Blood Glucose Monitoring System Owner's Booklet Instructions for Use
Verio Flex® Blood Glucose Monitoring System Owner's Booklet 1
Thanks for choosing OneTouch®! The OneTouch Verio Flex® Blood Glucose Monitoring System is one of the latest product innovations from OneTouch®. Your OneTouch Verio Flex® Meter is designed to connect (sync) with a variety of 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.
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.
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 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. 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.
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.
Test principle Glucose in the blood sample mixes with the enzyme FAD-GDH (see page 104) in the test strip and a small electric current is produced. The strength of this current calculates your blood glucose level. It then displays the blood glucose result and stores it in the meter memory. Use only OneTouch Verio® Control Solution and Test Strips with the OneTouch Verio Flex® Meter. BLUETOOTH® wireless technology BLUETOOTH® wireless technology is used by some smartphones and many other devices.
When using the OneTouch Verio Flex® System, we suggest you pair your OneTouch Verio Flex® Meter with a compatible wireless device and track your results. See page 31 for pairing instructions. Changes or modifications not expressly approved by the party responsible for compliance could void the user's authority to operate the equipment. This device complies with Part 15 of the FCC Rules.
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.
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. Additionally, other electronic devices should not affect the use of your meter. WARNING: The BLUETOOTH® feature on your meter sends test results to your compatible wireless device.
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 page 29 for more information. BLUETOOTH® trademark The BLUETOOTH® word mark and logos are 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.
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.................
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.........
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 14
Getting to know your system 1 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 (available 7 days a week, 8 a.m. - 8 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.
1 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.
Getting to know your system 1 *OneTouch Verio® Control Solution and Test Strips are available separately. For availability of test strips and control solution, contact Customer Service or ask your pharmacist or healthcare professional. You can use either OneTouch Verio® Level 3 Control Solution or OneTouch Verio® Level 4 Control Solution with your OneTouch Verio Flex® Meter. WARNING: Keep the meter and testing supplies away from young children.
1 Getting to know your system Getting to know your OneTouch Verio Flex® Blood Glucose Monitoring System Meter 18
Getting to know your system 1 19
1 Getting to know your system Getting to know your OneTouch Verio® Test Strip Test strip 20
Getting to know your system 1 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. Use the Range Indicator Arrow and Color Bar together to interpret your results.
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. Things you should know before using the Range Indicator feature: • The meter comes with pre-set range limits. The pre-set low range limit is 70 mg/dL and the pre-set high range limit is 180 mg/dL. You can change these limits as needed to meet your needs.
Getting to know your system 1 This page left blank intentionally.
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. 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.
Setting up your system 2 First time setup until the startTo turn your meter on, press and hold up screen appears. Once the device is on, release . The meter will now automatically prompt you to set the time and date. The SET icon will appear on the screen to indicate that the meter has entered setup mode. Setting the time Hour will flash • If the hour displayed is correct, press to confirm. • If the hour displayed is not correct, press or to change the hour and press to confirm.
2 Setting up your system AM/PM will flash • If the AM/PM displayed to is correct, press confirm. • If the AM/PM displayed is not correct, press or 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 to is correct, press confirm. • If the year displayed is not correct, press or to change the year and press to confirm.
Setting up your system 2 Month will flash • If the month displayed to is correct, press confirm. • If the month displayed is not correct, press or to change the month and press to confirm. Day will flash • If the day displayed is to correct, press confirm. • If the day displayed is not correct, press or to change the day and press to confirm.
2 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. Adjusting the time and date settings after first time setup You can adjust the meter's time and date settings after to turn the meter on, first time setup.
Setting up your system 2 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 symbol is not present on the screen the BLUETOOTH® feature is off. • To turn the BLUETOOTH® feature on press at the same time. • To turn the BLUETOOTH® feature off press at the same time.
2 Setting up your system Pairing Overview Pairing allows your OneTouch Verio Flex® Meter to communicate with compatible wireless devices. The devices must be within 26 feet of each other to pair and sync. Download the OneTouch Reveal® Mobile App from the appropriate app store before pairing your meter and compatible wireless device. Multiple OneTouch Verio Flex® Meters can be paired with your compatible wireless device.
