User`s Manual - BPL Medical Technologies
Transcription
User`s Manual - BPL Medical Technologies
Medical Technologies User’s Manual BPL LIFEPHONE PLUS BG / BPL LIFEPHONE PLUS. Version 2.3 Follow us on www.bplmedicaltechnologies.com Notice This manual describes the safe and effective operation of the BPL LIFEPHONE PLUS BG/ BPL LIFEPHONE PLUS wellness monitoring device. It is written for adult users and clinical professionals who operate, maintain, and/or troubleshoot the BPL LIFEPHONE PLUS BG/ BPL LIFEPHONE PLUS wellness monitoring device. Before using the BPL LIFEPHONE PLUS BG/ BPL LIFEPHONE PLUS wellness monitoring device or servicing the device — you must read and understand this manual and all other information accompanying the device and related options or accessories, as it contains important information concerning your safety and the safety of others. RESPONSIBILITY OF THE MANUFACTURER BPL Medical Technologies Private Limited (BPLMTPL) only considers itself responsible for any effects on safety, reliability and performance of the equipment if: Assembly operations, re-adjustments, modifications or repairs are done by persons authorized by BPLMTPL. The instrument is used according to the instructions for use presented in this manual. The device is transported, stored and used in environment conditions as specified in this User’s Manual. Accessories used are only those recommended by BPLMTPL. Contents of this document may not be reproduced in whole or in part in any form or by any means, electronic or mechanical, including photocopying and recording, or by any information storage or retrieval system without the written consent of BPL Medical Technologies Private Limited. 378-D-006 Rev 2.3 User’s Manual P a g e |1 CONTACT DETAILS Service Call center Number- 1800-4252355 The BPLMTPL Service Call center can assist with product troubleshooting to help with any issue with the BPL LIFEPHONE PLUS BG/ BPL LIFEPHONE PLUS wellness monitoring device or any of its accessories. To open a service call or obtain product support, call the above listed number or contact your local sales and service representative. For other product information please contact one of the offices listed below: BPL Medical Technologies Pvt. Ltd. 11th KM Bannerghatta Road, Arakere, Bengaluru – 560076. BPL Medical Technologies Pvt. Ltd. BPL Works, Palakkad, Kerala – 678007. Website: www.bplmedicaltechnologies.com Official language of this document is English. Due to continuing product innovation, specifications and operating characteristics listed in this document are subject to change without notice. 378-D-006 Rev 2.3 User’s Manual P a g e |2 Table of Contents Notice .................................................................... 1 TABLE OF CONTENTS ............................................................. 3 TABLE OF FIGURES ................................................................ 8 CHAPTER 1 GETTING ACQUAINTED .............................11 CONVENTIONS USED IN THE MANUAL .............................. 11 GENERAL SAFETY INFORMATION ...................................... 11 WELLNESS MONITOR SERVICING AND REPAIR .... 16 BATTERY USE AND MAINTENANCE ..................... 16 WELLNESS MONITOR CLEANING AND DISINFECTION ..................................................... 16 WELLNESS MONITOR ACCESSORIES .................... 17 GENERAL SYMBOLS AND MARKING .................................. 18 USE DURING AN EMERGENCY .......................................... 21 CHAPTER 2 OVERVIEW ...............................................22 INTENDED USE ............................................................. 22 INDICATIONS & CONTRAINDICATIONS FOR USE ................... 23 SPECIFIED SKILLS, TRAINING, KNOWLEDGE OF OPERATOR ..... 24 APPLICATION ENVIRONMENT .......................................... 24 FEATURES ................................................................... 24 CONTROLS, INDICATORS AND CONNECTORS ....................... 25 CHAPTER 3 SETTING UP THE BPL LIFEPHONE PLUS ......29 INITIAL INSPECTION ....................................................... 29 POWERING UP THE BPL LIFEPHONE PLUS ..................... 29 POWERING OFF THE BPL LIFEPHONE PLUS .................... 30 CHARGING THE INTERNAL BATTERIES ................................ 30 BATTERY CHARGER: PRECAUTIONS FOR USE ....................... 32 378-D-006 Rev 2.3 User’s Manual P a g e |3 AUTO POWER OFF........................................................ 33 CHAPTER 4 INSTALLING THE ‘CONSUMER APP’ ...........34 DOWNLOADING INSTRUCTIONS ....................................... 34 INSTALLATION INSTRUCTIONS .......................................... 35 CHAPTER 5 PAIRING MOBILE DEVICE WITH BPL LIFEPHONE PLUS.........................................................36 PAIRING WITH THE BPL LIFEPHONE PLUS FOR THE FIRST TIME ....................................................................................... 36 SUBSEQUENT PAIRING ................................................... 39 CHAPTER 6 BPL LIFEPHONE PLUS SERVER: QUICK REGISTRATION ...........................................................41 SETTING UP A BPL LIFEPHONE PLUS CLOUD SERVER ACCOUNT ......................................................................... 41 TERMS & CONDITIONS AND PRIVACY CONSENT .................. 44 FINISHING THE USER REGISTRATION PROCESS .................... 46 LOGGING OUT OF THE BPL LIFEPHONE PLUS .................. 47 CHAPTER 7 RECORDING ECGS USING THE BPL LIFEPHONE PLUS.........................................................49 THE BPL LIFEPHONE PLUS ECG ELECTRODES ............. 49 RECOMMENDED ENVIRONMENT FOR RECORDING ECGS ....... 50 INSTRUCTIONS TO BE FOLLOWED TO OBTAIN GOOD ECG RECORDINGS ...................................................................... 51 CHOOSING THE ECG RECORDING MODE ON “CONSUMER APP” ............................................................. 52 SKIN PREPARATION BEFORE EACH STEP OF ECG RECORDING .. 53 STEP1 OF ECG RECORDING ............................................. 53 STEP 2 OF ECG RECORDING ............................................ 55 378-D-006 Rev 2.3 User’s Manual P a g e |4 STEP 3 OF ECG RECORDING ............................................ 57 STEP 4 OF ECG RECORDING ............................................ 59 ADDING ADDITIONAL COMMENTS .................................. 63 SELECTING COMMON SYMPTOMS .................................. 64 SAVING YOUR ECG ONTO BPL LIFEPHONE PLUS SERVER 64 ALLOTMENT OF AN UNIQUE MEASUREMENT ID NUMBER ... 65 CHAPTER 8 ACTIVITY LOGGING MODE OF BPL LIFEPHONE PLUS.........................................................66 PROPER WEAR FOR TAKING ACTIVITY LOGS........................ 66 SETTING UP THE “CONSUMER APP” TO MEASURE ACTIVITY LOGS ....................................................................................... 67 STARTING THE ACTIVITY MEASUREMENT ........................... 70 CHAPTER 9 BLOOD GLUCOSE MEASUREMENT MODE ..75 SAFETY INFORMATION FOR BLOOD GLUCOSE MEASUREMENT 75 BPL LIFEPHONE PLUS BG & BLOOD GLUCOSE ACCESSORIES ....................................................................................... 77 KNOW YOUR ON CALL® SIMPLE BLOOD GLUCOSE TEST STRIPS ....................................................................................... 79 STORAGE AND HANDLING OF TEST STRIPS ......................... 80 INSTRUCTIONS TO PLACE A DROP OF BLOOD ONTO THE TEST STRIPS .............................................................................. 80 ON CALL® SIMPLE BLOOD GLUCOSE CONTROL SOLUTION .... 80 BPL LIFEPHONE PLUS BG: QUALITY CONTROL TEST ........ 81 PERFORMING A QUALITY CONTROL TEST USING “CONSUMERAPP” .............................................................. 81 USING “CONSUMER APP” TO MEASURE BLOOD GLUCOSE .... 85 STEP1 - GETTING A DROP OF BLOOD ............................. 85 378-D-006 Rev 2.3 User’s Manual P a g e |5 FINGERTIP TESTING ..................................................... 86 FOREARM AND PALM TESTING ...................................... 88 STEP2 - TESTING BLOOD GLUCOSE ................................ 90 COMPARING WELLNESS MONITOR AND LABORATORY RESULTS ....................................................................................... 94 CHAPTER 10 THE BPL LIFEPHONE PLUS SERVER ...........95 YOUR “CLOSED WALLET ACCOUNT” ON BPL LIFEPHONE PLUS SERVER .................................................................... 95 CHOOSING YOUR DOCTOR, SIGNING UP FOR CONSULTATION SERVICES ........................................................................... 95 SENDING YOUR ECG/ BG MEASUREMENTS TO YOUR DOCTOR ....................................................................................... 96 READING THE CONSULTATION NOTE FROM YOUR DOCTOR .. 97 REVIEWING PREVIOUSLY ACQUIRED RECORDINGS .............. 97 REVIEWING HISTORICAL RECORDINGS ON “CONSUMER APP” ....................................................................................... 97 CHAPTER 11 UNINSTALLING & UPGRADING “CONSUMER APP” .................................................... 100 REMOVE BPL LIFEPHONE PLUS FROM YOUR “CONSUMER APP”.............................................................................. 100 UNINSTALLING THE “CONSUMER APP” ......................... 100 UPGRADING THE “CONSUMER APP” ............................ 101 CHAPTER 12 CARE AND MAINTENANCE .................... 102 INSPECTION ............................................................. 102 CLEANING ............................................................... 102 CLEANING THE LANCING DEVICE .................................. 103 RECOMMENDED FREQUENCY OF MAINTENANCE TASKS .... 103 378-D-006 Rev 2.3 User’s Manual P a g e |6 CHAPTER 13 STORAGE & SERVICING ......................... 105 WELLNESS MONITOR STORAGE .................................... 105 STORAGE & HANDLING OF ON CALL® SIMPLE TEST STRIPS 105 SPECIAL INSTRUCTIONS FOR TEST STRIP IN THE VIAL ......... 106 SPECIAL INSTRUCTIONS FOR TEST STRIP IN THE FOIL POUCH ..................................................................................... 106 STORAGE & HANDLING OF ON CALL® SIMPLE CONTROL SOLUTION ....................................................................... 106 SERVICING THE BPL LIFEPHONEPLUS WELLNESS MONITOR ..................................................................................... 107 CHAPTER 14 DISPOSAL ............................................. 108 DISPOSAL OF THE LANCET ........................................... 108 CHAPTER 15 STANDARD ACCESSORIES ...................... 109 CHAPTER 16 TROUBLESHOOTING.............................. 111 CHAPTER 17 TECHNICAL SPECIFICATIONS .................. 114 CHAPTER 18 EMC GUIDANCE AND MANUFACTURER’S DECLARATIONS ........................................................ 118 USER’S MANUAL REVISON HISTORY.......................... 120 378-D-006 Rev 2.3 User’s Manual P a g e |7 Table of Figures Figure 1 - Know Your Wellness monitor – Top Side .................... 25 Figure 2 - Know Your Wellness monitor – Bottom Side .............. 25 Figure 3- BPL LIFEPHONE PLUS with fully charged battery ......... 30 Figure 4 - Opening USB cap cover .............................................. 30 Figure 5 - Battery Low Indicator ................................................. 32 Figure 6 - 'ConsumerApp' Shortcut ............................................ 35 Figure 7 - BPL LIFEPHONE PLUS STARTUP SCREEN ..................... 37 Figure 8 - KEYING IN THE DEFAULT PASSWORD ......................... 37 Figure 9 - SETTING UP A SECURE PIN ......................................... 38 Figure 10 - Change PIN confirmation screen .............................. 38 Figure 11 - BPL LIFEPHONE PLUS paired with mobile device ...... 39 Figure 12 – The Login Screen of ‘Consumer App’ ....................... 42 Figure 13 - Quick Registration Form -1 ....................................... 43 Figure 14 - Quick Registration Form - 2 ...................................... 44 Figure 15 - Privacy consent ........................................................ 45 Figure 16 - Accepting terms & conditions and Privacy policy ..... 45 Figure 17 - Home Screen on successful logon ............................ 46 Figure 18 - "Consumer App" Settings Menu ............................... 47 Figure 19 - Signing out ............................................................... 48 Figure 20 - ECG ELECTRODES ON BPL LIFEPHONE PLUS ............. 49 Figure 21 - Chest Electrode Placement Positions ....................... 50 Figure 22 - Starting the ECG Recording Mode ............................ 52 Figure 23 - Chest Electrode Placement for Step1 ....................... 54 Figure 24 – Finger Electrode Placement for Steps 1, 2, 3 & 4 ..... 54 Figure 25 - STEP 1 of ECG RECORDING ....................................... 55 Figure 26 - Chest electrode placement in Step 2 ........................ 56 378-D-006 Rev 2.3 User’s Manual P a g e |8 Figure 27 - STEP 2 of ECG RECORDING ....................................... 57 Figure 28 - Chest Electrode Placement for Step 3 ...................... 58 Figure 29 - STEP 3 of ECG RECORDING ....................................... 59 Figure 30 - Chest Electrode Placement for Step 4 ...................... 60 Figure 31 - STEP 4 of ECG RECORDING ....................................... 61 Figure 32 - Your ECG trace on Consumer App ............................ 62 Figure 33 - ECG view in Landscape mode ................................... 63 Figure 34 - Adding Comments .................................................... 63 Figure 35 - State your health condition ...................................... 64 Figure 36 - Saving ECG onto BPL LIFEPHONE PLUS server .......... 64 Figure 37 - ECG Recording Measurement ID number ................. 65 Figure 38 – Fix the holster onto the device ................................ 66 Figure 39 - Holstering BPL LIFEPHONE PLUS onto your waist band ................................................................................................... 67 Figure 40 - Logging onto BPL LIFEPHONE PLUS server ................ 69 Figure 41 - Setting your Activity profile ...................................... 70 Figure 42 - Populating User Profile details ................................. 70 Figure 43 - Stating the Activity measurement ............................ 71 Figure 44 - BPL LIFEPHONE PLUS in Acitvity Logging Mode ........ 72 Figure 45 - Triggering Activity Logging Mode ............................. 73 Figure 46 – Activity logging ........................................................ 