Blood Glucose Monitoring System - OneTouch

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Blood Glucose Monitoring SystemOwner'sBookletInstructions for Use

Blood Glucose Monitoring SystemOwner's Booklet1

Thanks for choosing OneTouch !The OneTouch Verio Blood Glucose Monitoring Systemis one of the latest product innovations from OneTouch .Every OneTouch Meter is designed to make it easy to testyour blood glucose and help you manage your diabetes.This Owner’s Booklet offers a complete explanationof how to use your new meter and testing supplies. Itreviews the do’s and don’ts of testing your blood glucoselevel. Please keep your Owner’s Booklet in a safe place;you may want to refer to it in the future.We hope OneTouch products and services will continueto be a part of your life.2

Meter Symbols and IconsLow BatteryBattery EmptyAbove RangeIn RangeBelow RangeLow Pattern message iconHigh Pattern message iconControl solution result3

Other symbols and iconsCautions and Warnings: Refer to the Owner'sBooklet and inserts that came with your systemfor safety-related information.Direct current4

This page left blank intentionally.5

Table of ContentsThe OneTouch Verio Blood Glucose Monitoring System.101Set up your system.12Getting to know your OneTouch Verio BloodGlucose Monitoring System. 12Turn your meter on.14Use the display backlight for better visibility.14First time setup. 15Set Language. 15Accept pre-set time, date and range limits.16Edit pre-set time, date and range limits. 21Adjust meter settings after first time setup. 27Check the meter serial number and software version. 322Take a test.34Test your blood glucose. 34OneTouch Delica Lancing Device. 37Getting a blood sample from the fingertip. 39Applying blood and reading results.46Removing the used lancet. 51Interpreting unexpected test results. 54Test with control solution. 576

3View messages that appearwith your test results.66Turn Messages off (or on). 784Review past results and averages. 82Downloading results to a computer. 875Care and maintenance. 88Storing your system. 88Cleaning and disinfection. 886Batteries.947Troubleshooting. 988Detailed informationabout your system. 110Comparing meter results to laboratory results. 110Technical Specifications.112System Accuracy.114Guarantee.120Electrical and safety standards.1209Index.1227

Before you beginBefore using this product to test your blood glucose,carefully read this Owner’s Booklet, and the insertsthat come with the OneTouch Verio Test Strips andOneTouch Verio Control Solution.IMPORTANT SAFETY INSTRUCTIONS: This meter and lancing device are for single patient useonly. Do Not share them with anyone else, includingfamily members! Do Not use on multiple patients! After use and exposure to blood, all parts of this kit areconsidered biohazardous. A used kit may potentiallytransmit infectious diseases even after you haveperformed cleaning and disinfection.For more information see: FDA Public Health Notification:“Use of Fingerstick Devices on More than One PersonPoses Risk for Transmitting Bloodborne Pathogens:Initial Communication" (2010) Notices/ucm224025.htm.CDC Clinical Reminder: “Use of Fingerstick Deviceson More than One Person Poses Risk for TransmittingBloodborne Pathogens” (2010) icesBGM.html.8

Intended useThe OneTouch Verio Blood Glucose Monitoring Systemis intended to be used for the quantitative measurementof glucose (sugar) in fresh capillary whole blood samplesdrawn from the fingertip. The system is intended to beused by a single patient and should not be shared.The OneTouch Verio Blood Glucose Monitoring Systemis intended for self-testing outside the body (in vitrodiagnostic use) by people with diabetes at home as an aidto monitor the effectiveness of diabetes control.The OneTouch Verio Blood Glucose Monitoring Systemis not to be used for the diagnosis of or screening ofdiabetes or for neonatal use. The OneTouch Verio BloodGlucose Monitoring System is not for use on criticallyill patients, patients in shock, dehydrated patients orhyperosmolar patients.Test principleGlucose in the blood sample mixes with the enzyme FADGDH (refer to page 112) in the test strip and a smallelectric current is produced. The strength of this currentchanges with the amount of glucose in the blood sample.Your meter measures the current and calculates yourblood glucose level. It then displays the blood glucoseresult and stores it in the meter memory.9

