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11:52 AM

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Blood Glucose Monitoring System
Link the Effects of Food to Glucose Results

Owners Booklet

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Welcome to the OneTouch family!
We know diabetes can be difficult to understand and manage. The right products and services can help make life with diabetes just a little bit easier. We hope the OneTouch Ultra 2 System works well for you. We designed this product to make testing easy and to help you manage your diabetes. You can use the meter for fast and simple tests. You can also use it to record information to go with your results. This owners booklet is designed to provide the information that you are looking for, when you need it. We hope you keep it handy. Of course, you may still have questions. If you do, our Customer Service representatives would be happy to answer your call. You can reach them at 227-8862, anytime24 hours a day. You can also obtain information at www.LifeScan.com.

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Table of contents
Starting the test process
Insert a test strip Check the code on the test strip vial before inserting the strip. Make sure the three contact bars are facing you. Push the strip in as far as it will go. Do not bend the strip.

pg. 10

Match the code displayed on the meter with the code on the test strip vial If the code on the meter does not match the code on the vial, press or to change the code. If the display changes to the APPLY BLOOD screen before you are ready, remove the strip and re-start the test process.

Setting up your system

Getting to know your OneTouch Ultra 2 Blood Glucose Meter and Test Strips Turning your meter on and off Using the meter display backlight Setting up your meter NOTE: Before testing, read this owners booklet carefully.
The meter will turn on, show a black start-up screen and then a code number. The first time you use the meter, the CAL CODE screen will display instead of a number.

Press match.

when the numbers
The meter is ready for testing when the APPLY BLOOD screen appears.

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Getting a blood sample
Prepare the OneTouch UltraSoft Blood Sampler Remove the blue cap and put a new lancet in the sampler. Twist off the protective disk. Replace the cap and cock the sampler.

pg. 14

Get a drop of blood Hold the OneTouch UltraSoft Blood Sampler firmly against your finger. Press the release button.
Applying blood pg. 25 and reading results
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 strip until the confirmation window is full. The meter will begin 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.

Gently squeeze and/or massage your fingertip until a round drop of blood of at least one microliter ( actual size) forms on your fingertip.
If the test results are lower than, higher than, or not what you expect, see pages 2829. iii

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Attaching flags or comments to your results
Add a meal flag to track different types of averages While viewing your test result, press to get the MEAL FLAG screen.
pg. 32 Reviewing past pg. 36 results and averages
Last result All results Result averages Downloading results
Add a comment While viewing a test result, press to get the COMMENT screen.
to highlight BEFORE MEAL or AFTER MEAL. To confirm your selection, press. The meal flag you chose will appear above the result. If you do not wish to add a meal flag, select NO FLAG and press. This will return you to the glucose result screen. iv
Press or to highlight an appropriate comment. To confirm your selection, press. The comment you chose appears below the result.

Meal flag

Control solution testing Caring for your system

pg. 42 pg. 47

Understanding error pg. 53 and other messages Detailed information pg. 60 about your system

Comment

pg. 65

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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 page 42 in the Control solution testing section. Intended use The OneTouch Ultra 2 Blood Glucose Monitoring System is intended to be used for the quantitative measurement of glucose (sugar) in fresh capillary whole blood. The OneTouch Ultra 2 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.

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The OneTouch Ultra 2 Blood Glucose Monitoring System
a b c Your new OneTouch Ultra 2 System Kit includes: f OneTouch Ultra 2 Meter (batteries included) OneTouch Ultra Control Solution OneTouch UltraSoft Blood Sampler If another type of lancing device was included, a see the separate instructions that came with that lancing device. e OneTouch UltraClear Cap OneTouch UltraSoft Sterile Lancets c Carrying Case d 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 reference guide, a control solution insert and a warranty registration card. If any items are missing from your kit, call Customer Service.

d e f g

WARNING: Keep the meter and testing supplies away from young children. Small items such as the battery door, batteries, test strips, lancets, protective disks on the lancets, and control solution vial cap are choking hazards.
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Getting to know your OneTouch Ultra 2 Blood Glucose Meter and test strips Front

Test port Display

Insert test strip here to turn meter on for testing

with battery door open

Test strip

Edge to apply sample

Meter battery

Confirmation window

OK button
Turns the meter on/off Turns the backlight on/off Confirms menu selections
Data port Backlight battery
mg/dL is the pre-set unit of measure
Battery door Contact bars

Insert into test port

Up and down buttons
Select or change information Indicates selection available using up or down button
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Turning your meter on CAUTION: If you see To perform a test, insert a test strip as far as it will go. any light areas within The meter will briefly perform system checks, then the the black start-up screen, display will turn on. there may be a problem or, with the meter. Call With the meter turned off, press and hold for two Customer Service. seconds to access MAIN MENU. Check that the screen shows solid black for two seconds. If it does, the display is working properly. If the meter does not power on, try changing the meter battery. See page 51. Using the meter display backlight When the meter is already on, press and hold backlight on or off. for two seconds to turn the

Turning your meter off There are several ways to turn your meter off: Press and hold for five seconds. Your meter will turn off by itself if left alone for two minutes. Go to MAIN MENU and press or to highlight METER OFF, then press. Before or after completing a test, remove the test strip. If you advance from the test result screen to the MAIN MENU by pressing , removing the strip will not turn the meter off. Use one of the three methods above.
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Setting the meter language, date and time You can change many of the settings that came pre-set with your meter. Before using your meter for the first time or if you change the meter battery, you should check and update these settings. Make sure you complete steps 1 through 8 below to ensure your desired settings are saved. 1. Turn the meter on, see page 3 2. Get to the LANGUAGE screen When using the meter for the first time, or after changing the meter battery, you will automatically start in the LANGUAGE screen. In other cases, from the MAIN MENU, press or to select SET UP. To confirm your selection, press. Then, press or to select METER SETTINGS. To confirm your selection, press. The display now shows the LANGUAGE screen.

