FLASH GLUCOSE MONITORING SYSTEM

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Operator’s ManualFLASH GLUCOSE MONITORING SYSTEMCAUTION: Federal law restricts this deviceto sale by or on the order of a physician.

ContentsReader Symbols . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1Important Safety Information . . . . . . . . . . . . . . . . . . . . . . . . . . . 2Indications for Use . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2Contraindications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3Getting to Know the System . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7Reader Kit . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8Sensor Kit . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9FreeStyle Libre Pro Software . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11Setting up the Reader for the First Time . . . . . . . . . . . . . . . . 12Using the Sensor . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14Applying the Sensor . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15Starting the Sensor . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 19Patient Wear . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 21Getting Sensor Data . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 22Removing the Sensor . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 25Charging the Reader . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 26

Reader Options . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 27Maintenance and Disposal . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 30Troubleshooting . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 31Reader Does Not Power On . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 31Problems at the Sensor Application Site . . . . . . . . . . . . . . . . . . 32Problems Starting the Sensor . . . . . . . . . . . . . . . . . . . . . . . . . . . . 33Problems Getting Sensor Data . . . . . . . . . . . . . . . . . . . . . . . . . . . 34Reader Error Messages . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 36Perform a Reader Test . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 37Customer Service . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 37System Specifications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 38Labeling Symbols . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 42Performance Characteristics . . . . . . . . . . . . . . . . . . . . . . . . . . . 44Electromagnetic Compatibility . . . . . . . . . . . . . . . . . . . . . . . . . 64Limited Warranty . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 74

Reader SymbolsSymbolWhat It MeansView previous/next screenOptionsLow batteryBattery chargingConfirm Sensor reminderCommunication strengthData to report1

Important Safety InformationIndications for UseThe FreeStyle Libre Pro Flash Glucose Monitoring System is a professionalcontinuous glucose monitoring (CGM) device indicated for detecting trendsand tracking patterns in persons (age 18 and older) with diabetes. The Systemis intended for use by health care professionals and requires a prescription.Readings from the FreeStyle Libre Pro Sensor are only made available topatients through consultation with a health care professional. The Systemdoes not require user calibration with blood glucose values.The FreeStyle Libre Pro System aids in the detection of glucose levelexcursions above or below the desired range, facilitating therapy adjustments.Interpretation of the FreeStyle Libre Pro Flash Glucose Monitoring Systemreadings should be based on the trends and patterns analyzed through timeusing the reports available.IMPORTANT: The device may inaccurately indicate hypoglycemia.The results of the clinical study conducted for this deviceshowed that 40% of the time when the device indicated thatuser sensor glucose values were at or below 60 mg/dL, userglucose values were actually in the range of 81-160 mg/dL.Therefore, interpretation of the FreeStyle Libre Pro Flash GlucoseMonitoring System readings should only be based on the trendsand patterns analyzed through time using the reports availableper the intended use.2

ContraindicationsThe FreeStyle Libre Pro Flash Glucose Monitoring Systemmust be removed prior to Magnetic Resonance Imaging (MRI),Computed Tomography (CT) scan, or high-frequency electricalheat (diathermy) treatment. The effect of MRI, CT scans, ordiathermy on the performance of the System has not beenevaluated. The exposure may damage the Sensor and mayimpact proper function of the device to detect trends and trackpatterns in the user’s glucose values during the wear period.WARNING: The FreeStyle Libre Pro Flash Glucose MonitoringSystem contains small parts that may be dangerous ifswallowed.CAUTION: Performance of the System when used with other implantedmedical devices, such as pacemakers, has not been evaluated. Some individuals may be sensitive to the adhesive thatkeeps the Sensor attached to the skin. If your patient noticessignificant skin irritation around or under their Sensor, theyshould remove the Sensor and stop using the FreeStyle LibrePro System. Follow your facility’s procedures for handlingskin reactions.3

