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Blood Glucose Monitoring System

Owner's Booklet

Easy Easy to Handle, Easy to Read Easy

Simple Blood Application

Confirms Confirms Enough Blood Is Applied Is

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The OneTouch SureStep System is intended for use outside the body (in vitro diagnostic use). It should be used only for testing purposes and only with fresh whole blood samples. It should not be used for the diagnosis of diabetes.

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L E A R N I N G
CAUTION: Before using any product to test your blood glucose (blood sugar), read all instructions and practice the test. Do all quality control checks as directed and consult with a diabetes Healthcare Professional. These recommendations apply to all blood glucose monitoring systems and are supported by the American Association of Diabetes Educators, the American Diabetes Association, the U.S. Food and Drug Administration, and the Advanced Medical Technology Association (AdvaMed - formerly known as the Health Industry Manufacturers Association). IMPORTANT: If you have followed the tips to ensure accuracy and your blood glucose results are still out of range, call your Healthcare Professional. The OneTouch SureStep System kit contains many small parts: strip holder, battery door, batteries, lancets, control solution bottle, etc. Keep the system out of the reach of small children because these parts may be dangerous if swallowed. If using a 10% bleach solution to disinfect the meter, be sure to completely remove any bleach from the meter and test strip holder with a cloth dampened with water. Bleach will react with the test strips and cause inaccurate results. Failure to remove the excess bleach may result in an error message ( , ) or an inaccurately high result.

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Table of Contents

Learning

Purpose What to Expect from Your System Warnings and Precautions Importance of Following Instructions OneTouch SureStep Test Strips Optional Color Chart Display Symbols

Coding

Coding the Meter

Checking

Checking the System Understanding Control Solution Results

Testing

Testing Your Blood Testing Tips for Accurate Results Test Procedures

www.LifeScan.com

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Results

Understanding Your Results How to Check if Your Meter is Working Correctly Comparing Meter and Laboratory Results Health Conditions Which Can Cause Out-of-Range Results

Maintenance

Caring for Your Meter General Care Cleaning the Meter Changing the Batteries Storage Instructions

Troubleshooting

Error Messages

Symbols

Settings
Changing Meter Settings Entering Set-Up Mode Changing the Date and Time Setting the Time

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Setting the Year Setting the Month Setting the Day Display of Last Results Unit of Measurement Beep Signals 14- and 30- Day Averages Time Format Date Format Exiting the Set-Up Mode

Memory

Background Information on Meter Memory Getting All Results from Meter Memory First Time Turning on Meter Uploading Memory Data

Specifications

Specifications Guarantee and Warranty

Quick Reference Index

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Welcome to LifeScan Congratulations! Youve chosen a product made by LifeScan, a leading company in providing products to help you manage your diabetes. OneTouch SureStep blood glucose monitoring products are widely available without a prescription. Blood glucose monitoring plays an important role in controlling your diabetes. A long-term study showed that keeping blood glucose levels close to normal can reduce the risk of complications by up to 60%. The results you get with the OneTouch SureStep System can help you and your Healthcare Professional monitor and adjust your treatment plan to gain better control of your diabetes.

Important phone numbers:

LifeScan Customer Services (24 hours a day, 7 days a week): U.S.A. English 227-8862 Espaol 381-7226 www.LifeScan.com
Everything you need to know about using the OneTouch SureStep System is included in this owners booklet and in the test strip package insert that comes in each box of test strips. It is important that you read both this booklet and the test strip package insert for critical information on how to use this product. A free instructional videotape is also available by calling LifeScan Customer Services. If you have any questions, please feel free to call the toll-free numbers to speak with our Customer Services Department. Remember to complete and mail the Warranty Registration Card. A complimentary gift is sent when we receive your Warranty Registration Card.
Meter Serial Number _____________________________________ Healthcare Professional _______________________________________ Pharmacist ________________________________________________ Diabetes Educator ___________________________________________ Other _____________________________________________________

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R E A D
Units of Measure for Meter Readouts
mg/dL milligrams/deciliter no decimal point mmol/L millimoles/liter decimal point

P L E A S E

Your OneTouch SureStep Meter can display results in two different units of measure. Milligrams per deciliter (mg/dL) is the standard unit in the United States. Because this meter may be purchased by people living in other parts of the world, it may be reset to another unit of measure called Millimoles per liter (mmol/L). This unit is not used in the United States except on your doctors recommendation. You can easily determine if the meter has been accidentally reset to the wrong unit of measure. Simply turn on the meter. The unit of measure will appear on the display with your last test result. When looking at a test result on the display, either mg/dL or mmol/L will appear with the result. A test result in mmol/L will have a decimal point. For more information, see pages 61-62, Unit of Measurement.

