Abbott FreeStyle Libre User Manual Download

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Product Overview

Reader

App

Sensor

Product Use

More Information

DOC39658 Rev. B 09/18

Interactive

Tutorial

Summary of Contents for FreeStyle Libre

Page 1: ...Product Overview Reader App Sensor Product Use More Information DOC39658 Rev B 09 18 Interactive Tutorial Next ...

Page 2: ...of the System has not been evaluated The exposure may damage the Sensor and may impact proper function of the device which could cause incorrect readings WARNINGS Do not ignore symptoms that may be due to low or high blood glucose if you are experiencing symptoms that are not consistent with your glucose readings consult your health care professional Checking Sensor glucose readings with a blood g...

Page 3: ...re grouped into categories for easy reference What to know about Alarms Alerts There are NO alarms or alerts unless you scan the Sensor What to know before using the System Review all product information before use Take standard precautions for transmission of blood borne pathogens to avoid contamination Who should not use the System Do not use the System in people less than 18 years of age The Sy...

Page 4: ... Kit in a refrigerator you can as long as the refrigerator is between 39 F and 77 F Do not freeze Store the Sensor Kit between 10 90 non condensing humidity When not to use the System Do NOT use if the Sensor Kit package Sensor Pack or Sensor Applicator appear to be damaged or already opened due to risk of no results and or infection Do NOT use if Sensor Kit contents are past expiration date Do NO...

Page 5: ...indicate interference for methyldopa used in some drugs to treat high blood pressure or tolbutamide infrequently used in some drugs to treat diabetes in the US at maximum circulating levels However concentrations of potential interferents in interstitial ﬂuid are unknown compared to circulating blood What to know about X Rays The Sensor should be removed prior to exposing it to an X ray machine Th...

Page 6: ...ients or for diagnosis or screening of diabetes See Using the Reader s Built in meter section of the Reader Kit User s Manual for additional important information on the use of the Reader s built in meter Where to charge your Reader Be sure to select a location for charging that allows the power adapter to be easily unplugged Do NOT block access to the charger due to the potential risk of electric...

Page 7: ...ions This Interactive Tutorial will help you learn how to set up and use your new System Topics include Product overview Reader setup use App setup use Sensor application start up Product use treatment decisions guide Pay special attention to and throughout this tutorial Click the icons to view important considerations about using the System For more details refer to the User s Manual and the Quic...

Page 8: ...cose readings The Reader also has a built in blood glucose meter which works with FreeStyle Precision Neo blood glucose test strips IMPORTANT Safety information about the System is in the User s Manual and the Quick Reference Guide Read all of the information in the User s Manual the Quick Reference Guide and the FreeStyle Precision Neo blood glucose test strip instructions for use before using yo...

Page 9: ...der or mobile app is used to wirelessly scan the Sensor and get glucose readings The Reader also has a built in blood glucose meter which works with FreeStyle Precision Neo blood glucose test strips IMPORTANT Safety information about the System is in the User s Manual and the Quick Reference Guide Read all of the information in the User s Manual the Quick Reference Guide and the FreeStyle Precisio...

Page 10: ...gs It can store approximately 90 days of glucose history as well as notes about activities insulin meals and exercising When scanning the Sensor automatically transmits data to the Reader The Reader is compact lightweight and easy to hold It has a backlit color touchscreen and uses a rechargeable battery The Reader is not waterproof Previous Next ...

Page 11: ... the Reader You can use it to start a Sensor get glucose readings from the Sensor and store your glucose history and notes you enter FreeStyle LibreLink app is available for download from the App Store The App is not compatible with all smartphones Before upgrading your smartphone or its operating system check www FreeStyleLibre com Previous Next ...

Page 12: ... Applicator Once you have assembled the Sensor you will apply it to the back of your upper arm It has a small ﬂexible 5mm long ﬁlament that is inserted just under the skin After the start up period the Sensor can be worn for up to the wear duration speciﬁed in your Sensor Kit s product insert IMPORTANT The Sensor is water resistant in up to 3 feet 1 meter of water Do not immerse longer than 30 min...

Page 13: ...he Sensor Glucose Reading screen appears after you use your device 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 What you see on the Reader Previous Next ...

Page 14: ...Product Overview Reader App Sensor Product Use More Information Sensor Glucose Readings What you see on the App Previous Next ...

Page 15: ...ent Date using the arrows on the touchscreen Touch next to continue Set the Current Time Touch next to continue Touch or to set your Target Glucose Range Work with your health care professional to determine your Target Glucose Range Touch next to continue The Reader now displays important information about how to understand the Glucose Trend Arrow Touch next to move through the next topics When th...

Page 16: ...for the Reader Touch OK to continue Set the Current Date using the arrows on the touchscreen Touch next to continue Set the Current Time Touch next to continue Touch or to set your Target Glucose Range Work with your health care professional to determine your Target Glucose Range Touch next to continue The Reader now displays important information about how to understand the Glucose Trend Arrow To...

Page 17: ...urrent Date using the arrows on the touchscreen Touch next to continue Set the Current Time Touch next to continue Touch or to set your Target Glucose Range Work with your health care professional to determine your Target Glucose Range Touch next to continue The Reader now displays important information about how to understand the Glucose Trend Arrow Touch next to move through the next topics When...

Page 18: ... using the arrows on the touchscreen Touch next to continue Set the Current Time Touch next to continue Touch or to set your Target Glucose Range Work with your health care professional to determine your Target Glucose Range Touch next to continue The Reader now displays important information about how to understand the Glucose Trend Arrow Touch next to move through the next topics When the setup ...

