AED 3 Operators Manual Rev A

About This Manual The issue date for the ZOLL AED 3 Operator's Manual (REF 9650-003750-12 Rev. A) is November, 2023. Copyright © 2023 ZOLL Medical Corporation. All rights reserved. AED Plus, AED Pro, CPR-D-padz, Pedi-padz, PlusTrac, Program Management Onboard, Real CPR Help, Rectilinear Biphasic, RescueNet, Stat-padz, Uni-padz, ZOLL, and ZOLL AED 3 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.

ZOLL Medical Corporation 269 Mill Road Chelmsford, MA USA 01824-4105 ZOLL International Holding B.V. Einsteinweg 8A 6662 PW Elst Netherlands ZOLL Medical Switzerland AG Baarerstrasse 8 6300 Zug Switzerland

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Intended Purpose The intended purpose of the ZOLL AED 3 is to help victims of sudden cardiac arrest. Using compatible ZOLL defibrillation electrodes which connect the patient to the ZOLL AED 3, the AED automatically analyzes the victim’s ECG rhythm to determine whether an electrical shock should be delivered. If the AED detects a shockable rhythm (coarse ventricular fibrillation or wide complex ventricular tachycardia), it alerts the rescuer that a shock is advised and then it either issues instructions to press the flashing shock button (semi-automatic model) or it automatically delivers the shock after a 3 second countdown (fully automatic model). The AED then prompts the rescuer to perform CPR for a pre-configured period of time.

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 ZOLL AED 3 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.

ZOLL AED 3 ® Controls and Indicators See “ZOLL AED 3 Control Functions” on the following page for a description of each of these controls. Status Indicator Defibrillation Pads Connector On/Off Button Liquid Crystal Display (LCD) Screen Shock Button Child Button

Speaker

Carrying Handle USB Connector Compartment

Battery Compartment

Support bar

Table 1: ZOLL AED 3 Control Functions Control/Indicator

Function

Status Indicator

A green check indicates that the ZOLL AED 3 defibrillator passed its last self test and is ready for use. No green check indicates that the AED has not passed its last self test or a battery has not been installed-see note on page 11 for more information.

AED Passed Self Test AED Failed Self Test

On/Off Button

Press to turn power ON or OFF.

Shock Button

Illuminates when the AED is charged and ready to deliver a shock to the patient. When pressed, it causes the AED to discharge its energy into the patient. Note: In Automatic models, the shock button does not illuminate.

Speaker

Provides audio prompts and metronome beeps to guide rescuers during a rescue; also provides audio prompts to indicate when service is required.

Defibrillation Pads Connector

This connector is used to attach the defibrillation pads to the ZOLL AED 3 defibrillator.

Liquid Crystal Display (LCD) Screen

A 2.1 x 3.7 inch touch screen for display and user input. During a rescue, it displays graphics to guide the rescuer.

Child Button

Illuminated button indicates the ZOLL AED 3 is in Child Mode in preparation for rescuing a pediatric patient. Illuminates when pressed while using CPR Uni-padz™; automatically lights up while using Pedi-padz® II.

Carrying Handle

The strap designed to make it easy to carry the AED.

USB Connector Compartment

The area used to connect a USB flash drive when importing/exporting files to or from the ZOLL AED 3 defibrillator.

Battery Compartment

Holds the battery pack used to power the AED.

Support Bar

Opens to hold the AED in an upright position.

Table of Contents Introduction Overview ... 1 Intended Users ... 2 Conventions ... 2 Safety Summary ... 2 Summary of Safety and Clinical Performance (SSCP) ... 2 Warnings ... 3 Cautions ... 6

Setting Up the ZOLL AED 3 Defibrillator ZOLL AED 3 Shipping Contents ... 8 Setting Up the Defibrillator ... 9 Important Notes ...11

Using the ZOLL AED 3 Defibrillator Overview ...12 When a Shock is Needed ...16 When a Shock is Not Needed ...17 ECG/CPR Dashboard ...17 When Emergency Medical Services Arrive ...18 After Using the ZOLL AED 3 ...18

Maintaining the ZOLL AED 3 Defibrillator Overview ...19 After Each Use ...19 Cleaning the ZOLL AED 3 Defibrillator ...20 Replacing the Battery Pack ...21 ZOLL AED 3 Operator’s Manual

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Self Tests ...23 Automatic Self-Test Transfer ...24 Troubleshooting ...25 Contacting Technical Service ...27 International Customers ...27

