AED Plus Administrator's Guide Rev E

This issue date for the ZOLL Fully Automatic AED Plus Administrator’s Guide, (REF 9650-0311-05 Rev. E) is December, 2019. Copyright © 2019 ZOLL Medical Corporation. All rights reserved. AED Plus, AED Pro, CPR-D-padz, M Series, Pedi-padz, Real CPR Help, Rectilinear Biphasic, RescueNet, Stat-padz and ZOLL are trademarks or registered trademarks of ZOLL Medical Corporation in the United States and/or other countries. All other trademarks and registered trademarks are the property of their respective owners. Caution: Federal law restricts this device to sale by or on the order of a licensed practitioner.

ZOLL Medical Corporation 269 Mill Road Chelmsford, MA USA 01824-4105 ZOLL International Holding B.V. Newtonweg 18 6662 PV ELST The Netherlands

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Table of Contents PREFACE ... V SAFETY SUMMARY... VI Warnings... vi Cautions ... vii Indications for Use... vii Contraindications for Use ... vii Intended Users of the Device ... vii Tracking Requirements... viii Notification of Adverse Events... viii Unpacking ... viii Conventions ... viii Symbols ...ix

INTRODUCTION ... 1 Using the Fully Automatic AED Plus ...1 Using Real CPR Help...2

OPERATION... 3 Operating Controls and Indicators...3 Using the Fully Automatic AED Plus Graphical User Interface ...5 Voice Prompts ...6 Using the LCD Display ...9 Using the Passive Airway Support System (PASS) ... 10 Using Electrodes... 11 Applying CPR-D-padz ... 12 Applying Pedi-padz II (Infant/Child Electrodes)... 13 Using the CPR Monitoring Function - Real CPR Help... 14 Using the Audio Recording Option ... 14

INSTALLATION AND SELF TEST...15 Inspecting the Unit... 15 Preparing the Fully Automatic AED Plus for Use... 15 Using the Self Test Feature... 16 Battery Installation Self Test ... 16 Power On Self Test ... 17 Manual Self Test... 17 Automatic Self Test... 18 Automatic Monthly Test... 18

Installing or Replacing Batteries... 18 Identifying Battery Condition ... 20

MAINTENANCE AND TROUBLESHOOTING ...22 Maintaining the Fully Automatic AED Plus... 22 Maintenance Checklist ... 22

Cleaning the Fully Automatic AED Plus ... 22 Optional Maintenance for Technical Professionals ... 23 Troubleshooting... 24 Contacting Technical Service ... 25 International Customers... 25

ZOLL ADMINISTRATION SOFTWARE ...26 Installing ZOLL Administration Software... 26 RescueNet Code Review Software ... 26 Setting Up Data Communications... 26

ORDERING ACCESSORIES ...27

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APPENDIX A: SPECIFICATIONS ... 29 Guidance and Manufacturer’s Declaration - Electromagnetic Compatibility ...32 Rectilinear Biphasic Waveform Characteristics ...37 Clinical Trial Results for the M Series Biphasic Waveform...41 Randomized Multi-Center Clinical Trial for Defibrillation of Ventricular Fibrillation (VF) and Ventricular Tachycardia (VT) ... 41 Pre-Clinical Study... 42 Published Clinical Data ... 42

ECG Analysis Algorithm Accuracy...43

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ZOLL AED PLUS Administrator’s Guide