Page 19: ...ing the arrows on the touchscreen Touch next to continue Set the Current Time Touch next to continue Touch or to set your Target Glucose Range Work with your health care professional to determine your Target Glucose Range Touch next to continue The Reader now displays important information about how to understand the Glucose Trend Arrow Touch next to move through the next topics When the setup is ...

Page 20: ...Sensor Product Use More Information Reader Home Screen The Reader Home Screen provides access to information about glucose readings and the System Press the Home Button to go to the Home Screen from any other screen Previous Next ...

Page 21: ...et Check Glucose Take Insulin or Alarm Touch to select how often the Reminder needs to Repeat Daily Once or Timer Select the Reminder Time using the arrows on the touchscreen Touch save to save all Reminder settings From the Reminders screen you can turn the reminder On Oﬀ or add new reminders Touch done to return to the Home Screen When reminders are On the next reminder time appears next to the ...

Page 22: ...t how often the Reminder needs to Repeat Daily Once or Timer Select the Reminder Time using the arrows on the touchscreen Touch save to save all Reminder settings From the Reminders screen you can turn the reminder On Oﬀ or add new reminders Touch done to return to the Home Screen When reminders are On the next reminder time appears next to the symbol on the Home Screen For example 8 30am Previous...

Page 23: ...s Target Range Control Solution Test Time Date Language System Status Reader Basics and Dose Increment Touch OK to save Touch System Status to view System information including current Sensor end date serial numbers for Sensor and Reader number of Sensors used number of tests performed using test strips Event Logs which may be used by Customer Service to help troubleshoot your System and perform a...

Page 24: ...ate a new account or login to your existing account LibreView Data Management Software is developed and distributed by Newyu Inc Use of FreeStyle LibreLink requires registration with LibreView a service provided by Abbott and Newyu Inc Conﬁrm your glucose unit of measure and tap NEXT Set your Target Glucose Range and tap NEXT Work with your health care professional to determine your Target Glucose...

Page 25: ...tions to review legal information and create a new account or login to your existing account LibreView Data Management Software is developed and distributed by Newyu Inc Use of FreeStyle LibreLink requires registration with LibreView a service provided by Abbott and Newyu Inc Conﬁrm your glucose unit of measure and tap NEXT Set your Target Glucose Range and tap NEXT Work with your health care prof...

Page 26: ... or login to your existing account LibreView Data Management Software is developed and distributed by Newyu Inc Use of FreeStyle LibreLink requires registration with LibreView a service provided by Abbott and Newyu Inc Conﬁrm your glucose unit of measure and tap NEXT Set your Target Glucose Range and tap NEXT Work with your health care professional to determine your Target Glucose Range Select how...

Page 27: ...eate a new account or login to your existing account LibreView Data Management Software is developed and distributed by Newyu Inc Use of FreeStyle LibreLink requires registration with LibreView a service provided by Abbott and Newyu Inc Conﬁrm your glucose unit of measure and tap NEXT Set your Target Glucose Range and tap NEXT Work with your health care professional to determine your Target Glucos...

Page 28: ...nsor Product Use More Information App Home Screen The App Home Screen provides access to information about glucose readings and the App To return to the Home Screen from another screen go to the Main Menu and tap Home Previous Next ...

Page 29: ...ber when to check glucose take insulin or as a general alarm How to do it Go to the Main Menu and tap Reminders Tap ADD REMINDER Name your reminder Tap the time ﬁelds to set the time for the reminder Tap DONE You will now see your reminder on the list along with the time you will receive it Previous Next ...

Page 30: ...t Go to the Main Menu and tap Reminders Tap ADD REMINDER Name your reminder Tap the time ﬁelds to set the time for the reminder Tap DONE You will now see your reminder on the list along with the time you will receive it Previous Next Note If you would like the reminder to repeat tap the slider to the right You can also select which days you would like to receive the reminder ...

Page 31: ...minder Tap DONE You will now see your reminder on the list along with the time you will receive it Previous Next Note There is one default reminder to help you remember to scan your Sensor This Scan Sensor reminder can be changed or disabled but cannot be deleted To turn oﬀ a reminder tap the slider to the left To delete a reminder swipe the reminder and tap the symbol The Scan Sensor reminder can...

Page 32: ... done Carbohydrate Units Choose grams or servings for food notes that you enter Tap SAVE when you are done Text to Speech Turn on Text to Speech to have the glucose reading read aloud when you scan the Sensor You will hear only your current glucose value and trend arrow direction along with whether you need to do a blood glucose test before making treatment decisions Additional information such as...

Page 33: ...scars moles stretch marks or lumps Select an area of skin that generally stays ﬂat during your normal daily activities no bending or folding Choose a site that is at least 1 inch 2 5 cm away from an insulin injection site To prevent discomfort or skin irritation you should select a diﬀerent site other than the one most recently used 0 00 0 10 Previous Next Sensor Application Site Selection Prepari...

Page 34: ... The application of the Sensor is not approved for other sites 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 Choose a site that is at least 1 inch 2 5 cm away from an insulin injection site To prevent discomfort or skin irritation you should select a diﬀerent site other than the one most...

Page 35: ...umps Select an area of skin that generally stays ﬂat during your normal daily activities no bending or folding Choose a site that is at least 1 inch 2 5 cm away from an insulin injection site To prevent discomfort or skin irritation you should select a diﬀerent site other than the one most recently used 0 00 0 10 Previous Next Caution Intense exercise may cause your Sensor to loosen due to sweat o...