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Purpose
People with diabetes use the OneTouch SureStep Blood Glucose Monitoring System to measure the level of glucose (sugar) in their blood. The system is intended for testing whole blood samples at the time when the blood sample is obtained.
study found that you should keep your blood glucose close to the levels of people without diabetes. You can reduce the risk of problems with the eyes, kidneys, and nervous system by about 60%. You should be aware that keeping your blood glucose level close to the levels of people without diabetes increases your risk of hypoglycemic events1 (low blood sugar). How often you need to test your blood glucose depends on many factors. These include your age, if you have type 1 or type 2 diabetes, your medications, and your health. Your Healthcare Professional will guide you. It is important that you make testing part of your daily routine.

Why Test Your Blood Glucose
Diabetes is a disease where the body has trouble controlling glucose levels properly. Glucose levels may change greatly and quickly. Glucose levels that are too high or too low can lead to serious health issues. This test enables a person to know what his or her glucose is at the time it is measured. In 1993 the National Institutes of Health finished the Diabetes Control and Complications Trial (DCCT.) This was a long-term study of people with type 1 diabetes. This 2

When Not to Use

Do not use OneTouch SureStep blood glucose results to determine whether

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or not you have diabetes. Only your doctor can diagnose this disease.
What to Expect from Your System
results can differ by more than 20% in some situations. See Comparing Meter and Laboratory Results for more information.
Blood glucose meters are clinically accurate, but not a substitute for a laboratory result. Originating from laboratory methods, glucose meter systems provide a convenient, portable way to test inexpensively and quickly. However, meter results can be affected by factors and conditions that do not affect laboratory results in the same way. Keep in mind that testing conditions for laboratories are tightly controlled and highly automated. Your meter glucose result should agree with a laboratory result to within 20% under normal conditions. A result within that range is considered clinically accurate when testing with the OneTouch SureStep Meter. However, 3
Blood glucose meters increase your ability to frequently check your blood sugar at reasonable cost so you can see the effect different foods, exercise, and medications can make on your glucose level. You can keep your blood glucose in better control with these devices. Make sure that you are familiar with the limitations of the system before testing. See important information in your OneTouch SureStep Test Strip Package Insert. Know the factors that can affect the accuracy of your results. Make sure that you understand your results before acting on them, especially if your results do not reflect how you

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feel. See Understanding Your Results on page 35.

Warnings and Precautions

Read all the instructions, including the test strip package insert, and practice the test with control solution (see Checking the System) before testing your blood glucose. Do all quality control checks as directed, including checking the meter display symbols (see Description of System), and consult your Healthcare Professional before using this product. The system contains small parts such as lancets, bottle caps, etc. Keep your system out of the reach of small children because these parts may be dangerous if swallowed. The test strip packaging contains a drying agent that may be harmful if inhaled or swallowed. It may also cause skin or eye irritation. 4

White Pad

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Optional Color Chart
Directly after reading a meter result, you can compare the color of the confirmation dot on the back of the test strip with the Color Chart on the test strip bottle label. The chart shows two shades of blue, which correspond to a very low blood glucose (50 mg/dL) level and a very high blood glucose (350 mg/dL) level. It also shows an off-white shade for new, unused test strips. Important: The sample color dots are only approximate. They can give you an indication of whether your glucose is very low (50 mg/dL) or very high (350 mg/dL). Results obtained using the sample color dots are not a replacement for a OneTouch SureStep meter test result. Do not use Color Chart to verify control solution tests.

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Display Symbols
The OneTouch SureStep Blood Glucose Meter uses symbols and error messages to guide you through a test and to help you determine if something is wrong. Carefully check that all symbols shown on the right appear each time you turn on your meter. To check that all display symbols are working, press and hold down the blue power button. This display check also appears briefly each time you turn on the meter. Call LifeScan Customer Services (2278862) if any segments are missing.

Display Check

When you turn on the meter, it automatically recalls and displays your most recent glucose result and the date it was measured.