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3. Choose a language Now press or to highlight the language of your choice. To confirm your selection, press. The display now shows the DATE FORMAT screen. NOTE: If you select the wrong language, press and hold for five seconds to turn the meter off. Then, turn the meter back on and re-start from step 1. 4. Set the date format Press or to highlight the date format choose month first (MM-DD-YYYY) or day first (DD-MM-YYYY). To confirm your selection, press. The display now shows the DATE SET UP screen.

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5. Set the date In the DATE SET UP screen, press or to change the first value. To confirm your selection, press. Press or to change the second value. To confirm your selection, press. Press or to change the year. To confirm your selection, press. The display now shows the TIME FORMAT screen. 6. Set the time format Press or to select the time format you preferAM/PM or 24 HR. To confirm your selection, press. The display now shows the TIME SET UP screen.

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7. Set the time Press or to set the hour. To confirm your selection, press.
Press or to set the minutes. To confirm your selection, press.
If you have selected the AM/PM time format, AM or PM will be displayed next to the minutes. Press or to set AM or PM. To confirm your selection, press. The display now shows the SETTINGS screen.
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8. Confirm your settings The choice YES will be highlighted at the bottom of the screen. If your settings are correct, press to confirm and save the settings and return to the MAIN MENU.

CAUTION: The

test strip vial contains drying agents that are harmful if inhaled or swallowed and may cause skin or eye irritation.

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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. 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. Insert the test strip into the test port as shown. Make sure the three contact bars are facing you. Push the strip in as far as it will go. Do not bend the strip. After the black start-up screen appears, the meter will display the code from your last test. If a flashing appears 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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3. 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, then briefly stop flashing, after which the display will advance to the APPLY BLOOD screen. If the codes already match, press to go to the APPLY BLOOD screen. When you do not make a change after five seconds, the display will advance to the APPLY BLOOD screen. The meter is now ready to perform a blood glucose test.
CAUTION: Matching the code on the meter and the code on the
test strip vial is essential to obtaining accurate results. Each time you test, check to make sure the code numbers match.
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NOTE: If the APPLY BLOOD screen appears before you are sure the codes match, remove the test strip, and re-start from step 1, see page 11. If you change APPLY BLOOD to APPLY CONTROL by mistake, press to change it back to APPLY BLOOD.

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Overview of the OneTouch UltraSoft Blood Sampler
Depth adjustment Puncture settings knob Ejection/Cocking control Release button OneTouch UltraSoft Sterile Lancet OneTouch UltraClear Cap (for alternate site sampling)

Depth indicator

Lancet holder Lancet point Protective disk
Blue cap (for fingertip sampling)
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 pages 4849. NOTE: If you do not have a OneTouch UltraSoft Blood Sampler, please refer to the instructions that came with your lancing device.
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Choosing the right sampling site at the right time The OneTouch Ultra 2 Meter allows you to sample blood from your fingertip, forearm or palm. At times, results obtained at the forearm or palm may be different from a fingertip measurement. Talk to your healthcare professional before you begin using your forearm or palm for sampling. Getting a blood sample If you are testing: Routinely before meals Use blood sample from your: Fingertip, forearm, or palm Fingertip, forearm, or palm
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

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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 healthcare 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 healthcare 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.

Lancing and sampling from your fingertip 1. Remove the blue cap by twisting it off

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2. Insert a sterile lancet into the OneTouch UltraSoft Blood Sampler Insert the lancet into the holder and push in firmly. Twist the protective disk until it separates from the lancet and save the disk for later use. Do not twist the lancet. Getting a blood sample
3. Replace the blue cap by twisting it back on until it is snug 4. Adjust the depth setting If necessary, twist the depth adjustment knob toward the smaller dots on the OneTouch UltraSoft Blood Sampler for a shallow puncture or toward the larger dots for a deeper puncture.
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5. Cock the OneTouch UltraSoft Blood Sampler Slide the ejection/cocking control back until it clicks. If it does not click, it may have been cocked when you inserted the lancet. Getting a blood sample
6. Puncture your finger Hold the OneTouch UltraSoft Blood Sampler firmly against the side of your finger. Press the release button. Remove the OneTouch UltraSoft Blood Sampler from your finger.

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7. Get a round drop of blood Gently squeeze and/or massage your fingertip until a round drop of blood of at least one microliter ( actual size) forms on your fingertip. Getting a blood sample
If the blood smears or runs, do not use that sample. Dry the area and gently squeeze another drop of blood or puncture a new site.

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Lancing and sampling from an alternate site Sampling from your palm or forearm allows you to use your fingertips less often. You may find that obtaining a blood sample from an alternate site is less painful than using a fingertip. Getting a blood sample from your forearm or palm is different than getting a sample from your fingertips. Forearm sampling Choose a fleshy area of the forearm away from bone, visible veins and hair. Sometimes there is less blood flow to the forearm than to the fingertips. To help you get a large enough drop of blood, you may gently massage or apply warmth to the site to increase blood flow. Palm sampling Choose a fleshy area on the palm below your thumb or pinky finger. Select a spot with no visible veins and away from deep lines which may cause your blood sample to smear.

Forearm

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OneTouch UltraClear Cap is used for forearm and palm sampling only. Replace the blue OneTouch UltraSoft Blood Sampler cap with the OneTouch UltraClear Cap.
Blue cap for fingertip sampling only
1. Remove the blue cap by twisting it off
2. Insert a sterile lancet into the OneTouch UltraSoft Blood Sampler Insert the lancet into the holder and push in firmly. Twist the protective disk until it separates from the lancet and save the disk for later use. Do not twist the lancet.

