Lifescan ONE TOUCH Profile User manual

Owner’s Booklet
Complete Diabetes Monitoring System
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IPR2023-00713 - U.S. Patent No. 8,840,635

INSIDE FRONT COVER
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The ONE TOUCH
®
BASIC
®
Diabetes 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).
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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 ONE TOUCH
®
BASIC
®
System
contains many small parts: test strip holder, battery
door, batteries, lancets, control solution vial, test
strips, test strip vial cap, etc. Keep the system out
of the reach of small children because these parts
may be dangerous if swallowed.
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TABLE OF CONTENTS
INTRODUCTION 1
PRECAUTIONS AND LIMITATIONS 2
Infection Control 3
GETTING STARTED 4
The Complete ONE TOUCH®BASIC®
Diabetes Monitoring System 4
ONE TOUCH®BASIC®
Blood Glucose Meter 6
ONE TOUCH®Test Strips 8
ONE TOUCH®Normal Control Solution 10
BEFORE TESTING 11
Setting Meter Code 11
Checking the System 13
LifeScan Customer Services: English 1 800 227-8862
Español 1 800 381-7226
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LifeScan Customer Services: English 1 800 227-8862
Español 1 800 381-7226
— Checking with the Check Strip 14
— Checking with Control Solution 18
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
LifeScan Customer Services: English 1 800 227-8862
Español 1 800 381-7226
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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
LifeScan Customer Services: English 1 800 227-8862
Español 1 800 381-7226
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1
INTRODUCTION
Congratulations! You’ve chosen a very easy-to-use blood glucose monitoring system
for home testing. When used properly, your ONE TOUCH
®
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 ONE TOUCH BASIC System is
included in this booklet. A free instructional videotape is also available by calling
LifeScan Customer Services.
Blood glucose monitoring plays an important role in controlling your diabetes.
The results you get with the ONE TOUCH 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 at 1 800 227-8862.
Thank you for choosing the ONE TOUCH
®
BASIC
®
Diabetes Monitoring System.
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.
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PRECAUTIONS AND
LIMITATIONS
The following information will
be useful to you and your health-
care professional when using the
ONE TOUCH
®
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 con-
sulting 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.
2
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Extremes in hematocrit (the amount
of red blood cells in the blood) can
affect test results. Very high hemat-
ocrits (above 60%) and very low
hematocrits (below 25%) can cause
false results.
1
Abnormally high levels of Vitamin C
or other reducing substances will
cause false low blood glucose
results.
2
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.
When testing, removal of the test
strip prior to display of the blood
glucose result may give you a
false result.
Infection Control
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.
3
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GETTING STARTED
The ONE TOUCH
®
BASIC
®
Diabetes Monitoring System
consists of three main products:
the ONE TOUCH
®
BASIC
®
Blood
Glucose Meter, ONE TOUCH
®
Test
Strips, and ONE TOUCH
®
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 ONE TOUCH
®
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 ONE TOUCH®
BASIC®Diabetes Monitoring
System
Your ONE TOUCH BASIC System
includes:
■ONE TOUCH BASIC Meter with
Two AAA Batteries (Installed)
■ONE TOUCH Test Strips
■ONE TOUCH Normal Control
Solution
4
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■Owner’s Booklet and Quick
Reference Guide
■Check Strip
■Penlet®Plus Adjustable Blood
Sampler
■Lancets
■Carrying Case
■Logbook
®
Normal Control
Solution
1
✔
5
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ONE TOUCH®BASIC®
Blood Glucose Meter
Study this diagram
and become familiar
with all the parts of
your ONE TOUCH
®
BASIC
®
Meter.
6
M Button
Test Strip
Holder C
M
Battery
Compartment
(on back)
Display
On/Off
Button
Test Area
with Protective
Coating
C Button
Data Port
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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 ONE TOUCH
®
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
ONE TOUCH BASIC Meter.
TEST STRIP HOLDER. The test
strip holder holds a ONE TOUCH
®
Test Strip in place when you per-
form a blood glucose or control
solution test. It must be removed
to clean the meter.
TEST AREA. The test area is locat-
ed 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.
7
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DATA PORT. Allows you to transfer
the 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.
ONE TOUCH®Test Strips
The ONE TOUCH
®
BASIC
®
Diabetes
Monitoring System measures the
amount of sugar (glucose) in whole
blood. When blood is applied to a
ONE TOUCH Test Strip, certain
compounds on the test strip react
with the blood to form a blue color.
The ONE TOUCH
®
BASIC
®
Meter
reads the color to determine the
blood glucose level.
Test Strip
Test Spot
8
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IMPORTANT TEST STRIP INFORMATION
■ONE TOUCH®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.
■ONE TOUCH Test Strips are intended for use with fresh whole blood or
ONE TOUCH®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 ONE TOUCH Test Strips made by LifeScan.
9
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ONE TOUCH®Normal Control
Solution
ONE TOUCH Normal Control
Solution is an important part of the
ONE TOUCH
®
BASIC
®
System. Use
it in two ways:
1) to practice the test procedure,
and
2) to make sure that the
ONE TOUCH
®
BASIC
®
Meter
and ONE TOUCH
®
Test Strips
are working together properly.
(Example)
®
Normal Control
Solution
10
Expiration
Date
For in vitro diagnostic use only.
Not intended for human consumption.
Discard 90 days after opening.
Discard Date:
________________________
Unopened exp. date
07/99
Lot No. VE234
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BEFORE TESTING
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
correctly. You must code the meter
before using it for the first time
and then every time you change
to another vial of ONE TOUCH
®
Test Strips.
Code the ONE TOUCH BASIC Meter
in these three easy steps:
CAUTION: If the code number
on the meter display does not
match the code number on the
vial of ONE TOUCH Test Strips,
test results may be false.
Note: You do not have to enter
the set-up mode to test. However,
the ONE TOUCH
®
BASIC
®
Meter
has a 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.
11
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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 match-
es 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.)
MC
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