Dario User Manual.indb
Contents
1. Q DARIO Dario User Guide Thriving with diabetes together 2014 LabStyle Innovation Ltd ALL RIGHTS RESERVED BASIC INFORMATION Please read this user guide thoroughly and feel free to contact our customer support www mydario com or your healthcare provided with any questions concerns or remarks you may have LabStyle Innovation LTD 9 Halamish Street Caesarea 3890000 Israel www mydario com Dario is a trademark of LabStyle European Patent application number 11780305 6 CE 0344 6031 01 Rev01 Issue Date 2 2014 Q DARIO TABLE OF CONTENTS CHAPTER 1 INTRODUCTION amp USER SAFETY Glucose Monitoring for a Mobile Age sssr 1 Intended USe saiman iiaa 1 Contraindications ssanie anni iniia 2 About These Instructions for USC ccs 2 Before Testing With Dario ccecesesseseeeeeeeensseeesseeeeens 2 Safety Definitions sseni 2 B E E E E A O E A E E A 3 NOCES kree e EE e EE e eE oa aeea SE 3 Practices Used in This Advanced User Guide 3 Procedure INStructiONns ccecssesesessseseseseseessseeseneetenees 3 Symbols and Descriptions ccccccccesseesessessesssnssesneessneessneeees 4 Additional Information cccccscssssssessssscsessesssesseesseeseenees 5 CHAPTER 2 DARIO SYSTEM OVERVIEW AND FEATURES Your Dario System at a Glance w eecesssesteseeeseeseseeees 6 Dario Components vis nisnsien resins nen delvieigeicasivar 6 Getting Started With Dario assesi 9 Assembl2. Chapter 1 Introduction amp User Safety Glucose Monitoring for a Mobile Age CHAPTER 1 INTRODUCTION amp USER SAFETY GLUCOSE MONITORING FOR A MOBILE AGE Congratulations on your choice of the Dario Blood Glucose Monitoring System BGMS Dario was created to make life easier for people with diabetes with the right tools information and support in your pocket It is a smartphone based monitoring system featuring a pocket sized meter with an integrated lancing device and test strips combined with an easy to use mobile application Living with diabetes is a daily challenge But with Dario in your pocket and the best support we can thrive with diabetes together This user guide will guide you through the proper setup and use of your 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 blood glucose values using fresh capillary whole blood from the fingertip The Dario BGMS is indicated for the quantitative measurement of glucose in fresh capillary whole blood samples drawn from the fingertips The system is intended to be used by a single patient and should not be shared The Dario BGMS is intended for self testing outside the body in vitro diagnostic use by people with diabetes at home as an aid in monitoring the effectiveness of diabetes control The
3. 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 are changed for each use Puncture depth maybe adjusted by removing the cover and moving the depth selection dial The cover is then put back on for use The lancing device is activated by sliding it with two fingers until it clicks and then pressing the release button Instructions on using the lancing device are included in Performing a Glucose Test on page Test Strip Cartridge Each test strip cartridge holds 25 strips The cartridge snaps into the modular Dario housing Chapter 2 Dario System Overview and Features Your Dario System at a Glance Description Test Strip The Dario test strip is the only strip which may be 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 Dario uses a 30G lancet The lancet is replaced by removing the lancing device cover pulling out the used lancet and replacing it with a sterile one u It is recommended that you carry spare cartridges and lancets in case of an emergency Note DARIO SYSTEM WELCOME KIT CONTENTS Once you remove th
4. Chapter 3 Checking Your Dario Glucose Meter Checking the Glucose Meter With the Check Strip Hey Mike INSERT ANEW STRIP LAST 7 DAYS 0 MEASUREMENTS 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 Do not use the Dario meter Contact customer support at www mydario com Error check strip measurement is out of range 0 Chapter 4 Testing Your Blood Glucose Level Blood Glucose Testing Precautions CHAPTER 4 TESTING YOUR BLOOD GLUCOSE 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 the Checking Your Glucose Meter With Dario Control Solutions on page 20 and Checking the Glucose Meter With the Check Strip on page 25 Do not use the system if control solution result is out of range The glucose meter in Dario measures the amount of glucose in your blood Once placing a small drop of blood from your 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 control solutions It is very importan
5. e If your blood glucose 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 e Please note that the exact blood glucose reading that constitutes a HIGH or LOW reading depends on many factors including individual differences and the time since your last meal FACTORS THAT MAY LEAD TO INACCURATE RESULTS 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 e Your hands may not have been washed thoroughly e Your glucose meter test strip port may be contaminated e Your test strip has been bent e The test strip is expired Check the use by date e The length of time that has passed since first opening the test strip package exceeds the allowed time Koz Chapter 4 Testing Your Blood Glucose Level Step One Inserting a New Lancet Into the Lancing Device e Test strips were stored incorrectly e Testing was done in a humid environment for humidity specifications refer toTechnical Specifications on page 48 e Your glucose meter has been dropped If your meter has been dropped and you are receiving error messages Note OF implausible
6. 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 control solutions Dario lancets and Dario application software Q DARIO Chapter 1 Introduction amp User Safety Contraindications CONTRAINDICATIONS The Dario BGMS should not be used e To diagnose diabetes e On children younger than four weeks old e To test blood taken from an artery or vein Glucose monitoring with the Dario BGMS is not recommended for independent use by people who are e Unable to follow the instructions provided with the system e Visually impaired ABOUT THESE INSTRUCTIONS FOR USE Before Testing With Dario Please read this User Guide carefully and thoroughly before testing your blood glucose for the first time These instructions will provide you with all the information you need for 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 misdiagnosis or damage to your device 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
