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Blood Glucose Monitoring System User’s Handbook...
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OneTouch® Vita™ System User’s Handbook Symbols Manufacturer Authorised Representative EC REP æ Caution: See instructions for use Serial number Lot Number In Vitro Diagnostic Medical Device Expiry Date Sterilised by irradiation STERILE R Low battery Direct current Storage temperature limits Consult instructions for use �...
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Clear instructions and visual aids will help you get comfortable using the OneTouch® Vita™ Meter, so you can expect to get reliable results every time you test. Please keep it handy.
Table of Contents Setting up your system Preparing for a test Testing with a fingertip sample Interpreting unexpected test results Testing with a forearm or palm sample Attaching after-meal flags to your test results Reviewing past results and averages Control solution testing Care and maintenance Battery Troubleshooting...
Before you begin Before using this product to test your blood glucose, carefully read the Starter Guide, this User’s Handbook and the inserts that come with the OneTouch® Vita™ Test Strips and OneTouch® Vita™ Control Solution. Intended use The OneTouch® Vita™ Blood Glucose Monitoring...
If the lancing device shown here is not included with your kit, see the user instructions for the lancing device included. * Some kits do not include OneTouch® Vita™ Test Strips or OneTouch® Vita™ Control Solutions. Test strips and control solutions are available separately.
Setting up your system Getting to know your OneTouch® Vita™ Blood Glucose Meter Test strip port Insert test strip here Meter to turn meter on Display 27/FEB/08 14:07 mmol/L is the pre-set unit of measurement mmol/L Indicates ▲▼ ▲▼ selection and...
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Setting up your system Turning your meter on MAIN MENU LAST RESULT Press and hold until the ALL RESULTS meter turns on. AVERAGES SETTINGS After the black start-up screen, appears. MAIN MENU METER OFF CAUTION: Display check. If you see any light areas within the black start-up screen, there may be a problem with the meter.
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Setting up your system If the pre-set language, date SETTINGS and time are correct, press ENGLISH 27/FEB/08 to return to the MAIN MENU 14:07 mmol/L If any setting is not correct, press to select CHANGE CHANGE and press (go to step 2). 2.
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Setting up your system 4. Set the time of day DATE AND TIME Press to set the hour DATE: and press 27 / FEB / 2008 Repeat this step to set the TIME: minutes. : 07 5. Confirm your settings SETTINGS If your settings are correct, ENGLISH...
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Setting up your system Turning your meter off after setup There are three ways to turn your meter off: • Press and hold for three seconds, • Your meter will turn off by itself if left alone for about two minutes, •...
Use OneTouch® Vita™ Test Strips only. • Unlike some blood glucose meters, it does not require a separate step to code your OneTouch® Vita™ system. • Make sure your meter and test strips are about the same temperature before you test.
Testing with a fingertip sample Lancing Device Release button Cocking control Depth indicator Blue (or black) cap (for fingertip sampling) OneTouch® Clear Cap Sterile lancet (for forearm and palm testing) Protective cover See pages 19–23. Lancet point Customer Care Freephone 0800 121 200 (UK) or 1800 535 676 (Ireland)
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Testing (fingertip) CAUTION: To reduce the chance of infection: • Never share a lancet or a lancing device with anyone. • Always use a new, sterile lancet each time you test. Always keep your meter and lancing device clean (see page 35). Obtaining a blood sample from the fingertip •...
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Testing (fingertip) 3. Adjust the depth setting Twist the blue/black 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.
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Testing (fingertip) Contact bars 5. Insert a test strip to turn the meter on Insert a test strip into the test strip port as shown, with the contact bars facing you. Test strip port APPLY SAMPLE When the screen APPLY SAMPLE appears on the display, you can apply your blood sample.
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Testing (fingertip) Approximate size 7. Get a round drop of blood Gently squeeze your finger until you get a round drop of blood. If the blood smears or runs, do not use that sample. Wipe the area and gently squeeze another drop of blood or puncture a new site.
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Testing (fingertip) Do not apply blood to the top of the test strip. Do not hold the meter and test strip underneath the blood drop. This may cause blood to run into the test strip port and damage the meter. 2.
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Testing (fingertip) Gently touch the channel to the edge of the blood drop. Be careful not to push the test strip against your fingertip or the test strip may not fill completely. • Do not smear or scrape the drop of blood with the test strip.
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Testing (fingertip) 3. Wait for the confirmation window to fill completely The blood drop will be drawn into the narrow channel and the confirmation window should fill completely. Confirmation window full When the confirmation window is full, this means you have applied enough blood.
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Testing (fingertip) After getting a result Once you have your result, you may: • Attach an after-meal flag to this result; see page 24, • Review your meter memory by pressing ; see page 26, • Turn the meter off by removing the test strip. Removing the used lancet Remove the lancing device cap.
Interpreting unexpected test results Refer to the following cautions whenever your test results are lower or higher than you expect. CAUTION: Low glucose results • If your test result is lower than 3.9 mmol/L or is shown , it may mean hypoglycaemia (low LOW GLUCOSE blood glucose).
