Dario 1015-01, User Manual

Page 1: ...Dario Blood Glucose Monitoring System User Guide...

Page 2: ...ease contact your health care provider for questions or concerns outside of the normal customer support hours Manufacturer LabStyle Innovation Ltd 9 Halamish St North Industrial Park Caesarea 3890000...

Page 3: ...19 Getting Started with the Dario System 20 Assembling the Dario System for the First Time 21 Inserting the Test Strip Cartridge 21 Inserting a Lancet 22 Setting Lancet Depth Optional 24 The Dario Ap...

Page 4: ...Disinfection 55 Step 1 Cleaning 55 Step 2 Disinfection 56 CHAPTER 6 TROUBLESHOOTING 60 Troubleshooting 60 Problem Solving 64 Test strip inserted but Please insert a new strip keeps appearing on the sc...

Page 5: ...5 Manufacturer s One Year Warranty 70 Supplies and Accessories 71 Contact Customer Support 71...

Page 6: ...ntended Use The Dario Blood Glucose Monitoring System consists of the Dario Blood Glucose Meter Dario Glucose Test Strips Dario Glucose Control Solutions and the Dario App as the display component of...

Page 7: ...n which uric acid levels in your blood may be elevated 11 mg dL such as gout you may get inaccurate results with this system If you have very high levels of triglyceride 810 mg dL you may get inaccura...

Page 8: ...the fingertip Use lancets only once Do not use any lancet or lancing device that has been used by another person Before Testing with the Dario System Please read this user guide carefully and thoroug...

Page 9: ...onditions Notes Notes provide additional information for the purpose of clarification Practices Used in This User Guide The following sections describe the formats and symbols used throughout this use...

Page 10: ...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...

Page 11: ...Do not use if seal is broken or missing In Vitro Diagnostic Batch code Expiry date Shelf life after you first opened the package Do not reuse Temperature limitation Catalog number Contents Manufactur...

Page 12: ...e Modifications to the Dario System not expressly approved by LabStyle Innovation Ltd will void your warranty and could result in injury Avoid testing with your Dario System in altitudes higher than 1...

Page 13: ...ent 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 t...

Page 14: ...stand your diabetes Our goal is to provide the right combination of tools knowledge and motivation that you need to succeed You can check your blood glucose with a small sample 0 3 l of your blood and...

Page 15: ...15 Dario Components The Dario System components are shown in the image below and described in the following table...

Page 16: ...one device It holds all the parts in place and consists of the lancing device the meter slot and the housing for the test strips cartridge Lancing Device and Cover C Lancet cover orange D Disposable...

Page 17: ...and replace it with a sterile one Disposable covers To avoid the risk of transmitting bloodborne pathogens it is advised to use the disposable sleeve to cover your smart mobile device while taking th...

Page 18: ...You can even share your diabetes management information with your health care provider The Dario System is compatible for use on iOS smart mobile devices The Dario Glucose Meter currently works with t...

Page 19: ...thcare Once you remove the exterior packaging you will find a white package with a tamper proof seal If the tamper proof seal is damaged or missing it is recommended that you return this Dario System...

Page 20: ...ks 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 Y...

Page 21: ...g the Dario App on page 25 Set up the Dario App on your smart mobile device using the Dario App instructions or the instructions provided on the Dario website at www mydario com Both ends of the Dario...

Page 22: ...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...

Page 23: ...ccidental injury dispose of used lancet in accordance with the instructions provided by your health care provider for biohazardous waste 3 Remove a new lancet from the packaging Do not use the lancet...

Page 24: ...com 5 Carefully twist off the lancet cap as shown in the image below Ensure that you do not bend the lancet while removing the cap Setting Lancet Depth Optional You can adjust the puncture depth of th...

Page 25: ...cose meter The Dario App also provides a step by step quick guide for operating the system Additionally instructional videos about the Dario App are located at www mydario com support getting started...

Page 26: ...on your smart mobile device and launch the App Store app Alternatively for quicker access you can use an app that scans QR codes to scan the following code 2 Search for the Dario App by LabStyle Innov...

Page 27: ...tore Creating Your Account and Personalizing Your Settings To setup your Dario App 1 After installing the Dario App on your mobile device press the orange Dario icon The icon appears on your smart mob...

Page 28: ...ase 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...

Page 29: ...of birth in the appropriate fields You can also upload a photo from your device by tapping UPLOAD PHOTO 4 Press DONE To set your diabetes profile 1 Tap the Menu icon in the upper left corner and sele...

Page 30: ...solution is placed on the edge of the test strip allowing the test strip to automatically draw the control solution into the yellow window Compare the results on the meter with the values displayed on...

Page 31: ...tion 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...

Page 32: ...st or testing your blood remove the glucose meter from the housing You should always store the glucose meter in the housing when you are not using it When not in use store the meter in the Dario Housi...

Page 33: ...n a compatible smart mobile device audio jack port For a list of compatible devices refer to www mydario com support getting started Removing a Test Strip from the Cartridge You should have a test str...

Page 34: ...use the removal indication lines as shown in the images below 2 Snap open the test strips cartridge cap by pushing up the edge 3 Remove a test strip from the cartridge as shown in the image below 4 C...

Page 35: ...idge cover to the closed position as described in step 4 Do not touch the yellow testing site when handling the test strip Do not use a damaged test strip Performing a Control Solution Test To perform...

