DCO_06397302A_OTUM_OBC_US_es

9/7/07

12:59 PM

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Blood Glucose Monitoring System Sistema de supervisin de glucosa en sangre
Just the Basics of Testing Slo lo bsico para la realizacin de pruebas
Owners Booklet Manual del propietario
DCO_06397302A_OTUM_OB_US_e

9/11/07

5:52 PM

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OneTouch UltraMini Blood Glucose Monitoring System Owners Booklet

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Welcome to the OneTouch family! OneTouch is committed to creating a world without limits for people with diabetes. The OneTouch UltraMini Meter makes it simple to get a test result and review past results. This owners booklet will help you learn how to use your meter properly. Please read it carefully. If you need assistance, please contact LifeScan Customer Service at 227-8862 (available 24 hours a day, seven days a week). Please also visit www.LifeScan.com for more information.

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Table of contents
Setting up your system...pg. 2 Starting the test process...pg. 7 Getting a blood sample...pg. 10 Applying blood and reading results..pg. 22 Reviewing past results..pg. 29 Downloading results to a computer..pg. 30 Control solution testing...pg. 32 Caring for your system..pg. 37 Understanding error and other messages..pg. 42 Detailed information about your system..pg. 48 Index...pg. 52

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Before you begin Before using this product to test your blood glucose, carefully read this booklet and the inserts that come with the OneTouch Ultra Test Strips and OneTouch Ultra Control Solution. Take note of warnings and cautions throughout this booklet, which are identified with. Many people find it helpful to practice the test with control solution before testing with blood for the first time. See pages 3236 in the Control solution testing section. Intended use The OneTouch UltraMini Blood Glucose Monitoring System is intended to be used for the quantitative measurement of glucose (sugar) in fresh capillary whole blood. The OneTouch UltraMini 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. It should not be used for the diagnosis of diabetes or for testing newborns. Test principle Glucose in the blood sample mixes with special chemicals in the test strip and a small electric current is produced. The strength of this current changes with the amount of glucose in the blood sample. Your meter measures the current, calculates your blood glucose level, displays the result, and stores it in its memory.

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The OneTouch UltraMini Blood Glucose Monitoring System
To test with the OneTouch UltraMini System, you will need the following: a. OneTouch UltraMini Meter (battery included) b. OneTouch Ultra Control Solution c. OneTouch Lancing Device If another type of lancing device was included, see the separate instructions that came with that lancing device. d. OneTouch AST Clear Cap e. OneTouch UltraSoft Sterile Lancets f. Carrying Case g. You will also need OneTouch Ultra Test Strips. Some kits do not include test strips. Test strips are sold separately. Documents in your kit include this owners booklet, a quick start guide, a quick reference guide, a control solution insert and a warranty registration card. If any items are missing from your kit, call LifeScan Customer Service at 227-8862.

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WARNING: Keep the meter and testing
supplies away from young children. Small items such as the battery door, battery, test strips, lancets, protective disks on the lancets and control solution vial cap are choking hazards.

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Setting up your system
Getting to know your OneTouch UltraMini Blood Glucose Meter and test strips

FRONT Display

mg/dL is the pre-set unit of measure
Edge to apply sample Confirmation window Up and down buttons Turns the meter on or off Select or change information
Test port Insert test strip here to turn meter on for testing

with battery door open

Battery door Meter battery Contact bars Insert into test port

TEST STRIP

Data port

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Turning your meter on To perform a test, insert a test strip as far as it will go. The display will turn on and the meter will briefly perform system checks. Or, to change the time and date, start with the meter off, then press and hold for five seconds until the start-up test screen appears. After the test screen, the pre-set time and date will appear on the display. Or, if you want to turn the meter on to review past results, start with the meter off, then press and release.
CAUTION: If any information is missing from the start-up test screen, there may be a problem with the meter. Call LifeScan Customer Service at 227-8862.
Every time you turn your meter on, a start-up test screen will appear for two seconds. All segments of the display should appear briefly on the test screen to tell you that the meter is working properly. To check that all display segments are working, as soon as the start-up test screen appears, press and hold to keep the test screen display on. Release to proceed to the next step. If the meter does not power on, try changing the meter battery. See pages 3940. Turning your meter off There are several ways to turn your meter off: Press and hold for two seconds, when reviewing past results. Your meter will turn off by itself if left alone for two minutes. Before or after completing a test, remove the test strip.

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Setting the time and date Your OneTouch UltraMini Meter comes with the time, date and unit of measure pre-set. Before using your meter for the first time or if you change the meter battery, you should check and update the time and date. Make sure you complete steps 1 to 7 below to ensure your desired settings are saved.
WARNING: If your display shows mmol/L rather than mg/dL, contact LifeScan Customer Service at 227-8862. You cannot change the unit of measure. Use of the wrong unit of measure may cause you to misinterpret your blood glucose level, and may lead to incorrect treatment.

Step 1

Turn the meter on, see page 3 After the test screen, the pre-set time and date will appear on the display for five seconds. The hour will now start flashing. NOTE: If a setting does not need to be updated, simply wait five seconds. The meter display will automatically advance to the next setting.

Step 2

Set the hour With the hour flashing on the display, press and release or to go forward or backward one hour. To 4 move faster, hold the or buttons down.

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When the correct hour appears on the display, wait five seconds. Your entry will be saved and you will move to the next setting. The minutes will now start flashing.

Step 3

Set the minutes Press or to change the minutes. When you have the correct minutes on the display, wait five seconds to move to the next setting. AM or PM will now start flashing.

Step 4

Set AM or PM AM or PM will be displayed next to the minutes. Press or to set AM or PM, then wait five seconds to move to the next setting. The year (last two digits only), month and day appear on the display and the year flashes.

Step 5

Set the year Press or to change the year. When you have the correct year on the display, wait five seconds to move to the next setting. The month will now start flashing.

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Step 6
Set the month Press or to change the month. When you have the correct month on the display, wait five seconds to move to the next setting. The day will now start flashing.

