Reader Symbols Symbol What it Means 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 Food note Rapid-acting insulin note...
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Symbol What it Means Time changed on Reader Reminders Blood glucose or ketone test Settings Control solution test result Low battery Battery charging Sensor too cold Sensor too hot...
Indications for Use The FreeStyle Libre Flash Glucose Monitoring System Reader (“Reader”) when used with a FreeStyle Libre System Sensor (“Sensor”) is indicated for measuring interstitial fluid glucose levels in people (age 4 and older) with diabetes mellitus . The Reader and Sensor are designed to replace blood glucose testing in the self-management of diabetes, including dosing of insulin .
. If you are experiencing symptoms that are not consistent with your glucose readings, consult your health care professional . • The FreeStyle Libre Flash Glucose Monitoring System (‘System’) contains small parts that may be dangerous if swallowed .
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CAUTION: • On rare occasions, you may get inaccurate Sensor glucose readings . If you believe that your glucose readings are not correct or are inconsistent with how you feel, perform a blood glucose test on your finger to confirm your glucose . If the problem continues, remove the current Sensor and apply a new one .
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System-Related Information • The Reader is designed to be used only with FreeStyle Optium blood glucose and blood ketone test strips and MediSense control solution . • Avoid getting dust, dirt, blood, control solution, water or other substances in the Reader’s USB and test strip ports . •...
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• If you have a medical appointment that includes strong magnetic or electromagnetic radiation, for example an X-ray, MRI (Magnetic Resonance Imaging) or CT (Computed Tomography) scan, remove the Sensor that you are wearing and apply a new one after the appointment .
Getting to Know Your System The FreeStyle Libre Flash Glucose Monitoring System (‘System’) has two main parts: a handheld Reader and a disposable Sensor that you wear on your body . You use the Reader to wirelessly scan the Sensor and get your glucose readings .
Reader Kit The Reader Kit includes: • • • FreeStyle Libre Power Adaptor Quick Start Guide • • Reader User’s Manual Performance Data • USB Cable Insert Touchscreen USB Port Used to charge the Reader and connect it to a computer.
Sensor Kit The Sensor Kit includes: • • Sensor Pack Product Insert • Sensor Applicator 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 .
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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.
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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...
Data Management Software To upload data from the Reader, please visit www .FreeStyleLibre .com and find out more about the data management software that you can use .
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 .
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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...
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Step Action The Reader now displays important information about two key topics to help you use the system: • How to understand the Glucose Trend Arrow included on the Glucose Reading screen . • How to return to the Home Screen from any other screen . When you scan your Sensor an arrow will indicate your recent glucose trend:...
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 FreeStyle Libre match before using your Sensor Pack and Sensor Pack Sensor Applicator . Sensor Packs and Sensor...
Applying Your Sensor Action Step Apply Sensors only on the back of your upper arm . Avoid areas with scars, moles, stretch marks or lumps . Select an area of skin that generally stays flat during your normal daily activities (no bending or folding) .
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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 .
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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 .
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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 apply a new one at a different site .
Starting Your Sensor Action Step Press the Home Button to turn on the Reader . Touch Start New Sensor . 22:23 No Active Sensor Start New Review Sensor History Hold the Reader within 4 cm (1 .5 inches) of the Sensor to scan it .
Checking Your Glucose Step Action Turn the Reader on by pressing 22:23 the Home Button, or touch Ends in 14 days Check Glucose from the Home Check Review Screen . Glucose History Hold the Reader within 4 cm (1 .5 inches) of your Sensor to scan it .
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Step Action The Reader displays your current glucose reading along with your glucose graph and an arrow Glucose Going indicating the direction your glucose is going . mmol 14:00 18:00 22:00...
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Sensor Glucose Readings Glucose Going Glucose Trend Arrow mmol Current Glucose Target Glucose Range 14:00 18:00 22:00 Notes: • The graph displays glucose readings up to 21 mmol/L . Glucose readings above 21 mmol/L are displayed at 21 mmol/L . •...
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The Glucose Trend Arrow gives you an indication of the direction your glucose is going . Glucose is rising quickly (more than 0 . 1 mmol/L per minute) Glucose is rising (between 0 .06 and 0 . 1 mmol/L per minute) Glucose is changing slowly (less than 0 .06 mmol/L per minute) Glucose is falling...
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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 2 .2 mmol/L . If HI appears on the Reader, your reading is higher than 27 .8 mmol/L .
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Display What to Do If your glucose is projected to be higher than Glucose Going 13 .3 mmol/L or lower than 3 .9 mmol/L within 15 minutes, you will see a message on the screen . mmol You can touch the message button for more Glucose Going information and set a reminder to check your High...
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 of your reading being obtained . You can track food, insulin, exercise and any medication you take .
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Step Action After you tick the box for food and Add Notes insulin notes, the symbol appears Rapid-Acting to the right of the Note . You can touch Insulin Long-Acting it to add more specific information to Insulin Enter Rapid-Acting Insulin your note .
