Avive AED User manual

Avive AED™
Quickstart Guide
IFU-00132 Rev B
™

Avive Contact
Address Avive Solutions
185 Valley Drive
Brisbane, CA 94005
Phone [phone]
Email Sales: [e-mail]
Medical Device Reporting: [e-mail]
Support: [e-mail]
Website www.avive.life

Welcome! We are here to guide you
through the process of using the Avive
AED™ to save a life.
NOTE: This guide only provides a brief overview of the Avive AED.
Users responsible for the care & maintenance of the Avive AED
should familiarize themselves with the deployment, operation, and
maintenance of the Avive AED by reviewing the Avive AED Owner’s
Manual available at www.avive.life/manuals.
Para obtener la versión en español del Manual del Dueño de Avive
AED, consulte la siguiente página web: www.avive.life/manuals/
1

Giving you
the power to
save lives.
2

16
Table of Contents
21
22
4
1 Initial Device Setup
62Getting to Know the Avive AED™
83When to Use the Avive AED™
94 Using the Avive AED™
8
Indications for Use
3.1
83.2 What is Cardiac Arrest?
4.2 Spanish Mode
9
4.1 Using the Avive AED™ in an Emergency
Red Status Light, Device is Beeping (Maintenance Required)
5.2
5.3 Recharging the Avive AED™
5.4 Replacing the Avive™ Pad Cartridge
185 Device Maintenance
19
6Operating & Storage Conditions 24
174.3 Backup Power Mode
18
Checking Device Readiness
5.1
3

After you’ve followed the steps above, your device
should be ready to help save a life!
Step 1: Remove the Avive AED™ 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 Avive™ USB Power Adapter with the
Avive USB Charging Cable to charge the battery. [See Section 5.3]
SECTION 1
4SECTION 1  INITIAL DEVICE SETUP
Initial Device Setup

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.
5SECTION 1  INITIAL DEVICE SETUP

H
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Getting to Know the Avive AED™
SECTION 2
6SECTION 2  GETTING TO KNOW THE AVIVE AED

Red Tab
Pull the Red Tab to access the packaged pads
in the Pad Cartridge, and activate the Avive
AED™ for use. [See Section 4.1]
IMPORTANT: Only pull the Red Tab in an
emergency. If the packaged pads have been
opened the Pad Cartridge will need to be
replaced.
Power Button
Press the Power Button to turn on
or turn off the Avive AED.
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 4.1]
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 4.2]
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 5.1 - 5.3 to
learn more about the Status Light]
D
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A
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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 5.4
for how to replace the Pad Cartridge]
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.
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.
Speaker
The Avive AED provides audio instructions and
notifications during use through this speaker.
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 recharge the
AED. [See Section 5.3 for how to recharge
the device]
IMPORTANT: Use the Avive™ USB Power
Adapter and Avive USB Charging Cable for
guaranteed charging performance.
H
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7SECTION 2  GETTING TO KNOW THE AVIVE AED

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.
3.2 – What is Cardiac Arrest?
3.1 – Indications for Use
Cardiac arrest is when the heart unexpectedly and suddenly stops pumping blood to the body,
and it is 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.
SECTION 3
8SECTION 3  WHEN TO USE THE AVIVE AED
When to Use the Avive AED™

SECTION 4
Step 1: Pull the Red Tab
Step 2: Apply Pads
Step 3: Stand Back - Automated Analysis & Treatment
4.1 – Using the Avive AED in an Emergency
9
SECTION 4  USING THE AVIVE AED
Using the Avive AED™
Continue on to next page for directions on
how to use the Avive AED in an emergency.

Step 1:
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.
Pull the Red Tab
4.1 – Using the Avive AED™ in an Emergency
10 SECTION 4  USING THE AVIVE AED

Child Mode:
For Children Press the Child Button.
The Avive AED 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.
4.1 – Using the Avive AED™ in an Emergency
11
SECTION 4  USING THE AVIVE AED

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.
Adult Child
Apply the pads to the patient’s bare skin. Placing the pads
correctly on the patient’s bare skin is crucial for the Avive
AED to correctly analyze and treat the patient.
Step 2:
Apply Pads to Patient
4.1 – Using the Avive AED™ in an Emergency
12 SECTION 4  USING THE AVIVE AED

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 & 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
4.1 – Using the Avive AED™ in an Emergency
13
SECTION 4  USING THE AVIVE AED

A. Heart Analysis
Once the pads are placed on the patient’s
bare skin, stand back and do not touch the
patient. The Avive AED will automatically
analyze the patient’s heart rhythm to
diagnose whether or not a defibrillation
shock is needed.
IMPORTANT: The Avive AED will provide you audible instructions and stop flashing the
Stand Back Lights when it is safe to touch the 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
!DO NOT TOUCH PATIENT
!
Step 3:
Stand Back - Automated Analysis & Treatment
4.1 – Using the Avive AED™ in an Emergency
14 SECTION 4  USING THE AVIVE AED

C. Perform CPR
After automated analysis and treatment (if needed),
the Avive AED will 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.
CPR Steps (Child)
CPR Steps (Adult)
4.1 – Using the Avive AED™ in an Emergency
15SECTION 4  USING THE AVIVE AED

The Avive AED™ comes equipped with an easily accessible Spanish Mode. Spanish
Mode is intended for users who prefer to receive audio instructions in the Spanish
Language. In Spanish Mode the Avive AED will provide all audio instructions in
Spanish.
Upon power on, the Avive AED will default to English Mode. To switch to Spanish
Mode press the Español Button, as indicated. Once the Avive AED has switched to
Spanish Mode, the Español Button will light up and the device will begin providing
audio instructions in Spanish.
To switch back to English Mode, press the Español Button again.
16 SECTION 4  USING THE AVIVE AED
4.2 – Spanish Mode

How to use the Avive AED™ 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 Avive™ USB Charging Cable and Avive Power Adapter to
be used in an emergency.
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.
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.
NOTE: When in Backup Power Mode the device
may take several seconds to initially power on.
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 4.1 - Using the Avive AED in an
Emergency”.
17SECTION 4  USING THE AVIVE AED
4.3 – Backup Power Mode

The Avive AED™ performs daily internal self-checks and will indicate via the Status Light if any
maintenance is required. The color of the Status Light indicates the functionality status as
illustrated below. The flashing behavior indicates the battery recharging state (See Section 5.3).
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 Avive™ products. For the full list of
supported compatible products, please see www.avive.life/products.
5.1 – Checking Device Readiness
Continue to learn how to
resolve device issues.
If the Status Light is blinking green, your device is
ready to use in an emergency.
Ready to Use
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.
Device Needs Attention!
18 SECTION 5  DEVICE MAINTENANCE
Device Maintenance
SECTION 5