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Freestyle Libre 14 day User Manual

Flash glucose monitoring system
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User's Manual
FLASH GLUCOSE MONITORING SYSTEM
CAUTION: Federal law restricts this device
to sale by or on the order of a physician.

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Summary of Contents for Freestyle Libre 14 day

  • Page 1 User’s Manual FLASH GLUCOSE MONITORING SYSTEM CAUTION: Federal law restricts this device to sale by or on the order of a physician.
  • Page 2 Your Name _________________________________________________...

  • Page 3: Table Of Contents

    FreeStyle Libre Software . . . . . . . . . . . . . . . . . . .
  • Page 4 Adding Notes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 50 Reviewing Your History .
  • Page 5 Maintenance and Disposal . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 83 Troubleshooting .

  • Page 6: Important Safety Information

    Important Safety Information Indications For Use The FreeStyle Libre 14 day Flash Glucose Monitoring System is a continuous glucose monitoring (CGM) device indicated for the management of diabetes in persons age 18 and older . It is designed to replace blood glucose testing for diabetes treatment decisions .

  • Page 7: Warnings

    • When you are experiencing symptoms that do not match the Sensor glucose readings • During the first 12 hours of wearing a FreeStyle Libre 14 day Sensor • During times of rapidly changing glucose (more than 2 mg/dL per minute) •...

  • Page 8: Cautions And Limitations

    WARNINGS (cont.) • Hypoglycemic unawareness: The System has not been evaluated for use in patients with hypoglycemic unawareness and will not automatically alert you of a hypoglycemic event without you scanning your Sensor . • No alarms without a Sensor scan: The System does not have alarms that will automatically notify you when you are having a severe low (hypoglycemic) or high (hyperglycemic) glucose event unless you scan your Sensor .
  • Page 9 Who should not use the System: • Do not use the System in people less than 18 years of age. The System is not approved for use in people under 18 years of age and Sensor readings in this population may be inaccurate . In general, continuous glucose monitoring systems are recognized to be less accurate in children than in adults .
  • Page 10 • Intense exercise may cause your Sensor to loosen due to sweat or movement of the Sensor . Remove and replace your Sensor if it starts to loosen and follow the instructions to select an appropriate application site . • The System uses all available glucose data to give you readings so you should scan your Sensor at least once every 8 hours for the most accurate performance .
  • Page 11 . What to know before you Apply the Sensor: • The Sensor Pack and Sensor Applicator are FreeStyle Libre packaged as a set (separately from the Reader) Sensor Pack and have the same Sensor code . Check that the...
  • Page 12 that generally stays flat during normal daily activities (no bending or folding) . Choose a site that is at least 1 inch away from an insulin injection site . When is Sensor Glucose different from Blood Glucose: • Physiological differences between the interstitial fluid and capillary blood may result in differences in glucose readings between the System and results from a fingerstick test using a blood glucose meter .
  • Page 13 What to know about X-Rays: • The Sensor should be removed prior to exposing it to an X-ray machine . The effect of X-rays on the performance of the System has not been evaluated . The exposure may damage the Sensor and may impact proper function of the device to detect trends and track patterns in glucose values during the wear period .
  • Page 14 What to know about the Reader’s Built-in Meter: • The FreeStyle Libre 14 day Reader has a built-in blood glucose meter that is designed to be used only with FreeStyle Precision Neo blood glucose test strips and MediSense Glucose and Ketone Control Solution .

  • Page 15: Reader Symbols

    Reader Symbols Symbol What It Means Sensor may be inaccurate . Check blood glucose with a test strip before making any treatment decisions Active Sensor Direction your glucose is going . See Checking Your Glucose section for more information Caution View previous/next screen Notes Add more information to notes...
  • Page 16 Symbol What It Means Time changed on Reader Reminders Blood glucose test Settings Control solution test result Low battery Battery charging Sensor too cold Sensor too hot...

  • Page 17: Getting To Know Your System

    Getting to Know Your System The FreeStyle Libre 14 day Flash Glucose Monitoring System has two main parts: a handheld Reader and a disposable Sensor that you wear on your body . The Sensor does not need to be calibrated with blood glucose values .

  • Page 18: Reader Kit

    Reader Kit The Reader Kit includes: • • • FreeStyle Libre 14 day Power Adapter Quick Start Guide • • Reader User’s Manual Quick Reference Guide • USB Cable • Interactive Tutorial on USB Touchscreen USB Port Used to charge the Reader and connect it to a computer.

  • Page 19: Sensor Kit

    Sensor Kit The Sensor Kit includes: • • Sensor Pack Alcohol wipe • • Sensor Applicator Product insert Sensor Pack Sensor Applicator Used with the Sensor Applicator to Applies the Sensor to your body . prepare the Sensor for use . The Sensor measures and stores glucose readings when worn on your body .
  • Page 20 The Reader Home Screen provides access to information about your glucose and the System . You can press the Home Button to get to the Home Screen . Home Screen Time Battery Level Current time set on Battery charge remaining. the Reader.
  • Page 21 The Sensor Glucose Readings screen appears after you use the Reader to scan your Sensor . Your Reading includes your Current Glucose, a Glucose Trend Arrow indicating which way your glucose is going, and a graph of your current and stored glucose readings . Sensor Glucose Readings Message Add Notes...