7. 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 You are instructed to place a drop of blood on the test strip Hey Mike PLACE A DROP OF BLOOD Chapter 4 Testing Your Blood Glucose Level Step Three Remove a Test Strip From the Cartridge 5 Set the lancing device for activation by sliding it with two fingers until it clicks gt 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 J 7 Apply a drop of blood to the tip of the yellow window of the test strip Capillary action will pull the blood into the strip AAEN 8 Important Verify that enough blood is applied to fill the window so that it turns red Do not put blood on top of the test strip O Chapter 4 Testing Your Blood Glucose Level Step Three Remove a Test Strip From the Cartridge When the meter detects that blood has been applied the Measuring message appears The border of the circle is gradually filled with orange indicating that the test is in progress Hey Mike Measuring 9 Remove your finger from the strip once the message appears Do not add blood to the test strip once you have remo
8. a list of devices which supports you daily with personalized tracking knowledge about your glucose trends and actionable insights e The system is discreet and compact The entire system easily fits in your pocket e By connecting to your smart mobile device it eliminates the need for additional hardware e No coding is required Insert a Dario test strip and you are ready to test e Testing is easy No navigating or buttons to press e Actionable insights and alerts allows easy analysis of trends and behavior e Instant sharing with caregivers allows sharing your data with your caregivers for efficient diabetes management Dario Components Your Dario system components are described in the table below Description Housing The modular Dario housing has a built in lancing device slots and covers for the snap in components lancet test strip cartridge and glucose meter Chapter 2 Dario System Overview and Features Your Dario System at a Glance Glucose meter The miniature glucose meter has An audio connector that is plugged into the headphone socket of the smart mobile device A strip port for insertion of the test strip The glucose meter receives its power from the mobile device and 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
9. closed immediately and replace the cartridge cover by pushing it into place until it clicks It is recommended to use the test strip immediately after removing it from the cartridge It is recommended not to use a test strip that has Note been outside of the cartridge for more than three 3 minutes If the cover does not close properly the cartridge may not have been Kote inserted correctly Q e Do not touch the yellow testing site when handling the test strip Caution e 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 Hey Mike TAP PLUS TO LOG YOUR FIRST ENTRY 2 Insert your meter into the audio plug of your smart mobile device Chapter 3 Checking Your Dario Glucose Meter Checking Your Glucose Meter With Dario Control Solutions A Connecting message appears followed by INSERT A NEW STRIP Verify that the meter is inserted as far as it can go into the socket of Note the smart mobile device 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 Hey Mike PLACE A DROP OF BLOOD 5 Shake the control solu
10. e Before using your meter for the first time e If you drop the meter e Whenever your result does not match the way you feel e If you have repeated a test and the blood glucose result is still lower or higher than expected e When you open a new test strip cartridge e 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 The result displayed on the meter should fall within the expected range printed on the test strip container label Obtaining a single result within the expected range is sufficient to verify system performance A result outside the range printed on the Test Strip container label may indicate the system is not performing correctly oO DARIO Chapter 3 Checking Your Dario Glucose Meter Chemical Composition J This control solution is not for use as a cleaning solution Note CHEMICAL COMPOSITION DarioTM Glucose Control Solution is an aqueous solution which contains D glucose as the reactive ingredient in the approximate concentration e Buffer 75mM e Polyvinylpyrrolidone 5 e Polyviny alcohol 5 e SDS 0 1 e Preservative 0 1 CONTROL
11. using the hexokinase method For method comparison the results were compared with results obtained using the hexokinase method with deproteination automatic analyser The hexokinase method is traceable to a NIST standard Chapter 5 CLEANING AND MAINTENANCE Cleaning CHAPTER 5 CLEANING AND MAINTENANCE This section provides cleaning and disinfecting information for your meter The Dario Glucose Monitoring System should be cleaned once a week and disinfected once a month 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 Do not e Expose the device to solvents e Get any moisture in the test strip slot e Spray any cleaning solution directly onto the glucose meter or the lancing device e Submerge any part of the Dario in liquid e Attempt to clean any internal parts e 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 drying before using Caution Contact with solvents can cause severe deterioration of plastic parts Caut and malfunct
12. CE Onder Directive MDD 93 42 EEC LabStyle Innovation Sterile Lancets 25 023 Under Directive MDD 93 42 EEC OOL Sae Chapter 1 Introduction amp User Safety Additional Information GENERAL PRECAUTIONS This section informs you of potential hazards which may harm your Dario system or cause it to not function properly Avoid using any system parts with broken seals or expired use by dates Do not attach or use a component if it is damaged in any way as it may not work properly e The Dario system is not water resistant and should not get wet If it does get wet wipe it with a clean dry cloth e Blood glucose testing with Dario should only be done in temperatures between 10 C 45 C 50 F 113 F Test results may not be correct if the room temperature is outside this range e Changes or modifications to the Dario system not expressly approved by LabStyle Innovation Ltd will void your warranty and could cause you harm e Avoid testing with your Dario system in altitudes higher than 3 400 meters 11 155 feet as accuracy cannot be assured e Do not leave the meter in very hot or cold places Do not leave it near a heat source radiator or in a car in hot or cold weather e Do not store or use meter or test strips in high humidity such as a bathroom or kitchen ADDITIONAL INFORMATION For your safety please observe the following recommendations when monitoring your blood gluc