74 Figure 47 - Saving your Activity Log ............................................ 74 Figure 48 – Wellness monitor & On Call ® Accessories ............... 77 Figure 49 - Known your On Call® Simple Test Strip ..................... 79 Figure 50 - Blood Glucose Calibration ........................................ 82 Figure 51 – Inserting the Test strip ............................................. 82 Figure 52 - Lancing Device with sterile lancet ............................ 85 378-D-006 Rev 2.3 User’s Manual P a g e |9 Figure 53 - Starting the BG Recording Mode .............................. 91 Figure 54 - Applying Blood Sample ............................................. 92 Figure 55 - Opting for a consultation ......................................... 96 Figure 56 - Records Menu on "Consumer App" .......................... 98 Figure 57 – Retrieving Records using "Consumer App" .............. 98 378-D-006 Rev 2.3 User’s Manual P a g e | 10 GETTING ACQUAINTED CHAPTER 1 GETTING ACQUAINTED Before attempting to operate this product, strictly observe all warnings and cautions provided on the equipment, accessories and those described in this document and the inserts that come with the packaging. Conventions Used In The Manual Warning! Caution! Indicates hazardous situations or practices that could result in serious injury or death. Indicates hazardous situations or practices that could result in minor injury or damage. Information that clarifies or information on an operating step. give additional General Safety Information Warning! Consult your physician before using BPL LIFEPHONE PLUS BG/ BPL LIFEPHONE PLUS wellness monitor. BPL LIFEPHONE PLUS BG wellness monitor is for in vitro diagnostic use only. The blood glucose monitoring system is to be used only outside the body for monitoring the effectiveness of diabetes control. It should not be used for the diagnosis of diabetes. Test only whole blood samples with the On Call® Simple Blood Glucose Test Strips and BPL LIFEPHONE PLUS BG wellness monitor Keep out of reach of children. The BPL LIFEPHONE PLUS BG/ BPL LIFEPHONE 378-D-006 Rev 2.3 User’s Manual P a g e | 11 378-D-006 Rev 2.3 GETTING ACQUAINTED PLUS wellness monitor has been designed for use by adults and is intended for self-testing and professional use. Do not use test strips that are torn, bent, or damaged in any way. Do not reuse test strips. Keep the test strips vial or the foil pouch away from children and animals. Consult your physician or healthcare professional before making any changes in your treatment plan based on your blood glucose test results. (See the test strip insert for more details.) Do not use the BPL LIFEPHONE PLUS BG/ BPL LIFEPHONE PLUS wellness monitor on patients with a cardiac pacemaker, ICDs or other implanted electronic devices. The BPL LIFEPHONE PLUS BG/ BPL LIFEPHONE PLUS wellness monitor does not support pacer pulse detection. The functioning of the BPL LIFEPHONE PLUS BG/ BPL LIFEPHONE PLUS may be impaired in the presence of pacemaker pulses. Hence, do not use the BPL LIFEPHONE PLUS BG/ BPL LIFEPHONE PLUS wellness monitor when recording ECGs from a patient with pacemaker. The measurements and readings obtained during the use of BPL LIFEPHONE PLUS BG/ BPL LIFEPHONE PLUS wellness monitor should be submitted to a medical professional for review. The purchase of this wellness monitor should not be substituted for the care recommended by your family physician, and User’s Manual P a g e | 12 378-D-006 Rev 2.3 GETTING ACQUAINTED cardiologist. The BPL LIFEPHONE PLUS BG/ BPL LIFEPHONE PLUS wellness monitor is not designed or intended for complete diagnosis of cardiac conditions and diabetes. This wellness monitor should never be used as a basis for starting or modifying treatment, or for making adjustments to your medication, diet or activity routines without independent confirmation by medical examination. Do not attempt self-diagnosis or selftreatment based on the measurements taken from the BPL LIFEPHONE PLUS BG/ BPL LIFEPHONE PLUS wellness monitor. It may lead to deterioration of your health. Do not operate the BPL LIFEPHONE PLUS BG/ BPL LIFEPHONE PLUS wellness monitor around medical equipment, life support equipment, or near any equipment that may be susceptible to any form of radio interference. Do not use this wellness monitor in places where wireless devices are prohibited (for example: on an airplane). Do not use this wellness monitor in the presence of flammable anesthetics, drugs or pressurized oxygen (such as in a hyperbaric chamber, ultraviolet sterilizer or oxygen tent). Do not use this wellness monitor during an MRI scan. Keep the BPL LIFEPHONE PLUS BG/ BPL LIFEPHONE PLUS wellness monitor out of reach of infants, small children, or anyone User’s Manual P a g e | 13 378-D-006 Rev 2.3 GETTING ACQUAINTED incapable of using the wellness monitor properly. ECG reports viewed or printed at any magnification other than 100% may appear distorted and could lead to misdiagnosis. Do not attempt to operate or take measurements from the BPL LIFEPHONE PLUS BG/ BPL LIFEPHONE PLUS while there is an external microphone or other accessories connected to your mobile phone. Do not take the BPL LIFEPHONE PLUS BG/ BPL LIFEPHONE PLUS wellness monitor apart. Taking the BPL LIFEPHONE PLUS BG/ BPL LIFEPHONE PLUS wellness monitor apart will void the warranty. Follow proper precautions and all local regulations when disposing of the BPL LIFEPHONE PLUS BG/ BPL LIFEPHONE PLUS wellness monitor and used battery. Electrical shock hazard. Keep the BPL LIFEPHONE PLUS BG/ BPL LIFEPHONE PLUS wellness monitor and all its accessories away from liquids. Do not immerse the BPL LIFEPHONE PLUS BG/ BPL LIFEPHONE PLUS wellness monitor, other accessories in any liquids. In case of accidental spillage, get it checked completely by authorized service personnel before using this BPL LIFEPHONE PLUS BG/ BPL LIFEPHONE PLUS wellness monitor. The use of multiple instruments connected to the same patient may pose a safety hazard User’s Manual P a g e | 14 GETTING ACQUAINTED due to the summation of leakage currents from each instrument. Any combination of instruments should be evaluated by local safety personnel before being put into service. Caution! Wrong placement of electrodes can give incorrect ECG. Ensure correct placement of electrodes. (See Figure 21). Periodically check the efficiency of devices and accessories. Contact the authorized Service Call Centre whenever the equipment appears to be malfunctioning. Do not place the unit in a position where it can fall & harm the patient should it fall. ECG signal can be disturbed if the BPL LIFEPHONE PLUS BG/ BPL LIFEPHONE PLUS wellness monitor is situated in proximity to the source of high voltage or electrical lines or near RF emitting devices such as X-Ray machines, electro surgical equipment, etc. Use only finger tips to touch the keypad. Using sharp objects or having sharp nails can damage the keys. Keep the BPL LIFEPHONE PLUS BG/ BPL LIFEPHONE PLUS wellness monitor dry and avoid exposing it to extreme temperatures or humidity or dusty environments. Do not leave it in your car. Recommended temperature range is specified under technical specifications. (See CHAPTER 17). Satisfactory maintenance procedures must be implemented, or equipment failure and health 378-D-006 Rev 2.3 User’s Manual P a g e | 15 GETTING ACQUAINTED hazards may result. WELLNESS MONITOR SERVICING AND REPAIR If the wellness monitor is found to be damaged or non-functional, do not open the covers or disassemble. Only qualified personnel may service Warning! the BPL LIFEPHONE PLUS BG/ BPL LIFEPHONE PLUS wellness monitor or may open the BPL LIFEPHONE PLUS BG/ BPL LIFEPHONE PLUS wellness monitor housing to access internal components. There are no internal BPL LIFEPHONE PLUS BG/ BPL LIFEPHONE PLUS wellness monitor components that are serviced by the operator. Contact authorized service personnel for any repair. BATTERY USE AND MAINTENANCE Do not attempt to disconnect the battery. Do not disassemble, puncture, or incinerate the Warning! wellness monitor and /or its accessories. Contact an authorized service personnel for battery replacement immediately when a LOW BATTERY condition occurs often even after charging. The wellness monitor will have limited usage after indication of LOW BATTERY. Avoid recharging batteries in the above mentioned condition. Risk of explosion exists. WELLNESS MONITOR CLEANING AND DISINFECTION 378-D-006 Rev 2.3 User’s Manual P a g e | 16 Caution! GETTING ACQUAINTED Disconnect Main Power while cleaning the equipment. Do not clean with ketones or other flammable agents. WELLNESS MONITOR ACCESSORIES Caution! Use only On Call® Simple Blood Glucose Test Strips with the BPL LIFEPHONE PLUS BG wellness monitor. Control solution tests are designed to be accurate only when tested between 5 and 35 °C. The control ranges shown on the test strip vial (or on the foil pouch) are not recommended ranges for your blood glucose level. Your personal blood glucose target ranges should be determined by your diabetes healthcare professional. Do not touch the test strip with the tip of the control solution bottle. Use only On Call® Simple Control Solution. See the control solution insert for more details. Test strips are to be used only outside the body for testing purposes. Do not use test strips that are torn, bent, or damaged in any way. Do not reuse test strips. Keep the test strips vial or the foil pouch away from children and animals. Do not use the lancet if the safety tab is missing or loose when you take the lancet out of the bag. Do not use the lancet if the needle is bent. Use caution whenever the lancet needle is 378-D-006 Rev 2.3 User’s Manual P a g e | 17 GETTING ACQUAINTED exposed. Never share lancets or the lancing device with other people. In order to reduce the risk of infection from prior use of the instrument, always use a new, sterile lancet. Do not reuse lancets. Avoid getting the lancing device or lancets dirty with hand lotion, oils, dirt or debris. The wellness monitor is used with a set of standard accessories. For reasons of safety and reliability, use only the original accessories provided by the manufacturer. The BPL LIFEPHONE PLUS BG/ BPL LIFEPHONE PLUS wellness monitor safety and performance are not guaranteed when non-approved replacement parts are used. For replacement of accessories, contact authorized service personnel immediately. Always clean and disinfect electrode region before patient use. Failure to properly clean and disinfect reusable electrodes before patient use may cause infectious materials to be transferred between users. The use of accessories other than those specified in the user’s manual can result in increased emissions or decreased immunity of the system. Do not attempt to use/operate the BPL LIFEPHONE PLUS BG/ BPL LIFEPHONE PLUS wellness monitor to take measurements while charging. General Symbols and Marking 378-D-006 Rev 2.3 User’s Manual P a g e | 18 GETTING ACQUAINTED The general symbols and markings that are found on the wellness monitor, accessories or packaging is listed below. TABLE 1- SYMBOLS/ MARKINGS ON THE BPL LIFEPHONE PLUS Serial Number. For in vitro diagnostic use only Attention, see operating instructions. Read Operating instructions before use. Do not dispose in domestic waste. Meets IEC type BF leakage current requirements TABLE 2- SYMBOLS/ MARKINGS ON OUTER PACKAGING Storage temperature limit. contains sufficient for n tests Use Lot by Lot number 378-D-006 Rev 2.3 User’s Manual P a g e | 19 GETTING ACQUAINTED Sterilized using Irradiation Control Range Catalog number Do not dispose in domestic waste. Recyclable. Read Operating instructions before use. This way up. Carton Box Stacking Limit. Relative humidity limit. Keep away from rain. Manufacturer’s address. 378-D-006 Rev 2.3 User’s Manual P a g e | 20 GETTING ACQUAINTED Fragile. Use during an Emergency EMERGENCY APPLICATION -The BPL LIFEPHONE PLUS BG/ BPL LIFEPHONE PLUS wellness monitor is NOT to be used as an emergency device. 378-D-006 Rev 2.3 User’s Manual P a g e | 21 OVERVIEW CHAPTER 2 OVERVIEW The BPL LIFEPHONE PLUS BG/ BPL LIFEPHONE PLUS is a battery operated wellness monitoring device that can be used to acquire 12-lead resting electrocardiographs, measure blood glucose(BG) in whole blood(MODEL: BPL LIFEPHONE PLUS BG) and recording physiological parameters to derive daily activity. For better utilization of the BPL LIFEPHONE PLUS BG/ BPL LIFEPHONE PLUS, it is necessary to carefully read the instructions contained in this user manual. Keep the manual for future reference. The following are the components available to the users of BPL LIFEPHONE PLUS BG/ BPL LIFEPHONE PLUS. The BPL LIFEPHONE PLUS BG/ BPL LIFEPHONE PLUS wellness monitor - A self-use device that can record ECG, BG (MODEL: BPL LIFEPHONE PLUS BG) and monitor physical activity of the user. The wellness monitor transmits the ECG, BG (in MODEL: BPL LIFEPHONE PLUS BG) and activity measurements to the user-supplied mobile device operating a compatible operating system. A user mobile application “ConsumerApp” to command the LIFEPHONE PLUS wellness monitor to collect vital signs & save to/retrieve from the BPL LIFEPHONE PLUS server. BPL LIFEPHONE PLUS server to store the ECG, BG (in MODEL: BPL LIFEPHONE PLUS BG) & Activity measurement records. A doctor application “Specialist App” to assist a doctor to check the measurements & update the user with clinical advisories. Intended Use The BPL LIFEPHONE Plus BG/ BPL LIFEPHONE Plus is a battery operated wellness monitor intended for self-use by adult users for, 378-D-006 Rev 2.3 User’s Manual P a g e | 22 OVERVIEW 1. The quantitative measurement of glucose (sugar) in fresh capillary whole blood from the fingertip, forearm and palm by people with diabetes at home as an aid in monitoring the effectiveness of diabetes control program. The measurements can also be done by health care professionals in a clinical setting. (Available only in BPL LIFEPHONE PLUS BG model). 2. Acquiring 12 lead resting ECG for triaging purposes. 