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103

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)

100

600

1.01

-0.02

95% CI

Slope

95% CI

Intercept

(mmol/L)

Std. Error

y.x

)

(mmol/L)

1.00 to 1.01

-0.12 to 0.08

0.64

0.99

Содержание Vario Flex

Страница 1: ...Blood Glucose Monitoring System Instructions for Use Owner s Booklet ...

Страница 2: ......

Страница 3: ...1 Owner s Booklet Blood Glucose Monitoring System ...

Страница 4: ...eter results are sent to the compatible devices either through BLUETOOTH Smart wireless or USB cable connection Every OneTouch Meter is designed to help you test your blood glucose and manage your diabetes This Owner s Booklet offers a complete explanation of how to use your new meter and testing supplies It reviews the do s and don ts of testing your blood glucose level Please keep your Owner s B...

Страница 5: ...ture On History Mode Past results Apply Sample Range Indicator Arrow Setting Mode Compatible Wireless Devices Visit www OneTouch ca 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 ...

Страница 6: ...4 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 ...

Страница 7: ...e 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 di...

Страница 8: ...e patient and should not be shared The OneTouch Verio Flex Blood Glucose Monitoring System is intended for self testing outside the body in vitro diagnostic use by people with diabetes at home and with their healthcare professionals in a clinical setting as an aid to monitor the effectiveness of diabetes control The OneTouch Verio Flex Blood Glucose Monitoring System is not to be used for the diag...

Страница 9: ... Verio Flex Meter BLUETOOTH Smart wireless technology BLUETOOTH Smart wireless technology is used by some smartphones and many other devices Your OneTouch Verio Flex Meter uses BLUETOOTH Smart wireless technology to pair and to send your glucose results to compatible wireless devices The OneTouch Verio Flex Meter is designed to work with the OneTouch Reveal Mobile App NOTE Some diabetes management...

Страница 10: ...icense exempt RSS standard s Operation is subject to the following two conditions 1 this device may not cause interference and 2 this device must accept any interference including interference that may cause undesired operation of the device 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 an...

Страница 11: ...gle patient use only WARNING In locations where cell phone use is not permitted such as hospitals some healthcare professional offices and airplanes you should turn the BLUETOOTH Smart feature off See page 27 for more information BLUETOOTH Smart trademark The BLUETOOTH word mark and logos are registered trademarks owned by Bluetooth SIG Inc and any use of such marks by LifeScan Scotland Ltd is und...

Страница 12: ... 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 58 4 Reviewing past results 68 ...

Страница 13: ...diting 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 ...

Страница 14: ...now your system Your OneTouch Verio Flex Blood Glucose Monitoring System Included with your kit OneTouch Verio Flex Meter CR2032 lithium coin cell battery included OneTouch Delica Lancing Device OneTouch Delica Lancets ...

Страница 15: ...g or defective in your kit contact the OneTouch Customer Care Line at 1 800 663 5521 Monday Friday 9am 8pm Eastern 6am 5pm Pacific or visit www OneTouch ca NOTE If another type of lancing device was included see the separate instructions for that lancing device ...

Страница 16: ...OneTouch Verio Control Solution and OneTouch Verio Test Strips are available separately For availability of test strips and control solution contact Customer Service or ask your pharmacist or healthcare professional WARNING Keep the meter and testing supplies away from young children Small items such as the battery door batteries test strips lancets protective covers on the lancets and control sol...

Страница 17: ...15 1 Getting to know your system This page left blank intentionally ...

Страница 18: ...16 1 Getting to know your system Meter Getting to know your OneTouch Verio Flex Blood Glucose Monitoring System ...

Страница 19: ...17 1 Getting to know your system ...

Страница 20: ...18 1 Getting to know your system Test strip Getting to know your OneTouch Verio Test Strip ...

Страница 21: ... 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 Use the Range Indicator Arrow and Colour Bar together to interpret your results ...

Страница 22: ...he pre set low range limit is 4 0 mmol L and the pre set high range limit is 10 0 mmol L You can change these limits as needed to meet your needs See page 75 for details on the pre set range limits and on editing your range limits If you decide to change your range limits the Range Indicator Arrows stored with previous results in meter memory will not change However any new tests will display Rang...