13. Chapter 4 Testing Your Blood Glucose Level Factors That Interfere With Blood Glucose Testing e Do not use a damaged test strip e Make sure that the gold contact area of the test strip is clean from dirt blood moisture and anything else These items will affect the test result and can cause an inaccurate blood glucose level result FACTORS THAT INTERFERE WITH BLOOD GLUCOSE TESTING e Certain substances can interfere with the blood glucose system and cause falsely high results For more information refer to the test strip package insert If you are taking medication or dietary supplements consult your doctor You should not use this system to test your blood glucose if you are critically ill examples include severe hypotension or shock hyperglycemic hyperosmolar state hypoxia diabetic ketoacidosis Certain health conditions such as serious illness and dehydration can Caution cause falsely 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 affect test Rote results INTERPRETING THE RESULTS If the displayed test result reflects the way you feel continue as instructed by your doctor If the test result does not reflect the way you feel please check your Dario system by running a control solution check Performing a Control Test on page 22 Repeat the blood g
14. L the percentage of results within 0 28 mmol L 0 56 mmol L and 0 83 mmol L 5 mg dL 10 mg dL and 15 mg dL of the reference values for glucose concentrations gt 4 2 mmol L 75 mg dL the percentage of results within 5 10 15 and 20 of the reference values _Glucose Units mg dL mmol L Dimensions Weight Memory Average Display Function Operational Temperature 104x211x11 mm 4 1x8 3x 4 in 7 day 14 day or 30 day averaging Dario application on a smart mobile device screen Glucose Meter Lancing Device AO gram 1 4 oz Unlimited results Memory is limited to smart mobile device memory Hypo warning Set by user 10 C 45 C 50 F 113 F Storage Temperature Strip 2 C 32 C 36 F 90 F Altitude Test Strip Operational Temperature Up to 3 400 meters 11 155feet 10 C 45 C 50 F 113 F Storage Temperature Strip 2 C 32 C 36 F 90 F Altitude Up to 3 400 meters 11 155feet p Do not store near solvents and ionizing radiation source Note COMPLIANCE WITH INTERNATIONAL STANDARDS This meter meets the electromagnetic immunity requirements as per EN ISO 15197 Annex A The chosen basis for electrostatic discharge immunity testing was basic standard IEC 61000 4 2 In addition it meets the electro magnetic emissions requirements as per EN 61326 Its electromagnetic emission is th
15. Notes Text marked with one of these symbols requires your attention to ensure safe and accurate use of your Dario system Warnings Warning indicates precautions needed to prevent possible risk of AN injury or damage to your health Do not proceed beyond a Warning message until you fully understand the conditions and you have taken the appropriate preventive action Koz Warning Chapter 1 Introduction amp User Safety Symbols and Descriptions Cautions Caution indicates precautions needed to prevent damage to your Q monitoring system Caution Do not proceed beyond a Caution message until you fully understand and observe the indicated conditions Notes p Notes are used to provide additional information for the purpose of Note clarification Practices Used in This Advanced User Guide Procedure Instructions e When appropriate procedures start with a symbol followed by a short description of the procedure to be performed e Procedure instructions are clearly identified and presented as numbered procedure steps e If relevant a system response is written below the procedure step and appears in italics e All procedures should be done in the order of the steps provided The examples and screen images used in this user guide are provided Note 28 examples only unless stated otherwise Words in Description Bold Italics System response that occurs as a result of a butto
16. R THE FIRST TIME Setting up the Dario System for the first time includes the following steps described in this section e Inserting a test strip cartridge see Inserting the Test Strip Cartridge on page 10 e Inserting a lancet see Inserting a Lancet on page 11 e Setting lancet depth optional see Setting Lancet Depth Optional on page 12 e Downloading the Dario application to your smart mobile device see Downloading amp Installing the Dario Application on page 13 e Setting up the Dario application on your smart mobile device using the Dario app instructions or the instructions provided on the Dario website Both ends of the housing have covers that are removable The lancet cover is the one with the small opening Please be careful not to put the cartridge cover on the lancing end This can damage the lancet and the lancing device Note Chapter 2 Dario System Overview and Features Assembling the Dario System for the First Time Inserting the Test 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 2 Hold the test strip cartridge with the side that opens on top as shown below 3 Insert the cartridge into the housing until it snaps into place 4 Replace the housing
17. SOLUTION Your Dario System Welcome Kit comes with two bottles of control solution H and M types e Avoid contact with the eye Contact your healthcare professional immediately if solution is swallowed injected or applied to the eye e Dye in control solution may stain skin clothing or surfaces e Store the control solution between 8 C 30 C 46 F 86 F Keep away from direct sunlight fluorescent light and heat Do not freeze e Once you open a new bottle of control solution mark the opening date on the bottle e Make sure that your control solution has not expired Check the expiration date on the bottle e Make sure that your control solution was not opened more than 3 months ago e Keep the control solution away from children e Shake the control solution well before using e Wipe the container tip clean after use and be sure to close the container tightly after each use e No reconstitution or dilution of the control solution is necessary Oo Chapter 3 Checking Your Dario Glucose Meter Checking Your Glucose Meter With Dario Control Solutions CHECKING YOUR GLUCOSE METER WITH DARIO CONTROL SOLUTIONS The following steps are required to perform a control solution test Removing the Glucose Meter From the Housing Before performing a control solution test it is necessary to remove the glucose meter from the housing The glucose meter is stored in the housing when not in use When not i
18. ay from the ridged orange panel 3 Push the meter into the housing at an angle and then push downwards until the meter clicks into place TEST LIMITATIONS Normal endogenous 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 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 Compound Limitation Ascorbic acid gt 4 mg dL Uric acid gt 9 mg dL Acetaminophen gt 6 mg dL Total bilirubin gt 40 mg dL Triglycerides gt 1 026 mg dL The drugs L dopa dopamine methyl dopa acetaminophen and ibuprofen will not interfere with Dario system blood glucose results when taken at therapeutic concentrations Patients undergoing oxygen therapy may yield false results 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 The reference values for this were obtained
