OneTouch VerioFlex Owner's Booklet
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OneTouch VerioFlex Owner's Booklet

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Blood Glucose Monitoring System
Owner's
Booklet
Instructions
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Do you have a question about the VerioFlex and is the answer not in the manual?

Questions and answers

Mary Ellen Pacific
January 19, 2025

Where is the charger for this device?

-1
1 comments:
Mr. Anderson
February 4, 2025

You can find a charger for the OneTouch Verio Flex at the following sources:

1. Diabetic Corner - They offer an aftermarket USB cable for the OneTouch Verio Flex meter at a lower price.
2. GoSupps - They sell a replacement USB charger for the OneTouch Verio Flex, priced at US$24.99 with international shipping available.

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Summary of Contents for OneTouch VerioFlex

  • Page 1 Blood Glucose Monitoring System Owner's Booklet Instructions for Use...
  • Page 3 Verio Flex Blood Glucose Monitoring System Owner's Booklet...
  • Page 4 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.
  • Page 5 Compatible Wireless Devices Visit www.OneTouch.com for information on which wireless devices are compatible with your OneTouch  Verio Flex™ Meter, and where/how to download the OneTouch Reveal® Mobile App on your compatible wireless device. Meter symbols and icons Meter Power Low Battery...

  • Page 6: Before You Begin

    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 OneTouch Verio® Test Strips, OneTouch Verio® Control Solution and the OneTouch® Delica® Lancing Device.
  • Page 7 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.

  • Page 8: Intended Use

    Intended use The 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 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.

  • Page 9: Test Principle

    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. Visit www.OneTouch.com for information on which wireless devices are compatible with your OneTouch Verio Flex™...
  • Page 10 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.
  • Page 11 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...
  • Page 12 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. These guidelines help ensure that your meter will not affect the operation of other nearby electronic devices.
  • Page 13 WARNING: In locations where cell phone use is not permitted, such as hospitals, some healthcare professional offices and airplanes, you should turn the BLUETOOTH® Smart feature off. See page 29 for more information. BLUETOOTH® Smart trademark The BLUETOOTH® word mark and logos are owned by the Bluetooth SIG, Inc.

  • Page 14: Table Of Contents

    Table of Contents  1 Getting to know your system ........14  2 Setting up your system ..........24 Setting up your meter ............. 24 Connecting to a compatible wireless device ....29 Turning the meter off ............35  3 Taking a test .............. 36 Testing your blood glucose ..........36 Testing with control solution..........60  4 Reviewing past results ..........70...
  • Page 15  5 Editing Your Settings ..........76 Editing time and date ............. 76 Editing 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 ................. 112...

  • Page 16: Getting To Know Your System

     1 Getting to know your system Your OneTouch Verio Flex™ Blood Glucose Monitoring System Included with your kit: OneTouch Verio Flex™ Meter (CR2032 lithium coin cell battery included) Lancing device Lancets...
  • Page 17 (available 7 days a week, 8 a.m. - 10 p.m. Eastern Time) at 1 888 567-3003 (English), 1 888 567-3010 (Spanish), or www.OneTouch.com. NOTE: If another type of lancing device was included, see the separate instructions for that lancing device.
  • Page 18 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® OneTouch Verio Level 3 Control Level 4 Control Solution* Solution* (vial with blue cap) (vial with red cap) OneTouch Verio®...
  • Page 19 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.
  • Page 20 Getting to know your system Getting to know your OneTouch Verio Flex™ Blood Glucose Monitoring System Meter...
  • Page 21 Getting to know your system...
  • Page 22 Getting to know your system Getting to know your OneTouch Verio® Test Strip Test strip...
  • Page 23 Getting to know your system The Range Indicator feature The 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.
  • Page 24 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 Things you should know before Below Range Result using the Range Indicator feature: • The meter comes with pre-set...
  • Page 25 Getting to know your system This page left blank intentionally.

  • Page 26: Setting Up Your System

     2 Setting up your system Setting up your meter Turn your meter on To 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.

  • Page 27: Setting The Time

    Setting up your system First time setup To 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.

  • Page 28: Setting The Date

    Setting up your system AM/PM will flash • If the AM/PM displayed is correct, press confirm. • If the AM/PM displayed is not 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.
  • Page 29 Setting up your system Month will flash • If the month displayed is correct, press confirm. • If the month displayed is not correct, press to change the month and press to confirm. Day will flash • If the day displayed is correct, press confirm.
  • Page 30 Setting up your system 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.

