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9650-000762-01 Rev. A
Administrator’s Guide
Indications for Use
The ZOLL AED 3 system is indicated for use when a suspected cardiac arrest victim has an apparent lack of circulation as indicated by:
• Unconsciousness
• Absence of breathing, and
• Absence of pulse and other signs of circulation.
The AED 3 system is indicated for adult and pediatric patients.
Contraindications for Use
Never use the unit for defibrillation when the patient
• Is conscious
• Is breathing, or
• Has a detectable pulse or other sign of circulation.
General Information
Federal (U.S.A.) law restricts this defibrillator to sale by or on the order of a physician.
The issue date for the ZOLL AED 3 Administrator’s Guide
(REF 9650-000762-01 Rev. A) is March, 2018.
Copyright © 2018 ZOLL Medical Corporation. All rights reserved. CPR-D-padz,
M Series, 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
Table of Contents
Preface
Conventions.................................................................................... iv
ZOLL AED 3 Safety Considerations ..................................................... iv
Tracking Requirements ..................................................................... iv
Notification of Adverse Events ............................................................ v
Technical Service .......................................................................... v
Software Licensing Statement ........................................................... 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
Audio Prompts............................................................................. 9
Chapter 2 Data Transfer
Data Storage ................................................................................. 14
Data and Audio Recording............................................................ 14
Exporting Files From the AED ....................................................... 15
Importing Files from a USB Flash Drive.......................................... 16
Troubleshooting Communication Issues ......................................... 18
Chapter 3 Maintenance
Self Tests ...................................................................................... 21
Self Test Functions...................................................................... 22
Optional Maintenance Tests.............................................................. 24
Physical Inspection ..................................................................... 24
Cleaning the ZOLL AED 3 Defibrillator............................................ 24
Optional Maintenance Test for Technical Professionals...................... 25
Battery Maintenance ....................................................................... 27
Identifying Battery Conditions ...................................................... 27
Chapter 4 Troubleshooting
Troubleshooting the AED ................................................................. 29
9650-000762-01 Rev. A ZOLL AED 3 Administrator’s Guide i
Appendix A Symbols
Symbols ........................................................................................ 33
Appendix B Specifications
Defibrillator Specifications................................................................ 37
Guidance and Manufacturer’s Declaration
- Electromagnetic Compatibility .................................................... 40
Rectilinear Biphasic Waveform Characteristics..................................... 44
Clinical Trial Results for the M Series Biphasic Waveform...................... 49
Randomized Multicenter Clinical Trial for Defibrillation of Ventricular
Fibrillation (VF) and Ventricular Tachycardia (VT) ........................ 49
Pre-Clinical Study ....................................................................... 50
Published Clinical Data ................................................................ 51
ECG Analysis Algorithm Accuracy ...................................................... 53
Clinical Performance Results......................................................... 54
Wireless Output Guidance and Manufacturer’s Declaration .................... 56
RF Transmission Emitted (IEC 60601-1-2)...................................... 56
FCC Notice................................................................................. 56
Canada, Industry Canada (IC) Notices ........................................... 56
Appendix C Accessories
Accessories .................................................................................... 57
Appendix D Configuration Settings
Overview ....................................................................................... 59
Setting Up Your Wireless Configuration .............................................. 65
For IT Setup Only ....................................................................... 65
Entering Supervisor Configuration Mode......................................... 66 ii ZOLL AED 3 Administrator’s Guide 9650-000762-01 Rev. A
Preface
The ZOLL AED 3 TM 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 a list of symbols that may be used in this guide or on the
ZOLL AED 3 defibrillator.
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iv
Appendix B—Contains specification information and the ZOLL ® Rectilinear
Biphasic TM 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 C—Contains a list of accessories for the ZOLL AED 3 defibrillator.
Appendix D—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.
ZOLL AED 3 Administrator’s Guide 9650-000762-01 Rev. A
3. Disposition of Device (e.g. received, lost, stolen destroyed, distributed to another organization).
4. New Location and/or Organization (if different from #1 above) - Company
Name, Address, Contact Name and Contact Phone number.
