User`s Manual
Contents
1. Freestyle Libre Software Version 1 0 User s Manual Table of Contents Contents Important Information about Your FreeStyle Libre software ccsccccsssssssssssees 1 Mtende d U eeen EE E EOE 1 System Requirements sseessesssesssesssessesssesseosseessoessosssessesssosssoessesssessoossoessoesssessesseossosssoessesssessossseossressossseeses 1 CUS OMO SOVICE oiire ucssecussscess sees csusvescssscceiucsssss 1 Getting to Know Your FreeStyle Libre software seccsssssssesoocscssscceesssssseccoossssssceossso 2 creano ROD OES eosa E E EE 3 Ea REDON A AAE IESE IA E AEE EE E ETEN E AEA 4 Seting Report PAalaIMCleTs cccsscscvssesccoanwarcescoedesseousseiceeneusnwsecexscses tuscbassescasedexSasteeasevesbawscbonsseneteasensessscereuseeseces 5 Pining Viewing and SAVING REDONS sccisvceiascnssswscsteastscantsecsdccesssausesdessausecdusecsvedvesesnorecwonstwens lt adbudacstdacdsccedenses 6 Understanding Your Reports sseessssecssscocssscocssscosssscososecosssecsssseesssseesssscosssecossseeosssee 7 GIG OS Pantern LS NCS eonenni EE EA E N 8 Changing Reader Settings ss ocescescsceecessssosccnscsnccucscessesesesscstacssesucsesssusssestcevecsnceisseestetesers 9 AdailonalFea ures osnon aE EEEE CEEL 11 SLALA A A E N E A O EE 11 Important Information about Your FreeStyle Libre software Intended Use FreeStyle Libre software is intended for use by individuals and health care professionals to aid in the review analysis2. Pattern Insights Mealtime Patterns S Weekly Summary Daily Log Reader Details Reader Profile Rosemary S Hampton PATIENT ID 99999 SERIAL JCMT193 F9999 READER TIME 12 30 READER DATE 2015 05 07 Set Report Parameters Timeframe 2 Weeks y 2015 04 23 2015 05 07 FROM TO Target Glucose Range 80 140 mg dL 4 4 7 8 mmol L Changes will not be saved to the Reader For Glucose Pattern Insights only DAILY EVENTS BREAKFAST 08 00 LUNCH 12 00 DINNER 18 00 9 BEDTIME 22 00 Ly Total Pages 6 Print Reports View Reports Selecting Reports Select one or more of the following reports that you would like to view or print Snapshot The Snapshot report shows a summary of the glucose Sensor usage carbohydrate and insulin data within the selected timeframe It also includes comments about the data Daily Patterns The Daily Patterns report shows glucose carbohydrate and insulin data over the typical day based on all days within the selected timeframe It includes the Ambulatory Glucose Profile a graph of the 10th 25th 50th median 75th and 90th percentiles of glucose readings The second page includes individual Sensor glucose readings Glucose Pattern Insights The Glucose Pattern Insights report shows glucose over the typical day based on all days within the selected timeframe It includes an assessment of Glucose Control Measures and the Ambula
3. connected Auto Save Auto Save is accessible through the File menu on the top menu bar If Auto Save is enabled the software will automatically save your reports whenever you print or view them You can choose the file name format and save location Export Data Export Data is accessible through the File menu on the top menu bar This allows you to export data from your Reader to a file that can be archived References IFCC Jeppsson JO Kobold U Barr J et al International Federation of Clinical Chemistry and Laboratory Medicine IFCC Approved IFCC reference method for the measurement of HbA1c in human blood Clin Chem Lab Med 2002 40 78 89 NGSP Little RR Rohlfing CL Wiedmeyer HM Myers GL Sacks DB Goldstein DE NGSP Steering Committee The national glycohemoglobin standardization program a five year progress report Clin Chem 2001 47 1985 1992 Nathan DM Kuenen J Borg R Zheng H Schoenfeld D Heine RJ for the Alc Derived Average Glucose ADAG Study Group Translating the hemoglobin A1c assay into estimated average glucose values Diabetes Care 2008 31 1473 8 Sacks DB Measurement of Hemoglobin A1c A new twist on the path to harmony Diabetes Care 2012 35 2674 2680 11 FreeStyle Libre software Version 1 0 User s Manual Labelling Symbols Patents www abbott us patents Disclaimers and Limitations of Liability The information contained in this User s Manual including but not limited to any produc
4. granted to print copies of this document for use solely by the FreeStyle Libre software user FreeStyle and related brand marks are trademarks of Abbott Diabetes Care Inc in various jurisdictions Other trademarks are the property of their respective owners Abbott Diabetes Care Ltd Range Road Witney Oxon 0X29 OYL UK ART30882 001 Rev A 03 14 12