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.
CAUTION: You may get an ERROR 5 message or an inaccurate result if the blood sample does not fill the confirmation window completely. See page 58. Discard the strip and re-start the test process.
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3. 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.
WARNING: If mg/dL does not appear with the test result, call Customer Service. Use of the wrong unit of measure may cause you to misinterpret your blood glucose level, and may lead to incorrect treatment. 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. Error messages If you get an ERROR message on your screen rather than a result, see pages 5359.
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Unexpected test results Refer to these cautions whenever your test results are lower than,
higher than, or not what you expect.
CAUTION: Dehydration and low glucose results
Applying blood and reading results You may get false low glucose results if you are severely dehydrated. If you think you are severely dehydrated, contact your healthcare professional immediately.
CAUTION: Low glucose results
If your test result is lower than 70 mg/dL or is shown as LOW GLUCOSE, 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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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. Applying blood and reading results

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Your meter allows you to attach optional notes to your blood glucose result. There are two kinds of notes and different reasons to apply them.
Note type Recommendation Meal flag Add a meal flag to every blood glucose result.
Benefit Allows you to link the effects of food to your blood glucose results. Provides you with separate averages for before-meal and after-meal tests.
Select an appropriate Helps track possible reasons comment whenever you for test results. test under conditions that you or your healthcare professional feel are worth noting.

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You can attach these notes just after a blood glucose test before you remove your used test strip from your meter. You can also modify notes when reviewing a past result. You will not be able to add a meal flag or comment to a result marked as a control solution test. You can choose not to attach a meal flag or comment after a blood glucose test. If you do not want to use this feature at all, you can turn it off so the meter will not prompt you to add notes or to select a type of result average to review. See page 9 for instructions.

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Add or change a meal flag If the flags/comments feature is turned on, the up arrow at the bottom right corner of the result screen will flash when a result is first displayed to remind you to enter a meal flag. To add or change a meal flag: 1. While viewing a result, press the MEAL FLAG screen 2. Press Attaching flags or comments to your results

AFTER MEAL

to display
to highlight BEFORE MEAL or
If you decide not to assign a flag to this result, select NO FLAG. 3. To confirm your selection, press The meal flag you chose will appear above the result on the result screen.

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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. 1. Obtain the required software and cable For order information and to learn more about OneTouch Diabetes Management Software, visit www.OneTouchDiabetesSoftware.com Reviewing past results and averages 2. 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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3. 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

4. Transfer data Follow the instructions provided with the OneTouch DMS to download the results from the meter. Once the command to start the download is sent from the computer to the meter, the meter display will show PC indicating that the meter is in communication mode. 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 CAUTION: Do not swallow a known amount of glucose and is used to check that the meter and the test strips are control solution; it is not for human consumption. working properly. Do a control solution test: Do not apply control solution to the skin or eyes as it may to practice the test process instead of cause irritation. 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 pages 28 and 29), or if you drop or damage the meter. NOTE: Use only OneTouch Ultra Control Solution with your OneTouch Ultra 2 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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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. 1. Check the code on the test strip vial before inserting the strip
2. Insert a test strip to turn on the meter Make sure the three contact bars are facing you. Push the strip in as far as it will go. Do not bend the strip.

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3. 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, then briefly stop flashing, after which the display will advance to the APPLY BLOOD screen. If the codes already match, press to go to the APPLY BLOOD screen. When you do not make a change after five seconds, the display will advance to the APPLY BLOOD screen. 4. Mark the test as a control solution test Press to change APPLY BLOOD to APPLY CONTROL. 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 control solution test.
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5. 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. 6. Read your result When the meter detects control solution in the test strip, it begins to count down from 5 to 1. Your result will then appear on the display, along with the date, time, unit of measure, and the words CONTROL SOLUTION. The control solution results can be viewed in the list of past results, but are not counted in your result averages.

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7. 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 4245, expired or contaminated control solution, expired or damaged test strip, use of a test strip or control solution past 100135 mg/dL its discard date, or (Example) a problem with the meter.
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 test 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 Customer Service.
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Caring for your system
Your OneTouch Ultra 2 Blood Glucose Monitoring System does not need any special maintenance. Storing your system Store your meter, strips, control solution and other items 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.

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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.
CAUTION: Do not use your test strips if your vial is damaged or
Caring for your system left open to air. This could lead to error messages or tests that read higher than the actual value. Call Customer Service immediately if the test strip vial is damaged.

Guarantee

LifeScan guarantees that the OneTouch Ultra 2 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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Electrical and safety standards This meter complies with CISPR 11: 2003, Class B (Radiated Only). Emissions of the energy used are low and not likely to cause interference in nearby electronic equipment. The meter has been tested for immunity to Level 3 electrostatic discharge as specified in IEC 61000-4-2. 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
CAN/CSA C22.2 61010-1:04, UL 61010-1:04, IEC 61010-1 and IEC 61010-2-101.
This product contains a lithium ion battery(ies), which contains perchlorate material - special handling may apply, see www.dtsc.ca.gov/hazardouswaste/perchlorate. As always, please dispose of battery(ies) according to your local environmental regulations. California Code of Regulations Title 22, Section 67384.4

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AFTER MEAL AVG. 38 AFTER MEAL flag. iv, 34 ALL RESULTS AVG. 38 Alternate site testing procedure. 21
Backlight, display. 3 Batteries. 2, 50 Battery, icon on display. 50, 58 BEFORE MEAL AVG. 38 BEFORE MEAL flag. iv, 34 Black start-up screen. ii, 3, 11 Buttons on meter. 2 Cable, OneTouch Interface. 40, 41 Cleaning your meter and sampler. 48, 49 Code. ii, 11, 44 Comment, adding or changing. iv, 35 Comment, reason for adding. 32 Comments feature, turning off or on. 9 Confirmation window. iii, 2, 26, 45 Connecting to a computer. 40, 41 Control solution. 1, 42 Control solution, result range. 46 Control solution, storing. 47 Control solution, testing. 42 Data port. 2, 41
Date format. 5 Date setting. 6 Dehydration. 28 Discard date, control solution. 48 Discard date, test strips. 48 Display check. ii, 3, 11 Downloading results to a computer. 40 Drop of blood, proper size. iii, 20, 24 Error messages. 27, 53 Expiration date, control solution. 48 Expiration date, test strips. 48 Fingertip testing procedure. iii, 17 Flags feature, turning off or on. 9 Forearm. 15, 21, 25 Forearm or palm sampling, important information. 15, 16, 24 Guarantee. 63 HIGH GLUCOSE message. 29, 37, 54 Hyperglycemia. 29 Hypoglycemia. 15, 16, 28 Infection, reduce the risk. 14 Intended use. v Kit components. 1 Lab results, comparing with meter results. 60

