VIVEST PowerBeat M Series Automated External Defibrillator User Manual

August 1, 2024
VIVEST

PowerBeat M Series Automated External Defibrillator

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Specifications:

  • Product Name: PowerBeat M Series Automated External
    Defibrillator

  • Manufacturer: ViVest Medical Technology Co., Ltd.

  • Intended Use: External defibrillation in patients with
    suspected cardiac arrest who are unresponsive, non-breathing, and
    pulse-free

  • Age Suitability: Adult mode for patients not younger than 8
    years old, Child mode for patients under 8 years old or weighing
    less than 25kg

Product Usage Instructions:

Before Use:

Thank you for purchasing the PowerBeat M Series Automated
External Defibrillator. Please read the manual carefully before use
and keep the device easily accessible after use.

Indication of Use:

The defibrillator should be applied when the patient is
unconscious, not breathing or has abnormal breathing, and is
unresponsive.

Contraindication of Use:

The defibrillator should not be used if the patient is
conscious, breathing, or has a detectable pulse or other sign of
circulation.

Intended User:

The device is intended for use by rescuers and emergency care
personnel who have completed training and certification
requirements applicable to the use of a defibrillator where the
operator controls delivery of shocks to the patient.

Service Requirements:

Service personnel must be authorized by the manufacturer,
trained and qualified, and have a full knowledge and understanding
of the contents of the manual.

FAQ:

Q: Can the defibrillator be used on conscious patients?

A: No, the defibrillator should only be used on unconscious
patients.

Q: How often should the pads be checked?

A: The pads should be checked regularly as part of maintenance,
refer to the manual for detailed instructions on maintenance
procedures.

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PowerBeat M Series Automated External Defibrillator
User Manual
ViVest Medical Technology Co., Ltd.

Before Use
Thank you for purchasing the PowerBeat M Series Automated External Defibrillator. Please read this manual carefully before use. Please keep the device for easy access after use. Version: 1.0 Date: 2023.09.11
Manufacturer
ViVest Medical Technology Co., Ltd. Unit 205, 206, 207, B1 Building, SIP BioBay, No.218, Xinghu Street, Suzhou Industrial Park, Suzhou Area, Suzhou Free Trade Pilot Zone, Jiangsu, China. TEL: +86-0512-65730937 FAX: +86-0512-65730937 Email: service@vivest.cn
Authorized EC Representative Shanghai International Holding Corp. GmbH (Europe)
Add: Eiffestrasse 80, 20537 Hamburg, Germany Tel: +49-40-2513175 Fax: +49-40-255726 E-mail: shholding@hotmail.com
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Copyright and Statement
This manual applies to the PowerBeat M Series Automated External Defibrillator. The copyright of this manual is owned by ViVest Medical Technology Co., Ltd. (Hereinafter called “VIVEST”). No organization or individual may reproduce this manual or any of its contents in any form without the company’s permission. The company does not assume any responsibility for any injury caused by failing to follow the instructions, precautions, warnings, or usage instructions in this manual. The copyright of the software in this product is owned by VIVEST. This software is protected by copyright laws and international treaty provisions that apply throughout the world. Without the permission of the company, any organization or individual may not copy, decompile, reverse engineer, or disassemble this software into a form that people can understand. VIVEST reserves the right to own the software. For information concerning any of our products, please contact VIVEST.
Conventions
This manual uses the following conventions: Within text, the name and labels for physical buttons and softkeys appear in boldface type (for example, “Press the Shock button”). This manual uses italics for audible prompts (for example, “Don’t touch patient, Analyzing”).
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Content
General Introduction ……………………………………………………………………………………………….. 1 Indication of Use ……………………………………………………………………………………………………………… 1 Contraindication of Use ……………………………………………………………………………………………………. 1 Intended Use ……………………………………………………………………………………………………………………1 Intended User …………………………………………………………………………………………………………………. 1 Product Features …………………………………………………………………………………………………………….. 1 Product Limitations ………………………………………………………………………………………………………….. 2
Safety Precautions ………………………………………………………………………………………………….. 3 Classification of Warning Messages ………………………………………………………………………………….. 3 Precaution Information …………………………………………………………………………………………………….. 3 Placement of the Device ……………………………………………………………………………………………………5
Installation and Preparation ……………………………………………………………………………………..7 Unpacking ………………………………………………………………………………………………………………………. 7 Control Panel ………………………………………………………………………………………………………………….. 7 Install the Battery …………………………………………………………………………………………………………… 10 Remove the Battery ……………………………………………………………………………………………………….. 10 Charge …………………………………………………………………………………………………………………………..11 Preconnect the Pads ……………………………………………………………………………………………………….11 Self-test System ……………………………………………………………………………………………………………..12
Use Automated External Defibrillator …………………………………………………………………….. 14 Brief operation steps ……………………………………………………………………………………………………….14 Turn on the Device ………………………………………………………………………………………………………… 14 Apply Pads …………………………………………………………………………………………………………………….15 To apply pads: ………………………………………………………………………………………………………………..15 Cardiac Rhythm Analysis …………………………………………………………………………………………………17 Shock Advised ………………………………………………………………………………………………………………. 18 No Shock Advised …………………………………………………………………………………………………………..18 Perform CPR ………………………………………………………………………………………………………………….19 Operation After Use ……………………………………………………………………………………………………….. 20 Pediatric Treatment …………………………………………………………………………………………………………20
Maintenance and Troubleshooting ………………………………………………………………………… 21 Regular Maintenance …………………………………………………………………………………………………….. 21
Check Pads ……………………………………………………………………………………………………………. 21 Check Status Indicator …………………………………………………………………………………………….. 22 Check Integrity and Cleanliness ……………………………………………………………………………….. 22
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Check Battery …………………………………………………………………………………………………………. 22 Cleaning ………………………………………………………………………………………………………………….22 Transport ……………………………………………………………………………………………………………………….22 Disposal ……………………………………………………………………………………………………………………….. 22 Troubleshooting …………………………………………………………………………………………………………….. 23 Cybersecurity …………………………………………………………………………………………………………25 Network Environment …………………………………………………………………………………………………….. 25 Data Interface ……………………………………………………………………………………………………………….. 25 User Access ………………………………………………………………………………………………………………….. 25 Data Exchange Method ………………………………………………………………………………………………….. 26 Bluetooth Transmission …………………………………………………………………………………………….26 4G Transmission …………………………………………………………………………………………………….. 26 Device Security Software ……………………………………………………………………………………………….. 26 Cyber Security Update …………………………………………………………………………………………………… 26 AED Data Storage …………………………………………………………………………………………………………. 26 ViBest-AED Data Management System …………………………………………………………………………… 27 Appendix 1 Accessories ……………………………………………………………………………………………. A Appendix 2 Symbols …………………………………………………………………………………………………. B Appendix 3 Glossaries ………………………………………………………………………………………………. F Appendix 4 Specifications ………………………………………………………………………………………….H Appendix 5 Defibrillation Waveform ……………………………………………………………………………L Appendix 6 ECG Analysis System …………………………………………………………………………….. N Appendix 7 EMC Guide ……………………………………………………………………………………………… P
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General Introduction

Indication of Use
PowerBeat M Series Automated External Defibrillator should be applied only when the patient has the following symptoms at the same time:
Unconsciousness Not breathing or abnormal breathing Unresponsiveness

Contraindication of Use
PowerBeat M Series Automated External Defibrillator can not be use if the patient: Is conscious, Is breathing, or Has a detectable pulse or other sign of circulation

Intended Use
The device is intended to be used for external defibrillation in patients with suspected cardiac arrest who are unresponsive, non-breathing, and pulse-free. Adult mode is suitable for patients who are not younger than 8 years old, and child mode is suitable for patients under 8 years old or weighing less than 25kg.
This product is intended for use in public or medical settings by qualified personnel trained in the use of CPR and AED, or by medical personnel who have received basic life support/advanced life support Use under the guidance of the central dispatcher.

Intended User
The device is intended to be used by rescuers and emergency care personnel who have completed training and certification requirements applicable to the use of a defibrillator where the operator controls delivery of shocks to the patient.
Service personnel must be authorized by the manufacturer, trained and qualified, and have a full knowledge and understanding of the contents of this manual.

