OneTouch Verio Flex Owner's Booklet
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OneTouch Verio Flex Owner's Booklet

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Summary of Contents for OneTouch Verio Flex

  • Page 1 Blood Glucose Monitoring System Owner's Booklet Instructions for Use...
  • Page 3 Blood Glucose Monitoring System Owner's Booklet...
  • Page 4 Meter results are sent to the compatible devices either through BLUETOOTH® SMART (wireless) or USB cable connection. Every OneTouch® Meter is designed to help you test your blood glucose and manage your diabetes. This Owner's Booklet offers a complete explanation of how to use your new meter and testing supplies.
  • Page 5 Compatible Wireless Devices Visit www.LifeScan.co.uk for information on which wireless devices are compatible with your OneTouch Verio Flex™ Meter, and where/how to download the software application on your compatible wireless device. Meter symbols and icons Meter Power Low Battery Battery Empty Control Solution Syncing BLUETOOTH®...
  • Page 6 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 Consult Instructions for Use Manufacturer Lot Number Serial Number Storage Temperature Limits In Vitro Diagnostic Device Do Not Re-use Sterilised by irradiation Not for general waste...

  • Page 7: Before You Begin

    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. IMPORTANT SAFETY INSTRUCTIONS: • This meter and lancing device are for single patient use only.

  • 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 system is intended to be used by a single patient and should not be shared.

  • Page 9: Test Principle

    The OneTouch Verio Flex™ Meter is designed to work with the OneTouch Reveal® Mobile App and many other diabetes applications on compatible wireless devices. NOTE: Some diabetes management apps, including the OneTouch Reveal®...
  • Page 10 Meter, and where/how to download the software application on your compatible wireless device. When using the OneTouch Verio Flex™ System, we suggest you pair your OneTouch Verio Flex™ Meter with a compatible wireless device and track your results. See page 29 for pairing instructions. Your meter is subject to and complies with applicable Worldwide Radio regulation guidelines.
  • Page 11 These guidelines help ensure that your meter will not affect the operation of other nearby electronic devices. Additionally, other electronic devices should not affect the use of your meter. WARNING: The BLUETOOTH® SMART feature on your meter sends test results to your compatible wireless device. To prevent other people's results from being sent to your compatible wireless device, Do Not let anyone else use your meter to test their blood glucose.

  • Page 12: Table Of Contents

    Table of Contents  1 Getting to know your system ........12  2 Setting up your system ..........22 Setting up your meter ............. 22 Connecting to a compatible wireless device ....27 Turning the meter off ............33  3 Taking a test ..............34 Testing your blood glucose ..........34 Testing with control solution..........

  • Page 13: Table Of Contents

     5 Editing Your Settings ..........74 Editing time and date ............. 74 Editing your range limits ..........75  6 Caring for your system ..........78  7 Battery ............... 82  8 Troubleshooting your system .........86  9 Detailed information about your system .....96 10 Index ................ 108...

  • Page 14: Getting To Know Your System

     1 Getting to know your system Your OneTouch Verio Flex™ Blood Glucose Monitoring System Included with your kit: Lancing device OneTouch Verio Flex™ Meter (CR2032 lithium coin cell battery included) OneTouch Verio® Lancets Test Strips*...
  • Page 15 Getting to know your system NOTE: If any item is missing or defective in your kit, contact OneTouch® Customer Care on 0800 121 200 (UK) or 1800 535 676 (Ireland) during the hours of 8:30am-6pm Monday-Friday, 9am-1pm Saturday. Or visit www.LifeScan.co.uk. NOTE: If another type of lancing device was included,...
  • Page 16 OneTouch Verio® Mid Control Test Strips* Solution* *OneTouch Verio® Control Solution and Test Strips are available separately. For availability of test strips and control solution, contact Customer Care or ask your pharmacist or healthcare professional. WARNING: Keep the meter and testing supplies away from young children.
  • Page 17 Getting to know your system This page left blank intentionally.
  • Page 18 Getting to know your system Getting to know your OneTouch Verio Flex™ Blood Glucose Monitoring System Meter...
  • Page 19 Getting to know your system...
  • Page 20 Getting to know your system Getting to know your OneTouch Verio® Test Strip Test strip...
  • Page 21 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 Colour Bar below the meter display.
  • Page 22 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 23 Getting to know your system This page left blank intentionally.

