AmZetta B.O.L.T Chest ECG User manual

ONE-TOUCH WIRELESS HEALTH TRACKER
BODY LIFE TRACKER
B.O.L.T Chest ECG User Manual
Product Name: B.O.L.T BE1
Device Model Number: VA07
Document No : AMZ-PRD-UM-B-BE1
Version : 2.0
Date : 31-Aug-2020

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Legal
Disclaimer
This publication/content contains proprietary information which is protected by copyright. No
part of this publication may be reproduced, transcribed, stored in a retrieval system, translated
into any language or computer language, or transmitted in any form whatsoever without the
prior written consent of the publisher. AmZetta Technologies Private Ltd. retains the right to
update, change or modify this publication at any time, without notice.
For Additional Information
Call AmZetta Technologies Private Ltd at 1800-572-4061.
Limitations of Liability
In no event shall AmZetta Technologies 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. AmZetta Technologies 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
Copyright © 2020 AmZetta Technologies Private Ltd. All Rights Reserved.
AmZetta Technologies Private Ltd.,
Kumaran Nagar, Semmenchery, Off Rajiv Gandhi Salai (OMR),
Chennai (TN) 600119, India.
All product names used in this publication are for identification purposes only and are
trademarks of their respective companies.

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Document History
Version
Date
Comment
1.0
27-Mar-2019
Initial Release
2.0
31-Aug-2020
EC Rep and CE marking details removed

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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 Essential Performance.................................................................... 7
4.2 Warning ................................................................................... 7
4.3 Caution ....................................................................................10
4.4 Care and Maintenance...................................................................10
4.5 Calibration Verification Procedure ....................................................11
4.6 Disposal....................................................................................11
5.0 Contraindications..............................................................................11
6.0 Product Features ..............................................................................12
7.0 Operating Environment.......................................................................12
8.0 Prerequisites ...................................................................................12
9.0 Using Mobile Application .....................................................................13
10.0 B.O.L.T Chest ECG Measurement procedure ..............................................15
11.0 Charging the B.O.L.T Chest ECG Devices ..................................................18
12.0 Battery Care ...................................................................................20
12.1 Replacement of Battery Pack ..........................................................20
13.0 Troubleshooting ...............................................................................21
14.0 Technical Specifications......................................................................23
15.0 Explanation of Indicators.....................................................................24
16.0 Certifications ..................................................................................26
17.0 FCC compliance statements .................................................................27
18.0 Emissions and immunity information .......................................................28
18.1 Electromagnetic emissions .............................................................28
12.2 Electromagnetic Immunity..............................................................29
19.0 Warranty Information.........................................................................32
20.0 Customer Care Support.......................................................................32
21.0 Contact us ......................................................................................33
22.0 Applicable Label Symbols ....................................................................34

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1.0 Intended Use
B.O.L.T Chest EGG is intended to acquire the single lead ECG parameters of adult users (18
years of age or older). 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 single lead 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 ECG device can be used to obtain clinical consultation from cardiologists or
healthcare practitioners.
B.O.L.T Chest ECG Device
ECG Electrode Cables

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Charging Adapter & USB Cable Disposable ECG Electrodes
3.0 Package Contents
S. No
Packing List
Quantity
1
B.O.L.T Chest ECG Device (VA07)
1
2
ECG Electrode cables
3
3
Disposable ECG Electrodes
3 Packs
4
Power Adapter
1
5
USB Cable
1
6
Warranty Card
1
7
Quick Reference Guide
1
8
USB Plug for USB Port
1
9
Travel bag
1
4.0 Product Quality Reliability and Safety
The ECG device has been designed with an emphasis on quality, reliability, and safety, but
manufacturer can only accept responsibility for these aspects, provided the following
conditions are met
The ECG device should be used as per the operating instructions mentioned in the
user manual provided by the manufacturer.
All modifications and repairs to the device are carried out by authorized service
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 ECG device must comply with regulation specified in warning and cautions.