Warnings/Limitations Review all product information before use. Physiologic differences between the interstitial fluid and capillary bloodmay result in differences in glucose readings. Differences in glucosereadings between interstitial fluid and capillary blood may be observedduring times of rapid change in blood glucose, such as after eating,dosing insulin, or exercising. Severe dehydration and excessive water loss may cause inaccurateresults. Do not reuse Sensors. The Sensor and Sensor Applicator are designedfor single use. Reuse may result in no glucose readings and infection.Not suitable for re-sterilization. Further exposure to irradiation maycause inaccurate results. Interfering Substances: Taking ascorbic acid (vitamin C) while wearingthe Sensor may falsely raise Sensor glucose readings. Taking salicylicacid (used in some pain relievers such as aspirin and some skin careproducts) may slightly lower Sensor glucose readings. The level ofinaccuracy depends on the amount of the interfering substance activein the body. Test results did not 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) atmaximum circulating levels. However, concentrations of potentialinterferents in interstitial fluid are unknown compared to circulatingblood.4

Take standard precautions for transmission of blood borne pathogensto avoid contamination.The Reader should be cleaned between patients.If a Sensor breaks inside a patient, remove with tweezers, treat anymedical complications and call Customer Service.Use of the System is not recommended in the critically ill populationsince performance is unknown due to different conditions andmedications.Sensor placement is not approved for sites other than the back of thearm. If placed in other areas, the Sensor may not function properly.If the Sensor Kit package or contents or the Reader appear to bedamaged, do not use as there may be a risk of electric shock, no results,and/or infection.Store the Sensor Kit between 39 F-77 F. While you don’t need to keepthe Sensor Kit in a refrigerator, you can as long as the refrigerator isbetween 39 F-77 F.Store the Sensor Kit between 10-90% non-condensing humidity.The System does not provide real-time results. Patients need to rely onblood glucose readings for monitoring glucose during System use.Clean hands prior to Sensor handling/insertion to help preventinfection.Clean the application site and ensure that it is dry prior to Sensorinsertion. This helps the Sensor stay attached to the body.5

6Change the application site for the next Sensor application to preventdiscomfort or skin irritation.Select an appropriate Sensor site to help the Sensor stay attached to thebody and prevent discomfort or skin irritation. Avoid areas with scars,moles, stretch marks, or lumps. Select an area of skin that generally staysflat during normal daily activities (no bending or folding). Choose a sitethat is at least 1 inch away from an insulin injection site.The Sensor should not be worn more than 14 days. Readings are notobtained after 14 days.The Sensor should be removed prior to exposing it to an X-ray machine.The effect of X-rays on the performance of the system has not beenevaluated. The exposure may damage the Sensor and may impactproper function of the device to detect trends and track patterns in theuser’s glucose values during the wear period.The FreeStyle Libre Pro Flash Glucose Monitoring System has not beenevaluated for use in pregnant women, persons on dialysis, or people lessthan 18 years of age.

Getting to Know the SystemThe FreeStyle Libre Pro Flash Glucose Monitoring System has three mainparts: a handheld Reader, a disposable Sensor, and FreeStyle Libre Prosoftware. A single FreeStyle Libre Pro Reader can be used to gather datafrom FreeStyle Libre Pro Sensors on multiple patients.IMPORTANT: Safety information about theSystem is in this Operator’s Manual. Read all ofthe information in the Operator’s Manual beforeusing the System.When opening the Reader Kit and Sensor Kit, check that the contentsare undamaged and that you have all parts listed. If any parts are missingor damaged, contact Customer Service.7

Reader KitThe Reader Kit includes: FreeStyle LibrePro ReaderUSB Cable Power AdapterOperator’s Manual Quick Start GuideTouchscreenUSB PortUsed to charge theReader and connectit to a computer.Home ButtonTurns the Reader on/offand takes you to theHome Screen from anyother screen.The Reader is used to start the Sensor on a patient and gather theirglucose readings. Multiple patients can have their Sensor started by thesame Reader.8

Sensor KitThe Sensor Kit includes: Sensor PackSensor ApplicatorSensor PackUsed with the Sensor Applicator toprepare the Sensor for use.Alcohol wipeProduct insertSensor ApplicatorApplies the Sensor to the patient’s body.The Sensor measures and stores glucose readings when worn on thebody. It initially comes in two parts: one part is in the Sensor Pack andthe other part is in the Sensor Applicator. By following theinstructions, prepare and apply the Sensor on the backof the patient’s upper arm. The Sensor has a small,flexible tip that is inserted just under the skin. TheSensor can be worn for up to 14 days.SensorMeasures glucose while on body(only visible after applied).9

The Reader Home Screen provides access to starting a new Sensor, gettingSensor data, and information about the System.Home ScreenBattery LevelTimeCurrent time set onthe Reader.Battery charge remaining.10:23pmOptionsTouch to view or changethe Reader’s options.Start New SensorTouch to start a newSensor.10Start NewSensorGet SensorDataGet Sensor DataTouch to download allglucose readings from theSensor into the Reader.

