixed Wing Aircraft,

Section 8.6, Test Cat. H, Aircraft Zone 1 and 2; EN 1789,

Sweep per EN 60068-2-6 Test Fc

IEC 60068-2-27; 100G

-1,250 to 15,000 ft.; -381 m to 4573 m

IP55

3.28 ft;1 m

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Defibrillator

Waveform Rectilinear Biphasic™

Defibrillator Charge Hold Time ZOLL AED 3/ZOLL AED 3 BLS models: 30 seconds

ZOLL AED 3 Automatic model: 3 seconds prior to automatic shock delivery

Energy Selection

Patient Safety

Charge Time

Automatic pre-programmed selection

(Adult mode: 120J, 150J, 200J; Child mode: 50J, 70J,

85J delivered into a 50 ohm patient)

All patient connections are electrically isolated.

Less than 10 seconds with new battery pack. With a depleted battery pack, the charge time is longer.

Time from first rhythm analysis to AED charged and ready to shock

With new battery pack: 8 seconds

With battery pack depleted by 15 200J discharges: 9 seconds

36 seconds Maximum time from power on to AED charged and ready to shock at 200J

Electrodes

Built in Defibrillator Self Test

Defibrillation Advisory

Shockable Rhythms

CPR Uni-padz, CPR-D padz, CPR Stat-padz, Stat-padz II, or Pedi-padz II

Included (verifies proper charging and discharging of the defibrillator)

Evaluates defibrillation pad connection and patient ECG to determine if defibrillation is required.

Ventricular fibrillation with average amplitude>100 microvolts and wide complex ventricular tachycardia

(with QRS duration > 120 msec) with rates greater than

150 BPM (adult mode) and 200 BPM (child mode).

Refer to “ECG Analysis Algorithm Accuracy” on page 45 for sensitivity and specificity performance.

10 to 300 ohms Electrode Patient Impedance

Measurement Range

Defibrillator Electrode ECG

Circuitry

ECG

ECG Bandwidth

Implanted Pacemaker Pulses

Detected

Protected

.67-20Hz

The ZOLL AED 3 defibrillator does not reject implanted pacemaker pulses.

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9650-000752-12 Rev. D

Display

Display type

Viewable area

(height • width)

ECG Sweep Speed

ECG Viewing time

Data Recording and Storage

3.84 seconds

ZOLL AED 3/

ZOLL AED 3 Automatic

ZOLL AED BLS

User configurable for 1 or 2 clinical events for a total of

120 minutes. Includes, ECG, patient impedance, audio prompts, and CPR data.

User configurable for 1 or 2 clinical events for a total for

120 minutes with audio recording disabled, or 60 minutes with audio recording enabled. Includes ECG, patient impedance, audio prompts, CPR data, and optional audio recording.

Battery

Operating Time

(Clinical Mode)

Typical new battery running at an ambient temperature of +20° C to +25° C (68° F to 77° F) can provide:

•

140 defibrillator discharges at maximum energy (200 joules), or

6 hours of continuous monitoring (with 2-minute CPR periods)

Note: CPR periods shorter than 2 minutes can decrease the operating time that can be obtained from a new battery.

Standby Life (years)

When using a battery stored for up to 2 years at 23° C

(73° F) and placed in a

ZOLL AED 3 defibrillator.

High resolution liquid crystal display with capacitive touch panel

2.12 in • 3.74 in

5.39 cm • 9.5 cm

25 mm/sec

Auto Self-Test Report OFF

Self-Test Interval (7 days)

Self-Test Interval (1 day)

Auto Self-Test Report ON

Self-Test Interval (7 days)

*Battery standby life will be shorter in areas with low Wi-Fi signal strength and/or more complex Wi-Fi authentication protocols.

CPR Monitoring

CPR

Compression Depth

Compression Rate

Metronome Rate: 105 ±2 CPM

0.75 to 4 inches ±0.25 inches

1.9 to 10.2 cm ±0.6 cm

50 to 150 compressions per minute

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Guidance and Manufacturer’s Declaration

- Electromagnetic Compatibility Guidance

The ZOLL AED 3 defibrillator is intended for use in the electromagnetic environment specified below. The customer or the user of the AED should assure that it is used in such an environment.

Emissions test Compliance Electromagnetic environment

- guidance

RF emissions CISPR11 Group 1 The AED 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

Harmonic Emission

IEC 61000 3-2

Voltage Fluctuations/

Flicker Emission

IEC 61000 3-3

Class B

Not applicable

Medical Electrical Equipment needs special precautions regarding EMC and needs to be installed and put into service according to EMC information provided in this document.

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The ZOLL AED 3 defibrillator is intended for use in the electromagnetic environment specified below. The customer or the user of the AED should assure that it is used in such an environment.

Immunity test

Electrostatic discharge (ESD)

IEC 61000-4-2

IEC 60601 test level

± 8 kV contact

± 15 kV air

Compliance level

± 8 kV contact

± 15 kV air

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%.

Electrical fast transient/burst

IEC 61000-4-4

Surge

IEC 61000-4-5

± 2 kV for power supply lines

± 1 kV for input/ output lines

± 1 kV differential mode

+/- 2 kV common mode

Not applicable

Voltage dips, short interruptions and voltage variations on power supply input lines.

IEC 61000-4-11

<5% Ut (>95% dip in Ut) for 0.5 cycle

40% Ut (60% dip in Ut) for 5 cycles

70% Ut (30% dip in Ut) for 25 cycles

<5% Ut

(>95%dip in Ut) for 5 sec

30 A/m

Not applicable

30 A/m Power frequency

(50/60 Hz) magnetic field

IEC 61000-4-8

Power frequency magnetic fields should be at levels characteristic of a typical location in a typical commercial or hospital environment.