19. cations How the Glucose Meter Works CHAPTER 7 TECHNICAL INFORMATION amp SPECIFICATIONS This section provides technical information on 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 The glucose meter detects the current and converts it into a blood glucose reading COMPATIBILITY The Dario app is compatible for use on the following smart mobile devices Devices Operating System iPhone 4 45 5 5S 5C iPod Touch 3rd amp 4th generation iPad 2 new iPad and iPad mini iPad with Retina display iOS 6 1 or above TECHNICAL SPECIFICATIONS Meter Specifications Result Range 10 600 mg dL 0 6 33 3 mmol L Calibration Plasma equivalent Sample F Fresh capillary whole blood Test Sample 10 3 microliter o Test Time 6 seconds o Assay Method Glucose Oxidase Biosensor Hematocrit Range 20 60 Chapter 7 Technical Information amp Specifications Compliance With International Standards Accuracy Power Supply Powerless for glucose concentrations lt 4 2 mmol L 75 mg d
20. ccccceceecseeeeeseeieeseeseeesteseeeseeneeeeeaees 30 Factors That May Lead to Inaccurate Results 30 Step One Inserting a New Lancet Into the Lancing DEVI CO oiii Torati anaana aan a aagana aa aTa aR 31 Step Two Removing the Glucose Meter From the MOUSINE arininn dinaan aiaa aa iaaa Naana 33 Step Three Remove a Test Strip From the Cartridge 34 Performing a Glucose Test ccecsscessesssesesesteseesseeneeeees 36 Step Five Returning the Meter to the Dario FHOUS UNS ieena enin a aa teens e oeenes 40 TESTI ALIOIS seee ee nsa EE 40 Performance Analysis w cccccssssesssessssessssssesnsessnsesssseseaeeees 41 CHAPTER 5 CLEANING AND MAINTENANCE D A P EE E 42 CHAPTER 6 TROUBLESHOOTING Troubles hoolig S255 os tsicessncessevesi sees co 03is6 ais tines tines bade ees eaa lately 43 PFOBDIEM SOWING wiisscscsseisstitienninath ach ain adi aarti eins 46 CHAPTER 7 TECHNICAL INFORMATION amp SPECIFICATIONS How the Glucose Meter WOrkKS ccccsesessecseseseseeseeneseeteees 48 COMPALIDINILY srna naniii 48 Technical Specifications cccececsessseseseseecsessessseessesseeees 48 Compliance With International Standards uu 49 Disposing Of Your Meter an ccccssessssscessesssseeessessessesssneseeneseens 50 CHAPTER 8 WARRANTY REPAIRS SERVICE amp SUPPLIES Repair POW CY aasan naaa sieeve 51 Manufacturers One Year Warranty sses 51 Service SUPPO hanora fia e aA 52 Supplies and ACCESSOLICS cecsessssessesssseseeseseesseesseseeeeseeeees 52
21. cover by sliding it into place until it clicks 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 Rete 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 sterile lancet as far as it will go and make sure it is firmly set rO 4 Carefully twist off the lancet cap Make sure not to bend the lancet while removing the cap 0 Oo Chapter 2 Dario System Overview and Features The Dario Application Setting Lancet Depth Optional The depth of the lancet as it punctures the skin of your fingertip can be adjusted by moving the lever between the numbers one to four printed on the dial One 1 is the shallowest depth and 4 is the deepest It is recommended to start with your lancet depth set to level one and adjust the level if necessary To set lancet depth 1 Move the lancing 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 THE DARIO APPLICATION Your Dario meter is operated via the app dis
22. e exterior packaging you will find a white package with a tamper proof seal If the tamper proof seal is missing it is Note recommended that you return this Dario System to where you purchased it as it has been opened As soon as you receive your Dario System Welcome Kit 1 Carefully unpack the kit and verify that it contains the following parts e Dario System including Blood Glucose Meter e Accessories Test strip cartridge 25 strips Sterile Lancets 25 lancets High Control Solution 1 bottle Medium Control Solution 1 bottle Check Strip 1 strip e Documentation User Instructions Short Guide and a Quick User Guide 2 If anything is missing please contact customer support at www mydario com OQ Chapter 2 Dario System Overview and Features Getting Started With Dario GETTING STARTED WITH DARIO Your Dario meter works seamlessly with your smart mobile device Simply download the Dario iOS application on your smart mobile device and it will automatically synchronize with the Dario device each time it is connected Your data is constantly synchronized to one place so that it is always with you on the go so you can stay in control of your health 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 So let s get started ASSEMBLING THE DARIO SYSTEM FO
23. ed by LabStyle Innovation 30G e If the lancet does not click into place or the lancet holder does not hold the lancet properly insert another sterile lancet sauton e If the problem persists it may be necessary to replace your Dario housing Contact Customer Support at www mydario com 5 Carefully twist off the lancet cap as shown above Make sure not to bend 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 until it clicks Be careful not to touch or bend the lancet STEP TWO REMOVING THE GLUCOSE METER FROM THE HOUSING Before starting the testing procedure you should remove the meter from the housing The meter is stored in the housing when not in use To remove the meter from the housing 1 Hold the housing so that the ridged orange panel is close to you and the end with the lancing device is facing away from you 2 Slide your thumb back on the ridged orange panel The meter will pop up a t7 PAA Chapter 4 Testing Your Blood Glucose Level Step Three Remove a Test Strip From the Cartridge 3 Grasp the meter with two fingers and remove from the housing 74 Do not plug the Dario meter into any device other than a compatible Q smart mobile device audio socket The list of compatible smart mobile device
24. et to off Verify that Mono Audio is set to off 2 Adjust the audio balance Settings gt General gt Accessibility gt Hearing The audio volume balance must be set in the middle between L and R 3 Make sure that your Ringer and Alerts volume is set to the maximum Settings gt Sounds Look at the RINGER AND ALERTS section and make sure that it is set to the maximum volume all the way to the right 4 Allow Dario to use your microphone Settings gt Privacy gt 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 gt Music gt Volume Limit Make sure that it is set to the maximum volume all the way to the right Insufficient blood detected try again with a new strip Not enough blood on the strip Repeat the measurement with a new strip The Strip is used please insert a new strip A strip was used more than once Perform anew measurement with a new strip Chapter 6 TROUBLESHOOTING Troubleshooting Message Content contact your physician Immediately High Measure with a new strip if recurs Possible Cause Recommended Action High glucose level Measurement result is above 600 mg dl 33 3 mmol l Repeat the measurement with a new strip If this recurs contact your physician Immediately If your measurement results are inconsi
