FCC ID: 2ACT5-Z02 Blood Glucose Meter

C1 Blood Glucose Monitoring System Owner's Booklet Instructions for Use C2 Blood Glucose Monitoring System Owner's Booklet 1 Thanks for choosing OneTouch!

The OneTouchVerio Flex Blood Glucose Monitoring System is one of the latest product innovations from OneTouch. Your OneTouchVerio Flex Meter is designed to connect

(sync) with a variety of compatible wireless 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 (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. Compatible wireless devices Visit www.OneTouch.com for information on which wireless devices are compatible with your OneTouchVerio Flex Meter, and where/how to download the OneTouchReveal Mobile App on your compatible wireless device. 2 Meter symbols and icons Meter Power Low Battery Battery Empty Control Solution Syncing BLUETOOTH Feature On History Mode (Past results) Apply Sample Range Indicator Arrow Setting Mode Other symbols and icons Cautions and Warnings: Refer to the Owner's Booklet and inserts that came with your system for safety-related information. Direct current Before you begin Before using this product to test your blood glucose, carefully read this Owner's Booklet, and the inserts that come with the OneTouchVerio Test Strips, OneTouchVerio Control Solutions and the OneTouchDelicaPlus Lancing Device. 3 IMPORTANT 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://wayback.archive-

it.org/7993/20170111013014/http://www.fda.gov/

MedicalDevices/Safety/AlertsandNotices/ucm224025.htm. CDC website on "Infection Prevention during Blood Glucose Monitoring and Insulin Administration" (2010) http://www.cdc. gov/injectionsafety/blood-glucose-monitoring.html. 4 Intended use The OneTouchVerio 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 OneTouchVerio 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. Limitations The OneTouchVerio Flex Blood Glucose Monitoring System is intended to be used by a single patient and should not be shared. The system is not to be used for the diagnosis of or screening of diabetes or for neonatal use. The system is not for use on critically ill patients, patients in shock, severely dehydrated patients or hyperosmolar patients. Test principle Glucose in the blood sample mixes with the enzyme FAD-GDH (see page76) 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 OneTouchVerio Control Solutions and Test Strips with the OneTouchVerio Flex Meter. Use of OneTouchVerio Test Strips with meters for which they are not intended may yield inaccurate results. 5 BLUETOOTH wireless technology BLUETOOTH wireless technology is used by some smartphones and many other devices. Your OneTouchVerio Flex Meter uses BLUETOOTH wireless technology to pair and to send your glucose results to compatible wireless devices. The OneTouchVerio Flex Meter is designed to work with the OneTouchReveal Mobile App. Visit www.OneTouch.com for information on which wireless devices are compatible with your OneTouchVerio Flex Meter, and where/how to download the OneTouchReveal Mobile App on your compatible wireless device. When using the OneTouchVerio Flex System, we suggest you pair your OneTouchVerio Flex Meter with a compatible wireless device and track your results. See page22 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. 6 NOTE: 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. 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. 7 If 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. WARNING: The BLUETOOTH 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 offices and airplanes, you should turn the BLUETOOTH feature off. See page20 for more information. Do Not leave your meter unattended or in a public place so that others may change your personal parameters or make physical connections to it. The meter has been designed defensively to ward off malicious intent and has been tested accordingly. BLUETOOTH trademark The BLUETOOTH word mark and logos are registered trademarks owned by the Bluetooth SIG, Inc. and any use of such marks by LifeScan Scotland Ltd. is under license. Other trademarks and trade names are those of their respective owners. 8 Table of Contents 1 Getting to know your system ............................................ 10 2 Setting up your system ........................................................ 16 Setting up your meter ...................................................................16 Connecting to a compatible wireless device ....................... 20 Turning the meter off ................................................................... 25 3 Taking a test .............................................................................26 Testing your blood glucose ........................................................ 26 Testing with control solution ..................................................... 44 4 Reviewing past results ..........................................................51 5 Editing Your Settings ............................................................ 55 Editing time and date ................................................................... 55 Editing your range limits ............................................................. 56 6 Caring for your system ........................................................ 59 7 Battery .......................................................................................64 8 Troubleshooting your system ........................................... 67 9 Detailed information about your system ...................... 74 10 Index ..........................................................................................82 9 1 Getting to know your system Your OneTouchVerio Flex Blood Glucose Monitoring System Included with your kit:

OneTouchVerio Flex Meter

(CR2032 lithium coin cell battery included) Lancing device Lancets NOTE: 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, 8:00 AM - 8:00 PM Eastern Time) at 1888567-3003 (English), 1888567-3010

(Espaol), or www.OneTouch.com. NOTE: If another type of lancing device was included, see the separate instructions for that lancing device. 10 Getting to know your system Available 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. OneTouchVerio Level 3 Control Solution*