Portable and mobile RF communications equipment should be used no closer to any part of the AED, including cables, than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter, or 30 cm, whichever is greater.

Recommended separation distance

Conducted RF

IEC 61000-4-6

3 Vrms

150 kHz to 80

MHz outside ISM bands a

10 Vrms

150 kHz to

80 MHz in ISM bands a

3 Vrms

10 Vrms d = 1.17 d = 1.20

P

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Immunity test (cont’d)

Radiated RF

IEC 61000-4-3

IEC 60601 test level (cont’d)

10 V/m

80 MHz to

2.5 GHz

Compliance level (cont’d)

10 V/m

Electromagnetic environment

- guidance (cont’d)

Recommended separation distance

d = 1.20

P

80 MHz to 800 MHz d = 2.30

P

800 MHz to 2.5 GHz where P is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer and d is the recommended separation distance in metres (m).

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.

Interference may occur in the vicinity of equipment marked with the following symbol:

The ZOLL AED 3 defibrillator is suitable for use in all professional and domestic establishments. It is not intended for use near intentional transmitters of radio energy outside the ranges stated in the above table, such as high frequency surgical equipment, radar installations, or radio transmitters. It is also not intended for use in fixed or rotary wing aircraft. Operation outside of this environment could result in the misinterpretation of the ECG rhythms or CPR signals, interference to the display or audio messages, or the inability to provide defibrillation therapy.

NOTE 1: Ut is the a.c. mains voltage prior to application of the test level.

NOTE 2: At 80 MHz, the higher frequency range applies.

NOTE 3: These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects and people.

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.

The compliance levels in the ISM frequency bands between 150 kHz and 80 MHz and in the frequency range 80 MHz to 2.5 GHz are intended to decrease the likelihood that mobile/portable communications equipment could cause interference if it is inadvertently brought into patient areas. For this reason, an additional factor of 10/3 is used in calculating the recommended separation distance for transmitters in these frequency ranges.

Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless) telephones and land mobile radios, amateur radio, AM and FM radio broadcast and TV broadcast cannot be predicted theoretically with accuracy. To assess the electromagnetic environment due to fixed RF transmitters, an electromagnetic site survey should be considered. If the measured field strength in the location in which the AED is used exceeds the applicable RF compliance level above, the ZOLL AED 3 defibrillator should be observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as reorienting or relocating the AED.

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

ZOLL AED 3 Administrator’s Guide

9650-000752-12 Rev. D

Recommended separation distances between portable and mobile RF communications equipment and the ZOLL AED 3 defibrillator

The ZOLL AED 3 is intended for use in an environment in which radiated RF disturbances are controlled. The customer or the user of the ZOLL AED 3 can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and the ZOLL AED 3 as recommended below, according to the maximum output power of the communications equipment.

The recommended separation distance should be the distance calculated from one of the equations below, or 30 cm, whichever is greater.

Separation distance in meters (m) according to frequency of transmitter

Rated maximum output power of transmitter in watts (W)

150 kHz to 80

MHz outside

ISM bands

d = ]

P

150 kHz to 80

MHz in ISM bands

d =

]

P

80 MHz to 800

MHz

d =

]

P

800MHz to 2.5

GHz

d =

]

P

0.01

0.1

0.17

0.37

1.17

0.12

0.38

1.20

0.12

0.38

1.20

0.23

0.73

2.3

100

3.69

11.70

3.79

12.00

3.79

12.00

7.27

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.

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Rectilinear Biphasic Waveform

Characteristics

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

Discharged into 25 ohm load

32 A First Phase

Maximum Initial

Current

First Phase

Average Current

28 A

First Phase

Duration

Interphase duration between first and second phases

Second Phase

Maximum Initial

Current

6 ms

150

33 A

Second Phase Average

Current

21 A

Second Phase Duration 4 ms

 sec

Discharged into 50 ohm load

26 A

22A

6 ms

150

 sec

19 A

14 A

4 ms

Discharged into 100 ohm load

21 A

16 A

6 ms

150

 sec

12 A

11 A

4 ms

Discharged into 125 ohm load

17 A

13 A

6 ms

150

 sec

11 A

10 A

4 ms

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Table 7. Delivered Energy at Each Defibrillator Setting into a Range of Loads

Load

25

50

75

100

125

150

175

Accuracy

Selected Energy

50 J 70 J

40 J

51 J

61 J

80 J

64 J

62 J

63 J

67 J

61 J

±15%

89 J

86 J

89 J

93 J

86 J

±15%

85 J

66 J

85 J

111 J

108 J

110 J

116 J

107 J

±15%

120 J

95 J

124 J

148 J

147 J

137 J

127 J

119 J

±15%

150 J

111 J

144 J

172 J

171 J

160 J

148 J

138 J

±15%

200 J

146 J

183 J

204 J

201 J

184 J

168 J

155 J

±15%

The efficacy of ZOLL’s Rectilinear Biphasic Waveform has been clinically verified during a Ventricular Fibrillation (VF) and Ventricular Tachycardia (VT) defibrillation study. This study (which was conducted using ZOLL M Series defibrillators) and the findings are described below. Since the ZOLL AED 3 defibrillator’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 AED Pro

® and ZOLL AED 3 defibrillation waveforms are considered substantially equivalent.

Figures 1 through 6 show the Rectilinear Biphasic waveforms that are produced when the ZOLL AED 3 defibrillator is discharged into loads of 25, 50, 75, 100,

125, 150, and 175 ohms at each energy setting (200, 150, 120, 85, 70, and 50 joules).

