OneTouch Ultra Owner's Booklet
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Ultra
Blood Glucose
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Owner's
Booklet

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Summary of Contents for OneTouch Ultra

  • Page 1 Ultra Ultra Ultra Blood Glucose Monitoring System Owner’s Booklet...
  • Page 2 Important Safety Information To be sure your meter is working properly, EVERY time you turn it on confirm that: All segments are visible in the display check display check Example The unit of measure is correct (mg/dL) The date and time are correct unit of measure date time...
  • Page 3 OneTouch Ultra System ® ® Owner’s Booklet...
  • Page 4 Read this first Each time you turn on your meter, the unit of measure will appear on the display with the R symbol. The unit of measure will also appear under every test result. You may misunderstand your blood glucose results if your meter is set to the incorrect unit of measure.
  • Page 5 If your meter is set to the other unit of measure, “mmol/L” will appear on the display. The test result will include a decimal point (Fig. 2). Unless your health care professional has told you to use this unit of measure, Do Not test your blood glucose.
  • Page 6 Ultra System Owner: ® ® You have chosen one of the best blood glucose monitoring systems available. This booklet has important information you must know about the OneTouch Ultra ® ® System. Please read it carefully. Blood glucose monitoring plays an important role in diabetes control. A long- term study showed that keeping blood glucose levels close to normal can reduce the risk of diabetes complications by up to 60%.* The results you get with the...
  • Page 7: Table Of Contents

    OneTouch Ultra Meter Display ® ® Meter Set-up OneTouch Ultra Test Strips ® ® Caring for Your OneTouch Ultra System ® ® Before Testing Meter Checking the Meter Display Lancing Device Coding the Meter Test Strips and Control Solutions Checking the System...
  • Page 8: About Your New System

    If you have been using another type of meter–one that provides whole-blood results–you may notice that your test results with the OneTouch Ultra ® ® System are about 12 % higher.
  • Page 9 Blood Glucose Meter, OneTouch Ultra ® ® ® ® Test Strips (may be sold separately), and OneTouch Ultra Control ® ® Solution (may be sold separately). These products have been designed, tested, and proven to work together to produce accurate blood glucose results.
  • Page 10 The OneTouch Ultra System is intended for use outside ® ® the body (in vitro diagnostic use). It should be used only for testing fresh capillary whole blood samples for glucose (sugar). It should not be used for the diagnosis of diabetes or for testing newborns.
  • Page 11 Low glucose results: If your test result is lower than 70 mg/dL or is shown as LO, it may mean hypoglycemia (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, and then repeat the test.
  • Page 12: The Complete Onetouch

    Complete OneTouch Ultra Blood Glucose ® ® Monitoring System OneTouch Ultra Meter OneTouch Ultra Control Solution ® ® ® ® (may be sold separately) Owner’s Booklet OneTouch Ultra Test Strips ® ® Lancing Device (may be sold separately) If another type of lancing device was...
  • Page 13: Onetouch ® Ultra ® Blood Glucose Meter

    OneTouch Ultra ® ® Blood Glucose Meter DISPLAY TEST PORT Symbols, simple The meter turns on messages, and test when you insert the results appear here. OneTouch Ultra Test ® ® Strip here. M BUTTON C BUTTON Used to enter into:...
  • Page 14: Onetouch ® Ultra ® Meter Display

    OneTouch Ultra ® ® Meter Display Indicates a control CODE solution test result. Appears with the code number of the test strips. Check your code every time you test. BLOOD DROP SYMBOL Tells you when to apply the sample. BATTERY SYMBOL...
  • Page 15 NOTE: mmol/L and . (decimal point) appear in display but are not used in this meter when displaying glucose results. If your meter is set to the correct unit of measure, “mg/dL” will appear on the display. Your test result will not include a decimal point. You cannot change this setting –...
  • Page 16: Onetouch ® Ultra ® Test Strips