  • Page 24: Setting Up Your System

    If you see any missing segments within the start-up screen, there may be a problem with the meter. Contact OneTouch® Customer Care on 0800 121 200 (UK) or 1800 535 676 (Ireland). NOTE: If you turned the meter on for the first time by...

  • Page 25: 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 26: Setting The Date

    Setting up your system 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, press confirm. • If the year displayed is not correct, press change the year and press to confirm.
  • Page 27 Setting up your system Day will flash • If the day displayed is correct, press confirm. • If the day displayed is not correct, press change the day and press to confirm. You are now ready to take a test. See the section Testing your blood glucose in Chapter 3.
  • Page 28 Setting up your system 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 to turn the meter on, then press and hold at the same time. The SET screen will appear.

  • Page 29: 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 30 NOTE: Some diabetes management apps, including the OneTouch Reveal® Mobile App, may not be available in your country. Visit www.LifeScan.co.uk to learn if the OneTouch Reveal® Mobile App is available in your country.
  • Page 31 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 32 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 33 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 wireless compatible device using the keypad on your compatible wireless device. CAUTION: Make sure the PIN you enter on your compatible device matches the PIN on your meter display.
  • Page 34 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 35: 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 36: Taking A Test

    OneTouch Verio® Test Strips Lancing device Sterile lancets 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 (6-44°C).
  • Page 37 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 38 System should not be used for patients within 24 hours of receiving a D-xylose absorption test as it may cause inaccurately high results. • Do Not use the OneTouch Verio® Family of Meters when PAM (Pralidoxime) is known or suspected to be in the patient's whole blood sample.
  • Page 39 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 40 Taking a test Getting to know your OneTouch® Delica® Lancing Device...
  • Page 41 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 Alternative site testing (AST).
  • Page 42 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 43: 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 44 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.
  • Page 45 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 46 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 47 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 48 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 49 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 50 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 51 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 52 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 53 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 54 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 3.9 mmol/L or is shown as LO (meaning the result is less than 1.1 mmol/L), it may mean hypoglycaemia (low blood glucose).
  • Page 55 Taking a test CAUTION: High results • If your result is above 10.0 mmol/L, it may mean hyperglycaemia (high blood glucose) and you should consider re-testing. Talk to your healthcare professional if you are concerned about hyperglycaemia. • HI is displayed when your result is over 33.3 mmol/L.
  • Page 56 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 57 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 58 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, prime the device again and then slide the ejection control forward until the lancet comes out.
  • Page 59 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 60: Testing With Control Solution

    Testing with control solution Control solution testing precautions OneTouch Verio® Control Solution is used to check that the meter and test strips are working together properly and that the test is performing correctly. (Control solution is available separately.)
  • Page 61 Taking a test • Tightly close the cap on the control solution vial immediately after use to avoid contamination or damage. See page 34 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 62 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 63 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 64 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 65: 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 66 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 67 Taking a test Checking if the result is in range Compare the result displayed on the meter to the range printed on your OneTouch Verio® Control Solution vial. If your control solution result falls outside the expected Example range range, repeat the test OneTouch Verio®...
  • Page 68 If you continue to get control solution results that fall outside the range printed on the control solution vial, Do Not use the meter, test strips, or control solution. Contact OneTouch® Customer Care on 0800 121 200 (UK) or 1800 535 676 (Ireland).
  • Page 69 Taking a test Cleaning the control solution cap Clean the top of the control solution cap with a clean, damp tissue or cloth.

  • Page 70: 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 71 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 72 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 73 Reviewing past results If you are still unable to send results to the compatible wireless device, please contact OneTouch® Customer Care on 0800 121 200 (UK) or 1800 535 676 (Ireland). NOTE: Inserting a test strip during the transmission will cancel the transfer of all results. The symbol appears on the screen and you can proceed with testing.