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Lancet, disposal. 31 Lancet, inserting in sampler. iii, 18, 22 Lancet, protective disk. iii, 14, 18, 22, 30 Lancing. iii, 17, 21 Language, choosing in set up. 5 LOW BATTERY message. 50, 58 LOW GLUCOSE message. 28, 37, 53 MAIN MENU screen. 3, 36 Meal flag, adding or changing. iv, 34 Meal flag, reason for adding. 32 mg/dL. 8, 27, 62 mmol/L. 8 Palm. 15, 21, 25 PC communication mode. 41 Plasma calibration. 60, 62 Repeated unexpected glucose results. 29 Result averages, before or after meal. 38 Result averages, 7-, 14-, and 30-day. 38 Result, last. 36 Result screen. 27, 34, 36 Results, all. 37 Results, reviewing past. 36 Sampler and cap. iii, 14, 17, 49 Sampler, depth setting. 14, 18, 23

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Table of Contents
THE OneTouch UltraSmart SYSTEM. 1 OneTouch UltraSmart Meter. 2 Navigation Buttons. 3 SmartButtons. 4 Display Symbols. 6 Display Contrast. 6 OneTouch Ultra Test Strips. 7 BEFORE TESTING. 9 Checking the Display. 9 Setting the Meter. 9 Coding the Meter. 10 Checking the System with Control Solution. 12 TESTING YOUR BLOOD. 19 Preparing the OneTouch UltraSoft Adjustable Blood Sampler.20 Lancing and Sampling from Your Fingertip. 23 Lancing and Sampling from an Alternate Site. 27 Step-by-Step Test Procedure.31 Discarding Used Test Strips and Lancets. 37 Special Messages. 38 COMPARING METER AND LABORATORY RESULTS. 40 CARING FOR YOUR SYSTEM. 42 Maintenance. 42 Cleaning the OneTouch UltraSoft Adjustable Blood Sampler. 42

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Batteries. 43 DISPLAY MESSAGES. 46 WARNINGS AND ERROR MESSAGES. 51 PROBLEMS AND POSSIBLE CAUSES.56 METER SET-UP. 58 Entering Basic Set-up Mode. 58 Selecting Display Language. 59 Setting Date and Time. 60 CUSTOM METER SET-UP SEQUENCE. 62 Set-up Menu. 62 Settings. 66 Diabetes Pill Set-up.68 Insulin Set-up.70 Insulin Pump Set-up.72 Advanced Feature Set-up.72 YOUR ELECTRONIC LOGBOOK. 77 Comments. 77 Rules for Adding Comments. 78 How to Add a Comment. 78 Logbook Entries. 82 Using the SmartButtons. 82 Rules for Logbook Entries. 84 Entering the Date and Time. 85 Exercise Logbook Entries.86 Health Logbook Entries.87

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Table of Contents (continued)
Ketones.89 HbA1c.91 Microalbumin.91 Cholesterol.92 Blood Pressure.92 Eye Exam.93 Foot Exam.93 Weight/Height.94 Doctor Visit.94 Medication Logbook Entries.95 Food Logbook Entries.101 Adding, Changing, or Deleting Logbook Information. 103 OneTouch UltraSmart FastFacts FEATURE.108 FastFacts Menu. 109 Logbook Memory.110 Glucose by Meals.110 Glucose Analysis.111 Interactive Graph of All Results.111 Graph by Time of Day.112 Average of All Results.113 Average by Time of Day.114 Average by Exercise.114 Glucose Range Info.115 Insulin Intake.116

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Hypoglycemia Information.120 Food Averages.121 Health Checks.121 Data Downloading. 122 SPECIFICATIONS. 125 PRODUCT SAFETY INFORMATION. 126 EXPLANATION OF SYMBOLS ON THE METER. 127 GUARANTEE. 127 INDEX. 128

Page x

THE OneTouch UltraSmart SYSTEM
The OneTouch UltraSmart System uses the latest blood glucose monitoring technology. It measures the glucose content of a blood sample by means of an electrical current produced in the test strip and is measured by the meter. Test results are plasma-calibrated. This makes it easier for you and your diabetes-care team to compare your meter results with laboratory tests. If you have been using another type of meterone that provides whole-blood resultsyou may notice that your test results with the OneTouch UltraSmart System are about 12% higher. The OneTouch UltraSmart Blood Glucose Monitoring System consists of three main products: the OneTouch UltraSmart Meter, OneTouch Ultra Test Strips, and OneTouch Ultra Control Solution. These products have been designed, tested, and proven to work together as a system to produce accurate blood glucose test results. Use no other test strips or control solution other than the OneTouch Ultra brand with your meter. Your system kit includes: OneTouch UltraSmart Meter OneTouch Ultra Control Solution OneTouch UltraSoft Adjustable Blood Sampler OneTouch UltraClear Cap OneTouch UltraSoft Sterile Lancets
Owners Booklet Carrying Case Quick Reference Guide Quick Start Guide Warranty Registration Card Two AAA Alkaline Batteries (Installed)
OneTouch Ultra Test Strips sold separately

Page 2

OneTouch UltraSmart Meter
OneTouch Ultra Test Strip
Test Port The meter turns on when you insert the OneTouch Ultra Test Strip here. Data Port Used to download logbook memory to a computer. Display with Backlight Test results, messages, symbols, and other data appear here.
SmartButtons (See pages 45 for description and use.)

