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Labelling Symbols

Consult instructions for use

Use-by date

Temperature limit

Catalogue number

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 radiation

CODE

Sensor code

Caution

Do not re-use

Humidity limitation

Sterilised using irradiation

Содержание FreeStyle Libre

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

Страница 2: ...Your Name _________________________________________________...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

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

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

Страница 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...

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

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

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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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