Avive AED User manual
IFU-00367 Rev A
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Avive AEDä Owner’s Manual
ä
IFU-00367 Rev A
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About this Owner’s Manual
This owner’s manual provides information on the setup, use, maintenance, and technical specifications of the
Avive AEDä. This information is subject to change. Please contact Avive or visit www.avive.life/AviveAED if
you have any questions.
Revision: A
Publication Date: 2022-11-15
Copyright Statement
©2022 Avive Solutions, Inc. All rights reserved.
Manufacturer Info
Avive Solutions, Inc.
185 Valley Drive
Brisbane, CA 94005
(800)-489-4428
Caution
U.S. Federal Law restricts this device to sale by or on the order of a physician.
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Avive AEDä Emergency Quick Reference
Avive AED Emergency Steps
Pull the Red Tab
1
Place pads as shown.
2Apply Pads
Do not touch the patient. Device will perform
Automated Analysis & Treatment, if necessary.
3Stand Back
www.avive.life
Follow these steps in a cardiac arrest emergency.
Adult Pad Placement Child Pad Placement
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Table of Contents
1. When to Use the Avive AED ................................................................................................................... 5
2. Warnings & Precautions ........................................................................................................................ 6
3. Initial Device Setup ................................................................................................................................ 8
4. Getting to Know the Avive AED .............................................................................................................. 9
5. Using the Avive AED ............................................................................................................................ 11
A. Using the Avive AED in an Emergency ............................................................................................................ 11
Step 1: Pull the Red Tab ................................................................................................................................................................ 11
Step 2: Apply Pads to Patient ........................................................................................................................................................ 12
Step 3: Stand Back - Automated Analysis & Treatment ............................................................................................................... 13
B. Child Mode - For Children Press the Child Button. .......................................................................................... 14
C. Spanish Mode ................................................................................................................................................ 14
D. Backup Power Mode ...................................................................................................................................... 15
E. Accessing & Sharing Event Data ..................................................................................................................... 16
F. Training Mode ............................................................................................................................................... 16
6. Device Readiness ................................................................................................................................. 17
A. Device Self-Tests ............................................................................................................................................ 17
B. Status Light .................................................................................................................................................... 17
C. Checking Status .............................................................................................................................................. 18
D. Speaker .......................................................................................................................................................... 18
7. Troubleshooting .................................................................................................................................. 18
A. Troubleshooting Guide .................................................................................................................................. 19
8. Maintenance ....................................................................................................................................... 20
A. Charging the Avive AED .................................................................................................................................. 20
B. Replacing the Avive Pad Cartridge .................................................................................................................. 21
C. Cleaning ......................................................................................................................................................... 22
D. Disposal ......................................................................................................................................................... 22
E. Software Updates .......................................................................................................................................... 22
9. Operating & Storage Conditions .......................................................................................................... 23
10. Meaning of Symbols & Device Markings .............................................................................................. 24
11. Technical Data ..................................................................................................................................... 25
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1. When to Use the Avive AED
ä
A. Indications for Use
The Avive Automated External Defibrillator (AED) is intended for emergency treatment of individuals who are
exhibiting symptoms of cardiac arrest. A person in cardiac arrest:
• Is unresponsive; and
• Is not breathing normally
The Avive AED analyzes the patient’s electrocardiogram, interprets the cardiac rhythm, and automatically
delivers an electrical shock to treat ventricular fibrillation or pulseless ventricular tachycardia.
The Avive AED is indicated for adult and pediatric patients over 1 years of age. When a patient is less than 8
years old, or weighs less than 55 lbs., the Avive AED should be used in Child Mode. Otherwise, the Avive AED
should be used in Adult Mode. Therapy should not be delayed in order to determine exact age and/or weight.
B. Contraindications for Use
Aviveä defibrillators should not be used if the patient is responsive or conscious.
C. What is Cardiac Arrest?
Cardiac arrest is when the heart unexpectedly and suddenly stops pumping blood to the body, caused by an
irregular heartbeat (arrhythmia). Cardiac arrest can happen to anyone – male, female, child, or adult – and
often happens suddenly, without warning signs. If left untreated, cardiac arrest will lead to death within
minutes.
A defibrillation shock provides the only effective treatment for cardiac arrest. Every minute that someone in
cardiac arrest does not receive a defibrillation shock reduces their survival chances, even if effective
defibrillation is eventually delivered.