5. Date change took effect.
Notification of Adverse Events
As a health care provider, you may have responsibilities under the Safe Medical
Devices Act (SMDA) for reporting to ZOLL and possibly to the 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
9650-000762-01 Rev. A ZOLL AED 3 Administrator’s Guide v
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.
vi ZOLL AED 3 Administrator’s Guide 9650-000762-01 Rev. A
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 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 is enabled 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 adult CPR 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 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
ZOLL AED 3 Administrator’s Guide 9650-000762-01 Rev. A
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 2 inches, the AED issues a PUSH HARDER prompt. The AED issues a
GOOD COMPRESSIONS prompt if the rescuer responds by increasing compression depth to 2 inches or more.
Using Defibrillation Pads
The ZOLL AED 3 defibrillator is compatible with the following adult and child defibrillation pads:
• 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 Pedi-padz II, the Child button automatically lights up.
The pads 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.
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.
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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.
4 ZOLL AED 3 Administrator’s Guide 9650-000762-01 Rev. A
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 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 Button — 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
ZOLL AED 3 Administrator’s Guide 9650-000762-01 Rev. A
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
1:46
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 2 and 2.4 inches (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
(in)
2.1
Rate
(cpm)
107
CPR Time
0:15
ECG rhythm
(optional)
ECG scale marker
Number of shocks
GOOD COMPRESSIONS
User prompt
1
0:02:15
Event elapsed time
Chest Compression Depth — Indicates the depth of the current CPR compressions.
NOTE If the chest compression depth is outside of the recommended
AHA/ERC range, the AED highlights the depth value inside a red box.
Chest Compression Rate —Indicates the rate of the current CPR compressions.
NOTE If the chest compression rate is outside of the recommended AHA/ERC range, the AED highlights the rate value inside a red box.
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.
8 ZOLL AED 3 Administrator’s Guide 9650-000762-01 Rev. A
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
REMOVE PAD PACKAGE
Definition/Action
Look, listen, or feel for the presence of breathing and/or airflow from the patient’s lungs.
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
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
NO SHOCK DELIVERED
START CPR
PUSH TO MATCH THE TONE
PUSH HARDER
If needed, use scissors to completely remove child’s shirt.
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.
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. (Adult patients only).
CPR compressions are consistently less than 2 inches deep. (Adult patients only)
ZOLL AED 3 Administrator’s Guide 9650-000762-01 Rev. A
Audio Prompt
GOOD COMPRESSIONS
CONTINUE CPR
ANALYSIS HALTED. KEEP
PATIENT STILL.
GIVE TWO BREATHS
STOP CPR
CPR ONLY MODE
Definition/Action
After prompting to Push Harder, rescuer has succeeded in delivering chest compressions at least 2 inches 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 inches deep. (Adult patients only).
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
•
Selected energy
•
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.
ZOLL AED 3 Administrator’s Guide 9650-00762-01 Rev. A
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 .
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
1.
Press and hold the On/Off button for longer than 5 seconds, then press the Device Configuration icon to enter AED Management mode.
2.
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 ( status bar at the bottom of the display screen.
)appears in the
Export Files icon
3.
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.
4.
Press Save (USB) or Send (Wi-Fi). When the AED has finished transferring data, it issues the prompt, DATA TRANSFER COMPLETE.
5.
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 62 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.
ZOLL AED 3 Administrator’s Guide 9650-00762-01 Rev. A
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.
1.
Insert the USB flash drive into the USB connector on the back of the AED.
2.
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
3.
Press the Device Configuration icon to enter AED Management mode.
Configuration
Device icon
4.
Press the Supervisor Access icon, enter your supervisor passcode, and press OK.
Supervisor
Access icon
Import Files icon
5.
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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6.
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.
7.
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.
ZOLL AED 3 Administrator’s Guide 9650-00762-01 Rev. A
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.
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 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 65.
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.
9650-00762-01 Rev. A ZOLL AED 3 Administrator’s Guide 19
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.
20 ZOLL AED 3 Administrator’s Guide 9650-00762-01 Rev. A
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 and the battery are within their expiration dates.
