LabStyle Dario User Manual
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Summary of Contents for LabStyle Dario
- Page 1 Dario User Guide Thriving with diabetes, together.
- Page 2 (www.mydario.com) or your healthcare provided with any questions, concerns or remarks you may have. LabStyle Innovation Ltd. 9 Halamish St. North Industrial Park Caesarea 3890000 Israel www.mydario.com Dario™ is a trademark of Labstyle innovation™ Ltd. European Patent application number 11780305.6 6031-01 Rev03...
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Page 3: Table Of Contents
Your Dario™ System at a Glance ...............6 Dario™ Components ..................6 Getting Started With Dario™ ................9 Assembling the Dario™ System for the First Time ........9 Inserting the Test Strip Cartridge ..............10 Inserting a Lancet ....................11 Setting Lancet Depth (Optional) ..............12 The Dario™... - Page 4 Step Three- Remove a Test Strip From the Cartridge......... 34 Step Four - Testing Your Blood Glucose............35 Performing a Glucose Test ................36 Step Five - Returning the Meter to the Dario™ Housing ......40 Test Limitations ....................40 Performance Analysis ..................41 ChapTer 5 –...
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Page 5: Chapter 1 - Introduction & User Safety
The Dario™ BGMS is not to be used for the diagnosis of or screening of diabetes or for neonatal use. The Dario™ Blood Glucose Meter (BGM) must be used with Dario™ blood glucose test strip, Dario™... -
Page 6: Contraindications
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™... -
Page 7: Cautions
Chapter 1 - Introduction & User Safety practices Used in this Advanced User Guide 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. -
Page 8: Symbols And Descriptions
An explanation is provided next to each symbol. Symbol description Symbol description Dario™ logo LabStyle Innovation logo Do not use if seal is broken or Consult instructions for use... -
Page 9: Additional Information
The Dario™ system is not water-resistant and should not get wet. If it does get wet, wipe it with a clean dry cloth. -
Page 10: Chapter 2 - Dario™ System Overview And Features
By connecting to your smart mobile device, it eliminates the need for additional hardware. y No coding is required. Insert a Dario™ test strip and you are ready to test. y Testing is easy. No navigating or buttons to press. - Page 11 Chapter 2 - Dario™ System Overview and Features Your Dario™ System at a Glance Component Description image Glucose The miniature glucose meter has: meter · An audio connector that is plugged into the headphone socket of the smart mobile device ·...
- Page 12 Once you remove the exterior packaging, you will find a white package with a tamper-proof seal. 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.
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Page 13: Getting Started With Dario
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. -
Page 14: Inserting The Test Strip Cartridge
Strip Cartridge ™ to insert the test strip cartridge: Remove the cartridge cover of the Dario™ housing by pushing it outwards (from the side with the removal indication lines) until it comes off. 1. Remove the new test strip cartridge from its pouch. -
Page 15: Inserting A Lancet
Chapter 2 - Dario™ System Overview and Features assembling the Dario™ System for the First time 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 end with the small opening) from the Dario™... -
Page 16: Setting Lancet Depth (Optional)
DariO™ appliCatiOn 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. -
Page 17: Downloading & Installing The Dario™ Application
Downloading & installing the Dario™ application You can download and install the Dario™ app to your smart mobile device using the Apple App Store. The app is downloaded and installed the same way as other Apps on your smart mobile device. -
Page 18: Creating Your Account & Personalizing Your Settings
Dario™ application 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. - Page 19 Chapter 2 - Dario™ System Overview and Features the Dario™ application 5. Press next when done. If nothing happens when you press next, verify that you agreed to the Terms and Conditions. You are automatically brought to the Personal Profile Screen.
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Page 20: Setting Your Personal Profile
Chapter 2 - Dario™ System Overview and Features the Dario™ application 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 profile ™... - Page 21 Chapter 2 - Dario™ System Overview and Features the Dario™ application 5. Select Get StarteD. You can do the Walkthrough at any time by tapping the icon. Select help > app walKthrOuGh. The First Entry screen appears. 6. We advise you to continue setting your Diabetes Profile, following the app...
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Page 22: Chapter 3 - Checking Your Dario™ Glucose Meter
Whenever you want to check the performance of a meter and test strip. ConTrol 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. -
Page 23: Chemical Composition
Chapter 3 - Checking Your Dario™ Glucose Meter Chemical Composition CheMiCal CoMPosiTion Dario™ Glucose Control Solution is an aqueous solution, which contains D-glucose as the reactive ingredient in the approximate concentration. y Buffer 75mM y Polyvinylpyrrolidone 5% y Polyviny alcohol 5% y SDS 0.1%... -
Page 24: Checking Your Glucose Meter With Dario™ Control Solutions
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. -
Page 25: Removing A Test Strip From The Cartridge
Chapter 7 – Technical Information & Specifications 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 Inserting the Test Strip Cartridge on page ™... -
Page 26: Performing A Control Test
Do not use a damaged test strip. Performing a Control Test ™ To perform a control test. 1. Tap the Dario™ icon on your smart mobile device to launch the Dario™ application. 2. Insert your meter into the audio plug of your smart mobile device. - Page 27 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. You are instructed to place a drop of blood on the test strip.
- Page 28 It is possible to delete this control test from memory, if desired. For more information, refer to the Dario™ Application User Guide at www.mydario.com. 9. When the test is done, remove the test strip.
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Page 29: Checking The Glucose Meter With The Check Strip
2. Connect the Dario™ meter to the smart mobile device as described in the previous section. 3. Insert the Dario™ Check Strip into the test strip port. A Check strip detected message appears. The border of the circle is gradually filled with blue, indicating that... - Page 30 Chapter 3 - Checking Your Dario™ Glucose Meter Checking the Glucose Meter With the Check strip 4. Within six (6) seconds, the test is completed and one of two messages appears: Message recommended action Check strip verified successfully Proceed with blood glucose testing.