Step 7

Set the day Press or to change the day. When you have the correct day on the display, wait five seconds to move to the next screen. Your time and date settings will be displayed for five seconds. After the five seconds, the settings will be saved and the meter will then turn off. If you want to adjust your settings, press or while the time and date are still on the display. You will be returned to the first set-up screen where you can begin with the hour.

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Starting the test process
Have these things ready when you test your blood glucose level: OneTouch UltraMini Meter OneTouch Ultra Test Strips Lancing device Sterile lancets with protective disks OneTouch Ultra Control Solution
CAUTION: If you cannot test due to a problem with
your testing supplies, contact your health care professional or LifeScan Customer Service at 227-8862. Failure to test could delay treatment decisions and lead to a serious medical condition.
NOTE: Use only OneTouch Ultra Test Strips with your OneTouch UltraMini Meter. Make sure your meter and test strips are about the same temperature before you test. Testing must be done within the operating temperature range (43111F). For the most accurate results, try to test as close to room temperature (6877F) as you can. You can perform a blood glucose test while your OneTouch UltraMini Meter is inside its case.

Check the code on the test strip vial before inserting the test strip Code numbers are used to calibrate your meter with the test strips you are using to obtain accurate test results. You must code the meter before using it for the first time and then every time you change to another vial of test strips.

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CAUTION: The test strip vial contains drying agents that are harmful if inhaled or swallowed and may cause skin or eye irritation. Step 2
Insert a test strip to turn on the meter Start with the meter off. If you have turned the meter on to change settings or review past results, turn it off. Remove a test strip from its vial. 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. Use each test strip immediately after removing it from the vial. Hold the meter as shown and insert the test strip into the test port. Make sure the three contact bars are facing you. Push the test strip in as far as it will go. Do Not bend the test strip.
CAUTION: OneTouch Ultra Test Strips are for single use only. Never
re-use a test strip that had either blood or control solution applied to it.
After the start-up test screen appears, the meter will display the code from your last test. If a constant and a flashing appear instead of a code number, such as when you are first using the meter, follow the 8 instructions on the next page to change to a numerical code.

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Match the code on the meter with the code on the test strip vial If the code on the meter does not match the code on the test strip vial, press or to match the code number on the test strip vial. The new code number will flash on the display for three seconds, and then stay constant for three seconds. The display will advance to the screen with the flashing blood drop icon R. If the codes already match, wait three seconds. The display will advance to the screen with the flashing blood drop icon R. The meter is now ready to perform a blood glucose test. NOTE: If the screen with the flashing blood drop icon R appears before you are sure the codes match, remove the test strip, wait until the meter turns off, then re-start from step 1, see page 7.
If you press by mistake so that the control solution test symbol CtL appears on the display, press again to change it back to the screen with the flashing blood drop icon R.
CAUTION: Matching the code on the meter and the code on the test strip vial is essential to obtain accurate results. Each time you test, check to make sure the code numbers match.

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Getting a blood sample Overview of the OneTouch Lancing Device
Release button Cocking control Depth indicator OneTouch AST Clear Cap* (for alternate site sampling)
Protective disk Blue (or black) cap* (for fingertip sampling) OneTouch UltraSoft Sterile Lancet

Lancet point

*The blue (or black) cap and OneTouch AST Clear Cap are also used for depth adjustment
NOTE: If you do not have a OneTouch Lancing Device, please refer to the instructions that came with your lancing device.
CAUTION: To reduce the chance of infection:
Make sure to wash the puncture site with soap and water before sampling. Never share a lancet or a lancing device with anyone. Always use a new, sterile lancetlancets are for single use only. Keep your meter and lancing device clean. See page 38.

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Choosing the right sampling site at the right time The OneTouch UltraMini Meter allows you to sample blood from your fingertip, forearm or palm. Forearm and palm sampling is also referred to as alternate site testing (AST). 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:

Getting a blood sample

Routinely before meals Prior to or more than two hours after: a meal a rapid-acting insulin injection or insulin pump bolus exercise 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 When you are concerned about the possibility of hypoglycemia (low blood sugar)
Fingertip, forearm, or palm

Fingertip

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CAUTION: Do Not test on your forearm 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 insulin pump bolus. Testing with a fingertip sample may identify hypoglycemia 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 insulin pump bolus, physical exercise, or you think your glucose level is changing rapidly. You are concerned about the possibility of hypoglycemia or an insulin reaction, such as when driving a car. This is especially important if you suffer from hypoglycemia unawareness (lack of symptoms to indicate an insulin reaction).
Remember: Consult with your health care professional before using your forearm or palm for testing.

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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. Preparing your sample site Before you test your blood glucose, wash your hands and forearm (if applicable) thoroughly with warm, soapy water. Rinse and dry.

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Blue (or black) cap for fingertip sampling only
The OneTouch AST Clear Cap is used for forearm and palm sampling only. Replace the blue (or black) cap with the OneTouch AST Clear Cap.

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Install the OneTouch AST Clear Cap on the OneTouch Lancing Device by snapping it on
Adjust the depth setting You may have to adjust the OneTouch Lancing Device to a deeper setting to get a large enough drop of blood from your forearm or palm. Twist the OneTouch AST Clear Cap toward the larger numbers to increase the depth.

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Puncture your forearm or palm Firmly press and hold the lancing device against your forearm or palm for a few seconds. Wait until the skin surface under the OneTouch AST Clear Cap changes color (as blood collects beneath the skin). This tells you there is enough blood flow for a good sample. Then press the release button while continuing to apply pressure. Keep holding the lancing device against your skin until a round drop of blood forms under the cap. When sampling blood from your forearm or palm, make sure the drop of blood is of at least one microliter ( actual size) before you release pressure and remove the lancing device.
Remove the OneTouch Lancing Device Carefully lift the lancing device away from your skin. Do Not smear the blood sample.

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NOTE: 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. If the sample drop of blood runs or spreads due to contact with hair or with a line in your palm, Do Not use that sample. Try puncturing again in a smoother area. Remember: You may have to adjust the lancing device to a deeper setting to get a large enough drop of blood ( actual size).

