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OneTouch® Verio™ User Guide Australia English

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Contents

1. A CAUTION If the words CONTROL SOLUTION do not appear on the screen repeat the test with a new test strip Ifthe problem persists contact Customer Service 1800 LifeScan Customer Service is available from 8 00AM to 6 00PM Monday Friday NOTE The result will be included in your averages and your averages will change too Check if the result is in range Compare the result displayed on the meter to the range printed on your OneTouch Verio Control Solution vial If your control solution result falls outside the expected range repeat the test with a new test strip Cleaning Clean the top of the control solution cap with a clean damp tissue or cloth Out of range results may be due to Not following the instructions detailed in Steps 1 5 Control solution is contaminated expired or past its discard date Test strip or test strip vial is damaged expired or past its discard date Giz F m 5 i ONETOUCH Verio a OneTouch Verio 5 7 7 7 mmol L Example range 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 see Step 2 Control solution results can be seen when reviewing past results but are not included in result averages AX CAUTION to 6 00PM Monday Friday for your blood gluco
2. Have these things ready when you test OneTouch Verio Meter OneTouch Verio Test Strips Lancing device Sterile lancets Use only OneTouch Verio Test Strips When you first open a vial of test strips record the discard date on the label Refer to the test strip insert or vial label for instructions on determining the discard date Unlike some blood glucose meters no separate step to code your OneTouch Verio System is required Make sure your meter and test strips are about the same temperature before you test Do Not open the test strip vial until you are ready to test Use the test strip immediately after removing it from the vial 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 After removing a test strip from the vial immediately close the lid tightly to avoid contamination and damage Store unused test strips only in their original vial After performing a test Do Not put the used test strip back in the vial Do Not re use a test strip that had blood or control solution applied to it Otherwise you may get an inaccurate low result 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 test strips in any way gt A CAUTION Do Not use your test strips if your vial i
3. screen there may be a problem SELJE with the meter Contact Customer Service 1800 LifeScan Customer Service is available from 8 00AM to 6 00PM Monday Friday Using the display backlight When the meter is on press and hold Q any time you want to turn the display backlight on or off Setting the meter language audio 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 go to Step 2 Go to the SETUP screen MAIN MENU From the MAIN MENU press 29 or E to highlight SETUP and press LAST RESULT ALL RESULTS RESULT AVG SETUP AV Then press ZA or Gd to select METER SETTINGS and press SET UP METER SETTINGS FLAGS COMMENTS SETTING UP YOUR SYSTEM 2 Choose a language Press ZY or EZ to highlight the language you want and press g Pressing fox after making your selection confirms each setting and takes you to the next screen When setting up your meter you can press to return to the previous screen to adjust a setting Set the audio function You can set your meter to beep to notify you during certain meter operations With the audio function on you will hear One beep when it is time to apply your sample or when a test result is displayed and Two beeps to alert you to a problem with the meter or test procedure Press or EZ to highligh
4. select Press or EZ to highlight ON E or EZ to select SETUP and FLAGS COMMENTS and press or OFF and press press Add or change a meal flag Meal flags and comments can be added right after you get a test result You can also change meal flags and comments when reviewing past results After testing your blood glucose result is displayed and appears to the right of MEAL FLAG on top of the screen MEAL FLAG a MEAL FLAG BEFORE MEAL AFTER MEAL a mmol L mmol L COMMENT w COMMENT w 08 10 10 1 45PM NOFLAG av 08 10 10 1 45PM Press Ato display the MEAL Press or EZ to highlight Your meal flag will appear here FLAG screen BEFORE MEAL or AFTER MEAL and press ATTACHING MEAL FLAGS OR COMMENTS TO YOUR TEST RESULTS 12 To change or remove a meal flag attached to a past result highlight the individual result see Section 4 Reviewing past results and averages The result screen will be displayed Follow steps 1 and 2 to change the meal flag To remove a meal flag highlight NO FLAG and press Add or change a comment When a glucose test result is displayed after a test W appears to the right of COMMENT at the bottom of the screen Press EZ to display the comment screen MEAL FLAG amp E mmol L COMMENT w 08 10 10 1 45PM Press 9 or EZ to highlight the desired COMMENT and press Available comments COMMENT NO COMMENT STRESS NOT ENO
