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LifeWatch V User Manual

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Dear LifeWatch V owner:
Thank you for selecting the LifeWatch V mobile medical phone.
This user manual includes information and instructions for using your new LifeWatch V device and should be
read carefully before starting to use the device.
If you have any questions about your LifeWatch V, please contact your representative:
Illustrations included in this manual are general representations only and are not meant to
comply with specific regulatory requirements.
By default, your device is provided with pre-set applications.
Installation of new applications may affect the performance of your device and is the sole
responsibility of the user.
Before using the LifeWatch V, medical functions please read the Warnings and
Precautions, Appendix A, thoroughly.
This User Guide is for the enhanced LifeWatch V mobile medical device, also known as the LifeWatch V+
device. For the sake of brevity, we will refer to the device as the LifeWatch V device due to the five main
medical functions included in the device:
♦
ECG
♦
Heart Rate
♦
Temperature
♦
Pulse oximeter (SpO
♦
Blood glucose
)
2
1

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Summary of Contents for LifeWatch LifeWatch V

  • Page 1 This User Guide is for the enhanced LifeWatch V mobile medical device, also known as the LifeWatch V+ device. For the sake of brevity, we will refer to the device as the LifeWatch V device due to the five main medical functions included in the device: ♦...
  • Page 2 Copyright 2013 LifeWatch Technologies Ltd.® All rights reserved. LifeWatch Technologies Ltd., LifeWatch Inc., LifeWatch Inc. logo, and LifeWatch V are trademarks or registered trademarks of LifeWatch AG®. All other brand names and product names used in this document are trade names, service marks, trademarks, or registered trademarks of their respective owners.
  • Page 3 ECG (1 lead), heart rate and body temperature. The LifeWatch V is able to transmit the test results by wireless communication to a remote server for storage. The LifeWatch V blood glucose monitoring system is intended to be used by a single person and should not be shared.
  • Page 4 Servicing of the device shall be done by qualified personnel only. • The user of the LifeWatch V should not take any actions of a medical or clinical nature based on his/her understanding or interpretation of test results without consulting a healthcare professional.
  • Page 5 Symbols on Equipment and Labeling The following section contains a description of symbols that may be located either on the LifeWatch V device or in documentation accompanying the device in order to draw attention to safety items and other important information.
  • Page 6 Label Description Warning, consult the accompanying text or documents Precaution; consult the accompanying text or documents Warning, potential biohazard Notes, indicates important general information for using the system successfully. Consult instructions for use Manufacturer and date of Manufacture XXXX Type BF Applied Part...
  • Page 7 Label Description In vitro device Store at specified temperatures; location of thermometer WEEE Directive for disposal of Electrical and Electronic Equipment Symbol for no alarms Symbol indicating a USB connector Symbol indicating location of glucose meter...