3. Monitors degree of physical activity to derive daily activity logs in the form of calories burnt and steps traversed. The BPL LIFEPHONE PLUS BG wirelessly transmits the acquired data to the user’s mobile phone via “BPL LIFEPHONE PLUS Consumer App”. Further, the acquired ECG and blood glucose measurements can be used by the healthcare practitioners using a mobile application, namely, “BPL LIFEPHONE PLUS Specialist App” to aid the assessment and medical management of conditions. Indications & Contraindications for Use The BPL LIFEPHONE PLUS BG/ BPL LIFEPHONE PLUS wellness monitor is one of the tools that clinicians and health-conscious individuals use to monitor personal health. It facilitates the user with data to monitor active lifestyle, blood sugar levels and cardiac health, which when managed in conjunction with a balanced diet and healthcare practitioner’s vigil, may result in a favorable influence on overall health. The BPL LIFEPHONE PLUS BG/ BPL LIFEPHONE PLUS wellness monitor: Is not intended to be used to take ECG measurements during patient transport. Is not designed to be used as a vital signs physiological monitor. 378-D-006 Rev 2.3 User’s Manual P a g e | 23 OVERVIEW Is not designed to be used for intracardiac applications. Is not designed to provide diagnostic alarms. Specified Skills, Training, Knowledge of Operator Users of this product must read and understand the various contents included in the accompanying documentation before attempting to operate the product as described in this User’s manual. For further information on available training on the use of this product, please contact a BPLMTPL sales representative, or the manufacturer. The contents in the accompanying documentation are written for adult users and clinical professionals who operate, maintain, and/or troubleshoot the BPL LIFEPHONE PLUS BG/ BPL LIFEPHONE PLUS wellness monitor. All illustrations in this manual are provided as examples only. They may not necessarily reflect your system’s setup or the data on your system. Application Environment This BPL LIFEPHONE PLUS BG/ BPL LIFEPHONE PLUS wellness monitor is a self-use device designed for health-conscious individuals and patients in a home setting. The wellness monitor can also be used by patients in a clinical setting under the direct supervision of physicians. It is restricted to be used on one patient at a time. Features The salient features that BPL LIFEPHONE PLUS BG/ BPL LIFEPHONE PLUS wellness monitor enables a physician or patient are: 378-D-006 Rev 2.3 User’s Manual P a g e | 24 OVERVIEW Acquire 12 channel ECG recordings, measure blood glucose in whole blood & activity measurements using the wellness monitor. View 12 lead ECG traces, blood sugar levels and daily activity charts. Edit user information data associated with the recording. Wirelessly transmit the measured recordings to the server. Access ECG recordings and BG measurements stored on the server. Print or save the recording in PDF format. Request professional clinical advisories based on your ECG recordings and BG measurements. Controls, Indicators and Connectors This section contains a description of the keys & visual indicators for user control. For simpler use of the instrument, first get familiar with the instrument and the method of operation. Figure 1 - Know Your Wellness monitor – Top Side Figure 2 - Know Your Wellness monitor – Bottom Side 378-D-006 Rev 2.3 User’s Manual P a g e | 25 OVERVIEW TABLE 3- Indicators Indicator Bluetooth Error Battery 378-D-006 Rev 2.3 Description of Behavior Color: Blue ON: BPL LIFEPHONE PLUS BG/ BPL LIFEPHONE PLUS is paired to a mobile device through Bluetooth. BLINKING: BPL LIFEPHONE PLUS BG/ BPL LIFEPHONE PLUS is currently in discoverable mode with Bluetooth ON. OFF: BPL LIFEPHONE PLUS BG/ BPL LIFEPHONE PLUS is not paired to any mobile device through Bluetooth. Color: Red ON: Error condition exists. OFF: No Error condition. Color: Bi-color Green and Red. Green ON: BPL LIFEPHONE PLUS BG/ BPL LIFEPHONE PLUS is ON and the battery level is good. Green BLINKING: Charging BPL LIFEPHONE PLUS BG/ BPL LIFEPHONE PLUS and the battery level is User’s Manual P a g e | 26 ECG Activity Blood Glucose OVERVIEW good. Red ON: BPL LIFEPHONE PLUS BG/ BPL LIFEPHONE PLUS is ON and the battery level is low and needs to be charged. Red BLINKING: Charging BPL LIFEPHONE PLUS BG/ BPL LIFEPHONE PLUS and the battery level is low. OFF: BPL LIFEPHONE PLUS BG/ BPL LIFEPHONE PLUS is powered OFF. Color: Green ON: BPL LIFEPHONE PLUS BG/ BPL LIFEPHONE PLUS is in ECG mode and is ready to acquire ECG. OFF: BPL LIFEPHONE PLUS BG/ BPL LIFEPHONE PLUS is not in ECG mode. Color: Green ON: BPL LIFEPHONE PLUS BG/ BPL LIFEPHONE PLUS is in Activity measurement mode. OFF: BPL LIFEPHONE PLUS BG/ BPL LIFEPHONE PLUS is not in Activity measurement mode. Color: Green ON: BPL LIFEPHONE PLUS BG is in Blood Glucose measurement mode. OFF: BPL LIFEPHONE PLUS BG is not in Blood Glucose measurement mode. TABLE 4- Keys Indicator Trigger Button Description of Behavior In the ECG Measurement Mode, this button is used as a user trigger to start the ECG acquisition. Power Used to power ON BPL LIFEPHONE PLUS BG/ BPL 378-D-006 Rev 2.3 User’s Manual P a g e | 27 Button 378-D-006 Rev 2.3 OVERVIEW LIFEPHONE PLUS. When the wellness monitor is OFF, pressing the power button will turn the BPL LIFEPHONE PLUS BG/ BPL LIFEPHONE PLUS wellness monitor ON. The Battery LED will glow to indicate that the wellness monitor has powered ON. The power button is also used to Power DOWN the BPL LIFEPHONE PLUS BG/ BPL LIFEPHONE PLUS. Keeping the power button pressed until the battery LED turns OFF will power down the wellness monitor. This may take up to 12 seconds. User’s Manual P a g e | 28 SETTING UP THE BPL LIFEPHONE PLUS CHAPTER 3 SETTING UP THE BPL LIFEPHONE PLUS This section guides the user through the initial setup and the battery charging procedure. Initial Inspection The BPL LIFEPHONE PLUS BG/ BPL LIFEPHONE PLUS was inspected mechanically and electrically before shipment. Check for mechanical damages such as dents or scratches on receipt of the wellness monitor. Depending on the / BPL LIFEPHONE PLUS you purchase, Some of the accessories as per list provided in this user’s manual may need to be purchased separately. Please check the list of contents on the outer carton for details on which components are included with your purchase. (See CHAPTER 9).Please contact the authorized Service Call Centre for information on ordering. Powering Up the BPL LIFEPHONE PLUS Press the POWER BUTTON key of the device. Observe the BATTERY LED indicator to know the status of the device. Battery Green ON: BPL LIFEPHONE PLUS BG/ BPL LIFEPHONE PLUS is ON and the battery level is good. Red ON: BPL LIFEPHONE PLUS BG/ BPL LIFEPHONE PLUS is ON and the battery level is low and needs to be charged. OFF: BPL LIFEPHONE PLUS BG/ BPL LIFEPHONE PLUS is powered OFF. 378-D-006 Rev 2.3 User’s Manual P a g e | 29 SETTING UP THE BPL LIFEPHONE PLUS Figure 3- BPL LIFEPHONE PLUS with fully charged battery Powering Off the BPL LIFEPHONE PLUS Keep the until the POWER BUTTON of the wellness monitor pressed BATTERY LED indicator turns OFF. Turning off the wellness monitor using the BUTTON may take up to 12 seconds. POWER When the BPL LIFEPHONE PLUS BG/ BPL LIFEPHONE PLUS is paired with the mobile device using the ‘Consumer App’ mobile application, exiting the application will shut down the BPL LIFEPHONE PLUS BG/ BPL LIFEPHONE PLUS. Charging the Internal batteries The BPL LIFEPHONE PLUS BG/ BPL LIFEPHONE PLUS wellness monitor uses rechargeable Lithium Polymer batteries. The battery charger is a ClassII direct-plug-in adaptor. To charge the batteries, remove the USB cover on the side-face and connect the battery charger provided, to the micro USB connector. Figure 4 - Opening USB cap cover 378-D-006 Rev 2.3 User’s Manual P a g e | 30 SETTING UP THE BPL LIFEPHONE PLUS Warning! Caution! Do not charge the wellness monitor with any other adapter or using a laptop computer. Do not dispose the BPL LIFEPHONE PLUS BG/ BPL LIFEPHONE PLUS or its accessories along with domestic waste. Follow local regulations for disposal. Do not throw the battery into fire, or heat. If the BPL LIFEPHONE PLUS BG/ BPL LIFEPHONE PLUS wellness monitor gives off an odor or generates excess heat, disconnect battery charger, turn off the wellness monitor immediately, place the wellness monitor in a container vessel such as a metal box and contact the authorized Service Call Centre. The wellness monitor is used with a set of standard accessories. For reasons of safety and reliability, use only the original accessories provided by the manufacturer. Do not use the BPL LIFEPHONE PLUS BG/ BPL LIFEPHONE PLUS wellness monitor device while charging the device. On connecting the charger to the BPL LIFEPHONE PLUS BG/ BPL LIFEPHONE PLUS faithfully, note the status by observing the battery indicator. 378-D-006 Rev 2.3 User’s Manual P a g e | 31 Battery SETTING UP THE BPL LIFEPHONE PLUS Green BLINKING: Charging BPL LIFEPHONE PLUS BG/ BPL LIFEPHONE PLUS and the battery level is good. Red BLINKING: Charging BPL LIFEPHONE PLUS BG/ BPL LIFEPHONE PLUS and the battery level is low. Figure 5 - Battery Low Indicator The battery takes about 4 hours to charge completely. A complete charge allows the use of the BPL LIFEPHONE PLUS BG/ BPL LIFEPHONE PLUS wellness monitor for about 2 days with each day constituting - 3 ECG recordings, 2 BG measurements and 8 hours of activity logging. Caution! Contact an authorized service personnel for battery replacement immediately when a LOW BATTERY condition occurs often even after charging. The wellness monitor will have limited usage. Avoid recharging batteries in this condition. Battery Charger: Precautions for use 378-D-006 Rev 2.3 User’s Manual P a g e | 32 Warning! SETTING UP THE BPL LIFEPHONE PLUS The “battery charger” can be damaged if dropped, struck or tampered with. Do not immerse in water or other liquids. Auto power OFF To preserve the battery charge, the BPL LIFEPHONE PLUS BG/ BPL LIFEPHONE PLUS is provided with an auto power off function that will activate automatically, after the current operation has been completed. The wellness monitor will turn off automatically if not used for a taking any measurements for a continuous duration of about 5 minutes. 378-D-006 Rev 2.3 User’s Manual P a g e | 33 INSTALLING THE ‘CONSUMER APP’ CHAPTER 4 INSTALLING THE ‘CONSUMER APP’ The BPL LIFEPHONE PLUS BG/ BPL LIFEPHONE PLUS “Consumer App” is supported on most Android based mobile devices running Android GingerBread operating system or later and have Bluetooth 2.1+ feature. This section guides the user through the mobile application installation procedure. Check with the authorized service center to ensure that your mobile device is compatible for use with BPL LIFEPHONE PLUS BG/ BPL LIFEPHONE PLUS wellness monitor. Downloading Instructions Follow the instructions listed below to install the ‘Consumer App’ mobile Application: Note down the version of the operating system loaded on your mobile device. Refer the user’s guide of the mobile device to know the procedure to locate the version of the operating system loaded on your mobile device. Downloading the BPL LIFEPHONE PLUS BG/ BPL LIFEPHONE PLUS Apps will incur data usage charges. Some mobile devices require an external memory card to download & install applications. Refer the user’s guide of the mobile device. Using the web browser on your mobile device, log on to www.BPLLIFEPHONEPLUS.IN to locate ‘Consumer App’ under the DOWNLOADS section. 378-D-006 Rev 2.3 User’s Manual P a g e | 34 INSTALLING THE ‘CONSUMER APP’ Download the appropriate application version for your mobile device based on version of the operating system loaded on your mobile device. Ensure that the permission to run/install applications from unknown sources is SET. Installation Instructions Install the BPL LIFEPHONE PLUS BG/ BPL LIFEPHONE PLUS ‘Consumer App’ mobile application. Figure 6 - 'ConsumerApp' Shortcut Ensure that the mobile phone 378-D-006 Rev 2.3 as icon appears on the application list of the shown in the illustration above. User’s Manual P a g e | 35 PAIRING MOBILE DEVICE WITH BPL LIFEPHONE PLUS CHAPTER 5 PAIRING MOBILE DEVICE WITH BPL LIFEPHONE PLUS Follow the steps listed below to pair the BPL LIFEPHONE PLUS BG/ BPL LIFEPHONE PLUS wellness monitor with the mobile device. Pairing with the BPL LIFEPHONE PLUS for the first time Enable the “Bluetooth” feature on your mobile device. Refer the user’s guide of the mobile device to know the procedure to turn on the Bluetooth on your mobile device. Press the POWER ON key to turn on the BPL LIFEPHONE PLUS wellness monitor and place it in the vicinity of the mobile device. Tap the “Consumer App” icon on the mobile device to launch the application. The application should launch as shown in Figure 7. 378-D-006 Rev 2.3 User’s Manual P a g e | 36 PAIRING MOBILE DEVICE WITH BPL LIFEPHONE PLUS Figure 7 - BPL LIFEPHONE PLUS STARTUP SCREEN To pair with the BPL LIFEPHONE PLUS BG/ BPL LIFEPHONE PLUS, enter pin <123456> and tap on OK, as shown in Figure 8. Figure 8 - KEYING IN THE DEFAULT PASSWORD Enter a new 6 digit pin of your choice and tap on SAVE as shown in Figure 9. 378-D-006 Rev 2.3 User’s Manual P a g e | 37 PAIRING MOBILE DEVICE WITH BPL LIFEPHONE PLUS Figure 9 - SETTING UP A SECURE PIN Note down and retain it for later reference and use The ‘Consumer App’ will now display the information screen shown in Figure 10. Figure 10 - Change PIN confirmation screen The ‘Consumer App’ will exit and in turn power off the BPL LIFEPHONE PLUS BG/ BPL LIFEPHONE PLUS wellness monitor. Turn ON the BPL LIFEPHONE PLUS BG/ BPL LIFEPHONE PLUS wellness monitor. Tap the “Consumer App” icon on the mobile device to launch the application and enter the new pin and pair with the 378-D-006 Rev 2.3 User’s Manual P a g e | 38 PAIRING MOBILE DEVICE WITH BPL LIFEPHONE PLUS BPL LIFEPHONE PLUS BG/ BPL LIFEPHONE PLUS wellness monitor. On successful pairing, the blue LED will glow on the BPL LIFEPHONE PLUS BG/ BPL LIFEPHONE PLUS wellness monitor. Figure 11 - BPL LIFEPHONE PLUS paired with mobile device Caution Bluetooth* pairing may be unsuccessful if the consumer App is forcefully closed. Bluetooth* Pairing fails in Android mobile phones if no BT pin is entered. Subsequent Pairing Turn ON the Bluetooth feature on your mobile device. Turn ON the BPL LIFEPHONE PLUS BG/ BPL LIFEPHONE PLUS wellness monitor and place it in the vicinity of the mobile device. Tap the “Consumer App” icon on the mobile device to launch the application. The BPL LIFEPHONE PLUS BG/ BPL LIFEPHONE PLUS wellness monitor will attempt to automatically pair with the mobile device. 378-D-006 Rev 2.3 User’s Manual P a g e | 39 PAIRING MOBILE DEVICE WITH BPL LIFEPHONE PLUS On successful pairing, the blue LED will glow on the BPL LIFEPHONE PLUS BG/ BPL LIFEPHONE PLUS wellness monitor. Based on the logged in status, the default screen or the login screen will appear on the ‘Consumer App’. 