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Applying blood and reading results
Once you have a blood sample and your meter shows the screen with the flashing blood drop icon R, you are ready to obtain a blood glucose result. If your meter does not show the screen with the flashing blood drop icon R, remove the unused test strip and re-start the test process. See page 7.
Prepare to apply the sample Keeping your finger extended and steady, move the meter and test strip toward the blood drop.
Do Not apply blood on the top of the test strip.
Do Not hold the meter and test strip underneath the blood drop. This may cause blood to run into the test port and damage the meter.

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When applying a drop of blood from your forearm or palm, keep your palm or forearm steady and bring the top edge of the test strip to the drop of blood with your other hand.
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.

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Reviewing past results
The meter stores a maximum of 500 blood glucose test results. When the meter memory is full, the oldest result is dropped as the newest is added. Results are stored automatically when you test, along with the time, date and unit of measure. You can review the results stored in the meter memory, starting with the most recent. If your meter is off, press and release to turn it on. After the start-up test screen, your most recent test result will appear on the display. M also appears to indicate memory mode. If you have just completed a test, leave the test strip in the meter and press to enter the memory mode. Your most recent blood glucose test result appears along with M. Press to move to the previous result stored in the meter. Then, press or to move forward or backward through all of your results. When youre finished reviewing past results, press and hold for two seconds until the meter turns off. NOTE: If no results are currently stored in the meter, will appear on the display.

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Downloading results to a computer
You can use your meter with OneTouch Diabetes Management Software (DMS) for storing your records and to help you spot patterns for planning meals, exercise, and medication. OneTouch DMS puts information downloaded from the meter into charts and graphs. If you are a current OneTouch DMS user, additional software updates may be required for use with the OneTouch UltraMini meter. Please visit www.OneTouchDiabetesSoftware.com.
Obtain the required software and cable For order information and to learn more about OneTouch Diabetes Management Software visit www.OneTouchDiabetesSoftware.com.
Install the software on a computer Follow the installation instructions provided with the Software. If using a OneTouch Interface Cable (USB format), install the software driver.
WARNING: To avoid a possible shock, Do Not insert a test strip when the meter is connected to a computer with the OneTouch Interface Cable.

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Get ready to transfer readings Connect the OneTouch Interface Cable to the COM or USB port on your computer. Make sure the meter is turned off. If you insert the cable while the meter is already on, the meter will not respond to computer commands. Then connect the other end of the OneTouch Interface Cable to the meter data port.

Interface Cable

Transfer data Follow the instructions provided with 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. You will not be able to perform a test when the meter is in communication mode.

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Control solution testing
OneTouch Ultra Control Solution contains a known amount of glucose and is used to check that the meter and the test strips are working properly. Do a control solution test: to practice the test process instead of using blood, once a week, whenever you open a new vial of test strips, if you suspect the meter or test strips are not working properly, if you have had repeated unexpected blood glucose results (as described on page 27), or if you drop or damage the meter.
NOTE: Use only OneTouch Ultra Control Solution with your OneTouch UltraMini Meter. Control solution tests must be done at room temperature (6877F). Make sure your meter, test strips, and control solution are at room temperature before testing.

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CAUTION: Do Not swallow control solution; it is not for human consumption.
Do Not apply control solution to the skin or eyes as it may cause irritation.
Performing a control solution test Start with the meter off. If you have turned the meter on to change settings or review past results, turn it off.
Check the code on the test strip vial before inserting the test strip
Insert a test strip to turn on the meter Make sure the three contact bars are facing you. Push the test strip in as far as it will go. Do Not bend the test strip.

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Match the code on the meter with the code on the test strip vial If the code on the meter does not match the code on the test strip vial, press or to match the code number on the test strip vial. The new code number will flash on the display for three seconds, and then stay constant for three seconds. The display will advance to the screen with the flashing blood drop icon R. If the codes already match, wait three seconds. The display will advance to the screen with the flashing blood drop icon R.

Step 4 (Example)

Mark the test as a control solution test IMPORTANT:
Mark all control solution tests with CtL. This will stop them from being stored as blood glucose results. Control solution results marked with CtL are not stored in the meters memory.
Press so that the control solution test symbol CtL appears in the upper right corner of the display. You must mark the test before you apply control solution. Once you have completed the test, you cannot change the marking. The meter is now ready to perform a 34 control solution test.

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If you decide not to do a control solution test, press again to remove CtL from the display.
Prepare and apply control solution Shake the control solution vial before each test. Remove the cap and squeeze the vial to discard the first drop. Then wipe the tip with a clean tissue or cloth. Hold the vial upside down and gently squeeze a hanging drop. Touch and hold the hanging drop of control solution to the narrow channel in the top edge of the test strip. Make sure the confirmation window fills completely. Control solution should not be applied to the flat face of the test strip.
Top edge Narrow channel Apply drop here
Read your result When the confirmation window is full, the meter will count down from 5 to 1. Your result will then appear on the display, along with CtL and the unit of measure.

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Check if the result is in range Compare the result displayed on the meter to the control solution range printed on the test strip vial. Each vial of test strips may have a different control solution range. If the results you get are not within this range, the meter and test strips may not be working properly. Repeat the control solution test. Out-of-range results may be due to: not following the instructions detailed on pages 3335, expired or contaminated control solution, expired or damaged test strip, use of a test strip or control solution past its discard date, or a problem with the meter.

100-135 mg/dL (Example)

CAUTION: The control solution range printed on the test strip vial is for OneTouch Ultra Control Solution only. It is not a recommended range for your blood glucose level. CAUTION: If you continue to get control solution results that fall outside the range printed on the test strip vial, Do Not use the meter, the test strips, or the control solution. Call LifeScan Customer Service at 227-8862. 36

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Caring for your system
Your OneTouch UltraMini Blood Glucose Monitoring System does not need any special maintenance. Storing your system Store your meter, test strips and control solution in your carrying case after each use. Store each item in a cool, dry place below 86F, but Do Not refrigerate. Keep all items away from direct sunlight and heat. Tightly close the cap on the test strip vial and/or control solution vial immediately after use to avoid contamination or damage. Store test strips only in their original vial. Checking for expiration or damage to test strips and control solution Test strips and control solution have expiration dates printed on their vials. When you first open a test strip or control solution vial, you must record the discard date (date opened plus three months) in the space provided on the label.
CAUTION: Do Not use the test strips or control solution after the expiration date printed on the vial or the discard date, whichever comes first, or your results may be inaccurate.

