LabStyle Dario User Manual Download Page 8

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Chapter 1 - Introduction & User Safety

Symbols and descriptions

SyMbolS And deSCrIptIonS

The following table shows a list of symbols which may appear throughout

this guide, on packaging or package inserts, or on the actual system parts. An

explanation is provided next to each symbol.

Symbol description

Dario™ logo

LabStyle Innovation

logo

Consult instructions for use

Do not use if seal is broken or

missing

In Vitro Diagnostic

Batch code

Expiry date

Shelf life following first opening

Do not reuse

Temperature limitation

Catalogue number

Contents

Manufacturer:

LabStyle Innovation

Ltd.

9 Halamish St.

North Industrial Park

Caesarea 3890000 Israel

Authorized Representative in the

European Community;

MDSS GmbH

Schiffgraben 41

30175 Hannover, Germany

Intended for self-testing

Sterilized using Gamma Radiation

Keep away from sunlight

Keep Dry

Symbol description

Manufacturer

Dario

Blood Glucose monitoring system

Under Directive IVDD 98/79/EC

LabStyle Innovation

Ltd.

Dario

Lancing Device

Under Directive MDD 93/42/EEC

LabStyle Innovation

Ltd.

Sterile Lancets (25)

Under Directive MDD 93/42/EEC

Gentrol Co., Ltd.

Summary of Contents for Dario

Page 1: ...DarioTM User Guide Thriving with diabetes together...

Page 2: ...ealthcare provided with any questions concerns or remarks you may have LabStyle InnovationTM Ltd 9 Halamish St North Industrial Park Caesarea 3890000 Israel www mydario com Dario is a trademark of Lab...

Page 3: ...Inserting a Lancet 11 Setting Lancet Depth Optional 12 The Dario Application 12 Downloading Installing the Dario Application 13 Creating Your Account Personalizing Your Settings 14 Setting Your Perso...

Page 4: ...r to the Dario Housing 40 Test Limitations 40 Performance Analysis 41 Chapter 5 CLEANING AND MAINTENANCE Cleaning 42 Chapter 6 TROUBLESHOOTING Troubleshooting 43 Problem Solving 46 Chapter 7 Technical...

Page 5: ...our new Dario BGMS We suggest that you read this guide thoroughly in order to familiarize yourself with the system and its many features Intended Use The Dario BGMS is intended for determination of bl...

Page 6: ...safe use and handling of your Dario Incorrect use of this system or failure to apply implement or follow the instructions and important information contained in this User Guide may lead to a misdiagn...

Page 7: ...iate procedures start with a symbol followed by a short description of the procedure to be performed y y Procedure instructions are clearly identified and presented as numbered procedure steps y y If...

Page 8: ...ate Shelf life following first opening Do not reuse Temperature limitation Catalogue number Contents Manufacturer LabStyle InnovationTM Ltd 9 Halamish St North Industrial Park Caesarea 3890000 Israel...

Page 9: ...n very hot or cold places Do not leave it near a heat source radiator or in a car in hot or cold weather y y Donotstoreorusemeterorteststripsinhighhumidity suchasabathroomorkitchen Additional Informat...

Page 10: ...knowledge about your glucose trends and actionable insights y y The system is discreet and compact The entire system easily fits in your pocket y y By connecting to your smart mobile device it elimina...

Page 11: ...tected storage Lancing Device and Cover The lancing device is built into the housing and uses disposable Dario lancets The lancing device cover prevents the user from unintentional punctures Lancets a...

Page 12: ...lancets in case of an emergency Dario System Welcome Kit Contents 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...

Page 13: ...io System for the First Time Setting up the Dario System for the first time includes the following steps described in this section y y Inserting a test strip cartridge see Inserting the Test Strip Car...

Page 14: ...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 2 Hold the test strip cartrid...

Page 15: ...een inserted correctly Inserting a Lancet To insert a lancet 1 Remove the Lancet Device Cover the end with the small opening from the Dario housing 2 Remove a new lancet from the packaging 3 Insert a...

Page 16: ...ing device lever so that the line on the lever is aligned with the correct depth 2 Return the lancing device cover by sliding it into place until it clicks Be careful not to touch or bend the lancet T...

Page 17: ...stem with the app the time and date must be correctly set on your smart mobile device For instructions on setting the time and date on your device please refer to the support materials for the device...

Page 18: ...a Dario user 3 In the SIGN UP screen input your First Name Last Name E mail and a Password You must also Confirm your Password and agree to the Terms and Conditions by tapping on the circle so that a...

Page 19: ...Overview and Features The Dario Application 15 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 Pe...

Page 20: ...his time you can tap SKIP and continue to setting your Diabetes Profile 1 Optional Enter your Gender Weight Height and Date of Birth It is also possible to upload a photo from your device by tapping U...

Page 21: ...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 t...

Page 22: ...the meter y y Whenever your result does not match the way you feel y y If you have repeated a test and the blood glucose result is still lower or higher than expected y y When you open a new test stri...