  • Page 8: Table Of Contents

    Charging the Battery ..............25 Getting Around Your Device ............27 Touch Control ................27 Home Screen ................28 LifeWatch V Health and Medical Functions ........30 Getting Started with the LifeWatch V Medical and Wellness Applications ............. 30 License Agreement ................ 30...
  • Page 9 First Time Launch ................31 Login Screen .................. 32 Guest Login ................32 Test Application ................34 Test General Description ............... 34 Test Screens Description ............... 35 History .................... 40 Performing Medical Tests .............. 42 Blood Glucose Monitoring System ........... 42 Glucose Test Troubleshooting ..........
  • Page 10 ECG/HR/BFA/Sp0 /Stress Level Analyzer Tests ..... 56 Body Temperature Test ............60 Blood Pressure Test ..............62 LifeWatch V Application Settings ........... 64 My Profile .................. 65 Sharing Permissions ..............66 Test Settings ................66 Measurement Units ..............66 Sounds ..................66 Calendar Application ................
  • Page 11 Method of Calculation ............... 71 Maintenance ..................72 Conditions of Use................72 Caring for your LifeWatch V ............72 Cleaning and Disinfecting .............. 73 Environment ................74 Preventive Maintenance ..............75 Troubleshooting ................76 Specifications ..................79 Basic Parameters ..............79 Declaration of RoHS Compliance ..........
  • Page 12 Warnings ................... 89 Radio Frequency (RF) Exposure (Precautions) ......93 General Statement on RF Energy ..........93 EMI Considerations..............93 Body Worn Operation ............... 94 Limiting Exposure to Radio Frequency (RF) Fields (Precautions) ............... 94 Distraction ..................95 Driving (Precautions) ..............95 Operating Machinery (Precautions) ..........
  • Page 13 Electrostatic Discharge (ESD) ..........96 Antenna..................96 Normal Use Position ..............96 Air Bags ..................96 Seizures/Blackouts ..............96 Repetitive Strain Injuries ............96 Emergency Calls ............... 97 Loud Noise ................97 Phone Heating ................97 Electrical Safety (Precautions) ............97 Accessories ................
  • Page 14 Hearing Aids ................98 Use of LifeWatch V with other Medical Devices ....... 98 Hospitals ................... 98 Aircraft ..................98 Interference in Cars ..............98 Explosive Environments (Precautions) .......... 99 Petrol Stations and Explosive Atmospheres ......99 Blasting Caps and Areas ............99...
  • Page 15 Installation of new applications may affect the performance of your device and is the sole responsibility of the user. WARNING The user of the LifeWatch V should not take any actions of a medical or clinical nature based on his/her diagnosis or interpretation of the test results, without consulting a healthcare professional.
  • Page 16 Pediatrics as defined below The following applications of the LifeWatch V as described in this User Manual and as intended for use by the manufacturer, are not within the scope of the Medical Device Directive 93/42/EEC and are therefore not considered as medical devices, nor are they covered by the this Directive: •...
  • Page 17 Test Age Group Blood Oxygen Adults, 21 years and older Saturation By adults and on pediatrics aged 12 years and above. Blood Glucose Pediatrics below the age of 12 years: under adult supervision only Monitoring System Excluding neonates and infants less than one year 1 Lead ECG Adults and pediatrics above 12 years of age Heart Rate...
  • Page 18 Diet Management (for subscribed users only) • Drug Management NOTE: The LifeWatch V can be used as a stand-alone device or via a subscription plan which offers different levels of functionality to service plan subscribers (see section “Offered Service Plans”).

  • Page 19: Lifewatch V Basic Operation

    For Your General Safety (Precautions) As the LifeWatch V device is a medical device that can be used both as a regular cell phone and as a medical device, this manual includes both warnings and precautions relating to the use of the LifeWatch V as a cell phone, AND warnings and precautions concerning the use of the LifeWatch V as a medical device.
  • Page 20 Your device can produce a loud sound. materials or liquids. Avoid contact with anything magnetic. Only use approved accessories. Don’t rely on your device for emergency communications. Before using the LifeWatch V medical functions please read Appendix A Warnings and Precautions thoroughly.

  • Page 21: Getting Started

    Getting Started Overview Gluco-meter slot Front camera Power on/off Electrode Speaker Menu Key Ear phone plug Home Key Volume +/– Back Key USB connector Microphone...
  • Page 22 Rear Cover Removed Thermometer Loudspeaker Rear Camera Reset Button Electrode MicroSD Card Slot Electrode with SP02 SIM card Slot sensor...
  • Page 23 Icons LifeWatch V icon Call icon Contacts icon Messages icon Applications icon...

  • Page 24: Starting Up

    Starting up Installing the SIM/microSD Card Switch off your device before installing SIM, or memory card. Open the SIM card holder by sliding it in the direction of the OPEN arrow Hold the SIM card by the cut corner and slip it into the card holder.

  • Page 25: Charging The Battery

    Charging the Battery Connect the supplied USB plug to the USB/adapter jack. Ensure that the plug is inserted with the correct orientation. Do not force the plug into the jack. USB input is 5 VDC: maximum 5.25VDC to minimum 4.75VDC at 1A max. Connect the USB cable’s USB plug to the adapter Connect the adapter to a standard AC wall outlet Disconnect the adapter when the battery is fully charged...
  • Page 26 Switching Your Device On/Off ♦ Hold Power to switch on your device. ♦ To switch it off, hold Power to get the device options. Select Power off, and then tap OK. Always place the adapter in easily accessible main plugs. In case of electrical malfunction of the device during the connection to the adapter, remove the adapter from main plug immediately.