    The OneTouch Ultra System measures the amount of glucose in ® ® whole blood. Blood is applied in the TOP EDGE of the OneTouch ® Ultra Test Strip and is automatically drawn into the reaction cell ® where the reaction takes place.
  • Page 17 Do Not use test strips from any vial that is damaged or left open to air. Write the discard date (6 months after first opening the vial) on the vial label when you first open it. Discard the remaining OneTouch Ultra Test ®...
  • Page 18: Before Testing

    To check that all display segments are working, with the meter off, press button and immediately hold the button down. Coding the Meter Code numbers are used to calibrate the OneTouch Ultra Meter ® ®...
  • Page 19 Step 1 Enter the Code Mode. Insert a test strip to turn on the meter. Push it all the way in until it will go no further. Avoid Example bending the test strip. The display check will NOTE: Date and time appear.
  • Page 20 Each time you test, check to make sure the code numbers match. Then the symbol will appear with mg/dL, indicating that the OneTouch Ultra System is ® ®...
  • Page 21: Checking The System

    Whenever you suspect that the meter or test strips are not working properly. If you have had repeated unexpected blood glucose test results (as described on page 3). After dropping the meter. NOTE: Refer to additional information in the OneTouch Ultra Control ® ®...
  • Page 22 Before you begin: Use only OneTouch Ultra Control Solution. ® ® Check the expiration date on the control solution vial. Record the discard date (date opened plus three months) on the vial label. Do Not use after expiration or discard date, whichever comes first.
  • Page 23 Step 1 Insert a test strip into the meter. mWARNING: If mg/dL does not appear with the R symbol, call LifeScan Customer Service at 1 800 227-8862.  Insert a test strip, contact bars Then the code number will end first and facing up, into appear, followed by the mg/dL the test port.
  • Page 24 Step 2 Mark this test as a control solution test. This marks the test as a control solution test. ➧ Press and release the button Ë appears on the display. NOTE: Mark all control solution tests with Ë to distinguish them from blood glucose tests in the meter memory.
  • Page 25 Step 3 Apply control solution to the test strip. To ensure an accurate control solution test, shake the vial, discard the first drop and wipe the dispenser tip before you begin. NARROW ChANNEL  Apply Drop here TOP EDGE Touch and hold a drop of control solution where the narrow channel meets the TOP EDGE of the test strip.
  • Page 26 Step 4 Compare control solution result to the range printed on the TEST STRIP VIAL. mCAUTION: The control solution range printed on the test strip vial is for OneTouch ® Ultra Control Solution ® CONTROL RANGE only. It is not a recommended range for your blood glucose level.
  • Page 27 Control solution out-of-range results may be due to: Incorrect unit of measure. Failure to discard the first drop of control solution and wipe the Error in performing the test. dispenser tip clean. Failure to shake the control Expired or contaminated solution vial well.
  • Page 28: Testing Your Blood

    Testing Your Blood Read this section and the test strip package insert carefully before testing. Make sure you have all items needed to test. OneTouch Ultra Meter ® ® OneTouch Ultra Test Strips ® ® Lancing Device Sterile Lancets with protective covers...
  • Page 29: Preparing The Lancing Device

    Device mCAUTION: To reduce the chance of infection: Never share a lancet or the lancing device with anyone. Always use a new, sterile lancet. Lancets are for single use only. Keep the OneTouch Ultra Meter and lancing device clean. ®...
  • Page 30 Step 1 Insert a Lancet. Turn the Lancing Device Cap counterclockwise to remove it. Insert the lancet into the lancet holder and push down firmly until it is fully seated. Do Not twist the lancet. Remove the protective cover from the lancet (see instructions for your lancets).
  • Page 31 Step 2 Cock the Lancing Device Slide the ejection/cocking control back until it clicks. If it does not click, the lancing device may have been cocked when the lancet was inserted. The lancing device is now ready for use. Step 3 Wash Your Hands and the Puncture Site.
  • Page 32: Fingertip Blood Sampling