Preface The Fully Automatic AED Plus® Administrator’s Guide is to be used by responsible medical authorities in conjunction with the Fully Automatic AED Plus Operator’s Guide (REF 9650-0310-05). The Fully Automatic AED Plus is to be used by trained rescuers to provide emergency defibrillation. It incorporates a sequence of visual and voice prompts to help rescuers follow established AHA/ERC Guidelines 2015 protocols for use of AEDs. It also incorporates recording/memory capabilities to allow medical control authorities to review rescuer’s use of the device. Recording includes ECG rhythms, event data, device identification, and optionally, voice recording of rescuer and ambient sounds. This information is available via an upload capability to a personal computer for event review and archiving. Both the American Heart Association (AHA) and the European Resuscitation Council (ERC) publish extensive information regarding the use of automated external defibrillators and their relationship to cardiopulmonary resuscitation. The following publications provide supplemental material to be used in conjunction with the ZOLL Fully Automatic AED Plus Administrator’s Guide and Operator’s Guide: 1. 2015 American Heart Association Guidelines for Cardiopulonary Resuscitation and Emergency Cardiovascular Care; Supplement to Circulation, Volume 132, Issue 18, November 3, 2015. 2. European Resuscitation Council Guidelines for Resuscitation 2015; Resuscitation (2015) Section 1-11, October 2015. This guide provides information about the operation and care of the Fully Automatic AED Plus unit. The administrator, and user should read each section carefully. Make sure to read the Safety Summary section. This guide is divided into six sections. Preface - This page. Safety Summary - Describes General Warnings and Cautions. Introduction- Provides a general product overview of the Fully Automatic AED Plus. Section 1 - Operation - Describes the functions of all controls and indicator lights of the Fully Automatic AED Plus. Section 2 - Installation, Self Test, Maintenance and Troubleshooting- Describes configuration of the unit, data communications, troubleshooting, maintenance and how to order accessories and supplies. Appendices - Provides the specifications of the Fully Automatic AED Plus, characteristics of the ZOLL Rectilinear Biphasic™ waveform, and information on the ECG Analysis Algorithm Accuracy.

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

Warnings • Use the Fully Automatic AED Plus unit only as described in this manual. Improper use of the device can cause death or injury. • DO NOT use or place the Fully Automatic AED Plus unit in service until you have read the Fully Automatic AED Plus Operator’s and Administrator’s Guides. • DO NOT use or place the Fully Automatic AED Plus unit in service if the unit’s status indicator window (located on the left side of the handle) displays a red “X”. • DO NOT use or place the Fully Automatic AED Plus unit in service if the unit emits a beeping tone. • Connect the electrode cable to the Fully Automatic AED Plus unit after installing batteries. • Keep the electrode cable connected to the Fully Automatic AED Plus unit at all times. • This device should only be used by properly trained individuals. • Only use electrodes labeled “Infant/Child” on children less than 8 years old or weighing less than 55 lbs (25 kg). Use CPR-D-padz® if victim is older than 8 years or weighs more than 55 lbs (25 kg). • Always stand clear of victim when delivering a shock. Defibrillation energy delivered to the victim may be conducted through the victim’s body and cause a lethal shock to those touching the victim. • DO NOT TOUCH the electrode surfaces, the victim, or any conductive material touching the victim during ECG analysis or defibrillation. • Move victim away from electrically conductive surfaces prior to use of equipment. • DO NOT use this unit near or within puddles of water. • Keep the victim as motionless as possible during ECG analysis. • DO NOT use this unit near flammable agents, such as gasoline, oxygen-rich atmospheres or flammable anesthetics. • Avoid radio frequency interference from high-power sources that might cause the defibrillator to interpret cardiac rhythms incorrectly by turning off cell phones and 2 way-radios. • Disconnect non-defibrillation protected electronic devices or equipment from victim before defibrillation. • Dry victim’s chest, if wet, before attaching electrodes. • Apply freshly opened and undamaged electrodes, within the electrode expiration date, to clean and dry skin to minimize burning. • DO NOT place the electrodes directly over the victim’s implanted pacemaker. Pacemaker stimuli may degrade the accuracy of ECG rhythm analyses or the pacemaker may be damaged by defibrillator discharges. • Check labeling inside the Fully Automatic AED Plus cover before using the cover as a Passive Airway Support System (PASS) device. Ensure it is intended for this use. • DO NOT use Passive Airway Support System (PASS) if there is a suspected head or neck injury. Place victim on a firm surface before performing cardiopulmonary resuscitation. • DO NOT recharge, disassemble, or dispose of batteries in fire. Batteries may explode, if mistreated. • Do not use or stack the Fully Automatic AED Plus unit with other equipment. If the unit is used or stacked with other equipment, verify proper operation prior to use. • Keep the Fully Automatic AED Plus unit away from magnetic resonance imaging (MRI) equipment.