•
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 TM 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 TM AED program management system or to another AED program management provider.
22 ZOLL AED 3 Administrator’s Guide 9650-000762-01 Rev. A
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
1.
2.
3.
4.
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.
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.
24 ZOLL AED 3 Administrator’s Guide 9650-000762-01 Rev. A
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.
ZOLL AED 3 Administrator’s Guide 9650-000762-01 Rev. A
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.
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.
Loss of audio prompts or display.
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.
Cycle power on the defibrillator by turning the AED off, and then on again.
CHANGE BATTERY
PLUG IN PADS CABLE
CHECK PADS
ANALYSIS HALTED;
KEEP PATIENT STILL
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.
Replace the battery pack.
Ensure that the defibrillation pads cable is properly plugged into the patient cable connector.
Reattach pads.
Keep the patient still during ECG analysis. If transporting the patient by stretcher or vehicle, stop all patient movement during analysis.
If the AED continues to fail, remove t he 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.
If the message persists, attach new pads.
If the message persists, remove the AED from service and contact ZOLL
Technical Service.
ZOLL AED 3 Administrator’s Guide 9650-000762-01 Rev. A
Table 6. ZOLL AED 3 Troubleshooting (Continued)
Problem
NO SHOCK DELIVERED
RELEASE SHOCK
BUTTON
ATTACH CORRECT
DEFIB PADS
REPLACE PADS
Operator Action
The Shock button was not pressed or an internal error occurred.
When prompted to press the button, do so within 30 seconds.
(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-D padz
•
CPR Stat padz
•
Pedi-Padz II (child pads)
•
Stat-padz II
Attach new defibrillation pads to the AED.
Technical Action
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.
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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32 ZOLL AED 3 Administrator’s Guide 9650-000762-01 Rev. A
Appendix A
Symbols
Symbols
Any or all of the following symbols may be used in this guide or on this equipment:
Table 7: Symbols
Symbol Description
Power On/Off.
Child button.
Shock button.
Warning: Dangerous voltage.
Fragile, handle with care.
Keep dry.
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Symbol Description
This end up.
Temperature limitation.
Federal law restricts this device to sale by or on the order of a physician.
Conformité Européenne Complies with medical device directive 93/42/EEC.
This product has been certified by the
Australian Communication and Media
Authority.
Complies with the Federal Communications
Commission.
Defibrillator-proof type BF equipment.
Contains lithium. Recycle or dispose of properly.
Keep away from open flame and high heat.
Do not open, disassemble, or intentionally damage.
Do not crush.
Non-rechargeable battery.
Return to a collection site intended for waste electrical and electronic equipment (WEEE).
Do not dispose of in unsorted trash.
Use by.
Latex-free.
ZOLL AED 3 Administrator’s Guide 9650-000762-01 Rev. A
Symbol Description
Do not reuse.
Not sterile.
Nonionizing electromagnetic radiation.
Manufacturer.
EC REP
Authorized representative in the European
Community.
Serial Number.
Catalog number.
MR Unsafe - keep away from magnetic resonance imaging (MRI) equipment.
LOT Batch code.
Consult instructions for use.
Refer to manual.
Use by date.
Protected against dust ingress.
Protected against jetting water.
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Appendix B
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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38
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
Refer to “Rectilinear Biphasic Waveform Characteristics” on page 44 and “Clinical Trial Results for the M Series
Biphasic Waveform” on page 49.
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-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 53 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.
ZOLL AED 3 Administrator’s Guide 9650-000762-01 Rev. A
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)
5
3
3*
*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
9650-000762-01 Rev. A ZOLL AED 3 Administrator’s Guide 39
Guidance and Manufacturer’s Declaration
- Electromagnetic Compatibility
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
RF emissions CISPR 11
Harmonic Emission
IEC 61000 3-2
Voltage Fluctuations/
Flicker Emission
IEC 61000 3-3
Group 1
Class B
Not applicable
Not applicable
The ZOLL AED 3 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.