  • Page 22: Freestyle Libre Software

    FreeStyle Libre Software FreeStyle Libre software can be used to view reports and change Reader settings . The software is compatible with most Windows and Mac operating systems . Go to www .FreeStyleLibre .com and follow onscreen instructions to download and install the software .

  • Page 23: Setting Up Your Reader For The First Time

    Setting up Your Reader for the First Time Before using the System for the first time, the Reader must be set up . Step Action Press the Home Button to turn on the Reader . If prompted, use the touchscreen to select your preferred language for the Reader .
  • Page 24 Step Action Set the Current Time . Touch next to continue . Current Time CAUTION: It is very important to set the time and date correctly . These values affect the Reader data and settings . back next Set your Target Glucose Range . Work with your Target Glucose Range health care professional to determine your Target...
  • Page 25 Step Action The Reader now displays important information about key topics to help you use the System: • How to understand the Glucose Trend Arrow included on the Glucose Reading screen . • When to do a blood glucose test . •...

  • Page 26: Using Your Sensor

    The Sensor Pack and Sensor Applicator are packaged as a set (separately from the Reader) and have the same Sensor code . Check that the Sensor codes match FreeStyle Libre before using your Sensor Pack and Sensor Sensor Pack Applicator . Do not use Sensor Packs and...

  • Page 27: Applying Your Sensor

    Applying Your Sensor Action Step Apply Sensors only on the back of your upper arm . If placed in other areas, the Sensor may not function properly and could give inaccurate readings . The application of the Sensor is not approved for other sites .
  • Page 28 Action Step Open the Sensor Pack by peeling the lid off completely . Unscrew the cap from the Sensor Applicator and set the cap aside . CAUTION: Do NOT use if the Sensor Pack or the Sensor Applicator seem to be damaged or already opened .
  • Page 29 Action Step The Sensor Applicator is prepared and ready to apply the Sensor . CAUTION: The Sensor Applicator now contains a needle . Do NOT touch inside the Sensor Applicator or put it back into the Sensor Pack . Place the Sensor Applicator over the prepared site and push down firmly to apply the Sensor to your body .
  • Page 30 Action Step Gently pull the Sensor Applicator away from your body . The Sensor should now be attached to your skin . Sensor Note: Applying the Sensor may cause bruising or bleeding . If there is bleeding that does not stop, remove the Sensor and contact your health care professional .

  • Page 31: Starting Your Sensor

    Starting Your Sensor Action Step Press the Home Button to turn on the Reader . Touch Start New Sensor . 10:23pm No Active Sensor Start New Review Sensor History Hold the Reader within 1 .5 inches (4 cm) of the Sensor to scan it .

  • Page 32: Checking Your Glucose

    Checking Your Glucose Step Action Turn the Reader on by pressing 10:23pm the Home Button or touch Ends in 14 days Check Glucose from the Home Check Review Screen . Glucose History Hold the Reader within 1 .5 inches (4 cm) of your Sensor to scan it .
  • Page 33 Step Action The Reader displays your current glucose reading along with your glucose graph and an arrow Glucose Going High indicating the direction your glucose is going . 10am...
  • Page 34 Sensor Glucose Readings Glucose Going Glucose Trend Arrow Check Blood Glucose When you see this symbol, do a blood glucose test before making treatment decisions. Current Glucose Target Glucose Range 10pm Notes: • While Sensor glucose readings are gathered in the System range of 40-500 mg/dL, the graph display range is 0-350 mg/dL for ease of review on screen .
  • Page 35 The Glucose Trend Arrow gives you an indication of the direction your glucose is going . Glucose is rising quickly (more than 2 mg/dL per minute) Glucose is rising (between 1 and 2 mg/dL per minute) Glucose is changing slowly (less than 1 mg/dL per minute) Glucose is falling (between 1 and 2 mg/dL per minute)
  • Page 36 The following table shows messages you may see with your glucose readings . Display What To Do If LO appears on the Reader, your reading is lower Low Glucose than 40 mg/dL . If HI appears on the Reader, your reading is higher than 500 mg/dL .
  • Page 37 Display What To Do If your glucose is projected to be higher than Glucose Going 240 mg/dL or lower than 70 mg/dL within 15 minutes, you will see a message on the screen . You can touch the message button for more Glucose Going information and set a reminder to check your High...

  • Page 38: Making Treatment Decisions

    Making Treatment Decisions Work with your health care professional to put together a plan for managing your diabetes that includes when to use the System information for making treatment decisions . WARNING: The System can replace blood glucose testing except in a few situations .

