Cilag G ONE TOUCH Select Plus Flex / Blood Glucose Monitoring System User Manual 1426723577390 generated

Cilag GmbH International ONE TOUCH Select Plus Flex / Blood Glucose Monitoring System 1426723577390 generated

UserManual.wiki >

User Manual

©2015LifeScan, Inc.LifeScan EuropeDivision of CilagGmbH InternationalGubelstrasse 346300 ZugSwitzerlandDistributed by:LifeScan UK & Ireland, A division of Johnson & Johnson Medical Limited,50-100 Holmers Farm Way,High Wycombe,Bucks,HP12 4DPUnited KingdomCall OneTouch® Customer Care on 0800121200 (UK) or 1800535 676 (Ireland) during the hours of 8:30am-6pm Monday-Friday, 9am-1pm Saturday. Or visit www.LifeScan.co.uk.C4Contents covered by one or more of the following U.S. patents: 5,708,247, 5,951,836, 6,241,862, 6,284,125, 7,112,265, 7,462,265, 7,807,031, and 8,398,664. Use of the monitoring device included herein is protected under one or more of the following U.S. patents: 6,413,410, 6,733,655, 7,250,105, 7,468,125, 8,066,866 and 8,093,903. Purchase of this device does not act to grant a use license under these patents. Such a license is granted only when the device is used with OneTouch® Select® Plus Test Strip. No test strip supplier other than LifeScan is authorized to grant such a license. The accuracy of results generated with LifeScan meters using test strips manufactured by anyone other than LifeScan has not been evaluated by LifeScan.Blood Glucose Meter, Test Strips, and Control SolutionLancing SystemLifeScan self-test blood glucose monitoring devices conform to the following EU Directives:IVDD (98/79/EC):MDD (93/42/EEC):PF3130451 Rev 1Rev. Date: 01/2015PF3130451 Rev 1Yellow = 5mm margin, Red = 10mm marginYellow = 5mm margin, Red = 10mm marginPF3130451Rev1_OTSPF_OB_C_GB_en_zug_R2.indd 4 3/12/15 11:27 AM Statement of Use: Verify status before each useEffectivity Date: Mar 18 2015 Status: Current State: ReleasedType: Project File Name: 3130451 Revision: 1

Blood Glucose Monitoring SystemInstructions for UseOwner's BookletC1Yellow = 5mm margin, Red = 10mm marginYellow = 5mm mamargiirgirgirgrgrgirgirgirgirgirgrgggrgigigigggiggggigiin, nn,n,nn, n, nnnnnn,nnnn,nnnn,nnn, ,,,,,,,,RRedRRed= = 100m10m10m100m10m10mmmm10mm110m1m10m11mm mmarginnPF3130451Rev1_OTSPF_OB_C_GB_en_zug_R2.indd 1 3/12/15 11:27 AM Statement of Use: Verify status before each useEffectivity Date: Mar 18 2015 Status: Current State: ReleasedType: Project File Name: 3130451 Revision: 1

C2Yellow = 5mm margin, Red = 10mm marginYellow = 5mm margin, Red = 10mm marginPF3130451Rev1_OTSPF_OB_C_GB_en_zug_R2.indd 2 3/12/15 11:27 AM Statement of Use: Verify status before each useEffectivity Date: Mar 18 2015 Status: Current State: ReleasedType: Project File Name: 3130451 Revision: 1

C3Yellow = 5mm margin, Red = 10mm marginYellow = 5mm margin, Red = 10mm marginPF3130451Rev1_OTSPF_OB_C_GB_en_zug_R2.indd 3 3/12/15 11:27 AM Statement of Use: Verify status before each useEffectivity Date: Mar 18 2015 Status: Current State: ReleasedType: Project File Name: 3130451 Revision: 1

PF No./Rev.: 3130451 Rev 1CPS Reference No.: Refer to References Section in Enable for CPS No. LFS Contact: Andrew MarkRev. Date: 12-Mar-15Language Sequence: EnglishJDE Item No.: N/ANo. of Covers: 4PMS N/A N/A Inside No. of pages: No. of sides: 1 2Process ColorsUncoated AreaSpot Colors Uncoated Area Special Instructions DielineN/A DielineDescription: Booklet, Owners, OTSPF, GB (zug) Art Agency: ForeignExchange Translations Job No.: 28801= CUT= SCORE= PERFN/AN/AN/A C M Y K Black N/A Leg1PF3130451Rev1_OTSPF_OB_C_GB_en_zug_R2.indd 1 3/12/15 11:27 AM Statement of Use: Verify status before each useEffectivity Date: Mar 18 2015 Status: Current State: ReleasedType: Project File Name: 3130451 Revision: 1

1Owner's BookletBlood Glucose Monitoring SystemSelect Plus Flex™Yellow= 5mm Red=7mm marginPF3130451Rev1_OTSPF_OB_I_GB_en_zug_R2.indd 1 3/12/15 11:35 AM Statement of Use: Verify status before each useEffectivity Date: Mar 18 2015 Status: Current State: ReleasedType: Project File Name: 3130451 Revision: 1

2Thanks for choosing OneTouch®!The OneTouchSelect Plus Flex™ Blood Glucose Monitoring System is one of the latest product innovations from OneTouch®.Your OneTouchSelect Plus Flex™ Meter is designed to connect (sync) with a variety of devices running software applications that let you review and graph your results, and help identify patterns. Meter results are sent to the compatible devices either through BLUETOOTH® SMART (wireless) or USB cable connection.Every OneTouch® Meter is designed to help you test your blood glucose and manage your diabetes.This Owner's Booklet offers a complete explanation of how to use your new meter and testing supplies. It reviews the do's and don'ts of testing your blood glucose level. 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 continue to be a part of your life. Yellow= 5mm Red=7mm marginPF3130451Rev1_OTSPF_OB_I_GB_en_zug_R2.indd 2 3/12/15 11:35 AM Statement of Use: Verify status before each useEffectivity Date: Mar 18 2015 Status: Current State: ReleasedType: Project File Name: 3130451 Revision: 1

3Meter symbols and iconsMeter PowerLow BatteryBattery EmptyControl SolutionSyncingBLUETOOTH® SMART Feature OnHistory Mode (Past results)Apply SampleRange Indicator ArrowSetting ModeCompatible Wireless DevicesVisit www.LifeScan.co.uk for information on which wireless devices are compatible with your OneTouchSelect Plus Flex™ Meter, and where/how to download the software application on your compatible wireless device.Yellow= 5mm Red=7mm marginPF3130451Rev1_OTSPF_OB_I_GB_en_zug_R2.indd 3 3/12/15 11:35 AM Statement of Use: Verify status before each useEffectivity Date: Mar 18 2015 Status: Current State: ReleasedType: Project File Name: 3130451 Revision: 1

4Other symbols and iconsCautions and Warnings: Refer to the Owner's Booklet and inserts that came with your system for safety-related information. Direct current Consult Instructions for Use Manufacturer Lot Number Serial Number Storage Temperature Limits In Vitro Diagnostic Device Do Not Re-use Sterilized by irradiation Not for general waste Use By Date Contains sucient for n tests Underwriters Laboratories certiﬁcationYellow= 5mm Red=7mm marginPF3130451Rev1_OTSPF_OB_I_GB_en_zug_R2.indd 4 3/12/15 11:35 AM Statement of Use: Verify status before each useEffectivity Date: Mar 18 2015 Status: Current State: ReleasedType: Project File Name: 3130451 Revision: 1

5Before you beginBefore using this product to test your blood glucose, carefully read this Owner's Booklet, and the inserts that come with the OneTouchSelect® Plus Test Strips, OneTouchSelect® Plus Control Solutions and the OneTouch®Delica® Lancing Device.IMPORTANT SAFETY INSTRUCTIONS:đƫ This meter and lancing device are for single patient use only. Do Not share them with anyone else, including family members! Do Not use on multiple patients!đƫ After use and exposure to blood, all parts of this kit are considered biohazardous. A used kit may potentially transmit infectious diseases even after you have performed cleaning and disinfection.Yellow= 5mm Red=7mm marginPF3130451Rev1_OTSPF_OB_I_GB_en_zug_R2.indd 5 3/12/15 11:35 AM Statement of Use: Verify status before each useEffectivity Date: Mar 18 2015 Status: Current State: ReleasedType: Project File Name: 3130451 Revision: 1

6Intended useThe OneTouchSelect Plus Flex™ Blood Glucose Monitoring System is intended to be used for the quantitative measurement of glucose (sugar) in fresh capillary whole blood samples drawn from the fingertip. The system is intended to be used by a single patient and should not be shared.The OneTouchSelect Plus Flex™ Blood Glucose Monitoring System is intended for self-testing outside the body (in vitro diagnostic use) by people with diabetes at home and with their healthcare professionals in a clinical setting as an aid to monitor the effectiveness of diabetes control.The OneTouchSelect Plus Flex™ Blood Glucose Monitoring System is not to be used for the diagnosis of or screening of diabetes or for neonatal use.The OneTouchSelect Plus Flex™ Blood Glucose Monitoring System is not for use on critically ill patients, patients in shock, dehydrated patients or hyperosmolar patients.Yellow= 5mm Red=7mm marginPF3130451Rev1_OTSPF_OB_I_GB_en_zug_R2.indd 6 3/12/15 11:35 AM Statement of Use: Verify status before each useEffectivity Date: Mar 18 2015 Status: Current State: ReleasedType: Project File Name: 3130451 Revision: 1

7Test principleGlucose in the blood sample mixes with the enzyme Glucose Oxidase (see page103) in the test strip and a small electric current is produced. The strength of this current changes with the amount of glucose in the blood sample. Your meter measures the current, calculates your blood glucose level, displays the result, and stores it in its memory.Use only OneTouchSelect® Plus Control Solutions and Test Strips with the OneTouchSelect Plus Flex™ Meter.BLUETOOTH® SMART wireless technologyBLUETOOTH® SMART wireless technology is used by some smartphones and many other devices. Your OneTouchSelect Plus Flex™ Meter uses BLUETOOTH® SMART wireless technology to pair and to send your glucose results to compatible wireless devices.The OneTouchSelect Plus Flex™ Meter is designed to work with the OneTouchReveal® Mobile App and many other diabetes applications on compatible wireless devices.Yellow= 5mm Red=7mm marginPF3130451Rev1_OTSPF_OB_I_GB_en_zug_R2.indd 7 3/12/15 11:35 AM Statement of Use: Verify status before each useEffectivity Date: Mar 18 2015 Status: Current State: ReleasedType: Project File Name: 3130451 Revision: 1

8NOTE: Some diabetes management apps, including the OneTouchReveal® Mobile App, may not be available in your country. Visit www.LifeScan.co.uk to learn if the OneTouchReveal® Mobile App is available in your country.Visit www.LifeScan.co.uk for information on which wireless devices are compatible with your OneTouchSelect Plus Flex™ Meter, and where/how to download the software application on your compatible wireless device.When using the OneTouchSelect Plus Flex™ System, we suggest you pair your OneTouchSelect Plus Flex™ Meter with a compatible wireless device and track your results. See page29 for pairing instructions.Your meter is subject to and complies with applicable Worldwide Radio regulation guidelines. Generally, these rules state two conditions specific to the operation of the device:1. This device may not cause harmful interference.2. This device must accept any interference received, including interference that may cause undesirable operation.LifeScan Europe declares that this equipment is in compliance with the applicable essential requirements and other relevant provisions of Directive 1999/5/EC.Yellow= 5mm Red=7mm marginPF3130451Rev1_OTSPF_OB_I_GB_en_zug_R2.indd 8 3/12/15 11:35 AM Statement of Use: Verify status before each useEffectivity Date: Mar 18 2015 Status: Current State: ReleasedType: Project File Name: 3130451 Revision: 1