(Example)

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The current code number is displayed. The number on the display must match the code number on the OneTouch SureStep Test Strip bottle.
Check that the pink side of the test strip faces up and firmly push the test strip into the test strip holder until it stops. Insert the test strip tapered-end first.
Apply blood to the center of the pink test square on the test strip.

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The meter is measuring your glucose level.
When the meter determines that your blood glucose level exceeds 500 mg/dL (27.8 mmol/L), it displays HI in virtually all cases.
The meter displays your test result in mg/dL or mmol/L together with the date and time of the test.

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you are not following all test steps or performing them incorrectly. the code number on the meter does not match the code number on the test strip bottle. the meter or test strip holder is dirty. the control solution is expired, or beyond its discard date, contaminated, or not well mixed. there is a problem with the test strip (expired, damaged, etc.). the meter has malfunctioned. the control solution test is performed outside of the temperature range 5995F (1535C). you have applied too much control solution. 21
If your control solution result falls outside the printed range, repeat the control solution test with a new test strip. If your second control solution result is also outside the printed range, call LifeScan Customer Services (227 8862). WARNING: Do NOT use your system to test your blood when your control solution results fall outside the printed range. You may get inaccurate blood glucose results. Call LifeScan Customer Services (2278862) if this occurs.

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T E S T I N G

Testing your Blood

Choose a clean, dry work surface. Make sure you have all the items needed for a blood test as shown.

Sterile Lancet Meter

Release Button Ejection/Cocking Control Cap
Depth Settings Depth Adjustment Knob
OneTouch SureStep Test Strip

Lancing Device

Depth Indicator

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Testing Tips for Accurate Results
There are several important steps you should follow before and during the test that will help you get accurate results.
Make sure the code on the meter display matches the code on the test strip bottle label. Do a test with OneTouch SureStep Glucose Control Solution to make sure the meter and test strip are working properly together. Make sure the test strip holder, lens area, and contact points on the meter are clean. See Cleaning the Meter for cleaning instructions. Make sure you applied enough blood to the test strip by checking that the confirmation dot turned completely blue. Make sure you did not apply too much blood to the test strip. You have applied too much blood if the white pad is soaked and there is no white visible.

Before Testing

Wash and dry your hands. Use a new, sterile lancet. Check the test strip expiration date and discard date (4 months after first opening the test strip bottle). Do not use the test strips after these dates. Compare the color of the confirmation dot on the Unused test strip with the color shown for an Unused color dot on the Color Chart on the test strip bottle label. If the color of the confirmation dot on the test strip is darker than the Unused color, do not use the test strip. 23

During Testing

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Compare the color of the confirmation dot on the test strip with the Unused color dot shown on the Color Chart on the test strip bottle label. If the color of

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9. Hold the lancing device firmly against the side of your finger. Firmer pressure will give a deeper puncture. Use a different spot each time to help prevent soreness and callus formation. Press the release button. If needed, gently massage your finger from base to tip to help obtain the needed volume of blood.
10. Apply one drop of blood to the center of the pink test square in one of the ways shown. Never add a second drop as this may cause inaccurate results.

Black Tip

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Turn the test strip so the pink test square faces your finger. Touch the center of the pink test square on the test strip to the drop of blood on your finger. The pink test square will quickly absorb blood.
Be careful not to apply too much blood, especially if you tend to bleed easily or are taking blood-thinning medications. If the entire white pad surrounding the pink test square is soaked, you have applied too much blood. Your test result may be inaccurate. You must start over with a new test strip. 29

Too Much Blood

Hold the test strip under your finger and touch the drop of blood to the center of the pink test square.

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11.Check the confirmation dot on the back of the test strip after a few seconds. If the confirmation dot is completely blue, go to step 12.

Enough Blood

If white patches or streaks appear on the confirmation dot, you have not applied enough blood to obtain an accurate test. You must start over with a new test strip.

Not Enough Blood

Confirmation Dot Front Back Back
If there is no color or if white patches or streaks appear after you have repeated the test, call LifeScan Customer Services (227 8862).

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12.Confirm that the meter is still on. Firmly insert the test strip, taperedend first, confirmation dot side down, into the test strip holder until it stops. CAUTION: If you do not firmly insert the test strip into the meter until it stops, the test may start but you may get an inaccurately low result. Do not remove test strip until countdown is complete. IMPORTANT: Immediately insert the test strip after applying the blood. If you do not insert the test strip within 2 minutes, discard the test strip and start over with a new test strip.
A flashing clock symbol appears while the meter is reading your result. Your glucose result appears in about 30 seconds. Do not remove strip until countdown is complete.The wait may be shorter or longer depending upon the current temperature. The test result is displayed alternating with the time, then with the date. The meter displays results between 0 and 500 mg/dL (0-27.8 mmol/L). If the result is above 500 mg/dL the meter displays HI in virtually all cases.

