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Abbott FreeStyle Libre, User Manual

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Abbott FreeStyle Libre User Manual Download Page 85

Reader moisture 

protection

Keep dry

Operating and storage 

altitude

-381 metres (-1,250 ft) to 3,048 metres 

(10,000 ft)

Reader display timeout

60 seconds (120 seconds when test  

strip is inserted)

Radio Frequency

13 .56 MHz RFID; ASK Modulation;  

124 dBuV/m

Data port

Micro USB 

Minimum Computer 

Requirements

System must only be used with 

EN60950-1 rated computers 

Mean service life 

Three years of typical use

Power Adaptor

Abbott Diabetes Care PRT25612

Operating temperature: 10°C to 40°C

USB Cable 

Abbott Diabetes Care PRT21373  

Length: 94 cm (37 inches)

80

Summary of Contents for FreeStyle Libre

Page 1: ...User s Manual FLASH GLUCOSE MONITORING SYSTEM...

Page 2: ...Your Name _________________________________________________...

Page 3: ...o Know Your System 8 Reader Kit 9 Sensor Kit 10 Data Management Software 13 Setting up Your Reader for the First Time 14 Using Your Sensor 17 Applying Your Sensor 18 Starting Your Sensor 22 Checking Y...

Page 4: ...Reminders 39 Using the Built in Meter 41 Blood Glucose Testing 43 Blood Ketone Testing 47 Control Solution Testing 52 Charging the Reader 56 Changing the Reader Settings 58 Living with Your System 61...

Page 5: ...ems Starting Your Sensor or Receiving Sensor Readings 67 Blood Glucose or Ketone Error Messages 70 Problems Checking Your Blood Glucose or Ketone 74 Perform a Reader Test 76 Customer Service 76 System...

Page 6: ...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...

Page 7: ...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 2...

Page 8: ...h diabetes mellitus The Reader and Sensor are designed to replace blood glucose testing in the self management of diabetes including dosing of insulin The indication for children age 4 17 is limited t...

Page 9: ...tch the Sensor glucose reading or suspect that your reading may be inaccurate check the reading by conducting a fingerstick test using a blood glucose meter If you are experiencing symptoms that are n...

Page 10: ...ing 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...

Page 11: ...ings Differences in glucose readings between interstitial fluid and capillary blood may be observed during times of rapid change in blood glucose such as after eating dosing insulin or exercising Do n...

Page 12: ...nce Imaging or CT Computed Tomography scan remove the Sensor that you are wearing and apply a new one after the appointment The effect of this type of procedure on the performance of the system has no...

Page 13: ...which works with FreeStyle Optium blood glucose and blood ketone test strips Your System comes in a Reader Kit and a Sensor Kit When opening your kits check that the contents are undamaged and that y...

Page 14: ...ys of glucose history and notes that you enter about activities such as taking insulin eating food or exercising This information can help you understand how these activities affect your glucose USB P...

Page 15: ...glucose readings when worn on your body It initially comes in two parts one part is in the Sensor Pack and the other part is in the Sensor Applicator By following the instructions you prepare and appl...

Page 16: ...23 Check Glucose Review History Time Current time set on the Reader Sensor Status Information about your current Sensor Battery Level Battery charge remaining Settings Touch to change the Reader s set...

Page 17: ...f your current and stored glucose readings Sensor Glucose Readings 21 15 9 3 14 00 18 00 22 00 4 0mmol L Glucose Going Low Rapid Acting Insulin Note Message Touch for more information Add Notes Touch...

Page 18: ...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 13...

Page 19: ...ton to turn on the Reader 2 If prompted use the touchscreen to select your preferred language for the Reader Touch OK to continue Note Use the pad of your finger Do NOT use your fingernail or any othe...

Page 20: ...et Glucose Range Touch next to continue Note Your Target Glucose Range is displayed on glucose graphs on the Reader and used to calculate your Time In Target 12 00 back next Current Time CAUTION It is...

Page 21: ...next to move to the next topic At the end of the Reader setup touch done to go to the Home Screen Note Charge the Reader if the battery level is low Only use the USB cable and power adaptor included...

Page 22: ...hould be used together or your Sensor glucose readings may be incorrect Intense exercise may cause your Sensor to loosen due to sweat or movement of the Sensor If your Sensor comes loose you may get n...