9If you experience meter interference problems, try moving your meter away from the source of the interference. You can also move the electronic device or its antenna to another location to solve the problem.These guidelines help ensure that your meter will not affect the operation of other nearby electronic devices. Additionally, other electronic devices should not affect the use of your meter.WARNING: The BLUETOOTH® SMART feature on your meter sends test results to your compatible wireless device. To prevent other people's results from being sent to your compatible wireless device, Do Not let anyone else use your meter to test their blood glucose. This meter is for single patient use only. WARNING: In locations where cell phone use is not permitted, such as hospitals, some healthcare professional oces and airplanes, you should turn the BLUETOOTH® SMART feature o. See page27 for more information.BLUETOOTH® SMART trademarkThe BLUETOOTH® SMART word mark and logos are owned by the Bluetooth SIG, Inc. and any use of such marks by LifeScan Europe is under license. Other trademarks and trade names are those of their respective owners.Yellow= 5mm Red=7mm marginPF3130451Rev1_OTSPF_OB_I_GB_en_zug_R2.indd 9 3/12/15 11:35 AM Statement of Use: Verify status before each useEffectivity Date: Mar 18 2015 Status: Current State: ReleasedType: Project File Name: 3130451 Revision: 1

10Table of Contents 1Getting to know your system ...................................12 2Setting up your system ............................................22Setting up your meter ..................................................... 22Connecting to a compatible wireless device ............... 27Turning the meter off ...................................................... 33 3Taking a test ..............................................................34Testing your blood glucose ............................................34Testing with control solution..........................................62 4Reviewing past results ............................................ 72Yellow= 5mm Red=7mm marginPF3130451Rev1_OTSPF_OB_I_GB_en_zug_R2.indd 10 3/12/15 11:35 AM Statement of Use: Verify status before each useEffectivity Date: Mar 18 2015 Status: Current State: ReleasedType: Project File Name: 3130451 Revision: 1

11 5Editing Your Settings ............................................... 76Editing time and date ..................................................... 76Editing your range limits ................................................ 77 6Caring for your system ............................................80 7Battery .......................................................................84 8Troubleshooting your system .................................88 9Detailed information about your system ...........100 10Index .........................................................................114Yellow= 5mm Red=7mm marginPF3130451Rev1_OTSPF_OB_I_GB_en_zug_R2.indd 11 3/12/15 11:35 AM Statement of Use: Verify status before each useEffectivity Date: Mar 18 2015 Status: Current State: ReleasedType: Project File Name: 3130451 Revision: 1

12 1Getting to know your systemYour OneTouchSelect Plus Flex™ Blood Glucose Monitoring SystemIncluded with your kit:OneTouchSelect Plus Flex™ Meter (CR2032 lithium coin cell battery included)Lancing device LancetsYellow= 5mm Red=7mm marginPF3130451Rev1_OTSPF_OB_I_GB_en_zug_R2.indd 12 3/12/15 11:35 AM Statement of Use: Verify status before each useEffectivity Date: Mar 18 2015 Status: Current State: ReleasedType: Project File Name: 3130451 Revision: 1

131 Getting to know your systemNOTE: If any item is missing or defective in your kit, contact Customer Service. Call OneTouch® Customer Care on 0800121200 (UK) or 1800535 676 (Ireland) during the hours of 8:30am-6pm Monday-Friday, 9am-1pm Saturday. Or visit www.LifeScan.co.uk.NOTE: If another type of lancing device was included, see the separate instructions for that lancing device. Yellow= 5mm Red=7mm marginPF3130451Rev1_OTSPF_OB_I_GB_en_zug_R2.indd 13 3/12/15 11:35 AM Statement of Use: Verify status before each useEffectivity Date: Mar 18 2015 Status: Current State: ReleasedType: Project File Name: 3130451 Revision: 1

141 Getting to know your systemOneTouchSelect® Plus Mid Control Solution*(vial with blue cap)OneTouchSelect® Plus High Control Solution*(vial with red cap)*OneTouchSelect® Plus Control Solution and Test Strips are available separately. For availability of test strips and control solution, contact customer service or your healthcare professional.Available separately:Items listed below are required, but may not be included in your kit:They are sold separately. Refer to your meter carton for a list of included items.OneTouchSelect® Plus Test Strips*Yellow= 5mm Red=7mm marginPF3130451Rev1_OTSPF_OB_I_GB_en_zug_R2.indd 14 3/12/15 11:35 AM Statement of Use: Verify status before each useEffectivity Date: Mar 18 2015 Status: Current State: ReleasedType: Project File Name: 3130451 Revision: 1

151 Getting to know your systemOneTouchSelect® Plus High Control Solution (vial with red cap) can be used in addition to OneTouchSelect® Plus Mid Control Solution (vial with blue cap). If you test with OneTouchSelect® Plus High Control Solution, you should always test with OneTouchSelect® Plus Mid Control Solution first. WARNING: Keep the meter and testing supplies away from young children. Small items such as the battery door, batteries, test strips, lancets, protective covers on the lancets, and control solution vial cap are choking hazards. Do Not ingest or swallow any items. Yellow= 5mm Red=7mm marginPF3130451Rev1_OTSPF_OB_I_GB_en_zug_R2.indd 15 3/12/15 11:35 AM Statement of Use: Verify status before each useEffectivity Date: Mar 18 2015 Status: Current State: ReleasedType: Project File Name: 3130451 Revision: 1

161 Getting to know your systemMeterGetting to know your OneTouchSelect Plus Flex™ Blood Glucose Monitoring SystemYellow= 5mm Red=7mm marginPF3130451Rev1_OTSPF_OB_I_GB_en_zug_R2.indd 16 3/12/15 11:35 AM Statement of Use: Verify status before each useEffectivity Date: Mar 18 2015 Status: Current State: ReleasedType: Project File Name: 3130451 Revision: 1

171 Getting to know your systemYellow= 5mm Red=7mm marginPF3130451Rev1_OTSPF_OB_I_GB_en_zug_R2.indd 17 3/12/15 11:35 AM Statement of Use: Verify status before each useEffectivity Date: Mar 18 2015 Status: Current State: ReleasedType: Project File Name: 3130451 Revision: 1

181 Getting to know your systemTest stripGetting to know your OneTouchSelect® Plus Test StripYellow= 5mm Red=7mm marginPF3130451Rev1_OTSPF_OB_I_GB_en_zug_R2.indd 18 3/12/15 11:35 AM Statement of Use: Verify status before each useEffectivity Date: Mar 18 2015 Status: Current State: ReleasedType: Project File Name: 3130451 Revision: 1

191 Getting to know your systemThe Range Indicator featureThe OneTouchSelect Plus Flex™ Meter automatically lets you know if your current result is below, above or within your range limits. It does this by displaying your current result with a Range Indicator Arrow, pointing to a corresponding Range Indicator Color Bar below the meter display. Use the Range Indicator Arrow and Color Bar together to interpret your results.Yellow= 5mm Red=7mm marginPF3130451Rev1_OTSPF_OB_I_GB_en_zug_R2.indd 19 3/12/15 11:35 AM Statement of Use: Verify status before each useEffectivity Date: Mar 18 2015 Status: Current State: ReleasedType: Project File Name: 3130451 Revision: 1

201 Getting to know your system3 Possible Range Indicator DisplaysA Range Indicator Arrow will appear just below your result after each test depending upon how you set your low and high range limits in the meter.Things you should know before using the Range Indicator feature:đƫ The meter comes with pre-set range limits. The pre-set low range limit is 3.9mmol/L and the pre-set high range limit is 10.0mmol/L. You can change these limits as needed to meet your needs. See page77 for details on the pre-set range limits and on editing your range limits.đƫ If you decide to change your range limits, the Range Indicator Arrows stored with previous results in meter memory will not change. However, any new tests will display Range Indicator Arrows which reflect your changes.ExampleBelow Range ResultExampleIn Range ResultExampleAbove Range ResultYellow= 5mm Red=7mm marginPF3130451Rev1_OTSPF_OB_I_GB_en_zug_R2.indd 20 3/12/15 11:35 AM Statement of Use: Verify status before each useEffectivity Date: Mar 18 2015 Status: Current State: ReleasedType: Project File Name: 3130451 Revision: 1

211 Getting to know your systemThis page left blank intentionally.Yellow= 5mm Red=7mm marginPF3130451Rev1_OTSPF_OB_I_GB_en_zug_R2.indd 21 3/12/15 11:35 AM Statement of Use: Verify status before each useEffectivity Date: Mar 18 2015 Status: Current State: ReleasedType: Project File Name: 3130451 Revision: 1

22 2Setting up your systemSetting up your meterTurn your meter onTo turn your meter on, press and hold until the start-up test screen appears. Once the device is on, release . You can also turn the meter on by inserting a test strip.CAUTION: If you see any missing segments within the start-up screen, there may be a problem with the meter. Contact Customer Service. Contact OneTouch® Customer Care on 0800121200 (UK) or 1800535 676 (Ireland).NOTE: If you turned the meter on for the first time by inserting a test strip instead of pressing , you will not be able to perform a glucose test until you complete the first time setup. Every time you turn your meter on, a start-up screen will appear for a few seconds. All segments of the display should appear briefly, indicating your meter is working properly. If the meter does not power on, check the battery.Yellow= 5mm Red=7mm marginPF3130451Rev1_OTSPF_OB_I_GB_en_zug_R2.indd 22 3/12/15 11:35 AM Statement of Use: Verify status before each useEffectivity Date: Mar 18 2015 Status: Current State: ReleasedType: Project File Name: 3130451 Revision: 1

232 Setting up your systemFirst time setupTo turn your meter on, press and hold until the start-up screen appears. Once the device is on, release . The meter will now automatically prompt you to set the time and date. The SET icon will appear on the screen to indicate that the meter has entered setup mode. Setting the timeHour will ﬂashđƫ If the hour displayed is correct, press to confirm.đƫ If the hour displayed is not correct, press or to change the hour and press to confirm.Minutes will ﬂashđƫ If the minutes displayed is correct, press to confirm.đƫ If the minutes displayed is not correct, press or to change the minutes and press to confirm.Yellow= 5mm Red=7mm marginPF3130451Rev1_OTSPF_OB_I_GB_en_zug_R2.indd 23 3/12/15 11:35 AM Statement of Use: Verify status before each useEffectivity Date: Mar 18 2015 Status: Current State: ReleasedType: Project File Name: 3130451 Revision: 1

242Setting up your systemSetting the dateAfter completing the time setup, the meter will automatically move to date setup.Year will ﬂashđƫ If the year displayed is correct, press to confirm.đƫ If the year displayed is not correct, press or to change the year and press to confirm.Month will ﬂashđƫ If the month displayed is correct, press to confirm.đƫ If the month displayed is not correct, press or to change the month and press to confirm.Yellow= 5mm Red=7mm marginPF3130451Rev1_OTSPF_OB_I_GB_en_zug_R2.indd 24 3/12/15 11:35 AM Statement of Use: Verify status before each useEffectivity Date: Mar 18 2015 Status: Current State: ReleasedType: Project File Name: 3130451 Revision: 1

252 Setting up your systemDay will ﬂashđƫ If the day displayed is correct, press to confirm. đƫ If the day displayed is not correct, press or to change the day and press to confirm.You are now ready to take a test. See the section Testing your blood glucose in Chapter 3. NOTE: After completing first time setup, a screen with three dashes will appear. Once you begin testing, your last result will appear in place of the three dashes, along with the date and time the test was taken. Yellow= 5mm Red=7mm marginPF3130451Rev1_OTSPF_OB_I_GB_en_zug_R2.indd 25 3/12/15 11:35 AM Statement of Use: Verify status before each useEffectivity Date: Mar 18 2015 Status: Current State: ReleasedType: Project File Name: 3130451 Revision: 1

262Setting up your systemAdjusting the time and date settings after ﬁrst time setupYou can adjust the meter's time and date settings after first time setup. Press and hold to turn the meter on, then press and hold and at the same time. The SET screen will appear. See page76.After adjusting the settings, your meter will exit settings mode and your last result screen will appear.Yellow= 5mm Red=7mm marginPF3130451Rev1_OTSPF_OB_I_GB_en_zug_R2.indd 26 3/12/15 11:35 AM Statement of Use: Verify status before each useEffectivity Date: Mar 18 2015 Status: Current State: ReleasedType: Project File Name: 3130451 Revision: 1