R E S U L T S

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Low or High Results

You have low blood sugar (hypoglycemia) if:
Your meter result is 60 mg/dL (3.3 mmol/L) or below.
The color dot comparison shows approximately 50 mg/dL (very low). You have high blood sugar (hyperglycemia) if:
C AUTION: If your meter result is very low, 20 mg/dL or less, and you do not have symptoms of low blood glucose, remove the test strip from the meter and look at the confirmation dot on the back of the test strip. You should do one of the following depending on the color of the confirmation dot on the test strip:
Your meter result is 180 mg/dL (10 mmol/L) or greater. The color dot comparison shows approximately 350 mg/dL (very high). If you have symptoms that match your test results, or if you continue to get results that fall below 60 mg/dL or above 180 mg/dL when you repeat the test, follow the advice of your Healthcare Professional.
If the confirmation dot is not completely blue or has white patches or white streaks (see How To Test Your Blood), repeat the test with a new test strip. If the problem continues, call LifeScan Customer Services (1-800-227-8862). If the confirmation dot is completely blue, compare the confirmation dot to the sample color dots on the Color Chart of the test strip label on the bottle. If this comparison indicates that your blood glucose is very low

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(50 mg/dL), conduct a Control Solution Test (see Checking The System). If the Control Solution test indicates that your meter and test strips are working together properly, repeat your blood glucose test with a new test strip. If you continue to receive a very low blood glucose test result, the low glucose result is likely to be correct and you should follow your Healthcare Professionals advice for treating low glucose levels. If the Control Solution test is out of range, call LifeScan Customer Services (1-800-227-8862). I MPORTANT: When proper procedures are followed, the meter will display HI in virtually all cases when your result is above 500 mg/dL (27.8 mmol/ L). The confirmation dot color will also be darker than the 350 mg/dL sample color dot on the test strip bottle label. This indicates very high blood 37

repeat the meter test in a climate-controlled place as soon as possible. The operating temperature is 5095F. The operating humidity is 1090%. You should always test within these ranges. You may also get inaccurate results if you test when both the temperature and relative humidity are near the limits defined above. If you test under these conditions, repeat the meter test in a climate-controlled place as soon as possible. Conditions affecting circulation to the hands may also lead to inaccurate results. These include shock, some drugs called vasoactive agents, and Raynauds disease.4, 7, 8
See the Important Technical and Healthcare Professional Information section in the OneTouch SureStep Test Strip package

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insert for typical accuracy and precision data for the OneTouch SureStep system. Make sure you read Important things to know before testing in the test strip package insert.You should also review Testing Tips for Accurate Results in the Testing Your Blood section.
dizziness, fainting, hunger, nervousness, irritability, or tremors?
Health Conditions Which Can Cause OutofRange Results
If you are getting results outside your target range and you believe the OneTouch SureStep Meter and OneTouch SureStep Test Strips are working together properly, ask yourself the following questions.
Do I have symptoms of high blood glucose (hyperglycemia): fatigue, dry mouth and skin, increased thirst or hunger, blurry vision, increased urination, rapid deep breathing, or a fruity smell to the breath? What have I eaten? How much have I exercised? Am I ill (common cold, flu, etc.)? Have I been under stress lately?
How do I feel? Do I have symptoms of low blood sugar (hypoglycemia): slurred speech, headache, tingling of lips, cool sweating, rapid heartbeat, disorientation, weakness, 40
If your Healthcare Professional has not already instructed you in dealing with these situations, you should contact your Healthcare Professional.

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Caring for Your Meter

General Care

Cleaning the Meter
C AU T I O N : Use water to clean the meter. Do not get water inside the meter case. Never immerse the meter or hold it under running water. Do not use alcohol, glass cleaners, or any other cleansers to clean the test strip holder or lens area. N OT E : For Healthcare Professionals or caregivers who assist multiple users, to disinfect the meter, cleanse the meter as described below using a 10% bleach solution (9 parts water, 1 part bleach) and then clean again with water to remove any remaining bleach. Thoroughly dry the meter. Failure to remove the excess bleach may result in an error message ( , ) or an inaccurately high result.
Keep your meter dry and avoid exposing it to extremes in temperature. Do not store your meter or test strips in your car or in the refrigerator or freezer. Dropping the meter can damage the electronics. If you drop your meter, do a control solution test (see Checking the System) and a display segment check (see Display Symbols) before using the meter to test your blood. Do not take the meter apart. Sensitive parts could be damaged causing inaccurate results. Taking the meter apart will also void your warranty.

