OneTouch® Vita™ User Guide Great Britain
Contents
1. 25 System Accuracy Results for Glucose Concentrations lt 4 2 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 83 mmol L 56 1 37 66 89 4 59 66 98 5 65 66 System Accuracy Results for Glucose Concentrations 24 2 mmol L Percent and number of meter results that match the laboratory test Within 5 Within 10 Within 15 Within 20 38 2 204 534 71 7 383 534 89 5 478 534 97 9 523 534 System Accuracy Results across the entire Glucose Range Percent and number of meter results that match the laboratory test Within 0 83 mmol L or 20 98 0 588 600 Therefore 98 of the total results obtained with the OneTouch Vita System achieved the goal suggested by the diabetes experts Regression Statistics J Number of Number of Intercept Samples were tested in duplicate on each l Aa Subjects Tests mmol L of three test strip lots Results indicate that the OneTouch Vita System compares o w fw 1 033 0 596 well with a laboratory method 95 CI Std Error 0 95 Cl Slope nee S mmol L mmol L 1 020 0 742 0 90449 0 977 1 046 0 449 TROUBLESHOOTING AND DETAILED INFORMATION ABOUT YOUR SYSTEM 26 Precision Standard Within Run Precision 100 venous blood Target Glucose Mean Glucose Coefficient of tests per glucose level mmol L mmol L ceyaton variation mmol L Total Precision 2002. e Tightly close the cap on the vial immediately after use to avoid contamination and damage e Store unused test strips only in their original vial e 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 e Do not return the used test strip to the vial after performing a test e Do not re use a test strip that had blood or control solution applied to it Test strips are for single use only e Write the discard date 6 months after first opening the vial on the vial label when you first open it A CAUTION Do not use your test strips if your vial is damaged or left open to air This could lead to error messages or inaccurate results Contact Customer Care on 0800 121 200 UK or 1800 535 676 Ireland immediately if the test strip vial is damaged e Ifyou 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 e The test strip vial contains drying agents that are harmful if inhaled or swallowed and may cause skin or eye irritation e 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 Cocking control Release button Lancing Depth indicator device cap Clear Cap for fingertip for forearm and palm sampling
3. very high blood glucose Re test your blood glucose If the result is HIGH GLUCOSE again this indicates a severe problem with your blood glucose control Obtain and follow instructions from your healthcare professional immediately Repeated unexpected glucose results e If you continue to get unexpected results check your system with control solution See Section 5 Control solution testing e If you are experiencing symptoms that are not consistent with your blood glucose results and you have followed all instructions in this User Guide call your healthcare professional Never ignore symptoms or make significant changes to your diabetes control programme without speaking to your healthcare professional Unusual red blood cell count e A haematocrit percentage of your blood that is red blood cells that is either very high above 55 or very low below 30 can cause false results Testing with a forearm or palm sample The OneTouch Vita Meter lets you obtain a blood sample from your A CAUTION Talk to vour healthcare professional forearm or palm Getting a drop of blood from these alternate sites may be Reacts oe se Pee A a less painful than a fingertip sample ad P J If you are testing Use blood sample from your Before or more than two hours after e a meal Fingertip forearm or palm e a rapid acting insulin injection or insulin pump bolus e exercise TESTING YOUR BLOOD GLUCOSE 10 A CAUTION Do not test
4. results All results average If the meal flags feature is off selecting AVERAGES from the MAIN MENU will lead directly to the ALL RESULTS AVG screen For each of the 7 14 and 30 day periods leading up to the current date the meter will display the number of results NUM and the average of these results AVG Press to go back to the AVERAGES screen To return to the MAIN MENU highlight MENU then press Q Meal averages The meter will display the averages of all before meal BFR and after meal AFT results for each of the 7 14 and 30 day periods leading up to the current date This screen is not available when the meal flags feature is off Fasting average For each of the 7 14 and 30 day periods leading up to the current date the meter will display the number of results NUM and the average of these results AVG This screen is not available when the flags feature is off e In result averages a HI result is always counted as 33 3 mmol L and a LO result is always counted as 1 1 mmol L See nterpreting unexpected test results in Section 2 for more information on high and low glucose results ALL RESULTS AVG MEAL AVGS FASTING AVG LAST 7 DAYS 14 DAYS 30 DAYS LAST 7 DAYS 14 DAYS 30 DAYS LAST 7 DAYS 14 DAYS 30 DAYS MENU NUM lt 30 125 mmol L BFR AFT SS S 64 7 8 6 9 84 NUM 6 21 30 MENU e The meter calculates averages based on the 7 14 and 30 day periods ending on th
