Glucose Monitoring System For Your Smartphone | Manage your...

1

DarioTM User Guide

Thriving with diabetes

2

© 2016 LabStyle InnovationTM Ltd., ALL RIGHTS RESERVED

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. 8 Hatokhen St. North Industrial Park Caesarea 3088900 Israel

www.mydario.com

Dario™ is a trademark of LabStyle Innovation™ Ltd.

European Patent application number 11780305.6

US: Product is covered by one or more patents and /or patent applications – the list is detailed at the DarioTM website.

6071-01 Rev C

II

http://www.mydario.com/

3

Contents ...................................................................................................................................................... 1 CHAPTER 1 – INTRODUCTION & USER SAFETY .................................................................................... 5

GLUCOSE MONITORING FOR A MOBILE AGE .................................................................... 5

INTENDED USE .................................................................................................................. 5

CONTRAINDICATIONS .................................................................................................... 6

ABOUT THESE INSTRUCTIONS FOR USE ............................................................................... 6

SYMBOLS AND DESCRIPTIONS ............................................................................................ 8

GENERAL PRECAUTIONS .................................................................................................... 9

ADDITIONAL INFORMATION ............................................................................................ 9

CHAPTER 2 – DARIO™ SYSTEM OVERVIEW AND FEATURES ................................................................ 11 YOUR DARIO™ SYSTEM AT A GLANCE ............................................................................. 11

DARIO™ SYSTEM WELCOME KIT CONTENTS ................................................................... 13

GETTING STARTED WITH DARIO™ .................................................................................. 13

ASSEMBLING THE DARIO™ SYSTEM FOR THE FIRST TIME .................................................... 14

THE DARIO™ APPLICATION ............................................................................................ 18

CHAPTER 3 – CHECKING YOUR DARIO™ GLUCOSE METER .................................................................. 22 CONTROL SOLUTION ....................................................................................................... 22

CONTROL SOLUTION TEST PRINCIPLE ................................................................................ 23

CHEMICAL COMPOSITION .............................................................................................. 23

CHECKING YOUR DARIO™ GLUCOSE METER WITH CONTROL SOLUTION ............................... 24

CHAPTER 4 – TESTING YOUR BLOOD GLUCOSE LEVEL ........................................................................ 30 BLOOD GLUCOSE TESTING PRECAUTIONS ......................................................................... 30

FACTORS THAT INTERFERE WITH BLOOD GLUCOSE TESTING ............................................... 31

INTERPRETING THE RESULTS ............................................................................................ 32

MEASUREMENT RANGE ................................................................................................... 32

FACTORS THAT MAY LEAD TO INACCURATE RESULTS ..................................................... 33

STEP ONE - INSERTING A NEW LANCET INTO THE LANCING DEVICE ............................... 33

4

STEP TWO - REMOVING THE GLUCOSE METER FROM THE HOUSING ............................. 35

STEP THREE- REMOVE A TEST STRIP FROM THE CARTRIDGE ................................................ 37

STEP FOUR - TESTING YOUR BLOOD GLUCOSE ................................................................... 39

STEP FIVE - RETURNING THE METER TO THE DARIO™ HOUSING .................................... 42

TEST LIMITATIONS ......................................................................................................... 43

PERFORMANCE ANALYSIS ................................................................................................ 43

CHAPTER 5 – GLUCOSE METER BATTERY .......................................................................................... 45 (Applicable for P/N 1021-03 and above) .......................................................................................... 45

BATTERY STATUS ........................................................................................................... 45

REPLACING THE BATTERY .............................................................................................. 46

CHAPTER 6 – CLEANING AND MAINTENANCE ................................................................................... 47 CLEANING AND DISINFECTING ..................................................................................... 47

CHAPTER 7 – TROUBLESHOOTING ................................................................................................... 49 TROUBLESHOOTING ..................................................................................................... 49

PROBLEM SOLVING ......................................................................................................... 52

CHAPTER 8 – TECHNICAL INFORMATION & SPECIFICATIONS .............................................................. 54 HOW THE GLUCOSE METER WORKS ................................................................................. 54

COMPATIBILITY ............................................................................................................ 54

TECHNICAL SPECIFICATIONS ............................................................................................. 54

COMPLIANCE WITH INTERNATIONAL STANDARDS ......................................................... 56

DISPOSING OF YOUR METER ............................................................................................ 56

CHAPTER 9 – WARRANTY, REPAIRS SERVICE & SUPPLIES ................................................................... 57 REPAIR POLICY ................................................................................................................ 57

MANUFACTURERS ONE YEAR WARRANTY ...................................................................... 57

SERVICE SUPPORT ............................................................................................................ 58

SUPPLIES AND ACCESSORIES .............................................................................................. 58

CONTACT CUSTOMER SUPPORT: ...................................................................................... 59

Chapter 1 - Introduction & User Safety

5

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 miniature 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.

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

Dario™ Blood Glucose Monitoring System (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 effectiveness 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™ control solutions are for use with the Dario™ Blood Glucose Test Strips and the Dario™ Blood Glucose Meter and to check that the meter and test strips are working together properly and the test is performing correctly.

Chapter 1 - Introduction & User Safety

6

CONTRAINDICATIONS

The Dario™ BGMS should not be used:

• To diagnose and screen diabetes

• On children younger than four weeks old.

• To test blood taken from an artery or vein

Glucose monitoring with the Dario™ BGMS is not recommended for independent use by people who are:

• Unable to follow the instructions provided with the system.

• Visually 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.


7

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

When appropriate, procedures start with a “ ” symbol, followed by a short description of the procedure to be performed.

Procedure instructions are clearly identified and presented as numbered procedure steps.

If relevant, a system response is written below the procedure step and appears in italics.

All 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

8

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.

8 Hatokhen St. North Industrial Park Caesarea 3088900 Israel

Authorized Representative in the European Community; MDSS GmbH Schiffgraben 41 30175 Hannover, Germany

Caution

Sterilized using Gamma Radiation

Keep away from sunlight

Keep Dry

Symbol Description Manufacturer

0344

DarioTM Blood Glucose monitoring system Under Directive IVDD 98/79/EC LabStyle InnovationTM Ltd.

0197

Sterile Lancets (25) Under Directive MDD 93/42/EEC

Beijing Ruicheng Medical Supplies Co., Ltd.

Relative Humidity Electronic equipment. Do not disposed of in the normal waste stream not

Environmental protection classification per IEC 60529 IP22

9

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.

The Dario™ system is not water-resistant and should not get wet. If it does get wet, wipe it with a clean dry cloth.

Blood glucose testing with Dario™ should only be done in temperatures between 10°C - 45°C (50°F - 113°F) and at relative humidity between 15-85%.

Test results may not be correct if the room temperature is outside this range.

Changes or modifications to the Dario™ system not expressly approved by LabStyle Innovation™ Ltd. will void your warranty and could cause you harm.

Avoid testing with your Dario™ system in altitudes higher than 10,000 feet (3,048 meters), as accuracy cannot be assured.

Do 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.

Do not store or use meter or test strips in high humidity, such as a bathroom or kitchen.

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 biohazardous and can potentially transmit infectious diseases, even after you have performed cleaning and disinfection.

ADDITIONAL INFORMATION

For your safety, please observe the following recommendations when monitoring your blood glucose using the Dario™ system:

It 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.

It is recommended that you periodically compare the test results from your Dario™ BGMS with another laboratory test system that is well-maintained and

10

monitored by your healthcare provider.

Do 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.

Never make significant changes to your diabetes control program or ignore physical symptoms without consulting with your healthcare professional.

11

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 Dario™ is a cloud-based, diabetes management solution that includes novel software applications combined with the stylish, 'all-in-one', compact, Dario™ Smart Meter (all in one: lancing device, strip cartridge and mini meter). Together with a smart mobile device Dario™ is the absolute Diabetes Management Solution, allowing one to monitor and gain insights with the information needed to manage blood sugars in one’s pocket every step of the way. The Dario™ Personalized Smart Meter Dario aims at providing the precise combination of Tools, Knowledge and Motivation through a compact, personalized pocket-sized, all-in-one glucose meter. Patients can check their blood glucose with a tiny sample of 0.3 μl of their blood and get answers within 6 seconds, the same way they check everything else in life - on their mobile device. Dario connects to smart mobile devices via an easy-to-use mobile app that provides real-time and actionable information so that your patients always know exactly where they stand and what to do next. Dario logs and tracks their glucose levels, and helps them know how food intake and exercise are affecting their diabetes. Dario also alerts you, the caregiver, when your patients need special attention.

Dario™ Components

Your Dario™ system components are described in the table below.

12

Component Description Glucose meter A Dario™ Meter

B Dario™ meter release panel

The miniature glucose meter has:

· An audio connector that is plugged into the headphone socket of the smart mobile device

· A strip port for insertion of the test strip.

The glucose meter receives its power from a battery and does not require any other electrical source. When not in use, the meter snaps into its slot in the housing for protected storage.

Lancing Device and Cover C Orange cover

D Disposable lancet

E Lancet release button

F Lancet loader

G Depth selector lever

The lancing device is built into the housing and uses disposable Dario™ lancets. The orange lancing device cover prevents the user from unintentional punctures. Lancets are changed for each use. Puncture depth may be adjusted, by removing the cover and moving the depth selection dial. The cover is then put back on for use. The lancing device is activated by sliding it with two fingers until it clicks and then pressing the release button. Instructions on using the lancing device are included in page 39.

H Test Strip Cartridge Test strip are sold separately in packages of 25, 50, and 100 test strips. Each test strip cartridge holds 25 strips. The cartridge snaps into the modular Dario™ housing.

Test Strip The Dario™ test strip is the only strip which may be used with the Dario™ system. A new test strip is inserted into the test strip port of the glucose meter prior to each glucose measurement.

Lancets Dario™ uses a 30G lancet. The lancet is replaced by removing the orange lancing device cover, pulling out the used lancet and replacing it with a sterile one.

It is recommended that you carry spare cartridges and lancets in case of an emergency.

13

DARIO™ SYSTEM WELCOME KIT CONTENTS

Once you remove the tamper-proof sealed exterior packaging, you will find a white package. If the tamper-proof seal is missing, it is recommended that you return this Dario™ System to where you purchased it, as it has been opened.

As soon as you receive your Dario™ System Welcome Kit:

1. Carefully unpack the kit and verify that it contains the following parts:

Dario™ System including Lancing Device and built in Blood Glucose Meter

Sterile Lancets (25 lancets)

Documentation: User Instructions for Use and a Quick User Guide.

2. If anything is missing, please contact customer support at www.mydario.com/support.

3. Test strips and Lancets are available in your local pharmacies. For additional information please contact your local representative (www.mydario.com/support).

4. Additional DarioTM accessories (i.e. Control Solution) can be ordered via your local representatives or the Dario™ App.

For details on the products availability please refer to section Supplies and Accessories

GETTING STARTED WITH DARIO™

Your Dario™ meter works seamlessly with your smart mobile device. Simply download the Dario™ application on your smart mobile device and it will automatically synchronize with the Dario™ device each time it is connected.

Your data is constantly synchronized to one place so that it is always with you on the go, so you can stay in control of your health.

Your data is saved under your username on your smart mobile devices and on the Dario™ cloud, with easy access through the Dario™ application and also My Dario™ website.

So let’s get started!

http://www.mydario.com/support

http://www.mydario.com/support

14

ASSEMBLING THE DARIO™ SYSTEM FOR THE FIRST TIME

Setting up the Dario™ System for the first time includes the following steps described in this section:

Inserting a test strip cartridge (see “Inserting the Test Strip Cartridge” on this page )

Inserting a lancet (see page 15)

Setting lancet depth (optional) (see page 16)

Downloading the Dario™ application to your smart mobile device (see p

age18)

Setting up the Dario™ application on your smart mobile device using the Dario™ app instructions or the instructions provided on the Dario™ website.

Both ends of the housing have covers that are removable. The lancet cover is orange with the small opening. Please be careful not to put the cartridge cover on the lancing end. This can damage the lancet and the lancing device.

Inserting the Test Strip Cartridge

❖ To insert the test strip cartridge:

Remove the carbon paper from the device and open the white cover

1. Remove the new test strip cartridge from its pouch.

2. Hold the test strip cartridge with the side that opens, facing up (as shown below).

3. Insert the cartridge into the housing until it snaps into place.

15

4. Replace the housing cover by sliding it into place until it clicks.

If the cover does not close properly, the cartridge may not have been inserted correctly.

Inserting a Lancet

❖ To insert a lancet:

1. Remove the Lancet Device Cover (the Orange cap) from the Dario™ housing.

2. Remove a new lancet from the packaging.

16

3. Insert a sterile lancet as far as it will go and make sure it is firmly set.

4. Carefully twist off the lancet cap. Make sure not to bend the lancet while removing the cap.

Setting Lancet Depth (Optional)

The depth of the lancet, as it punctures the skin of your fingertip, can be adjusted by moving the lever between the numbers one to four (printed on the dial). One (1) is the shallowest depth and (4) is the deepest. It is recommended to start with your

lancet depth set to level one and adjust the level if necessary.

❖ To set lancet depth:

1. Move the lancing device lever so that the line on the lever is aligned with the

correct depth.

17

2. Return the lancing device cover by sliding it into place until it clicks. Be careful not to touch or bend the lancet.

Enabling the Glucose Meter 1. Slide your thumb back on the ridged orange panel to release the DarioTM meter

2. Remove the transparent tape to enable the battery connectors (Only for 1021-03)

18

3. Place the DarioTM meter back into the housing by pushing it in until it is locked into place

THE DARIO™ APPLICATION

The Dario™ is compatible on both iOS and Android operating systems. For full list of compatible devices please refer to http://www.mydario.com/support/getting-started.