MAINTENANCE

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Always clean the meter when this symbol appears.
1. Press down at the top end (near blue power button) of the test strip holder and slide it away from the meter.
2. Wipe the test strip holder gently with a cotton swab or soft cloth dampened with water. Thoroughly wipe the gray area on the inside cover. Clean both sides of the test strip holder base, especially around the hole. Dry the test strip holder completely with a soft cloth or lintfree tissue.
Cover Top of Base Bottom of Base

Inside Cover

Gray Area
Hole (clean both sides) Base

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3. Dampen a cotton swab or soft cloth with water and wipe the lens area and contact points with it. Do not scratch the lens area. Dry with a soft cloth or tissue that does not contain lint, lotion, or perfume. Do not use abrasive materials such as paper towels.

Contact Points Lens Area

4. Slide the test strip holder into the meter, press down, and push forward at the test strip insertion point until you hear a click. Make sure the test strip holder is firmly in place and does not extend beyond the meter.

Getting All Results from Meter Memory
To get the results stored in the meters memory:

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5. Each time you press and let go of the green C button, the meter displays the next most recent of your 150 stored test results. The date and time of each result is displayed alternately under the test result. If the test result was marked as a control solution result, CTL appears under the result. 6. To scroll quickly through the results, press and hold the green C button.
Green C Button Blue Power Button (Examples)
7. If a test resulted in an error message, the error message is stored in the memory. Note: A HI result is included in your 14day and 30day averages as 500 mg/dL.

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First Time Turning on Meter
The first time you turn on your meter you will see the following symbol. This shows that there are no test results in memory.
See www.OneTouchSureStep.com or call LifeScan's Data Management Line at 382-7226 for more information.
You will also see this symbol after you turn on your meter when your last test ended in an error and the meter did not display a glucose result.

Uploading Memory Data

Test results stored in the memory may be uploaded to a personal computer using InTouch software. 67

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The performance of the OneTouch SureStep Blood Glucose Monitoring System was tested under the conditions below. See Important Technical and Healthcare Professional Information in the OneTouch SureStep Test Strips package insert for typical accuracy and precision data.

SPECIFICATIONS

Power Supply: Two AAA alkaline batteries Battery Life: Approximately 18 months when doing two tests per day Result Range: 0500 mg/dL (027.8 mmol/L). Higher results are virtually always displayed as HI Display: Liquid crystal Blood Source: Whole blood Calibration: Plasma equivalent Hematocrit Range: 2560%
Size: 3.5" (8.9 cm) x 2.4" (6.1 cm) x 0.8" (2.0 cm) Weight: 3.8 ounces (with batteries) Operating Temperature Range*: 5095F (1035C) Operating Humidity Range*: 1090% relative humidity (noncondensing) Memory: 150 results (blood glucose and control solution).
*See Comparing Meter and Laboratory Results for additional information.

Apply a drop of blood to the center of the pink test square on the front of the test strip. The confirmation dot on the back should be completely blue for an accurate test.
If any white patches or streaks appear on the blue confirmation dot, you have not applied enough blood for an accurate test. You must start the test over with a new test strip to avoid inaccurately low results. * Never add a second drop of blood.
If there is no white visible on the white pad, you have applied too much blood. You must start the test over with a new test strip to avoid inaccurately high results. * Be careful not to apply too much blood, especially if you tend to bleed easily or are taking blood-thinning medications.