5. test TESTING YOUR BLOOD GLUCOSE 8 Wait for the confirmation window to fill completely The blood drop will be drawn into the narrow channel and the confirmation window should fill completely When the confirmation window is full this means you have applied enough blood Now you can move the test strip away from the blood drop and wait for the meter to count down from 5 to 1 Confirmation window full v C Full Not full Read your result on the meter Your blood glucose level appears on the display along with the unit of measure and the date and time of ra the test i If mmol L does not appear with the test result contact Customer Care on 0800 121 200 UK or 1800 535 676 Ireland After getting a result Once you have your result you may e Attach a meal flag or fasting flag to this result see Section 3 Attaching meal flags and fasting flags to your test results or e Review your meter memory by pressing see Section 4 Reviewing past results and averages or e Turn the meter off by removing the test strip Removing the used lancet Remove the lancing device cap Place the lancet protective cover on a hard surface and push the lancet tip into the cover Remove the lancet and place it in a container for sharp objects Replace the lancing device cap Disposing of the used lancet and test strip It is important to discard the used lancet carefully after each use to avoid unintended lancet stick in
6. testing See Testing LANCING DEVICE with a forearm or palm sample in Section 2 Lancet point Sterile lancet Protective cover If the lancing device shown here is not included with your kit see the user instructions for that lancing device TESTING YOUR BLOOD GLUCOSE 5 Always keep your meter and lancing device clean see Caring for your A CAUTION To reduce the chance of infection system in Section 6 e Never share a lancet or a lancing device with anyone e Always use a new sterile lancet each time you test Getting a blood sample from the fingertip Before testing wash your hands thoroughly with warm soapy water Rinse and dry Snap off the lancing Insert a sterile lancet Twist off the protective device cap Firmly push the lancet into the cover and save it for later use holder Replace the lancing device cap Adjust the depth setting Twist the lancing device cap until the desired setting appears Smaller numbers are for shallower punctures which may be less painful Shallower punctures work for children and most adults Deeper punctures work well for people with thick or callused skin Cock the lancing device Slide the cocking control back until it clicks If it does not click that s okay It may have been cocked when you inserted the lancet TESTING YOUR BLOOD GLUCOSE 6 Insert a test strip to turn the meter on Insert a test strip into the test strip port as shown with the co
7. ES to select result averages SETTINGS Press or W to highlight your selection and press QB METER OFF Last Result The meter will display your most recent result Press BD to return to the MAIN MENU Unitof Flag measure All Results The meter will display four results at a time starting with the most recent ALL RESULT The following symbols may also appear mmol L 11 OCT 10 01 10 OCT 17221 HI ifthe result was above 33 3 mmol L O9 OCT 07 03 LO if the result was below 1 1 mmol L O8 OCT 08 33 C ifthe result is from a control solution test ifthe result is flagged BEFORE MEAL ifthe result is flagged AFTER MEAL X ifthe result is flagged FASTING MENU When the meter memory is full the oldest result is dropped as the newest is added Press VW to move backward and to move forward through your results Pressing and holding or VW allows you to move more quickly To view details of an individual result press or YW to highlight the result then press D if you wish to add or remove a meal flag for this result see Section 3 Attaching meal flags and fasting flags to your test results To return to the previous screen press D To return to the MAIN MENU highlight MENU then press D REVIEWING PAST RESULTS AND AVERAGES 15 Averages The meter will display three types of averages e ALL RESULTS AVG to view all test results e MEAL AVGS to view before and after meal results e FASTING AVG to view fasting
8. ONE OUCH Vita Blood Glucose Monitoring System USER GUIDE Replaces User s Handbook AW 06607902A Rev date 05 2009 Contents Setting up your system j Testing your blood glucose Attaching meal flags and fasting flags to your test results Reviewing past results and averages Control solution testing Care and maintenance Troubleshooting and detailed information about your system A PS oa wa Direct Current E Low Battery SN Serial Number Lot Number teal Manufacturer Authorised Representative In Vitro Diagnostic Medical Device Expiry Date r Sterilised by irradiation Storage temperature limits Consult instructions for use Do not re use Oda Caution Refer to instructions for use Contains sufficient for lt n gt tests Separate collection of batteries The system described herein is covered by one or more of the following U S patents 5 708 247 5 951 836 6 241 862 6 284 125 and 7 112 265 Use of the monitoring device included herein is protected under one or more of the following U S patents 6 413 410 6 733 655 7 250 105 Purchase of this device does not act to grant a use licence under these patents Such a licence is granted only when the device is used with OneTouch Vita Test Strips No test strip supplier other than LifeScan is authorised to grant such a licence The accuracy of results generated with LifeScan meters using test strips manu