272 Setting up your systemConnecting to a compatible wireless device Turning the BLUETOOTH® SMART feature on or oIn order to connect your meter with your compatible wireless device, the BLUETOOTH® SMART feature will need to be turned on. The symbol will appear on the meter screen when the BLUETOOTH® SMART feature is on. When the symbol is not present on the screen the BLUETOOTH® SMART feature is off.đƫ To turn the BLUETOOTH® SMART feature on press and at the same time.đƫ To turn the BLUETOOTH® SMART feature off press and at the same time.The symbol indicates the BLUETOOTH® SMART feature is onNOTE: The BLUETOOTH® SMART feature will turn OFF during a blood glucose test.Yellow= 5mm Red=7mm marginPF3130451Rev1_OTSPF_OB_I_GB_en_zug_R2.indd 27 3/12/15 11:35 AM Statement of Use: Verify status before each useEffectivity Date: Mar 18 2015 Status: Current State: ReleasedType: Project File Name: 3130451 Revision: 1

282Setting up your systemPairing OverviewPairing allows your OneTouchSelect Plus Flex™ Meter to communicate with compatible wireless devices. The devices must be within 8meters of each other to pair and sync. Download the OneTouchReveal® Mobile App from the appropriate app store before pairing your meter and compatible wireless device.NOTE: Some diabetes management apps, including the OneTouchReveal® Mobile App, may not be available in your country. Visit www.LifeScan.co.uk to learn if the OneTouchReveal® Mobile App is available in your country.Multiple OneTouchSelect Plus Flex™ Meters can be paired with your compatible wireless device. For example, your compatible wireless device can be paired with a meter at home and another at work. To pair multiple meters, repeat the pairing instructions for each meter. See page29 for pairing instructions. Your OneTouchSelect Plus Flex™ Meter can be paired with multiple compatible wireless devices. To pair multiple compatible wireless devices, repeat the pairing instructions for each compatible wireless device.Yellow= 5mm Red=7mm marginPF3130451Rev1_OTSPF_OB_I_GB_en_zug_R2.indd 28 3/12/15 11:35 AM Statement of Use: Verify status before each useEffectivity Date: Mar 18 2015 Status: Current State: ReleasedType: Project File Name: 3130451 Revision: 1

292 Setting up your systemPairing Instructions1. Start by turning your meter on using the button2. The BLUETOOTH® SMART feature is turned on by pressing and togetherThe symbol will appear to indicate that the BLUETOOTH® SMART feature is on. 3. Open the OneTouchReveal® Mobile App and follow instructions to pair meter with your compatible wireless deviceYellow= 5mm Red=7mm marginPF3130451Rev1_OTSPF_OB_I_GB_en_zug_R2.indd 29 3/12/15 11:35 AM Statement of Use: Verify status before each useEffectivity Date: Mar 18 2015 Status: Current State: ReleasedType: Project File Name: 3130451 Revision: 1

302Setting up your system4. Look for "OneTouch" and the last 4 characters of the meter serial number on the compatible wireless device display to correctly identify your meterYellow= 5mm Red=7mm marginPF3130451Rev1_OTSPF_OB_I_GB_en_zug_R2.indd 30 3/12/15 11:35 AM Statement of Use: Verify status before each useEffectivity Date: Mar 18 2015 Status: Current State: ReleasedType: Project File Name: 3130451 Revision: 1

312 Setting up your system5. When prompted by the OneTouchReveal® Mobile App, the meter will display a six digit PIN numberEnter the PIN number into your wireless compatible device using the keypad on your compatible wireless device.Example of PIN number display on meterCAUTION: Make sure the PIN you enter on your compatible device matches the PIN on your meter display. If a PIN number unexpectedly appears on your meter display, cancel the PIN request by either inserting a test strip to take a test or press the button to enter History Mode.6. Wait for your compatible wireless device to indicate that your meter and compatible wireless device are paired Yellow= 5mm Red=7mm marginPF3130451Rev1_OTSPF_OB_I_GB_en_zug_R2.indd 31 3/12/15 11:35 AM Statement of Use: Verify status before each useEffectivity Date: Mar 18 2015 Status: Current State: ReleasedType: Project File Name: 3130451 Revision: 1

322Setting up your systemSyncing to send results wirelessly to the OneTouchReveal® Mobile AppAfter pairing the meter with your compatible wireless device, you are ready to send results to the OneTouchReveal® Mobile App.1. Open the OneTouchReveal® Mobile App on your compatible wireless device2. Press and hold to turn the meter on and make sure the BLUETOOTH® SMART feature is ON as indicated by ( )If needed, press and at the same time to turn the BLUETOOTH® SMART feature on.The Sync symbol ( ) flashes on the meter display. "Syncing Data" will appear on the app to notify you that the meter is communicating with the app. Syncing DataAfter syncing, the Sync symbol will disappear, the "Syncing Data" message will disappear on the app, and the app will display a list of any new results sent from the meter. NOTE: Inserting a test strip during the transmission will cancel the transfer of all results. The flashing symbol appears on the screen and you can proceed with testing.Yellow= 5mm Red=7mm marginPF3130451Rev1_OTSPF_OB_I_GB_en_zug_R2.indd 32 3/12/15 11:35 AM Statement of Use: Verify status before each useEffectivity Date: Mar 18 2015 Status: Current State: ReleasedType: Project File Name: 3130451 Revision: 1

332 Setting up your systemTurning the meter oThere are three ways to turn your meter off:đƫ Press and hold for several seconds until the meter turns off.đƫ Remove the test strip.đƫ Your meter will turn off by itself if left alone for two minutes.NOTE: Following a glucose test, the meter will still be available for BLUETOOTH® SMART connection for up to 4 hours. See page57 for more details.Yellow= 5mm Red=7mm marginPF3130451Rev1_OTSPF_OB_I_GB_en_zug_R2.indd 33 3/12/15 11:35 AM Statement of Use: Verify status before each useEffectivity Date: Mar 18 2015 Status: Current State: ReleasedType: Project File Name: 3130451 Revision: 1

34Testing your blood glucoseTest your blood glucoseNOTE: Many people find it helpful to practice testing with control solution before testing with blood for the first time. See page62. Preparing for a testHave these things ready when you test: OneTouchSelect Plus Flex™ Meter OneTouchSelect® Plus Test Strips Lancing device Sterile lancets 3Taking a testNOTE: đƫ Use only OneTouchSelect® Plus Test Strips. đƫ Make sure your meter and test strips are about the same temperature before you test.đƫ Do Not test if there is condensation (water build-up) on your meter. Move your meter and test strips to a cool, dry spot and wait for the meter surface to dry before testing.đƫ Keep test strips in a cool, dry place between 5°C and 30°C. Yellow= 5mm Red=7mm marginPF3130451Rev1_OTSPF_OB_I_GB_en_zug_R2.indd 34 3/12/15 11:35 AM Statement of Use: Verify status before each useEffectivity Date: Mar 18 2015 Status: Current State: ReleasedType: Project File Name: 3130451 Revision: 1

353 Taking a testđƫ Do Not open the test strip vial until you are ready to remove a test strip and perform a test. Use the test strip immediately after removing it from the vial, especially in high humidity environments. đƫ Tightly close the cap on the vial immediately after use to avoid contamination and damage.đƫ Store unused test strips only in their original vial.đƫ Do Not return the used test strip to the vial after performing a test.đƫ Do Not re-use a test strip that had blood or control solution applied to it. Test strips are for single use only.đƫ Do Not test with a test strip that is bent or damaged. đƫ With clean, dry hands, you may touch the test strip anywhere on its surface. Do Not bend, cut or modify the test strip in any way.IMPORTANT: If another person assists you with testing, the meter, lancing device and cap should always be cleaned and disinfected prior to use by that person. See page80.Yellow= 5mm Red=7mm marginPF3130451Rev1_OTSPF_OB_I_GB_en_zug_R2.indd 35 3/12/15 11:35 AM Statement of Use: Verify status before each useEffectivity Date: Mar 18 2015 Status: Current State: ReleasedType: Project File Name: 3130451 Revision: 1

363 Taking a testNOTE: Comparing your blood glucose test results taken with this meter to your results taken from a different meter is not recommended. Results may differ between meters and are not a useful measure of whether your meter is working properly. To check your meter accuracy, you should periodically compare your meter results to those obtained from a lab. See page100 for more information.CAUTION: đƫ Do Not use the OneTouchSelect Plus Flex™ System when PAM (Pralidoxime) is known or suspected to be in the patient's whole blood sample, as it may cause inaccurate results. đƫ Do Not use your test strips if your vial is damaged or left open to air. This could lead to error messages or inaccurate results. Contact Customer Service immediately if the test strip vial is damaged. Contact OneTouch® Customer Care on 0800121200 (UK) or 1800535 676 (Ireland).đƫ If you cannot test due to a problem with your testing supplies, contact your healthcare professional. Failure to test could delay treatment decisions and lead to a serious medical condition.Yellow= 5mm Red=7mm marginPF3130451Rev1_OTSPF_OB_I_GB_en_zug_R2.indd 36 3/12/15 11:35 AM Statement of Use: Verify status before each useEffectivity Date: Mar 18 2015 Status: Current State: ReleasedType: Project File Name: 3130451 Revision: 1

373 Taking a testđƫ The test strip vial contains drying agents that are harmful if inhaled or swallowed and may cause skin or eye irritation.đƫ Do Not use test strips after the expiration date printed on the vial. Yellow= 5mm Red=7mm marginPF3130451Rev1_OTSPF_OB_I_GB_en_zug_R2.indd 37 3/12/15 11:35 AM Statement of Use: Verify status before each useEffectivity Date: Mar 18 2015 Status: Current State: ReleasedType: Project File Name: 3130451 Revision: 1

383 Taking a testGetting to know your OneTouch®Delica® Lancing DeviceYellow= 5mm Red=7mm marginPF3130451Rev1_OTSPF_OB_I_GB_en_zug_R2.indd 38 3/12/15 11:35 AM Statement of Use: Verify status before each useEffectivity Date: Mar 18 2015 Status: Current State: ReleasedType: Project File Name: 3130451 Revision: 1

393 Taking a testNOTE: đƫ The OneTouch®Delica® Lancing Device uses ONLY OneTouch®Delica® Lancets. đƫ If another type of lancing device was included, see the separate instructions for that lancing device. đƫ The OneTouchSelect Plus Flex™ Blood Glucose Monitoring System has not been evaluated for Alternate Site Testing (AST). Use only fingertips when testing with the system. đƫ The OneTouch®Delica® Lancing System does not include the materials needed to perform Alternate Site Testing (AST). The OneTouch®Delica® Lancing System should not be used on the forearm or palm with the OneTouchSelect Plus Flex™ Blood Glucose Monitoring System. Yellow= 5mm Red=7mm marginPF3130451Rev1_OTSPF_OB_I_GB_en_zug_R2.indd 39 3/12/15 11:35 AM Statement of Use: Verify status before each useEffectivity Date: Mar 18 2015 Status: Current State: ReleasedType: Project File Name: 3130451 Revision: 1

403 Taking a testLancing precautionsCAUTION: To reduce the chance of infection and disease spread by blood: đƫ Make sure to wash the sample site with soap and warm water, rinse and dry before sampling. đƫ The lancing device is intended for a single user. Never share a lancet or lancing device with anyone.đƫ Always use a new, sterile lancet each time you test.đƫ Always keep your meter and lancing device clean (See page80). đƫ The meter and lancing device are for single patient use only. Do Not share them with anyone, including family members! Do Not use on multiple patients! đƫ After use and exposure to blood, all parts of this kit are considered biohazardous. A used kit may transmit infectious diseases even after you have performed cleaning and disinfection. Yellow= 5mm Red=7mm marginPF3130451Rev1_OTSPF_OB_I_GB_en_zug_R2.indd 40 3/12/15 11:35 AM Statement of Use: Verify status before each useEffectivity Date: Mar 18 2015 Status: Current State: ReleasedType: Project File Name: 3130451 Revision: 1

413 Taking a testPreparing the lancing device1. Remove the lancing device cap Remove the cap by turning it counterclockwise and then pulling it straight off of the device. Yellow= 5mm Red=7mm marginPF3130451Rev1_OTSPF_OB_I_GB_en_zug_R2.indd 41 3/12/15 11:35 AM Statement of Use: Verify status before each useEffectivity Date: Mar 18 2015 Status: Current State: ReleasedType: Project File Name: 3130451 Revision: 1