Page 36: ...pp Sensor Product Use More Information Preparing the Application Site Clean application site with an alcohol wipe and allow site to dry before proceeding This helps the Sensor stay attached to your body 0 00 0 10 Previous Next ...

Page 37: ... Preparing the Application Site Clean application site with an alcohol wipe and allow site to dry before proceeding This helps the Sensor stay attached to your body 0 00 0 10 Previous Next Note The area MUST be clean and dry or the Sensor may not stick to the site ...

Page 38: ...by peeling the lid oﬀ completely Unscrew the cap from the Sensor Applicator and set the cap aside Place the Sensor Pack on a ﬂat hard surface and line up the dark mark on the Sensor Applicator with the dark mark on the Sensor Pack Press ﬁrmly down on the Sensor Applicator until it comes to a stop Lift the Sensor Applicator out of the Sensor Pack The Sensor Applicator is prepared and ready to apply...

Page 39: ...he Sensor Applicator with the dark mark on the Sensor Pack Press ﬁrmly down on the Sensor Applicator until it comes to a stop Lift the Sensor Applicator out of the Sensor Pack The Sensor Applicator is prepared and ready to apply the Sensor 0 00 0 24 Previous Next Caution The Sensor Pack and Sensor Applicator are packaged as a set separately from the Reader and have the same Sensor code Check that ...

Page 40: ...licator and set the cap aside Place the Sensor Pack on a ﬂat hard surface and line up the dark mark on the Sensor Applicator with the dark mark on the Sensor Pack Press ﬁrmly down on the Sensor Applicator until it comes to a stop Lift the Sensor Applicator out of the Sensor Pack The Sensor Applicator is prepared and ready to apply the Sensor 0 00 0 24 Previous Next Caution Do NOT use if the Sensor...

Page 41: ...Applicator and set the cap aside Place the Sensor Pack on a ﬂat hard surface and line up the dark mark on the Sensor Applicator with the dark mark on the Sensor Pack Press ﬁrmly down on the Sensor Applicator until it comes to a stop Lift the Sensor Applicator out of the Sensor Pack The Sensor Applicator is prepared and ready to apply the Sensor 0 00 0 24 Previous Next Caution The Sensor Applicator...

Page 42: ...and push down ﬁrmly to apply the Sensor to your body Gently pull the Sensor Applicator away from your body The Sensor should now be attached to your skin Make sure the Sensor is secure after application Put the cap back on the Sensor Applicator Discard the used Sensor Pack and Sensor Applicator according to local regulations 0 00 0 17 Previous Next ...

Page 43: ...ull the Sensor Applicator away from your body The Sensor should now be attached to your skin Make sure the Sensor is secure after application Put the cap back on the Sensor Applicator Discard the used Sensor Pack and Sensor Applicator according to local regulations 0 00 0 17 Previous Next Caution Do NOT push down on the Sensor Applicator until placed over prepared site to prevent unintended result...

Page 44: ...plicator away from your body The Sensor should now be attached to your skin Make sure the Sensor is secure after application Put the cap back on the Sensor Applicator Discard the used Sensor Pack and Sensor Applicator according to local regulations 0 00 0 17 Previous Next Note Applying the Sensor may cause bruising or bleeding If there is bleeding that does not stop remove the Sensor and contact y...

Page 45: ...arting it with the Reader How to do it with the Reader Press the Home Button to turn on the Reader Touch Start New Sensor Hold the Reader within 1 5 inches 4 cm of the Sensor to scan it This starts your Sensor If sounds are turned on the Reader beeps when the Sensor has been successfully activated The Sensor can be used to check your glucose after the start up period During the start up period you...

Page 46: ... If sounds are turned on the Reader beeps when the Sensor has been successfully activated The Sensor can be used to check your glucose after the start up period During the start up period you can scan the Sensor to check its status 0 00 0 10 Previous Next Note If the Sensor is not successfully scanned within 15 seconds the Reader displays a prompt to scan the Sensor again Touch OK to return to the...

Page 47: ...der and the App to check your glucose you must start the Sensor with the Reader ﬁrst How to do it with the App Tap the scan button Hold the top of your iPhone near the Sensor Hold still until you hear a tone and or feel a vibration This completes the scan The Sensor can be used to check your glucose after the start up period While the Sensor is starting up you can navigate away from the App Previo...

Page 48: ...you must start the Sensor with the Reader ﬁrst How to do it with the App Tap the scan button Hold the top of your iPhone near the Sensor Hold still until you hear a tone and or feel a vibration This completes the scan The Sensor can be used to check your glucose after the start up period While the Sensor is starting up you can navigate away from the App Previous Next Note You can either tap the bl...

Page 49: ... the Sensor Hold still until you hear a tone and or feel a vibration This completes the scan The Sensor can be used to check your glucose after the start up period While the Sensor is starting up you can navigate away from the App Previous Next Note If your Sensor is not successfully scanned you may receive a Scan Error Tap the scan button and scan again Remember that FreeStyle LibreLink and Reade...

Page 50: ... the application site or if your device reports a problem with the Sensor currently in use Taking action early can keep small problems from turning into larger ones How to do it Pull up the edge of the adhesive that keeps your Sensor attached to your skin Slowly peel away from your skin in one motion Discard the used Sensor following directions from your health care professional See the Maintenanc...