Your Dario™ meter is operated via the app displayed on the screen of your smart mobile device. The mobile device receives information from the glucose meter, displays and stores it. The app also provides a step-by-step Quick Guide for operating the system. Additionally, you can find more instructional videos on the Dario™ Application at www.mydario.com/support/getting-started.

Instructions for downloading the app are provided in the next section.

Downloading & Installing the Dario™ Application

You can download and install the Dario™ app to your smart mobile device using the Apple App Store or Google Play. The app is downloaded and installed the same way as other Apps on your smart mobile device. The Dario™ app is free of charge and is customized for your smart mobile device.

Downloading the app from the App Store requires data connectivity.

For accurate use of the Dario™ system with the app, the time and date must be correctly set on your smart mobile device. For instructions on setting the time and date on your device, please refer to the support materials for the device.

http://www.mydario.com/support/getting-started


http://www.mydario.com/support/getting-started.

19

❖ To download the Dario™ App:

1. Turn on your smart mobile device and launch the App Store app. Alternately, for

quicker access, you can use an app that scans codes to scan the following code.

2. Search for the Dario™ app by LabStyle Innovation™ Ltd and tap on the Dario™ icon.

3. Tap Free and then tap Install.

4. Enter your password information as required in your device.

The application downloads. Once installed, the orange Dario™ icon appears on your smart mobile device home screen.

The Dario™ app needs to be installed once for each of your smart mobile devices.

Updates may be downloaded periodically from the App Store/Google Play.

Creating Your Account & Personalizing Your Settings

❖ To setup your Dario™ App:

1. After installing the Dario™ app on your mobile device, click on the orange

Dario™ icon . The icon appears on your mobile device Home screen.

The Dario™ screen appears.

2. Select Get Started to register as a Dario™ user. You can connect with

Facebook or alternatively sign up by inputting your name, phone number,

email, and password. You must also confirm your Password.

3. Continue by following the instructions on the screen to sign up.

Your password must have at least seven characters, an upper case letter, a lower case letter and a number.

Your e-mail address and password will be used for future login to the

14

20

app and to the Dario™ web-portal.

If you already have a Dario™ account, you may skip this section by tapping Log in at the bottom of the screen.

4. Press Create Account when done.

The First Entry screen appears.

You can edit your e-mail address and password and set the Dario™ app language and region by going to the menu and then selecting SETTINGS > ACCOUNT SETTINGS.

Setting Your Personal and Diabetes Profiles

❖ To set your personal profile:

1. Tap the Menu icon on the top left corner and selecting SETTINGS > PERSONAL INFORMATION.

2. Tap the pencil on the upper right corner to edit the information.

3. Enter your Gender, Weight, Height and Date of Birth. It is also possible to upload a photo from your device by tapping UPLOAD PHOTO.

4. Press DONE (√)

❖ To set your diabetes profile:

21

1. Tap the Menu icon on the top left corner and selecting SETTINGS > DIABETES PROFILE, and under MANAGE MY GOALS > SET MY GOALS

2. Tap the pencil on the upper right corner to edit the information.

3. Select your preferred Carbs measurement units

4. Press DONE (√)

5. We advise you to continue setting your Diabetes Profile, following the app instructions. Completing your profile will allow full app functionality.

You can do the Walkthrough at any time by tapping the icon.

Select HELP&INFO > GUIDE ME.

15

16

22

CHAPTER 3 – CHECKING YOUR DARIO™ GLUCOSE METER

This section provides information on checking the accuracy of your meter.

You may test the accuracy of your meter with a control solution.

To ensure that your results are always accurate, you need to check the performance of your meter in the following cases:

If you drop the meter.

Whenever your result does not match the way you feel.

If you have repeated a test, and the blood glucose result is still lower or higher than expected.

Whenever you want to check the performance of a meter and test strip.

CONTROL SOLUTION

The Control Solution confirms that the meter and test strips are performing as expected. A drop of control solution is placed on a test strip (using a piece of paper). Compare the results on the meter with the value s displayed on the test strip cartridge.

Dario™ Control Solution package can be ordered separately. Please contact your local representative for ordering information. Dario™ Control Solution package comes with two bottles of control solution (Level H, Level M).

Avoid contact with the eye. Contact your healthcare professional immediately if solution is swallowed, injected, or applied to the eye.

Dye in control solution may stain skin, clothing, or surfaces.

Store the control solution between 8°C-30°C (46°F-86°F). Keep away from direct sunlight, fluorescent light, and heat. Do not freeze.

Once you open a new bottle of control solution, mark the opening date on the bottle.

Make sure that your control solution has not expired. Check the expiration date on the bottle.

Make sure that your control solution was not opened more than 3 months ago.

23

Keep the control solution away from children.

Shake the control solution well before using.

Wipe the container tip clean after use and be sure to close the container tightly after each use.

No reconstitution or dilution of the control solution is necessary.

CONTROL SOLUTION TEST PRINCIPLE

Dario™ Glucose Control Solution contains a known amount of glucose that reacts with chemicals on the Dario™ test strip.

When applying a drop of control solution to the test strip, following the same procedure that is used for whole blood, the glucose in the control solution reacts with chemicals in the test strip.

The result displayed on the meter should fall within the expected range printed on the test strip cartridge label. Obtaining a single result within the expected

Range is sufficient to verify system performance. A result outside the range printed on the Test Strip cartridge label may indicate the system is not performing correctly.

This control solution is not for use as a cleaning solution.

CHEMICAL COMPOSITION

Dario™ Glucose Control Solution is an aqueous solution, which contains D-glucose as the reactive ingredient in the approximate concentration.

Buffer 2.1%

Polyvinylpyrrolidone 5%

Polyviny alcohol 5%

SDS 0.1%

Preservative 0.1%

24

CHECKING YOUR DARIO™ GLUCOSE METER WITH CONTROL SOLUTION

The following steps are required to perform a control solution test.

Removing the Glucose Meter from the Housing

Before performing a control solution test, it is necessary to remove the glucose meter from the housing.

The glucose meter is stored in the housing when not in use.

When not in use, store the meter in the Dario™ housing. Do not leave your meter connected to your smart mobile device with the screen in ON mode for more than two (2) minutes, as it can get warm and can affect accuracy.

❖ To remove the meter from the housing:

1. Hold the housing so that the ridged orange panel is close to you and the end with

the lancing device is facing away from you.

2. Slide your thumb back on the ridged orange panel. The meter will pop up.

25

3. Grasp the meter with two fingers and remove from the housing.

Do not plug the Dario™ meter into any device other than a compatible smart mobile device audio socket. The list of compatible smart mobile devices is provided on www.mydario.com/support/getting-started.

Removing a Test Strip from the Cartridge

You should have a test strip cartridge already inserted in your Dario™ housing. If this is not the case, please go to page 14.

❖ To remove a test strip from the cartridge:

1. Remove the Cartridge Cover of the Dario™ housing by pushing it outwards until

it comes off (use the removal indication lines).

2. Snap open the case by pushing up the edge.

26

3. Remove a test strip from the cartridge.

4. Snap the case closed immediately and replace the cartridge cover by pushing it

into place until it clicks.

It is recommended to use the test strip immediately after removing it from the cartridge. It is recommended not to use a test strip that has been outside of the cartridge for more than three (3) minutes.


Do not touch the yellow testing site when handling the test strip

Do not use a damaged test strip

Performing a Control Solution Test

❖ To perform a control solution test:

1. Tap the Dario™ icon on your smart mobile device to launch the Dario™

application.

2. Tap the Menu icon on the top left corner and selecting HELP & INFO > CONTROL

SOLUTION TEST.

27

3. Insert your meter into the audio plug of your smart mobile device.

A Connecting... message appears, followed by INSERT A NEW STRIP.

Verify that the meter is inserted as far as it can go into the socket of the smart mobile device.

4. Hold the test strip with the gold contacts facing the meter.

5. Without bending the strip, insert it into the test strip port (marked in orange) of

the Dario™ glucose meter as far as it will go.

Verify the test strip direction as shown to

the left

You are instructed to place a drop of control solution on the test strip.

To screen notification changes

The Dario™ meter direction (logo facing up)

28

6. Shake the control solution container and apply a drop of control solution to a piece of paper.

7. Hold the paper and move it so that the solution touches the tip of the yellow window of the strip.

8. Important: Verify that enough control solution is applied to fill the window so that it turns red. Do not put control solution on top of the test strip.

When the meter detects that the solution was applied, the “Measuring...” message appears. The orange rotating in the circle indicates that the test is in progress.

9. The test result appears on the screen after six (6) seconds. Read your result.

The control solution test result appears on the screen and it’s not saved to memory.

10. When the test is done, remove the test strip.

11. Compare the results on the meter with the values displayed on the test strip cartridge.

12. If the results are:

Within the acceptable range, then your meter is ready for use.

Outside of the acceptable range, perform the test again. If the problem recurs, contact customer support at www.mydario.com.

13. Disconnect the meter from your smart mobile device.

14. Wipe the tip of the control solution container clean and tightly seal the container.

The Dario™ Glucose Control Solution ranges printed on the test strip cartridge label, are intended for the Dario™ test strip cartridge only.


29

The glucose concentrations in these solutions, when measured by systems other than Dario™ Glucose Monitoring System, may differ.

Applying too much or too little control solution to the test strip may cause out- of-range results.

Do not use your Dario™ Glucose Monitoring System to test your blood if your control solution result falls outside of the acceptable range.

15. Place the meter back into the housing:

a. Hold the meter at an angle with the part that connects to the smart mobile device facing away from the ridged orange panel.

b. Push the meter into the housing at an angle and then push downwards until the meter clicks into place.

30

CHAPTER 4 – TESTING YOUR BLOOD GLUCOSE LEVEL

The glucose meter in Dario™ measures the amount of glucose in your blood. Once placing a small drop of blood from your fingertip onto the test strip, the result will be displayed in six (6) seconds.

Carefully read and follow the instructions provided in this chapter and in the package inserts for the test strips and control solutions. It is very important to follow the instructions in order to prevent an incorrect result or improper treatment.

Do not put any fluid into the test strip port.

Once you start your Dario™ app, follow the prompts on the screen.

BLOOD GLUCOSE TESTING PRECAUTIONS

The meter, test strips, and control solutions are only for use outside the body (in vitro). Do not eat the test strips. Do not swallow or inject control solutions, or use control solutions for any purpose other than testing your blood glucose.

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

It is advised that you wash hands thoroughly with soap and water before and after handling the meter, lancing device, or test strips.

Incorrect test results can cause the wrong therapy recommendation to be made and may lead to serious adverse health effects. Therefore, please follow these instructions carefully.

Test Strip Precautions

Only use Dario™ test strips. Using other test strips with this glucose meter can produce inaccurate results.

Inspect each test strip cartridge before opening it for the first time. If you see any damage to the cartridge lid, or if anything prevents the lid from closing properly, do not use the test strips.

Store unused test strips in their original cartridge. Do not remove test strips from the test strip cartridge and put them into another container.

31

Close the cartridge tightly right after you remove a test strip. This helps keep the test strips dry.

Be sure to check the “Use by” date on the test strip cartridge. Do not use the test strips after that date.

Be sure to write down the date the strips were first opened. Check the date when using the strips. If the date surpasses the shelf life after first opening, do not use the strips from this cartridge.

Use the test strip immediately after removing it from the cartridge.

Use the test strips as indicated in this guide.

Do not store your test strips in temperatures below 2°C (36°F) or above 32°C (90°F), and below 10% or above 90% of relative humidity.

Do not refrigerate your test strip cartridge while it is open. Do not put them in a freezer.

Do not expose your test strips to direct sunlight, moisture or humidity, which can damage your test strips and lead to inaccurate results.

Do not apply blood or control solution to the test strip before inserting it into the glucose meter.

Do not reuse test strips. Once control solution or blood is placed on a test strip, discard the strip. If you need to retest, use a new test strip.

Do not bend, cut, or alter the test strips.

Do not get dirt, food, or other material on the test strip.

It is recommended to use the test strip immediately after removing it from the cartridge. It is recommended not to use a test strip that has been outside of the cartridge for more than three (3) minutes.

Do not touch the yellow testing site when handling the test strip.

Do not use a damaged test strip.

Make sure that the gold contact area of the test strip is clean from dirt, blood, moisture and anything else. These items will affect the test result and can cause an inaccurate blood glucose level result.

FACTORS THAT INTERFERE WITH BLOOD GLUCOSE TESTING

Certain substances can interfere with the blood glucose system and cause falsely high results. For more information, refer to the test strip package insert. If you are taking medication or dietary supplements, consult your healthcare professional.

32

You should not use this system to test your blood glucose if you are critically ill (examples include: severe hypotension or shock, hyperglycemic-hyperosmolar state, hypoxia, diabetic ketoacidosis).

Certain health conditions, such as serious illness and dehydration, can cause falsely high test results in glucose meters. If you are very sick or think you are dehydrated, or are urinating frequently, call your doctor immediately.

Dirty or wet hands could affect your results. Alcohol can affect test results.

INTERPRETING THE RESULTS

If the displayed test result reflects the way you feel, continue as instructed by your doctor.

If the test result does not reflect the way you feel, please check your Dario™ system by running a control solution check (Performing a Control Test on page 22). Repeat the blood glucose test afterward. If your blood glucose result still doesn’t match how you feel and you have followed the instructions provided here, follow your healthcare provider’s instructions.

