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Blood Glucose Monitoring SystemOwner'sBookletInstructions for Use

Blood Glucose Monitoring SystemOwner's Booklet1

Thanks for choosing OneTouch !The OneTouch Verio Flex Blood Glucose MonitoringSystem is one of the latest product innovations fromOneTouch .Your OneTouch Verio Flex Meter is designed to connect(sync) with a variety of compatible wireless devicesrunning software applications that let you review andgraph your results, and help identify patterns. Meterresults are sent to the compatible devices either throughBLUETOOTH (wireless) or USB cable connection.Every OneTouch Meter is designed to help you test yourblood glucose and manage your diabetes.This Owner's Booklet offers a complete explanationof how to use your new meter and testing supplies. Itreviews the do's and don'ts of testing your blood glucoselevel. Please keep your Owner's Booklet in a safe place;you may want to refer to it in the future.We hope OneTouch products and services will continueto be a part of your life.2

Compatible wireless devicesVisit www.OneTouch.com for information onwhich wireless devices are compatible with yourOneTouch Verio Flex Meter, and where/how todownload the OneTouch Reveal Mobile App on yourcompatible wireless device.Meter symbols and iconsMeter PowerLow BatteryBattery EmptyControl SolutionSyncingBLUETOOTH Feature OnHistory Mode (Past results)Apply SampleRange Indicator ArrowSetting Mode3

Other symbols and iconsCautions and Warnings: Refer to the Owner'sBooklet and inserts that came with your systemfor safety-related information.Direct currentBefore you beginBefore using this product to test your bloodglucose, carefully read this Owner's Booklet, andthe inserts that come with the OneTouch Verio TestStrips, OneTouch Verio Control Solutions and theOneTouch Delica Plus Lancing Device.4

IMPORTANT SAFETY INSTRUCTIONS: This meter and lancing device are for single patientuse only. Do Not share them with anyone else,including family members! Do Not use on multiplepatients! After use and exposure to blood, all parts of this kit areconsidered biohazardous. A used kit may potentiallytransmit infectious diseases even after you haveperformed cleaning and disinfection.For more information see: FDA Public Health Notification:"Use of Fingerstick Devices on More than One PersonPoses Risk for Transmitting Bloodborne Pathogens:Initial Communication" (2010) Notices/ucm224025.htm.CDC Clinical Reminder: "Use of Fingerstick Deviceson More than One Person Poses Risk for TransmittingBloodborne Pathogens" (2010) icesBGM.html.5

Intended useThe OneTouch Verio Flex Blood Glucose MonitoringSystem is intended to be used for the quantitativemeasurement of glucose (sugar) in fresh capillary wholeblood samples drawn from the fingertip.The OneTouch Verio Flex Blood Glucose MonitoringSystem is intended for self-testing outside the body(in vitro diagnostic use) by people with diabetes at homeas an aid to monitor effectiveness of diabetes control.LimitationsThe OneTouch Verio Flex Blood Glucose MonitoringSystem is intended to be used by a single patient andshould not be shared. The system is not to be used forthe diagnosis of or screening of diabetes or for neonataluse. The system is not for use on critically ill patients,patients in shock, severely dehydrated patients orhyperosmolar patients.6

Test principleGlucose in the blood sample mixes with the enzymeFAD-GDH (see page 108) in the test strip and a smallelectric current is produced. The strength of thiscurrent calculates your blood glucose level. It thendisplays the blood glucose result and stores it in themeter memory.Use only OneTouch Verio Control Solutions and TestStrips with the OneTouch Verio Flex Meter. Use ofOneTouch Verio Test Strips with meters for which theyare not intended may yield inaccurate results.BLUETOOTH wireless technologyBLUETOOTH wireless technology is used bysome smartphones and many other devices. YourOneTouch Verio Flex Meter uses BLUETOOTH wirelesstechnology to pair and to send your glucose results tocompatible wireless devices.The OneTouch Verio Flex Meter is designed to work withthe OneTouch Reveal Mobile App.7

Visit www.OneTouch.com for information onwhich wireless devices are compatible with yourOneTouch Verio Flex Meter, and where/how todownload the OneTouch Reveal Mobile App on yourcompatible wireless device.When using the OneTouch Verio Flex System, wesuggest you pair your OneTouch Verio Flex Meter witha compatible wireless device and track your results. Seepage 31 for pairing instructions.Changes or modifications not expressly approved by theparty responsible for compliance could void the user'sauthority to operate the equipment.This device complies with Part 15 of the FCC Rules.Operation is subject to the following two conditions:(1) this device may not cause harmful interference and(2) this device must accept any interference received,including interference that may cause undesiredoperation.8

NOTE: This equipment has been tested and foundto comply with the limits for a Class B digital device,pursuant to part 15 of the FCC Rules. These limits aredesigned to provide reasonable protection againstharmful interference in a residential installation. Thisequipment generates, uses and can radiate radiofrequency energy and, if not installed and used inaccordance with the instructions, may cause harmfulinterference to radio communications. However, thereis no guarantee that interference will not occur in aparticular installation. If this equipment does causeharmful interference to radio or television reception,which can be determined by turning the equipmentoff and on, the user is encouraged to try to correct theinterference by one or more of the following measures: Reorient or relocate the receiving antenna. Increase the separation between the equipment andreceiver. Connect the equipment into an outlet on a circuitdifferent from that to which the receiver is connected. Consult the dealer or an experienced radio/TVtechnician for help.9