FreeStyle Libre Pro SoftwareFreeStyle Libre Pro software can be used to create reports based onglucose readings from the most recently downloaded Sensor. Thesoftware is compatible with most Windows and Mac operating systems.Go to www.FreeStyleLibrePro.com and follow onscreen instructions todownload and install the software.INTENDED USEThe FreeStyle Libre Pro software is intended for use by healthcare professionals to aid in the review, analysis and evaluation ofa patient’s glucose readings uploaded from the FreeStyle LibrePro Flash Glucose Monitoring System in support of an effectivediabetes health management program.11

Setting up the Reader for the First TimeBefore using the System for the first time, the Reader must be set up.StepAction1Press the Home Button to turn on the Reader.2If prompted, use the touchscreen to select yourpreferred language for the Reader. Touch OK tocontinue. Note: Use the pad of your finger. Do NOT useyour fingernail or any other object on the screen.312 Set the Current Date using the arrows on thetouchscreen. Touch next to continue.Current Date11June2017backnext

Step45Action12 am00backnextbackto140mgdLnextWhile using the Reader, pressthe Home button to return tothe Home screen.backCAUTION: It is very important to set the timeand date correctly for correct interpretationof Sensor data.?Target GlucoseRange806 Set the Current Time. Touch next to continue.Current Time Set the Target Glucose Range. Touch next tocontinue. Note: The Target Glucose Range is displayed onthe Daily Graph on the Reader once Sensor datahas been downloaded. While the glucose dataare gathered in the System range of 40-500 mg/dL,the Daily Graph display range is 0-350 mg/dL forease of review on screen.The Reader now indicates how to return to theHome Screen from any other screen. Touch doneto go to the Home Screen.doneNote: Charge the Reader if the battery level is low. Only use the USBcable and power adapter included with the System.13

Using the SensorAfter you assemble and apply the Sensor to your patient’s body, startthe Sensor with the Reader and confirm it is working. The Sensor storesglucose readings every 15 minutes for up to 14 days. The first reading isstored 1 hour after the Sensor is successfully started.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 usingFreeStyle Librethe Sensor Pack and Sensor Applicator. SensorSensor PackPacks and Sensor Applicators with the sameCODE XXXSensor code should be used together orXXXXXXXXXSensor glucose readings may be incorrect.t DiR ev.B0tAbbo9/13YYYY-MM-DDC14C30tes391abeareLtd. Rang eRoad, W29 0 Yitney, Oxon, OXL, UKDO

Applying the SensorStep1Action pply Sensors only on the back of your patient’sAupper arm. Avoid areas with scars, moles, stretchmarks, or lumps.Select an area of skin that generally stays flatduring normal daily activities (no bending orfolding). Choose a site that is at least 1 inch(2.5 cm) away from an insulin injection site.To prevent discomfort or skin irritation, youshould select a different site other than theone most recently used.2 lean application site with an alcohol wipe andCallow site to dry before proceeding. This helpsthe Sensor stay attached to the body. ote: The area MUST be clean and dry, or theNSensor may not stick to the site.15

ActionStep3LidCap16 pen the Sensor Pack by peeling the lid offOcompletely. Unscrew cap from the SensorApplicator and set the cap aside. CAUTION: Do NOT use if the Sensor Pack orthe Sensor Applicator seem to be damagedor already opened. Do NOT use if pastexpiration date.4 Lineup the dark mark on the Sensor Applicatorwith the dark mark on the Sensor Pack. Pressfirmly down on the Sensor Applicator until itcomes to a stop.5Lift the Sensor Applicator out of the Sensor Pack.