Do 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. The blood glucose reading displayed on your smart mobile device by Dario™ BGMS should not be the only information you use to make decisions about your health. Always consult a health care professional to interpret and understand the measurement results.

MEASUREMENT RANGE

Your meter measures blood glucose results in the range of 10 mg/dL to 600 mg/ dL (0.5-33.3 mmol/L). Results that are outside of this range should be reviewed according to the procedure below. If your test result is lower than 10 mg/dL (0.5 mmol/L),”LOW!” is displayed

instead of a result.

LOW may indicate that your blood glucose is very low (possibly severe hypoglycemia). Follow your doctor’s instructions immediately and repeat the test.

33

If the result is higher than 600 mg/dL (33.3 mmol/L), “HIGH!” is displayed instead of a result.

If your blood glucose test results in a LOW or HIGH message, repeat the blood glucose test following all of the instructions provided in “Step Four - Testing Your Blood Glucose” on page 39.

If your blood glucose test results in a LOW or HIGH message a second time, follow the protocol established by your health care professional or contact your healthcare provider immediately.

Please note that the exact blood glucose reading that constitutes a HIGH or LOW reading depends on many factors, including individual differences, and the time since your last meal.

FACTORS THAT MAY LEAD TO INACCURATE RESULTS

Certain medications, food supplements, medical treatments and health conditions can interfere with the blood glucose system and cause inaccurate results.

Incorrect testing technique or improper storage or handling of the Dario™ may also lead to implausible test results which don’t match the way you feel. These include:

Your hands may not have been washed thoroughly

Your glucose meter test strip port may be contaminated.

Your test strip has been bent.

The test strip is expired. Check the “use by” date.

The length of time that has passed since first opening the test strip package exceeds the allowed time.

Test strips were stored incorrectly.

Testing was done in a humid environment (for humidity specifications, refer to Technical Specifications on page 54).

Your glucose meter has been dropped.

If your meter has been dropped and you are receiving error messages or implausible results, contact customer support. Do not rely on the blood glucose measurement alone in making health care decisions.

STEP ONE - INSERTING A NEW LANCET INTO THE LANCING DEVICE

Use a new sterile lancet in your lancing device every time you test your

34

blood glucose to prevent infection.

❖ To insert a lancet:

1. Remove the Lancet Device Cover from the Dario™ Housing.

The lancet cover is the orange cover.

2. Remove the used lancet by grasping it and pulling it straight out of its housing.

Dispose of used lancet in a safe manner so as not to cause accidental injury.


Do not use the lancet if the cap is missing or damaged. Please contact customer support at www.mydario.com.


35

4. Insert a sterile lancet and make sure that it is firmly in place.

It is recommenced to use LabStyle Innovation™ (30G).

If the lancet does not click into place or the lancet holder does not hold the lancet properly, insert another sterile lancet.

If the problem persists, it may be necessary to replace your Dario™ housing. Contact Customer Support at www.mydario.com.

5. Carefully twist off the lancet cap as shown above. Make sure not to bend the lancet needle.

6. If necessary, set the depth of the lancing device. For additional information, see 16.

7. Replace the lancing device cover by sliding it into place until it clicks. Be careful

not to touch or bend the lancet.

STEP TWO - REMOVING THE GLUCOSE METER FROM THE HOUSING

Before starting the testing procedure, you should remove the meter from the housing.

The meter is stored in the housing when not in use.

❖ To remove the meter from the housing:

1. Hold the housing so that the ridged orange panel is close to you and the end with the lancing device is facing away from you.

2. Slide your thumb back on the ridged orange panel in the arrow direction.


36

The meter will pop up.

3. Grasp the meter with two fingers and remove from the housing.

Do not plug the Dario™ meter into any device other than a compatible smart mobile device audio socket. The list of compatible smart mobile devices is provided on www.mydario.com/support/getting-started.

Tap the Dario™ icon on your smart mobile device to launch the Dario™ application before you connect the Dario™ meter.

4. Insert your meter into the audio plug of your smart mobile device. Verify that the

meter is inserted as far as it can go into the socket of the smart mobile device.

The Dario™ meter The screen notification

direction (logo facing up) changes

A Connecting... message appears, followed by INSERT A NEW STRIP.

37

STEP THREE- REMOVE A TEST STRIP FROM THE CARTRIDGE

You should have a test strip cartridge already inserted in your Dario™ housing. If this is not the case, please go to page 14.

1. Wash your hands with warm soapy water and dry thoroughly. If you use alcohol wipes to cleanse fingers, make sure the area is completely dry before lancing finger.

2. Remove the Cartridge Cover of the Dario™ housing by pushing it outwards until

it comes off (use the removal indication lines).

3. Open the lid by pushing up the edge.

38

4. Remove a test strip from the cartridge.

5. Close both the lid and cartridge cover.


6. Hold the test strip with the gold contacts facing upward.

7. Without bending the strip, insert it into the test strip port of the Dario™ glucose

meter as far as it will go.

Verify the test strip direction as shown to

the left

You are instructed to place a drop of blood on the test strip.

39

STEP FOUR - TESTING YOUR BLOOD GLUCOSE

Testing Information and Guidelines

The meter requires only a small drop of blood, about the size of a sugar grain (0.3µL) at least, to perform the test. For best results, select a puncture site along the side of a fingertip.

While applying blood to the test strip you should verify that enough blood is applied to fill the window so that it turns completely red.

Testing blood from sites other than the fingertip may give inaccurate results.

If too little blood is applied to the test strip, an alert informs you that your sample size is too small and you should try again with a new strip.

If a test strip error occurs, perform another test with a new test strip.

Blood glucose results are automatically saved to memory. The results remain on the screen for 15 minutes.

If an error message or symbol appears on the screen, refer to Chapter 7 – Troubleshooting on page 49 for additional information.


When not in use, store the meter in the Dario™ housing. Do not leave your meter connected to your smart mobile device with the screen in ON mode for more than three (3) minutes, as it can get warm and can affect accuracy.

To prevent malfunction of the meter, keep the test strip port free of blood, moisture, dirt, or dust.

Performing a Glucose Test

1. Set the lancing device for activation by sliding it with two fingers as far as it goes.

40

2. Place the fingertip orange lancing device cover to the side of your and press the release button to prick your finger.

3. Apply a drop of blood to the tip of the yellow window of the test strip. Capillary

action will pull the blood into the strip.

Important: Verify that enough blood is applied to fill the window so that it turns

red. Do not put blood on top of the test strip.

When the meter detects that blood has been applied the “Measuring...” message appears. The border of the circle is gradually filled with orange, indicating that the test is in progress.

41

Remove your finger from the strip once the message appears.

Do not add blood to the test strip once you have removed your finger, as you may receive an inaccurate result.

4. The test result appears on the screen after approximately six (6) seconds. Read your result.

The glucose test result is automatically saved to memory. If for some reason you do not see a result, go to your Logbook.

If a phone call is received during a measurement, the test will be stopped and will not be saved. A message test strip is used will appear on the result screen.

5. When the test is done, remove the test strip. Dispose of the test strip in accordance with instructions provided by your healthcare professional for bio-hazardous waste.

6. Remove the lancet from the lancing device (see page 34). Dispose of the used

lancet according to local guidelines.

When the test strip is removed from the glucose meter, the message “Please insert new test strip” appears.

7. You may continue to input data into your Dario™ application.

8. Return the meter to the housing as described in the next section.

42

STEP FIVE - RETURNING THE METER TO THE DARIO™ HOUSING

❖ To return the meter to the Dario™ Housing:


2. Hold the meter at an angle with the part that connects to the smart mobile device facing away from the ridged orange panel.

3. Push the meter into the housing at an angle and then push downwards until the

meter clicks into place.

43

TEST LIMITATIONS

Normal endogenous (within body) natural levels of uric acid, ascorbate (vitamin C), bilirubin, triglycerides, and hemoglobin do not interfere with your blood glucose results. Elevated levels of these compounds in your blood may, however, interfere with the accuracy of your blood glucose results obtained with the Dario™ System. The system should not be used if blood levels of these compounds exceed the limitations detailed in the table below.

Compound Limitation

Ascorbic acid > 4 mg/dL

Uric acid > 5 mg/ dL

Acetaminophen > 6 mg/dL

Total bilirubin > 35 mg/dL

Triglycerides > 810 mg/ dL

The drugs L-dopa, dopamine, methyl-dopa, acetaminophen, and ibuprofen will not interfere with Dario™ system blood glucose results when taken at therapeutic concentrations.

Patients undergoing oxygen therapy may yield false results.

PERFORMANCE ANALYSIS Dario™ BGMS was tested on 600 samples using capillary blood samples and three Dario™ test strips lots. Results were compared to YSI ® analyzer. The table below compares the performance of the two methods. Acceptance criteria in ISO15197:2013 are Ninety-five percent (95%) of the measured glucose values shall fall within either ±0.83 mmol/L of the average measured values of the reference measurement procedure at glucose concentrations < 5.5 mmol/L or within ±15% at glucose concentrations ≥ 5.5 mmol/L.

Accuracy: Dario™ BGMS

for glucose concentrations <5.5 mmol/L for glucose concentrations ≥ 5.5 mmol/L

Within ± 0.28 mmol/L



Within ± 5 % Within ± 10 % Within ± 15 %

175 / 216 (81.0%)

213 / 216 (98.6%)

216 / 216 (100.0%)

330 / 384 (85.9%)

372 / 384 (96.9%)

382 / 384 (99.5%)

44

Intermediate Precision: Dario™ BGMS

Glucose Concentration range

1.67-2.78 5.33-8 15.55-23.33

Average, mmol/L 2.69 5.77 16.42

Standard Deviation, mmol/L

0.129 0.17 0.4

Coefficient of Variation, %

4.8 2.9 2.4

Max 3.16 6.33 17.78

Min 2.33 5.39 15.55

Max-Min 0.83 0.94 2.22

45

CHAPTER 5 – GLUCOSE METER BATTERY (Applicable for P/N 1021-03 and above) BATTERY STATUS Only when the “battery is low”, a low battery indicator appears within the app (in the upper left side of the screen). A "battery level is low" popup will appear each time the glucose meter is placed in the smart mobile device which will require closure to proceed.

Replace the battery to ensure successful and accurate measurements. While "Battery is low" the system will allow you to do few more measurement until completely drained. Upon battery drainage, "battery drained" indicator will appear within the app (in the upper left side of the screen). When the battery is empty a measurement cannot take place and an error message will appear on the main application circle

46

REPLACING THE BATTERY Your meter comes with one 3V CR1220 lithium battery installed. The battery lasts up to one year depending on the usage. Follow the instructions below to replace the battery. 1. Turn the meter over with the Dario logo facing down

2. Lift off the back cover by pulling firmly from the notch by the battery

cover, on the side of the glucose meter

3. Remove the battery by taking it out from the battery tray

4. Insert the new battery with the “+” side facing up and snap it into place

5. Press the back panel back in place until you hear a locking "click"

USED BATTERY DISPOSAL

Electrical products should not be disposed of with household waste.

Please recycle where facilities exist. Check with your local authority or retailer for recycling advice.

47

CHAPTER 6 – CLEANING AND MAINTENANCE This section provides cleaning and disinfecting information for your meter.

Since you are the only person operating your personal Dario it is recommended that you disinfect the device once a week. If a care taker is assisting you with blood glucose testing or they disinfect the device, they should wear gloves to protect themselves when handling the meter.

CLEANING AND DISINFECTING

The outer surfaces may be cleaned when you feel that your Dario™ is visibly dirty. It is advised to disinfect your Dario™ once a week to avoid transmitting bloodborne pathogens.

Wipe the Dario™ Blood Glucose Monitoring System with disinfecting, germicidal wipes (GermiCide3 by GERMIPHENE)

1. Before disinfecting your Dario™ take out the test strips cartridge from the device.

2. Before you clean and disinfect your Dario™ pre-clean the outside with a

disinfecting wipe.

3. With a new disinfecting wipe, disinfect your Dario™, using the GermiCide3 wipes.

In addition, follow the instructions on the disinfecting wipe container label for safe

handling of the wipes.

4. Wipe each side of your Dario™, with moderate pressure 3 times using the following

method:

a. Wipe the Dario™ up and down 5 times

b. Wipe the Dario™ left and right 5 times

c. Avoid getting disinfectant inside the test strip port

5. After 3 minutes of contact time, let air dry

You should wash your hands thoroughly with soap and water after handling the Dario™.

48

If you have any questions about cleaning and disinfecting your Dario™ contact Customer Support at [email protected]

Do not:

Get any moisture in the test strip.

Spray any cleaning solution directly onto the glucose meter or the lancing device

Submerge any part of the Dario™ in liquid

Attempt to clean any internal parts

Attempt to dry any parts using a blow dryer

Please observe the following cautions when cleaning the Dario™ system to avoid damaging the device:

If the device becomes wet, wipe off all moisture and allow sufficient time for drying before using.

mailto:[email protected]

49

CHAPTER 7 – TROUBLESHOOTING

In this chapter you will find information about all the symbols and error messages which may be displayed on the Dario™ app. To ensure safe and accurate use of Dario™, please pay attention to all symbols and messages when you use the system. They provide you with important information.

If you still have questions after reading this chapter, contact customer support at www.mydario.com.

An error message can appear as a popup or as a message within the main circle.

TROUBLESHOOTING

The following table lists some typical conditions that may occur with the Dario™ System.