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Fully Automatic AED Plus Administrator’s Guide

Cautions • Do not disassemble the unit. A shock hazard exists. Refer all servicing to qualified personnel. • There are no replaceable parts in this unit without the use of tools, and no user replaceable parts while the unit is in clinical operation on a patient. • Use only commercially available type 123 lithium manganese dioxide batteries. Discard batteries properly after removal from unit. Use only batteries from recommended manufacturers. • If the device is stored outside the recommended environmental conditions, the electrode pads and/ or batteries may be damaged or their useful life reduced. • Safety and effectiveness data submitted by ZOLL Medical Corporation to the Food and Drug Administration (FDA) to obtain approval to market are based upon the use of ZOLL accessories such as disposable electrodes. The use of electrodes from sources other than ZOLL is not recommended. ZOLL makes no representations or warranties regarding the performance or effectiveness of its products when used in conjunction with electrodes from other sources. If unit failure is attributable to the use of accessories not manufactured by ZOLL, this may void ZOLL’s warranty. • The CPR-D-padz electrode can be connected to other ZOLL Defibrillators with Multifunction Cables. Defibrillation can be administered when connected to other ZOLL defibrillators. The CPR function does not operate with any device other than the AED Plus and AED Pro®.

Indications for Use Use the Fully Automatic AED Plus when a suspected cardiac arrest victim has an apparent LACK OF CIRCULATION as indicated by: • Unconsciousness; and • Absence of normal breathing; and • Absence of a pulse or signs of circulation. This device is intended for use by personnel who have been trained in its operation. Users should receive training in basic life support/AED, advanced life support or a physician-authorized emergency medical response training program. When the victim is less than 8 years of age or weighs less than 55 lbs (25 kg), the Fully Automatic AED Plus should be used with Fully Automatic AED Plus Pediatric Electrodes. Therapy should not be delayed to determine the victim’s exact age or weight.

Contraindications for Use Do NOT use the Fully Automatic AED Plus when the victim: • Is conscious; or • Is breathing; or • Has a detectable pulse or other signs of circulation.

Intended Users of the Device This device is intended for use by personnel who have been trained in its operation. Users should receive training in basic life support/AED, advanced life support or a physician-authorized emergency medical response training program. The Real CPR Help® function provides a metronome designed to encourage rescuers to perform chest compressions at the AHA recommended rate of 100-120 compressions per minute. Voice and visual prompts encourage a compression depth of 5 - 6 cm for adult victims. The Real CPR Help function is not intended for use on victims under 8 years of age.

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Tracking Requirements U.S Federal Law (21 CFR 821) requires the tracking of defibrillators. As an owner of this device, you have the responsibility under this law to notify ZOLL Medical Corporation if this product has been received, lost, stolen or destroyed or has been donated, resold or otherwise distributed to a different organization. If any of the events described above occur, please contact ZOLL Medical Corporation in writing with the following information: 1. Originator’s organization - Company Name, Address, Contact Name and Contact Phone Number. 2. Part Number/Model Number and Serial Number. 3. Disposition of Device (e.g. received, lost, stolen destroyed, distributed to another organization). 4. New Location and/or Organization (if different from #1 above) - Company Name, Address, Contact Name and Contact Phone number. 5. Date change took effect.

Notification of Adverse Events As a health care provider, you may have responsibilities under the Safe Medical Devices Act (SMDA) for reporting to ZOLL and possibly to the FDA, the occurrence of certain events. These events, described in 21 CFR Part 803, include device related death and serious injury or illness. In any event, as part of our Quality Assurance Program, ZOLL should be notified of any device failures or malfunction. This information is required to assure that ZOLL provides only the highest quality products.

Unpacking • Carefully inspect each packing container for damage. • Examine the unit for any signs of damage that may have occurred during shipping. • If the contents are incomplete or damaged or if the unit fails to pass its self test as indicated by a Red “X” in the status indicator window after battery installation, contact ZOLL Medical Corporation’s Technical Service Department. • Review the shipping list to insure that all items ordered were received.

Conventions Throughout this document, voice prompts are indicated by capital italicized letters, such as CALL FOR HELP.

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

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

unit.

NOTE Notes contain additional information on using the defibrillator.

