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

B.O.L.T Chest ECG User Manual
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Legal
Disclaimer
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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.

B.O.L.T Chest ECG User Manual
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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

B.O.L.T Chest ECG User Manual
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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

B.O.L.T Chest ECG User Manual
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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

B.O.L.T Chest ECG User Manual
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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.

B.O.L.T Chest ECG User Manual
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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.

B.O.L.T Chest ECG User Manual
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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.

B.O.L.T Chest ECG User Manual
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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.

B.O.L.T Chest ECG User Manual
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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.