50

Message Content Possible Cause / Recommended Action

To reconnect your Dario. If the problem recurs, some adjustments might be required. Check the following settings on your device:

Smart device volume setting inappropriately.

Follow the instructions on the app to adjust the settings in your mobile device: 1. Make sure that Mono Audio is set to

off:

· Verify that Mono Audio is set to off.

2. Adjust the audio balance:

· The audio volume balance must be set in the middle between L and R.

3. Make sure that your Ringer and Alerts volume is set to the maximum:

4. Allow Dario™ to use your microphone:

5. Make sure that your music volume is set to the maximum.

6. Make sure that your phone’s battery is fully charged

Insufficient blood detected, try again with a new strip

Not enough blood on the strip.

Repeat the measurement with a new strip.

The Strip is used, please insert a new strip

A strip was used more than once.

Perform a new measurement with a new strip

High! Measure with a new strip, if recurs contact your physician Immediately

High glucose level.

Measurement result is above 600 mg/dL (33.3 mmol/L). Repeat the measurement with a new strip. If this recurs, contact your physician Immediately. If your measurement results are inconsistent with the way you feel, contact customer support at www.mydario.com.

Temperature out of range. Move to an area between 10-45°C (50°-113°F), wait 30 minutes and try again

The meter was left in an extreme temperature environment.

Move to a cooler or warmer area, wait at least 30 minutes and repeat the measurement with a new strip.


51


Dario™ device failure (0x00). If the problem occurs again, please contact Dario™’s customer support

Communication failure.

Contact customer support at www.mydario.com/support


Firmware software failure.



Voltage Failure


Unknown device, please connect Dario™ Another device is inserted into the smart mobile device’s audio connector.

· If another device is connected to the earphone plug, disconnect it in order to connect Dario™. You can still use the Dario™ app if another device is connected.

· If you received this message while the Dario™ meter is connected, disconnect and reconnect the meter. If this message still appears, contact customer support at www.mydario.com/support

Hypo warning Hypoglycemia event occurred

You received a measurement result lower than defined in the hypo warning section under Blood Glucose Thresholds. Contact your physician immediately.

"Your battery level is low" – popup and a low battery indicator

Replace Dario's battery. Please refer to chapter 5 for further details

"Your battery level is low, please replace your battery" – error message in the main app circle

Replace Dario's battery. Please refer to chapter 5 for further details

52

PROBLEM SOLVING Test strip inserted but “Please insert a new strip” keeps appearing on the screen.

The test strip was removed before the reading was completed or strip or meter is defective.

Repeat the measurement, using a new test strip.

Check the meter with control solution (see Checking the Glucose Meter on page 22). If the result is not okay, contact customer support at

www.mydario.com/support. If the result is okay, test with a new test strip.

Cannot pierce skin with lancet.

The needle depth may be incorrect. Adjust the lancet depth lever to a different depth level.

The lancet needle may be bent. Replace the lancet.

The cartridge cover may be in the place of the lancing device cover. Please be careful to return each cover to the correct end.

The lancet does not fit correctly into the lancing device.

The lancet may be faulty or you may be using a lancet that is not approved for use with the Dario™ System. Replace the lancet with a different Dario™ lancet. If the problem persists, you may need to replace the Dario™ housing. Contact customer

support at www.mydario.com/support.

Cannot remove the used needle from the lancing device.

The lancet may be faulty or you may be using a lancet that is not approved for use with the Dario™ System. Pull the needle carefully and straight out from lancet.

Lancing Device does not operate correctly.

The lancing device spring or handle may be faulty. Make sure that you set the lancing device for activation by sliding it with two fingers until it clicks (see page 39). Then you can press the button to puncture your skin.

Lancet Depth Indicator lever is stuck.

The indicator lever may be faulty. Replace the Dario™ housing. Contact customer support at www.mydario.com/support.


http://www.mydario.com/support.


53

Lancing Device release button does not work properly.

The lancing device is faulty. Replace the Dario™ housing. Contact customer support at www.mydario.com/support.

“Strip is used and should be replaced” message appears.

An incoming phone call during blood testing will result in this message appearing. It is

recommended to set your smart mobile device to flight mode before performing a test.

Forgotten Dario™ password.

If you forget your password, tap on FORGOT PASSWORD in the LOG IN screen. An email with instructions for resetting your password will be sent to you.

My smart mobile device battery died.

If the battery of your smart mobile device is out of power, use a different device. Download the Dario™ application and login to your account.


54

CHAPTER 8 – TECHNICAL INFORMATION & SPECIFICATIONS This section provides technical information on your Dario™ System.

HOW THE GLUCOSE METER WORKS

The Dario™ system determines the amount of glucose in fresh capillary blood using electrochemical biosensor technology. An electrical current is generated by the reaction of glucose with the reagent on the test strip (glucose oxidase). The strength of the current produced by the reaction depends on the amount of glucose in the blood sample. The glucose meter detects the current and converts it into a blood glucose reading.

COMPATIBILITY

Dario™ is compatible for use on smart mobile devices. For full list of compatible devices please refer to www.mydario.com/support/getting-started/

TECHNICAL SPECIFICATIONS

Meter Specifications

Result Range 10-600 mg/dL (0.5-33.3 mmol/L)

Calibration Plasma-equivalent

Sample Fresh capillary whole blood

Test Sample 0.3 microliter

Test Time 6 seconds

Assay Method Glucose Oxidase Biosensor

Hematocrit Range 20% - 60%

Power Supply From the smart phone or mobile device (Applicable for P/N 1021-02) / 3V CR1220 Lithium Battery (Applicable for P/N 1021-03)

Glucose Units mg/dL / mmol/L

Dimensions 104x211x11 mm (4.1x8.3x.4 in)

Weight 40 gram (1.4 oz)

Memory Unlimited results - memory is limited to mobile device memory

Average 7-day, 14-day or 30-day averaging

Display Dario™ application on a smart mobile device screen

Function Hypo warning: set by user

Meter Life Time 5 years

http://www.mydario.com/support/getting-started/

55

Do not store near solvents and ionizing radiation source.

Glucose Meter/Lancing Device

Environmental Storage

1021-02 – Meter: -40°C to + 85°C (-40°F to +185°F)

1021-03 – Meter with battery: 0°C to 35°C (32°F to 95°F)

Test Strip

Operational Temperature and Relative Humidity 10°C-45°C (50°F-113°F ), 15-85%

Storage Temperature Strip and Relative Humidity 2°C-32°C (36°F-90°F), 10-90%

Operational Altitude Up to 10,000 feet (3,048 meters)

56

COMPLIANCE WITH INTERNATIONAL STANDARDS

This meter meets the electromagnetic immunity requirements as per EN ISO 15197. The chosen basis for electrostatic discharge immunity testing was basic standard IEC 61000-4-2. In addition, it meets the electro-magnetic emissions requirements as per EN 61326. This meter complies with the applicable standards for Electromagnetic Compatibility; however it is not recommended that it be used in the presence of strong electromagnetic fields. When using this meter, keep away from sources of electromagnetic disturbances such as electric motors or radio transmitting equipment. This meter should not affect the normal operation of other devices. If this does occur, provide more distance between the meter and the affected device. Your meter is an electronic device. When disposing of your meter follow all local environmental regulations.

DISPOSING OF YOUR METER

The product may come into contact with blood during measurement. Used products therefore carry a risk of infection.

Please dispose of used products according to the regulations applicable in your country. For information about correct disposal, please contact your local council or authority.

The product falls outside the scope of the European Directive 2002/96/EC (Directive on waste electrical and electronic equipment (WEEE)).

57

CHAPTER 9 – WARRANTY, REPAIRS SERVICE & SUPPLIES

This section provides repair, warranty, service support and ordering information for your Dario™ System.

REPAIR POLICY

When under warranty, repair and service must be performed by LabStyle InnovationTM Ltd. When the LabStyle InnovationTM warranty is not applicable, repairs may be performed by LabStyle InnovationTM Ltd. on a parts and labor basis.

After replacement, verify that the unit is fully functional by performing the normal setup procedure.

Do not remove the covers of the device components. Only perform maintenance procedures specifically described in this user guide.

MANUFACTURERS ONE YEAR WARRANTY

It is important to LabStyle Innovation™ Ltd. that you are completely satisfied with your Dario™ BGMS. LabStyle Innovation™ Ltd. warrants your new Dario™ will be free from defects in materials and workmanship for a period of one (1) year from the date of the original purchase. If during this time the Dario™ does not work properly because of a defect in materials or workmanship, LabStyle Innovation™ Ltd. agrees to replace or repair, free of charge any and all parts proven to be defective and subject to warranty. This warranty is in lieu of all other warranties, expressed or implied, including any implied warranty of merchantability or fitness for any purpose, other than stated herein. This warranty does not apply to the performance of a Dario™ BGMS that has been damaged by accident or has been altered, misused, tampered with, or abused in any way. This warranty only applies to the original purchaser of the meter and/or its agents.

Chapter 8 - Warranty, Repairs Service & Supplies

Service Support

58

SERVICE SUPPORT

Repairs of the Dario™ System under warranty must be made at authorized repair centers. If the device needs repair, contact LabStyle InnovationTM Ltd. customer support or your local distributor www.mydario.com/support.

If you need to ship the device, please pack the device and its accessories carefully to prevent shipping damage.

SUPPLIES AND ACCESSORIES

Dario™ BGMS supplies and accessories are available from LabStyle InnovationTM Ltd. or from your local distributor. For a list of distributors, please visit www.mydario.com.

Item Catalog Number

System

Dario™ Welcome Kit

Test Strip Cartridge

Dario™ Test Strip (2 x 25)



Lancet

Dario™ Lancet (1 x 100)

Dario™ Lancet (1 x 25)

Control Solution Dario™ Control Solution (2x1.25 ml)


59

CONTACT CUSTOMER SUPPORT:

You may contact customer support with any question or issue about DarioTM and its accessories anytime by emailing us [email protected] or on the website: www.mydario.com

If you have questions or need assistance outside the operational days and times, please contact your health care provider.

mailto:[email protected]


60

Life is easier with DarioTM in your pocket

LabStyle InnovationTM Ltd. | 8 Hatokhen St. North Industrial Park Caesarea 3088900 Israel | www.mydario.com


Dario® Blood Glucose Monitoring System

User Guide

2

© 2017 LabStyle Innovation® Ltd., ALL RIGHTS RESERVED

BASIC 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. Internationally 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. 8 Hatokhen St. North Industrial Park Caesarea 3088900, 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.

6172-05 Rev A


3

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 Before Testing with the Dario System ...................................................................... 8 Safety Definitions .................................................................................................. 9

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 BLOOD GLUCOSE LEVEL ....................................................... 40

Table of Contents

4

Blood Glucose Testing Precautions .........................................................................40 Test Strip Precautions ...........................................................................................41 Factors That Interfere with Blood 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 Blood 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 TROUBLESHOOTING .................................................................................. 60 Troubleshooting ...................................................................................................60 Problem Solving....................................................................................................63 Test strip inserted but “Please insert a new strip” keeps appearing on the screen........63 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. .........................................64 Lancing device does not operate correctly. ..............................................................64 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. .....................................................................65

CHAPTER 7 TECHNICAL INFORMATION AND SPECIFICATIONS .......................................... 66 How the Glucose Meter Works ..............................................................................66 Compatibility........................................................................................................66 Technical Specifications .........................................................................................66 Compliance with Electrical and Safety Standards ......................................................67 Disposing of Used Products....................................................................................68

CHAPTER 8 WARRANTY, REPAIRS AND SUPPLIES ............................................................ 69 Repair Policy ........................................................................................................69

5

Manufacturer’s One Year Warranty ........................................................................69 Supplies and Accessories .......................................................................................70 Contact Customer Support ....................................................................................70

6

CHAPTER 1

INTRODUCTION AND IMPORTANT SAFETY INSTRUCTIONS

Glucose Monitoring for a Mobile Age

Congratulations on your choice of the Dario Blood 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. But 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 Blood Glucose Monitoring System consists of the Dario Blood Glucose Meter, Dario Glucose Test Strips, Dario Glucose Control Solutions and the Dario App as the display component of the Dario Blood Glucose Monitoring System. The Dario Blood Glucose Monitoring System is intended for the quantitative measurement of glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips. The Dario Blood Glucose Monitoring System is intended to be used by a single person and should not be shared.

The Dario Blood 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 Blood Glucose Monitoring System should not be used for the diagnosis or screening of diabetes or for neonatal use.

The Dario Blood Glucose Test Strips are for use with the Dario Blood Glucose Meter to quantitatively measure glucose (sugar) in fresh capillary whole blood samples drawn from the fingertip.

7

The Dario Glucose Control Solutions are for use with the Dario Blood Glucose Meter and the Dario Blood 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.

This device is not intended for use in healthcare or assisted-use settings such as hospitals, physician offices, or long-term care facilities because it has not been cleared by FDA for use in these settings, including for routine assisted testing or as part of glycemic control procedures. Use of this device on multiple patients may lead to transmission of Human Immunodeficiency Virus

8

(HIV), Hepatitis C Virus (HCV), Hepatitis B Virus (HBV), or other bloodborne pathogens.

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 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 Bloodborne

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 Bloodborne 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.

Before 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. Internationally visit www.mydario.com.

http://www.fda.gov/medicaldevices/safety/alertsandnotices/ucm224025.Htm

http://www.cdc.gov/injectionsafety/fingerstick-devicesbgm.html


9

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

A Warning indicates precautions you need to take to prevent 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.