Product Features

The PowerBeat M Series Automated External Defibrillator is divided into 2 models, PowerBeat M1 and PowerBeat M3 (Hereinafter referred to `the device’). The 2 models have similar functions except below the following:

Model

PowerBeat M1

PowerBeat M3

Function Button

Child Button

PowerBeat M1 supports 4 operating modes: Standby mode, Rescue mode, Continuous VF/VT recognition mode, and Maintenance mode.
PowerBeat M3 supports 3 operating modes: Standby mode, Rescue mode and Maintenance mode
The mainly used functions and features of the device are shown as follow:

1

Function

Model

Voice and Light Guidance

Heart Rhythm Analysis

Defibrillation

Self-test System

Continuous VF/VT Recognition Function

Volume Control

Child Mode (under 8 years old or weighing less than 25kg)

Record

Data Transmission

PowerBeat M1

PowerBeat M3

Product Limitations
The device is an infrequently-used device, it has certain limitations as outlined below:
Routine maintenance is needed to ensure the device is ready for use. See Chapter 5 for details.
This device is not intended for use in patients with implanted and activated ICDS. This device should not be used in an MRI environment.

2

Safety Precautions

Classification of Warning Messages
Warning Messages are generally divided into 3 categories, as described below:

Danger

Warning statements alert you to conditions or actions that can result in personal injury or death.

Warning

Indicates potential risks or risks caused by unsafe operations,which could result in personal injury or property damage if not avoided.

Caution

Used to emphasize instructions or reminders so that users can operate this device safely.

Precaution Information
Danger

  1. The device comes out with high voltage during defibrillation and may cause severe personal injury or even death. Therefore, defibrillation should be performed by a professionally trained layperson.
  2. Components replacement can only be performed by the manufacturer. Other personnel must not attempt to open the shell to repair the device and replace components. Otherwise, there is a risk of electric shock.
  3. Do not disassemble or modify the device without the manufacturer’s authorization, or it may lead to personal injury or even death.
  4. Nobody should touch the patient during defibrillation, and other MEDICAL EQUIPMENT which has no DEFIBRILLATION-PROOF insulation should be disconnected from the PATIENT during defibrillation.
  5. During defibrillation, move away from the patient and remove all metal equipment connected to the patient, failure to do so may result in an electric shock.
  6. There may be a danger of electric shock or personal injury if the defibrillation energy is not released normally.
  7. To prevent fire or explosion, do not use the device in an environment with flammable gases or concentrated oxygen.
  8. Be sure not to charge the disposable battery. Charging the disposable battery may cause a fire or explosion. When charging the rechargeable battery, be sure to use a dedicated charger.
  9. Do not burn or incinerate the battery. Burning or incinerating the battery may cause a fire or explosion.
  10. Do not perform maintenance on the device during use.
  11. Do not remove the battery when the device enters rescue mode or when the device is placed in public places.
  12. Improper operation may cause the battery to heat up, catch fire, or explode. Please read the warnings carefully before using rechargeable batteries.

3

  1. If you find that the battery leaks or gives off a bad smell, stay away immediately. If the electrolyte leaks into the skin or clothing, wash it immediately with water. If the electrolyte seeps out and gets into your eyes, do not rub your eyes, wash them immediately with clean water and see a doctor.
  2. In order to ensure the expected life of the battery, if the rechargeable battery is not used for a long time, please charge the rechargeable battery at least every three months.
  3. When the battery reaches its expiration date, or when the battery is found to be smelly, deformed, discolored or distorted, the battery should be stopped from being used and disposed of in accordance with local regulations.
    Warning
  4. The defibrillation can only be performed by those technicians who are professionally trained and familiar with the operation of the device.
  5. Ensure the device is carefully placed to avoid damage to the pads or device, or injury to the patient or operator during use.
  6. To prevent the device from falling or dropping, the device should be placed and affixed in a position that prevents it from falling or dropping. If the device falls or is dropped, it must be checked immediately for any damage.
  7. Do not use expired or dry pads as they will not completely adhere to the skin.
  8. Do not repeatedly or rapidly charge and discharge the device except as necessary during the rescue. If the device test requires repeatedly internal discharges, wait at least one minute after every 3 discharges.
  9. Do not connect the pads to other pads or metal objects in contact with the patient, for the conductive gel coating on the pads may stick to other objects. It is recommended to keep a distance of at least 5cm. Defibrillation with an insufficient conductive gel may cause a skin burn.
  10. Before defibrillation, shave body hair from the patient’s chest if necessary. Excessive body hair may cause skin burns.
  11. Do not wipe the patient’s skin with alcohol. Alcohol will dry the skin and cause skin burns.
  12. If the patient has an implanted pacemaker, do not place the pads directly near the implanted pacemaker.
  13. Do not use the device if the device has been soaked with liquid or lots of water on the surface. The conductive part of the device must not be in contact with other conductive parts (including the ground).
  14. To avoid accidental electric shock, no functional examination may be performed when the device is connected to the patient.
  15. Do not use alcohol or other solutions to soak or clean the pads. This may damage the pads and cause the device to malfunction.
  16. Moving or carrying the patient during heart rhythm analysis can cause diagnostic delays or errors.
  17. Pads should adhere to a flat skin surface instead of the folded skin surface. If the pads are not placed in the right place, it will affect the heart rhythm analysis and may cause wrongful defibrillation.
  18. When using the device, the operator must keep the PATIENT’s body (such as exposed skin or head and limbs) away from touching conductive fluids (such as gel, blood, or saline) and metal objects (such as a bed frame or a stretcher), to prevent alternate pathways for the defibrillation
    4

current.
16) Do not place the device near an apparatus that emits strong Radio- Frequency(RF) signals. Radiofrequency emissions cause incorrect analysis of the heart rhythms.
17) Use pads, batteries, and other accessories provided by VIVEST only. The company is not responsible for any problems caused by the use of components not approved by VIVEST.
18) The device cannot work if the battery is flat and/or uninstalled. Replace the battery immediately if the device is detecting low battery power or the battery is overdue for replacement.
19) If the device is taken out from the highest storage temperature or the lowest storage temperature and put into use immediately, the performance of the device may differ from expectations. The device must not be stored or used outside of the environmental limits specified in this manual.
20) Improper operation may cause runtime errors. Please follow this manual strictly.
21) Only the service personnel should configure the device to use Bluetooth. The use of Bluetooth will not result in any risk to the device or its use.
22) When the status indicator of the device is found to be off, the service personnel should try to replace the battery to return the device to normal.
23) Be sure not to touch the patient during defibrillation, or it may cause a risk of electric shock.
Caution:

  1. If any damage occurs to the device, please contact the manufacturer for repair. 2) Please pay attention to all caution and warning signs on the device and accessories. 3) If the device is stored, transported, or used outside the limited environment range, the
    performance in this user manual may not be achieved.

  2. The device can be expected to be operated under 50°C, but it is recommended to use under 40°C to avoid burning patients.

  3. It is recommended to provide at least one extra battery for each device available in a public place.
    Placement of the Device
    The device can be fixed or carried according to user needs:
    When fixed, the device should be placed around emergency equipment (such as fire extinguishers, first aid kits, etc.) at a suitable temperature, and keep away from moisture and dust. To ensure correct placement of the device:

  4. The ambient temperature at which the device is placed should be between 0°C and 50°C (long term placement). Severe fluctuation of the ambient temperature may significantly shorten the battery’s service life and affect the performance of the pads.

  5. It should be stored in a dry place with a relative humidity of 5% to 95%.

  6. It should be stored away from any direct sunlight. Long-time exposure to direct sunlight will accelerate the aging of the device.

