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Summary of Contents for LabStyle Dario LC
- Page 1 Dario® Blood Glucose Monitoring Systems User Guide Applicable to meters models: 1021-04 Dario with Lightning connector (in US - Dario® LC) 1021-06 Dario with USB-C connector (in US -Dario® USB-C)
- Page 2 8 Hatokhen St. North Industrial Park Caesarea 3088900, Israel www.mydario.com Dario® is a trademark of LabStyle Innovation® Ltd . European Patent application number 11780305.6 United States: Product is covered by one or more patents and/or patent applications – the list is detailed at the Dario website at www.mydario.com.
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Page 3: Table Of Contents
Table of Content: CHAPTER 1 INTRODUCTION AND IMPORTANT SAFETY INSTRUCTIONS ..............6 ......6 LUCOSE ONITORING FOR A OBILE ............7 UIDE COPE ..............7 NTENDED ............8 YSTEM IMITATIONS ........9 MPORTANT AFETY NSTRUCTIONS ......11 EFORE ESTING WITH THE ARIO YSTEM ............11... - Page 4 ......38 ERFORMING A ONTROL OLUTION CHAPTER 4 TESTING YOUR BLOOD GLUCOSE LEVEL ..44 .......44 LOOD LUCOSE ESTING RECAUTIONS ...........45 TRIP RECAUTIONS ..47 ACTORS NTERFERE WITH LOOD LUCOSE ESTING ..........48 NTERPRETING THE ESULTS .............48 EASUREMENT ANGE ....50 ACTORS EAD TO NACCURATE ESULTS NSERTING A ANCET INTO THE...
- Page 5 ............79 ROBLEM OLVING “P ” EST STRIP INSERTED BUT LEASE INSERT A NEW STRIP KEEPS ..........79 APPEARING ON THE SCREEN .........80 OU CANNOT PIERCE SKIN WITH LANCET . 80 HE LANCET DOES NOT FIT CORRECTLY INTO THE LANCING DEVICE .
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Page 6: Chapter 1 Introduction And Important Safety Instructions
CHAPTER 1 INTRODUCTION AND IMPORTANT SAFETY INSTRUCTIONS Glucose Monitoring for a Mobile Age Congratulations on your choice of the Dario System. The Dario System was created to make life easier for people with diabetes by providing the right tools, information, and support in your pocket. It is a smart phone-based monitoring system, featuring a pocket- sized meter with an integrated lancing device and test strips, combined with an easy-to-use mobile... -
Page 7: User Guide Scope
User Guide Scope The user guide is covering the use of the Dario LC and USB-C Blood Glucose Monitoring System with the following meter models: Dario LC (model 1021-04) for use with selected iPhone mobile devices with Lightning connector Dario USB-C (model 1021-06) for use with... -
Page 8: System Limitations
fingertips. The Dario with Lightning connector (in US - Dario® LC) and Dario with USB-C connector (in US - Dario® USB-C) Blood Glucose Monitoring System is intended to be used by a single person and should not be shared. The Dario with Lightning connector (in US - Dario® LC) and Dario with USB-C connector (in US -Dario®... -
Page 9: Important Safetyi
• Testing glucose from sites other than the fingertip • Testing patients who are critically ill, in shock, or dehydrated Certain health conditions, such as serious illness and dehydration, can cause false test results in glucose meters. You should not use this system to test your blood glucose if you are critically ill. - Page 10 This device is not intended for use in healthcare or assisted-use settings such as hospitals, physician offices, or long-term care facilities because it has not been cleared by FDA for use in these settings, including for routine assisted testing or as part of glycemic control procedures.
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Page 11: Before Testing With The Safety Definitions
them before and after every test. Unwashed hands may lead to inaccurate results. Make sure there is no grease, oil ,or lotion on the fingertip. Use lancets only once. Do not use any lancet or lancing device that has been used by another person . -
Page 12: Practices Used Int
Cautions A Caution indicates precautions you need to take to prevent damage to your monitoring system . Do not proceed beyond a Caution message until you fully understand and observe the indicated conditions . Notes Notes provide additional information for the purpose of clarification . - Page 13 System response that occurs as a result of pressing a button or performing a task. Bold Italics Emphasize important information. Symbol Description Manufacturer Dario System LabStyle Under Directive Innovation Ltd. 0344 IVDD 98/79/EC Beijing Sterile Lancets Ruicheng Under Directive Medical...