  • Page 31: Connecting To A Compatible Wireless Device

    Setting up your system Connecting to a compatible wireless device Turning the BLUETOOTH® Smart feature on or off 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®...
  • Page 32 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...
  • Page 33 2. The BLUETOOTH® Smart feature is turned on by pressing together 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 device...
  • Page 34 Setting up your system 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...
  • Page 35 Setting up your system 5. When prompted by the OneTouch Reveal® 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.
  • Page 36 After 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 device 2. Press and hold to turn the meter on and make sure the BLUETOOTH®...

  • Page 37: Turning The Meter Off

    Setting up your system 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.

  • Page 38: Taking A Test

    NOTE: • 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.
  • Page 39 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.
  • Page 40 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 OneTouch Verio® Family of Meters when PAM (Pralidoxime) is known or suspected to be in the whole blood sample.
  • Page 41 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.
  • Page 42 Taking a test Getting to know your OneTouch® Delica® Lancing Device...
  • Page 43 Taking a test NOTE: • 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).
  • Page 44 Taking a test 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. • The lancing device is intended for a single user. Never share a lancet or lancing device with anyone.

  • Page 45: Preparing The Lancing Device

    Taking a test Preparing the lancing device 1. Remove the lancing device cap Remove the cap by turning it counterclockwise and then pulling it straight off of the device.
  • Page 46 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.
  • Page 47 Taking a test 3. Replace the lancing device cap Place the cap back onto the device; turn clockwise to secure the cap. Do Not overtighten.
  • Page 48 Taking a test 4. 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.
  • Page 49 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.
  • Page 50 Taking a test Getting a blood sample 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 thoroughly with warm, soapy water. Rinse and dry completely. 1.
  • Page 51 Taking a test 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.
  • Page 52 Taking a test 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. Apply your sample to the opening of the channel. Be sure to apply your sample immediately after you get a drop of blood.
  • Page 53 Taking a test When it touches your sample, the test strip wicks blood into the channel. 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 5 to 1.
  • Page 54 Taking a test 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.
  • Page 55 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, Example the meter will also display a Range Below Range Result Indicator Arrow below your glucose result to indicate if your result is below, above or within your range...
  • Page 56 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 70 mg/dL or is shown as LO (meaning the result is less than 20 mg/dL), it may mean hypoglycemia (low blood glucose).
  • Page 57 Taking a test 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.
  • Page 58 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.
  • Page 59 Taking a test 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 turning it counterclockwise and then pulling it straight off of the device.
  • Page 60 Taking a test 3. 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.
  • Page 61 Taking a test 4. 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.

  • Page 62: Testing With Control Solution

    (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.
  • Page 63 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.
  • Page 64 Taking a test 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.
  • Page 65 Taking a test 2. Wait for the flashing blood drop icon ( ) to appear on the display 3. Press until the control solution icon ( appears on the display Preparing the control solution 1. Before removing the cap, shake the vial gently 2.
  • Page 66 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...

  • Page 67: Applying The Control Solution

    Taking a test 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 2. Touch the channel on the side of the test strip to the control solution 3.
  • Page 68 Taking a test 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, 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.
  • Page 69 Taking a test Checking if the result is in range Each 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...
  • Page 70 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.
  • Page 71 Taking a test Cleaning the control solution cap Clean the top of the control solution cap with a clean, damp tissue or cloth.

  • Page 72: Reviewing Past Results

     4 Reviewing past results 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.
  • Page 73 Reviewing past 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. Sending your results to the app If the BLUETOOTH®...
  • Page 74 Reviewing past results To 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.
  • Page 75 Reviewing past results If you are still unable to send results to the compatible wireless device, please call Customer Service. Contact us at 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.

  • Page 76: Downloading Results To A Computer

    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).
  • Page 77 Reviewing past results 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.

  • Page 78: Editing Your Settings

    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.

  • Page 79: Editing Your Range Limits

    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 70 mg/dL and the pre-set high range limit is 180 mg/dL.
  • Page 80 Editing Your Settings 1. 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 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...
  • Page 81 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...

  • Page 82: Caring For Your System

     6 Caring for your system 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 41°F and 86°F and below 65% relative humidity. Keep all items away from direct sunlight and heat.
  • 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 or www.staples.com. For more information on purchase options, visit www.onetouch.com/disinfection, or contact Customer...
  • Page 84 Caring for your system 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. 1. Use a Clorox® Germicidal Wipe to wipe the outside of the meter and lancing device To clean your meter, hold...
  • Page 85 Caring for your system 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 page 82.
  • Page 86 • 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.
  • Page 87 (available 7 days a week, 8 a.m. - 10 p.m. Eastern Time) at 1 888 567-3003 (English), 1 888 567-3010 (Spanish), or www.OneTouch.com. Cleaning and Disinfecting Cycles The meter, lancing device and cap can be cleaned daily for 3 years and have been tested up to 2879 cleaning cycles.