The ZOLL AED 3 is suitable for use in all establishments, including domestic establishments and those directly connected to the public low voltage power supply network that supplies buildings used for domestic purposes.
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.
40 ZOLL AED 3 Administrator’s Guide 9650-000762-01 Rev. A
The ZOLL AED 3 defibrillator’s essential performance is energy delivery, ECG rhythm analysis, and CPR feedback, as specified on page 37 to page 39. The ZOLL
AED 3 defibrillator meets basic safety and essential performance when it is operated in the electromagnetic environment specified in the following tables.
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 IEC 60601 test level
Electrostatic discharge (ESD)
IEC 61000-4-2
± 8 kV contact
± 15 kV air
Compliance level
± 8 kV contact
± 15 kV air
Electromagnetic environment - guidance
The relative humidity should be at least 5%.
Electrical fast transient/burst
IEC 61000-4-4
Surge
IEC 61000-4-5
Voltage dips, short interruptions and voltage variations on power supply input lines.
IEC 61000-4-11
Power frequency
(50/60 Hz) magnetic field
IEC 61000-4-8
± 2 kV for power supply lines
± 1 kV for input/ output lines
± 1 kV differential mode
+/- 2 kV common mode
<5% U
T
(>95% dip in U cycle
T
) for 0.5
40% U
T in U
T
(60% dip
) for 5 cycles
70% U
T in U
T cycles
(30% dip
) for 25
<5% U
T
(>95%dip in U
T for 5 sec
)
30 A/m
Not applicable
Not applicable
Not applicable
Not applicable
Not applicable
Not applicable
Not applicable
Not applicable
30 A/m
Conducted RF
IEC 61000-4-6
3 Vrms
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 d = 1.2
P outside ISM bands
3 Vrms
150 kHz to 80
MHz outside ISM bands a
10 Vrms
150 kHz to
80 MHz in ISM bands a
10 Vrms d = 1.2
P within ISM bands
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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 = 1.2
P 80 MHz to 800 MHz d = 2.3
P
800 MHz to 2.5 GHz where P is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer and d is the recommended separation distance in metres (m).
b
Field strengths from fixed RF transmitters, as determined by an electromagnetic site survey, c should be less than the compliance level in each frequency range.
d
Interference may occur in the vicinity of equipment marked with the following symbol:
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.
The ZOLL AED 3 defibrillator is MR unsafe. Keep the defibrillator away from magnetic resonance imaging (MRI) equipment.
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.
Adverse effects of ESD may include loss of audio prompts or visual display. See “Chapter 4
Troubleshooting” on page 29 for more information.
NOTE 1: U
T
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.
a The ISM (industrial, scientific and medical) bands between 150 KHz and 80 MHz are
6.765 MHz to 6.795 MHz; 13.553 MHz to 13.567 MHz; 26.957 MHz to 27.283 MHz; and
40.66 MHz to 40.70 MHz.
b The compliance levels in the ISM frequency bands between 150 kHz and 80 MHz and in the frequency range 80 MHz to 2.5 GHz are intended to decrease the likelihood that mobile/portable communications equipment could cause interference if it is inadvertently brought into patient areas. For this reason, an additional factor of 10/3 is used in calculating the recommended separation distance for transmitters in these frequency ranges.
c Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless) telephones and land mobile radios, amateur radio, AM and FM radio broadcast and TV broadcast cannot be predicted theoretically with accuracy. To assess the electromagnetic environment due to fixed RF transmitters, an electromagnetic site survey should be considered. If the measured field strength in the location in which the AED 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.
d Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 10 V/m.
ZOLL AED 3 Administrator’s Guide 9650-000762-01 Rev. A
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 = 1.2
P
150 kHz to
80 MHz in ISM bands d = 1.2
P
80 MHz to
800 MHz d = 1.2
P
800MHz to
2.5 GHz d = 2.3
P
0.01
0.1
1
0.12
0.38
1.2
0.12
0.38
1.2
0.12
0.38
1.2
0.23
0.73
2.3
10
100
3.8
12
3.8
12
3.8
12
7.3
23
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.
