LabStyle Dario User manual

Dario® Blood Glucose Monitoring System
User Guide

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© 2016 LabStyle Innovation® Ltd., ALL RIGHTS RESERVED
ASIC INFORMATION
Please read this user guide thoroughly. If you have questions, you can contact
our customer support toll-free in the U.S. at 1-800-895-5921, 9:00 AM – 5:00
PM EST Monday through Friday or visit www.mydario.com.
Please contact your health care provider for questions or concerns outside of
the normal customer support hours.
Manufacturer:
LabStyle Innovation® Ltd.
9 Halamish St.
North Industrial Park Caesarea 3890000, Israel
www.mydario.com
Dario® is a trademark of LabStyle Innovation® Ltd.
European Patent application number 11780305.6
United States: Product is covered by one or more patents and/or patent
applications – the list is detailed at the Dario website at www.mydario.com.
6071-05 R02

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CHAPTER 1 INTRODUCTION AND IMPORTANT SAFETY INSTRUCTIONS ...............................6
Glucose Monitoring for a Mobile Age....................................................................... 6
Intended Use ........................................................................................................ 6
System Limitations................................................................................................. 7
Important Safety Instructions.................................................................................. 7
efore Testing with the Dario System ...................................................................... 8
Safety Definitions .................................................................................................. 8
Warnings ........................................................................................ 9
Cautions ......................................................................................... 9
Notes ............................................................................................ 9
Practices Used in This User Guide............................................................................ 9
Procedure Instructions ....................................................................... 9
Symbols and Descriptions .................................................................. 11
General Precautions..............................................................................................12
Additional Information..........................................................................................12
CHAPTER 2 DARIO SYSTEM OVERVIEW AND FEATURES................................................... 14
Your Dario System at a Glance ...............................................................................14
Dario Components................................................................................................15
Supported Platforms for the Dario App ...................................................................18
Dario System Welcome Kit Contents.......................................................................19
Getting Started with the Dario System ....................................................................20
Assembling the Dario System for the First Time .......................................................21
Inserting the Test Strip Cartridge............................................................................21
Inserting a Lancet .................................................................................................22
Setting Lancet Depth (Optional) .............................................................................24
The Dario App ......................................................................................................25
Downloading and Installing the Dario App ...............................................................25
Creating Your Account and Personalizing Your Settings.............................................27
Setting Your Personal and Diabetes Profiles.............................................................29
CHAPTER 3 CHECKING YOUR DARIO GLUCOSE METER.................................................... 30
Dario Control Solution...........................................................................................30
Control Solution Precautions..................................................................................30
Control Solution Test Principle ...............................................................................31
Chemical Composition ..........................................................................................31
Checking Your Glucose Meter with Dario Control Solutions.......................................32
Removing the Glucose Meter from the Housing.......................................................32
Removing a Test Strip from the Cartridge................................................................33
Performing a Control Solution Test.........................................................................35
CHAPTER 4 TESTING YOUR LOOD GLUCOSE LEVEL ....................................................... 40
Table of Contents

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lood Glucose Testing Precautions .........................................................................40
Test Strip Precautions ...........................................................................................41
Factors That Interfere with lood Glucose Testing....................................................42
Interpreting the Results.........................................................................................43
Measurement Range.............................................................................................43
Factors That May Lead to Inaccurate Results ...........................................................44
Step One: Inserting a New Lancet into the Lancing Device.........................................45
Step Two: Opening the Dario App...........................................................................45
Step Three: Inserting the Smart Mobile Device into the Disposable Cover...................46
Step Four: Removing the Glucose Meter from the Housing .......................................46
Step Five: Testing Your lood Glucose.....................................................................47
Testing Information and Guidelines ...................................................... 47
Removing a Test Strip from the Cartridge ............................................... 49
Performing a Glucose Test ................................................................. 51
Step Six: Returning the Meter to the Dario Housing..................................................54
Test Strip Limitations ............................................................................................54
CHAPTER 5 CLEANING AND MAINTENANCE................................................................... 55
Cleaning and Disinfection ......................................................................................55
Step 1: Cleaning....................................................................................................55
Step 2: Disinfection...............................................................................................56
CHAPTER 6 TROU LESHOOTING .................................................................................. 60
Troubleshooting ...................................................................................................60
Problem Solving....................................................................................................64
Test strip inserted but “Please insert a new strip” keeps appearing on the screen........64
You cannot pierce skin with lancet..........................................................................64
The lancet does not fit correctly into the lancing device............................................64
Cannot remove the used needle from the lancing device. .........................................65
Lancing device does not operate correctly...............................................................65
Lancet Depth Indicator lever is stuck.......................................................................65
Lancing device release button does not work properly..............................................65
“Strip is used and should be replaced” message appears in the Dario App. .................65
I forgot my Dario password....................................................................................65
My smart mobile device battery died......................................................................66
CHAPTER 7 TECHNICAL INFORMATION AND SPECIFICATIONS.......................................... 67
How the Glucose Meter Works ..............................................................................67
Compatibility........................................................................................................67
Technical Specifications.........................................................................................67
Compliance with Electrical and Safety Standards......................................................68
Disposing of Used Products....................................................................................68
CHAPTER 8 WARRANTY, REPAIRS AND SUPPLIES............................................................ 70
Repair Policy ........................................................................................................70

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Manufacturer’s One Year Warranty ........................................................................70
Supplies and Accessories .......................................................................................71
Contact Customer Support ....................................................................................71

