Abbott FreeStyle Libre 2, Manual

Page 1: ...by Abbott Patent https www abbott com patents Distributor and registration holder Geffen Medical Ltd 5 Kinneret Bnei Brak B S R 3 P O Box 48092Tel Aviv 6148002 Israel 6364 03 6900300 Approval no 26304...

Page 2: ...Your Name _________________________________________________ 224 257 4 6 4 6 ART41600 101_rev A_cover indd 3 4 ART41600 101_rev A_cover indd 3 4 10 7 20 2 54 PM 10 7 20 2 54 PM...

Page 3: ...12 Data Management Software 15 Setting up Your Reader for the First Time 16 Using Your Sensor 19 Applying Your Sensor 20 Starting Your Sensor 24 Checking Your Glucose 25 Alarms 31 Setting Alarms 34 S...

Page 4: ...Cleaning 74 Maintenance 74 Disposal 75 Troubleshooting 76 Reader Does Not Power On 76 Problems at the Sensor Application Site 77 Problems Starting Your Sensor or Receiving Sensor Readings 78 Problems...

Page 5: ...e Time changed on Reader Sound and Vibration ON Sound ON Vibration OFF Sound OFF Vibration ON Sound and Vibration OFF Symbol What It Means Sensor communicating with Reader Sensor not communicating wit...

Page 6: ...sisting the child to manage the Reader and Sensor and also for interpreting or assisting the child to interpret Sensor glucose readings Contraindications The Sensor must be removed prior to Magnetic R...

Page 7: ...remove the Sensor On rare occasions you may get inaccurate Sensor glucose readings If you believe your glucose readings are not correct or do not match how you feel perform a blood glucose test on yo...

Page 8: ...ke sure the Reader has sufficient charge and that sound and or vibration are turned on What to know about the Reader s Built in Meter The Reader is designed to be used only with FreeStyle Optium blood...

Page 9: ...our System The FreeStyle Libre 2 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 th...

Page 10: ...re 2 Reader USB Cable Power Adapter User s Manual Quick Start Guide Performance Data Insert The Reader gets glucose readings from your Sensor and can also issue glucose alarms if they are turned on It...

Page 11: ...dNote 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 Note Sound Vibration setting and Signa...

Page 12: ...eferred language for the Reader Touch OK to continue Note Use the pad of your finger Do NOT use your fingernail or any other object on the screen Data Management Software To upload data from the Reade...

Page 13: ...m next back When you scan your Sensor an arrow will indicate your recent glucose trend Rising quickly Rising Changing slowly Falling Falling quickly done back While using the Reader press the Home but...

Page 14: ...ick to the site Using Your Sensor CAUTION 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 before...

Page 15: ...lts or injury Step Action 3 Open the Sensor Pack by peeling the lid off completely Unscrew the cap from the Sensor Applicator and set the cap aside 4 Line up the dark mark on the Sensor Applicator wit...

Page 16: ...uch Start New Sensor to scan your Sensor Start New Sensor Review History No Active Sensor 22 23 minutes New Sensor Starting Up 60 Sensor can be used in OK Step Action 8 Gently pull the Sensor Applicat...

Page 17: ...hin 4 cm 1 5 inches of your Sensor to scan it Your 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...

Page 18: ...Glucose readings above 350 mg dL are displayed at 350 mg dL The symbol may appear indicating the Reader time was changed Gaps in the graph may result or glucose readings may be hidden All available gl...

Page 19: ...r than 240 mg dL or lower 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 your glucose Display What To Do 350 250 1...

Page 20: ...sed to calculate your Time In Target Alarms When in range of the Reader your Sensor automatically communicates with the Reader to give you Low and High Glucose Alarms if you turn them ON These alarms...

Page 21: ...r for 20 minutes Make sure the Reader s sound and or vibration settings are on and your Reader is near you If any alarms are turned on the Home screen indicates the sound vibration setting Sound and V...

Page 22: ...70 done Low Glucose Alarm Alarm How to Set High Glucose Alarm The High Glucose Alarm is off by default Touch the slider to turn the alarm on The alarm level is initially set to 240 mg dL You can use t...

Page 23: ...additional updates Setting Alarm Sounds Step Action 1 From the Home screen touch the Settings symbol Touch Sound Vibration to change the alarm sounds 2 Touch the sound or vibration setting you would l...

Page 24: ...smiss the alarm and check your glucose You will only receive one alarm per high glucose episode What you See What it Means Scan Sensor now Signal Loss Alarm Yes No The Signal Loss Alarm notifies you i...

Page 25: ...ng Acting Insulin Food 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 tr...

Page 26: ...Button again to go to the Home Screen 2 Touch the Review History icon Check Glucose Scan Sensor to check glucose Check Glucose Review History Ends in 14 days 22 23 Step Action 3 Use the arrows to vie...

Page 27: ...e last 15 minutes OK Logbook 23 Feb 22 23 23 Feb 06 37 22 Feb 23 09 143 98 108 mg dL Daily Graph A graph of your Sensor glucose readings by day The graph shows your Target Glucose Range and symbols fo...

Page 28: ...a Time InTarget A graph showing the percentage of time your Sensor glucose readings were above below or within your Target Glucose Range Low Glucose Events Information about the number of low glucose...