5. you to save all selected reports to your computer as a PDF document The Print All button opens the standard print window to allow printing of all selected reports Understanding Your Reports IMPORTANT Work with your health care professional to understand your reports Use the report labels and legends to understand your reports Additional information is provided below e Estimated A1c in the reports uses your Sensor glucose data This may not match your Alc measured in a laboratory The formula is based on the published reference which compared average Sensor glucose and laboratory measured A1c A1c Avg SG 46 7 28 7 A1c Avg SG 2 59 1 59 e Out of range Sensor glucose and blood glucose values are displayed as follows mg dL mmol L Out of range value Displayed in reports Sensor glucose above 500 mg dL 27 8 mmol L 500 mg dL 27 8 mmol L Blood glucose above 500 mg dL 27 8 mmol L 500 mg dL 27 8 mmol L Sensor glucose below 40 mg dL 2 2 mmol L 40 mg dL 2 2 mmol L Blood glucose below 20 mg dL 1 1 mmol L 20 mg dL 1 1 mmol L Blood ketone above 8 0 mmol L 8 0 mmol L e Glucose values are labeled as high when higher than 240 mg dL 13 3 mmol L and low when lower than 70 mg dL 3 9 mmol L A low glucose event uses the same low threshold e Sensor data captured is the percentage of possible Sensor data the Reader recorded from scanning your Sensor To maximise this percentage wear your Sensor for the en
6. and evaluation of information such as Sensor glucose readings blood glucose test results blood ketone test results and other data uploaded from the FreeStyle Libre Flash Glucose Monitoring System in support of an effective diabetes health management program FreeStyle Libre software is not intended for the diagnosis of or screening for diabetes mellitus Users should be aware that the FreeStyle Libre software is merely an information management tool and it is therefore not intended to substitute for the support of a health care professional Individuals should always consult their health care professional if they have any queries or concerns about diabetes management System Requirements A computer running one of the following operating systems e Microsoft Windows 7 32 or 64 bit e Microsoft Windows XP Service Pack 3 e Microsoft Windows 8 32 or 64 bit e OS X Mavericks At minimum a computer with a USB 2 0 compliant hub with a dual core 1 6 GHz processor and 2 GB RAM Customer Service is available to answer any questions you may have about FreeStyle Libre software Go to www AbbottDiabetesCare com or the Reader Kit User s Manual for your Customer Service phone number Printed User s Manuals are available upon request Getting to Know Your FreeStyle Libre software The FreeStyle Libre software Home Screen allows you to access the different features of the application for creating reports and changing Reader settings Before yo
7. e Pressing poate will adjust the time and date on the Reader to match your computer s time and date This will not affect the data recorded prior to the update Clock Style 12 hour am pm 24 hour Sounds and Volume Notification Tone Notification Vibrate Touch Tone Vibrations High On On On Low off Off Off Language English vy Time and Date You can change the Reader time and date to match the Computer time and date by clicking the Update button You can also change the Clock Style to either 12 hour or 24 hour CAUTION It is very important to set the time and date correctly These values affect the Reader data and settings Sounds and Vibrations You can change the volume of the Reader s notification tones and turn on or off notification tones notification vibrations and touch tones Language You can change the language on the Reader This option is only available on Readers with multiple languages Target Glucose Range You can set the target glucose range for the Reader Work with your health care professional to determine your Target Glucose Range The Target Glucose Range can be set within 70 to 180 mg dL 3 9 to 10 0 mmol L Note On the Reader the Target Glucose Range is displayed on glucose graphs and used to calculate your Time in Target Reader Profile You can change the name and or ID that will be printed on the reports The name and ID will be saved to the Reader but will not b
8. e visible on the Reader itself You can add notes to glucose readings and strip results on the Reader There are five standard notes available and you can add up to six custom notes e Add notes to the list by clicking the Add Note button and typing in the desired note text e Change the order that notes are displayed on the Reader by using the up and down arrows Delete a note by clicking the X symbol Reminders You can change reminders set on the Reader e Select Reminder Type Check Glucose Take Insulin Alarm or Custom by using the dropdown menu Select Reminder Frequency Once Daily or Timer by using the dropdown menu Set Reminder Time by using the up and down arrows or by typing in the desired time Turn Reminder On or Off Note Use the Add Reminder button to create up to 12 reminders 10 Additional Features Software Update If a software update is available a message will be shown on the FreeStyle Libre software Home Screen Follow the on screen instructions to perform the update You can uninstall the application using the normal uninstall procedure on the computer s operating system Uninstalling the application will erase the installation files Any reports that were saved on the computer can still be viewed as a PDF even if the software is uninstalled Auto Launch Auto Launch is accessible through the File menu on the top menu bar If Auto Launch is enabled the software will launch when a Reader is
