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Dario 1021-02 Meter User Manual

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Dario® Blood Glucose
Monitoring System
User Guide
Applicable to meter model:
1021-02 Dario Meter
1

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Summary of Contents for Dario 1021-02 Dario Meter

  • Page 1 Dario® Blood Glucose Monitoring System User Guide Applicable to meter model: 1021-02 Dario Meter...
  • Page 2 Dario Application. The photographs and screenshots are for illustrative purposes only; the layout and function of the Android version of the Dario Application is identical. The location of the audio jack may vary by smart phone. The information provided in the User Guide is relevant to both compatible iOS and Android smart phone devices.

  • Page 3: Table Of Contents

    YSTEM ............10 AFETY EFINITIONS ........11 RACTICES SED IN UIDE .............14 ENERAL RECAUTIONS ..........15 DDITIONAL NFORMATION CHAPTER 2 DARIO SYSTEM OVERVIEW AND FEATURES ..16 ........16 ARIO YSTEM AT A LANCE ............17 ARIO OMPONENTS OMPATIBLE LATFORMS WITH THE ARIO LOOD LUCOSE ............19...
  • Page 4 ......36 ERFORMING A ONTROL OLUTION CHAPTER 4 TESTING YOUR BLOOD GLUCOSE LEVEL ..42 .......42 LOOD LUCOSE ESTING RECAUTIONS ...........43 TRIP RECAUTIONS ..45 ACTORS NTERFERE WITH LOOD LUCOSE ESTING ..........46 NTERPRETING THE ESULTS .............47 EASUREMENT ANGE ....48 ACTORS EAD TO NACCURATE ESULTS NSERTING A ANCET INTO THE...
  • Page 5 ............77 ROBLEM OLVING “P ” EST STRIP INSERTED BUT LEASE INSERT A NEW STRIP KEEPS ..........77 APPEARING ON THE SCREEN .........78 OU CANNOT PIERCE SKIN WITH LANCET . 78 HE LANCET DOES NOT FIT CORRECTLY INTO THE LANCING DEVICE .

  • Page 6: Chapter 1 Introduction And Important Safety Instructions

    . User Guide Scope The user guide is covering the use of the Dario Blood Glucose Monitoring System with the following meter models: For use with selected iPhone &...

  • Page 7: Intended Use

    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.

  • Page 8: Important Safetyi

    • 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. •...
  • Page 9 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.

  • Page 10: Before Testing With The Safety Definitions

    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.

  • Page 11: Practices Used Int

    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 .
  • Page 12 Words in: 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.
  • Page 13 Symbol Description Symbol Description LabStyle Innovation Dario logo Ltd. logo Consult instructions Do not use if package for use is damaged Batch code In Vitro Diagnostic...

  • Page 14: General Precautions

    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.

  • Page 15: Additional Information

    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.

  • Page 16: Chapter 2 Dario System Overview And Features

    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...

  • Page 17: Dario Components

    Dario Components The Dario System components are shown in the image below and described in the following table.
  • Page 18 The Dario Housing (also referred to as Housing 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.

  • Page 19: Monitoring System

    (I) Cartridge The cartridge snaps into the modular Cover (white) Dario Housing. The Dario Test Strip is the only strip Test 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.

  • Page 20: Dario System Kitc

    For the latest list of compatible devices please refer to www.mydario.com/support/getting-started/. Dario System Kit Contents As soon as you receive your Dario System 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 •...

  • Page 21: Getting Started With The Assembling The Dario

    Dario System to where you purchased it, as it has been previously opened. 2. If anything is missing from the Dario System Kit, Error! Reference source not found., for contact information please see page 89.

  • Page 22: Inserting The Tests

    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 22.

  • Page 23: Inserting A Lancet

    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.
  • Page 24 • 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. Error! Reference source not found., for contact information please see page 5.

  • Page 25: (Optional )

    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 .

  • Page 26: The Dario App

    Google Play. 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 Apple App Store or Google Play requires data connectivity.
  • Page 27 Android). 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. Install the App. 4. Follow the registration flow as shown on App.

  • Page 28: Creating Youra

    Dario icon . The icon appears on your smart mobile device’s Home screen. 2. Select Sign Up to register a Dario user. Dario App registration requires email and Password to create your account. 3. Continue by following the instructions on the screen to register.