  • Page 27: Getting Around Your Device

    Waking Up Your Device Press Power to activate your screen display. Drag the icon to the right. NOTE: If you have set an unlock pattern, PIN or password for your device you’ll need to draw the pattern or enter the PIN/password to unlock your screen. Getting Around Your Device Touch Control You can use finger gestures to control your device.

  • Page 28: Home Screen

    Home Screen You can modify your Home Screen. Set your own wallpaper, add the widgets or application shortcuts you need, or remove them as you like. Extended Home Screen The Home Screen extends beyond the screen width, giving you lots more space to add more stuff.
  • Page 29 Adding Items to Your Home Screen Tap Application to explore the application screen. Tap and hold the desired app until it added to the home screen. Removing Items from Your Home Screen Tap and hold the item you want to delete until the “Remove” is shown on the screen. Drag the item to the “Remove”area.

  • Page 30: Lifewatch V Health And Medical Functions

    LifeWatch V Health and Medical Functions Getting Started with the LifeWatch V Medical and Wellness Applications Press the LifeWatch V icon on the desktop. This activates the application and opens the license agreement. License Agreement Please read the license agreement. The login screen appears after accepting the terms.

  • Page 31: First Time Launch

    First Time Launch The first time you open the application the registration screens are displayed. For registered user - enter your user name and password and tap on the “Sign In” button. For new user - tap on “Create Account” in order to start the registration process.

  • Page 32: Login Screen

    Login Screen This is the log-in screen for LifeWatch V medical applications. Use the keypad to enter your quick access code. The Start screen appears. Some LifeWatch V features are available to subscribers only! Guest log-in Guest Login Select Guest Login to start Guest Mode.
  • Page 33 Start Screen Select the required application to start. Application Icon Test Diet Drug Calendar Information...

  • Page 34: Test Application

    Test Application Test General Description The LifeWatch V performs the following tests: ♦ ECG - The graphical recording of your heart activity, to be used whenever you are concerned about your heart rhythm (history of Arrhythmias) or if you experience the following symptoms of abnormal heart rhythms: ♦...

  • Page 35: Test Screens Description

    Test Screens Description Use to cycle between tests and select the relevant Wheel test Information Press to open the relevant information about the Icon selected test type Test Type Displays test type Start Button Press to start testing History Press to display test history (3 last tests) Button Reminder Press to display the calendar...
  • Page 36 Press a button to change the display on the Start screen. Press To display Reminder NOTE: Tapping opens the Reminder Creation window for the current type of test. History Note: Tapping the graph opens History, see page 40.
  • Page 37 Test Wheel Icons BFA (body fat Blood Glucose Temperature analysis) Stress Level HR (heart rate) (electrocardiogram) Analyzer Blood Oxygen Blood Pressure Saturation (SPO2) NOTE: For tests involving the use of electrodes it is important to: a. Clean electrodes with a lint free dry cloth b.
  • Page 38 Each test type has its own units and scale values Warning - The user of the LifeWatch V should not take any actions of a medical or clinical nature based on his/her diagnosis or interpretation of the test results, without...
  • Page 39 Test Results Icons Reminder - Opens the Reminder window Share - Opens the Sharing Selection popup, share the results via Email or SMS Notepad Comment - Pop-up for commenting on results. Auto sharing results are sent without the comments Call - Initiate a call to the Call Center (Premium Users) Crossed-out apple means before meal Apple means after meal Retake test...

  • Page 40: History

    History The screen default is to show the last test type chosen. Scroll using the wheel to change test type. Wheel – scroll to change test type All Tests– show all tests (all types) Other Users – displays the test results of other users that you “follow” Graph –...
  • Page 41 Share Results– select to open Sending (SMS/email) option.