25. he meter from your smart mobile device 13 Wipe the tip of the control solution container clean and tightly seal the container The Dario Glucose Control Solution ranges printed on the test strip Note Cartridge label are intended for the Dario test strip cartridge only O Chapter 3 Checking Your Dario Glucose Meter Checking the Glucose Meter With the Check Strip The glucose concentrations in these solutions when measured by systems other than Dario Glucose Monitoring System may differ Note Applying too much or too little control solution to the test strip may Note cause out of range results Do not use your Dario Glucose Monitoring System to test your blood Caution if your control solution result falls outside of the acceptable 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 into the housing at an angle and then push downwards until the meter clicks into place CHECKING THE GLUCOSE METER WITH THE CHECK STRIP 1 Open the Dario application 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 the test is in progress Koz
26. ing the Dario System for the First Time 9 Inserting the Test Strip Cartridge sssrin 10 Inserting a Lanett iics acs diintia ian sia anera iai 11 Setting Lancet Depth Optional wc cccccsssessssesseseeseasees 12 The Dario Application cccccsccsesssesssseessesssseesssnesssneesens 12 Downloading amp Installing the Dario Application 13 Creating Your Account amp Personalizing Your Settings 14 Setting Your Personal Profile ccccccessesesesesseesseeeeneeees 16 CHAPTER 3 CHECKING YOUR DARIO GLUCOSE METER Control Test Principle cccecsesessssecsssesessesessessseesseessessenees 18 Chemical Composition w ceeccsesecsescsesessesessesestessseesseesenees 19 Control Solutionsissa 19 Checking Your Glucose Meter With Dario Control SOMWRI OWNS acisssnsesstustiesesssisssteasansanasicsasraiensshsassedavgedetgh Oeaneadensdlansss 20 Removing the Glucose Meter From the Housing 20 Removing a Test Strip From the Cartridge 21 Performing a Control Test ccccscsssssecssescsesssseetsseessseeeeees 22 QO Checking the Glucose Meter With the Check Strip 25 DARIO CHAPTER 4 TESTING YOUR BLOOD GLUCOSE LEVEL Blood Glucose Testing PreCautions cccccssssseseesseseeees 27 Test Strip Precautions ccecscsesesessessssessssesseseesesseeeeeneeees 28 Factors That Interfere With Blood Glucose Testing 29 Interpreting the Results c ccccessessesesteseeessessestesesneseeneseens 29 Measurement Range
27. ioning of the instrument and accessories aution DISINFECTING Disinfection should performed with PDI Super Sani Cloth Germicidal Wipes Q DARIO Chapter 6 TROUBLESHOOTING Troubleshooting 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 They provide you with important information If you still have questions after reading this chapter contact customer support at www mydario com An error message can appear as a popup or as a message within the main circle Error Please ensure that there are no volume limitations in the device settings For more instructions visit O http www mydario com support ERROR OK DARIO DEVICE FAILURE 0x03 IF THE PROBLEM OCCURS PLEASE CONTACT DARIO TROUBLESHOOTING The following table lists some typical conditions that may occur with the Dario System Chapter 6 TROUBLESHOOTING Troubleshooting Message Content Please ensure that there are no volume limitations in the device settings For more instructions visit http www mydario com support Possible Cause Recommended Action Smart device volume setting inappropriately Check the following settings in your mobile device il vee sure that Mono Audio is s
28. lkthrough help or to get started WALKTHROUGH GET STARTED 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 Note HELP gt APP WALKTHROUGH The First Entry screen appears DARIO R Hey Mike TAP PLUS TO LOG YOUR FIRST ENTRY 6 We advise you to continue setting your Diabetes Profile following the app instructions Completing your profile will allow full app functionality Chapter 3 Checking Your Dario Glucose Meter Control Test Principle CHAPTER 3 CHECKING YOUR DARIO GLUCOSE METER This section provides information on checking the accuracy of your meter Before using your meter for the first time you should test the accuracy of your meter There are two ways of testing the accuracy of your glucose meter e Control Solution Confirms that the meter and test strips are performing as expected A drop of control solution is placed on a test strip using a piece of paper Compare the results on the meter with the values displayed on the test strip cartridge e Check Strip Confirms that the meter is performing as expected The reusable check strip that is supplied with the Welcome Kit is used to test the meter s performance To ensure that your results are always accurate you need to check the performance of your meter in the following cases
29. lucose test afterward Warning If your blood glucose result still doesn t match how you feel and you have followed the instructions provided here follow your healthcare provider s instructions Do not change your treatment based on a single result that does not match how you feel or if you believe that your test result could be AN incorrect 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 professional to interpret and understand the measurement results Koz Warning Chapter 4 Testing Your Blood Glucose Level Measurement Range MEASUREMENT RANGE Your meter measures blood glucose results in the range of 10 mg dL to 600 mg dL 0 6 33 3 mmol L Results that are outside of this range should be reviewed according to the procedure below e If your test result is lower than 10 mg dL 0 6 mmol L LOW is displayed instead of a result LOW may indicate that your blood glucose is very low possibly severe hypoglycemia Follow your doctor s instructions immediately and Warning repeat the test e If the result is higher than 600 mg dL 33 3 mmol L HIGH is displayed instead of a result e If your blood glucose test results in a LOW or HIGH message repeat the blood glucose test following all of the instructions provided in Step Four Testing Your Blood Glucose on page 35