423 Taking a test2. Insert a sterile lancet into the lancing device Align the lancet as shown here, so that the lancet fits into the lancet holder. Push the lancet into the device until it snaps into place and is fully seated in the holder. Twist the protective cover one full turn until it separates from the lancet. Save the protective cover for lancet removal and disposal. See page59. Yellow= 5mm Red=7mm marginPF3130451Rev1_OTSPF_OB_I_GB_en_zug_R2.indd 42 3/12/15 11:35 AM Statement of Use: Verify status before each useEffectivity Date: Mar 18 2015 Status: Current State: ReleasedType: Project File Name: 3130451 Revision: 1

433 Taking a test3. Replace the lancing device cap Place the cap back onto the device; turn clockwise to secure the cap. Do Not overtighten. Yellow= 5mm Red=7mm marginPF3130451Rev1_OTSPF_OB_I_GB_en_zug_R2.indd 43 3/12/15 11:35 AM Statement of Use: Verify status before each useEffectivity Date: Mar 18 2015 Status: Current State: ReleasedType: Project File Name: 3130451 Revision: 1

443 Taking a test4. Adjust the depth setting The lancing device has seven puncture depth settings, numbered 1 through 7. Smaller numbers are for a shallower puncture and the larger numbers are for a deeper puncture. Shallower punctures work for children and most adults. Deeper punctures work well for people with thick or callused skin. Turn the depth wheel to choose the setting. NOTE: A shallower fingertip puncture may be less painful. Try a shallower setting first and increase the depth until you find the one deep enough to get a blood sample of the proper size.5. Cock the lancing device Slide the cocking control back until it clicks. If it does not click, it may already have been cocked when you inserted the lancet. Yellow= 5mm Red=7mm marginPF3130451Rev1_OTSPF_OB_I_GB_en_zug_R2.indd 44 3/12/15 11:35 AM Statement of Use: Verify status before each useEffectivity Date: Mar 18 2015 Status: Current State: ReleasedType: Project File Name: 3130451 Revision: 1

453 Taking a testPreparing the meter1. Insert a test strip to turn the meter onInsert a test strip into the test strip port with the contact bars facing you. NOTE: No separate step to code the meter is required. The flashing blood drop icon () appears on the display. You can now apply your blood sample to the test strip.Yellow= 5mm Red=7mm marginPF3130451Rev1_OTSPF_OB_I_GB_en_zug_R2.indd 45 3/12/15 11:35 AM Statement of Use: Verify status before each useEffectivity Date: Mar 18 2015 Status: Current State: ReleasedType: Project File Name: 3130451 Revision: 1

463 Taking a testGetting a blood sample from the ﬁngertipChoose a different puncture site each time you test.Repeated punctures in the same spot may cause soreness and calluses.Before testing, wash your hands thoroughly with warm, soapy water. Rinse and dry completely.1. Puncture your ﬁngerHold the lancing device firmly against the side of your finger. Press the release button. Remove the lancing device from your finger. Yellow= 5mm Red=7mm marginPF3130451Rev1_OTSPF_OB_I_GB_en_zug_R2.indd 46 3/12/15 11:35 AM Statement of Use: Verify status before each useEffectivity Date: Mar 18 2015 Status: Current State: ReleasedType: Project File Name: 3130451 Revision: 1

473 Taking a test2. Get a round drop of blood Gently squeeze and/or massage your fingertip until a round drop of blood forms on your fingertip.NOTE: If the blood smears or runs, Do Not use that sample. Dry the area and gently squeeze another drop of blood or puncture a new site.Yellow= 5mm Red=7mm marginPF3130451Rev1_OTSPF_OB_I_GB_en_zug_R2.indd 47 3/12/15 11:35 AM Statement of Use: Verify status before each useEffectivity Date: Mar 18 2015 Status: Current State: ReleasedType: Project File Name: 3130451 Revision: 1

483 Taking a testApplying blood and reading results Prepare to apply the sampleKeeping your finger extended and steady, move the meter and test strip toward the blood drop.Do Not apply blood on the top of the test strip.Do Not hold the meter and test strip underneath the blood drop. This may cause blood to run into the test strip port and damage the meter.Do Not allow blood to enter the Data Port.Yellow= 5mm Red=7mm marginPF3130451Rev1_OTSPF_OB_I_GB_en_zug_R2.indd 48 3/12/15 11:35 AM Statement of Use: Verify status before each useEffectivity Date: Mar 18 2015 Status: Current State: ReleasedType: Project File Name: 3130451 Revision: 1

493 Taking a testApplying the sampleLine up the test strip with the blood drop so that the narrow channel on the edge of the test strip is almost touching the edge of the blood drop.Gently touch the channel to the edge of the blood drop.Yellow= 5mm Red=7mm marginPF3130451Rev1_OTSPF_OB_I_GB_en_zug_R2.indd 49 3/12/15 11:35 AM Statement of Use: Verify status before each useEffectivity Date: Mar 18 2015 Status: Current State: ReleasedType: Project File Name: 3130451 Revision: 1

503 Taking a testđƫ Do Not press the test strip too firmly against the puncture site or the channel may be blocked from filling properly. đƫ Do Not smear or scrape the drop of blood with the test strip.đƫ Do Not apply more blood to the test strip after you have moved the drop of blood away.đƫ Do Not move the test strip in the meter during a test or you may get an error message or the meter may turn off.đƫ Do Not remove the test strip until the result is displayed or the meter will turn off.Yellow= 5mm Red=7mm marginPF3130451Rev1_OTSPF_OB_I_GB_en_zug_R2.indd 50 3/12/15 11:35 AM Statement of Use: Verify status before each useEffectivity Date: Mar 18 2015 Status: Current State: ReleasedType: Project File Name: 3130451 Revision: 1

513 Taking a testWait for the confirmation window to fill completely.The blood drop will be drawn into the narrow channel and the confirmation window should fill completely.Yellow= 5mm Red=7mm marginPF3130451Rev1_OTSPF_OB_I_GB_en_zug_R2.indd 51 3/12/15 11:35 AM Statement of Use: Verify status before each useEffectivity Date: Mar 18 2015 Status: Current State: ReleasedType: Project File Name: 3130451 Revision: 1

523 Taking a testCAUTION: You may get an error message or an inaccurate result if the blood sample does not fill the confirmation window completely. Discard the used strip and re-start the test process with a new test strip.When the confirmation window is full, this means you have applied enough blood. The Countdown screen will appear. Now you can move the test strip away from the drop of blood and wait for the meter to count down (about 5 seconds). Countdown ScreenYellow= 5mm Red=7mm marginPF3130451Rev1_OTSPF_OB_I_GB_en_zug_R2.indd 52 3/12/15 11:35 AM Statement of Use: Verify status before each useEffectivity Date: Mar 18 2015 Status: Current State: ReleasedType: Project File Name: 3130451 Revision: 1

533 Taking a testViewing your resultYour result appears on the display, along with the unit of measure, and the date and time of the test. After your glucose result appears, the meter will also display a Range Indicator Arrow below your glucose result to indicate if your result is below, above or within your range limits (see page19). The arrow will point to the appropriate Range Indicator Color Bar on the meter as a visual reminder.ExampleBelow Range ResultExampleIn Range ResultExampleAbove Range ResultCAUTION: Do Not make immediate treatment decisions based on the Range Indicator feature. Treatment decisions should be based on the numerical result and healthcare professional recommendation and not solely on where your result falls within your range limits. WARNING: Conﬁrm that the unit of measure mmol/L is displayed. If your display shows mg/dL rather than mmol/L, stop using the meter and contact Customer Service.Yellow= 5mm Red=7mm marginPF3130451Rev1_OTSPF_OB_I_GB_en_zug_R2.indd 53 3/12/15 11:35 AM Statement of Use: Verify status before each useEffectivity Date: Mar 18 2015 Status: Current State: ReleasedType: Project File Name: 3130451 Revision: 1

543 Taking a testInterpreting unexpected resultsRefer to the following cautions when your results are higher or lower than what you expect.CAUTION: Low resultsIf your result is below 3.9mmol/L or is shown as LO (meaning the result is less than 1.1mmol/L), it may mean hypoglycemia (low blood glucose). This may require immediate treatment according to your healthcare professional's recommendations. Although this result could be due to a test error, it is safer to treat first, then do another test.NOTE: When your glucose result is below 1.1mmol/L, both the LO and the Range Indicator Arrow will flash on the meter screen.CAUTION: Dehydration and low results You may get false low results if you are severely dehydrated. If you think you are severely dehydrated, contact your healthcare professional immediately. Yellow= 5mm Red=7mm marginPF3130451Rev1_OTSPF_OB_I_GB_en_zug_R2.indd 54 3/12/15 11:35 AM Statement of Use: Verify status before each useEffectivity Date: Mar 18 2015 Status: Current State: ReleasedType: Project File Name: 3130451 Revision: 1

553 Taking a testCAUTION: High results đƫ If your result is above 10.0mmol/L, it may mean hyperglycemia (high blood glucose) and you should consider re-testing. Talk to your healthcare professional if you are concerned about hyperglycemia.đƫ HI is displayed when your result is over 33.3mmol/L. You may have severe hyperglycemia (very high blood glucose). Re-test your blood glucose level. If the result is HI again, this indicates a severe problem with your blood glucose control. Obtain and follow instructions from your healthcare professional immediately.NOTE: When your glucose result is above 33.3mmol/L, both the HI and the Range Indicator Arrow will flash on the meter screen.Yellow= 5mm Red=7mm marginPF3130451Rev1_OTSPF_OB_I_GB_en_zug_R2.indd 55 3/12/15 11:35 AM Statement of Use: Verify status before each useEffectivity Date: Mar 18 2015 Status: Current State: ReleasedType: Project File Name: 3130451 Revision: 1

563 Taking a testCAUTION: Repeated unexpected resultsđƫ If you continue to get unexpected results, check your system with control solution.đƫ If you are experiencing symptoms that are not consistent with your results and you have followed all instructions in this Owner's Booklet, call your healthcare professional. Never ignore symptoms or make significant changes to your diabetes management program without speaking to your healthcare professional.Unusual red blood cell countA hematocrit (percentage of your blood that is red blood cells) that is either very high (above 55%) or very low (below 30%) can cause false results.Yellow= 5mm Red=7mm marginPF3130451Rev1_OTSPF_OB_I_GB_en_zug_R2.indd 56 3/12/15 11:35 AM Statement of Use: Verify status before each useEffectivity Date: Mar 18 2015 Status: Current State: ReleasedType: Project File Name: 3130451 Revision: 1

573 Taking a testSending your results to the appIf the BLUETOOTH® SMART feature on the meter is turned on, indicated by the BLUETOOTH® SMART symbol ( ), the meter will automatically send the latest result to any paired wireless compatible device. The compatible wireless device must have the app running and have already been paired to the meter before sending a result.NOTE: The compatible wireless device must have the app open and have already been paired to the meter before sending a result. See page28. NOTE: If the BLUETOOTH® SMART feature on the meter is turned off, or the meter is out of range, the result is not sent to the compatible wireless device. The result is saved in the meter memory with the current date and time, and will be sent to the app the next time you sync. The sent results are also stored in the meter. To sync, the app must be open and running on your compatible wireless device.To ensure that glucose test results are successfully sent to the app, turn on the BLUETOOTH® SMART feature and check the following:đƫ The compatible wireless device and meter are both turned on, and the app is running.đƫ The meter is correctly paired with your compatible wireless device.Yellow= 5mm Red=7mm marginPF3130451Rev1_OTSPF_OB_I_GB_en_zug_R2.indd 57 3/12/15 11:35 AM Statement of Use: Verify status before each useEffectivity Date: Mar 18 2015 Status: Current State: ReleasedType: Project File Name: 3130451 Revision: 1