  • Page 42: Performing Medical Tests

    LifeWatch V device or authorized for use with the device. 1. To start the glucose test press Start. The screen rotates to the horizontal mode, please hold the LifeWatch V horizontally. The meter and lancing device are for single patient use. Do not share...
  • Page 43 2. A new screen opens, select Before or After meal. 3. Please insert a new glucose strip into the glucose slot when instructed Glucose strips are for single use only; dispose of used strips as per the instructions included with the strips. 4.
  • Page 44 Screw off the cap of Lancing Device. Insert a lancet into the lancet holder and push down firmly until it is fully seated. Twist the protective disk until it separates from the lancet. Replace the lancet device cap. Turn the cap until it is snug but not too tight.
  • Page 45 The adjustable tip offers 5 levels of skin penetration. Twist the adjustable tip in either direction until the number lines up with the Arrow: 1-2 for soft or thin skin, 3-4 for average skin, 5 for thick or calloused skin. Please select the most suitable depth for you to avoid unnecessary pain.
  • Page 46 5. Take a blood sample using the lancing device (see supplied lancing device instructions). 6. Place the finger with the acquired drop of blood at the tip of the glucose strip, as shown on the screen and below.
  • Page 47 7. The Processing screen appears, after a few seconds the results screen appears. 8. When the test is completed the results screen appears. Remove the used test strip and lancet; dispose of them. After 5-10sec of delay – it’ll be possible to: ♦...

  • Page 48: Glucose Test Troubleshooting

    If you are experiencing symptoms that are not consistent with your blood glucose test results AND you have followed all the instructions described in the LifeWatch V User Manual, call your healthcare professional. A red blood cell count (hematocrit) that is either very high (above 55%) or very low (below 30%) can cause false results.

  • Page 49: Alternative Site Testing (Ast)

    Alternative Site Testing (AST) Important: There are limitations for doing AST. Do Not Use AST for continuous glucose monitoring (CGM) calibration and insulin dose calculations. Please consult your healthcare professional before you do AST. What is AST? Alternative site testing (AST) means that people use parts of the body other than fingertips to check their blood glucose levels.
  • Page 50 We strongly recommend that you perform AST ONLY in the following intervals: ♦ In a pre-meal or fasting state (more than 2 hours since the last meal). ♦ Two hours or more after taking insulin. ♦ Two hours or more after exercise. Do NOT use AST if: ♦...

  • Page 51: Control Solution Test

    Control Solution Test Why Use the Control Solution? Ensure that your LifeWatch V and LifeWatch V Test Strips are working together properly. Practice testing without having to use your own blood. Perform Control solution tests when: ♦ First receive your LifeWatch V.
  • Page 52 3. The screen rotates to the horizontal mode, please hold the LifeWatch V horizontally. Insert the new glucose strip into the glucose slot when instructed. Glucose strips are for single use only; dispose of used strips as per the instructions included with the strips.
  • Page 53 Place the drop of control solution on the strip in the LifeWatch V as shown. The drop is drawn into the test strip. Move the cap away when the strip window is filled The Processing screen appears, after a few seconds...
  • Page 54 Remove the used test strip and dispose of it. 10. Compare the result of your control solution test to the range printed on your LifeWatch V Blood Glucose Test Strip vial label for the control solution level that you used.

  • Page 55: Control Solution Troubleshooting

    Control Solution Troubleshooting Problem Possible Cause(s) Solution 1. Rerun the test with a new Test Strip and Control solution 1. Not enough control solution is test results are placed on the Test Strip. apply sufficient control solution to fill Test Strip tip.

  • Page 56: Ecg/Hr/Bfa/Sp0 /Stress Level Analyzer Tests

    ECG/HR/BFA/Sp0 /Stress Level Analyzer Tests Recommended Preparations - Wash and dry your hands. If your fingers are too dry or are extremely cool, accurate measurements may not be possible. Condition Actions Hands are dry. Slightly moisten hands with a wet towel, then measure. Your hands are cold Warm your hands by immersing in warm water or staying in a warm room.
  • Page 57 Use the scroll wheel to cycle between the various tests. To start the test press Start. The screen rotates to the horizontal mode, please hold the LifeWatch V horizontally. NOTE: The ECG test is shown as an example. Place your two index fingers on the sensors located on the...
  • Page 58 Location of Sensors Right side, top in horizontal position Left side, bottom in horizontal position...
  • Page 59 When the test is completed the results are presented on the “Result Screen” SP02 Heart Rate It is now possible to: ♦ Retake the test by pressing the Retest button ♦ Use the Scroll Wheel to scroll to another test ♦...

  • Page 60: Body Temperature Test

    In order to achieve the intended accuracy, body temperature measurement should be performed within an ambient temperature range of 22-26°C The screen rotates to the horizontal mode, please hold the LifeWatch V horizontally. Follow the screen instructions and place the thermometer on your forehead when instructed.
  • Page 61 When the counter reaches 0 the test starts followed by beeps. Move the device from left to right, until the beeping stops (about 5 seconds). The processing screen appears while you are moving the device on your forehead, the test ends when the beeping stops. When the test is completed the results screen appears.