NOTE The ZOLL AED 3 incorporates RF receivers for Wi-Fi operation (see “Wireless
Output Guidance and Manufacturer’s Declaration” on page 56). Other equipment may interfere with ZOLL AED 3 Wi-Fi operations, even if that equipment complies with CISPR emissions requirements.
9650-000762-01 Rev. A ZOLL AED 3 Administrator’s Guide 43
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
29 A First Phase
Maximum Initial
Current
First Phase
Average Current
26 A
First Phase
Duration
Interphase duration between first and second phases
Second Phase
Maximum Initial
Current
6 ms
150
30 A
Second Phase Average
Current
18 A
Second Phase Duration 4 ms
sec
Discharged into 50 ohm load
27 A
24 A
6 ms
150 sec
19 A
14 A
4 ms
Discharged into 100 ohm load
20 A
16 A
6 ms
150 sec
12 A
10 A
4 ms
Discharged into 125 ohm load
16 A
13 A
6 ms
150 sec
11 A
9 A
4 ms
44 ZOLL AED 3 Administrator’s Guide 9650-000762-01 Rev. A
Table 8. 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
37 J
50 J
54 J
69 J
61 J
60 J
57 J
65 J
60 J
±15%
82 J
84 J
80 J
91 J
84 J
±15%
85 J
57 J
80 J
97 J
95 J
91 J
103 J
95 J
±15%
120 J
86 J
118 J
134 J
142 J
133 J
124 J
116 J
±15%
150 J
109 J
145 J
166 J
165 J
155 J
145 J
135 J
±15%
200 J
139 J
209 J
196 J
194 J
178 J
192 J
177 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
ZOLL M Series 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).
9650-000762-01 Rev. A ZOLL AED 3 Administrator’s Guide 45
The vertical axis shows the current in amperes (A); the horizontal axis shows the duration in milliseconds (ms).
Figure 1.
Rectilinear Biphasic Waveforms at 200 Joules
46
Figure 2.
Rectilinear Biphasic Waveforms at 150 Joules
ZOLL AED 3 Administrator’s Guide 9650-000762-01 Rev. A
Figure 3.
Rectilinear Biphasic Waveforms at 120 Joules
Figure 4.
Rectilinear Biphasic Waveforms at 85 Joules
9650-000762-01 Rev. A ZOLL AED 3 Administrator’s Guide 47
Figure 5.
Rectilinear Biphasic Waveforms at 70 Joules
Figure 6.
Rectilinear Biphasic Waveforms at 50 Joules
48 ZOLL AED 3 Administrator’s Guide 9650-000762-01 Rev. A
Clinical Trial Results for the M
Series Biphasic Waveform
The efficacy of the ZOLL Rectilinear Biphasic waveform has been clinically verified during a study of defibrillation of Ventricular Fibrillation (VF) and
Ventricular Tachycardia (VT). A feasibility study was performed initially for defibrillation of VF/VT (n=20) on two separate groups of patients to ensure waveform safety and energy selection. Subsequently, a separate, multicenter, randomized clinical trial was performed to verify the waveform’s efficacy. A description of this study is provided below. The study was performed using
ZOLL defibrillation systems consisting of ZOLL defibrillators, the ZOLL
Rectilinear Biphasic waveform, and ZOLL defibrillation pads.
Randomized Multicenter Clinical Trial for
Defibrillation of Ventricular Fibrillation (VF) and Ventricular Tachycardia (VT)
Overview: The defibrillation efficacy of the ZOLL Rectilinear Biphasic waveform was compared to a monophasic damped sine waveform in a prospective, randomized, multicenter study of patients undergoing ventricular defibrillation for VF/VT during electrophysiological studies, ICD implants, and test. A total of
194 patients were enrolled in the study. Ten patients who did not satisfy all protocol criteria were excluded from the analysis, leaving a study population of
184.
Objectives: The primary goal of this study was to compare the first shock efficacy of the 120 J Rectilinear Biphasic waveform with a 200 J monophasic waveform. The secondary goal was to compare all shock (three consecutive
120, 150, and 170 joules) efficacy of the Rectilinear Biphasic waveform with that of a monophasic waveform (three consecutive 200, 300, and 360 joules).