Page 51: ...blem with the Sensor currently in use Taking action early can keep small problems from turning into larger ones How to do it Pull up the edge of the adhesive that keeps your Sensor attached to your skin Slowly peel away from your skin in one motion Discard the used Sensor following directions from your health care professional See the Maintenance and Disposal section of the Reader Kit User s Manua...

Page 52: ...ings to the Reader If sounds are turned on the Reader beeps when the Sensor has been successfully scanned The Reader displays the current glucose reading along with a glucose graph and an arrow indicating the direction the glucose is going Play 0 00 0 14 Previous Next Product Use Checking Glucose with a Sensor Understanding Sensor Readings Reader Understanding Sensor Readings App Treatment Decisio...

Page 53: ... on the Home Screen Hold the Reader within 1 5 inches 4 cm of the Sensor to scan it The Sensor wirelessly sends glucose readings to the Reader If sounds are turned on the Reader beeps when the Sensor has been successfully scanned The Reader displays the current glucose reading along with a glucose graph and an arrow indicating the direction the glucose is going Play 0 00 0 14 Previous Next ...

Page 54: ...ssly sends glucose readings to the Reader If sounds are turned on the Reader beeps when the Sensor has been successfully scanned The Reader displays the current glucose reading along with a glucose graph and an arrow indicating the direction the glucose is going Play 0 00 0 14 Previous Next Note If the Sensor is not successfully scanned within 15 seconds the Reader displays a prompt to scan the Se...

Page 55: ...ucose on the Home Screen Hold the Reader within 1 5 inches 4 cm of the Sensor to scan it The Sensor wirelessly sends glucose readings to the Reader If sounds are turned on the Reader beeps when the Sensor has been successfully scanned The Reader displays the current glucose reading along with a glucose graph and an arrow indicating the direction the glucose is going Play Previous Next ...

Page 56: ... it with the App Tap the scan button Hold the top of your iPhone near the Sensor Hold still until you hear a tone and or feel a vibration This completes the scan The App displays the current glucose reading along with a glucose graph and an arrow indicating the direction the glucose is going Previous Next ...

Page 57: ...r iPhone near the Sensor Hold still until you hear a tone and or feel a vibration This completes the scan The App displays the current glucose reading along with a glucose graph and an arrow indicating the direction the glucose is going Previous Next Note If your Sensor is not successfully scanned you may receive a Scan Error Tap the scan button and scan again ...

Page 58: ... 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 Glucose readings above 350 mg dL are displayed at 350 mg dL For sequential readings above 350 mg dL a line is displayed at 350 mg dL Note The symbol may appear indicating the Reader time was changed Gaps in the graph may result or glucose readings may be hidden Pre...

Page 59: ...The Glucose Trend Arrow may not always appear with your reading When there is no Glucose Trend Arrow you will see a symbol telling you to do a blood glucose test before making treatment decisions 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 fallling between 1 and 2 mg dL ...

Page 60: ...an 240 mg dL or lower than 70 mg dL within 15 minutes you will see a or a message on the screen You can touch the message button for more information and set a reminder to check your glucose When there is a message you will see a symbol telling you to do a blood glucose test before making treatment decisions Note If you are not sure about a message or reading contact your health care professional ...

Page 61: ...than 240 mg dL or lower than 70 mg dL you will see a or message on the screen You can touch the message button for more information and set a reminder to check your glucose When there is a message you will see a symbol telling you to do a blood glucose test before making treatment decisions Note If you are not sure about a message or reading contact your health care professional before you do anyt...

Page 62: ... your reading is lower than 40 mg dL If HI appears on the Reader your reading is higher than 500 mg dL You can touch the message button for more information If you get a LO or HI result on the Reader you will see a symbol teling you to do a blood glucose test before making treatment decisions Note If you are not sure about a message or reading contact your health care professional before you do an...

Page 63: ...to 500 mg dL to accommodate glucose readings above 350 mg dL Note The symbol may appear indicating the smartphone s time was changed Gaps in the graph may result or glucose readings may be hidden Note Your current glucose value determines the background color on the My Glucose screen High glucose above 240 mg dL Between the Target Glucose Range and high or low glucose level Within the Target Gluco...

Page 64: ...Previous Next ...

Page 65: ...he Glucose Trend Arrow may not always appear with your reading When there is no Glucose Trend Arrow you will see a symbol telling you to do a blood glucose test before making treatment decisions 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 fallling between 1 and 2 mg dL p...

Page 66: ... than 240 mg dL or lower than 70 mg dL within 15 minutes you will see a or a message on the screen You can touch the symbol for more information and set a reminder to check your glucose When there is a message you will see a symbol telling you to do a blood glucose test before making treatment decisions Note If you are not sure about a message or reading contact your health care professional befor...

Page 67: ...er than 240 mg dL or lower than 70 mg dL you will see a or message on the screen You can touch the symbol for more information and set a reminder to check your glucose When there is a message you will see a symbol telling you to do a blood glucose test before making treatment decisions Note If you are not sure about a message or reading contact your health care professional before you do anything ...

Page 68: ...O appears your reading is lower than 40 mg dL If HI appears your reading is higher than 500 mg dL You can touch the symbol for more information If you get a LO or HI result you will see a symbol telling you to do a blood glucose test before making treatment decisions Note If you are not sure about a message or reading contact your healthcare professional before you do anything Previous Next ...

Page 69: ...Product Overview Reader App Sensor Product Use More Information Using Sensor Glucose Readings for treatment decisions Treatment Decisions Guide Reader App Previous Next ...