CPR should be performed as soon as possible on a patient in cardiac arrest, to maintain blood flow and oxygen
to the brain. However, it is critical to note that CPR alone cannot return a heartbeat to a normal rhythm. The
survival chances of someone in cardiac arrest is largely dependent on how soon they receive treatment from a
defibrillator
Important: It is important to note that a cardiac arrest victim’s chance at survival is largely dependent on how
soon they receive treatment. Every minute the victim does not receive treatment, their survival chances
decrease by 7-10%. Therefore, treatment from an AED cannot guarantee survival. In addition, in some cases,
the root cause of the victim experiencing cardiac arrest makes it highly unlikely that person will survive, even if
treatment is available.
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2. Warnings & Precautions
The following section describes how to use your Avive AEDä safely. Please read these warnings
and precautions carefully.
Warnings describe something that can cause serious personal injury or death.
Precautions describe something that can cause minor personal injury, or damage to the Avive AED.
Warnings
Flammable Agents – If the Avive AED is used to give a shock in the presence of flammable agents, there is a
risk of explosion. Move flammable agents such as supplemental oxygen, oxygen delivery devices, gasoline, and
pressurized cannisters away from the Avive AED and defibrillation pads.
Environment – Do not operate the Avive AED outside of the specified operating conditions. Do not store the
Avive AED outside of the specified storage conditions.
Dry Chest – Dry off the patient’s chest if wet before applying electrode pads.
Battery Fluids – The Avive AED battery is rechargeable via the USB Charging Port on the product. Do not try to
open the unit to access the battery. Do not attempt to replace the battery. Do not open, crush, or burn the
unit, or it may explode or catch fire.
Fluids – Do not let fluids get into the Avive AED. While the fully assembled Avive AED has an IP rating of 54,
exposure to fluids can still damage the device. When an Aviveä Pad Cartridge is not installed, the device is
susceptible to water damage. Do not use the Avive Power Adapter when it is wet. Avoid spilling any fluids on
the Avive AED or its accessories. Exposing the Avive AED to excess water and particle ingress or spilling fluids
into the Avive AED may damage it or cause a fire or shock hazard. Do not use the Avive AED in puddles of
water.
Accessories – Using damaged or expired equipment or accessories may cause the Avive AED to perform
improperly, and/or injure the patient or the user. Use of accessories and cables other than those specified or
provided by the manufacturer of this equipment could result in increased electromagnetic emissions or
decreased electromagnetic immunity of this equipment.
Avive Accessories Only – Only use accessories approved by Avive for use with the Avive AED. Using
unauthorized accessories may cause the Avive AED to perform improperly, and/or injure the patient or the
user, and their use may void Avive’s warranty.
Patient Handling – Do not touch the patient while the Avive AED is analyzing the patient’s heart rhythm or
during defibrillation. Touching the patient during heart rhythm analysis can lead to an incorrect or delayed
analysis. Touching the patient during defibrillation can cause electric shock to the user, and potentially reduce
the efficacy of defibrillation.
RF Devices – Keep cell phones and other radiofrequency (RF) devices at least 1ft (31 cm) from the Avive AED.
Pads – Do not allow the pads to contact other electrodes or metal parts that are in contact with the patient.
Implanted Pacemakers – Do not apply pads directly over an implanted pacemaker in the patient.
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Choking & Asphyxiation – Keep the Avive AEDä and its accessories out of reach of children to avoid the
potential risk of inhalation, swallowing of small parts or strangulation by cables.
Do Not Modify – Do not modify or attempt to disassemble the Avive AED.
Stacked Equipment – Use of this equipment adjacent to or stacked with other equipment should be avoided
because it could result in improper operation. If such use is necessary, this equipment and the other
equipment should be observed to verify that they are operating normally
Precautions
Device Handling – Do not intentionally drop, throw, mishandle, or apply excessive force to the Avive AED.
Rough handling can damage the device and its accessories and may invalidate the warranty.
Multiple Defibrillators - Do not apply a second defibrillator to the patient before removing the Avive AED.
Maintenance – Improper maintenance may damage the Avive AED or cause it to function improperly.
Maintain the Avive AED according to directions.
Skin Burns – Do not let the pads touch each other or other electrodes, lead wires, dressings, medicine
patches, etc. Such contact can cause skin burning and potentially reduce the efficacy of defibrillation.