A significance level of p=0.05 or less was considered statistically significant using Fischer’s Exact test. Also, differences between the two waveforms were considered statistically significant when the customary 95% or AHArecommended 90% 1 greater than 0%.
confidence interval between the two waveforms was
Results: The study population of 184 patients had a mean age of 63±14 years. Of these, 143 patients were male. 98 patients were in the biphasic group
(ventricular fibrillation/flutter, n=80; ventricular tachycardia, n=18) and 86 patients were in the monophasic group (ventricular fibrillation/flutter, n=76; ventricular tachycardia, n=10). There were no adverse events or injuries related to the study.
1.Kerber RE, et al., “Automated External Defibrillators for Public Access Defibrillation: Recommendations for Specifying and Reporting
Arrhythmia Analysis Algorithm Performance, Incorporating New Waveforms, and Enhancing Safety,” Circ J Am Heart Assoc.
1997;95:1677-1682.
“… the task force suggests that to demonstrate superiority of an alternative waveform over standard waveforms, the upper boundary of the 90% confidence interval of the difference between standard and alternative waveforms must be <0% (ie, alternative is greater than standard).”
9650-000762-01 Rev. A ZOLL AED 3 Administrator’s Guide 49
50
The first shock, first induction efficacy of biphasic shocks at 120 J was 99% versus 93% for monophasic shocks at 200 J (p=0.0517, 95% confidence interval of the difference of –2.7% to 16.5% and 90% confidence interval of the difference of –1.01% to 15.3%).
First shock efficacy p-value
95% confidence interval
90% confidence interval
Monophasic
93%
0.0517
Biphasic
99%
–2.7% to 16.5%
–1.01% to 15.3%
Successful defibrillation with Rectilinear Biphasic shocks was achieved with
58% less delivered current than with monophasic shocks (14±1 amperes versus 33±7 amperes, p=0.0001).
The difference in efficacy between the Rectilinear Biphasic and the monophasic shocks was greater in patients with high transthoracic impedance (greater than
90 ohms). The first shock, first induction efficacy of biphasic shocks was 100% versus 63% for monophasic shocks for patients with high impedance (p=0.02,
95% confidence interval of the difference of –0.0217% to 0.759% and 90% confidence interval of the difference of 0.037% to 0.706%).
First shock efficacy
(high impedance patients) p-value
95% confidence interval
90% confidence interval
Monophasic
63%
Biphasic
100%
0.02
–0.0217% to 0.759%
0.037% to 0.706%
A single patient required a second biphasic shock at 150 joules to achieve
100% efficacy versus six patients for whom monophasic shocks of up to 360 joules were required for 100% total defibrillation efficacy.
Conclusion: The data demonstrate the equivalent efficacy of low energy
Rectilinear Biphasic shocks compared to standard high energy monophasic shocks for transthoracic defibrillation for all patients at the 95% confidence level. The data also demonstrate the superior efficacy of low energy Rectilinear
Biphasic shocks compared to standard high energy monophasic shocks in patients with high transthoracic impedance at the 90% confidence level. There were no unsafe outcomes or adverse events due to the use of Rectilinear
Biphasic waveform.
Pre-Clinical Study
To support pediatric usage for the ZOLL Rectilinear Bi-Phasic Waveform, ZOLL submitted pre-clinical data to the FDA as part of a 510(k) submission for its
AED Pro device (cleared by the FDA under K041892). The protocol for this preclinical study, along with a summary of the results, have been submitted to FDA under AED Pro PMA application (P160022). A summary of this study is presented below.