The OneTouch Verio Blood GlucoseMonitoring SystemIncluded with your kit:OneTouch Verio Meter(2 AAA batteries included)Carrying CaseOneTouch Delica Lancing DeviceOneTouch Delica Sterile LancetsNOTE: The OneTouch Delica Lancing Device uses ONLYOneTouch Delica Lancets.If another type of lancing device was included, see theseparate instructions for that lancing device.10

Available separately:Items pictured below are required, butmay not be included in your kit:They are sold separately. Refer to your meter carton for alist of included items.OneTouch Verio OneTouch Verio OneTouch Verio Level 3 ControlTest Strips*Level 4 ControlSolution*Solution**OneTouch Verio Control Solution and Test Strips areavailable separately. For availability of test strips andcontrol solution, contact Customer Service or ask yourpharmacist or healthcare professional.You can use either OneTouch Verio Level 3 ControlSolution or OneTouch Verio Level 4 Control Solutionwith your OneTouch Verio Meter.WARNING: Keep the meter and testing suppliesaway from young children. Small items such as the batterydoor, batteries, test strips, lancets, protective covers on thelancets, and control solution vial cap are choking hazards.Do Not ingest or swallow any items.11

1Set up your systemGetting to know your OneTouch Verio Blood Glucose Monitoring SystemMeter12

Set up your system 1Test strip13

1 Set up your systemTurn your meter onuntil thePress and holdstart-up screen appears. Oncethe start-up screen is displayed,release .NOTE: If you see any missing pixels within the start-upscreen, there may be a problem with the meter. As yourpartner in diabetes care, we welcome you to contactus (7 days a week, 8 a.m. - 10 p.m. Eastern Time) at1 888 567-3003 (English), 1 888 567-3010 (Español),or www.OneTouch.com.Use the display backlight for bettervisibilityThe backlight comes on automatically whenever themeter is turned on. After a few seconds of no activity, thebacklight will dim. Pressing any button or inserting a teststrip will turn the backlight back on.14

Set up your system 1First time setupBefore using your meter for the first time, you shouldcheck to make sure the pre-set language, time and datein the meter are correct. This ensures that the correct timeand date are assigned to each of your test results.Set LanguageThe first time you turn the meteron, the Set Language screenappears.In the Set Language screen,orto highlight thepresslanguage you want and press.after making yourPressingselection confirms each settingand takes you to the next screen.When setting up your meteryou can press to return tothe previous screen to adjust asetting.After setting the language, theMeter Buttons screen appearsto remind you how each meterbutton works. Press .15

1 Set up your systemAccept pre-set time, date and range limitsStep 1: Set timeThe Set Time screen will bedisplayed next.If the time is correct, pressto save.If you need to edit the time pressorto highlight Edit andpress(see page 21).Saved will appear to confirmthat the time displayed is nowstored in the meter.16

Set up your system 1Step 2: Set dateThe Set Date screen will bedisplayed next.If the date is correct, pressto save.If you need to edit the date pressorto highlight Edit andpress(see page 21).Saved will appear to confirmthat the date displayed is nowstored in the meter.17

1 Set up your systemStep 3: Set low and high range limitsYour low and high range limits are used by your meter to: Tell you when a test result is within, below or above therange limits set in the meter. Provide messages that let you know: When you should treat a low blood glucose result. Your progress staying within your blood glucoserange. When you have developed a pattern of bloodglucose results below the low limit or above thehigh limit set in the meter.NOTE: The low and high range limits you set apply toall glucose test results. This includes tests taken beforeor after mealtimes, medications and around any otheractivities that may affect your blood glucose.CAUTION:Be sure to talk to your healthcare professional about thelow and high range limits that are right for you. Whenselecting or changing your limits, you should considerfactors such as your lifestyle and diabetes therapy. Nevermake significant changes to your diabetes care planwithout consulting your healthcare professional.18

Set up your system 1The meter is pre-set with a lowlimit of 70 mg/dL and a high limitof 180 mg/dL.If the low and high range limitsto save.are correct, pressIf you need to edit the pre-setlimits to fit your needs pressorto highlight Edit and press(see page 21).Saved will appear to confirm thelow and high limits displayed arenow stored in the meter.19

