Cilag Z ONE TOUCH Verio Flex / Blood Glucose Monitoring System User Manual

Cilag GmbH International ONE TOUCH Verio Flex / Blood Glucose Monitoring System

Contents

User Manual

©2015LifeScan, Inc.Manufactured by: LifeScan EuropeDivision of CilagGmbH InternationalGubelstrasse 346300 ZugSwitzerlandMeter made in China.As your partner in diabetes care, we welcome you to contact us (7 days a week, 8 a.m. - 10 p.m. Eastern Time) at 1888567-3003 (English), 1888567-3010 (Español), or www.OneTouch.com.Rev. Date: PF 3125983 Rev 1Contents covered by one or more of the following U.S. patents: 6,179,979, 6,193,873, 6,284,125, 6,716,577, 6,749,887, 6,797,150, 6,863,801, 6,872,298, 7,045,046, 7,498,132, 7,846,312, 8,449,740, 8,529,751 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, 6,890,421, 8,163,162, 7,749,371, 8,449,740 and 8,529,751. 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 Verio® 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.10/2014PF 3125983 Rev 1C4Yellow = 5mm margin, Red = 10mm marginYellow = 5mm margin, Red = 10mm marginPF3125983Rev1_OTVF_OB_C_US_en_zug_R4.indd 4 1/12/15 10:48 AMPending 510k Review
Blood Glucose Monitoring SystemInstructions for UseOwner's BookletC1Yellow = 5mm margin, Red = 10mm marginYellow = 5mm margin, Red = 10mm marginPF3125983Rev1_OTVF_OB_C_US_en_zug_R4.indd 1 1/12/15 10:49 AMPending 510k Review
C2Yellow = 5mm margin, Red = 10mm marginYellow = 5mm margin, Red = 10mm marginPF3125983Rev1_OTVF_OB_C_US_en_zug_R4.indd 2 1/12/15 10:49 AMPending 510k Review
C3Yellow = 5mm margin, Red = 10mm marginYellow = 5mm margin, Red = 10mm marginPF3125983Rev1_OTVF_OB_C_US_en_zug_R4.indd 3 1/12/15 10:49 AMPending 510k Review
PF No./Rev.: 3125983 Rev 1CPS Reference No.: Refer to References Section in Enable for CPS No. LFS Contact: Susan CabralRev. Date: 12-Jan-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 InstructionsDielineN/A DielineDescription: Booklet, Owners, OTVF, US (zug) Art Agency: ForeignExchange Translations Job No.: 25677= CUT= SCORE= PERFN/AN/AN/A C M Y KBlack N/A Leg1PF3125983Rev1_OTVF_OB_C_US_en_zug_R4.indd 1 1/12/15 10:49 AMPending 510k Review
1Owner's BookletBlood Glucose Monitoring SystemYellow= 5mm Red=7mm marginPF3125983Rev1_OTVF_OB_I_US_en_zug_R4.indd 1 1/12/15 10:52 AMPending 510k Review
2Thanks for choosing OneTouch®!The OneTouchVerioFlex™ Blood Glucose Monitoring System is one of the latest product innovations from OneTouch®.Your OneTouchVerio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 marginYellow= 5mm Red=7mm marginPF3125983Rev1_OTVF_OB_I_US_en_zug_R4.indd 2 1/12/15 10:52 AMPending 510k Review
3Meter symbols and iconsMeter PowerLow BatteryBattery EmptyControl SolutionSyncingBLUETOOTH® SMART Feature OnHistory Mode (Past results)Apply SampleRange Indicator ArrowSetting ModeCompatible Wireless DevicesVisit www.OneTouch.com for information on which wireless devices are compatible with your OneTouchVerioFlex™ Meter, and where/how to download the software application on your compatible wireless device.Yellow= 5mm Red=7mm marginYellow= 5mm Red=7mm marginPF3125983Rev1_OTVF_OB_I_US_en_zug_R4.indd 3 1/12/15 10:53 AMPending 510k Review
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 Before you beginBefore using this product to test your blood glucose, carefully read this Owner's Booklet, and the inserts that come with the OneTouchVerio® Test Strips, OneTouchVerio® Control Solution and the OneTouch®Delica® Lancing Device.Yellow= 5mm Red=7mm marginYellow= 5mm Red=7mm marginPF3125983Rev1_OTVF_OB_I_US_en_zug_R4.indd 4 1/12/15 10:53 AMPending 510k Review
5IMPORTANT SAFETY INSTRUCTIONS:• 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!• 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.For more information see: FDA Public Health Notification: "Use of Fingerstick Devices on More than One Person Poses Risk for Transmitting Bloodborne Pathogens: Initial Communication" (2010) http://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/ucm224025.htm.CDC Clinical Reminder: "Use of Fingerstick Devices on More than One Person Poses Risk for Transmitting Bloodborne Pathogens" (2010) http://www.cdc.gov/injectionsafety/Fingerstick-DevicesBGM.html.Yellow= 5mm Red=7mm marginYellow= 5mm Red=7mm marginPF3125983Rev1_OTVF_OB_I_US_en_zug_R4.indd 5 1/12/15 10:53 AMPending 510k Review
6Intended useThe OneTouchVerio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VerioFlex™ Blood Glucose Monitoring System is intended for self-testing outside the body (in vitro diagnostic use) by people with diabetes at home as an aid to monitor effectiveness of diabetes control. The OneTouchVerioFlex™ Blood Glucose Monitoring System is not to be used for the diagnosis of or screening of diabetes or for neonatal use.The OneTouchVerio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 marginYellow= 5mm Red=7mm marginPF3125983Rev1_OTVF_OB_I_US_en_zug_R4.indd 6 1/12/15 10:53 AMPending 510k Review
7Test principleGlucose in the blood sample mixes with the enzyme FAD-GDH (see page103) in the test strip and a small electric current is produced. The strength of this current calculates your blood glucose level. It then displays the blood glucose result and stores it in the meter memory.Use only OneTouchVerio® Control Solution and Test Strips with the OneTouchVerioFlex™ Meter.BLUETOOTH® SMART wireless technology BLUETOOTH® SMART wireless technology is used by some smartphones and many other devices. Your OneTouchVerioFlex™ Meter uses BLUETOOTH® SMART wireless technology to pair and to send your glucose results to compatible wireless devices.The OneTouchVerioFlex™ Meter is designed to work with the OneTouchReveal® Mobile App.NOTE: Some diabetes management apps, including the OneTouchReveal® Mobile App, may not be available in your country. Visit www.OneTouch.com to learn if the OneTouchReveal® Mobile App is available in your country.Yellow= 5mm Red=7mm marginYellow= 5mm Red=7mm marginPF3125983Rev1_OTVF_OB_I_US_en_zug_R4.indd 7 1/12/15 10:53 AMPending 510k Review
8Visit www.OneTouch.com for information on which wireless devices are compatible with your OneTouchVerioFlex™ Meter, and where/how to download the software application on your compatible wireless device.When using the OneTouchVerioFlex™ System, we suggest you pair your OneTouchVerioFlex™ Meter with a compatible wireless device and track your results. See page31 for pairing instructions.Changes or modifications not expressly approved by the party responsible for compliance could void the user’s authority to operate the equipment.This device complies with Part 15 of the FCC Rules. Operation is subject to the following two conditions: (1) this device may not cause harmful interference and (2) this device must accept any interference received, including interference that may cause undesired operation.Yellow= 5mm Red=7mm marginYellow= 5mm Red=7mm marginPF3125983Rev1_OTVF_OB_I_US_en_zug_R4.indd 8 1/12/15 10:53 AMPending 510k ReviewFor Canada - IC: Statement acc. RSS Gen Issue 3, Sect. 7.1.3 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
