Lifescan ONETOUCH BASIC User Manual

Basic

Owner's Booklet

Blood

Glucose

Monitoring

System

Simple

Easy To Handle

Proven Accuracy

The OneTouch®Basic®Blood Glucose Monitoring System is intended for in vitro diagnostic use for quantitative determination of glucose in whole blood as an aid in monitoring effectiveness of diabetes management in the home and in clinical settings. It is not intended for use in the diagnosis of diabetes or for neonatal testing (newborns 0 – 4 weeks old).

CAUTION: Before using any product to test your blood glucose (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 Health Industry Manufacturers Association.

IMPORTANT: The OneTouch

Basic®System kit contains many small parts: test strip holder, battery door, batteries, lancets, control solution vial, etc. Keep the system kit out of the reach of small children because these parts may be dangerous if swallowed.

TABLE OF CONTENTS

INTRODUCTION . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1

PRECAUTIONS AND LIMITATIONS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2

Infection Control . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3

GETTING STARTED . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4

The OneTouch OneTouch OneTouch OneTouch

BEFORE TESTING . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .11

Setting Meter Code . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .11

Checking the System . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .13

— Checking with the Check Strip . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .14

— Checking with Control Solution . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .18

Basic®Blood Glucose Monitoring System . . . . . . . . . . . . . . . . . . . . . . . . . . .5

Basic®Blood Glucose Meter . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .6

Basic®, Profile®, OneTouch®II Test Strips . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .8

Normal Control Solution . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .10

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TESTING YOUR BLOOD . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .25

Abbreviated Test Procedure . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .25

Detailed Test Procedure . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .26

— Getting a Drop of Blood . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .27

— How to Test Your Blood . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .33

Special Messages . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .38

Checking the Amount of Blood on the Test Strip . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .39

COMPARING METER AND LABORATORY RESULTS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .42

USING THE METER MEMORY . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .45

Entering the Memory Mode . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .45

Recalling Test Results . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .46

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SETTING METER OPTIONS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .47

Entering and Using the Set-Up Mode . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .47

Clock (Time and Date) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .49

— Setting the Time . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .50

— Setting the Date . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .51

Beep Prompts . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .52

Language . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .53

Time Format . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .54

Date Format . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .54

Unit of Measure . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .55

Decimal Separator . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .55

Exiting the Set-Up Mode . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .56

SOLVING PROBLEMS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .57

Test Procedure Messages . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .57

Error Messages . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .62

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TAKING CARE OF YOUR METER . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .72

Doing a Daily Check . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .73

Cleaning the Meter . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .73

Replacing the Batteries . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .78

SPECIFICATIONS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .82

GUARANTEE AND WARRANTY . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .83

30-Day Money-Back Guarantee . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .83

Three-Year Warranty . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .83

INDEX . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .85

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INTRODUCTION

Congratulations! You’ve chosen a very easy-to-use blood glucose monitoring system for home testing. When used properly, your OneTouch®Basic®System will give you the accurate test results you need, in just a few simple steps.

Everything you need to know about using the OneTouch®Basic®System is included in this booklet. A free instructional videotape is also available by calling LifeScan Customer Services at 1 800 227-8862.

Blood glucose monitoring plays an important role in controlling your diabetes. The results you get with the OneTouch®Basic®System can help you and your healthcare professional monitor and adjust your treatment plan (diet, exercise, and medication) to help you gain better control of your diabetes.

If you have any questions, please call LifeScan Customer Services, or visit www.LifeScan.com.

Thank you for choosing the OneTouch

P.S. Don’t forget to complete and mail the warranty service card. When we receive your warranty card, we’ll send you a complimentary gift to show our appreciation. See your warranty card for details.

Basic®Blood Glucose Monitoring System.

PRECAUTIONS AND LIMITATIONS

The following information will be useful to you and your healthcare professional when using the OneTouch Basic®System to monitor your blood glucose level.

If you experience symptoms that are not consistent with your blood glucose test results AND you believe you have followed all instructions described in the owner’s booklet, contact your healthcare professional immediately.

Never make significant changes to your medication program or ignore physical

symptoms without consulting your healthcare professional.