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

-5

-10

-15

-20

-25

-30

0 2 4 6 8 10

12 14

Figure 1.

Rectilinear Biphasic Waveforms at 200 Joules

25Ω

50Ω

75Ω

100Ω

125Ω

150Ω

175Ω

18 20

-5

-10

-15

-20

-25

0 2 4 6 8 10

12 14

Figure 2.

Rectilinear Biphasic Waveforms at 150 Joules

25Ω

50Ω

75Ω

100Ω

125Ω

150Ω

175Ω

18 20

ZOLL AED 3 Administrator’s Guide

9650-000752-12 Rev. D

-5

-10

-15

-20

0 2 4 6 8 10

12 14

Figure 3.

Rectilinear Biphasic Waveforms at 120 Joules

25Ω

50Ω

75Ω

100Ω

125Ω

150Ω

175Ω

18 20

-5

-10

-15

-20

0 2 4 6 8 10

12 14

Figure 4.

Rectilinear Biphasic Waveforms at 85 Joules

25Ω

50Ω

75Ω

100Ω

125Ω

150Ω

175Ω

18 20

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ZOLL AED 3 Administrator’s Guide

-5

-10

-15

-20

0 2 4 6 8 10

12 14

Figure 5.

Rectilinear Biphasic Waveforms at 70 Joules

25Ω

50Ω

75Ω

100Ω

125Ω

150Ω

175Ω

18 20

-5

-10

-15

0 2 4 6 8 10

12 14

Figure 6.

Rectilinear Biphasic Waveforms at 50 Joules

25Ω

50Ω

75Ω

100Ω

125Ω

150Ω

175Ω

18 20

ZOLL AED 3 Administrator’s Guide

9650-000752-12 Rev. D

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 the following tables summarizes the accuracy of the ECG analysis algorithm as tested against ZOLL’s ECG Rhythm Database.

The algorithm sequence takes approximately six to nine seconds and proceeds as follows:

•

Divides the ECG rhythm into three-second segments.

•

Filters and measures noise and artifact.

•

Measures baseline content (‘waviness’ at the correct frequencies) of the signal.

•

Measures QRS rate, width, and variability.

•

Measures amplitude and temporal regularity (‘auto-correlation’) of peaks and troughs.

•

Determines if two out of three segments are shockable then prompts the user to treat the patient.

•

Stops analyzing the ECG after detecting a shockable rhythm and alerts the user that the device is ready to deliver a shock.

•

Prompts the user to return to CPR if the ECG rhythm is determined to be non-shockable.

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Clinical Performance Results

The following two tables represent clinical performance results of adult and pediatric patients.

Table 8. Clinical Performance Results (Adult Patients)

Rhythms Sample

Size

Performance

Goals

Observed

Performance

90%

One-sided

Lower

Confidence

Limit

Shockable

Coarse VF

Rapid VT

Intermediate

Fine VF

Other VT

536

Non-shockable

NSR

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

Asystole

2210

819

115

Sensitivity

>90%

>75%

Specificity

>99%

>95%

Report only

>99%

>98%

>99%

Sensitivity

>94%

>99%

>94%

>99%

>97%

>87%

>89%

Table 9. Clinical Performance Results (Pediatric Patients)

Rhythms Sample

Size

Performance

Goals

Observed

Performance

90%

One-sided

Lower

Confidence

Limit

Shockable

Coarse VF

Rapid VT

Non-shockable

NSR

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

Asystole

208

348

Intermediate

Fine VF

Other VT

Sensitivity

>90%

>75%

Specificity

>99%

>95%

Report only

>99%

>NA

>81%

>93%

>96%

>98%

>97%

>90%

>NA

>69%

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Table 10. Rhythm Recognition Detector Categories (Adult Patients)

Shock

Non-shockable

VF and VT

680

All Other ECG Rhythms

3171

A true positive (680) is a correct classification of a shockable rhythm. A true negative (3171) is a correct classification of all rhythms for which a shock is not indicated. A false positive (1) is an organized or perfusing rhythm or asystole that has been incorrectly classified as a shockable rhythm. A false negative (5) is a VF or VT associated with cardiac arrest that has been incorrectly classified as non-shockable.

Table 11. Rhythm Recognition Detector Categories (Pediatric Patients)

Shock

Non-shockable

VF and VT

121

All Other ECG Rhythms

619

A true positive (121) is a correct classification of a shockable rhythm. A true negative (619) is a correct classification of all rhythms for which a shock is not indicated. A false positive (10) is an organized or perfusing rhythm or asystole that has been incorrectly classified as a shockable rhythm. A false negative (0) is a VF or VT associated with cardiac arrest that has been incorrectly classified as non-shockable.

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Wireless Output Guidance and

Manufacturer’s Declaration

RF Transmission Emitted (IEC 60601-1-2)

The ZOLL AED 3 unit complies with IEC 60601-1-2 for medical electrical equipment and medical electrical systems that include RF transmitters as specified below.

Data Rates Standard Frequency

Range

802.11b

802.11g

2412-2472 MHz

Effective Radiated

Power

100 mW

32 mW

Modulation

Type

DSSS

OFDM

802.11n

802.11a

802.11n

2412-2472 MHz

5180-5320 MHz

5500-5700 MHz

5745-5825 MHz

5180-5320 MHz

5500-5700 MHz

5745-5825 MHz

32 mW

OFDM

1, 2, 5.5, 11 Mbps

6, 9, 12, 24, 36, 48,

54 Mbps

6.5, 13, 19.5, 26, 39,

52, 58.5, 65 Mbps

6, 9, 12, 24, 36, 48,

54 Mbps

6.5, 13, 19.5, 26, 39,

52, 58.5, 65 Mbps

FCC Notice

Contains FCC ID: MCQ-CCi.MX28

ZOLL Medical Corporation has not approved any changes or modifications to this device by the user. Any changes or modifications could void the user’s authority to operate the equipment. See 47 CFR Section 15.21.