9NOTE: This equipment has been tested and found to comply with the limits for a Class B digital device, pursuant to part 15 of the FCC Rules. These limits are designed to provide reasonable protection against harmful interference in a residential installation. This equipment generates, uses and can radiate radio frequency energy and, if not installed and used in accordance with the instructions, may cause harmful interference to radio communications. However, there is no guarantee that interference will not occur in a particular installation. If this equipment does cause harmful interference to radio or television reception, which can be determined by turning the equipment off and on, the user is encouraged to try to correct the interference by one or more of the following measures: • Reorient or relocate the receiving antenna.• Increase the separation between the equipment and receiver.• Connect the equipment into an outlet on a circuit different from that to which the receiver is connected.• Consult the dealer or an experienced radio/ TV technician for help.Yellow= 5mm Red=7mm marginYellow= 5mm Red=7mm marginPF3125983Rev1_OTVF_OB_I_US_en_zug_R4.indd 9 1/12/15 10:53 AMPending 510k Review
10If 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. Yellow= 5mm Red=7mm marginYellow= 5mm Red=7mm marginPF3125983Rev1_OTVF_OB_I_US_en_zug_R4.indd 10 1/12/15 10:53 AMPending 510k Review
11BLUETOOTH® 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.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29 for more information.Yellow= 5mm Red=7mm marginYellow= 5mm Red=7mm marginPF3125983Rev1_OTVF_OB_I_US_en_zug_R4.indd 11 1/12/15 10:53 AMPending 510k Review
12Table of Contents 1 Getting to know your system ...................................14 2 Setting up your system ............................................24Setting up your meter .....................................................24Connecting to a compatible wireless device ...............29Turning the meter off ...................................................... 35 3 Taking a test ..............................................................36Testing your blood glucose ............................................36Testing with control solution..........................................60 4 Reviewing past results ............................................70Yellow= 5mm Red=7mm marginYellow= 5mm Red=7mm marginPF3125983Rev1_OTVF_OB_I_US_en_zug_R4.indd 12 1/12/15 10:53 AMPending 510k Review
13 5 Editing Your Settings ............................................... 76Editing time and date ..................................................... 76Editing your range limits ................................................ 77 6 Caring for your system ............................................80 7 Battery .......................................................................86 8 Troubleshooting your system .................................90 9 Detailed information about your system ...........100 10 Index .........................................................................110Yellow= 5mm Red=7mm marginYellow= 5mm Red=7mm marginPF3125983Rev1_OTVF_OB_I_US_en_zug_R4.indd 13 1/12/15 10:53 AMPending 510k Review
14 1 Getting to know your systemYour OneTouchVerioFlex™ Blood Glucose Monitoring SystemIncluded with your kit:OneTouchVerioFlex™ Meter (CR2032 lithium coin cell battery included)Lancing deviceLancets OneTouchVerio® Test Strips*Yellow= 5mm Red=7mm marginYellow= 5mm Red=7mm marginPF3125983Rev1_OTVF_OB_I_US_en_zug_R4.indd 14 1/12/15 10:53 AMPending 510k Review
151 Getting to know your systemNOTE: If any item is missing or defective in your kit, contact Customer Service. As your partner in diabetes care, we welcome you to contact us (7 days a week, 8 a.m. - 10 p.m. Eastern Time) at 1888567-3003 (English), 1888567-3010 (Español), or www.OneTouch.com.NOTE: If another type of lancing device was included, see the separate instructions for that lancing device. Yellow= 5mm Red=7mm marginYellow= 5mm Red=7mm marginPF3125983Rev1_OTVF_OB_I_US_en_zug_R4.indd 15 1/12/15 10:53 AMPending 510k Review
161 Getting to know your systemAvailable separately:Items pictured 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Verio® Level 3 Control Solution* (vial with blue cap)OneTouchVerio® Test Strips**OneTouchVerio® Control Solution and Test Strips are available separately. For availability of test strips and control solution, contact Customer Service or ask your pharmacist or healthcare professional. You can use either OneTouchVerio® Level 3 Control Solution or OneTouchVerio® Level 4 Control Solution with your OneTouchVerioFlex™ Meter. OneTouchVerio® Level 4 Control Solution* (vial with red cap)Yellow= 5mm Red=7mm marginYellow= 5mm Red=7mm marginPF3125983Rev1_OTVF_OB_I_US_en_zug_R4.indd 16 1/12/15 10:53 AMPending 510k Review
171 Getting to know your systemWARNING: 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 marginYellow= 5mm Red=7mm marginPF3125983Rev1_OTVF_OB_I_US_en_zug_R4.indd 17 1/12/15 10:53 AMPending 510k Review
181 Getting to know your systemMeterGetting to know your OneTouchVerioFlex™ Blood Glucose Monitoring SystemYellow= 5mm Red=7mm marginYellow= 5mm Red=7mm marginPF3125983Rev1_OTVF_OB_I_US_en_zug_R4.indd 18 1/12/15 10:53 AMPending 510k Review
191 Getting to know your systemMeterYellow= 5mm Red=7mm marginYellow= 5mm Red=7mm marginPF3125983Rev1_OTVF_OB_I_US_en_zug_R4.indd 19 1/12/15 10:53 AMPending 510k Review
201 Getting to know your systemTest stripGetting to know your OneTouchVerio® Test StripYellow= 5mm Red=7mm marginYellow= 5mm Red=7mm marginPF3125983Rev1_OTVF_OB_I_US_en_zug_R4.indd 20 1/12/15 10:53 AMPending 510k Review
211 Getting to know your systemThe Range Indicator featureThe OneTouchVerio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 marginYellow= 5mm Red=7mm marginPF3125983Rev1_OTVF_OB_I_US_en_zug_R4.indd 21 1/12/15 10:53 AMPending 510k Review
221 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:• The meter comes with pre-set range limits. The pre-set low range limit is 70mg/dL and the pre-set high range limit is 180mg/dL. 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.• 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 marginYellow= 5mm Red=7mm marginPF3125983Rev1_OTVF_OB_I_US_en_zug_R4.indd 22 1/12/15 10:53 AMPending 510k Review
231 Getting to know your systemThis page left blank intentionally.Yellow= 5mm Red=7mm marginYellow= 5mm Red=7mm marginPF3125983Rev1_OTVF_OB_I_US_en_zug_R4.indd 23 1/12/15 10:53 AMPending 510k Review