  • Page 74: Downloading Results To A Computer

    To learn more about diabetes management tools available to you, contact OneTouch® Customer Care on 0800 121 200 (UK) or 1800 535 676 (Ireland) during the hours of 8:30am-6pm Monday-Friday, 9am-1pm Saturday.
  • Page 75 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 contact OneTouch® Customer Care on 0800 121 200 (UK) or 1800 535 676 (Ireland).

  • Page 76: 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 77: 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 3.9 mmol/L and the pre-set high range limit is 10.0 mmol/L.
  • Page 78 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 to change the value between 3.3 mmol/L-6.1 mmol/L, 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...
  • Page 79 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 80: Caring For Your System

     6 Caring for your system Storing your system Store your meter, test strips, control solution and other items in your carrying case. Keep in a cool, dry place between 5°C and 30°C. Do Not refrigerate. Keep all items away from direct sunlight and heat. Cleaning and disinfection Cleaning and disinfection are different and both should be performed.
  • Page 81 Caring for your system • 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. (See page 16.) • Do Not spray cleaning solution on the meter or immerse it in any liquid.
  • Page 82 Caring for your system 2. Wipe dry with a clean, soft cloth Disinfecting your meter, lancing device and cap The meter, lancing device and cap should be disinfected periodically. Clean your meter, lancing device and cap prior to disinfecting. For disinfecting, obtain regular household bleach (containing a minimum of 5.5% sodium hypochlorite as the active ingredient)*.
  • Page 83 1 minute Wash hands thoroughly with soap and water after handling the meter, lancing device and cap. If you see signs of wear, please contact OneTouch® Customer Care on 0800 121 200 (UK) or 1800 535 676 (Ireland).

  • Page 84: 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 85 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 OneTouch® Customer Care on 0800 121 200 (UK) or 1800 535 676 (Ireland).
  • Page 86 Battery 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.
  • Page 87 Battery This page left blank intentionally.

  • Page 88: Troubleshooting Your System

    1.1 mmol/L. Improper use may cause an inaccurate result without producing an error message. NOTE: If the meter is on but does not operate (locks-up), contact OneTouch® Customer Care on 0800 121 200 (UK) or 1800 535 676 (Ireland). What it means You may have a very...
  • Page 89 Troubleshooting your system What it means You may have a very high blood glucose level (severe hyperglycaemia), over 33.3 mmol/L. NOTE: When your glucose result is above 33.3 mmol/L, both the HI and the Range Indicator Arrow will flash on the meter screen. What to do Re-test your blood glucose level.
  • Page 90 (6-44°C). If you do not get another HI .t message, you can proceed with testing. If this message continues to appear, contact OneTouch® Customer Care on 0800 121 200 (UK) or 1800 535 676 (Ireland).
  • Page 91 (6-44°C). If you do not get another LO.t message, you can proceed with testing. If this message continues to appear, contact OneTouch® Customer Care on 0800 121 200 (UK) or 1800 535 676 (Ireland).
  • Page 92 If you cannot resolve the error with your meter, contact OneTouch® Customer Care on 0800 121 200 (UK) or 1800 535 676 (Ireland). They will refer to the error number and code to help troubleshoot the problem.
  • Page 93 What it means There is a problem with the meter. What to do Do Not use the meter. Contact OneTouch® Customer Care on 0800 121 200 (UK) or 1800 535 676 (Ireland). What it means Error message could be caused either by a used test strip or a problem with the meter or test strip.
  • Page 94 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 OneTouch® Customer Care on 0800 121 200 (UK) or 1800 535 676 (Ireland).
  • Page 95 • There may be a problem with the meter. What to do Repeat the test with a new test strip; see page 48 or page 63. If the error message appears again, contact OneTouch® Customer Care on 0800 121 200 (UK) or 1800 535 676 (Ireland).
  • Page 96 What to do Repeat the test with a new test strip; see page 48 or page 63. If the error message appears again, contact OneTouch® Customer Care on 0800 121 200 (UK) or 1800 535 676 (Ireland). What it means Meter battery power is low...
  • Page 97 Contact Customer Care to report this occurrence, unless this is your first use of the meter. You can still perform a blood glucose test or control solution test and get an accurate result. Contact OneTouch® Customer Care on 0800 121 200 (UK) or 1800 535 676 (Ireland).