This device complies with part 15 of the FCC Rules. Operation is subject to the following two conditions: (1) This device may not cause harmful interference, and (2) this device must accept any interference received, including interference that may cause undesired operation.

The user is cautioned to maintain 20 cm (8 inches) of space from the product to ensure compliance with FCC requirements.

Canada, Industry Canada (IC) Notices

Contains Model ConnectCard

for i.MX28 Radio, IC: 1846A-CCi.MX28

This device complies with Industry Canada license-exempt RSS standard(s).

Operation is subject to the following two conditions: (1) this device may not cause interference, and (2) this device must accept any interference, including interference that may cause undesired operation of the device.

FCC/IC/EU: This device is limited to indoor use in the 5150MHz to 5250MHz band.

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Appendix B

Accessories

The following accessories are compatible for use with the ZOLL AED 3 defibrillator. To order any of these items, contact your local ZOLL representative.

NOTE The use of accessories other than those specified in this appendix may result in increased emissions or decreased immunity of the

ZOLL AED 3 defibrillator.

REF Accessory

Defibrillation Pads

• CPR Uni-padz

• CPR-D padz

• CPR Stat-padz

• Stat-padz II

• Pedi-padz II

Battery

• AED 3 Battery Pack

Carry Cases

• Battery Case

• Replacement Shoulder Strap

• AED 3 Carry Case

• Small Rigid Plastic Case

• Large Rigid Plastic Case

8900-000260

8900-0800-01

8900-0402

8900-0801-01

8900-0810-01

8000-000696

8000-001251

8000-001252

8000-001250

8000-001253

8000-001254

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Accessory

Wall Mounts/Cabinets

• Standard Surface Wall Cabinet

• Semi-recessed Wall Cabinet

• Fully-recessed Wall Cabinet

• Device Wall Mount Bracket

• Case Wall Mount Bracket

• Strobe for Standard Surface Wall Cabinet

• Strobe for Semi/Fully-recessed Wall Cabinet

Wall Signs

• ILCOR Flush Wall Sign (AED)

• ILCOR 3D Wall Sign (AED)

• ILCOR Flush Wall Sign (DAE)

• ILCOR 3D Wall Sign (DAE)

• ILCOR Flush Wall Sign (DEA)

• ILCOR 3D Wall Sign (DEA)

Simulation/Training

• ZOLL AED Simulator

• Training CPR Uni-padz

Documentation

• ZOLL AED 3 Operator’s Manual

REF

8000-001256

8000-001257

8000-001258

8000-001255

8000-001266

8000-001259

8000-001267

8000-001260

8000-001261

8000-001262

8000-001263

8000-001264

8000-001265

8000-000925

8900-000264

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Appendix C

Configuration Settings

Overview

This section describes the configurable settings for the ZOLL AED 3 defibrillator.

The configuration settings can be manually selected through the use of the LCD touch screen, or automatically configured by reading a configuration file directly from a USB flash drive.

Press the Device Configuration icon to access the configuration window. To

Device

Configuration icon import a configuration file from a USB flash drive, see “Importing Files from a

USB Flash Drive” on page 16.

There are two levels of configuration settings: user and supervisor. The supervisor settings are indicated by the Supervisor Access icon. You need a pass

Supervisor

Access icon code to access these advanced settings (the default passcode is listed under “Set

Supervisor Passcode” on page 54). Press the icons on the screen to access the configuration settings below. Once you set up your AED to put it into service,

ZOLL recommends that you create a new supervisor passcode.

User/Supervisor

Setting

Language

Description Values

User configurable for one language

(up to three possible languages depending on the ordered device configuration).

•

Language 1

•

(default)

Language 2

•

Language 3

Note: This setting is also available to the Supervisor user.

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User/Supervisor

Setting

Lay Rescuer Prompts

Description

Note: This setting is also available to the Supervisor user.

Check Breathing Prompts

Note: This setting is also available to the Supervisor user.

CPR Depth Measure Units

When enabled (ON), the AED issues the following audio and text prompts after completion of the power-on selftest and entry into clinical mode:

STAY CALM

CHECK RESPONSIVENESS

CALL FOR HELP

Note: If defibrillation pads are preattached to the patient, these prompts are not issued.

Allows you to enable the check breathing prompts, “Open Airway and

Check Breathing”, based on the guidelines you want to follow.

When disabled (OFF), these prompts are not issued.

Note: If defibrillation pads are preattached to the patient, these prompts are not issued.

Allows you to set the CPR depth measurement units to inches or centimeters.

Note: This setting is also available to the Supervisor user.

Date

Allows you to manually set the date on the AED.

Values

•

ON (default)

OFF

OFF (default)

Inches--in

Centimeters--cm

Note: The default value depends on the AED’s primary language.

Month/Day/Year

Note: This setting is also available to the Supervisor user.

Time

Allows you to manually set the time and to specify the time zone.

•

00:00:00

Note: This setting is also available to the Supervisor user.

When Auto Adjust for Daylight

Savings is enabled (ON), the AED’s

24-hour clock automatically adjusts for Daylight Savings Time.

Note: You must select a time zone for this setting to work.