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CAUTION: Do Not use your test strips if your vial is damaged or left open to air.
This could lead to error messages or tests that read higher than the actual value. Call LifeScan Customer Service at 227-8862 immediately if the test strip vial is damaged.
Cleaning your meter To clean your meter, wipe the outside with a soft cloth dampened with water and mild detergent. Do Not use alcohol or another solvent to clean your meter.
Do Not get any liquids, dirt, dust, blood, or control solution inside the meter through the test port or the data port. Never spray cleaning solution on the meter or immerse it in any liquid. Cleaning your OneTouch Lancing Device and OneTouch AST Clear Cap To clean these items, wipe them with a soft cloth dampened with water and mild detergent. Do Not immerse the OneTouch Lancing Device in any liquid. To disinfect these items, prepare a solution of one part household bleach to ten parts water. Wipe the OneTouch Lancing Device with a soft cloth dampened with this solution. Immerse the caps only in this solution for 30 minutes. After disinfecting, rinse briefly with water and allow both to air dry.

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Battery Your OneTouch UltraMini Meter uses one 3.0 Volt CR 2032 lithium battery (or equivalent). Replacement batteries can be found in most stores where batteries are sold. Your meter comes with the battery already installed. A battery icon low battery. appears in the far right-hand side of the meter display to indicate

You may have a very high blood glucose level (severe hyperglycemia), over 600 mg/dL.

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Message
What it means The meter has detected that the temperature is above the system operating range. Do Not perform a test until the meter and test strips reach a temperature within the operating range of 43111 F. The meter has detected that the temperature is below the system operating range. Do Not perform a test until the meter and test strips reach a temperature within the operating range of 43111 F.
What to do Repeat the test after the meter and test strips have reached a temperature within the operating range.
Repeat the test after the meter and test strips have reached a temperature within the operating range.
Understanding error messages

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What it means No result in memory, such as the first time use of the meter. or, Your meter was unable to recall this result.
What to do You can still perform a blood glucose test and get an accurate test result. Contact LifeScan Customer Service at 227-8862 to report this occurrence if this is not your first time use of the meter. Do Not use the meter. Contact LifeScan Customer Service at 227-8862. Repeat the test with a new test strip; see pages 2225. If this message continues to appear, contact LifeScan Customer Service at 227-8862.
Error message indicates there is a problem with the meter. Error message could be caused either by a used test strip or a problem with the meter.

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What it means Error message indicates that the blood or control solution sample was applied before the meter was ready.
What to do Repeat the test with a new test strip. Apply a blood or control solution sample only after the flashing blood drop icon R appears on the display. If this message continues to appear, contact LifeScan Customer Service at 227-8862.
One of the following may apply:
You may have high glucose and have tested in an environment near the low end of the systems operating temperature range (43111 F). or, see top of next page
If you tested in a cool environment, repeat the test in a warmer environment with a new test strip; see pages 2225. If this error message appears again, contact LifeScan Customer Service at 227-8862.

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What it means There may be a problem with the test strip. For example, it may have been damaged or moved during testing. or, The sample was improperly applied. or,

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Alternate site testing procedure. 16 Battery. 2, 39 Battery, icon on display. 39, 47 Buttons on meter. 2 Cable, OneTouch Interface. 30 Cleaning your meter and lancing device. 38 Code. 7, 33 Confirmation window. 2, 25, 35 Connecting to a computer. 31 Control solution. 1, 32 Control solution, result range. 36 Control solution, storing. 37 Control solution, testing. 32 Data port. 2, 31 Date setting. 5, 6 Dehydration. 26 Discard date, control solution. 37 Discard date, test strips. 37 Downloading results to a computer. 30 Drop of blood, proper size. 16, 20, 21 Er (Error) messages. 26, 42 Expiration date, control solution. 37 Expiration date, test strips. 37 Fingertip testing procedure. 13 Forearm. 11, 17, 20, 23 Forearm or palm sampling, important information. 11, 12, 21 Guarantee. 51 HI (high glucose) message. 27, 42 Hyperglycemia. 27 Hypoglycemia. 11, 12, 26 Infection, reduce the risk. 10 Intended use. iv Lab results, comparing with meter results. 48 Lancet, disposal. 28 Lancet, inserting in lancing device. 14, 18 Lancet, protective disk. 10, 14, 18, 28 Lancing device and cap. 10, 13 Lancing device, OneTouch AST Clear Cap. 10, 18, 19

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Lancing device, depth setting. 10, 14, 19 LO (low glucose) message. 26, 42 Low battery icon. 39, 47 Low battery message. 39, 47 mg/dL. 4, 26, 50 mmol/L. 4 Palm. 11, 17, 20, 23 PC communication mode. 31 Plasma calibration. 48, 50 Repeated unexpected glucose results. 27 Result screen. 25, 29 Results, reviewing past. 29 Set up. 4 Software, OneTouch Diabetes Management. 30 Start-up test screen. 3, 8 Storing your control solution. 37 Storing your meter. 37 Storing your test strips. 37 Symbols. 51 System components. 1
Technical specifications. 50 Temperature error message. 43 Temperature. 7, 26, 32, 37, 43, 45, 50 Testing procedure. 7 Test screen. 3, 8 Test strip, applying drop of blood. 2, 22, 24, 25 Test strip, confirmation window. 2, 25, 33 Test strip, contact bars. 2, 8 Test strip, disposal. 28 Time setting. 4, 5 Turning meter off. 3 Turning meter on for reviewing results. 3, 29 Turning meter on for testing. 3, 8 Unexpected test results. 26, 27 Unit of measure. 4, 26

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Reminders
Time of day Before breakfast Before lunch or dinner 1 hour after meals 2 hours after meals Between 2 a.m. and 4 a.m. Your target ranges from your health care professional
Patent information The system described herein is covered by one or more of the following U.S. patents: 5,708,247, 5,951,836, 6,241,862, and 6,284,125. Use of the monitoring device included herein is protected under one or more of the following U.S. patents: 6,413,410, 6,733,655. 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 Ultra Test Strips. No test strip supplier other than LifeScan is authorized 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.