  • Page 39: Making Treatment Decisions - Getting Started

    Making Treatment Decisions – Getting Started Before you start using the System for treatment decisions, make sure you have a good understanding of how the System works for your body . Continue to use your blood glucose meter for treatment decisions until you are comfortable with the information you receive from your System.
  • Page 40 • Talk to your health care professional about how your insulin works . The more you understand about your insulin, including how long it takes to start working and how long it lasts in your body, the more likely you will be to make better treatment decisions .
  • Page 41 If glucose is rising quickly or falling quickly, you will see the symbol . Whenever you see the symbol, do a blood glucose test and treat based on that result . Glucose Sensor Glucose Rising 80 mg/dL Quickly Blood Glucose 100 mg/dL Blood Glucose 70 mg/dL...
  • Page 42 No Current Glucose Number When there is no Current Glucose number, such as when you receive an error message or a LO or HI result, you don’t have enough information to make a treatment decision . When there is no Current Glucose you will see symbol .
  • Page 43 You Have Low or High Blood Glucose Symptoms Don’t ignore symptoms that may be due to low or high blood glucose . Do a blood glucose test and treat based on that result . Symptoms Don’t Match Readings There may be times when your symptoms don’t match your Sensor glucose readings .

  • Page 44: Making Treatment Decisions - Advanced

    Making Treatment Decisions – Advanced After you scan your Sensor, use all of the information on the screen when deciding what to do or what treatment decision to make. Check Blood Glucose Glucose Trend Arrow When you see this symbol, do a blood glucose test Direction your glucose is going before making a treatment decision Arrow...
  • Page 45 This table provides some information on how you can factor the Glucose Trend Arrow into your treatment decisions . Remember that you should never make a treatment decision based on the Glucose Trend Arrow alone . Treatment Decision Considerations Glucose Trend Low Glucose Glucose in...
  • Page 46 Treatment Decision Considerations Glucose Trend Low Glucose Glucose in High Glucose Arrow (< 70 mg/dL) Target Range (> 240 mg/dL) You will see the If you are about to eat, If you are about to eat, symbol . Do not take insulin to cover take insulin to cover treat based on Sensor...
  • Page 47 Treatment Decision Considerations Glucose Trend Low Glucose Glucose in High Glucose Arrow (< 70 mg/dL) Target Range (> 240 mg/dL) You will see the If you are about to eat, If you are about to eat, symbol . Do not take insulin to cover take insulin to cover treat based on Sensor...
  • Page 48 Example Scenarios Next are some example scenarios to help you understand how to use the information on your screen . Always use all of the information on the screen before deciding what to do or what treatment decision to make . If you are not sure about what to do, consult your health care professional .
  • Page 49 What you see What it means Before breakfast, your current glucose is Before breakfast: 115 mg/dL . The graph shows that your glucose 8:06am Ends in 2 days is going up and so does the trend arrow Consider what might be causing your glucose to go up and what you might do to prevent a high glucose .
  • Page 50 What you see What it means When you checked your glucose before lunch, Before lunch: it was 90 mg/dL and rising . Before eating lunch, 12:00pm Ends in 3 days you took enough insulin to cover the meal and a little more since your trend arrow was 12pm 90 minutes later, your current glucose is After lunch:...
  • Page 51 What you see What it means After exercising, you are feeling shaky, sweaty, After exercising: and dizzy – symptoms you generally get when 5:47pm Ends in 9 days you have low glucose . But, your current glucose is 204 mg/dL . Anytime you get a reading that doesn’t match how you feel, do a blood glucose test .
  • Page 52 What you see What it means After dinner, your current glucose is 215 mg/dL After dinner: but there is no trend arrow . There is also the 7:49pm Ends in 10 days symbol on the screen . Anytime you see the symbol, you should do a blood glucose test before deciding what 11am...
  • Page 53 Other considerations Deciding how much rapid-acting insulin to take for different meals and situations can be difficult . Work with your health care professional to discuss different situations and what might work best for you . Here are some questions to consider: Meal dosing •...
  • Page 54 Bedtime • How often do you check your glucose before bed? • What do you consider a safe bedtime glucose? • What do you do if your bedtime glucose is high? • What do you do if your bedtime glucose is low? •...

  • Page 55: Adding Notes

    Adding Notes Notes can be saved with your glucose readings . You can add a note at the time of your glucose reading or within 15 minutes after your reading was obtained . You can track food, insulin, exercise, and any medication you take .
  • Page 56 Step Action After you check the box for food and Add Notes insulin notes, the symbol appears Rapid-Acting Insulin to the right of the note . You can touch Long-Acting it to add more specific information to Insulin Enter Rapid-Acting Insulin Food your note .

  • Page 57: Reviewing Your History

    Reviewing Your History Reviewing and understanding your glucose history can be an important tool for improving your glucose control . The Reader stores about 90 days of information and has several ways to review your past glucose readings, notes, and other information . Step Action Press the Home Button to turn on...
  • Page 58 Step Action Use the arrows to view the available options . Review History Logbook Daily Graph Daily Patterns Average Glucose Time In Target 1 / 2 Low Glucose Events Sensor Usage IMPORTANT: Work with your health care professional to understand your glucose history .