24 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. 1888567-3003.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 marginYellow= 5mm Red=7mm marginPF3125983Rev1_OTVF_OB_I_US_en_zug_R4.indd 24 1/12/15 10:53 AMPending 510k Review
252 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 flash• If the hour displayed is correct, press to confirm.• If the hour displayed is not correct, press or to change the hour and press to confirm.Minutes will flash• If the minutes displayed is correct, press to confirm.• If the minutes displayed is not correct, press or to change the minutes and press to confirm.Yellow= 5mm Red=7mm marginYellow= 5mm Red=7mm marginPF3125983Rev1_OTVF_OB_I_US_en_zug_R4.indd 25 1/12/15 10:53 AMPending 510k Review
262Setting up your systemSetting the dateAfter completing the time setup, the meter will automatically move to date setup.Year will flash• If the year displayed is correct, press to confirm.• If the year displayed is not correct, press or to change the year and press to confirm.AM/PM will flash• If the AM/PM displayed is correct, press to confirm.• If the AM/PM displayed is not correct, press or to change AM/PM and press to confirm.Yellow= 5mm Red=7mm marginYellow= 5mm Red=7mm marginPF3125983Rev1_OTVF_OB_I_US_en_zug_R4.indd 26 1/12/15 10:53 AMPending 510k Review
272 Setting up your systemSetting the dateAfter completing the time setup, the meter will automatically move to date setup.Month will flash• If the month displayed is correct, press to confirm.• If the month displayed is not correct, press or to change the month and press to confirm.Day will flash• If the day displayed is correct, press to confirm. • 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 marginYellow= 5mm Red=7mm marginPF3125983Rev1_OTVF_OB_I_US_en_zug_R4.indd 27 1/12/15 10:53 AMPending 510k Review
282Setting 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 marginYellow= 5mm Red=7mm marginPF3125983Rev1_OTVF_OB_I_US_en_zug_R4.indd 28 1/12/15 10:53 AMPending 510k Review
292 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.• To turn the BLUETOOTH® SMART feature on press and at the same time.• 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 marginYellow= 5mm Red=7mm marginPF3125983Rev1_OTVF_OB_I_US_en_zug_R4.indd 29 1/12/15 10:53 AMPending 510k Review
302Setting up your systemPairing OverviewPairing allows your OneTouchVerioFlex™ Meter to communicate with compatible wireless devices. The devices must be within 26feet 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.OneTouch.com to learn if the OneTouchReveal® Mobile App is available in your country.Multiple OneTouchVerio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31 for pairing instructions. Your OneTouchVerio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 marginYellow= 5mm Red=7mm marginPF3125983Rev1_OTVF_OB_I_US_en_zug_R4.indd 30 1/12/15 10:53 AMPending 510k Review
312 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 marginYellow= 5mm Red=7mm marginPF3125983Rev1_OTVF_OB_I_US_en_zug_R4.indd 31 1/12/15 10:53 AMPending 510k Review
322Setting 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 marginYellow= 5mm Red=7mm marginPF3125983Rev1_OTVF_OB_I_US_en_zug_R4.indd 32 1/12/15 10:53 AMPending 510k Review
332 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 marginYellow= 5mm Red=7mm marginPF3125983Rev1_OTVF_OB_I_US_en_zug_R4.indd 33 1/12/15 10:53 AMPending 510k Review
342Setting 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 marginYellow= 5mm Red=7mm marginPF3125983Rev1_OTVF_OB_I_US_en_zug_R4.indd 34 1/12/15 10:53 AMPending 510k Review
352 Setting up your systemTurning the meter oThere are three ways to turn your meter off:• Press and hold for several seconds until the meter turns off.• Remove the test strip.• 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71 for more details.Yellow= 5mm Red=7mm marginYellow= 5mm Red=7mm marginPF3125983Rev1_OTVF_OB_I_US_en_zug_R4.indd 35 1/12/15 10:53 AMPending 510k Review
36Testing your blood glucosePreparing for a blood glucose testNOTE: Many people find it helpful to practice testing with control solution before testing with blood for the first time. See page60. Have these things ready when you test: OneTouchVerioFlex™ Meter OneTouchVerio® Test Strips Lancing device Sterile lancets  3 Taking a testNOTE: • Use only OneTouchVerio® Test Strips. • Unlike some blood glucose meters, no separate step to code your OneTouchVerioFlex™ System is required.• Testing must be done within operating temperature range (50-104°F).• Make sure your meter and test strips are about the same temperature before you test.• Keep test strips in a cool, dry place between 41°F and 86°F. Yellow= 5mm Red=7mm marginYellow= 5mm Red=7mm marginPF3125983Rev1_OTVF_OB_I_US_en_zug_R4.indd 36 1/12/15 10:53 AMPending 510k Review
373 Taking a test• 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.• 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.• Tightly close the cap on the vial immediately after use to avoid contamination and damage.• Store unused test strips only in their original vial.• Do Not return the used test strip to the vial after performing a test.• Do Not re-use a test strip that had blood, control solution, or any contaminants applied to it. Test strips are for single use only. • 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.• When you first open a vial of test strips, record the discard date on the label. Refer to the test strip insert or vial label for instructions on determining the discard date. Yellow= 5mm Red=7mm marginYellow= 5mm Red=7mm marginPF3125983Rev1_OTVF_OB_I_US_en_zug_R4.indd 37 1/12/15 10:53 AMPending 510k Review
383 Taking a test• 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. IMPORTANT: If another person assists you with testing, the meter should always be cleaned prior to use by that person. See page80.CAUTION: • The OneTouchVerioFlex™ Blood Glucose Monitoring System should not be used for patients within 24 hours of receiving a D-xylose absorption test as it may cause inaccurately high results.• Do Not use the OneTouchVerio® Family of Meters when PAM (Pralidoxime) is known or suspected to be in the patient's whole blood sample.• 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. 1888567-3003.Yellow= 5mm Red=7mm marginYellow= 5mm Red=7mm marginPF3125983Rev1_OTVF_OB_I_US_en_zug_R4.indd 38 1/12/15 10:53 AMPending 510k Review
393 Taking a test• 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.• The test strip vial contains drying agents that are harmful if inhaled or swallowed and may cause skin or eye irritation.• Do Not use test strips after the expiration date (printed on the vial) or the discard date, whichever comes first, or your results may be inaccurate.Yellow= 5mm Red=7mm marginYellow= 5mm Red=7mm marginPF3125983Rev1_OTVF_OB_I_US_en_zug_R4.indd 39 1/12/15 10:53 AMPending 510k Review
