AMERICAN MEGATRENDS INDIA PRIVATE AMI-ECG-02 B.O.L.T Chest ECG User Manual AMI BOLT

ONE-TOUCH WIRELESS HEALTH TRACKER

BODY LIFE TRACKER

B.O.L.T Chest ECG

User Manual

Model: VA 07

Document No : AMI-PRD-UM-B-VA 07

Version : 1.1

Date : 14.05.2018

B.O.L.T Chest ECG User Manual Model No: VA 07

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update, change or modify this publication at any time, without notice.

For Additional Information

Call American Megatrends India Private Ltd at 1800-200-8001.

Limitations of Liability

In no event shall American Megatrends India Private Ltd be held liable for any loss, expenses, or

damage of any kind whatsoever, whether direct, indirect, incidental, or consequential, arising

from the design or use of this product or the support materials provided with the product.

Limited Warranty

No warranties are made, either expressed or implied, with regard to the contents of this work, its

merchantability, or fitness for a particular use. American Megatrends India Private Ltd assumes

no responsibility for errors and omissions or for the uses made of the material contained herein

or reader decisions based on such use.

Trademark and Copyright Acknowledgments

AMERICAN MEGATRENDS INDIA PRIVATE LTD.,

KUMARAN NAGAR,

SEMMENCHERY, OFF RAJIV GANDHI SALAI (OMR),

CHENNAI (TN) 600119.

All product names used in this publication are for identification purposes only and are

trademarks of their respective companies.

B.O.L.T Chest ECG User Manual Model No: VA 07

Document History

Version

Date

Comment

1.0

31-12-2015

Initial Release

1.1

14-05-2018

Updated with new images and contents

B.O.L.T Chest ECG User Manual Model No: VA 07

Table of Contents

1.0 Intended Use .................................................................................... 5

2.0 Product Description ............................................................................ 5

3.0 Package Contents .............................................................................. 6

4.0 Product Quality Reliability and Safety ...................................................... 6

4.1 Warning ...................................................................................... 6

4.2 Caution ........................................................................................ 8

4.3 Care and Maintenance ...................................................................... 8

4.4 Disposal ....................................................................................... 8

5.0 Contraindications ............................................................................... 9

6.0 Product Features ............................................................................... 9

7.0 Operating Environment ........................................................................ 9

8.0 Prerequisites .................................................................................... 9

9.0 Using Mobile Application ..................................................................... 10

10.0 B.O.L.T Chest ECG Measurement procedure .............................................. 10

11.0 Charging the B.O.L.T Chest ECG Devices .................................................. 12

12.0 Troubleshooting ............................................................................... 14

13.0 Technical Specifications ...................................................................... 16

14.0 Explanation of Indicators/Symbols .......................................................... 17

15.0 Certifications .................................................................................. 19

16.0 FCC compliance statements ................................................................. 20

17.0 Warranty Information ......................................................................... 21

18.0 Customer Care Support ....................................................................... 21

19.0 Contact us ...................................................................................... 22

B.O.L.T Chest ECG User Manual Model No: VA 07

Model VA 07 – B.O.L.T Chest ECG

1.0 Intended Use

B.O.L.T Chest EGG is intended to acquire the ECG parameters of adult users. The acquired

ECG parameters can be used to obtain clinical consultation from cardiologists or healthcare

practitioners.

2.0 Product Description

B.O.L.T Chest ECG device is a portable monitoring system which can measure/monitor the

electrical activity of the heart over a period of time using the ECG electrodes placed on the

user`s body. The device monitors the ECG waveform from the Left & Right chest with a

reference Electrode. The acquired and processed ECG data obtained from the device is

transmitted to a mobile device wirelessly for further processing and analysis. The ECG data

acquired by the device can be used to obtain clinical consultation from cardiologists or

healthcare practitioners.

B.O.L.T Chest ECG Device ECG Electrode Cables

B.O.L.T Chest ECG User Manual Model No: VA 07

Charging Adapter & USB Cable Disposable ECG Electrodes

3.0 Package Contents

S. No

Packing List

Quantity

1

B.O.L.T Chest ECG Device

1

2

ECG Electrode cables

3

Disposable ECG Electrodes

3 Pack

4

Power Adapter

1

5

USB Cable

1

6

Warranty Card

1

7

Quick Reference Guide

1

8

Dust Cap for USB Port

1

4.0 Product Quality Reliability and Safety

The device has been designed with an emphasis on quality, reliability and safety, but AMI can

only accept responsibility for these aspects, provided the following conditions are met

 The device should be used as per the operating instructions mentioned in the user

manual provided by AMI.

