Avive AED User manual

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Avive AEDä Owner’s Manual
ä

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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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5. Using the Avive AED
ä
A. Using the Avive AED in an Emergency
Step 1: Pull the Red Tab
Step 2: Apply Pads
Step 3: Stand Back – Automated Analysis & Treatment
Step 1: Pull the Red Tab
First, activate the Avive AED by pulling the Red
Tab. The unit can also be activated by pressing
the Power Button.
Once powered on, the Avive AED will begin
providing audio instructions. Stay calm and follow
all audio instructions.
Continue to next page for the next step.

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Step 2: Apply Pads to Patient
Apply the pads to the patient’s bare skin. Placing the pads correctly on the patient’s bare skin is crucial for the
Avive AEDä to correctly analyze and treat the patient.
a) Remove Clothing & Expose Patient’s Chest
Before placing the pads, the Avive AED will direct you to expose the
patient’s bare chest and remove the patient’s bra if necessary.
NOTE: Dry off the patient’s chest if it is wet or sweaty. A wet chest
can reduce the success of treatment.
NOTE: Remove hair where the pads will be placed, if necessary.
b) Peel Open Package & Remove Pads
Once the patient’s chest is exposed, peel open
the package you pulled from the device, and take
out the pads inside.
c) Peel and Place each Pad
Peel each pad from the white liner and firmly stick
on the patient’s bare skin exactly as shown in the
picture on each pad.
Adult Pad Placement Child Pad Placement
Continue to next page for the next step.

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Step 3: Stand Back - Automated Analysis & Treatment
a) Heart Analysis
Once the pads are placed on the patient’s bare skin, stand back and
do not touch the patient. The Avive AEDä will automatically analyze
the patient’s heart rhythm to diagnose whether or not a
defibrillation shock is needed.
DO NOT TOUCH PATIENT
b) Automated Treatment
If the Avive AED determines that a shock is required, the AED will
automatically deliver a defibrillation shock to the patient. Stand back
and do not touch the patient.
DO NOT TOUCH PATIENT
IMPORTANT: The Avive AED will provide you audible instructions and
stop flashing the Stand Back Lights when it is safe to touch the
patient.
c) Perform CPR
After automated analysis and treatment (if needed), the Avive AED will audibly instruct you that it is safe to
touch the patient and to perform CPR. The device will provide hands-only CPR instructions. The Avive AED will
instruct you when to stop CPR so that it can re-analyze the patient’s heart rhythm and deliver treatment (if
needed).
NOTE: Continue following instructions from the Avive AED until the patient regains consciousness or Emergency
Medical Services arrive and take over care of the patient.
After the emergency situation has been resolved, make sure to maintain the Avive AED and accessories [See
Section 8A].

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B. Child Mode - For Children Press the Child Button.
The Avive AEDä will power on in Adult Mode. If the patient is a
child under 8 years old or under 55 lbs., make sure to switch the
Avive AED to Child Mode by pressing the Child Button.
When switched to Child Mode, the device will verbally indicate
“Now in Child Mode,” and the Child Button will light up. To switch
back to Adult Mode, press the Child Button again.
C. Spanish Mode
The Avive AED will provide audio instructions in English Language
by default. If Spanish language is preferred, switch the Avive AED
to Spanish Language by pressing the Español Button.
When switched to Spanish Language, the device will verbally
indicate in Spanish that it is in Spanish mode, and the Español
button will light up. To switch back to English language, press the
Español Button again.