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

Defibrillation protected Type BF patient connection ATTENTION: Refer to manual for more information

DANGEROUS VOLTAGE

MR unsafe: keep away from magnetic resonance imaging equipment Not new battery cells

New battery cells

Do Not push button

Push button

Do not use this manufacturer

Ok to use this manufacturer

Unit equipped to treat adult and pediatric victims

Manufacturer

Return to a collection site intended for waste electrical and electronic equipment (WEEE). Do not dispose of in unsorted trash. Authorized representative in the European Community

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Serial Number

Catalogue number

Consult instructions for use

Prescription only

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Fully Automatic AED Plus Administrator’s Guide

Introduction Using the Fully Automatic AED Plus The Fully Automatic AED Plus is an automatic external defibrillator (AED) that uses voice prompts and visual indicators to guide the rescuer through a resuscitation sequence that may include defibrillation and/or cardiopulmonary resuscitation (CPR). The unit incorporates the ZOLL Rectilinear Biphasic Defibrillation waveform, and operates in either adult or pediatric mode. The Fully Automatic AED Plus supports both adult and pediatric defibrillation electrode pads, and automatically adjusts the defibrillation energy based on the type of electrode pads connected to it. Following attachment of electrodes to a victim’s chest, the defibrillator monitors the electrocardiographic (ECG) rhythm of the victim’s heart, analyzes that rhythm, and determines whether the rhythm is shockable or non-shockable. When needed, defibrillation energy is delivered automatically by the device without the user taking any action, through these same electrodes. When the unit detects a shockable rhythm, it charges and issues the warning SHOCK WILL BE DELIVERED IN THREE (TWO), (ONE), followed by a loud shock tone. A shock is then delivered automatically by the unit. The rescuer will then be prompted to perform CPR for a period of two minutes, after which the unit automatically initiates a new ECG analysis. The Fully Automatic AED Plus has an optional cover that can be used as a PASS (Passive Airway Support System) to support the victim’s neck and shoulders in a position that assists in maintaining an open airway. Some versions also contain disposable accessories (razor, barrier mask, scissors, and a towel). The Fully Automatic AED Plus is powered by ten commercially available consumer brand lithium-manganese dioxide batteries. The Fully Automatic AED Plus can: • Perform periodic self tests to ensure its continual readiness. • Use a one-piece electrode assembly (CPR-D-padz) that facilitates proper electrode placement and that is easy to apply to the victim. • Analyze heart rhythm and inform the rescuer if the rhythm is shockable or non-shockable. • Deliver defibrillation treatment to victims of cardiac arrest who exhibit shockable ECG rhythms. • Provide voice prompts and graphics to guide the rescuer regarding what to do and when to do it during a cardiac emergency, such as calling for help or giving CPR to the victim. • Provide audible beeps to encourage rescuers to provide CPR compressions at 100-120 CPM (requires CPR-D-padz). • Monitor the depth of chest compressions during CPR and provide voice prompts, if compression depth is inadequate (requires CPR-D-padz). • Provide a unit cover that functions as a Passive Airway Support System (PASS). (Note the PASS feature is standard with some versions of the product and optional with others.) • Upload data from the defibrillator to a computer to store events or print event reports. • Use commercially available batteries.