5. very low blood glucose level severe hypoglycaemia below 1 1 mmol L You may have a very high blood glucose level severe hyperglycaemia over 33 3 mmol L Meter is too hot above 44 C or too cold below 6 C to work correctly There is a problem with the meter Error message could be caused either by a used test strip or a problem with the meter The sample was applied before the meter was ready What to do This may require immediate treatment according to your health care 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 health care professional right away Move the meter and test strips to a cooler or 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 TEMPERATURE ERROR message you can proceed with testing Do Not use the meter Contact Customer Service 1800 LifeScan Customer Service is available from 8 00AM to 6 00PM Monday Friday 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 Service 1800 LifeScan Customer Service is available from 8 00AM to 6 00PM Monday Friday Repeat the te
6. 30 day periods leading up to the current date the meter will display the number of results obtained NUM and the average of those results AVG From any screen showing averages press Qio go back to the previous screen If you do not have results in the past 7 14 and 30 day periods the NUM and AVG columns will show zero 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 Interpreting unexpected test results in Section 2 for more information on high and low glucose results RESULT AVG ALL RESULTS AVG BEFORE MEAL AVG AFTER MEAL AVG MENU avy ALL RESULTS AVG mmol L DAYS NUM AVG i 14 8 1 14 34 TT 30 43 T5 AFTER MEAL AVG mmol L DAYS NUM AVG 7 0 0 14 0 0 30 0 The meter calculates averages based on the 7 14 and 30 day periods ending on the current date setting If you change your date setting your averages may change too Result averages provide information from past results Do Not use result averages to make immediate treatment decisions Downloading results to a computer OneTouch Diabetes Management Software DMS can store all of your records and help you spot patterns for planning meals exercise insulin dosing and medication For order information and to learn more about downloading data to a computer visit www OneTouch com au or contact Customer Service 1800 LifeScan Customer Service is available from 8 00
7. 797 150 6 863 801 6 872 298 7 045 046 and 7 498 132 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 Purchase of this device does not act to grant a use license under these patents Such a license is granted only when the device is used with OneTouch Verio Test Strip No test strip supplier other than LifeScan is authorised to grant such a license The accuracy of results generated with LifeScan meters using test strips manufactured by anyone other than LifeScan has not been evaluated by LifeScan Symbols Cautions and Warnings Refer to the User Guide and inserts that came with your system for safety related information Direct current Consult Instructions for Use Backlight On Off Low Battery In Vitro Diagnostic Medical Device Do not reuse Manufacturer Serial number Eee Contains sufficient for lt n gt tests Upper storage temperature limitation Lot Number r e 4 Expiration Date serf Sterilised by irradiation HOB Oo gt 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 Verio Test Strips and OneTouch Verio Control Solution 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
8. AM to 6 00PM Monday Friday To transfer meter data follow the instructions provided with the OneTouch DMS to download the results from the meter Once the command to start the download is sent from the computer to the meter the meter display will show PC indicating that the meter is in communication mode A WARNING To avoid possible shock Do Not insert a test strip while the meter is connected to a computer PC REVIEWING PAST RESULTS AND AVERAGES 15 Control solution testing When to test with control solution OneTouch Verio Control Solution is used to check that the meter and test strips are working together properly and that you are performing the test correctly Control solution is available separately Use only OneTouch Verio Control Solution Any level can be used to check your system e When you first open a new vial of control solution record the discard date on the vial label Refer to the control solution insert or vial label for instructions on determining the discard date Make sure your meter test strips and control solution are at the same temperature before testing e Tightly close the cap on the control solution vial immediately after use to avoid contamination or damage A CAUTION Do Not swallow or ingest control solution Do Not apply control solution to the skin or eyes as it may cause irritation Do Not use control solution after the expiration da