Page 36: ...he audio jack port of the smart mobile device 4 Hold the test strip with the gold contacts facing the meter 5 Without bending the strip insert it into the test strip port marked in orange of the Dario...

Page 37: ...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 Wh...

Page 38: ...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 Sys...

Page 39: ...39 the ridged orange panel Then push the meter into the housing at an angle and push downwards until the meter clicks into place...

Page 40: ...l solutions are only intended for use outside the body in vitro Do not eat the test strips Do not swallow or inject control solutions or use control solutions for any purpose other than testing your b...

Page 41: ...st strips from the test strip cartridge and put them into another container Close the cartridge tightly right after you remove a test strip This helps to keep the test strips dry Check the Use by date...

Page 42: ...od moisture and any other material An unclean test strip will affect the test result and can cause an inaccurate blood glucose level result Factors That Interfere with Blood Glucose Testing Certain su...

Page 43: ...ing 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 under...

Page 44: ...erican Diabetes Association 2015 Standards of Medical Care in Diabetes 2015 Diabetes Care 38 Supplement 1 S14 S87 Factors That May Lead to Inaccurate Results Certain medications food supplements medic...

Page 45: ...ion always use a new sterile lancet in your lancing device each time you test your blood glucose Insert a new lancet into the lancing device as described in Inserting a Lancet on page 22 If necessary...

Page 46: ...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 Fr...

Page 47: ...o test your blood glucose Before beginning the test ensure you understand the information provided in Testing Information and Guidelines Testing your blood glucose consists of the following two proced...

Page 48: ...ge or symbol appears on the screen refer to CHAPTER 6 TROUBLESHOOTING on page 60 for additional information Dirty or wet hands could affect your test results Alcohol can affect test results When not i...

Page 49: ...trip from the cartridge 1 Wash your hands with warm soapy water and dry thoroughly If you use alcohol wipes to clean your fingers ensure the puncture area is completely dry before lancing your finger...

Page 50: ...ve inserted the cartridge correctly 6 Hold the test strip with the gold contacts facing upward 7 Without bending the strip insert it into the test strip port of the Dario Glucose Meter as far as it wi...

Page 51: ...se 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 wi...

Page 52: ...p 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...

Page 53: ...lt does not display you can view it in your Logbook in the Dario App For more information refer to the Dario App User Guide at www mydario com In case an error message appear you may need to start the...

Page 54: ...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 2 Hold th...

Page 55: ...ior to use Cleaning and disinfection is a two steps process and should be done once a week Cleaning and disinfection refer to different actions Cleaning removes dirt and blood while disinfection kills...

Page 56: ...hogens that may spread infection Using a second clean Super Sani Cloth Germicidal Disposable Wipe Disinfect the meter on all four 4 surfaces and the audio plug by wiping up and down at least two 2 tim...

Page 57: ...57...

Page 58: ...device and call customer support toll free in the U S at 1 800 895 5921 9 00 AM 5 00 PM EST Monday through Friday Please contact your health care provider for questions outside of the customer suppor...

Page 59: ...vice while taking the blood glucose test The disposable sleeves are available in your Welcome Kit You can order additional disposable sleeves from customer support by calling toll free in the U S at 1...

Page 60: ...u still have questions after reading this chapter call customer support toll free in the U S at 1 800 895 5921 9 00 AM 5 00 PM EST Monday through Friday or contact customer support at www mydario com...

Page 61: ...t to OFF 2 Adjust the audio balance Audio volume balance must be set in the middle of L and R 3 Ensure that your ringer and alerts volume is set to the maximum level 4 Allow Dario to use your micropho...

Page 62: ...L Repeat the measurement with a new test strip If this message recurs contact your health care provider Immediately If your measurement results are inconsistent with the way you feel contact customer...

Page 63: ...0 AM PM EST Monday through Friday or visit www mydario com Unknown device please connect Dario Another device is connected to your smart mobile device s audio plug port If another device is connected...

Page 64: ...pierce skin with lancet The needle depth may be incorrect Adjust the lancet depth lever to a different depth For more information refer to Setting Lancet Depth Optional on page 24 The lancet needle ma...

Page 65: ...n refer to step 1 in Performing a Glucose Test on page 51 Lancet Depth Indicator lever is stuck The indicator lever may be faulty Replace the Dario Housing Contact customer support toll free in the U...

Page 66: ...y 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 acc...

Page 67: ...by the reaction depends on the amount of glucose in the blood sample The glucose meter detects the current and converts it into a blood glucose reading Compatibility Dario is compatible for use on iOS...

Page 68: ...ance with Electrical and Safety Standards The Dario Blood Glucose Meter has been tested to electrostatic discharge as specified in IEC 61000 4 2 The Dario Blood Glucose Meter has been tested for immun...

Page 69: ...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 Directiv...

Page 70: ...satisfied with your Dario Blood Glucose Monitoring System LabStyle Innovation Ltd warrants that your new Dario will be free from defects in materials and workmanship for a period of one 1 year from th...

Page 71: ...01 Dario Control Solution 2x2 5 ml Disposable Covers 1028 01 Dario Disposable Covers 1 x 100 Software 1022 01 Smart mobile device software Contact Customer Support You may contact customer support wit...