  7. To avoid the blockage of the speaker, the device should not be placed in an environment with lint or dust.

  8. Do not place the device near a strong magnetic field.
    When carrying, the device shall be equipped with specialized portable package, and follow the below contents:
    5

  9. The environment temperature should be at 0°C to 50°C, relative humidity environment should be in 0% to 95%, temperature or humidity out of scope may shorten the service life and performance of AED. 2) When carrying, do not close to strong magnetic field.
    6

Installation and Preparation
This chapter mainly introduces the components and appearance structure of the device, the functions of the buttons and indicators of the control panel, and the installation of key components.
Unpacking
To ensure the integrity of the device, carefully take out all components from the packaging case and follow the steps below to check the device: 1) Check the intact of the device shell. 2) Check whether the pads pre-connect to the device. 3) Check the seal and expiration date of the pads. 4) Check the expiration date of the battery.
Control Panel
The PowerBeat M1 control panel is shown below: C

The graphic description:

Figure III- 1 PowerBeat M1 control panel

Name

Description

A: Power Button B: Status Indicator

In standby mode, press the power button to enter rescue mode.
In rescue mode, press the power button for at least 2 seconds to return to standby mode.
Indicates the current status of the device: Green light flash shows that the device is in standby mode and
ready to use. Red light flash shows that the device fails to pass the self- test
and needs maintenance. Green lights steady shows that the device is in use. Light off shows that the battery is not installed or the device is in
abnormal situation.

7

Name
C: Pads Indicator
D: Heart Rhythm Analysis Indicator
E: Shock Button
F: Shock Indicator G: CPR Indicator
H: Function Button
I: Volume Indicator J: Continuous VF/VT Recognition mode Indicator K: Speaker L: Battery M: Pads Cable Connector N: Pads Storage Box O: Microphone

Description Indicates the status of pads connection: Light off shows that the pads are connected normally. Red light flash shows that the pads are not connected or
connected abnormally. Indicates the status of heart rhythm analysis: Green light flash shows that the device is analyzing heart
rhythm. Light off shows that the device is not in analyzing stage.
Press the shock button to deliver defibrillation energy after the charge is finished.
Orange light flash to guide operators to press shock button when charge is finished.
Indicates the device is in the CPR stage.

  1. Adjust the volume. Press the function button less than 1 second to switch the maximum volume and minimum volume to each other. 2) Switch the mode. Press the function button for at least 3 seconds to switch rescue mode and continuous VF/VT recognition mode to each other.
    Blue lights steady indicates that the volume of the device is minimum.
    White lights on indicates that the device is in continuous VF/VT recognition mode.
    Sends voice prompts and beep sounds.
    Supply power to the device.
    Pads connect to the host through the connector.
    To store the pads.
    Used optionally to record audio during rescue.

The PowerBeat M3 control panel is shown below:

8

The graphic description:

Figure III- 2 PowerBeat M3 control panel

Name

Description

A: Power Button

In standby mode, press the power button to enter rescue mode.
In rescue mode, press the power button for at least 2 seconds to return to standby mode.

B: Status Indicator
C: Pads Indicator D: Heart Rhythm Analysis Indicator E: Shock Button

Indicates the current status of the device: Green light flash shows that the device is in standby mode and
ready to use. Red light flash shows that the device fails to pass the self- test
and needs maintenance. Green lights steady shows that the device is in use. Light off shows that the battery is not installed or the device is in
abnormal situation. Indicates the status of pads connection: Light off shows that the pads are connected normally. Red light flash shows that the pads are not connected or
connected abnormally. Indicates the status of heart rhythm analysis: Green light flash shows that the device is analyzing heart
rhythm. Light off shows that the device is not in analyzing stage.
Press the shock button to deliver defibrillation energy after the charge is finished.

F: Shock Indicator

Orange light flash to guide operators to press shock button when charge is finished.

G: CPR Indicator H: Child Button

Indicates the device is in the CPR stage.
If you need to enter the child mode, press this button, and the device will voice into the child mode. Please hold down the child button for 3 seconds, and hold down this button for 3 seconds to switch the device to the child mode.
(To return to the adult mode, the device should shut down and

9

Name

Description restart).

Flash blue indicates long press the child button to enter child mode. I: Child mode Indicator
Blue lights on indicates that the child energy is active.

J: Speaker

Send voice prompts.

K: Battery

Supply power to the device.

L: Pads Cable Connector

Pads connect to the host through the connector.

M: Pads Storage Box To store the pads.

N: Microphone

Used optionally to record audio during an incident.

Install the Battery
The device accepts the following battery: Disposable Battery (LiMno2) Rechargeable Battery (Li-ion)
To install the batetery: 1) Push the battery tail into the battery compartment. 2) Push the battery to the bottom of the battery compartment. 3) Finally, check whether the buckle of the battery is fully inserted into the battery slot.

Figure III- 3 Install the battery
After the battery is installed, the device will run self-test automatically. Refer to Chapter 3.6 for details.
Remove the Battery
When the `Low Battery’ prompt is indicated, please replace the battery immediately. After removing the battery, please wait for 30 seconds before installing new battery. To remove the battery: 1) Make sure the machine is in standby mode, if the device is in rescue mode, press the Power button for at least 2 seconds to enter standby mode.
10

  1. Press the battery buckle. 3) Immediately remove the battery.
    Figure III- 4 Remove the battery
    Charge
    The rechargeable battery is equipped with a dedicated battery charger that can hold two rechargeable batteries for charging at the same time. The battery charger is connected to the power supply and the battery is not inserted: The indicator flashes green slowly in the form of a breathing light. Battery charger failure: The indicator flashes red. Charging: The indicator light flashes green. Charge finished: The indicator lights green. The battery charger shows below:
    Figure III- 5 Battery charger
    Preconnect the Pads
    The pads are pre-connected when the device leaves the factory, but it is still necessary to check whether the pads connector is inserted properly before use. Before using, please check whether the pads package is in good condition and whether expired. If the package is damaged or the electrode is expired, please contact the dealer or manufacturer in time for replacement. When inserting the pads connector into the socket, be sure to insert tightly.
    11

Figure III- 6 Connect pads to the host

Warning

  1. Never use a damaged, wrinkled, and folded pads, or it may cause dangerous such as leakage current and unwanted burns on skin.
  2. Don’t reuse the disposable pads. Repeated use may cause performance degradation or cross infection.

Self-test System
The device performs the following self tests to verify unit integrity and its readiness for emergency use:
· User Self-test · Battery Installation Self -test · Power On Self-test · Periodic Self-test · Quick status check

User self-test Service personnel authorized by manufacturer can run user self- test if necessary.

Battery installation self-test
The device performs a self-test whenever batteries are installed. Then the device enters into the standby mode at the end of the battery installation self-test.
The status indicator blinks green in the standby mode shows that all the tests passed.
Otherwise, the status indicator flash red, with 5 times of Beep sound, to warning the operator or service personnel.

Power on self-test

The device performs a self test whenever the unit is turned on, this will notify the operator of any failures identified during the self-test.

If detected… Pads expired

Voice Prompt Pads Overdue

Pads connector not detected Battery expired

Plug in Pads Connector Battery Overdue

Device failure

Equipment Fail

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Battery is low Battery is about to run out

Low Battery Low Battery, replace battery immediately

Periodic self-test
Periodic self-test will be carried out daily, weekly, monthly, and quarterly. The default self-test configuration is weekly self-test, monthly self-test, and quarterly self-test. Service personnel can set daily self-test as required. The default period self-test time is 3 am.
Caution:

  1. Only in the standby mode when the battery is installed, the device will automatically detect at a preset time.
  2. If the device self-test result is normal, the operator can start rescue immediately.
  3. If the device self-test result is abnormal, contact the maintenance personnel or the manufacturer for repair.

Quick status check
In standby mode, the device supports a quick status check by pressing the Function button of PowerBeat M1 or the Child button of PowerBeat M3 to check whether the device is capable of emergency use.
If the check result is normal, the status indicator blinks green once.
If the check result is abnormal, the status indicator flashes red once, and the device emits three beacons.