Setting up your system 2 Pairing Instructions 1. Start by turning your meter on using the button 2. The BLUETOOTH® feature is turned on by pressing and together The symbol will appear to indicate that the BLUETOOTH® feature is on. 3.
2 Setting up your system 4.
Setting up your system 2 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. If a PIN number unexpectedly appears on your meter display, cancel the PIN request by either inserting a test strip to button to enter History Mode.
2 Setting up your system Syncing to send results wirelessly to the OneTouch Reveal® Mobile App 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 to turn the meter on and make sure 2. Press and hold the BLUETOOTH® feature is ON as indicated by ( ) and If needed, press BLUETOOTH® feature on.
Setting up your system 2 Turning the meter off There are three ways to turn your meter off: for several seconds until the meter • Press and hold 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 page 71 for more details.
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 page 60. Have these things ready when you test: OneTouch Verio Flex® Meter 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.
Taking a test 3 • 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.
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 page 80.
Taking a test 3 • If you cannot test due to a problem with your testing supplies, contact your healthcare professional. Failure to test could delay treatment decisions and lead to a serious medical condition. • The test strip vial contains drying agents that are harmful if inhaled or swallowed and may cause skin or eye irritation. • Do Not use test strips after the expiration date (printed on the vial) or the discard date, whichever comes first, or your results may be inaccurate.
3 Taking a test Getting to know your OneTouch® Delica® Lancing Device 40
Taking a test 3 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). Use only fingertips when testing with the system. • The OneTouch® Delica® Lancing System does not include the materials needed to perform Alternate Site Testing (AST).
3 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. • Always use a new, sterile lancet each time you test. • Always keep your meter and lancing device clean (See page 80). • The meter and lancing device are for single patient use only.
Taking a test 3 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.
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 page 57.
Taking a test 3 3. Replace the lancing device cap Place the cap back onto the device; turn clockwise to secure the cap. Do Not overtighten.
3 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. Deeper punctures work well for people with thick or callused skin. Turn the depth wheel to choose the setting. NOTE: A shallower fingertip puncture may be less painful.
Taking a test 3 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.
3 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. 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.
Taking a test 3 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.
3 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. Holding the meter at a slight angle, guide the channel to the blood drop.
Taking a test 3 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. Blood should not be applied on the top of the test strip or to the top edge of the test strip.
3 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. • 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.
Taking a test 3 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 page 21). The arrow will point to the appropriate Range Indicator Color Bar on the meter as a visual reminder.
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 70 mg/dL or is shown as LO (meaning the result is less than 20 mg/dL), it may mean hypoglycemia (low blood glucose). This may require immediate treatment according to your healthcare professional's recommendations. Although this result could be due to a test error, it is safer to treat first, then do another test.
Taking a test 3 CAUTION: High results • If your result is above 180 mg/dL, it may mean hyperglycemia (high blood glucose) and you should consider re-testing. Talk to your healthcare professional if you are concerned about hyperglycemia. • HI is displayed when your result is over 600 mg/dL. You may have severe hyperglycemia (very high blood glucose). Retest your blood glucose level. If the result is HI again, this indicates a severe problem with your blood glucose control.
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.
Taking a test 3 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. 2. Cover the exposed lancet tip Before removing the lancet, place the lancet protective cover on a hard surface then push the lancet tip into the cupped side of the cover.
3 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.
Taking a test 3 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.
3 Taking a test 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.
Taking a test 3 • Tightly close the cap on the control solution vial immediately after use to avoid contamination or damage. See page 36 for more information on testing. CAUTION: • Do Not swallow or ingest control solution. • Do Not apply control solution to the skin, eyes, ears or nose as it may cause irritation. • Do Not use control solution after the expiration date (printed on the vial label) or the discard date, whichever comes first, or your results may be inaccurate.
3 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. • If you drop or damage the meter. Preparing your meter for a control solution test 1.
Taking a test 3 2. Wait for the flashing blood drop icon ( ) to appear on the display or until the 3. Press control solution icon ( ) appears on the display 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.
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.
Taking a test 3 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.
3 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. CAUTION: Make sure you press or until the control appears before you begin a control solution solution icon test.