(vial with blue cap) OneTouchVerio Level 4 Control Solution*

(vial with red cap) OneTouchVerio Test Strips*

*OneTouchVerio 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 OneTouchVerio Level 3 Control Solution or OneTouchVerio Level 4 Control Solution with your OneTouchVerio Flex Meter. 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. 11 1 Getting to know your system Getting to know your OneTouchVerio Flex Blood Glucose Monitoring System Meter 12 1 Getting to know your system Getting to know your OneTouchVerio Test Strip Test strip 13 1 Getting to know your system The Range Indicator feature The OneTouchVerio 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. 14 1 Getting to know your system 3 Possible Range Indicator Displays A 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. Example Below Range Result Example In Range Result Example Above Range Result 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 70mg/dL and the pre-set high range limit is 180mg/dL. You can change these limits as needed to meet your needs. See page56 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. 15 1 2 Setting up your system Setting up your meter Turn your meter on until the start-up test To turn your meter on, press and hold screen appears. Once the device is on, release turn the meter on by inserting a test strip. You can also 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. CAUTION:

If you see any missing segments within the start-up screen, there may be a problem with the meter. Contact Customer Service. Contact us at 1888567-3003. NOTE: If you turned the meter on for the first time by inserting a test strip instead of pressing perform a glucose test until you complete the first time setup.

, you will not be able to 16 Setting up your system First time setup To turn your meter on, press and hold screen appears. Once the device is on, release 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. until the start-up

. The meter Setting the time Hour will flash If the hour displayed is correct, to confirm. press If the hour displayed is not correct, press to change the hour and press to confirm. or Minutes will flash If the minutes displayed is correct, press to confirm. If the minutes displayed is not correct, press change the minutes and press or to to confirm. 17 2 Setting up your system AM/PM will flash If the AM/PM displayed is correct, to confirm. If the AM/PM displayed is not press or correct, press to change AM/PM and press to confirm. Setting the date After completing the time setup, the meter will automatically move to date setup. Year will flash If the year displayed is correct, to confirm. press If the year displayed is not correct, press to change the year and press to confirm. or Month will flash If the month displayed is correct, to confirm. press If the month displayed is not or correct, press change the month and press to confirm. to 18 2 Setting up your system Day will flash press If the day displayed is correct, to confirm. If the day displayed is not correct, to change the day or press 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. Adjusting the time and date settings after first time setup You can adjust the meter's time and date settings after first time setup. Press and hold and press and hold will appear. See page55. to turn the meter on, then at the same time. The SET screen After adjusting the settings, your meter will exit settings mode and your last result screen will appear. 19 2 Setting up your system Connecting to a compatible wireless device Turning the BLUETOOTH feature on or off In order to connect your meter with your compatible wireless device, the BLUETOOTH feature will need to be turned on. The symbol will appear on the meter screen when the BLUETOOTH feature is on. When the on the screen the BLUETOOTH feature is off. symbol is not present To turn the BLUETOOTH feature on press and at the same time. To turn the BLUETOOTH feature off press and at the same time. symbol The indicates the BLUETOOTH feature is on NOTE: The BLUETOOTH feature will turn OFF during a blood glucose test. 20 2 Setting up your system Pairing Overview Pairing allows your OneTouchVerio Flex Meter to communicate with compatible wireless devices. The devices must be within 26feet of each other to pair and sync. Download the OneTouchReveal Mobile App from the appropriate app store before pairing your meter and compatible wireless device. Multiple OneTouchVerio 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 page22 for pairing instructions. Your OneTouchVerio 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. 21 2 Setting up your system Pairing Instructions 1. Start by turning your meter on using the button 2. The BLUETOOTH feature is turned on by pressing and together symbol will appear to indicate The that the BLUETOOTH feature is on. 3. Open the OneTouchReveal Mobile App and follow instructions to pair meter with your compatible wireless device 4. Look for "OneTouch" and the last 4 characters of the meter serial number on the compatible wireless device display to correctly identify your meter 22 2 Setting up your system 5. When prompted by the OneTouchReveal Mobile App, the meter will display a six digit PIN number Enter the PIN number into your compatible wireless device using the keypad on your compatible wireless device. CAUTION:

Make sure the PIN you enter on your compatible wireless 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. Example of PIN number display on meter 6. Wait for your compatible wireless device to indicate that your meter and compatible wireless device are paired 23 2 Setting up your system Syncing to send results wirelessly to the OneTouchReveal Mobile App After pairing the meter with your compatible wireless device, you are ready to send results to the OneTouchReveal Mobile App. 1. Open the OneTouchReveal Mobile App on your compatible wireless device 2. Press and hold the BLUETOOTH feature is ON as indicated by (

to turn the meter on and make sure

) and If needed, press BLUETOOTH feature on. at the same time to turn the

) flashes on The Sync symbol (

the meter display. "Syncing Data"

will appear on the app to notify you that the meter is communicating with the app. Syncing Data 24 2 Setting up your system After 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 the screen and you can proceed with testing. symbol appears on Turning the meter off 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 connection for up to 4 hours. See page52 for more details. 25 2 3 Taking a test Testing your blood glucose Preparing for a blood glucose test NOTE: Many people find it helpful to practice testing with control solution before testing with blood for the first time. See page44. Have these things ready when you test:

OneTouchVerio Flex Meter OneTouchVerio Test Strips Lancing device Sterile lancets NOTE:

Use only OneTouchVerio Test Strips. Unlike some blood glucose meters, no separate step to code your OneTouchVerio Flex System is required. Testing must be done within operating temperature range

(50-104F). Make sure your meter and test strips are about the same temperature before you test. 26 Taking a test Keep test strips in a cool, dry place between 41F and 86F. 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. 27 3 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 page59. CAUTION:

The OneTouchVerio Flex Blood Glucose Monitoring System should not be used within 24 hours of receiving a D-xylose absorption test as it may cause inaccurately high results. Do Not use the OneTouchVerio Family of Meters when PAM (Pralidoxime) is known or suspected to be in the 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. Contact us at 1888567-3003. 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. 28 3 Taking a test 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. Getting to know your OneTouchDelicaPlus Lancing Device 1 2 3 4 5 6 Release button Slider control Depth indicator Depth wheel Lancing device cap Protective cover 29 3 Taking a test NOTE:

The OneTouchDelicaPlus Lancing Device uses OneTouchDelica or OneTouchDelicaPlus Lancets. If another type of lancing device was included, see the separate instructions for that lancing device. The OneTouchVerio Flex Blood Glucose Monitoring System has not been evaluated for Alternate Site Testing

(AST). Use only fingertips when testing with the system. The OneTouchDelicaPlus Lancing System does not include the materials needed to perform Alternate Site Testing (AST). The OneTouchDelicaPlus Lancing System should not be used on the forearm or palm with the OneTouchVerio Flex Blood Glucose Monitoring System. Lancing precautions CAUTION:

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. Contaminants on the skin may affect results. The lancing device is intended for a single user. Never share a lancet or lancing device with anyone. 30 3 Taking a test Always use a new, sterile lancet each time you test. Always keep your meter and lancing device clean

(See page59). 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. Do Not use lancets after the expiration date printed on the lancet packaging. Preparing your lancing device 1. Remove the lancing device cap Remove the cap by rotating it and then pulling it straight off the device. 31 3 Taking a test 2. 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 page41. 3. Replace the lancing device cap Place the cap back onto the device; turn the cap or push the cap straight on to secure it. Ensure the cap is aligned as shown in the image. 32 3 Taking a test 4. Adjust the depth setting The device has 13 puncture depth settings (each dot shown between numbers 1 to 7 on the Depth Wheel indicates an additional available depth setting). Adjust the depth by turning the depth wheel. Smaller numbers are for a shallower puncture and larger numbers for a deeper puncture. NOTE: 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 Pull the slider back until it clicks. If it does not click, it may already have been cocked when you inserted the lancet. 33 3 Taking a test Preparing the meter 1. 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. Sampling blood from the fingertip Choose a different puncture site each time you test. Repeated punctures in the same spot may cause soreness and calluses. Before testing, wash your hands and the sample site with warm, soapy water. Rinse and dry completely. Contaminants on the skin may affect results. 34 3 Taking a test 1. Puncture your finger Hold 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. 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. Applying blood and reading results Applying the sample 1. Apply the sample to the test strip You can apply blood to either side of the test strip. 35 Sampling blood from the fingertip Choose a different puncture site each time you test. Repeated punctures in the same spot may cause soreness and calluses. Before testing, wash your hands and the sample site with warm, soapy water. Rinse and dry completely. Contaminants on the skin may affect results. 3 Taking a test 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. When it touches your sample, the test strip wicks blood into the channel. 36 3 Taking a test 2. Wait for the channel to fill completely The 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 5to 1. Blood should not be applied on the top of the test strip or to the top edge of the test strip. NOTE:

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. 37 3 Taking a test Viewing your result Your 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 page14). The arrow will point to the appropriate Range Indicator Color Bar on the meter as a visual reminder. Example Below Range Result CAUTION:

Example In Range Result Example Above Range Result 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. 38 3 Taking a test Interpreting unexpected results Refer to the following cautions when your results are higher or lower than what you expect. CAUTION:

Low results If your result is below 70mg/dL or is shown as LO (meaning the result is less than 20mg/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 20mg/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. 39 3 Taking a test CAUTION:

High results If your result is above 180mg/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 600mg/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 600mg/dL, both the HI and the Range Indicator Arrow will flash on the meter screen. 40 3 Taking a test CAUTION:

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 count A 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. Removing the used lancet NOTE: 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 rotating it and then pulling it straight off the device. 41 3 Taking a test 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 flat side of the disk. 3. Eject the lancet Holding the lancing device directed downwards, push the slider forward until the lancet comes out of the lancing device. If the lancet fails to eject properly, cock the device then push the slider control forward until the lancet comes out. 42 3 Taking a test 4. Replace the lancing device cap Place the cap back onto the device; turn the cap or push the cap straight in to secure it. Ensure the cap is aligned as shown in the image. 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. Disposing of the used lancet and test strip Discard 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. 43 3 Taking a test Testing with control solution Control solution testing precautions OneTouchVerio 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 OneTouchVerio Level 3 Control Solution or OneTouchVerio Level 4 Control Solution with your OneTouchVerio 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. Tightly close the cap on the control solution vial immediately after use to avoid contamination or damage. See page26 for more information on testing. 44 3 Taking a test 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. When 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 test 1. Insert a test strip to turn the meter on 45 3 Taking a test 2. Wait for the flashing blood drop