Page 23: ...at is at least 2 5 cm 1 inch away from an insulin injection site To prevent discomfort or skin irritation you should select a site other than the one most recently used 2 Wash application site using p...

Page 24: ...rk mark on the Sensor Applicator with the dark mark on the Sensor Pack On a hard surface press down firmly on the Sensor Applicator until it comes to a stop 5 Lift the Sensor Applicator out of the Sen...

Page 25: ...pared site and push down firmly to apply the Sensor to your body CAUTION The Sensor Applicator now contains a needle Do NOT touch inside the Sensor Applicator or put it back into the Sensor Pack CAUTI...

Page 26: ...ying 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 9 Make sure that the Sensor is secure after application...

Page 27: ...s when the Sensor has been successfully activated The Sensor can be used to check your glucose after 60 minutes Note If the Sensor is not successfully scanned within 15 seconds the Reader displays a p...

Page 28: ...Sensor wirelessly sends glucose readings to the Reader If sounds are turned on the Reader beeps when the Sensor has been successfully scanned Note If the Sensor is not successfully scanned within 15 s...

Page 29: ...ction 3 The Reader displays your current glucose reading along with your glucose graph and an arrow indicating the direction your glucose is going 21 15 9 3 mmol L Glucose Going Low 14 00 18 00 22 00...

Page 30: ...dings above 21 mmol L are displayed at 21 mmol L The symbol may appear indicating that the Reader time was changed Gaps in the graph may result or glucose readings may be hidden 21 15 9 3 Glucose Goin...

Page 31: ...ose 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 between 0...

Page 32: ...27 8 mmol L You can touch the message button for more information Check your blood glucose on your finger with a test strip If you get a second LO or HI result contact your health care professional i...

Page 33: ...glucose is projected to be higher than 13 3 mmol L or lower than 3 9 mmol L within 15 minutes you will see a message on the screen You can touch the message button for more information and set a remin...

Page 34: ...eading screen add notes by touching the symbol in the upper right corner of the touchscreen If you do not want to add notes you can press the Home Button to go to the Home Screen or hold the Home Butt...

Page 35: ...s Enter grams or carb portion information Note Food and rapid acting insulin notes are shown on your glucose graphs and in your Logbook as symbols 4 Touch OK to save your Notes You can review your Not...

Page 36: ...out 90 days of information and has several ways to review your past glucose readings notes and other information Step Action 1 Press the Home Button to turn on the Reader Press the Home Button again t...

Page 37: ...view the available options Logbook Daily Graph Average Glucose Review History 1 2 Daily Patterns Time In Target Low Glucose Events Sensor Usage IMPORTANT Work with your health care professional to und...

Page 38: ...st If you have entered Notes with a glucose reading the symbol appears in that row For more information about the symbols see Reader Symbols section Touch the entry to review the detailed information...

Page 39: ...plays glucose readings up to 21 mmol L Glucose readings above 21 mmol L are displayed at 21 mmol L You might see gaps in the graph during times when you have not scanned at least once in 8 hours The s...

Page 40: ...ur Target Glucose Range are orange while readings in range are blue Daily Patterns A graph showing the pattern and variability of your Sensor glucose over a typical day The thick black line shows the...

Page 41: ...is displayed above the graph The bar graph displays the low glucose events in four different 6 hour periods of the day Sensor Usage Information about how often you scan your Sensor The Reader reports...

Page 42: ...n the skin can be removed with warm soapy water or isopropyl alcohol 2 Discard the used Sensor See Disposal section When you are ready to apply a new Sensor follow the instructions in the Applying You...

Page 43: ...n site or if the Reader reports a problem with the Sensor currently in use Taking action early can keep small problems from turning into larger ones CAUTION If the glucose readings from the Sensor do...

Page 44: ...t which Type of reminder you want to set Check Glucose Take Insulin or Other 3 Touch to select how often you want the reminder to Repeat Once Daily or Timer Note You can set the reminders for a specif...

Page 45: ...reminders are On the next reminder time appears next to the reminder symbol on the Home Screen For example 08 30 Your reminder comes on even if the Reader is turned off Touch OK to dismiss your remin...

Page 46: ...as 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 connect...

Page 47: ...it from its foil packet Only use a test strip once Do not use expired test strips as they may cause inaccurate results Do not use a wet bent scratched or damaged test strip Do not use the test strip...

Page 48: ...using the built in meter Step Action 1 Wash your hands and the test site with warm soapy water for accurate results Thoroughly dry your hands and the test site To warm the site apply a warm dry pad or...