378-D-006 Rev 2.3 User’s Manual P a g e | 40 BPL LIFEPHONE PLUS SERVER: QUICK REGISTRATION CHAPTER 6 BPL LIFEPHONE PLUS SERVER: QUICK REGISTRATION You will use your BPL LIFEPHONE PLUS cloud server account to use one or all of the following features: Upload and view ECG & BG measurements, and Activity Logs. Request for Case from your doctor and View cases. View ECG, BG measurement and Activity measurement Charts. Buy subscription packages. Use net banking/credit card to make payments. View feedback provided by Specialists. Modify account information. Add additional family members as secondary users. Setting Up A BPL LIFEPHONE PLUS CLOUD SERVER Account Follow the instructions listed below to setup an account on the BPL LIFEPHONE PLUS cloud server. Enable the Internet connectivity feature on you mobile device. Refer the user’s guide of the mobile device to know the procedure to use the data connectivity feature on your mobile device. Connecting to the BPL LIFEPHONE PLUS cloud server will incur data usage charges. Check to ensure that the data connectivity is working faithfully by logging onto www.BPLLIFEPHONEPLUS.IN on the web browser of your mobile device. A high speed data connection using 3G, 4G or WiFi will better the user experience and performance. 378-D-006 Rev 2.3 User’s Manual P a g e | 41 BPL LIFEPHONE PLUS SERVER: QUICK REGISTRATION Follow the instructions detailed in CHAPTER 5 to use the “Consumer App” mobile application to connect to the BPL LIFEPHONE PLUS BG/ BPL LIFEPHONE PLUS wellness monitor. The screen shown in Figure 12 will be displayed on the “Consumer App”. Figure 12 – The Login Screen of ‘Consumer App’ On the ‘Login Screen’ of the ‘Consumer App’, tap on “New user? Sign Up” to setup a new account. Caution Do not skip this step as it contains important terms and conditions and privacy policies that you have to read and understand before using the BPL LIFEPHONE PLUS BG/ BPL LIFEPHONE PLUS wellness monitor and the BPL LIFEPHONE PLUS cloud server. 378-D-006 Rev 2.3 User’s Manual P a g e | 42 BPL LIFEPHONE PLUS SERVER: QUICK REGISTRATION Populate the details onto the Quick registration screen shown in Figure 13. Tap on “NEXT” on the screen displayed on the “Consumer App”. Figure 13 - Quick Registration Form -1 Set the ‘Consumer Category’ as “PERSONAL USE”. Other Consumer Categories are meant for Registered Medical Practitioners. Contact authorized Service Call Centre to know more about other “consumer categories”. 378-D-006 Rev 2.3 User’s Manual P a g e | 43 BPL LIFEPHONE PLUS SERVER: QUICK REGISTRATION Populate the remaining fields of the Quick registration screen shown in and tap on NEXT Figure 14 - Quick Registration Form - 2 Consult your telecom operator for details on SMS charges that are applicable to your mobile connection. Terms & Conditions And Privacy Consent The last step of Registration requires your review of the Terms and conditions. Follow the procedure listed below to launch the Terms and conditions dialog. Tap on the “Privacy consent” link to read the privacy terms shown in Figure 15 and tap on OK. 378-D-006 Rev 2.3 User’s Manual P a g e | 44 BPL LIFEPHONE PLUS SERVER: QUICK REGISTRATION Figure 15 - Privacy consent Next, read the ‘Terms and conditions’. Tap on check the box shown in Figure 16 to agree to all terms. Figure 16 - Accepting terms & conditions and Privacy policy Click on Register to complete the Quick registration process. For clarifications on the Terms &/OR the privacy consent, contact the authorized service center. 378-D-006 Rev 2.3 User’s Manual P a g e | 45 BPL LIFEPHONE PLUS SERVER: QUICK REGISTRATION Finishing the User Registration Process On completing the Quick registration process, you will receive an SMS confirming successful registration of the user. Subsequently, you can logon to the BPL LIFEPHONE PLUS BG/ BPL LIFEPHONE PLUS cloud server from the “Consumer App” using the login screen shown in Figure 12. On successful logon, the username will appear on the home screen of the “Consumer App” as show in Figure 17. Figure 17 - Home Screen on successful logon 378-D-006 Rev 2.3 User’s Manual P a g e | 46 BPL LIFEPHONE PLUS SERVER: QUICK REGISTRATION The BPL LIFEPHONE PLUS server may require you to change your password on a regular basis as a security measure. The secure BPL LIFEPHONE PLUS cloud server may limit a login session to a finite duration, say, a few hours to ensure that your data and login information is not compromised. Connecting to the BPL LIFEPHONE PLUS cloud server will incur data usage charges. Logging out of the BPL LIFEPHONE PLUS Follow the instructions listed below to sign-out of the BPL LIFEPHONE PLUS. On the home screen, click on the settings icon The screen shown in Figure 18 will open out, tap on sign-out. Figure 18 - "Consumer App" Settings Menu Confirm sign-out as shown in Figure 19. 378-D-006 Rev 2.3 User’s Manual P a g e | 47 BPL LIFEPHONE PLUS SERVER: QUICK REGISTRATION Figure 19 - Signing out Alternatively, you can sign-out from the Tray Icon menu. 378-D-006 Rev 2.3 User’s Manual P a g e | 48 RECORDING ECGs USING THE BPL LIFEPHONE PLUS CHAPTER 7 RECORDING ECGs USING THE BPL LIFEPHONE PLUS This section gives a brief description of the simple “4-STEP” ECG recording process using the BPL LIFEPHONE PLUS BG/ BPL LIFEPHONE PLUS wellness monitor. The 12 lead resting ECG of adult users acquired using the BPL LIFEPHONE PLUS BG/ BPL LIFEPHONE PLUS wellness monitor is intended to be used for triaging purposes. The acquired data can be used to obtain clinical consultation from cardiologists or healthcare practitioners. The BPL LIFEPHONE PLUS ECG ELECTRODES The BPL LIFEPHONE PLUS BG/ BPL LIFEPHONE PLUS wellness monitor includes two sets of metal electrodes, namely, finger electrodes and chest electrodes as shown in Figure 20. While the finger electrodes have a depression to place the fingers, the chest electrodes have small protrusions on them. Figure 20 - ECG ELECTRODES ON BPL LIFEPHONE PLUS Warning! The BPL LIFEPHONE PLUS BG/ BPL LIFEPHONE PLUS is a self – use device. Do not hold the wellness monitor to take ECG recordings from other personnel. Do not let other personnel 378-D-006 Rev 2.3 User’s Manual P a g e | 49 RECORDING ECGs USING THE BPL LIFEPHONE PLUS Warning! take recordings on you. Ensure that you are not in contact with any other personnel when taking ECG recordings. Ensure that in all four steps, the indicators face you. Wrong placement will yield incorrect recordings. During the ECG measurement, the BPL LIFEPHONE PLUS BG/ BPL LIFEPHONE PLUS wellness monitor has to be held in four positions on as shown in Figure 21. Figure 21 - Chest Electrode Placement Positions Familiarize yourself with the placement positions. All illustrations and notes on electrode placements are for a male person with a well-toned chest. Consult your physician for more information on electrode placements. Recommended environment for recording ECGs Choose a place as far as possible from electrical lines or from source of static electricity. The mobile device power adapter may degrade signal detection. Do not attempt to use the BPL LIFEPHONE PLUS BG/ BPL LIFEPHONE PLUS while charging the mobile device. Avoid placing the wellness monitor close to other diagnostic or therapeutic equipment like X- ray machines, ultrasound 378-D-006 Rev 2.3 User’s Manual P a g e | 50 RECORDING ECGs USING THE BPL LIFEPHONE PLUS machines etc. that could be a source of excessive interference and ECG signal distortion. If it is impossible to position the BPL LIFEPHONE PLUS BG/ BPL LIFEPHONE PLUS away from other electrical equipment, switch off such equipment when recording an ECG. To obtain better quality ECGs, record in a room where the temperature is between 20 to 25 degrees centigrade. This precaution prevents the user from feeling cold, which could increase shivering and contribute to muscle tremor. Refer to other Cautions & Warnings stated in 1.3. Instructions to be followed to obtain good ECG recordings Sit comfortably on a chair with back and arms supported (left arm in particular) during all stages of the ECG recording. Alternatively, you can lie down with the arms supported during the recording process. Breathe calmly for 10 seconds before each step. Lowfrequency noise, such as those produced by respiration, causes the tracing to wander above and below the baseline. Relax your body muscles. Being relaxed is very important to get good quality ECG recording. Ensure that the fingers of opposite hands do not touch each other while taking the ECG recordings. The amplitude and shape/morphology of the ECG traces may be affected Avoid trunk or body movement while recording ECG. Avoid looking down at the wellness monitor while recording ECG. This is to ensure relaxed state during recording ECGs. Ensure that the chest electrode placements are understood well before use. Refer to Figure 21. 378-D-006 Rev 2.3 User’s Manual P a g e | 51 RECORDING ECGs USING THE BPL LIFEPHONE PLUS Do not press too firmly on the electrode contacts. This is to minimize noise that may appear on the ECG traces due to muscle tremor. CHOOSING the ECG RECORDING MODE ON “Consumer App” Turn ON the BPL LIFEPHONE PLUS BG/ BPL LIFEPHONE PLUS wellness monitor and pair it with the same mobile device that was used during the registration. Refer to CHAPTER 5 & CHAPTER 6. On successful pairing, the blue LED will glow on the BPL LIFEPHONE PLUS BG/ BPL LIFEPHONE PLUS wellness monitor. Input the username and password details of your BPL LIFEPHONE PLUS BG/ BPL LIFEPHONE PLUS cloud server account on the login screen. Figure 22 - Starting the ECG Recording Mode 378-D-006 Rev 2.3 User’s Manual P a g e | 52 RECORDING ECGs USING THE BPL LIFEPHONE PLUS On the home screen of the “Consumer App” tap on the ECG icon as shown in Figure 22 The ECG indicator will glow on the BPL LIFEPHONE PLUS BG/ BPL LIFEPHONE PLUS wellness monitor indicating that the BPL LIFEPHONE PLUS BG/ BPL LIFEPHONE PLUS wellness monitor has been set to “ECG RECORDING MODE”. Skin Preparation before each step of ECG recording Locate the electrode placement position on your body, for this step of ECG recording. Refer Figure 21. Rub with a gauze pad. Three to five gentle strokes will be sufficient. Rub the skin with mild soap and water to remove skin oils. Ensure that the excess water in the skin is wiped off. Use a wet tissue to wipe off fingers (left and right index fingers) and the area on skin where the electrodes need be placed. Step1 of ECG recording Follow the skin preparation procedures detailed in 7.5 Sit comfortably on a chair with back and arms supported (left hand in particular) and breathe calmly for a few seconds. Place the BPL LIFEPHONE PLUS BG/ BPL LIFEPHONE PLUS in such a way that the chest electrodes are in contact with the lower portion of the chest area just above the base of the ribs as shown in Figure 23. 378-D-006 Rev 2.3 User’s Manual P a g e | 53 RECORDING ECGs USING THE BPL LIFEPHONE PLUS Figure 23 - Chest Electrode Placement for Step1 Locate the intersection of an imaginary line joining the center of the thigh (or left nipple) and the line joining the umbilicus (or navel). Place the index fingers from both hands as shown in Figure 24. Figure 24 – Finger Electrode Placement for Steps 1, 2, 3 & 4 Touch the electrodes gently; do not hold it hard. Ensure that the fingers of opposite hands do not touch each other while taking the ECG recordings. Locate the Trigger button using your thumb. The “Consumer App” screen will appear as shown in Figure 25. 378-D-006 Rev 2.3 User’s Manual P a g e | 54 RECORDING ECGs USING THE BPL LIFEPHONE PLUS Figure 25 - STEP 1 of ECG RECORDING Ensure that the electrode contact with the skin is maintained during all stages of the recording. Breathe calmly for a few seconds and press the trigger button. The BPL LIFEPHONE PLUS BG/ BPL LIFEPHONE PLUS will sound beeps indicating that the ECG recording is in progress. Avoid body movement while recording ECG. Hold the BPL LIFEPHONE PLUS BG/ BPL LIFEPHONE PLUS in position until a long beep is sounded and the screen of the “Consumer App” changes to Step 2 of ECG recording. Step 2 of ECG recording Repeat the skin preparation procedures detailed in 7.5. Place the BPL LIFEPHONE PLUS BG/ BPL LIFEPHONE PLUS in such a way that the chest electrodes are in contact with harder surface of the chest as shown in Figure 26. 378-D-006 Rev 2.3 User’s Manual P a g e | 55 RECORDING ECGs USING THE BPL LIFEPHONE PLUS Figure 26 - Chest electrode placement in Step 2 This position can be located by placing the chest electrodes on the imaginary horizontal line connecting the nipples of a well-toned chest. Ladies: In steps 2, 3 and 4 keep the wellness monitor on harder surface of the chest around breasts. Place the index fingers from both hands as shown in Figure 24. Locate the Trigger button using your thumb. The screen on “Consumer App” will appear as shown in Figure 27. 378-D-006 Rev 2.3 User’s Manual P a g e | 56 RECORDING ECGs USING THE BPL LIFEPHONE PLUS Figure 27 - STEP 2 of ECG RECORDING Ensure that the back and arms are supported; in particular, the left arm. Breathe calmly for a few seconds and press the trigger button. Hold the BPL LIFEPHONE PLUS BG/ BPL LIFEPHONE PLUS in position until a long beep is sounded and the screen of the “Consumer App” changes to Step 3 of ECG recording. Step 3 of ECG recording Repeat the skin preparation procedures detailed in 7.5. Place the BPL LIFEPHONE PLUS BG/ BPL LIFEPHONE PLUS as shown in Figure 28. 378-D-006 Rev 2.3 User’s Manual P a g e | 57 RECORDING ECGs USING THE BPL LIFEPHONE PLUS Figure 28 - Chest Electrode Placement for Step 3 To locate this position, Place your left hand (in horizontal position) on your chest in such a way that the index finger of your left hand is on the left nipple. In such a condition, o The electrode position for the STEP3 is at position pointed by the tip of the little finger. o Tilt wellness monitor by an angle of 45° towards left. Ladies: In steps 2, 3 and 4 keep the wellness monitor on harder surface of the chest around breasts. Place the index fingers from both hands as shown in Figure 24. Locate the Trigger button using your thumb. Avoid looking down at the wellness monitor while recording ECG. The screen on “Consumer App” will appear as shown in Figure 29. 378-D-006 Rev 2.3 User’s Manual P a g e | 58 RECORDING ECGs USING THE BPL LIFEPHONE PLUS Figure 29 - STEP 3 of ECG RECORDING Ensure that the back and arms are supported; in particular, the left hand. Avoid body movement while recording ECG. Breathe calmly for a few seconds and press the trigger button. Hold the BPL LIFEPHONE PLUS BG/ BPL LIFEPHONE PLUS in position until a long beep is sounded and the screen of the “Consumer App” changes to Step 4 of ECG recording. Step 4 of ECG recording Repeat the skin preparation procedures detailed in 7.5. Place the BPL LIFEPHONE PLUS BG/ BPL LIFEPHONE PLUS as shown in Figure 30. 