1 Set up your systemSetup complete appears on thescreen. Your meter is now readyfor use.After a few seconds, the MainMenu will appear on the screen.See page 32.NOTE: If the meter was turnedon by inserting a test strip, theApply Blood screen appearsinstead of the Main Menu. Seepage 44.20

Set up your system 1Edit pre-set time, date and range limitsStep 1: Edit the timeorTo change the time pressto set the hour and press .Repeat this step to set theminutes and am or pm.When the time is correct, press.If you need to make anoradjustment, presshighlight Edit and pressrepeat Step 1.to, then21

1 Set up your systemSaved will appear to confirm thatthe time displayed is now storedin the meter.Step 2: Edit the dateorTo change the date pressto set the month and press.Repeat this step to set the dayand year.22

Set up your system 1When the date is correct, press.If you need to make anoradjustment, presshighlight Edit and pressrepeat Step 2.to, thenSaved will appear to confirm thatthe date displayed is now storedin the meter.23

1 Set up your systemStep 3: Edit your low and high range limitsTo change the pre-set Low Limitorto the desiredpressvalue between 60 mg/dL and110 mg/dL and press .To change the pre-set High Limitpressorto the desiredvalue between 120 mg/dL and300 mg/dL and press .24

Set up your system 1When your low and high rangelimits are correct, press .If you need to make anoradjustment, presshighlight Edit and pressrepeat Step 3.to, thenSaved will appear to confirm thatthe low and high limits displayedare now stored in the meter.25

1 Set up your systemSetup complete appears on thescreen. Your meter is now readyfor use.After a few seconds, the MainMenu will appear on the screen.See page 32.NOTE: If the meter was turnedon by inserting a test strip, theApply Blood screen appearsinstead of the Main Menu. Seepage 44.26

Set up your system 1Adjust meter settings after first time setupYou can adjust the meter settings at any time. When youturn your meter on, the Main Menu is displayed after thestart-up screen. A blue bar highlights the current selectionon the meter display.1. Get to the Settings screenFrom the Main Menu, pressorto highlight Settings andpress .27

1 Set up your system2. Select the settingSelect the specific setting youwant to modify and press .To change your low or high limits,highlight Tool Settings and press, then select Range and press.NOTE: For information onMessages, see page 66.Once the setting you want to modify is displayed, thefirst entry on the screen will be highlighted.28

Set up your system 13. Pressorto change to yourdesired value, then press .To skip a highlighted entry, simply press . Each timeyou press , the next entry on the screen will behighlighted.For example, if you want to change the time, highlightTime/Date on the Settings screen and press .4. Next, highlight Timeand press .ExampleTime Setting Change29

1 Set up your systemThe current time set in themeter is displayed.orto5. Presschange the hour andpress .6. Repeat this step tochange the minutesand am or pm.30

Set up your system 1Once you have advanced throughevery entry on the setting screen,Saved will be displayed toconfirm that your changes havebeen stored in the meter.NOTE: To help ensure that thetime and date in your meterare set correctly, once every 6months a screen will prompt youto confirm the time and date setin the meter.If they are correct, press . Ifnot correct, pressortohighlight Edit Time/Date andpress . Follow the steps inpage 27 to adjust the time and date. Once the time anddate are set correctly, pressorto highlight Doneand press . After a few seconds, the Main Menu willappear on the screen.If you turned the meter on by inserting a test strip, theApply Blood screen will be displayed.31

1 Set up your systemCheck the meter serial number andsoftware versionThe meter serial number and software version are storedin your meter. You can check this information at any time.1. Get to the Meter InfoscreenFrom the Main Menu, pressorto highlight Settings andpress .2. Select Meter Info andpress32

Set up your system 1The meter information isdisplayed.3. Pressto return to the Settings screenTurn the meter off after setup.There are two ways to turn your meter off: Press and holdturns off.Or,for several seconds until the meter Your meter will turn off by itself if left alone for twominutes.33