- Page 14 The following table lists and describes the symbols that appear throughout this guide, on packaging or package inserts, or on the actual system parts. Symbol Description Symbol Description LabStyle Innovation Dario logo Ltd. logo Consult instructions Do not use if package for use is damaged...
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Page 15: General Precautions
• 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... -
Page 16: Additional Information
Additional Information For your safety, observe the following recommendations when monitoring your blood glucose using the Dario System : • It is recommended that you have a backup testing method available. Failure to test could cause a delay in treatment decisions and lead to a serious medical condition. -
Page 17: Chapter 2 Dario System Overview And Features
CHAPTER 2 DARIO SYSTEM OVERVIEW AND FEATURES This chapter provides an overview of the Dario System components and describes how to set up the Dario System for the first time . Your Dario System at a Glance The Dario System is a cloud-based diabetes management solution that combines software applications with a stylish all-in-one device. -
Page 18: Dario Components
Dario Components The Dario System components are shown in the image below and described in the following table. - Page 19 Component Description The miniature glucose meter consists of Glucose Meter the following components: (A) Dario meter • A connector that is plugged into the (B) Dario meter port of your smart mobile device • A strip port for insertion of the test release panel strip The glucose meter receives its power...
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Page 20: Monitoring System
Compatible Platforms with the Dario Blood Glucose Monitoring System The Dario LC and Dario USB-C Glucose Meters use smart phone technology to view and store unlimited numbers of glucose test results. You can also track other diabetes information and view graphs and... -
Page 21: Dario System Kitc
The Dario LC System is compatible for use on iOS smart mobile devices. The Dario LC Glucose Meter currently works with the following Apple® iPhone® devices running iOS 10, 11, 12,13 and iPhone devices: 5, 5s, SE, 6, 6 Plus, 6s, 6s Plus, 7, 7 Plus, 8, 8 Plus, X, XR, Xs, Xs Max, 11, 11 Pro and 11 Pro Max. - Page 22 Dario® USB-C) Blood Glucose Monitoring System Quick Guide • Dario with Lightning connector (in US - Dario® LC) and Dario with USB-C connector (in US - Dario® USB-C) Blood Glucose Monitoring System User Guide • Dario Test Strips (not provided within Dario welcome kit) The Dario System also includes the following components that are sold separately:...
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Page 23: Getting Started With The Assembling The Dario
• Canada: toll-free at 1-800-461-0991 or www.mydario.ca 3. Dario System components and accessories (e.g., test strips, lancets, control solution, disposable covers) can be ordered from: • Your local Dario representative. • Selected pharmacies. • From the Dario App. • By contacting customer support: •... -
Page 24: Inserting The Tests
• Insert a test strip cartridge, as described in Inserting the Test Strip Cartridge on page • Insert a lancet, as described in Inserting a Lancet on page • Set the lancet depth, if desired, as described in Setting Lancet Depth (Optional) on page •... -
Page 25: Inserting A Lancet
3. Hold the test strip cartridge with the side that opens facing up, as shown in the image below. 4. Insert the cartridge into the housing until it snaps into place . 5. Return the white housing cover by sliding it into place until it clicks, as shown in the image below. - Page 26 4. Insert a sterile lancet as far as it will go and ensure it is firmly set. • Only use a lancet authorized by LabStyle Innovation Ltd. (30G) • If the lancet does not set into place or the...
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Page 27: (Optional )
• Canada: toll-free at 1-800-461-0991 or www.mydario.ca 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 the lancet by moving the lever between the numbers 1 and 4 (printed on the dial). -
Page 28: The Dario App
2. Replace the lancing device cover by sliding it into place until it clicks. Be careful not to touch or bend the lancet. The Dario App The Dario App is available on the App Store for iPhone and on Google Play for Android devices. For full list of compatible devices, refer to the list of devices in Compatible Platforms with the Dario... - Page 29 Android). 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 Innovation Ltd. 3. Install the App. 4. Follow the registration flow as shown on App.
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Page 30: Creating Youra
The Dario App needs to be installed once on each of your smart mobile devices. Updates may be downloaded periodically from the App Store or Google Play. 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 . -
Page 31: Setting Yourp
Your email address and password will be used to log in to the Dario App and the Dario web portal. If you already have a Dario account, you can skip the next steps. 4. Press Create Account when done. The First Entry screen appears, as shown in the image below. - Page 32 3. Enter your gender, weight, height, and date 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 select SETTINGS >...