•

Dateline

•

American Samoa

•

Hawaii

•

Alaska

•

N. A. Pacific

•

N. A. Mountain

•

N. A. Central

•

N. A. Eastern

(default)

•

Cuba

•

Columbia

•

Venezuela

•

Atlantic (includes

Puerto Rico and

Virgin Islands)

•

Paraguay

•

Newfoundland

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User/Supervisor

Setting

Time (cont’d)

Note: This setting is also available to the Supervisor user.

Description Values

•

Chile

•

Falkland Islands

•

Greenland

•

Brazil (São

Paulo)

•

Mid Atlantic

(including the east coast of

Brazil)

•

Azores

•

UTC

•

Western Europe

•

Central Europe

•

Namibia

•

Algeria

•

Eastern Europe

•

Egypt

•

Lebanon

•

Syria

•

Kaliningrad

•

Iraq

•

Moscow

•

Arabia

•

Iran

•

Samara

•

Afghanistan

•

Western Asia

•

Yekaterinburg

•

India

•

Central Asia

•

Omsk

•

Southeast Asia

•

Krasnoyarsk

•

Irkutsk

•

China

•

W. Australia

•

Japan (includes

Korea)

Yakutsk

•

Central Australia

•

E. Australia

•

Vladivostok

•

Central Pacific

(includes Guam)

•

Srednekolymsk

•

New Zealand

•

Kamchatka

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Supervisor Setting

(Advanced)

Number of Clinical Cases

Description Values

Sets the number of patient cases that are stored in nonvolatile memory.

•

2 (default)

Self-Test Interval (Days)

Sets the period of time between automated self-tests in standby state.

•

1 day

•

7 days (default)

Auto Self-Test Report

Audio Recording

(ZOLL AED 3 BLS model only)

When enabled (ON) and following the completion of a periodic self test, the

ZOLL AED 3 will attempt to link to

ZOLL PlusTrac via an active Wi-Fi connection.

Note: The device history Wi-Fi configuration setup must be completed for this to function (see

“Setting Up Device History Wi-Fi

Configuration” on page 61).

Enables audio recording during

Rescue Mode.

•

OFF (default)

•

OFF (default)

Device Display

(ZOLL AED 3 BLS model only)

Set Supervisor Passcode

Allows you to select information displayed on the LCD screen during clinical use.

Lay User -- Displays text prompts and graphics.

CPR Only - Displays text prompts and the CPR Dashboard during the CPR cycle.

CPR and ECG - Displays text prompts, the patient’s ECG rhythm, and the CPR Dashboard during the

CPR cycle.

Allows you to change the passcode used to enter Supervisor mode.

•

Lay User

•

CPR Only

•

CPR and ECG

(default)

•

Six numeric digits

Note: The AED ships with a default

Supervisor passcode of 123456. ZOLL recommends that you change the default passcode as soon as the new device setup is complete.

Write the new passcode on the line below and put this document in a secure location for future reference.

____________________________

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Supervisor Setting

(Advanced)

Device ID

Description Values

Allows you to input an alpha-numeric device identifier for RescueNet Code

Review.

•

Eleven alphanumeric digits

User/Supervisor

Setting

Export Files

Description Values

Note: This setting is also available to the general user.

Import Files

You can upload files from the AED to a

USB flash drive or through a wireless connection.

Note: You can only upload configuration files to a USB flash drive, not through Wi-Fi.

You can download files from a USB flash drive to the AED.

•

Clinical Archives

•

(all)

Clinical Archives

(new)

•

Device History

•

Configuration

•

Configuration

•

System Software

•

Root Certificates

Supervisor Setting

Adult Energy Settings

Child Energy Settings

Breathe During CPR

Prompt

Description

Sets the energy level in joules for an adult patient for the first, second, and third shocks.

Sets the energy level in joules for a child patient for the first, second, and third shocks.

When this option is enabled (ON), the

AED prompts Give Two Breaths every

30 recognized compressions.

Values

Shock 1

•

120 J (default)

•

150 J

•

200 J

Shock 2

•

120 J

•

150 J (default)

•

200 J

Shock 3

•

120 J

•

150 J

•

200 J (default)

Shock 1

•

50 J (default)

•

70 J

•

85 J

Shock 2

•

50 J

•

70 J (default)

•

85 J

Shock 3

•

50 J

•

70 J

•

85 J (default)

•

OFF (default)

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Supervisor Setting

Continue CPR Prompt

CPR Prompt Interval

Start with CPR Period

No Shock CPR Period

Post Shock CPR Period

Wi-Fi Settings

Description

“Continue CPR” prompt will be repeated every “N” seconds (based on the CPR Prompt Interval) if CPR compressions stop during the CPR interval.

When this option is disabled (OFF), the “Continue CPR” prompt is not issued during the CPR period.

This option determines the interval for the following prompts:

•

START CPR

•

CONTINUE CPR

Sets the duration of the "Start with

CPR" period once defibrillation pads are attached to the patient.

Values

•

ON (default)

•

OFF

•

10 seconds

(default)

15 seconds

Sets the duration of the CPR period following a No Shock Advised result from the analysis.

Sets the duration of the CPR period following the delivery of a shock.

•

Off

•

30 seconds

•

60 seconds

(default)

90 seconds

•

120 seconds

•

150 seconds

•

180 seconds

•

60 seconds

•

90 seconds

•

120 seconds

•

(default)

150 seconds

•

180 seconds

•

60 seconds

•

90 seconds

•

120 seconds

(default)

•

150 seconds

•

180 seconds

These icons contain the settings to set up your wireless connection. See

“Setting Up Your Wireless

Configuration” on page 57, for more information.