  • Page 59: Logbook

    Notes you entered . You can add or edit (change) Notes for the most recent Logbook entry, provided your glucose reading was within the last 15 minutes and you have not used FreeStyle Libre software to create reports .

  • Page 60: Daily Graph

    Daily Graph A graph of your Sensor glucose readings by day . Daily Graph (mg/dL) The graph shows your Target Glucose Range and symbols for food or rapid-acting insulin notes you have entered . Notes: • 22 Feb While Sensor glucose readings are gathered in Wednesday the System range of 40-500 mg/dL, the Daily Graph display range is 0-350 mg/dL for ease...

  • Page 61: Other History Options

    Other History Options Use the arrows to view information about your last 7, 14, 30, or 90 days . Information about the average of your Sensor Average Glucose glucose readings . The overall average for the time Average: mg/dL is displayed above the graph . The average is also shown for four different 6-hour periods of the day .
  • Page 62 A graph showing the percentage of time your Time In Target Sensor glucose readings were above, below, or Above within your Target Glucose Range . In Target Below Target Range 80-140 mg/dL Last 7 Days Time In Target Information about the number of low glucose Low Glucose events measured by your Sensor .

  • Page 63: Removing Your Sensor

    Removing Your Sensor Step Action Pull up the edge of the adhesive that keeps your Sensor attached to your skin . Slowly peel away from your skin in one motion . Note: Any remaining adhesive residue on the skin can be removed with warm soapy water or isopropyl alcohol .

  • Page 64: Replacing Your Sensor

    Replacing Your Sensor Your Sensor automatically stops working after 14 days of data and must be replaced . You should also replace your Sensor if you notice any irritation or discomfort at the application site or if the Reader reports a problem with the Sensor currently in use .

  • Page 65: Using Reminders

    Using Reminders You can use Reminders to help you remember to check your glucose, take insulin, or as a general alarm . Action Step From the Home Screen, touch the symbol . 10:23pm Ends in 10 days Check Review Glucose History Touch to select which Type of reminder you want Set Reminder...
  • Page 66 Step Action Set the reminder Time using the arrows on the touchscreen . Touch save . From the Reminders screen, you can turn the Reminders reminder On/Off or add new reminders . 8:30am Touch done to return to the Home Screen . 12:30pm 00:00:00 add new...

  • Page 67: Using The Reader's Built-In Meter

    . Intended Use The FreeStyle Libre 14 day Reader’s built-in meter is for use outside the body only (in vitro diagnostic use) in the quantitative measurement of glucose in fresh whole blood for self testing by lay users from the fingers .
  • Page 68 IMPORTANT: • Use only FreeStyle Precision Neo test strips . Other test strips may produce inaccurate results . • Read all the instructions in this section . Failure to follow instructions may cause incorrect blood glucose results . Practice the testing procedures before using the Reader’s built-in meter .
  • Page 69 IMPORTANT: (cont.) • The Reader is for use by a single person . It must not be used on more than one person including other family members due to the risk of spreading infection . All parts of the Reader are considered biohazardous and can potentially transmit infectious diseases, even after performing the cleaning and disinfection procedure .

  • Page 70: Blood Glucose Testing

    Blood Glucose Testing You can use the built-in meter to check your blood glucose, whether you are wearing a Sensor or not . Be sure to read the test strip instructions for use prior to using the built-in meter . Step Action CAUTION: Test on your fingers in accordance...
  • Page 71 Step Action Check the test strip expiration date . Do not use expired test strips as they may give inaccurate results . Open the foil test strip packet at the notch and tear down to remove the test strip . Use the test strip immediately after removing from the foil packet .
  • Page 72 Step Action Use your lancing device to obtain a blood drop Apply Blood and apply blood to the white area at the end of the test strip . Refer to your lancing device instructions for use if you need help using your lancing device .
  • Page 73 Step Action Note: (cont.) • E-3 means the blood drop is too small, or incorrect test procedure, or there may be a problem with the test strip . • E-4 means the blood glucose level may be too high to be read by the system or there may be a problem with the test strip .
  • Page 74 IMPORTANT: The built-in meter displays results from 20 - 500 mg/dL . Low or high blood glucose results can indicate a potentially serious medical condition . The expected glucose range for a non-diabetic, non-pregnant fasting adult is under 100 mg/dL . Two hours after meals, levels should be less than 140 mg/dL .
  • Page 75 Display What To Do If your glucose is higher than 240 mg/dL or lower Low Glucose than 70 mg/dL, you will see a message on the screen . You can touch the message button for more information and set a reminder to check High Glucose your glucose .