  • Page 88: Battery

     7 Battery Replacing the battery Your 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.
  • Page 89 Battery 1. Remove the old battery Start with the meter turned off. Remove the battery cover by 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.
  • Page 90 Battery 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.
  • Page 91 Battery 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.

  • Page 92: Troubleshooting Your System

     8 Troubleshooting your system Error and other messages The 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.
  • Page 93 Troubleshooting your system What it means You 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 do Re-test your blood glucose level.
  • Page 94 Troubleshooting your system What it means Meter is too hot (above 104°F) 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 (50-104°F).
  • Page 95 Troubleshooting your system What it means Meter is too cold (below 50°F) 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 (50-104°F).
  • Page 96 Troubleshooting your system Error Screens If 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.
  • Page 97 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 1 888 567-3003. What it means Error message could be caused either by a used test strip or a problem with the meter or test strip.
  • Page 98 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 solution sample only after the flashing symbol appears on the display. If this message continues to appear, contact Customer Service.
  • Page 99 Troubleshooting your system 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.
  • Page 100 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 page 50 or page 65. If the error message appears again, contact Customer Service.
  • Page 101 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.

  • Page 102: Detailed Information About Your System

    Comparing meter results to laboratory results Results 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™...
  • Page 103 • Your hematocrit is above 60% or below 20%. • You are severely dehydrated. For additional information, refer to the OneTouch Verio® Test Strip Insert. Sacks, D.B.: "Carbohydrates." Burtis, C.A., and Ashwood E.R. (ed.), Tietz Textbook of Clinical Chemistry,...
  • Page 104 • Take your meter and testing supplies with you to the lab. 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.
  • Page 105 Detailed information about your system 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.

  • Page 106: Technical Specifications

    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 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®...
  • Page 107 Detailed information about your system Memory 500 test results Operating ranges Temperature: 50-104°F Relative humidity: non-condensing 10-90% Altitude: up to 10,000 feet Hematocrit: 20-60% Reported result range 20-600 mg/dL Sample Fresh capillary whole blood Sample volume 0.4 µL Size 2.05(W) x 3.38(L) x 0.63(T)  inches Test time 5 seconds Unit of measure...
  • Page 108 Detailed information about your system Lay User Accuracy User 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.
  • Page 109 Detailed information about your system Fingertip Results for Glucose Concentrations <75 mg/dL Percent (and number) of meter results that match the laboratory test Within ±5 mg/dL Within ±10 mg/dL Within ±15 mg/dL 76.2% (16/21) 95.2% (20/21) 95.2% (20/21) Fingertip Results for Glucose Concentrations ≥75 mg/dL Percent (and number) of meter results that match the laboratory test Within ±5%...
  • Page 110 Detailed information about your system Regression Statistics Samples 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) 0.99 2.98...
  • Page 111 Detailed information about your system Precision Within Run Precision (300 Venous Blood Samples Tested per Glucose Level) Data generated using the OneTouch Verio Flex™ Meter. Target Mean Standard Coefficient Glucose Glucose Deviation of Variation (mg/dL) (mg/dL) (mg/dL) 36.5 0.83 2.26 88.5 1.72...
  • Page 112 Detailed information about your system Total Precision (600 Control Solution Tests per Glucose Level) Data generated using the OneTouch Verio Flex™ Meter. Glucose Mean Standard Coefficient Level Ranges Glucose Deviation of Variation (mg/dL) (mg/dL) (mg/dL) Level 2 37.14 0.92 2.48 (25-49) Level 3 117.68...
  • Page 113 Detailed information about your system Guarantee LifeScan 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.

  • Page 114: Index

    10 Index Batteries Batteries, replacing Battery empty icon Battery empty warning Battery low icon 3, 98 BLUETOOTH® Smart feature 7, 11, 29, 71 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 60, 61...
  • Page 115 Index Error messages EXTREME HIGH GLUCOSE message 55, 91 EXTREME LOW GLUCOSE message 54, 90 Fingertip testing procedure First time setup 25, 30 Guarantee Hyperglycemia 55, 91 Hypoglycemia 54, 90 Icons 3, 4 Infection, reduce the chance Intended use Kit components Lancing device 14, 40, 43 Limitations...
  • Page 116 Index Start-up screen Storing your system Symbols 3, 4 Syncing 34, 71 Technical specifications Temperature 36, 68, 80, 92, 93, 105 Test principle Test strip 20, 47, 62 Test strip, applying drop of blood Test strip, discard and expiration dates Test strip, silver prongs Time setting 25, 28...
  • Page 117 Notes...
  • Page 118 Notes...
  • Page 120 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.

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