Related Manuals for B.O.L.T BT4
Summary of Contents for B.O.L.T BT4
- Page 1 ONE-TOUCH WIRELESS HEALTH TRACKER BODY LIFE TRACKER B.O.L.T User Manual Product Names: B.O.L.T BT4 Device Model Numbers: VA01, VA01-0, VA01-1, VA01-2 Document No : AMZ-PRD-UM-B-BT4 Version : 1.2 Date : 26.08.2019...
- Page 2 B.O.L.T User Manual Legal Disclaimer This publication/content contains proprietary information which is protected by copyrights. 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.
- Page 3 B.O.L.T User Manual Document History Version Date Comment 15-Jul-2019 Initial Release 23-Aug-2019 Bluetooth security labelling 26-Aug-2019 Spo2 Pulse rate range updated © Copyright 2019, All Rights Reserved. AmZetta Technologies Private Ltd.
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Page 4: Table Of Contents
6. Contraindications ................17 7. Product Features ................17 8. Operating Environment ................18 9. Prerequisites ..................18 Using B.O.L.T Application ..............18 10.1 Downloading and Installing B.O.L.T application on your mobile device ..18 10.2 Using Sliding and Settings Screens ...........21 Blood Pressure Measurement Procedure ..........22 11.1 Blood Pressure measurement with B.O.L.T ........23... - Page 5 B.O.L.T User Manual Technical Specifications ..............40 Certifications ..................44 Emissions and immunity information .............47 21.1 Electromagnetic emissions ............47 21.2 Electromagnetic Immunity ............48 Warranty Information ................50 Customer Care Support ..............50 Contact us ..................51 © Copyright 2019, All Rights Reserved. AmZetta Technologies Private Ltd.
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Page 6: Intended Use
Home users are advised to contact their physician if any abnormal values are indicated. B.O.L.T, NIBP model Base unit (VA01) along with an inflatable cuff (VA01-0) that is wrapped around the upper arm, is a fully automatic, non-invasive, wireless blood pressure measurement system intended to measure the diastolic and systolic blood pressures and pulse rate of an adult individual. -
Page 7: Product Description
B.O.L.T User Manual 2. Product Description The B.O.L.T Patient Physiological Monitor which is called as B.O.L.T Life tracker is a patient vitals measuring and monitoring device which can be used by home users as well at a clinical setting like physician office for spot-checking and measuring of the following patient’s physiological parameters: ... - Page 8 B.O.L.T User Manual Base Unit (Model VA01) The B.O.L.T patient monitor system is elegantly designed with a small form factor. The device has two LED indicators that display power status and Bluetooth connectivity status. The device has an on/off slide switch on the side and a USB power socket. The device has one accessories port with an accessory connector to connect IRT Thermometer and Pulse Oximeter.
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Page 9: Know Your Unit
B.O.L.T User Manual Non-Invasive Blood Pressure (Model VA01-0) NIBP Cuff (model VA01-0) measures non-invasively the blood pressure (the pressures of systolic and diastolic) and pulse rate (PR). The NIBP is based on the oscillometric method. The NIBP is connected to the base unit via the accessory port in the base unit. -
Page 10: Package Contents Of B.o.l.t
The B.O.L.T devices should be used as per the operating instructions mentioned in the user manual provided by the manufacturer. All modifications and repairs to the devices should be carried out by authorized manufacturer personnel or their agents. -
Page 11: Essential Performance
Highly recommended to use manufacturer supplied power adapter and USB cable for charging the B.O.L.T base unit. Keep the B.O.L.T devices out of reach of infants, children, or pets, since inhalation or swallowing of small parts is dangerous or even fatal. - Page 12 Regularly check that the operation of the B.O.L.T device does not result in the prolonged impairment of patient blood circulation. Do not use the B.O.L.T device to monitor the user who is operated with HF surgical equipment. 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.
- Page 13 B.O.L.T User Manual The user is recommended to insert the given accessory connector plug in the accessory connector port when the accessory is not connected. Inserting Accessory Connector Plug Removing Accessory Connector Plug The user can remove the Accessory connector plug while connecting the accessory.
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Page 14: Caution
The responsible organization and the user must verify the compatibility of the display and SpO2 probe before use to avoid patient injury. This probe is only for use with the B.O.L.T device. Do not attempt to use this probe with other medical devices. - Page 15 B.O.L.T User Manual Do not expose the thermometer to the temperature extremes below 14 °F or over 131 °F (- 10 / 55 °C) or excessive humidity (> 85 % RH non-condensing). Nail polish or false fingernails may cause inaccurate SpO2 readings.