F E R E N C E

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Numerics 14-and 30-day averages. 19, 60, 63, 65 A Accuracy. 39 Applying sample Adequate amount. 30 Blood. 28-30 Control solution. 17 Not enough. 30 Pink test square. 11, 17, 28-29 Too much. 17, 23, 29 B Batteries Changing. 44-46 Symbol indicating replacement. 12, 44 Battery compartment. 7, 45-46 Beep signals. 62-63 Blood Applying. 28-30 Obtaining. 24-25, 28 Blood glucose Results. 31-33 Target ranges. 35, 40 Test. 22-34 C C Button. 7 Changing code number. 14
Changing meter settings. 58-64 Marking control solution result. 19 Changing Batteries. 44-46 Code numbe14 Meter settings. 58-64 Checking Code number. 16, 26 Confirmation dot. 18, 30 System. 15-21 Cleaning Contact points. 43 Disinfecting. 41 Display symbol. 12, 42 Lens area. 43 Meter. 41-44 Test strip holder. 42-43 Code number. 11 Changing. 13-14 Displayed at meter power up. 13, 16, 26 Coding the meter. 13-14 Color Chart. 9 Checking confirmation dot against. 32-33 Unused test strip. 7, 23, 27 Very low or very high. 9, 36 Comparing meter and lab results. 3, 38-40 Confirmation dot. 8 Checking (control solution test). 18

I N D E X

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Checking (blood test). 30 Color of unused test strip. 17, 23, 27 Comparing to Color Chart. 9, 32-33 Facing down when inserting test strip. 11, 18, 31 Patches or streaks appear. 30 Control solution Applying. 17 Discard date. 4, 17 Expiration date. 4, 17 Marking result. 19 Out of range. 17, 20-21 Results. 20-21 Storage. 47 Test. 15-21 Contact points. 7 Cleaning. 43 D Data port. 7 Date and time Changing. 59-61 Format. 64 Discard date Control solution. 4,17 Test strip. 4, 16, 23, 27 Display Of last result. 61 Screen. 7

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The system described herein is covered by one or more of thefollowing U.S. patents: D367,109, D371,198, D428,150, 5,418,142, 5,515,170, 5,526,120, 5,563,031, 5,605,837, 5,780,304, 5,789,255, 5,922,530, 5,968,836, 6,045,567, 6,156,051, 6,197,040, 6,335,203 and 6,491,870. Use of the monitoring device described herein is protected under the U.S. patents 4,935,346. Purchase of the monitoring system described herein does not act to grant a use license under this patent. Such a license is granted only when the device is used with SureStep Pro or OneTouch SureStep Test Strips. No test strip supplier other than LifeScan, Inc. is authorized to grant such a license. Carrying cases made in China. Lancets made in Japan. The accuracy of results generated with LifeScan meters using test strips manufactured by anyone other than LifeScan has not been evaluated by LifeScan.
OneTouch is a trademark of LifeScan, Inc. 2002 LifeScan, Inc. Milpitas, CA 95035 Rev. 4/03 AW 050-745-03A
El Folleto para el Propietario del OneTouch SureStep se encuentra disponible en espaol. Para recibir su copia gratuita, favor de llamar al nmero gratis 381-7226. The OneTouch SureStep instructional materials are available in Spanish. To receive your free copy, please call toll-free 381-7226. LifeScan Customer Services toll-free numbers: U.S.A. English 227-8862 Espaol 381-7226 (24 hours, 7 days a week) Visit the LifeScan Web site at: www.LifeScan.com

AW 05074503A

LSX034=05223302A

10/4/02

1:00 PM

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Glucose Control Solution
I M P O R T A N T : Please read this information before
using ONETOUCH SURESTEP Glucose Control Solution. Purpose of the Control Solution
Use ONETOUCH SURESTEP Glucose Control Solution to check if the ONETOUCH SURESTEP meter and ONETOUCH SURESTEP test strips are working together properly. A control solution test is performed exactly like a blood test except that control solution is used as a sample instead of your blood.This control solution is a liquid with a known amount of glucose in it. ONETOUCH SURESTEP Glucose Control Solution is NOT for use as a cleaning solution.
ONETOUCH SURESTEP Glucose Control Solution

Glucos

Shake befor Not Intende Discard 3 m Discard date Lot No. Exp. Date

LIFESCAN I

How the Control Solution Works
ONETOUCH SURESTEP Glucose Control Solution contains a known amount of glucose that reacts with chemicals on the ONETOUCH SURESTEP Test Strip. When you apply a drop of control solution to the pink test square on the test strip,glucose in the control solution reacts with chemicals in the test strip to create a blue color.The result displayed on the meter should fall within the expected range printed on the test strip bottle label.A result outside the range printed on the test strip bottle label indicates the system is not performing correctly.
ONETOUCH SURESTEP Test Strips
ONETOUCH SURESTEP Control Range

(Example)

When to Use OneTouch SureStep Glucose Control Solution
When to do a control solution test. Before testing your blood for the first time. Every time you open a new bottle of test strips. If you drop the meter. To check that the meter and test strips are working together properly. If your results do not reflect how you feel. After you clean the meter. If the system is working together properly and you follow the testing steps correctly, you should get results within the expected range. Do not use the system to test your blood until you have received a control solution test result within the expected range printed on the test strip bottle label.