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Setting Up Your Wireless Configuration

This section describes how to set up a wireless connection for your AED for uploading both clinical archives and the device history. The wireless settings are accessible when the ZOLL AED 3 defibrillator is in AED Management Mode. The

Wi-Fi settings are located in the Supervisor menu for advanced users. You need a six-digit pass code to enter the Supervisor menu (see “Set Supervisor

Passcode” on page 54 for more information). The configuration setup has two options for both clinical archives and device history:

•

Quick Setup - For users with a simple configuration using the default settings.

•

IT Setup - For users with a more complex configuration using specific wireless settings.

NOTE Prior to setting up your clinical archive configuration, visit zollonline.com to create a ZOLL Case Review account.

NOTE Prior to setting up your device history configuration, refer to the

PlusTrac Activation Certificate (in your documentation folder) for instructions on how to register for AED Program Management.

You can also automatically configure the Wi-Fi settings for the AED by downloading a configuration file directly from a USB flash drive. For detailed information on how to do this, see “Importing Files from a USB Flash Drive” on page 16.

For IT Setup Only

Client certificates are needed for the Wi-Fi configuration setup only if you are using the TLS method of Wi-Fi authentication. When you select TLS during the

Wi-Fi setup, you will need to select a client certificate as part of the setup process.

Additional root certificates are only needed if you are not using the ZOLL standard Self-Signed (SSL) Certificate. If you are not using an SSL Certificate, you need to import the root SSL certificate to use either before you start the

Wi-Fi configuration, or during the process of setting up the configuration. For detailed information on how to import a root certificate, see “Importing Files from a USB Flash Drive” on page 16.

ZOLL supports the following root and client certificates:

Root Certificates

.pem (b64 encoded)

.der (binary)

.p7b (Microsoft Chained Certificate)

Client Certificates

.pfx (binary)

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Entering Supervisor Configuration Mode

To enter configuration mode, follow the steps below:

Device

Configuration icon

1. Press and hold down the On/Off button for more than 5 seconds. Then press the Device Configuration icon to access the configuration window.

Supervisor

Access icon

2. Press the Supervisor icon, and enter your six-digit passcode. You will need to set up the configuration settings for both the clinical archives as well as the device history. See the following sections for step-by-step instructions on both of these configuration setups.

Setting Up Clinical Archive Wi-Fi Configuration

Clinical Archive

Wi-Fi icon

Press the Clinical Archive Wi-Fi icon to access the Select Wi-Fi Setup Level window and make one of the following selections:

•

Quick Setup - for a simple configuration using the default settings (go to

"Quick Setup for Clinical Archives" below).

•

IT Setup - for a more complex configuration using non-standard wireless setup settings (go to “IT Setup for Clinical Archives” on page 59).

Quick Setup for Clinical Archives

1. Press the Quick Setup button to access the Clinical Archive Quick Settings window and enter the applicable information in the following fields:

Wireless button

•

Network (SSID)--Press the wireless button to the right of this field to search for available wireless networks. Select a network from the list and press

OK.

Alternately, you can use the alpha-numeric keypad to enter the SSID

(Service Set IDentifier) name that identifies your wireless network access point. Press OK.

•

Password (Pre-Shared Key) - Use the alpha-numeric keypad to enter the pre-shared key (password) to the wireless access point. Press OK.

•

Server Settings - Press the Server Settings field to display the Server

Settings window. Use the alpha-numeric keypad to enter the following server information.

Address

User ID

Passcode

The default is dxsvc.zollonline.com. If you are using the default server, keep this entry the same.

Otherwise, enter the URL address of the host server. Press OK.

Use the alpha-numeric keypad

to enter the username of the host server. Press OK.

Note: If you have set up a ZOLL Case Review account on zollonline.com, use the ID you specified for that account.

Use the alpha-numeric keypad to enter your password of the host server. Press OK.

Note: If you have set up a ZOLL Case Review account on zollonline.com, use the passcode you specified for that account.

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2. Press the Test Wi-Fi button in the Clinical Archive Quick Settings window to test the server connectivity.

NOTE If connectivity is not successful, check your wireless configuration settings.

3. Press Save at the bottom right of the screen to save the changes. The AED displays the message SAVING CONFIGURATION, PLEASE WAIT. When the

AED has saved the configuration, it displays the Advanced Configuration window.

IT Setup for Clinical Archives

1. Press the Clinical Archive Wi-Fi icon.

Clinical Archive

Wi-Fi icon

2. Press the IT Setup button to access the Clinical Archive Wi-Fi Settings window.

3. Press the Network Settings icon. The Network Settings window displays.

4. In the DHCP (Dynamic Host Configuration Protocol) field, select ON or OFF:

Network

Settings icon

•

If you select ON, all necessary information is obtained from the network.

Press OK and go to step 6.

•

If you select OFF, all of the network setup fields display in the Network

Settings window. Go to step 5 to enter the static information.

5. You can either keep all of the displayed default settings and press OK, or you can enter information in the following fields:

Server

Settings icon

•

Local IP Address - Use the numeric keypad to enter your Local

IP address (format is xxx.xxx.xxx.xxx where xxx = 000-255). Press OK.

•

Gateway IP Address - Use the numeric keypad to enter your Gateway IP address (format is xxx.xxx.xxx.xxx where xxx = 000-255). Press OK.

•

Subnet Mask - Use the numeric keypad to enter your Subnet Mask (format is xxx.xxx.xxx.xxx where xxx = 000-255). Press OK.