DCO_06397301A_OTUM_COV.qxd

05/04/06

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Blood Glucose Monitoring System Sistema de supervisin de glucosa en sangre
Just the Basics of Testing Slo lo bsico para la realizacin de pruebas
Owners Booklet Manual del propietario
DCO_06397301A_OTUM_OB_EN.qxd

05/05/06

9:15 AM

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OneTouch UltraMini Blood Glucose Monitoring System Owners Booklet

Page ii

Welcome to the OneTouch UltraMini family! OneTouch is committed to creating a world without limits for people with diabetes. The OneTouch UltraMini Meter makes it simple to get a test result and review past results. This owners booklet will help you learn how to use your meter properly. Please read it carefully. If you need assistance, please contact LifeScan Customer Service at 227-8862 (available 24 hours a day, seven days a week). Please also visit www.LifeScan.com for more information.

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Table of contents
Setting up your system...pg. 2 Starting the test process...pg. 7 Getting a blood sample...pg. 10 Applying blood and reading results..pg. 22 Reviewing past results..pg. 27 Control solution testing...pg. 28 Caring for your system..pg. 33 Understanding error and other messages..pg. 37 Detailed information about your system..pg. 43 Index...pg. 47

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Before you begin Before using this product to test your blood glucose, carefully read this booklet and the inserts that come with the OneTouch Ultra Test Strips and OneTouch Ultra Control Solution. Take note of warnings and cautions throughout this booklet, which are identified with. Many people find it helpful to practice the test with control solution before testing with blood for the first time. See pages 2832 in the Control solution testing section. Intended use The OneTouch UltraMini Blood Glucose Monitoring System is intended to be used for the quantitative measurement of glucose (sugar) in fresh capillary whole blood. The OneTouch UltraMini System is intended for use outside the body (in vitro diagnostic use) by people with diabetes at home and by healthcare professionals in a clinical setting as an aid to monitor the effectiveness of diabetes control. It should not be used for the diagnosis of diabetes or for testing newborns. Test principle Glucose in the blood sample mixes with special chemicals in the test strip and a small electric current is produced. The strength of this current changes with the amount of glucose in the blood sample. Your meter measures the current, calculates your blood glucose level, displays the result, and stores it in its memory.

9:16 AM

Page 1
The OneTouch UltraMini Blood Glucose Monitoring System
To test with the OneTouch UltraMini System, you will need the following: a. OneTouch UltraMini Meter (battery included) b. OneTouch Ultra Control Solution c. OneTouch Lancing Device If another type of lancing device was included, see the separate instructions that came with that lancing device. d. OneTouch AST Clear Cap e. OneTouch UltraSoft Sterile Lancets f. Carrying Case g. You will also need OneTouch Ultra Test Strips. Some kits do not include strips. Strips are sold separately. Documents in your kit include this owners booklet, a quick start guide, a quick reference guide, a control solution insert and a warranty registration card. If any items are missing from your kit, call LifeScan Customer Service at 227-8862.

g f c d

WARNING: Keep the meter and testing
supplies away from young children. Small items such as the battery door, battery, test strips, lancets, protective disks on the lancets and control solution vial cap are choking hazards.

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Setting up your system
Getting to know your OneTouch UltraMini Blood Glucose Meter and test strips

FRONT Display

mg/dL is the pre-set unit of measure
Edge to apply sample Confirmation window Up and down buttons Turns the meter on or off Select or change information
Test port Insert test strip here to turn meter on for testing

with battery door open

Battery door Meter battery
Contact bars Insert into test port

TEST STRIP

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Turning your meter on To perform a test, insert a test strip as far as it will go. The display will turn on and the meter will briefly perform system checks. Or, to change the time and date, start with the meter off, then press and hold for five seconds until the start-up test screen appears. After the test screen, the pre-set time and date will appear on the display. Or, if you want to turn the meter on to review past results, start with the meter off, then press and release.
CAUTION: If any information is missing from the start-up test screen, there may be a problem with the meter. Call LifeScan Customer Service at 227-8862.
Every time you turn your meter on, a start-up test screen will appear for two seconds. All segments of the display should appear briefly on the test screen to tell you that the meter is working properly. To check that all display segments are working, as soon as the start-up test screen appears, press and hold to keep the test screen display on. Release to proceed to the next step. If the meter does not power on, try changing the meter battery. See pages 3536. Turning your meter off There are several ways to turn your meter off: Press and hold for two seconds, when reviewing past results. Your meter will turn off by itself if left alone for two minutes. Before or after completing a test, remove the test strip.

Step 6

Set the day Press or to change the day. When you have the correct day on the display, wait five seconds to move to the next screen. Your time and date settings will be displayed for five seconds. After the five seconds, the settings will be saved and the meter will then turn off. If you want to adjust your settings, press or while the time and date are still on the display. You will be returned to the first set-up screen where you can begin with the hour.

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Starting the test process
Have these things ready when you test your blood glucose level: OneTouch UltraMini Meter OneTouch Ultra Test Strips Lancing device Sterile lancets with protective disks OneTouch Ultra Control Solution
CAUTION: If you cannot test due to a problem with your testing supplies, contact your healthcare professional or LifeScan Customer Service at 227-8862. Failure to test could delay treatment decisions and lead to a serious medical condition.
NOTE: Use only OneTouch Ultra Test Strips with your OneTouch UltraMini Meter. Make sure your meter and test strips are about the same temperature before you test. Testing must be done within the operating temperature range (43111F). For the most accurate results, try to test as close to room temperature (6877F) as you can. You can perform a blood glucose test while your OneTouch UltraMini Meter is inside its case.