Precautions

Do not swallow or inject the control solution. Do not put the control solution in your eyes. The control solution is for use outside the body (in vitro use). The control solution contains a dye that stains clothing. WAR N I NG: The system contains small parts such as lancets, bottle caps, etc. Keep your system out of the reach of small children because these parts may be dangerous if swallowed.
How to Store and Handle the Control Solution
The control solution is ready to use when you purchase it. Do not store the control solution at temperatures above 86F (30C). Do not refrigerate or freeze. Use the control solution before the expiration date shown on the bottle. The control solution can be used for 3 months after first opening the bottle. Write the discard date (3 months from the date opened) on the bottle when you open it. Throw away the bottle after the discard date. Wipe the bottle tip with a clean tissue that does not contain lotion or perfume. Tightly reseal the bottle after each use.
How to Perform a Control Solution Test What you need:
ONETOUCH SURESTEP Glucose Control Solution (The bottle contains enough control solution for at least 75 tests) A ONETOUCH SURESTEP Meter and Owners Booklet ONETOUCH SURESTEP Test Strips

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Performing the Test:
1. Turn on the meter. Check that the code number on the meter matches the code number on the test strip bottle label. 2. Shake the control solution bottle.Apply one drop to the center of the pink test (Example) square on the front of the test strip. 3. Check the confirmation dot on the back of the test strip to make sure it is completely blue.This shows that you applied enough control solution. If any white patches or streaks appear on the confirmation dot,you did not apply enough control solution for an accurate test. Start the test over with a new test strip. If the white pad on both sides of the pink test square is soaked with control solution, you applied too much control solution. Do not insert a test strip that has too much control solution on it. Start the test over with a new test strip. Refer to the Checking the System section of your ONETOUCH SURESTEP Meter Owners Booklet for detailed instructions.

Green C Button

The ONETOUCH SURESTEP Color Chart is not to be used with control solution tests

Control Solution Range

At room temperature,at least 95% of ONETOUCH SURESTEP Glucose Control Solution results should fall within the expected range printed on the test strip bottle label.
ONETOUCH SURESTEP Test Strips ONETOUCH SURESTEP Control Range
Control solution test results should fall within the printed range on the test strip bottle. If a control solution test result falls outside the range, repeat the control test. Control results that fall outside the range may indicate:
not following all test steps or performing them incorrectly. code number on the meter does not match the code number on the test strip bottle. a dirty meter or test strip holder. control solution is expired, or beyond its discard date, contaminated, or not well mixed.
a problem with the test strip (expired, damaged, etc.). meter malfunction. the control solution test is performed outside of the temperature range 5995F (1535C). applying too much control solution.
If your control solution result falls outside the printed range,first repeat the control solution test with a new test strip.If your second control solution result is also outside the printed range,call LifeScan Customer Services at 2278862.

WARNING

Do NOT use your system to test your blood when your control solution results fall outside the printed range. You may get inaccurate blood glucose results. Call LifeScan Customer Services at 2278862 if this occurs.

Chemical Composition

ONETOUCH SURESTEP Glucose Control Solution is a buffered, stabilized, aqueous solution of D-glucose containing glycerol and a dye.The amount of glucose present is sufficient to read within the range printed on the test strip bottle label.

Availability

ONETOUCH SURESTEP Glucose Control Solution and other LifeScan products are available from Authorized LifeScan Distributors and from retail pharmacies. O U R CO M M I T M E N T TO YO U Our goal is to provide you with quality healthcare products and dedicated customer service. If you are not fully satisfied with this product, we offer a no-risk, money-back guarantee. We will refund your purchase within 30 days. Please contact us regarding a refund or with questions about the use of any LifeScan product. or write to: Call toll-free: LifeScan Customer Services U.S.A English 227-Gibraltar Drive Espaol 381-7226 Milpitas, CA 95035 Canada 663-5521

Covered by U.S. patent 5,605,837.

AW 052-233-02A Rev. 8/02

2002 LifeScan Inc,

Printed in U.S.A.

Milpitas, California 95035