30. n press Names of menus buttons and screens Bold Italics Used to emphasize important information Chapter 1 Symbols an Introduction amp User Safety d 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 an Symbol Description Symbol Description Q Dario logo DARIO LabStyle Innovation logo oo Consult instructions for use Do not use if seal is broken or missing IVD In Vitro Diagnostic LOT Batch code z Expiry date aA Shelf life following first opening ad Do not reuse Re Temperature limitation REF q ad a8 Catalogue number Contents Manufacturer LabStyle Innovation LTD Authorized Representative in the European Community wl 9 Halamish Street Ec Rep MDSS GmbH Caesarea 3890000 Schiffgraben 41 Israel 30175 Hannover Germany SELF Intended for self testing STERILEIR Sterilized using Gamma Radiation se Pte AN Keep away from sunlight am Keep Dry Symbol Description Manufacturer Dario Blood Glucose monitoring system 0343 Under Directive IVDD 98 79 EC EPs ley noyation Dario Lancing Device
31. n 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 Caution affect accuracy To remove the meter from the housing 1 Hold the housing so that the ridged orange panel is close to you and the end with the lancing device is facing away from you 2 Slide your thumb back on the ridged orange panel The meter will pop up a17 3 Grasp the meter with two fingers and remove from the housing Chapter 3 Checking Your Dario Glucose Meter Checking Your Glucose Meter With Dario Control Solutions Do not plug the Dario meter into any device other than a compatible smart mobile device audio socket The list of compatible smart eran mobile devices is provided in Chapter 6 Technical Information amp 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 10 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 Chapter 3 Checking Your Dario Glucose Meter Checking Your Glucose Meter With Dario Control Solutions 4 Snap the case
32. nd to the Dario web portal P If you already have a Dario account you may skip this section Chapter 2 Dario System Overview and Features The Dario Application First Name Last Name E mail Password Confirm Password I agree to 5 Press Next when done If nothing happens when you press Next verify that you agreed to the Nte Terms and Conditions You are automatically brought to the Personal Profile Screen GT UPLOAD PHOTO CO Gender 7 Weight f Height Date of Birth mg dL 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 Note SETTINGS gt ACCOUNT SETTINGS Setting Your Personal Profile To set your personal profile p If you do not want to setup your profile at this time you can tap SKIP Note 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 UPLOAD PHOTO 2 Select your preferred measurement unit system mg dL or mmol L by tapping either the mg dL button or mmol L button 3 Press DONE You can update your settings at any time by tapping the Menu icon Note n the top left corner and selecting SETTINGS A screen appears with the option to do a Wa
33. ng 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 Lancing Device does not operate correctly The lancing device spring or handle may be faulty Make sure that you set the lancing device for activation by sliding it with two fingers until it clicks see page 38 Then you can press the button to puncture your skin Lancet Depth Indicator lever is stuck The indicator lever may be faulty Replace the Dario housing Contact customer support at www mydario com OO 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 at 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 Forgotten Dario password If you forget your password tap on FORGOT PASSWORD in the LOG IN screen An email with instructions for resetting your password will be sent to you My smart mobile device battery died If the battery of your smart mobile device is out of power use a different device Download the Dario application and login to your account Chapter 7 Technical Information amp Specifi
34. on 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 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 This warranty is in lieu of all other warranties expressed or implied including any implied warranty of merchantability or fitness for any purpose other than stated herein This warranty does not apply to the performance of a Dario BGMS that has been damaged by accident or has been altered misused tampered with or abused in any way This warranty only applies to the original purchaser of the meter and or its agents DARIO Chapter 8 Warranty Repairs Service amp 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 If you need to ship the device please pack the device and its accessories carefully to prevent shipping damage SUPPLIES AND ACCESSORIES Dario BGMS supplies and accessories are available from LabStyle Innovation Ltd or from your local distributor F
35. ood is applied to the test strip an alert informs you that your sample size is too small and you should try again with a new strip e If atest strip error occurs perform another test with a new test strip e Blood glucose results are automatically saved to memory The results remain on the screen for 15 minutes e If an error message or symbol appears on the screen refer to Chapter 6 TROUBLESHOOTING for additional information e Dirty or wet hands could affect your results Alcohol can affect test results e 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 To prevent malfunction of the meter keep the test strip port free of blood moisture dirt or dust Always store the glucose meter in the Caution Dario housing when not in use Performing a Glucose Test 1 Tap the Dario icon on your smart mobile device to launch the Dario application DARIO R Hey Mike TAP PLUS TO LOG YOUR FIRST ENTRY Chapter 4 Testing Your Blood Glucose Level Step Three Remove a Test Strip From the Cartridge 2 Insert your meter into the audio plug of your smart mobile device Verify that the meter is inserted as far as it can go into the socket of the smart mobile device Y a A Connecting message appears followed by
36. or a list of distributors please visit www mydario com Catalog Number 1015 01 System f Dario Welcome Kit 1016 01 Dario Test Strip 1 x 25 1024 01 Dario Test Strip 2 x 25 1018 01 Dario Lancet 1 x 100 1019 01 Dario Lancet 1 x 25 1004 02 Dario Control Solution H 1004 03 Dario Control Solution M 1034 01 Check Strip Dario Check Strip 1022 01 Smart mobile device software application ver 2 x Test Strip Cartridge Lancet Control Solution Software rO Life is easier with Dario in your pocket DARIO LabStyle Innovation LTD 9 Halamish Street Caesarea 3890000 Israel www mydario com