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Page 33: Chapter 3 Checking Your Dario Glucose Meter
CHAPTER 3 CHECKING YOUR DARIO GLUCOSE METER This chapter provides information on checking the accuracy of your meter with a control solution. To ensure that your results are always accurate, you need to check the performance of your meter in the following cases: •... -
Page 34: Est Principle
• The dye in the control solution may stain skin, clothing, or surfaces • Store the control solution in an area where the temperature is between 46°F-86°F (8°C-30°C). Keep away from direct sunlight, fluorescent light, and heat • Do not freeze •... -
Page 35: Chemical Composition
result within the expected range to verify system performance. A result outside the range printed on the test strip cartridge label may indicate the system is not performing correctly. The control solution is not for use as a cleaning solution. Chemical Composition Dario Control Solution is an aqueous solution that contains d-glucose as the reactive ingredient in the... - Page 36 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 the meter can get warm which can affect the accuracy of the reading.
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Page 37: Meter From The Housing Trip From The Cartridge
device port. For a list of compatible devices, refer to - • USA: www.mydario.com/support/getting- started / • Canada: www.mydario.ca/support/getting- started/ Removing a Test Strip from the Cartridge You should have a test strip cartridge already inserted in your Dario Housing. If this is not the case, refer to Inserting the Test Strip Cartridge on page... -
Page 38: Performing A Control Solution Test
3. Remove a test strip from the cartridge, as shown in the image below. 4. Close the cartridge cap immediately and return the white cartridge cover to the closed position by pushing it into place until it clicks. You should use the test strip immediately after removing it from the cartridge. - Page 39 The First Entry screen appears, as shown in the image below. 2. Insert the meter into the port of your smart mobile device, as shown in the image below. A “Connecting...” message appears in the Dario App and then the screen displays the following instruction: INSERT A NEW STRIP The Dario Meter should The screen...
- Page 40 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 . Verify the test strip direction, as shown in the image below. The Dario App screen instructs you to place a drop of blood on the test strip, as shown in the image below.
- Page 41 When the meter detects the solution “Measuring...” message appears. The orange rotating in the circle indicates that the test is in progress, as shown in the image below. The glucose test result appears on the screen after six (6) seconds and is automatically saved to memory .
- Page 42 • USA: toll-free Monday to Friday, 9:00AM – 5:00PM EST at 1-800-895-5921 or www.mydario.com • Canada: toll-free at 1-800-461-0991 or www.mydario.ca 7. When the test is done, remove the test strip and follow your health care provider’s instructions for disposal . 8.
- Page 43 10. Place the meter back into the housing by holding the meter at an angle with the part that connects to the smart mobile device facing away from the ridged orange panel. Then, push the meter into the housing at an angle and push downwards until the meter clicks into place.
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Page 44: Chapter 4 Testing Your Blood Glucose Level
CHAPTER 4 TESTING YOUR BLOOD GLUCOSE LEVEL The Dario Glucose Meter measures the amount of glucose in your blood. Once you place a small drop of blood from your fingertip onto the test strip, the result will display in six (6) seconds on the screen in the Dario App . -
Page 45: Test Strip Precautions
for Transmitting Bloodborne Pathogens” (2010). You can find this document at www.cdc.gov. The meter and lancing device are for single- patient use only. Do not share them with anyone including other family members. Do not use on multiple patients. It is advised that you wash your hands thoroughly with soap and warm water before and after handling the meter, lancing device, or test strips . - Page 46 • 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 the cartridge tightly right after you remove a test strip. This helps to keep the test strips dry •...
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Page 47: Factors That Interfere With Blood Glucose Testing
• Do not get dirt, food, or other substances on the test strip • It is recommended that you use the test strip immediately after removing it from the cartridge. It is not recommended that you use a test strip that has been outside of the cartridge for more than three (3) minutes •... -
Page 48: Interpreting The Results
hyperglycemic-hyperosmolar state, hypoxia, and diabetic ketoacidosis). Unwashed hands could affect your results. Alcohol can affect test results . Interpreting the Results If the displayed test result is consistent with how you feel, continue as instructed by your health care provider . If the test result is inconsistent with how you feel, check your Dario System by running a control solution check, as described in... - Page 49 Results outside of this range should be reviewed according to the following information . • If your test result is lower than 20 mg/dL (1.1 mmol/L), “LOW! Measure with a new strip, if recurs contact your physician immediately” displays instead of a result LOW may indicate that your blood glucose is very low (possibly severe hypoglycemia).