403 Taking a testGetting to know your OneTouch®Delica® Lancing DeviceYellow= 5mm Red=7mm marginYellow= 5mm Red=7mm marginPF3125983Rev1_OTVF_OB_I_US_en_zug_R4.indd 40 1/12/15 10:53 AMPending 510k Review
413 Taking a testNOTE: • The OneTouch®Delica® Lancing Device uses ONLY OneTouch®Delica® Lancets. • If another type of lancing device was included, see the separate instructions for that lancing device. • The OneTouchVerioFlex™ Blood Glucose Monitoring System has not been evaluated for Alternate Site Testing (AST). Use only fingertips when testing with the system. • 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VerioFlex™ Blood Glucose Monitoring System. Yellow= 5mm Red=7mm marginYellow= 5mm Red=7mm marginPF3125983Rev1_OTVF_OB_I_US_en_zug_R4.indd 41 1/12/15 10:53 AMPending 510k Review
423 Taking a testLancing precautionsCAUTION: To reduce the chance of infection and disease spread by blood: • Make sure to wash the sample site with soap and warm water, rinse and dry before sampling. • The lancing device is intended for a single user. Never share a lancet or lancing device with anyone.• Always use a new, sterile lancet each time you test.• Always keep your meter and lancing device clean (See page80). • 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! • 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 marginYellow= 5mm Red=7mm marginPF3125983Rev1_OTVF_OB_I_US_en_zug_R4.indd 42 1/12/15 10:53 AMPending 510k Review
433 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 marginYellow= 5mm Red=7mm marginPF3125983Rev1_OTVF_OB_I_US_en_zug_R4.indd 43 1/12/15 10:53 AMPending 510k Review
443 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57. Yellow= 5mm Red=7mm marginYellow= 5mm Red=7mm marginPF3125983Rev1_OTVF_OB_I_US_en_zug_R4.indd 44 1/12/15 10:53 AMPending 510k Review
453 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 marginYellow= 5mm Red=7mm marginPF3125983Rev1_OTVF_OB_I_US_en_zug_R4.indd 45 1/12/15 10:53 AMPending 510k Review
463 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 marginYellow= 5mm Red=7mm marginPF3125983Rev1_OTVF_OB_I_US_en_zug_R4.indd 46 1/12/15 10:53 AMPending 510k Review
473 Taking a testPreparing the meter1. Insert a test strip to turn the meter on Insert a test strip into the test strip port with the gold side of the test strip and the two silver prongs 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 marginYellow= 5mm Red=7mm marginPF3125983Rev1_OTVF_OB_I_US_en_zug_R4.indd 47 1/12/15 10:53 AMPending 510k Review
483 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 marginYellow= 5mm Red=7mm marginPF3125983Rev1_OTVF_OB_I_US_en_zug_R4.indd 48 1/12/15 10:53 AMPending 510k Review
493 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. 2. 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 marginYellow= 5mm Red=7mm marginPF3125983Rev1_OTVF_OB_I_US_en_zug_R4.indd 49 1/12/15 10:53 AMPending 510k Review
503 Taking a testApplying blood and reading resultsApplying the sample1. Apply the sample to the test stripYou can apply blood to either side of the test strip.Apply your sample to the opening of the channel.Be sure to apply your sample immediately after you get a drop of blood.Holding the meter at a slight angle, guide the channel to the blood drop.Yellow= 5mm Red=7mm marginYellow= 5mm Red=7mm marginPF3125983Rev1_OTVF_OB_I_US_en_zug_R4.indd 50 1/12/15 10:53 AMPending 510k Review
513 Taking a testApplying blood and reading resultsApplying the sample1. Apply the sample to the test stripYou can apply blood to either side of the test strip.Apply your sample to the opening of the channel.Be sure to apply your sample immediately after you get a drop of blood.When it touches your sample, the test strip wicks blood into the channel.2. Wait for the channel to fill completelyThe blood drop will be drawn into the narrow channel. The channel should fill completely.The channel turns red and the meter will count down from 5 to 1.Blood should not be applied on the top of the test strip or to the top edge of the test strip.Yellow= 5mm Red=7mm marginYellow= 5mm Red=7mm marginPF3125983Rev1_OTVF_OB_I_US_en_zug_R4.indd 51 1/12/15 10:53 AMPending 510k Review
523 Taking a testNOTE: • Do Not smear or scrape the sample with the test strip. • Do Not press the test strip too firmly against the puncture site or the channel may be blocked from filling properly. • Do Not apply more blood to the test strip after you have moved the drop of blood away. • 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. • Do Not remove the test strip until the result is displayed or the meter will turn off. Yellow= 5mm Red=7mm marginYellow= 5mm Red=7mm marginPF3125983Rev1_OTVF_OB_I_US_en_zug_R4.indd 52 1/12/15 10:53 AMPending 510k Review
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21). 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 mg/dL is displayed. If your display shows mmol/L rather than mg/dL, stop using the meter and contact Customer Service.Yellow= 5mm Red=7mm marginYellow= 5mm Red=7mm marginPF3125983Rev1_OTVF_OB_I_US_en_zug_R4.indd 53 1/12/15 10:53 AMPending 510k Review
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 70mg/dL or is shown as LO (meaning the result is less than 20mg/dL), 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 20mg/dL, 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 marginYellow= 5mm Red=7mm marginPF3125983Rev1_OTVF_OB_I_US_en_zug_R4.indd 54 1/12/15 10:53 AMPending 510k Review
553 Taking a testInterpreting unexpected resultsRefer to the following cautions when your results are higher or lower than what you expect.CAUTION: High results • If your result is above 180mg/dL, it may mean hyperglycemia (high blood glucose) and you should consider re-testing. Talk to your healthcare professional if you are concerned about hyperglycemia.• HI is displayed when your result is over 600mg/dL. 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 600mg/dL, both the HI and the Range Indicator Arrow will flash on the meter screen.Yellow= 5mm Red=7mm marginYellow= 5mm Red=7mm marginPF3125983Rev1_OTVF_OB_I_US_en_zug_R4.indd 55 1/12/15 10:53 AMPending 510k Review
563 Taking a testCAUTION: Repeated unexpected results• If you continue to get unexpected results, check your system with control solution.• 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 60%) or very low (below 20%) can cause false results.Yellow= 5mm Red=7mm marginYellow= 5mm Red=7mm marginPF3125983Rev1_OTVF_OB_I_US_en_zug_R4.indd 56 1/12/15 10:53 AMPending 510k Review
573 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 marginYellow= 5mm Red=7mm marginPF3125983Rev1_OTVF_OB_I_US_en_zug_R4.indd 57 1/12/15 10:53 AMPending 510k Review
583 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 marginYellow= 5mm Red=7mm marginPF3125983Rev1_OTVF_OB_I_US_en_zug_R4.indd 58 1/12/15 10:53 AMPending 510k Review