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Navigation Buttons Note: Press and release buttons. Do Not hold buttons down for an extended period of time.
Back Button (Off Button) Go back to previous display on certain screens. Press and hold for two seconds to turn off the meter.
Arrow Button Scroll through menus, code numbers, and logbook.
OK Button (Backlight Button) Accept entries and move to next display. Press and hold for two seconds to turn on backlight.

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SmartButtons The SmartButtons are your keys to getting the most out of your OneTouch UltraSmart Meter. They allow you to enter information about your diabetes management plan into the large logbook memory. There are SmartButtons for exercise, health, medication, and food. The FastFacts SmartButton is used to view the records in the logbook memory. You may press any SmartButton to turn on the meter and move directly to the category.

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STEP 1 Insert a Test Strip into the Meter.
To turn on the meter, insert a test strip, contact bars end first and facing up, into the test port. Push it all the way in until it will go no further. OneTouch UltraSmart will appear briefly on the display. Then Code 9 (Example), Check Code is displayed. Be sure the meter and test strip codes match. If they do not, code the meter correctly (see pages 1012).
STEP 2 Select Control Solution.

Apply Blood

Apply Blood will appear on the display first. Use the Arrow button to select Control Solution. The meter will automatically identify the test as a control solution test in the logbook. There are three choices in test mode. Use the Arrow button to select one. Do Not apply a sample until your choice appears on the display. Apply Blood for fingertip blood sample. Alternate Site for forearm and palm blood samples. Control Solution for checking the system.

15 Control Solution

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Note: You must select Control Solution to distinguish control solution tests from blood glucose tests. Marked control solution tests will not be included in your averages. Do Not use Control Solution mode for testing blood.
STEP 3 Apply Control Solution to the Test Strip.
To ensure an accurate control solution test, shake the vial, discard the rst drop and wipe the dispenser tip before you begin.

NARROW CHANNEL

TOP EDGE Apply Drop Here
Touch and hold a drop of control solution where the narrow channel meets the TOP EDGE of the strip.
Note: If you do not apply the control solution within three minutes, the meter will turn itself off. Remove the test strip and insert it back into the test port to restart the test procedure.

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CONFIRMATION WINDOW
The control solution will be drawn into the narrow channel. When the confirmation window is full, the meter will count down from 5 to 1.

STEP 4

WARNING: If mg/dL does not appear with the Control Solution result, call LifeScan Customer Service at 227-8862.
The control solution test result will appear on the display.
Compare Control Solution Result to the Control Range Printed on the TEST STRIP VIAL.
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.

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STEP 6 Puncture Your Forearm or Palm.
Press and hold the Sampler against your forearm or palm for a few seconds, then press the release button. Keep holding the Sampler and OneTouch UltraClear Cap against your skin until a round drop of blood forms under the cap. Maintain pressure until the drop of blood is at least 1L ( actual size).
STEP 7 Remove the Sampler.
Carefully lift the sampler away from your skin. Do Not smear the blood sample. 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 Sampler to a deeper setting to get a large enough drop of blood ( actual size).

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Step-by-Step Test Procedure
STEP 1 Insert Test Strip.
Insert a test strip, contact bars end first and facing up, into the test port. Push it all the way in until it will go no further. The meter will turn on automatically. OneTouch UltraSmart will appear briefly on the display. Then the code number will appear. Be sure the meter and test strip codes match. If they do not, code the meter correctly (see pages 10-12 for Coding the Meter).

Insert This End

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STEP 2 Select Test Mode.

Note: There are three choices in test mode. For blood testing, use the Arrow button to select: Apply Blood for fingertip blood sample Alternate Site for forearm and palm blood samples Do Not use Control Solution mode when testing blood. Control Solution is for checking the system
Apply Blood will appear on the display first. If you are testing with a fingertip blood sample, proceed to Step 3.

Alternate Site

If you are testing with a blood sample from the forearm or palm, use the Arrow button to scroll to Alternate Site.
Before you test with blood, make sure Apply Blood or Alternate Site is displayed on the screen. Correct test mode selection is important to ensure all blood and control solution tests are properly included or excluded from averages. Failure to select the correct test mode may cause blood averages to be incorrect.

References

1. Surwit, R.S., and Feinglos, M.N.: Diabetes Forecast (1988), April, 4951. 2. Sacks, D.B.: Carbohydrates. Burtis, C.A., and Ashwood, E.R. (ed.), Tietz Textbook of Clinical Chemistry. Philadelphia: W.B. Saunders Company (1994), 959.

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CARING FOR YOUR SYSTEM
Maintenance Your OneTouch UltraSmart Meter does not require special maintenance or cleaning. Take care to avoid getting dirt, dust, blood, control solution, or liquids inside the meter through the test port or data port. 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 UltraSmart Meter is a precision instrument. Please handle it with care. Do Not use alcohol or any other solvent to clean your meter. Cleaning the OneTouch UltraSoft Adjustable Blood Sampler Clean the Sampler and OneTouch UltraSoft and OneTouch UltraClear Caps with soap and water. To disinfect the Sampler, prepare a disinfectant solution of one part household bleach to 10 parts water. Dampen a cloth with this solution and wipe the Sampler thoroughly. Soak only the cap or caps for at least 30 minutes in the disinfectant solution. Do Not soak the Sampler in liquid. Rinse the Sampler and cap with water and dry thoroughly.