Page 70: ...may not accurately reﬂect blood glucose levels Do a blood glucose test if you see the Check Blood Glucose symbol The symbol means your Sensor glucose reading may not be accurate For example there may be times when you get a low glucose reading but you do not actually have low glucose Do a blood glucose test if you think your glucose readings are not correct or do not match how you feel Do not igno...

Page 71: ... Lunch After Exercising Before Dinner After Dinner What you see When you wake up your current glucose is 65 mg dL and the trend arrow shows it is changing slowly There is a Reader App message at the top of the screen and the symbol What it means Anytime you see the symbol you should do a blood glucose test before deciding what to do Reader App Previous Next ...

Page 72: ...ner What you see Before breakfast your current glucose is 115 mg dL The graph shows that your glucose is going up and so does the trend arrow What it means Consider what might be causing your glucose to go up and what you might do to prevent a high glucose For example How much insulin should you take before your meal Since you see should you consider taking a little more insulin Reader App Previou...

Page 73: ... Lunch After Exercising Before Dinner After Dinner What you see After breakfast your current glucose is 108 mg dL The trend arrow shows it is going down quickly There is a Reader App message at the top of the screen and the symbol What it means Anytime you see the symbol you should do a blood glucose test before deciding what to do Reader App Previous Next ...

Page 74: ...le more since your trend arrow was 90 minutes after lunch your current glucose is 225 mg dL The graph shows that your glucose is still going up and so does the trend arrow Before Lunch Reader App After Lunch Reader App What it means Don t take a correction dose within 2 hours of your meal dose This may result in insulin stacking and low glucose Consider what might be causing your glucose to go up ...

Page 75: ...ng Before Dinner After Dinner What you see After exercising you are feeling shaky sweaty and dizzy symptoms you generally get when you have low glucose But your current glucose is 204 mg dL What it means Anytime you get a reading that doesn t match how you feel do a blood glucose test Note The Check Blood Glucose symbol will NOT appear in this situation Reader App Previous Next ...

Page 76: ...ner What you see Before dinner your current glucose is 134 mg dL The graph shows that your glucose is going down and so does the trend arrow What it means Consider what might be causing your glucose to go down and what you might do to prevent a low glucose For example How much insulin should you take before your meal Since you see should you consider taking a little less insulin Reader App Previou...

Page 77: ...e Breakfast After Breakfast Lunch After Exercising Before Dinner After Dinner What you see After dinner your current glucose is 215 mg dL but there is no trend arrow There is also the symbol on the screen What it means Anytime you see the symbol you should do a blood glucose test before deciding what to do Reader App Previous Next ...

Page 78: ...Information Treatment Decisions Guide Knowledge Check 1 What would you do if you scanned your Sensor and saw this symbol with your reading Do not treat based on this reading check my blood glucose with a test strip Make a treatment decision Previous Next ...

Page 79: ...and saw this symbol with your reading Do not treat based on this reading check my blood glucose with a test strip Make a treatment decision Incorrect Don t make treatment decisions based on a Sensor glucose reading that includes this symbol The symbol means your Sensor glucose reading may not be accurate Please click Previous and try again Previous Next ...

Page 80: ...your Sensor and saw this symbol with your reading Do not treat based on this reading check my blood glucose with a test strip Make a treatment decision Correct Anytime you see this symbol check your blood glucose with a test strip before making treatment decisions The symbol means your Sensor glucose reading may not be accurate Previous Next ...

Page 81: ...2 What would you do if you are getting ready to eat lunch you scan your Sensor and you get a reading that your glucose level is above your target range and changing slowly Do not treat based on this reading check my blood glucose with a test strip Make a treatment decision such as take insulin Previous Next ...

Page 82: ...et a reading that your glucose level is above your target range and changing slowly Do not treat based on this reading check my blood glucose with a test strip Make a treatment decision such as take insulin Incorrect You could check your blood glucose with a test strip but you don t have to unless you have symptoms that don t match your reading Please click Previous and try again Previous Next ...

Page 83: ... lunch you scan your Sensor and you get a reading that your glucose level is above your target range and changing slowly Do not treat based on this reading check my blood glucose with a test strip Make a treatment decision such as take insulin Correct Based on your reading and what you are about to eat consider how much insulin you should take Previous Next ...

Page 84: ...de Knowledge Check 3 What would you do if your body was telling you that your glucose was low but when you scanned your Sensor your reading was high Do not treat based on this reading check my blood glucose with a test strip Do something to lower glucose such as take insulin Previous Next ...

Page 85: ...Sensor your reading was high Do not treat based on this reading check my blood glucose with a test strip Do something to lower glucose such as take insulin Incorrect If you feel low trust your symptoms Check your blood glucose with a test strip and treat accordingly The Sensor may be inaccurate sometimes Remember the symbol will NOT appear in this situation Please click Previous and try again Prev...

Page 86: ...you scanned your Sensor your reading was high Do not treat based on this reading check my blood glucose with a test strip Do something to lower glucose such as take insulin You re right Anytime you get a reading that doesn t match how you feel check your blood glucose with a test strip before you make a treatment decision Remember the symbol will NOT appear in this situation Previous Next ...

Page 87: ... Which of the following scenarios would avoid insulin stacking You took your full breakfast insulin dose and ate breakfast 75 minutes later your glucose was high so you took a correction insulin dose You took your full breakfast insulin dose and ate breakfast 75 minutes later your glucose was high You know insulin takes some time to work so you decided to do nothing and scan again later Previous N...