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Page 50: Factors That May Lead To Inaccurate Results
Two hours after meals (OGTT) < 140 mg/dL (7.8 mmol/L) Reference: American Diabetes Association (2017). Standards of Medical Care in Diabetes – 2017. Diabetes Care, 40 (Supplement 1): S1-S132. 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. -
Page 51: Step One: Inserting A New Lancet Into The Lancing Device
• USA: toll-free Monday to Friday, 9:00AM – 5:00PM EST at 1-800-895-5921 or www.mydario.com • Canada: toll-free at 1-800-461-0991 or www.mydario.ca Do not rely on the blood glucose measurement alone in making health care decisions. Step One: Inserting a New Lancet into the Lancing Device To prevent infection, always use a new, sterile lancet in your lancing device each time you... -
Page 52: Step Three ( Relevant To The Us Market Only ): Inserting The Smart Mobile Device Into The Disposable Cover
Step Three (relevant to the US market only): Inserting the Smart Mobile Device into the Disposable Cover Before starting the testing procedure, you should cover your phone with a disposable cover. To avoid the risk of transmitting bloodborne pathogens, it is recommended that you use a disposable sleeve to cover your smart mobile device while taking the blood glucose test. -
Page 53: Step Five: Testing Your Blood Glucose
Place the glucose meter connector into the smart mobile device port at the bottom of the disposable cover. Verify that the meter is inserted as far as it goes into the port of the smart mobile device and no other device or cable is connected to the smart mobile device. - Page 54 • While applying blood to the test strip, verify that you apply enough blood to fill the test strip window so that it turns completely red • Testing blood from sites other than the fingertip may generate inaccurate results • If you have not applied enough blood to the test strip, an alert displays that informs you that the sample size is too small and you should try again with a new strip.
- Page 55 In case of a test strip error you may need to replace the test strip and test with a new test strip. Removing a Test Strip from the Cartridge You should have a test strip cartridge already inserted in your Dario Housing. If this is not the case, refer to Inserting the Test Strip Cartridge...
- Page 56 4. Remove a test strip from the cartridge, as shown in the image below. 5. Close both the lid and cartridge cover. If the cover does not close properly, you may not have inserted the cartridge correctly. 6. Hold the test strip with the gold contacts facing upward.
- Page 57 Performing a Glucose Test If you receive a phone call while the glucose measurement is in progress, Dario will stop the test and the results will not be saved. To avoid interruption of the glucose test, you can set your phone to airplane mode before beginning this procedure.
- Page 58 3. Apply a drop of blood to the tip of the yellow window of the test strip, as shown in the images below. Capillary action will pull the blood into the strip. Important: Continue applying blood to the test strip until the window turns red, which indicates that enough blood has been collected to take a reading.
- Page 59 When the meter detects that blood has been applied, the “Measuring...” message appears in the Dario App. The border of the circle gradually fills with orange, indicating that the test is in progress. 4. Remove your finger from the strip once the above message appears.
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Page 60: Tep Ix Eturning The Eter To The Ario Ousing
strip. To avoid an interruption of your glucose test, you may want to set your smart mobile device to airplane mode prior to starting your test. 6. You may continue to complete the information about the glucose measurement that displays on the Dario App screen (e.g., measurement setting, carb consumption, exercise, insulin intake). -
Page 61: Test Strip Limitations
Test Strip Limitations If you are taking acetaminophen containing drugs (e.g. Tylenol) or Vitamin C (ascorbic acid) you may get inaccurate results with this system. If you have a disease or condition in which uric acid levels in your blood may be elevated (> 11 mg/dL), such as gout, you may get inaccurate results with this system. -
Page 62: Chapter 5 Cleaning And Maintenance
CHAPTER 5 CLEANING AND MAINTENANCE This chapter provides information for cleaning and disinfecting for your Dario Glucose Monitoring System. The Dario System should be cleaned and disinfected once a week. The Dario System should be properly maintained for safe and accurate use. The meter should be properly cleaned and disinfected to prevent the spread of infectious diseases. -
Page 63: Step 1: Cleaning
orange lancet cover and white cartridge cover, or test strips. Step 1: Cleaning Clean the meter, housing, orange lancet cover, and white cartridge cover using a disinfection wipe: • In the USA - use a Super Sani-Cloth • In Canada – use Germidice These wipes have been proven safe for use with the Dario meter, housing, orange lancet cover, and white cartridge cover. - Page 64 • Disinfect the meter on all four (4) surfaces by wiping up and down at least two (2) times to each direction, as shown in the images on the following page. Do not allow any moisture to get into the test strip port •...