9. ing this parameter allows more glucose readings below 70 mg dL 3 9 mmol L before causing the Likelihood of Low Glucose to go from Low to Moderate to High The allowance is based on both the frequency and value of low readings These settings translate approximately to 2 of readings at 50 mg dL 2 8 mmol L or 4 of readings at Small 60 mg dL 3 3 mmol L 4 of readings at 50 mg dL 2 8 mmol L or 8 of readings at 60 mg dL 3 3 mmol L Medium 10 of readings at 50 mg dL 2 8 mmol L or 20 of readings at Large 60 mg dL 3 3 mmol L Printing Viewing and Saving Reports When the report parameters are set you can choose to Print Reports or View Reports while the Reader is connected Click Print Reports to print reports without viewing The software will then display a print window You should confirm your printer settings and select Print Reports can be printed in colour or black and white Click View Reports to view save and then print reports The software will display the selected reports You can navigate through these reports to view them on screen either by selecting the report name from the dropdown menu or by clicking through the pages e g 1 6 e The W and ws buttons can be used to fit the report within the window zoom out and zoom in to the report on the screen e The Back button goes back to the Create Reports screen where you can change report selections or parameters e The Save button prompts
10. or you can select a custom start and end date within the last 90 days Target Glucose The Target Glucose Range is displayed on some glucose graphs and used to calculate Range your Time in Target You can select a range within 70 to 180 mg dL 3 9 to 10 0 mmol L Note The range must be at least 30 mg dL 1 7 mmol L wide e g 90 to 120 mg dL 5 0 to 6 7 mmol L in order to generate reports These additional parameters are used only by the Glucose Pattern Insights report and are saved to the Reader They are set using the Edit button within the Set Report Parameters window Daily Events Daily Events define the periods during the day used to analyse the Glucose Control Measures You can set the typical times of your Breakfast Lunch Dinner and Bedtime Median Goal The Median Goal parameter sets the glucose level for which Median Glucose is reported as Low Moderate or High when compared with this goal You can select one of the values below Goal A1c equivalent 126 mg dL 7 0 mmol L 6 0 or 42 mmol mol 140 mg dL 7 8 mmol L 6 5 or 48 mmol mol 154 mg dL 8 6 mmol L 7 0 or 53 mmol mol 169 mg dL 9 4 mmol L 7 5 or 58 mmol mol 183 mg dL 10 2 mmol L 8 0 or 64 mmol mol 197 mg dL 10 9 mmol L 8 5 or 69 mmol mol Low Glucose The Low Glucose Allowance parameter sets the threshold for which Likelihood of Low Allowance Glucose is reported as Low Moderate or High You can set this allowance to Small Medium or Large Increas
11. ses Glucose Control Measures as Low Moderate or High based on these criteria Assessment Glucose Control Measure OK Low Moderate Likelihood of Less than 10 likelihoodof Between 10 and 50 Greater than 50 likelihood Low Glucose exceeding the low glucose likelihood of exceeding the of exceeding the low allowance low glucose allowance glucose allowance Median Glucose Less than goal Greater than goal Greater than goal compared to AND goal More than 20 and 40 mg dL 2 2 mmol L greater than the whole day median Variability Less than 35 mg dL Between Low and High Greater than a level that Below Median 1 9 mmol L would support achieving Median to 10th the Median Goal without percentile potentially causing low glucose See Setting Report Parameters section for information about the Low Glucose Allowance setting Changing Reader Settings The Reader Settings section lets you make changes to General Reader settings Target Glucose Range Reader Profile Notes and Reminders Remember to click the Save To Reader button after you make changes Note Do not disconnect the Reader while you are making changes to the Reader settings Your settings may not be saved if you disconnect the Reader during the saving process Reader Settings fone e Time and Date Reader Time and Date Ti t Gl R i ge ee eae Thursday 22 October 2015 11 28 Reader Profile Computer Time and Date a Thursday 22 October 2015 11 31 otes Renate Updat