If your test result is 60 mg/dL or lower, this indicates low blood glucose (hypoglycemia). The meter will display

the test result along with the message danger call.dr. You should immediately treat hypoglycemia as recommended by your healthcare professional.

If the message hi danger call.dr. appears on the meter display, this indicates severe high blood glucose (hyperglycemia). Contact your doctor immediately.

Extremes in hematocrit (the amount of red blood cells in the blood) can affect test results. Very high hematocrits (above 55%) and very low hematocrits (below 30%) can cause false results.

When testing, removal of the test strip prior to display of the blood glucose result may give you a false result.

Infection Control

Abnormally high levels of Vitamin C or other reducing substances will cause false low blood glucose results.

Normal levels of reducing substances have little effect on blood glucose results.

Do not use blood samples with preservatives that contain fluoride (gray-top test tubes). You will get false low results.

Use universal blood precautions. All patient samples and materials with which they come in contact are considered biohazards and should be handled as if capable of transmitting infection. Follow proper precautions in accordance with federal, state, and local regulations when disposing of all materials.

GETTING STARTED

The OneTouch®Basic®Blood Glucose Monitoring System consists of three main products: the OneTouch

Blood Glucose Meter, OneTouch

Basic

Basic®, Profile®, OneTouch®II Test Strips, and OneTouch

Normal Control Solution. These products have been designed, tested, and proven to work together as a system to produce accurate blood glucose test results. Only LifeScan manufactures OneTouch

Basic®System products. Attempting to substitute other products may affect the

accuracy of your test results and limit the ability of LifeScan to help you solve problems that may arise.

The Complete OneTouch®Basic Blood Glucose Monitoring System

■

OneTouch®Basic®Meter (Batteries installed)

■

Owner’s Booklet

■

Quick Reference Guide

■

Check Strip

■

OneTouch®Normal Control Solution

■

OneTouch®Penlet®Plus Adjustable Blood Sampler

■

Lancets

■

Carrying Case

■

Logbook

■

OneTouch®Basic®, Profile®, OneTouch®II Test Strips (May be sold separately)

OneTouch®Basic

M Button

Test Strip Holder

Battery Compartment (on back)

Display

On/Off Button

Test Area with Protective Coating

C Button

Data Port

Blood Glucose Meter

Study this diagram and become familiar with all the parts of your OneTouch Basic®Meter.

ON/OFF BUTTON. This button

turns the meter on and off.

DISPLAY. The large, easy-to-read display

is where you read the simple messages that guide you through testing. Your test results are displayed here.

BATTERY COMPARTMENT. Holds two

AAA batteries. The batteries are already installed in your meter.

M BUTTON. The OneTouch

Basic

Meter automatically stores your test results. Use the M button to recall the information stored in your meter’s memory and to review your meter’s option settings.

C BUTTON. Use the C button to change

the option settings on the OneTouch Basic®Meter.

TEST STRIP HOLDER. The test strip

holder holds a OneTouch

Profile

, OneTouch®II Test Strip in place

Basic®,

when you perform a blood glucose or control solution test. It must be removed to clean the meter.

TEST AREA. The test area is located

under the test strip holder. There is a clear, protective coating over the test area that must be kept clean and undamaged for accurate results.

DATA PORT. Allows you to transfer the

Test Spot

information stored in the meter’s memory to a computer to view, analyze, and print. Please contact the LifeScan Data Management Line at 1 800 382-7226 for more information about data management software products.

OneTouch®Basic®, Profile®, OneTouch

The OneTouch®Basic®Blood Glucose Monitoring System measures the amount of sugar (glucose) in whole blood. When blood is applied to a OneTouch Test Strip, certain compounds on the test strip react with the blood to form a blue color. The OneTouch reads the color to determine the blood glucose level.

II Test Strips

Basic®, Profile®, OneTouch®II

Basic®Meter

Test Strip

IMPORTANT TEST STRIP INFORMATION

■

OneTouch®Basic®, Profile®, OneTouch®II Test Strips can be damaged by heat and light. Keep them sealed in the original vial. Store the vial in a cool, dry place below 86°F (30°C). Do not refrigerate. Do not place in direct heat or sunlight.

■

OneTouch®Basic®, Profile®, OneTouch®II Test Strips are intended for use with fresh whole blood or OneTouch®Normal Control Solution. Do not use them with plasma or serum samples. Results will not be accurate.