  • Page 76: Control Solution Testing

    Control Solution Testing You should do a control solution test when you are not sure of your test strip results and want to check that your Reader’s built-in meter and test strips are working properly . IMPORTANT: • Control solution results should fall within the control solution range printed on the test strip instructions for use .
  • Page 77 Action Step From the Home Screen, touch the Settings 10:23pm Ends in 10 days . Touch Control Solution Test to do symbol a control solution test . Check Review Glucose History Settings Sounds Target Range Control Solution Test 1 / 3 Check the test strip expiration date .
  • Page 78 Action Step Insert the test strip with the three black lines facing up . Push the strip until it stops . Note: The Reader’s built-in meter turns off after 2 minutes of inactivity . Remove and reinsert the unused test strip to restart the built-in meter . Shake the control solution bottle to mix the Apply Control Solution solution .
  • Page 79 Action Step You will see a butterfly on the screen while you wait for the result . Do not remove the test strip (cont.) while the butterfly is on the screen . If sounds are turned on, the Reader beeps once when the result is ready .
  • Page 80 Control Solution Results 10:23pm Compare the control solution result to the range printed on the test strip instructions for use . The result on your screen should be in this range . Control solution results are marked on Control Solution Test the results screen and in the Logbook with a symbol .

  • Page 81: Charging The Reader

    Charging the Reader A fully charged Reader battery should last up to 7 days . Your battery life may vary depending on your usage . A Low Battery message Low Battery accompanies your result when you have enough charge remaining for about one day of use .

  • Page 82: Changing The Reader Settings

    Changing the Reader Settings You can go to the Settings menu to change many settings on the Reader, like Time & Date or Sounds . The Settings menu is also where you go to do a Control Solution Test or to check the System Status . Action Step To get to the Settings menu, touch the Settings...
  • Page 83 Action Step Touch the setting you want to change: Sounds – Set tones and vibrations Target Range – Set range displayed on Reader glucose graphs Control Solution Test – Perform a Control Solution test Time & Date – Change the Time or Date Language –...
  • Page 84 Action Step • View Event Logs: A list of events recorded by the Reader, which may be used by Customer Service to help (cont.) troubleshoot your System • Perform a Reader Test: The Reader Test will perform internal diagnostics and allow you to check that the Display is showing all pixels, Sounds (including both tones and vibrations) are working, and the Touchscreen is responding when touched...

  • Page 85: Living With Your System

    Living With Your System Your System can be used during a wide variety of activities . Activity What You Need To Know Bathing, The Reader is not water-resistant and should Showering, and NEVER be submerged in water or other liquid . Swimming Your Sensor is water-resistant and can be worn while bathing, showering, or swimming .
  • Page 86 Activity What You Need To Know Traveling by Air You can safely use your System at all times while on an aircraft . • The Reader is classed as a Medical-Portable Electronic Device (M-PED) that meets all required M-PED emission standards for safe use onboard an aircraft: RTCA/DO160, Section 21, Category M .
  • Page 87 Activity What You Need To Know Traveling by Air • The System can be exposed to common electrostatic (ESD) and electromagnetic (cont.) interference (EMI), including airport metal detectors . You can keep your Reader on while going through these . Note: If you are changing time zones, you can change the time and date settings on the Reader by touching the Settings symbol...

  • Page 88: Maintenance And Disposal

    Maintenance and Disposal Cleaning and Disinfecting the Reader Cleaning and disinfecting your Reader is important to prevent the spread of infectious diseases . The Reader has a mean use life of 3 years and has been validated for 156 cleaning and disinfection cycles (the equivalent of 1 cycle per week for 3 years) .
  • Page 89 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 . Use of this device on multiple patients may lead to transmission of Human Immunodeficiency Virus (HIV), Hepatitis C Virus (HCV), Hepatitis B Virus (HBV), or other bloodborne pathogens .
  • Page 90 To clean and disinfect your Reader, you will need Clorox Healthcare Bleach Germicidal Wipes, EPA Reg . #67619-12 . These disinfectant wipes contain a 0 .55% Sodium Hypochlorite (NaOCl) solution and have been shown to be safe for use with the Reader . They may be purchased at major online retailers, such as Walmart .com, Amazon .com, and OfficeDepot .com .
  • Page 91 Step Action For disinfection, use a second bleach wipe to wipe all outside surfaces of the Reader until they are wet . Make sure liquid does not get into the test strip and USB ports . Allow the Reader surfaces to remain wet for 60 seconds . Dry with clean paper towel to remove any residual moisture .
  • Page 92 IMPORTANT: If you require assistance or if you notice any signs of deterioration on the Reader (such as clouding or crazing on the display of the Reader, corroding or eroding of the plastic housing, or cracking of plastic housing or display) or if the Reader does not turn on, discontinue use of the Reader and contact Customer Service at 1-855-632-8658 .

  • Page 93: Troubleshooting

    Troubleshooting This section lists problems or observations that you may have, the possible cause(s), and recommended actions . If the Reader experiences an error, a message will appear on the screen with directions to resolve the error . Reader Does Not Power On Problem What It May Mean What To Do...

  • Page 94: Problems At The Sensor Application Site

    Problems at the Sensor Application Site Problem What It May Mean What To Do The Sensor is The site is not free 1 . Remove the Sensor . not sticking of dirt, oil, hair, or 2 . Consider shaving and/or to your skin .