Страница 23: ...21 1 Getting to know your system This page left blank intentionally ...

Страница 24: ...here may be a problem with the meter Contact the OneTouch Customer Care Line at 1 800 663 5521 NOTE If you turned the meter on for the first time by inserting a test strip instead of pressing you will not be able to perform a glucose test until you complete the first time setup Every time you turn your meter on a start up screen will appear for a few seconds All segments of the display should appe...

Страница 25: ... 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 Minutes will flash If the minutes displayed are correct press to confirm If the minutes displayed are not correct press or to change the minutes ...

Страница 26: ... date setup Year will flash If the year displayed is correct press to confirm If the year displayed is not correct press or to change the year and press to confirm AM PM will flash If the AM PM displayed is correct press to confirm If the AM PM displayed is not correct press or to change AM PM and press to confirm ...

Страница 27: ...displayed is not correct press or to change the month and press to confirm Day will flash If the day displayed is correct press to confirm If the day displayed is not correct press or to change the day and press to confirm You are now ready to take a test See the section Testing your blood glucose in Chapter 3 ...

Страница 28: ... on then press and hold and at the same time The SET screen will appear See page 74 After adjusting the settings your meter will exit settings mode and your last result screen will appear 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 ...

Страница 29: ...rned on The symbol will appear on the meter screen when the BLUETOOTH Smart feature is on When the symbol is not present on the screen the BLUETOOTH Smart feature is off To turn the BLUETOOTH Smart feature on press and at the same time To turn the BLUETOOTH Smart feature off press and at the same time The symbol indicates the BLUETOOTH Smart feature is on NOTE The BLUETOOTH Smart feature will turn...

Страница 30: ...t be available in your country Visit www OneTouch ca to learn if the OneTouch Reveal Mobile App is available in your country Multiple OneTouch Verio Flex Meters can be paired with your compatible wireless device For example your compatible wireless device can be paired with a meter at home and another at work To pair multiple meters repeat the pairing instructions for each meter See page 29 for pa...

Страница 31: ...er on using the button 2 The BLUETOOTH Smart feature is turned on by pressing and together The 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 ...

Страница 32: ...30 2 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 ...

Страница 33: ...evice Example of PIN number display on meter CAUTION Make sure the PIN you enter on your compatible device matches the PIN on your meter display If a PIN number unexpectedly appears on your meter display cancel the PIN request by either inserting a test strip to take a test or press the button to enter History Mode 6 Wait for your compatible wireless device to indicate that your meter and compatib...

Страница 34: ...N as indicated by If needed press and at the same time to turn the BLUETOOTH Smart feature on The Sync symbol flashes on the meter display Syncing Data will appear on the app to notify you that the meter is communicating with the app Syncing Data After syncing the Sync symbol will disappear the Syncing Data message will disappear on the app and the app will display a list of any new results sent f...

Страница 35: ...ff Press and hold for several seconds until the meter turns off Remove the test strip Your meter will turn off by itself if left alone for two minutes NOTE Following a glucose test the meter will still be available for BLUETOOTH Smart connection for up to 4 hours See page 69 for more details ...

Страница 36: ...uch Verio Flex Meter OneTouch Verio Test Strips Lancing device Sterile lancets 3 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 6 44 C Make sure your meter and test strips are about the same temperature before you test Keep test strip...

Страница 37: ...after use to avoid contamination and damage Store unused test strips only in their original vial Do Not return the used test strip to the vial after performing a test Do Not re use a test strip that had blood control solution or any contaminants applied to it Test strips are for single use only With clean dry hands you may touch the test strip anywhere on its surface Do Not bend cut or modify the ...

Страница 38: ...at person See page 78 CAUTION The OneTouch Verio Flex Blood Glucose Monitoring System should not be used for patients within 24 hours of receiving a D xylose absorption test as it may cause inaccurately high results Do Not use the OneTouch Verio Family of Meters when PAM Pralidoxime is known or suspected to be in the patient s whole blood sample Do Not use your test strips if your vial is damaged ...