Taking a test 3 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 to either the OneTouch Verio® Level 3 Control Solution or OneTouch Verio® Level 4 Control Solution range printed on the test strip vial, depending on the type of control solution you used.
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.
Taking a test 3 Cleaning the control solution cap Clean the top of the control solution cap with a clean, damp tissue or cloth.
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. 1. When the meter is off, press and hold History Mode on to turn The ( ) symbol indicates you are viewing your past results.
Reviewing past results 4 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® feature on the meter is turned on, indicated by the BLUETOOTH® symbol ( ), the meter will automatically send the latest result to any paired compatible wireless device.
4 Reviewing past results 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. • The BLUETOOTH® feature on both devices is running (indicated by ) and the devices are within 26 feet of each other.
Reviewing past results 4 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.
4 Reviewing past results 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 (available 7 days a week, 8 a.m. - 8 p.m. Eastern Time) at 1 888 567-3003 (English), 1 888 567-3010 (Spanish), or www.OneTouch.com.
Reviewing past results 4 Once the command to start the download is sent from the computer to the meter, the meter display will show the flashing Sync symbol ( ) indicating that the meter is in communication mode. Do Not insert a test strip while the meter is connected to a computer. If you are unable to download your results to a computer, please call Customer Service. Contact us at 1 888 567-3003.
5 Editing Your Settings Editing time and date 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 and at the same time. The SET screen will appear, and the hour will flash. For instructions on adjusting the time and date, see page 25. After adjusting the settings, you will exit settings mode and your last glucose result screen will appear.
Editing Your Settings 5 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. To edit the pre-set range limits press and hold and at the same time. The SET screen will appear with the current low range limit displayed, and the number and range indicator arrow will flash.
5 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 or to change the value between 60 mg/dL-110 mg/dL, and then press . 2. Review the pre-set high range limit displayed • To accept the pre-set high range limit, press . • To edit the pre-set high range limit, press or to change the value between 90 mg/dL-300 mg/dL, and then press .
Editing Your Settings 5 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 OneTouch Reveal® Mobile App on your compatible wireless device to change the range limits stored in your meter.
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. 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.
Caring for your system 6 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 Service. Contact us at 1 888 567-3003.
6 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 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.
Caring for your system 6 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. 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.
6 Caring for your system 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.
Caring for your system 6 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.
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. If the meter does not turn on, you may need to replace the battery. See below for instructions.
Battery 7 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.
7 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. Contact us at 1 888 567-3003. 3.
Battery 7 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.
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. NOTE: If the meter is on but does not operate (locks-up), contact Customer Service. Contact us at 1 888 567-3003.
Troubleshooting your system 8 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. If the result is HI again, obtain and follow instructions from your healthcare professional right away.
8 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). 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 1 888 567-3003.
Troubleshooting your system 8 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). 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 1 888 567-3003.
8 Troubleshooting your system 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 1 888 567-3003. They will refer to the error number and code to help troubleshoot the problem.
Troubleshooting your system 8 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. What to do Repeat the test with a new test strip; see page 50 or page 65. If this message continues to appear, contact Customer Service. Contact us at 1 888 567-3003.
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 solution sample only after the flashing symbol appears on the display. If this message continues to appear, contact Customer Service. Contact us at 1 888 567-3003.
Troubleshooting your system 8 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 page 50 or page 65. If the error message appears again, contact Customer Service. Contact us at 1 888 567-3003.
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 page 50 or page 65. If the error message appears again, contact Customer Service. Contact us at 1 888 567-3003. What it means Meter battery power is low but there is still enough battery power to perform a test. The flashing low ) icon will battery ( continue to appear until the battery is replaced.
Troubleshooting your system 8 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.
9 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.
Detailed information about your system 9 Meter results can be affected by factors that do not affect lab results in the same way. Specific factors that may cause your meter result to vary from your lab result may include: • You have eaten recently. This can cause a result from fingertip testing to be up to 70 mg/dL higher than a lab test using blood drawn from a vein.1 • Your hematocrit is above 60% or below 20%. • You are severely dehydrated.
9 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 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.
Detailed information about your system 9 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.