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Batteries Your OneTouch UltraSmart Meter comes with two AAA alkaline batteries already installed. The batteries will provide you with enough power to perform up to 540 tests, depending on backlight use. When replacing the batteries, use only two AAA alkaline batteries. The meter will alert you when the power is getting low by displaying two different messages:
1. When this message appears on the display, the batteries are low and should be replaced as soon as possible. The backlight will no longer turn on.

Low Batteries!

You should replace the batteries soon See Owners Booklet
2. When this message appears on the display, you cannot test, enter data in your electronic logbook, or use the FastFacts feature until you change the batteries.

Batteries!

You MUST replace the batteries now See Owners Booklet

Page 44

To replace the batteries, first turn off the meter. Turn the meter over and locate the battery compartment.

The system is ready to accept a blood sample from the fingertip.
You may now apply the fingertip blood sample.
The system is ready to accept a blood sample from the forearm or palm.
You may now apply the forearm or palm blood sample.

Control Solution

The system is ready to accept a control solution sample.
You may now apply the control solution.

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Five-second countdown. After the countdown, the meter will display the test result. A test result in mg/dL.

None required.

WARNING: If mg/dL does not appear with the test result, call LifeScan Customer Service at 227-8868.
A test result outside of your target range with a message prompting you to add a comment.
If you wish to add a comment, press the OK button (see page 78).

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A blood glucose test result in the range of 240 mg/dL to 600 mg/dL with a suggestion to check your ketone levels.
Follow the instructions of your healthcare professional regarding ketone testing.
mg/dL Do you need a snack? Comment? Press OK
Follow the instructions of your healthcare professional.

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WARNINGS AND ERROR 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 a warning or an error message. In the event of a problem, refer to the information under ACTION. Assistance is available from LifeScan Customer Service 24 hours a day, seven days a week at 227-8862. MESSAGE
You may have a very low blood glucose level, lower than 20 mg/dL.
Treat this condition immediately according to your healthcare professionals recommendations. Although this message could be due to a test error, it is safer to treat first and then repeat the test. You should retest your blood glucose level and if HIGH GLUCOSE appears again, call your healthcare professional immediately.
You may have a very high blood glucose level, exceeding 600 mg/dL.

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Error 1 Call customer service See Owners Booklet
There may be a problem with the meter or the meter may need to be reset.
To reset the meter, you must turn the meter off and enter Set-up mode (see pages 5861). Reset the language, time, and date. You must also reset the meter code to match the code on the test strip vial. If you continue to get an Error 1 message, Do Not use the meter. Call LifeScan Customer Service at 227-8862 for a replacement meter. Repeat the test with a new test strip. Refer to pages 78 for test strip information. If the error message persists, call LifeScan Customer Service at 227-8862.

Error 2 Meter or strip problem Please repeat test See Owners Booklet
Error message that could be caused by either a used test strip or a problem with the meter.

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Error 3 Meter not ready Please repeat test See Owners Booklet
Error message that indicates that the blood or control solution sample was applied before Apply Blood, Alternate Site, or Control Solution appeared on the display.
Repeat the test with a new test strip. Apply the blood or control solution sample only after Apply Blood, Alternate Site, or Control Solution appears on the display. Refer to pages 3335 for information on sample application. 1)If you tested in a cool environment, repeat the test in a warmer environment with a new test strip. If you were testing in a normal or warm environment, repeat the test with a new test strip (see pages 78 for test strip information).
Error 4 Strip problem Please repeat test See Owners Booklet
1)You may have high glucose and have tested in an environment near the low end of the systems operating temperature range (43111F/644C).

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2)The sample was improperly applied.
ACTION 2)If you applied the blood incorrectly, review pages 3335 on blood application and repeat the test with a new test strip. 3)If the error message appears again, call LifeScan Customer Service at 227-8862.
3)There may be a problem with the test strip. For example, it may have been damaged or moved during testing.
Error 5 Invalid test Please repeat test See Owners Booklet
1)Repeat the test 1)Error message that indicates the meter has with a new test strip. Refer to detected a problem pages 3335 for with the test strip. information on Possible causes are sample application. test strip damage or an incompletely filled confirmation window. 2)There may be a problem with the meter. 2)If the error message appears again, call LifeScan Customer Service at 227-8862.

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The battery sign appears on the display. The power of the batteries is getting low. The backlight will be disabled when the battery sign is displayed. You can complete about 100 more tests from the time this symbol first appears. Battery power is too low to run a test.
Test results will still be accurate, but replace the batteries as soon as possible.
Replace the batteries at once.
Meter is outside of operating temperature range Test not possible See Owners Booklet
The meter has detected that the temperature is outside the system operating range. Do Not perform a test until the meter and test strips reach a temperature within the operating range (43111F/644C).

Use the Arrow button to scroll through the menu. Press the OK button on your selection. Repeat these steps until all of your insulin types have been selected.

Select insulin(s)

Insulin 1: Insulin 2:
Regular Lente NPH Ultralen Premixed
To save your insulin choices, use the Arrow button to scroll to Save and press the OK button.

Insulin 1:

Insulin 2:

Regular

Page 72
Insulin Pump Set-up If you are using an insulin pump, the OneTouch UltraSmart Meter allows you to store current information about your pump. The factory setting will be set as if you do not use a pump.
Select Insulin Pump on the Set-up Menu and press the OK button.