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Interpreting unexpected test results CAUTION: High glucose results (continued) • is displayed when your blood glucose HIGH GLUCOSE level is higher than 33.3 mmol/L. You may have severe hyperglycae mia (very high blood glucose). Re-test your blood glucose. If the result is again, HIGH GLUCOSE this indicates a serious problem with your blood...
Testing with a forearm or palm sample The OneTouch® Vita™ Meter allows you to obtain a blood sample from your forearm or palm. Collecting a drop of blood from these “alternative sites” may be less painful than a fingertip sample.
1. Insert a lancet and snap on the clear cap Carefully insert a new, sterile lancet (see page 9). Snap on the OneTouch® Clear Cap. 2. Adjust the depth setting You may need a deeper setting to get a sufficient sample for testing.
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Testing (forearm or palm) 3. Choose a sample site • Before testing, make sure you wash the puncture site with soap and water. Rinse and dry thoroughly. • Choose a spot that is not close to bone, veins or hair. Massage the site to increase blood flow.
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Testing (forearm or palm) 4. Lance your forearm or palm • Firmly press and hold the lancing device against the sample site. • Looking through the clear cap, you should see the sample site change colour as blood collects under the skin. This lets you know that there is adequate blood to obtain a sufficient sample for Forearm or Palm...
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Testing (forearm or palm) 6. Apply the sample to the test strip Keep your forearm or palm steady and use your other hand to bring the top edge of the test strip to the drop of blood. Forearm Palm • See pages 12–15 for more information on applying the blood sample to the test strip.
Attaching after-meal flags to your test results Your meter allows you to attach an after-meal flag to your blood glucose results. You can attach an after-meal flag straight after a blood glucose test. You can also add or remove a meal flag when reviewing a past result.
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Attaching after-meal flags Using the after-meal flag feature 27/FEB/08 14:07 1. Adding an after-meal flag To add an after-meal flag, the meal flag feature must be turned on. mmol/L When a glucose test result is AFTER MEAL? � � displayed, the up arrow at the bottom right corner of the screen will 27/FEB/08...
Reviewing past results and averages If your meter is off, press and hold until the meter turns on. If you have just completed a test, press to get to the MAIN MENU From the , choose: MAIN MENU MAIN MENU LAST RESULT •...
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Reviewing past results All results The meter will display four results at a time, starting with the most recent. The following symbols may also appear: if the result was above ALL RESULTS 33.3 mmol/L mmol/L 08/FEB 10:01 if the result was below 07/FEB 17:21 1.1 mmol/L...
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Reviewing past results Averages AVERAGES The meter will display two types ALL RESULTS AVG of averages: MEAL AVERAGES • all test results MENU • after-meal results AVERAGES ALL RESULTS AVG MEAL AVERAGES MENU All results average If the meal flags feature is off, selecting from the AVERAGES...
Reviewing past results Average of all unflagged results Meal averages MEAL AVERAGES mmol/L The meter will display the averages � LAST of all AFTER MEAL results for the 7 DAYS past 7 days, 14 days and 30 days. 14 DAYS This screen is not available when 30 DAYS the meal flags feature is off.
• D o not apply control solution to the skin or eyes as it may cause irritation. • U se only OneTouch® Vita™ Control Solution with your OneTouch® Vita™ Meter. • C ontrol solution tests must be done at room temperature (20–25°C).
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Control solution testing 2. Press to display the screen APPLY CONTROL When the screen APPLY CONTROL APPLY CONTROL is displayed, you can be sure that the test result will be correctly recorded in the meter memory as a control solution test. �...
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If the problem persists, contact Customer Care on 0800 121 200 (UK) or 1800 535 676 (Ireland). 5. Check if the result is in range Compare the result displayed on the meter to the OneTouch® Vita™ on the Control Solution range printed test strip vial.
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1800 535 676 (Ireland). The control solution range(s) printed on the test strip • vial are for OneTouch® Vita™ Control Solution only. They are not recommended ranges for your blood glucose level. Customer Care Freephone 0800 121 200 (UK) or 1800 535 676 (Ireland)
Keep in a cool, dry place below do not 30°C, but refrigerate. Keep all items away from direct sunlight and heat. OneTouch® Vita™ Test Strips With clean, dry hands, you may touch the test strip Do not anywhere on its surface. bend, cut or modify the test strips in any way.
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Do not spray cleaning solution on the meter or immerse • it in any liquid. Cleaning your lancing device and OneTouch® Clear Cap To clean these items, wipe them with a soft cloth dampened Do not with water and mild detergent.
Battery Battery Meter battery Your OneTouch® Vita™ Meter uses one 3.0 Volt CR 2032 lithium battery (or equivalent). See pages 43–44 for information on when to change the meter battery. WARNING: To avoid a possible shock, Do not change the battery while the meter is connected to a computer.