Страница 39: ...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 ...

Страница 40: ...38 3 Taking a test Getting to know your OneTouch Delica Lancing Device ...

Страница 41: ...ch 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 ...

Страница 42: ...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 78 The meter and lancing device are for single patient use only Do Not share them with anyone including family members Do Not use on multiple patients After use and exposure to blood all parts of this kit are considered biohazardous A used kit may transmit infec...

Страница 43: ...41 3 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 ...

Страница 44: ...own 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 55 ...

Страница 45: ...43 3 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 ...

Страница 46: ...ost adults Deeper punctures work well for people with thick or callused skin Turn the depth wheel to choose the setting NOTE A shallower fingertip puncture may be less painful Try a shallower setting first and increase the depth until you find the one deep enough to get a blood sample of the proper size 5 Cock the lancing device Slide the cocking control back until it clicks If it does not click i...

Страница 47: ... 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 ...

Страница 48: ...t 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 ...

Страница 49: ...rop 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 ...

Страница 50: ...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 ...

Страница 51: ...nel 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 ...

Страница 52: ...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 ...

Страница 53: ...ppropriate Range Indicator Colour Bar on the meter as a visual reminder Example Below Range Result Example In Range Result Example Above Range Result CAUTION Do Not make immediate treatment decisions based on the Range Indicator feature Treatment decisions should be based on the numerical result and healthcare professional recommendation and not solely on where your result falls within your range ...

Страница 54: ...his may require immediate treatment according to your healthcare professional s recommendations Although this result could be due to a test error it is safer to treat first then do another test NOTE When your glucose result is below 1 1 mmol L both the LO and the Range Indicator Arrow will flash on the meter screen CAUTION Dehydration and low results You may get false low results if you are severe...

Страница 55: ... HI is displayed when your result is over 33 3 mmol L You may have severe hyperglycemia very high blood glucose Re test your blood glucose level If the result is HI again this indicates a severe problem with your blood glucose control Obtain and follow instructions from your healthcare professional immediately NOTE When your glucose result is above 33 3 mmol L both the HI and the Range Indicator A...

Страница 56: ...sults and you have followed all instructions in this Owner s Booklet call your healthcare professional Never ignore symptoms or make significant changes to your diabetes management program without speaking to your healthcare professional Unusual red blood cell count A hematocrit percentage of your blood that is red blood cells that is either very high above 60 or very low below 20 can cause false ...

Страница 57: ...ull 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 ...

Страница 58: ...ection 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 ...

Страница 59: ...lace 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 ...

Страница 60: ...handling the meter test strips lancing device and cap 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 NOTE Use only OneTouch Verio Control Solution with your OneTouch Verio Flex Meter When...

Страница 61: ...age 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 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 ...

Страница 62: ...w vial of test strips If you suspect that the meter or test strips are not working properly If you have had repeated unexpected blood glucose readings If you drop or damage the meter Preparing your meter for a control solution test 1 Insert a test strip to turn the meter on ...

Страница 63: ...ke the vial gently 2 Remove the vial cap and place it on a flat surface with the top of the cap pointing up 3 Squeeze the vial to discard the first drop 2 Wait for the flashing blood drop icon to appear on the display 3 Press or until the control solution icon appears on the display ...

Страница 64: ... 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 ...

Страница 65: ...rol 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 3 Wait for the channel to fill completely 2 Touch the channel on the side of the test strip to the control solution ...

Страница 66: ...nit of measure and for control solution and stored in the meter Control solution results can be seen when reviewing past results on the meter CAUTION Make sure you press or until the control solution icon appears before you begin a control solution test Invalid results may be logged into your history if you applied control solution to the test strip without following the steps beginning on page 60...

Страница 67: ...esult displayed on the meter to the range printed on your OneTouch Verio Control Solution vial If your control solution result falls outside the expected range repeat the test with a new test strip CAUTION The range printed on the control solution vial is for control solution tests only and is not a recommended range for your blood glucose level ...

