Lifescan SPD2410BD User Manual

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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

L’achat du système de surveillance de la glycémie décrit aux présentes n’accorde 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®.

Pro or OneTouch®SureStep®Test Strips/

AW 05090602A

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 fabriquées par quiconque autre que LifeScan n’a pas été évaluée par LifeScan.

One Touch®Customer Care Line/ Ligne InfoSoins One Touch®:

Monday – Friday 9AM – 8PM Eastern Time, 6AM – 5PM Pacific Time/

Lundi au vendredi, 9 H – 20 H (Heure de l’Est), 6 H – 17 H (Heure du Pacifique)

Canada 1 800 663-5521 U.S.A./É.-U. 1 800 227-8862 www.OneTouch.ca

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.

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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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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.

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.

Remember to complete and mail the Warranty Registration Card.

Important phone numbers:

OneTouch®Customer Care Line:

CANADA 1 800 663-5521 www.OneTouch.ca

Meter Serial Number _____________________________________

Healthcare Professional _______________________________________

Pharmacist ________________________________________________

Diabetes Educator ___________________________________________

Other _____________________________________________________

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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.

iii

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Units of Measure for Meter Readouts

mmol/L millimoles/liter decimal point

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

PLEASE READ

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Table of Contents

Learning 2

Purpose 2 What to Expect from Your System 3 Warnings and Precautions 4 Importance of Following Instructions 5 OneTouch 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

OneTouch®Customer Care Line: CANADA 1 800 663-5521 www.OneTouch.ca

SureStep®Test Strips 8

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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

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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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

vii

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Purpose

People with diabetes use the OneTouch Monitoring System to measure the level of glucose (sugar) in their blood. The sys-

LEARNING

tem is intended for testing whole blood samples at the time when the blood sample is obtained.

SureStep®Blood Glucose

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

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 or

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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 Meter and 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

LEARNING

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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 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 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

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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.

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.

If you

LEARNING

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 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.

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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 Adjustable Blood Sampler

■

OneTouch®FinePoint™ Lancets

■

Carrying Case

■

Logbook

■

OneTouch®SureStep®Test Strips (May be sold separately)

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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

AW 052-178-01B Made in U.S.A.

NRTL /C

OneTouch®SureStep®Blood Glucose Meter

DATA PORT

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

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

Opened

Cover

Base

The cover protects the lens area and the base holds the OneTouch

SureStep®Test Strip.

LEARNING

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OneTouch®SureStep®Test Strips

Front Back

Pink Test

Square

White Pad

Confirmation Dot

White Tip Black Tip

When blood is applied to the pink test square, it is absorbed and a chemical reaction takes place. A blue colour 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 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 confirm proper blood application. When it turns completely blue, enough blood has been applied for an accurate test.

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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 replacement for a OneTouch

SureStep®meter test result. Do not use Colour Chart to verify control solution tests.

LEARNING

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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.

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 the OneTouch Line at 1 800 663-5521 if any segments are missing.

Customer Care

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)

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The current code number is displayed.

The number on the display must match the code number on the OneTouch

SureStep

Test Strip vial.

(Example)

Apply blood to the centre 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.

LEARNING

and

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The meter is measuring your glucose level.

LEARNING

The meter displays your test result

in mmol/L or mg/dL together with the date and time of the test.

(Example)

When the meter determines

that your blood glucose level exceeds 27.8 mmol/L (500 mg/dL), it displays

in virtually all

cases.

(Example) (Example)

Clean the meter and test strip holder.

(Example)

Replace the two AAA alkaline batteries.

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Coding the Meter

A code number is printed on each test strip vial 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 vial label.

Display Check (Example)

CODING

CAUTION: If the code number on the

meter display does NOT match the code number on the test strip vial 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.

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.

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2. Compare the code number on the test

strip vial 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 vial. 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 Canada. Refer to Changing Meter Settings if you need to verify or change the settings, such as date, time, or unit of measurement. See page 58 for a complete listing of features that can be changed.

▼

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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 vial 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.