9. Customer Service 1800 LifeScan Customer Service is available from 8 00AM to 6 00PM Monday Friday Check your meter settings Battery Meter battery door Backlight battery Backlight battery Removing the meter battery will not affect your stored results However you may need to re set your meter settings See Setting the meter language audio date and time in Section 1 O Dispose of batteries Dispose of batteries according to your local environmental regulations CARE AND MAINTENANCE 19 7 Troubleshooting and detailed information about your system Troubleshooting The OneTouch Verio Meter displays messages when there are problems with the test strip with the meter or when your blood glucose levels are above 33 3 mmol L or below 1 1 mmol L Improper use may cause an inaccurate result without producing an error message In this section screens that display SEE OWNER S BOOKLET mean you should refer to this User Guide Message WARNING LOW GLUCOSE BELOW 1 1 mmol L WARNING HIGH GLUCOSE ABOVE 33 3 mmol L WARNING TEMPERATURE ERROR OUT OF OPERATING RANGE SEE OWNER S BOOKLET WARNING ERROR 1 METER PROBLEM CALL CUSTOMER SERVICE WARNING ERROR 2 METER OR STRIP PROBLEM RETEST WITHA NEW STRIP WARNING ERROR 3 METER WAS NOT READY RETEST WITHA NEW STRIP What it means You may have a
10. ONE OUCH Verio Blood Glucose Monitoring System USER GUIDE Owner s Booklet refers to User Guide Contents Setting up your system Testing your blood glucose 3 Attaching meal flags or comments to your test results 12 4 Reviewing past results and averages 14 Control solution testing 16 oo Care and maintenance Troubleshooting and detailed information about your system 20 LifeScan self test blood glucose monitoring devices conform to the following EU Directives IVDD 98 79 EQ C Blood Glucose Meter Test Strips 0344 and Control Solution MDD 93 42 EEC C Lancets 0120 Distributed by Johnson amp Johnson Medical Pty Ltd C E Blood sampler 1 5 Khartoum Road North Ryde NSW 2113 Australia Customer Service ABN 85 000 160 403 Call Customer Service 1800 LifeScan Customer Service is available from 8 00 AM to 6 00 PM Monday Friday www OneTouch com au LifeScan Inc 1000 Gibraltar Dr If you have any questions about the use of any LifeScan product Milpitas CA 95035 USA contact Customer Service 1800 LifeScan Customer Service is available from 8 00 AM to 6 00 PM Monday Friday If you cannot reach Customer Service contact your health care Ef LIFESCAN professional for advice RL afohmon fohmon company 2010 LifeScan Inc The system described herein is covered by one or more of the following U S patents 6 179 979 6 193 873 6 284 125 6 475 372 6 716 577 6 749 887 6
11. 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 Lifetime Warranty By completing and returning the warranty application enclosed you can become a member of the Johnson amp Johnson Medical JJM Pty Ltd OneTouch Verio Program This membership provides you with the OneTouch Verio warranty by JJM which covers you for both the blood glucose meter you have just purchased and any replacement meter you receive from JJM in the future The OneTouch Verio warranty covers any defects in material or workmanship whenever appearing but does not apply to battery defects accidental damage normal wear and tear or if the meter is misused TROUBLESHOOTING AND DETAILED INFORMATION ABOUT YOUR SYSTEM 24
12. UGH FOOD ILLNESS NO COMMENT TOO MUCH FOOD FEEL HYPO MILD EXERCISE MENSES period TIMEX RICE HARD EXERCISE VACATION MEDICATION OTHER 10f3 av AFTER MEAL amp Your comment will appear here To change or remove a comment attached to a past result highlight the individual result see Section 4 Reviewing past results and averages The result screen will be displayed Follow steps 1 and 2 to change the comment To remove a previously entered comment highlight NO COMMENT and press ATTACHING MEAL FLAGS OR COMMENTS TO YOUR TEST RESULTS 13 4 Reviewing past results and averages Reviewing past results and averages If your meter is off press and hold fox until the black start up screen appears Once the black start up screen is displayed release g If you have just completed a test press Bto get to the MAIN MENU from the result screen From the MAIN MENU choose LAST RESULT to view your most recent result ALL RESULTS to review up to 500 of your most recent results RESULT AVG to view averages for RESULT AVG all test results all before meal results all after meal results MAIN MENU SETUP Press N or BZ to highlight your selection and press g Mealflag Unitof measure Last result AFTER MEAL The meter will display your most recent result Press amp to return to the MAIN MENU E mmol L Comment TOO MUCH FOOD w 08 10 10 1 45PM Date Time All results The mete
13. 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 Intended use The OneTouch Verio Blood Glucose Monitoring System is intended to be used for the quantitative measurement of glucose sugar in fresh capillary whole blood The OneTouch Verio System is intended for self testing outside the body in vitro diagnostic use by people with diabetes at home and by health care professionals in a clinical setting as an aid to monitor the effectiveness of diabetes control The OneTouch Verio Blood Glucose Monitoring System should not be used for The diagnosis of diabetes e Testing newborns Patients within 24 hours of receiving a D xylose absorption test as it may cause inaccurately high results The OneTouch Verio Blood Glucose Monitoring System INCLUDED WITH YOUR KIT Sterile Lancet ONETOUCH Verio Lancing Device Carrying Case OneTouch Verio Meter OneTouch Verio batteries included Test Strips If another type of lancing device was included see the separate instructions for that lancing device AVAILABLE SEPARATELY REARS Mic Corie bowton Une wt Onetan Pern Soete ONETOUCH Verio Clear Cap Ne OneTouch Verio Control Solution For availability of control solution contact Customer Service 1800 LifeScan or contact www OneTouch