) to appear on the display icon (

3. Press and hold control solution icon (

on the display or until the

) appears Preparing the control solution 1. Before removing the cap, shake the vial gently 2. 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 46 3 Taking a test 4. 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 Applying the control solution 1. Hold the meter so that the side edge of the test strip is at a slight angle to the drop of control solution 47 3 Taking a test 2. Touch the channel on the side of the test strip to the control solution 3. Wait for the channel to fill completely Viewing your control solution result After the control solution is applied, the meter will count down until the test is complete. Your result is displayed along with the date, time,

(for control unit of measure, and solution) and stored in the meter. Control solution results can be seen when reviewing past results on the meter. CAUTION: Make sure you press and hold or until the control solution icon 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 page45. appears before you begin a 48 3 Taking a test Checking if the result is in range Each vial of test strips has both OneTouchVerio Level3 Control Solution and OneTouchVerio Level 4 Control Solution ranges printed on its label. Compare the result displayed on the meter to either the OneTouchVerio Level 3 Control Solution or OneTouchVerio Level4 Control Solution range printed on the test strip vial, depending on the type of control solution you used. CAUTION:

Example range OneTouchVerio Level 3 Control Solution Control Range 102-138mg/dL OneTouchVerio Level 4 Control Solution Control Range 298-403mg/dL The range printed on the test strip vial is for control solution tests only and is not a recommended range for your blood glucose level. 49 3 Taking a test Causes of out-of-range results Out-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. Contact us at 1888567-3003. Cleaning the control solution cap Clean the top of the control solution cap with a clean, damp tissue or cloth. 50 3 4 Reviewing past results 4 Reviewing past results on your meter Your 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 off, press and hold History Mode on to turn The (

) symbol indicates you are viewing your past results.

) symbol indicates if the result was below, above The (

or within range at the time of the test, by pointing to the appropriate color bar. 2. Scroll through your results by pressing to move backwards and to move forward through your results Using the meter without syncing to an app The 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. 51 Reviewing past results Sending your results to the app If the BLUETOOTH feature on the meter is turned on, indicated by the BLUETOOTH symbol (

automatically send the latest result to any paired compatible wireless device. The compatible wireless device must have the app running and have already been paired to the meter before sending a result.

), the meter will NOTE: The compatible wireless device must have the app open and have already been paired to the meter before sending a result. See page21. NOTE: If the BLUETOOTH 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 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. 52 4 Reviewing past results The BLUETOOTH feature on both devices is running

(indicated by other.

) and the devices are within 26feet of each 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 symbol (

the meter screen.

) remaining on Example If you are still unable to send results to the compatible wireless device, please call Customer Service. Contact us at 1888567-3003. NOTE: Inserting a test strip during the transmission will cancel the transfer of all results. The screen and you can proceed with testing. symbol appears on the Downloading results to a computer Your 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

(7days a week, 8:00 AM - 8:00 PM Eastern Time) at 1888567-3003 (English), 1888567-3010 (Espaol), or www.OneTouch.com. 53 4 Reviewing past results 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 OneTouchVerio 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

communication mode.

) indicating that the meter is in 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 us at 1888567-3003. 54 4 5 Editing Your Settings 5 Editing time and date You can adjust the meter's time and date settings after first time setup. Press and hold press and hold will appear, and the hour will flash. to turn the meter on, then at the same time. The SET screen and For instructions on adjusting the time and date, see page17. 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 OneTouchReveal 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. 55 Editing Your Settings Editing your range limits Your 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 70mg/dL and the pre-set high range limit is 180mg/dL. To edit the pre-set range limits press and hold with the current low range limit displayed, and the number and range indicator arrow will flash. at the same time. The SET screen will appear and 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. 56 5 Editing Your Settings 1. Review the pre-set low range limit displayed To accept the pre-set low range

. To edit the pre-set low range limit, press or limit, press the value between 60mg/dL-

110mg/dL, and then press to change

. 2. Review the pre-set high range limit displayed To accept the pre-set high range

. To edit the pre-set high range limit, press or limit, press the value between 90mg/dL-

300mg/dL, and then press to change

. Your meter will exit settings mode and your last result screen will appear. 57 5 Editing Your Settings NOTE: 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 OneTouchReveal 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. 58 5 6 Caring for your system 6 Storing your system Once opened, store your meter, test strips, control solution and other items in your carrying case. Keep in a cool, dry place between 41F and 86F and below 65% relative humidity. Keep all items away from direct sunlight and heat. Cleaning and disinfection Cleaning 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. For cleaning information, see page60 and for disinfecting information, see page61. 59 Caring for your system 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 OneTouchVerio Flex System and can be obtained from retail websites offering disinfection products, e.g., www.officedepot.com or www.staples.com. For more information on purchase options contact Customer Service. Contact us at 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. Cleaning your meter, lancing device and cap The 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. 60 6 Caring for your system 1. Use a Clorox Germicidal Wipe to wipe the outside of the meter and lancing device To 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. 2. Wipe dry with a clean, sterile gauze Disinfecting your meter, lancing device and cap The 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 disinfecting Follow step 1 of page60. 61 6 Caring for your system 2. Use a new Clorox Germicidal Wipe to wipe the outside of the meter, lancing device and cap until the surface is damp Be 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 1minute. 3. Wipe dry with a clean, sterile gauze Wash 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. 62 6 Caring for your system The OneTouchVerio Flex System withstood cleaning and disinfection cycles well in excess of LifeScan's recommendation. See page63 for more details. Examples 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, 8:00 AM - 8:00PM Eastern Time) at 1888567-3003 (English), 1888567-3010