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Page 31: Chapter 4 - Testing Your Blood Glucose Level
LeveL This section provides information on testing your blood glucose with your meter. Before using your Dario™ for the first time, we recommend to verify that the system gives accurate results. Check the performance of your glucose meter by following Checking Your Glucose Meter With Dario™... -
Page 32: Test Strip Precautions
Blood Glucose Testing Precautions Test strip Precautions y Only use Dario™ test strips. Using other test strips with this glucose meter can produce inaccurate results. y 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 33: Factors That Interfere With Blood Glucose Testing
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... -
Page 34: Measurement Range
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: y Your hands may not have been washed thoroughly y Your glucose meter test strip port may be contaminated. -
Page 35: Step One - Inserting A New Lancet Into The Lancing Device
Use a new sterile lancet in your lancing device every time you test your blood glucose to prevent infection. ™ To insert a lancet: 1. Remove the Lancet Device Cover from the Dario™ Housing. You can identify the Lancet Device Cover by the small opening in the cover. - Page 36 Chapter 4 - Testing Your Blood Glucose Level step one - inserting a new Lancet into the Lancing device 2. Remove the used lancet as follows: a. Pull the tab next to the lancet holder with your thumb. b. Press the orange button firmly with your other hand to keep lancet position and pull the lancet out of the lancing device.
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Page 37: Step Two - Removing The Glucose Meter From The Housing
If the lancet does not click into place or the lancet holder does not hold the lancet properly, insert another sterile lancet. y If the problem persists, it may be necessary to replace your Dario™ housing. Contact Customer Support at www.mydario.com. -
Page 38: Step Three- Remove A Test Strip From The Cartridge
Chapter 7 – Technical Information & Specifications. 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 Inserting the Test Strip Cartridge on page 1. -
Page 39: Step Four - Testing Your Blood Glucose
Chapter 4 - Testing Your Blood Glucose Level step Four - Testing Your Blood Glucose 3. Snap open the case by pushing up the edge. 4. Remove a test strip from the cartridge. 5. Snap the case closed and replace the housing cover by sliding it into place until it clicks. -
Page 40: Performing A Glucose Test
Dirty or wet hands could affect your results. Alcohol can affect test results. y 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. - Page 41 A Connecting... message appears, followed by INSERT A NEW STRIP. 3. Hold the test strip with the gold contacts facing upward. 4. Without bending the strip, insert it into the test strip port of the Dario™ glucose meter as far as it will go.
- Page 42 Chapter 4 - Testing Your Blood Glucose Level step Four - Testing Your Blood Glucose 5. Set the lancing device for activation by sliding it with two fingers until it clicks. 6. Place the lancing device cover (side with the small opening) to the side of your fingertip and press the release button to prick your finger.
- Page 43 The glucose test result is automatically saved to memory. If for some reason you do not see a result, go to your Logbook (see Dario™ app User Guide on the Dario™ website). If a phone call is received during a measurement, the test will be stopped and will not be saved.
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Page 44: Step Five - Returning The Meter To The Dario™ Housing
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. -
Page 45: Performance Analysis
Chapter 4 - Testing Your Blood Glucose Level Performance analysis PerForManCe anaLYsis The performance data for the Dario™ system was obtained using capillary blood from diabetic patients (method comparison, accuracy), venous blood (repeatability) and control solution (reproducibility). The system is calibrated with venous blood containing various glucose concentrations. -
Page 46: Chapter 5 - Cleaning And Maintenance
CLEANING If your Dario™ components are soiled, the outer surfaces may be wiped with a soft, lint- free cloth slightly dampened with mild soap and water solution or 70% ethyl alcohol. Clean the Dario™ Blood Glucose Monitoring System with IPA 70% (isopropanol) wipes (Medline, USA) once a week and with the disinfection agent Super Sani Cloths Wipes once a month. -
Page 47: Chapter 6 - 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. - Page 48 4. Allow Dario™ to use your microphone: Settings > privacy > Microphone · · Make sure that the Dario™ app is set to on (green). 5. Make sure that your music volume is set to the maximum: Settings > Music > Volume Limit ·...
- Page 49 · 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™...
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Page 50: 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. C ontact customer www.mydario.com. - Page 51 Chapter 6 - TROUBLESHOOTING problem Solving Lancing Device release button does not work properly. The lancing device is faulty. Replace the Dario™ housing. Contact customer support www.mydario.com. “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.
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Page 52: Chapter 7 - Technical Information & Specifications
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... -
Page 53: Compliance With International Standards
Memory Unlimited results Memory is limited to smart 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. Glucose Meter/lancing Device Operational Temperature 10°C-45°C (50°F-113°F) Storage Temperature Strip 2°C-32°C (36°F-90°F) -
Page 54: Disposing Of Your Meter
Chapter 7 - Technical Information & Specifcations Disposing of your Meter 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. -
Page 55: Chapter 8 - Warranty, Repairs Service & 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™... -
Page 56: Service Support
Chapter 8 - Warranty, Repairs Service & Supplies Service Support SeRviCe SuPPoRt Repairs of the Dario™ System under warranty must be made at authorized repair centers. If the device needs repair, contact LabStyle Innovation Ltd. service department or your local distributor. - Page 57 Life is easier with Dario in your pocket LabStyle Innovation Ltd. | 9 Halamish St. North Industrial Park Caesarea 3890000 Israel www.mydario.com...
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