Step 1

Check the code on the test strip vial before inserting the strip Code numbers are used to calibrate your meter with the test strips you are using to obtain accurate test results. You must code the meter before using it for the first time and then every time you change to another vial of test strips.

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CAUTION: The test strip vial contains drying agents that are harmful if inhaled or swallowed and may cause skin or eye irritation. Step 2
Insert a test strip to turn on the meter Start with the meter off. If you have turned the meter on to change settings or review past results, turn it off. Remove a test strip from its vial. 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. Use each test strip immediately after removing it from the vial. Hold the meter as shown and insert the test strip into the test port. Make sure the three contact bars are facing you. Push the strip in as far as it will go. Do not bend the strip.

CAUTION: OneTouch Ultra Test Strips are for single use only. Never
re-use a strip that had either blood or control solution applied to it.
After the start-up test screen appears, the meter will display the code from your last test. If a constant and a flashing appear instead of a code number, such as when you are first using the meter, follow the instructions on the next page to change to a numerical code.

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Match the code on the meter with the code on the test strip vial If the code on the meter does not match the code on the test strip vial, press or to match the code number on the test strip vial. The new code number will flash on the display for three seconds, and then stay constant for three seconds. The display will advance to the screen with the flashing blood drop icon R. If the codes already match, wait three seconds. The display will advance to the screen with the flashing blood drop icon R. The meter is now ready to perform a blood glucose test. NOTE: If the screen with the flashing blood drop icon R appears before you are sure the codes match, remove the test strip, wait until the meter turns off, then re-start from step 1, see page 7. If you press by mistake so that the control solution test symbol CtL appears on the display, press again to change it back to the screen with the flashing blood drop icon R.
CAUTION: Matching the code on the meter and the code on the test strip vial is essential to obtain accurate results. Each time you test, check to make sure the code numbers match.

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Getting a blood sample Overview of the OneTouch Lancing Device
Release button Cocking control Depth indicator OneTouch AST Clear Cap* (for alternate site sampling)
Protective disk Blue cap* (for fingertip sampling) OneTouch UltraSoft Sterile Lancet

Lancet point

*The blue cap and OneTouch AST Clear Cap are also used for depth adjustment
NOTE: If you do not have a OneTouch Lancing Device, please refer to the instructions that came with your lancing device.
CAUTION: To reduce the chance of infection:
Make sure to wash the puncture site with soap and water before sampling. Never share a lancet or a lancing device with anyone. Always use a new, sterile lancetlancets are for single use only. Keep your meter and lancing device clean. See page 34.

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Choosing the right sampling site at the right time The OneTouch UltraMini Meter allows you to sample blood from your fingertip, forearm or palm. Forearm and palm sampling is also referred to as alternate site testing (AST). At times, results obtained at the forearm or palm may be different from a fingertip measurement. Talk to your healthcare professional before you begin using your forearm or palm for sampling.
If you are testing: Use blood sample from your:

Getting a blood sample

Remove the OneTouch Lancing Device Carefully lift the lancing device away from your skin. Do not smear the blood sample.

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NOTE: 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. If the sample drop of blood runs or spreads due to contact with hair or with a line in your palm, do not use that sample. Try puncturing again in a smoother area. Remember: You may have to adjust the lancing device to a deeper setting to get a large enough drop of blood ( actual size).

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Applying blood and reading results
Once you have a blood sample and your meter shows the screen with the flashing blood drop icon R, you are ready to obtain a blood glucose result. If your meter does not show the screen with the flashing blood drop icon R, remove the unused test strip and re-start the test process. See page 7.
Prepare to apply the sample The drop of blood should be next to the top edge of the test strip. Blood should not be applied to the flat surface of the test strip. When applying a drop of blood from your forearm or palm, keep your palm or forearm steady and bring the top edge of the test strip to the drop of blood with your other hand.

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Apply the sample Touch and hold the drop of blood to the narrow channel in the top edge of the test strip. Blood will be drawn into the strip. Keep holding the drop of blood to the top edge of the test strip until the confirmation window is full.

Top edge

NOTE: Do not smear or scrape the drop of blood with the test strip. Do not press the test strip too firmly against your puncture site. Do not apply more blood to the test strip after you have moved the drop of blood away. Do not move the test strip in the meter during a test.
Narrow channel Apply drop here
Read your result When the meter detects blood in the test strip, it begins to count down from 5 to 1. Then, your blood glucose level appears on the display, along with the unit of measure, and the date and time of the test. Blood glucose results are automatically stored in the meters memory.
CAUTION: If you test at the low end of the operating range (43F) and your glucose is high (over 180 mg/dL), the reading on your meter may be lower than your actual glucose. In this situation, repeat the test in a warmer environment with a new test strip as soon as possible.

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CAUTION: You may get an Er 5 message or an inaccurate result if the blood sample does not
fill the confirmation window completely. See page 42. Discard the strip and re-start the test process.
WARNING: If mg/dL does not appear with the test result, call LifeScan Customer
Service at 227-8862. Use of the wrong unit of measure may cause you to misinterpret your blood glucose level, and may lead to incorrect treatment.
Error messages If you get an Er message on your screen rather than a result, see pages 3742.

Unexpected test results

Refer to these cautions whenever your results are lower than, higher than, or otherwise not what you expect.
CAUTION: Dehydration and low glucose results
Severe dehydration resulting from excessive water loss may cause false low results. If you think you are suffering from severe dehydration, contact your healthcare professional immediately.
CAUTION: 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 healthcare professionals recommendations. Although this result could be due to a test error, it is safer to treat first, then do another test.