CHECKING

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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 vial. 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 vial and

replace the vial cap. Close it tightly.

◆

Check the expiration date and discard date. Do not use the test strips after these dates.

◆

Compare the colour of the confirmation dot on the test strip with the “Unused” colour dot shown on the Colour Chart on the test strip vial label. If the colour of the confirmation dot on the test strip is darker than that shown on the Colour Chart, do not use the test strip. The result may be inaccurate.

CHECKING

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NOTE: If opening the test strip vial for

the first time, write the discard date (4 months from today) on the vial label and perform a control solution test following the instructions below.

4. Shake the control solution vial. Apply 1

drop of control solution to the centre of the pink test square.

◆

The first time you open the control solution vial, 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 vial.

◆

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.

CHECKING

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5. Turn the test strip over and check to see

that the confirmation dot is completely blue. If it is not, discard the test strip. Repeat the test with a new test strip, applying a larger drop of control solution to the centre of the pink test square.

6. Firmly insert the

test strip, confirmation dot side down, into the test strip holder until it stops.

CAUTION: If you do not firmly insert the

test strip into the meter until it stops, you may get an inaccurately low result.

IMPORTANT: Immediately insert the test

strip after applying the control solution. If you do not insert the test strip within 2 minutes, discard the test strip and start over with a new test strip.

CHECKING

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A flashing clock symbol appears while the meter is reading your result. The control solution result appears in about 30 seconds. The wait may be shorter or longer depending upon the current temperature.

7. Press the green C button to mark the test

result as a control solution result ( ) in meter memory. Marking the control result prevents it from being included in the 14- and 30-day blood glucose averages.

(Example)

NOTE: Pressing the green C button

again while the glucose level is displayed removes the marker.

8. Compare the result

with the control range printed on the test strip vial label.

(Example)

OneTouch SureStep Control Range

CHECKING

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CAUTION: The range printed on the test

strip vial label is the expected range for control solution results. It is NOT a recommended range for your blood glucose level.

(Example)

9. Record the control solution test result in

your logbook. Place a C next to the result to mark it as a control solution test.

NOTES

DATE TEST

TEST

RESULT

DATE

TIME

INSULIN/ MEDICATION

TEST

RESULT

TIME

INSULIN/ MEDICATION

NOTES

Understanding Control Solution Results

Control solution test results should fall within the printed range on the test strip vial label. If a control solution test result falls outside the range, repeat the control test. Control results that fall outside the range may indicate that:

CHECKING

Page 30

◆

you are not following all test steps or performing them incorrectly.

◆

the code number on the meter does not match the code number on the test strip vial.

◆

the meter or test strip holder is dirty.

◆

the control solution is expired, or beyond its discard date, contaminated, or not well mixed.

◆

there is a problem with the test strip (expired, damaged, etc.).

◆

the meter has malfunctioned.

◆

the control solution test is performed outside of the temperature range 15–35°C (59–95°F).

◆

you have applied too much control solution.

If your control solution result falls outside the printed range, repeat the control solution test with a new test strip. If your second control solution result is also outside the printed range, call the OneTouch

Customer

Care Line at 1 800 663-5521.

WARNING: Do NOT use your system to test

your blood when your control solution results fall outside the printed range. You may get inaccurate blood glucose results. Call the OneTouch

Customer Care Line

at 1 800 663–5521 if this occurs.

CHECKING

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Choose a clean, dry work surface. Make sure you

TESTING

have all the items needed for a blood test as shown.

Testing your Blood

Sterile Lancet

Meter

Cap

Release Button

Ejection/Cocking Control

Lancing Device

Depth Settings

Depth Indicator

Depth Adjustment Knob

OneTouch

SureStep

Test Strip

Page 32

Testing Tips for Accurate Results

There are several important steps you should follow before and during the test that will help you get accurate results.

Before Testing

◆

Wash and dry your hands.

◆

Use a new, sterile lancet.

◆

Check the test strip expiration date and discard date (4 months after first opening the test strip vial). Do not use the test strips after these dates.