  • Page 95: Problems Starting Your Sensor Or Receiving

    Problems Starting Your Sensor or Receiving Sensor Readings Display What It May Mean What To Do New Sensor Sensor is not ready Wait until the 60 minute Sensor Starting Up to read glucose . start-up period has completed . Scan The Reader is not Hold the Reader within Timeout...
  • Page 96 Display What It May Mean What To Do Scan Error The Reader Try scanning again . was unable to Note: You may need to move communicate with away from potential sources of the Sensor . electromagnetic interference . Sensor Error The System is Scan again after the duration unable to provide a...
  • Page 97 Display What It May Mean What To Do Glucose Your Sensor is too Move to a location where the Reading hot or too cold . temperature is appropriate and Unavailable scan again in a few minutes . Sensor The Sensor was Your Reader can only be used Already in started by another...

  • Page 98: Blood Glucose Error Messages

    Blood Glucose Error Messages Error What It May Mean What To Do Message The temperature is 1 . Move the Reader and test too hot or too cold strips to a location where the for the Reader to temperature is within the test work correctly .
  • Page 99 Error What It May Mean What To Do Message Blood drop is too 1 . Review the testing small . instructions . 2 . Repeat the test using a new test strip . Incorrect test 3 . If the error reappears, contact procedure .
  • Page 100 Error What It May Mean What To Do Message Blood was applied 1 . Review the testing to the test strip too instructions . soon . 2 . Repeat the test using a new test strip . 3 . If the error reappears, contact Customer Service .
  • Page 101 Error What It May Mean What To Do Message Test strip may be 1 . Check that you are using damaged, used, or the correct test strip for the Reader does not the Reader . (See test strip recognize it . instructions for use to verify your strip is compatible with the Reader) .

  • Page 102: Problems Checking Your Blood Glucose

    . Service . Reader battery is too Charge the Reader . low . The test strip is Insert a new FreeStyle Precision damaged, used, or Neo test strip . unrecognizable by the Reader . Reader is outside Move the Reader to a of its operating temperature between 50 °F and...
  • Page 103 Problem What It May Mean What To Do The test Blood sample is too 1 . See test strip instructions does not small . for use for re-application start after instructions . applying 2 . Repeat the test using a new the blood test strip .

  • Page 104: Perform A Reader Test

    Perform a Reader Test If you think the Reader is not working properly, you System Status can check the Reader by performing a Reader Test . System Info Touch the Settings symbol from the Home Reader Test Screen, select System Status and then select Reader Test .

  • Page 105: System Specifications

    System Specifications See test strip and control solution instructions for use for additional specifications . Sensor Specifications Sensor glucose assay Amperometric electrochemical sensor method Sensor glucose reading 40 to 500 mg/dL range Sensor size 5 mm height and 35 mm diameter Sensor weight 5 grams Sensor power source...
  • Page 106 Sensor data Up to 14 days 8 hours (glucose readings stored every Sensor memory 15 minutes) Operating temperature 50 °F to 113 °F Sensor Applicator and Sensor Pack storage 39 °F to 77 °F temperature Operating and storage 10-90%, non-condensing relative humidity IP27: Can withstand immersion into 3 ft (one meter) of water for up to 30...
  • Page 107 Reader Specifications Blood glucose assay 20 to 500 mg/dL range Reader size 95 mm x 60 mm x 16 mm Reader weight 65 grams Reader power source One lithium-ion rechargeable battery Reader battery life 7 days of typical use Reader memory 90 days of typical use Reader operating 50 °F to 113 °F...
  • Page 108 Reader moisture Keep dry protection Operating and storage -1,250 ft (-381 meters) to 10,000 ft altitude (3,048 meters) 60 seconds (120 seconds when test Reader display timeout strip is inserted) Near Field Communication* (13 .56 MHz Radio Frequency RFID); ASK Modulation; 124 dBuV/m; 1 .5 inch communication range Data port Micro USB...
  • Page 109 . The Sensor and Reader are protected by proprietary data format, memory mapping, and cyclic redundancy check (CRC) generation and verification of data . Quality of Service (QoS): QoS for the FreeStyle Libre 14 day Reader and Sensor wireless communications using the near field communications is assured within the effective range...

  • Page 110: Labeling Symbols

    Labeling Symbols Consult instructions for Use-by date Temperature limit Catalog number Manufacturer Serial number Batch code Keep dry Type BF applied part Non-ionizing radiation Sensor code Caution CODE Sterilized using Do not re-use irradiation MR unsafe Humidity limitation FCC Declaration of Do not use if package Conformity mark is damaged...
  • Page 111 CAUTION: Federal law restricts this device to sale by or on the order of a physician . This product contains electronic equipment, batteries, sharps and materials that may contact bodily fluids during use . Dispose of product in accordance with all applicable local regulations .