Transferring Patient Data Overview ...28 Exporting Patient Files ...28 Using ZOLL RescueNet® EventSummary Software ...30 Using RescueNet Case Review Software ...30 Troubleshooting Communication Issues ...31

Appendix A Symbols ...32

Appendix B Specifications ...37

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ZOLL AED 3 Operator’s Manual

Introduction 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. It uses audio and visual prompts to guide the rescuer through a resuscitation sequence that may include defibrillation and/or cardiopulmonary resuscitation (CPR). The defibrillator provides Real CPR Help® corrective rate and depth prompting for adult victims and an active metronome for both adult and child victims. The ZOLL AED 3 defibrillator incorporates the ZOLL® Rectilinear BiphasicTM Defibrillation waveform, and operates in either adult or child mode. The ZOLL AED 3 defibrillator is available in three models: ZOLL AED 3, ZOLL AED 3 Automatic, and ZOLL AED 3 BLS. The ZOLL AED 3 and ZOLL AED 3 BLS models function in semi-automatic mode where the rescuer initiates the shock. The ZOLL AED 3 Automatic model automatically initiates the shock without rescuer intervention. The defibrillator has two operating modes: Rescue Mode and AED Management Mode. In Rescue Mode, the LCD screen displays graphics that are coordinated with audio prompts to guide you through a rescue. In AED Management Mode, the icons on the touch screen allow you to change configuration settings and upload files.

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Intended Users The ZOLL AED 3 defibrillator is intended to be used by responders who have been trained in CPR and the use of an AED to defibrillate victims of cardiac arrest. The CPR monitoring function provides a metronome designed to encourage rescuers to perform chest compressions at the recommended rate of at least 100 compressions per minute for both adult and child victims. The defibrillator provides voice and visual prompts to encourage a minimum compression depth of 2 inches for adult victims and basic instructions for child victims.

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 device.

NOTE Notes contain important additional information about using the defibrillator.

Safety Summary The following section describes general warnings and safety considerations for administrators, rescuers, and victims.

Summary of Safety and Clinical Performance (SSCP) The Summary of Safety and Clinical Performance (SSCP) is available in 2

ZOLL AED 3 Operator’s Manual

the European database on medical devices (Eudamed) – https://ec.europa.eu/tools/eudamed. The Basic UDI-DI is 08479460DSK

Warnings • Use the ZOLL AED 3 defibrillator only as described in this manual. Improper use of the AED can cause death or injury. • DO NOT use or place the defibrillator in service until you have read the ZOLL AED 3 Operator’s Manual. • DO NOT use or place the ZOLL AED 3 defibrillator in service if the green check () is not displayed in the AED’s status indicator window (located to the right of the On/Off button). The green check displays when the AED is ready to use. • DO NOT use or place the ZOLL AED 3 defibrillator in service if the unit emits a beeping tone when it is off. • DO NOT perform any unauthorized modification to the ZOLL AED 3 defibrillator. • DO NOT disassemble the unit. A shock hazard exists. Refer all servicing to qualified personnel. • The ZOLL AED 3 defibrillator is not intended for use in fixed or rotary wing aircraft. • Connect the defibrillation pads cable to the defibrillator BEFORE installing the battery pack. • Keep the defibrillation pads cable connected to the defibrillator at all times. • The ZOLL AED 3 defibrillator should only be used by properly trained individuals. • Use the ZOLL AED 3 CPR Uni-padz defibrillation pads for both adult and child victims. The ZOLL AED 3 CPR Uni-padz defibrillation pads may be used on children less than 8 years old or weighing less than 55 lbs (25 kg) when the Child button has been pressed. ZOLL AED 3 Operator’s Manual

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• The ZOLL AED 3 defibrillator is capable of delivering 200 joules. If necessary, the defibrillator can be completely deactivated by turning it off and removing the battery pack. • For safety, the semi-automatic version of the ZOLL AED 3 defibrillator automatically disarms a fully charged unit after 30 seconds if the Shock button is not pressed. • Always stand clear of the 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 defibrillation pad surfaces, the victim, or any conductive material touching the victim during ECG analysis or defibrillation. • Move the victim away from electrically conductive surfaces prior to use of equipment. • DO NOT use the ZOLL AED 3 defibrillator near or within puddles of water. • Keep the victim as motionless as possible during ECG analysis. • DO NOT use the ZOLL AED 3 defibrillator near flammable agents, such as gasoline, oxygen-rich atmospheres or flammable anesthetics. • MR Unsafe - Keep the ZOLL AED 3 defibrillator away from magnetic resonance imaging (MRI) equipment. • Turn off cell phones and two-way radios to avoid radio frequency interference from high-power sources that might cause the defibrillator to interpret cardiac rhythms incorrectly. • Disconnect non-defibrillation protected electronic devices or equipment from victim before defibrillation. • Dry victim’s chest, if wet, before attaching defibrillation pads. • Apply freshly opened and undamaged defibrillation pads (within the defibrillation pads expiration date) to clean and dry skin to minimize burning. 4

