LabStyle Dario User manual

DarioTM User Guide
Thriving with diabetes, together.

II
BASIC INFORMATION
Please read this user guide thoroughly and feel free to contact our customer
support (www.mydario.com)or your healthcare provided with any questions,
concerns or remarks you may have.
LabStyle InnovationTM 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
© 2014 LabStyle InnovationTM Ltd., ALL RIGHTS RESERVED
6031-01 Rev03

III
Table of ConTenTs
ChapTer 1 – InTroduCTIon & user safeTy
Glucose Monitoring for a Mobile Age ...............................................................1
Intended Use ............................................................................................................1
Contraindications...................................................................................................2
About These Instructions for Use......................................................................2
Before Testing With Dario™.............................................................................2
Safety Definitions................................................................................................2
Cautions.............................................................................................................3
Notes...................................................................................................................3
Practices Used in This Advanced User Guide..............................................3
Procedure Instructions ...................................................................................3
Symbols and Descriptions .................................................................................. 4
Additional Information..........................................................................................5
ChapTer 2 – darIo™ sysTem overvIew and feaTures
Your Dario™ System at a Glance .......................................................................6
Dario™ Components..........................................................................................6
Getting Started With Dario™..............................................................................9
Assembling the Dario™ System for the First Time........................................9
Inserting the Test Strip Cartridge..................................................................10
Inserting a Lancet...............................................................................................11
Setting Lancet Depth (Optional)...................................................................12
The Dario™ Application ..................................................................................... 12
Downloading & Installing the Dario™ Application................................... 13
Creating Your Account & Personalizing Your Settings ............................14
Setting Your Personal Profile ..........................................................................16
ChapTer 3 – CheCkIng your darIo™ gluCose meTer
Control Test Principle .........................................................................................18
Chemical Composition ......................................................................................19
Control Solution....................................................................................................19
Checking Your Glucose Meter With Dario™ Control Solutions .............20
Removing the Glucose Meter From the Housing.....................................20
Removing a Test Strip From the Cartridge..................................................21
Performing a Control Test .............................................................................. 22
Checking the Glucose Meter With the Check Strip................................... 25
ChapTer 4 – TesTIng your blood gluCose level
Blood Glucose Testing Precautions................................................................. 27
Test Strip Precautions .....................................................................................28
Factors That Interfere With Blood Glucose Testing ................................... 29
Interpreting the Results .....................................................................................29
Measurement Range .........................................................................................30

IV
Factors That May Lead to Inaccurate Results..............................................30
Step One - Inserting a New Lancet Into the Lancing Device..................... 31
Step Two - Removing the Glucose Meter From the Housing................... 33
Step Three- Remove a Test Strip From the Cartridge.................................34
Step Four - Testing Your Blood Glucose......................................................... 35
Performing a Glucose Test............................................................................. 36
Step Five - Returning the Meter to the Dario™ Housing...........................40
Test Limitations....................................................................................................40
Performance Analysis ........................................................................................41
ChapTer 5 – CleanIng and maInTenanCe
Cleaning.................................................................................................................42
ChapTer 6 – TroubleshooTIng
Troubleshooting...................................................................................................43
Problem Solving ...................................................................................................46
ChapTer 7 – TeChnICal InformaTIon & speCIfICaTIons
How the Glucose Meter Works.......................................................................48
Compatibility........................................................................................................48
Technical Specifications ....................................................................................48
Compliance With International Standards ...................................................49
Disposing of Your Meter....................................................................................50
ChapTer 8 – warranTy, repaIrs servICe & supplIes
Repair Policy .......................................................................................................... 51
Manufacturers One Year Warranty................................................................. 51
Service Support.................................................................................................... 52
Supplies and Accessories.................................................................................. 52

Glucose Monitoring for a Mobile Age
Chapter 1 - Introduction & User Safety
1
CHAPTER 1 – INTRODUCTION & USER SAFETY
GLUCOSE MONITORING FOR A MOBILE AGE
Congratulations on your choice of the Dario™ Blood Glucose Monitoring System
(BGMS). Dario™ was created to make life easier for people with diabetes - with
the right tools, information and support in your pocket. It is a smartphone-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. But with Dario™ in your pocket and the
best support, we can thrive with diabetes together.
This user guide will guide you through the proper setup and use of your new Dario™
BGMS. We suggest that you read this guide thoroughly in order to familiarize
yourself with the system and its many features
INTENDED USE
The Dario™ BGMS is intended for determination of blood glucose values using
fresh capillary whole blood from the fingertip.
The Dario™ BGMS is indicated for the quantitative measurement of glucose in fresh
capillary whole blood samples drawn from the fingertips.
The system is intended to be used by a single patient and should not be shared.
The Dario™ BGMS is intended for self-testing outside the body (in vitro diagnostic
use) by people with diabetes at home as an aid in monitoring the eectiveness of
diabetes control.
The Dario™ BGMS is not to be used for the diagnosis of or screening of diabetes or
for neonatal use.
The Dario™ Blood Glucose Meter (BGM) must be used with Dario™ blood glucose
test strip, Dario™ control solutions, Dario™ lancets and Dario™ application
software.

Chapter 1 - Introduction & User Safety
Contraindications
2
CONTRAINDICATIONS
The Dario™ BGMS should not be used:
yTo diagnose diabetes.
yOn children younger than four weeks old.
yTo test blood taken from an artery or vein.
Glucose monitoring with the Dario™ BGMS is not recommended for independent
use by people who are:
yUnable to follow the instructions provided with the system.
yVisually impaired.
ABOUT THESE INSTRUCTIONS FOR USE
Before Testing With Dario™
Please read this User Guide carefully and thoroughly before testing your blood
glucose for the first time. These instructions will provide you with all the
information you need for safe use and handling of your Dario™.
Incorrect use of this system, or failure to apply, implement or follow the instructions
and important information contained in this User Guide, may lead to a misdiagnosis
or damage to your device.
If you have any questions, please contact customer support at 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.
Warnings
Warning: indicates precautions needed to prevent possible risk of
injury or damage to your health.
Do not proceed beyond a Warning message until you fully understand
the conditions and you have taken the appropriate preventive action.