2Take a testTest your blood glucoseNOTE: Many people find it helpful to practice testing withcontrol solution before testing with blood for the firsttime. See page 57.Preparing for a testHave these things ready when you test: OneTouch Verio Meter OneTouch Verio Test Strips Lancing device Sterile lancetsNOTE: Use only OneTouch Verio Test Strips. Unlike some blood glucose meters, no separate step tocode your OneTouch Verio System is required. Make sure your meter and test strips are about thesame temperature before you test. Keep test strips in a cool, dry place between 41 F and86 F. Do Not test if there is condensation (water build-up) onyour meter. Move your meter and test strips to a cool,dry spot and wait for the meter surface to dry beforetesting.34

Take a test 2 Do Not open the test strip vial until you are ready toremove a test strip and perform a test. Use the teststrip immediately after removing it from the vial. Tightly close the cap on the vial immediately after useto avoid contamination and damage. Store unused test strips only in their original vial. Do Not return the used test strip to the vial afterperforming a test. Do Not re-use a test strip that had blood or controlsolution applied to it. Test strips are for single use only. With clean, dry hands, you may touch the test stripanywhere on its surface. Do Not bend, cut or modifythe test strip in any way. When you first open a vial of test strips, record thediscard date on the label. Refer to the test strip insertor vial label for instructions on determining the discarddate.IMPORTANT: If another person assists you with testing,the meter, lancing device and cap should always becleaned and disinfected prior to use by that person. Seepage 88.35

2 Take a testCAUTION: The OneTouch Verio Blood Glucose MonitoringSystem should not be used for patients within 24 hoursof receiving a D-xylose absorption test as it may causeinaccurately high results. Do Not use the OneTouch Verio Family of Meterswhen PAM (Pralidoxime) is known or suspected to be inthe patient's whole blood sample. Do Not use your test strips if your vial is damagedor left open to air. This could lead to error messagesor inaccurate results. Contact Customer Serviceimmediately if the test strip vial is damaged.1 888 567-3003. If you cannot test due to a problem with your testingsupplies, contact your healthcare professional. Failureto test could delay treatment decisions and lead to aserious medical condition. The test strip vial contains drying agents that areharmful if inhaled or swallowed and may cause skin oreye irritation. Do Not use test strips after the expiration date (printedon the vial) or the discard date, whichever comes first,or your results may be inaccurate.36

Take a test 2OneTouch Delica Lancing DeviceNOTE: The OneTouch Delica Lancing Device uses ONLYOneTouch Delica Lancets.If the lancing device shown here is different from thedevice included in your kit, please see the separate insertfor your lancing device.37

2 Take a testNOTE: The OneTouch Verio Blood Glucose MonitoringSystem has not been evaluated for Alternate SiteTesting (AST). Use only fingertips when testing withthe system. The OneTouch Delica Lancing System does notinclude the materials needed to perform Alternate SiteTesting (AST). The OneTouch Delica Lancing Systemshould not be used on the forearm or palm with theOneTouch Verio Blood Glucose Monitoring System.CAUTION:To reduce the chance of infection and disease spread byblood: Make sure to wash the sample site with soap and warmwater, rinse and dry before sampling. The lancing device is intended for a single user. Nevershare a lancet or lancing device with anyone. Always use a new, sterile lancet each time you test. Always keep your meter and lancing device clean (seepage 88). The lancing device is for single patient use only. Do Notshare them with anyone, including family members! DoNot use on multiple patients!38

Take a test 2Getting a blood sample from the fingertipChoose a different puncture site each time you test.Repeated punctures in the same spot may cause sorenessand calluses.Before testing, wash your hands thoroughly with warm,soapy water. Rinse and dry completely.1. Remove the lancing device capRemove the cap by turning it counterclockwise and thenpulling it straight off of the device.39

2 Take a test2. Insert a sterile lancet into the lancingdeviceAlign the lancet as shownhere, so that the lancet fitsinto the lancet holder. Pushthe lancet into the deviceuntil it snaps into place andis fully seated in the holder.Twist the protective coverone full turn until itseparates from the lancet.Save the protective coverfor lancet removal anddisposal. See page 51.40

Take a test 23. Replace the lancing device capPlace the cap back onto the device; turn clockwise tosecure the cap.Do Not overtighten.41