9. a Control Solution only It is not a recommended range for your blood glucose level Out of range results may be due to e not following the instructions detailed in steps 1 5 e use of control solution that is contaminated expired or past its discard date e use of a test strip that is contaminated damaged expired or past its discard date e a problem with the meter or e control solution test was performed outside the correct temperature range 20 25 C CONTROL SOLUTION TESTING 18 Care and maintenance Changing the battery Your OneTouch Vita Meter uses one 3 0 Volt CR 2032 lithium battery or equivalent Meter battery See Troubleshooting in Section 7 for information on when to change the meter battery Remove the old battery Make sure the meter is turned off Open the battery door and pull up on the battery ribbon Insert the new battery With the side facing up toward you place the battery in the compartment within the fold of the ribbon Push the battery until it snaps into the battery clasp Replace the battery door If the meter does not power on after you have replaced the battery check that the battery is correctly installed with the side up If the meter still does not power on contact Customer Care on 0800 121 200 UK or 1800 535 676 Ireland Check your meter settings Removing the meter battery will not affect your stored results however you may nee
10. control solution tests Standard per glucose level Glucose Levels Mean Glucose Coefficient of deviation To mmol L mmol L tami variation Results show that the greatest variability observed between test strips when tested with blood is 3 5 or less Electrical and safety standards This meter complies with CISPR 11 2003 Class B Radiated Only Emissions of the energy used are low and not likely to cause interference in nearby electronic equipment The meter has been tested for immunity to Level 3 electrostatic discharge as specified in IEC 61000 4 2 This meter has been tested for immunity to radio frequency interference over the frequency range 80 MHz to 2 5 GHz at 3 V m as specified in IEC 61000 4 3 Degree of protection rating IP31 Guarantee LifeScan guarantees that the OneTouch Vita 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 TROUBLESHOOTING AND DETAILED INFORMATION ABOUT YOUR SYSTEM 27
11. d to re set your meter settings See Setting the meter language date and time in Section 1 Dispose of battery Dispose of batteries according to your local environmental regulations Please recycle or dispose of used batteries using your local battery collection systems and in compliance with your local environmental laws and regulations Batteries contain chemicals that if released may affect the environment and human health The crossed out wheelie bin symbol indicates the need for the separate collection for batteries CARE AND MAINTENANCE 19 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 4 C and 30 C but Do not refrigerate Keep all items away from direct sunlight and heat OneTouch Vita Test Strips With clean dry hands you may touch the test strip anywhere on its surface Do not bend cut or modify the test strips in any way Checking for expiration or damage to test strips and control solution Expiration dates for test strips and control solutions are printed on their vial labels When you first open a new vial of test strips or control solution record the discard date on the label Refer to the test strip insert or control solution insert for instructions on determining the discard date A CAUTION Do not use the test strips or control solution after the expiration date or the discard date wh
12. e current date setting If you change your date setting your averages may change too e Result averages provide information from past results Do not use result averages to make immediate treatment decisions Downloading results to a computer You can store and analyse your test results by downloading them from the meter to a computer For more information or to obtain the required software and interface cable visit www LifeScan co uk or call Customer Care on 0800 121 200 UK or 1800 535 676 Ireland Follow the installation instructions provided with the software then connect the cable and transfer your data NOTE Make sure the meter is turned off when you connect the cable to the meter data port You will not be able to perform a test while the meter is downloading data A WARNING To avoid a possible shock do not insert a test strip while the meter is connected to a computer REVIEWING PAST RESULTS AND AVERAGES 16 Control solution testing When to test with control solution OneTouch Vita Control Solution is used to practice the test and to check that the meter and test strips are working properly Control solution is available separately A CAUTION e Do not swallow control solution it is not for human consumption e Do not apply control solution to the skin or eyes as it may cause irritation e Do a control test before performing your first blood glucose test whenever you open a n