Page 49: ...se your lancing device to obtain a blood drop and apply blood to the white area at the end of the test strip If sounds are turned on the Reader beeps once to let you know that you have applied enough...

Page 50: ...t strip according to test strip instructions for use Your Blood Glucose Results Blood glucose results are marked on the results screen and in the Logbook with the symbol Note Contact your health care...

Page 51: ...sage button for more information Check your blood glucose again with a test strip If you get a second LO or HI result contact your health care professional immediately 3 5mmol L Low Glucose 16 1mmol L...

Page 52: ...ybutyrate It is important to consider doing this when You are unwell Your glucose is higher than 13 3 mmol L You and your health care professional decide you should Note Ensure that you read the test...

Page 53: ...packet 4 Note Use only blood ketone test strips Do not put urine on the test strip Insert the test strip with the three black lines facing up Push the strip in until it stops e g Expiry date 31 March...

Page 54: ...nstructions for use for re application instructions 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 6 Afte...

Page 55: ...Blood ketone is expected to be lower than 0 6 mmol L Blood ketone may be higher when you are unwell fasting have exercised hard or if glucose levels are not controlled If your blood ketone result rem...

Page 56: ...ormation High Ketone HI mmol L Ketone Test If HI appears on the Reader your ketone result is higher than 8 mmol L You can touch the message button for more information Repeat the ketone test with a ne...

Page 57: ...iscard control solution three months after opening Refer to control solution instructions for use The control solution range is a target range for control solution only not for your blood glucose or k...

Page 58: ...at the notch and tear down to remove the test strip Ends in 14 days 22 23 Check Glucose Review History Sound Vibration Target Range Control Solution Test Settings 1 3 e g Expiry date 31 March 2021 D5...

Page 59: ...on Apply a drop of control solution to the white area at the end of the test strip If sounds are turned on the Reader beeps once to let you know that you have applied enough control solution You will...

Page 60: ...are marked on the results screen and in the Logbook with a symbol Note Repeat the control solution test if the results are outside the range printed on the test strip instructions for use Stop using...

Page 61: ...le into the USB port on the Reader OK Please charge the Reader to continue using it Low Battery Charging CAUTION Ensure that you select a location for charging that allows the power adaptor to be easi...

Page 62: ...ery is low to 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 Fully charge your Reader be...

Page 63: ...or Sounds The Settings menu is also where you go to do a Control Solution Test or to check the System Status Step Action 1 To get to the Settings menu touch the Settings symbol on the Home Screen Ends...

Page 64: ...ption only available on Readers with multiple languages System Status Check Reader information and performance View System Information The Reader will display information about your System including C...

Page 65: ...t 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...

Page 66: ...s water resistant and can be worn while bathing showering or swimming Note Do NOT take your Sensor deeper than 1 metre 3 feet or immerse it longer than 30 minutes in water Sleeping Your Sensor should...

Page 67: ...esults To avoid removing your Sensor you may request another type of screening If you do choose to go through a full body scanner you must remove your Sensor The Sensor can be exposed to common electr...

Page 68: ...xture of 1 part household bleach to 9 parts water Gently wipe the exterior of the Reader and allow to air dry Cracking or flaking of or damage to the Reader housing are signs of deterioration If you n...

Page 69: ...rior to disposing such as by using a cloth dampened with a mixture of one part household bleach to nine parts water Note Readers and Sensors contain non removeable batteries and must not be incinerate...

Page 70: ...the error Reader Does Not Power On Problem What it May Mean What to Do Reader does not power on after you press the Home Button or insert a test strip Reader battery is too low Charge the Reader Read...

Page 71: ...nd consider shaving 3 Follow the instructions in Applying and Starting Your Sensor sections Skin irritation at the Sensor application site Seams or other constrictive clothing or accessories causing f...

Page 72: ...not ready to read glucose Wait until the 60 minute Sensor start up period has completed Scan Timeout The Reader is not held close enough to the Sensor Hold the Reader within 4 cm 1 5 inches of the Se...

Page 73: ...new Sensor you will no longer be able to scan your old Sensor If you would like to begin using the new Sensor select Yes Scan Error The Reader was unable to communicate with the Sensor Try scanning a...

Page 74: ...r device Your Reader can only be used with a Sensor that it started Scan the Sensor again with the device that started it Or apply and start a new Sensor Check Sensor The Sensor tip may not be under y...

