EasEasy to Handle, y to Handle, EasEasy to Ready to Read
Simple Blood ApplicationSimple Blood Application
ConfirmConfirms s Enough Enough Blood IBlood Is Applieds Applied
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.
i
CAUTION:
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
LEARNING
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).
Before using any product to test your blood glucose (blood sugar), read
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.
ii
Table of Contents
Learning2
Purpose2
What to Expect from Your System3
Warnings and Precautions4
Importance of Following Instructions5
OneTouch
Optional Color Chart9
Display Symbols10
Coding13
Coding the Meter13
Checking15
Checking the System15
Understanding Control Solution Results20
Testing22
Testing Your Blood22
Testing Tips for Accurate Results23
Test Procedures24
®
SureStep®Test Strips8
www.LifeScan.com
iii
Results35
Understanding Your Results35
How to Check if Your Meter is Working Correctly37
Comparing Meter and Laboratory Results38
Health Conditions Which Can Cause Out-of-Range Results40
Maintenance41
Caring for Your Meter41
General Care41
Cleaning the Meter41
Changing the Batteries44
Storage Instructions47
Troubleshooting48
Error Messages48
Symbols56
Symbols56
Settings58
Changing Meter Settings58
Entering Set-Up Mode59
Changing the Date and Time59
Setting the Time60
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iv
Setting the Year60
Setting the Month61
Setting the Day61
Display of Last Results61
Unit of Measurement61
Beep Signals6214- and 30- Day Averages63
Time Format64
Date Format64
Exiting the Set-Up Mode64
Memory65
Background Information on Meter Memory65
Getting All Results from Meter Memory65
First Time Turning on Meter67
Uploading Memory Data67
Specifications68
Specifications68
Guarantee and Warranty69
Quick Reference70
Index72
www.LifeScan.com
v
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
LEARNING
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 1 800 227-8862
Español1 800 381-7226
www.LifeScan.com
Meter Serial Number _____________________________________
Healthcare Professional _______________________________________
Other _____________________________________________________
Everything you need to know about using the
®
OneTouch
owner’s booklet and in the test strip package
®
SureStep®System is included in this
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.
vi
Units of Measure for Meter Readouts
LEARNING
mg/dL
milligrams/deciliter
no decimal point
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”.
PLEASEREAD
mmol/L
millimoles/liter
decimal point
vii
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
LEARNING
intended for testing whole blood samples 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 Complications 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 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
1
events
(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.
When Not to Use
Do not use OneTouch®SureStep®blood
glucose results to determine whether
2
or not you have diabetes. Only your
doctor can diagnose this disease.
What to Expect from Your System
◆
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,
results can differ by more than ±20% in
some situations. See Comparing Meterand Laboratory Results for more information.
◆
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
3
LEARNING
feel. See Understanding Your Results
on page 35.
Warnings and Precautions
◆
Read all the instructions, including the
LEARNING
test strip package insert, and practice the
test with control solution (see Checkingthe System) before testing your blood
glucose. Do all quality control checks as
directed, including checking the meter
display symbols (see Description ofSystem), 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.
◆
Do not use the test strips after the expiration date printed on the bottle label or
more than 4 months 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 3 months 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 temperature or relative humidity may affect
results particularly if both the temperature and humidity are either high or low.
If you test under these conditions, repeat
4
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 lifethreatening medical complications such
as diabetic ketoacidosis. Some factors
causing dehydration are vomiting, diarrhea, inadequate fluid intake, some
drugs (for example, diuretics), sustained
uncontrolled diabetes, and shock.
4
have these symptoms, consult your
Healthcare Professional immediately,
even if your glucose reading is not
unusually high.
◆
Because some diseases can be transmitted by blood, use care when disposing of
used lancets and test strips.
NOTE: Blood glucose monitoring
requires the help of a Healthcare
If you
LEARNING
Professional. Work with your Healthcare
Professional to set your own target
blood glucose values, arrange your testing 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 instructions, you may get inaccurate results,
which can lead to improper treatment.
5
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)
Allows you to transfer the information stored in the meter’s
memory to a computer to view,
analyze, and print.
DISPLAY
Shows your test results and
symbols that guide you
through the test.
LENS AREA
Contains the meter optics that
reads the glucose level. Test
strip holder covers the lens area.
SERIAL NUMBER
(Example)
BATTERY COMPARTMENT
Holds two AAA alkaline batteries.
Front
Back
7
C
BUTTON (Green)
Codes the meter, changes the meter
settings, marks control solution test
results, and scrolls through the
memory.
POWER BUTTON (Blue)
Turns the meter on and off, accesses
the memory, and navigates through
the set-up mode.
CONTACT POINTS
Sense the position and orientation of
the OneTouch®SureStep®Test Strip.