Страница 68: ...t its discard date Meter test strips and or control solution were not all at the same temperature when the control solution test was performed A problem with the meter Dirt or contamination in the small well on the top of the control solution cap CAUTION If you continue to get control solution results that fall outside the range printed on the control solution vial Do Not use the meter test strips...

Страница 69: ...67 3 Taking a test Cleaning the control solution cap Clean the top of the control solution cap with a clean damp tissue or cloth ...

Страница 70: ...lood 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 to turn History Mode on The symbol indicates you are viewing your past results The symbol indicates if the result was below above or within range at the time of the test by pointing to the appropriate co...

Страница 71: ...compatible wireless device must have the app running and have already been paired to the meter before sending a result NOTE The compatible wireless device must have the app open and have already been paired to the meter before sending a result See page 28 NOTE If the BLUETOOTH Smart feature on the meter is turned off or the meter is out of range the result is not sent to the compatible wireless de...

Страница 72: ...th 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 8 meters of each other The meter will attempt to transmit results up to 4 hours after a test even if the meter appears to be off This is indicated by the BLUETOOTH Smart symbol remaining on the meter screen E...

Страница 73: ...results to the compatible wireless device please call the OneTouch Customer Care Line at 1 800 663 5521 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 ...

Страница 74: ...ontact the OneTouch Customer Care Line at 1 800 663 5521 Monday Friday 9am 8pm Eastern 6am 5pm Pacific or visit www OneTouch ca Connect only to a computer certified to UL 60950 1 To transfer meter data follow the instructions provided with the diabetes management software product to download the results from the meter You will need a standard micro USB interface cable to connect your OneTouch Veri...

Страница 75: ...he 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 the OneTouch Customer Care Line at 1 800 663 5521 ...

Страница 76: ...gs mode and your last glucose result screen will appear The adjusted time and date will be displayed once a new glucose test has been completed and the result appears on the screen NOTE You will not be able to perform a blood glucose test until you finish editing the time and date NOTE The OneTouch Reveal Mobile App on your compatible wireless device checks and updates the time and date in your me...

Страница 77: ...urrent low range limit displayed and the number and range indicator arrow will flash NOTE The low and high range limits you set apply to all glucose test results This includes tests taken before or after mealtimes medications and around any other activities that may affect your blood glucose CAUTION Be sure to talk to your healthcare professional about the low and high range limits that are right ...

Страница 78: ... press or 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 high range limit press or to change the value between 5 0 mmol L 16 7 mmol L and then press Your meter will exit settings mode and your last result screen will appear ...

Страница 79: ...mits Changing your range limits does not affect how past results are displayed NOTE You will not be able to perform a glucose test until you finish editing the range limits NOTE You can use the OneTouch Reveal Mobile App on your compatible wireless device to change the range limits stored in your meter See the instructions that came with the app for more information ...

Страница 80: ...ge 80 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 your meter lancing device and cap The meter lancing device and cap should be cleaned whenever they are visibly dirty and before disinfection Clean your meter at least...

Страница 81: ...the data port See page 16 Do Not spray cleaning solution on the meter or immerse it in any liquid 1 Holding the meter with the test strip port pointed down use a soft cloth dampened with water and mild detergent to wipe the outside of the meter and lancing device Be sure to squeeze out any excess liquid before you wipe the meter Wipe the outside of the cap ...

Страница 82: ...ce and cap prior to disinfecting For disinfecting obtain regular household bleach containing a minimum of 5 5 sodium hypochlorite as the active ingredient Prepare a solution of 1 part household bleach and 9 parts water or obtain equivalent 0 55 sodium hypochlorite wipes Follow manufacturer s instruction for handling and storage of bleach 2 Wipe dry with a clean soft cloth ...

Страница 83: ...sure to squeeze out any excess liquid before you wipe the meter 2 After wiping cover the surface you are disinfecting with the soft cloth dampened with the bleach solution or 0 55 equivalent sodium hypochlorite wipe for 1 minute Wipe with a clean damp soft cloth and allow to air dry Wash hands thoroughly with soap and water after handling the meter lancing device and cap If you see signs of wear p...