◆

Compare the colour of the confirmation dot on the Unused test strip with the colour shown for an “Unused” colour dot on the Colour Chart on the test strip vial label. If the colour of the confirmation dot on the test strip is darker than the “Unused” colour, do not use the test strip.

◆

Make sure the code on the meter display matches the code on the test strip vial label.

◆

Do a test with OneTouch®SureStep Glucose Control Solution to make sure the meter and test strip are working properly together.

◆

Make sure the test strip holder, lens area, and contact points on the meter are clean. See Cleaning the Meter for cleaning instructions.

During Testing

◆

Make sure you applied enough blood to the test strip by checking that the confirmation dot turned completely blue.

◆

Make sure you did not apply too much blood to the test strip. You have applied too much blood if the white pad is soaked and there is no white visible.

TESTING

Page 33

Test Procedures

1. Remove the lancing device cap. Insert a

lancet into the lancet holder. Push down firmly until the lancet is seated in the

TESTING

lancet holder.

CAUTION: Only

one person should use the lancing device.

CAUTION: Never share a lancet with

another person. Lancets are for single

use only. Always use a new, sterile lancet.

2. Carefully remove the lancet’s protective

cover. Replace the lancing device’s cap.

Page 34

3. If you are using an adjustable

sampler, adjust the puncture depth setting as needed.

4. Cock the lancing device.

5. Use warm, soapy water to wash your

hands. Dry them thoroughly. To increase blood flow to the fingertips, massage your hand two or three times from wrist to fingertips.

6. Press the blue power button to turn

on the meter. The display check appears briefly. Carefully check that all symbols appear. Your last test result appears next. (If this is your first test, – – – appears instead.)

TESTING

Page 35

TESTING

(Example)

Make sure a test strip is not in the meter when you turn it on.

Next, the code number appears.

7. Compare the code number on the meter

display with the code number on the test strip vial. If they do not match, press the green

C button until the

codes match.

These two symbols will alternate on the display. The meter is now ready to perform a test. The meter will turn off automatically after 2 minutes if a test strip is not inserted.

Apply blood to Insert test strip

test strip into meter

Page 36

8. Remove a test strip from the vial and

replace the vial cap. Close it tightly.

◆

Check the expiration date and discard date. Do not use the test strips after these dates.

◆

Compare the colour of the confirmation dot on the test strip with the

“

Unused” colour dot shown on the Colour Chart on the test strip vial label. If the colour of

the confirmation dot on the test strip is darker than that shown on the Colour Chart, do not use the test strip. The result may be inaccurate.

CAUTION: Use a test strip as soon as

possible after removing it from the vial. Prolonged exposure to moisture, light, or heat can cause inaccurate results. Store test strips tightly capped in the original vial in a cool, dry place away from direct heat and sunlight. Never transfer test strips to another container.

NOTE: If opening the test strip vial

for the first time, write the discard date (4 months from day of opening) on the vial label and perform a control solution test following the instructions in

Checking the System.

TESTING

Page 37

9. Hold the lancing device firmly against the

side of your finger. Firmer pressure will give a deeper puncture. Use a different spot each time to help prevent soreness and callus formation. Press the release

TESTING

button. If needed, gently massage your finger from base to tip to help obtain the needed volume of blood.

10. Apply one drop of blood to the centre of

the pink test square in one of the ways shown. Never add a second drop as this

may cause inaccurate results.

Front Back

White Tip Black Tip

Pink Test

Square

White Pad

Confirmation Dot

Page 38

◆

Turn the test strip so the pink test square faces your finger. Touch the centre of the pink test square on the test strip to the drop of blood on your finger. The pink test square will quickly absorb blood.

TESTING

Be careful not to apply too much blood, especially if you tend to bleed easily or are taking blood-thinning medications.

◆

Hold the test strip under your finger and touch the drop of blood to the centre of the pink test square.

If the entire white pad surrounding the pink test square is soaked, you have applied too much blood. Your test result may be inaccurate. You must start over with a new test strip.