!

10

The examples and screen images used in this User Guide are provided as examples only (unless stated otherwise).

Words Description

Bold Names of menus, buttons, and screens.

Italics System response that occurs as a result of pressing a button or performing a task.

Bold Italics Emphasize important information.

Words Description

0344

Dario Blood Glucose Monitoring system Under Directive IVDD 98/79/EC

LabStyle Innovation Ltd.

0197

Sterile Lancets Under Directive MDD 93/42/EEC

Beijing Ruicheng Medical Supplies Co., Ltd.

!

11

Symbols and Descriptions

The following table lists and describes the symbols that appear throughout this guide, on packaging or package inserts, or on the actual system parts.

Symbol Description Symbol Description

Dario logo

LabStyle Innovation Ltd. logo

Consult instructions for use

Do not use if seal is broken or missing

In Vitro Diagnostic

Batch code

Expiry date

Shelf life after you first opened the package

Do not reuse

Temperature limitation

Catalog number

Contents

Manufacturer: LabStyle Innovation Ltd. 8 Hatokhen St. North Industrial Park Caesarea 3088900 Israel

Authorized Representative in the European Community: MDSS GmbH

Schiffgraben 41 30175 Hannover Germany

Intended for self-testing

Sterilized using Gamma Radiation

Keep away from sunlight

Keep dry

Warning - indicates precautions you need to take to prevent possible risk of injury

Caution - indicates precautions you need to take to prevent damage to your monitoring system

Note - provide additional information for the purpose of clarification

!

1M

12

General Precautions

This section provides information about potential hazards that may harm your Dario System or cause it to not function properly.

Inspect the Dario System prior to use. Avoid using any part of the system with broken seals or expired dates. Do not attach or use a component if it is damaged in any way, as it may not work properly.

• The Dario System is not water-resistant and should not get wet. If

it does get wet, wipe it with a clean, dry cloth.

• Blood glucose testing with the Dario System should only be done

in temperatures between 50°F-95°F (10°C-35°C) and relative

humidity between 15-85%. Test results may not be correct if the

room temperature and/or humidity are outside this range.

• Modifications to the Dario System not expressly approved by

LabStyle Innovation Ltd. will void your warranty and could result in

injury.

• Avoid testing with your Dario System in altitudes higher than

10,000 feet (3,048 meters), as accuracy cannot be assured.

• Do 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.

• Do not store the meter or test strips in an area where the humidity

is outside of the range 10-90%, such as a bathroom or kitchen.

• Do not use in oxygen rich environment and with flammable

anaesthetics and flammable agents.

Additional Information

For your safety, observe the following recommendations when monitoring your blood glucose using the Dario System:

• It is recommended that you have a backup testing method

available. Failure to test could cause a delay in treatment decisions

and lead to a serious medical condition. Examples of backup

testing methods include a backup glucose meter device or testing

by a laboratory. Ask your health care provider about other possible

backup methods.

13

• Do not change your treatment based on a single result that is

inconsistent with how you feel or if you believe that your test

result could be incorrect. Contact your health care provider for

further advice.

• Never make changes to your diabetes control program or ignore

physical symptoms without consulting with your health care

provider.

14

CHAPTER 2

DARIO SYSTEM OVERVIEW AND FEATURES

This chapter provides an overview of the Dario System components and describes how to set up the Dario System for the first time.

Your Dario System at a Glance

The Dario System is a cloud-based diabetes management solution that combines software applications with a stylish all-in-one device. The all-in-one device features a lancing device, test strip cartridge, and a compact meter. Together with a smart mobile device, the Dario System puts everything in your pocket that you need to monitor and understand your diabetes. Our goal is to provide the right combination of tools, knowledge, and motivation that you need to succeed.

You can check your blood glucose with a small sample (0.3μl) of your blood and receive results within (6) six seconds.

You can check and track your blood glucose readings the same way you check everything else in life —on your mobile device.

The Dario Glucose Meter connects to smart mobile devices with an easy-to-use mobile app. The Dario App provides real-time and actionable information so that you always know where you stand and what to do next.

The Dario System not only logs and tracks your glucose levels, but also food, activity, moods, and more. The Dario System can even alert your caregivers when you need special attention.

15

Dario Components

The Dario System components are shown in the image below and described in the following table.

16

Component Description

Glucose Meter

(A) Dario meter

(B) Dario meter

release panel

The miniature glucose meter consists of the following components:

• A Lightning connector that is plugged into the

Lightning port of your smart mobile device.

• A strip port for insertion of the test strip.

The glucose meter receives its power from the mobile device. It does not require batteries or any other electrical source. When not in use, the meter snaps into its slot in the housing for protected storage.

(J) Dario Housing The Dario Housing (also referred to as the device housing or simply “housing”) is the main part of the Dario all-in-one device. It holds all the parts in place and consists of the lancing device, the meter slot, and the housing for the test strips cartridge.

Lancing Device and Cover

(C) Lancet cover (orange)

(D) Disposable lancet

(E) Lancet release button

(F) Lancet loader

(G) Lancet depth lever

The lancing device is built into the housing and uses disposable Dario Lancets. The orange lancing device cover prevents the user from unintentional punctures. You must change lancets after each use. For more information about using the lancing device, refer to CHAPTER 4 TESTING YOUR BLOOD GLUCOSE LEVEL on page 40.

(H) Test strip cartridge

Each test strip cartridge holds 25 strips. Test strips are sold separately.

The cartridge snaps into the modular Dario Housing.

17

Component Description

Test Strip The Dario Test Strip is the only strip which is used with the Dario System. A new test strip is inserted into the test strip port of the glucose meter prior to each glucose measurement.

Lancets The Dario System uses a 30G lancet. To replace the lancet, remove the orange lancing device cover, pull out the used lancet, and replace it with a sterile one.

Disposable covers

(applicable to the US market only)

To avoid the risk of transmitting bloodborne pathogens, it is advised to use the disposable sleeve to cover your smart mobile device while taking the blood glucose test. When the test is concluded, remove the cover from your smart mobile device and dispose it together with the used lancet and test strip in accordance with the instructions provided by your health care provider for biohazardous waste.

It is recommended that you carry spare test strip cartridges and lancets in case of an emergency.

!

18

Supported Platforms for the Dario App

The Dario Glucose Meter uses smart phone technology to view and store unlimited numbers of glucose test results. You can also track other diabetes information and view graphs and trends. You can even share your diabetes management information with your health care provider. The Dario System is compatible for use on iOS smart mobile devices. The Dario Glucose Meter currently works with the following Apple® iPhone® devices running iOS 9, 10, 11 and iPhone devices: 5, 5S, SE, 6, 6 Plus, 6S, 6S Plus, 7 and 7 Plus.

For the latest list of compatible devices please refer to www.mydario.com/support/getting-started/.


19

Dario System Welcome Kit Contents

As soon as you receive your Dario System Welcome Kit:

1. Carefully unpack the kit and verify that it contains the following parts:

• Dario System, which includes the lancing device and built in blood

glucose meter

• Dario 25 Sterile Lancets (10 Sterile Lancets in the USA)

• Dario 10 Disposable Covers (4.5”X 8.25”) (available in the US

market only)

• Dario Blood Glucose Monitoring System Quick Guide

• Dario Blood Glucose Monitoring System User Guide

The Dario System also includes the following components which are not included in Dario System Welcome Kit and are sold separately:

• Dario Test Strips

• Dario Sterile Lancets

• Dario Disposable Covers (4.5”X 8.25”) (available in the US market

only)

• Dario Control Solution Level 1 (Medium) and 2(High)

• Super Sani Cloth® Germicidal Disposable Wipes by PDI Healthcare

Once you remove the exterior packaging, you will find a white package with a tamper-proof seal. If the tamper-proof seal is damaged or missing, it is recommended that you return this Dario System to where you purchased it, as it has been previously opened.

2. If anything is missing from the Welcome Kit, contact customer support

toll-free in the U.S. at 1-800-895-5921, 9:00 AM-5:00 PM EST Monday

through Friday. Internationally visit www.mydario.com.

3. Dario System components and accessories (e.g., test strips, lancets,

control solution, disposable covers) can be ordered from:

Your local Dario representative.

Local pharmacies.

From within the Dario App.

!


20

By contacting customer support toll-free in the U.S. at 1-800-895-

5921, 9:00 AM-5:00 PM EST Monday through Friday.

Internationally by visiting www.mydario.com.

For details on product availability, refer to Supplies and Accessories on

page 70.

Getting Started with the Dario System

Your Dario Glucose Meter works seamlessly with your smart mobile device. Simply download the Dario App on your compatible smart mobile device and it will automatically synchronize with the Dario device each time it is connected.

Your data is constantly synchronized to one place so that it is always with you on the go.

Your data is saved under your username on your smart mobile devices and on the Dario cloud. You have easy access to your data through the Dario App and at www.mydario.com.


21

Assembling the Dario System for the First Time

To set up the Dario System for the first time, you must complete the following procedures:

• Insert a test strip cartridge, as described in Inserting the Test Strip

Cartridge on page 21.

• Insert a lancet, as described in Inserting a Lancet on page 22.

• Set the lancet depth, if desired, as described in Setting Lancet

Depth (Optional) on page 24.

• Download and install the Dario App to your smart mobile device,

as described in Downloading and Installing the Dario App on page

25.

• Set up the Dario App on your smart mobile device using the Dario

App instructions or the instructions provided on the Dario website

at www.mydario.com.

Both ends of the Dario Housing have covers that are removable. The lancet cover is orange with the small opening. Be careful not to put the cartridge cover on the lancing end. This can damage the lancet and the lancing device.

Inserting the Test Strip Cartridge

To insert the test strip cartridge:

1. Remove the carbon paper from the device and open the white cover.

2. Remove the new test strip cartridge from its pouch.

3. Hold the test strip cartridge with the side that opens facing up, as shown

in the image below.

!

22

4. Insert the cartridge into the housing until it snaps into place.

5. Return the housing cover by sliding it into place until it clicks, as shown in

the image below.

If the cover does not close properly, the cartridge may not have been inserted correctly. Ensure you have properly inserted the cartridge, as described in steps 3 and 4.

Inserting a Lancet

To insert a lancet:

1. Remove the orange lancet device cover from the Dario Housing, as

shown in the images below.

!

23

2. Remove the used lancet, if one exists, by grasping and pulling it straight

out of its housing.

To avoid accidental injury, dispose of used lancet in accordance with the instructions provided by your health care provider for biohazardous waste.


Do not use the lancet if the cap is missing or damaged.

4. Insert a sterile lancet as far as it will go and ensure it is firmly set.

• Only use a lancet authorized by LabStyle Innovation Ltd.

(30G).

• If the lancet does not set into place or the lancet holder

does not hold the lancet properly, insert another sterile

lancet.

• If the problem persists, you may need to replace your Dario

Housing. Contact customer support toll-free in the U.S. at

1-800-895-5921, 9:00 AM-5:00 PM EST Monday through

Friday. Internationally visit www.mydario.com.

!

!

24

5. Carefully twist off the lancet cap, as shown in the image below. Ensure

that you do not bend the lancet while removing the cap.

Setting Lancet Depth (Optional)

You can adjust the puncture depth of the lancet by moving the lever between

the numbers 1 and 4 (printed on the dial). 1 is the shallowest depth and 4 is

the deepest. It is recommended that you start with the lancet depth set to 1

and adjust the level upwards if necessary.

To set lancet depth:

1. Move the lancing device lever so that the line on the lever is aligned with

the correct depth number, as shown in the image below.

2. Replace the lancing device cover by sliding it into place until it clicks. Be

careful not to touch or bend the lancet.

25

The Dario App

The Dario App is available on the iOS operating system. For full list of compatible devices, refer to the list of devices in Supported Platforms for the Dario App on page 18 or at www.mydario.com/support/getting-started.

Your Dario Glucose Meter is operated from the Dario App displayed on the screen of your smart mobile device. The mobile device displays and stores information received from the glucose meter. The Dario App also provides a step-by-step quick guide for operating the system. Additionally, instructional videos about the Dario App are located at www.mydario.com/support/getting-started.

You can use the Dario App to conveniently store and manage your diabetes information, review trends, or share information with your health care provider.

Downloading and Installing the Dario App

You can download and install the Dario App to your smart mobile device using the Apple App Store®. The Dario App downloads and installs just like any other app on your smart mobile device. The Dario App is free of charge and is customized for your smart mobile device.

Downloading the Dario App from the App Store requires data connectivity.

For accurate use of the Dario System with the app, the time and date must be correctly set on your smart mobile device. For instructions on setting the time and date, refer to the documentation for your device.

!

!




26

To download the Dario App from the Apple App Store:

1. Turn on your smart mobile device and launch the App Store app.

Alternatively, for quicker access, you can use an app that scans QR codes

to scan the following code:

2. Search for the Dario App by LabStyle Innovation Ltd. and tap on the Dario

icon.

3. Tap Free and then tap Install.

4. Enter your password information as required by your device.

The application downloads. Once installed, the orange Dario icon appears on your smart mobile device home screen, as shown in the image below.

27

The Dario App needs to be installed once on each of your smart mobile devices.

Updates may be downloaded periodically from the App Store.

Creating Your Account and Personalizing Your Settings

To setup your Dario App:

1. After installing the Dario App on your mobile device, press the orange

Dario icon . The icon appears on your smart mobile device’s Home

screen.

2. Select Get Started to register as a Dario user.

The Registration screen displays, as shown in the image below.

!

!