Page 88: ...ate breakfast 75 minutes later your glucose was high so you took a correction insulin dose You took your full breakfast insulin dose and ate breakfast 75 minutes later your glucose was high You know insulin takes some time to work so you decided to do nothing and scan again later Incorrect Taking multiple doses of rapid acting insulin too close together may lead to insulin stacking and low glucose...

Page 89: ...ose and ate breakfast 75 minutes later your glucose was high so you took a correction insulin dose You took your full breakfast insulin dose and ate breakfast 75 minutes later your glucose was high You know insulin takes some time to work so you decided to do nothing and scan again later That s correct Since you did not take multiple doses of rapid acting insulin too close together you avoided ins...

Page 90: ...ons Guide Knowledge Check 5 What would you do if you scanned your Sensor before exercise and you got this Reading Reader App Do not treat based on this result check my blood glucose with a test strip Do something to bring my glucose up like eat or take glucose tablets Previous Next ...

Page 91: ... not treat based on this result check my blood glucose with a test strip Do something to bring my glucose up like eat or take glucose tablets Incorrect Although your glucose reading is low anytime you see this symbol check your blood glucose with a test strip before making treatment decisions The symbol means your Sensor glucose reading may not be accurate Please click Previous and try again Previ...

Page 92: ...d your Sensor before exercise and you got this Reading Reader App Do not treat based on this result check my blood glucose with a test strip Do something to bring my glucose up like eat or take glucose tablets That s right Anytime you see this symbol check your blood glucose with a test strip before making treatment decisions Previous Next ...

Page 93: ...verview Reader App Sensor Product Use More Information Treatment Decisions Guide Knowledge Check Congratulations you have ﬁnished the knowledge assessment Click Next to learn more about the System Previous Next ...

Page 94: ...rm soapy water for accurate results Thoroughly dry your hands To warm the site apply a warm dry pad or rub vigorously for a few seconds Check the FreeStyle Precision Neo 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 t...

Page 95: ...l packet Insert the test strip with the three black lines at the end facing up Push the strip in until it stops Previous Next Caution Test on your ﬁngers in accordance with the Intended Use Intended Use The FreeStyle Libre 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 fr...

Page 96: ...warm dry pad or rub vigorously for a few seconds Check the FreeStyle Precision Neo 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 Insert the test strip with the three black lines at the end facing up Pu...

Page 97: ...e site apply a warm dry pad or rub vigorously for a few seconds Check the FreeStyle Precision Neo 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 Insert the test strip with the three black lines at the e...

Page 98: ... applied enough blood You will see a butterﬂy on the screen while you wait for your result Do not remove the test strip while the butterﬂy is on the screen If sounds are turned on the Reader beeps once when your result is ready If the butterﬂy does not appear you may not have applied enough blood to the test strip Apply a second drop of blood to the test strip within 5 seconds of the ﬁrst drop If ...

Page 99: ...tterﬂy still does not appear or if more than 5 seconds have passed discard the test strip Turn oﬀ the Reader and repeat the steps in this section with a new test strip Previous Next Caution Test on your ﬁngers in accordance with the Intended Use Intended Use The FreeStyle Libre Reader s built in meter is for use outside the body only in vitro diagnostic use in the quantitative measurement of gluco...

Page 100: ...ounds are turned on the Reader beeps once when your result is ready If the butterﬂy does not appear you may not have applied enough blood to the test strip Apply a second drop of blood to the test strip within 5 seconds of the ﬁrst drop If the butterﬂy still does not appear or if more than 5 seconds have passed discard the test strip Turn oﬀ the Reader and repeat the steps in this section with a n...

Page 101: ...hecking Glucose with a Test Strip How to do it After reviewing your result remove and discard the used test strip according to local regulations Blood glucose results are marked on the results screen and in the Reader s Logbook with the symbol 0 00 0 32 Previous Next ...

Page 102: ...e 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 It is not intended to be used for testing neonatal blood samples or for the diagnosis or screening of diabetes The FreeStyle Libre Reader s built in meter is indicated for the home lay user in the management of patients with diabetes It is intended t...

Page 103: ... may constitute a choking hazard You should clean and disinfect the Reader once per week The Reader should also be cleaned and disinfected prior to being handled by any person providing testing assistance to the user Refer to the Maintenance and Disposal section of the Reader Kit User s manual for instructions The Reader is for use by a single person It must not be used on more than one person inc...

Page 104: ...After reviewing your result remove and discard the used test strip according to local regulations Blood glucose results are marked on the results screen and in the Reader s Logbook with the symbol 0 00 0 32 Previous Next Note If you are using the App you can enter your blood glucose result into the App s Logbook ...

Page 105: ... on the Reader Check your glucose From the Glucose Reading screen add notes by touching the symbol Select the checkbox next to the note you would like to add Touch the down arrow to view additional note options After checking the box for food and insulin notes the symbol appears to the right of the note Touch to add more speciﬁc information to the note Then touch OK Touch OK to save notes Previous...

Page 106: ...he checkbox next to the note you would like to add Touch the down arrow to view additional note options After checking the box for food and insulin notes the symbol appears to the right of the note Touch to add more speciﬁc information to the note Then touch OK Touch OK to save notes Previous Next Note You can add a note at the time of your glucose reading or within 15 minutes after your reading w...

Page 107: ...mation Adding Notes How to do it with the App Tap the symbol on the My Glucose screen Select the checkbox next to the note you would like to add After you check the box you can add more speciﬁc information to your note Tap DONE to save your note Previous Next ...