Step6ActionT he Sensor Applicator is prepared and ready toapply the Sensor.CAUTION: The Sensor Applicator nowcontains a needle. Do NOT touch inside theSensor Applicator or put it back into theSensor Pack.7 lace the Sensor Applicator over the preparedPsite and push down firmly to apply the Sensor tothe body.CAUTION: Do NOT push down on the SensorApplicator until placed over prepared site toprevent unintended results or injury.17

ActionStep8Sensor ently pull the Sensor Applicator away from theGbody. The Sensor should now be attached to theskin.Note: Applying the Sensor may cause bruisingor bleeding. If there is bleeding that does notstop, remove the Sensor, and apply a new one ata different site.9 ake sure the Sensor is secure after application.MPut the cap back on the Sensor Applicator.Discard the used Sensor Pack and SensorApplicator according to your facility’s procedures.18

Starting the SensorActionStep12Press the Home Button to turn on the Reader.Touch Start New Sensor.10:23pmStart NewSensorGet SensorData3 old the Reader within 1.5 inches (4 cm) of theHSensor to start it. If sounds are turned on, theReader beeps when the Sensor has been started.You can check the Sensor has successfully startedin 2 minutes.Sensor StartingCheck Sensor statuswhen prompted in:2minutesOKNote: If communication is not established within15 seconds, the Reader displays a prompt to tryagain. Touch OK to return to the Home Screenand touch Start New Sensor to start the Sensor.19

Step4ActionReminderCheck Sensor Status?no5yesSensor WorkingSensor can be used forup to 14 more days.20 hen prompted, touch yes to check the SensorWstatus. Hold the Reader within 1.5 inches (4 cm)of the Sensor to verify Sensor is working.OKTouch OK to go to the Home Screen.

Patient WearThe Sensor stores your patient’s glucose readings every 15 minutes for upto 14 days. The first reading is stored 1 hour after the Sensor is successfullystarted.IMPORTANT: The Sensor should not be worn for more than 14 days. Data can be downloaded at anytime from Sensors that are on or offthe body. Before your patient goes home, review and give them the “Livingwith Your FreeStyle Libre Pro Sensor” section of the insert in theSensor Kit.CAUTION: Intense exercise may cause the Sensor to loosendue to sweat or movement of the Sensor. If the Sensorbecomes loose, the Sensor readings may be unavailable orunreliable. Your patient should return to your facility forapplication of a new Sensor.21

Getting Sensor DataData can be downloaded at anytime from Sensors that are on or offthe body.StepAction12 Press the Home Button to turn on the Reader.Start NewSensor3Touch Get Sensor Data.10:23pmGet SensorDataHold the Reader within 1.5 inches (4 cm) of theSensor. If sounds are turned on, the Reader willbeep when all the data has been successfullydownloaded from the Sensor. This may take upto 5 seconds.Note: If communication is not established within15 seconds, the Reader displays a prompt to tryagain. Touch OK to return to the Home Screenand touch Get Sensor Data again.22

Step4ActionSensor Data ReceivedDays Recorded7Sensor can be used forup to 7 more days.view5nextTo create reports,connect Reader to acomputer.backThe Reader will indicate how many days ofSensor wear are left, if any. Touch view toview the daily graph. Touch next. For moreinformation about the daily graph, see DailyGraph section.doneTo create reports, connect the Reader to acomputer. See Creating Reports section in theFreeStyle Libre Pro software User’s Manual. TheUser’s Manual can be found in the Help Menu ofthe software. Touch done to return to the HomeScreen.Note: The Home Screen will show thissymbolnear the top of the screen whenthere is new Sensor data in the Reader that hasnot been transferred to a computer. A reportshould be generated from this data before thenext Sensor is downloaded.23

Daily GraphOKDaily Graph(mg/dL)3502501505012am6am12pm22 FebWednesday6pm12amThe Daily Graph shows the Sensor glucose readingsby day and the Target Glucose Range that is set onthe Reader. You can change the target glucose rangeby touching the Options symbolon the HomeScreen and selecting Target Range.Notes: If you want the graph to show the currentpatient’s target range, set their target range beforedownloading their data. The graph displays glucose readings up to350 mg/dL. Glucose readings above 350 mg/dLare displayed at 350 mg/dL. For sequentialreadings above 350 mg/dL, a line is displayed at350 mg/dL.24

Removing the SensorThe Sensor automatically stops working and should be removed 14 daysafter being started. You should also replace the Sensor if there is anyirritation or discomfort at the application site or if the Reader reports aproblem with the Sensor currently in use.Step12Action ull up the edge of the adhesive that keeps thePSensor attached to the skin. Slowly peel awayfrom the skin in one motion.Note: Any remaining adhesive residue on theskin can be removed with warm soapy water orisopropyl alcohol. iscard the used Sensor according to your facility’s procedures.DSee Maintenance and Disposal section.25