13

Use Automated External Defibrillator
This chapter mainly introduces usage of the device. There are voice and indicator prompt during rescue.
Brief operation steps
Rescue Mode:
1. Press the Power button to turn on the device. 2. Remove any clothing from the patient’s chest and take out pads. 3. Attach the pads to the patient according to the figure instruction. 4. Operate according to the voice prompt:
If a shockable heart rhythm is detected, press the Shock button to defibrillate. If a non-shockable heart rhythm is detected, the device will enter CPR stage. 5. Perform CPR to patient.
Continuous VF/VT Recognition mode: (PowerBeat M1 Only)
1. When the device is in the CPR stage and the result of the last heart rhythm analysis is No Shock Advice, while the patient remains conscious (responsive, breathing and pulse), long press the Function button for > 3 seconds to enter the continuous VF/VT recognition mode
2. During continuous VF/VT recognition mode: If a shockable heart rhythm is detected, the device will switch to rescue mode and reanalyzes the rhythm. If the analysis result is `shock advised’, the device will charge to preset energy and defibrillate, and then enters CPR stage. If a non-shockable heart rhythm is detected, the device will re-analyze the rhythm. Press the Function button for at least 3 seconds, the device will switch to rescue mode.

Warning

  1. The use of this continuous VF/VT recognition pattern must be confirmed by a paramedic trained in its use in order to provide a nondiagnostic indication of shockable and non-shockable heart rhythm for patients who are responding to treatment and breathing normally, but may have discomfort in the cardiac area.
  2. In the continuous VF/VT recognition mode, the device continuously identifies the patient’s heart rhythm to evaluate whether the patient has a shockable or non-shockable heart rhythm. In this mode, someone needs to supervise the patient so that if the patient’s heart rhythm or health condition changes, the ambulance crew can effectively care for the patient.

Turn on the Device

Press the power button to turn on the device.

Step Action

Voice Prompt

1

Press the Power (Figure IV-1)

button

Call for help

14

Indicator
Status indicator light stays green during all the rescue process.

Figure IV- 1 Press the power button

Apply Pads

To apply pads:

Step Action

Voice Prompt

Indicator

Remove patient’s upper

body clothing. If necessary,

remove the patient’s chest

1

hair and dry the patient’s skin to ensure good contact

Remove clothing

between the electrode and

the patient’s skin. (Figure

IV-2)

2

Take out the electrode bag from the pads storage box at the bottom of the device, then tear open the package and take out the pads.

Remove Pads Package from Back of AED Tear open package, take out the pads

Pads Indicator flash red till the pads are applied properly.

(Figure IV-3)

Remove the liner of the

pads and apply the pads on

the exposed skin of the Remove Liner from Pads

3

patient according to the diagram. The position should be consistent with

Apply Chest

Pads

to

Patient’s

the diagram on the pads.

(Figure IV-4, Figure IV-5)

Figure IV- 2 Patient Preparations 15

Figure IV- 3 Open pads storage box
Figure IV- 4 Remove pads liner
When attaching the pads, firmly adhere to one side at first and then press it smoothly to the other side, make it completely attached to the skin to avoid air bubbles. Do this way for both two pads. Adults and children (PowerBeat M3 only) share the same pads, but it is attached to different parts of the patient’s body:
Attachment position of electrode on child body: Place one electrode in the middle of the chest between the nipples and the other in the middle of the back (anterior-posterior).
Attachment position of electrode on adult body: One of the electrodes was applied to the patient’s right chest and below the clavicle as illustrated, and the other electrode was applied to the patient’s left chest and above the rib in the maxillary line.
Those two positions are shown in the figure below:
16

Figure IV- 5 pads position on the patient

Warning

  1. The pads must be placed flat on the patient’s skin. Not doing so may lead to an incorrect heart rhythm analysis and wrongful defibrillation.
  2. Leaving bubbles between the pads and the patient’s skin when attaching the pads may result in burns.
  3. Make sure the pads have a good contact with the patient’s body, a poor contact might cause skin burns.

Cardiac Rhythm Analysis

While the pads are applyed:

Step Action

Voice Prompt

Indicator

The device will analyze

the patient’s heart

1

rhythm as long as the Don’t

Touch

Patient, Heart rhythm analysis

pads are attached to the Analyzing Heart Rhythm

indicator flash green.

patient correctly.(Figure

IV-6)

If the pads are not

2

attached analysis

properly, will

the be

Poor Pads Contact, Check Pads

Pads indicator flash red.

interrupted.

3

If signal interference is detected…

Eliminate signal interference

/

4

If motion interference is detected…

Keep Patient Still

/

17

Figure IV- 6 Cardiac Rhythm Analysis
At this point, nobody is allowed to touch the patient or pads. Keep the distance between the patient and the device about 10cm to 90cm, and the distance between the operator and the patient should be less than the distance of one arm.

Warning

Do not touch or shake the patient in the process of cardiac rhythm analysis, otherwise it will affect the result!

Shock Advised

While a shockable rehthm is detected:

Step 1

Action
If a shockable heart rhythm is detected…

Voice Prompt Shock Advised Do not Touch Patient, Charging Press Flashing Shock Button

Indicator
Shock indicator orange.

flash

2

Press

the

Shock Shock Delivered

button(Figure IV-7)

Begin CPR

Shock indicator turned off and CPR indicator flash green.

3

If the Shock button is not pressed within 30
seconds

Shock Button not Pressed, Shock Cancelled

Shock indicator turned off.

If the patient’s heart

4

rhythm turns into a nonshockable rhythm within

Heart Rhythm Shock Cancelled

Changed,

Shock indicator turned off.

30 seconds

Figure IV- 7 Press Flashing shock button
The device will detect the pads connection continually during charge process, it will stop charge and prompt the operator to check the pads connection if poor contact is detected. During the whole rescue process, please pay attention to the patient. If the patient wakes up, shut the device down immediately.
Warning Nobody should touch the patient during defibrillation!
No Shock Advised
18

While a non-shockable rhythm is detected:

Step 1

Action
If a non-shockable heart rhythm is detected…

Voice Prompt No Shock Advised Begin CPR

Indicator CPR indicator flash green

Perform CPR

After the defibrillation:

Step Action

Voice Prompt

Hands crossed and placed

on the patient’s chest, and

1

follow the beat sound for Beep…Beep…Beep…

chest compressions.(Figure

IV-8)

CPR indicator flash green

2

After 30 times of compress, give two breaths.

Breathe…Breathe

CPR indicator flash green

Stop CPR

CPR indicator turned off

3

After 2 minutes of CPR… Don’t Touch Patient, and heart rhythm analyze

Analyzing Heart Rhythm

indicator flash green.

Figure IV- 8 Start CPR
Adult mode contains 2 kinds of compression-to-ventilation ratio, while child mode contains 3 kinds of compression-to-ventilation ratio. Service personnel can modify the compression-to-ventilation ratio using the configuration software:

Mode

Compression-to-ventilation ratio

Adult mode

30:2 (Default) Only compression

Child mode

30:2 15:2 (Default) Only compression

When CPR is over, the device will reanalyze the patient’s heart rhythm.
19

Operation After Use
After using the device, perform the following steps: 1) Press the Power button for at least 2 seconds to enter the standby mode 2) Check the appearance of the device for damage or dirt. If technical support for damage is needed, please contact the manufacturer. If it is dirty, please clean it up, refer to Chapter 5 for details. 3) Dispose of disposable defibrillation electrodes in accordance with local regulations after use, and take out the new defibrillation electrodes (check expiration date), put it into the electrode box of the device. 4) In order to ensure that the device has sufficient power during the next usage, please check the battery power. If the battery power is low, please replace the battery (or charge the battery).
Pediatric Treatment
For patients less than 25kg (55 lb.) or under 8 years old, most of the patients who have cardiac arrests are not from cardiac problems. The rescue steps shown below: 1. Begin CPR, ask someone to call the emergency center and the nearest AED, and perform
CPR till get AED. 2. After obtaining AED, turn it on and press the child button to enter the child mode, the child
indicator light starts to flash, the device will issue a voice prompt “To enter the child mode, press the child button for 3 seconds”, press and hold the child button for 3 seconds, the device will send out The voice prompts “Child mode”. At this time, the device switches to child Mode. The child mode indicator light is always blue and the defibrillation energy decreases from 150J to 50J. 3. Remove the patient’s upper body clothing, expose the front chest and back, and place one electrode in the middle of the chest between the nipples and the other in the middle of the back. 4. Follow the voice prompts. If an electric shock is recommended, press the Shock button. Otherwise, the device will directly enter the CPR stage.
Caution: Do not miss the best first aid time just to determine the patient’s age. If the patient’s age cannot be determined, treat the patient in an adult mode.
20

Maintenance and Troubleshooting
This chapter describes the regular maintenance, transport, disposal, and troubleshooting of the device. Some of those operations should be guided by the authorized service personnel.
Regular Maintenance
The expected service life of the device is 10 years. In order to ensure the reliability of the device, service personnel should carry out routine maintenance and inspection of the device during the service period. If the machine is more than 5 years old, the frequency of routine maintenance and inspection should be increased appropriately.
The device minimizes required maintenance by using extensive self-tests to simplify the maintenance process. The device will monitor its essential performance automatically during use and run periodic self-test automatically in standby mode. Refer to Chapter 3.5 for details.
By visually checking the status indicator every day, the service personnel can know that whether the device has passed the self-test within the last 24 hours and confirm whether the device is ready for use. To calibrate the impedance and check the accuracy of discharge energy, please contact the manufacturer. By connecting to the device management system, you can remotely manage the device, reducing onsite maintenance. All maintenance work performed must comply with local regulations.