 All modifications and repairs to the device are carried out by authorized AMI

personnel or their agents.

 Do not use the device when charging with a wall mount adapter as it may introduce

noise in the waveform.

 The device must comply with regulation specified in warning and cautions.

4.1 Warning

 All users should read the user manual thoroughly. An electronic version of the current

copy of this manual can be obtained from the official website.

 Read the Intended use, Warnings and Cautions carefully before the use of the

product.

 Do not plug or unplug the AC adapter with wet hands.

 Do not clean the device while the power is ON.

 Use of the device is restricted to one patient at a time.

 Exposure of the device to water is prohibited.

B.O.L.T Chest ECG User Manual Model No: VA 07

 Do not expose the device to strong shocks or vibrations.

 The device is designed for adults and not recommended for the neonates, pediatrics

and infants.

 Do not disassemble, repair, or modify the device by yourself, as this could affect the

safety, and voids the warranty of the device if the seal is broken.

 The user is recommended to insert the given USB plug in the USB port of the ECG

device during battery mode operation.

Inserting USB Plug

Removing USB Plug

 The user can remove the USB Plug while charging the device.

 Adhesives present in consumables like disposable ECG electrodes are free from any

harmful substances. However, if any allergic reaction/irritation is observed, remove

the part immediately from human contact. Clean the area with a mild soap and water

to remove any residual particles of adhesive.

 Keep the device away from infants, small children or anyone who is incapable of using

the device in an appropriate manner.

 Make sure that the ECG electrodes positioning place are clean shaved for accurate

B.O.L.T Chest ECG User Manual Model No: VA 07

ECG measurement.

 Do not attempt self-diagnosis or self-treatment based on the measurements provided

by the device.

 Remove electrodes, patient lead wires, and recorder from patient before

defibrillation.

4.2 Caution

 Do not use unauthorized parts and accessories.

 Do not store or use this device in locations which are maintained above/below the

specified temperature and humidity ranges.

 Wrong positioning of the ECG electrodes may lead to inaccurate readings.

 Use only American Megatrends India Specified batteries and charging devices.

4.3 Care and Maintenance

 Store the device and the components in a clean and safe location.

 Charge the device for minimum two hours during first time usage.

 Do not disassemble, repair or modify the device and the components by yourself.

 Wipe the device using 70% Isopropyl alcohol and let air dry.

 Do not clean with ketones or other flammable agents.

4.4 Disposal

Dispose of the instrument, accessories and consumables according to local disposal and

recycling laws

This symbol is applicable for EU member countries only.

To avoid potential negative consequences for the environment and possibly human health,

care should be taken while disposing (i) for EU member countries - in accordance with WEEE

(Directive on Waste Electrical and Electronic Equipment), or (ii) for all other countries, in

accordance with local disposal and recycling laws.

 Disposable ECG Electrodes used with the ECG device are considered as disposable

products.

 The ECG Electrodes needs to be disposed after the single member usage to avoid

cross-contamination.

 The ECG Electrodes disposal after use should adhere to the local authority

guidelines/norms.

B.O.L.T Chest ECG User Manual Model No: VA 07

5.0 Contraindications

The analyzed results from the ECG device are not by itself sufficient to make a correct

diagnosis of the patient`s clinical condition. A detailed clinical history of the patient is also

required together with the results of any other tests suggested by a doctor. The results

depend on the person`s ability to usage. If the fundamental procedure is not followed then

the result obtained during the ECG monitoring will not be considered accurate, and therefore

the test results are not acceptable.

6.0 Product Features

 Provides & Displays ECG waveform

 Measures Heart Rate Variability (HRV), Respiration rate (RR) and Heart Conditions

Available for Android and Windows smartphones and tablets.

 Easy-to-use B.O.L.T app instantly displays results and health condition.

 Comfortable accessories to use.

 Ability to store data in B.O.L.T Personal Health Cloud.

 Maintain historical / trend data of all vital statistics measured.

 Multi-language support.

 Multi-user login support with built-in security to safeguard and protect personal

health data.

 Rechargeable Battery.

 Extensible API to support integration with external health systems and web

applications.

7.0 Operating Environment

B.O.L.T Chest ECG device has been designed for use in the hospitals, clinics or directly by

the patient at home to monitor the heart conditions. The user or the physician is

responsible for ensuring that the device is stored and used in appropriate environmental

conditions.

8.0 Prerequisites

Some basic requirements must be adopted as mentioned below to ensure better operation

of the product.