Too Much

Blood

Front

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11.Check the confirmation dot on the back

of the test strip after a few seconds. If the confirmation dot is completely blue, go to step 12.

TESTING

Enough Blood

Confirmation Dot

If white patches or streaks appear on the confirmation dot, you have not applied enough blood to obtain an accurate test. You must start over with a new test strip.

Not Enough

Blood

Front

Back

If there is no colour or if white patches or streaks appear after you have repeated the test, call the OneTouch Care Line at 1 800 663–5521.

Back

Customer

Page 40

12.Confirm that the

meter is still on. Firmly insert the test strip, taperedend first, confirmation dot side down, into the test strip holder until it stops.

CAUTION: If you do not firmly insert the

test strip into the meter until it stops, the test may start but you may get an inaccurately low result. Do not remove test strip until countdown is complete.

IMPORTANT: Immediately insert the

test strip after applying the blood. If you do not insert the test strip within 2 minutes, discard the test strip and start over with a new test strip.

A flashing clock symbol appears while the meter is reading your result. Your glucose result appears in about 30 seconds. Do not remove strip until countdown is complete. The wait may be shorter or longer depending upon the current temperature.

The test result is displayed alternating with the time, then with the date. The meter displays results between 0-27.8 mmol/L (0 and 500 mg/dL). If the result is above 27.8 mmol/L (500 mg/dL) the meter displays

virtually all cases.

TESTING

(Examples)

Page 41

IMPORTANT: When proper procedures

are followed, the meter will display HI in virtually all cases when your result is above 27.8 mmol/ L (500 mg/dL). The confirmation dot colour will also be

TESTING

darker than the 19.4 mmol/ L (350 mg/ dL) sample colour dot on the Colour Chart. This indicates very high blood glucose (severe hyperglycemia). Follow the advice of your Healthcare Professional.

If you get an error message, see “What to do” in Troubleshooting.

(Example)

If you get an error message instead of a number as a result, you can quickly check to see if your glucose is very low (2.8 mmol/L) or very high (19.4 mmol/L) prior to troubleshooting the error message. To quickly see if your glucose is very low (2.8 mmol/L) or very high (19.4 mmol/L), compare the colour of the test strip confirmation dot with the sample colour dots on the Colour Chart on the test strip vial label.

◆

If the test strip confirmation dot colour is approximately the same as or lighter than the “2.8 mmol/L” colour dot, your glucose level is very low.

◆

If the test strip confirmation dot colour is approximately the same as or darker

Page 42

than the “19.4 mmol/L” sample colour dot, your glucose level is very high.

CAUTION: The Sample colour dots are

only approximate. They should be used only as a guide in the event you get an error message instead of a numerical result. They can give you an indication of whether your glucose is very low 2.8 mmol/ L (50 mg/dL) or very high 19.4 mmol/ L (350 mg/dL) while you troubleshoot the error message. Results obtained using the

sample colour dots are not a replacement for a OneTouch

SureStep

meter test result. Do not use Colour Chart to verify control solution tests.

13. Record your test result in your logbook.

If a test result falls outside of the target range that you and your Healthcare Professional have established and you

cannot link it to diet, exercise, medication, or stress, repeat the test.

14. Remove and discard the test strip.

15. Turn off the meter by pressing the blue

power button. The meter automatically turns off 3 minutes after it displays your test result.

16. Remove the lancing device cap.

Removing Lancing Device Cap

TESTING

Page 43

17. Place the protective

cover on a hard surface and push the lancet tip into it.

TESTING

18. Point the lancet down and away from

you. Eject the used lancet into a container for sharp objects.

CAUTION: To reduce the risk of an acci-

dental needle stick, carefully follow the lancet and lancing device instructions for safe removal and disposal of used lancets.

19. Return the lancing device to its original

position, following the lancing device instructions.

Page 44

Understanding Your Results

The result is displayed on the meter as a plasma glucose value. The system’s plasma calibration makes it easier for you to compare meter results with lab results. See

Comparing Meter and Laboratory Results

for more information.