Page 108: ...creen Select the checkbox next to the note you would like to add After you check the box you can add more speciﬁc information to your note Tap DONE to save your note Previous Next Note You cannot add a blood glucose result note to a glucose reading See Reviewing History section for how to enter blood glucose results in the App s Logbook ...

Page 109: ... on the My Glucose screen Select the checkbox next to the note you would like to add After you check the box you can add more speciﬁc information to your note Tap DONE to save your note Previous Next Note Notes are shown on your glucose graphs and in your Logbook as symbols See App Symbols section for more information ...

Page 110: ...e an important tool for improving your glucose control Both the Reader and App store about 90 days of information and have several ways to review your past glucose readings notes and other information How to do it with the Reader Touch the Review History icon on the Home Screen Use the arrows to view the available options Previous Next ...

Page 111: ...cose control Both the Reader and App store about 90 days of information and have several ways to review your past glucose readings notes and other information How to do it with the Reader Touch the Review History icon on the Home Screen Use the arrows to view the available options Previous Next Important Work with your health care professional to understand your glucose history ...

Page 112: ...ew Reader App Sensor Product Use More Information Reviewing History How to do it with the App From the Main Menu tap Logbook to view the Logbook or tap on one of the other history options under Reports Previous Next ...

Page 113: ...rmation Reviewing History How to do it with the App From the Main Menu tap Logbook to view the Logbook or tap on one of the other history options under Reports Previous Next Important Work with your health care professional to understand your glucose history ...

Page 114: ...Low Glucose Events Sensor Usage What data is used Sensor scan results and blood glucose test results from each day What does this show Shows entries for each time you scanned your Sensor or performed a blood glucose test If you entered notes with a glucose reading the symbol appears Touch the entry to review detailed information including any notes you entered Example Previous Next ...

Page 115: ...e Glucose Daily Patterns Time In Target Low Glucose Events Sensor Usage What data is used Sensor glucose readings from each day What does this show Shows a graph of your Sensor glucose readings by day The blue bar indicates your Target Glucose Range Symbols indicate any food or rapid acting insulin notes you have entered Example Previous Next ...

Page 116: ...se Daily Patterns Time In Target Low Glucose Events Sensor Usage What data is used Sensor glucose readings collected in the last 7 14 30 and 90 days What does this show Shows information about the average of your Sensor glucose readings It includes the overall average and the average for four diﬀerent 6 hour periods of the day Example Previous Next ...

Page 117: ... History Logbook Daily Graph Average Glucose Daily Patterns Time In Target Low Glucose Events Sensor Usage What data is used Sensor glucose readings collected in the last 7 14 30 and 90 days What does this show Shows the pattern and variability of your Sensor glucose over a typical day Example Previous Next ...

Page 118: ...Daily Graph Average Glucose Daily Patterns Time In Target Low Glucose Events Sensor Usage What data is used Sensor glucose readings collected in the last 7 14 30 and 90 days What does this show Shows the percentage of time your Sensor glucose readings were above below or within your Target Glucose Range Example Previous Next ...

Page 119: ...se Daily Patterns Time In Target Low Glucose Events Sensor Usage What data is used Sensor glucose readings collected in the last 7 14 30 and 90 days What does this show Shows the number of low glucose events measured by your Sensor It includes the total number of events and the events in four diﬀerent 6 hour periods of the day Example Previous Next ...

Page 120: ...ns Time In Target Low Glucose Events Sensor Usage What data is used Sensor glucose readings collected in the last 7 14 30 and 90 days What does this show Shows how often you scan your Sensor It includes an average of how many times you scanned your Sensor each day and the percentage of possible Sensor data the Reader recorded from your scans Example Previous Next ...

Page 121: ...se Events Sensor Usage What data is used Sensor scan results from each day You can also use the Logbook to manually enter your blood glucose test results What does this show Shows entries for each time you scanned your Sensor as well as notes you added The Logbook also lets you record a blood glucose test you performed To do this tap the symbol and enter your result Example Previous Next ...

Page 122: ...Graph Average Glucose Daily Patterns Time In Target Low Glucose Events Sensor Usage What data is used Sensor glucose readings from each day What does this show Shows a graph of your Sensor glucose readings by day The green bar indicates your Target Glucose Range Symbols indicate any notes you have entered Example Previous Next ...

Page 123: ...Glucose Daily Patterns Time In Target Low Glucose Events Sensor Usage What data is used Sensor glucose readings collected in the last 7 14 30 and 90 days What does this show Shows information about the average of your Sensor glucose readings It includes the overall average and the average for diﬀerent periods of the day Example Previous Next ...

Page 124: ...History Logbook Daily Graph Average Glucose Daily Patterns Time In Target Low Glucose Events Sensor Usage What data is used Sensor glucose readings collected in the last 7 14 30 and 90 days What does this show Shows the pattern and variability of your Sensor glucose over a typical day Example Previous Next ...

Page 125: ...ily Graph Average Glucose Daily Patterns Time In Target Low Glucose Events Sensor Usage What data is used Sensor glucose readings collected in the last 7 14 30 and 90 days What does this show Shows the percentage of time your Sensor glucose readings were above below or within your Target Glucose Range Example Previous Next ...

Page 126: ...Glucose Daily Patterns Time In Target Low Glucose Events Sensor Usage What data is used Sensor glucose readings collected in the last 7 14 30 and 90 days What does this show Shows the number of low glucose events measured by your Sensor It includes the total number of events and the events in diﬀerent periods of the day Example Previous Next ...