13. essage continues to appear contact Customer Care on 0800 121 200 UK or 1800 535 676 Ireland One of the following may apply You may have tested in an environment near the low end of the system s operating range or The test strip may have been damaged or moved during testing or The sample was improperly applied or There may be a problem with the meter The meter has detected a problem with the test strip Possible causes are test strip damage or an incompletely filled confirmation window Meter battery is low but still has enough power to perform a test Meter battery is low but still has enough power to perform a test What to do Repeat the test with a new test strip see Applying blood and reading results in Section 2 or Section 5 Control solution testing Contact Customer Care on 0800 121 UK or 1800 355 676 ireland Repeat the test with a new test strip Apply a blood or control solution sample only after APPLY SAMPLE or APPLY CONTROL appears on the display If this message continues to appear contact Customer Care on 0800 121 UK or 1800 355 676 ireland Make sure you are testing within the operating range 10 44 C and repeat the test with a new test strip see Applying blood and reading results in Section 2 or Section 5 Control solution testing If this message continues to appear contact Customer Care on 0800 121 200 UK or 1800 535 676 Ireland Repeat the test with a new te
14. ew vial of test strips if you suspect that the meter and test strips are not working properly if you have repeated unexpected blood glucose results if you drop or damage the meter e Use only OneTouch Vita Control Solution with your OneTouch Vita Meter e Control solution tests must be done at room temperature 20 25 C Make sure your meter test strips and control solution are at the same temperature before testing e When you open a new vial of control solution record the discard date date opened plus 3 months on the vial label e Control solution is available free of charge from Customer Care on 0800 121 200 UK or 1800 535 676 Ireland e Tightly close the cap on the control solution vial immediately after use to avoid contamination or damage How to test with control solution Insert a test strip to turn the meter on Wait for the APPLY SAMPLE screen to appear on the display Press to display the APPLY CONTROL APPLY CONTROL screen on a When the APPLY CONTROL screen is displayed you can be sure that the test result will be Ili correctly recorded in the meter memory as a Test strip port control solution test Prepare and apply control solution Shake the control solution vial and remove the cap Squeeze the vial to discard the first drop then wipe the tip with a clean tissue or cloth Touch and hold a hanging drop of control solution to the narrow channel in the top edge o
15. f the test strip CONTROL SOLUTION TESTING 17 NARROW CHANNEL Control solution should not be applied on top of the test strip Apply drop here TOP EDGE When the confirmation window is full the meter will count down from 5 to 1 Confirmation window full Read your result Your control solution result will then appear on the display along with the date time unit of measure and the words CONTROL TEST 11 0CT 08 14 07 lf LO A CAUTION If the words CONTROL TEST do not appear on the screen repeat the test CONTROL TESD with a new test strip If the problem persists contact Customer Care on 0800 121 200 UK or Example 1800 535 676 Ireland Control solution results can be seen when reviewing past results but are not included in result averages Check if the result is in range Compare the result displayed on the meter to the OneTouch Vita Control Solution range printed on the test strip vial If your control solution result falls outside the expected range repeat the test with a new test strip OneTouch Vita 5 7 7 6 mmol L Example range A CAUTION e If you continue to get control solution test results that fall outside the range printed on the test strip vial Do not use the meter the test strips or the control solution Contact Customer Care on 0800 121 200 UK or 1800 535 676 Ireland e The control solution range printed on the test strip vial is for OneTouch Vit
16. factured by anyone other than LifeScan has not been evaluated by LifeScan Call Customer Care on 0800 121 200 UK or 1800 535 676 Ireland Or visit us at www LifeScan co uk amp LIFESCAN AL afohmonsfohmon company 2009 LifeScan Inc LifeScan self test blood glucose monitoring devices conform to the following EU Directives IVDD 98 79 EC C Blood Glucose Meter Test Strips and Control Solution 0344 MDD 93 42 EEC C Lancets 0050 C C Blood Sampler tal LifeScan Inc Milpitas CA 95035 USA Ec REP LifeScan Regulatory Affairs Europe Division of Ortho Clinical Diagnostics France 1 rue Camille Desmoulins TSA 40007 92787 Issy les Moulineaux Cedex 09 France Distributed by LifeScan UK Ireland A div of Ortho Clinical Diagnostics Johnson amp Johnson 50 100 Holmers Farm Way High Wycombe Bucks HP12 4DP United Kingdom www LifeScan co uk Made in China Before you begin Before using this product to test your blood glucose carefully read this User Guide and the inserts that come with the OneTouch Vita Test Strips and OneTouch Vita Control Solution Intended use The OneTouch Vita Blood Glucose Monitoring System is intended to be used for the quantitative measurement of glucose sugar in fresh capillary whole blood The OneTouch Vita System is intended for self testing outside the body in vitro diagnostic use by people with diabetes at home and by heal