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...
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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 .
The Logbook and Daily Graph show detailed information, while other history options show summaries of information over a number of days . Logbook Entries for each time that you have scanned your Logbook Sensor or performed a blood glucose or ketone 23 Feb test .
Daily Graph A graph of your Sensor glucose readings by day . Daily Graph (mmol/L) The graph shows your Target Glucose Range and symbols for food or rapid-acting insulin notes that you have entered . Notes: 00:00 12:00 24:00 • 22 Feb The graph displays glucose readings up to Wednesday...
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: mmol/L is displayed above the graph . The average is also shown for four different 6-hour periods of the day .
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A graph showing the percentage of time that your Time In Target Sensor glucose readings were above, below or Above within your Target Glucose Range . In Target Below Target Range 4.4-10.0 mmol/L Last 7 Days Time In Target Information about the number of low-glucose Low Glucose Events events measured by 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 .
Replacing Your Sensor Your Sensor automatically stops working after 14 days of wear 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 .
Using Reminders You can use Reminders to help you remember things like checking your glucose or taking insulin . Step Action From the Home Screen, touch the symbol . 22:23 Ends in 14 days Check Review Glucose History Touch to select which Type of reminder you want Set Reminder to set: Check Glucose, Take Insulin or Other .
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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 . 08:30 Touch done to return to the Home Screen . 12:30 00:00:00 add new...
Using the Built-in Meter The Reader has a built-in meter that can be used to test your blood glucose and blood ketone or to test the meter and strips with control solution . WARNING: Do NOT use the built-in meter while the Reader is connected to a plug socket or a computer .
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IMPORTANT: • Use the Reader within the test strip operating temperature range as blood glucose and ketone results obtained outside the range may be less accurate . • Use only FreeStyle Optium test strips . • Use a test strip immediately after removing it from its foil packet .
Blood Glucose Testing You can use the built-in meter to check your blood glucose, whether you are wearing a Sensor or not . You can perform a blood glucose test on your fingertip or approved alternative site . Be sure to read the test strip instructions for use prior to using the built-in meter .
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Step Action Check the test strip expiry date . 13758 2021/ 03 e .g . Expiry date: 31 March 2021 Open the foil test strip packet at the notch and tear down to remove the test strip . Use the test strip immediately after removing it from the foil packet .
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Step Action You will see a butterfly on the screen while you wait for your result . If sounds are turned on, the Reader beeps once when your result is ready . After reviewing your result, remove and discard the used test strip according to test strip instructions for use .
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Display What to Do If LO appears on the Reader, your result is lower Low Glucose than 1 .1 mmol/L . If HI appears on the Reader, your result is higher than 27 .8 mmol/L . You can touch mmol the message button for more information .
After you get your blood glucose result, you can add Notes by touching symbol . If you do not want to add a Note, press the Home Button to go to the Home Screen or hold the Home Button to turn the Reader off . Blood Ketone Testing You can use the built-in meter to check your blood ketone (β-hydroxybutyrate) .
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Step Action Check the test strip expiry date . 13758 2021/ 03 e .g . Expiry date: 31 March 2021 Open the foil test strip packet at the notch and tear down to remove the test strip . Use the test strip immediately after removing it from the foil packet .
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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 . If sounds are turned on, the Reader beeps once Ketone Test to let you know that you have applied enough blood .
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Your Blood Ketone Results 22:23 Blood ketone results are marked on the results screen and in the Logbook with the word Ketone . mmol Ketone Test Notes: • Blood ketone is expected to be lower than 0 .6 mmol/L . •...
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Display What to Do If your blood ketone is high, you will see a High Ketone message on the screen . You can touch the message button for more information . mmol Ketone Test If HI appears on the Reader, your ketone result is High Ketone higher than 8 mmol/L .
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 and test strips are working properly . You can do a control solution test with a blood glucose or ketone test strip .
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Action Step From the Home Screen, touch the Settings 22:23 Ends in 14 days . Touch Control Solution Test to do symbol a control solution test . Check Review Glucose History Settings Sound & Vibration Target Range Control Solution Test 1 / 3 Check the test strip expiry date .
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Action Step Insert the test strip with the three black lines facing up . Push the strip until it stops . Shake the control solution bottle to mix the Apply Control Solution solution . Apply a drop of control solution to the white area at the end of the test strip .
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Control Solution Results 22:23 Compare the control solution result to the range printed on the test strip instructions for use . The result on your screen should be mmol in this range . Control solution results are marked on Control Solution Test the results screen and in the Logbook with a symbol .
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 accompanies your result when you have enough charge remaining for about one day Low Battery of use .
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Notes: • You must charge the Reader when the battery is low keep using the Reader . • To fully charge the battery, charge the Reader for at least three hours . • Only use the USB cable and power adaptor included with the system .