  • Page 29: Setting Yourp

    You can edit your email address and password and set the Dario App language and region by tapping the Menu icon and selecting SETTINGS > ACCOUNT INFORMATION Setting Your Personal and Diabetes Profiles To set your personal profile: 1. Tap the Menu icon in the upper left corner and select MY PROFILE.
  • Page 30 1. Tap the Menu icon in the upper left corner and select SETTINGS > DIABETES PROFILE, and under SETTINGS > 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.

  • Page 31: Chapter 3 Checking Your Dario Glucose Meter

    • 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.

  • Page 32: Est Principle

    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.

  • Page 33: Chemical Composition

    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. The remaining chemical components of the Dario Control Solution are: •...
  • Page 34 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...

  • Page 35: Meter From The Housing Trip From The Cartridge

    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, refer to Inserting the Test Strip Cartridge on page To remove a test strip from the cartridge: 1.

  • Page 36: Performing A Control Solution Test

    • 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.
  • Page 37 2. Insert the meter into the 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...
  • Page 38 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. 5. Shake the control solution container and apply a...
  • Page 39 (6) seconds and is automatically saved to memory . You can delete this control test from memory, if desired. Alternatively, the Dario System includes a function for specific control solution tests. Control solution tested values must be tested under the "Control solution test"...
  • Page 40 Applying too much or too little control solution to the test strip may cause out-of- range results . Do not use your Dario System to test your blood if your control solution result falls outside of the acceptable target values.
  • Page 41 done 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.

  • Page 42: Chapter 4 Testing Your Blood Glucose Level

    . 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...

  • Page 43: Test Strip Precautions

    . listed in Test Strip Precautions 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.
  • Page 44 • 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. •...

  • Page 45: Factors That Interfere With Blood Glucose Testing

    • 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.

  • Page 46: Interpreting The Results

    . 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 36.

  • Page 47: Measurement Range

    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”...

  • Page 48: Factors That May Lead To 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: •...

  • Page 49: Step One: Inserting A New Lancet Into The Lancing Device

    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.

  • Page 50: Step Three: Inserting The Smart Mobile Device Into The Disposable Cover

    Step Three: 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 recommended that you use a disposable sleeve to cover your smart mobile device while taking the blood glucose test.

  • Page 51: Step Four: Removing The Glucose Meter From The Housing

    A “Connecting...” message appears in the Dario App, and then the screen displays the following instruction: INSERT A NEW STRIP.
  • Page 52 • Unwashed 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.
  • Page 53 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, refer to Inserting the Test Strip Cartridge on page 22.
  • Page 54 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...
  • Page 55 The Dario App instructs you to place a drop of blood on the test strip, as shown in the image below. 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.
  • Page 56 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. 3. Apply a drop of blood to the tip of the yellow window of the test strip, as shown in the images below.
  • Page 57 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. In case an error message appears, you may need to start the measurement process again.

  • Page 58: Tep Ix Eturning The Eter To The Ario Ousing

    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: 1. Disconnect the meter from your smart mobile device.

  • Page 59: Test Strip Limitations

    (> 810 mg/dL), you may get inaccurate results with this system. This system should not be used when undergoing xylose absorption tests. Packed cell volume: Dario BGMS Test Strip suitable range is 20~60%.

  • Page 60: Chapter 5 Cleaning And Maintenance

    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.

  • Page 61: Step 1: Cleaning

    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 manufactured by Professional Disposables International, Inc.
  • Page 62 • 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 following images demonstrate how to wipes to clean and disinfect your Dario System.
  • Page 63 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.
  • Page 64 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).
  • Page 65 • 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:...

  • Page 66: Chapter 6 Test Strips

    The blood glucose result is displayed on Dario App screen. By touching a drop of blood to the tip of Dario Blood Glucose Test Strip, the strip’s reaction chamber automatically draws the blood into the strip through capillary action.

  • Page 67: Reagent Composition (Per Strip)

    6. Do not transfer test strips from one cartridge to another. The Dario Test Strip is structured as follows: Yellow Window Apply a drop of blood here. • Before Applying Blood –...