14. ars on the display along with the unit of measure and the date and time of the test If mmol L does not appear with the test result contact Customer Service 1800 LifeScan Customer Service is available from 8 00AM to 6 00PM Monday Friday A CAUTION If the words CONTROL SOLUTION appear on the screen repeat the test with a new test strip Bi orgs If the problem persists contact Customer Service 1800 LifeScan Customer Service is available from 8 00AM to 6 00PM Monday Friday pe oK Example After getting a result Once you have your result you may Attach meal flags or comments to this result see Section 3 Attaching meal flags or comments to your test results Or Review your meter memory by pressing ox see Section 4 Reviewing past results and averages Or 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 Used test strips and lancets may be considered biohazardous waste in your area Be sure to follow your health care professional s recommendations or your local regulations for proper disposal TESTING YOUR BLOOD GLUCOSE 8 Interpreting unexpected test results Refer to the following cau
15. be included in result averages Your meter was unable to recall this result This result will not be included in result averages 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 If the error message appears again contact Customer Service 1800 LifeScan Customer Service is available from 8 00AM to 6 00PM Monday Friday Repeat the test with a new test strip see Applying blood and reading results in Section 2 or Section 5 Control solution testing If the error message appears again contact Customer Service 1800 LifeScan Customer Service is available from 8 00AM to 6 00PM Monday Friday This symbol is displayed when the meter battery is low and will continue to appear until the battery is replaced Test results will still be accurate but replace the battery as soon as possible see Replacing the batteries in Section 6 If this error is displayed while the meter is in the operating range 6 44 C replace the meter battery immediately see Replacing the batteries in Section 6 If this error is displayed when the meter is cold move the meter and test strips to a warmer area and test again with a new test strip when the meter and test strips are within the operating range 6 44 You can still perform a blood glucose test and get an accurate result Contact Customer Service 1800 LifeScan Customer Service is available
16. ce in any liquid To disinfect these items prepare a solution of one part household bleach to nine 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 18 Replacing the batteries Your OneTouch Verio Meter uses two 3 0 Volt CR 2032 lithium batteries One battery powers the meter only and the other powers the backlight See Troubleshooting in Section 7 for information on when to change the meter battery Replace the backlight battery when the backlight no longer comes on Remove the old battery Start with the meter turned off Open the battery door and pull up firmly on the plastic battery tab The plastic battery tab with the symbol is for the meter battery and the plastic tab with the symbol is for the backlight battery A WARNING To avoid a possible shock Do Not change either battery while the meter is connected to a computer Insert the new battery With the side facing up toward you place the battery in the compartment within the fold of the plastic battery tab 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 meter battery check that the battery is correctly installed with the side up If the meter still does not power on contact
17. com au or ask for control solution where you obtain your test strips For availability of the Clear Cap contact Customer Service 1800 LifeScan or contact www OneTouch com au A 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 solution vial cap are choking hazards Do Not ingest or swallow any items Setting up your system The OneTouch Verio Blood Glucose Meter and Test Strips Test strip port TEST STRIP Insert test strip here to turn meter on Display mmol L is the pre set Channel to unit of measure apply sample AV Indicates menu selection available using ONETOUCH Wats up or down button Silver prongs Insert into test strip port i OK button Turns the meter on off Back button e Confirms menu Go back to selections previous screen Up and down buttons Press and Data port Connect to download hold to turn Select or change i information backlight on off sp campiei SETTING UP YOUR SYSTEM 1 Turning your meter on MAIN MENU Press and hold until the black start up screen appears Once the black start up screen is displayed LAST RESULT release After the black start up screen the MAIN MENU is displayed fees teases pment p ayec RESULT AVG A CAUTION If you see any light areas within the black start up
