OneTouch ONETOUCH SURESTEP (WITH DATA PORT) User manual

Blood
Glucose
Monitoring
System
Owner's Booklet
EasEasy to Handle,y to Handle, EasEasy to Ready to Read
Simple Blood ApplicationSimple Blood Application
ConfirmConfirmss EnoughEnough Blood IBlood Is Applieds Applied
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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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LEARNING
ii
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, bat-
tery 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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iii
Learning 2
Purpose 2
What to Expect from Your System 3
Warnings and Precautions 4
Importance of Following Instructions 5
OneTouch®SureStep®Test Strips 8
Optional Color Chart 9
Display Symbols 10
Coding 13
Coding the Meter 13
Checking 15
Checking the System 15
Understanding Control Solution Results 20
Testing 22
Testing Your Blood 22
Testing Tips for Accurate Results 23
Test Procedures 24
Table of Contents
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Results 35
Understanding Your Results 35
How to Check if Your Meter is Working Correctly 37
Comparing Meter and Laboratory Results 38
Health Conditions Which Can Cause Out-of-Range Results 40
Maintenance 41
Caring for Your Meter 41
General Care 41
Cleaning the Meter 41
Changing the Batteries 44
Storage Instructions 47
Troubleshooting 48
Error Messages 48
Symbols 56
Symbols 56
Settings 58
Changing Meter Settings 58
Entering Set-Up Mode 59
Changing the Date and Time 59
Setting the Time 60
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v
Setting the Year 60
Setting the Month 61
Setting the Day 61
Display of Last Results 61
Unit of Measurement 61
Beep Signals 62
14- and 30- Day Averages 63
Time Format 64
Date Format 64
Exiting the Set-Up Mode 64
Memory 65
Background Information on Meter Memory 65
Getting All Results from Meter Memory 65
First Time Turning on Meter 67
Uploading Memory Data 67
Specifications 68
Specifications 68
Guarantee and Warranty 69
Quick Reference 70
Index 72
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LEARNING
vi
Welcome to LifeScan
Congratulations! You’ve 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. Remember to complete and mail the Warranty
Registration Card. A complimentary gift is sent when
we receive your Warranty Registration Card.
Everything you need to know about using the
OneTouch
®
SureStep
®
System is included in this
owner’s 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 video-
tape 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.
Meter Serial Number _____________________________________
Healthcare Professional _______________________________________
Pharmacist ________________________________________________
Diabetes Educator ___________________________________________
Other _____________________________________________________
Important phone numbers:
LifeScan Customer Services
(24 hours a day, 7days a week):
U.S.A. English 1 800 227-8862
Español 1 800 381-7226
www.LifeScan.com
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vii
LEARNING
PLEASE READ
Units of Measure for Meter Readouts
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 doctor’s 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”.
mmol/L
millimoles/liter
decimal point
mg/dL
milligrams/deciliter
no decimal point
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LEARNING
2
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 sam-
ples at the time when the blood sample
is obtained.
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 Compli-
cations Trial (DCCT.) This was a long-term
study of people with type 1 diabetes. This
study found that you should keep your blood
glucose close to the levels of people with-
out diabetes. You can reduce the risk of
problems with the eyes, kidneys, and ner-
vous system by about 60%. You should be
aware that keeping your blood glucose level
close to the levels of people without dia-
betes increases your risk of hypoglycemic
events
1
(low blood sugar).
How often you need to test your blood glu-
cose depends on many factors. These
include your age, if you have type 1or
type 2diabetes, your medications, and
your health. Your Healthcare Professional
will guide you. It is important that you
make testing part of your daily routine.
When Not to Use
Do not use OneTouch®SureStep®blood
glucose results to determine whether
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3
LEARNING
or not you have diabetes. Only your
doctor can diagnose this disease.
What to Expect from Your System
◆Blood glucose meters are clinically accu-
rate, but not a substitute for a laboratory
result. Originating from laboratory
methods, glucose meter systems provide
a convenient, portable way to test inex-
pensively 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 auto-
mated. 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,
results can differ by more than ±20% in
some situations. See Comparing Meter
and Laboratory Results for more infor-
mation.
◆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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LEARNING
4
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 sys-
tem out of the reach of small children
because these parts may be dangerous if
swallowed. The test strip packaging con-
tains a drying agent that may be harmful
if inhaled or swallowed. It may also
cause skin or eye irritation.
◆Do not use the test strips after the expi-
ration date printed on the bottle label or
more than 4months after first opening
the bottle, whichever comes first. You
may get inaccurate results if you use the
test strips after these dates.
◆Do not use strips that are bent, cut, or
altered in any way.