Page 29: ...a new Sensor when you first scan it 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 irri...

Page 30: ...you want the reminder to Repeat Once Daily or Timer Note You can set the reminders for a specific time e g 08 30 am or as a timer e g 3 hours from the current time 4 Set the reminder Time using the a...

Page 31: ...ess accurate Use only FreeStyle Optium test strips Use a test strip immediately after removing from its foil packet Only use a test strip once Do not use expired test strips as they may cause inaccura...

Page 32: ...s Step Action 2 Check the test strip expiry date 3 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 packe...

Page 33: ...nd water and thoroughly dry them 143mg dL 22 23 Display What To Do mg dL Low Glucose LO mg dL High Glucose HI If LO appears on the Reader your result is lower than 20 mg dL If HI appears on the Reader...

Page 34: ...r hands To warm the site apply a warm dry pad or rub vigorously for a few seconds Note Use only fingertip samples for blood ketone testing Step Action 2 Check the test strip expiry date 3 Open the foi...

Page 35: ...t strip instructions for use Ketone Test Apply Blood IMPORTANT After performing a blood ketone test wash your hands with soap and water and thoroughly dry them Your Blood Ketone Results Blood ketone r...

Page 36: ...PORTANT Control solution results should fall within the control solution range printed on the test strip instructions for use Do NOT use control solution past the expiry date Discard control solution...

Page 37: ...t Diabetes Care Ltd Range Road Witney Oxon OX29 0YL Made in UK 4 C Step Action 4 Insert the test strip with the three black lines facing up Push the strip until it stops 5 Shake the control solution b...

Page 38: ...y should last up to 4 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 of use Plug the incl...

Page 39: ...ply to alarms Time Date Change the Time or Date Reminders See Using Reminders section for information on setting reminders Control Solution Test Perform a control solution test Language Change the lan...

Page 40: ...ther 1 0 or 0 5 units for use with insulin notes Living With Your System Activities Your System can be used during a wide variety of activities Activity What You Need To Know Bathing Showering and Swi...

Page 41: ...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 expo...

Page 42: ...municipal waste collection Separate collection for electrical and electronic equipment waste per Directive 2012 19 EC in the European Union is required Contact the manufacturer for details As Readers...

Page 43: ...the Signal Loss Alarm shows again after scanning your Sensor contact Customer Service Problems at the Sensor Application Site Problem What It May Mean What To Do The Sensor is not sticking to your ski...

Page 44: ...May Mean What To Do Glucose Reading Unavailable Your Sensor is too hot or too cold Move to a location where the temperature is appropriate and scan again in a few minutes Sensor Already in Use The Sen...

Page 45: ...r 20 minutes Try scanning your Sensor If the Signal Loss Alarm is on and shows again after scanning your Sensor contact Customer Service Sound vibration are turned off Check the Reader s sound and vib...

Page 46: ...ff the Reader 2 Repeat the test using a new test strip 3 If the error reappears contact Customer Service Error Message What It May Mean What To Do E 3 Blood drop is too small or Incorrect test procedu...

Page 47: ...r Reader 3 If the error reappears contact Customer Service Error Message What It May Mean What To Do E 7 Test strip may be damaged used or the Reader does not recognise it 1 Check that you are using t...

Page 48: ...and 45 C and then try to power it on Reader is in a power saving mode Press the Home Button then insert a test strip Problem What It May Mean What To Do The test does not start after applying the blo...

Page 49: ...rtment responsible for medical devices in your country Please refer to your government website for details of how to contact your competent authority A serious incident means any incident that directl...

Page 50: ...e protection Keep dry Sensor transmission range 6 metres 20 ft unobstructed Operating temperature 10 C to 45 C Sensor Applicator and Sensor Pack storage temperature 4 C to 25 C Operating and storage r...

Page 51: ...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 2 402 2 480 GHz BLE GF...

Page 52: ...ment and that if adjacent or stacked use is necessary the System should be observed to verify normal operation in the configuration in which it will be used Guidance and manufacturer s declaration ele...

Page 53: ...st IEC 60601 test level Compliance Level Electromagnetic environment guidance Surge IEC 61000 4 5 1 kV differential mode 2 kV common mode 1 kV differential mode 2 kV common mode Mains power quality sh...

Page 54: ...ted RF IEC 61000 4 3 10V m 80 MHz to 2 7 GHz 10V m Recommended separation distance 80 MHz to 800 MHz 800 MHz to 2 5 GHz 1 2 d 1 2 d 2 3 d IMMUNITY test IEC 60601 test level Compliance Level Electromag...

Page 55: ...hould be less than the compliance level in each frequency range b Interference may occur in the vicinity of equipment marked with the following symbol NOTE 1 At 80 MHz and 800 MHz the higher frequency...

Page 56: ...oved in partnership with others The OFL allows the licensed fonts to be used studied modified and redistributed freely as long as they are not sold by themselves The fonts including any derivative wor...

Page 57: ...ames specified as such after the copyright statement s OriginalVersion refers to the collection of Font Software components as distributed by the Copyright Holder s ModifiedVersion refers to any deriv...

Page 58: ...ART41600 101_rev A_manual indd 107 ART41600 101_rev A_manual indd 107 10 7 20 2 55 PM 10 7 20 2 55 PM...