2 Take a test4. Adjust the depth settingThe lancing device has sevenpuncture depth settings,numbered 1 through 7.Smaller numbers are for ashallower puncture and thelarger numbers are for adeeper puncture. Shallowerpunctures work for childrenand most adults. Deeperpunctures 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 untilyou find the one deep enough to get a blood sample ofthe proper size.42

Take a test 25. Cock the lancing deviceSlide the cocking controlback until it clicks. If it doesnot click, it may alreadyhave been cocked whenyou inserted the lancet.6. Insert a test strip to turn the meter onInsert a test strip into thetest strip port with the goldside of the test strip andthe two silver prongs facingyou.No separate step to codethe meter is required.43

2 Take a testWhen the Apply Bloodscreen appears on thedisplay, you can apply yourblood sample to either sideof the test strip.7. Puncture your fingerHold the lancing devicefirmly against the side ofyour finger. Press the releasebutton. Remove the lancingdevice from your finger.44

Take a test 28. Get a round drop of bloodGently squeeze and/ormassage your fingertip untila round drop of blood formson your fingertip.If the blood smears or runs,Do Not use that sample. Drythe area and gently squeezeanother drop of blood orpuncture a new site.45

2 Take a testApplying blood and reading results1. Apply the sample to the test stripYou 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 adrop of blood.46

Take a test 2Holding the meter at a slightangle, guide the channel tothe blood drop.When it touches yoursample, the test strip wicksblood into the channel.47

2 Take a test2. Wait for the channel to fill completelyThe blood drop will be drawn into the narrow channel. Thechannel should fill completely.The channel turns red and the meter will count down from5 to 1.Blood should not be applied on the top of the test strip orto the top edge of the test strip. Do Not smear or scrape the sample with the teststrip. Do Not press the test strip too firmly against thepuncture site or the channel may be blocked fromfilling properly. Do Not apply more blood to the test strip after youhave moved the drop of blood away. Do Not move the test strip in the meter during a testor you may get an error message or the meter mayturn off. Do Not remove the test strip until the result isdisplayed or the meter will turn off.48

Take a test 23. Read your result on the meterYour blood glucose resultappears on the display, alongwith the unit of measure, and thedate and time of the test.If mg/dL does not appearwith the blood glucose result,contact Customer Service.1 888 567-3003.ExampleCAUTION:Control solution appears on the screen whenIftesting your blood glucose, repeat the test with a new teststrip. If the problem persists, contact Customer Service.1 888 567-3003.49

2 Take a testKnow whether your current glucose testresult is within, below or above your rangeWhen your blood glucose result is displayed after a test,the meter will display a color-coded dot to tell you ifyour result is within range, below your low limit or aboveyour high limit set in the meter. See page 18 andpage 27.In RangeBelow RangeAbove RangeExampleIn Range ResultThe OneTouch Verio Meter scans your test resultsand displays messages to let you know how you areprogressing and help you better manage your diabetes.These messages are automatically displayed on the screenwith your test result when certain conditions are met. Seepage 66 for more information on messages.50

Take a test 2After getting a blood glucose resultOnce you have your blood glucose result, you may: Press and holdOr,to return to the Main Menu. Press and holdfor several seconds until the meterturns off. The meter will also automatically turn off ifleft alone for two minutes.Removing the used lancetNOTE: This lancing device has an ejection feature, so youdo not have to pull out the used lancet.1. Remove the lancing device capRemove the cap by turningit counterclockwise andthen pulling it straight offof the device.51

2 Take a test2. Cover the exposed lancet tipBefore removing the lancet, place the lancet protectivecover on a hard surface then push the lancet tip into thecupped side of the cover.3. Eject the lancetSlide the ejection controlforward until the lancetcomes out of the lancingdevice. Return the ejectioncontrol to its back position.If the lancet fails to ejectproperly, cock the deviceagain and then slide theejection control forward untilthe lancet comes out.52

Take a test 24. Replace the lancing device capPlace the cap back onto the device; turn clockwise tosecure the cap.Do Not overtighten.It is important to use a new lancet each time you obtaina blood sample. This will help prevent infection and sorefingertips.53