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D. Backup Power Mode
How to use the Avive AED
ä
with a depleted battery during an emergency.
In the event the Avive AED has a depleted battery when you need to use it during an emergency, the device
can be used in Backup Power Mode. In this mode, the Avive AED can be powered via the Aviveä USB Charging
Cable and Avive Power Adapter to be used in an emergency.
IMPORTANT: An Avive AED should only be used in Backup Power Mode as a last resort if there is no other
functional AED available. Keep your device charged and ready to go.
Step 1: Connect Avive AED to an Avive USB Power Adapter
To use the AED in Backup Power Mode, you must keep the
device connected to an Avive USB Power Adapter with an
Avive USB Charging Cable for the duration of the emergency.
Step 2: Power On & Follow Instructions
Wait a few seconds after connecting to the power source
and then pull the Red Tab or press the Power Button to
power on the Avive AED. Once powered on, the AED will
provide instructions as detailed in “Section 5.A. - Using the
Avive AED in an Emergency.”
NOTE: When in Backup Power Mode the device may take several seconds to initially power on.

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E. Accessing & Sharing Event Data
The Avive AEDä stores data gathered during emergency use of the product and automatically transfers the
data to Avive Solutions, Inc. once it establishes a network connection.
Event data can be accessed after emergency use of the Avive AED by visiting www.avive.life/Event-Data
F. Training Mode
Install an Aviveä Training Cartridge to switch the Avive AED to Training Mode. Training Mode allows a user to
practice using the Avive AED in a training environment.
When a Training Cartridge is installed, there is no electrical connection between the training pads and the
Avive AED. In Training Mode, the Avive AED provides audio instructions as if it were being used in an
emergency, however, the device will not actually analyze a heart rhythm or deliver defibrillation therapy.
Audio instructions are for user training only.
Download the Avive App to a smartphone and install an Avive Training Cartridge to get started training with
the Avive AED.
For more information, visit www.avive.life/AviveAED/Training
CAUTION – The Training Cartridge is for training only and cannot deliver therapy. It is recommended that the
Avive AED is stored with an Avive Pad Cartridge installed.

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6. Device Readiness
A. Device Self-Tests
The Avive AEDä performs daily, weekly, and monthly internal self-tests to check device readiness. The Avive
AED indicates device readiness via the Status Light [See Section 6B] and Speaker [See Section 6D].
B. Status Light
The color of the Status Light indicates the functionality status as illustrated below. The flashing behavior
indicates the battery charging state.
The status of the Avive AED should be checked periodically to ensure it is ready for emergency use. In addition
to checking the Status Light on the Avive AED, the device status may also be checked through a variety of
compatible Aviveä products. For the full list of supported compatible products, visit www.avive.life/products.
Ready to Use
If the Status Light is blinking green, your device is ready to
use in an emergency.
Device Needs Attention!
If the Status Light is blinking red, or the device is beeping,
then your device needs attention! Press and hold the Power
Button for 5 seconds and the Avive AED will tell you what is
wrong.
Ready to Use
Needs Attention
Battery
Charging
Status Light blinks once every
second
!"#$%&'(1s
!"#$%&'(1s
Battery
Fully Charged
Status Light quickly blinks twice
every 10 seconds
!"#$%&'(10s
!)*+,-./10s
Battery
Not Charging
Status Light blinks once every
10 second
!"#$%&'(10s
!)*+,-./10s

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C. Checking Status
To check the status of your Avive AEDä, press and hold the Power Button on the device for 5 seconds. The
device will verbally tell you its status.
D. Speaker
The Avive AED will periodically produce audible beeps when the device determines that it needs attention.
When cartridges are installed or removed from the Avive AED, it will provide an audible announcement.
7. Troubleshooting
If your device’s Status Light is blinking red and/or beeping, press and hold the Power Button on the device for
5 seconds. The device will verbally tell you what is wrong.
Battery Low – The Avive AED has a rechargeable battery, and over time the device’s battery will drain
if it is not connected to a charger. As soon as the Avive AED indicates that it has a low battery, the
device should be connected to the Aviveä USB Power Adapter with the Avive USB Charging Cable to
recharge.
Important: The Avive AED is still safe to use with a Low Battery. A charged AED should be
used if available.
Pad Cartridge is:
• Expired – If the Pad Cartridge is expired it will need to be
replaced. The expiration date can be found on the back of
the Pad Cartridge.
• Previously Used – Once the packaged pads have been
opened the Pad Cartridge will need to be replaced.
• Not Installed – A Pad Cartridge must be installed to
operate the Avive AED. If there is a Training Cartridge, no
cartridge, or an invalid cartridge installed, the device will
not be ready for use.
[See Section 8B to learn how to replace the Pad Cartridge]
Extreme Temperatures – If the AED is too hot or too cold it cannot operate. Only store and operate
your device in the recommended environmental conditions. [See Section 9]
Device Not Operable – In the unlikely case that the Avive AED self-diagnoses a device
malfunction you should contact Avive Customer Support immediately to resolve the issue.