28

3. Continue by following the instructions on the screen to register. You can

register by entering your e-mail address and password; or, alternatively,

you can connect with Facebook.

Your password must have at least seven (7) characters and include an upper case letter, a lower case letter, and a number.

Your e-mail address and password will be used to log in to the Dario App and the Dario web portal.

If you already have a Dario account, you can skip the next steps.

4. Press Create Account when done.

The First Entry screen appears, as shown in the image below.

You can edit your e-mail address and password and set the Dario

App language and region by tapping the Menu icon and selecting SETTINGS > ACCOUNT INFORMATION.

!

!

!

!

29

Setting Your Personal and Diabetes Profiles

To set your personal profile:

1. Tap the Menu icon in the upper left corner and select SETTINGS >

PERSONAL INFORMATION.

2. Tap the pencil icon in the upper right corner to edit the information.

3. Enter your gender, weight, height, and date of birth in the appropriate

fields. You can also upload a photo from your device by tapping UPLOAD

PHOTO.

4. Press DONE

To set your diabetes profile:

1. Tap the Menu icon in the upper left corner and select

SETTINGS>DIABETES PROFILE, and under MANAGE MY GOALS > SET MY

GOALS

2. Tap the pencil icon in the upper right corner to edit the information.

3. Select your preferred carbs measurement unit.

4. Press DONE

You can complete the Walkthrough at any time by selecting HELP&INFO > GUIDE ME.

!

30

CHAPTER 3

CHECKING YOUR DARIO GLUCOSE METER

This chapter provides information on checking the accuracy of your meter with a control solution.

To ensure that your results are always accurate, you need to check the performance of your meter in the following cases:

• If you drop the meter.

• Whenever your result is inconsistent with how you feel.

• If you have repeated a test and the blood glucose result is still

lower or higher than expected.

• Whenever you want to check the performance of the meter and a

test strip.

Dario Control Solution

The Dario Control Solution confirms that the meter and test strips are performing as expected. A drop of control solution is placed on the edge of the test strip, allowing the test strip to automatically draw the control solution into the yellow window. Compare the results on the meter with the values displayed on the test strip cartridge.

The Dario Control Solution package can be ordered separately as indicated in page 20. The Dario Control Solution package comes with two bottles of control solution (Level 1 (M), Level 2 (H)).

Control Solution Precautions

Note the following about the control solution:

• Avoid contact with your eyes. Contact your health care provider

immediately if solution is swallowed, injected, or comes in contact

with your eye.

• The dye in the control solution may stain skin, clothing, or

surfaces.

Store the control solution in an area where the temperature is

between 46°F-86°F (8°C-30°C). Keep away from direct sunlight,

31

fluorescent light, and heat.

• Do not freeze.

• Once you open a new bottle of control solution, mark the date on

the bottle.

• Ensure that your control solution has not expired. Check the

expiration date on the bottle.

• Ensure that your control solution was not opened more than three

(3) months ago.

• Keep the control solution out of reach from children.

• Shake the control solution well before using.

• After each use, wipe the container tip clean and close the

container tightly.

• No reconstitution or dilution of the control solution is necessary.

Control Solution Test Principle

The Dario Control Solution contains a known amount of glucose that reacts with chemicals on the Dario Test Strip.

Following the same procedure you would use to check your blood, you will apply a drop of control solution to a test strip. The glucose in the control solution reacts with chemicals in the test strip.

The result displayed on the meter should fall within the expected range printed on the test strip cartridge label. You only need to obtain a single result within the expected range to verify system performance. A result outside the range printed on the test strip cartridge label may indicate the system is not performing correctly.

The control solution is not for use as a cleaning solution.

Chemical Composition

Dario Control Solution is an aqueous solution that contains D-glucose as the reactive ingredient in the approximate concentration.

!

32

The remaining chemical components of the Dario Control Solution are:

• Buffer 75mM

• Polyvinylpyrolidone 5%

• Polyethylene glycol 5%

• SDS 0.1%

• Preservative 0.1%

Checking Your Glucose Meter with Dario Control Solutions

To perform a control solution test, you must perform the following three procedures:

• Removing the Glucose Meter from the Housing

• Removing a Test Strip from the Cartridge

• Performing a Control Solution Test

Removing the Glucose Meter from the Housing

Before performing a control solution test or testing your blood, remove the glucose meter from the housing. You should always store the glucose meter in the housing when you are not using it.

When not in use, store the meter in the Dario Housing. Do not leave your meter connected to your smart mobile device with the screen in ON mode for more than two (2) minutes, as the meter can get warm which can affect the accuracy of the reading.

To remove the meter from the housing:

1. Hold the housing so that the ridged orange panel is close to you and the

end with the lancing device is facing away from you.

2. Slide your thumb back on the ridged orange panel in the direction

indicated by the arrow, as shown in the image below. The meter will pop

up.

33

3. Grasp the meter with two fingers and remove it from the housing.

Do not plug the Dario Glucose Meter into any device other than a compatible smart mobile device Lightning port. For a list of compatible devices, refer to www.mydario.com/support/getting-started.


You should have a test strip cartridge already inserted in your Dario Housing. If this is not the case, refer to Inserting the Test Strip Cartridge on page 21.



34

To remove a test strip from the cartridge:

1. Remove the cartridge cover of the Dario Housing by pushing it outwards

until it comes off (use the removal indication lines), as shown in the

images below.

2. Snap open the test strips cartridge cap by pushing up the edge.

3. Remove a test strip from the cartridge, as shown in the image below.

4. Close the cartridge cap immediately and return the white cartridge cover

to the closed position by pushing it into place until it clicks.

35

You should use the test strip immediately after removing it from the cartridge. It is not recommended that you use a test strip that has been outside of the cartridge for more than three (3) minutes.

If the cover does not close properly, the cartridge may not have been inserted correctly. Ensure that you have correctly, returned the cartridge cover to the closed position as described in step 4.

• Do not touch the yellow testing site when handling the test

strip.

• Do not use a damaged test strip.

Performing a Control Solution Test

To perform a control test:

1. Tap the Dario icon on your smart mobile device to launch the Dario App.

The First Entry screen appears, as shown in the image below.

2. Insert the meter into the Lightning port of your smart mobile device, as

shown in the image below.

A “Connecting...” message appears in the Dario App and then the screen displays the following instruction: INSERT A NEW STRIP.

!

!

36

Verify that the meter is inserted as far as it can go into the Lightning port of the smart mobile device and no other device or cable is connected to the smart mobile device.

3. Hold the test strip with the gold contacts facing the meter.

4. Without bending the strip, insert it into the test strip port (marked in

orange) of the Dario Glucose Meter as far as it will go.

Verify the test strip direction, as shown in the image below.

The Dario App screen instructs you to place a drop of blood on the test strip, as shown in the image below.

!

The Dario Meter

should be inserted

with logo facing up.

The screen

notification changes.

37

5. Shake the control solution container and apply a drop of control solution

onto the edge of the test strip, allowing the test strip to automatically

draw the control solution into the yellow window.

Important: Verify that you apply enough control solution to fill the window so that it turns red. Do not put control solution on top of the test strip.

When the meter detects the solution, the “Measuring...” message appears. The orange rotating in the circle indicates that the test is in progress, as shown in the image below.

The glucose test result appears on the screen after six (6) seconds and is automatically saved to memory.

!

38

You can delete this control test from memory, if desired. For more information, refer to the Dario App User Guide at www.mydario.com.

6. Compare the results on the meter with the values displayed on the test

strip cartridge. If the results are:

• Within the acceptable target values, then your meter is ready for

use.

• Outside of the acceptable target values, perform the test again with

a new test strip. If the problem recurs, contact customer support

toll-free in the U.S. at 1-800-895-5921, 9:00 AM-5:00 PM EST

Monday through Friday. Internationally visit www.mydario.com.

7. When the test is done, remove the test strip and follow your health care

provider’s instructions for disposal.


9. Wipe the tip of the control solution container clean and tightly seal the

container.

The Dario Control Solution target values printed on the test strip cartridge label are intended for the Dario Test Strip Cartridge only.

When measured by systems other than the Dario Blood Glucose Monitoring System, the glucose concentrations in these solutions may differ.

Applying too much or too little control solution to the test strip may cause out-of-range results.

Do not use your Dario Blood Glucose Monitoring System to test your blood if your control solution result falls outside of the acceptable target values.

!

!

!

!



39

The Dario Blood Glucose Monitoring System includes a function for specific control solution tests. Control solution tested values must be tested under the "Control solution test" function:

Menu icon , selecting HELP&INFO > CONTROL SOLUTION TEST or the results will be included in the blood glucose averaging functions of the device.

10. Place the meter back into the housing by holding the meter at an angle

with the part that connects to the smart mobile device facing away from

the ridged orange panel. Then, push the meter into the housing at an

angle and push downwards until the meter clicks into place.

40

CHAPTER 4

TESTING YOUR BLOOD GLUCOSE LEVEL

The Dario Glucose Meter measures the amount of glucose in your blood. Once you place a small drop of blood from your fingertip onto the test strip, the result will display in six (6) seconds on the screen in the Dario App.

Carefully read and follow the instructions provided in this chapter and in the package inserts for the test strips and control solutions. It is very important to follow the instructions to prevent an incorrect result or improper treatment.

Do not put any fluids into the test strip port.

Once you start the Dario App, follow the prompts on the screen.

Blood Glucose Testing Precautions

The meter, test strips, and control solutions are only intended for use outside the body (in vitro). Do not eat the test strips. Do not swallow or inject control solutions, or use control solutions for any purpose other than testing your blood glucose.

FDA Public Health Notification: “Use of Fingerstick Devices on More than One Person Poses Risk for Transmitting Bloodborne 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 Bloodborne Pathogens” (2010). You can find this document at www.cdc.gov.

The meter and lancing device are for single-patient use only. Do not share them with anyone including other family members. Do not use on multiple patients.

It is advised that you wash your hands thoroughly with soap and warm water before and after handling the meter, lancing device, or test strips.

!

http://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/ucm224025.htm

http://www.cdc.gov/injectionsafety/Fingerstick-DevicesBGM.html

41

Incorrect test results may result in the wrong therapy recommendation and may lead to serious adverse health conditions. Therefore, follow the proceeding instructions carefully and read the items listed in Test Strip Precautions below.

Test Strip Precautions

• Only use Dario Test Strips. Using other test strips with the Dario Glucose

Meter can produce inaccurate results.

• Inspect each test strip cartridge before opening it for the first time. If you

see any damage to the cartridge lid, or if anything prevents the lid from

closing properly, do not use the test strips.

• Run a control test every time you open a new test strip cartridge. For

additional information, refer to Checking Your Glucose Meter with Dario

Control Solutions on page 32.

• Store unused test strips in their original cartridge. Do not remove test

strips from the test strip cartridge and put them into another container.

• Close the cartridge tightly right after you remove a test strip. This helps

to keep the test strips dry.

• Check the “Use by” date on the test strip cartridge. Do not use the test

strips after that date.

• Write down the date the test strip cartridge was first opened. Check this

date before you use a test strip from this cartridge. If the current date

exceeds the shelf life, do not use the test strips from this cartridge. Refer

to the Instructions for Use information on the test strip cartridge

packaging.

• Do not move tests strips from one cartridge to another.

• Use the test strip immediately after removing it from the cartridge.

• Use the test strips as indicated in this guide.

• Do not store your test strips in temperatures below 36°F (2°C) or above

90°F (32°C).

• Store your test strips in an area where the relative humidity is between

10-90%.

• Do not place the test strips in a freezer.

• Do not expose your test strips to direct sunlight or moisture.

42

• Do not apply blood or control solution to the test strip before inserting it

into the glucose meter.

• Do not reuse test strips. Once control solution or blood is placed on a test

strip, discard the strip. If you need to retest, use a new test strip.

• Do not bend, cut, or alter the test strips.

• Do not get dirt, food, or other substances on the test strip.

• It is recommended that you use the test strip immediately after removing

it from the cartridge. It is not recommended that you use a test strip that

has been outside of the cartridge for more than three (3) minutes.

• Do not touch the yellow testing site when handling the test strip.

• Do not use a damaged test strip.

• Make sure that the gold contact area of the test strip is clean from dirt,

blood, moisture, and any other material. An unclean test strip will affect

the test result and can cause an inaccurate blood glucose level result.

Factors That Interfere with Blood Glucose Testing

Certain substances can interfere with the blood glucose system and cause inaccurate results. For more information, refer to the test strip package insert. If you are taking medication or dietary supplements, consult your health care provider.

You should not use this system to test your blood glucose if you are critically ill (examples include: severe hypotension or shock, hyperglycemic-hyperosmolar state, hypoxia, and diabetic ketoacidosis).

Certain health conditions, such as serious illness and dehydration, can cause false test results in glucose meters. If you are very sick or think you are dehydrated, or are urinating frequently, call your health care provider immediately.


!

43

Interpreting the Results

If the displayed test result is consistent with how you feel, continue as instructed by your health care provider.

If the test result is inconsistent with how you feel, check your Dario System by running a control solution check, as described in Performing a Control Solution Test on page 35. Repeat the blood glucose test afterward. If your blood glucose result is still inconsistent with how you feel and you have followed the instructions provided in this chapter, follow your health care provider’s instructions.

Do not change your treatment based on a single result that is inconsistent with how you feel or if you believe that your test result is incorrect. The blood glucose reading displayed on your smart mobile device by Dario System should not be the only information you use to make decisions about your health. Always consult your health care provider to interpret and understand the measurement results.