  • Page 98: Detailed Information About Your System

    • Your haematocrit 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 99 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.
  • Page 100 Detailed information about your system Testing with your OneTouch Verio Flex™ Meter at the lab: • Test within 15 minutes of the lab test. • Use only a fresh, capillary blood sample from your fingertip. • Follow all instructions in this Owner's Booklet for performing a blood glucose test.

  • Page 101: 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 102 Detailed information about your system Operating ranges Temperature: 6-44°C Relative humidity: non-condensing 10-90% Altitude: up to 3048 metres Haematocrit: 20-60% Reported result range 1.1-33.3 mmol/L Sample Fresh capillary whole blood Sample volume 0.4 μL Size 52.0(W) x 86.0(L) x 16.0(T) mm Test time 5 seconds Unit of measure mmol/L Weight...
  • Page 103 5.55 mmol/L, and within 15% of a laboratory method when the glucose concentration is 5.55 mmol/L or higher. Samples from 100 patients were tested using both the OneTouch Verio Flex™ System and the YSI 2300 Glucose Analyser laboratory instrument. System Accuracy Results for Glucose Concentrations <5.55 mmol/L...
  • Page 104 Detailed information about your system System Accuracy Results for Glucose Concentrations ≥5.55 mmol/L Percent (and number) of meter results that match the laboratory test Within ±5% Within ±10% Within ±15% 62.9% (283/450) 94.7% (426/450) 99.3% (447/450) System Accuracy Results for Glucose Concentrations between 2.1 mmol/L and 25.9 mmol/L Within ±0.83 mmol/L or ±15%...
  • Page 105 Detailed information about your system Regression Statistics Samples were tested in duplicate 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 (mmol/L) 1.01...
  • Page 106 Detailed information about your system User Performance Accuracy A study evaluating glucose values from fingertip capillary blood samples obtained by 167 lay persons showed the following results: 93.1% within ±0.83 mmol/L of the medical laboratory values at glucose concentrations below 5.55 mmol/L, and 98.6% within ±15% of the medical laboratory values at glucose concentrations at or above 5.55 mmol/L.
  • Page 107 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 (mmol/L) (mmol/L) (mmol/L) 0.05 2.26 0.10 1.95 0.14 1.95...
  • Page 108 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 (mmol/L) (mmol/L) (mmol/L) 2.06 0.05 2.48 (1.39-2.72) 6.53 0.13 2.05 (5.67-7.67)
  • Page 109 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 110: Index

    10 Index Batteries Batteries, replacing Battery empty icon Battery empty warning Battery low icon 3, 94 BLUETOOTH® SMART feature 7, 9, 27, 69 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 expiry dates 58, 59...
  • Page 111 Index Error messages EXTREME HIGH GLUCOSE message 53, 87 EXTREME LOW GLUCOSE message 52, 86 Fingertip testing procedure First time setup 23, 28 Guarantee Hyperglycaemia 53, 87 Hypoglycaemia 52, 86 Icons 3, 4 Infection, reduce the chance Intended use Kit components Lancing device 12, 39, 41, 78 mmol/L...
  • Page 112 Index Storing your system Symbols 3, 4 Syncing 32, 69 Technical specifications Temperature 34, 66, 78, 88, 89, 100 Test principle Test strip 18, 45, 60 Test strip, applying drop of blood Test strip, discard and expiry dates Test strip, silver prongs Time setting 23, 26 Turning meter off...
  • Page 113 Notes...
  • Page 114 Notes...
  • Page 116 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 authorised to grant such a license.

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