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Using Real CPR Help The CPR-D-padz include a sensor that detects the rate and depth of CPR chest compressions. This sensor is placed (as part of the electrodes application) on the victim’s chest so that it is located between the rescuer’s hands and the victim’s lower sternum during chest compressions. When the rescuer performs CPR compressions, the sensor detects their rate and depth and sends the information to the Fully Automatic AED Plus unit. When used with CPR-D-padz, the Fully Automatic AED Plus monitors the depth and rate of CPR chest compressions. It provides a CPR metronome function designed to encourage rescuers to perform chest compressions at the AHA/ERC recommended rate of 100-120 compressions per minute (CPM) as well as voice and visual prompts to encourage a compression depth of 5 - 6 cm for adult victims. WARNING! Real CPR Help is intended for use on adult victims only; do not use on victims under 8 years of age. The adaptive metronome function is disabled during periods when CPR should not be performed (for example, during ECG analyses and defibrillation shock sequences). During periods when CPR may be indicated, the metronome begins issuing audible beeps following detection of the rescuer’s first few compressions. The beeps continue automatically (at rates described below) until a few seconds after chest compressions are halted by the rescuer or until the recommended “CPR period” ends (2 minutes for AHA and ERC protocols). If the rescuer ceases chest compressions during the CPR period, metronome beeps stop within a few seconds after compressions are halted. Audible beeps resume during the CPR period following any re-initiation of CPR compressions. If no CPR compressions are detected during “CPR periods”, the Fully Automatic AED Plus periodically re-issues the CONTINUE CPR prompt. The rate of beeps issued by the Fully Automatic AED Plus adaptive metronome function adapts to the rescuer’s actual chest compression rate. The metronome will beep at 100 CPM when chest compressions are delivered at greater than 80 compressions per minute (CPM). Should the rescuer fail to deliver compressions at 80 CPM or greater, the metronome will beep at a rate that is approximately 15 CPM higher than the rescuer’s actual rate. This increased metronome rate is intended to encourage the rescuer to increase his/her chest compression rate until the recommended 100 CPM rate is achieved. The metronome beeps at a minimum rate of 60 CPM in cases where the rescuer’s compression rate is substantially below 60 CPM. During CPR, the Fully Automatic AED Plus may issue one or more audible prompts based on the depth of chest compressions detected. When Real CPR Help determines that compression depth is consistently less than 5 cm, a PUSH HARDER prompt will be issued. A GOOD COMPRESSION prompt will be issued if the rescuer responds by increasing compression depth to 5 cm or more. The Fully Automatic AED Plus unit can be configured to display the FULLY RELEASE text prompt to remind the user to lift the hands off the chest during CPR. By default, this text prompt is not enabled.

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Fully Automatic AED Plus Administrator’s Guide

Operation This section describes the following functions: • Operating Controls and Indicators • Using the Fully Automatic AED Plus Graphical User Interface • Voice Prompts • Using the LCD Display • Using the Passive Airway Support System (PASS) • Using Electrodes • Applying CPR-D-padz • Applying Pedi-padz® II (Infant/Child Electrodes) • Using the CPR Monitoring Function - Real CPR Help • Using the Audio Recording Option

Operating Controls and Indicators See Table 1: Control Functions for an explanation of each of these controls. LCD Display (not supplied on some units)

Electrode Connector

Graphics

IrDA Port (on side of unit)

Indicator Lights

Status Indicator

ON OF F

Battery Compartment (bottom)

Auto mat ic

Carrying Handle On/Off Button Speaker (bottom)

Shock Indicator

Figure 1: Identifying Operating Controls and Indicators

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Table 1: Control Function Control/Indicator

Description

ON/OFF Button

Turns power ON or OFF. When held depressed for > 5 seconds initiates self test or data communications. If it is necessary to abort a shock when the unit is charged, pressing this button will discharge the unit.

Indicator lights

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

Shock Indicator

Illuminates when the Fully Automatic AED Plus is charged and in the process of delivering a shock to the victim. When the Fully Automatic AED Plus is not charged the lighted indicator is extinguished.

Pictograms

Icons that explain the series of steps needed for resuscitation and defibrillation.

Status Indicator Illuminated check mark indicates the unit passed its last self test and is ready for use. Illuminated “X” indicates unit has failed its self test and is not ready for use

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LCD Display

Displays elapsed time, shock count, user prompts, CPR compression depths and ECG waveforms.

IrDA Port™

Provides a communications link between the defibrillator and a personal computer or another IrDA equipped device.

PASS Cover (optional)

Some Fully Automatic AED Plus models include a cover that may be used as a shoulder support to aid victim airway management. The PASS can be ordered separately for other Fully Automatic AED Plus models (see “Ordering Accessories” on page 27).

Battery Compartment

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

Electrode Connector

Connector for attaching electrodes to the Fully Automatic AED Plus.

Speaker

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

Microphone (optional)

When voice recording option is installed, this microphone picks up and records ambient sounds, including rescuer’s voice.

Fully Automatic AED Plus Administrator’s Guide

Using the Fully Automatic AED Plus Graphical User Interface The Fully Automatic AED Plus graphical user interface (see Figure 2) is visible on the top of the unit when the cover is removed. The pictograms are reminders of the steps to follow when performing a rescue and reinforce instructions provided through voice prompts and optional display messages. Each pictogram on the device is associated with an indicator light (LED) and voice prompts. This combination draws attention to the graphics in a sequence defined by current protocols for use of an Automated External Defibrillator (AED) by the AHA and ERC.