583 Taking a testđƫ The Bluetooth feature on both devices is running (indicated by ) and the devices are within 8meters of each other.đƫ The meter will attempt to transmit results up to 4 hours after a test, even if the meter appears to be off. This is indicated by the BLUETOOTH® SMART symbol ( ) remaining on the meter screen.ExampleIf you are still unable to send results to the compatible wireless device, please call Customer Service. Contact OneTouch® Customer Care on 0800121200 (UK) or 1800535 676 (Ireland).NOTE: Inserting a test strip during the transmission will cancel the transfer of all results. The symbol appears on the screen and you can proceed with testing. Using the meter without syncing to an appThe meter can be used without a compatible wireless device or the app. You can still test your blood glucose and review up to 500 results on the meter.Yellow= 5mm Red=7mm marginPF3130451Rev1_OTSPF_OB_I_GB_en_zug_R2.indd 58 3/12/15 11:35 AM Statement of Use: Verify status before each useEffectivity Date: Mar 18 2015 Status: Current State: ReleasedType: Project File Name: 3130451 Revision: 1

593 Taking a testRemoving the used lancetNOTE: This lancing device has an ejection feature, so you do not have to pull out the used lancet.1. Remove the lancing device cap Remove the cap by turning it counterclockwise and then pulling it straight off of the device. 2. Cover the exposed lancet tip Before removing the lancet, place the lancet protective cover on a hard surface then push the lancet tip into the cupped side of the cover. Yellow= 5mm Red=7mm marginPF3130451Rev1_OTSPF_OB_I_GB_en_zug_R2.indd 59 3/12/15 11:35 AM Statement of Use: Verify status before each useEffectivity Date: Mar 18 2015 Status: Current State: ReleasedType: Project File Name: 3130451 Revision: 1

603 Taking a test3. Eject the lancet Slide the ejection control forward until the lancet comes out of the lancing device. Return the ejection control to its back position. If the lancet fails to eject properly, cock the device again and then slide the ejection control forward until the lancet comes out. Yellow= 5mm Red=7mm marginPF3130451Rev1_OTSPF_OB_I_GB_en_zug_R2.indd 60 3/12/15 11:35 AM Statement of Use: Verify status before each useEffectivity Date: Mar 18 2015 Status: Current State: ReleasedType: Project File Name: 3130451 Revision: 1

613 Taking a test4. Replace the lancing device cap Place the cap back onto the device; turn clockwise to secure the cap. Do Not overtighten. It is important to use a new lancet each time you obtain a blood sample. Do Not leave a lancet in the lancing device. This will help prevent infection and sore fingertips. Yellow= 5mm Red=7mm marginPF3130451Rev1_OTSPF_OB_I_GB_en_zug_R2.indd 61 3/12/15 11:35 AM Statement of Use: Verify status before each useEffectivity Date: Mar 18 2015 Status: Current State: ReleasedType: Project File Name: 3130451 Revision: 1

623 Taking a testDisposing of the used lancet and test stripDiscard the used lancet carefully after each use to avoid unintended lancet stick injuries. Used lancets and test strips may be considered biohazardous waste in your area. Be sure to follow your healthcare professional's recommendations or local regulations for proper disposal. Wash hands thoroughly with soap and water after handling the meter, test strips, lancing device and cap. Testing with control solutionControl solution testing precautionsOneTouchSelect® Plus Control Solution is used to check that the meter and test strips are working together properly and that the test is performing correctly. (Control solution is available separately.)NOTE: đƫ OneTouchSelect® Plus High Control Solution (vial with red cap) can be used in addition to OneTouchSelect® Plus Mid Control Solution (vial with blue cap). If you test with OneTouchSelect® Plus High Control Solution, you should always test with OneTouchSelect® Plus Mid Control Solution first. Yellow= 5mm Red=7mm marginPF3130451Rev1_OTSPF_OB_I_GB_en_zug_R2.indd 62 3/12/15 11:35 AM Statement of Use: Verify status before each useEffectivity Date: Mar 18 2015 Status: Current State: ReleasedType: Project File Name: 3130451 Revision: 1

633 Taking a testđƫ When you first open a new vial of control solution, record the discard date on the vial label. Refer to the control solution insert or vial label for instructions on determining the discard date. đƫ Tightly close the cap on the control solution vial immediately after use to avoid contamination or damage.đƫ Do Not open the test strip vial until you are ready to remove a test strip and perform a test. Use the test strip immediately after removing it from the vial, especially in high humidity environments. đƫ Control solution tests must be done at room temperature (20-25°C). Make sure your meter, test strips and control solutions are at room temperature before testing. CAUTION: đƫ Do Not swallow or ingest control solution.đƫ Do Not apply control solution to the skin or eyes as it may cause irritation.đƫ Do Not use control solution after the expiration date (printed on the vial label) or the discard date, whichever comes first, or your results may be inaccurate. Yellow= 5mm Red=7mm marginPF3130451Rev1_OTSPF_OB_I_GB_en_zug_R2.indd 63 3/12/15 11:36 AM Statement of Use: Verify status before each useEffectivity Date: Mar 18 2015 Status: Current State: ReleasedType: Project File Name: 3130451 Revision: 1

643 Taking a testDo a control solution testđƫ Whenever you open a new vial of test strips.đƫ If you suspect that the meter or test strips are not working properly.đƫ If you have had repeated unexpected blood glucose results.đƫ If you drop or damage the meter.Preparing your meter for a control solution test1. Insert a test strip to turn the meter onInsert the test strip with the test strip port and contact bars facing you.Yellow= 5mm Red=7mm marginPF3130451Rev1_OTSPF_OB_I_GB_en_zug_R2.indd 64 3/12/15 11:36 AM Statement of Use: Verify status before each useEffectivity Date: Mar 18 2015 Status: Current State: ReleasedType: Project File Name: 3130451 Revision: 1

653 Taking a testPreparing the control solution1. Before removing the cap, shake the vial gently2. Remove the vial cap and place it on a ﬂat surface with the top of the cap pointing up 3. Squeeze the vial to discard the ﬁrst drop 2. Wait for the ﬂashing blood drop icon ( ) to appear on the display3. Press or until the control solution icon ( ) appears on the displayYellow= 5mm Red=7mm marginPF3130451Rev1_OTSPF_OB_I_GB_en_zug_R2.indd 65 3/12/15 11:36 AM Statement of Use: Verify status before each useEffectivity Date: Mar 18 2015 Status: Current State: ReleasedType: Project File Name: 3130451 Revision: 1

663 Taking a test4. Wipe both the tip of the control solution vial and the top of the cap with a clean, damp tissue or cloth 5. Squeeze a drop into the small well on the top of the cap or onto another clean, non-absorbent surface Yellow= 5mm Red=7mm marginPF3130451Rev1_OTSPF_OB_I_GB_en_zug_R2.indd 66 3/12/15 11:36 AM Statement of Use: Verify status before each useEffectivity Date: Mar 18 2015 Status: Current State: ReleasedType: Project File Name: 3130451 Revision: 1

673 Taking a testApplying the control solution1. Hold the meter so that the narrow channel at the top edge of the test strip is at a slight angle to the drop of control solution3. Wait for the channel to ﬁll completely2. Touch the channel on the top edge of the test strip to the control solutionYellow= 5mm Red=7mm marginPF3130451Rev1_OTSPF_OB_I_GB_en_zug_R2.indd 67 3/12/15 11:36 AM Statement of Use: Verify status before each useEffectivity Date: Mar 18 2015 Status: Current State: ReleasedType: Project File Name: 3130451 Revision: 1

683 Taking a testViewing your control solution resultAfter the control solution is applied, the meter will count down until the test is complete. Your result is displayed along with the date, time, unit of measure, and (for control solution) and stored in the meter.Control solution results can be seen when reviewing past results on the meter.CAUTION: Make sure you press or until the control solution icon appears before you begin a control solution test. An screen may appear if you applied control solution to the test strip without following the steps beginning on page64. See page97 for more information.Yellow= 5mm Red=7mm marginPF3130451Rev1_OTSPF_OB_I_GB_en_zug_R2.indd 68 3/12/15 11:36 AM Statement of Use: Verify status before each useEffectivity Date: Mar 18 2015 Status: Current State: ReleasedType: Project File Name: 3130451 Revision: 1

693 Taking a testChecking if the result is in rangeExample RangeOneTouchSelect® Plus Mid Control Solution Control Range 5.7-7.7mmol/LOneTouchSelect® Plus High Control Solution Control Range 16.5-22.4mmol/LCompare the result displayed on the meter to the range printed on your OneTouchSelect® Plus Control Solution vial. If your control solution result falls outside the expected range, repeat the test with a new test strip.CAUTION: The control solution ranges printed on the control solution vial are for control solution tests only and are not recommended ranges for your blood glucose level.Yellow= 5mm Red=7mm marginPF3130451Rev1_OTSPF_OB_I_GB_en_zug_R2.indd 69 3/12/15 11:36 AM Statement of Use: Verify status before each useEffectivity Date: Mar 18 2015 Status: Current State: ReleasedType: Project File Name: 3130451 Revision: 1

703 Taking a testCauses of out-of-range resultsOut-of-range results may be due to: đƫ Not following the instructions for performing a control solution test. đƫ Control solution is contaminated, expired, or past its discard date. đƫ Test strip or test strip vial is damaged, expired, or past its discard date. đƫ Meter, test strips and/or control solution were not all at the same temperature when the control solution test was performed. đƫ A problem with the meter. đƫ Dirt or contamination in the small well on the top of the control solution cap. CAUTION: If you continue to get control solution results that fall outside the range printed on the control solution vial, Do Not use the meter, test strips, or control solution. Contact Customer Service. Contact OneTouch® Customer Care on 0800121200 (UK) or 1800535 676 (Ireland).Yellow= 5mm Red=7mm marginPF3130451Rev1_OTSPF_OB_I_GB_en_zug_R2.indd 70 3/12/15 11:36 AM Statement of Use: Verify status before each useEffectivity Date: Mar 18 2015 Status: Current State: ReleasedType: Project File Name: 3130451 Revision: 1

713 Taking a testCleaning the control solution capClean the top of the control solution cap with a clean, damp tissue or cloth. Yellow= 5mm Red=7mm marginPF3130451Rev1_OTSPF_OB_I_GB_en_zug_R2.indd 71 3/12/15 11:36 AM Statement of Use: Verify status before each useEffectivity Date: Mar 18 2015 Status: Current State: ReleasedType: Project File Name: 3130451 Revision: 1

72 4Reviewing past results2. Scroll through your results by pressing to move backwards and to move forward through your resultsReviewing past results on your meterYour meter stores your most recent 500 blood glucose and control solution test results and displays them in the order the tests were taken. The ( ) symbol will appear on your screen when in History Mode.1. When the meter is o, press and hold to turn History Mode onThe ( ) symbol indicates you are viewing your past results.The ( ) symbol indicates if the result was below, above or within range at the time of the test, by pointing to the appropriate color bar.Yellow= 5mm Red=7mm marginPF3130451Rev1_OTSPF_OB_I_GB_en_zug_R2.indd 72 3/12/15 11:36 AM Statement of Use: Verify status before each useEffectivity Date: Mar 18 2015 Status: Current State: ReleasedType: Project File Name: 3130451 Revision: 1

734 Reviewing past resultsDownloading results to a computerYour meter can work with diabetes management software, which provides a visual way to track key factors that affect your blood sugar. To learn more about diabetes management tools available to you, contact Customer Service. Call OneTouch® Customer Care on 0800121200 (UK) or 1800535 676 (Ireland) during the hours of 8:30am-6pm Monday-Friday, 9am-1pm Saturday. Or visit www.LifeScan.co.uk.Connect only to a computer certified to UL 60950-1 ( ).To transfer meter data, follow the instructions provided with the diabetes management software product to download the results from the meter. You will need a standard micro USB interface cable to connect your OneTouchSelect Plus Flex™ Meter to a computer to download results (not included).Yellow= 5mm Red=7mm marginPF3130451Rev1_OTSPF_OB_I_GB_en_zug_R2.indd 73 3/12/15 11:36 AM Statement of Use: Verify status before each useEffectivity Date: Mar 18 2015 Status: Current State: ReleasedType: Project File Name: 3130451 Revision: 1

744 Reviewing past resultsOnce the command to start the download is sent from the computer to the meter, the meter display will show the flashing Sync symbol ( ) indicating that the meter is in communication mode.Do Not insert a test strip while the meter is connected to a computer.If you are unable to download your results to a computer, please call Customer Service. Contact OneTouch® Customer Care on 0800121200 (UK) or 1800535 676 (Ireland).Yellow= 5mm Red=7mm marginPF3130451Rev1_OTSPF_OB_I_GB_en_zug_R2.indd 74 3/12/15 11:36 AM Statement of Use: Verify status before each useEffectivity Date: Mar 18 2015 Status: Current State: ReleasedType: Project File Name: 3130451 Revision: 1