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Page 16: Care And Maintenance
Do not disassemble, repair, or modify the device by yourself, as this could affect the safety, and voids the warranty of the device. The B.O.L.T device and accessories are non-sterile. Use a soft cloth to clean the B.O.L.T device. Do not use any abrasive or volatile cleaners. If necessary, you may wipe the cuff with a soft, damp cloth. -
Page 17: Calibration Verification Procedure
6. Contraindications not recommended for people with serious arrhythmia, patients implanted The B.O.L.T device is with an electrical device, patients with preeclampsia, atrial fibrillation, peripheral arterial disease, and patients undergoing intravascular therapy or arterio-venous shunt or people who received a mastectomy. Consult your doctor during pregnancy, arrhythmia, and arteriosclerosis. -
Page 18: Operating Environment
Safe and convenient to use. 8. Operating Environment The B.O.L.T device has been designed for use in the hospitals, clinics or directly by the adult patient at home to monitor the health conditions. The user or the physician is responsible for ensuring that the device is stored and used in recommended environmental conditions. - Page 19 B.O.L.T User Manual 14. Select the Terms and Conditions and User agreement checkboxes and Click create my account to complete the user registration. 15. On successful completion of user creation, a verification link will be mailed to the user email ID.
- Page 20 B.O.L.T User Manual Home Screen Result Screen Above application screens general illustration purpose only. Actual application screens may vary. You can also login as a guest user while no login account is available, which might not store the measured vital parameters in the cloud storage space on the measured parameters.
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Page 21: Using Sliding And Settings Screens
B.O.L.T Model and logout. Sliding Screen Settings Screen:- Settings screen allows the user to access B.O.L.T website, User Manual, Language settings, near and dear settings, Change password, Cloud options, Legal info and Contact info. Setting Screen... -
Page 22: Blood Pressure Measurement Procedure
B.O.L.T User Manual Save in Cloud option is enabled by default. Use can turn-off if required. Guest users will not save the test results. 11. Blood Pressure Measurement Procedure Indication of Use: The device is designed to measure blood pressure (systolic and diastolic) and pulse rate for adult patients with arm circumference range between 22.0 cm to 42.0 cm. -
Page 23: Blood Pressure Measurement With B.o.l.t
B.O.L.T User Manual 11.1 Blood Pressure measurement with B.O.L.T B.O.L.T device enables connecting an air hose through which the pulses are picked-up and blood pressure is monitored. Connecting air hose with the device and launching B.O.L.T application 1. Insert the BP connector plug into the BP socket firmly as shown above. - Page 24 B.O.L.T User Manual Measuring BP with B.O.L.T 7. On successful login of the B.O.L.T application, you will be directed to the home screen. 8. Click on the information icon to understand the options. 9. Select “How is my health” option to perform Master Health checkup or select “Check Vitals”...
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Page 25: Blood Pressure Classification For Adults
B.O.L.T User Manual 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. User cancel test instants while taking measurement using the back button 11.2 Blood Pressure Classification for Adults... -
Page 26: Blood Oxygen Level Measurement Procedures Using Pulse Oximeter
The spo2 probe will not work indipendnetly. 12.1 Blood Oxygen Level measurement with B.O.L.T B.O.L.T enables connecting a SpO2 probe through which the blood oxygen level is measured. Connecting SpO2 probe with the B.O.L.T device Insert the SpO2 connector into the socket firmly as shown below. - Page 27 B.O.L.T User Manual Measuring Blood Oxygen Level with B.O.L.T 1. Clean the rubber pad of the SpO2 probe touching the finger gently with a soft cloth dampened with 70% isopropyl alcohol and let air dry or use a soft dry cloth to clean before measurement.
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Page 28: Blood Oxygen Level Classification
B.O.L.T User Manual SpO2 Display value is a moving average of the last 5 readings from the SpO2 probe, which are taken at 60 Hz. 12.2 Blood Oxygen Level Classification Please note that this table can give only a generic view. Consult with your physician for accurate assessment. -
Page 29: Temperature Measurement Procedures Using Infrared Thermometer
SpO2 is in the abnormal range. A functional tester cannot be used to assess the accuracy of the pulse Oximeter probe or the accuracy of the B.O.L.T pulse oximeter. The responsible organization can verify the functionality (but not the accuracy) of the SpO2 sensor with a functional tester. -
Page 30: Body Temperature Measurement With B.o.l.t
B.O.L.T User Manual 13.1 Body Temperature measurement with B.O.L.T B.O.L.T enables connecting an IR Thermometer through which the body temperature is measured. Connecting IR Thermometer with the device Insert the IR Thermometer connector into the socket firmly as shown below. -
Page 31: Temperature Classification
BMI Range Category <20 Under Weight 20-25 Normal Weight 25-30 Over Weight >30 Obesity Once the measurement is completed, Kindly switch off the B.O.L.T device using sliding button. © Copyright 2019, All Rights Reserved. AmZetta Technologies Private Ltd. -
Page 32: Battery Care
Charge the base unit using the power adapter and view the charge level in the mobile application software. To view the Battery Level, after pairing with the B.O.L.T device, Click battery icon at top right corner in the application. -
Page 33: Replacement Of Battery Pack
B.O.L.T User Manual 15.1 Replacement of Battery Pack It is highly recommended changing the battery of the base unit for every 2 years at the authorized service center. Use manufacturer recommended battery for replacement. Both shelf life & service life of the battery is 2 years. -
Page 34: Troubleshooting
Restart the B.O.L.T device communication error vitals and Bluetooth indicator and restart the entire starts blinking process again B.O.L.T device switched ON, but Bluetooth pairing not showing in the list of the Restart the B.O.L.T device, problem available Bluetooth device in the... - Page 35 B.O.L.T User Manual Connect the respective No charge in the B.O.L.T device switched ON, but power adaptor to the battery no LED is glowing B.O.L.T device and charge. Then power ON, if still the LED is not glowing kindly get it repaired in the...