- Page 65 To ensure effective disinfection, let the solution sit on the meter, housing, orange lancet cover, and white cartridge cover for at least two (2) minutes. Allow the meter, housing, orange lancet cover, white cartridge cover and cartridge cap to completely dry before use.
- Page 66 If you notice changes in appearance (such as color fading, cracking, discoloration or display malfunctions) or you are obtaining results that are not accurate, stop using the meter or lancing device and call customer support: • USA: toll-free Monday to Friday, 9:00AM – 5:00PM EST at 1-800-895-5921 or www.mydario.com •...
- Page 67 Do not: • Allow any moisture to get into the test strip port • Spray any cleaning solution directly onto the glucose meter or the lancing device • Submerge any part of the Dario System in liquid • Attempt to clean any internal parts •...
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Page 68: Chapter 6 Test Strips
When the chamber is full the Dario, Dario LC and Dario USB-C meters start to measure the blood glucose level. It is a simple and practical system for the daily monitoring of your blood glucose level. -
Page 69: Reagent Composition (Per Strip)
2. Keep the test strip port free of dust. 3. The test strip is sensitive to humidity, keep it in 10%-90% Relative Humidity and cool environment. 4. Do not store in direct sunlight. 5. After pulling out the test strip from its cartridge, seal the cap of the cartridge tightly to protect test strips. -
Page 70: System Limitations
• Dario Blood Glucose Test strips should be used with Dario/Dario LC/Dario USB-C meters only • Insert a test strip into the test strip port in the glucose meter with gold-colored bars facing up and toward the meter • A test strip is sensitive to humidity. Therefore, you... -
Page 71: Performing A Test
• Consult with your healthcare professional for the blood glucose range that is appropriate for you Test Result Range The Dario, Dario LC and Dario USB-C meters read blood glucose results between 20-600 mg/dL (1.1- 33.3 mmol/L). Unexpected Results High or low blood glucose results can indicate potentially serious medical conditions. -
Page 72: Control Of The Unexpected Results
mg/dL (33.3 mmol/L). You may have high blood glucose • If “Low! Measure with a new strip, if recurs contact your physician immediately” is displayed, your blood glucose result may be lower than 20 mg/dL (1.1 mmol/L). You may have low blood glucose Control of The Unexpected Results If your blood glucose result seems unusually high,... -
Page 73: Checking By A Control Solution
• Was the test strip used before the expiration date? • Were the test strips stored at extreme temperatures such as in the car during very cold or hot weather? • Were the test strips stored in areas of high humidity such as the kitchen or the bathroom? Checking by a Control Solution Control solution test... -
Page 74: Control Solution Procedure
Test control solution at 64-86°F (18-30°C) environment. Control Solution Procedure To conduct a control solution test, refer to Performing a Control Solution Test on page 38. Understanding Your Control Solution Test • If your glucose control solution test result is within the acceptable range, you can feel confident that your test strips and meter are working correctly •... - Page 75 accuracy of this product, the product is used outside of the control of the Manufacturer and Distributor and the result may accordingly be affected by environmental factors and / or user error. A person who is the subject of the test should consult a doctor for further confirmation of the result.
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Page 76: Chapter 7 Troubleshooting
CHAPTER 7 TROUBLESHOOTING This chapter provides information about all the symbols and error messages that may display in the Dario App. To ensure safe and accurate use of Dario, pay attention to all symbols and messages that occur while using the system as they provide you with important information. -
Page 77: Troubleshooting
Troubleshooting The following table lists some typical conditions that may occur with the Dario System. Message Content Possible Cause / Recommended Action There is not enough blood on Insufficient blood the test strip. detected, try again Repeat the measurement with with a new strip a new test strip. - Page 78 Message Content Possible Cause / Recommended Action LOW! Measure Glucose level is below operating with a new strip, if range recurs contact Measurement result is below your physician 20 mg/dL (1.1 mmol/L). Repeat immediately the measurement with a new test strip. If this message recurs, contact your health care provider Immediately.