754 Reviewing past resultsThis page left blank intentionally.Yellow= 5mm Red=7mm marginPF3130451Rev1_OTSPF_OB_I_GB_en_zug_R2.indd 75 3/12/15 11:36 AM Statement of Use: Verify status before each useEffectivity Date: Mar 18 2015 Status: Current State: ReleasedType: Project File Name: 3130451 Revision: 1

76 5Editing Your SettingsEditing time and dateYou can adjust the meter's time and date settings after first time setup. Press and hold to turn the meter on, then press and hold and at the same time. The SET screen will appear, and the hour will flash.For instructions on adjusting the time and date, see page23. After adjusting the settings, you will exit settings mode and your last glucose result screen will appear. The adjusted time and date will be displayed once a new glucose test has been completed and the result appears on the screen.NOTE: You will not be able to perform a blood glucose test until you finish editing the time and date. NOTE: The OneTouchReveal® Mobile App on your compatible wireless device checks and updates the time and date in your meter each time you sync. Check the time and date often on your compatible wireless device to be sure they are correct. See the App instructions for more information.Yellow= 5mm Red=7mm marginPF3130451Rev1_OTSPF_OB_I_GB_en_zug_R2.indd 76 3/12/15 11:36 AM Statement of Use: Verify status before each useEffectivity Date: Mar 18 2015 Status: Current State: ReleasedType: Project File Name: 3130451 Revision: 1

775 Editing Your SettingsEditing your range limitsYour meter uses low and high range limits to tell you when your result is below, above or within your set range. The meter comes with pre-set range limits that can be changed. The pre-set low range limit is 3.9mmol/L and the pre-set high range limit is 10.0mmol/L. To edit the pre-set range limits press and hold and at the same time. The SET screen will appear with the current low range limit displayed, and the number and range indicator arrow will flash.NOTE: The low and high range limits you set apply to all glucose test results. This includes tests taken before or after mealtimes, medications and around any other activities that may affect your blood glucose.CAUTION: Be sure to talk to your healthcare professional about the low and high range limits that are right for you. When selecting or changing your limits, you should consider factors such as your lifestyle and diabetes therapy. Never make significant changes to your diabetes care plan without consulting your healthcare professional.Yellow= 5mm Red=7mm marginPF3130451Rev1_OTSPF_OB_I_GB_en_zug_R2.indd 77 3/12/15 11:36 AM Statement of Use: Verify status before each useEffectivity Date: Mar 18 2015 Status: Current State: ReleasedType: Project File Name: 3130451 Revision: 1

785Editing Your Settings1. Review the pre-set low range limit displayedđƫ To accept the pre-set low range limit, press .đƫ To edit the pre-set low range limit, press or to change the value between 3.3mmol/L-6.1mmol/L, and then press .2. Review the pre-set high range limit displayedđƫ To accept the pre-set high range limit, press .đƫ To edit the pre-set high range limit, press or to change the value between 5.0mmol/L-16.7mmol/L, and then press .Your meter will exit settings mode and your last result screen will appear. Yellow= 5mm Red=7mm marginPF3130451Rev1_OTSPF_OB_I_GB_en_zug_R2.indd 78 3/12/15 11:36 AM Statement of Use: Verify status before each useEffectivity Date: Mar 18 2015 Status: Current State: ReleasedType: Project File Name: 3130451 Revision: 1

795 Editing Your SettingsNOTE: If you change your range limits, this will only affect whether future test results are displayed as below, above or within your range limits. Changing your range limits does not affect how past results are displayed. NOTE: You will not be able to perform a glucose test until you finish editing the range limits. NOTE: You can use the OneTouchReveal® Mobile App on your compatible wireless device to change the range limits stored in your meter. See the instructions that came with the app for more information.Yellow= 5mm Red=7mm marginPF3130451Rev1_OTSPF_OB_I_GB_en_zug_R2.indd 79 3/12/15 11:36 AM Statement of Use: Verify status before each useEffectivity Date: Mar 18 2015 Status: Current State: ReleasedType: Project File Name: 3130451 Revision: 1

80 6Caring for your systemCleaning and disinfectionCleaning and disinfection are different and both should be performed. Cleaning is part of your normal care and maintenance and should be performed prior to disinfection, but cleaning does not kill germs. Disinfection is the only way to reduce your exposure to disease. For cleaning information, see page80 and for disinfecting information, see page82.Storing your systemStore your meter, test strips, control solution and other items in your carrying case. Keep in a cool, dry place between 5°C and 30°C. Do Not refrigerate. Keep all items away from direct sunlight and heat. Cleaning your meter, lancing device and capThe meter, lancing device and cap should be cleaned whenever they are visibly dirty and before disinfection. Clean your meter at least once per week. For cleaning obtain regular strength liquid dish soap and a soft cloth. Prepare a mild detergent solution by stirring 2.5mL of regular strength liquid dish soap into 250mL of water. Yellow= 5mm Red=7mm marginPF3130451Rev1_OTSPF_OB_I_GB_en_zug_R2.indd 80 3/12/15 11:36 AM Statement of Use: Verify status before each useEffectivity Date: Mar 18 2015 Status: Current State: ReleasedType: Project File Name: 3130451 Revision: 1

816 Caring for your systemđƫ Do Not use alcohol or any other solvent.đƫ Do Not allow liquids, dirt, dust, blood or control solution to enter the test strip port or the data port. (See page16.)đƫ Do Not spray cleaning solution on the meter or immerse it in any liquid.1. Holding the meter with the test strip port pointed down, use a soft cloth dampened with water and mild detergent to wipe the outside of the meter and lancing deviceBe sure to squeeze out any excess liquid before you wipe the meter. Wipe the outside of the cap.Yellow= 5mm Red=7mm marginPF3130451Rev1_OTSPF_OB_I_GB_en_zug_R2.indd 81 3/12/15 11:36 AM Statement of Use: Verify status before each useEffectivity Date: Mar 18 2015 Status: Current State: ReleasedType: Project File Name: 3130451 Revision: 1

826Caring for your systemDisinfecting your meter, lancing device and capThe meter, lancing device and cap should be disinfected periodically. Clean your meter, lancing device and cap prior to disinfecting. For disinfecting, obtain regular household bleach (containing a minimum of 5.5% sodium hypochlorite as the active ingredient)*. Prepare a solution of 1 part household bleach and 9 parts water.*Follow manufacturer’s instruction for handling and storage of bleach.2. Wipe dry with a clean, soft clothYellow= 5mm Red=7mm marginPF3130451Rev1_OTSPF_OB_I_GB_en_zug_R2.indd 82 3/12/15 11:36 AM Statement of Use: Verify status before each useEffectivity Date: Mar 18 2015 Status: Current State: ReleasedType: Project File Name: 3130451 Revision: 1

836 Caring for your system1. Hold the meter with the test strip port pointed down Use a soft cloth dampened with this solution to wipe the outside of the meter and lancing device until the surface is damp. Be sure to squeeze out any excess liquid before you wipe the meter.2. After wiping, cover the surface you are disinfecting with the soft cloth dampened with the bleach solution for 1 minuteThen wipe with a clean, damp, soft cloth.Wash hands thoroughly with soap and water after handling the meter, lancing device and cap.If you see signs of wear, please contact Customer Service. Contact OneTouch® Customer Care on 0800121200 (UK) or 1800535 676 (Ireland).Yellow= 5mm Red=7mm marginPF3130451Rev1_OTSPF_OB_I_GB_en_zug_R2.indd 83 3/12/15 11:36 AM Statement of Use: Verify status before each useEffectivity Date: Mar 18 2015 Status: Current State: ReleasedType: Project File Name: 3130451 Revision: 1

84 7BatteryReplacing the batteryYour OneTouchSelect Plus Flex™ Meter uses one CR2032 lithium coin cell battery.IMPORTANT: Use only one CR2032 lithium coin cell battery with your meter. Do Not use rechargeable batteries. Use of an incorrect battery type may result in your meter providing fewer tests than normal. If the meter does not turn on, you may need to replace the battery. See below for instructions. WARNING: Certain batteries may cause leaking which can damage the meter or cause the battery to lose power sooner than normal. Replace leaking battery immediately.NOTE: After replacing the battery, you will be prompted to set time and date, as if you are turning the meter on for the first time. 1. Remove the old battery Start with the meter turned off. Remove the battery cover by sliding it downward. Yellow= 5mm Red=7mm marginPF3130451Rev1_OTSPF_OB_I_GB_en_zug_R2.indd 84 3/12/15 11:36 AM Statement of Use: Verify status before each useEffectivity Date: Mar 18 2015 Status: Current State: ReleasedType: Project File Name: 3130451 Revision: 1

857 BatteryPull up on the battery ribbon to lift the battery out of the compartment. Do Not remove the battery while the meter is connected to a computer. 2. Insert the new battery Insert one CR2032 lithium coin cell battery on top of the battery ribbon, with the plus (+) side up. If the meter does not power on after you have replaced the meter battery, check that the battery is correctly installed. If the meter still does not power on, contact Customer Service. Contact OneTouch® Customer Care on 0800121200 (UK) or 1800535 676 (Ireland).Yellow= 5mm Red=7mm marginPF3130451Rev1_OTSPF_OB_I_GB_en_zug_R2.indd 85 3/12/15 11:36 AM Statement of Use: Verify status before each useEffectivity Date: Mar 18 2015 Status: Current State: ReleasedType: Project File Name: 3130451 Revision: 1

867Battery3. Replace battery cover by sliding it upwards onto the meter5. Dispose of battery Dispose of the battery according to your local environmental regulations. 4. Check your meter settings Removing the meter battery will not affect your stored results. However, you will need to check your date and time settings. Yellow= 5mm Red=7mm marginPF3130451Rev1_OTSPF_OB_I_GB_en_zug_R2.indd 86 3/12/15 11:36 AM Statement of Use: Verify status before each useEffectivity Date: Mar 18 2015 Status: Current State: ReleasedType: Project File Name: 3130451 Revision: 1

877 BatteryThis page left blank intentionally.Yellow= 5mm Red=7mm marginPF3130451Rev1_OTSPF_OB_I_GB_en_zug_R2.indd 87 3/12/15 11:36 AM Statement of Use: Verify status before each useEffectivity Date: Mar 18 2015 Status: Current State: ReleasedType: Project File Name: 3130451 Revision: 1

88 8Troubleshooting your systemError and other messagesThe OneTouchSelect Plus Flex™ Meter displays messages when there are problems with the test strip, with the meter or when your glucose levels are above 33.3mmol/L or below 1.1mmol/L. Improper use may cause an inaccurate result without producing an error message. NOTE: If the meter is on but does not operate (locks-up), contact Customer Service. Contact OneTouch® Customer Care on 0800121200 (UK) or 1800535 676 (Ireland).What it meansYou may have a very low blood glucose level (severe hypoglycemia), below 1.1mmol/L.NOTE: When your glucose result is below 1.1mmol/L, both the LO and the Range Indicator Arrow will flash on the meter screen.What to doThis may require immediate treatment. Although this message could be due to a test error, it is safer to treat first and then do another test. Always treat according to your healthcare professional’s recommendations.Yellow= 5mm Red=7mm marginPF3130451Rev1_OTSPF_OB_I_GB_en_zug_R2.indd 88 3/12/15 11:36 AM Statement of Use: Verify status before each useEffectivity Date: Mar 18 2015 Status: Current State: ReleasedType: Project File Name: 3130451 Revision: 1

89Troubleshooting your system 8 What it meansYou may have a very high blood glucose level (severe hyperglycemia), over 33.3mmol/L.NOTE: When your glucose result is above 33.3mmol/L, both the HI and the Range Indicator Arrow will flash on the meter screen.What to doRe-test your blood glucose level. If the result is HI again, obtain and follow instructions from your healthcare professional right away.Yellow= 5mm Red=7mm marginPF3130451Rev1_OTSPF_OB_I_GB_en_zug_R2.indd 89 3/12/15 11:36 AM Statement of Use: Verify status before each useEffectivity Date: Mar 18 2015 Status: Current State: ReleasedType: Project File Name: 3130451 Revision: 1