17. g flags may help you manage your diabetes ATTACHING MEAL FLAGS AND FASTING FLAGS TO YOUR TEST RESULTS 13 Using the flags feature Adding a meal flag or fasting flag 11 OCT 08 09 30 To add any flag the meal flag feature must be turned on When a glucose test result is displayed the up down arrows at the bottom left corner of the screen e will flash mea AV 11 0CT 08 09 30 Press LY or Y to select a flag and press Gy 7 7 Available flags are Blank no flag e FASTING mney AFTER MEAL 11 0CT 08 Choosing not to add a flag Indicates an after meal flag is added If you do not want to add a flag press amp instead of A or Y You wil go to the MAIN MENU Removing a flag from a result 11 OCT 08 You can remove a flag from any test result While your test result is displayed press or Y until none of the flag options are displayed Blank and press QB Your flag will be removed and you will go to the MAIN MENU Indicates no flag was added or flag is removed ATTACHING MEAL FLAGS AND FASTING FLAGS TO YOUR TEST RESULTS 14 Reviewing past results and averages Reviewing past results and averages If your meter is off press and hold amp until the meter turns on If you have just completed a test press Bs to get to the MAIN MENU From the MAIN MENU choose e LAST RESULT to view your most recent result e ALL RESULTS to review up to 500 of your most recent results or AVERAGES AVERAG
18. gertip sample in Section 2 for more information on applying the blood sample to the test strip See Interpreting unexpected results in Section 2 for more information on unexpected test results e See Testing with a fingertip sample in Section 2 for information on disposing the used lancet Forearm Palm TESTING YOUR BLOOD GLUCOSE 12 3 Attaching meal flags and fasting flags to your test results Turning the flags feature off Your meter allows you to attach a before meal after meal or fasting flag to your blood glucose results A before meal blood glucose test is taken just before the start of meal An after meal blood glucose test is typically taken one to two hours after the start of your meal A fasting blood glucose test is taken after you have not eaten for at least 8 hours Typically this is the first test of the day You can also add or remove a meal flag when reviewing a past result in the meter memory Your meter comes pre set with the flags feature turned on If you do not want to use this feature you can turn it off From the MAIN MENU press or Y to select SETTINGS and press Gy From the SETTINGS screen select FLAGS and press Q SETTINGS METER SETTINGS FLAGS SERIAL NUMBER MENU Press Y to highlight YES then press D to confirm the setting and ONET TOON return to the MAIN MENU CHANGE TO OFF NO a We suggest you talk to your healthcare professional to see how meal flags and fastin
19. ichever comes first or your results may be inaccurate Cleaning and caring for your meter Wipe the outside with a soft cloth dampened with water and mild detergent to remove dirt or other contaminants To avoid damaging your meter e Do not use alcohol or another solvent e Do not allow liquids dirt dust blood or control solution to enter the test strip port or the data port Refer to meter illustration in Section 1 Setting up your system e Do not spray cleaning solution on the meter or immerse it in any liquid Cleaning your lancing device and clear cap To clean these items wipe them with a soft cloth dampened with water and mild detergent to remove dirt or other contaminants Do not immerse the lancing device in any liquid as it may damage your lancing device To disinfect these items prepare a solution of one part household bleach to ten parts water Wipe the lancing device with a soft cloth dampened with this solution Immerse the caps only in this solution for 30 minutes Rinse briefly with water and allow both to air dry CARE AND MAINTENANCE 20 7 Troubleshooting and detailed information about your system Troubleshooting The OneTouch Vita Meter displays messages when there are problems with the test strip with the meter or when your blood glucose levels are higher than 33 3 mmol L or lower than 1 1 mmol L Improper use may cause an inaccurate result without producing an error message In this sectio