12. t specifications is subject to change without notice For the most up to date information please visit our website www AbbottDiabetesCare com Abbott Diabetes Care makes no representations or warranties of any kind concerning the contents of this User s Manual To the maximum extent permissible under applicable law under no circumstances will Abbott Diabetes Care be liable for any loss or other damages pertaining to the use of this User s Manual Copyright and Trademarks Copyright 2014 Abbott This software includes the following third party libraries and components Qt Copyright 2013 Digia Plc and or its subsidiary ies Licensed under LGPL Version 2 1 with LGPL Digia Exception Version 1 1 SimpleCrypt Copyright 2011 Andre Somers QuaZip Copyright 2005 2012 Sergey A Tachenov and contributors Licensed under LGPL Version 2 1 Zlib Copyright 1995 2010 Jean loup Gailly and Mark Adler QtSingleApplication Copyright 2013 Digia Plc and or its subsidiary ies OpenSSL Copyright 1998 2008 The OpenSSL Project Copyright 1995 1998 Eric Young Additional copyright and licence information for the above third party software is located in the readme txt file accompanying this software This document is the property of Abbott Diabetes Care Inc and shall not be reproduced distributed disclosed or used for manufacture or sale of Systems without the express written consent of Abbott Diabetes Care Inc Permission is
13. tire timeframe and scan at least once every 8 hours Sometimes information may appear to be missing from reports if e You did not wear the Sensor for the entire timeframe e You did not scan at least once every 8 hours e You did not enter food and or insulin information in the Reader e You changed the time on the Reader e There was an excess of information to include in the report Glucose Pattern Insights The Glucose Pattern Insights report includes an assessment of the following three Glucose Control Measures for each of the 5 time periods there are 2 periods between Bedtime and Breakfast in the typical day e Likelihood of Low Glucose is the probability that low glucose values have exceeded an allowable user defined threshold e Median Glucose is an indication of when the median glucose has exceeded a user defined goal Median glucose is strongly correlated to Alc Variability Below Median is a measure of the spread of glucose data below the median It is calculated as the difference between the 50th and 10th percentile glucose readings for the time period Important When variability below median is high it is difficult to achieve the median goal without increasing the likelihood of low glucose Factors that could contribute to variability below median include erratic diet incorrect or missed medication alcohol consumption variations in activity level or illness Note The Glucose Pattern Insights report asses
14. tory Glucose Profile a graph of the 10th 25th 50th median 75th and 90th percentiles of glucose readings The second page includes individual Sensor glucose readings See Glucose Pattern Insights section for more information Mealtime Patterns The Mealtime Patterns report shows glucose carbohydrate and insulin data for typical meals based on all food notes within the selected timeframe Monthly Summary The Monthly Summary report shows glucose and Sensor usage data in a calendar format for each month within the selected timeframe Weekly Summary The Weekly Summary report shows daily glucose carbohydrate insulin and other data in a weekly format for each week within the selected timeframe Daily Log The Daily Log report shows the detailed glucose carbohydrate insulin and other data for each day within the selected timeframe This report is the only one that includes strip test results Reader Details The Reader Details report shows the current settings on the Reader and any changes to the settings over the last 30 days Setting Report Parameters IMPORTANT Work with your health care professional to set your report parameters These two parameters are used in all reports They are set within the Set Report Parameters window and are used to generate reports They do not change any settings on your Reader Timeframe The Timeframe selects the date range that will be used for all reports You can select the last 1 to 4 weeks
15. u start using the application Connect your Reader to the computer using the USB cable in your Reader Kit Plug one end into the USB port on the Reader and the other end into the USB port on the computer Use only the USB cable included with the System Add a Reader Profile if you want to create reports FreeStyle Libre Welcome to FreeStyle Libre Software Create Reports Use the information on your Reader to create view save and print a variety of reports Change Reader Settings Modify settings on your Reader including date time and target glucose range Reader Connected Rosemary S Hampton PATIENT ID 99999 READER TIME 12 30 READER DATE 2015 05 07 SERIAL JCMT193 F9999 If you have connected the FreeStyle Libre Reader but the application does not recognise it try these troubleshooting tips e Connect only one Reader to the computer at a time The application may not work when multiple Readers are connected e Secure the connection Double check that the USB cable is securely connected to both the Reader and the computer WARNING DO NOT use the Reader s built in meter while the Reader is connected to an electrical outlet or a computer Creating Reports The Create Reports screen lets you select reports and set report parameters Selected reports can be viewed printed and saved as a PDF Create Reports Select Reports Ft i Snapshot Daily Patterns Glucose
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