 B.O.L.T Chest ECG device is designed to be operated with applications like Android, or

Windows.

 The Android OS version of the computer/mobile device should be 4.0 or higher.

 The Windows OS version of the computer/mobile device should be 8 or higher.

B.O.L.T Chest ECG User Manual Model No: VA 07

9.0 Using Mobile Application

Downloading and Installing Mobile application on your computer/mobile device

1. Download and Install the “B.O.L.T “Application from Play store/Application

store/Windows application market.

2. On successful installation, launch the application on the mobile device.

3. Create a User Name with your Email ID or use Facebook Credentials for login.

You can also login as a guest user while internet unavailability

which might not store the measured vital parameters in the cloud storage

space on the measured parameters.

10.0 B.O.L.T Chest ECG Measurement procedure

1. Position the disposable ECG electrodes on the user`s body as shown below.

Note: Kindly replace all the 3 ECG electrodes in case of 24 hours

usage. While replacing, do not place the electrodes in the same

position. Instead, place it slightly away / adjacent to the previous

location.

2. Ensure that the positioning spots of the human body are clean shaved.

3. Connect the ECG electrode cables to the ECG device with appropriate matching color

on connectors of the ECG device. RA is white color, LA is black color and LL is red

color.

RA – Right Arm, LA – Left Arm & LL – Left Leg

B.O.L.T Chest ECG User Manual Model No: VA 07

4. Clip/button the ECG Electrode cable to the disposable ECG electrode as shown below.

5. Once the setup is connected ensure that the user is comfortable with the

measurement.

6. Switch ON the mobile device, and Enable Bluetooth & Wi-Fi Internet Connectivity.

7. Switch ON the ECG device using the slide power button.

8. Blue LED on the ECG device will start blinking, which means that the ECG device is

searching for Bluetooth device for pairing.

9. Launch the B.O.L.T application from the mobile device.

10. On successful login, Choose Check vitals menu.

11. Choose the ECG option from the mobile application test list.

12. Choose the ECG device from the available list of vitals devices.(e.g. AMI Chest ECG 01)

13. Confirm the device selection and provide default pairing password 1234 for pairing

the ECG device (on request for the first time pairing).

14. Ensure that the Bluetooth LED stops blinking in the E.C.G device.

15. Select “Start” option to perform the ECG data monitoring/measurement.

16. Monitoring vitals data will be displayed within a couple of minutes on the application

screen.

17. Once the test is completed, Click Stop and proceed back to home screen.

18. Click to upload the result to the cloud on demand for further analysis.

19. Kindly ensure to remove the disposable ECG electrodes from the user body and

dispose in the disposable container after completing the test.

On Successful pairing of the mobile device, Blue LED stops blinking

in the device. Ensure that the save option is enabled for storing the data

in the cloud.

B.O.L.T Chest ECG User Manual Model No: VA 07

For sync to occur successfully between the device and the tablet

there must be a valid Bluetooth connection.

Bluetooth indicator starts blinking if the paring connection

between the device and tablet is lost.

11.0 Charging the B.O.L.T Chest ECG Devices

The Chest ECG is operated with an inbuilt rechargeable battery, which can be charged using

the power adapter and USB cable as guided below. It is mandatory to charge the devices for a

minimum period of 2 hours before the first time usage. Kindly connect the devices to the

power source, if low battery status is indicated in the mobile application screen.

Power adapter & USB cable B.O.L.T Chest ECG device

Charging Procedure:-

1. Connect the USB cable to the power adapter.

2. Connect the micro USB port to the ECG device`s power port (USB port).

3. Plug the adapter into the AC mains (110V, 60Hz or 230V, 50Hz).

B.O.L.T Chest ECG User Manual Model No: VA 07

4. Switch ON the AC mains to charge the device.

5. Check whether the power indicator turns red while charging the device.

B.O.L.T Chest ECG User Manual Model No: VA 07

12.0 Troubleshooting

PROBLEM

POSSIBLE CAUSE

SOLUTION

Application not installing from

the App store/Play

store/Windows market

1. Internet/Data

disconnection

2. Memory space

unavailability

1. Check your Internet

connectivity

2. Move some of the

application from

Phone storage to

SD card

3. If the issue persists,

delete some

unwanted

application and try

to install the B.O.L.T

application.

Application Login problem

Internet/Data

disconnection

Enable Internet connection

through mobile data or Wi-

Fi and try to login.

Change Password is not getting

updated

Internet/Data

disconnection

Enable internet connection

through mobile data or Wi-

Fi and try again.