These guidelines help ensure that your meter will notaffect the operation of other nearby electronic devices.Additionally, other electronic devices should not affectthe use of your meter.If you experience meter interference problems, trymoving your meter away from the source of theinterference. You can also move the electronic device orits antenna to another location to solve the problem.WARNING: The BLUETOOTH feature on your metersends test results to your compatible wireless device. Toprevent other people's results from being sent to yourcompatible wireless device, Do Not let anyone else useyour meter to test their blood glucose. This meter is forsingle patient use only.10

WARNING: In locations where cell phone use is notpermitted, such as hospitals, some healthcare professionaloffices and airplanes, you should turn the BLUETOOTH feature off. See page 29 for more information.BLUETOOTH trademarkThe BLUETOOTH word mark and logos are registeredtrademarks owned by the Bluetooth SIG, Inc. and any useof such marks by LifeScan Scotland Ltd. is under license.Other trademarks and trade names are those of theirrespective owners.11

Table of Contents1Getting to know your system.142Setting up your system.24Setting up your meter.24Connecting to a compatible wireless device .29Turning the meter off.353Taking a test. 36Testing your blood glucose.36Testing with control solution.624Reviewing past results.7212

5Editing Your Settings.78Editing time and date.78Editing your range limits.796Caring for your system. 827Battery. 908Troubleshooting your system. 949Detailed information about your system. 10410 Index.11613

1 Getting to know your systemYour OneTouch Verio Flex Blood GlucoseMonitoring SystemIncluded with your kit:OneTouch Verio Flex Meter (CR2032 lithium coincell battery included)Lancing deviceLancets14

Getting to know your system 1NOTE: If any item is missing or defective in your kit, contactCustomer Service. As your partner in diabetes care, wewelcome you to contact us (7 days a week, 8:00 AM 8:00 PM Eastern Time) at 1 888 567-3003 (English),1 888 567-3010 (Español), or www.OneTouch.com.NOTE: If another type of lancing device was included,see the separate instructions for that lancing device.15

1 Getting to know your systemAvailable separately:Items pictured below are required, but may not beincluded in your kit:They are sold separately. Refer to your meter carton for alist of included items.OneTouch Verio Level 4 ControlSolution*(vial with red cap)OneTouch Verio Level 3 ControlSolution*(vial with blue cap)OneTouch Verio Test Strips*16

Getting to know your system 1*OneTouch Verio Control Solution and Test Strips areavailable separately. For availability of test strips andcontrol solution, contact Customer Service or ask yourpharmacist or healthcare professional.You can use either OneTouch Verio Level 3 ControlSolution or OneTouch Verio Level 4 Control Solutionwith your OneTouch Verio Flex Meter.WARNING: Keep the meter and testing supplies awayfrom young children. Small items such as the battery door,batteries, test strips, lancets, protective covers on thelancets, and control solution vial cap are choking hazards.Do Not ingest or swallow any items.17

1 Getting to know your systemGetting to know your OneTouch Verio Flex Blood Glucose Monitoring SystemMeter18

Getting to know your system 119

1 Getting to know your systemGetting to know your OneTouch Verio Test StripTest strip20

Getting to know your system 1The Range Indicator featureThe OneTouch Verio Flex Meter automatically letsyou know if your current result is below, above orwithin your range limits. It does this by displaying yourcurrent result with a Range Indicator Arrow, pointing toa corresponding Range Indicator Color Bar below themeter display. Use the Range Indicator Arrow and ColorBar together to interpret your results.21

1 Getting to know your system3 Possible Range Indicator DisplaysA Range Indicator Arrow willappear just below your resultafter each test depending uponhow you set your low and highrange limits in the meter.ExampleThings you should know beforeBelow Range Resultusing the Range Indicator feature: The meter comes with pre-setrange limits. The pre-set lowrange limit is 70 mg/dL andthe pre-set high range limit is180 mg/dL. You can changethese limits as needed to meetyour needs. See page 79 fordetails on the pre-set rangelimits and on editing yourrange limits. If you decide to changeyour range limits, the RangeIndicator Arrows stored withprevious results in metermemory will not change.However, any new tests willdisplay Range Indicator Arrowswhich reflect your changes.22ExampleIn Range ResultExampleAbove Range Result

Getting to know your system 1This page left blank intentionally.23

2Setting up your systemSetting up your meterTurn your meter onTo turn your meter on, pressand holduntil the startup test screen appears. Oncethe device is on, release .You can also turn the meteron by inserting a test strip.Every time you turn your meter on, a start-up screen willappear for a few seconds. All segments of the displayshould appear briefly, indicating your meter is workingproperly. If the meter does not power on, check thebattery.CAUTION:If you see any missing segments within the start-upscreen, there may be a problem with the meter. ContactCustomer Service. Contact us at 1 888 567-3003.NOTE: If you turned the meter on for the first time byinserting a test strip instead of pressing , you will notbe able to perform a glucose test until you complete thefirst time setup.24