378-D-006 Rev 2.3 User’s Manual P a g e | 59 RECORDING ECGs USING THE BPL LIFEPHONE PLUS Figure 30 - Chest Electrode Placement for Step 4 To locate this position, retain the horizontal position to same as that in STEP 3; now, move the chest electrodes further to your left until the right chest electrode is on the left side of the nipple. Ladies: In steps 2, 3 and 4, keep the wellness monitor on harder surface of the chest around breasts. Place the index fingers from both hands as shown in Figure 24. You can touch either the left index finger or thumb, whichever is more comfortable. Locate the Trigger button using your thumb. Avoid looking down at the wellness monitor while recording ECG. The screen on “Consumer App” will appear as shown in Figure 31. 378-D-006 Rev 2.3 User’s Manual P a g e | 60 RECORDING ECGs USING THE BPL LIFEPHONE PLUS Figure 31 - STEP 4 of ECG RECORDING Ensure that the back and arms are supported; in particular, the left hand. Avoid body movement while recording ECG. Breathe calmly for a few seconds and press the trigger button. Hold the BPL LIFEPHONE PLUS BG/ BPL LIFEPHONE PLUS in position until a long beep is sounded to complete all stages of the recording. The completion is indicated by the “Consumer App” by displaying all 12 leads of ECG as illustrated in Figure 32. Warning! Do not attempt self-diagnosis or self-treatment based on the measurements taken from the BPL LIFEPHONE PLUS BG/ BPL LIFEPHONE PLUS wellness monitor. It may lead to deterioration of your health. 378-D-006 Rev 2.3 User’s Manual P a g e | 61 RECORDING ECGs USING THE BPL LIFEPHONE PLUS The summary of all four steps including the heart rate will be shown on the “Consumer App” as illustrated in Figure 32. Figure 32 - Your ECG trace on Consumer App A total of 12 leads of ECG are shown on the “Consumer App”. The lead labels, namely, Lead I, Lead II, Lead III, aVR, avL, aVF, MCL1, MCL2, MCL3, MCL4, MCL5, MCL6 are displayed on the left. Touch and slide your finger on the screen to view all 12 leads of ECG. Slide to the right to view up to ten seconds of ECG. 378-D-006 Rev 2.3 User’s Manual P a g e | 62 RECORDING ECGs USING THE BPL LIFEPHONE PLUS Enable auto rotation on your mobile device to view the ECG traces on landscape mode. Rotate the mobile device to view the ECGs in landscape mode as shown in Figure 33. Figure 33 - ECG view in Landscape mode Adding additional comments Scroll down to the comments field as shown in Figure 34. Figure 34 - Adding Comments Key in your 378-D-006 Rev 2.3 comments and User’s Manual Tap on “NEXT”. P a g e | 63 RECORDING ECGs USING THE BPL LIFEPHONE PLUS Selecting Common symptoms Qualify your ECG recording by stating your health condition at the time of taking this ECG measurement as shown in Figure 35 Figure 35 - State your health condition Saving your ECG onto BPL LIFEPHONE PLUS server Tap on “Save” to start saving ECG record on to the server. Figure 36 - Saving ECG onto BPL LIFEPHONE PLUS server 378-D-006 Rev 2.3 User’s Manual P a g e | 64 RECORDING ECGs USING THE BPL LIFEPHONE PLUS Connecting to the BPL LIFEPHONE PLUS cloud server will incur data usage charges. A high speed data connection using 3G, 4G or Wi-Fi will better the user experience and performance. Allotment of an unique Measurement ID number On successful login and saving of the ECG recordings onto the server, the BPL LIFEPHONE PLUS BG/ BPL LIFEPHONE PLUS server, allots a unique measurement ID. The measurement ID is displayed on the “Consumer App” as shown in Figure 37. Figure 37 - ECG Recording Measurement ID number Warning! The measurements and readings obtained during the use of BPL LIFEPHONE PLUS BG/ BPL LIFEPHONE PLUS wellness monitor should be submitted to a medical professional for review. The purchase of this wellness monitor should not be substituted for the care recommended by your family physician, and cardiologist. Click on “NO” to complete the ECG recording and storing process without sending it to a doctor for consultation. The records can be accessed from the BPL LIFEPHPONEPLUS cloud server from your personal computer. Refer 10.3, to familiarize yourself with the procedure of sending your ECG recordings to your doctor. 378-D-006 Rev 2.3 User’s Manual P a g e | 65 ACTIVITY LOGGING MODE OF BPL LIFEPHONE PLUS CHAPTER 8 ACTIVITY LOGGING MODE OF BPL LIFEPHONE PLUS The “Activity Logging Mode” of the BPL LIFEPHONE PLUS BG/ BPL LIFEPHONE PLUS facilitates the user with data to monitor active lifestyle, which when managed in conjunction with a balanced diet and healthcare practitioner’s vigil, may result in a favorable influence on overall health. Caution Always consult a physician before starting any new diet or exercise program. This system is not to be used for diagnostic purposes and is not intended to be a substitute for the medical advice or supervision of your personal physician. Proper Wear for taking Activity Logs The BPL LIFEPHONE PLUS BG/ BPL LIFEPHONE PLUS includes a holster with a belt clip. Fix the holster onto the wellness monitor as shown in Figure 38 Figure 38 – Fix the holster onto the device The clip allows you to attach the BPL LIFEPHONE PLUS BG/ BPL LIFEPHONE PLUS firmly to material such as a stiff waist belt as shown in Figure 39. Caution Never slide the wellness monitor on to thick materials as it may strain and damage the clip. The BPL LIFEPHONE PLUS BG/ BPL LIFEPHONE PLUS is intended to log activity measurements 378-D-006 Rev 2.3 User’s Manual P a g e | 66 ACTIVITY LOGGING MODE OF BPL LIFEPHONE PLUS with the wellness monitor holstered onto to a stiff waist band. Holstering the wellness monitor to any other portion of the body may yield incorrect readings. To attach the clip: Gently press to lift the clip lever to open the clip mouth. Slide the clip in such a way that the waist band is between the lower portion of the clip mouth and the holster. Allow the clip lever to close and check to ensure that the BPL LIFEPHONE PLUS BG/ BPL LIFEPHONE PLUS wellness monitor if firmly secured. Figure 39 - Holstering BPL LIFEPHONE PLUS onto your waist band Setting up the “Consumer App” to measure Activity logs Press the POWER BUTTON key of the wellness monitor. Check to ensure that the Figure 3. BATTERY indicator glows GREEN as shown in Charge the BPL LIFEPHONE PLUS BG/ BPL LIFEPHONE PLUS to ensure that the wellness monitor does not power down while logging activity measurements. 378-D-006 Rev 2.3 User’s Manual P a g e | 67 ACTIVITY LOGGING MODE OF BPL LIFEPHONE PLUS For instructions on charging your BPL LIFEPHONE PLUS BG/ BPL LIFEPHONE PLUS battery, refer 3.4. Pair it with the same mobile device that was used during the registration. Refer to CHAPTER 5 & CHAPTER 6. On successful pairing, the blue LED will glow on the BPL LIFEPHONE PLUS BG/ BPL LIFEPHONE PLUS wellness monitor as shown in Figure 11. Input the username and password details of your BPL LIFEPHONE PLUS BG/ BPL LIFEPHONE PLUS cloud server account on the login screen shown in Figure 40 Ensure that the Internet connectivity feature on your mobile device is enabled and working faithfully. Connecting to the BPL LIFEPHONE PLUS BG/ BPL LIFEPHONE PLUS cloud server will incur data usage charges. 378-D-006 Rev 2.3 User’s Manual P a g e | 68 ACTIVITY LOGGING MODE OF BPL LIFEPHONE PLUS Figure 40 - Logging onto BPL LIFEPHONE PLUS server Tap on “Login. The “Consumer App” will attempt logging onto the BPL LIFEPHONE PLUS server using secure authentication schemes. On successful logon, the BPL LIFEPHONE PLUS BG/ BPL LIFEPHONE PLUS screen will appear. On the home screen, click on the settings icon the settings menu shown in Figure 18. 378-D-006 Rev 2.3 User’s Manual to open up P a g e | 69 ACTIVITY LOGGING MODE OF BPL LIFEPHONE PLUS Figure 41 - Setting your Activity profile Key in your name, gender, height & weight and tap on save. Figure 42 - Populating User Profile details The details are important information used by the BPL LIFEPHONE PLUS in its “step count” and “calories burnt” calculations. Starting the Activity Measurement The saved information will be displayed as shown in Figure 43 378-D-006 Rev 2.3 User’s Manual P a g e | 70 ACTIVITY LOGGING MODE OF BPL LIFEPHONE PLUS Figure 43 - Stating the Activity measurement To enable ease of wear, the mobile device need not be carried along with the BPL LIFEPHONE PLUS wellness monitor, while taking activity logs and measurements. The BPL LIFEPHONE PLUS wellness monitor, can measure readings and sync with the mobile device after you choose to stop monitoring the activity logs. However, the access to the paired mobile device will be needed to view, save and upload the activity logs onto your BPL LIFEPHONE PLUS cloud server account. Tap on Start to begin logging Activity measurements. Continue with your daily active lifestyle. Check to ensure that the “Activity” Indicator on the BPL LIFEPHONE PLUS is blinking. 378-D-006 Rev 2.3 User’s Manual P a g e | 71 ACTIVITY LOGGING MODE OF BPL LIFEPHONE PLUS Figure 44 - BPL LIFEPHONE PLUS in Acitvity Logging Mode A complete charge allows the use of the BPL LIFEPHONE PLUS BG/ BPL LIFEPHONE PLUS wellness monitor for about 2 days with each day constituting - 3 ECG measurements, 2 BG measurements and 8 hours of activity logging. When you choose to stop your daily activity measurement, follow the steps listed below to view the activity log. Remove the holster from your waist belt along with the wellness monitor. Place the BPL LIFEPHONE PLUS BG/ BPL LIFEPHONE PLUS close to the mobile device to which it was paired to. The BPL LIFEPHONE PLUS BG/ BPL LIFEPHONE PLUS will attempt to re-connect automatically to display the steps travelled and the calories burnt during this activity session. In case the “Consumer App” on the mobile is closed, launch the “Consumer App”. The secure BPL LIFEPHONE PLUS cloud server may limit a login session to a finite duration, say, a few hours to ensure that your data and login 378-D-006 Rev 2.3 User’s Manual P a g e | 72 ACTIVITY LOGGING MODE OF BPL LIFEPHONE PLUS information is not compromised. You may have to login again. Check to ensure that you are logged into the BPL LIFEPHONE PLUS server. You may log back into the server by tapping on “Login” on the home screen to launch the login screen shown in Figure 40. Tap on the “Activity Logging Mode” icon as shown in Figure 45. Figure 45 - Triggering Activity Logging Mode The Activity logging screen will get updated with the activity measurements applicable to this session. Refer Figure 46. 378-D-006 Rev 2.3 User’s Manual P a g e | 73 ACTIVITY LOGGING MODE OF BPL LIFEPHONE PLUS Figure 46 – Activity logging Tap on STOP to add a comment for this activity session. Tap on save. The “Consumer App” will attempt to save the activity log onto the BPL LIFEPHONE PLUS server. On successful saving, the following confirmatory dialog will be shown. Figure 47 - Saving your Activity Log 378-D-006 Rev 2.3 User’s Manual P a g e | 74 BLOOD GLUCOSE MEASUREMENT MODE CHAPTER 9 BLOOD GLUCOSE MEASUREMENT MODE The “Blood Glucose Measurement Mode” of the BPL LIFEPHONE PLUS BG wellness monitor facilitates the user with data to monitor the effectiveness of diabetes control. Before attempting to operate this product, strictly observe all warnings and cautions provided on the equipment, accessories and those described in this document and the inserts that come with the packaging. Safety Information for Blood Glucose measurement Warning! Test only whole blood samples with the On Call® Simple Blood Glucose Test Strips and BPL LIFEPHONE PLUS BG wellness monitor BPL LIFEPHONE PLUS BG wellness monitor is for in vitro diagnostic use only. It is to be used only outside the body for monitoring the effectiveness of diabetes control. It should not be used for the diagnosis of diabetes. Consult your physician before using BPL LIFEPHONE PLUS BG wellness monitor. Keep out of reach of children. The BPL LIFEPHONE PLUS BG wellness monitor has been designed for use by adults and is intended for self-testing and professional use. Do not use test strips that are torn, bent, or damaged in any way. Do not reuse test strips. Keep the test strips vial or the foil pouch away from children and animals. The BPL LIFEPHONE PLUS BG wellness monitor is not designed or intended for complete 378-D-006 Rev 2.3 User’s Manual P a g e | 75 BLOOD GLUCOSE MEASUREMENT MODE diagnosis of cardiac conditions and diabetes. This wellness monitor should never be used as a basis for starting or modifying treatment, or for making adjustments to your medication, diet or activity routines without independent confirmation by medical examination. Dispose of blood samples and materials carefully. Treat all blood samples as if they are infectious materials. Follow proper precautions and obey all local regulations when disposing of blood samples and materials. Electrical shock hazard. Keep the BPL LIFEPHONE PLUS BG/ BPL LIFEPHONE PLUS wellness monitor and all its accessories away from liquids. Do not immerse the BPL LIFEPHONE PLUS BG wellness monitor, other accessories in any liquids. In case of accidental spillage, get it checked completely by authorized service personnel before using this BPL LIFEPHONE PLUS BG/ BPL LIFEPHONE PLUS wellness monitor. Caution! Periodically check the efficiency of devices and accessories. Contact the authorized Service Call Centre whenever the equipment appears to be malfunctioning. Keep the BPL LIFEPHONE PLUS BG wellness monitor dry and avoid exposing it to extreme temperatures or humidity or dusty environments. Do not leave it in your car. Recommended temperature range is specified 378-D-006 Rev 2.3 User’s Manual P a g e | 76 BLOOD GLUCOSE MEASUREMENT MODE under technical specifications. (See CHAPTER 17). BPL LIFEPHONE PLUS BG & Blood Glucose Accessories Before testing, read the instructions carefully and learn about all the components of your BPL LIFEPHONE PLUS BG wellness monitor. Figure 48 – Wellness monitor & On Call ® Accessories 378-D-006 Rev 2.3 User’s Manual P a g e | 77 BLOOD GLUCOSE MEASUREMENT MODE BPL LIFEPHONE PLUS BG wellness monitor: Reads the On Call® Simple Blood Glucose Test Strips and measures the blood glucose concentration and transmits the measured data to the “Consumer App” on your mobile phone. On Call® Simple Blood Glucose Test Strips: Strips with a