Measurement Range

Your meter measures blood glucose results in the range of 20 mg/dL to 600 mg/dL (1.1-33.3 mmol/L). Results outside of this range should be reviewed according to the following information.

• If your test result is lower than 20 mg/dL (1.1 mmol/L), “LOW!

Measure with a new strip, if recurs contact your physician

immediately” displays instead of a result.

LOW may indicate that your blood glucose is very low (possibly severe hypoglycemia). Follow your health care provider’s instructions immediately and repeat the test.

• If the result is higher than 600 mg/dL (33.3 mmol/L(, “HIGH!

Measure with a new strip, if recurs contact your physician

immediately” displays instead of a result.

44

If your blood glucose test results in a LOW! or HIGH! message,

repeat the blood glucose test following all of the instructions in

Step Five: Testing Your Blood Glucose on page 47.

• If your blood glucose test results in a LOW! or HIGH! message a

second time, follow the protocol established by your health care

provider or contact your health care provider immediately.

• Note that many factors determine whether your blood glucose

reading is outside the range of 20 mg/dL-600 mg/ dL (1.1-33.3

mmol/L), including individual differences and the time since your

last meal.

The American Diabetes Association suggests that the following expected glucose values for individuals without diabetes:

Before eating (FPG) < 126 mg/dL

Two hours after meals (OGTT) < 200 mg/dL

Reference: American Diabetes Association (2015). Standards of Medical Care in Diabetes – 2015. Diabetes Care, 38 (Supplement 1): S14-S87.

Factors That May Lead to Inaccurate Results

Certain medications, food supplements, medical treatments, and health conditions can interfere with the blood glucose system and cause inaccurate results.

Incorrect testing technique or improper storage or handling of the Dario System may also lead to inaccurate test results which are inconsistent with how you feel. The following conditions could lead to incorrect results:

• Your hands may not have been washed thoroughly.

• Your glucose meter test strip port may be contaminated.

• Your test strip has been bent.

• The test strip is expired. Check the 'Use By' date.

• The length of time that has passed since first opening the test strip

package exceeds the shelf life.

• Test strips were stored incorrectly.

• Testing was done in a humid environment (for humidity

specifications, refer to General Precautions on page 12).

45

• Your glucose meter has been dropped.

If your meter has been dropped and you are receiving error messages or implausible results, contact customer support toll-free in the U.S. at 1-800-895-5921, 9:00 AM-5:00 PM EST Monday through Friday. Internationally visit www.mydario.com.

Do not rely on the blood glucose measurement alone in making health care decisions.

Step One: Inserting a New Lancet into the Lancing Device

To prevent infection, always use a new, sterile lancet in your lancing device each time you test your blood glucose.

Insert a new lancet into the lancing device, as described in Inserting a Lancet on page 22.

If necessary, set the depth of the lancing device. For more information, refer to Setting Lancet Depth (Optional) on page 24.

Return the lancing device (orange) cover by sliding it into place until it clicks. Be careful not to touch or bend the lancet.

Step Two: Opening the Dario App

Before connecting the Dario Glucose Meter into your smart mobile device, open the Dario App by tapping the Dario icon on your smart mobile device Home screen.

!

!

46

Step Three (relevant to the US market only): Inserting the Smart Mobile Device

into the Disposable Cover

Before starting the testing procedure, you should cover your phone with a disposable cover.

To avoid the risk of transmitting bloodborne pathogens, it is advised that you use a disposable sleeve to cover your smart mobile device while taking the blood glucose test. The disposable cover protects the mobile device from direct contact with blood during the glucose measurement. The disposable sleeves are available in your Dario System Welcome Kit. You can order additional disposable sleeves from customer support by calling toll-free in the U.S. at 1-800-895-5921, 9:00 AM-5:00 PM EST Monday through Friday. Internationally visit www.mydario.com.

Insert your smart mobile device into the disposable cover so that the opening at the bottom of the sleeve fits over the Lightning port, as shown in the image below.

Step Four: Removing the Glucose Meter from the Housing

Before starting the testing procedure, remove the meter from the housing, as described in Removing the Glucose Meter from the Housing on page 32. You should always store the meter in the housing when you are not using it.

!

47

Place the glucose meter Lightning connector into the Lightning port at the bottom of the disposable cover. Verify that the meter is inserted as far as it goes into the Lightning port of the smart mobile device and no other device or cable is connected to the smart mobile device.

A “Connecting...” message appears in the Dario App, and then the screen displays the following instruction: INSERT A NEW STRIP.

Step Five: Testing Your Blood Glucose

You are now ready to test your blood glucose. Before beginning the test, ensure you understand the information provided in Testing Information and Guidelines.

Testing your blood glucose consists of the following two procedures:

• Removing a Test Strip from the Cartridge

• Performing a Glucose Test

Testing Information and Guidelines

• To perform the test, the meter requires only a small drop of blood

about the size of a sugar grain (0.3μL). For best results, select a

puncture site along the side of the fingertip.

The Dario Meter

should be inserted

with logo facing up.

The screen

notification changes.

48

• While applying blood to the test strip, verify that you apply enough

blood to fill the test strip window so that it turns completely red.

• Testing blood from sites other than the fingertip may generate

inaccurate results.

• If you have not applied enough blood to the test strip, an alert

displays that informs you that the sample size is too small and you

should try again with a new strip. Blood glucose results are

automatically saved to memory. The results remain on the screen

in the Dario App for 15 minutes.

• If a test strip error occurs (e.g. "used strip"), perform another test

with a new test strip.

• If an error message or symbol appears on the screen, refer to

CHAPTER 6 TROUBLESHOOTING on page 60 for additional

information.

• Dirty or wet hands could affect your test results.

• Alcohol can affect test results.

• When not in use, store the meter in the Dario Housing. Do not

leave your meter connected to your smart mobile device with the

screen in ON mode for more than two (2) minutes, as it can get

warm and can affect the accuracy of the test.

To prevent malfunction of the meter, keep the test strip port free of blood, moisture, dirt, or dust. Always store the glucose meter in the Dario Housing when not in use.

In case of a meter error, you may need to remove and insert the meter to allow the meter to reconnect to the smart mobile device.

In case of a test strip error you may need to replace the test strip and test with a new test strip.

49


You should have a test strip cartridge already inserted in your Dario Housing. If this is not the case, refer to Inserting the Test Strip Cartridge on page 21.

To remove a test strip from the cartridge:

1. Wash your hands with warm, soapy water and dry thoroughly. If you use

alcohol wipes to clean your fingers, ensure the puncture area is

completely dry before lancing your finger.

2. Remove the cartridge cover of the Dario Housing by pushing it outwards

until it comes off (use the removal indication lines), as shown in the

image below.

3. Open the lid by pushing up the edge, as shown in the image below.

!

50

4. Remove a test strip from the cartridge, as shown in the image below.

5. Close both the lid and cartridge cover.

If the cover does not close properly, you may not have inserted the cartridge correctly.

6. Hold the test strip with the gold contacts facing upward.

7. Without bending the strip, insert it into the test strip port of the Dario

Glucose Meter as far as it will go.

Verify the test strip direction, as shown in the image below.

The Dario App instructs you to place a drop of blood on the test strip, as shown in the image below.

!

51

8. Proceed to the next section.

Performing a Glucose Test

If you receive a phone call while the glucose measurement is in progress, Dario will stop the test and the results will not be saved. To avoid interruption of the glucose test, you can set your phone to airplane mode before beginning this procedure. For more information, refer to your mobile device’s instructions.

1. Set the lancing device for activation by sliding it with two fingers as far as

it will go, as shown in the image below.

2. Place your fingertip over the hole on the lancing device and press the

orange release button with your thumb to prick your finger, as shown in

the images below.

!

52

3. Apply a drop of blood to the tip of the yellow window of the test strip, as

shown in the images below. Capillary action will pull the blood into the

strip.

Important: Continue applying blood to the test strip until the window turns red, which indicates that enough blood has been collected to take a reading. Do not put blood on top of the test strip.

!

53

When the meter detects that blood has been applied, the “Measuring...” message appears in the Dario App. The border of the circle gradually fills with orange, indicating that the test is in progress.

4. Remove your finger from the strip once the above message appears.

Do not add blood to the test strip once you have removed your finger because you may receive an inaccurate result.

5. The test result appears on the screen after approximately six (6) seconds.

The glucose test result is automatically saved to memory. If a result does not display, you can view it in your Logbook in the Dario App. For more information, refer to the Dario App User Guide at www.mydario.com.

In case an error message appear, you may need to start the measurement process again. If error recurs, refer to CHAPTER 6 TROUBLESHOOTING on page 60 section for further information

If you receive a phone call while a measurement is in progress, the test will stop and the results will not be saved. The following message will display on the result screen: “The Test Strip Is Used” and you will have to start the test over with a new test strip. To avoid an interruption of your glucose test, you may want to set your smart mobile device to airplane mode prior to starting your test.

!

54

6. You may continue to complete the information about the glucose

measurement that displays on the Dario App screen (e.g., measurement

setting, carb consumption, exercise, insulin intake).

7. When the test is done, remove the test strip and disposable cover and

dispose of them in accordance with the instructions provided by your

health care provider for biohazardous waste.

8. Remove the lancet from the lancing device, as described in step 2 in

Inserting a Lancet on page 22 and dispose of the used lancet in

accordance with the instructions provided by your health care provider

for biohazardous waste.

When the test strip is removed from the glucose meter, the following message appears in the Dario App: “Please insert new test strip.”

Step Six: Returning the Meter to the Dario Housing

To return the meter to the Dario Housing:


2. Hold the meter at an angle with the Lightning plug facing away from the

ridged orange panel.

3. Push the meter into the housing at an angle and then push downwards

until the meter clicks into place.

Test Strip Limitations

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.

55

CHAPTER 5

CLEANING AND MAINTENANCE

This chapter provides information for cleaning and disinfecting for your Dario Glucose Monitoring System.

The Dario Blood Glucose Monitoring System should be cleaned and disinfected once a week. The Dario System should be properly maintained for safe and accurate use. The meter should be properly cleaned and disinfected to prevent the spread of infectious diseases.

Cleaning and Disinfection

The outer surfaces should be cleaned when you notice that your Dario is visibly dirty. It is advised to clean and disinfect your Dario System once a week to avoid transmitting bloodborne pathogens.

If someone else is operating the meter to assist you with testing, he or she should clean and disinfect the meter, housing, orange lancet cover and white cartridge cover prior to use.

Cleaning and disinfection is a two steps process and should be done once a week. Cleaning and disinfection refer to different actions. Cleaning removes dirt and blood while disinfection kills the bloodborne pathogens. Before disinfecting your system, first clean the meter, housing, orange lancet cover, and white cartridge cover.

Failure to properly clean your device prior to disinfection can damage your device and/or transmit blood borne pathogens

Wash your hands thoroughly with soap and water before and after handling the meter, housing, orange lancet cover and white cartridge cover, or test strips.

Step 1: Cleaning

Clean the meter, housing, orange lancet cover, and white cartridge cover using a Super Sani-Cloth Germicidal Disposable Wipe to remove visible dirt, blood, or other substances. Super Sani-Cloth Germicidal Disposable Wipes have been proven safe for use with the Dario meter, housing, orange lancet cover, and white cartridge cover. Super Sani-Cloth Germicidal Disposable Wipes are

56

manufactured by Professional Disposables International, Inc. and are available online through amazon.com and officedepot.com. Before cleaning, remove the meter from its housing. The meter must not be connected to the mobile device while cleaning.

Clean the meter, housing, orange lancet cover, and white cartridge cover by wiping the outside surfaces with a Super Sani-Cloth Germicidal Disposable Wipe to remove all visible dirt. Remove the white cartridge cover and wipe the cartridge cap as well. Before you begin, squeeze out any excess liquid from the wipe so that it is damp but not dripping wet. Take extreme care not to get liquid on the test strip port.

Step 2: Disinfection

Prior to disinfection ensure you have properly cleaned your device as recommended in Step 1: Cleaning. Disinfect the meter, housing, orange lancet cover, and white cartridge cover using a clean Super Sani-Cloth Germicidal Disposable Wipe to kill the bloodborne pathogens that may spread infection.

Using a second clean Super Sani-Cloth Germicidal Disposable Wipe:

• Disinfect the meter on all four (4) surfaces by wiping up and down at least two (2) times to each direction, as shown in the images on the following page. Do not allow any moisture to get into the test strip port.

• Disinfect the housing, orange lancet cover, and white cartridge cover by wiping the outer surfaces. Ensure that you wipe all parts including the housing, the white cartridge cover, and the orange lancet cover up and down at least two (2) times in each direction as demonstrated in the images on the following page.

• Remove the white cartridge cover and disinfect the cartridge cap by wiping up and down thoroughly at least two (2) times in each direction as demonstrated in the images on the following page.

• It is very important to let the liquid from the wipe sit on the outer surface for at least two (2) minutes. Be extremely careful to avoid getting liquid onto the test strip port.

The images below demonstrate how to use Super Sani-Cloth Germicidal Disposable Wipes to clean and disinfect your Dario System.

58

To ensure effective disinfection, let the solution sit on the meter, housing, orange lancet cover, and white cartridge cover for at least two (2) minutes. Allow the meter, housing, orange lancet cover, white cartridge cover and cartridge cap to completely dry before use. Wipe off any remaining residues with a clean, soft, and dry paper cloth.

Your Dario System has an expected life of three (3) years. It should withstand the cleaning and disinfection recommended (156 cycles) in this user guide.