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...
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Action Step Touch the setting that you want to change: Sound & Vibration – Set sounds 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 –...
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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 and vibration are working, and the Touchscreen is responding when touched Reader Basics –...
Living with Your System Activities 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 .
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Activity What You Need to Know Travelling by Air You may use your System while on an aircraft, following any requests from the flight crew . • Some airport full-body scanners include x-ray or millimetre radio-wave, which you cannot expose your Sensor to .
Activity What You Need to Know Travelling by Air symbol may appear on your glucose graph, (cont.) indicating that the Reader time was changed . Gaps in the graph may result or glucose readings may be hidden . Cleaning You may clean the Reader as often as desired using a cloth dampened with a mixture of 1 part household bleach to 9 parts water .
Disposal Reader, Sensor, USB Cable and Power Adaptor: These devices must not be disposed of via municipal waste collection . Separate collection for electrical and electronic equipment waste per Directive 2012/19/EU in the European Union is required . Contact the manufacturer for details .
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...
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 . Clean the site with plain to your skin .
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...
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Display What it May Mean What to Do New Sensor You scanned a new Your Reader can only be used Found Sensor before your with one Sensor at a time . previous Sensor If you start a new Sensor, you ended .
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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 started by another...
Blood Glucose or Ketone 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 .
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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 Customer Service .
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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 .
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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 recognise it . instructions for use to verify your strip is compatible with the Reader .)
Problems Checking Your Blood Glucose or Ketone Problem What it May Mean What to Do The Reader Test strip is not 1 . With the three black lines does not inserted correctly facing up, insert the test strip start a or not inserted fully into the strip port until it test after...
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Problem What it May Mean What to Do The test Blood sample is 1 . See test strip instructions does not too small . for use for re-application start after instructions . applying 2 . Repeat the test using a new the blood test strip .
Perform a Reader Test If you think the Reader is not working properly, you can System Status check the Reader by performing a Reader Test . Touch System Info the Settings symbol from the Home Screen, select Reader Test System Status and then select Reader Test . Event Log Note: The Reader Test will perform internal diagnostics and will allow you to check that the display, sounds and...
System Specifications See test strip and control solution instructions for use for additional specifications . Sensor Specifications Sensor glucose Amperometric electrochemical sensor assay method Sensor glucose 2 .2 to 27 .8 mmol/L reading range Sensor size 5 mm height and 35 mm diameter Sensor weight 5 grams Sensor power source...
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8 hours (glucose readings stored every Sensor memory 15 minutes) Operating temperature 10°C to 45°C Sensor Applicator and Sensor Pack storage 4°C to 25°C temperature Operating and storage 10–90%, non-condensing relative humidity IP27: Can withstand immersion into Sensor water resistance one metre (three ft) of water for up to and ingress protection 30 minutes .
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Reader Specifications Blood glucose assay 1 .1 to 27 .8 mmol/L range Blood ketone assay range 0 .0 to 8 .0 mmol/L 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 Seven days of typical use Reader memory...
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System must only be used with Requirements EN60950-1 rated computers Mean service life Three years of typical use Abbott Diabetes Care PRT25612 Power Adaptor Operating temperature: 10°C to 40°C Abbott Diabetes Care PRT21373 USB Cable Length: 94 cm (37 inches)
Labelling Symbols Consult instructions for use Use-by date Temperature limit Catalogue number Manufacturer Date of Manufacture CE Mark Serial number Authorised Representative in Single sterile barrier the European Community system Batch code Keep dry Type BF applied part Non-ionising radiation CODE Sensor code Caution...
EMC information provided in this manual. • Portable and mobile RF communications equipment can affect the System. • The use of accessories, transducers and cables other than those specified by Abbott Diabetes Care may result in increased EMISSIONS or decreased IMMUNITY of the System.
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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 –...
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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...
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IMMUNITY IEC 60601 Compliance Electromagnetic test test level level environment – guidance Voltage dips, short <5% U <5% U Mains power quality should be that interruptions and (>95% dip in (>95% dip in of a typical domestic, commercial voltage variations ) for 0.5 cycle ) for 0.5 cycle or hospital environment.
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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...
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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 metres (m).
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Field strengths from fixed transmitters, such as base stations for radio (mobile/wireless) 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.
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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.
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NOTE 2 These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects and people. Hereby, Abbott Diabetes Care Ltd . declares that the radio equipment type FreeStyle Libre Reader is in compliance with Directive 2014/53/EU .
User‘s Manual . Abbott’s sole obligation is to replace the Reader, free of charge, with a same or alternative meter as determined by Abbott in its sole discretion . Your replacement may be a different model or type . This Warranty covers only the Reader, does not cover disposable accessories, extends only to the original purchaser, and is not assignable or transferable .
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Questions and answers
Should I put the applicator in a sharps container if it is unused? Do the sensors have a battery?