chemical reagent system used with the meter to measure glucose concentration in blood. On Call® Lancing Device: Used with sterile On Call® lancets to prick the fingertip for blood sample collection. The packaged lancing device has multiple depth settings, allowing users to adjust the depth of the puncture and minimize discomfort. It can also eject the used On Call® lancets. On Call® Clear Cap: Used with the On Call® lancing device and sterile On Call® lancet to draw a blood sample from the forearm or palm. On Call® Sterile Lancets: Used with the On Call® lancing device to draw a blood sample. Sterile On Call® lancets are inserted into the On Call® lancing device with each blood draw and discarded after use. On Call® Simple Control Solution: Verifies the proper operation of the blood glucose monitoring system by checking the test strips and meter against a pre-calibrated On Call® Simple Control Solution. On Call® Simple Control Solution 1 is all you need most of the time. On Call® Simple Control Solution 0 and Control Solution 2 are also available if you want to do a level 0 or level 2 test. The three levels of control solution, CTRL 0, CTRL 1 and CTRL 2 are available in the On Call® Simple Glucose Control Solution package which is sold separately. Carrying Case: Provides portability for blood glucose testing wherever you go. 378-D-006 Rev 2.3 User’s Manual P a g e | 78 BLOOD GLUCOSE MEASUREMENT MODE Know your On Call® Simple Blood Glucose Test Strips The On Call® Simple Blood Glucose Test Strips are thin strips with a chemical reagent which works with the BPL LIFEPHONE PLUS BG wellness monitor to measure the glucose concentration in whole blood. After the strip is inserted into the wellness monitor, blood is applied to the sample tip of the On Call® Simple test strip. The blood is then automatically absorbed into the reaction cell where the reaction takes place. A transient electrical current is formed during the reaction and the blood glucose concentration is calculated based on the electrical current detected by the BPL LIFEPHONE PLUS BG wellness monitor. The wellness monitor is calibrated to calculate/measure plasma equivalent results. Figure 49 - Known your On Call® Simple Test Strip Warning 378-D-006 Rev 2.3 Apply the sample only to the sample tip of the On Call® Simple test strip. Do not apply blood or control solution to the top of the test strip as this may result in an inaccurate reading. User’s Manual P a g e | 79 BLOOD GLUCOSE MEASUREMENT MODE Storage and Handling of Test Strips There are specific instructions to be followed to store the Blood Glucose Test Strips. Refer to section Storage & Handling of On Call® Simple Test Strips. Instructions to place a drop of blood onto Test Strips Hold the blood drop to the sample tip of the test strip until the check window is completely full. If the check window does not fill, then do not add more blood to the test strip. If you do, then you may get an error message or an inaccurate test result. On Call® Simple Blood Glucose Control Solution The On Call® Simple Glucose Control Solution contains a known concentration of glucose. It is used to confirm that your BPL LIFEPHONE PLUS BG wellness monitor and test strips are working together properly and that you are performing the test correctly. It is important to run a quality control test regularly to make sure you are getting correct results. For details on the storage and handling of the control solution refer to STORAGE & SERVICING. 378-D-006 Rev 2.3 User’s Manual P a g e | 80 BLOOD GLUCOSE MEASUREMENT MODE BPL LIFEPHONE PLUS BG: Quality Control Test The quality control test confirms that the test strips and wellness monitor are working together properly, and that you are performing the test correctly. It is important to perform this test: Before you first use your wellness monitor, to familiarize yourself with its operation. Before using a new box of test strips. When you suspect that the wellness monitor or test strips are not working properly. When you suspect that your test results are inaccurate, or if they are inconsistent with how you feel. When you suspect your wellness monitor is damaged. After cleaning your wellness monitor. At least once a week. Performing a Quality Control Test using “ConsumerApp” Press the POWER BUTTON key of the wellness monitor. Check to ensure that the BATTERY indicator glows GREEN as shown in Figure 3. Pair it with the same mobile device that was used during the registration. Refer to CHAPTER 5 & CHAPTER 6. On successful pairing, the blue LED will glow on the BPL LIFEPHONE PLUS BG wellness monitor as shown in Figure 11. On the home screen, click on the settings icon to open up the settings menu shown in Figure 50 and select Blood glucose calibration. 378-D-006 Rev 2.3 User’s Manual P a g e | 81 BLOOD GLUCOSE MEASUREMENT MODE Figure 50 - Blood Glucose Calibration Insert the strip in the slot of the device as shown in Figure 51 and wait for the beep. Figure 51 – Inserting the Test strip Observe the illustration screen change to blood drop placement prompt. If the screen does not change, the test strip has not been inserted correctly. 378-D-006 Rev 2.3 User’s Manual P a g e | 82 BLOOD GLUCOSE MEASUREMENT MODE Shake the control solution bottle well, then squeeze it gently and discard the first drop. If the tip clogs, tap the tip gently on a clean, hard surface. Then shake again and use. Squeeze out a second small drop on a clean nonabsorbent surface. Touch the sample tip of the test strip to the control solution drop. Do not apply control solution to the test strip directly from the bottle. If the control solution sample does not fill the check window, do not add a second drop. Discard the test strip and start over with a new test strip. Once a sufficient sample has been applied, the result will be displayed on the “Consumer App”. The control solution test results should be within the control range (CTRL 1) printed on the test strip vial (or on the foil pouch). This means that your blood glucose monitoring system is working properly and that you are performing the procedure correctly. The control solution range is the expected range for the control solution results. It is not a recommended range for a blood glucose level. Remove the strip and discard it. If the result falls outside the indicated control range: Confirm you are matching the correct range. Control Solution 1 results should be matched to the CTRL 1 range printed on the test strip vial (or on the foil pouch). Check the expiration date of the test strip and control solution. Make sure that the test strip vial and control solution bottle have not been opened for more than 6 months. Discard any test strips or control solution that has expired. 378-D-006 Rev 2.3 User’s Manual P a g e | 83 BLOOD GLUCOSE MEASUREMENT MODE Confirm the temperature in which you are testing is between 10 and 35 °C. Make sure that the test strip vial and control solution bottle have been tightly capped. Confirm that you are using the On Call® Simple Control Solution. Make sure that you followed the test procedure correctly. After checking all of the conditions listed above, repeat the quality control test with a new test strip. If your results still fall outside of the control range shown on the test strip vial (or on the foil pouch), your wellness monitor may be defective. Contact your local distributor for help. Three levels of control solution are available labeled Control Solution 0, Control Solution 1 and Control Solution 2. Control Solution 1 is sufficient for most all self-testing needs. If you think your meter or strips may not be working correctly, you may also want to do a level 0 or level 2 test. The ranges for CTRL 0, CTRL 1 and CTRL 2 are displayed on the test strip vial (or on the foil pouch). Simply repeat step 4 through 6, using Control Solution 0 or Control Solution 2. For confirmation of results, Control Solution 0 tests should fall within the CTRL 0 range, Control Solution 1 tests should fall within the CTRL 1 range, and Control Solution 2 tests should fall within the CTRL 2 range. If the control solution’s test results do not fall within the respective ranges, DO NOT use the system to test blood, as the system may not be working properly. If you cannot fix the problem, contact your local distributor for help. 378-D-006 Rev 2.3 User’s Manual P a g e | 84 BLOOD GLUCOSE MEASUREMENT MODE Please contact your local distributor for information on ordering the On Call® Simple Glucose Control Solution kit, which contains Control Solution 0, Control Solution 1 and Control Solution 2. Using “Consumer App” to measure Blood Glucose The following steps will show how to use the BPL LIFEPHONE PLUS BG wellness monitor, test strips, lancing device and sterile lancets together to measure your blood glucose concentration. Step1 - Getting a Drop of Blood The BPL LIFEPHONE PLUS BG wellness monitor requires a very small drop of blood which may be obtained from the fingertip, palm (at base of the thumb) or forearm. Before testing, choose a clean, dry work surface. Familiarize yourself with the procedure & make sure you have all the items needed to obtain a drop of blood. Prior to testing, wipe the test site with an alcohol swab or soapy water. Use warm water to increase blood flow if necessary. Then dry your hands and the test site thoroughly. Make sure there is no cream or lotion on the test site. Figure 52 - Lancing Device with sterile lancet 378-D-006 Rev 2.3 User’s Manual P a g e | 85 BLOOD GLUCOSE MEASUREMENT MODE Fingertip testing For fingertip sampling, adjust the depth penetration to reduce the discomfort. You do not need the clear cap for fingertip sampling. 2. Unscrew the lancing device cover from the body of the lancing device. Insert a sterile lancet into the lancet holder and push it until the lancet comes to a complete stop in the lancing device. 3. Hold the lancet firmly in the lancing device and twist the safety tab of the lancet until it loosens. Then pull the safety tab off the lancet. Save the safety tab for lancet disposal. 4. Carefully screw the cover back onto the lancing device. Avoid contact with the exposed needle. Make sure the cover is fully sealed on the lancing device. 5. Adjust the puncture depth by rotating the lancing device cover. There are a total of 11 puncture depth settings. To reduce the 378-D-006 Rev 2.3 User’s Manual P a g e | 86 BLOOD GLUCOSE MEASUREMENT MODE discomfort, use the lowest setting that still produces an adequate drop of blood. Adjustments 0 - 1.5 For delicate skin 2 – 3.5 For normal skin 4-5 For calloused or thick skin Caution Increased pressure of the lancing device against the finger will also increase the puncture depth. 6. Pull the cocking barrel back to set the lancing device. You may hear a click, while the release button changes to orange to indicate the lancing device is now loaded and ready for obtaining a drop of blood. 7. Prior to testing, clean your hands with an alcohol wipe or wash your hands with soap. Use warm water to increase blood flow 378-D-006 Rev 2.3 User’s Manual P a g e | 87 BLOOD GLUCOSE MEASUREMENT MODE in your fingers if necessary. Dry your hands thoroughly. Massage the hand from the wrist up to the fingertip a few times to encourage blood flow. 8. Hold the lancing device against the side of the finger to be lanced with the cover resting on the finger. Push the release button to prick your fingertip. You may hear a click as the lancing device activates. Gently massage from the base of the finger to the tip of the finger to obtain the required blood volume. Avoid smearing the drop of blood. For the greatest reduction in pain, lance on the sides of the fingertips. Rotation of sites is recommended. Repeated punctures in the same spot can make your fingers sore and callused. Forearm and Palm Testing The forearm and palm areas have less nerve endings than the fingertip. For that reason, you may find that obtaining blood from 378-D-006 Rev 2.3 User’s Manual P a g e | 88 BLOOD GLUCOSE MEASUREMENT MODE these sites is less painful than from the fingertip. The procedure for forearm and palm sampling is different. You need the clear cap to draw blood from these sites. The clear cap is not adjustable for puncture depth. You should consult your healthcare professional before choosing to perform forearm or palm testing. Caution! When blood glucose levels are changing rapidly such as after a meal, an insulin dose or exercise, blood from the fingertips may show these changes more rapidly than blood from other areas. Fingertips should be used if testing is within 2 hours of a meal, an insulin dose or exercise and any time you feel glucose levels are changing rapidly. You should test with the fingertips anytime there is a concern for hypoglycaemia or you suffer from hypoglycaemia unawareness. 1. Screw the clear cap onto the lancing device. 2. Choose a puncture site on the forearm or palm. Select a soft and fleshy area of the forearm or palm that is clean and dry, away from bone, and free of visible veins and hair. 378-D-006 Rev 2.3 User’s Manual P a g e | 89 BLOOD GLUCOSE MEASUREMENT MODE To bring fresh blood to the surface of the puncture site, massage the puncture site vigorously for a few seconds until you feel it getting warm. 3. Place the lancing device against the puncture site. Press and hold the clear cap against the puncture site for a few seconds. Press the release button of the lancing device. Do not immediately lift the lancing device from the puncture site. Continue to hold the lancing device against the puncture site until you can confirm a sufficient blood sample has formed. For details pertaining to disposal of lancet, refer to DISPOSAL. Step2 - Testing Blood Glucose 378-D-006 Rev 2.3 User’s Manual P a g e | 90 Press the BLOOD GLUCOSE MEASUREMENT MODE POWER BUTTON key of the wellness monitor. Check to ensure that the BATTERY indicator glows GREEN as shown in Figure 3. Pair it with the same mobile device that was used during the registration. Refer to CHAPTER 5 & CHAPTER 6. On successful pairing, the blue LED will glow on the BPL LIFEPHONE PLUS BG wellness monitor as shown in Figure 11. Figure 53 - Starting the BG Recording Mode On the home screen of the “Consumer App” tap on the Blood sugar icon as shown in Figure 53Figure 22 378-D-006 Rev 2.3 User’s Manual P a g e | 91 BLOOD GLUCOSE MEASUREMENT MODE The successful setting up of the “BG RECORDING MODE” is indicated by the BG indicator on the front face of the BPL LIFEPHONE PLUS BG wellness monitor. Insert the strip in the slot of the device as shown in Figure 51 and wait for the beep. Observe the illustration screen change to blood drop placement prompt. If the screen does not change, the test strip has not been inserted correctly. Touch the blood sample to the sample tip at the end of the test strip. Figure 54 - Applying Blood Sample Caution! Do not apply the sample to the front or back of the test strip. Do not smear the blood drop onto the test strip. Do not press your finger against the test strip. Once a sufficient sample has been applied, the result will be displayed on the “Consumer App”. After inspection, follow the on-screen instructions to save the record on the BPL LIFEPHONE PLUS server. 