TEST STRIP HOLDER
Closed
Test Strip
Insertion
Point
The cover protects the lens area and
the base holds the OneTouch
Opened
Cover
Base
®
SureStep®Test Strip.
LEARNING
OneTouch®SureStep®Test Strips
FrontBack
Pink Test
Square
White Pad
Confirmation
Dot
White TipBlack Tip
When blood is applied to the pink test
square, it is absorbed and a chemical reaction takes place. A blue color forms in the
LEARNING
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 confirm proper blood application. When it turns completely blue, enough
blood has been applied
for an accurate test.
8
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.
LEARNING
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.
9
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.
LEARNING
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.
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)
10
The current code number is displayed.
The number on the display must match the
code number on the OneTouch
®
SureStep
®
Test Strip bottle.
(Example)
Apply blood to the center
of the pink test square
on the test strip.
Check that the pink side of
the test strip faces up
firmly push the test strip
into the test strip holder
until it stops. Insert the
test strip tapered-end first.
11
LEARNING
and
The meter is measuring
your glucose level.
LEARNING
The meter displays your
test result
in mg/dL or
mmol/L together with the
date and time of the test.
(Example)
When the meter determines
that your
blood glucose level exceeds 500 mg/dL
(27.8 mmol/L), it displays
HI
in virtually all
cases.
(Example)(Example)
Clean the meter and test
strip holder.
(Example)
Replace the two AAA
alkaline batteries.
12
Coding the Meter
A code number is printed on each test strip
bottle label. The code numbers (ranging
from 1 to 21) are used to calibrate the
meter.
Each time you test, check that the code
number on the meter display matches the
code number on the test strip bottle label.
CAUTION: If the code number on the
meter display does NOT match the code
number on the test strip bottle label,
you may get inaccurate results.
1. Press the blue power button to turn on
the meter.
Make sure there is not a test strip in the
meter when you turn it on.
Display Check(Example)
The display check appears briefly. Carefully
check that all symbols appear. The result of
your last blood glucose or control solution
test appears.
If you are turning on the
meter for the first time, – – –
appears on the display.
◆
Next, a code number
appears for a few
seconds.
13
CODING
2. Compare the code number on the test
strip bottle with the code number on the
meter display.
(Example)
If the code numbers match, you may
begin testing.
3. If the code numbers
CODING
do not match, press
the green C button.
Continue pressing
until the code number on the display matches the code
number on test strip bottle. The meter
will retain this code until you change it.
Green C Button
(Example)
NOTE: If the meter advances past the
code number before you are able to
change it, continue pressing the green
button until the code number appears.
CAUTION: Your meter has been preset
to meet the needs of most users in the
United States. Refer to “Changing Meter
Settings” if you need to verify or change
the settings, such as date, time or unit of
measurement. See p. 58 for a complete
listing of features that can be changed.
14
▼
Checking the System
Glucos
Shake befor
Not Intende
Discard 3 m
Discard date
Lot No.
Exp. Date
Use OneTouch®SureStep®Glucose Control
Solution to check if the meter and 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. Practice the
test with the control solution before testing
your blood for the first time.
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.
OneTouch
WARNING:
◆
Do not use the control
SureStep®Glucose
Control Solution
solution to clean the meter.
◆
Do not swallow or inject the control
solution or put it in your eyes.
◆
The control solution is for use outside
the body (in vitro use).
◆
The control solution contains a dye
that stains clothing.
15
®
CHECKING
1. Press the blue power button to turn on
the meter. The display check appears
briefly. Carefully check that all symbols
appear. Make sure a test strip is not in
the meter when you turn it on.
2. Compare the code number on the meter
display with the code number on the
test strip bottle. If they do not match,
press the green C button until the codes
match.
Green C Button
▼
(Example)
3. Remove a test strip from the bottle and
replace the bottle cap. Close it tightly.
◆
Check the expiration date and discard
date. Do not use the test strips after
these dates.
◆
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
the confirmation dot on the test strip is
darker than that shown on the Color
Chart, do not use the test strip. The
result may be inaccurate.
CHECKING
16
NOTE: If opening the test strip bottle for
the first time, write the discard date
(4 months from today) on the bottle
label and perform a control solution test
following the instructions below.
4. Shake the control solution bottle. Apply 1
drop of control solution to the center of
the pink test square.
◆
The first time you open the control
solution bottle, write the discard date
on the label in the space provided. The
discard date for control solution is 3
months from the date you first open
the bottle.
◆
Check expiration date and discard
date. Do not use the control solution
after these dates.
◆
If the entire white pad surrounding the
pink test square is soaked, you have
applied too much Glucose Control
Solution.
CAUTION: Applying too much control
solution may cause out–of–range results
and may make the meter dirty.
17
CHECKING
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