(Espaol), or www.OneTouch.com. Cleaning and Disinfecting Cycles The meter, lancing device and cap can be cleaned daily for 3years 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. 63 6 7 Battery Replacing the battery Your OneTouchVerio Flex Meter uses one CR2032 lithium coin cell battery. WARNING: CHEMICAL BURN HAZARD. DO NOT INGEST BATTERY. This product contains a coin/button cell battery. If swallowed, it can quickly cause severe internal burns and can lead to death. Keep new and used batteries away from children. If you think batteries might have been swallowed, seek immediate medical attention. 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. 64 Battery 1. Remove the old battery Start with the meter turned off. Remove the battery cover by pressing and sliding it downward. 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. 65 7 Battery 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 us at 1888567-3003. 3. Replace battery cover by sliding it upwards onto the meter 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. 5. Dispose of battery Dispose of the battery according to your local environmental regulations. 66 7 8 Troubleshooting your system 8 Error and other messages The OneTouchVerio Flex Meter displays messages when there are problems with the test strip, with the meter or when your glucose levels are above 600mg/dL or below 20mg/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. Contact us at 1888567-3003. What it means You may have a very low blood glucose level (severe hypoglycemia), below 20mg/dL. NOTE: When your glucose result is below 20mg/dL, both the LO and the Range Indicator Arrow will flash on the meter screen. What to do This 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. 67 Troubleshooting your system What it means You may have a very high blood glucose level (severe hyperglycemia), over 600mg/dL. NOTE: When your glucose result is above 600mg/dL, both the HI and the Range Indicator Arrow will flash on the meter screen. What to do Re-test your blood glucose level. If the result is HI again, obtain and follow instructions from your healthcare professional right away. What it means Meter is too hot (above 104F) to perform a test. What to do Move 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 (50-104F). If you do not get another HI .t message, you can proceed with testing. If this message continues to appear, contact Customer Service. Contact us at 1888567-3003. 68 8 Troubleshooting your system What it means Meter is too cold (below 50F) to perform a test. What to do Move 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 (50-104F). If you do not get another LO.t message, you can proceed with testing. If this message continues to appear, contact Customer Service. Contact us at 1888567-3003. Error Screens If there is a problem with your meter, the following error screens 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 us at 1888567-3003. They will refer to the error number and code to help troubleshoot the problem. Example Error Screen Code 69 8 Troubleshooting your system What it means There is a problem with the meter. What to do Do Not use the meter. Contact Customer Service. Contact us at 1888567-3003. What it means Error message could be caused either by a used test strip or a problem with the meter or test strip. What to do Repeat the test with a new test strip; see page35 or page47. If this message continues to appear, contact Customer Service. Contact us at 1888567-3003. 70 8 Troubleshooting your system What it means The sample was applied before the meter was ready. What to do Repeat the test with a new test strip. Apply a blood or control symbol appears solution sample only after the flashing on the display. If this message continues to appear, contact Customer Service. Contact us at 1888567-3003. What it means One 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 do Repeat the test with a new test strip; see page35 or page47. If the error message appears again, contact Customer Service. Contact us at 1888567-3003. 71 8 Troubleshooting your system What it means The meter has detected a problem with the test strip. Possible cause is test strip damage. What to do Repeat the test with a new test strip; see page35 or page47. If the error message appears again, contact Customer Service. Contact us at 1888567-3003. What it means Meter battery power is low but there is still enough battery power to perform a test. The flashing low

) icon will continue to battery (

appear until the battery is replaced. What to do Replace the meter battery soon. 72 8 Troubleshooting your system What it means There is not enough battery power to perform a test. What to do Replace the battery immediately. What it means No 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 do Contact 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 us at 1888567-3003. 73 8 9 Detailed information about your system Comparing meter results to laboratory results Results obtained from the OneTouchVerio 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 OneTouchVerio Flex Meter is considered accurate when it is within 15mg/dL of a laboratory method when the glucose concentration is lower than 75mg/dL and within 15% of a laboratory method when the glucose concentration is 75mg/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 70mg/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 OneTouchVerio 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. 74 Detailed information about your system Guidelines for obtaining an accurate meter to lab comparison Before 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. Testing with your OneTouchVerio 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. Comparing your meter results to those taken from another meter 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. 75 9 Detailed information about your system Technical specifications Assay method FAD-GDH (flavin adenine dinucleotide dependent glucose dehydrogenase) Automatic shutoff Two minutes after last action Battery ratings Battery type BLUETOOTH Technology Calibration Data port type Memory Operating ranges 3.0 V d.c. (CR2032 lithium coin cell battery), One replaceable 3.0 Volt CR2032 lithium coin cell battery