■

Do not use test strips beyond the expiration date on the vial.

■

When you open a new vial of test strips, record the discard date on the vial. The discard date for test strips is four months after first opening the vial.

■

Do not use test strips that are bent, torn, cut, or changed in any way.

■

Use each test strip immediately after removing it from the vial; replace the vial cap and close it tightly.

■

Never transfer test strips to a new vial or any other container. Always carry test strips in their original container. Do not carry loose test strips in your meter case.

■

Do not use bleach (or products containing bleach) near the test strips.

■

For reliable results, use only OneTouch®Basic®, Profile®, OneTouch®II Test Strips made by LifeScan.

OneTouch®Normal Control

Normal Control

Solution

OneTouch®Normal Control Solution is an important part of the OneTouch Basic®System. Use it in two ways:

1) to practice the test procedure, and

2) to make sure that the OneTouch

Basic®Meter and OneTouch®Basic®,

Profile working together properly.

, OneTouch®II Test Strips are

Expiration Date

For in vitro diagnostic use only. Not intended for human consumption. Discard 90 days after opening.

Discard Date:

________________________

Unopened exp. date

Lot No. VE234

07/99

(Example)

BEFORE TESTING

Note: You do not have to enter the set-up mode to test. However, the OneTouch number of settings you can change, including the language, time and date, display formats, and the unit of measure. For a description of these options and how to set them, see page 47.

Basic®Meter has a

correctly. You must code the meter before using it for the first time and then every time you change to another vial of OneTouch

Profile

, OneTouch®II Test Strips.

Basic®,

CAUTION: If the code number on the meter display does not match the code number on the vial of OneTouch®Basic®, Profile®, OneTouch

II Test Strips, test results

may be false.

Setting Meter Code

Code numbers are used to enable your meter to provide consistent measurements. For this reason, it is important that the code is set

Code the OneTouch these three easy steps:

Basic®Meter in

Step 1: Press the On/Off Button.

When turning meter on, all display symbols will appear. The last test result will then appear on the display for a moment. (If using the meter for the first time, the message code-- will appear on the display.) If you have already coded the meter, your current test strip code followed by the message check code will momentarily appear on the display. The following will then appear:

(Example)

Step 2: Match the Code Numbers.

The code number on the test strip vial ranges from 1 to 16. If the code number on the meter display matches the code number on the test strip vial, you can begin testing. If the two code numbers do not match, follow Step 3. (When you first use the meter, code-- will appear, showing that there is no code stored in the memory.)

Step 3: Code the Meter.

While the meter displays code--, or after the word insert is displayed, press and release the C button; the code number will appear. Continue pressing the C button until the number on the display matches the code number on the test strip vial. The code number is now set for the test strips you are using. The meter will remember this code number until you change it. You are now ready to do a test.

Checking the System

There are two ways to check that your OneTouch properly. The check strip is used to check that the meter is operating properly. OneTouch Solution is used to check that both the meter and the test strips are working together as a system, and that you are doing the test correctly. It is very important that you do these simple checks routinely for accurate results.

Basic®System is working

Normal Control

Checking with the Check Strip

✔

80403U

A purple and white check strip is included in the carrying case of your OneTouch

Basic®System. Before doing a check strip test, make sure the test strip holder, test area, and check strip are clean, dry, and lint-free. Do the check strip test at room temperature (between 64° and 79°F [18°–26°C] ).

Front

(Example)

Back

Do a check strip test:

✔

■

At least once each day you test your blood

■

After cleaning the meter

■

Whenever your blood glucose test results are not consistent with how you feel, or when you think your results are not accurate

■

If you drop the meter

■

If you get the meter wet

■

Whenever the following message appears:

How to do a check strip test:

Step 1: Press the On/Off Button. Insert Side 1 of the Check Strip.

When insert code 10 (Example) strip appears, slide the notched end of

the check strip into the test strip holder with Side 1 (purple side) facing up. wait appears for a moment.

Step 2: When apply sample

✔

M C

✔

Appears, Remove the Check Strip from the Test Strip Holder.

Note: This is the only time you should remove a strip during a test.