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A. Troubleshooting Guide
Issue
Possible Causes
Solutions
Status Light or periodic
beeping indicates that
the AED Needs Attention
Battery is Low
The AED requires charging. Refer to the Maintenance section
[Section 8A] on how to charge your AED.
Pad Cartridge is expired
The Pad Cartridge needs to be replaced. Contact Avive for a
replacement Pad Cartridge
Pad Cartridge has been used
The Pad Cartridge needs to be replaced. Contact Avive for a
replacement Pad Cartridge.
Training Cartridge is installed
The Training Cartridge is for training only and cannot deliver
therapy. When training is complete, install a new or unused Pad
Cartridge.
No cartridge is installed
Install a Pad Cartridge.
Invalid Cartridge is installed
Install a valid Pad Cartridge. Only use Aviveä Pad Cartridges.
Failed Self-Test
Refer to the Checking Status section [Section 6C] to help
determine which tests failed.
AED outside operating
temperature limits
Move your device to the allowable operating range of 0°C – 50°C
for at least 24 hours to ensure proper operation.
AED is not Charging [See
Section 6B for battery
charging states]
AED outside battery charging
temperature limits
Move your device to the allowable battery charging temperature
range of 0°C – 45°C for at least 1 hour.
Power Adapter or Charging Cable
disconnected.
Check to make sure the Charging Cable is firmly plugged into the
Power Adapter, that the Power Adapter is completely plugged
into an outlet, and that the Charging Cable is fully inserted into
the Charging Port.
Power Adapter or Charging Cable
damaged.
Do NOT use Power Adapters or Charging cables with visible
damage. Contact Avive for replacement components.
Device is unresponsive:
• No Status Light blinking
• No audio when the Power
Button is pressed or
when Red Tab is pulled
• Power Button is not
backlit when pressed
Battery has been discharged
The AED may require charging. Refer to the Maintenance section
[Section 8A] on how to charge your AED.
The AED has been stored in an
extremely cold or hot
environment.
As a safety measure, the AED shuts down when stored outside
of the allowable Storage Conditions. Move your device to the
allowable operating range of 0°C – 50°C for at least 24 hours.
The AED has been damaged and
is inoperable.
Contact Avive to resolve the issue.

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8. Maintenance
A. Charging the Avive AEDä
Connect the Aviveä USB Power Adapter to the Avive AED with the Avive USB Charging Cable to recharge the
device. See Section 6B on the Status Light to check that your device is charging.
1) Connect the Avive USB Power Adapter to the Avive USB Charging Cable.
2) Plug the Avive USB Power Adapter into an outlet.
3) Plug the USB Charging Cable into the Avive AED.
IMPORTANT: The Status Light may blink green or red when the device is in any of its charging states to indicate
its functionality status. To determine which charging state the device is in, pay attention to the frequency that
the Status Light blinks [See Section 6B].
CHARGING TIPS:
• The best way to prevent a low battery is to store the
Avive AED in room temperature conditions, connected to
the Avive USB Power Adapter with the Avive USB
Charging Cable.
• After you’ve connected the Avive AED to the charger,
make sure the device is charging or fully charged.
Caution – Only use Avive approved charging accessories to charge the Avive AED.
For more information on available charging accessories approved for use in charging the Avive AED visit
www.avive.life/AviveAED/accessories