Dario® Blood Glucose Monitoring System User Guide
© 2016 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 or visit www.mydario.com. Please contact your health care provider for questions or concerns outside of the normal customer support hours.
Table of Contents CHAPTER 1 INTRODUCTION AND IMPORTANT SAFETY INSTRUCTIONS ...............................6 Glucose Monitoring for a Mobile Age....................................................................... 6 Intended Use ........................................................................................................ 6 System Limitations................................................................................................. 7 Important Safety Instructions............................
Blood Glucose Testing Precautions .........................................................................41 Test Strip Precautions ...........................................................................................42 Factors That Interfere with Blood Glucose Testing....................................................43 Interpreting the Results.........................................................................................44 Measurement Range................................................
Manufacturer’s One Year Warranty ........................................................................71 Supplies and Accessories .......................................................................................72 Contact Customer Support ....................................................................................
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.
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.
(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.
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.
! The examples and screen images used in this User Guide are provided as examples only (unless stated otherwise). Words Bold Description 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.
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 Dario logo Description LabStyle Innovation Ltd.
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.
• • 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.
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.
Dario Components The Dario System components are shown in the image below and described in the following table.
Component Glucose Meter (A) Dario meter (B) Dario meter release panel Description The miniature glucose meter consists of the following components: • An audio connector that is plugged into the audio jack 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.
Component Test Strip Description 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.
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 and Android smart mobile devices.
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 10 Sterile Lancets • Dario 10 Disposable Covers (4.37”X 8.
contacting customer support toll-free in the U.S. at 1-800-895-5921, 9:00 AM-5:00 PM EST Monday through Friday. For details on product availability, refer to Supplied and Accessories on page 71. 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.
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.
4. 5. Insert the cartridge into the housing until it snaps into place. 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.
2. Remove the used lancet, if one exists, by grasping and pulling it straight out of its housing. ! 3. Remove a new lancet from the packaging. ! 4. 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. Insert a sterile lancet as far as it will go and ensure it is firmly set.
• • • 5. 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 or visit www.mydario.com. Carefully twist off the lancet cap, 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. The Dario App The Dario App is available on the iOS and Android operating systems. 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.
! For accurate use of the Dario System with the Dario 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. To download the Dario App: 1. Turn on your smart mobile device and launch the applications store app (Google Play or App Store). Alternatively, for quicker access, you can use an app that scans QR codes to scan the following code: 2.
! The Dario application needs to be installed once on each of your smart mobile devices. ! Updates may be downloaded periodically from the application stores. Creating Your Account and Personalizing Your Settings To setup your Dario App: 1. 2. 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. Select Sign Up to register as a Dario user. Dario App registration requires Email and Password to create your account.
3. 4. 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. Press Register when done.
! You can edit your e-mail address and password and set the Dario App language and region by tapping the Menu icon selecting SETTINGS > ACCOUNT INFORMATION. and Setting Your Personal and Diabetes Profiles To set your personal profile: 1. 2. 3. Tap the Menu icon in the upper left corner and select MY PROFILE. Tap the pencil icon in the upper right corner to edit the information. Enter your gender, weight, height, and date of birth in the appropriate fields.
2. 3. Tap the pencil icon in the upper right corner to edit the information. Select your preferred carbs measurement unit. 4. Press DONE ! You can complete the Walkthrough at any time by selecting HELP&INFO > VIDEO GUIDES.
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.
• • • • • • • • 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, 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.
The remaining chemical components of the Dario Control Solution are: • • • • • Buffer 75mM Polyvinylpyrolidone 5% Polyethylene glycol 5% SDS 0.1% Preservative 0.
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 audio jack port. For a list of compatible devices, refer to www.mydario.com/support/gettingstarted. 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 21.
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. 3. Snap open the test strips cartridge cap by pushing up the edge. 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.
! 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.
The Dario Meter should be inserted with logo facing up. ! 3. 4. The screen notification changes. Verify that the meter is inserted as far as it can go into the audio jack port of the smart mobile device. Hold the test strip with the gold contacts facing the meter. 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. 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.
! 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.
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.
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.
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.
• 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.
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 36. Repeat the blood glucose test afterward.
• 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 48. • 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.
• ! Your glucose meter has been dropped. If your meter has been dropped and you are receiving error messages or implausible results, contact customer support tollfree in the U.S. at 1-800-895-5921, 9:00 AM-5:00 PM EST Monday through Friday or visit www.mydario.com. Do not rely on the blood glucose measurement alone in making health care decisions.
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 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.
Place the glucose meter audio jack into the plug port at the bottom of the disposable cover. Verify that the meter is inserted as far as it goes into the audio port of the smart mobile device. A “Connecting...” message appears in the Dario App, and then the screen displays the following instruction: INSERT A NEW STRIP. The Dario Meter should be inserted with logo facing up. The screen notification changes. Step Five: Testing Your Blood Glucose You are now ready to test your blood glucose.
• • • • • • • • 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.
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 21. To remove a test strip from the cartridge: 1. 2. 3. 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.
4. Remove a test strip from the cartridge, as shown in the image below. 5. Close both the lid and cartridge cover. ! 6. 7. If the cover does not close properly, you may not have inserted the cartridge correctly. Hold the test strip with the gold contacts facing upward. 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.
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.
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.
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.
6. 7. 8. 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). 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.
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.
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.
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.
Do not: • • • • • Allow any moisture to get into the test strip port connector. 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.
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 tollfree in the U.S. at 1-800-895-5921, 9:00 AM-5:00 PM EST Monday through Friday or contact customer support at www.mydario.com.
Troubleshooting The following table lists some typical conditions that may occur with the Dario System. Possible Cause / Recommended Message Content To reconnect your Dario. If the problem recurs, some adjustments might be required. Check the following settings on your device: Insufficient blood detected, try again with a new strip The Strip is used, please insert a new strip The smart device volume is set inappropriately.
Message Content Possible Cause / Recommended HIGH! Measure with a new strip, if recurs contact your physician Immediately Glucose level is above operating range. LOW! Measure with a new strip, if recurs contact your physician Immediately Glucose level is below operating range 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. Dario device failure (0x00).
Message Content Possible Cause / Recommended Dario device failure (0x01). If the problem occurs again, please contact Dario’s customer support Firmware software failure. Dario device failure (0x02). If the problem occurs again, please contact Dario’s customer support Voltage failure. Unknown device, please connect Dario Another device is connected to your smart mobile device’s audio plug port. Try disconnecting and reconnecting the meter.
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 33). If the result is outside of the acceptable target values, contact customer support toll-free in the U.S.
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 or visit www.mydario.com. Lancing device does not operate correctly.
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.
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.
Meter Specifications 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 Size 4.2x1.3x0.6 in (107x34x16 mm) Weight 40 gram (1.4 oz.) Meter Life Time 3 years Do not store near solvents and ionizing radiation sources.
Please dispose of used products according to the regulations applicable in your state. For information about correct disposal, please contact your health care provider. The product falls outside the scope of the European Directive 2002/96/EC (Directive on waste electrical and electronic equipment (WEEE)).
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 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.
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 1015-01 Dario Welcome Kit 1105-01 Dario Test Strip (1 x 25) 1024-01 Dario Test Strip (2 x 25) 1074-01 Dario Test Strip (4 x 25) 1018-01 Dario Lancet (1 x 100) 1054-01 Dario Control Solution (2x2.