    Blood Sampling The OneTouch Ultra System requires a very small blood drop to ® ® perform a test. You may obtain it from a fingertip or forearm. (See page 25 for information on obtaining a blood sample from the forearm.) Choose a different puncture site each time you test.
  • Page 33: Forearm Blood Sampling

    forearm Blood Sampling The forearm has fewer nerve endings than the fingertip so you may find that obtaining a blood sample from the forearm may be much less painful than using the fingertip. The technique for forearm sampling is different from fingertip sampling. Also there are differences between forearm samples and fingertip samples that you should understand.
  • Page 34 Step 3 Massage the Area. To increase blood flow to the puncture site, massage the area gently. For individuals who experience difficulty in getting sufficient blood for a test, rubbing the area more vigorously or applying heat briefly may be helpful. Step 4 Position the Lancing Device.
  • Page 35 If bruising occurs, you may choose to lance a fingertip instead. If you are having difficulty obtaining blood from the forearm, call LifeScan Customer Service at 1 800 227-8862. Important information about forearm testing Under certain conditions, blood glucose test results obtained using samples taken from your forearm may differ significantly from fingertip samples.
  • Page 36: Step-By-Step Test Procedure

    Step-by-Step Test Procedure Insert This End Step 1 Insert Test Strip. Insert a test strip, contact bars end first and facing up, into the test port. Push it in until it will go no further. The meter will turn on and the display check will appear briefly.
  • Page 37 Step 2 Get a Blood Sample. Obtain a round drop of blood using the lancing device. The blood sample must be large enough ( sample size) to fill the confirmation window. Step 3 Prepare to Apply Sample. Keeping your finger extended and steady, move the meter and test strip toward the blood drop.
  • Page 38 When applying a drop of blood from your forearm, keep your forearm steady and bring the top edge of the test strip to the drop of blood with your other hand. forearm Step 4 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.
  • Page 39 Be careful not to push the test strip against your fingertip or the test strip may not fill completely. NOTE: • Do Not smear or scrape the drop of blood with the test strip. • Do Not apply more blood to the test strip after you have moved the drop of blood away.
  • Page 40 NOTE: If you do not apply a blood sample within two minutes after the symbol appears, the meter will turn itself off. You must remove the test strip and insert it back into the meter to restart the test procedure. Step 6 Accurate Results in Just 5 Seconds.
  • Page 41: Discarding Used Test Strips And Lancets

    Discarding Used Test Strips and Lancets It is important to discard the used lancet carefully after each use to avoid unintended lancet stick injuries. 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.
  • Page 42: Special Messages

    Special Messages The OneTouch Ultra Meter displays ® ® results between 20 and 600 mg/dL. If your blood glucose test result is lower than 20 mg/dL, lo will appear on the meter display. This may mean severe hypoglycemia (low blood glucose)
  • Page 43 Consult your health care professional about when and how Example to test for ketones. NOTE: Do Not use a ketone strip with the OneTouch Ultra Meter. ® ®...
  • Page 44: Using The Meter Memory

    Using the Meter Memory Your OneTouch Ultra Meter stores the 150 most recent blood glucose and ® ® control solution test results with date and time in its memory. It also provides you with 14- and 30-day averages of your blood glucose test results. If your 14-day and 30-day test result averages are not what you expect, you should not rely on them.
  • Page 45 Step 2 Recall Test Results. The most recent test result with date and time will appear. Press and release the button and the next most recent test result will appear. The meter will recall up to your last 150 test results in order from the most recent to the oldest.
  • Page 46: Downloading Test Results To A Personal Computer

    Call LifeScan Customer Service at 1 800 227-8862 for more information. Step 1 Install OneTouch Diabetes Management Software. ® Follow the instructions provided in the OneTouch Diabetes ® Management Software User’s Manual. Step 2 Connect the OneTouch Interface ®...
  • Page 47 Pressing the button will also turn the meter off. To learn more about OneTouch Diabetes Management ® Software or to obtain a OneTouch Interface Cable separately, ® call LifeScan Data Management Line at 1 800 382-7226 or visit us at www.OneTouchDiabetes.com.
  • Page 48: Comparing Meter And Laboratory Results