•

Primary DNS (Domain Name Server) IP Address - Use the numeric keypad to enter your Primary DNS IP address (format is xxx.xxx.xxx.xxx where xxx = 000-255). Press OK.

•

Secondary DNS IP Address - Use the numeric keypad to enter your

Secondary DNS IP Address (format is xxx.xxx.xxx.xxx where xxx = 000-255). Press OK.

6. Press OK to save the Network settings.

7. Press the Server Settings icon to access the Server Settings window and enter information in the following fields:

•

Mode: Select URL or IP.

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•

Address - The default is dxsvc.zollonline.com. Use the alpha-numeric keypad to change this default only if your URL/IP is different than the default.

NOTE If you are not using the default value, you need to make an entry in the DNS table for the default value, and you will have to import a new SSL root certificate. For detailed information on how to import a root certificate, see “Importing Files from a USB Flash Drive” on page 16.

•

Port - The default is 443. Change this default only if your port is different than the default.

•

User ID - Use the alpha-numeric keypad to enter the User ID. Press OK.

NOTE If you have set up a ZOLL Case Review account on zollonline.com, use the ID you specified for that account.

•

Passcode - Use the alpha-numeric keypad to enter the Passcode. Press OK.

Profile

Settings icon

NOTE If you have set up a ZOLL Case Review account on zollonline.com, use the Passcode you specified for that account.

8. Press OK to save the Server settings.

9. Press the Profile Settings icon and enter information in the following fields in the Profile Settings window:

•

Network (SSID) - Use the alpha-numeric keypad to enter the SSID (Service

Set IDentifier) name that identifies your wireless access point.

•

Hidden SSID - Select ON or OFF.

•

Authentication - Select the method of Wi-Fi Authentication: PSK (Preshared Key), PEAP (Protected Extensible Authentication Protocol), or TLS

(Transport Layer Security). See the table below for the next step based on the method you selected.

Field(s) to Complete Wi-Fi

Method

PSK

PEAP

Password (Pre-Shared Key) - Use the alpha-numeric keypad to enter the password to the wireless access point. Press OK.

Username - Use the alpha-numeric keypad to enter the username. Press OK.

TLS

Password - Use the alpha-numeric keypad to enter the password to the wireless access point. Press OK.

User Identity - Use the alpha-numeric keypad to enter the user identity. Press OK.

Private Key Password - Use the alpha-numeric keypad to enter the password. Press OK.

Client Certificate - Choose a client certificate from the list and press OK.

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10. Press OK to save the Profile settings.

11. Press the Test Wi-Fi button in the Clinical Archive Wi-Fi Settings window to test the server connectivity.

NOTE If connectivity is not successful, check your wireless configuration settings.

12. Press Save to save the Wi-Fi settings. The AED displays the message

SAVING CONFIGURATION, PLEASE WAIT. When the AED has saved the configuration, it displays the Advanced Configuration window.

Setting Up Device History Wi-Fi Configuration

Device

History Wi-Fi icon

Press the Device History Wi-Fi icon to access the Select Wi-Fi Setup Level window and make one of the following selections:

•

Quick Setup - for a simple configuration using the default settings (go to

"Quick Setup for Device History" below).

•

IT Setup - for a more complex configuration using non-standard wireless setup settings (go to “IT Setup for Device History” on page 62)

Quick Setup for Device History

1. Press the Device History Wi-Fi icon to access the Device History Quick Settings window and enter the applicable information in the following fields:

•

Network (SSID)--Press the wireless button to the right of this field to search for available wireless networks. Select a network from the list and press

OK.

Alternately, you can use the alpha-numeric keypad to enter the SSID

(Service Set IDentifier) name that identifies your wireless network access point. Press OK.

•

Password (Pre-Shared Key) - Use the alpha-numeric keypad to enter the pre-shared key (password) to the wireless access point. Press OK.

•

Server Settings - Press the Server Settings field to display the Server

Settings window. Use the alpha-numeric keypad to enter the following server information.

Address

User ID

The default is dxsvc.zollonline.com. If you are using the default server, keep this entry the same.

Otherwise, enter the URL address of the host server. Press OK.

Use the alpha-numeric keypad

to enter the username of the host server. Press OK.

Passcode

Use the alpha-numeric keypad to enter your password of the host server. Press OK.

2. Press the Test Wi-Fi button in the Device History Quick Settings window to test the server connectivity.

NOTE If connectivity is not successful, check your wireless configuration settings.

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3. Press Save at the bottom right of the screen to save the changes. The AED displays the message SAVING CONFIGURATION, PLEASE WAIT. When the

AED has saved the configuration, it displays the Advanced Configuration window.

IT Setup for Device History

1. Press the Device History Wi-Fi icon.

Device History

Wi-Fi icon

2. Press the IT Setup button to access the Device History Wi-Fi Settings window.

3. Press the Network Settings icon. The Network Settings window displays.

4. In the DHCP (Dynamic Host Configuration Protocol) field, select ON or OFF:

Network

Settings icon

•

If you select ON, all necessary information is obtained from the network.

Press OK and go to step 6.

•

If you select OFF, all of the network setup fields display in the Network

Settings window. Go to step 5 to enter the static information.

5. You can either keep all of the displayed default settings and press OK, or you can enter information in the following fields:

•

Local IP Address - Use the numeric keypad to enter your Local IP address

(format is xxx.xxx.xxx.xxx where xxx = 000-255). Press OK.

•

Gateway IP Address - Use the numeric keypad to enter your Gateway IP address (format is xxx.xxx.xxx.xxx where xxx = 000-255). Press OK.

