Avive P210015C Automated External Defibrillator System User Guide

Avive P210015C Automated External Defibrillator System User Guide

Introduction

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.

Initial Device Setup

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]

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.

SECTION 2 Getting to Know the Avive AED

• A. 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.

• 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 4.1]

• 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 4.2]

• 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 5.1 – 5.3 to learn more about the Status Light]

• 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 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.

• 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 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.

SECTION 4 When to Use the Avive AED

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.

What is Cardiac Arrest?

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.

Using the Avive AED

Using the Avive AED in an Emergency

Step 1: Pull the Red Tab
Step 2: Apply Pads determine exact age and/or weight.
Step 3: Stand Back – Automated Analysis & Treatment

Using the Avive AED in an Emergency

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.

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.

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 AED 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.

• 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.

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 AED will automatically analyze the patient’s heart rhythm to diagnose whether or not a defibrillation The Avive AED will instruct you when to stop CPR so that 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

• 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.

IMPORTANT: The Avive AED will provide you audible instructions and stop flashing the Stand Back Lights when it is safe to touch the patient

Spanish Mode
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.

Backup Power 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.

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 4.1 – Using the Avive AED in an Emergency”.
  NOTE: When in Backup Power Mode the device may take several seconds to initially power on.

Device Maintenance

Checking Device Readiness

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.

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.

Red Status Light, Device is Beeping (Maintenance Required)

To find out why your device’s Status Light may be 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 Avive 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 5.4 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 6] 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.

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.

Recharging the Avive AED

Connect the Avive USB Power Adapter to the Avive AED with the Avive USB Charging Cable to recharge the device.
IMPORTANT: The Status Light may blink green or red when the device is in any of its charging states to indicate its functionality status (See Section 5.1). To determine which charging state the device is in, pay attention to the frequency that the Status Light blinks

Different charging states for the device:

Replacing the Avive Pad Cartridge

Removing a Pad Cartridge

IMPORTANT: Replace the pad cartridge if it’s expired, previously used, or the sealed pad package has been opened. (See Section 5.2)

1. Firmly pull back and lift up on both snaps on the back of the device to release the cartridge.

TIP: The Avive AED will verbally confirm once it senses that a new Pad Cartridge is correctly installed.

Installing a New Pad Cartridge

1. Install a new Pad Cartridge by first aligning the cartridge with the back of the AED. Push the cartridge firmly into the recess
   on the back of the AED.

2. IMPORTANT: Press down firmly on the corners of the cartridge. Make sure the cartridge is fully inserted around all sides of the
   AED.

Operating & Storage Conditions

Operating Conditions

The Avive AED should only be used in the following environmental conditions:

installed) – dust protected, splash and spray proof.
IMPORTANT: Do not expose the Avive AED to any liquids or dust when a Pad Cartridge is not installed.

Storage Conditions

It is important the Avive AED be stored within the following environmental ranges.
If the device is stored outside these ranges, then the device may be damaged and no longer functional for emergency use.

60ºC)
Humidity| 5 – 95% non-condensing
Altitude| -280 ft. to 15,000 ft. (-85 m to 4572 m)

IMPORTANT: If the device has been stored outside of 0ºC-50ºC, then it should be returned to ambient temperature for at least 24 hours.

STORAGE TIP:
To keep your device healthy and looking good, store it:

• In a clean and dry place
• At room temperature
• Out of direct sunlight

Customer Support

Address Avive Solutions
223 Mississippi Street, Suite 2 San
Francisco, CA 94107
Phone 1-800-489-4428
Email Sales: sales@avive.life
Medical Device Reporting: reporting@avive.life
Support: support@avive.life
Website www.avive.life

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