37. ose using the Dario system e It is always a good idea to have a back up testing method available Failure to test could cause a delay in treatment decisions and lead to a serious medical condition Examples of back up testing methods include a back up glucose meter device or testing by a laboratory Ask your healthcare provider about other possible back up methods e It is recommended that you periodically compare the test results from your Dario BGMS with another test system that you know is well maintained and monitored by a healthcare provider e Do not change your treatment based on a single result that does not match how you feel or if you believe that your test result could be incorrect e Never make significant changes to your diabetes control program or ignore physical symptoms without consulting with your healthcare professional Oo Chapter 2 Dario System Overview and Features Your Dario System at a Glance CHAPTER 2 DARIO SYSTEM OVERVIEW AND FEATURES This section provides an overview of the Dario system components and how it is set up for the first time YOUR DARIO SYSTEM AT A GLANCE The Dario is a compact all in one glucose monitoring system that incorporates a lancing device a disposable strip cartridge and a miniature glucose meter that snap into a durable pocket sized housing The miniature glucose meter attaches to your smart mobile device see Compatibility on page 48 for
38. played 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 Additionally you can find more instructions on the Dario Application User Guide at www mydario com Instructions for downloading the app are provided in the next section OO Chapter 2 Dario System Overview and Features The Dario Application The app can be used to conveniently store and manage your diabetes information review trends or share information with your healthcare provider Downloading amp 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 The Dario app is free of charge and is customized for your smart mobile device Downloading the app from the App Store requires data connectivity Note For accurate use of the Dario system with the app the time and date must be correctly set on your smart mobile device For instructions on Nofe setting the time and date on your device please refer to the support materials for the device To download the Dario App 1 Turn on your smart mobile device and launch the App Store app Alternately for quicker access you can use an app that scans codes to scan the follo
39. range If this problem occurs again please contact Dario s customer support Fault in check strip or meter Repeat the check strip measurement again If the error recurs contact customer support at www mydario com Chapter 6 TROUBLESHOOTING Problem Solving 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 strip or meter are defective e Repeat the measurement using a new test strip e Check the meter with a check strip see Checking the Glucose Meter With the Check Strip on page 25 If the result is not okay contact customer support at www mydario com If the result is okay test with a new test strip Cannot pierce skin with lancet e The needle depth may be incorrect Adjust the lancet depth lever to a different depth level e The lancet needle may be bent Replace the lancet e The cartridge cover may be in the place of the lancing device cover Please be careful to 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 Replace the lancet with a different Dario lancet If the problem persists you may need to replace the Dario housing Contact customer support at www mydario com Cannot remove the used needle from the lanci
40. results contact customer support Do not rely on the blood glucose measurement alone in making health Warning care decisions STEP ONE INSERTING A NEW LANCET INTO THE LANCING DEVICE Use a new sterile lancet in your lancing device every time you test your Note 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 Note cover 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 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 manner so as not to cause accidental Note injury f LA NK 3 Remove anew lancet from the packaging Do not use the lancet if the cap is missing or damaged Please contact Note customer support at www mydario com 4 Insert a sterile lancet and make sure that it is firmly in place rO Chapter 4 Testing Your Blood Glucose Level Step Two Removing the Glucose Meter From the Housing e Only use a lancet authoriz
41. s is provided in Chapter 7 Technical Information amp Caution 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 10 1 Wash your hands with warm soapy water and dry thoroughly If you use alcohol wipes to cleanse fingers make sure the area is completely dry before lancing finger 2 Remove the Cartridge Cover of the Dario housing by pushing it outwards until it comes off use the removal indication lines Chapter 4 Testing Your Blood Glucose Level Step Three Remove a Test Strip From the Cartridge 3 Snap open the case by pushing up the edge 5 Snap the case closed and replace the housing cover by sliding it into place until it clicks If the cover does not close properly the cartridge may not have been Kets inserted correctly STEP FOUR TESTING YOUR BLOOD GLUCOSE Testing Information and Guidelines e The meter requires only a small drop of blood about the size of a sugar grain 0 3yL to perform the test For best results select a puncture site along the side of a fingertip e Testing blood from sites other than the fingertip may give inaccurate results O Chapter 4 Testing Your Blood Glucose Level Step Three Remove a Test Strip From the Cartridge e If too little bl
42. stent with the way you feel contact customer support at www mydario com Temperature out of range Move to an area between 10 45 C 50 113 F wait 30 minutes and try again The meter was left in an extreme temperature environment Move to a cooler or warmer area wait at least 30 minutes and repeat the measurement with a new strip Dario device failure 0x01 If the problem occurs again please contact Dario s customer support Firmware software failure Contact customer support at www mydario com Dario 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 device is inserted into the smart mobile device s audio connector 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 meter is connected disconnect and reconnect the meter If this message still appears contact customer support at www mydario com Hypo warning Hypoglycemia event occurred You received a measurement result lower than defined in the hypo warning section under Blood Glucose Thresholds see page 46 in your Diabetes Profile Contact your physician immediately Check strip measurement is out of