  • Page 68: System Limitations

    • Dario Blood Glucose Test strips should be used with Dario/Dario LC/Dario USB-C meters only. • Insert a test strip into the test strip port in the glucose meter with gold-colored bars facing up and toward the meter. • A test strip is sensitive to humidity. Therefore, you...

  • Page 69: Performing A Test

    • Consult with your healthcare professional for the blood glucose range that is appropriate for you. Test Result Range The Dario meter read blood glucose results between 20-600 mg/dL (1.1-33.3 mmol/L). Unexpected Results High or low blood glucose results can indicate potentially serious medical conditions.

  • Page 70: Control Of The Unexpected Results

    • Repeat the test with a new strip. • Run a control solution test with Dario Glucose Control Solution. • If the control solution test result is within the...

  • Page 71: Checking By A Control Solution

    Control solution check ensures that you are doing a test correctly and that your system is working properly. Make sure you use the proper control solution for the test strips you have: Dario® Blood Glucose Test Strips require Dario® Glucose Control Solution.

  • Page 72: Control Solution Procedure

    Test control solution at 64-86°F (18-30°C) environment. Control Solution Procedure To conduct a control solution test, refer to Performing a Control Solution Test on page 36. Understanding Your Control Solution Test • If your glucose control solution test result is within the acceptable range, you can feel confident that your test strips and meter are working correctly.
  • Page 73 the subject of the test should consult a doctor for further confirmation of the result. The Manufacturers and Distributors of this product shall not be liable for any losses, liability, claims, costs or damages whether direct or indirect or consequential arising out of or related to an incorrect diagnosis, whether positive or negative, in the use of this product.

  • Page 74: Chapter 7 Troubleshooting

    89.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.

  • Page 75: Troubleshooting

    Troubleshooting The following table lists some typical conditions that may occur with the Dario System. Message Content Possible Cause / Recommended Action There is not enough blood on Insufficient blood the test strip. detected, try again Repeat the measurement with with a new strip a new test strip.
  • Page 76 If this message recurs, contact your health care provider Immediately. If your measurement results are inconsistent with the way you feel, contact customer support. Dario device Communication failure. failure (0x00). If the problem Try disconnecting and occurs again, reconnecting the meter.

  • Page 77: Problem Solving

    If another device is connected to the audio plug, 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.

  • Page 78: You Cannot Pierce Skin With Lancet

    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.

  • Page 79: Lancing Device Does Not Operate Correctly

    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. Error! Reference source not found., for contact information please see page 88.

  • Page 80: My Smart Mobile Device Battery Died

    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.

  • Page 81: Chapter 8 Technical Information And Specifications

    The glucose meter detects the current and converts it into a blood glucose reading. Compatibility Dario is compatible for use on iOS and Android smart mobile devices. For a complete list of compatible devices, please refer to www.mydario.com/support/getting-started/.
  • Page 82 “96.6% within ±15% and 100% within ±20% of the medical laboratory values at the entire glucose concentrations range.” Method Comparison: Dario® BGMS for Android for glucose concentrations < 75 mg/dL for glucose concentrations ≥75 mg/dL Within ±...

  • Page 83: Technical Specifications

    Repeatability Precision: Dario® BGMS Glucose concentration 30-50 51-110 111-150 151-250 251-400 range mg/dL Average mg/dL 47.9 74.0 126.3 214.5 343.1 Standard Deviation mg/dL Coefficient of Variation, % Android Precision: Intermediate Precision: Dario® BGMS Glucose Concentration range 30-50 96-144 280-420 mg/dL Average mg/dL 43.2...

  • Page 84: Compliance With Electrical And Safety Standards

    IP 21 particulate matter Meter part number 1021-02 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.

  • Page 85: Disposing Of Used Products

    Dario glucose meter device does not connect to the mobile device wirelessly. Users are required to unlock their smart mobile device prior accessing the Dario App to take a glucose measure test, as such they are assured of ongoing authorization access.
  • Page 86 Dario App and cloud servers. Users data is stored and transmitted through the Dario App and/or web portal to and from the remote server in encrypted form.

  • Page 87: Chapter 9 Warranty, Repairs And Supplies

    (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.

  • Page 88: Supplies And Accessories

    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.

  • Page 89: Contact Customer Support

    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 toll-free Monday to Friday, 9:00AM – 5:00PM EST at 1-800-895-5921. • On the website at www.mydario.com.

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