Insulin Pump

Do you use an insulin pump?
Select Yes to use this feature and press the OK button. You can then use this feature to enter your bolus doses and total insulin amounts. If you do not use an insulin pump or you do not wish to set up this feature now, select No and press the OK button. After choosing Yes or No, the meter will return you to the Set-up Menu.
Advanced Feature Set-up The final item on the Set-up Menu is called Advanced Features. These features allow you to: Choose the number of days included in your glucose test averages Input your usual meal schedule Include your target glucose range Customize your hypoglycemic level

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ADVANCED FEATURES Averages Schedule Glucose Range Before Meal After Meal Hypo Level
FACTORY SETTINGS 14 days Pre-set (see pages 7475) 90130 mg/dL 70 mg/dL
CUSTOM SETTINGS 7, 30, 60, 90 days Personal Personal Personal Personal
Select Advanced Features as follows:
Select Advanced Features and press the OK button.
The first advanced feature is averages. Each time you test, the meter is set to display a 14-day average of your glucose tests along with your test result. You can change the number of days that make up this average to the last 7, 30, 60, or 90 days. Scroll to the number of days you want to include in your test display average and press the OK button. You can still look at averages for all five time periods by reviewing your electronic logbook.

Advanced Features

Averages Schedule Glucose Range Before Meal After Meal Hypo Level 7 Day 70

Page 74

Averages Schedule Glucose Range Before Meal After Meal Hypo Level 14 Day Pre-set Personal 90-130 --- - --70
Next, the meter will prompt you to select time periods for your usual meal schedule. When you set this feature all of your test results will be tagged with the mealtime. To view a pre-set meal schedule select Pre-set and press the OK button.

To exit Set-up mode, choose Exit Set-up and press the OK button.

Page 77

YOUR ELECTRONIC LOGBOOK
The OneTouch UltraSmart electronic logbook is the meter memory. It stores over 3,000 records. The SmartButtons allow you to enter information about your diabetes management plan, including exercise, health, medication, and food.
Comments Information that you store in your electronic logbook along with a test result is called a comment. Following is a list of comments that you may store. DEFINITION COMMENTS ON GLUCOSE RESULTS After During Exercise Before Health Medication Food Stress Menses None Before After After Breakfast Before Breakfast After Lunch Before Lunch Breakfast Lunch Breakfast After Before Dinner After Lunch Dinner Night After Dinner Night Lunch Feel Hypo Vacation Illness Other

Page 78

Rules for Adding Comments Following are rules for adding comments in your logbook. If you wish to add a comment to a test result, press the OK button while viewing the test result. Use the Arrow button to scroll up and down through the various menus and choices. Use the OK button to make a selection. You must save your selections by using the Arrow button to highlight Save and pressing the OK button. Prior to seeing the logbook display, you may press the Back button and return to the previous display to review or edit the information you have stored. To remove an entry, select - - - from the menu. Press and hold the Back button to turn off the meter. After one minute of no activity, the meter will turn off automatically. To go back into the logbook, press the FastFacts SmartButton. With Logbook highlighted, press the OK button.

OK OK OK OK

You can comment on a test as occurring before or after a meal, how you are feeling at the time of the test, and if there was any exercise involved. In all, you may add one food comment, one exercise comment, and up to six health comments to a test result.
How to Add a Comment Following are the steps you take to comment on a test result.

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The meter will automatically prompt you to add a comment when you have a test result outside of your glucose target range. You can, however, add a comment to a test result whether or not Comment? Press OK appears. In this example, we will comment on a test result with food, exercise, and health information. With any test result (or test result with average) on the display, press the OK button. You will be able to add comments for food, health, and exercise.

Page 119

Bolus will display your average bolus intake for each mealtime (Breakfast, Lunch, Dinner, Night) based on your schedule (see pages 7376).
Insulin Intake Pump Bolus Daily Average Daily Totals

Pump Bolus 14 Day (Avg.)

This example shows the average bolus intake in units by time. The number of logbook entries appears in parentheses.

(14) (14)

Breakfast 6.0 6:00am - 11:00am Lunch 8.0 11:00am - 5:00pm
Daily Average displays the average of the total daily pump insulin. This example is for the last 14 days. The number of entries is listed in parentheses. An asterisk (*) means there are days with no entries.
Insulin Intake Pump 14 Day (Avg.) Total Daily Pump Insulin (12)*

Page 120

Insulin Intake Pump Daily Totals Pump Daily Totals gives the pump totals you have entered for each day. If you did not enter a pump total for a day, - - - will appear.
Insulin Intake Pump Daily Totals
Sep 14-02 Sep 14-02 Sep 13-02 Sep 12-02 ---------Sep 10-02 85.0 92.0 82.5 76.5 ----84.0
HYPOGLYCEMIA INFORMATION If you select Hypo Info from the FastFacts menu, the meter will display the actual number of hypoglycemic events defined by the level set in Advanced Features (see page 76). The number of events before and after meals and during the night for the last 7, 14, 30, 60, and 90 days is displayed. Use the Arrow button to view the other time periods.
Hypo Info (70 mg/dL or less) Hypo Info (70 mg/dL or less) 6 Total - 14 Days:
Bef Brkft Aft Brkft Bef Lunch Aft Lunch

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FOOD AVERAGES Select Food Averages to view average daily intake of carbohydrates, fats, calories, and proteins over the last 7, 14, 30, 60, and 90 days. The number of tests that make up each average is shown on the left in parentheses.

Food Averages

Breakfast 14 Day (Avg.) (14) (14) (10) (12) Carbs: Fats: Calories: Proteins: 362 14
HEALTH CHECKS To view results and dates of various check-ups, select Health Checks. Scroll to the type of Health Check using the Arrow button and press the OK button. The entries for each will appear on the display.
Ketones B.P. Weight Height Dr. Visit HbA1c Chol
Health Checks trace Sep 3- 02 120/80 Sep 3- 02 150.0 Sep 3- 02 67.0 Sep 3- 02 done Sep 3- 02 5.2% Sep 3- Sep 3- 02
Health Checks HbA1c: Sep 3- 02 Jul 14- 02 5.2% 5.9%

Page 122

SOURCES FOR HELP
Information Contact LifeScan Customer Service or visit the Website at: www.LifeScan.com
This choice prompts you to contact LifeScan Customer Service or visit our Web site when you need help with testing. Call LifeScan Customer Service, at 227-8862, 24 hours a day, seven days a week.
Data Downloading Transferring test results to your personal computer for home viewing requires OneTouch Diabetes Management Software from LifeScan and a OneTouch Interface Cable. OneTouch Diabetes Management Software and a OneTouch Interface Cable are not included with your OneTouch UltraSmart System. For order information and to learn more about OneTouch Diabetes Management Software, visit www.OneTouchDiabetesSoftware.com.