Daily maintenance

Monthly maintenance

After Rescue maintenance

Maintenance Content
Check the status indicator
Check device and accessories
Replace the pads Check battery power and expiration date Manual self-test

Warning

The device has NO user-serviceable components. ALL Components of the device can only be replaced or renewed by the manufacturer. If any
problem occurs, contact the maintenance personnel or the manufacturer.

Check Pads
The defibrillation pads of the device are disposable. If the pads has been used or the package is damaged, contact local distributor or manufacturer to replace in time.
Please check the date on the package to confirm whether it is expired. Expired electrodes should be disposed of according to local regulations.
In addition, the device can detect the expiration date of the pads through self-test. If the pads expired, the status indicator flashes red in standby mode. Check whether the pads cable is damaged, if damaged, please replace the pads immediately. Check whether the pads connector has been inserted. If not, insert it into the conntector socket.
21

Check Status Indicator
The device standby status indicator is located at the top center of the panel, which indicates the status of device. The flashing green light indicates that the device is normal state and ready to use. The flashing red light indicates that the device has failed the self-test and needs to
maintenance. Please contact the manufacturer as soon as possible.
Check Integrity and Cleanliness

  1. Check the integrity of the device, refer to chapter 3.2. 2) Check whether the device is dusty or dirty, especially the pads connector and pads connector socket. 3) Check whether the appearance of device have scratches or other marks of damage, especially near the pads connector and pads connector socket. If any scratches or damage are found, contact the manufacturer for maintenance.
    Check Battery
    In standby mode or after defibrillation, the battery power may be low. In standby mode, the device will detect the remain battery power and validity period of the battery through self-test. If expired or low power, the status indicator flashes red and the device sends voice alarm, please review and confirmation in time. After rescue, service personnel should check the remain battery power and the effective date. If low power or expired, replace the battery (or charge the rechargeable battery) immediately. The replaced battery should be disposed of according to local regulations. After the new battery is installed, the device automatically performs a battery installation self-test.
    Caution: After the low battery is prompted for the first time, the battery can still provide at least 30 times defibrillation. To avoid adverse impact on subsequent use, replace the battery immediately after the low battery is prompted.
    Cleaning
    The outside of the device can be cleaned with a soft cloth dampened in soapy water, chlorine bleach (2 tablespoons per quart or liter of water), or 96% ethanol.
    Caution:
    Do not immerse the device in fluids. Do not clean the accessories (Battery, Pads).
    Transport
    If it is necessary to transport the device to a maintenance point, the battery must be removed from the device, and packaged separately and shipped with the device. The device can be transported using general ways, but it must be protected from severe shocks, vibrations and rain and snow during transportation.
    Disposal
    The device and its accessories should be disposed of in accordance with local regulations.
    22

Troubleshooting
Some common failures are listed below. They should be checked one by one in order to troubleshoot the failure. Please contact the manufacturer’s designated professional personnel to repair the device.

Failure

Causes

Response

Message

Battery is not installed

Install the battery

N/A

Fail to turn the device on

Invalid or expired battery Replace the battery

N/A

Mainboard error or other factors

Contact the manufacturer for maintenance

N/A

Invalid or expired battery Replace battery

N/A

The device suddenly shut down

Mainboard error or other factors

Contact the manufacturer for maintenance

N/A

In standby mode, the device make a Beep sound every 5 seconds, totally 5 times in continuous 25s, cycle once every hour

The device found a failure while performing self-test

Contact the manufacturer for maintenance

The device make a Beep sound every 5 seconds, totally 5 times in continuous 25s, cycle once every hour

Defibrillation charging time is too long
Voice prompt “low battery”

Battery/device failure Insufficient battery Insufficient battery

Stop using the device and contact manufacturer for maintenance.
Replace battery
Replace battery

The pads don’t stick to the patient’s chest.

Attach the pads to the patient’s chest

The device cancels the charging state automatically during charging.

Poor contact between pads and patient
Damage of pads, cables, or pads connector

Check pads contact of patient
Replace pads

Charge failure
Charge failure Low battery Poor pads connect, check pads Poor pads connect, check pads Poor pads connect, check pads

Damage of pads socket

Contact the manufacturer for maintenance

Poor pads connect, check pads

23

Failure

Causes Insufficient battery

Response Replace battery

Status indicator is switched off

Damage of the status indicator

Contact the manufacturer for maintenance

Device failure Data transport failed

Contact the manufacturer for maintenance

Power on self-test failed

SIM card error

Contact the manufacturer for maintenance

Defibrillation pads expired

Replace pads

Low battery/Battery expired/Battery mismatch

Replace battery

Mainboard error or other Contact manufacturer

factors

for repair

Message
N/A
The device make a Beep sound every 5 seconds, totally 5 times in continuous 25s, cycle once every hour
The device make a Beep sound every 5 seconds, totally 5 times in continuous 25s, cycle once every hour.
N/A
Pads overdue
Low battery/Battery Overdue/Battery Mismatch
Equipment failure

24

Cybersecurity

This chapter mainly introduces information of cybersecurity.

Network Environment

PowerBeat M series defibrillator wakes up regularly for self-test under standby mode. After waking up, Bluetooth is turned off and 4G is turned on, and data is uploaded to the cloud server through 4G. In rescue mode and continuous VF/VT recognition mode, Bluetooth and 4G are both turned off, there is no network environment. In maintenance mode, Bluetooth and 4G are both turned on, and service personnel can config the device through Bluetooth and 4G.
Standby mode: 4G Maintenance mode: Bluetooth & 4G Rescue mode (after the pads are connected to the patient): no network environment Continuous VF/VT recognition mode: no network environment

Network Architecture

Network Type

Bandwidth

4G environment

CS

LTE-CAT1

10kbps

Bluetooth environment CS

BLE4.0

3kbps

Data Interface
PowerBeat M series defibrillators have two external data interfaces, which are 4G and Bluetooth.

User Access

The intended use environment of PowerBeat M series defibrillators is public places or medical places, and must operated by trained professionals or emergency responders.

In addition, the management agency of the AED deployment site needs to manage and maintain the AED device to ensure that the AED can provide treatment capabilities when needed. Therefore, AED users need to be classified.

User role

Responsibility

Require

Access permission

Operator

Rescue with PowerBeat Series defibrillators.

M-

Professionally trained in defibrillation and first aid

No permission

Service personnel

Install the PowerBeat M series defibrillator device, use the ViTools toolbox APP to connect to the PowerBeat M series defibrillator device, configure device parameters, upload data, and upgrade the host software.

Received professional

training from the

manufacturer

and

obtained authorization

from the manufacturer

All parameters can be set

Caution:

  1. The network interface and data interface of this device are not directly open to end users.
    25

  2. Network security related operations can only be performed by maintenance personnel or under the guidance of maintenance personnel!