90Troubleshooting your system8What it meansMeter is too hot (above 44°C) to perform a test.What to doMove the meter and test strips to a cooler area. Insert a new test strip when the meter and test strips are within the operating range (10-44°C). If you do not get another HI .t message, you can proceed with testing.If this message continues to appear, contact Customer Service. Contact OneTouch® Customer Care on 0800121200 (UK) or 1800535 676 (Ireland).Yellow= 5mm Red=7mm marginPF3130451Rev1_OTSPF_OB_I_GB_en_zug_R2.indd 90 3/12/15 11:36 AM Statement of Use: Verify status before each useEffectivity Date: Mar 18 2015 Status: Current State: ReleasedType: Project File Name: 3130451 Revision: 1

91Troubleshooting your system 8 What it meansMeter is too cold (below 10°C) to perform a test.What to doMove the meter and test strips to a warmer area. Insert a new test strip when the meter and test strips are within the operating range (10-44°C). If you do not get another LO.t message, you can proceed with testing.If this message continues to appear, contact Customer Service. Contact OneTouch® Customer Care on 0800121200 (UK) or 1800535 676 (Ireland).Yellow= 5mm Red=7mm marginPF3130451Rev1_OTSPF_OB_I_GB_en_zug_R2.indd 91 3/12/15 11:36 AM Statement of Use: Verify status before each useEffectivity Date: Mar 18 2015 Status: Current State: ReleasedType: Project File Name: 3130451 Revision: 1

92Troubleshooting your system8Example Error Screen CodeError ScreensIf there is a problem with your meter, there are six possible error screens that may appear. Along with an error number, there is also an error code in the upper left corner of your meter screen. If you cannot resolve the error with your meter, contact Customer Service. Contact OneTouch® Customer Care on 0800121200 (UK) or 1800535 676 (Ireland). They will refer to the error number and code to help troubleshoot the problem. Yellow= 5mm Red=7mm marginPF3130451Rev1_OTSPF_OB_I_GB_en_zug_R2.indd 92 3/12/15 11:36 AM Statement of Use: Verify status before each useEffectivity Date: Mar 18 2015 Status: Current State: ReleasedType: Project File Name: 3130451 Revision: 1

93Troubleshooting your system 8 What it meansThere is a problem with the meter.What it meansError message could be caused either by a used test strip or a problem with the meter or test strip.What to doDo Not use the meter. Contact Customer Service. Contact OneTouch® Customer Care on 0800121200 (UK) or 1800535 676 (Ireland).What to doRepeat the test with a new test strip; see page49 or page67. If this message continues to appear, contact Customer Service. Contact OneTouch® Customer Care on 0800121200 (UK) or 1800535 676 (Ireland).Yellow= 5mm Red=7mm marginPF3130451Rev1_OTSPF_OB_I_GB_en_zug_R2.indd 93 3/12/15 11:36 AM Statement of Use: Verify status before each useEffectivity Date: Mar 18 2015 Status: Current State: ReleasedType: Project File Name: 3130451 Revision: 1

94Troubleshooting your system8What it meansThe sample was applied before the meter was ready.What to doRepeat the test with a new test strip. Apply a blood or control solution sample only after the flashing symbol appears on the display. If this message continues to appear, contact Customer Service. Contact OneTouch® Customer Care on 0800121200 (UK) or 1800535 676 (Ireland).Yellow= 5mm Red=7mm marginPF3130451Rev1_OTSPF_OB_I_GB_en_zug_R2.indd 94 3/12/15 11:36 AM Statement of Use: Verify status before each useEffectivity Date: Mar 18 2015 Status: Current State: ReleasedType: Project File Name: 3130451 Revision: 1

95Troubleshooting your system 8 What it meansThe meter has detected a problem with the test strip. Possible cause is test strip damage.What to doRepeat the test with a new test strip. See page34 for taking a blood glucose test, or page64 for taking a control solution test. If the error message appears again, contact Customer Service. Contact OneTouch® Customer Care on 0800121200 (UK) or 1800535 676 (Ireland).Yellow= 5mm Red=7mm marginPF3130451Rev1_OTSPF_OB_I_GB_en_zug_R2.indd 95 3/12/15 11:36 AM Statement of Use: Verify status before each useEffectivity Date: Mar 18 2015 Status: Current State: ReleasedType: Project File Name: 3130451 Revision: 1

96Troubleshooting your system8What it meansOne of the following may apply:đƫ Not enough blood or control solution was applied or was added after the meter began to count down.đƫ The test strip may have been damaged or moved during testing.đƫ The sample was improperly applied.đƫ There may be a problem with the meter.What to doRepeat the test with a new test strip. See page34 for taking a blood glucose test, or page64 for taking a control solution test. If the error message appears again, contact Customer Service. Contact OneTouch® Customer Care on 0800121200 (UK) or 1800535 676 (Ireland).Yellow= 5mm Red=7mm marginPF3130451Rev1_OTSPF_OB_I_GB_en_zug_R2.indd 96 3/12/15 11:36 AM Statement of Use: Verify status before each useEffectivity Date: Mar 18 2015 Status: Current State: ReleasedType: Project File Name: 3130451 Revision: 1

97Troubleshooting your system 8 What it meansThe meter has detected a problem with the test strip. Possible cause is that you did not apply the correct sample type to the test strip when prompted by the meter for a blood or control solution sample.What to doRepeat the test with a new test strip. See page34 for taking a blood glucose test, or page64 for taking a control solution test. If the error message appears again, contact Customer Service. Contact OneTouch® Customer Care on 0800121200 (UK) or 1800535 676 (Ireland).Yellow= 5mm Red=7mm marginPF3130451Rev1_OTSPF_OB_I_GB_en_zug_R2.indd 97 3/12/15 11:36 AM Statement of Use: Verify status before each useEffectivity Date: Mar 18 2015 Status: Current State: ReleasedType: Project File Name: 3130451 Revision: 1

98Troubleshooting your system8What it meansThere is not enough battery power to perform a test.What to doReplace the battery immediately.What it meansMeter battery power is low but there is still enough battery power to perform a test. The flashing low battery () icon will continue to appear until the battery is replaced. What to doReplace the meter battery soon.Yellow= 5mm Red=7mm marginPF3130451Rev1_OTSPF_OB_I_GB_en_zug_R2.indd 98 3/12/15 11:36 AM Statement of Use: Verify status before each useEffectivity Date: Mar 18 2015 Status: Current State: ReleasedType: Project File Name: 3130451 Revision: 1

99Troubleshooting your system 8 What it meansNo result in memory, such as the first time use or when you have chosen to delete all the results after downloading to a computer.What to doContact Customer Service to report this occurrence, unless this is your first use of the meter. You can still perform a blood glucose test or control solution test and get an accurate result. Contact OneTouch® Customer Care on 0800121200 (UK) or 1800535 676 (Ireland).Yellow= 5mm Red=7mm marginPF3130451Rev1_OTSPF_OB_I_GB_en_zug_R2.indd 99 3/12/15 11:36 AM Statement of Use: Verify status before each useEffectivity Date: Mar 18 2015 Status: Current State: ReleasedType: Project File Name: 3130451 Revision: 1

100 9Detailed information about your systemComparing meter results to laboratory resultsResults obtained from the OneTouchSelect Plus Flex™ Meter and laboratory tests are reported in plasma-equivalent units. However, your meter result may differ from your lab result due to normal variation. A result from your OneTouchSelect Plus Flex™ Meter is considered accurate when it is within 0.83mmol/L of a laboratory method when the glucose concentration is lower than 5.55mmol/L and within 15% of laboratory method when the glucose concentration is 5.55mmol/L or higher.Meter results can be affected by factors that do not affect lab results in the same way. Specific factors that may cause your meter result to vary from your lab result may include:đƫ You have eaten recently. This can cause a result from fingertip testing to be up to 3.9mmol/L higher than a lab test using blood drawn from a vein.1đƫ Your hematocrit is above 55% or below 30%.đƫ You are severely dehydrated.For additional information, refer to the OneTouchSelect® Plus Test Strip Insert.1Sacks, D.B.: "Carbohydrates." Burtis, C.A., and Ashwood E.R. (ed.), Tietz Textbook of Clinical Chemistry, Philadelphia: W.B. Saunders Company (1994), 959.Yellow= 5mm Red=7mm marginPF3130451Rev1_OTSPF_OB_I_GB_en_zug_R2.indd 100 3/12/15 11:36 AM Statement of Use: Verify status before each useEffectivity Date: Mar 18 2015 Status: Current State: ReleasedType: Project File Name: 3130451 Revision: 1

101Detailed information about your system 9 Guidelines for obtaining an accurate meter to lab comparisonBefore going to the lab:đƫ Perform a control solution test to make sure your meter is working properly. đƫ Do Not eat for at least 8 hours before you test your blood.đƫ Take your meter and testing supplies with you to the lab.Yellow= 5mm Red=7mm marginPF3130451Rev1_OTSPF_OB_I_GB_en_zug_R2.indd 101 3/12/15 11:36 AM Statement of Use: Verify status before each useEffectivity Date: Mar 18 2015 Status: Current State: ReleasedType: Project File Name: 3130451 Revision: 1

102Detailed information about your system9Comparing your meter results to those taken from another meterComparing your blood glucose test results taken with this meter to your results taken from a different meter is not recommended. Results may differ between meters and are not a useful measure of whether your meter is working properly.Testing with your OneTouchSelect Plus Flex™ Meter at the lab:đƫ Test within 15 minutes of the lab test. đƫ Use only a fresh, capillary blood sample from your fingertip. đƫ Follow all instructions in this Owner's Booklet for performing a blood glucose test. Yellow= 5mm Red=7mm marginPF3130451Rev1_OTSPF_OB_I_GB_en_zug_R2.indd 102 3/12/15 11:36 AM Statement of Use: Verify status before each useEffectivity Date: Mar 18 2015 Status: Current State: ReleasedType: Project File Name: 3130451 Revision: 1

103Detailed information about your system 9 Technical SpeciﬁcationsAssay method Glucose Oxidase biosensorAutomatic shuto Two minutes after last actionBattery ratings 3.0 V d.c. (CR2032 lithium coin cell battery) Battery type One replaceable 3.0 Volt CR2032 lithium coin cell battery (or equivalent)Biological source Aspergillus NigerBLUETOOTH® SMART Technology:Frequency Range: 2.4-2.4835 GHzOperating Range Distance: minimum 8metres (unobstructed)Operating Channels: 40 ChannelsSecurity Encryption: 128-bit AES (Advanced Encryption Standard)Calibration Plasma-equivalentData port type Micro USB Compatible with USB 2.0Memory 500 test resultsYellow= 5mm Red=7mm marginPF3130451Rev1_OTSPF_OB_I_GB_en_zug_R2.indd 103 3/12/15 11:36 AM Statement of Use: Verify status before each useEffectivity Date: Mar 18 2015 Status: Current State: ReleasedType: Project File Name: 3130451 Revision: 1

104Detailed information about your system9Operating ranges Temperature: 10-44°CRelative humidity: non-condensing 10-90%Altitude: up to 3048metersHematocrit: 30-55%Reported result range 1.1-33.3mmol/LSample Fresh capillary whole bloodSample volume 1.0μLSize 52(W) x 86(L) x 16(T)millimetersTest time Average test time is 5 secondsUnit of measure mmol/LWeight Approximately 50gramsYellow= 5mm Red=7mm marginPF3130451Rev1_OTSPF_OB_I_GB_en_zug_R2.indd 104 3/12/15 11:36 AM Statement of Use: Verify status before each useEffectivity Date: Mar 18 2015 Status: Current State: ReleasedType: Project File Name: 3130451 Revision: 1