Device requests for Bluetooth

pairing password

Bluetooth pairing

permission required

Give the password as 1234

Bluetooth communication

disconnected while measuring

vitals and Bluetooth indicator

starts blinking

Bluetooth

communication error

Close the application.

Restart the ECG device and

restart the entire process

again

ECG device switched ON, but not

showing in List of available

Bluetooth device in the

application

Bluetooth pairing

problem

Restart the ECG device,

Then try to connect again.

ECG device switched ON, but

Bluetooth (Blue) LED not

blinking.

ECG device not booted

properly

Connect the respective

power adaptor to the

device and power ON, if

still blue LED is not glowing

kindly get it repaired in the

B.O.L.T Chest ECG User Manual Model No: VA 07

authorized service center.

ECG device switched ON, but no

LED is glowing

No charge for battery

Connect the respective

power adaptor to the ECG

device and charge. Then

power ON, if still blue LED

is not glowing kindly get it

repaired in authorized

service center

B.O.L.T Chest ECG User Manual Model No: VA 07

13.0 Technical Specifications

Product Name

B.O.L.T Chest ECG

Model

VA 07

B.O.L.T Chest ECG Unit

Unit Dimensions

85 (L) X 40 (H) X 20 (D) mm

Unit Weight

45 grams (Including Battery)

Heart Rate

30 to 200 BPM

Heart Accuracy

+/- 1% or 1 BPM whichever is greater

Heart Resolution

1 BPM

Respiration

7-120 RPM

Respiration Resolution

1 RPM

Respiration Accuracy

+/- 2 RPM

ECG Channels

Single Channel

Input Dynamic Range

10mV Peak-to-Peak

Bluetooth

Bluetooth 4.0 EDR or Lower, Bluetooth Low Energy

(BLE)

Radio Protocol Bluetooth

(BDR+EDR) / BLE

Operating Frequency Range

2400 MHz – 2483.5 MHz;

Verified RF Power

BT: -05.45 dBm / BLE: -5.46 dBm

Circuitry

Frequency Response

0.5 Hz to 40Hz

CMRR

120 dB

Input impedance

> 5 MOhm

Differential Range

+/- 5 mV

A/D Sampling Rate

500 samples/second

Resolution

24 bit

Power Requirements

Power Source

DC 5V 2A

Battery Type

3.7 -850mAh Li-Poly Battery

Environmental Specification

Operational Temperature

+10 to +45 degree C

Operational Humidity

10% to 95% (non-condensing)

Storage Temperature

-20 to +60 degrees C

Storage Humidity

10% to 95% (non-condensing)

B.O.L.T Chest ECG User Manual Model No: VA 07

14.0 Explanation of Indicators/Symbols

Indicators/

Symbols

Function/Description

The indicator displays full battery power of the gadget in the computer/mobile

device.

The indicator displays low battery power of the gadget in the computer/mobile

device.

(Blue)

o Flashing of the Bluetooth light indicates that the gadget is waiting for

pairing with the mobile/tab.

o Steady Bluetooth light indicates that the gadget is paired and ready for

the measurement.

(Green)

o Steady green light indicates that the gadget is operating in battery mode.

(Red)

Steady red light indicates that the gadget is in the charging mode.

Symbol for “DISPOSAL”

Symbol for “KEEP DRY”

Symbol for “MANUFACTURER”

Symbol for “MANUFACTURED DATE”

Symbol for “SERIAL NUMBER”

Symbol for “EUROPEAN REPRESENTATIVE”

Symbol for “EUROPEAN CONFORMITY”

Symbol for “Federal Communication Commission”

B.O.L.T Chest ECG User Manual Model No: VA 07

Symbol for “Follow Instructions for use”

Symbol for “Warning”

Symbol for “Caution”

Symbol for “Temperature limitation”

Symbol for “Fragile”

Symbol for protected against access to hazardous parts with a finger and against

vertically falling water drops when tilted up to 15 degrees

B.O.L.T Chest ECG User Manual Model No: VA 07

15.0 Certifications

COUNCIL DIRECTIVE 93/42/EEC of 14 June 1993 concerning medical devices.