- Page 36 B.O.L.T User Manual Make sure new, clean Application displays Temperature taken is probe cover is attached thermometer reading as High/ not within a typical and the thermometer is human temperature properly inserted into the range ear canal. SPO2 or Temperature probe...
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Page 37: Explanation Of Indicators/Symbols
IR thermometer measures and exceeds to the higher level specified range. IR thermometer measures and exceeds to the lower level specified range. Flashing of the Bluetooth light indicates that the B.O.L.T device is waiting for pairing with the mobile/tab. - Page 38 B.O.L.T User Manual Symbol for “MANUFACTURED DATE” Symbol for “SERIAL NUMBER” Symbol for “EUROPEAN REPRESENTATIVE” Symbol for “EUROPEAN CONFORMITY” Symbol for “Federal Communication Commission” Symbol for “Follow Instructions for use” Symbol for “Warning” Symbol for “Caution” Symbol for “Notes with additional Information”...
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Page 39: Acronyms Used
Symbol for “No SpO2 Alarms” Dashes replace the readings when the pulse oximeter device is unable to detect a usable signal. 18. Acronyms Used B.O.L.T – Body Life Tracker NIBP - Non-Invasive Blood Pressure BP – Blood Pressure SYS – Systolic Blood Pressure DIA –... -
Page 40: Technical Specifications
B.O.L.T User Manual 19. Technical Specifications Product Name B.O.L.T BT4 Base Unit Device Model Number VA01 Base Unit Dimensions 130 (L) X 40.3 (H) X 75 (D) mm Base Unit Weight 220 grams (Including Battery) Power Source DC 5V 2A Battery 3.7V Li-Polymer 850mAH... - Page 41 B.O.L.T User Manual seconds to show the final reading after user initiate the measure in the application. IRT Unit Dimensions 84.8 (L) X 18 (H) X 26.6 (D) mm (Highest width along the profile) IRT Unit Weight 42 grams Minimum time required between each...
- Page 42 B.O.L.T User Manual Bluetooth Wireless Technology Information: Bluetooth Compliance: Version 4.1 Dual mode BR/EDR/low energy Operating Frequency: 2.4 to 2.480 GHz Output Power: TX: 4.4 dBm / -3.79 dBm Operating Range: 10 meter radius (line of sight) Operation: Slave Antenna Type: Integrated chip type antenna...
- Page 43 B.O.L.T User Manual Accuracy Summary – Finger SpO2 Finger Oxygen Saturation Range (Arms %) 70 – 100% 2.57 70-80% 2.46 80-90% 2.65 90-100% 2.61 © Copyright 2019, All Rights Reserved. AmZetta Technologies Private Ltd.
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Page 44: Certifications
B.O.L.T User Manual This graph shows plots of the error (SpO2 – SaO2) by SaO2 using the pulse oximeter (VA01-2) with a linear regression fit and upper 95% and lower 95% limits of agreement. Each sample data point is identified by subject from a clinical study in non-motion conditions. - Page 45 B.O.L.T User Manual Systems; Harmonised Standard covering the essential requirements of article 3.1(b) of Directive 2014/53/EU. EN 62304:2006/AC: 2008 Medical device software - Software life-cycle processes. EN ISO 10993-1:2009/AC: 2010 Biological evaluation of medical devices- Part1: Evaluation and Testing within a risk management process.
- Page 46 B.O.L.T User Manual FCC compliance statements FCC ID: 2AFV6-AMI-BU-2 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.
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Page 47: Emissions And Immunity Information
Guidance and manufacturer’s declaration – electromagnetic emissions The B.O.L.T device is intended for use in the electromagnetic environment specified below. The customer or the user of the B.O.L.T device should assure that it is used in such an environment. Electromagnetic environment –... -
Page 48: Electromagnetic Immunity
Guidance and manufacturer’s declaration – electromagnetic immunity The B.O.L.T device is intended for use in the electromagnetic environment specified below. The customer or the user of the B.O.L.T device should assure that it is used in such an environment. - Page 49 Guidance and manufacturer’s declaration – electromagnetic immunity The B.O.L.T device is intended for use in the electromagnetic environment specified below. The customer or the user of the B.O.L.T device should assure that it is used in such an environment.
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Page 50: Warranty Information
To assess the electromagnetic environment due to fixed RF transmitters, an electromagnetic site survey should be considered. If the measured field strength in the location in which the B.O.L.T device is used exceeds the applicable RF compliance level above, the B.O.L.T device should be observed to verify normal operation. -
Page 51: Contact Us
B.O.L.T User Manual 24. 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.com European Representative CMC Medical Devices &...