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B.O.L.T Chest ECG User Manual

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14.0

Technical Specifications

Product Name

B.O.L.T BE1

Device Model Number

VA07

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)

Bluetooth Operating Frequency

2402-2480 MHz

Type of modulation

Gaussian frequency shift modulation

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

Degree of protection

IP22

Applied part

Type BF applied part

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

3.7V 850mAh Li-Poly Battery

Environmental Specification

Operational Temperature

+10 to +45 degree C

Содержание B.O.L.T BE1

Страница 1: ...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 ...

Страница 2: ...ate 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 Tec...

Страница 3: ... ECG User Manual Copyright 2020 All Rights Reserved AmZetta Technologies Private Ltd Page 3 Document History Version Date Comment 1 0 27 Mar 2019 Initial Release 2 0 31 Aug 2020 EC Rep and CE marking details removed ...

Страница 4: ...t 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...

Страница 5: ... 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 proc...

Страница 6: ...uality 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 ...

Страница 7: ...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 fa...

Страница 8: ...commended 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 ...

Страница 9: ...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 ...

Страница 10: ...ructions 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 an...

Страница 11: ...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 disposa...

Страница 12: ...rnal 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 ...

Страница 13: ...mputer 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 ...

Страница 14: ...B O L T Chest ECG User Manual Copyright 2020 All Rights Reserved AmZetta Technologies Private Ltd Page 14 Measurement Screen Above application screens are for general illustration purpose only ...

Страница 15: ...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 ...

Страница 16: ...he 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 devic...

Страница 17: ...itoring 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...

Страница 18: ...nbuilt 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 US...

Страница 19: ... 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 ...

Страница 20: ... 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...

Страница 21: ...a 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...

Страница 22: ... authorized service center ECG device switched ON but no LED is glowing No charge for the battery Connect the respective power adapter to the ECG device and charge Then power ON if still blue LED is not glowing kindly get it repaired in the authorized service center Application displays unexpected readings Used in dusty and unstable environmental conditions Clean the device and accessories with a ...

Страница 23: ...ut Dynamic Range 10mV Peak to Peak Bluetooth Bluetooth 4 0 EDR or Lower Bluetooth Low Energy BLE Bluetooth Operating Frequency 2402 2480 MHz Type of modulation Gaussian frequency shift modulation 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 Degree of protection IP22 Applied part Type BF applied part Circuitry Frequen...

Страница 24: ...ors 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 I Symbol for power ON O Symbol for power OFF 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 ...

Страница 25: ...trically noisy environments and transmits physiological data once per second If data is lost the device will transmit data again one second later If the connection is lost the B O L T Pro application Bluetooth symbol will change from Blue to Grey and become available for a connection in a few seconds Authentication and Encryption Supported Encryption Key Size 128 bits AES advanced encryption stand...

Страница 26: ...llateral Standard Electromagnetic disturbances Requirements and tests IEC 60601 1 2015 E Medical electrical equipment Part 1 General requirements for basic safety and essential performance IEC 60601 1 6 2010 AMD1 2013 Medical electrical equipment Part 1 6 General requirements for basic safety and essential performance Collateral standard Usability EN 62304 2006 AC 2008 Medical device software Soft...

Страница 27: ...les 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 installat...

Страница 28: ... The customer or the user of the B O L T ECG should assure that it is used in such an environment Emissions test Compliance Electromagnetic environment guidance RF emissions EN 55011 Group 1 The B O L T ECG uses RF energy only for its internal function Therefore its RF emissions are very low and are not likely to cause any interference in nearby electronic equipment RF emissions EN 55011 Class B T...

Страница 29: ...tic environment guidance Electrostatic discharge ESD EN 61000 4 2 8kV contact 15kV air 8kV contact 15kV air Floors should be wood concrete or ceramic tile If floors are covered with synthetic material the relative humidity should be at least 30 Electrical fast transient burst EN 61000 4 4 2 kV for power supply Lines 2 kV for power supply Lines Mains power quality should be that of a typical commer...

Страница 30: ...Cycles 0 UT 250 300 Cycle 70 UT 25 26 Cycles 0 UT 250 300 Cycle Power frequency 50 60 Hz magnetic field EN 61000 4 8 30 A m 30 A m Power frequency magnetic fields should be at levels characteristic of a typical location in a typical commercial or hospital environment Note UT is the AC mains voltage prior to application of the test level ...

Страница 31: ...nications equipment As per table 9 3 Vrms 150 kHz to 80 MHz 6 V in ISM and amateur radio bands between 0 15 MHz and 80 MHz 80 AM at 1 kHz 10 V m 80 MHz to 2 7 GHz 80 AM at 1kHz 3 V m 2 7 GHz to 6 GHz 80 AM at 1kHz Proximity fields from RF wireless communications equipment As per table 9 Portable and mobile RF communications equipment should be used no closer to any part of B O L T ECG including ca...

Страница 32: ...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 c...

Страница 33: ... Contact us AMZETTA TECHNOLOGIES PRIVATE LIMITED Kumaran Nagar Semmenchery Off Rajiv Gandhi Salai OMR Chennai TN 600119 India Tel 044 61240022 044 30165922 Fax 044 61240025 Toll free number India 1800 572 4061 Toll free number USA 1833 222 5444 Email support amzbolt com Website www amzbolt com www amzetta co in ...

Страница 34: ... Number Symbol for Manufacturer Catalog Symbol for Manufacturer Symbol for Manufactured Date Symbol for Temperature limitation Symbol for Warning Symbol for Caution Symbol for Federal Communication Commission Symbol for Fragile Symbol for Protect from heat and radioactive sources indication Symbol for KEEP DRY Symbol for Follow Instructions for use Symbol for TYPE BF APPLIED PARTS ...

Страница 35: ...pO2 Alarms Symbol for Direct Current Symbol for Non ionizing Radiation Symbol for Ingress protection The device is protected against solid foreign objects of 12 5mm and greater and against vertically falling water drops when ENCLOSURE is tilted up to 15 angle Symbol for Do not Reuse Symbol for Indicating that the manufacturer s instructions for use are available in an electronic format ...

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