It is recommended that you clean and disinfect the entire system as least once per week and whenever you notice blood, dirt, or visible residue.

If you notice changes in appearance (such as color fading, cracking, discoloration or display malfunctions) or you are obtaining results that are not accurate, stop using the meter or lancing device and call customer support toll-free in the U.S. at 1-800-895-5921, 9:00 AM-5:00 PM EST Monday through Friday. Internationally visit www.mydario.com. Please contact your health care provider for questions outside of the customer support hours.

The cleaning and disinfection performance testing on the Dario System was done using the Super Sani-Cloth Germicidal Disposable Wipes with EPA registration number 9480-4 (Active ingredient: Quaternary ammonium chlorides and isopropanol).

Cleaning and disinfection is important to prevent the spread of disease. If you are interested in additional information about the importance of disinfection, refer to the following articles:

• “FDA Public Health Notification: Use of Fingerstick Devices on

More than One Person Poses Risk for Transmitting Bloodborne

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 Bloodborne Pathogens”

(2010). You can find this document at www.cdc.gov.

59

Do not:

• Allow any moisture to get into the test strip port.

• Spray any cleaning solution directly onto the glucose meter

or the lancing device.

• Submerge any part of the Dario System in liquid.

• Attempt to clean any internal parts.

• Attempt to dry any parts using a blow dryer.

Please observe the following cautions when cleaning the Dario System to avoid damaging the device:

If the device becomes wet, wipe off all moisture and allow sufficient time for the device to dry before using.

To avoid the risk of transmitting bloodborne pathogens, it is recommended that you use a disposable sleeve to cover your smart mobile device while taking the blood glucose test. The disposable sleeves are available in your Welcome Kit. You can order additional disposable sleeves from customer support by calling toll-free in the U.S. at 1-800-895-5921, 9:00 AM-5:00 PM EST Monday through Friday or by visiting www.mydario.com. For more information about using the disposable cover, refer to instruction on how to use Disposable Covers on page 46.

If you notice signs of deterioration such as clouding, cracking, crazing, etc., or the meter stops functioning as expected, stop using the meter and contact customer support toll-free in the U.S. at 1-800-895-5921, 9:00 AM-5:00 PM EST Monday through Friday. Internationally visit www.mydario.com. Please contact your health care provider for questions outside of the customer support hours.

!


60

CHAPTER 6

TROUBLESHOOTING

This chapter provides information about all the symbols and error messages that may display in the Dario App. To ensure safe and accurate use of Dario, pay attention to all symbols and messages that occur while using the system as they provide you with important information.

If you still have questions after reading this chapter, call customer support toll-free in the U.S. at 1-800-895-5921, 9:00 AM-5:00 PM EST Monday through Friday. Internationally contact customer support through www.mydario.com. Please contact your health care provider for questions outside of the customer support hours.

An error message can appear in the Dario App as a message within the results area, as shown in the images below.

Troubleshooting

The following table lists some typical conditions that may occur with the Dario System.


Insufficient blood detected, try again with a new strip

There is not enough blood on the test strip.

Repeat the measurement with a new test strip.


61


The Strip is used, please insert a new strip

A test strip was used more than once.

Perform a new measurement with a new test strip.

HIGH! Measure with a new strip, if recurs contact your physician Immediately

Glucose level is above operating range.

Measurement result is above 600 mg/dL (33.3 mmol/L). Repeat the measurement with a new test strip. If this message recurs, contact your health care provider Immediately. If your measurement results are inconsistent with the way you feel, contact customer support toll-free in the U.S. at 1-800-895-5921, 9:00 AM-5:00 PM EST Monday through Friday. Internationally visit www.mydario.com.

LOW! Measure with a new strip, if recurs contact your physician Immediately

Glucose level is below operating range

Measurement result is below 20 mg/dL (1.1 mmol/L). Repeat the measurement with a new test strip. If this message recurs, contact your health care provider Immediately. If your measurement results are inconsistent with the way you feel, contact customer support toll-free in the U.S. at 1-800-895-5921, 9:00 AM-5:00 PM EST Monday through Friday. Internationally visit www.mydario.com.

Temperature out of range. Move to an area between 50°-95°F (10-35°C), wait 30 minutes and try again

The meter was left in an extreme temperature environment.

Move to a cooler or warmer area, wait at least 30 minutes and repeat the measurement with a new test strip.

62


Dario device failure (0x00). If the problem occurs again, please contact Dario’s customer support

Communication failure.

Try disconnecting and reconnecting the meter.

Clean the lightning connector with a dry cloth, If problem recurs, contact customer support toll-free in the U.S. at 1-800-895-5921, 9:00 AM-5:00 PM EST Monday through Friday. Internationally visit www.mydario.com.


Firmware software failure.


Clean the lightning connector with a dry cloth, If problem recurs, contact customer support toll-free in the U.S. at 1-800-895-5921, 9:00 AM-5:00 PM EST Monday through Friday. Internationally visit www.mydario.com.


Voltage failure.


Clean the lightning connector with a dry cloth, If problem recurs, contact customer support toll-free in the U.S. at 1-800-895-5921, 9:00 AM-PM EST Monday through Friday. Internationally visit www.mydario.com.

Unknown device, please connect Dario

Another device is connected to your smart mobile device’s Lightning port.




63


Unknown device, please connect Dario

If another device is connected to the Lightning port, disconnect it and connect the Dario Glucose Meter. You can still use the Dario App if another device is connected.

If you received this message while the Dario Glucose Meter is connected, disconnect and reconnect the meter. If this message still appears, contact customer support toll-free in the U.S. at 1-800-895-5921, 9:00 AM-5:00 PM EST Monday through Friday. Internationally visit www.mydario.com.

Hypo warning A hypoglycemia event occurred.

You received a measurement result lower than defined in the hypo warning section under Blood Glucose Thresholds. Contact your health care provider immediately.

Problem Solving

Test strip inserted but “Please insert a new strip” keeps appearing on the

screen.

The test strip was removed before the reading was completed or test strip or meter is defective.

• Repeat the measurement using a new test strip.

• Check the meter with control solution, as described in Checking

Your Glucose Meter with Dario Control Solutions on page 32). If the

result is outside of the acceptable target values, contact customer

support toll-free in the U.S. at 1-800-895-5921, 9:00 AM-5:00 PM

EST Monday through Friday. Internationally visit

www.mydario.com. If the result is within the acceptable target

values, test your glucose again with a new test strip.

64

You cannot pierce skin with lancet.

• The needle depth may be incorrect. Adjust the lancet depth lever

to a different depth. For more information, refer to Setting Lancet

Depth (Optional) on page 24.

• The lancet needle may be bent. Replace the lancet. For more

information, refer to Step One: Inserting a New Lancet into the

Lancing Device on page 45.

• The cartridge cover may be in the place of the lancing device

cover. Please be careful to return each cover to the correct end.

The lancet does not fit correctly into the lancing device.

The lancet may be faulty or you may be using a lancet that is not approved for use with the Dario System. Replace the lancet with a different Dario Lancet. If the problem persists, you may need to replace the Dario Housing. Contact customer support toll-free in the U.S. at 1-800-895-5921, 9:00 AM-5:00 PM EST Monday through Friday. Internationally visit www.mydario.com.

Cannot remove the used needle from the lancing device.

The lancet may be faulty or you may be using a lancet that is not approved for use with the Dario System. Pull the needle carefully and straight out from lancet.

Replace the lancet with a different Dario Lancet. If the problem persists, you may need to replace the Dario Housing. Contact customer support toll-free in the U.S. at 1-800-895-5921, 9:00 AM-5:00 PM EST Monday through Friday. Internationally visit www.mydario.com.

Lancing device does not operate correctly.

The lancing device spring or handle may be faulty. Ensure that you set the lancing device for activation by sliding it with two fingers until it clicks. Then, press the button to puncture your skin. For more information, refer to step 1 in Performing a Glucose Test on page 51).

65

Lancet Depth Indicator lever is stuck.

The indicator lever may be faulty. Replace the Dario Housing. Contact customer support toll-free in the U.S. at 1-800-895-5921, 9:00 AM-5:00 PM EST Monday through Friday. Internationally visit www.mydario.com.

Lancing device release button does not work properly.

The lancing device is faulty. Replace the Dario Housing. Contact customer support toll-free in the U.S. at 1-800-895-5921, 9:00 AM-5:00 PM EST Monday through Friday. Internationally visit www.mydario.com.

“Strip is used and should be replaced” message appears in the Dario App.

This message appears if you receive an incoming call. It is recommended that you set your smart mobile device to airplane mode before performing a test.

I forgot my Dario password.

If you forget your password, tap on FORGOT PASSWORD on the LOG IN screen. You will receive an e-mail with instructions for resetting your password.

My smart mobile device battery died.

If the battery of your smart mobile device is out of power, charge your device or use a different device. Download the Dario App onto that device and login to your account.

66

CHAPTER 7

TECHNICAL INFORMATION AND SPECIFICATIONS

This chapter provides technical information about your Dario System.

How the Glucose Meter Works

The Dario System determines the amount of glucose in fresh capillary blood using electrochemical biosensor technology. An electrical current is generated by the reaction of glucose with the reagent on the test strip (glucose oxidase). The strength of the current produced by the reaction depends on the amount of glucose in the blood sample. The glucose meter detects the current and converts it into a blood glucose reading.

Compatibility

Dario is compatible for use on iOS smart mobile devices. For full list of compatible devices, please refer to www.mydario.com/support/getting-started/

Technical Specifications


Result Range 20-600 mg/dL (1.1-33.3 mmol/L)

Calibration Plasma-equivalent

Sample Fresh capillary whole blood

Test Sample 0.3 microliter

Test Time 6 seconds

Assay Method Glucose Oxidase Biosensor

Hematocrit Range 20% - 60%

Operating Temperature 50°F-95°F (10°C-35°C)



67


Operating Relative Humidity 15-85%

Altitude Up to 10,000 feet (3,048 meters)

Memory

Unlimited results

Memory is limited to smart mobile

device memory

Power Source From the smart phone or mobile

device

Meter Size 1.34x0.63x0.4 in (34x16x10 mm)

Weight 40 gram (1.4 oz.)

Meter Life Time 3 years

Protection degree from ingress

of water or particulate matte IP 21

Part number 1021-04

Do not store near solvents and ionizing radiation sources.

Compliance with Electrical and Safety Standards

The Dario Blood Glucose Meter has been tested for: • Electrostatic discharge as specified in IEC 61000-4-2.

• Immunity to radio frequency interference at the frequency range

and test levels specified in IEC 61000-4-3.

• EMC and is in compliance with IEC 60601-1-2.

• Electro-magnetic emission requirements as per EN 61326

68

Disposing of Used Products

The product may come into contact with blood during measurement. Used products (i.e., test strips and lancets) therefore carry a risk of infection.

Please dispose of used products according to the regulations applicable in your country. For information about correct disposal, please contact your health care provider or your local council/authority.

The product falls outside the scope of the European Directive 2002/96/EC (Directive on waste electrical and electronic equipment (WEEE)).

69

CHAPTER 8

WARRANTY, REPAIRS AND SUPPLIES

This chapter provides repair, warranty, service support, and ordering information for your Dario System.

Repair Policy

When under warranty, repair and service must be performed by LabStyle Innovation Ltd. When the LabStyle Innovation Ltd. warranty is not applicable, repairs may be performed by LabStyle Innovation Ltd. on a parts and labor basis.

After replacement, verify that the unit is fully functional by performing the normal setup procedure.

Do not remove the covers of the device components. Only perform maintenance procedures specifically described in this user guide.

Manufacturer’s One Year Warranty

It is important to LabStyle Innovation Ltd. that you are completely satisfied with your Dario Blood Glucose Monitoring System. LabStyle Innovation Ltd. warrants that your new Dario will be free from defects in materials and workmanship for a period of one (1) year from the date of the original purchase. If during this time the Dario does not work properly because of a defect in materials or workmanship, LabStyle Innovation Ltd. agrees to replace or repair, free of charge, any and all parts proven to be defective and subject to warranty. This warranty is in lieu of all other warranties, expressed or implied, including any implied warranty of merchantability or fitness for any purpose, other than stated herein. This warranty does not apply to the performance of a Dario Blood Glucose Monitoring System that has been damaged by accident or has been altered, misused, tampered with, or abused in any way. This warranty only applies to the original purchaser of the meter and/or its agents.

70

Supplies and Accessories

Dario System supplies and accessories are available from LabStyle Innovation Ltd. or from customer support at www.mydario.com.

Item Catalog Number

System 1138 – Dario Welcome Kit

Test Strip Cartridge 1105 – Dario Test Strip (1 x 25)

1024 – Dario Test Strip (2 x 25)

1074 – Dario Test Strip (4 x 25)

Lancet 1018 – Dario Lancet (1 x 100)

Control Solution 1054 – Dario Control Solution

(2x2.5 ml)

Disposable Covers (available

for the US market only)

1128 – Dario Disposable Covers (1

x 100)

Software 1022-01 – Smart mobile device

application

Contact Customer Support

You may contact customer support with any questions or issues about Dario and its accessories using one of the following methods:

• By phone between 9:00 AM-5:00 PM Monday through Friday at

1-800-895-5921, a toll-free number in the U.S.

• Through e-mail by sending a message to [email protected].

• Internationally on our website at www.mydario.com.

Please contact your health care provider for questions outside of the customer support hours.


Glucose Monitoring System For Your Smartphone | Manage your...

Documents

Transcript of Glucose Monitoring System For Your Smartphone | Manage your...