18. djust 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 TESTING YOUR BLOOD GLUCOSE 10 Choose a sample site Before testing wash your hands and forearm if applicable thoroughly with warm soapy water Rinse and dry Choose a fleshy spot away from bone veins and hair Gently massage or apply warmth to the site to increase blood flow Select a fleshy spot with no visible veins and avoid deep lines which may cause your blood sample to smear Lance your forearm or palm Firmly press and hold the lancing device against the sample site Looking through the clear cap wait until you see the sample site change colour as blood collects under the skin This lets you know that there is enough blood to obtain a sufficient sample for testing Press the release button while continuing to apply pressure Hold the lancing device firmly against your skin until a round drop of blood forms under the cap You may need to wait a little longer to get a large enough drop of blood from the forearm or palm Do Not squeeze the site excessively Remove the lancing device Carefully lift the lancing device away from your skin without smearing the sample If your sample runs or spreads because of hair on the forearm or a line in your palm sample again in another area Apply the sample to the test strip Keep your f
19. from 8 00AM to 6 00PM Monday Friday to report this occurrence unless this is your first use of the meter You can still perform a blood glucose test and get an accurate result but contact Customer Service 1800 LifeScan Customer Service is available from 8 00AM to 6 00PM Monday Friday to report this occurrence TROUBLESHOOTING AND DETAILED INFORMATION ABOUT YOUR SYSTEM 21 Detailed information about your system Comparing meter results to laboratory results Results obtained from the OneTouch Verio Meter and laboratory tests are reported in plasma equivalent units However your meter result may differ from your lab result due to normal variation A result from your OneTouch Verio Meter is considered accurate when it is within 15 of the lab result Meter results can be affected by factors that do not affect lab results in the same way which may cause a difference of more than 15 Specific factors that may cause your meter result to vary from your lab result by more than 15 include e You have eaten recently This can cause a result from fingertip testing to be up to 3 8 mmol L higher than a lab test using blood drawn from a vein Your haematocrit is above 60 or below 20 e You are severely dehydrated e For additional information refer to the OneTouch Verio Test Strip Insert Guidelines for obtaining accurate meter to lab comparisons Before going to the lab Perform a control solution test
20. ing device clean Never share a lancet or a lancing device with anyone see Caring for your system in Section 6 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 cover and save it for later use the 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 O Insert a test strip to turn the meter on Insert the test strip into the test strip port with the gold side of the strip and the two silver prongs facing you No separate step to code the meter is required A When the APPLY SAMPLE screen appears on the display you can apply APPLY your blood sample 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 f
21. inger until you get a round drop of blood If the blood smears or runs Do Not use that sample Otherwise you may get an inaccurate low result Wipe the area and gently squeeze another drop of blood or puncture a new site Applying blood and reading results Apply the sample to the test strip Anl rane pply drop You can apply blood to either side of the test strip Apply your sample to af hinod here the opening of the channel Test strip port Silver prongs ee Holding the meter at a slight angle guide the channel to the blood drop When it touches your sample the test strip wicks blood into Channel the channel TESTING YOUR BLOOD GLUCOSE 7 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 counts 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 e 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 e Do Not move the test strip in the meter during a test Do Not remove the test strip until the result is displayed Read your result on the meter Your blood glucose level appe