20. ite e Choose a spot away from bone veins and hair Massage the site to increase blood flow e Select a spot with no visible veins and avoid deep lines which may cause your blood sample to smear Forearm Palm TESTING YOUR BLOOD GLUCOSE 11 Lance your forearm or palm e Firmly press and hold the lancing device against the sample site e Looking through the clear cap you should see the sample site change colour as blood collects under the skin This lets you know that there is adequate blood to obtain a sufficient sample for testing Forearm or Palm e Press the release button while continuing to apply pressure Forearm e Keep holding the lancing device against your skin until a round drop of blood forms under the cap Do not press on the site excessively Forearm or Palm Remove the lancing device Carefully lift the lancing device away from your skin Do not smear the blood sample If the drop of blood runs or spreads due to contact with hair or a line in your palm Do not use the sample Try lancing again in a smoother area If bruising occurs at an alternate site or you have difficulty getting a sample consider sampling from a fingertip instead You may want to review the choice of sites with your healthcare professional Apply the sample to the test strip Keep your forearm or palm steady and use your other hand to bring the top edge of the test strip to the drop of blood e See Testing with a fin
21. juries Used test strips and lancets may be considered biohazardous waste in your area Be sure to follow your healthcare professional s recommendations or local regulations for proper disposal TESTING YOUR BLOOD GLUCOSE 9 Interpreting unexpected test results Refer to the following cautions whenever your test results are lower or higher than what you expect A CAUTION Low glucose results e If your test result is lower than 3 9 mmol L or is shown as LOW GLUCOSE it may mean hypoglycaemia low blood glucose Treat this condition immediately 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 e If you test at the low end of the operating range 10 C and your blood glucose is high you may get an inaccurate low result Re test in a warmer environment with a new test strip Dehydration and low glucose results e You may get false low glucose results if you are severely dehydrated If you think you are severely dehydrated contact your healthcare professional immediately High glucose results e If your test result is higher than 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 e HIGH GLUCOSE is displayed when your blood glucose level is higher than 33 3 mmol L You may have severe hyperglycaemia
22. meter on Display mmol L is the pre set unit of measurement AY Indicates selection and settings available using up or down button Up and down buttons Select or change OK button information Turns the meter on off Confirms selections and l settings Data port Connect to download to computer Turning your meter on Press and hold until the meter turns on After the black start up screen the MAIN MENU appears TEST STRIP Edge to apply sample Confirmation window NESS OnEToUCH lt c TOUCH Contact bars Insert into test strip port MAIN MEN LAST RESULT ALL RESULTS AVERAGES SETTINGS METER OFF A CAUTION If you see any light areas within the black start up screen there may be a problem with the meter Contact Customer Care on 0800 121 200 UK or 1800 535 676 Ireland SETTING UP YOUR SYSTEM 1 Setting the meter language date and time Before using your meter for the first time you should check these settings When using the meter for the first time you will automatically start at the LANGUAGE screen then the SETTINGS screen Go to the SETTINGS screen From the MAIN MENU press O MNNMENU Then press or W to Aor Y to highlight LAST RESULT select METER SETTINGS and SETTINGS and press QB ALL RESULTS press Q AVERAGES SETTINGS METER OFF If the pre set language date and time are correct press amp to return to the MAIN MENU If any setting is
23. n screens that display SEE USER S HANDBOOK means you should refer to this User Guide Message WARNING LOW GLUCOSE BELOW 1 1 mmol L HIGH GLUCOSE ABOVE 33 3 mmol L LOW GLUCOSE BELOW 1 1 mmol L CONTROL TEST What it means You may have a very low blood glucose level severe hypoglycaemia lower than 1 1 mmol L You may have a very high blood glucose level severe hyperglycaemia above 33 3 mmol L Your control solution test result is below 1 1 mmol L What to do This may require immediate treatment according to your healthcare professional s recommendations Although this message could be due to a test error it is safer to treat first and then do another test Re test your blood glucose If the result is HIGH GLUCOSE again obtain and follow instructions from your healthcare professional without delay Test again with control solution and a new test strip If the result is LOW GLUCOSE again do not use the meter Contact Customer Care on 0800 121 200 UK or 1800 535 676 Ireland TROUBLESHOOTING AND DETAILED INFORMATION ABOUT YOUR SYSTEM 21 Message What it means What to do Your control solution test result is above Test again with control solution and 33 3 mmol L a new test strip If the result is HIGH HIGH GLUCOSE GLUCOSE again do not use the meter ABOVE 33 3 mmol L Contact Customer Care on 0800 121 200 UK or 1800 535 676 Ireland CONTROL TEST Meter is too hot above 44 C to M