Page 127: ...rget Low Glucose Events Sensor Usage What data is used Sensor glucose readings collected in the last 7 14 30 and 90 days What does this show Shows how often you scan your Sensor It includes the total number of scans an average of how many times you scanned your Sensor each day and the percentage of possible Sensor data the App recorded from your scans Example Previous Next ...

Page 128: ...re may damage the Sensor and may impact proper function of the device which could cause incorrect readings WARNINGS Do not ignore symptoms that may be due to low or high blood glucose if you are experiencing symptoms that are not consistent with your glucose readings consult your health care professional Checking Sensor glucose readings with a blood glucose meter Under the following conditions Sen...

Page 129: ...re grouped into categories for easy reference What to know about Alarms Alerts There are NO alarms or alerts unless you scan the Sensor What to know before using the System Review all product information before use Take standard precautions for transmission of blood borne pathogens to avoid contamination Who should not use the System Do not use the System in people less than 18 years of age The Sy...

Page 130: ... Kit in a refrigerator you can as long as the refrigerator is between 39 F and 77 F Do not freeze Store the Sensor Kit between 10 90 non condensing humidity When not to use the System Do NOT use if the Sensor Kit package Sensor Pack or Sensor Applicator appear to be damaged or already opened due to risk of no results and or infection Do NOT use if Sensor Kit contents are past expiration date Do NO...

Page 131: ...indicate interference for methyldopa used in some drugs to treat high blood pressure or tolbutamide infrequently used in some drugs to treat diabetes in the US at maximum circulating levels However concentrations of potential interferents in interstitial ﬂuid are unknown compared to circulating blood What to know about X Rays The Sensor should be removed prior to exposing it to an X ray machine Th...

Page 132: ...patients or for diagnosis or screening of diabetes See Using the Reader s Built in meter section of the Reader Kit User s Manual for additional important information on the use of the Reader s built in meter Where to charge your Reader Be sure to select a location for charging that allows the power adapter to be easily unplugged Do NOT block access to the charger due to the potential risk of elect...

Page 133: ...of the System has not been evaluated The exposure may damage the Sensor and may impact proper function of the device which could cause incorrect readings WARNINGS Do not ignore symptoms that may be due to low or high blood glucose if you are experiencing symptoms that are not consistent with your glucose readings consult your health care professional Checking Sensor glucose readings with a blood g...

Page 134: ...re grouped into categories for easy reference What to know about Alarms Alerts There are NO alarms or alerts unless you scan the Sensor What to know before using the System Review all product information before use Take standard precautions for transmission of blood borne pathogens to avoid contamination Who should not use the System Do not use the System in people less than 18 years of age The Sy...

Page 135: ... Kit in a refrigerator you can as long as the refrigerator is between 39 F and 77 F Do not freeze Store the Sensor Kit between 10 90 non condensing humidity When not to use the System Do NOT use if the Sensor Kit package Sensor Pack or Sensor Applicator appear to be damaged or already opened due to risk of no results and or infection Do NOT use if Sensor Kit contents are past expiration date Do NO...

Page 136: ...indicate interference for methyldopa used in some drugs to treat high blood pressure or tolbutamide infrequently used in some drugs to treat diabetes in the US at maximum circulating levels However concentrations of potential interferents in interstitial ﬂuid are unknown compared to circulating blood What to know about X Rays The Sensor should be removed prior to exposing it to an X ray machine Th...

Page 137: ...patients or for diagnosis or screening of diabetes See Using the Reader s Built in meter section of the Reader Kit User s Manual for additional important information on the use of the Reader s built in meter Where to charge your Reader Be sure to select a location for charging that allows the power adapter to be easily unplugged Do NOT block access to the charger due to the potential risk of elect...

Page 138: ... before making any treatment decisions Sensor Direction glucose is going Caution View previous next screen Notes Add more information to notes Food note Rapid acting insulin note Time changed on Reader Reminders Blood glucose test Settings Control solution test result Low battery Battery charging Sensor too cold Sensor too hot Previous Next ...

Page 139: ...making any treatment decisions Scan button Direction glucose is going Caution Add edit notes Manually entered blood glucose result note Add blood glucose result note Food note Insulin Rapid or Long acting note Exercise note Time change Main menu Multiple Custom notes Share report Additional information Calendar Sensor too cold Sensor too hot Previous Next ...

Page 140: ...ed in your Sensor Kit s product insert Sensor memory 8 hours glucose readings stored every 15 minutes Operating temperature 50 F to 113 F Sensor Applicator and Sensor Pack storage temperature 39 F to 77 F Operating and storage relative humidity 10 90 non condensing Sensor water resistance IP27 Can withstand immersion into 3 ft one meter of water for up to 30 minutes Protected against insertion of ...

Page 141: ...rage altitude 1 250 ft 381 meters to 10 000 ft 3 048 meters Reader display timeout 60 seconds 120 seconds when test strip is inserted Radio Frequency Near Field Communication 13 56 MHz RFID ASK Modulation 124 dBuV m 1 5 inch communication range Data port Micro USB Minimum Computer Requirements System must only be used with EN60950 1 rated computers Mean service life 3 years of typical use Reader c...

Page 142: ...nsor 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 Reader and Sensor wireless communications using the near ﬁeld communications is assured within the eﬀective range of 4 cm between the Sensor and Reader that is speciﬁed to occur within 15 seconds Previous Home ...

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