22. orearm or palm steady and use your other hand to bring the side of the test strip channel to the drop of blood See Testing with a fingertip sample in Section 2 for more information on applying the blood sample to the test strip a Forearm Forearm or Palm See Interpreting unexpected test results in Section 2 Forearm for more information on unexpected test results TESTING YOUR BLOOD GLUCOSE 11 3 Attaching meal flags or comments to your test results Your OneTouch Verio Meter allows you to attach notes to any blood glucose result There are two kinds of notes and different reasons to use them Allows you to link the effects of food to your blood glucose results Provides you with separate averages for before meal and after meal tests Select an appropriate comment whenever you Helps track possible reasons for test results test under conditions that you or your health care professional feel are worth noting ry We suggest you talk to your health care professional to see how meal flags and comments may help you manage your diabetes Turning the meal flags comments feature on and off Before using your meter for the first time you should check this setting MAIN MENU SETUR FLAGS COMMENTS LAST RESULT ALL RESULTS METER SETTINGS ON RESULT AVG FLAGS COMMENTS SETUP Ay Av Av From the MAIN MENU press From the SETUP screen
23. r will display four results at a time starting with the most recent The following symbols may also appear HI ifthe result was above 33 3 mmol L ALL RESULTS LO if the result was below 1 1 mmol L aT if a comment was added to the result C if the result is from a control solution test see Section 5 Control solution testing 18 09 8 15AM 5 0 if the result is flagged BEFORE MEAL 17 09 10 23AM 6 2 C if the result is flagged AFTER MEAL 16 09 11 44AM HI 1 of 4 MENU Av When the memory is full the oldest result is erased as the newest is added Press Z to move backward and ZY to move forward through your results Pressing and holding ZY or Gd allows you to move more quickly To view details of an individual result press ZY or BZ to highlight the result then press g If you wish to add or change a meal flag or comment for this result see Section 3 Attaching meal flags or comments to your test results To return to the previous screen press Q To return to the MAIN MENU highlight MENU then press g REVIEWING PAST RESULTS AND AVERAGES 14 Result averages The meter will display three types of averages e All test results Before meal results After meal results If the flags comments feature is off selecting RESULT AVG from the MAIN MENU will lead directly to the ALL RESULTS AVG screen To return to the MAIN MENU from the RESULT AVG screen highlight MENU then press g For each of the 7 14 and
24. rm or palm when You think your blood glucose is rapidly falling such as within two hours of exercise or a rapid acting insulin injection or pump bolus Testing with a fingertip sample may identify hypoglycaemia or an insulin reaction sooner than testing with a forearm or palm sample It has been less than two hours after a meal a rapid acting insulin injection or pump bolus physical exercise or you think your blood glucose level is changing rapidly 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 Remember Consult your health care professional before using your forearm or palm for testing lt Choose a different puncture site each time you test Repeated punctures in the same spot may cause soreness and calluses 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 health care professional 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 Insert a lancet and snap on clear cap Carefully insert a new sterile lancet Snap on the clear cap A
25. s damaged or left open to air This could lead to error messages or inaccurate results If you find that the vial is uncapped or damaged in any way before you begin using a new vial of test strips contact Customer Service at 1800 LifeScan immediately Customer Service is available from 8 00AM to 6 00PM Monday Friday This meter meets all applicable standards but some cell phones may interfere with the proper operation of your meter if next to the meter during testing e Ifyou cannot test due to a problem with your testing supplies contact your health care 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 TESTING YOUR BLOOD GLUCOSE 5 Lancing Device Cocking control Release button Sterile lancet Clear cap for forearm and palm testing Lancing device cap See Testing with a forearm or palm sample in Section 2 for fingertip testing Protective cover Lancet point A CAUTION To reduce the chance of infection Make sure to wash the sample site with soap and warm Always use a new sterile lancet each time you test water rinse and dry before sampling Always keep your meter and lanc
26. se level CONTROL SOLUTION TESTING 17 If you continue to get control solution test results that fall outside the range printed on the control solution vial Do Not use the meter test strips or control solution Contact Customer Service 1800 LifeScan Customer Service is available from 8 00AM Control solution ranges printed on control solution vials are for control solution tests only and are not recommended ranges Care and maintenance 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 below 30 C but Do Not refrigerate Keep all items away from direct sunlight and heat Cleaning and caring for your meter Wipe the outside with a soft cloth dampened with water and mild detergent 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 Refer to meter illustration in Section 1 Setting up your system Do Not spray cleaning solution on the meter or immerse it in any liquid NOTE For health care professionals or caregivers who assist multiple users to disinfect the meter cleanse the meter using a 10 bleach solution nine parts water one part bleach Cleaning your lancing device and clear cap To clean these items wipe them with a soft cloth dampened with water and mild detergent Do Not immerse the lancing devi