•

Subnet Mask - Use the numeric keypad to enter your Subnet Mask (format is xxx.xxx.xxx.xxx where xxx = 000-255). Press OK.

•

Primary DNS (Domain Name Server) IP Address - Use the numeric keypad to enter your Primary DNS IP address (format is xxx.xxx.xxx.xxx where xxx = 000-255). Press OK.

•

Secondary DNS IP Address - Use the numeric keypad to enter your

Secondary DNS IP Address (format is xxx.xxx.xxx.xxx where xxx = 000-255). Press OK.

6. Press OK to save the Network settings.

Server

Settings icon

7. Press the Server Settings icon and enter information in the following fields:

•

Mode: Select URL or IP.

•

Address - The default is dxsvc.zollonline.com. Use the alpha-numeric keypad to change this default only if your URL/IP is different than the default.

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•

Port - The default is 443. Change this default only if your port is different than the default.

•

User ID - Use the alpha-numeric keypad to enter the User ID. Press OK.

NOTE If you are using the default server, this field automatically populates.

•

Passcode - Use the alpha-numeric keypad to enter the Passcode. Press OK.

Profile

Settings icon

NOTE If you are using the default server, this field automatically populates.

8. Press OK to save the Server settings.

9. Press the Profile Settings icon and enter information in the following fields:

•

Network SSID - Use the alpha-numeric keypad to enter the SSID (Service

Set IDentifier) name that identifies your wireless access point.

•

Hidden SSID - Select ON or OFF.

•

Authentication - Select the method of Wi-Fi Authentication: PSK (Preshared Key), PEAP (Protected Extensible Authentication Protocol), or TLS

(Transport Layer Security). See the table below for the next step based on the method you selected.

Field(s) to Complete Wi-Fi

Method

PSK

PEAP

TLS

Password (Pre-Shared Key) - Use the alpha-numeric keypad to enter the password to the wireless access point. Press OK.

Username - Use the alpha-numeric keypad to enter the username. Press OK.

Password - Use the alpha-numeric keypad to enter the password to the wireless access point. Press OK.

User Identity - Use the alpha-numeric keypad to enter the user identity. Press OK.

Private Key Password - Use the alpha-numeric keypad to enter the password. Press OK.

Client Certificate - Choose a client certificate from the list and press OK.

10. Press OK to save the Profile settings.

11. Press the Test Wi-Fi button in the Device History Wi-Fi window to test the server connectivity.

NOTE If connectivity is not successful, check your wireless configuration settings.

12. Press Save to save the Wi-Fi settings. The AED displays the message

SAVING CONFIGURATION, PLEASE WAIT. When the AED has saved the configuration, it displays the Advanced Configuration window.

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Key features

Automatic External Defibrillator (AED)
Adult and pediatric use
Audio and Visual Prompts
LCD Touch Screen
ZOLL Real CPR Help®
Data Recording and Storage
USB Connectivity
Wireless Communication

Frequently asked questions

There are three ZOLL AED 3 models: ZOLL AED 3, ZOLL AED 3 Automatic, and ZOLL AED 3 BLS.

The ZOLL AED 3 is compatible with CPR Uni-padz, CPR-D-padz, CPR Stat-padz, Stat-padz II, and Pedi-padz II defibrillation pads.

You can transfer data from the ZOLL AED 3 to a computer using a USB flash drive or a wireless access point.

You can transfer clinical archives (patient data), device history (self-test reports), and configuration settings.

Administrator’s Guide

Table of Contents

Preface

Chapter 1 Overview

Chapter 2 Data Transfer

Chapter 3 Maintenance

Chapter 4 Troubleshooting

Appendix A Specifications

Appendix B Accessories

Appendix C Configuration Settings

Preface

Conventions

ZOLL AED 3 Safety Considerations

Tracking Requirements

Notification of Adverse Events

Technical Service

International Customers

Software Licensing Statement

Chapter 1

Overview

ZOLL AED 3 User Interface

Child Mode

Real CPR Help

Using Defibrillation Pads

Data Recording and Storage

Post Event Analysis

Transferring Files Using a USB

Flash Drive

Wi-Fi Communication

ZOLL AED 3 Operation

Operating Controls and Indicators

Graphical Display Area

AED Management Mode

Rescue Mode

GOOD COMPRESSIONS

Audio Prompts

Chapter 2

Data Transfer

Data Storage

Data and Audio Recording

Exporting Files From the AED

Exporting Files

Using RescueNet Code Review Software

Using Case Review Software

Importing Files from a USB Flash Drive

Importing Files

Troubleshooting Communication Issues

Chapter 3

Maintenance

Self Tests

Self Test Functions

Optional Maintenance Tests

Physical Inspection

Cleaning the ZOLL AED 3 Defibrillator

Optional Maintenance Test for Technical

Professionals

Test Procedure (ZOLL AED 3 and ZOLL AED 3 BLS

Models)

Test Procedure (ZOLL AED 3 Automatic Models)

Battery Maintenance

Identifying Battery Conditions

Chapter 4

Troubleshooting

Troubleshooting the AED

Appendix A

Specifications

Defibrillator Specifications

Guidance and Manufacturer’s Declaration

- Electromagnetic Compatibility Guidance

Rectilinear Biphasic Waveform

Characteristics

ECG Analysis Algorithm Accuracy

Clinical Performance Results

Wireless Output Guidance and

Manufacturer’s Declaration

RF Transmission Emitted (IEC 60601-1-2)

FCC Notice

Canada, Industry Canada (IC) Notices

Appendix B

Accessories

**Test Procedure (ZOLL AED 3 Automatic Models)**