  • Page 62: Blood Pressure Test

    The screen rotates to the horizontal mode, please hold the LifeWatch Phone horizontally. Your LifeWatch phone will instruct you to sit down, install the inflatable cuff of your blood pressure device around your left arm and to turn...
  • Page 63 Your LifeWatch phone will display an animation until the completion of the test. When the test is completed the result screen appears. It is now possible to: ♦ Retake the test by pressing the Retest button ♦ Use the Scroll Wheel to scroll to another test ♦...

  • Page 64: Lifewatch V Application Settings

    LifeWatch V Application Settings The LifeWatch V application settings are divided into categories: My Profile Sharing Permissions Test Settings Measurement units Sounds...

  • Page 65: My Profile

    My Profile Press My Profile to open the profile details. The details that have been entered during the registration process are displayed. To change a detail, select it by pressing it and then either enter the new details in the field or if there is a pop-up box, change the setting. Pop-up Example Gender...

  • Page 66: Sharing Permissions

    Sharing Permissions Select Sharing Permissions to display the list of people already assigned for sharing and to add new sharing contacts. Test Settings Press on Test Settings to open the tests options screen. It is possible to set the desired test goal for each test.

  • Page 67: Calendar Application

    Calendar Application The Calendar application displays the set test times and medication use in a calendar format. You can select to display only tests or only medications. The details are presented when you click on a date with active remainders.

  • Page 68: Drug Reminder

    Drug Reminder Using the Drug Reminder application to create reminders for the medications that you are taking, including usage monitoring. The dosage, time periods, length of use and any special instructions may be added. It is possible to check the Reminder details, freeze (pause) the Reminder or delete the Reminder.
  • Page 69 Offered Service Plans Basic plan - this entry-level package consists of automatic on-line medical measurement analysis & indications. Premium Plan - in addition to the basic health features, this plan offers a professional human diagnostic interpretation of the measurements taken by the users, powered by a 24/7 call center staffed accordingly. Basic Premium Feature...
  • Page 70 LifeWatch V Ecosystem The LW V handset includes a service enablement platform, to support the transmission of data to be analyzed, evaluated and communicated to health professionals and call center personnel. This platform is cloud-based, making it simple to offer a wide range of high-value services such as automatic reply and self-analysis of ECG measurements, information storage, history and statistics presentation, sharing the information with authorized third parties (doctors, parents etc.).

  • Page 71: How To Login

    Web Portal You will be able to take measurements via the LifeWatch V device and manage your health via either the device or the web. You can manage your health, track and trend your measurements, print reports, share your data with your physician, set-up reminders, access your diet plan (if subscribed) and log your medication intake.

  • Page 72: Maintenance

    Caring for your LifeWatch V ♦ Do not open or attempt to repair your LifeWatch V yourself; do not tamper or attempt to remove the battery. Only authorized service personnel may repair the device. Incorrect replacement by inadequately trained personnel would result in an unacceptable RISK ♦...

  • Page 73: Cleaning And Disinfecting

    Cleaning and Disinfecting Clean and disinfect the LifeWatch V after each time you are using the glucose meter function and whenever blood and organic debris are visible on the surface. Step 1- Cleaning: Dispense a fresh towelette. Wipe the entire device surface thoroughly.

  • Page 74: Environment

    Environment ♦ Keep the device away from extreme heat. Do not leave it on the dashboard of a car or near a heater. Do not leave it in any place that is extremely damp or dusty ♦ As the device is not waterproof, do not use it or store it where liquids such as water, juice, coffee, etc.

  • Page 75: Preventive Maintenance

    Preventive Maintenance The following simple preventive maintenance tasks should be performed weekly to ensure the continued maximum capacity performance of the device, and to reduce the possibility of failure: ♦ Mechanical Inspection - Check for splits, cracks or imperfections in the case. If you have any questions or doubts, call your service provider.