Note: Do not apply control solution to the check strip.

Step 3: When insert side 2 Appears, Turn the Check Strip Over and Slide It Back into the Test Strip Holder.

It should go in notched end first, Side 2 (white side) facing up. The meter counts down from four to zero and then gives you a check strip result.

(Example)

If these messages appear, repeat the check strip test. If these messages appear again, clean your meter and repeat the test. If you do not obtain an acceptable (Aok) check strip reading, redo A will appear each time you turn on your meter, indicating that your last check strip test was outside of the check strip range printed on the back of the meter. This message will continue to appear until you perform a check strip test and get a reading that falls within the correct check strip range.

CAUTION: If your check strip test result is out of range, your meter may not be working properly. Do not use the meter to test your blood until you get a check strip reading that is within the correct range printed on the back of the meter. For assistance, call LifeScan Customer Services at 1 800 227-8862.

To clean and maintain the check strip:

■

Make sure both sides of the check strip are clean. If necessary, wipe the check strip with a soft cloth or tissue dampened with water. Dry it completely.

■

Norm

al Control

Solution

Do not

get blood, alcohol, control solution, or any other fluid (except water) on the check strip.

■

Do not scratch the check strip.

■

Do not leave the check strip in sunlight.

■

If you lose or damage the check strip, call LifeScan Customer Services at 1 800 227-8862 for a free replacement.

Checking with Control Solution

OneTouch®Normal Control Solution contains a known amount of glucose that reacts with OneTouch

Profile

, OneTouch®II Test Strips. Control

Basic®,

solution should be used to practice the test procedure and to make sure your

meter and test strips are working together properly as a system.

Before you use the OneTouch

Basic

Meter to test your blood glucose for the first time, practice the procedure using control solution. When you can do three tests in a row that are within the expected range, you are ready to test your blood.

Do a control solution test:

■

For practice, before testing your blood with the

OneTouch®Basic

Meter for the first time

■

When you begin using a new vial of test strips

■

At least once a week

■

Whenever you suspect that the meter or test strips are not working properly

■

When your blood glucose test results are not consistent with how you feel, or when you think your results are not accurate

■

If you drop the meter

■

If you get the meter wet

The control solution test procedure is just like blood glucose testing, except that you use OneTouch®Normal Control Solution instead of blood.

Control solution test tips

■

Shake the control solution vial thoroughly before using.

■

If there are any bubbles on the top of the vial, wipe them off with a clean tissue.

■

Apply a full drop of control solution to the center of the test spot and cover it completely. Do not dab, wipe, or smear control solution on the test spot.

■

Avoid contaminating the control solution. Do not touch the test spot with the tip of the vial.

IMPORTANT CONTROL SOLUTION TEST INFORMATION

■

Use only OneTouch®Normal Control Solution.

■

Check the expiration date of the control solution. Do not use if expired.

■

Record the discard date on the control solution vial. Discard the vial three months after first opening.

■

The OneTouch®Normal Control Range printed on the test strip vial is for OneTouch

Normal Control Solution only. It is not a recommended range for

your blood glucose level.

■

Store the control solution at room temperature below 86°F (30°C). Do not refrigerate.

■

Control solution should not be used as a cleaning solution for the meter.

Warning

■

For external use only. Do not swallow or inject control solution or put control solution drops into your eyes.

How to do a control solution test:

Step 1: Press On/Off Button. Insert Test Strip.

The code number that appears on the meter display should match the code number on the test strip vial. When insert

code10 (Example) strip appears,

slide a OneTouch

(Example)

Basic®, Profile®, OneTouch holder, notched end first, with the test

II Test Strip into the test strip

spot facing up. Make sure you push the test strip in all the way until it stops. wait appears for a moment, then

apply sample

appears for five minutes or until you apply a drop of control solution to the test spot on the test strip.

Step 2: Apply Control Solution.

o r m

l G

s e C

n t r

S o

Shake the control solution vial well before using. Remove the cap and apply a drop of control solution to the middle of the test spot, covering it completely.

Step 3: Control Solution Result Appears in 45 Seconds.

Compare the control solution test result with the OneTouch

Normal Control Range printed on the test strip vial. When you get a control solution test result within the control range, you are ready to test your blood.

(Example)

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