378-D-006 Rev 2.3 User’s Manual P a g e | 92 BLOOD GLUCOSE MEASUREMENT MODE Connecting to the BPL LIFEPHONE PLUS cloud server will incur data usage charges. A high speed data connection using 3G, 4G or Wi-Fi will better the user experience and performance. Compare them to the target goals set by your diabetes healthcare professional. Discard the used test strip safely. Warning! Dispose off blood samples and materials carefully. Treat all blood samples as if they are infectious materials. Follow proper precautions and obey all local regulations when disposing of blood samples and materials. On successful login and saving of the BG recordings onto the server, the BPL LIFEPHONE PLUS server, allots a unique measurement ID. The measurement ID is displayed on the “Consumer App” Warning! The measurements and readings obtained during the use of BPL LIFEPHONE PLUS BG/ BPL LIFEPHONE PLUS wellness monitor should be submitted to a medical professional for review. The purchase of this wellness monitor should not be substituted for the care recommended by your family physician, and cardiologist. Click on “NO” to complete the BG recording and storing process without sending it to a doctor for consultation. The records can be accessed from the BPL LIFEPHPONEPLUS cloud server from your personal computer. Refer 10.3, to familiarize yourself with the procedure of sending your BG recordings to your doctor. 378-D-006 Rev 2.3 User’s Manual P a g e | 93 BLOOD GLUCOSE MEASUREMENT MODE Comparing wellness monitor and laboratory results Your BPL LIFEPHONE PLUS wellness monitor and laboratory results both report the glucose concentration in the serum or plasma component of your blood. However, the results may differ somewhat due to normal variation. The BPL LIFEPHONE PLUS wellness monitor results can be affected by factors and conditions that do not affect laboratory results in the same way. See On Call® Simple Test Strips’ package insert for typical accuracy and precision data, and for important information on limitations. To ensure a reasonable comparison, follow these guidelines Before you go to the lab: Bring your BPL LIFEPHONE PLUS BG wellness monitor, test strips and control solution with you to the lab. Make sure your BPL LIFEPHONE PLUS BG wellness monitor is clean. Perform a quality control test to make sure the BPL LIFEPHONE PLUS BG wellness monitor is working properly. Comparisons will be more accurate if you do not eat for at least four hours (preferably eight hours) before testing. At the lab: Wash your hands before obtaining a blood sample. Obtain blood samples for a laboratory test and for your BPL LIFEPHONE PLUS BG wellness monitor within 10 minutes of each other. This will ensure an accurate comparison of results. Never use your BPL LIFEPHONE PLUS BG wellness monitor with blood that has been placed in test tubes containing fluoride or other anticoagulants which are not suggested. This will cause falsely low results 378-D-006 Rev 2.3 User’s Manual P a g e | 94 THE BPL LIFEPHONE PLUS SERVER CHAPTER 10 THE BPL LIFEPHONE PLUS SERVER You will use your BPL LIFEPHONE PLUS cloud server account to use one or all of the following features: Upload and view ECG, BG measurements and Activity Logs. Request for Case from your doctor and View cases. View ECG, BG measurement and Activity measurement Charts. Buy subscription packages. Use net banking/credit card to make payments. View feedback provided by Specialists. Modify account information. Add additional family members as secondary users. Your “closed wallet account” on BPL LIFEPHONE PLUS server To use your BPL LIFEPHONE PLUS cloud server account, you must subscribe to a secure personal health record storage service. By subscribing to the BPL LIFEPHONEPLUS server you can Upload and view ECG , BG measurements and Activity Logs. Print ECGs records. View your activity trends. Request for Consultation from your doctor and View cases. View feedback provided by Specialists. Add additional family members as secondary users. For a detailed understanding about your subscription contact a BPLMTPL sales representative. Choosing your doctor, signing up for consultation services The BPL LIFEPHONE PLUS cloud server enables users to choose, select and connect with specific Healthcare providers & hospitals. 378-D-006 Rev 2.3 User’s Manual P a g e | 95 THE BPL LIFEPHONE PLUS SERVER To ensure faithful delivery of services, the BPL LIFEPHONE PLUS server enables up to three tiers of clinical advisory support. In order to select or choose a specialist doctor or to connect with your family physician through the BPL LIFEPHONEPLUS cloud server, contact a BPLMTPL sales representative. Sending your ECG/ BG measurements to your doctor The ECGs and BG measurements acquired through the BPL LIFEPHONE PLUS BG/ BPL LIFEPHONE PLUS wellness monitor can be sent to a physician or healthcare practitioner for consultation to aid the assessment and management of medical conditions including, cardiovascular diseases. To send your ECG, BG for Consultation follow the steps listed below: Follow the steps detailed in CHAPTER 7 to acquire an ECG up to section 7.12. Similarly refer to CHAPTER 9 for details on BG measurement mode In section 7.13, where the allotment of a unique measurement ID is detailed, the option to send an ECG/ BG recording for consultation is provided. Click YES. Figure 55 - Opting for a consultation 378-D-006 Rev 2.3 User’s Manual P a g e | 96 THE BPL LIFEPHONE PLUS SERVER Follow the instructions on the screen to choose your mode of payment for this consultation and complete the secure payment formalities. On successful completion of payment, a “case id” is assigned for this consultation. The BPL LIFEPHONEPLUS server automatically ensures that the saved ECG/BG measurement record is sent to the preferred doctor that you have signed-up with. Reading the Consultation note from your doctor The BPL LIFEPHONE PLUS server notifies the response from your doctor in three formats SMS notification to your mobile device; Tap on the “Feedback” icon on your “Consumer App” home screen. Email notification to your registered email account. Web advisory available for reference on your BPL LIFEPHONE PLUS cloud server account. Reviewing previously acquired recordings The records acquired through the BPL LIFEPHONE PLUS BG/ BPL LIFEPHONE PLUS wellness monitor should be saved on to the BPL LIFEPHONE PLUS cloud server. The web-login of the BPL LIFEPHONE PLUS server provides access to all your records on your personal computer. Logon to www.bpllifephoneplus.in to sign-in to your account. For a detailed understanding about your subscription contact a BPLMTPL sales representative. Reviewing historical recordings on “Consumer App” On the home screen of the “Consumer App”, tap on the “Records” icon shown in Figure 56 378-D-006 Rev 2.3 User’s Manual P a g e | 97 THE BPL LIFEPHONE PLUS SERVER Figure 56 - Records Menu on "Consumer App" The screen shown in Figure 57 will be displayed to enable easier access and retrieval of previously acquired recordings from the BPL LIFEPHONE PLUS cloud server Figure 57 – Retrieving Records using "Consumer App" MY DATA Access to previously acquired recordings that have never been sent to a specialist for consultation MY CASES Access to previously acquired recordings that have been sent to a specialist for consultation UNSAVED RECORDS Access to previously acquired recordings that have never been saved onto to the BPL LIFEPHONE PLUS server. In rare situations where the saving of the acquired records from the wellness monitor to the cloud server is not done, the mobile 378-D-006 Rev 2.3 User’s Manual P a g e | 98 THE BPL LIFEPHONE PLUS SERVER Application can temporarily save the data to enable delayed upload onto the server. Caution The “Consumer App” is not intended to store physiological recordings. Risk of “data loss” exists. You must save all the records onto the BPL LIFEPHONEPLUS server. 378-D-006 Rev 2.3 User’s Manual P a g e | 99 UNINSTALLING & UPGRADING “Consumer App” CHAPTER 11 UNINSTALLING & UPGRADING “Consumer App” Follow the instructions listed below to uninstall the application. Remove BPL LIFEPHONE PLUS from your “Consumer App” This procedure is to assist the user to remove a paired BPL LIFEPHONE PLUS BG/ BPL LIFEPHONE PLUS wellness monitor from your “Consumer App”. With the BPL LIFEPHONE PLUS BG/ BPL LIFEPHONE PLUS wellness monitor in the “OFF” condition, launch the “Consumer App”. Click on the tray Icon on you mobile device to launch the settings menu. Tap on “Remove Paired Device”. Ensure that the BPL LIFEPHONE PLUS BG/ BPL LIFEPHONE PLUS wellness monitor is OFF before attempting to un-pair from it using the “Consumer App”. Uninstalling the “Consumer App” Locate the ‘Consumer App’ amongst the installed list of applications on your mobile device. Caution Executing the next step will clear all unsaved logs. Upload all unsaved logs in the Consumer App onto the BPL LIFEPHONE PLUS BG/ BPL LIFEPHONE PLUS server. Tap on Clear Data and Clear Cache. Now tap on uninstall to uninstall the App. Turn ON the Bluetooth feature on your mobile device. 378-D-006 Rev 2.3 User’s Manual P a g e | 100 UNINSTALLING & UPGRADING “Consumer App” Under the list of available devices, un-pair the BPL LIFEPHONE PLUS BG/ BPL LIFEPHONE PLUS wellness monitor and restart your mobile device. Log on to www.bpllifephoneplus.in to know about the 101Bluetooth friendly name of the BPL LIFEPHONE PLUS. A log file, namely, LPP_userlog.txt may have been created on the mobile device. Locate the file on your mobile device and delete it. For detailed instructions, contact the Service Call Centre. Upgrading the “Consumer App” Ensure that unsaved records in the application, if any, are uploaded onto the server before upgrading the application. Follow the Application uninstallation instructions to uninstall the ‘Consumer App’ installed on your mobile device. Follow the Application installation instructions to install the new ‘Consumer App’. 378-D-006 Rev 2.3 User’s Manual P a g e | 101 CARE AND MAINTENANCE CHAPTER 12 CARE AND MAINTENANCE Periodic maintenance and functional inspection are necessary for proper use and functioning of the wellness monitor. This section gives details on such routine maintenance steps. Warning! If these failures cannot be corrected, immediately remove the wellness monitor from usage and contact authorized service personnel or agency or an authorized agency. There are no user repairable or serviceable parts for this wellness monitor. Inspection Check the BPL LIFEPHONE PLUS BG/ BPL LIFEPHONE PLUS wellness monitor and its accessories for mechanical damages such as dents or scratches or cracks. If any damages are observed, do not attempt to switch ON or use the wellness monitor. Contact authorized service personnel immediately. If the BPL LIFEPHONE PLUS BG/ BPL LIFEPHONE PLUS wellness monitor gives off an odor or generates excess heat, disconnect battery charger, turn off the wellness monitor immediately, place the wellness monitor in a container vessel such as a metal box and contact the authorized Service Call Centre. Contact an authorized service personnel for battery replacement immediately when a LOW BATTERY condition occurs often even after charging. The wellness monitor will have limited usage after indication of LOW BATTERY. Avoid recharging batteries in the above mentioned condition. Risk of explosion exists. Cleaning The outer surface of the wellness monitor and the ‘battery charger’ can be cleaned with a dry cloth. Disconnect the power 378-D-006 Rev 2.3 User’s Manual P a g e | 102 CARE AND MAINTENANCE before cleaning. Do not allow liquid to enter through connectors or through the openings provided on the cabinet. Household detergents or other chemical products should not be used. Do not scratch the electrodes. Warning! Do not allow any fluids to permeate the instrument case. Don’t pour or spray cleaners or disinfectants directly on the unit for cleaning. Do not use abrasive cleaners, or strong solvents such as acetone, or acetone based compounds. After cleaning the wellness monitor, remember to inspect the wellness monitor for any visible moisture or condensation. If any moisture or signs of fluid accumulation is found, do not attempt to switch ON or use the wellness monitor. Contact authorized service personnel immediately. Do not immerse the “battery charger” in water or other liquids. When using it, do not place it on or near sources of heat. Keep the outside of the instrument clean and free of dust & dirt. Cleaning the Lancing Device Use mild soap and warm water to clean with a soft cloth as required. Carefully dry the device thoroughly. Do not immerse the lancing device. Please refer to the lancing device insert for more details. Recommended Frequency of Maintenance Tasks TABLE 5- Periodic Maintenance of BPL LIFEPHONE PLUS 378-D-006 Rev 2.3 User’s Manual P a g e | 103 CARE AND MAINTENANCE COMPONENT RECOMMENDED FREQUENCY MAINTENANCE TASK Cleaning the Wellness monitor After every measurement. Section 12.1 & Section 12.2 Cleaning the Battery charger After every charging cycle Section 12.1 & Section 12.2 Substitution of rechargeable battery Once every three years Contact BPLMTPL service personnel Safety checks(leakage current) Once every three years Contact BPLMTPL service personnel Observing the wellness monitor and charger for damages After every use Section 12.1 378-D-006 Rev 2.3 User’s Manual P a g e | 104 STORAGE & SERVICING CHAPTER 13 STORAGE & SERVICING This section guides the user through the storage and servicing procedures to be followed by the users of BPL LIFEPHONE PLUS. Wellness monitor Storage Always store the wellness monitor & its accessories in predefined temperature conditions as described under specified TECHNICAL SPECIFICATIONS. It is extremely important to store wellness monitor and its accessories in recommended environment conditions for proper functioning of wellness monitor. Storage outside recommended condition can affect proper functioning or may result in damage to wellness monitor and its accessories. Storage & Handling of On Call® Simple Test Strips Store test strips in a cool, dry place at 2-30 °C (36-86 °F). Store them away from heat and direct sunlight. Do not freeze or refrigerate. Do not store or use test strips in a humid place such as a bathroom. Do not store the wellness monitor, the test strips or control solution near bleach or cleaners that contain bleach. The test strip should be used immediately after removing it from the container. Repeated insertion & removal of a test strip into the wellness monitor strip port may result in reading errors. Do not use your test strips past the unopened expiration date printed on the label. Using test strips past the unopened expiration date may produce incorrect test results. Note: The expiration date is printed in Year-Month format. 