593 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 marginYellow= 5mm Red=7mm marginPF3125983Rev1_OTVF_OB_I_US_en_zug_R4.indd 59 1/12/15 10:53 AMPending 510k Review
603 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Verio® 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: • Use only OneTouch Verio® Level 3 Control Solution or OneTouch Verio® Level 4 Control Solution with your OneTouch Verio Flex™ Meter. Either level can be used to check your system. • 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. Yellow= 5mm Red=7mm marginYellow= 5mm Red=7mm marginPF3125983Rev1_OTVF_OB_I_US_en_zug_R4.indd 60 1/12/15 10:53 AMPending 510k Review
613 Taking a test• Tightly close the cap on the control solution vial immediately after use to avoid contamination or damage.See page36 for more information on testing.CAUTION: • Do Not swallow or ingest control solution.• Do Not apply control solution to the skin, eyes, ears or nose as it may cause irritation.• 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 marginYellow= 5mm Red=7mm marginPF3125983Rev1_OTVF_OB_I_US_en_zug_R4.indd 61 1/12/15 10:53 AMPending 510k Review
623 Taking a testWhen to do a control solution test• When you open a new vial of test strips. • If you suspect that the meter or test strips are not working properly. • If you have had repeated unexpected blood glucose readings.• If you drop or damage the meter. Preparing your meter for a control solution test1. Insert a test strip to turn the meter onYellow= 5mm Red=7mm marginYellow= 5mm Red=7mm marginPF3125983Rev1_OTVF_OB_I_US_en_zug_R4.indd 62 1/12/15 10:53 AMPending 510k Review
633 Taking a testPreparing your meter for a control solution test1. Insert a test strip to turn the meter onPreparing 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 display 3. Press or until the control solution icon ( ) appears on the display Yellow= 5mm Red=7mm marginYellow= 5mm Red=7mm marginPF3125983Rev1_OTVF_OB_I_US_en_zug_R4.indd 63 1/12/15 10:53 AMPending 510k Review
643 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 marginYellow= 5mm Red=7mm marginPF3125983Rev1_OTVF_OB_I_US_en_zug_R4.indd 64 1/12/15 10:53 AMPending 510k Review
653 Taking a testApplying the control solution1. Hold the meter so that the side 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 side of the test strip to the control solutionYellow= 5mm Red=7mm marginYellow= 5mm Red=7mm marginPF3125983Rev1_OTVF_OB_I_US_en_zug_R4.indd 65 1/12/15 10:53 AMPending 510k Review
663 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. Invalid results may be logged into your history if you applied control solution to the test strip without following the steps beginning on page62. Yellow= 5mm Red=7mm marginYellow= 5mm Red=7mm marginPF3125983Rev1_OTVF_OB_I_US_en_zug_R4.indd 66 1/12/15 10:53 AMPending 510k Review
673 Taking a testChecking if the result is in rangeExample rangeOneTouch Verio® Level 3 Control Solution Control Range 102-138 mg/dLEach vial of test strips has both OneTouch Verio® Level 3 Control Solution and OneTouch Verio® Level 4 Control Solution ranges printed on its label. Compare the result displayed on the meter to either the OneTouch Verio® Level 3 Control Solution or OneTouch Verio® Level 4 Control Solution range printed on the test strip vial, depending on the type of control solution you used.CAUTION: The range printed on the control solution vial is for control solution tests only and is not a recommended range for your blood glucose level.OneTouch Verio® Level 4 Control Solution Control Range 298-403 mg/dLYellow= 5mm Red=7mm marginYellow= 5mm Red=7mm marginPF3125983Rev1_OTVF_OB_I_US_en_zug_R4.indd 67 1/12/15 10:53 AMPending 510k Review
683 Taking a testCauses of out-of-range resultsOut-of-range results may be due to: • Not following the instructions for performing a control solution test. • Control solution is contaminated, expired, or past its discard date. • Test strip or test strip vial is damaged, expired, or past its discard date. • Meter, test strips and/or control solution were not all at the same temperature when the control solution test was performed. • A problem with the meter. • 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 test strip vial, Do Not use the meter, test strips, or control solution. Contact Customer Service. 1888567-3003.Yellow= 5mm Red=7mm marginYellow= 5mm Red=7mm marginPF3125983Rev1_OTVF_OB_I_US_en_zug_R4.indd 68 1/12/15 10:53 AMPending 510k Review
693 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 marginYellow= 5mm Red=7mm marginPF3125983Rev1_OTVF_OB_I_US_en_zug_R4.indd 69 1/12/15 10:53 AMPending 510k Review
70 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 marginYellow= 5mm Red=7mm marginPF3125983Rev1_OTVF_OB_I_US_en_zug_R4.indd 70 1/12/15 10:53 AMPending 510k Review
714 Reviewing past resultsUsing 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.Sending 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30. 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.Yellow= 5mm Red=7mm marginYellow= 5mm Red=7mm marginPF3125983Rev1_OTVF_OB_I_US_en_zug_R4.indd 71 1/12/15 10:53 AMPending 510k Review
724 Reviewing past resultsTo ensure that glucose test results are successfully sent to the app, turn on the BLUETOOTH® SMART feature and check the following:• The compatible wireless device and meter are both turned on, and the app is running.• The meter is correctly paired with your compatible wireless device.• The Bluetooth feature on both devices is running (indicated by ) and the devices are within 26feet of each other.• 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.ExampleYellow= 5mm Red=7mm marginYellow= 5mm Red=7mm marginPF3125983Rev1_OTVF_OB_I_US_en_zug_R4.indd 72 1/12/15 10:53 AMPending 510k Review
734 Reviewing past resultsIf you are still unable to send results to the compatible wireless device, please call Customer Service. 1888567-3003.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. Yellow= 5mm Red=7mm marginYellow= 5mm Red=7mm marginPF3125983Rev1_OTVF_OB_I_US_en_zug_R4.indd 73 1/12/15 10:53 AMPending 510k Review
744 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. As your partner in diabetes care, we welcome you to contact us (7 days a week, 8 a.m. - 10 p.m. Eastern Time) at 1888567-3003 (English), 1888567-3010 (Español), or www.OneTouch.com.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VerioFlex™ Meter to a computer to download results (not included).Yellow= 5mm Red=7mm marginYellow= 5mm Red=7mm marginPF3125983Rev1_OTVF_OB_I_US_en_zug_R4.indd 74 1/12/15 10:53 AMPending 510k Review