Charging the ReaderOKLow BatteryA fullycharged Reader battery should last up to 2 weeks. The battery lifemayPleasevarydepending on your usage.charge the Reader tocontinue using it.Plug the included USB cable into an electricaloutlet using the included power adapter. Then,plug the other end of the USB cable into the USBport on the Reader.ChargingCAUTION: Be sure to select a location forcharging that allows the power adapter to beeasily unplugged.Notes: You must charge the Reader when the battery is lowtokeep using the Reader. To fully charge the battery, charge the Reader for at least3 hours. Only use the USB cable and power adapter included withthe system. Fully charge the Reader before storing it for more than3 months.26

Reader OptionsYou can go to the Options menu to check Sensor or System Status orchange settings on the Reader, like Time & Date or Sounds.ActionStep1T o get to the Options menu, touch the Optionson the Home Screen.symbol10:23pmStart NewSensorGet SensorDataOptionsCheck Sensor StatusTarget RangeSounds1/227

Step2ActionTouch the option you want to view or change:Check Sensor Status – Check if a Sensor is working or hasendedTarget Range – Set range displayed on Reader Daily GlucosegraphSounds – Set tones and vibrationsTime & Date – Change the Time or DateLanguage – Change the language on the Reader (option onlyavailable on Readers with multiple languages)System Status – Check Reader information and performance View System Information: The Reader will display informationabout the system including:- Reader serial and version numbers- Sensor serial number for most recently downloaded Sensor- Sensor version for most recently downloaded Sensor- Sensor start date and time for most recently downloadedSensor- Sensor download date and time for most recentlydownloaded Sensor- Amount of data downloaded from Sensor28

Step2(cont.)Action Perform a Reader Test: The Reader Test will perform internaldiagnostics and allow you to check that the display isshowing all pixels, sounds (including both tones andvibrations) are working, and the touchscreen is respondingwhen touched View Event Logs: A list of events recorded by the Reader,which may be used by Customer Service to help troubleshootthe SystemTouch OK when you are done.29

Maintenance and DisposalCleaningYou may clean the Reader using a damp cloth. Gently wipe the exterior ofthe Reader and allow to air dry.CAUTION: Do NOT place the Reader in water or other liquids.Avoid getting dust, dirt, water, or any other substance in theUSB port.MaintenanceThe FreeStyle Libre Pro Flash Glucose Monitoring System has noserviceable parts.DisposalThis product should be disposed of in accordance with all applicable localregulations related to the disposal of electronic equipment, batteries,sharps, and materials potentially exposed to body fluids.Contact Customer Service for further information on the appropriatedisposal of system components.30

TroubleshootingThis section lists problems or observations that may occur, the possiblecause(s), and recommended actions. If the Reader experiences an error, amessage will appear on the screen with directions to resolve the error.Reader Does Not Power OnProblemReader does notpower on afteryou press theHome Button.What It May MeanWhat To DoReader battery istoo low.Charge the Reader.Reader is outsideof its operatingtemperature range.Move the Reader to atemperature between 50 Fand 113 F and then try topower it on.If the Reader still does not power on after trying these steps, contactCustomer Service.31

Problems at the Sensor Application Site32ProblemWhat It May MeanWhat To DoThe Sensor is notsticking to thepatient’s skin.The site is not freeof dirt, oil, hair, orsweat.1. Remove the Sensor.2. Consider shaving and/orcleaning the site with soapand water.3. Follow the instructions inApplying and Starting theSensor sections.Skin irritationat the Sensorapplication site.Seams or otherconstrictiveclothing oraccessories causingfriction at the site.Ensure that nothing rubs onthe site.The patient maybe sensitive to theadhesive material.Follow your facility’sprocedures for handlingskin reactions.

Problems Starting the SensorDisplayWhat It May MeanWhat To DoSensor EndedYou may be tryingto start a usedSensor.If you need to start a Sensor,then apply and start a newone. Otherwise, return to theHome Screen to get Sensordata.CommunicationErrorThe Readerwas unable tocommunicate withthe Sensor.Hold the Reader within1.5 inches (4 cm) of the Sensor.The Systemhas detected aproblem with theSensor.Apply and start a new Sensor.Replace SensorNote: You may need tomove away from potentialsources of electromagneticinterference.33

Problems Getting Sensor DataDisplay34What It May MeanWhat To DoData TransferErrorThe Reader is notheld close enoughor long enough tothe Sensor.Hold the Reader within1.5 inches (4 cm) of theSensor for up to 5 seconds.New SensorFoundThe Sensor wasnever started.If you would like to beginusing this Sensor, touch Yes.CommunicationErrorThe Readerwas unable tocommunicate withthe Sensor.Hold the Reader within1.5 inches (4 cm) of theSensor.Note: You may need tomove away from potentialsources of electromagneticinterference.