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STEP 1 Install OneTouch Diabetes

Management Software.

Install OneTouch Diabetes Management Software on your computer following the instructions provided in the OneTouch Diabetes Management Software User Manual.
STEP 2 Connect the OneTouch

Interface Cable.

Connect the OneTouch Interface Cable to a serial port on the back of your computer. With the meter turned on, connect the OneTouch Interface Cable to the data port located on the upper left side of the meter. Be sure the cable plug is inserted all the way.
Note: While in the communication mode, you will be unable to perform a blood glucose test.

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STEP 3 Transfer Data.
Follow the instructions in the OneTouch Diabetes Management Software User Manual to initiate the data transfer command. PC will appear on the display once the first command is received, indicating that the meter is in the communication mode. You are now ready to transfer all test resultswith date and timestored in the meter memory to your computer. If the command is not received within one minute, the meter will turn itself off. You may also press and hold the Back button to turn off the meter. For order information and to learn more about OneTouch Diabetes Management Software, visit www.OneTouchDiabetesSoftware.com or call LifeScan Data Management Line at 382-7226.

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SPECIFICATIONS
Result Range: Calibration: Sample: Sample Size: Test Time: Assay Method: Power Source: Battery Life: 20 to 600 mg/dL Plasma-equivalent Fresh capillary whole blood Minimum 1 microliter (L) 5 seconds Glucose oxidase biosensor Two AAA alkaline batteries About six months at three tests per day (one test using backlight) mg/dL Over 3,000 records Three minutes after inserting a test strip if sample has not been applied; one minute after all other user actions Approx. 3.8 in. (L) x 2.3 in. (W) x 0.9 in. (H) 2.8 ounces (with batteries) Temperature 43111F/644C Relative humidity 1090% Hematocrit 3055%
Glucose Units: Memory: Automatic Shutoff:
Size: Weight: Operating Ranges:

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PRODUCT SAFETY INFORMATION
The OneTouch UltraSmart System complies with the following standard: UL (Underwriters Laboratories Standard) UL 60601-1 Internally powered equipment. Battery operated with two 1.5 volt AAA alkaline batteries. This unit is not suitable for use in the presence of flammable anesthetic mixture with air, oxygen or nitrous oxide. Continuous mode of operation. IPX4 degree of protection against ingress of water. This is a level of water resistance (protection against splashing water). Type BF applied part degree of protection against electrical shock. This is a level of electrical safety protection for the user suitable for this medical device.

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High Glucose. v, 38, 51 Hyperglycemia. v, 3839, 5051 Hypoglycemia. v, 2122, 3839, 5051 Hypoglycemia Information (Hypo Info). 109, 120 Hypoglycemia Level. 73, 76 Insulin Dosages. 97 Insulin Intake. 116 Insulin Pump. 98100, 118120 Insulin Pump Set-up. 72 Insulin Set-up. 7071 Intended Use. iv Interface Cable, OneTouch. 122124 Laboratory Results. 4041 Lancets. 1, 1920, 24, 28, 37 Lancet Disposal. 37 Logbook. iii, 4, 77107, 109110 Logbook, Electronic. iii, 77107 Logbook Entries. 82107 Logbook Entries, Editing or Deleting. 103, 105107 Logbook Entries, Exercise. 83, 8687 Logbook Entries, Food. 83, 101102 Logbook Entries, Health. 83, 8794 Logbook Entries, Medication. 83, 95100 Low Glucose. v, 38, 51 Maintenance, Meter. 42 Maintenance, OneTouch UltraSoft Adjustable Blood Sampler. 42

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Meal Schedule. 7275 Medication Logbook Entries. 83, 95100 Medication Menu. 95 Medication SmartButton. 45, 77, 8283 Memory. 77107 Message, Check Ketones. 39, 50 Message, Snack. 39, 50 Messages, Display. 4650 Messages, Error. 5155 Messages, Special. 3839 Messages, Warning. 5155 Milligrams per Deciliter. 9, 17, 36, 49, 125 Off Button. 3 OK Button. 3 OneTouch Diabetes Management Software. 64, 6870, 122124 OneTouch Interface Cable. 122124 OneTouch Ultra Control Solution. 1, 1218 OneTouch UltraClear Cap. 1, 19, 2830 OneTouch Ultra Test Strips. 1, 78 OneTouch UltraSmart Meter. 13 OneTouch UltraSmart System. 18 OneTouch UltraSoft Adjustable Blood Sampler. 1, 1920, 2330 Owners Booklet. 1 Palm. 2122, 27, 30, 33 Problems and Possible Causes. 5657

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Product Safety Information. 126 Quick Reference Guide. 1 Quick Start Guide. 1 Reduce Chance of Infection. 20 Repeated Unexpected Results. v Schedule, Meal. 7275 Settings. 6667 Set-up, Basic Meter. 5861 Set-up, Custom Meter. 6276 Set-up Menu. 6263 Specifications. 125 Syringe Totals. 117118 System Overview. iii8 Temperature Range. 8, 13, 36, 53, 55, 125 Test Mode. 15, 32 Test Port. 2, 31 Test Procedure. 3135 Time Format. 64, 66 Time Setting. 60 Unexpected Results. v Unit of Measure, mg/dL. 9, 17, 36, 49, 125 Vial, Control Solution. 1213, 1618 Vial, Test Strip. 8, 1012, 17 Warning Messages. 5155 Warranty Registration Card. iii, 1 Week, Beginning of. 64, 6667