ZOLL AED 3 Operator’s Manual

• DO NOT place the defibrillation pads directly over a victim’s implanted pacemaker. Pacemaker stimuli may degrade the accuracy of ECG rhythm analyses, or the pacemaker may be damaged by defibrillator discharges. • The ZOLL AED 3 defibrillator does not reject implanted pacemaker pulses. • DO NOT disassemble a battery pack or dispose of it in fire. DO NOT try to recharge the nonrechargeable battery pack. If mishandled, the battery pack may explode. • DO NOT use or stack the ZOLL AED 3 defibrillator with other equipment. If the defibrillator must be used or stacked with other equipment, verify proper operation prior to use. • DO NOT connect the ZOLL AED 3 defibrillator to a computer or other device (using the USB port) while the defibrillation pads are still connected to the victim. • The ZOLL AED 3 USB port is intended for use with a flash drive only. DO NOT insert wireless adapters or other unauthorized devices into the USB port. • Check the expiration date on the defibrillation pads packaging. DO NOT use defibrillation pads that have passed their expiration date. • The use of accessories and cables other than those specified in the ZOLL AED 3 Administrator’s Guide may result in increased emissions or decreased immunity of the ZOLL AED 3 defibrillator.

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• To satisfy FCC RF exposure requirements for mobile transmitting devices, a separation distance of 20 cm or more should be maintained between the antenna of this device and persons during device operations. To ensure compliance, operations at closer than this distance are not recommended. The antenna (located internally in top front of device) used for this transmitter must not be co-located in conjunction with any other antenna or transmitter.

Cautions • The ZOLL AED 3 defibrillator may not perform to specifications when stored at the upper or lower extreme limits of storage temperature and then immediately put into use. • Use only the ZOLL AED 3 nonrechargeable, disposable battery pack with the ZOLL AED 3 defibrillator. • Keep a new spare battery pack with the device at all times. • When the unit displays the CHANGE BATTERY message, replace the battery pack with a new one as soon as possible. • Dispose of battery packs in accordance with federal, state, and local regulations. Battery packs should be shipped to a reclamation facility for recovery of metal and plastic compounds as the proper method of waste management. • ZOLL defibrillation pads contain no hazardous materials and may be disposed of in general trash unless contaminated with pathogens. Use appropriate precautions when disposing of contaminated defibrillation pads. • If the ZOLL AED 3 defibrillator is stored outside the recommended environmental conditions, the defibrillation pads and/or battery pack may be damaged or their useful life reduced.

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ZOLL AED 3 Operator’s Manual

• 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 defibrillation pads and batteries. The use of defibrillation pads and batteries 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 defibrillation pads and batteries from other sources. If AED failure is attributable to the use of accessories not manufactured by ZOLL, this may void ZOLL's warranty. • The ZOLL AED 3 CPR Uni-padz defibrillation pads may be connected to the ZOLL AED Plus® or AED Pro® defibrillators and function as adult defibrillation pads; however, the device only produces a constant metronome during CPR intervals, it does not provide Real CPR Help. • When Stat-padz® II and Pedi-padz II are connected to the ZOLL AED 3 defibrillator, the device only produces a constant metronome during CPR intervals; it does not provide Real CPR Help. • Prior to use, assess Wi-Fi performance for possibility of Radio Frequency Interference (RFI) in your environment of use. • 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 Electromagnetic Compatibility section of the ZOLL AED 3 Administrator's Guide, such as high frequency surgical equipment, radar installations, or radio transmitters. It is also not intended for use in fixed or rotary wing aircraft. Operation outside of this environment could result in the misinterpretation of the ECG rhythms or CPR signals, interference to the display or audio messages, or the inability to provide defibrillation therapy. • If multiple devices are transmitting simultaneously to the same access point, Wi-Fi data transfer slows down. If the access point is too overloaded, data transmission failures may occur.