DisplayWhat It May MeanWhat To DoSensor StartingThe Sensor hasnot completedstarting.Wait for the reminder tocheck Sensor status. Thiswill take approximately 2minutes.No DataAvailableThere is no dataavailable todownload.Sensor data is usuallyavailable for download80 minutes after a Sensorwas started. Try again afterthis time.Sensor ErrorThere is no dataavailable fromthis Sensor. TheSensor may notbe working.If the Sensor was recentlyapplied, wait 1 hour and tryagain. If this doesn’t work,contact Customer Service.35

DisplayData to ReportWhat It May MeanYou have not yetgenerated reportsfrom the dataalready on theReader.What To DoTo create reports from thedata already on the Reader,connect the Reader to acomputer. Or, to overwritewith data from the currentSensor, touch yes.Reader Error MessagesDisplay36What It May MeanWhat To DoE-2Reader error.Turn off the Reader and tryagain. If the error reappears,contact Customer Service.E-9Reader error.Turn off the Reader and tryagain. If the error reappears,contact Customer Service.

Perform a Reader TestSystem StatusSystem InfoReader TestEvent LogOKIf you think the Reader is not working properly, youcan check the Reader by performing a Reader Test.from the HomeTouch the Options symbolScreen, select System Status and then selectReader Test.Note: The Reader Test will perform internaldiagnostics and will allow you to check that thedisplay, sounds, and touchscreen are workingproperly.Customer ServiceCustomer Service is available to answer any questions you may haveabout the FreeStyle Libre Pro Flash Glucose Monitoring System. Please goto the back cover of this manual for your Customer Service phone number.37

System SpecificationsSensor Specifications38Sensor glucose assaymethodAmperometric electrochemical sensorSensor glucose readingrange40 to 500 mg/dLSensor size5 mm height and 35 mm diameterSensor weight5 gramsSensor power sourceOne silver oxide batterySensor wear periodUp to 14 days

Sensor memoryUp to 14 days (glucose readings storedevery 15 minutes)Operating temperature50 F to 113 FSensor Applicator andSensor Pack storagetemperature39 F to 77 FOperating and storagerelative humidity10-90%, non-condensingSensor water resistanceIP27: Can withstand immersion into3 ft (one meter) of water for up to30 minutesOperating and storagealtitude-1,250 ft (-381 meters) to 10,000 ft(3,048 meters)39

Reader Specifications40Reader size95 mm x 60 mm x 16 mmReader weight65 gramsReader power sourceOne lithium-ion rechargeable batteryReader battery life2 weeks of typical useReader Sensor memory1 SensorReader operatingtemperature50 F to 113 FReader storagetemperature-4 F to 140 FOperating and storagerelative humidity10-90%, non-condensingReader moistureprotectionKeep dry

Operating and storagealtitude-1,250 ft (-381 meters) to 10,000 ft(3,048 meters)Reader display timeout60 secondsRadio FrequencyNear Field Communication*(13.56 MHz RFID); ASK Modulation;124 dBuV/m;1.5 inch communication rangeData portMicro USBMinimum ComputerRequirementsSystem must only be used withEN60950-1 rated computersMean service life3 years of typical usePower AdapterAbbott Diabetes Care PRT25611Operating temperature: 50 F to 104 FUSB CableAbbott Diabetes Care PRT21373Length: 37 inches (94 cm)* Security measures: The communication between Reader and Sensor is a short range nearfield communication method making it difficult to interfere with or intercept data that isbeing transferred. The Sensor and Reader are protected by proprietary data format, memorymapping, and cyclic redundancy check (CRC) generation and verification of data.Quality of Service (QoS): QoS

Power Adapter Operator’s Manual Quick Start Guide The Reader is used to start the Sensor on a patient and gather their glucose readings . Multiple patients can have their Sensor started by the same Reader . USB Port Used to charge the Reader and connect it to a computer. Touchscreen Home Button Turns the Reader on/o and takes .

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