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. Please read
this manual carefully before you start using 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 phone is provided with pre-set applications.
Installation of new applications may affect the performance of your phone and is the sole
responsibility of the user.
Before using the LifeWatch V medical and wellness functions please read the Warnings
and Precautions, Appendix A, thoroughly.

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Copyright Declaration Copyright ©2012 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.
The information and screens provided in this manual are subject to change without notice.
LifeWatch Technologies Ltd. SHALL NOT BE LIABLE FOR TECHNICAL OR EDITORIAL ERRORS OR OMISSIONS
CONTAINED HEREIN; NOR FOR INCIDENTAL OR CONSEQUENTIAL DAMAGES RESULTING FROM THE
FURNISHING, PERFORMANCE, OR USE OF THIS MATERIAL.
Authorized representatives:
Europe
Obeliss.a
BoulevardGénéral
Wahis53
1030 Brussels,BELGIUM
Tel:+(32)2.732.59.54
Fax: +(32)2.732.60.03
E-mail: [e-mail]
USA
Lifewatch, Inc.
O’Hare International Center
10255West Higgins Road
Suite120
Rosemont, IL 60018
Tel: [phone]
Fax: [phone]
Toll Free: 800-633-3361
Fax: [phone]
Email: [e-mail]
Israel
LifeWatch
Technologies Ltd.
2PekerisSt.
Rehovot76100
Israel
Tel: [phone]
Fax: [phone]
Email: [e-mail]
For self-testing

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LifeWatch V Kit Contents
LifeWatch V
Adapter
Earphones
User manual
Quick user guide
USB cable
Optional –LifeWatch V Gluco Accessories Kit
Contents
1 lancing device
10 lancets
Gluco strip vial
Control solution
10 Alcohol pads
Disinfection pads
Gluco strip Quick user guide
Lancer Quick user guide
Contraindications
In order to use this device, you must be able to:
Understand the operation principles as described in this manual
Operate a LifeWatch V and the LifeWatch V Application
Operate a touch screen
General contraindications for all medical modules:
The LifeWatch V is not intended for use by persons with external defibrillators
The LifeWatch V is not intended for the treatment or alleviation of disease
The LifeWatch V is not to be used in a magnetic resonance imaging (MRI) environment

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Warning:
Do not expose the unit to rain or moisture
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.
Classifications of test results obtained for medical modules or for wellness applications into categories
such as “Low”, “Normal”, “Average”, etc. are based on well-established and widely accepted clinical
sources; as other classifications may exist, the test results should not constitute the sole basis for
diagnosis or for deciding on the appropriate course of medical treatment or therapy.
Important Symbols
A number of symbols are used throughout this manual in order to draw attention to safety items and other
important information.
Symbols on Equipment and Labeling
The following section contains a description of symbols that may be located on either the equipment or the
documentation.

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Label
Description
Warning, consult accompanying text or documents
Precaution; consult accompanying text or documents
Warning, potential biohazard
Notes, indicates important general information for using the system
successfully.
Consult instructions for use
XXXX
Manufacturer and date of Manufacture
Type BF Applied Part

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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

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Table of Contents
LifeWatch V Basic Operation...........................................................20
For Your General Safety (Precautions)....................................20
Getting Started...............................................................................22
Overview...................................................................................22
Starting up ................................................................................25
Charging the Battery.................................................................27
Getting Around Your Device..........................................................29
Touch Control ...........................................................................29
Home Screen............................................................................30
Status and Notification Icons....................................................32
Applications and Settings ..............................................................34
Settings.....................................................................................35
Phone Calls....................................................................................37

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Dialer Screen............................................................................37
Making Calls .............................................................................37
Call Screen ...............................................................................39
Receiving Calls.........................................................................40
Adjusting Your Call Settings .....................................................41
Contacts....................................................................................42
Importing/Exporting Contacts from/to the microSD Card .........42
Entering Text.............................................................................44
Messaging.................................................................................46
Email..............................................................................................48
Creating an Email Account .......................................................49
Receiving Emails ......................................................................49
Composing and Sending an Email ...........................................50
Replying to or Forwarding an Email..........................................50

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Getting Connected to the Internet..................................................51
Adding a New GPRS/EDGE/3G Connection............................52
Turning On Wi-Fi ......................................................................52
Using the Device as a Wi-Fi Hotspot........................................53
Browsing the Internet................................................................54
Bluetooth®................................................................................57
Making the Most of Multimedia......................................................59
Taking Pictures with Your Camera...........................................59
Sorting out Your Phone Settings ..............................................64
Security Settings.......................................................................67
Protecting Your Device with a PIN or Password ......................68
Managing Your Device Memory ....................................................72
Privacy: Reset to Factory Settings ...........................................72
Managing Applications...................................................................73

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Managing Other Settings..........................................................73
Other Applications..........................................................................73
Calculator..................................................................................73
SIM Tool Kit ..............................................................................73
LifeWatch V Health and Medical Functions ...................................74
Getting Started with the LifeWatch V Medical
and Wellness Applications.............................................................74
License Agreement........................................................................74
First Time Launch ..........................................................................75
Login Screen..................................................................................76
Guest Login...............................................................................76
Test Application ................................................................................78
Test General Description ...............................................................78

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Test Screens Description...............................................................79
History............................................................................................84
Performing Tests............................................................................86
Blood Glucose Test ..................................................................86
Glucose Test Troubleshooting..................................................92
Alternative Site Testing (AST) ..................................................93
Control Solution Test................................................................95
Control Solution Troubleshooting .............................................99
ECG/HR/BFA/SP02/Stress Level Analyzer Tests..................100
Body Temperature Test..........................................................103
LifeWatchV Medical Application Settings ....................................105
My Profile................................................................................106
Sharing Permissions...............................................................107
Test Settings...........................................................................107