Page 75: ...he temperature is within the test strip operating range See test strip instructions for use for the appropriate range 2 Wait for the Reader and test strips to adjust to the new temperature 3 Repeat th...

Page 76: ...w the testing instructions 2 Repeat the test using a new test strip 3 If the error reappears contact Customer Service E 4 The blood glucose level may be too high to be read by the system or There may...

Page 77: ...the error reappears contact Customer Service E 6 The test strip may not be compatible with the Reader 1 Check that you are using the correct test strip for the Reader See test strip instructions for...

Page 78: ...t strip for the Reader See test strip instructions for use to verify your strip is compatible with the Reader 2 Repeat the test using a test strip for use with your Reader 3 If the error reappears con...

Page 79: ...st strip into the strip port until it stops 2 If the Reader still does not start a test contact Customer Service Reader battery is too low Charge the Reader The test strip is damaged used or unrecogni...

Page 80: ...est using a new test strip 3 If the test still does not start contact Customer Service Sample applied after the Reader turned off 1 Review the testing instructions 2 Repeat the test using a new test s...

Page 81: ...Service phone number Reporting of Serious Incidents If a serious incident has occurred in relation to this device it should be reported to Customer Service In European Union Member States serious inci...

Page 82: ...al specifications Sensor Specifications Sensor glucose assay method Amperometric electrochemical sensor Sensor glucose reading range 2 2 to 27 8 mmol L Sensor size 5 mm height and 35 mm diameter Senso...

Page 83: ...erature 4 C to 25 C Operating and storage relative humidity 10 90 non condensing Sensor water resistance and ingress protection IP27 Can withstand immersion into one metre three ft of water for up to...

Page 84: ...m 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 90 days of typical use Reader operating te...

Page 85: ...trip is inserted Radio Frequency 13 56 MHz RFID ASK Modulation 124 dBuV m Data port Micro USB Minimum Computer Requirements System must only be used with EN60950 1 rated computers Mean service life Th...

Page 86: ...Manufacturer Date of Manufacture CE Mark Serial number Authorised Representative in the European Community Single sterile barrier system Batch code Keep dry Type BF applied part Non ionising radiatio...

Page 87: ...ority IMDA Standard for Short Range Devices registration DB106503 Electromagnetic Compatibility The System needs special precautions regarding EMC and needs to be installed and put into service accord...

Page 88: ...nce RFemissions CISPR11 Group1 TheSystemusesRFenergyonly foritsinternalfunction Therefore itsRFemissionsareverylow andarenotlikelytocauseany interferenceinnearbyelectronic equipment RFemissions CISPR1...

Page 89: ...4 2 8kVcontact 15kVair 8kVcontact 15kVair Floorsshouldbewood concrete orceramictile Iffloorsarecovered withsyntheticmaterial therelative humidityshouldbeatleast30 Electricalfast transient burst IEC61...

Page 90: ...cles 70 UT 30 dip in UT for 25 cycles 5 UT 95 dip in UT for 5 seconds Mainspowerqualityshouldbethat ofatypicaldomestic commercial orhospitalenvironment Iftheuser oftheSystemrequirescontinued operation...

Page 91: ...ctedRF IEC61000 4 6 6Vrms 150kHzto 80MHz 6Vrms PortableandmobileRF communicationsequipmentshould beusednoclosertoanypartofthe System includingcables thanthe recommendedseparationdistance calculatedfro...

Page 92: ...manufacturer and d istherecommendedseparationdistanceinmetres m FieldstrengthsfromfixedRFtransmitters asdeterminedbyanelectromagneticsitesurveya shouldbelessthanthecompliancelevelineachfrequencyrangeb...

Page 93: ...ue 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 ab...

Page 94: ...tic 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...

Page 95: ...Diabetes Care Ltd declares that the radio equipment type FreeStyle Libre Reader is in compliance with Directive 2014 53 EU The full text of the EU declaration of conformity is available at the follow...

Page 96: ...ct or preclude any other rights which you may have by law For warranty service contact Customer Service for assistance and or instructions for obtaining a replacement Reader Please go to the back cove...

Page 97: ...www abbott com patents Distributed by Local Responsible Person Abbott Laboratories Limited Abbott Diabetes Care 20 F AIATower 183 Electric Road North Point Hong Kong Tel 5808 4196 Abbott Laboratories...

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