27. st with a new test strip Apply a blood or control solution sample only after APPLY SAMPLE appears on the display If this message continues to appear contact Customer Service 1800 LifeScan Customer Service is available from 8 00AM to 6 00PM Monday Friday TROUBLESHOOTING AND DETAILED INFORMATION ABOUT YOUR SYSTEM 20 Message WARNING ERROR 4 STRIP FILL PROBLEM RETEST WITHA NEW STRIP WARNING ERROR 5 STRIP PROBLEM RETEST WITHA NEW STRIP 5 E mmol L 08 10 10 1 45PM WARNING m LOW BATTERY REPLACE BATTERY NOW SEE OWNER S BOOKLET ALL RESULTS mmol L 19 09 2 25PM 5 7 17 09 10 23AM 6 2 C 16 09 11 44AM HI 1of4 MENU av 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 The meter has detected a problem with the test strip Possible cause is test strip damage Meter battery is low but still has enough power to perform a test Meter battery does not have enough power to perform a test Meter may be too cold below 6 C to work correctly No result in memory such as the first time use of the meter Or Your meter was unable to recall this result This result will not
28. t ON or OFF and press Set the date In the DATE SET UP screen press A or BZ to change the first value and press g Repeat these steps to set the second value then the year SETTING UP YOUR SYSTEM 3 LANGUAGE ENGLISH DATE SET UP SET DATE 0 10 2010 DD MM YYYY Set the time of day TIME SET UP Press or BZ to set the hour and press g Repeat this step to set the minutes SET TIME Press N or EZ to set AM or PM and press 9 f 15 PM Confirm your settings SETTINGS If your settings are correct make sure that YES is highlighted then press to save them ENGLISH and return to the MAIN MENU 08 10 10 11 15 AM If you need to change a setting press ZY or BZ to highlight NO and press g You will return to the LANGUAGE screen A WARNING The unit of measure mmol L should be displayed here If your display shows mg dL rather than mmol L contact Customer Service 1800 LifeScan Customer Service is available from 8 00AM to 6 00PM Monday Friday Use of the wrong unit of measure may cause you to misinterpret your blood glucose level and may lead to incorrect treatment Turning your meter off after setup There are two ways to turn your meter off Press and hold for one second Or Your meter will turn off by itself if left alone for two minutes SETTING UP YOUR SYSTEM 4 2 Testing your blood glucose Testing with a fingertip sample Preparing for a test
29. te printed on the vial label or the discard date whichever comes first or your results may be inaccurate Do a control solution test e Whenever you open a new vial of test strips Ifyou have had repeated unexpected blood If you suspect that the meter or test strips are not glucose results working properly If you drop or damage the meter 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 Prepare the control solution Remove the vial cap and place it on a flat Wipe both the tip of the control solution vial and the top of the surface with the top of the cap pointing up cap with a clean damp tissue or cloth Squeeze the vial to discard the first drop Then squeeze a drop into the small well on the top of the cap or onto another clean non absorbent surface CONTROL SOLUTION TESTING 16 Apply the control solution Hold the meter so that the side edge of the test strip is at a slight angle to the drop of control solution Touch the channel on the side of the test strip to the control solution Wait for the channel to fill completely Read your result The meter will count down from 5 to 1 Your result is displayed along with the date time unit of measure and the words CONTROL SOLUTION The meter automatically marks the result as a control solution test
30. thin 20 OneTouch Verio System meets this higher accuracy specification 303 486 62 4 446 486 91 8 481 486 99 0 485 486 99 8 and exceeds the goal suggested by diabetes experts System Accuracy Results across the entire Glucose Range ae F Percent and number of meter results that match the laboratory test Within 0 7 mmol L or 15 595 600 99 2 Regression Statistics l of of Intercept Samples were tested in duplicate on three Subjects Tests mmol L test strip lots Results indicate that the 95 Cl 95 Cl Std Error Slope Intercept Sa 0 986 to 1 003 0 109 to 0 087 0 641 0 988 well with a laboratory method Precision Within Run Precision 300 Venous Blood Tests Target Mean Standard Coefficient Glucose Glucose Deviation of Variation mmol L mmol L mmol L Results show that the greatest variability observed between test strips when tested with blood is 2 72 or less Total Precision 600 Control Solution Tests Glucose Mean Standard Coefficient Level Ranges Glucose Deviation of variation mmol L mmol L mmol L TROUBLESHOOTING AND DETAILED INFORMATION ABOUT YOUR SYSTEM 23 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