Страница 84: ...an normal If the meter does not turn on you may need to replace the battery See below for instructions WARNING Certain batteries may cause leaking which can damage the meter or cause the battery to lose power sooner than normal Replace leaking battery immediately NOTE After replacing the battery you will be prompted to set time and date as if you are turning the meter on for the first time 1 Remov...

Страница 85: ...ected to a computer 2 Insert the new battery Insert one CR2032 lithium coin cell battery on top of the battery ribbon with the plus side up If the meter does not power on after you have replaced the meter battery check that the battery is correctly installed If the meter still does not power on contact the OneTouch Customer Care Line at 1 800 663 5521 ...

Страница 86: ... onto the meter 5 Dispose of battery Dispose of the battery according to your local environmental regulations 4 Check your meter settings Removing the meter battery will not affect your stored results However you will need to check your date and time settings ...

Страница 87: ...85 7 Battery This page left blank intentionally ...

Страница 88: ...s on but does not operate locks up contact the OneTouch Customer Care Line at 1 800 663 5521 What it means You may have a very low blood glucose level severe hypoglycemia below 1 1 mmol L NOTE When your glucose result is below 1 1 mmol L both the LO and the Range Indicator Arrow will flash on the meter screen What to do This may require immediate treatment Although this message could be due to a t...

Страница 89: ...hyperglycemia 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 If the result is HI again obtain and follow instructions from your healthcare professional right away ...

Страница 90: ...o 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 6 44 C If you do not get another HI t message you can proceed with testing If this message continues to appear contact the OneTouch Customer Care Line at 1 800 663 5521 ...

Страница 91: ...o 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 6 44 C If you do not get another LO t message you can proceed with testing If this message continues to appear contact the OneTouch Customer Care Line at 1 800 663 5521 ...

Страница 92: ...x 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 the OneTouch Customer Care Line at 1 800 663 5521 They will refer to the error number and code to help troubleshoot the problem ...

Страница 93: ... either by a used test strip or a problem with the meter or test strip What to do Do Not use the meter Contact the OneTouch Customer Care Line at 1 800 663 5521 What to do Repeat the test with a new test strip see page 48 or page 63 If this message continues to appear contact the OneTouch Customer Care Line at 1 800 663 5521 ...

Страница 94: ...ied 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 the OneTouch Customer Care Line at 1 800 663 5521 ...

Страница 95: ... 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 48 or page 63 If the error message appears again contact the OneTouch Customer Care Line at 1 800 663 5521 ...

Страница 96: ...will continue to appear until the battery is replaced What to do Replace the meter battery soon 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 48 or page 63 If the error message appears again contact the OneTouch Customer Care Line at 1 800 663 5521 ...

Страница 97: ...emory such as the first time use or when you have chosen to delete all the results after downloading to a computer What to do Contact Customer Service to report this occurrence unless this is your first use of the meter You can still perform a blood glucose test or control solution test and get an accurate result Contact the OneTouch Customer Care Line at 1 800 663 5521 ...

Страница 98: ...f laboratory method when the glucose concentration is 5 55 mmol L or higher Meter results can be affected by factors that do not affect lab results in the same way Specific factors that may cause your meter result to vary from your lab result may include You have eaten recently This can cause a result from fingertip testing to be up to 3 9 mmol L higher than a lab test using blood drawn from a vei...

Страница 99: ...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 ...

Страница 100: ...aken from a different meter is not recommended Results may differ between meters and are not a useful measure of whether your meter is working properly Testing with your OneTouch Verio Flex Meter at the lab Test within 15 minutes of the lab test Use only a fresh capillary blood sample from your fingertip Follow all instructions in this Owner s Booklet for performing a blood glucose test ...

Страница 101: ... d c CR2032 lithium coin cell battery Battery type One replaceable 3 0 Volt CR2032 lithium coin cell battery or equivalent BLUETOOTH Smart Technology Frequency range 2 4 2 4835 GHz Operating Range Distance minimum 8 meters unobstructed Operating Channels 40 Channels Security Encryption 128 bit AES Advanced Encryption Standard Calibration Plasma equivalent Data port type Compatible with USB 2 0 Mem...