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4.1 Essential Performance
The ability to detect single lead ECG, respiration rate (RESP), and heart rate (HR) as per IEC
60601-2-27 using Disposable ECG Electrodes.
4.2 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.
All modifications and repairs to the ECG device should be carried out by authorized
service personnel or their agents.
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.
No modification of this device is allowed.
Use only the type of power source that is indicated on the label.
Unplug the device before servicing/cleaning.
Only trained personnel is allowed to service the device.
Do not expose the device to strong shocks or vibrations.
Check the electrical connections periodically; any defects noticed, like loose
connections, damaged by insulation in the electrical wires etc., should be reported
and rectified immediately.
Keep the ECG device out of reach of infants, children, or pets, since inhalation or
swallowing of small parts is dangerous or even fatal.
Disposable ECG electrodes are meant only for a single time usage on a user and need
to be disposed after the single use to avoid cross-contamination.
Clean the device and accessories with a soft cloth dampened with 70% isopropyl
alcohol before taking a measurement from one user to another to avoid cross-
contamination.
Retake the reading when the application displays unexpected errors/readings by
following the mandatory instructions given in the measurement section.
Do not use the ECG device in an MRI suite.
The ECG 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.

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Highly recommended to use manufacturer supplied power adapter and USB cable for
charging the ECG device.
Exposure of the device to water is prohibited.
Do not use the ECG device to monitor the user who is operated with HF surgical
equipment.
The ECG device should not be used adjacent to or stacked with other equipment, and
that if adjacent or stacked use is necessary, the device should be observed to verify
normal operation in the configuration in which it will be used.
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 ECG device.
Adhesives present in 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.
Make sure that the ECG electrodes positioning place are clean shaved for accurate
ECG measurement.
The ECG electrodes should not contact any other conductive surfaces or earth
ground, at any time.
Exposure to unsuitable environmental conditions may cause the ECG device to
malfunction and provide inaccurate readings.

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The ECG device must be used according to the indications given by the manufacturer
in the user manual with particular attention to Intended use.
Inappropriate application or duration of ECG electrodes may result in tissue damage.
Highly recommended to use manufacturer supplied disposable ECG electrodes for the
measurement.
Use only the manufacturer recommended ECG electrodes for the measurements,
mixing of the electrode types may adversely affect the reading.
Highly recommended to use only the manufacturer supplied power adapter and USB
cable for charging the ECG device.
In case of any incident or malfunctioning of the ECG device, the user is required to
inform the manufacturer without any delay.
The device has been designed to pair with a single tablet/mobile phone during
patient monitoring activities. It is not possible to view patient data from multiple
tablets/mobile phones.
If the user is uncertain about the accuracy of any measurement, it is the responsibility
of the user to verify the vital signs by an alternative means if deemed necessary and
make certain that the accessories and the device are functioning properly.
Use of accessories, transducers, or cables with the ECG device other than those
specified may result in increased emissions or decreased immunity of the ECG device.
Portable RF communications equipment (including peripherals such as antenna
cables and external antennas) should be used no closer than 30 cm (12 inches) to any
part of the ECG device including cables specified by the manufacturer. Otherwise,
degradation of the performance of this device may occur.
To avoid measurement errors, avoid taking measurements near a strong
electromagnetic field radiated interference signal.
Do not attempt self-diagnosis or self-treatment based on the measurements provided
by the device.
Remove electrodes, patient lead wires, and recorder from the patient before
defibrillation.
Highly recommended for changing the battery of the base unit at the manufacturer
authorized service center.
The manufacturer cannot be held responsible for any damage caused by the user to
the device by failing to follow the warnings and instructions mentioned in this
manual.
Servicing and troubleshooting procedures on the software or hardware components
may only be performed by authorized service centers.
The power adapter is given only for charging the device and should not be used while
charging.