754 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. As your partner in diabetes care, we welcome you to contact us (7 days a week, 8 a.m. - 10 p.m. Eastern Time) at 1888567-3003 (English), 1888567-3010 (Español), or www.OneTouch.com.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VerioFlex™ Meter to a computer to download results (not included).Once 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. 1888567-3003.Yellow= 5mm Red=7mm marginYellow= 5mm Red=7mm marginPF3125983Rev1_OTVF_OB_I_US_en_zug_R4.indd 75 1/12/15 10:53 AMPending 510k Review
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25. 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 marginYellow= 5mm Red=7mm marginPF3125983Rev1_OTVF_OB_I_US_en_zug_R4.indd 76 1/12/15 10:53 AMPending 510k Review
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 70mg/dL and the pre-set high range limit is 180mg/dL. 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 marginYellow= 5mm Red=7mm marginPF3125983Rev1_OTVF_OB_I_US_en_zug_R4.indd 77 1/12/15 10:53 AMPending 510k Review
785Editing Your Settings1. Review the pre-set low range limit displayed• To accept the pre-set low range limit, press .• To edit the pre-set low range limit, press or to change the value between 60mg/dL-110mg/dL, and then press .2. Review the pre-set high range limit displayed• To accept the pre-set high range limit, press .• To edit the pre-set high range limit, press or to change the value between 90mg/dL-300mg/dL, and then press .Your meter will exit settings mode and your last result screen will appear. Yellow= 5mm Red=7mm marginYellow= 5mm Red=7mm marginPF3125983Rev1_OTVF_OB_I_US_en_zug_R4.indd 78 1/12/15 10:53 AMPending 510k Review
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 marginYellow= 5mm Red=7mm marginPF3125983Rev1_OTVF_OB_I_US_en_zug_R4.indd 79 1/12/15 10:53 AMPending 510k Review
80 6 Caring for your systemCleaning and disinfectionCleaning and disinfection are different. Both should be performed at least once per week. Cleaning is part of your normal care and maintenance, but does not kill germs. You should clean your meter, lancing device and cap before disinfecting. After use and exposure to blood, all parts of this kit may transmit infectious diseases. Disinfection is the only way to reduce your exposure to disease.Storing your systemStore your meter, test strips, control solution and other items in your carrying case. Keep in a cool, dry place between 41°F and 86°F. Keep all items away from direct sunlight and heat. Yellow= 5mm Red=7mm marginYellow= 5mm Red=7mm marginPF3125983Rev1_OTVF_OB_I_US_en_zug_R4.indd 80 1/12/15 10:53 AMPending 510k Review
816 Caring for your systemFor cleaning information, see page82 and for disinfecting information, see page83.For cleaning and disinfecting, Clorox® Germicidal Wipes* containing 0.55% sodium hypochlorite as the active ingredient have been shown to be safe for use with the OneTouchVerioFlex™ System and can be obtained from retail websites offering disinfection products, e.g., www.officedepot.com. For more information on purchase options, visit www.onetouch.com/disinfection, or contact Customer Service. 1888567-3003.*Other products, such as Clorox® Disinfecting Wipes, have not been tested and should not be used. Only Clorox® Germicidal Wipes should be used. Follow manufacturer's instruction for handling and storage of wipes. Clorox® is a registered trademark of the Clorox Company.IMPORTANT: If another person assists you with testing, the meter, lancing device and cap should always be cleaned and then disinfected prior to use by that person.Yellow= 5mm Red=7mm marginYellow= 5mm Red=7mm marginPF3125983Rev1_OTVF_OB_I_US_en_zug_R4.indd 81 1/12/15 10:53 AMPending 510k Review
826Caring for your system2. Wipe dry with a clean, sterile gauzeCleaning your meter, lancing device and capThe meter, lancing device and cap should be cleaned at least once per week. Be sure to clean the meter, lancing device and cap before disinfecting.1. Use a Clorox® Germicidal Wipe to wipe the outside of the meter and lancing deviceTo clean your meter, hold it with the test strip port pointed down. Be sure to squeeze out any excess liquid before you wipe the meter.Wipe the outside of the lancing device cap.Yellow= 5mm Red=7mm marginYellow= 5mm Red=7mm marginPF3125983Rev1_OTVF_OB_I_US_en_zug_R4.indd 82 1/12/15 10:53 AMPending 510k Review
836 Caring for your systemDisinfecting your meter, lancing device and capThe meter, lancing device and cap should be disinfected at least once per week. Be sure to clean the meter, lancing device and cap before disinfecting.1. First, clean your meter, lancing device and cap prior to disinfectingFollow step 1 of page82. 2. Use a new Clorox® Germicidal Wipe to wipe the outside of the meter, lancing device and cap until the surface is dampBe sure to squeeze out any excess liquid before you wipe the meter. Hold the meter with the test strip port pointed down.Allow the surface of the meter, lancing device and cap to remain damp for 1 minute.Yellow= 5mm Red=7mm marginYellow= 5mm Red=7mm marginPF3125983Rev1_OTVF_OB_I_US_en_zug_R4.indd 83 1/12/15 10:53 AMPending 510k Review
846Caring for your system3. Wipe dry with a clean, sterile gauzeWash hands thoroughly with soap and water after handling the meter, lancing device and cap. • Do Not use alcohol or any other solvent. • Do Not allow liquids, dirt, dust, blood or control solution to enter the test strip port or the data port. • Do Not squeeze the germicidal wipe into test strip port. • Do Not spray cleaning solution on the meter and lancing device. • Do Not immerse the meter and lancing device in any liquid. The OneTouchVerioFlex™ System withstood cleaning and disinfection cycles well in excess of LifeScan's recommendation. See page85 for more details.Yellow= 5mm Red=7mm marginYellow= 5mm Red=7mm marginPF3125983Rev1_OTVF_OB_I_US_en_zug_R4.indd 84 1/12/15 10:53 AMPending 510k Review
856 Caring for your systemExamples of damage to the meter may include fogged display, cracked housing or lens, illegible labels, button not working or meter malfunction (such as repeated error messages). Examples of damage to the lancing device and cap may include cracking, illegible depth setting numbers and lancing device malfunction (such as failure to load, cock or release).Do Not use your meter or lancing device if you see evidence of such damage. If you have questions about cleaning or disinfecting, or if you see evidence of physical damage, contact Customer Service. As your partner in diabetes care, we welcome you to contact us (7 days a week, 8 a.m. - 10 p.m. Eastern Time) at 1888567-3003 (English), 1888567-3010 (Español), or www.OneTouch.com.Cleaning and Disinfecting CyclesThe meter, lancing device and cap can be cleaned daily for 3 years and have been tested up to 2879 cleaning cycles.The meter, lancing device and cap can be disinfected weekly for 3 years, and have been tested up to 412 cleaning and disinfection cycles.Yellow= 5mm Red=7mm marginYellow= 5mm Red=7mm marginPF3125983Rev1_OTVF_OB_I_US_en_zug_R4.indd 85 1/12/15 10:53 AMPending 510k Review