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Battery 2. Insert the new battery With the “+” side facing up towards you, place the battery in the compartment within the fold of the ribbon. Push the battery until it snaps into the battery clasp. Replace the battery door. If the meter does not power on after you have replaced the battery, check that the battery is correctly installed with the “+”...
Troubleshooting The OneTouch® Vita™ Meter displays messages when there are problems with the test strip, with the meter, or when your blood glucose levels are higher than 33.3 mmol/L or lower than 1.1 mmol/L. Improper use may cause an inaccurate result without producing an error message.
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Troubleshooting Message What it means What to do Re-test your You may have WARNING a very high blood glucose. HIGH GLUCOSE blood glucose the result is HIGH ABOVE 33.3 mmol/L level (severe again, GLUCOSE hyperglycaemia), consult your health AFTER MEAL? �...
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Troubleshooting Message What it means What to do Move the meter and Meter is too WARNING test strips to a cooler hot (above TEMPERATURE area. Insert a new test 44°C) to work ERROR strip when the meter correctly. TEMPERATURE TOO HIGH and test strips are SEE USER’S HANDBOOK within the operating...
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Troubleshooting Message What it means What to do Do not There is a use the meter. WARNING problem with Contact Customer Care ERROR 1 the meter. on 0800 121 200 (UK) or METER PROBLEM 1800 535 676 (Ireland). CALL CUSTOMER SERVICE Error message Repeat the test with...
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Troubleshooting Message What it means What to do One of the following may apply: WARNING ERROR 4 You may have Make sure you STRIP PROBLEM tested in an are testing within environment the operating SEE USER’S HANDBOOK near the low end temperature range of the system’s (10–44°C) and operating repeat the test with...
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Troubleshooting Message What it means What to do The meter has Repeat the test WARNING detected a with a new test ERROR 5 problem with strip. See blood STRIP PROBLEM OR SAMPLE TOO SMALL the test strip. application (pages Possible causes 12–15) or control RETEST WITH A NEW STRIP...
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Troubleshooting Message What it means What to do Meter battery Once the 27/FEB/08 14:07 is low but still BATTERY/REPLACE has enough BATTERY SOON power to message is displayed, mmol/L perform a test. this symbol will AFTER MEAL continue to appear until you replace the battery.
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Troubleshooting Message What it means What to do No result in You can still perform memory, such as a blood glucose test – – – the first time use and get an accurate of the meter, or result. Contact your meter was Customer Care on unable to recall 0800 121 200 (UK)
Detailed information about your system Technical specifications Reported result range 1.1–33.3 mmol/L Calibration Plasma-equivalent Sample Fresh capillary whole blood Testing time 5 seconds Assay method Glucose oxidase biosensor Meter power source One 3.0 Volt CR 2032 lithium battery or equivalent Unit of measurement mmol/L 350 test results...
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3 V/m as specified in IEC 61000-4-3. Degree of protection rating: IP32 Guarantee LifeScan guarantees that the OneTouch® Vita™ Meter will be free of defects in material and workmanship for three years, valid from the date of purchase. The guarantee extends only to the original purchaser and is not transferable.
Index Alternative site testing procedure............19 Averages ......................28 Battery ......................36 Buttons on meter ..................2 Cleaning your meter and lancing device ..........35 Control solution testing ................30 Data port ......................2 Date setting .....................4 Dehydration ....................17 Discard/use-by date, control solution and test strips ....34 Display check ....................3 Disposal, lancets and test strips ............
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Index MAIN MENU screen ................3, 26 Meal flags feature ..................24 mmol/L ................... 2, 5, 15, 46 OneTouch® Clear Cap ............... 1, 8, 20 Plasma calibration ..................46 Results, reviewing past ................26 Settings ......................3 Start-up screen ....................3 Storing your system ................... 34 Symbols ......................i...
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Expected blood glucose levels for people without diabetes are: Before breakfast 3.9–5.8 mmol/L Before lunch or dinner 3.9–6.1 mmol/L 1 hour after meals < 8.9 mmol/L 2 hours after meals < 6.7 mmol/L Between 02:00 and 04:00 >3.9 mmol/L You should consult your health care professional to set the range of expected blood glucose values and testing times that are appropriate for you, and discuss the meaning of your test results.
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NOTES: Customer Care Freephone 0800 121 200 (UK) or 1800 535 676 (Ireland)
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NOTES: Customer Care Freephone 0800 121 200 (UK) or 1800 535 676 (Ireland)
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LifeScan self-test blood glucose monitoring devices conform to the following EU Directives: IVDD (98/79/EC): Blood Glucose Meter, Test Strips, and Control Solution. 0344 MDD (93/42/EEC): Lancets 0120 Blood Sampler LifeScan, Inc. Milpitas, CA 95035 U.S.A. LifeScan Regulatory Affairs Europe Division of Ortho-Clinical Diagnostics France 1, rue Camille Desmoulins 92787 Issy-les-Moulineaux Cedex 09 France...