31. tions whenever your test results are higher or lower than what you expect A CAUTION Low glucose results If your test result is below 3 8 mmol L or is shown as LOW GLUCOSE it may mean hypoglycaemia low blood glucose This may require immediate treatment according to your health care professional s recommendations Although this result could be due to a test error it is safer to treat first then do another test Dehydration and low glucose results You may get false low glucose results if you are severely dehydrated If you think you are severely dehydrated contact your health care professional immediately High glucose results If your test result is above 10 0 mmol L it may mean hyperglycaemia high blood glucose and you should consider re testing Talk to your health care professional if you are concerned about hyperglycaemia HIGH GLUCOSE is displayed when your blood glucose level is over 33 3 mmol L You may have severe hyperglycaemia 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 health care professional immediately Repeated unexpected glucose results If you continue to get unexpected results check your system with control solution See Section 5 Control solution testing If you are experiencing symptoms that are not consistent with your blood glucose results and you have follo
32. 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 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 User Guide for performing a blood glucose test 1 Sacks D B Carbohydrates Burtis C A and Ashwood E R Ed Tietz Textbook of Clinical Chemistry Philadelphia W B Saunders Company 1994 959 Technical specifications Memory 500 test results Reported resultrange 1 1 33 3 mmol L Automatic shutoff Two minutes after last action Calibration Plasma equivalent Size 74 7 mm x 55 5 mm x 19 9 mm Sample Fresh capillary whole blood Sample volume 0 4 uL Test time 5 seconds Assay method GDH FAD glucose dehydrogenase Operating ranges alae ai Anana toeni elative humidity non condensing 10 Power source Two 3 0 Volt CR 2032 lithium batteries Altitude up to T meters Haematocrit 20 60 Weight Approximately 52 6 grams with batteries Expected meter Minimum six months at average of four battery life testo perday Battery ratings 2x3 0V 60 mA Unit of measure mmol L 2 x CR 2032 batteries direct current Performance Characteristics System Accuracy Diabetes experts have suggested that glucose meters should agree within 0 8 mmol L of a laboratory method
33. wed all instructions in this User Guide call your health care professional Never ignore symptoms or make significant changes to your diabetes management program without speaking to your health care professional Unusual red blood cell count A haematocrit percentage of your blood that is red blood cells that is either very high above 60 or very low below 20 can cause false results Testing with a forearm or palm sample The OneTouch Verio System lets you test with a blood sample from your fingertip forearm or palm At times results obtained at the forearm or palm may be different from a fingertip measurement Talk to your health care professional before you begin using your forearm or palm for sampling If you are testing Use blood sample from your Routinely before meals Prior to or more than two hours after a meal a rapid acting insulin injection or insulin pump bolus e exercise Fingertip forearm or palm When your blood glucose is changing rapidly such as within two hours after a meal within two hours after a rapid acting insulin injection or insulin pump bolus or during or within two hours after exercise Fingertip When you are concerned about the possibility of hypoglycaemia low blood sugar When the forearm or palm results do not agree with the way you feel during illness or during times of stress TESTING YOUR BLOOD GLUCOSE 9 m A CAUTION Do Not test on your forea
34. 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 However experts have suggested greater accuracy of Blood Glucose Monitoring Systems is desirable The OneTouch Verio Blood Glucose Monitoring System has demonstrated accuracy within 0 7 mmol L of the laboratory method for glucose concentrations lower than 4 4 mmol L and within 15 of the laboratory method for glucose concentrations 4 4 or higher Samples from 100 patients were tested using both the OneTouch Verio System and the YSI 2300 glucose analyser laboratory instrument TROUBLESHOOTING AND DETAILED INFORMATION ABOUT YOUR SYSTEM 22 System Accuracy Results for Glucose Concentrations lt 4 4 mmol L Percent and number of meter results that match the laboratory test The OneTouch Verio System has demonstrated accuracy Within 0 3 mmol L Within 0 6 mmol L Within 0 7 mmol L Within 0 8 mmol L Within 0 7 mmol L of the laboratory method for glucose 93 114 81 6 110 114 96 5 114 114 100 0 114 114 100 0 concentrations lower than 4 4 mmol L and within 15 of the laboratory method for glucose System Accuracy Results for Glucose Concentrations 24 4 mmol L concentrations 4 4 mmol L or Percent and number of meter results that match the laboratory test higher Therefore 99 2 of the total results obtained with the Within 5 Within 10 Within 15 Wi

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