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CAUTION: High glucose results
If your test result is higher than 180 mg/dL, it may mean hyperglycemia (high blood glucose). If you are uncertain about this test result, consider re-testing. Your healthcare professional can work with you to determine what actions, if any, you should take if your results are higher than 180 mg/dL. If your meter displays HI, you may have a very high blood glucose level (severe hyperglycemia) exceeding 600 mg/dL. Re-check your glucose level. If the result is HI again, this may indicate a severe problem with your blood glucose control and it is important you obtain and follow instructions from your healthcare professional without delay.
CAUTION: Repeated unexpected glucose results
If you continue to get unexpected results, check your system with control solution. See Control solution testing, pages 2832. If you are experiencing symptoms that are not consistent with your blood glucose results and you have followed all instructions in this booklet, call your healthcare professional. Never ignore symptoms or make significant changes to your diabetes control program without speaking to your healthcare professional.

CAUTION: Unusual red blood cell count
A hematocrit (percentage of your blood that is red blood cells) that is either very high (above 55%) or very low (below 30%) can cause false results.

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After getting a result
Once you have read your result, you may: Review your meter memory by pressing to enter memory mode, see page 27, or Turn the meter off by removing the test strip. Removing the used lancet Remove the lancing device cap by snapping it off. Cover the exposed lancet tip before removing the lancet. Place the lancet protective disk on a hard surface. Push the lancet tip into the disk. Remove the lancet and place it in a container for sharp objects. Replace the cap. Disposing of the used lancet and test strip It is important to discard the used lancet carefully after each use to avoid unintended lancet stick injuries. Used test strips and lancets may be considered biohazardous waste in your area. Be sure to follow your local regulations for proper disposal.

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Reviewing past results
The meter stores a maximum of 50 blood glucose test results. When the meter memory is full, the oldest result is dropped as the newest is added. Results are stored automatically when you test, along with the time, date and unit of measure. You can review the results stored in the meter memory, starting with the most recent. If your meter is off, press and release to turn it on. After the start-up test screen, your most recent test result will appear on the display. M also appears to indicate memory mode. If you have just completed a test, leave the test strip in the meter and press to enter the memory mode. Your most recent blood glucose test result appears along with M. Press to move to the previous result stored in the meter. Then, press or to move forward or backward through all of your results. When youre finished reviewing past results, press and hold for two seconds until the meter turns off. NOTE: If no results are currently stored in the meter, will appear on the display.

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Control solution testing
OneTouch Ultra Control Solution contains a known amount of glucose and is used to check that the meter and the test strips are working properly. Do a control solution test: to practice the test process instead of using blood, once a week, whenever you open a new vial of test strips, if you suspect the meter or test strips are not working properly, if you have had repeated unexpected blood glucose results (as described on page 25), or if you drop or damage the meter.

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Check if the result is in range Compare the result displayed on the meter to the control solution range printed on the test strip vial. Each vial of test strips may have a different control solution range. If the results you get are not within this range, the meter and strips may not be working properly. Repeat the control solution test. Out-of-range results may be due to: not following the instructions detailed on pages 2931, expired or contaminated control solution, expired or damaged test strip, use of a test strip or control solution past its discard date, or a problem with the meter.

100-135 mg/dL (Example)

CAUTION: The control solution range printed on the test strip vial is for OneTouch
Ultra Control Solution only. It is not a recommended range for your blood glucose level.
CAUTION: If you continue to get control solution results that fall outside the range printed on the test strip vial, do not use the meter, the test strips, or the control solution. Call LifeScan Customer Service at 227-8862. 32

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Caring for your system
Your OneTouch UltraMini Blood Glucose Monitoring System does not need any special maintenance. Storing your system Store your meter, strips and control solution in your carrying case after each use. Store each item in a cool, dry place below 86F, but do not refrigerate. Keep all items away from direct sunlight and heat. Tightly close the cap on the test strip vial and/or control solution vial immediately after use to avoid contamination or damage. Store test strips only in their original vial. Checking for expiration or damage to strips and control solution Test strips and control solution have expiration dates printed on their vials. When you first open a test strip or control solution vial, you must record the discard date (date opened plus three months) in the space provided on the label.
CAUTION: Do not use the strips or control solution after the expiration date printed on the vial or the discard date, whichever comes first, or your results may be inaccurate.

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CAUTION: Do not use your test strips if your vial is damaged or left open to air.
This could lead to error messages or tests that read higher than the actual value. Call LifeScan Customer Service at 227-8862 immediately if the test strip vial is damaged.
Cleaning your meter To clean your meter, wipe the outside with a soft cloth dampened with water and mild detergent. Do not use alcohol or another solvent to clean your meter.
Do not get any liquids, dirt, dust, blood, or control solution inside the meter through the test port. Never spray cleaning solution on the meter or immerse it in any liquid. Cleaning your OneTouch Lancing Device and OneTouch AST Clear Cap To clean these items, wipe them with a soft cloth dampened with water and mild detergent. Do not immerse the OneTouch Lancing Device in any liquid. To disinfect these items, prepare a solution of one part household bleach to ten parts water. Wipe the OneTouch Lancing Device with a soft cloth dampened with this solution. Immerse the caps only in this solution for 30 minutes. After disinfecting, rinse briefly with water and allow both to air dry.

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Battery Your OneTouch UltraMini Meter uses one 3.0 Volt CR 2032 lithium battery (or equivalent). Replacement batteries can be found in most stores where batteries are sold. Your meter comes with the battery already installed. The meter shows a battery icon the condition of the battery. in the far right-hand side of the display to indicate
When the battery icon first appears along with the unit of measure, there is enough power for a minimum of 100 more tests. You should replace the battery as soon as possible. When the battery icon appears by itself, there is not enough battery power remaining to perform a test. You must install a new battery before using your meter. Replacing the battery
Remove the old battery Start with the meter off. Open the battery door and pull up on the battery ribbon.

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Insert the new battery With the + side facing up toward you, place the battery in the compartment within the fold of the ribbon. Push the battery until it snaps into place. Insert the two battery door tabs into the matching holes, and push down until you hear the door click into place. If the meter does not power on after you have replaced the battery, check that the battery is correctly installed with the + side up. If the meter still does not power on, call LifeScan Customer Service at 227-8862.