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Measurement Units.................................................................107
Sounds....................................................................................107
Diet Application...............................................................................108
General ........................................................................................108
Meal Planner ..........................................................................108
Exercise Tracker ....................................................................109
Weight Tracker .......................................................................109
Water Tracker ........................................................................109
Measurement Tracker ............................................................109
Calendar Application......................................................................110
Drug Reminder ................................................................................111
Heart Rate Calculation Method......................................................112
Introduction.............................................................................112
Method of Calculation.............................................................112

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Maintenance ....................................................................................113
Conditions of Use.........................................................................113
Caring for your LifeWatch V.........................................................113
Cleaning..................................................................................113
Disinfecting .............................................................................113
Environment............................................................................114
Preventive Maintenance.................................................................115
Troubleshooting..............................................................................116
Specifications..................................................................................117
Declaration of RoHS Compliance...........................................122
Disposal of Your Device .........................................................122
Appendix A Warnings and Precautions .......................................123
Warnings.................................................................................124

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Radio Frequency (RF) Exposure (Precautions)...........................128
General Statement on RF Energy ..........................................128
EMI Considerations.................................................................128
Body Worn Operation .............................................................128
Limiting Exposure to Radio Frequency (RF) Fields (Precautions)128
Distraction....................................................................................129
Driving (Precautions) ..............................................................129
Operating Machinery (Precautions)........................................129
Product Handling (Precautions)...................................................129
General Statement on Handling and Use...............................129
Children...................................................................................130
Demagnetization.....................................................................130
Electrostatic Discharge (ESD) ................................................130
Antenna...................................................................................130

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Normal Use Position...............................................................130
Air Bags ..................................................................................130
Seizures/Blackouts.................................................................130
Repetitive Strain Injuries.........................................................131
Emergency Calls.....................................................................131
Loud Noise..............................................................................131
Phone Heating........................................................................131
Electrical Safety (Precautions).....................................................131
Accessories ............................................................................131
Connection to a Car................................................................131
Faulty and Damaged Products...............................................131
General Statement on Interference ........................................132
Pacemakers............................................................................132
Hearing Aids ...........................................................................132
Use of LifeWatch V with other Medical Devices.....................132

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Hospitals .................................................................................132
Aircraft.....................................................................................132
Interference in Cars ................................................................133
Explosive Environments (Precautions)........................................133
Petrol Stations and Explosive Atmospheres...........................133
Blasting Caps and Areas ........................................................133
Index.................................................................................................134

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WARNINGS
Use the device only for the purposes described in the instructions for use.
To prevent fire, do not expose the device to moisture or excessive heat. Refer servicing to
qualified personnel only.
Do not use this device if it is not working properly, or if it has suffered any damage.
WARNING Device not suitable for use in the presence of flammable anesthetic mixture with air or with Oxygen
or Nitrous Oxide.
WARNING
For optimal use of the LifeWatch V it should be connected to the Internet.
By default, your phone is provided with pre-set applications.
Installation of new applications may affect the performance of your phone 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
understanding or interpretation of test results without consulting a healthcare professional.

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Intended Use
The LifeWatch V is a medical device designed for self-testing in order to measure and display blood oxygen
saturation, blood glucose, ECG (1 lead), heart rate, body fat percentage, stress level analyzer and body
temperature. The LifeWatch V is intended for use in the following population groups:
Adults
Pediatrics as defined per medical module
The following applications of the LifeWatch V as described in this User Manual, 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:
Stress Level Analyzer
Diet Management
Drug Management
Body Fat Analysis
Test
Age Group
Pulse oximeter
Adults, 21 years and older
Blood Glucose meter
Adults and pediatrics above 12 years
Pediatrics below the age of 12 years: under adult supervision only
Excluding neonates and infants less than one year
1 Lead ECG
Adults and pediatrics above 12 years of age
Heart Rate
Adults and pediatrics above 12 years of age
Stress Level Analyzer
Adults, 21 years and older

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Body Fat Analyzer
Adults, 21 years and older
Thermometer
Adults and pediatrics above 12 years
Pediatrics below the age of 12 years: under adult supervision only
Excluding neonates and infants less than one year
Device Definition
The LifeWatch V is a state-of-the-art mobile device (smartphone) with medical and non-medical capabilities
designed for the maximum convenience of its users. The LifeWatch V includes the following modules and
applications:
Pulse oximeter/SpO2 (oxygen saturation)
Blood Glucose meter
1 Lead ECG
Heart Rate
Thermometer
Body Fat Analyzer
Stress Level Analyzer
Diet Management
Drug Management
NOTE: The LifeWatch V can be used as a stand-alone device or via a subscription plan; full functionality is
available only to paying subscribers.

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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.
Do not make or receive handheld calls while
driving; do not text while driving.
Keep the device away from pacemakers, ICDs
and other electronic medical devices (at least 6
inches/15 cm).
Don’t use the device at gas/petrol stations.
Do not expose the device to extreme
temperatures.
Keep your phone at least 15 mm away from your
ear or body while making calls.
Switch the device off when asked to in hospitals
and medical facilities.
Your phone may produce a bright or flashing light.
Avoid contact with liquids. Keep your phone dry.
Small parts may cause choking.
Switch the device off when told to in aircrafts
and airports.