    ® glucose value should agree with a laboratory measurement within ±20% most of the time under normal conditions. A result within that range is considered accurate when testing with the OneTouch ® Ultra Meter. However, results can differ by more than ±20% in ®...
  • Page 49 While at the lab: Make sure that the meter test and the lab test are performed within 15 minutes of each other. Wash your hands before obtaining a blood sample. Use only fresh capillary blood obtained from the fingertip. You may still have a variation from the laboratory result because blood glucose levels can change significantly over short periods, especially if you have recently eaten, exercised, taken medication, or experienced stress.
  • Page 50: Meter Set-Up

    Meter Set-up You may need to update the meter settings when you first receive your meter or when you replace the battery. Follow these instructions. If you need assistance, call LifeScan Customer Service at 1 800 227-8862. Step 1 Enter the meter set-up. •...
  • Page 51 If you use the 12-hour format, the AM or PM will change each time you reach 12:00. Be sure the AM/PM setting is correct when you set the hour. Step 2 Set the hour. Press and release the button to change the hour.
  • Page 52 Step 4 Set the AM/PM or 24-hour time format. Press and release the button to choose between AM/PM and 24-hour formats. Press and release the button to move to the next step. Step 5 Set the year. Press and release the button to change to the desired year.
  • Page 53 Step 6 Set the month. Press and release the button to change to the desired month. Press and release the button to move to the next step. Step 7 Set the day. Press and release the button to change to the desired day. Press and release the button.
  • Page 54 If your meter has shut off after setting the day, you have completed the meter set-up and saved your changes. If either mg/dL or mmol/L is flashing on the display, continue below. Step 8 Set the unit of measure to mg/dL. Press and release the button until mg/dL appears on the display.
  • Page 55 NOTE: The 14- and 30-day averages in the meter memory are calculated from results obtained during the 14 and 30 calendar days preceding the current date and time settings. When the date and time are changed, the averages may change. If your 14-day and 30-day test averages are not what you expect, Do Not rely on them.
  • Page 56: Caring For Your Onetouch ® Ultra ® System

    LifeScan recommends that you store the meter in its carrying case after each use. A cloth dampened with water and mild detergent can be used to wipe down the outside of the meter. Your OneTouch Ultra Meter is a ®...
  • Page 57: Test Strips And Control Solutions

    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 vial or control solution vial for instructions on determining the discard date. Battery Your OneTouch Ultra Meter comes with a pre-installed 3.0 V ®...
  • Page 58 When the symbol appears on the display by itself, it means that the battery will not provide enough power for a test. You must change the battery. To replace the battery, make sure that the meter is turned off. Turn the meter over and locate the battery compartment.
  • Page 59 Step 3 Place the Cover. Place the cover over the battery compartment. Push down until you hear the tab click into place. Step 4 Check the Time, Date, and Unit of Measure. After replacing the battery, turn the meter on by inserting a test strip or pressing the button.
  • Page 60: Display Messages And Problem-Solving Guide