  • Page 76: Troubleshooting

    Troubleshooting Low/critical battery Recharge the device for at least one hour Message Device temperature is too high or low, device Exceeding device temperature temperature should be 10 to 40 °C Device battery is low Charge the device USB cable or earphone is Disconnect USB cable or earphone before use connected to the device Fully cover the three electrodes...
  • Page 77 Check if the adapter is properly connected; if the phone battery was completely animation drained it may take up to one hour until the charging animation appears. historicalrecords/can Make sure the internet connection is available and that your LifeWatch V service not receive ECG plan is active analysis from the...
  • Page 78 Your device is hot to When you use applications that require more power or use applications on your the touch device for an extended period of time, your device may feel hot to the touch. This is normal and should not affect your device’s lifespan or performance A connection is not Ensure that the PC data cable you are using is compatible with your device established when you...

  • Page 79: Specifications

    Specifications Basic Parameters LCD Parameter 4.3 inch 480*800 Pixels (WVGA) Touch Lens Yes (Capacitive Touch screen) Processor Dual-core, Cortex A9, 1GHz Memory 4GB Flash + 1GB RAM Android™ OS JB 4.1.2 Storage Card Micro-SD, up to 32GB FM Radio Battery Capacity 1480 mAh LI-IO, BAK512880P Cellular Communication WCDMA Bands...
  • Page 80 GSM Bands 850/900/1800/1900MHz Short Range Communication Wi-Fi(WLAN) IEEE 802.11b/g/n Bluetooth revision Ver. 3.0 Main Camera Pixel Camera technology CMOS Auto Focus Picture Size Max 3264×2448 Zoom Digital zoom 4X Front Camera Pixel 0.3MP Camera technology CMOS...
  • Page 81 Picture Size Max 640*480 Physical Dimensions (H*W*D) 132*71*13 mm Weight 157 gram Environmental +10ºC to +40ºC Operating temperature Note: Body temperature measurement should be performed within an ambient temperature range of 22-26°C Humidity 10% to 95%, non-condensing Atmospheric pressure 70 kPa to 106 kPa *Temperature range of -25ºC to +75 ºC Transportation and Storage *Humidity range of 0 to 95%...
  • Page 82 Medical Sensors Specifications ECG sample rate 250 samples /sec transmission Sample resolution 12 bits Heart Rate HR measurement range 40 to 240 bpm HR accuracy ± 5 bpm or 10% whichever is greater R-R interval measured range 225 to 2000 msec R-R interval measured ±...
  • Page 83 Number of R-R intervals ≥40 which have to be measured is variable SPO2 Oxygen saturation range: 70 to 100 % Red 660 nanometers Measurement wavelengths: Infrared 910 nanometers The device does not have the capability to detect an SpO2 Alarm indication or pulse rate physiological alarm condition SPO2 Accuracy Root Mean Square (RMS) error: 3.5%...
  • Page 84 Blood Glucose Monitoring System Enzyme Type GDH-FAD 0.7 μL Sample Size Reaction Time 7 seconds Haematocrit Range 20-60% (35-55) Blood Detect No Blood Detect mechanism AST - Alternative Site Testing Yes AST Applicable Sample Type Capillary Code Type No code Precision ±5% ±15mg/dL if ≧75mg/dl;...

  • Page 85: Declaration Of Rohs Compliance

    To minimize the environmental impacts and take more responsibilities to the earth we live on, this document shall serve as a formal declaration that the LifeWatch V manufactured by LifeWatch Technologies Ltd. complies with Directive 2011/65 /EC of the European Parliament - RoHS (Restriction of Hazardous Substances) - with respect to the following substances: •...
  • Page 86 Specific Absorption Rate (SAR) information SAR tests are conducted using standard operating positions accepted by the FCC with the phone transmitting at its highest certified power level in all tested frequency bands, although the SAR is determined at the highest certified power level, the actual SAR level of the phone while operating can be well below the maximum value, in general, the closer you are to a wireless base station antenna, the lower the power output.
  • Page 87 Note: This equipment has been tested and found to comply with the limits for a Class B digital device, pursuant to part 15 of the FCC Rules. These limits are designed to provide reasonable protection against harmful interference in a residential installation.

  • Page 88: Appendix A Warnings And Precautions

    Appendix A Warnings and Precautions WARNING Potential Biohazard Healthcare professionals or persons using the LifeWatch V device on multiple patients should be aware of the following and should follow the infection control procedure approved by their facility. All products or objects which come in contact with human blood, even after cleaning, should be handled as if capable of transmitting viral diseases.