ZOLL AED 3 Administrator’s Guide 9650-000762-01 Rev. A
To demonstrate the safety and efficacy of our Rectilinear Bi-Phasic Waveform when used to treat pediatric VF patients, ZOLL conducted a study using a porcine model of pediatric patients less than 8 years of age. This study included 18 piglets in three (3) size groups (two (2) animals weighing 4 kg, eight (8) animals weighing 8 kg, and eight (8) animals weighing 16 kg) and compared the defibrillation dose/response curves observed using proposed biphasic waveform with those observed using a standard monophasic damped sine wave (DSW) defibrillator to treat short duration (~ 30 seconds) ventricular fibrillation. The study demonstrated that the biphasic waveform defibrillates pediatric pigs with equal efficacy but lower energy (on a Joules/kg basis) than traditional monophasic damped sine wave defibrillators. To confirm the safety of the proposed biphasic waveform in pediatric patients, we studied and compared measures of cardiac function before and after both DSW and
Rectilinear Bi-Phasic Waveform defibrillation shocks over a range of relevant energies. The study demonstrated that the biphasic defibrillation produced equivalent or milder disturbances of cardiac function when compared to traditional DSW defibrillation at the same energies.
Another animal study compared the ZOLL rectilinear biphasic (RLB) waveform to a biphasic truncated exponential (BTE) waveform. The study, using an immature porcine model (n=21), was a prospective, randomized, controlled design to determine the dose response curves for the RLB and BTE defibrillation waveforms. A weight range from 4 to 24 Kg for an animal represented a pediatric patient. The weight ranging from 4 to 8 Kg represented a patient less than 1 year old (infant subgroup), and the weight range from 16 to 24 Kg represented a pediatric patient between the ages of 2 and 8 years (young children subgroup).
The ZOLL RLB waveform demonstrated a superior capability to defibrillate a porcine pediatric model with < 90% of the D50 energy required for a BTE waveform (D50 energy: RLB 25.6 ± 15.7 J, BTE 28.6 ±17.0 J, P = 0.0232; D90 energy: RLB 32.6 ± 19.1 J, BTE 37.8 ± 23.2 J, P = 0.0228).
The ECG ST segment changes (mV) and LV pressure changes (dP/dt) following a defibrillation shock were compared between the RLB waveform to the BTE waveform. The RLB waveform had an average ST segment increase above baseline of 0.138 ± 0.136 mV (N=401 shocks) compared to the BTE waveform’s average increase of 0.146 ± 0.148 mV (N=396 shocks). The RLB waveform had an average dP/dt at the 40 mmHg threshold (the point in time when an animal’s blood pressure exceeded 40 mmHg spontaneously) of 1987 ±
411 mmHg/s (N=496 shocks) compared to the BTE waveform’s average dP/dt of 2034 ± 425 mmHg/s (N=496 shocks).
Published Clinical Data
Additional clinical data was included with PMA application P160022 to support out-of-hospital use of ZOLL’s Rectilinear Bi-Phasic defibrillation waveform. The data reported by Hess et al in Resuscitation (82 (2011) 685–689) is considered sufficient to support ZOLL’s defibrillation waveform in the out-of-hospital environment. The resulting clinical paper, “Performance of a rectilinear biphasic waveform in defibrillation of presenting and recurrent ventricular fibrillation: A prospective multicenter study,” was included with PMA application P160015. A summary of the study is presented below:
9650-000762-01 Rev. A ZOLL AED 3 Administrator’s Guide 51
Objectives: The study tested the hypothesis that shock success differs with initial and recurrent episodes of ventricular fibrillation (VF).
Methods: From September 2008 to March 2010 out-of-hospital cardiac arrest patients with VF as the initial rhythm at 9 study sites were defibrillated by paramedics using a rectilinear biphasic waveform. Shock success was defined as termination of VF within 5 s post-shock. The study used generalized estimating equation (GEE) analysis to assess the association between shock type (initial versus defibrillation) and shock success.
Results: Ninety-four patients presented in VF. Mean age was 65.4 years,
78.7% were male, and 80.9% were bystander-witnessed. VF recurred in 75
(79.8%). There were 338 shocks delivered for initial (n = 90) or recurrent (n =
248) VF available for analysis. Initial shocks terminated VF in 79/90 (87.8%) and subsequent shocks in 209/248 (84.3%). GEE odds ratio (OR) for shock type was 1.37 (95% CI 0.68–2.74). After adjusting for potential confounders, the OR for shock type remained insignificant (1.33, 95% CI 0.60–2.53). The study observed no significant difference in ROSC (54.7% versus 52.6%, absolute difference 2.1%, p = 0.87) or neurologically intact survival to hospital discharge (21.9% versus 33.3%, absolute difference 11.4%, p = 0.31) between those with and without VF recurrence.