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Setting Up the ZOLL AED 3 Defibrillator ZOLL AED 3 Shipping Contents Check the ZOLL AED 3 shipping container for the following contents: • 1 ZOLL AED 3 defibrillator • 1 ZOLL AED 3 battery pack • 1 package containing CPR Uni-padz defibrillation pads (with scissors attached) • 1 ZOLL AED 3 documentation packet NOTE If the contents are incomplete or damaged, contact ZOLL Medical Corporation’s Technical Service Department. See “Contacting Technical Service” on page 27 for more information.

AED Passed Self Test AED Failed Self Test

8

NOTE If the ZOLL AED 3 defibrillator fails to pass its self test (indicated by a UNIT FAILED prompt or if the green check is not displayed in the status indicator window) after installing a new battery, make sure the defibrillation pads are plugged in properly.

ZOLL AED 3 Operator’s Manual

Setting Up the Defibrillator Follow the steps below to prepare the ZOLL AED 3 defibrillator for use. 1. Remove the defibrillation pads package from the cardboard box in the shipping container.

1 2

< 8 Years (< 55lbs/25kg)

™

defibrillation pads package WARNING! Do not open sealed defibrillation pads until immediately prior to use.

2. Plug the defibrillation pads cable connector into the defibrillation pads port.

Plug in defibrillation pads cable connector WARNING! To prepare for an emergency, keep the defibrillation pads cable connected to the AED at all times. Do not reuse defibrillation pads.

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3. Remove the battery pack from the shipping container. 4. Hold the battery pack by the side tabs with the label facing out. Insert the battery pack into the back of the AED until it clicks into place, lining up the notch on the end of the battery to the corresponding recess in the battery well. The defibrillator runs an automatic self test.

battery notch WARNING! To ensure the ZOLL AED 3 defibrillator is ready for use, monitor its status weekly. Verify that the AED has passed its periodic self test by confirming the green check is displayed in the status indicator window.

< 8 Years (< < 55lbs/25kg)

2

1

™

5. While facing the front of the defibrillator, insert the defibrillation pads package into the back of the AED so that the label on the package is facing you with the defibrillation pads cable on the right.

Insert defibrillation pads package 10

ZOLL AED 3 Operator’s Manual

AED Passed Self Test AED Failed Self Test

6. Verify that the green check () appears in the status indicator window and that the defibrillator does not emit a beeping tone. This indicates that the new battery pack and defibrillation pads are properly installed and the ZOLL AED 3 defibrillator is ready for use. NOTE If the defibrillator fails to pass its self test (the green check does not display in the status window or it issues the UNIT FAILED audio prompt) after battery installation, remove the battery and unplug the defibrillation pads and repeat steps 2 through 6. If the AED fails to pass its self test a second time, contact ZOLL Medical Corporation’s Technical Service Department. See “Contacting Technical Service” on page 27 for more information. 7. Place the defibrillator into service in accordance with your local guidelines and hang the rescue poster on the wall near the defibrillator. NOTE The ZOLL AED 3 defibrillator ships with a default Supervisor passcode (which is published in the ZOLL AED 3 Administrator’s Guide). The AED Administrator should change the default passcode after the set up of the device is complete. See www.zoll.com for the latest version of the ZOLL AED 3 Administrator’s Guide. NOTE Defibrillator pads are defibrillation-proof Type BF applied parts.

Important Notes • Make sure the defibrillation pads are always connected to the defibrillator and the battery is installed. • To ensure adequate power availability during an emergency, monitor the device status weekly or per local guidelines. Verify that the AED has passed its periodic self test by confirming that the green check is displayed in the status indicator window. • If you change the battery while the AED is in Rescue Mode (with the defibrillation pads cable connected), the AED automatically powers on displaying the battery icon and then shuts down. Press and release the On/Off button to restart the AED. ZOLL AED 3 Operator’s Manual

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Using the ZOLL AED 3 Defibrillator Overview Use the ZOLL AED 3 defibrillator when a suspected cardiac arrest victim has an apparent lack of circulation as indicated by ALL of the following symptoms: • Unconsciousness • Absence of normal breathing • Absence of a pulse or signs of circulation Call for help, retrieve the defibrillator, and bring it to the patient’s side. Follow the basic steps on the following pages to treat the suspected cardiac arrest patient:

12

1

Press the On/Off button to turn on the defibrillator and follow the voice prompts.

2.

Press the Child button (only if the patient is a child and you are using CPR Uni-padz).

3.

Place defibrillation pads on the patient (follow the defibrillator’s voice prompts).

4.

Shock patient, if instructed.

5.

Start CPR.

ZOLL AED 3 Operator’s Manual