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CHAPTER 1
INTRODUCTION AND IMPORTANT SAFETY INSTRUCTIONS
Glucose Monitoring for a Mobile Age
Congratulations on your choice of the Dario lood Glucose Monitoring System.
The Dario System was created to make life easier for people with diabetes by
providing the right tools, information, and support in your pocket. It is a smart
phone-based monitoring system, featuring a pocket-sized meter with an
integrated lancing device and test strips, combined with an easy-to-use mobile
application.
Living with diabetes is a daily challenge. ut with the Dario System in your
pocket and the best support, you can thrive with diabetes.
This user guide describes how to properly setup and use your new Dario
System. It is recommended that you read this guide thoroughly in order to
familiarize yourself with the system and its many features.
Intended Use
The Dario lood Glucose Monitoring System consists of the Dario lood
Glucose Meter, Dario Glucose Test Strips, Dario Glucose Control Solutions and
the Dario App as the display component of the Dario lood Glucose Monitoring
System. The Dario lood Glucose Monitoring System is intended for the
quantitative measurement of glucose (sugar) in fresh capillary whole blood
samples drawn from the fingertips. The Dario lood Glucose Monitoring
System is intended to be used by a single person and should not be shared.
The Dario lood Glucose Monitoring System is intended for self-testing outside
the body (in vitro diagnostic use) by people with diabetes at home to monitor
the effectiveness of diabetes control. The Dario lood Glucose Monitoring
System should not be used for the diagnosis or screening of diabetes or for
neonatal use.
The Dario lood Glucose Test Strips are for use with the Dario lood Glucose
Meter to quantitatively measure glucose (sugar) in fresh capillary whole blood
samples drawn from the fingertip.

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The Dario Control Solutions are for use with the Dario lood Glucose Meter
and the Dario lood Glucose Test Strips to check that the meter and test strips
are working together properly and that the test is performing correctly.
System Limitations
The Dario System should not be used for the following purposes:
• The diagnosis of, or screening for, diabetes.
• Testing the glucose levels of neonates (children younger than 4
weeks of age).
• Testing glucose levels of arterial or venous blood.
• Testing glucose from sites other than the fingertip.
• Testing patients who are critically ill, in shock, or dehydrated.
If you are taking acetaminophen containing drugs (e.g. Tylenol) or
Vitamin C (ascorbic acid) you may get inaccurate results with this
system. If you have a disease or condition in which uric acid levels
in your blood may be elevated (> 11 mg/dL), such as gout, you may
get inaccurate results with this system. If you have very high levels
of triglyceride (> 810 mg/dL), you may get inaccurate results with
this system. This system should not be used when undergoing
xylose absorption tests.
Important Safety Instructions
The meter and lancing device are for single-patient use. Do not share them
with anyone, including other family members. Do not use on multiple patients.
All parts of the kit are considered bio-hazardous and can potentially transmit
infectious diseases even after you have performed disinfection.
For important instructions for disinfecting your meter and lancing device, refer
to CHAPTER 5 CLEANING AND MAINTENANCE on page 55.
The U.S. Food and Drug Administration (FDA) and the Centers for Disease
Control and Prevention (CDC) have issued warnings and notifications regarding
the risk of bloodborne pathogen transmission when blood glucose monitoring

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systems have been used by more than one individual. Refer to the following
documents for more information:
• “FDA Public Health Notification: Use of Fingerstick Devices on More
than One Person Poses Risk for Transmitting loodborne
Pathogens: Initial Communication” (2010). You can find this
document at www.fda.gov.
• “CDC Clinical Reminder: Use of Fingerstick Devices on More than
One Person Poses Risk for Transmitting loodborne Pathogens”
(2010). You can find this document at www.cdc.gov.
CAUTION:
To ensure accurate results, wash your hands with
warm, soapy water and dry them before and after every test.
Unwashed hands may lead to inaccurate results. Make sure there
is no grease, oil, or lotion on the fingertip. Use lancets only once.
Do not use any lancet or lancing device that has been used by
another person.
efore Testing with the Dario System
Please read this user guide carefully and thoroughly before testing your blood
glucose for the first time. These instructions provide the information that you
need for safe use and handling of your Dario.
Incorrect use of this system may lead to an inaccurate glucose reading or
damage to your device.
If you have any questions, contact customer support at 1-800-895-5921, 9:00
AM – 5:00 PM EST Monday through Friday or visit www.mydario.com.
Safety Definitions
Safety instructions are provided for the protection of Dario System users. This
user guide includes three types of important messages: Warnings, Cautions,
and Notes. Text marked with one of these symbols requires your attention to
ensure safe and accurate use of your Dario System.

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Warnings
A
Warning
indicates
precautions
you need
to
take to
pre
vent
possible risk of injury.
Do not proceed beyond a Warning message until you fully
understand the conditions and have taken the appropriate
preventive action.
Cautions
A
Caution indicates precautions
you need
to
take to
prevent
damage to your monitoring system.
Do not proceed beyond a Caution message until you fully
understand and observe the indicated conditions.
Notes
Notes provide additional information for the purpose of
clarification.
Practices Used in This User Guide
The following sections describe the formats and symbols used throughout this
user guide, on the Dario System packaging and inserts, and on actual system
parts.
Procedure Instructions
• Procedure instructions are clearly identified and presented as
numbered steps.
• If relevant, a system response is written below the step in italics.
You should perform all procedures in the order of the steps provided.
The examples and screen images used in this
U
ser
G
uide are
provided as examples only (unless stated otherwise).
!
!

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W
ords
Descript
ion
old
Names of menus, buttons
,
and screens
.
Italics
System response that occurs as a result of
pressing
a
button or performing a task.
Bold Italics
E
mphasize important information
.