(or equivalent) Frequency band: 2.4-2.4835 GHz Maximum power: 0.4 mW Operating Range Distance: minimum 26.25feet (unobstructed) Operating Channels: 40 Channels Security Encryption: 128-bit AES

(Advanced Encryption Standard) Plasma-equivalent Compatible with USB 2.0 500 test results Temperature: 50-104F Relative humidity: non-condensing 10-90%

Altitude: up to 10,000feet Hematocrit: 20-60%

76 9 Detailed information about your system Reported result range 20-600mg/dL Sample Fresh capillary whole blood Sample volume 0.4L Size Test time Unit of measure Weight 2.05(W) x 3.38(L) x 0.63(T) inches 5 seconds mg/dL Approximately 1.76ounces Lay User Accuracy User Accuracy of the system was assessed at 3 clinical sites. 172 patients tested their blood using the OneTouchVerio Flex System where results were compared to the YSI 2300 Glucose Analyzer laboratory Instrument. Fingertip Results for Glucose Concentrations <75mg/dL Percent (and number) of meter results that match the laboratory test Within 5mg/dL Within 10mg/dL Within 15mg/dL 76.2% (16/21) 95.2% (20/21) 95.2% (20/21) 77 9 Detailed information about your system Fingertip Results for Glucose Concentrations 75mg/dL Percent (and number) of meter results that match the laboratory test Within 5% Within 10% Within 15% Within 20%

58.3%

(88/151) 88.7%

(134/151) 98.0%

(148/151) 99.3%

(150/151) Regression Statistics Samples were tested on each of three test strip lots. Results indicate that the OneTouchVerio Flex System compares well with a laboratory method.

# of Subjects

# of Tests Slope 172 172 0.99 95% CI Slope 95% CI Intercept

(mg/dL) Std. Error

(Sy.x)

(mg/dL) Intercept

(mg/dL) 2.98 R2 0.97 to 1.01

-1.59 to 7.55 14.0 0.98 78 9 Detailed information about your system Precision Within Run Precision (300 Venous Blood Samples Tested per Glucose Level) Data generated using the OneTouchVerio Flex Meter. Target Glucose

(mg/dL) Mean Glucose

(mg/dL) Standard Deviation

(mg/dL) Coefficient of Variation

(%) 40 90 130 200 350 36.5 88.5 127.9 199.3 344.6 0.83 1.72 2.50 3.94 6.18 2.26 1.95 1.95 1.98 1.79 Results show that the greatest variability observed between test strips when tested with blood is 0.83mg/dL SD or less at glucose levels less than 75mg/dL or 1.98% CV or less at glucose levels at 75mg/dL or above. 79 9 Detailed information about your system Total Precision (600 Control Solution Tests per Glucose Level) Data generated using the OneTouchVerio Flex Meter. Glucose Level Ranges

(mg/dL) Level 2

(25-49) Level 3

(102-138) Level 4

(298-403) Mean Glucose

(mg/dL) 37.14 117.68 348.99 Standard Deviation

(mg/dL) Coefficient of Variation

(%) 0.92 2.41 8.31 2.48 2.05 2.38 80 9 Detailed information about your system Guarantee LifeScan guarantees that the OneTouchVerio 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 standards This 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 IEC61326-1 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. 81 9 10 Index AST Batteries Batteries, replacing Battery empty icon Battery empty warning Battery low icon BLUETOOTH feature Buttons on meter Cleaning your meter, lancing device and cap Comparing meter results to laboratory results Compatible wireless devices Control solution Control solution, discard and expiration dates Control solution, testing Data port Date setting Dehydration Disinfecting your meter, lancing device and cap Display check Disposal, lancets and test strips Downloading results to a computer Edit date Edit range limits Edit time Error messages EXTREME HIGH GLUCOSE message 30 64 64 3 73 3, 72 6, 8, 20, 52 12 60 74 2 45 44, 45 44, 48, 50 12 18, 19 39, 74 61 16 43 53 55 56 55 67 40, 68 82 EXTREME LOW GLUCOSE message Fingertip testing procedure First time setup Guarantee Hyperglycemia Hypoglycemia Icons Infection, reduce the chance Intended use Kit components Lancet Lancet, expiration date Lancing device Limitations mg/dL Pairing PIN Plasma calibration Range Indicator feature Range limits setting Results, reviewing past Serial number Settings Software, diabetes management Start-up screen Storing your system 83 39, 67 26 17, 21 81 40, 68 39, 67 3 30 5 10 29, 31 30 10, 29, 31 5 12, 77 21, 22 23 74, 76 14 56 51 22 17, 19, 55 53 16 59 Index10 Index Symbols Syncing Technical specifications Temperature Test principle Test strip Test strip, applying drop of blood Test strip, discard and expiration dates Test strip, silver prongs Time setting Turning meter off Turning meter on Unexpected results Unit of measure Unusual red blood cell count (hematocrit) 3 24, 52 76 26, 27, 50, 59, 68, 69, 76 5 13, 34, 45 35 27 13 17, 19 25 16, 34, 45 39, 41 12, 77 74, 76 84 10 C3 C4 As your partner in diabetes care, we welcome you to contact us (7 days a week, 8:00 AM - 8:00 PM Eastern Time) at 1888567-3003 (English), 1888567-3010 (Espaol), or www.OneTouch.com. MeterMade in China Manufactured by:

LifeScan Europe GmbH Gubelstrasse 34 6300 Zug Switzerland Patent https://www.onetouch.com/patents AW 06932406A 2018-2020 LifeScan IP Holdings, LLC. Rev. Date: 09/2020 AW 06932406A

OneTouch Ultra Plus Flex Edit date/time Editar fecha/hora FCC ID: 2ACT5-Z02 AW 07294802A Edit range Editar rango On/off Encendido/apagado SN: XXXXXXXX OneTouch Ultra Plus Flex Edit date/time Editar fecha/hora FCC ID: 2ACT5-Z02 PF 050481 Rev 01 Edit range Editar rango On/off Encendido/apagado Description: Lbl Meter UPF USenes Art Agency: Acolad Job No.: 73971 File Name: FILE-PF-050481 MC Rev.: 01 Agency Contact: Arun Sathya Kumar CPS Reference No.: For CPS number refer to the DMS object under Links & Attachments JDE Item No.: N/A Rev. Date: 05-Dec-22 ADS No./Rev.: DEV-REC-0000561 Rev 07 ADS ID: ML-01ag Dieline No./Rev.: FILE-PF-043485 Rev 02 No. of Covers:

Language Sequence: English, Spanish Inside No. of pages:

No. of sides: 1 2 N/A N/A Spot Colors Process Colors Uncoated Area Special Instructions Dieline PMS N/A N/A N/A 533 C M Y K Black Uncoated Area N/A N/A Dieline

= CUT

= SCORE

= PERF

OneTouch Verio Flex

+ | Et dateltime + Edar a fecha/hore 8 8 paso apomedo _AW069521054 NHN SN: XXXXXXXX Blood lucas Meter editor deguco ena sange 15887305 |Eih +1 888567300 stl) Invi dognostc For sel-esting +s dando inva Paatadogrsic, lesan ope ode incinas 800g, Seietared Fade enchna CCID 2ACTS.202 Re Ose

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(2018 2022 can PHotings LIC AN O6205H

PHOENIX TESTLAB GmbH Product Certification Department Koenigswinkel 10 32825 Blomberg Germany Date: 07/02/2023 Attestation FCC Justification Statement about Antenna Gain Information This device complies with the FCC limits for fundamental and spurious emissions solely by radiated measurements as documented in the test report. Therefore, neither antenna manufacturers data sheets, antenna reference design specification nor Antenna Under Test (AUT) reports as required for the FCC certification under CFR 47 Part 15. FCC ID: 2ACT5-Z02 FCC Rule Part Section: 15-247 If you have any questions, please feel free to contact me Contact Person:

Position in the Company: VP Regulatory Affairs Date of Signature:

7th February 2023 Oyinkan Donaldson ___________________________ Signatory

(signature of the applicant)

PHOENIX TESTLAB GmbH Product Certification Department Koenigswinkel 10 32825 Blomberg Germany Date: 2023-02-07 Attestation Section 2.911(d)(5)(ii)

(KDB 986446 D01 Covered Equipment) LifeScan Europe GmbH (the applicant) certifies that the equipment for which authorization is sought is not covered equipment prohibited from receiving an equipment authorization pursuant to section 2.903 of the FCC rules. LifeScan Europe GmbH (the applicant) certifies that, as of the date of the filing of the application, the applicant [is / is not] identified on the Covered List as an entity producing covered equipment. Type of Equipment subject to FCC Certification:

FCC ID: 2ACT5-Z02 If you have any questions, please feel free to contact me Contact Person:

Position in the Company: VP Regulatory Affairs Date of Signature:

7th February 2023 Oyinkan Donaldson ___________________________ Signatory

(signature of the applicant)

CSA Internal | 3rd Party Request for Confidentiality Date: 09 Aug 2022 Subject: Confidentiality Request for FCC ID: 2ACT5-Z02 and IC: 12202A-Z02 Pursuant to FCC 47 CRF 0.457(d) and 0.459 and IC RSP-100, Section 12.4, the applicant requests that a part of the subject FCC application be held confidential. Type of Confidentiality Requested Short Term Short Term Short Term Short Term Short Term Short Term Short Term Short Term Short Term Permanent Permanent*1 Permanent Permanent Permanent Permanent Permanent*3 Exhibit Block Diagrams External Photos Internal Photos Operation Description/Theory of Operation Parts List & Placement/BOM Tune-Up Procedure Schematics Test Setup Photos Users Manual LifeScan Europe GmbH has spent substantial effort in developing this product and it is one of the first of its kind in industry. Having the subject information easily available to "competition" would negate the advantage they have achieved by developing this product. Not protecting the details of the design will result in financial hardship. Permanent Confidentiality:

The applicant requests the exhibits listed above as permanently confidential be permanently withheld from public review due to materials that contain trade secrets and proprietary information not customarily released to the public. Short-Term Confidentiality:

The applicant requests the exhibits selected above as short term confidential be withheld from public view for a period of ___(specify number of days not to exceed 180) ___ days from the date of the Grant of Equipment Authorization and prior to marketing. This is to avoid premature release of sensitive information prior to marketing or release of the product to the public. Applicant is also aware that they are responsible to notify Phoenix Testlab GmbH in the event information regarding the product or the product is made available to the public. Phoenix Testlab GmbH will then release the documents listed above for public disclosure pursuant to FCC Public Notice DA 04-1705. NOTE for Industry Canada Applications:

IC currently only distinguishes Permanent Confidentiality exhibits as shown above. Short Term confidentiality is not considered applicable to IC applications. Sincerely, By:

(Signature/Title2) Oyinkan Donaldson

(Print name) 1 - The asterisked items (*) require further information to be provided to the TCB before permanent confidentiality will be extended to these exhibits. Please refer to FCC KDB 726920 and the specific Document link for D01 found at:

https://apps.fcc.gov/oetcf/kdb/forms/FTSSearchResultPage.cfm?switch=P&id=41731 and review section II, 3) regarding specific information that must accompany these requests. 2 - Must be signed by applicant contact given for applicant on the FCC site, or by the authorized agent if an appropriate authorized agent letter has been provided. Letters should be placed on appropriate letterhead.

Declaration of Product Identity To whom it may concern:

We, LifeScan Europe GmbH, Gubelstrasse 34 6300 Zug, Switzerland Declare that our products:

Product name: Blood glucose meter with BLE 5.0 Model number: OneTouch Ultra Plus Flex And Product name: Blood glucose meter with BLE 5.0 Model number: OneTouch Verio Flex have the same technical construction including software design, RF module, circuit design and PCB layout. The mentioned difference(s) between the models will not affect its electromagnetic emissions, radio-frequency output signal characteristics and output power level. The differences between the models are the colour of the plastic housing (white for Verio Flex and blue for Ultra Plus Flex), keypad colour to match the plastic housings and the strip port connector contact positions. The Ultra Plus Flex will be the model on sale in Hong Kong. Yours Faithfully, Name: Oyinkan Donaldson Title: VP Regulatory Affairs Tel: +44 1463 382322 Email address: odonalds@lifescan.com Date of Issue: 21 Dec 2022

Authority to Act as Agent Date: 09 Aug 2022 Phoenix Test Lab GmbH CSA Group Bayern GmbH, Ms. Christa Jaeger and Ms. Marie Schuster are authorized to act on our behalf, until otherwise notified, for applications to Phoenix Test Lab GmbH. We certify that we are not subject to denial of federal benefits, that includes FCC benefits, pursuant to Section 5301 of the Anti-Drug Abuse Act of 1988, 21 U.S.C. 862. Further, no party, as defined in 47 CFR 1.2002 (b), to the application is subject to denial of federal benefits, that includes FCC benefits. We also declare that the information provided to the FCC is true and correct to the best of our knowledge (47 CFR 2.911(d)) and we have been informed of the grantee responsibilities (47 CFR 2.909) with regard to certified equipment. Thank you, This authorization is valid until further written notice from LifeScan Europe GmbH By:

(Signature1) Printed Name: Oyinkan Donaldson Title:

VP Regulatory Affairs On behalf of: LifeScan Europe GmbH Address: LifeScan Scotland Ltd, Beechwood Park North, Inverness, IV2 3ED, UK Telephone No: +44 1463 382322 Email: odonalds@lifescan.com 1 - Must be signed by applicant contact given for applicant on the FCC site, or by the authorized agent if an appropriate authorized agent letter has been provided. Letters should be placed on appropriate letterhead.

CSA Group Confidential - Internal Date: 2023-02-07 PHOENIX TESTLAB GmbH Product Certification Department Koenigswinkel 10 32825 Blomberg Germany Attestation Certification designating a U.S. Agent for Service of Process Section 2.911(d)(7)

(KDB 986446 D01 Covered Equipment) LifeScan Europe GmbH (the applicant) as required by section 2.911(d)(7), designate below contact located in the United States for purposes of acting as the applicants agent for service of process. The applicant also acceptance to maintain an agent for no less than one year after the grantee has terminated all marketing and importation or the conclusion of any Commission-related proceeding involving the equipment. Type of Equipment subject to FCC Certification:

FCC ID: 2ACT5-Z02 Sincerely yours, Applicant/Grantee _________________

(Signature) US Agent Electronically Signed 2023-02-07 21:07:09 UTC - 173.49.11.98 Nintex AssureSign Michele Fusello ___________________

(Signature) d71c64c5-5453-4777-8041-afa2015bee6a LifeScan Europe GmbH LifeScan Global Corporation Oyinkan Donaldson Michele Fusello VP Regulatory Affairs Americas Product Quality Manager odonalds@lifescan.com mfusello@lifescan.com 20 Valley Stream Parkway Malvern, PA 19355