What to do You can still perform a blood glucose test and get an accurate test result. Contact LifeScan Customer Service at 2278862 to report this occurrence if this is not your first time use of the meter.
Error message indicates there is a problem with the meter. Error message could be caused either by a used test strip or a problem with the meter.
Do not use the meter. Contact LifeScan Customer Service at 227-8862. Repeat the test with a new test strip; see pages 2223. If this message continues to appear, contact LifeScan Customer Service at 227-8862.

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What it means Error message indicates that the blood or control solution sample was applied before the meter was ready.
What to do Repeat the test with a new test strip. Apply a blood or control solution sample only after the flashing blood drop icon R appears on the display. If this message continues to appear, contact LifeScan Customer Service at 227-8862.
One of the following may apply:
You may have high glucose and have tested in an environment near the low end of the systems operating temperature range (43111 F). or, see top of next page
If you tested in a cool environment, repeat the test in a warmer environment with a new test strip; see pages 2223. If this error message appears again, contact LifeScan Customer Service at 227-8862.

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What it means There may be a problem with the test strip. For example, it may have been damaged or moved during testing. or,
What to do If you tested in a normal or warm environment, repeat the test with a new test strip; see pages 2223. If this error message appears again, contact LifeScan Customer Service at 227-8862. If you applied the blood incorrectly, review pages 2223 on blood application and repeat the test with a new test strip. If the error message appears again, contact LifeScan Customer Service at 227-8862. If this error message appears again, contact LifeScan Customer Service at 227-8862.
The sample was improperly applied. or,
There may be a problem with the meter.

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What it means The meter has detected a problem with the test strip. Possible causes are test strip damage or an incompletely filled confirmation window. Meter battery is low but there is enough power to perform a test.
What to do Repeat the test with a new test strip. Refer to pages 2223 for information on sample application.
When the battery icon first appears, there is enough power for a minimum of 100 more tests. Test results will still be accurate, but replace the battery as soon as possible. Replace the meter battery.
The symbol appears on the display by itself when the meter battery does not have enough power to perform a test.

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Battery ratings Symbols
One 3.0 V d.c., 3 mA (one CR 2032 battery)

direct current

Cautions and Warnings: Refer to safety-related notes in the owners booklet and inserts that came with your meter and testing supplies.
Low battery Direct current Electrical and safety standards The meter has been tested for immunity to Level 4 electrostatic discharge as specified in IEC 61000-4-2. This meter has been tested for immunity to radio frequency interference over the frequency range 80MHz to 2.5GHz at 3V/m as specified in IEC 61000-4-3. Degree of protection rating: IP32 Guarantee LifeScan guarantees that the OneTouch UltraMini 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.

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Alternate site testing procedure. 16 Battery. 2, 35 Battery, icon on display. 35, 42 Buttons on meter. 2 Cleaning your meter and lancing device. 34 Code. 7, 29 Confirmation window. 2, 23, 31 Control solution. 1, 28 Control solution, result range. 32 Control solution, storing. 33 Control solution, testing. 28 Date setting. 5, 6 Dehydration. 24 Discard date, control solution. 33 Discard date, test strips. 33 Drop of blood, proper size. 16, 20, 21 Er (Error) messages. 24, 37 Expiration date, control solution. 33 Expiration date, test strips. 33 Fingertip testing procedure. 13 Forearm. 11, 17, 20, 22 Forearm or palm sampling, important information. 11, 12, 21 Guarantee. 46 HI (high glucose) message. 25, 37 Hyperglycemia. 25 Hypoglycemia. 11, 12, 24 Infection, reduce the risk. 10 Intended use. iv Lab results, comparing with meter results. 43 Lancet, disposal. 26 Lancet, inserting in lancing device. 14, 18 Lancet, protective disk. 10, 14, 18, 26 Lancing device and cap. 10, 13 Lancing device, OneTouch AST Clear Cap. 10, 18, 19 Lancing device, depth setting. 10, 14, 19 LO (low glucose) message. 24, 37

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Low battery icon. 35, 42 Low battery message. 35, 42 mg/dL. 4, 24, 45 mmol/L. 4 Palm. 11, 17, 20, 22 Plasma calibration. 43, 45 Repeated unexpected glucose results. 25 Result screen. 23, 27 Results, reviewing past. 27 Set up. 4 Start-up test screen. 3, 8 Storing your control solution. 33 Storing your meter. 33 Storing your test strips. 33 Symbols. 46 System components. 1 Technical specifications. 45 Temperature error message. 38 Temperature. 7, 23, 28, 33, 38, 40, 45 Testing procedure. 7
Test screen. 3, 8 Test strip, applying drop of blood. 2, 22 Test strip, confirmation window. 2, 23, 31 Test strip, contact bars. 2, 8, 29 Test strip, disposal. 26 Time setting. 4, 5 Turning meter off. 3 Turning meter on for reviewing results. 3, 27 Turning meter on for testing. 3, 8 Unexpected test results. 24, 25 Unit of measure. 4, 24

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Reminders
Time of day Before breakfast Before lunch or dinner 1 hour after meals 2 hours after meals Between 2 a.m. and 4 a.m. Your target ranges from your healthcare professional
Patent information The system described herein is covered by one or more of the following U.S. patents: 5,708,247, 5,951,836, 6,241,862, and 6,284,125. Use of the monitoring device included herein is protected under one or more of the following U.S. patents: 6,413,410, 6,733,655. 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 Ultra Test Strips. No test strip supplier other than LifeScan is authorized 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.

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Call LifeScan Customer Service toll-free, 24 hours a day, 7 days a week/ Llame gratuitamente a Servicio de atencin al cliente de LifeScan, 24 horas al da, 7 das a la semana English 227-8862 Espaol 381-7226 Or/O bien, Visit us at/ Visitenos en: English www.LifeScan.com Espaol www.OneTouchEnEspanol.com
2006 LifeScan, Inc. Milpitas, CA 95035 AW 06397301A

Rev. date: 04/2006