105Detailed information about your system 9 System AccuracyDiabetes experts have suggested that glucose meters should agree within 0.83mmol/L of a laboratory method when the glucose concentration is lower than 5.55mmol/L, and within 15% of a laboratory method when the glucose concentration is 5.55mmol/L or higher. Samples from 100 patients were tested using both the OneTouchSelect Plus Flex™ System and the YSI 2300 Glucose Analyzer laboratory instrument.System Accuracy Results for Glucose Concentrations <5.55mmol/LPercent (and number) of meter results that match the laboratory test Within ±0.28mmol/LWithin ±0.56mmol/LWithin ±0.83mmol/L67.2%(121/180)93.3%(168/180)96.7%(174/180)Yellow= 5mm Red=7mm marginPF3130451Rev1_OTSPF_OB_I_GB_en_zug_R2.indd 105 3/12/15 11:36 AM Statement of Use: Verify status before each useEffectivity Date: Mar 18 2015 Status: Current State: ReleasedType: Project File Name: 3130451 Revision: 1

106Detailed information about your system9System Accuracy Results for Glucose Concentrations *5.55mmol/LPercent (and number) of meter results that match the laboratory testWithin ±5% Within ±10% Within ±15% 63.3%(266/420)95.5%(401/420)99.8%(419/420)System Accuracy Results for Glucose Concentrations between 1.5mmol/L and 26.8mmol/LPercent (and number) of meter results that match the laboratory testWithin ±0.83mmol/L or ±15%98.8% (593/600)NOTE: Where 1.5mmol/L represents the lowest glucose reference value and 26.8mmol/L represents the highest glucose reference value (YSI value).Yellow= 5mm Red=7mm marginPF3130451Rev1_OTSPF_OB_I_GB_en_zug_R2.indd 106 3/12/15 11:36 AM Statement of Use: Verify status before each useEffectivity Date: Mar 18 2015 Status: Current State: ReleasedType: Project File Name: 3130451 Revision: 1

107Detailed information about your system 9 User Performance AccuracyA study evaluating glucose values from fingertip capillary blood samples obtained by 174 lay persons showed the following results:100.0% within ±0.83mmol/L of the medical laboratory values at glucose concentrations below 5.55mmol/L, and 95.9% within ±15% of the medical laboratory values at glucose concentrations at or above 5.55mmol/L.96.6% of the total number of samples were within ±0.83mmol/L or ±15% of the medical laboratory values.Yellow= 5mm Red=7mm marginPF3130451Rev1_OTSPF_OB_I_GB_en_zug_R2.indd 107 3/12/15 11:36 AM Statement of Use: Verify status before each useEffectivity Date: Mar 18 2015 Status: Current State: ReleasedType: Project File Name: 3130451 Revision: 1

108Detailed information about your system9Regression StatisticsSamples were tested in duplicate on each of three test strip lots. Results indicate that the OneTouchSelect Plus Flex™ System compares well with a laboratory method.# of Subjects # of Tests Slope Intercept (mmol/L)100 600 0.98 -0.0195% CI Slope95% CI Intercept (mmol/L)Std. Error (Sy.x) (mmol/L)R20.97 to 0.98 -0.08 to 0.07 0.50 0.99Yellow= 5mm Red=7mm marginPF3130451Rev1_OTSPF_OB_I_GB_en_zug_R2.indd 108 3/12/15 11:36 AM Statement of Use: Verify status before each useEffectivity Date: Mar 18 2015 Status: Current State: ReleasedType: Project File Name: 3130451 Revision: 1

109Detailed information about your system 9 PrecisionWithin Run Precision (300 Venous Blood Samples Tested per Glucose Level)Data generated using the OneTouchSelect Plus Flex™ Meter.Target Glucose (mmol/L)Mean Glucose (mmol/L)Standard Deviation (mmol/L)Coecient of Variation (%)2.22 2.57 0.09 3.583.61 3.91 0.11 2.696.67 6.86 0.15 2.1511.10 10.73 0.20 1.8319.43 19.43 0.41 2.12Results show that the greatest variability observed between test strips when tested with blood is 0.25mmol/L SD or less at glucose levels less than 5.55mmol/L, or 4.5% CV or less at glucose levels at 5.55mmol/L or above.Yellow= 5mm Red=7mm marginPF3130451Rev1_OTSPF_OB_I_GB_en_zug_R2.indd 109 3/12/15 11:36 AM Statement of Use: Verify status before each useEffectivity Date: Mar 18 2015 Status: Current State: ReleasedType: Project File Name: 3130451 Revision: 1

110Detailed information about your system9Total Precision (600 Control Solution Tests per Glucose Level)Data generated using the OneTouchSelect Plus Flex™ Meter.Glucose Level Ranges (mmol/L)Mean Glucose (mmol/L)Standard Deviation (mmol/L)Coecient of Variation (%)Low (1.67-2.78)2.52 0.07 2.71Mid (5.33-7.99)6.13 0.11 1.82High (15.54-23.31)20.31 0.34 1.65Yellow= 5mm Red=7mm marginPF3130451Rev1_OTSPF_OB_I_GB_en_zug_R2.indd 110 3/12/15 11:36 AM Statement of Use: Verify status before each useEffectivity Date: Mar 18 2015 Status: Current State: ReleasedType: Project File Name: 3130451 Revision: 1

111Detailed information about your system 9 Software UpdatesLifeScan will periodically notify you about software and feature upgrades to your meter. The OneTouch Select Plus Flex™ Meter software can be upgraded by connecting to a PC via USB cable connection and visiting www.LifeScan.co.uk and following the step-by-step instructions. Software updates will not affect your settings and historical data in your meter.GuaranteeLifeScan guarantees that the OneTouchSelect Plus Flex™ Meter will be free of defects in material and workmanship for three years, valid from the date of purchase. The guarantee extends only to the original purchaser and is not transferable. Yellow= 5mm Red=7mm marginPF3130451Rev1_OTSPF_OB_I_GB_en_zug_R2.indd 111 3/12/15 11:36 AM Statement of Use: Verify status before each useEffectivity Date: Mar 18 2015 Status: Current State: ReleasedType: Project File Name: 3130451 Revision: 1

112Detailed information about your system9Electrical and safety standardsThis meter complies with CISPR 11: Class B (Radiated Only). Emissions of the energy used are low and not likely to cause interference in nearby electronic equipment. The meter has been tested for immunity to electrostatic discharge as specified in IEC 61326-2-6. This meter complies with immunity to radio frequency interference as specified in IEC 61326-1 and 61326-2-6.The meter meets the requirements for immunity to electrical interference at the frequency range and test level specified in international standard ISO 15197.Use of this meter near electrical or electronic equipment that are sources of electromagnetic radiation, may interfere with proper operation of this meter. It is advisable to avoid testing in close proximity to sources of electromagnetic radiation.Do Not use the equipment where aerosol sprays are being used, or when oxygen is being administered.Yellow= 5mm Red=7mm marginPF3130451Rev1_OTSPF_OB_I_GB_en_zug_R2.indd 112 3/12/15 11:36 AM Statement of Use: Verify status before each useEffectivity Date: Mar 18 2015 Status: Current State: ReleasedType: Project File Name: 3130451 Revision: 1

113Detailed information about your system 9 This page left blank intentionally.Yellow= 5mm Red=7mm marginPF3130451Rev1_OTSPF_OB_I_GB_en_zug_R2.indd 113 3/12/15 11:36 AM Statement of Use: Verify status before each useEffectivity Date: Mar 18 2015 Status: Current State: ReleasedType: Project File Name: 3130451 Revision: 1

114AST 39Batteries 84Batteries, replacing 84Battery empty icon 3Battery empty warning 98Battery low icon 3, 98Blood glucose, testing 34BLUETOOTH® SMART feature 7, 9, 27, 57Buttons on meter 16Cleaning your meter, lancing device and cap 80Comparing meter results to laboratory results 100Compatible wireless devices 3Control solution 64Control solution, discard and expiration dates 63Control solution, testing 62, 68, 70Data port 16Date setting 24, 26Dehydration 54, 100Disinfecting your meter, lancing device and cap 82Display check 22Disposal, lancets and test strips 62Downloading results to a computer 73Edit date 76Edit range limits 77 10IndexYellow= 5mm Red=7mm marginPF3130451Rev1_OTSPF_OB_I_GB_en_zug_R2.indd 114 3/12/15 11:36 AM Statement of Use: Verify status before each useEffectivity Date: Mar 18 2015 Status: Current State: ReleasedType: Project File Name: 3130451 Revision: 1

115Index 10Edit time 76Error messages 88EXTREME HIGH GLUCOSE message 55, 89EXTREME LOW GLUCOSE message 54, 88Fingertip testing procedure 34First time setup 23, 28Guarantee 111Hyperglycemia 55, 89Hypoglycemia 54, 88Icons 3, 4Infection, reduce the chance 40Intended use 6Kit components 12Lancing device 12, 39, 41, 80mmol/L 16, 104Pairing 28, 29PIN 31Plasma calibration 100, 103Range Indicator feature 19Range limits setting 77Results, reviewing past 72Serial number 31Settings 23, 26, 76Software, diabetes management 73Yellow= 5mm Red=7mm marginPF3130451Rev1_OTSPF_OB_I_GB_en_zug_R2.indd 115 3/12/15 11:36 AM Statement of Use: Verify status before each useEffectivity Date: Mar 18 2015 Status: Current State: ReleasedType: Project File Name: 3130451 Revision: 1

116Index10Start-up screen 22Storing your system 80Symbols 3, 4Syncing 32, 57Technical specifications 103Temperature 34, 63, 70, 80, 90, 91, 104Test strip 18, 45, 64Test strip, applying drop of blood 48, 49Test strip, contact bars 18Time setting 23, 26Turning meter off 33Turning meter on 22, 45, 64Unexpected results 54, 56Unit of measure 16, 104Unusual red blood cell count (hematocrit) 100, 104Yellow= 5mm Red=7mm marginPF3130451Rev1_OTSPF_OB_I_GB_en_zug_R2.indd 116 3/12/15 11:36 AM Statement of Use: Verify status before each useEffectivity Date: Mar 18 2015 Status: Current State: ReleasedType: Project File Name: 3130451 Revision: 1

PF No./Rev.: 3130451 Rev 1CPS Reference No.: Refer to References Section in Enable for CPS No. LFS Contact: Andrew MarkRev. Date: 12-Mar-15Language Sequence: EnglishJDE Item No.: N/ANo. of Covers:PMS N/A N/A Inside No. of pages: 116No. of sides: 1 2Process ColorsUncoated AreaSpot Colors Uncoated Area Special Instructions DielineN/A DielineDescription: Booklet, Owners, OTSPF, GB (zug) Art Agency: ForeignExchange Translations Job No.: 28801= CUT= SCORE= PERFN/AN/AN/A Black N/A C M Y KPF3130451Rev1_OTSPF_OB_I_GB_en_zug_R2.indd 1 3/12/15 11:36 AM Statement of Use: Verify status before each useEffectivity Date: Mar 18 2015 Status: Current State: ReleasedType: Project File Name: 3130451 Revision: 1

•••••••••••••••••••••••••••Approver ListApprover: David Latham (GPL) Approval Date: 3/16/2015 6:54:46 AMApprover: Ken Armstrong (Packaging) Approval Date: 3/17/2015 6:33:15 AMApprover: Laura Avancena (Marketing) Approval Date: 3/18/2015 8:05:56 PMApprover: Paul Fisher (Quality) Approval Date: 3/16/2015 9:06:47 AMApprover: Brian Guthrie (RnD) Approval Date: 3/16/2015 10:07:35 AMApprover: Ray Amphlett (Regulatory) Approval Date: 3/16/2015 1:00:24 PMApprover: Martin ONeill (OPS) Approval Date: 3/13/2015 11:55:17 AMSites Impacted: Inverness Statement of Use: Verify status before each useEffectivity Date: Mar 18 2015 Status: Current State: ReleasedType: Project File Name: 3130451 Revision: 1

This device complies with Part 15 of the FCC Rules and with Industry Canada license-exempt RSS standard(s). 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 undesired operation. Le présent appareil est conforme aux CNR d'Industrie Canada applicables aux appareils radio exempts de licence. L'exploitation est autorisée aux deux conditions suivantes : (1) l'appareil ne doit pas produire de brouillage, et (2) l'utilisateur de l'appareil doit accepter tout brouillage radioélectrique subi, même si le brouillage est susceptible d'en compromettre le fonctionnement