Figure 2: Graphical User Interface The Fully Automatic AED Plus unit contains an LCD display (some special models do not have an LCD) that displays elapsed time, number of shocks delivered, text messages corresponding to the voice prompts, and depth of CPR compressions. The LCD can also be configured to display the acquired ECG signals. When the Fully Automatic AED Plus is turned on, the unit automatically initiates the sequence of voice prompts and graphic illuminations for a rescue event. The sequence continues until the Fully Automatic AED Plus is turned off or the electrodes are disconnected from the victim for an extended period of time. As soon as electrodes are attached to the victim and impedance of the connection is verified, the unit stops cycling through the above-mentioned voice and graphic illumination sequence and automatically begins analysis of the ECG rhythm. Following the results of this ECG analysis, voice prompts tell the rescuer whether a shockable or non-shockable rhythm has been detected. If a shockable ECG rhythm is present, the graphics illuminate and voice prompts automatically inform the user that a shock is about to be delivered. When no shock is advised, the Fully Automatic AED Plus issues the audio prompts, NO SHOCK ADVISED

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and START CPR, and illuminates the CPR-related graphics. A period of 2 minutes (depending upon device configuration) is then allowed for rescuer CPR. Following this “CPR period”, the Fully Automatic AED Plus automatically re-initiates a new ECG rhythm analysis. The Fully Automatic AED Plus automatically adjusts defibrillation energy to adult or pediatric levels based on the type of electrodes attached to the unit. In its factory default configuration, the unit delivers the first three shocks at 120J, 150J, and 200J respectively in adult mode, and at 50J, 70J, and 85J in pediatric mode. However, the device can be configured to deliver shocks at other energy levels, as long as the setting for each successive shock is the same or greater than the setting for the preceding shock. Shocks are delivered automatically; the heart icon (and associated LED) located in the center of the graphical user interface will light up, and the unit will emit a loud tone when a shock is delivered. Consult the Fully Automatic AED Plus Operator’s Guide for more details on the graphics included in the unit’s graphic interface, the audio prompts issued at each step in the treatment protocol and the rescuer action associated with these audio and visual prompts. Loss of contact between the electrodes and the victim interrupts ECG analysis and/or shock delivery until the electrodes are re-attached and results in a CHECK ELECTRODE PADS prompt to the operator.

Voice Prompts During clinical use of the Fully Automatic AED Plus, you may hear the following voice prompts. Table 2: Clinical Voice Prompts

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Voice Prompt

Definition

UNIT OK.

Fully Automatic AED Plus has successfully passed its power up self tests.

UNIT FAILED.

Fully Automatic AED Plus has failed its power up self tests and is not usable for victim care.

CHANGE BATTERIES.

Fully Automatic AED Plus self test has detected a low battery condition that is insufficient for the device’s use for victim care. Replace batteries immediately.

STAY CALM.

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

CHECK RESPONSIVENESS.

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

CALL FOR HELP.

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

OPEN AIRWAY.

Place victim in the supine position and perform Head Tilt – Chin Lift or Jaw – Thrust maneuver to open victim’s airway.

CHECK BREATHING.

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

GIVE TWO BREATHS.

If victim is not breathing, give two rescue breaths.

PLUG IN CABLE.

Ensure that the electrode cable is properly connected to the Fully Automatic AED Plus electrode connector.

ATTACH DEFIB PADS TO PATIENT’S BARE CHEST.

Attach defibrillation pads to the victim’s bare chest.

Fully Automatic AED Plus Administrator’s Guide

Voice Prompt

Definition

CHECK ELECTRODE PADS.

Previously attached electrodes are not making good contact with the victim’s skin or the electrodes are defective.

ADULT PADS.

Fully Automatic AED Plus has detected adult electrode pads connected to it and adjusted defibrillation energy settings to adult levels.

PEDIATRIC PADS.

Fully Automatic AED Plus has detected pediatric electrode pads connected to it and adjusted defibrillation energy settings to pediatric levels.

DON’T TOUCH PATIENT, ANALYZING.

Do not touch victim, an ECG rhythm analysis is in progress or about to begin.

