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Related Manuals for Dario 1015-01
Summary of Contents for Dario 1015-01
- Page 1 Dario® Blood Glucose Monitoring System User Guide...
- Page 2 Dario® is a trademark of LabStyle Innovation® Ltd. European Patent application number 11780305.6 United States: Product is covered by one or more patents and/or patent applications – the list is detailed at the Dario website at www.mydario.com. 6071-05 Rev.A...
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Page 3: Table Of Contents
..............Symbols and Descriptions 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... - Page 4 Lancet Depth Indicator lever is stuck...............65 Lancing device release button does not work properly..........65 “Strip is used and should be replaced” message appears in the Dario App....65 I forgot my Dario password..................65 My smart mobile device battery died..............66 CHAPTER 7 TECHNICAL INFORMATION AND SPECIFICATIONS ..........
- Page 5 Manufacturer’s One Year Warranty ................70 Supplies and Accessories ..................71 Contact Customer Support ..................71...
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Page 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... -
Page 7: System Limitations
The Dario 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: •... -
Page 8: Before Testing With The Dario System
AM – 5:00 PM EST Monday through Friday or visit www.mydario.com. Safety Definitions Safety instructions are provided for the protection of Dario System users. This user guide includes three types of important messages: Warnings, Cautions, and Notes. Text marked with one of these symbols requires your attention to... -
Page 9: Warnings
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 •... - Page 10 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.
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Page 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 LabStyle Innovation Ltd. Dario logo logo Consult instructions Do not use if seal is for use broken or missing In Vitro Diagnostic... -
Page 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. - Page 13 by a laboratory. Ask your health care provider about other possible backup methods. • 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.
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Page 14: Chapter 2 Dario System Overview And Features
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... -
Page 15: Dario Components
Dario Components The Dario System components are shown in the image below and described in the following table. - Page 16 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.
- Page 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.
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Page 18: Supported Platforms For The Dario App
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. -
Page 19: Dario System Welcome Kit Contents
1-800-895-5921, 9:00 AM-5:00 PM EST Monday through Friday or visit www.mydario.com/support/contact. Contact your health care provider for questions outside of the customer support hours. Additional Dario accessories (e.g., control solution, disposable covers) can be ordered from your local representatives or the Dario App, or by... -
Page 20: Getting Started With The Dario System
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. -
Page 21: Assembling The Dario System For The First Time
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. -
Page 22: Inserting A Lancet
Ensure you have properly inserted the cartridge, as described in steps 3 and 4. Inserting a Lancet To insert a lancet: Remove the orange lancet device cover from the Dario Housing, as shown in the images below. - Page 23 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. Remove a new lancet from the packaging. Do not use the lancet if the cap is missing or damaged.
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Page 24: Setting Lancet Depth (Optional)
• 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. -
Page 25: 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. - Page 26 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: Search for the Dario App by LabStyle Innovation Ltd. and tap on the Dario icon. Tap Free and then tap Install.
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Page 27: Creating Your Account And Personalizing Your Settings
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: After installing the Dario App on your mobile device, press the orange Dario icon . - Page 28 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 Create Account when done. The First Entry screen appears, as shown in the image below.
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Page 29: Setting Your Personal And Diabetes Profiles
Setting Your Personal and Diabetes Profiles To set your personal profile: Tap the Menu icon in the upper left corner and select SETTINGS > PERSONAL INFORMATION. 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. -
Page 30: Chapter 3 Checking Your Dario Glucose Meter
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 31: Control Solution Test Principle
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. -
Page 32: Checking Your Glucose Meter With Dario Control Solutions
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... -
Page 33: Removing A Test Strip 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 21. - Page 34 To remove a test strip from the cartridge: 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. Snap open the test strips cartridge cap by pushing up the edge.
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Page 35: Performing A Control Solution Test
Performing a Control Solution Test To perform a control test: 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. Tap the Menu icon on the top left corner and selecting HELP & INFO >... - Page 36 A “Connecting...” message appears in the Dario App and then the screen displays the following instruction: INSERT A NEW STRIP. The screen The Dario Meter notification changes. should be inserted with logo facing up. Verify that the meter is inserted as far as it can go into the audio jack port of the smart mobile device.
- Page 37 The Dario App screen instructs you to place a drop of control solution on the test strip, as shown in the image below. 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.
- Page 38 10. 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.
- Page 39 the ridged orange panel. Then, push the meter into the housing at an angle and push downwards until the meter clicks into place.
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Page 40: Chapter 4 Testing Your Blood Glucose Level
(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. -
Page 41: Test Strip Precautions
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. -
Page 42: Factors That Interfere With Blood Glucose Testing
• 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. •... -
Page 43: 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 35. Repeat the blood glucose test afterward. -
Page 44: 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 45: 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 46: Step Three: Inserting The Smart Mobile Device Into The Disposable Cover
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 or visiting www.mydario.com. -
Page 47: Step Five: Testing Your Blood Glucose
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. - Page 48 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.
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Page 49: Removing A Test Strip From The Cartridge
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. - Page 50 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.
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Page 51: Performing A Glucose Test
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. - Page 52 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.
- Page 53 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.
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Page 54: Step Six: Returning The Meter To The Dario Housing
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: Disconnect the meter from your smart mobile device. -
Page 55: 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. 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. -
Page 56: Step 2: Disinfection
• 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 connector. The images below demonstrate how to use Super Sani-Cloth Germicidal Disposable Wipes to clean and disinfect your Dario System. - Page 58 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 in this user guide.
- Page 59 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.
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Page 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. - Page 61 Check the following settings on your device: Follow the instructions in the Dario App to adjust the settings in your mobile device: Ensure that Mono Audio is set to OFF. Adjust the audio balance. Audio volume...
- Page 62 Move to a cooler or warmer area, wait at least minutes and try again 30 minutes and repeat the measurement with a new test strip. Dario device failure (0x00). Communication failure. If the problem occurs Try disconnecting and reconnecting the meter.
- Page 63 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.
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Page 64: Problem Solving
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. -
Page 65: Cannot Remove The Used Needle From The Lancing Device
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. -
Page 66: 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 67: Chapter 7 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 smart mobile devices. For full list of compatible devices, please refer to www.mydario.com/support/getting-... -
Page 68: Compliance With Electrical And Safety Standards
IEC 61000-4-3. • The Dario Blood Glucose Meter has been tested for EMC and is in compliance with IEC 60601-1-2. Disposing of Used Products The product may come into contact with blood during measurement. Used... - Page 69 Please dispose of used products according to the regulations applicable in your country. 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)).
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Page 70: Chapter 8 Warranty, Repairs And Supplies
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. - Page 71 1022-01 Smart mobile device software 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.
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