Lifescan Blood Glucose Meter User manual

The system described herein is covered by one or more of the following U.S.
Patents/ Le système décrit aux présentes est protégé par un ou plusieurs
des brevets américains suivants: 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/et
6,491,870. Use of the monitoring device described herein is protected under
the U.S. patents 4,935,346/L’utilisation du dispositif de surveillance décrit
aux présentes est protégée par le brevet américain 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/
L’achat du système de surveillance de la glycémie décrit aux présentes n’ac-
corde pas de licence en vertu de ces brevets. Une telle licence est accordée
seulement lorsque le dispositif est utilisé avec les bandelettes réactives
SureStep®Pro ou OneTouch®SureStep®.
AW 05090602A
© 2003 LifeScan, Inc.
Milpitas, CA 95035
CA/OB/OTSS Rev. 08/2003
One Touch®Customer Care Line/ Ligne InfoSoins One Touch®:
Monday – Friday 9AM – 8PM Eastern Time, 6AM – 5PM Pacific Time/
Lundi au vendredi, 9H – 20 H (Heure de l’Est), 6H – 17 H
(Heure du Pacifique)
Canada 1 800 663-5521 U.S.A./É.-U. 1 800 227-8862
www.OneTouch.ca
No test strip supplier other than LifeScan, Inc. is authorized to grant such a
license. The accuracy of results generated with LifeScan meters using test
strips manufactured by anyone other than LifeScan has not been evaluated
by LifeScan/Aucun fournisseur de bandelettes de test autre que LifeScan
Inc. n’est autorisé à accorder une telle licence. L’exactitude des résultats
produits par les lecteurs LifeScan utilisant les bandelettes réactives fa-
briquées par quiconque autre que LifeScan n’a pas été évaluée par LifeScan.
Distributed by/Distribué par: LifeScan Canada Ltd./Produits médicaux
LifeScan Canada Itée, Burnaby, B.C./C.-B. V5C 6C6
Manufacturer/Fabricant:
LifeScan Inc., Milpitas, CA 95035, U.S.A./É.-U.
DCO_05090602A_OTSS_OBC_CAN 12/3/03 9:44 AM Page 2

i
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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ii
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.
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. If you have any questions,
please feel free to call the toll-free number to
speak with our Customer Care Line.
Meter Serial Number _____________________________________
Healthcare Professional _______________________________________
Pharmacist ________________________________________________
Diabetes Educator ___________________________________________
Other _____________________________________________________
Important phone numbers:
OneTouch®Customer Care Line:
CANADA 1 800 663-5521
www.OneTouch.ca
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iii
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 Diabetes Educator
Section of the Canadian Diabetes 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 may contain many small parts: test strip holder,
battery door, batteries, lancets, control solution bottle, test strips, test strip bottle
cap, 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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iv
PLEASE READ
Units of Measure for Meter Readouts
Your OneTouch®SureStep® Meter can display results in two different units of measure,
millimoles per liter (mmol/L) or milligrams per deciliter (mg/dL). The mmol/L unit is
standard in Canada. The mg/dL unit is standard in the United States. Please contact
your Healthcare Professional to determine the unit of measure you should use. If the
incorrect unit of measure is used, you may get inaccurate results, which can lead to
improper treatment.
mg/dL
milligrams/deciliter
no decimal point
mmol/L
millimoles/liter
decimal point
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v
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 Colour 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
OneTouch®Customer Care Line: CANADA 1 800 663-5521 www.OneTouch.ca
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vi
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
OneTouch®Customer Care Line: CANADA 1 800 663-5521 www.OneTouch.ca
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vii
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
OneTouch®Customer Care Line: CANADA 1 800 663-5521 www.OneTouch.ca
DCO_05090602A_OTSS_OB_CA_ENG 12/3/03 1:27 PM Page vii

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DCO_05090602A_OTSS_OB_CA_ENG 12/3/03 1:27 PM Page 1

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 sys-
tem is intended for testing whole blood
samples at the time when the blood sam-
ple 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 1diabetes. 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
glucose 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 or
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3
LEARNING
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 labo-
ratory 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 labo-
ratory results in the same way. Keep in
mind that testing conditions for labora-
tories 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 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 may contain 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 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
DCO_05090602A_OTSS_OB_CA_ENG 12/3/03 1:27 PM Page 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
Adjustable Blood Sampler
■
OneTouch® FinePoint™
Lancets
■Carrying Case
■Logbook
■OneTouch®SureStep®Test Strips
(May be sold separately)
6
..
DCO_05090602A_OTSS_OB_CA_ENG 12/3/03 1:27 PM Page 6

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 colour 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
colour, 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 Colour Chart
Directly after reading a meter result, you
can compare the colour of the confirmation
dot on the back of the test strip with the
Colour Chart on the test strip bottle label.
The chart shows two shades of blue, which
correspond to a very low blood glucose
(2.8 mmol/L) level and a
very high blood glucose
(19.4 mmol/L) level. It also
shows an off-white shade
for new, unused test strips.
Important: The sample colour dots are
only approximate. They can give you an
indication of whether your glucose is very
low (2.8 mmol/L) or very high (19.4
mmol/L). Results obtained using the
sample colour dots are not a replace-
ment for a OneTouch®SureStep®meter
test result. Do not use Colour Chart to
verify control solution tests.
DCO_05090602A_OTSS_OB_CA_ENG 12/3/03 1:27 PM Page 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.
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 the OneTouch
®
Customer Care
Line at 1 800 663-5521 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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11
LEARNING
The current code number is displayed.
The number on the display must match the
code number on the OneTouch
®
SureStep
®
Test Strip vial.
(Example)
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 centre
of the pink test square
on the test strip.
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