86 7 BatteryReplacing the batteryYour OneTouchVerio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 marginYellow= 5mm Red=7mm marginPF3125983Rev1_OTVF_OB_I_US_en_zug_R4.indd 86 1/12/15 10:53 AMPending 510k Review
877 BatteryReplacing the batteryYour OneTouchVerio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.Pull 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. 1888567-3003.Yellow= 5mm Red=7mm marginYellow= 5mm Red=7mm marginPF3125983Rev1_OTVF_OB_I_US_en_zug_R4.indd 87 1/12/15 10:53 AMPending 510k Review
887Battery3. 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 marginYellow= 5mm Red=7mm marginPF3125983Rev1_OTVF_OB_I_US_en_zug_R4.indd 88 1/12/15 10:53 AMPending 510k Review
897 BatteryThis page left blank intentionally.Yellow= 5mm Red=7mm marginYellow= 5mm Red=7mm marginPF3125983Rev1_OTVF_OB_I_US_en_zug_R4.indd 89 1/12/15 10:53 AMPending 510k Review
90 8 Troubleshooting your systemError and other messagesThe OneTouchVerioFlex™ Meter displays messages when there are problems with the test strip, with the meter or when your glucose levels are above 600mg/dL or below 20mg/dL. 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. 1888567-3003.What it meansYou may have a very low blood glucose level (severe hypoglycemia), below 20mg/dL.NOTE: When your glucose result is below 20mg/dL, 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 marginYellow= 5mm Red=7mm marginPF3125983Rev1_OTVF_OB_I_US_en_zug_R4.indd 90 1/12/15 10:53 AMPending 510k Review
91Troubleshooting your system8 What it meansYou may have a very high blood glucose level (severe hyperglycemia), over 600mg/dL.NOTE: When your glucose result is above 600mg/dL, 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 marginYellow= 5mm Red=7mm marginPF3125983Rev1_OTVF_OB_I_US_en_zug_R4.indd 91 1/12/15 10:53 AMPending 510k Review
92Troubleshooting your system8What it meansMeter is too hot (above 104°F) 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 (50-104°F). If you do not get another HI .t message, you can proceed with testing.If this message continues to appear, contact Customer Service. 1888567-3003.Yellow= 5mm Red=7mm marginYellow= 5mm Red=7mm marginPF3125983Rev1_OTVF_OB_I_US_en_zug_R4.indd 92 1/12/15 10:53 AMPending 510k Review
93Troubleshooting your system8 What it meansMeter is too cold (below 50°F) 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 (50-104°F). If you do not get another LO.t message, you can proceed with testing.If this message continues to appear, contact Customer Service. 1888567-3003.Yellow= 5mm Red=7mm marginYellow= 5mm Red=7mm marginPF3125983Rev1_OTVF_OB_I_US_en_zug_R4.indd 93 1/12/15 10:53 AMPending 510k Review
94Troubleshooting 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. 1888567-3003. They will refer to the error number and code to help troubleshoot the problem. Yellow= 5mm Red=7mm marginYellow= 5mm Red=7mm marginPF3125983Rev1_OTVF_OB_I_US_en_zug_R4.indd 94 1/12/15 10:53 AMPending 510k Review
95Troubleshooting your system8 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. 1888567-3003.What to doRepeat the test with a new test strip; see page50 or page65. If this message continues to appear, contact Customer Service. 1888567-3003.Yellow= 5mm Red=7mm marginYellow= 5mm Red=7mm marginPF3125983Rev1_OTVF_OB_I_US_en_zug_R4.indd 95 1/12/15 10:53 AMPending 510k Review
96Troubleshooting 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. 1888567-3003.Yellow= 5mm Red=7mm marginYellow= 5mm Red=7mm marginPF3125983Rev1_OTVF_OB_I_US_en_zug_R4.indd 96 1/12/15 10:53 AMPending 510k Review
97Troubleshooting your system8 What it meansOne of the following may apply:• Not enough blood or control solution was applied or more was added after the meter began to count down.• The test strip may have been damaged or moved during testing.• The sample was improperly applied.• There may be a problem with the meter.What to doRepeat the test with a new test strip; see page50 or page65. If the error message appears again, contact Customer Service. 1888567-3003.Yellow= 5mm Red=7mm marginYellow= 5mm Red=7mm marginPF3125983Rev1_OTVF_OB_I_US_en_zug_R4.indd 97 1/12/15 10:53 AMPending 510k Review
98Troubleshooting your system8What 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.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50 or page65. If the error message appears again, contact Customer Service. 1888567-3003.Yellow= 5mm Red=7mm marginYellow= 5mm Red=7mm marginPF3125983Rev1_OTVF_OB_I_US_en_zug_R4.indd 98 1/12/15 10:53 AMPending 510k Review
99Troubleshooting your system8 What it meansThere is not enough battery power to perform a test.What to doReplace the battery immediately.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. 1888567-3003.Yellow= 5mm Red=7mm marginYellow= 5mm Red=7mm marginPF3125983Rev1_OTVF_OB_I_US_en_zug_R4.indd 99 1/12/15 10:53 AMPending 510k Review
100 9 Detailed information about your systemComparing meter results to laboratory resultsResults obtained from the OneTouchVerio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VerioFlex™ Meter is considered accurate when it is within 15mg/dL of a laboratory method when the glucose concentration is lower than 75mg/dL and within 15% of laboratory method when the glucose concentration is 75mg/dL 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:• You have eaten recently. This can cause a result from fingertip testing to be up to 70mg/dL higher than a lab test using blood drawn from a vein.1• Your hematocrit is above 60% or below 20%.• You are severely dehydrated.For additional information, refer to the OneTouchVerio® 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 marginYellow= 5mm Red=7mm marginPF3125983Rev1_OTVF_OB_I_US_en_zug_R4.indd 100 1/12/15 10:53 AMPending 510k Review
101Detailed information about your system9 Guidelines for obtaining an accurate meter to lab comparisonBefore going to the lab:• Perform a control solution test to make sure your meter is working properly. • Do Not eat for at least 8 hours before you test your blood.• Take your meter and testing supplies with you to the lab.Yellow= 5mm Red=7mm marginYellow= 5mm Red=7mm marginPF3125983Rev1_OTVF_OB_I_US_en_zug_R4.indd 101 1/12/15 10:53 AMPending 510k Review
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VerioFlex™ Meter at the lab:• Test within 15 minutes of the lab test. • Use only a fresh, capillary blood sample from your fingertip. • Follow all instructions in this Owner's Booklet for performing a blood glucose test. Yellow= 5mm Red=7mm marginYellow= 5mm Red=7mm marginPF3125983Rev1_OTVF_OB_I_US_en_zug_R4.indd 102 1/12/15 10:53 AMPending 510k Review