Pad Adhesion - Do not use expired, previously used, or previously opened electrode pads because they may
not provide good contact with the skin, which may impact performance.
Patient Handling – Disconnect the patient from all non-defibrillator proof electrical medical equipment before
defibrillation. In addition, make sure the pads and patient are not in contact with electrically conductive
surfaces such as a metal bed frame or stretcher, and do not touch metal objects in contact with the patient.
Skin Irritation – Do not leave the electrode pads on a patient for more than 24 hours.
Cleaning - Do not sterilize the Avive AED or its accessories. Do not use harsh chemicals, flammable agents, or
solvents to clean the device. Clean the device according to directions.
Exposed Contacts – Do not touch exposed electrical contacts on the Avive AED, when no Aviveä Pad Cartridge
is installed. Do not touch exposed electrical contacts on the Avive Pad Cartridge during installation.
Pad Packaging – The Avive Pad Cartridge must be replaced after the sealed pad packaging has been opened.
Operating in a Hot Environment – If the Avive AED has been stored and being used in a hot environment the
product and its components may be hot to the touch, and cause discomfort.
Radio Frequency Interference: Equipment operating in close proximity to the Avive AED may emit
electromagnetic or radiofrequency interference. If use of equipment in close proximity is necessary, observe
the Avive AED to verify normal operation. Avoid operating the Avive AED near diathermy equipment,
cauterizers, security systems, or RFID sources.
Aircraft: Do not operate the Avive AED in an aircraft environment.
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3. Initial Device Setup
Step 1: Remove the Avive AEDä from the packaging.
Step 2: Press the Power Button. The Avive AED will run some initialization self-checks to make
sure it is ready to go. You will be prompted to press the Child Button and Español Button to
ensure they are functioning properly.
Once initialization is complete, the Avive AED will prompt you to press the Power Button to
power off the AED.
Step 3: Connect the device to the Aviveä USB Power Adapter with the Avive USB Charging
Cable to charge the battery. [See Section 8A]
After you’ve followed the steps above, your device should be ready to help save a life!
Account Setup
Be sure to set up an account and register your device for device tracking, product warranty, and the full
benefits of the Avive platform. Visit www.avive.life/register or install the Avive App on your smartphone to get
started.
Tracking Requirements
Avive Solutions, Inc. is required to track each Avive AED per U.S. medical device regulations.
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4. Getting to Know the Avive AED
ä
See next page for descriptions of each identified feature.
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A. Red Tab
Pull the Red Tab to access the packaged pads in
the Pad Cartridge and activate the Avive AEDä for
use. [See Section 5A]
IMPORTANT: Only pull the Red Tab in an
emergency. If the packaged pads have been
opened the Pad Cartridge will need to be
replaced.
B. Power Button
Press the Power Button to turn on or turn off the
Avive AED.
C. Child Button
Upon power on, the Avive AED defaults to Adult
Mode. When treating children under 8 years old
or under 55 lbs, it is important to press the Child
Button to switch the device into Child Mode. Press
the Child Button again to switch the device back to
Adult Mode. [See Section 5B]
D. Español Button
Upon power on, the Avive AED defaults to
providing audio instructions in English. Press the
Español Button to switch the device to Spanish
Mode, which will provide audio instructions in
Spanish. Press the Español Button again to switch
back to English Mode. [See Section 5C]
E. Status Light
If this light is blinking green, your device is ready
to use! If it’s blinking red, then the Avive AED
needs attention. [See Section 6B]
F. Pad Cartridge
Self-adhesive pads used for treatment are stored
in a sealed package within the Pad Cartridge. The
pads are accessed by pulling the Red Tab out from
the Pad Cartridge and peeling open the package.
[See Section 8B]
IMPORTANT: The Pad Cartridge is single-use,
disposable and must be replaced after the
expiration date is reached or the Pad Cartridge has
been used.
G. Stand Back Light
When this light is flashing – stand back, and do not
touch the patient. The Stand Back Light flashes
when the device is analyzing the patient’s heart
rhythm or delivering therapy. It is important that
no one touches the patient during this time.
H. Speaker
The Avive AED provides audio instructions and
notifications during use through this speaker.
I. USB Charging Port
The Avive AED has a rechargeable battery. Use the
USB Charging Port to connect the device to a
charger in order to charge the AED. [See Section
8A]
IMPORTANT: Use the Avive
ä
USB Power
Adapter and Avive USB Charging Cable for
guaranteed charging performance.
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