    Display Messages and Problem-Solving Guide Following is a summary of all display messages. These messages help to identify certain problems but do not appear in all cases when a problem has occurred. Improper use may cause an inaccurate result without producing an error message or a symbol.
  • Page 61 MESSAGE WhAT IT MEANS ACTION This is the code number Make sure that this code number matches the code stored in the meter. number on the vial of the test strips you are using. mCAUTION: Matching the code on the meter and the code on the test strip vial is Example essential to obtain accurate...
  • Page 62 MESSAGE WhAT IT MEANS ACTION A blood glucose test None required. result in mg/dL. mWARNING: If mg/dL does not appear with the test result, call LifeScan Customer Service at Example 1 800 227-8862 for assistance. A blood glucose test Follow the instructions result with a suggestion of your health care to check your ketone...
  • Page 63 MESSAGE WhAT IT MEANS ACTION You should retest your You may have a very high glucose level and if blood glucose level, appears again, call your exceeding 600 mg/dL. health care professional immediately. Treat this condition You may have a very low blood glucose level, immediately according to your health care...
  • Page 64 MESSAGE WhAT IT MEANS ACTION A control solution test None required. result stored in the memory. No result in memory, such You can still perform a as the first time use of the blood glucose test and get meter. an accurate test result. Call LifeScan Customer Your meter was unable to Service at...
  • Page 65 MESSAGE WhAT IT MEANS ACTION Error message that indicates Do Not use the meter. that there is a problem with Call LifeScan the meter. Customer Service at 1 800 227-8862 for a replacement meter. Error message could be Repeat the test with a caused either by a used test new test strip.
  • Page 66 MESSAGE WhAT IT MEANS ACTION Error message that indicates one of the following conditions may be present: 1. You may have high 1. If you tested in a cool glucose and have tested in environment, repeat the an environment near the test in a warmer low end of the system’s environment with a new...
  • Page 67 MESSAGE WhAT IT MEANS ACTION Error 4 4. There may be a problem 4. If the error message continued with the meter. appears again, call LifeScan Customer Service at 1 800 227-8862. Error message that indicates Repeat the test with a that the meter has detected new test strip.
  • Page 68 Confirm that your meter is set in mg/dL. If not, call LifeScan Customer Service at 1 800 227-8862. Note to users of OneTouch ® Diabetes Management Software: Do Not transfer data from a meter that has experienced a loss of power.
  • Page 69 If the meter does not display a message after inserting a test strip: POSSIBLE CAUSE WhAT TO DO No power Replace the battery. No battery or battery Check that the battery is incorrectly installed correctly installed with the positive “+” side up. Test strip inserted Insert the test strip correctly incorrectly or incompletely...
  • Page 70: Specifications

    Specifications Result Range: 20 to 600 mg/dL Calibration: Plasma-equivalent Sample: Fresh capillary whole blood Test Time: 5 seconds Assay Method: Glucose oxidase biosensor Power Source: One replaceable 3.0 V (#2032 or equivalent) lithium battery Battery Life: About 1,000 tests (about one year at three tests per day) Glucose Units: mg/dL Memory: 150 blood glucose and control solution tests Automatic Shutoff: Two minutes after last user action...
  • Page 71: Guarantee

    Guarantee The makers guarantee that the OneTouch Ultra Meter shall be free ® ® of defects in material and workmanship for a period of three years. This guarantee is valid from the date of purchase. The guarantee extends only to the original purchaser and is not transferable.
  • Page 72: Index

    Checking the Meter Display ................... 10 Checking the System with Control Solution ............13 Coding the Meter ....................10 Control Solution, Before you begin ................ 14 Control Solution, Checking the System with ............13 Control Solution, OneTouch Ultra ..............13 ® ®...
  • Page 73 Step-by-Step Test Procedure .................. 28 Temperature Range, Blood Testing ..............14, 62 Temperature Range, Control Solution Testing ............14 Test Port ........................5 Test Procedure, Step-by-Step ................. 28 Test Strip Information, Important ................9 Test Strips, OneTouch Ultra ................. 8 ® ® Time, Changing ......................43 Unexpected Results ....................
  • Page 74 Notes...
  • Page 75 Glucose Ranges Your Target Times of day for people without Ranges, mg/dL diabetes, mg/dL Before 70 –105 breakfast Before lunch 70 –110 or dinner 1 hour Less than 160 after meals 2 hours Less than 120 after meals Between Greater than 70 2 and 4 Source: Krall, L.P., and Beaser, R.S.: Joslin Diabetes Manual.
  • Page 76 6,733,655. Purchase of this device does not act to grant a use LifeScan Europe license under these patents. Such a license is granted only when the Version F Division of Cilag GmbH device is used with OneTouch Ultra Test Strips. No test strip ® ®...

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