Page 23: ...professional immediately if solution is swallowed injected or applied to the eye y y Dye in control solution may stain skin clothing or surfaces y y Store the control solution between 8 C 30 C 46 F 8...

Page 24: ...g 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 mo...

Page 25: ...l 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 T...

Page 26: ...is recommended not to 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 y y...

Page 27: ...ut 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 5 Shake the contr...

Page 28: ...t 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 10 Compare the results on the meter with the va...

Page 29: ...ceptable range 14 Place the meter back into the housing a Hold the meter at a angle with the part that connects to the smart mobile device facing away from the ridged orange panel b Push the meter int...

Page 30: ...6 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 Error check strip measure...

Page 31: ...r fingertip onto the test strip the result will be displayed in six 6 seconds Carefully read and follow the instructions provided in this chapter and in the package inserts for the test strips and con...

Page 32: ...irst opened Check the date when using the strips If the date surpasses the shelf life after first opening do not use the strips from this cartridge y y Use the test strip immediately after removing it...

Page 33: ...high test results in glucose meters If you are very sick or think you are dehydrated or are urinating frequently call your doctor immediately Dirty or wet hands could affect your results Alcohol can...

Page 34: ...cose test results in a LOW or HIGH message a second time follow the protocol established by your health care professional or contact your healthcare provider immediately y y Please note that the exact...

Page 35: ...meter has been dropped and you are receiving error messages or implausible results contact customer support Do not rely on the blood glucose measurement alone in making health care decisions Step One...

Page 36: ...ncet position and pull the lancet out of the lancing device If you prefer it is possible to remove the lancet by grasping it and pulling it straight out of its housing Dispose of used lancet in a safe...

Page 37: ...the lancet needle 6 If necessary set the depth of the lancing device For additional information see Setting Lancet Depth Optional on page 12 7 Replace the lancing device cover by sliding it into place...

Page 38: ...hnical 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 I...

Page 39: ...lace until it clicks If the cover does not close properly the cartridge may not have been inserted correctly Step Four Testing Your Blood Glucose Testing Information and Guidelines y y The meter requi...

Page 40: ...ppears on the screen refer to Chapter 6 TROUBLESHOOTING for additional information y y Dirty or wet hands could affect your results Alcohol can affect test results y y When not in use store the meter...

Page 41: ...er is inserted as far as it can go into the socket of the smart mobile device A Connecting message appears followed by INSERT A NEW STRIP 3 Hold the test strip with the gold contacts facing upward 4 W...

Page 42: ...ancing device cover side with the small opening to the side of your fingertip and press the release button to prick your finger 7 Apply a drop of blood to the tip of the yellow window of the test stri...

Page 43: ...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 an...

Page 44: ...within body natural levels of uric acid ascorbate vitamin C bilirubin triglycerides and hemoglobin do not interfere with your blood glucose results Elevated levels of these compounds in your blood ma...

Page 45: ...y venous blood repeatability and control solution reproducibility The system is calibrated with venous blood containing various glucose concentrations The reference values for this were obtained using...

Page 46: ...on agent Super Sani Cloths Wipes once a month Do not y y Expose the device to solvents y y Get any moisture in the test strip slot y y Spray any cleaning solution directly onto the glucose meter or th...

Page 47: ...urate use of Dario please pay attention to all symbols and messages when you use the system They provide you with important information If you still have questions after reading this chapter contact c...

Page 48: ...n L and R 3 Make sure that your Ringer and Alerts volume is set to the maximum Settings Sounds Look at the RINGER AND ALERTS section and make sure that it is set to the maximum volume all the way to t...

Page 49: ...ario device failure 0x02 If the problem occurs again please contact Dario s customer support Voltage Failure Contact customer support at www mydario com Unknown device please connect Dario Another dev...

Page 50: ...return each cover to the correct end 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...

Page 51: ...d testing will result in this message appearing It is recommended to set your smart mobile device to flight mode before performing a test Forgotten Dario password If you forget your password tap on FO...

Page 52: ...rip glucose oxidase The strength of the current produced 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...

Page 53: ...art 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 Altitude Up to 3 400 m...

Page 54: ...t Used products therefore carry a risk of infection Please dispose of used products according to the regulations applicable in your country For information about correct disposal please contact your l...

Page 55: ...Warranty It is important to LabStyle Innovation Ltd that you are completely satisfied with your Dario BGMS LabStyle Innovation Ltd warrants your new Dario will be free from defects in materials and wo...

Page 56: ...ing damage Supplies and Accessories Dario BGMS supplies and accessories are available from LabStyle InnovationTM Ltd or from your local distributor For a list of distributors please visit www mydario...

Page 57: ...Life is easier with DarioTM in your pocket LabStyle InnovationTM Ltd 9 Halamish St North Industrial Park Caesarea 3890000 Israel www mydario com...

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