SHOCK ADVISED.

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

NO SHOCK ADVISED.

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

ANALYSIS HALTED. KEEP PATIENT STILL.

ECG rhythm analysis has been halted due to excessive ECG signal artifact. Stop any ongoing CPR and keep the victim as motionless as possible.

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

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

SHOCK DELIVERED.

A defibrillation shock has just been delivered to the victim.

NO SHOCK DELIVERED.

No shock was delivered to the victim because an error condition was detected.

n SHOCKS DELIVERED.

A total of n shocks have been delivered since the Fully Automatic AED Plus was turned on.

START CPR.

Begin CPR.

CONTINUE CPR.

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

PUSH HARDER.

CPR compressions are consistently less than 5 cm deep.

GOOD COMPRESSIONS.

After prompting to Push Harder, rescuer has succeeded in delivering chest compressions at least 5 cm deep.

STOP CPR.

Stop CPR, the Fully Automatic AED Plus is about to begin an ECG rhythm analysis.

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

Table 2b Non-Clinical Voice Prompts

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Voice Prompt

Definition

IF NEW BATTERIES, PRESS BUTTON.

Press the Battery Reset Button located in the battery compartment after replacing ALL batteries in the device with new batteries.

NON-RESCUE MODE.

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

COMMUNICATIONS ESTABLISHED.

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

Fully Automatic AED Plus Administrator’s Guide

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

Shock Count

Elapsed Time

CPR Depth of Compression Indicator

05:25

SHOCKS: 05

CHECK RESPONSIVENESS

With ECG

SHOCKS: 05

5 cm depth

CHECK RESPONSIVENESS

6 cm depth

05:25

5 cm depth 6 cm depth

Without ECG

Figure 3: LCD Displays NOTE Some special Fully Automatic AED Plus models do not have an LCD.

Shock Count (Upper left corner of screen): Indicates the total number of defibrillation shocks delivered by the Fully Automatic AED Plus since it was last powered on. Shock count is saved through brief power off periods (< 5 seconds). When the Fully Automatic AED Plus is turned off for more than 5 seconds, the shock count is reset to 0. Elapsed Time (Upper right corner of screen): Indicates the total time in minutes and seconds that has elapsed since the Fully Automatic AED Plus was last powered on. Elapsed time continues to be counted through brief power off periods (< 5 seconds). When the Fully Automatic AED Plus is turned off for more than 5 seconds, elapsed time is reset to 00:00. When elapsed time exceeds 99 minutes and 59 seconds, the timer wraps around to 00:00 and continues counting. CPR Depth of Compression Indicator (Right side of screen): A bar graph is displayed that shows the depth of chest compressions measured during the delivery of CPR. Indicator lines are displayed in the bar graph area at 5 and 6 cm of compression depth to provide reference points for rescuers performing CPR. Visual User Prompts (Lower 1/3 of screen): Whenever the Fully Automatic AED Plus issues a voice prompt, the text of the voice prompt is simultaneously displayed on the LCD display. ECG Waveform (Center portion of screen): Although Fully Automatic AED Plus units do not display ECG waveforms in their factory default configuration, the device can be specifically set up to continuously display ECG signals as they are acquired. Devices configured to display the ECG waveform are recommended for environments where the device is used by qualified medical personnel.

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Using the Passive Airway Support System (PASS) If there is no evidence of head or neck trauma, the head tilt chin lift method is the recommended maneuver for opening the airway. The PASS may be placed under the victim’s shoulders to help maintain head tilt. WARNING! DO NOT use PASS if suspected head or neck injury. Place victim on a firm surface before performing CPR. If the victim requires airway support and there is no evidence of head or neck trauma, roll the victim on his/her side and then roll him/her back over so that the PASS is under the victim’s shoulders causing the head to tilt backwards. For PASS COVERS only: The shape of the PASS, when placed under the shoulders of the victim, can be used to help maintain an open airway (see Figure 4).

The unit cover also functions as the Passive Airway Support System (PASS).

Place the PASS under the victim to lift his/her shoulders. Do not use the PASS if there is a suspected head or neck injury.

Figure 4: Using the PASS Cover

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Fully Automatic AED Plus Administrator’s Guide