◆Do not use the control solution after the
expiration date printed on the bottle label
or more than 3months after first opening
the bottle, whichever comes first. Control
solution results may not be reliable if you
use the solution after these dates.
◆Testing at a very high or very low temper-
ature or relative humidity may affect
results particularly if both the tempera-
ture and humidity are either high or low.
If you test under these conditions, repeat
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LEARNING
the test in a climate-controlled location
as soon as possible.
◆Excessive water loss (severe dehydration)
may cause false low results.
2,3
Severe
dehydration, if untreated, can lead to life-
threatening medical complications such
as diabetic ketoacidosis. Some factors
causing dehydration are vomiting, diar-
rhea, inadequate fluid intake, some
drugs (for example, diuretics), sustained
uncontrolled diabetes, and shock.
4
If you
have these symptoms, consult your
Healthcare Professional immediately,
even if your glucose reading is not
unusually high.
◆Because some diseases can be transmit-
ted by blood, use care when disposing of
used lancets and test strips.
NOTE: Blood glucose monitoring
requires the help of a Healthcare
Professional. Work with your Healthcare
Professional to set your own target
blood glucose values, arrange your test-
ing times, and discuss the meaning of
your blood glucose results.
Importance of Following Instructions
Your OneTouch
®
SureStep
®
Blood Glucose
Monitoring System will provide accurate
glucose results that can help you control
your diabetes, if you follow the directions
in this Owner’s Booklet and the test strip
package insert. Be sure to check the test
strip package insert each time you open a
new box of test strips for important
updates. If you do not follow the instruc-
tions, you may get inaccurate results,
which can lead to improper treatment.
5
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The Complete OneTouch®
SureStep®Blood Glucose
Monitoring System
■
OneTouch®SureStep® Meter
(Batteries installed)
■Owner’s Booklet
■Quick Reference Guide
■
OneTouch® SureStep®
Control Solution
■
OneTouch® Penlet®Plus
Automatic Blood Sampler
■
OneTouch® FinePoint™
Lancets
■Carrying Case
■Logbook
■OneTouch®SureStep®Test Strips
(May be sold separately)
6
..
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L 5037 ZG 00171
1 800 227-8862
1 800 381-7226
1 800 663-5521
UNITED STATES:
CANADA:
Milpitas, CA 95035
BLOOD GLUCOSE METER
Toll-free customer service:
English
Español
© LIFESCAN INC. 1998
AW 052-178-01B Made in U.S.A.
®
B1
NRTL /C
DISPLAY
Shows your test results and
symbols that guide you
through the test.
OneTouch®SureStep®Blood Glucose Meter
POWER BUTTON (Blue)
Turns the meter on and off, accesses
the memory, and navigates through
the set-up mode.
BATTERY COMPARTMENT
Holds two AAA alkaline batteries.
C BUTTON (Green)
Codes the meter, changes the meter
settings, marks control solution test
results, and scrolls through the
memory.
LENS AREA
Contains the meter optics that
reads the glucose level. Test
strip holder covers the lens area. Back
CONTACT POINTS
Sense the position and orientation of
the OneTouch®SureStep®Test Strip.
SERIAL NUMBER
(Example)
The cover protects the lens area and
the base holds the OneTouch®
SureStep®Test Strip.
Cover
Base
Opened
Test Strip
Insertion
Point
DATA PORT
Allows you to transfer the infor-
mation stored in the meter’s
memory to a computer to view,
analyze, and print.
Closed
TEST STRIP HOLDER
7
LEARNING
Front
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LEARNING
8
OneTouch®SureStep®Test Strips
When blood is applied to the pink test
square, it is absorbed and a chemical reac-
tion takes place. A blue color forms in the
confirmation dot on the back of the test
strip and is read by the meter to determine
the blood glucose level; the darker the
color, the higher the blood glucose level.
White Tip is inserted into the
meter. The side where you
apply blood must be face
up when you insert the test
strip.
Pink Test Square is where
you apply a drop of blood.
White Pad absorbs the
excess blood that may
extend beyond the pink test
square.
Do not apply blood directly
onto the white pad.
Black Tip helps the meter
detect that the strip has
been inserted properly.
Confirmation Dot on the
back of the test strip is
where you check to con-
firm proper blood applica-
tion. When it turns com-
pletely blue, enough
blood has been applied
for an accurate test.
Front Back
Pink Test
Square
White Pad
Confirmation
Dot
White Tip Black Tip
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9
LEARNING
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
(1 800 227–8862) if any segments are
missing.
When you turn on the meter,
it automatically recalls and
displays your most recent
glucose result and the date it
was measured.
LEARNING
10
(Example)
Display Check
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