  • Page 89: Warnings

    The LifeWatch V is not intended for use in the diagnosis of myocardial infarction or for chest pain monitoring. • Due to the risk of ignition or fire, the LifeWatch V is not intended for use in a hyperbaric chamber, within an oxygen tent or in the presence of flammable anesthetics / medical gases. •...
  • Page 90 Heart failure Warning • The LifeWatch V device should not be used to monitor chest pain and it cannot predict or diagnose a heart attack (myocardial infarction). • Do not operate the LifeWatch V in combination with the following medical electronic devices as this may cause a malfunction of this device: •...
  • Page 91 • No modification of this equipment is allowed. • The LifeWatch V generates, uses, and can radiate radio frequency energy and, if not used in accordance with the instruction manual, may cause harmful interference to radio communications. • The LifeWatch V employs cellular technology. The location of the LifeWatch V and the associated environment, including cellular phone coverage in the particular area, may cause transmission interruption or delay.
  • Page 92 Glucose strips are for single use only; dispose of used strips as per glucose strip instructions. • Perform control-solution tests for any new vial or if “abnormal” results are shown. Perform disinfection after using the LifeWatch V glucose meter following the instructions on the Cleaning & Disinfecting section. ECG/HR/BFA/Stress Level test •...

  • Page 93: Radio Frequency (Rf) Exposure (Precautions)

    Thermometer • Clean thermometer to allow proper readings. • Clean the thermometer lens with a lint free dry cloth. • Do not use the thermometer shortly after exercising, bathing or coming indoors. • Do not use the thermometer on children under 1 year of age. •...

  • Page 94: Body Worn Operation

    ‘hands-free’ devices to keep mobile phones away from the head and body when using the LifeWatch V device as a cell phone. Further information on this subject can be obtained from the WHO home page http://www.who.int/peh-emf (WHO Fact sheet 193: June 2011).

  • Page 95: Distraction

    Distraction Driving (Precautions) Using the device as a phone or medical device while driving (even with a hands free kit) can cause distraction and lead to an accident. You must comply with local laws and regulations restricting the use of wireless devices while driving. Operating Machinery (Precautions) Full attention must be given to operating machinery in order to reduce the risk of an accident.

  • Page 96: Children

    Children Do not leave your device and its accessories within the reach of small children or allow them to play with it. They can hurt themselves or others, or they can accidentally damage the device. Your device contains small parts with sharp edges that can cause an injury or may become detached and create a choking hazard.

  • Page 97: Emergency Calls

    ♦ Do not grip the device too tightly. ♦ Press the buttons lightly. ♦ Use the special features which are designed to minimize the times of pressing buttons, such as Message Templates and Predictive Text. ♦ Take occasional breaks to stretch and relax. Emergency Calls This phone, like any wireless phone, operates using radio signals, which cannot guarantee connection under all conditions;...

  • Page 98: Hearing Aids

    You may also consult your hearing aid manufacturer to discuss alternatives. Use of LifeWatch V with other Medical Devices Please consult your doctor and the device manufacturer to determine if the operation of your phone may interfere with the operation of your medical device.

  • Page 99: Explosive Environments (Precautions)

    Explosive Environments (Precautions) Petrol Stations and Explosive Atmospheres In locations with potentially explosive atmospheres, obey all posted signs instructing to turn off wireless devices such as your phone or other radio equipment. Areas with potentially explosive atmospheres include fuelling areas, below decks on boats, fuel or chemical transfer or storage facilities, areas where the air contains chemicals or particles, such as grain, dust, or metal powders.

  • Page 100: Index

    Index Basic Operation ........19 Getting Started with the LifeWatch V Medical and Health Applications ..30 Blood Glucose Test ......... 42 Gluco Troubleshooting ...... 48, 55 Charging the Battery ....... 25 Health and Medical Functions ....30 Control Solution Test ....... 51 History .............
  • Page 101 Starting up ..........24 Test Screens Description ......35 Switching Your Phone On/Off ....26 Test Wheel Icons ........37 Test Results ..........38 Touch Control .......... 27 Test Results Icons ........39 UG-00097 rev01 10/13...

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