  • Page 112: Performance Characteristics

    Performance Characteristics Clinical Study Overview Performance of the FreeStyle Libre 14 day Flash Glucose Monitoring System (the System) was evaluated in a clinical study. The study was conducted at 4 centers with a total of 95 subjects with diabetes (84.2% Type 1, 15.8% Type 2). All subjects were aged eighteen and older. Subjects in the study required insulin to manage their diabetes.
  • Page 113 Agreement with CGM Glucose Levels Agreement between CGM and venous blood was characterized by using paired CGM and Yellow Springs Instrument measurements (YSI). The accuracy of CGM versus YSI reference was assessed by calculating the percentage of System readings that were within 15%, 20%, 30% and 40% for reference values 80 mg/dL and above, and 15 mg/dL, 20 mg/dL, 30 mg/dL and 40 mg/dL for values below 80 mg/dL.
  • Page 114 Agreement on Day 1 against YSI Reference The accuracy of CGM versus YSI reference on the first day of Sensor wear was assessed by calculating the percentage of System readings that were within 15%, 20%, 30% and 40% for reference values 80 mg/dL and above, and within 15 mg/dL, 20 mg/dL, 30 mg/dL and 40 mg/dL for values below 80 mg/dL by hourly intervals.
  • Page 115 Overall Accuracy against YSI reference Accuracy was measured by comparing the absolute relative difference between the System and reference YSI glucose values. The absolute relative difference measures the level of disagreement between the System and the reference value, but does not tell you whether the System glucose value was, on average, higher or lower than the reference glucose value.
  • Page 116 Table 4: Number and Percent of Results within BG Values* CGM Glucose Number of Within Within Within Within Outside Level CGM-Reference ±15% / ±20% / ±30% / ±40% / ±40% / (mg/dL) Pairs ±15mg/dL ±20mg/dL ±30mg/dL ±40mg/dL ±40mg/dL Overall 9234 75.8 87.0 96.1...
  • Page 117 Overall Accuracy against BG values Accuracy was measured by comparing the absolute relative difference between the System and BG values. The absolute relative difference measures the level of disagreement between the System and the BG value, but does not tell you whether the System glucose value was, on average, higher or lower than the BG value.
  • Page 118 Concurrence of System and Reference (CGM vs. YSI) The percentage of concurring glucose values (CGM vs. YSI) in each glucose reference range is presented for each CGM range in Table 6. For example, in the clinical study, when the System glucose results were within the 81 to 120 mg/dL range, actual blood glucose values were less than 40 mg/dL 0% of the time, between 40 and 60 mg/dL 0.1% of the time, between 61 and 80 mg/dL 2.7% of the time, between 81 and 120 mg/dL 68.1% of the time, between 121 and 160 mg/dL 27.7% of the time,...
  • Page 119 Table 6: Concurrence Analysis by Glucose Level YSI Glucose Level (mg/dL) 121- 161- 201- 251- 301- 351- 401- (mg/dL) <40* 40-60 61-80 >500* <40 44.4 33.3 22.2 40-60 31.0 48.3 17.9 61-80 34.0 59.0 81-120 68.1 27.7 0.0 2498 121-160 0.0 71.2 20.7 0.0 2625 161-200 0.0...
  • Page 120 Concurrence Analysis by Glucose Trend Arrow Trend Arrow accuracy of the System, as assessed by concurrence analysis, is presented in Table 7. For example, in the clinical study, when the trend arrow indicated that glucose was changing slowly (-1 to 1 mg/dL/min (g) ), actual glucose levels in the body were falling quickly (i) 0.2% of the time, falling (m) 2.6% of the time, changing slowly (g) 86.6% of the time, rising (k) 4.2% of the time, and rising quickly (h) 0.6% of the time.
  • Page 121 Agreement with ‘LO’ and ‘HI’ CGM Reading against YSI Reference The System reports glucose concentrations between 40 and 500 mg/dL. When the System determines that glucose level is below 40 mg/dL, it will report as ‘LO’ . When the System determines that glucose level is above 500 mg/dL, it will report as ‘HI’...
  • Page 122 Accuracy by Day of Wear The Sensor can be worn for up to 14 days. To show Sensor performance over time, the absolute relative difference between the System and reference YSI glucose values over the wear duration is presented in Table 10. Table 10: Difference Measures by Day (YSI Reference) Number of CGM- Median Absolute...
  • Page 123 The accuracy of CGM versus YSI reference and BG reference was assessed by calculating the percentage of System readings that were within 15%, 20%, 30% and 40% for reference values 80 mg/dL and above, and 15 mg/dL, 20 mg/dL, 30 mg/dL and 40 mg/dL for values below 80 mg/dL.
  • Page 124 System Glucose Availability The System is designed to produce a glucose reading after each user initiated scan that is performed throughout the wear period after the start-up time. Table 12 shows the number of available glucose readings reported by all Sensors and the expected number based on the total number of scan attempts.
  • Page 125 Detection of Hypoglycemic and Hyperglycemic Events Table 13 shows the accuracy of the System’s Glucose Messages in informing the user of low or high glucose events within 15 minutes before or after the true low or high blood glucose value. Percentages are displayed for three different parameters: •...
  • Page 126 Table 13: Detection of Hypoglycemic and Hyperglycemic Events 15 Minute Type of Notification Notification Status Interval Notification of Hypoglycemic Events Detection Rate (%) 77.6 (Low Glucose message) Missed Detection Rate (%) 22.4 False Notification Rate (%) 52.5 Notification of Hyperglycemic Events Detection Rate (%) 84.7 (High Glucose message)
  • Page 127 Precision Precision of the System was evaluated by comparing the results from two separate Sensors worn on the same subject at the same time. Table 14 provides data from two separate Sensors worn on 95 subjects at the same time, providing 15,283 real-time pairs of CGM measurements, with a mean CV of 5.6%.