Data Exchange Method
Bluetooth Transmission
PowerBeat M series defibrillator is in maintenance mode, the device turns on Bluetooth, and the mobile APP (ViTools) connects to the device via Bluetooth through authorization verification, and mainly completes the following functions through data interaction:
4G upload and download control Modify AED configuration, read and view AED configuration Upgrade software View self-test results
4G Transmission
PowerBeat M series defibrillators mainly complete the following functions through 4G under maintenance mode:
AED configuration upload Resource file download and update Upload of rescue data
PowerBeat M series defibrillator is in standby mode and performs weekly / monthly / quarterly scheduled self-tests, it mainly completes the following functions through 4G:
Upload of rescue data
Caution:

  1. During the rescue data upload process, the power indicator light flashes green and red at the same time, until the rescue data transmission is completed, the power indicator light returns to the normal standby state.
  2. If the rescue data upload fails, the device will re-upload it after the next selftest until the rescue data is uploaded successfully.

Device Security Software
No security software is required for PowerBeat M Series defibrillators.

Cyber Security Update
There are no user-required cybersecurity updates for PowerBeat M Series defibrillators.

AED Data Storage

The device will store the data during operation in the internal memory. The data type recorded by the device is as shown in the figure below:

Type of data

Data description

ECG data

ECG rhythm

Log data

Important events after the device are powered on, mainly include power on and off data, device status, rescue time, pads adhesion, button operation,

26

Self-test data Recording data

heart rhythm analysis, charge and discharge, CPR duration, CPR operation and prompt information, discharge times and prompt information.
Data and results of device self-tests, including periodic self-tests, battery installation self-tests, power-on self-tests, and quick status checks.
Audio data during rescue

ViBest-AED Data Management System

PowerBeat M series defibrillators have a built-in 4G module, which can transmit AED data to the data management system through 4G communication to achieve device management. In the data management system, service personnel can see the device status, pads validity period, battery power, location information, etc.

When the device status is abnormal or the accessories expired, the system will automatically send reminder information to service personnel for timely maintenance. After the device completes the rescue, it can upload rescue data (patient ECG data, log data, recording data, etc.) to the data management system.

Primary function

Secondary function

Describe

Front page

None

View AED maps, availability stats, and more

Basic Information

Device Information

View basic information such as device serial number, model, software version, production date, validity period, status, and accessory validity period.

Daily

Self-test

management event

View AED self-inspection data on a daily, weekly, monthly, quarterly basis, and send a notification to the administrator if the self-inspection fails, such as low battery power, expired electrodes, etc.

Log management

Rescue data

Check the patient’s ECG data, log data, recording data, etc. collected during the AED rescue process

User Info

View the logged in user’s account, role, email, etc.

System Management

System Message

Check the system software version number, release date, running time, etc.

Account Managemen Add, modify, and deactivate sub-accounts t

Caution:

  1. The data management system can only be operated by maintenance personnel.
  2. The above section only describes the data management system content related to the PowerBeat M series automated external defibrillator.
  3. For detailed instructions on the use of the ViBest-AED data management system, please contact the after-sales staff of VIVEST.

27

Appendix 1 Accessories

Accessories: Name Disposable Battery (LiMno2) Pads (PowerBeat M1)
Pads (PowerBeat M3) Rechargeable Battery (Li-ion) Battery Charger

Model BAT-PT01 PAZD-PT01 PAZD-PT02 PAZD-PT03 PAZD-PT04 BAT-PT02 MAC01

Quantity 1

Unit Case

1

Packet

1

Packet

1

Case

1

Case

Note Standard

Standard

(Shipped randomly

according

to

purchased model)

Optional Optional

Packing list: Name User Manual Product Certification Warranty Card Packing List

Quantity 1 1 1 1

Unit Copy Copy Copy Copy

Remarks: The Standard Accessories and Packing list shall be provided to the customer along with the device, and the accurate contents shall be subject to the provisions in the Packing list.

A

Appendix 2 Symbols

Symbol
IP65

Description Ingress protection of the device classified as IP65 according to IEC 60529

IP54

Ingress protection of battery charger classified as IP54 according to IEC 60529

Caution. Consult accompanying documentation

Defibrillation-Proof Type BF Applied Part

Warning, electricity

General warning sign

Operating instructions Follow instructions for use Dangerous voltage Stand-by Return to a collection site intended for Waste Electrical and Electronic Equipment (WEEE). Do not dispose of in unsorted trash General symbol for recovery/recyclable
Atmospheric pressure limitation

B

Temperature limitation Humidity limitation Date of manufacture Use by date This way up Use no hooks Stacking limit by number Fragile, handle with care Keep away from rain Do not dispose of in fire
Do not deform or damage Do not re-use Non-sterile Latex free
C

Batch code Catalogue Number Serial Number Manufacturer Authorized representative in the European Community Direct current Pads Icon
Analysis Icon CPR Icon Function Button:
Adjusting device volume Switching Device Modes Child Button
Shock Button.
D

Power Button
E

Appendix 3 Glossaries

Glossary Standby Mode

Description The device will turn to standby mode after the battery installed.

Rescue Mode

The device will turn to rescue mode when the power button was pressed.

Continuous VF/VT Recognition mode

That is, the continuous detection mode, which must be operated by specialized personnel who have received training and qualifications from VIVEST to provide continuous heart rhythm detection for patients who are responsive, breathing, and have a pulse but may have cardiac discomfort. This mode only recognizes shockable and non-shockable rhythms (PowerBeat M1 only).

Pads

Contains defibrillation electrode, cable, and cable connector.

Self-test

The device uses the internal program to perform self-test on the environment where the device is located and each module in the system.

Defibrillation

The method of striking the heart with a certain current to stop ventricular fibrillation.

Pacemaker

An implantable cardiac pacing maker that stimulates the heart with electrical pulses.

Periodic self-test

When the device is in the standby mode, daily self-test, weekly self-test, and monthly self-test are performed automatically to detect batteries, internal circuits, buttons, software, etc.

Cardiac arrest

Ventricular fibrillation is the most common cause of sudden cardiac arrest due to sudden termination of ejection function.

Impedance

The device detected the electrical impedance between two pads attached to the patient’s skin.

Shockable rhythm

Pulseless ventricular tachycardia or ventricular fibrillation, which can lead to cardiac arrest.

Non-shockable rhythm

The cardiac rhythm identified by the device as unsuitable for electric shock.

Sensitivity

True positive, that is, the probability that the test is not missed.

Specificity Motion artifacts

True negative, that is, the detection of the probability of no miscarriage of justice.
Noise caused by muscle movement, cardiopulmonary resuscitation, or static electricity may interfere with cardiac analysis.

F

New battery Manufacturer ECG CPR ICD bpm AED EMC LED AHA SCA AAMI VF VT

Battery that is well packed, unsealed, and valid. Unless otherwise specified, the company described in this manual is VIVEST. Electrocardiograph. Cardiopulmonary resuscitation, a technique for rescuing patients in cardiac arrest with artificial respiration and chest compressions. Implantable cardioverter defibrillator Beat per minute Automated external defibrillator Electromagnetic Compatibility Light emitting diode American Heart Association Sudden Cardiac Arrest Association for Advancement of Medical Instrument ventricular fibrillation ventricular tachycardia

G

Appendix 4 Specifications

Safety Specification Features Safety Classification Internally powered ME equipment

Protection against electric shock
Particle and Water Ingress
Operational mode

Defibrillation-Proof Type BF Applied Part. IP65 Continuous operation

Security Degree

Not AP type or APG type device

ME Equipment Type Portable

Physical parameters

Size

2.09in3.39in5.91in

(heightwidthlength) 5.3cm8.6cm15cm

Weight (including battery)

1.54 lb. (0.7kg)

Tolerable impact / falling damage

Free to fall from a height of 1.5 m on a hard surface

Environmental parameters

Operation condition

Temp: -15°C to 50°C (Can work for at least 60 minutes after moving from room temperature to -20°C) Relative humidity: 0% to 95%, non-condensing Atmospheric pressure range: 50.4kPa to 106kPa

Storage condition

Short-term Temp: -40°C to 70°C (Within one week) Long-term Temp: 0°C to 50°C Relative humidity: 0% to 95%, non-condensing Atmospheric pressure range: 59.4kPa to 106kPa

Transportation condition

Short-term Temp: -40°C to +70°C (Within one week) Long-term Temp: 5°C to 50°C Relative humidity: 0% to 95%, non-condensing Atmospheric pressure range: 59.4kPa to 106kPa

Altitude

4500m

Defibrillation Shockable Rhythm Waveform

VT/VF Truncated biphasic exponential waveform

H

Energy level

Automatic pre-programmed selection (Adult mode: 150J; Pediatric mode: 50J)

Output control

Manual operation (In rescue mode, the shock button should be pressed manually).