43. t to follow the instructions in order to prevent an incorrect result or improper treatment Q Do not put any fluid into the test strip port Caution Once you start your Dario app follow the prompts on the screen BLOOD GLUCOSE TESTING PRECAUTIONS The meter test strips and control solutions are only for use outside AN 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 Warning testing your blood glucose Incorrect test results can cause the wrong therapy recommendation to be made and may lead to serious adverse health effects Therefore please follow these instructions carefully Q DARIO Chapter 4 Testing Your Blood Glucose Level Blood Glucose Testing Precautions Test Strip Precautions e Only use Dario test strips Using other test strips with this 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 Run a control test every time you open a new test strip cartridge For additional information see Checking Your Glucose Meter With Dario Control Solutions on page 20 Store unused test strips in their original cartridge Do not remove test strips from the test strip cartridge and put them into another container Close
44. the cartridge tightly right after you remove a test strip This helps keep the test strips dry Be sure to check the Use by date on the test strip cartridge Do not use the test strips after that date Be sure to write down the date the strips were first 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 Use the test strip immediately after removing it from the cartridge Use the test strips as indicated in this guide Do not store your test strips in temperatures below 2 C 36 F or above 32 C 90 F Do not refrigerate your test strips Do not put them in a freezer Do not expose your test strips to direct sunlight moisture or humidity which can damage your test strips and lead to inaccurate results 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 material on the test strip It is recommended to use the test strip immediately after removing it from the cartridge It is recommended not to use a test strip that has been outside of the cartridge for more than three 3 minutes Do not touch the yellow testing site when handling the test strip
45. tion container and apply a drop of control solution to a piece of paper 6 Hold the paper and move it so that the solution touches the tip of the yellow window of the strip 7 Important Verify that enough control solution is applied to fill the window so that it turns red Do not put control solution on top of the test strip O Chapter 3 Checking Your Dario Glucose Meter Checking Your Glucose Meter With Dario Control Solutions When the meter detects that the solution was applied the Measuring message appears The orange rotating in the circle indicates that the test is in progress Hey Mike Measuring 8 The test result appears on the screen after six 6 seconds Read your result and look at the test strip The glucose test result is automatically saved to memory The result appears on the screen and is automatically saved to memory It is possible to delete this control test from memory if desired J For more information refer to the Dario Application User Guide at Note www mydario com 9 When the test is done remove the test strip 10 Compare the results on the meter with the values displayed on the test strip cartridge T11 If the results are e within the acceptable range then your meter is ready for use e outside of the acceptable range perform the test again If the problem recurs contact customer support at www mydario com 12 Disconnect t
46. us low Interference from other electrically driven equipment is not to be anticipated Chapter 7 Technical Information amp Specifications 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 For information about correct disposal please contact your local council or authority 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 Service amp Supplies Repair Policy CHAPTER 8 WARRANTY REPAIRS SERVICE amp SUPPLIES This section provides repair warranty service support and ordering information for your Dario System REPAIR POLICY When under warranty repair and service must be performed by LabStyle Innovation Ltd When the LabStyle Innovation warranty is not applicable repairs may be performed by LabStyle Innovation Ltd or authorized representatives on a parts and labor basis After replacement verify that the unit is fully functional by performing the normal setup procedure Do not remove the covers of the device components Only perform Warning maintenance procedures specifically described in this user guide MANUFACTURERS ONE YEAR WARRANTY It is important to LabStyle Innovati
47. ved your finger as Warning You may receive an inaccurate result 10 The test result appears on the screen after approximately six 6 seconds Read your result 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 A message test strip is used will appear Warning onthe result screen 11 When the test is done remove the test strip Dispose of the test strip as per local regulations for bio hazardous waste 12 Remove the lancet from the lancing device see page 32 Dispose of the used lancet according to local guidelines When the test strip is removed from the glucose meter the message Please insert new test strip appears 13 You may continue to input data into your Dario application For more information refer to the Dario Application User Guide at www mydario com 14 Return the meter to the housing as described in the next section O Chapter 4 Testing Your Blood Glucose Level Step Five Returning the Meter to the Dario Housing STEP FIVE 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 the meter at a angle with the part that connects to the smart mobile device facing aw
48. wing code 2 Search for the Dario app by LabStyle Innovation Ltd Health amp Fitness category and tap on the Dario icon 3 Tap Free and then tap Install 4 Enter your App Store password information as required The application downloads Once installed the orange Dario icon appears on your smart mobile device home screen The Dario app needs to be installed once for each of your smart mobile Kota devices P Updates may be downloaded periodically from the App Store Note OO Chapter 2 Dario System Overview and Features The Dario Application Creating Your Account amp Personalizing Your Settings To setup your Dario App 1 After installing the Dario app on your mobile device click on the orange Dario icon 3 The icon appears on your mobile device Home screen The Dario LOG IN SIGN UP screen appears Q DARIO SIGN UP CONTACT US 2 Select SIGN UP to register as a Dario user 3 Inthe 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 check mark appears 4 Continue by following the instructions on the screen to sign up m Your password must have at least seven characters an upper case Note letter a lower case letter and a number Your e mail address and password will be used for future login to the Note aPP a
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