24. not correct press or VW to select CHANGE and press go to step 2 Choose a language Now press or Y to highlight the language you want and press Q Pressing G9 after making your selection confirms each setting and takes you to the next screen If at any point you make the wrong selection simply press and hold amp until the meter turns off Then turn the meter back on and re start from step 1 SELLING UP YOUR SYSTEM 2 SETTINGS METER SETTINGS FLAGS SERIAL NUMBER MENU ENGLISH 11 OCT 08 11S mmol L OK CHANGE LANGUAGE ENGLISH Set the date The date and time formats have been pre set You cannot change these settings DATE 11 OCT FANY In the DATE AND TIME screen press or VY to change the year and press OK Repeat these steps to set the month and day TIME 11 15 Set the time of day Press or VW to set the hour and press D Repeat this step to set the minutes DATE 11 OCT 2008 TIME fl 15 SETTINGS Confirm your settings If your settings are correct press amp to save them and return to the MAIN MENU ENGLISH 11 OCT 08 If not press or W to highlight CHANGE and press Q You will return to the LANGUAGE screen 11 15 CHANGE A WARNING The unit of measure mmol L should be displayed here If your display shows mg dL rather than mmol L contact Customer Care on 0800 121 200 UK or 1800 535 676 Ireland You cannot change the unit of mea
25. ntact bars facing you APPLY SAMPLE 6 Test strip port When the APPLY SAMPLE screen appears on the display you can apply your blood sample Lance your finger Hold the lancing device firmly against the side of your finger Press the release button Approximate size Get a round drop of blood Gently squeeze your finger until you get a round drop of blood If the blood smears or runs Do not use that sample Wipe the area and gently squeeze another drop of blood or puncture a new site TESTING YOUR BLOOD GLUCOSE 7 Applying blood and reading results Prepare to apply the sample Keeping your finger extended and steady move the meter and test strip toward the blood drop Fingertip Do not apply blood on the top of the test strip Do not hold the meter and test strip underneath the blood drop This may cause blood to run into the test strip port and damage the meter Apply the sample Line up the test strip with the blood drop so that the narrow channel on the edge of the test strip is almost touching the edge of the blood drop Gently touch the channel to the edge of the blood drop Be careful not to push the test strip against your fingertip or the test strip may not fill completely e Do not smear or scrape the drop of blood with the test strip e Do not apply more blood to the test strip after you have moved the drop of blood away e Do not move the test strip in the meter during a
26. o results in memory to display 03 OCT T 1323 ong MORDUA 01 OCT 10 12 HI MENU LAST BFR 7 DAYS 14 DAYS 6 4 30 DAYS 6 9 MENU LAST NUM 7 DAYS 0 14 DAYS 21 30 DAYS 30 MENU TROUBLESHOOTING AND DETAILED INFORMATION ABOUT YOUR SYSTEM 24 Detailed information about your system Technical specifications Reported result range 1 1 33 3 mmol L Calibration Plasma equivalent Sample Fresh capillary whole blood Test time 5 seconds Assay method Glucose oxidase biosensor Meter power source One 3 0 Volt CR 2032 lithium battery or equivalent Unit of measure mmol L Memory 500 test results System Accuracy Automatic shutoff Size Weight Operating ranges Battery ratings About 2 minutes after last action 95x65x25mm Approximately 58 grams with battery Temperature 10 44 C Relative humidity 10 90 Altitude up to 3048 metres Haematocrit 30 55 1x3 0V d c 60 mA 1 x CR 2032 battery or equivalent direct current Diabetes experts have suggested that glucose meters should agree within 0 83 mmol L of a laboratory method when the glucose concentration is lower than 4 2 mmol L and within 20 of a laboratory method when the glucose concentration is 4 2 mmol L or higher Samples from 100 diabetic patients at 1 clinical center were tested using both the OneTouch Vita System and the YSI Model 2300 Glucose Analyser laboratory test TROUBLESHOOTING AND DETAILED INFORMATION ABOUT YOUR SYSTEM
27. on your forearm or palm when e You think your blood glucose is rapidly falling such as within two hours of exercise or a rapid acting insulin injection or insulin pump bolus Testing with a fingertip sample may identify hypoglycaemia or an insulin reaction sooner than testing with a forearm or palm sample e t has been less than two hours after a meal a rapid acting insulin injection or insulin pump bolus physical exercise or you think your glucose level is changing rapidly e You are ill or during times of stress e You are concerned about the possibility of hypoglycaemia or an insulin reaction such as when driving a car This is especially important if you suffer from hypoglycaemia unawareness lack of symptoms to indicate an insulin reaction Getting a blood sample Getting a blood sample from your forearm or palm is different than getting a sample from your fingertips Follow these instructions to get a sufficient blood drop for testing Before testing make sure to wash the puncture site with soap and water Rinse and dry thoroughly The clear cap is for forearm and palm sampling only Replace the blue cap with the clear cap Insert a lancet and snap on clear cap Carefully insert a new sterile lancet Snap on the clear cap Adjust the depth setting You may need a deeper setting to get a sufficient sample for testing Twist the cap to increase the depth Be sure to cock the lancing device Choose a sample s