Operational impedance limitation of patient

20 to180

Battery Status (20±2°C)

Charging time (Disposable battery)

New Battery
New battery depletes of 6 maximum energy discharge New battery depletes of 15 maximum energy discharge

Battery Status (20±2°C)

from initially switching power on to readiness for maximum energy discharge
Less than 19 seconds

from the initial analysis to readiness for maximum discharge
Less than 17 seconds

from the second analysis to readiness for maximum discharge
Less than 8 seconds

Less than 19 seconds

Less than 17 seconds

Less than 8 seconds

Less than 19 seconds

Less than 17 seconds

Less than 8 seconds

from

initially

switching power

on to readiness

for maximum

energy

discharge

from the analysis readiness maximum discharge

initial to for

from the second

analysis

to

readiness for

maximum

discharge

New,

fully Less than 12 Less than 10 Less than 8

charged Battery seconds

seconds

seconds

Charging time (Rechargeable battery)

New,

fully

charged battery

deplete of 6 Less than 12 Less than 10 Less than 8

maximum

seconds

seconds

seconds

energy

discharge

New,

fully

charged battery

deplete of 15 Less than 12 Less than 10 Less than 8

maximum

seconds

seconds

seconds

energy

discharge

ECG analysis system

I

Analysis accuracy
Cardiac arrest threshold

Comply with IEC60601-2-4 requirements <0.2mV

Artifacts detection

Support
If an interfering signal that affects the accuracy of the heart rhythm analysis is detected, the device will delay performing the analysis and give a prompt. If the interference lasts for more than 20 seconds, the device will stop prompting and force the decision result.

Pads Specification Length

Combined by pads connector, wires, and a pair of disposable defibrillation electrodes.
1.0m

Service life Battery

4 years

Type

Disposable battery (LiMnO2 Battery), 12V/1500mAh (Standard) Rechargeable battery (Li-ion Battery), 7V/3450mAh (Optional)

The number of maximum energy discharges which are available from a new and fully charged battery
standby life(Ambient temperature 20°C± 2°C, new battery, weekly self-test, loaded into the device do not turn on the use, do not connect 4G to send self- test results.)
Service life

Disposable battery: a) New battery can charge and discharge at least 130 times in rated energy of 150J at 20°C±2°C environment. b) New battery can charge and discharge at least 20 times in rated energy of 150J at -15°C environment. c) new battery, after the first reminder of low battery, can charge and discharge at least 30 times.

Rechargeable battery: d) New fully charged battery can charge and discharge at least 250 times in rated energy of 150J at 20°C±2°C environment. e) New fully charged battery can charge and discharge at least 20 times in rated energy of 150J at -15°C environment. f) New fully charged battery, after the first reminder of low battery, can charge and discharge at least 30 times.

Disposable battery

Rechargeable battery

3 years 3.5 years

3 months before recharge
5 years (about 300 times of chargedischarge cycle)

Battery Charger (Optional)

Safety Classification Class I

Protection against

IP54

J

harmful ingress of water or particulate matter Power Supply Rated input power
Charge time
Service Life Device Production date Service Life Record
Recording function
Data Storage ECG Data Self-test Data Communication Capacity

AC 220V, 50Hz 60VA At 20°C ± 2°C environment, the battery charger charges 2 rechargeable batteries at the same time, and the fully charged time is not more than 3 hours and 40 minutes. A single rechargeable battery should take no more than 2 hours and 30 minutes to fully charged. 10 years
See label on back of device 10 years
Immediately after the device is powered on, use the microphone to collect and record ambient sound information
24 hours of ECG data 3650 copies
Support mobile communication 4G and GPS positioning

K

Appendix 5 Defibrillation Waveform
The defibrillation waveform of the device is a truncated biphasic exponential waveform, Waveform parameters are automatically adjusted as a function of patient defibrillation impedance. In the diagram below, D is the duration of phase 1 and E is the duration of phase 2 of the waveform, F is the interphase delay (500 s), and P1 is the peak current.

P1: phase 1 peak current D: Phase 1 pulse width E: phase 2 pulse width F: Time interval between Phase 1 and Phase 2

The device delivers shocks to load impedances from 25 to 180 ohms. The duration of each phase of the waveform is dynamically adjusted based on delivered charge, in order to compensate for patient impedance variations, as shown below:

Energy output under various impedances (Adult mode):

Load impedance
()

Phase 1 pulse width
D(MS)
±15%

Phase 2 pulse width
E(MS)
±15%

Time interval between Phase 1
and Phase 2
F(MS)

Peak current P1 (A)
±15%

Energy output (J)
±15%

±15%

25

2.8

2.8

0.5

61.0

128

50

4.5

4.5

0.5

33.5

150

75

6.3

5.0

0.5

23.4

155

100

8

5.3

0.5

18.0

157

125

9.7

6.4

0.5

14.5

158

150

11.5

7.7

0.5

12.0

160

175

12

8

0.5

10.5

158

Energy output under various impedances (Child mode):

Load impedance
()

Phase 1 pulse width
D(MS)

Phase 2 pulse width
E(MS)

Time interval between Phase 1
and Phase 2

±15%

±15%

F(MS)

±15%

Peak current P1 (A)
±15%

Energy output (J)
±15%

L

25

2.8

2.8

50

4.5

4.5

75

6.3

5.0

100

8.0

5.3

125

9.0

6.0

150

9.0

6.0

175

9.0

6.0

0.5

36.0

43.4

0.5

19.6

50.0

0.5

13.5

52.0

0.5

10.3

52.2

0.5

8.4

52.3

0.5

7.0

50.0

0.5

6.0

49.0

M

Appendix 6 ECG Analysis System
Summarize The defibrillator’s ECG analysis system, which automatically identifies patient’s heart rhythm and provide shock advise to the operator, offers untrained operators the possibility of life-saving treatment in treating patients with nausea and arrhythmias. The analysis system has the following functions: Judgment of electrode contact Recognition and erasure of pacemaker signal Recognition of the shockable heart rhythm Detection of cardiac arrest Detection of Interference

Judgment of electrode contact
The defibrillator will automatically detect the thoracic impedance of the patient. If the impedance value is within the set threshold value, the electrode will be judged to be firmly in contact and the heart rhythm analysis can be started. If the chest impedance value exceeds the set threshold, the electrode is judged to have inadequate contact or to be improperly connected to the defibrillator, at which point the operator is advised to re-insert the electrode.
Recognition and erasure of pacemaker signal
The pulse signal of a buried pacemaker may interfere with the correct identification of arrhythmias. The defibrillator will first identify and erase the pacing signal, and then enter the rhythm analysis. Based on the results of the analysis, the shock or no shock prompt is given.
Recognition of the shockable heart rhythm
The heart rate analysis was based on the sliding ECG data window of 4S, and the analysis required about 10s. During this period, at least 4 sliding Windows were judged to be ventricular fibrillation before the final shock decision could be made, otherwise it was deemed to be no shock.
The following table illustrates the algorithmic performance of the defibrillator ECG analysis system.

Meet the requirements of IEC 60601-2-4 and AHA

Rhythm

Samples

Performance requirement

Actual Performance

90% one-sided lower confidence limit

Shockable rhythm ­ Coarse VF

231

sensitivity >90%

99.5%

99.4%

Shockable rhythm ­ 81
VT

sensitivity >75%

98.7%

98.5%

Non-shockable rhythm ­ Normal Sinus Rhythm

362

specificity >99%

100%

100%

Non-shockable rhythm ­ Asystole

103

specificity >95%

100%

100%

N

Non-shockable rhythm ­

all other non-shockable

520

rhythm

specificity >95% 99.1%

99.1%

Data Source: PhysioNet, a public database of adult ECG data collected from various hospitals.
Detection of cardiac arrest
Pause threshold is peak-peak 0.2mV. Be careful that the electrical signal peak pea is less than 0.2mV, the system will recognize the pause and give a warning that electric shock is not recommended, and CPR will be initiated.
Detection of Interference
The defibrillator’s ECG analysis system detects interference, which may be caused by external sources such as posture movements or electrical noise. Postural movement includes patient movement, rescuer movement, vehicle movement, etc.; External sources of electronic noise: e.g., mobile phones, radios, etc. If interference is detected, the system sends a voice warning to the rescuer, at which point the operator should remove the interference as soon as possible to minimize artifacts in the ECG, and the system continues to perform heart rate analysis.