This device complies with the following normative documents:

 EN 301489-1:V3.2.0:2017 ElectroMagnetic Compatibility (EMC) standard for radio

equipment and services; Part 17: Specific conditions for Broadband Data Transmission

Systems; Harmonised Standard covering the essential requirements of article 3.1(b) of

Directive 2014/53/EU

 EN ISO 10993-5:2009 Biological evaluation of medical devices - Part 5: Tests for in

vitro cytotoxicity

 EN ISO 10993-10:2010 Biological evaluation of medical devices -- Part 10: Tests for

irritation and skin sensitization

 EN 60601-1:2012 General requirements for basic safety and essential performance

 EN 60601-1-2-2007/AC: 2010 General requirements for safety -Collateral standard:

Electromagnetic compatibility.

 EN 60601-1-6:2010 Collateral standard: Usability

 IEC 60601-1-4:1996 General requirements for safety- Collateral standard:

Programmable electrical medical systems.

 IEC 60601-1-11:2010 Medical electrical equipment - Part 1-11: General requirements

for basic safety and essential performance - Collateral standard: Requirements for

medical electrical equipment and medical electrical systems used in the home

healthcare environment

 IEC 60601- 2-27:2011 Medical electrical equipment ─ Part 2-27: Particular

requirements for the basic safety and essential performance of electrocardiographic

monitoring equipment

B.O.L.T Chest ECG User Manual Model No: VA 07

16.0 FCC compliance statements

FCC ID: 2AFV6-AMI-ECG-02

This device complies with Part 15 of the FCC Rules. Its operation is subject to the following

two conditions:

(1) This device may not cause harmful interference, and

(2) This device must accept any interference received, including interference that may cause

undesired operation.

FCC Caution

 Any changes or modifications not expressly approved by the party responsible for

compliance could void the user's authority to operate this equipment.

Part 15B compliance statements for digital devices:

NOTE: This equipment has been tested and found to comply with the limits for a Class B digital

device, pursuant to part 15 of the FCC Rules. These limits are designed to provide reasonable

protection against harmful interference in a residential installation.

This equipment generates, uses and can radiate radio frequency energy And, if not installed

and used in accordance with the instructions, may cause harmful interference to radio

communications. However, there is no Guarantee that interference will not occur in a

particular installation.

If this equipment does cause harmful interference to radio or television Reception, which can

be determined by turning the equipment off and on

The user is encouraged to try or to correct the interference by one or more of

The following measures:

— Reorient or relocate the receiving antenna.

— Increase the separation between the equipment and receiver.

— Connect the equipment to an outlet on a circuit different from that to which the

receiver is connected.

— Consult the dealer or an experienced radio/TV technician for help.

For more information kindly visit our website: www.amibolt.com

B.O.L.T Chest ECG User Manual Model No: VA 07

17.0 Warranty Information

The B.O.L.T is warranted to be free from defects in materials and workmanship within one

year from the date of purchase when used in accordance with the provided instructions. The

warranty is extended only to the end user. The company will repair free of charge any part or

parts of the product if the defect is due to the faulty material or workmanship.

To obtain warranty service contact customer care support by calling 1800-200-8001.

Enclose the warranty card, Proof of Purchase. Include a letter, with your name, address,

phone number, and description of the specific problem. Pack the product carefully to prevent

damage in transit.

The warranty shall not apply to defects resulting from:

o Unauthorized modification/misuse/mishandling of the device.

o Operation of the device outside the environmental specifications of the

product (e.g.: temperature, electrical requirements etc.)

o Any other reason external to the equipment (e.g.: accidents, vibrations etc.)

18.0 Customer Care Support

AMI’s flexible approach allows the customers to get Technical Support and Warranty services

for B.O.L.T through our customer care support.

 Toll-free number (India): 1800–200–8001

 Customer Care Support timings: 10 am - 6 pm Monday – Friday (Except National

Holidays)

 E-mail address: support@amibolt.com

B.O.L.T Chest ECG User Manual Model No: VA 07

19.0 Contact us

AMERICAN MEGATRENDS INDIA PRIVATE LTD.,

KUMARAN NAGAR,

SEMMENCHERY, OFF RAJIV GANDHI SALAI (OMR)

CHENNAI (TN) 600119

Tel – (91) 44 66540922, Fax – (91) 44 66540901

Website: www.amibolt.com; www.amiindia.co.in

European Representative

American Megatrends International GmbH

Truderingerstraße (Truderinger Strasse) 283

81825 München (Munich), Deutschland (Germany)

Tel: [49] 89 969995-10

Email: europesales@ami.com

AMERICAN MEGATRENDS INDIA PRIVATE AMI-ECG-02 B.O.L.T Chest ECG User Manual AMI BOLT

AMERICAN MEGATRENDS INDIA PRIVATE LIMITED B.O.L.T Chest ECG AMI BOLT

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