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4.3 Caution
Do not use unauthorized parts and accessories for the measurement which may
result in inaccurate readings.
Do not store or use this device in locations which are maintained above/below the
specified temperature and humidity ranges.
Use the ECG device in the environment as described in this user manual. Otherwise,
you will compromise the device’s performance and reduce its lifetime.
Do not use the device in an operating theatre nor in the presence of inflammable
liquids or detergents, nor in the presence of inflammable anesthetic gases, oxygen or
nitrogen.
Wrong positioning of the ECG electrodes may lead to inaccurate readings.
Use only manufacturer specified batteries and charging devices.
4.4 Care and Maintenance
Store the device and the components in a clean and safe location.
User is highly recommended to follow the instructions provided in this user manual
for safe operation.
Changes or modifications not approved by the manufacturer will void the user
warranty.
Keep the accessories and device away from rain, sweat, and water.
Avoid operating the ECG device in dusty and unstable temperature environments.
Charge the device for minimum of two hours during first time usage.
Do not disassemble, repair or modify the device and the components by yourself, as
this could affect the safety, and voids the warranty of the device if the seal is broken.
Wipe the device using 70% Isopropyl alcohol and let it air dry and do not use any
other hazardous solvent to clean the device.
Do not spill any liquid into the device.
Unexpected mechanical damage of the device must be intimate to the manufacturer
immediately.
Verify the device operation is normal and safe if the device is not been used for an
extended period of time.
Do not clean with ketones or other flammable agents.
Do not service or perform maintenance procedure while in use with patients.
Servicing and troubleshooting procedures on the software or hardware components
may only be performed by authorized service centers.

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For service or consumables contact Toll-free number (India): 1800–572–4061.
Service life of the ECG device is 5 years.
4.5 Calibration Verification Procedure
This calibration verification procedure, technical descriptions, circuit diagrams, component
part lists and assembly instructions are restricted to access by the responsible service
personnel and is not applicable in normal usage.
4.6 Disposal
Dispose of the device, 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.
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.

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6.0 Product Features
Displays ECG waveform
Measures Heart Rate Variability (HRV), Respiration rate (RR) and Heart Conditions
Available for Android 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 recommended
environmental conditions as mentioned in the environmental specification given in
the technical specification section in this user manual.
8.0 Prerequisites
Some basic requirements must be adopted as mentioned below to ensure better operation
of the product.
Profile of the user should be minimum of 8 years of education.
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 4.2 or higher.
The Windows OS version of the computer/mobile device should be 7.1 or higher.

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Windows OS version sample application & SDK will be provided on
request
9.0 Using Mobile Application
Downloading and Installing the Mobile application on your computer/mobile device
1. Download and Install the “B.O.L.T “Application from Play store/Application store.
2. On successful installation, launch the application on the mobile device.
3. Click Signup and 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.
Launch Screen Login Screen

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Measurement Screen
Above application screens are for general illustration purpose
only.

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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 in color and LL is red
color.
RA –Right Arm, LA –Left Arm & LL –Left Leg

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4. Clip/button the ECG Electrode cable to the disposable ECG electrode as shown below.
5. Once the setup is connected to 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 (I) 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.

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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. 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.
20. Once the measurement is completed, kindly switch OFF (O) the ECG device using
sliding button.
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.
For sync to occur successfully between the device and the tablet
there must be a valid Bluetooth connection.

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Bluetooth indicator starts blinking if the pairing connection
between the ECG device and mobile device 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).

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3. Plug the adapter into the AC mains (110V, 60Hz or 230V, 50Hz).
4. Switch ON the AC mains to charge the device.
5. Check whether the power indicator turns red while charging the device.
6. The device should not be operated in charging mode.
7. To view the Battery Level, after pairing with the ECG device, Click battery icon at
top right corner in the application. You can also view under settings option.

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12.0 Battery Care
The power adapter is included in the pack and the specifications are mentioned
below.
AC input: 100-240V, Frequency: 50Hz to 60Hz, 0.35A Max, DC output: +5V @ 2A
Connect the power adapter to the power source and micro USB port to the base
unit`s USB Power Socket.
Charge the base unit for a minimum of two hours during the first time usage.
The mobile application indicates the battery low status when the battery level goes
below 25% and shows critically low status when the battery level goes below 10%.
To view the Battery Level, after pairing with the ECG device, Click battery icon at top
right corner in the application. You can also view under settings option.
Even though Over-charging is mitigated in the design, it`s recommended to unplug
the power adapter from the power source when the charge level reaches 100%.
When the charge is low, please connect the base unit to the power source using the
power adapter.
The device should not be operated in charging mode.
If the device is in storage, check the battery every 3 months to ensure that it is still
able to charge and power up the device.
12.1 Replacement of Battery Pack
It is highly recommended changing the battery of the base unit for every 2 year at the
authorized service center. Use manufacturer recommended battery for replacement.
Both shelf life & service life of the battery is 2 year.