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 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® Technology Frequency range: 2.4-2.4835 GHz Maximum power: 0.4 mW Operating Range Distance: minimum 26.
Detailed information about your system 9 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 mg/dL Weight Approximately 1.
9 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.
Detailed information about your system 9 Fingertip Results for Glucose Concentrations <75 mg/dL Percent (and number) of meter results that match the laboratory test Within ±5 mg/dL 76.2% (16/21) Within ±10 mg/dL Within ±15 mg/dL 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% 58.3% (88/151) Within ±10% Within ±15% Within ±20% 88.7% (134/151) 98.0% (148/151) 107 99.
9 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) 172 172 0.99 2.98 95% CI Slope 95% CI Intercept (mg/dL) Std. Error (Sy.x) (mg/dL) R2 0.97 to 1.01 -1.59 to 7.55 14.0 0.
Detailed information about your system 9 Precision Within Run Precision (300 Venous Blood Samples Tested per Glucose Level) Data generated using the OneTouch Verio Flex® Meter. Target Glucose (mg/dL) Mean Glucose (mg/dL) Standard Deviation (mg/dL) Coefficient of Variation (%) 40 36.5 0.83 2.26 90 88.5 1.72 1.95 130 127.9 2.50 1.95 200 199.3 3.94 1.98 350 344.6 6.18 1.79 Results show that the greatest variability observed between test strips when tested with blood is 0.
9 Detailed information about your system Total Precision (600 Control Solution Tests per Glucose Level) Data generated using the OneTouch Verio Flex® Meter. Glucose Level Ranges (mg/dL) Mean Glucose (mg/dL) Standard Deviation (mg/dL) Coefficient of Variation (%) Level 2 (25-49) 37.14 0.92 2.48 Level 3 (102-138) 117.68 2.41 2.05 Level 4 (298-403) 348.99 8.31 2.
Detailed information about your system 9 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. 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.
10 Index AST 41 Batteries 86 Batteries, replacing 86 Battery empty icon 3 Battery empty warning 99 Battery low icon 3, 98 BLUETOOTH® feature 7, 11, 29, 71 Buttons on meter 18 Cleaning your meter, lancing device and cap 82 Comparing meter results to laboratory results 100 Compatible wireless devices 3 Control solution 62 Control solution, discard and expiration dates 60, 61 Control solution, testing 60, 66, 68 Data port 18 Date setting 26, 28 Dehydration 54, 101 Disinfecting your meter, lancing device and
Index 10 Error messages EXTREME HIGH GLUCOSE message EXTREME LOW GLUCOSE message Fingertip testing procedure First time setup Guarantee Hyperglycemia Hypoglycemia Icons Infection, reduce the chance Intended use Kit components Lancing device Limitations mg/dL Pairing PIN Plasma calibration Range Indicator feature Range limits setting Results, reviewing past Serial number Settings Software, diabetes management 113 90 55, 91 54, 90 36 25, 30 111 55, 91 54, 90 3, 4 42 6 14 14, 40, 43 6 18, 105 30, 31 33 100,
10 Index Start-up screen 24 Storing your system 80 Symbols 3, 4 Syncing 34, 71 Technical specifications 104 Temperature 36, 68, 80, 92, 93, 105 Test principle 7 Test strip 20, 47, 62 Test strip, applying drop of blood 50 Test strip, discard and expiration dates 37 Test strip, silver prongs 20 Time setting 25, 28 Turning meter off 35 Turning meter on 24, 47, 62 Unexpected results 54, 56 Unit of measure 18, 105 Unusual red blood cell count (hematocrit) 101, 105 114
Notes 115
Notes 116
Contents covered by one or more of the following U.S. patents: 6,179,979, 6,193,873, 6,284,125, 6,716,577, 6,749,887, 6,797,150, 6,863,801, 6,872,298, 7,045,046, 7,498,132, 7,846,312, 8,449,740, 8,529,751 and 8,398,664. Use of the monitoring device included herein is protected under one or more of the following U.S. patents: 6,413,410, 6,890,421, 8,163,162, 7,749,371, 8,449,740 and 8,529,751. Purchase of this device does not act to grant a use license under these patents.