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Page 79: Problem Solving
Message Content Possible Cause / Recommended Action Unknown device, Another device is connected to please connect your smart mobile device’s Dario. Lightning or USB-C port. If another device is connected to the Lightning or USB-C port, disconnect it and connect the Dario Glucose Meter. -
Page 80: You Cannot Pierce Skin With Lancet
Dario Control Solutions on page 35). If the result is outside of the acceptable target values, contact customer support: • USA: toll-free Monday to Friday, 9:00AM – 5:00PM EST at 1-800-895-5921 or www.mydario.com • Canada: toll-free at 1-800-461-0991 or www.mydario.ca If the result is within the acceptable target values, test your glucose again with a new test strip. -
Page 81: Cannot Remove The Used Needle From The Lancing Device
• USA: toll-free Monday to Friday, 9:00AM – 5:00PM EST at 1-800-895-5921 or www.mydario.com • Canada: toll-free at 1-800-461-0991 or www.mydario.ca Cannot remove the used needle from the lancing device. The lancet may be faulty or you may be using a lancet that is not approved for use with the Dario System. -
Page 82: Lancing Device Release Button Does Not Work Properly
• Canada: toll-free at 1-800-461-0991 or www.mydario.ca Lancing device release button does not work properly. The lancing device is faulty. Replace the Dario Housing. Contact customer support: • USA: toll-free Monday to Friday, 9:00AM – 5:00PM EST at 1-800-895-5921 or www.mydario.com •... -
Page 83: Chapter 8 Technical Information And Specifications
CHAPTER 8 TECHNICAL INFORMATION AND SPECIFICATIONS This chapter provides technical information about 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). - Page 84 concentrations <5.5 mmol/l (100 mg/dl)or within ±15% at glucose concentrations ≥5.5 mmol/l (100 mg/dl). Results were calculated across all data points and are summarized below: ® Accuracy: Dario LC BGMS (Dario with Lightning connector) For glucose concentrations <5.5 For glucose concentrations ≥ 5.5 mmol/l (100mg/dL) mmol/l (100mg/dL) Within ±...
- Page 85 Precision* The criteria are within 95% for standard deviation (STD) 3mg/dL (0.15 mmol/dl) at the below 100mg/dL (5.55mmol/L), for coefficient of variation (CV) 4% at the above 100mg/dL (5.55mmol/L). The precision studies using control solution (Intermediate Precision) and blood (Repeatability Precision) are shown below.
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Page 86: Technical Specifications
Repeatability Precision: Dario® LC BGMS 1.7-2.8 2.9-6.1 6.2-8.3 8.4-13.9 14.0 - Glucose mmol/L mmol/L mmol/L mmol/L 22.2 Concentrati (30- 50 (51-110 (111- (151-250 mmol/L on range mg/dL) mg/dL) mg/dL) (251- mg/dL) mg/dL) 2.75 5.74 7.41 10.89 19.39 Average mmol/L mmol/L mmol/L mmol/L mmol/L... -
Page 87: Compliance With Electrical And Safety Standards
Meter Specifications Operating Relative 15-85% Humidity Altitude Up to 10,000 feet (3,048meters) Unlimited results. Memory is Memory limited to smart mobile device memory From the smart phone or mobile Power Source device 1.3 x 0.63 x 0.39 in Meter Size (32.9 x 16.1 x 9.9 mm) Weight 40 gram (1.4 oz.) -
Page 88: Disposing Of Used Products
The Health Insurance Portability and Accountability Act of 1996 (“HIPPA”) privacy rule provides guidance on security standards for the protection of EPHI (Electronic Protected Health Information), Labstyle Innovation Ltd. has performed a risk analysis and has implemented the standard and applicable security... - Page 89 Security Rule and HITECH Act requirements for breach notification. Labstyle Innovation Ltd. ongoing compliance program includes policies and procedures for secure cloud operations. Labstyle Innovation uses commercially reasonable standards of technology and operational security to protect users’ glucose measurements data within the Dario App and cloud servers.
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Page 90: Chapter 9 Warranty, Repairs And Supplies
Manufacturer’s One Year Warranty It is important to LabStyle Innovation Ltd. that you are completely satisfied with your Dario 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 the date of the original purchase. -
Page 91: Supplies And Accessories
This warranty only applies to the original purchaser of the meter and/or its agents. Supplies and Accessories Dario System supplies and accessories are available from LabStyle Innovation Ltd. or from customer support. Item Catalog Number System 1138-02 –... -
Page 92: Contact Customer Support
Contact Customer Support You may contact customer support with any questions or issues about Dario and its accessories using one of the following methods: • By phone: • USA: toll-free Monday to Friday, 9:00AM – 5:00PM EST at 1-800-895-5921 or www.mydario.com •...
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