Practices Used in This Advanced User Guide
Chapter 1 - Introduction & User Safety
3
Cautions
Caution: indicates precautions needed 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 are used to provide additional information for the purpose of
clarification.
Practices Used in This Advanced User Guide
Procedure Instructions
yWhen appropriate, procedures start with a “ ” symbol, followed by a short
description of the procedure to be performed.
yProcedure instructions are clearly identified and presented as numbered
procedure steps.
yIf relevant, a system response is written below the procedure step and appears
in italics.
yAll procedures should be done in the order of the steps provided.
The examples and screen images used in this user guide are provided
as examples only (unless stated otherwise).
Words in: Description
Bold Names of menus, buttons and screens
Italics System response that occurs as a result of a button press
Bold Italics Used to emphasize important information

Chapter 1 - Introduction & User Safety
Symbols and Descriptions
4
SYMBOLS AND DESCRIPTIONS
The following table shows a list of symbols which may appear throughout
this guide, on packaging or package inserts, or on the actual system parts. An
explanation is provided next to each symbol.
Symbol Description Symbol Description
Dario™ logo LabStyle InnovationTM logo
Consult instructions for use Do not use if seal is broken or
missing
In Vitro Diagnostic Batch code
Expiry date Shelf life following first opening
Do not reuse Temperature limitation
Catalogue number Contents
Manufacturer:
LabStyle InnovationTM Ltd.
9 Halamish St.
North Industrial Park
Caesarea 3890000 Israel
Authorized Representative in the
European Community;
MDSS GmbH
Schigraben 41
30175 Hannover, Germany
Intended for self-testing Sterilized using Gamma Radiation
Keep away from sunlight Keep Dry
Symbol Description Manufacturer
DarioTM Blood Glucose monitoring system
Under Directive IVDD 98/79/EC LabStyle InnovationTM Ltd.
DarioTM Lancing Device
Under Directive MDD 93/42/EEC LabStyle InnovationTM Ltd.
Sterile Lancets (25)
Under Directive MDD 93/42/EEC Gentrol Co., Ltd.

Chapter 1 - Introduction & User Safety
General Precautions
5
GENERAL PRECAUTIONS
This section informs you of potential hazards which may harm your Dario™ system
or cause it to not function properly:
Avoid using any system parts with broken seals or expired “use by” dates. Do not
attach or use a component if it is damaged in any way, as it may not work properly.
yThe Dario™ system is not water-resistant and should not get wet. If it does get
wet, wipe it with a clean dry cloth.
yBlood glucose testing with Dario™ should only be done in temperatures
between 10°C - 45°C (50°F - 113°F). Test results may not be correct if the room
temperature is outside this range.
yChanges or modifications to the Dario™ system not expressly approved by
LabStyle Innovation™ Ltd. will void your warranty and could cause you harm.
yAvoid testing with your Dario™ system in altitudes higher than 3,400 meters
(11,155 feet), as accuracy cannot be assured.
yDo not leave the meter in very hot or cold places. Do not leave it near a heat
source (radiator) or in a car in hot or cold weather.
yDo not store or use meter or test strips in high humidity, such as a bathroom or kitchen.
ADDITIONAL INFORMATION
For your safety, please observe the following recommendations when monitoring
your blood glucose using the Dario™ system:
yIt is always a good idea to have a back-up testing method available. Failure to
test could cause a delay in treatment decisions and lead to a serious medical
condition. Examples of back-up testing methods include a back-up glucose
meter device or testing by a laboratory. Ask your healthcare provider about
other possible back-up methods.
yIt is recommended that you periodically compare the test results from your
Dario™ BGMS with another test system that you know is well-maintained and
monitored by a healthcare provider.
yDo not change your treatment based on a single result that does not match how
you feel or if you believe that your test result could be incorrect.
yNever make significant changes to your diabetes control program or ignore
physical symptoms without consulting with your healthcare professional.

Your Dario™ System at a Glance
Chapter 2 - Dario™ System Overview and Features
6
CHAPTER 2 – DARIO™ SYSTEM OVERVIEW AND
FEATURES
This section provides an overview of the Dario™ system components and how it is
set up for the first time.
YOUR DARIO™ SYSTEM AT A GLANCE
The Dario™ is a compact “all-in-one” glucose monitoring system that incorporates
a lancing device, a disposable strip cartridge and a miniature glucose meter that
snap into a durable pocket-sized housing. The miniature glucose meter attaches to
your smart mobile device (see Compatibility on page 48 for a list of devices), which
supports you daily with personalized tracking, knowledge about your glucose trends
and actionable insights.
yThe system is discreet and compact. The entire system easily fits in your
pocket.
yBy connecting to your smart mobile device, it eliminates the need for additional
hardware.
yNo coding is required. Insert a Dario™ test strip and you are ready to test.
yTesting is easy. No navigating or buttons to press.
yActionable insights and alerts – allows easy analysis of trends and behavior.
yInstant sharing with caregivers – allows sharing your data with your caregivers
for ecient diabetes management.
Dario™ Components
Your Dario™ system components are described in the table below.
Component Description Image
Housing The modular Dario™ housing has
a built-in lancing device, slots and
covers for the snap-in components
(lancet, test strip cartridge, and
glucose meter).