O

Appendix 7 EMC Guide

Warning

  1. Except for accessories sold by the manufacturer of the device, using accessories that are not specified may result in an increase in device emission or a decrease in immunity.
  2. The device should not be used in proximity to or stacked with other devices. If it must be used in proximity to or stacked with other devices, it should be observed to verify that it works properly in its configuration.
  3. You need to protect the device EMC and install and maintain it in an environment that meets the following EMC information.
  4. Even if other equipment meets CISPR’s launch requirements, it can cause interference with the device.
  5. Other devices that contain RF radiofrequency emission may affect this device (for example, mobile phones with wireless computers).

ESSENTIAL PERFORMANCE:
The essential performance of PowerBeat M series AED is to deliver defibrillation therapy and accurately differentiate between shockable and non- shockable rhythms.

Electromagnetic Emissions

Guidelines and manufacturer’s claims for Electromagnetic Launches

The device is intended for use in the following specified electromagnetic environments, and the purchaser or user should ensure that it is used in this electromagnetic environment:

Emission Test

COMPLIANCE

ELECTROMAGNETIC ENVIRONMENTGUIDANCE

Radio-frequency emission
CISPR 11

Group 1

The device uses RF energy only for its internal functions, so its RF emission is low and the likelihood of interference with nearby electronics is minimal.

Radio-frequency emission
CISPR 11

Class B

The device is suitable for use in all facilities, including domestic facilities and directly connected to the domestic residential public low voltage power grid.

P

Electromagnetic Immunity

Guidelines and manufacturer’s declaration of Electromagnetic Immunity

The device is intended for use in the following specified electromagnetic environments, and the purchaser or user should ensure that it is used in this electromagnetic environment:

IMMUNITY TEST

IEC 60601 TEST LEVEL

COMPLIANCE LEVEL

ELECTROMAGNETIC

ENVIRONMENT

GUIDANCE

Electrostatic Discharge
IEC 61000-4-2

±6kV contact ±8kV air

±6kV contact ±8kV air

Floors should be wood, concrete or tile. The relative humidity should be at least 30% if they are covered with synthetic materials.

PFMF (50Hz/60Hz) IEC 61000-4-8

3A/m

3A/m

The power-frequency magnetic field shall have the horizontal characteristics of a typical site in a typical commercial or hospital environment.

Note: UT refers to the AC network voltage before the test voltage is applied.

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Guidelines and manufacturer’s declaration of Electromagnetic Immunity

The device is intended for use in the following specified electromagnetic environments, and the purchaser or user should ensure that it is used in this electromagnetic environment:

IMMUNITY TEST IEC 60601 TEST LEVEL

COMPLIANCE LEVEL

ELECTROMAGNETIC ENVIRONMENT – GUIDANCE

Portable and mobile RF communications equipment should not be used closer to any part of the device, including cables, than the recommended isolation distance, which is calculated by a formula corresponding to the transmitter frequency.

Recommended separation distance:

Conducted RF IEC 61000-4-3

3V (effective value) 150kHz~80MHz (Expect ISM bands a)

3V (effective value)

d=1.17

10V (effective value) 150kHz~80MHz (ISM bands a)

10V (effective

value)

d=1.20

Radiated RF IEC 61000-4-3

10V/m 80MHz~2.5GHz

10V/m

d=1.2 80MHz~800MHz
d=2.3 800MHz~2.5GHz
In which:
P—-Based on the transmitter manufacturer’s maximum transmitter output rating in watts (W).
d—-Is the recommended isolation distance in meters (m) b.
The field intensity of a stationary RF transmitter is determined by surveying the electromagnetic field c and should be lower than the coincidence level in each frequency ranged.
Interference may occur near equipment marked with the

following symbols: Note: 1) In 80 MHz and 800 MHz environment, the formula of higher frequency band is adopted. 2) These guidelines are not suitable for all situations. Electromagnetic propagation is affected by

R

absorption and reflection from building objects and human bodies.
a: The engineering medical frequency band between 150kHz and 80MHz refers to 6.765M~6.795MHz 13.553MHz~13.567MHz 26.957MHz~27.283MHz and 40.66MHz~40.70MHz.
b: Coincidence levels in the engineering medical frequency band between 150kHz and 80MHz and in the frequency range of 80MHz to 2.5GHz are used to reduce the possibility of interference caused by mobile/portable communication devices being accidentally brought into the patient area. For this reason, the additional factor 10/3 is used to calculate the recommended isolation distance for transmitters in these frequency ranges

c: Stationary transmitter, such as: wireless cellular/cordless phones and ground mobile radio base station Am and FM radio amateur radio and television broadcasting, etc., could not accurately predict the field intensity in theory, to assess stationary rf transmitter electromagnetic environment, electromagnetic site survey should be taken into account. If the measured:
If the field intensity of PowerBeat M series AED is higher than the applicable RF compliance level above, the device should be observed to verify its normal operation. If abnormal performance is observed, additional measures may be necessary, such as reorientation or positioning of the device.

d: In the whole frequency range of 150kHz~80MHz, the field intensity should be lower than 3V/m

Recommended isolation distances between portable and mobile RF communications equipment and PowerBeat M series AED

The device is intended for use in electromagnetic environments where rf disturbance is controlled. Depending on the maximum rated output power of the communication equipment, the purchaser or user can protect against EMI by maintaining the minimum distance between portable and mobile RF communication equipment (transmitters) and the device as recommended below:

Separation distance according to frequency of transmitter(m)

Rated maximum output power of transmitter(W)

150kHz~80MHz
(Except ISM band)
d=1.17

150kHz~80MHz (ISM band) d=1.2

80MHz~800MHz d=1.2

800MHz~2.5GHz d=2.3

0.01

0.12

0.12

0.12

0.23

0.1

0.37

0.38

0.38

0.73

1

1.17

1.20

1.20

2.3

10

3.70

3.79

3.79

7.27

100

11.70

12.00

12.00

23.00

For the maximum rated output power of the transmitter not listed in the above table, the recommended isolation distance D, in meters (m), can be determined by the formula in the corresponding transmitter frequency column, where P is the maximum rated output power of the transmitter provided by the transmitter manufacturer, in watts (W).

Note:

  1. At 80MHz and 800MHz frequency points, the formula of higher frequency band is adopted

  2. The engineering medical frequency band between 150kHz and 80MHz refers to 6.765

MHz~6.795MHz

13.553MHz~13.567MHz

26.957MHz~27.283MHz

and

S

40.66MHz~40.70MHz 3) The additional factor 10/3 is used to calculate the recommended isolation distance for
transmitters in the 150kHz to 80MHz engineering medical band and 80MHz to 2.5GHz frequency range to reduce the possibility of interference caused by portable/mobile communication equipment being accidentally brought into the patient area 4) These guidelines may not be appropriate in all cases where electromagnetic propagation is affected by absorption and reflection from building objects and human bodies Regulatory Compliance VIVEST solemnly declares that PowerBeat M series Automated External Defibrillator complies with the relevant provisions of the relevant medical equipment standards: IEC 60601-1:2005+A1:2012 Medical electrical equipment ­Part 1: General requirements for basic safety and essential performance, IEC 60601-2-4:2010+AMD1:2018 Medical electrical equipment ­ Part 2-4: Particular requirements for the basic safety and essential performance of cardiac defibrillators, IEC 60601-1-2:2014 Medical electrical equipment­Part 1-2: General requirements for basic safety and essential performance­Collateral Standard: Electromagnetic disturbances­Requirements and tests, IEC 60601-1-12:2014 Medical electrical equipment ­ Part 1-12: General requirements for basic safety and essential performance ­ Collateral Standard: Requirements for medical electrical equipment and medical electrical systems intended for use in the emergency medical services environment.
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