2 Take a testDisposing of the used lancet and test stripDiscard the used lancet carefully after each use to avoidunintended lancet stick injuries. Used lancets and teststrips may be considered biohazardous waste in yourarea. Be sure to follow your healthcare professional'srecommendations or local regulations for proper disposal.Wash hands thoroughly with soap and water afterhandling the meter, test strips, lancing device and cap.Interpreting unexpected test resultsRefer to the following cautions whenever your bloodglucose results are higher or lower than what you expect.CAUTION:Low blood glucose resultsIf your blood glucose result is below 70 mg/dL or is shownas EXTREME LOW GLUCOSE, (meaning the result is lessthan 20 mg/dL), it may mean hypoglycemia (low bloodglucose). This may require immediate treatment accordingto your healthcare professional’s recommendations.Although this result could be due to a test error, it is saferto treat first, then do another test.54

Take a test 2CAUTION:Dehydration and low blood glucose resultsYou may get false low blood glucose results if youare severely dehydrated. If you think you are severelydehydrated, contact your healthcare professionalimmediately.High blood glucose resultsIf your blood glucose result is above 180 mg/dL, it maymean hyperglycemia (high blood glucose) and you shouldconsider re-testing. Talk to your healthcare professional ifyou are concerned about hyperglycemia.EXTREME HIGH GLUCOSE is displayed when your bloodglucose result is over 600 mg/dL. You may have severehyperglycemia (very high blood glucose). Re-test yourblood glucose level. If the result is EXTREME HIGHGLUCOSE again, this indicates a severe problem with yourblood glucose control. Obtain and follow instructions fromyour healthcare professional immediately.55

2 Take a testCAUTION:Repeated unexpected blood glucose resultsIf you continue to get unexpected results, check yoursystem with control solution. See page 57.If you are experiencing symptoms that are not consistentwith your blood glucose results and you have followed allinstructions in this Owner’s Booklet, call your healthcareprofessional. Never ignore symptoms or make significantchanges to your diabetes management program withoutspeaking to your healthcare professional.Unusual red blood cell countA hematocrit (percentage of your blood that is red bloodcells) that is either very high (above 60%) or very low (below20%) can cause false results.56

Take a test 2Test with control solutionOneTouch Verio Control Solution is used to check thatthe meter and test strips are working together properlyand that the test is performing correctly. (Control solutionis available separately.)NOTE: Use only OneTouch Verio Level 3 Control Solution orOneTouch Verio Level 4 Control Solution with yourOneTouch Verio Meter. Either level can be used tocheck your system. When you first open a new vial of control solution,record the discard date on the vial label. Refer to thecontrol solution insert or vial label for instructions ondetermining the discard date. Tightly close the cap on the control solution vialimmediately after use to avoid contamination ordamage.57

2 Take a testCAUTION: Do Not swallow or ingest control solution. Do Not apply control solution to the skin or eyes as itmay cause irritation. Do Not use control solution after the expirationdate (printed on the vial label) or the discard date,whichever comes first, or your results may beinaccurate.Do a control solution test Whenever you open a new vial of test strips. If you suspect that the meter or test strips are notworking properly. If you have had repeated unexpected blood glucoseresults. If you drop or damage the meter.58

Take a test 2Performing a control solution test1. Insert a test stripto turn the meter onWait for the Apply Bloodscreen to appear on thedisplay.NOTE: The same ApplyBlood screen that appearsduring a blood glucose testalso appears during a controlsolution test.59

2 Take a test2. Prepare the control solutionRemove the vial cap and place iton a flat surface with the top ofthe cap pointing up.Squeeze the vial to discard thefirst drop.ExampleOneTouch Verio Level3 Control SolutionWipe both the tip of the controlsolution vial and the top of thecap with a clean, damp tissue orcloth.60

Take a test 2Then, squeeze a drop into thesmall well on the top of thecap or onto another clean,non-absorbent surface.3. Apply the control solutionHold the meter so that theside edge of the test strip isat a slight angle to the dropof control solution.Touch the channel on the sideof the test strip to the controlsolution. Wait for the channelto

is one of the latest product innovations from OneTouch . Every OneTouch Meter is designed to make it easy to test your blood glucose and help you 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.

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