  • Page 128: Electromagnetic Compatibility (Emc)

    Electromagnetic Compatibility (EMC) • The System needs special precautions regarding EMC and needs to be installed and put into service according to the EMC information provided in this manual. • Portable and mobile RF communications equipment can affect the System. •...
  • Page 129 Guidance and manufacturer’s declaration – electromagnetic emissions The System is intended for use in the electromagnetic environment specified below. The customer or the user of the System should assure that it is used in such an environment. Electromagnetic Emissions test Compliance environment –...
  • Page 130 Guidance and manufacturer’s declaration – electromagnetic immunity The System is intended for use in the electromagnetic environment specified below. The customer or the user of the System should assure that it is used in such an environment. IMMUNITY IEC 60601 Compliance Electromagnetic test...
  • Page 131 IMMUNITY IEC 60601 Compliance Electromagnetic test test level Level environment – guidance Surge ±1 kV ±1 kV Mains power quality should be that differential differential of a typical domestic, commercial, IEC 61000-4-5 mode mode or hospital environment. ±2 kV common ±2 kV common mode mode...
  • Page 132 IMMUNITY IEC 60601 Compliance Electromagnetic test test level Level environment – guidance Power frequency 30 A/m 30 A/m Power frequency magnetic fields (50/60 Hz) should be at levels characteristic magnetic field of a typical location in a typical domestic, commercial, or hospital IEC 61000-4-8 environment.
  • Page 133 IMMUNITY IEC 60601 Compliance Electromagnetic test test level Level environment – guidance Conducted RF 6 Vrms 6 Vrms Portable and mobile RF communications equipment should IEC 61000-4-6 150 kHz to be used no closer to any part of the 80 MHz System, including cables, than the recommended separation distance calculated from the equation...
  • Page 134 IMMUNITY IEC 60601 Compliance Electromagnetic test test level Level environment – guidance Recommended separation Radiated RF 10 V/m 10 V/m distance IEC 61000-4-3 80 MHz to 2.7 GHz 80 MHz to 800 MHz 800 MHz to 2.5 GHz P is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer and d is the recommended separation distance in meters (m).
  • Page 135 Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless) telephones and land mobile radios, amateur radio, AM and FM radio broadcast and TV broadcast cannot be predicted theoretically with accuracy. To assess the electromagnetic environment due to fixed RF transmitters, an electromagnetic site survey should be considered. If the measured field strength in the location in which the System is used exceeds the applicable RF compliance level above, the System should be observed to verify normal operation.
  • Page 136 Recommended separation distances between portable and mobile RF communications equipment and the System The System is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The customer or the user of the System can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and the System as recommended below, according to the maximum output power of the communications equipment.
  • Page 137 For transmitters rated at a maximum output power not listed above, the recommended separation distance d in meters (m) can be estimated using the equation applicable to the frequency of the transmitter, where P is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer.
  • Page 138 Font License ©2013 Abbott Licensed under the Apache License, Version 2 .0 (the “License”); you may not use this file except in compliance with the License . You may obtain a copy of the License at: http://www .apache .org/licenses/LICENSE-2 .0 Unless required by applicable law or agreed to in writing, software distributed under the License is distributed on an “AS IS”...

  • Page 139: Limited Warranty

    Limited Warranty We hope that you are happy with your FreeStyle Libre 14 day system . Please refer to the User’s Manual before using your Reader for the first time . Abbott Diabetes Care (“Abbott”) warrants that the FreeStyle Libre 14 day reader (“Reader”) shall be free from defects in material and workmanship for a period of...
  • Page 140 Your Rights Under State Law: This Limited Warranty gives you specific legal rights, and you may also have other rights that vary from state to state . FreeStyle, Libre, and related brand marks are trademarks of Abbott Diabetes Care Inc . in various jurisdictions .
  • Page 141 References: “FDA Public Health Notification: Use of Fingerstick Devices on More than One Person Poses Risk for Transmitting Bloodborne Pathogens: Initial Communication” (2010) http://www .fda .gov/MedicalDevices/Safety/AlertsandNotices/ucm224025 . “CDC Clinical Reminder: Use of Fingerstick Devices on More than One Person Poses Risk for Transmitting Bloodborne Pathogens”...
  • Page 142 Customer Service: 1-855-632-8658 Monday through Friday, 8AM to 8PM Eastern Standard Time www.FreeStyleLibre.com FreeStyle, Libre, and related brand marks are trademarks of Abbott Diabetes Care Inc. in various jurisdictions. Other trademarks are the property of their respective owners. Patent: https://www.abbott.com/patents Manufacturer:...

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