28. ove the meter and test strips to a work correctly cooler area Insert a new test strip when silt RE the meter and test strips are within the operating range 10 44 C If you do SS anaes not get another TEMPERATURE ERROR SEE USER S HANDBOOK message you can proceed with testing Meter is too cold below 10 C to Move the meter and test strips to a TEMPERATURE work correctly warmer area Insert a new test strip ERROR when the meter and test strips are within TEMPERATURE the operating range 10 44 C If you do TOO LOW not get another TEMPERATURE ERROR SEE USER S HANDBOOK message you can proceed with testing There is a problem with the meter Do not use the meter Contact ERROR 1 Customer Care on 0800 121 200 UK or 1800 535 676 Ireland METER PROBLEM CONTACT CUSTOMER SERVICE TROUBLESHOOTING AND DETAILED INFORMATION ABOUT YOUR SYSTEM 22 Message WARNING ERROR 2 METER OR STRIP PROBLEM RETEST WITHA NEW STRIP ERROR 3 METER WAS NOT READY RETEST WITHA NEW STRIP ERROR 4 STRIP PROBLEM SEE USER S HANDBOOK WARNING ERROR 5 STRIP PROBLEM OR SAMPLE TOO SMALL RETEST WITHA NEW STRIP WARNING Com LOW BATTERY REPLACE BATTERY SOON SEE USER S HANDBOOK 11 0CT 08 mmol L T V AFTER MEALL What it means Error message could be caused either by a used damaged test strip or a problem with the meter The sample was applied before the meter was ready If this m
29. st strip See Applying blood and reading results in Section 2 or Section 5 Control solution testing for instructions on properly filling the confirmation window Contact Customer Care on 0800 121 200 UK or 1800 535 676 Ireland This message will appear when you turn the meter on and there is enough power for a minimum of 100 more tests Press to continue but replace the battery as soon as possible see Changing the battery in Section 6 Once the LOW BATTERY REPLACE BATTERY SOON message is displayed this symbol will continue to appear until you replace the battery Test results will still be accurate but replace the battery as soon as possible see Changing the battery in Section 6 TROUBLESHOOTING AND DETAILED INFORMATION ABOUT YOUR SYSTEM 23 Message What it means What to do WARNING Meter battery does not have enough power to Replace meter battery see Changing the battery Cm perform a test in Section 6 LOW BATTERY REPLACE BATTERY NOW SEE USER S HANDBOOK No result in memory such as the first time use You can still perform a blood glucose test and get of the meter or your meter was unable to recall an accurate result this result This result will not be included in NO DATA result averages AL RESULTS Your meter was unable to recall this result This You can still perform a blood glucose test and get mmol L result will not be included in result averages an accurate result 04 OCT 09 44 LO since there are n
30. sure Use of the wrong unit of measure may cause you to misinterpret your blood glucose level and may lead to incorrect treatment SEITING UP YOUR SYSTEM 3 Checking the meter serial number You can check your meter serial number at any time Go to the SERIAL NUMBER screen From the MAIN MENU press or YJ to highlight SETTINGS and press QB Then press or VW to select SERIAL NUMBER and press QJ METER SETTINGS FLAGS SERIAL NUMBER Your serial number is displayed Press 9 to return to the MAIN MENU LAXGLOQ6 Turning your meter off after setup There are three ways to turn your meter off Press and hold Q for three seconds Or e Your meter will turn off by itself if left alone for about two minutes Or From the MAIN MENU press or VY to highlight METER OFF then press GB SETTING UP YOUR SYSTEM A Testing your blood glucose Testing with a fingertip sample Preparing for a test Have these things ready when you test OneTouch Vita Meter OneTouch Vita Test Strips Lancing device Sterile lancets e Use only OneTouch Vita Test Strips e Unlike some blood glucose meters no separate step to code your OneTouch Vita system is required e Make sure your meter and test strips are about the same temperature before you test e For the most accurate results test as close to room temperature 20 25 C as you can see Detailed information about your system in Section 7
31. thcare professionals in a clinical setting as an aid to monitor the effectiveness of diabetes control It should not be used for the diagnosis of diabetes or for testing newborns Test principle Glucose in the blood sample mixes with special chemicals in the test strip and a small electric current is produced The strength of this current changes with the amount of glucose in the blood sample Your meter measures the current calculates your blood glucose level displays the result and stores it in its memory The OneTouch Vita Blood Glucose Monitoring System INCLUDED WITH YOUR KIT OneTouch Vita Test Strips e Sterile Lancet OneTouch Vita Meter battery included If the lancing device shown here is not included with your kit see the user instructions for that lancing device Lancing Device AVAILABLE SEPARATELY OneTouch Vita Control Solution Clear Cap Control solution is available free of charge from Customer Care on 0800 121 200 UK or 1800 535 676 Ireland A WARNING Keep the meter and testing supplies away from young children Small items such as the battery door battery test strips lancets protective covers on the lancets and control solution vial cap are choking hazards Do not ingest or swallow any items Setting up your system The OneTouch Vita Blood Glucose Meter and test strips METER Test strip port Insert test strip here to turn
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