103Detailed information about your system9 Technical specificationsAssay method FAD-GDH (flavin adenine dinucleotide dependent glucose dehydrogenase)Automatic shuto Two minutes after last action Battery 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)BLUETOOTH® SMART TechnologyFrequency range: 2.4-2.4835 GHzOperating Range Distance: minimum 26.25feet (unobstructed)Operating Channels: 40 ChannelsSecurity Encryption: 128-bit AES (Advanced Encryption Standard)Calibration Plasma-equivalentData port type Compatible with USB 2.0Memory 500 test resultsYellow= 5mm Red=7mm marginYellow= 5mm Red=7mm marginPF3125983Rev1_OTVF_OB_I_US_en_zug_R4.indd 103 1/12/15 10:53 AMPending 510k Review
104Detailed information about your system9Operating ranges Temperature: 50-104°FRelative humidity: non-condensing 10-90%Altitude: up to 10,000feetHematocrit: 20-60%Reported result range 20-600mg/dLSample Fresh capillary whole bloodSample volume 0.4µLSize 2.05(W) x 3.38(L) x 0.63(T)inchesTest time 5 secondsUnit of measure mg/dLWeight Approximately 1.76ouncesLay User AccuracyUser Accuracy of the system was assessed at 3clinical sites. 172 patients tested their blood using the OneTouchVerioFlex™ System where results were compared to the YSI 2300 Glucose Analyzer laboratory Instrument.Yellow= 5mm Red=7mm marginYellow= 5mm Red=7mm marginPF3125983Rev1_OTVF_OB_I_US_en_zug_R4.indd 104 1/12/15 10:53 AMPending 510k Review
105Detailed information about your system9 Fingertip Results for Glucose Concentrations <75mg/dLPercent (and number) of meter results that match the laboratory testWithin ±5mg/dL Within ±10mg/dL Within ±15mg/dL76.2% (16/21) 95.2% (20/21) 95.2% (20/21)Fingertip Results for Glucose Concentrations ≥75mg/dLPercent (and number) of meter results that match the laboratory testWithin ±5% Within ±10% Within ±15%58.3% (88/151) 88.7% (134/151) 98.0% (148/151)Number and percentage of all results falling within ±15mg/dL or ±15%Within 15mg/dL or ±15%97.7% (168/172)Yellow= 5mm Red=7mm marginYellow= 5mm Red=7mm marginPF3125983Rev1_OTVF_OB_I_US_en_zug_R4.indd 105 1/12/15 10:53 AMPending 510k Review
106Detailed information about your system9Regression StatisticsSamples were tested on each of three test strip lots. Results indicate that the OneTouchVerioFlex™ System compares well with a laboratory method.# of Subjects # of Tests Slope Intercept (mg/dL)172 172 0.99 2.9895% CI Slope 95% CI Intercept (mg/dL)Std. Error (Sy.x) (mg/dL)R20.97 to 1.01 -1.59 to 7.55 14.0 0.98Yellow= 5mm Red=7mm marginYellow= 5mm Red=7mm marginPF3125983Rev1_OTVF_OB_I_US_en_zug_R4.indd 106 1/12/15 10:53 AMPending 510k Review
107Detailed information about your system9 PrecisionWithin Run Precision (300 Venous Blood Samples Tested per Glucose Level)Data generated using the OneTouchVerioFlex™ Meter.Target Glucose (mg/dL)Mean Glucose (mg/dL)Standard Deviation (mg/dL)Coecient of Variation (%)40 36.5 0.83 2.2690 88.5 1.72 1.95130 127.9 2.50 1.95200 199.3 3.94 1.98350 344.6 6.18 1.79Results show that the greatest variability observed between test strips when tested with blood is 0.83mg/dL SD or less at glucose levels less than 75mg/dL or 1.98% CV or less at glucose levels at 75mg/dL or above.Yellow= 5mm Red=7mm marginYellow= 5mm Red=7mm marginPF3125983Rev1_OTVF_OB_I_US_en_zug_R4.indd 107 1/12/15 10:53 AMPending 510k Review
108Detailed information about your system9Total Precision (600 Control Solution Tests per Glucose Level)Data generated using the OneTouchVerioFlex™ Meter.Glucose Level Ranges (mg/dL)Mean Glucose (mg/dL)Standard Deviation (mg/dL)Coecient of Variation (%)Level 1(25-49)37.14 0.92 2.48Level 2(102-138)117.68 2.41 2.05Level 3(298-403)348.99 8.31 2.38Yellow= 5mm Red=7mm marginYellow= 5mm Red=7mm marginPF3125983Rev1_OTVF_OB_I_US_en_zug_R4.indd 108 1/12/15 10:53 AMPending 510k Review
109Detailed information about your system9 GuaranteeLifeScan guarantees that the OneTouchVerio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. Electrical 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.Do Not use the equipment where aerosol sprays are being used, or when oxygen is being administered.Yellow= 5mm Red=7mm marginYellow= 5mm Red=7mm marginPF3125983Rev1_OTVF_OB_I_US_en_zug_R4.indd 109 1/12/15 10:53 AMPending 510k Review
110AST 41Batteries 86Batteries, replacing 86Battery empty icon 3Battery empty warning 99Battery low icon 3, 98BLUETOOTH® SMART feature 7, 11, 29, 71Buttons on meter 18Cleaning your meter, lancing device and cap 82Comparing meter results to laboratory results 100Compatible wireless devices 3Control solution 62Control solution, discard and expiration dates 60, 61Control solution, testing 60, 66, 68Data port 18Date setting 26, 28Dehydration 54, 100Disinfecting your meter, lancing device and cap 83Display check 24Disposal, lancets and test strips 60Downloading results to a computer 74Edit date 76Edit range limits 77Edit time 76 10 IndexYellow= 5mm Red=7mm marginYellow= 5mm Red=7mm marginPF3125983Rev1_OTVF_OB_I_US_en_zug_R4.indd 110 1/12/15 10:53 AMPending 510k Review
111Index 10Error messages 90EXTREME HIGH GLUCOSE message 55, 91EXTREME LOW GLUCOSE message 54, 90Fingertip testing procedure 36First time setup 25, 30Guarantee 109Hyperglycemia 55, 91Hypoglycemia 54, 90Icons 3, 4Infection, reduce the chance 42Intended use 6Kit components 14Lancing device 14, 41, 43mg/dL 18, 104Pairing 30, 31PIN 33Plasma calibration 100, 103Range Indicator feature 21Range limits setting 77Results, reviewing past 70Serial number 33Settings 25, 28, 76Software, diabetes management 74Start-up screen 24Yellow= 5mm Red=7mm marginYellow= 5mm Red=7mm marginPF3125983Rev1_OTVF_OB_I_US_en_zug_R4.indd 111 1/12/15 10:53 AMPending 510k Review
112Index10Storing your system 80Symbols 3, 4Syncing 34, 71Technical specifications 103Temperature 36, 68, 80, 92, 93, 104Test principle 7Test strip 20, 47, 62Test strip, applying drop of blood 50Test strip, discard and expiration dates 37Test strip, silver prongs 20Time setting 25, 28Turning meter off 35Turning meter on 24, 47, 62Unexpected results 54, 56Unit of measure 18, 104Unusual red blood cell count (hematocrit) 100, 104Yellow= 5mm Red=7mm marginPF3125983Rev1_OTVF_OB_I_US_en_zug_R4.indd 112 1/12/15 10:53 AMPending 510k Review
PF No./Rev.: 3125983 Rev 1CPS Reference No.: Refer to References Section in Enable for CPS No. LFS Contact: Susan CabralRev. Date: 12-Jan-15Language Sequence: EnglishJDE Item No.: N/ANo. of Covers:PMS N/A N/A Inside No. of pages: 112No. of sides: 1 2Process ColorsUncoated AreaSpot Colors Uncoated Area Special InstructionsDielineN/A DielineDescription: Booklet, Owners, OTVF, US (zug) Art Agency: ForeignExchange Translations Job No.: 25677= CUT= SCORE= PERFN/AN/AN/A Black N/A C M Y KYellow= 5mm Red=7mm marginPF3125983Rev1_OTVF_OB_I_US_en_zug_R4.indd 1 1/12/15 10:54 AMPending 510k Review

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