B.O.L.T BT4, User Manual

Page 1: ...NE 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: ...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 provid...

Page 3: ...yright 2019 All Rights Reserved AmZetta Technologies Private Ltd Document History Version Date Comment 1 0 15 Jul 2019 Initial Release 1 1 23 Aug 2019 Bluetooth security labelling 1 2 26 Aug 2019 Spo2...

Page 4: ...ication on your mobile device 18 10 2 Using Sliding and Settings Screens 21 11 Blood Pressure Measurement Procedure 22 11 1 Blood Pressure measurement with B O L T 23 11 2 Blood Pressure Classificatio...

Page 5: ...tta Technologies Private Ltd 19 Technical Specifications 40 20 Certifications 44 21 Emissions and immunity information 47 21 1 Electromagnetic emissions 47 21 2 Electromagnetic Immunity 48 22 Warranty...

Page 6: ...B O L T application and the results are displayed by the B O L T application on the screen of the smart devices computer This device is applicable for use by an adult and it can be used in a clinical...

Page 7: ...unctional blood Oxygen saturation SpO2 and Pulse Rate PR non invasively and Measurement of the Body Temperature through auditory canal non invasively The B O L T system is modularly designed and consi...

Page 8: ...mobile devices or computers through Bluetooth and utilizes the Software application to operate and control the devices attached to the base unit Functions like activating and stopping the device and...

Page 9: ...lectric method The Pulse oximeter is connected to the base unit via the accessory port in the base unit IRT Thermometer Model VA01 1 The IRT thermometer VA01 1 measures body temperature in the ear can...

Page 10: ...t USB Plug 1 11 Accessory Connector Plug 1 12 Travel Bag 1 5 Product Quality Reliability and Safety The B O L T devices have been designed with an emphasis on quality reliability and safety but the ma...

Page 11: ...hly 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 swallo...

Page 12: ...he 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 The B O L T device should not be used a...

Page 13: ...ermometer probe during the temperature measurement If the thermometer probe is ever accidentally used without a probe cover attached the readings may be incorrect In that case clean the lens with a so...

Page 14: ...operly Use of accessories transducers or cables with the B O L T device other than those specified may result in increased emissions or decreased immunity of the B O L T device Portable RF communicati...

Page 15: ...er is outside recommended size range poor pulse quality venous pulsations anemia or low hemoglobin concentrations cardio green and other intravascular dyes carboxyhemoglobin methemoglobin dysfunctiona...

Page 16: ...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 Clean the rub...

Page 17: ...device is not recommended for people with serious arrhythmia patients implanted with an electrical device patients with preeclampsia atrial fibrillation peripheral arterial disease and patients underg...

Page 18: ...r higher The iOS version of the Smartphone Tablet should be 9 or higher 10 Using B O L T Application 10 1 Downloading and Installing B O L T application on your mobile device 1 Download and Install B...

Page 19: ...completion of user creation a verification link will be mailed to the user email ID 16 On successful verification User can be able to login 17 On successful Login enter near and dear details under se...

Page 20: ...een Result Screen Above application screens are for general illustration purpose only Actual application screens may vary You can also login as a guest user while no login account is available which m...

Page 21: ...king the slider option in the home screen as shown below user can access profile info settings sharing app change B O L T Model and logout Sliding Screen Settings Screen Settings screen allows the use...

Page 22: ...t Relax yourself user in a comfortable position Avoid eating exercising and smoking for 30 minutes before taking a measurement Avoid taking measurements during stressful times Avoid sitting with cross...

Page 23: ...bove 2 Switch ON I the device using the ON OFF sliding switch 3 Enable Bluetooth and Internet Connectivity on the mobile device 4 Launch the B O L T application on the mobile device 5 Choose the live...

Page 24: ...ed Status o Disconnected Status 13 Wrap the cuff around the upper arm of the right hand above the elbow 14 Ensure that the arrow in the BP cuff points the artery along the middle finger of the right h...

Page 25: ...ation for Adults The World Health Organization WHO has created the following classification for assessing high blood pressure Hypertension Please note that this table can give only a generic view as o...

Page 26: ...rt present on the finger before the measurement Clean the surface of the fingertip before the measurement Relax yourself or the user in a comfortable position Remain stable during the measurement Plac...

Page 27: ...and as displayed above 6 Click start play after inserting the finger inside the SpO2 probe 7 Pause to display the SpO2 values 8 On successful measurement the SpO2 value and Pulse rate will be displaye...

Page 28: ...SpO2 Classification Range Hypoxemia low 95 Normal 95 100 The rubber part which is present in spo2 finger area is LATEX FREE and hence we are not adding any additional symbols in the sticker The pulse...

Page 29: ...ermometer Indication of Use The IRT probe Infrared Thermometer is designed for measuring the body temperature from the ear canal of an intended operator patient user in home hospital or clinical envir...

Page 30: ...he individual test and continue 2 Select the Thermometer option from the application screen 3 Follow the below instruction as per image for placing the probe cover and use probe cover over the tip of...

Page 31: ...ned for calculating and estimating body composition parameters by using measured weight and height of an intended operator patient user in home hospital or clinical environment 14 1 Measuring BMI with...

Page 32: ...level goes below 10 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 bat...

Page 33: ...of the battery is 2 years Replacement procedure 1 Switch off the base unit before removing the back cover for the battery replacement 2 Remove the single screw on the upper portion of the battery cov...

Page 34: ...ection 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 co...

Page 35: ...inflate the BP cuff Bluetooth communication error Close the application Restart the B O L T device and restart the entire process again Spo2 probe not connected Spo2 probe connection error If Connect...

Page 36: ...mperature range Make sure new clean probe cover is attached and the thermometer is properly inserted into the ear canal SPO2 or Temperature probe connector not inserting properly Probe connection erro...

Page 37: ...specified range Low 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: ...on Symbol for Follow Instructions for use Symbol for Warning Symbol for Caution Symbol for Notes with additional Information Symbol for Temperature limitation Symbol for TYPE BF APPLIED PARTS Symbol f...

Page 39: ...s 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 Systo...

Page 40: ...of sight Non Invasive Blood Pressure Blood pressure measurement method Oscillometric method with automatic inflation measurement Cuff Pressure range 0 to 280 mmHg Measurement Pressure SYS 40 to 260mm...

Page 41: ...mW sr SPO2 range 70 to 100 below 70 Unspecified SpO2 Measurement Accuracy Arms 70 to 100 2 6 below 70 Unspecified SpO2 Pulse Rate Range 30 to 250 BPM SpO2 Pulse Accuracy 2 BPM SpO2 Unit Dimensions 58...

Page 42: ...nments 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 BOLT application Bluetooth symbol will change...

Page 43: ...O L T User Manual 43 Copyright 2019 All Rights Reserved AmZetta Technologies Private Ltd Accuracy Summary Finger SpO2 Range Finger Oxygen Saturation Arms 70 100 2 57 70 80 2 46 80 90 2 65 90 100 2 61...

Page 44: ...lateral standard Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment IEC 80601 2 30 2009 AMD1 2013 Medical electrical equipment Particu...

Page 45: ...8 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 EN ISO 10993...

Page 46: ...its 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 a...

Page 47: ...r or the user of the B O L T device 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 device...

Page 48: ...c 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 typi...

Page 49: ...s 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 Porta...

Page 50: ...om 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...

Page 51: ...jiv 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 ww...