2015-01 means January, 2015. 378-D-006 Rev 2.3 User’s Manual P a g e | 105 STORAGE & SERVICING Special Instructions for Test strip in the Vial Test strips must be stored in the original vial with the cap tightly closed. This keeps them in good working condition. Do not transfer test strips to a new vial or any other container. Replace the cap on the test strip vial immediately after removing a test strip. A new vial of test strips may be used for 6 months after being first opened. Write the opened expiration date on the vial label after opening. Discard the vial 6 months after you first open it. Usage after this period may result in inaccurate readings. Special Instructions for Test strip in the Foil Pouch Tear the pouch carefully starting from the tear gap. Avoid damaging or bending the test strip. Use the test strip immediately after removing it from the pouch. Storage & Handling of On Call® Simple Control Solution Store the control solution at 2-30 °C (36-86 °F). Do not refrigerate or freeze. If the control solution is cold, do not use until it has warmed to room temperature. Use before the unopened expiration date that is shown on the bottle. Note: The expiration date is printed in Year-Month format. 2015-01 means January, 2015. Each bottle of control solution can be used for 6 months after you first open it. Record the opened and the resulting expiration date on the bottle label. 378-D-006 Rev 2.3 User’s Manual P a g e | 106 STORAGE & SERVICING Servicing the BPL LIFEPHONEPLUS Wellness Monitor If the BPL LIFEPHONE PLUS BG/ BPL LIFEPHONE PLUS wellness monitor needs servicing, contact an authorized service center or the manufacture. Please provide detailed information/accurate description of the problem to the service personnel. This will ensure quick service and repair of the unit. If possible, use the original shipping carton to return the BPL LIFEPHONE PLUS BG/ BPL LIFEPHONE PLUS wellness monitor for servicing. This will help minimize damage during shipping. Warning! Do not open the covers, unscrew the wellness monitor screws or disassemble BPL LIFEPHONE PLUS BG/ BPL LIFEPHONE PLUS wellness monitor. There is no user serviceable parts inside. Service and repair should be performed only by authorized and/or trained service personnel. 378-D-006 Rev 2.3 User’s Manual P a g e | 107 DISPOSAL CHAPTER 14 DISPOSAL Disposal of the wellness monitor and/or its accessories must be done according to local regulations. Alternatively, the wellness monitor and/or its accessories must be handed over to specific organization who deals with recycling of electrical and electronic devices as per Waste Electrical and Electronic Equipment (WEEE) directive. Disposal of the lancet 1. Unscrew the lancing device cover. Place the safety tab of the lancet on a hard surface. Then carefully insert the lancet needle into the safety tab. 2. Press the release button to make sure that the lancet is in the extended position. Slide the ejection button forward to discard the used lancet. Place the lancing device cover back on the lancing device. By facilitating correct disposal of the product and its accessories, you are protecting the environment and health of mankind. Recycling of material allow reduced usage of raw materials. More information on product recycling can be obtained from your local authorities, from community recycling agencies or the establishment from where you purchased the wellness monitor. Warning! Do not dispose the wellness monitor or its accessories along with domestic waste. Follow local regulations for disposal. 378-D-006 Rev 2.3 User’s Manual P a g e | 108 STANDARD ACCESSORIES CHAPTER 15 STANDARD ACCESSORIES TABLE 6- STANDARD ACCESSORIES SL.NO PART CODE ITEM QTY 1 M78013 Battery charger 1 2 M78004 Training CD 1 3 M78016 1 4 M78017 5 M78018 6 M78019 7 M78020 8 M78021 9 M78022 BLOOD GLUCOSE TEST STRIPS VIAL - 10 BLOOD GLUCOSE CONTROL SOLUTION BLOOD GLUCOSE LANCET POUCH - 10 LANCING DEVICE WITH CLEAR CAP PACK INSERT - TEST STRIP PACK INSERT CON.SOLN. PACK INSERT - LANC. DEVICE 1 1 1 1 1 1 Depending on the BPL LIFEPHONE PLUS / BPL LIFEPHONE PLUS BG you purchase, some of the accessories as per the list provided in this user’s manual may have to be purchased separately. Please check the list of contents on the outer carton for details on which components are included with your purchase. Please contact the authorized Service Call Centre for information on ordering. 378-D-006 Rev 2.3 User’s Manual P a g e | 109 Warning! STANDARD ACCESSORIES The unit is to be used only with the set of recommended accessories. For reasons of safety and reliability, use only original accessories provided/supplied by the manufacturer or equipment supplier. The safety and performance of the BPL LIFEPHONE PLUS BG/ BPL LIFEPHONE PLUS wellness monitor are not guaranteed when nonapproved replacement parts and supplies are used. For replacement of accessories or disposable kits, contact authorized service personnel immediately. The use of accessories and cables other than those specified in the user’s manual can result in increased emissions or decreased immunity of the system. 378-D-006 Rev 2.3 User’s Manual P a g e | 110 TROUBLESHOOTING CHAPTER 16 TROUBLESHOOTING The following table summarizes occasionally occur and their causes. problems, which may TABLE 7- During Use with your “Consumer App” PROBLEM CAUSE SOLUTION Bluetooth pairing issues. Mobile device not in the vicinity of the wellness monitor. “Bluetooth” feature not enabled on the mobile device Remove all the devices in the paired device list of your phone and start the Consumer application on the mobile again. Follow the steps detailed in CHAPTER 5. Slow response of “Consumer App” Too many open applications Close all applications other than “Consumer App”. Refer the user’s manual of your mobile device. Unable to upload data Internet data connectivity feature not enabled on your mobile device Reset the settings for the internet on the mobile phone. If the problem persists check the settings with the Mobile operator. Mobile Software not responding Unknown Close the “Consumer App”. Power down the device by holding the power button for 12 seconds. ECG screen does not progress to next step Bluetooth connection between mobile device & BPL LifePhone Plus is lost Close the Consumer App, restart your mobile device and repeat ECG recording. 378-D-006 Rev 2.3 User’s Manual P a g e | 111 TROUBLESHOOTING TABLE 8- During Use for recording ECGs PROBLEM Base line wandering. (ECG moves slowly up and down). Mains Interference. (Sine wave of 50Hz). Muscle interference. (Random interference resembles AC interference). CAUSE SOLUTION Insufficient electrode contact. Electrode surface dirty. Body movement. Due to user breathing heavily. Clean the skin, electrodes and repeat recording by following all the instructions in CHAPTER 7. User close to power lines. Other equipment close to patient. Patient in contact with other metallic parts or others. Keep the patient away from mains or other equipment. User is uncomfortable, feeling cold and shivering. Poor electrode contact. Relax & breathe calmly. Clean metal electrode & skin. Repeat recording by following instructions in CHAPTER 7. TABLE 9- During Use for recording BG measurements PROBLEM Unable to begin BG measurement 378-D-006 Rev 2.3 CAUSE SOLUTION Strip insertion timeout Insert the test strip within specified time Wrong type of strip inserted Wrong strip inserted. User’s Manual Use of contaminated strip P a g e | 112 TROUBLESHOOTING Automatic exit out of BG mode Not inserting the test strip within the BG timeout duration Insert the test strip within the BG timeout duration (about 1minute) Blood sample timeout error Not placing the blood sample on the test strip within the timeout duration Place the blood sample on the test strip within the timeout duration BG high / Low ambient temperature Triggering BG measurement in an environments that is outside the specified operating temperature Move to an environment that has a temperature within the specified operating conditions. 378-D-006 Rev 2.3 User’s Manual P a g e | 113 TECHNICAL SPECIFICATIONS CHAPTER 17 TECHNICAL SPECIFICATIONS PARAMETERS SPECIFICATION PERFORMANCE CHARACTERISTICS ECG ACQUIRED ECG LEADS ACQUISITION TYPE FREQUENCY RESPONSE Lead1, Lead2, Lead3, aVl, aVR, aVF, Modified Chest lead 1, Modified Chest lead2, Modified Chest lead3, Modified Chest lead4, Modified Chest lead5, Modified Chest lead6. STEP 1: Lead1, Lead2, Lead3, aVR, avL, aVF - Simultaneous STEP 2: MCL1,MCL2 Simultaneous STEP 3: MCL3,MCL4 Simultaneous STEP 4: MCL5,MCL6 Simultaneous Each STEP is sequentially acquired. ECG measurement in steps with signal bandwidth of 0.3Hz to 25Hz. INPUT DYNAMIC RANGE 10mV Peak to Peak. DIFFERENTIAL RANGE +/-5mV. 378-D-006 Rev 2.3 User’s Manual P a g e | 114 TECHNICAL SPECIFICATIONS A/D SAMPLING RATE 250 samples/sec. RESOLUTION 12 bits. HR Range 45 to 180 bpm. HR accuracy +/-5% or 5bpm. Patient interface Four stainless-steel electrodes are exposed; two at the front and two at rear end of the wellness monitor. These electrodes make contact with the patient's skin. Classification Type BF BLOOD GLUCOSE (Applicable for LIFEPHONE PLUS BG models only) Measurement Range Blood Glucose Module with a range of 10 - 600mg/dL. Result Calibration Plasma-equivalent Sample Fresh capillary whole blood 378-D-006 Rev 2.3 User’s Manual P a g e | 115 TECHNICAL SPECIFICATIONS Minimum Sample Size 0.4µL Test Time 4 seconds ACTIVITY Sensor 3-Axis, Digital Accelerometer based activity sensing support. Sensor Accuracy +/-2g. Setting Range Precision of Step Counting Height: 150 cm to 190 cm. Features Wearable Device specification Observed +/- 5% accuracy with manual counting test. Steps walked, Total Time, Calories burnt. The wellness monitor has been designed & tuned to be worn on the hip. The wellness monitor could be worn on a belt or trouser but it should fit snugly on the body. POWER REQUIREMENTS POWER ADAPTER 378-D-006 Rev 2.3 AC input 100-240V, 50/60Hz, DC output 5V/1.0A, IEC60601-1 compliant. User’s Manual P a g e | 116 TECHNICAL SPECIFICATIONS Li-Polymer Battery, 3.7V, 650mAh. BATTERY CHARGING TIME FROM TOTAL DISCHARGE 240 minutes from total discharge. BATTERY LIFE Typically 2 days with each day constituting - 3 ECGs, 2 BG and 8 hours of activity. ENVIRONMENTAL SPECIFICATIONS OPERATING TEMPERATURE OPERATING TEMPERATURE for BLOOD GLUCOSE MEASUREMENT 0°C to 35°C 5°C to 35°C STORAGE TEMPERATURE 0°C to 45°C TRANSPORTATION TEMPERATURE 0°C to 45°C RELATIVE HUMIDITY 10% to 90% ATMOSPHERIC PRESSURE 700 – 1060hPa PHYSICAL CHARACTERISTICS DIMENSIONS ( L x W x T) 70mm x 70mm x 35mm. WEIGHT 80g (Approximately) 378-D-006 Rev 2.3 User’s Manual P a g e | 117 EMC GUIDANCE AND MANUFACTURER’S DECLARATIONS CHAPTER 18 EMC GUIDANCE AND MANUFACTURER’S DECLARATIONS The BPL LIFEPHONE PLUS BG/ BPL LIFEPHONE PLUS WELLNESS MONITOR and its accessories may become sensitive to interference from other RF energy sources including power lines. RF energy sources include other medical devices, wireless devices, information technology equipment, and radio/television transmission. These devices can cause harmful interference to the BPL LIFEPHONE PLUS BG/ BPL LIFEPHONE PLUS wellness monitor and/or system or cause the BPL LIFEPHONE PLUS BG/ BPL LIFEPHONE PLUS wellness monitor and/or system to fail to perform its intended function or degrade its intended performance. Should interference be encountered, one or all of the following scenarios may be observed: Artifact on the ECG trace. Unintended change on operating state. Unintended operational performance. Unit lockup. If, during the operation of the BPL LIFEPHONE PLUS BG/ BPL LIFEPHONE PLUS wellness monitor and/or system, there is any undesired deviation from its intended operational performance, you must avoid, identify and resolve the adverse electromagnetic effect before continuing to use the BPL LIFEPHONE PLUS BG/ BPL LIFEPHONE PLUS wellness monitor and/or system. To locate the source of interference, conduct the following checks: Inspect the BPL LIFEPHONE PLUS BG/ BPL LIFEPHONE PLUS wellness monitor & its accessories for any mechanical damages. 378-D-006 Rev 2.3 User’s Manual P a g e | 118 EMC GUIDANCE AND MANUFACTURER’S DECLARATIONS Check if original accessories provided by the manufacturer are used. Check if the interference occurs only when the wellness monitor is in close proximity to certain devices. Check if the interference occurs only in certain locations. Check if the interference is intermittent or constant. Once the source of the interference is located, attempt to attenuate the EMC coupling path by distancing the wellness monitor from the source of the interference as much as possible. If it is impossible to position the BPL LIFEPHONE PLUS BG/ BPL LIFEPHONE PLUS away from other electrical equipment, switch off such equipment when recording an ECG. 378-D-006 Rev 2.3 User’s Manual P a g e | 119 User’s MANUAL REVISON HISTORY User’s MANUAL REVISON HISTORY Revision History Rev. No. 1.0 1.1 2.0 2.1 2.2 2.3 Date 17-10-14 10-12-14 04-03-15 10-03-15 05-05-15 29-05-15 378-D-006 Rev 2.3 Changes Release Updated illustrations & figures Updated Blood Glucose feature details Updated salient features Updated Figure Numbers Added note on standard accessory list User’s Manual P a g e | 120 8. 0*.),)*- )64*(**65),) .)-()-)- ..))*(6+ 6*- +6).)6 $"&&-!%#% ## , *:;)< 94*.&.*)) *9)855*.) 7855*. &.6 !"#$%&& '(&&$%&&")*+ !""#$!""# %&"!!# '()*+++(,-*..*).&/0**)))-*.1(,* 3*.%.*)=***4 3*.%.*)=***4 2!"3*.%.*)*43*-**))43*.%.*)*43*-*)4)* -.)*,.5) ),.*5*.*) )*.)$*).*)-6*- +**.(**