Страница 102: ...Relative humidity non condensing 10 90 Altitude up to 3048 meters Hematocrit 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 Approximately 50 grams ...

Страница 103: ...hin 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 Analyzer laboratory instrument System Accuracy Results for Glucose Concentrations 5 55 mmol L Percent and number of meter results that match the laboratory test Within 0 28 mmol L Within 0 56 mmol L Within 0 8...

Страница 104: ...h 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 99 5 597 600 NOTE Where 2 1 mmol L represents the lowest glucose reference value and 25 9 mmol L represents the highest glucose reference value YSI value ...

Страница 105: ...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 100 600 1 01 0 02 95 CI Slope 95 CI Intercept mmol L Std Error Sy x mmol L R2 1 00 to 1 01 0 12 to 0 08 0 64 0 99 ...

Страница 106: ...ed 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 97 6 of the total number of samples were within 0 83 mmol L or 15 of the medical laboratory values ...

Страница 107: ...mmol L Mean Glucose mmol L Standard Deviation mmol L Coefficient of Variation 2 2 2 0 0 05 2 26 5 0 4 9 0 10 1 95 7 2 7 1 0 14 1 95 11 1 11 1 0 22 1 98 19 4 19 1 0 34 1 79 Results show that the greatest variability observed between test strips when tested with blood is 0 10 mmol L SD or less at glucose levels less than 5 55 mmol L or 1 98 CV or less at glucose levels at 5 55 mmol L or above ...

Страница 108: ... Solution Tests per Glucose Level Data generated using the OneTouch Verio Flex Meter Glucose LevelRanges mmol L Mean Glucose mmol L Standard Deviation mmol L Coefficient of Variation Low 1 39 2 72 2 06 0 05 2 48 Mid 5 67 7 67 6 53 0 13 2 05 High 16 56 22 39 19 37 0 46 2 38 ...

Страница 109: ...d Only Emissions of the energy used are low and not likely to cause interference in nearby electronic equipment The meter has been tested for immunity to electrostatic discharge as specified in IEC 61326 2 6 This meter complies with immunity to radio frequency interference as specified in IEC 61326 1 and 61326 2 6 The meter meets the requirements for immunity to electrical interference at the freq...

Страница 110: ...ng meter results to laboratory results 96 Compatible wireless devices 3 Control solution 60 Control solution discard and expiration dates 58 59 Control solution testing 58 64 66 Data port 16 Date setting 24 26 Dehydration 52 96 Disinfecting your meter lancing device and cap 80 Display check 22 Disposal lancets and test strips 58 Downloading results to a computer 72 Edit date 74 Edit range limits 7...

Страница 111: ...107 Hyperglycemia 53 87 Hypoglycemia 52 86 Icons 3 5 Infection reduce the chance 40 Intended use 6 Kit components 12 Lancing device 12 38 41 78 mmol L 16 100 Pairing 28 29 PIN 31 Plasma calibration 96 99 Range Indicator feature 19 Range limits setting 75 Results reviewing past 68 Serial number 30 Settings 23 26 74 Software diabetes management 72 Start up screen 22 ...

Страница 112: ...8 89 100 Test principle 7 Test strip 18 45 60 Test strip applying drop of blood 48 Test strip discard and expiration dates 35 Test strip silver prongs 18 Time setting 23 26 Turning meter off 33 Turning meter on 22 45 60 Unexpected results 52 54 Unit of measure 16 100 Unusual red blood cell count hematocrit 96 100 ...

Страница 113: ...111 Notes ...

Страница 114: ...112 Notes ...

Страница 115: ......

Страница 116: ... 371 8 449 740 and 8 529 751 as well as corresponding patents in other jurisdictions Purchase of this package does not act to grant a use license under these patents in any jurisdiction outside of Canada A license for use in Canada is granted only when the monitoring device is used with OneTouch Verio Test Strip No test strip supplier other than LifeScan is authorized to grant such a license The a...

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