Conclusions: Presenting VF was terminated with one shock in 87.8% of cases.
The study observed no significant difference in the frequency of shock success between initial versus recurrent VF. VF recurred in the majority of patients and did not adversely affect shock success, ROSC, or survival.
52 ZOLL AED 3 Administrator’s Guide 9650-000762-01 Rev. A
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 9. 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
80
Non-shockable
NSR
AF, SB, SVT, Heart block, idioventricular, PVCs
Asystole
2210
819
115
69
28
Sensitivity
>90%
>75%
Specificity
>99%
>95%
>95%
Report only
Report only
>99%
>98%
>99%
>99%
>99%
Sensitivity
>94%
>99%
>99%
>94%
>99%
>99%
>97%
>87%
>89%
Table 10. 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
42
79
208
348
29
Intermediate
Fine VF
Other VT
0
44
Sensitivity
>90%
>75%
Specificity
>99%
>95%
>95%
Report only
Report only
>99%
>99%
>99%
>99%
>99%
>NA
>81%
>93%
>96%
>98%
>97%
>90%
>NA
>69%
ZOLL AED 3 Administrator’s Guide 9650-000762-01 Rev. A
Table 11. Rhythm Recognition Detector Categories (Adult Patients)
Shock
Non-shockable
VF and VT
680
5
All Other ECG Rhythms
1
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 12. Rhythm Recognition Detector Categories (Pediatric Patients)
Shock
Non-shockable
VF and VT
121
0
All Other ECG Rhythms
10
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.
Standard Frequency
Range
802.11b
802.11g
2412-2472 MHz
2412-2472 MHz
802.11n
2412-2472 MHz
Effective Radiated
Power
100 mW
32 mW
32 mW
Modulation
Type
DSSS
OFDM
OFDM
Data Rates
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
802.11a
802.11n
5180-5320 MHz
5500-5700 MHz
5745-5825 MHz
5180-5320 MHz
5500-5700 MHz
5745-5825 MHz
32 mW
32 mW
FCC Notice
Contains FCC ID: MCQ-CCi.MX28
OFDM
OFDM 6.5, 13, 19.5, 26, 39,
52, 58.5, 65 Mbps
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.
NOTE “Harmful interference” is defined by the FCC as follows:
Any emission, radiation, or induction that endangers the functioning of a radio navigation service or other safety services or seriously degrades, obstructs, or repeatedly interrupts a radio communication service operating in accordance with FCC rules.
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 TM 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 5150 MHz to 5250 MHz band.
ZOLL AED 3 Administrator’s Guide 9650-000762-01 Rev. A
Appendix C
Accessories
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-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
8900-0800-01
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
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
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Appendix D
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 62). 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
ON
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
ZOLL AED 3 Administrator’s Guide 9650-000762-01 Rev. A
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.
•
1
•
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 69).
Enables audio recording during
Rescue Mode.
•
ON
•
OFF (default)
•
ON
•
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.
____________________________
ZOLL AED 3 Administrator’s Guide 9650-000762-01 Rev. A
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)
•
ON
•
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 65, for more information.
64 ZOLL AED 3 Administrator’s Guide 9650-000762-01 Rev. A
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 62 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 67).
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.
ZOLL AED 3 Administrator’s Guide 9650-000762-01 Rev. A
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.
ZOLL AED 3 Administrator’s Guide 9650-000762-01 Rev. A
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 70)
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.
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.
ZOLL AED 3 Administrator’s Guide 9650-000762-01 Rev. A
•
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.
9650-000762-01 Rev. A ZOLL AED 3 Administrator’s Guide 71
72 ZOLL AED 3 Administrator’s Guide 9650-000762-01 Rev. A
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