You and your Healthcare Professional have established target ranges for your blood glucose levels and any actions you should take in response to your test results. Follow your Healthcare Professional’s recommendations to receive the maximum benefit from testing.

If a test result falls outside of the target range that you and your Healthcare Professional have established and you cannot link it to diet, exercise, medication, or stress, repeat the test. If the result is similar and

still outside of your range, review Testing

Tips for Accurate Results.

If you get an error message instead of a number as a test result, compare the test strip confirmation dot to the sample colour dots on the Colour Chart on the test strip vial label. If the comparison indicates your glucose is very low or very high and you have symptoms, follow the advice of your Healthcare Professional. If you do not have symptoms, follow the “What to Do” recommendations in Troubleshooting to resolve the problem. Repeat the test with a new test strip using the procedures outlined in Troubleshooting. If you continue to get an error or other message, call the OneTouch Customer Care Line 1 800 663–5521.

RESULTS

Page 45

Low or High Results

You have

◆

You have high blood sugar (hyperglycemia) if:

◆

RESULTS

If you have symptoms that match your test results, or if you continue to get results that fall below 3.3 mmol/L or above 10 mmol/L when you repeat the test, follow the advice of your Healthcare Professional.

low blood sugar

(hypoglycemia) if:

Your meter result is 3.3 mmol/L (60 mg/dL) or below.

The colour dot comparison shows approximately 2.8 mmol/L (50 mg/dL) (very low).

Your meter result is 10 mmol/L (180 mg/dL) or greater.

The colour dot comparison shows approximately 19.4 mmol/L (350 mg/dL) (very high).

CAUTION:

◆

If your meter result is very low, 1.1 mmol/L (20 mg/dL) or less, and you do not have symptoms of low blood glucose, remove the test strip from the meter and look at the confirmation dot on the back of the test strip. You should do one of the following depending on the colour of the confirmation dot on the test strip:

■

If the confirmation dot is not completely blue or has white patches or white streaks (see “How To Test Your Blood”), repeat the test with a new test strip. If the problem continues, call the OneTouch®Customer Care Line at 1 800 663-5521.

■

If the confirmation dot is completely blue, compare the confirmation dot to the sample colour dots on the Colour Chart of the test strip label on the vial. If this comparison indicates that your

Page 46

blood glucose is very low (2.8 mmol/ L), conduct a Control Solution Test (see “Checking The System”). If the Control Solution test indicates that your meter and test strips are working together properly, repeat your blood glucose test with a new test strip. If you continue to receive a very low blood glucose test result, the low glucose result is likely to be correct and you should follow your Healthcare Professional’s advice for treating low glucose levels. If the Control Solution test is out of range, call the OneTouch®Customer Care Line at 1 800 663-5521.

I MPORTANT: When proper procedures are

followed, the meter will display “HI” in virtually all cases when your result is above

27.8 mmol/ L (500 mg/dL). The confirmation dot colour will also be darker than the

“19.4 mmol/ L” sample colour dot on the test strip vial label. This indicates very high blood glucose (severe hyperglycemia). Follow the advice of your Healthcare Professional. If you have never experienced blood glucose levels this high or have not been instructed in how to deal with them by your Healthcare Professional, you should contact your Healthcare Professional at once.

How to Check if Your Meter is Working Correctly

The easiest way to check if your meter and test strip are working together properly is to run a test with OneTouch Glucose Control Solution. See Checking the System for more information.

SureStep

RESULTS

Page 47

Comparing Meter and Laboratory Results

The OneTouch®SureStep®System is plasma calibrated. Because most laboratories measure plasma glucose, you can directly compare your meter test results with the lab results. However, your meter blood glucose test result may differ somewhat from your laboratory result due to normal sources of variation. Meter results can be affected by factors and conditions that do not affect laboratory results in the same way. Your meter glucose result should agree with a laboratory result within ±20% most of the

RESULTS

time under normal conditions. A result within that range is considered accurate when testing with the OneTouch However, results can differ by more than ±20% in some situations. Such results are more likely to occur under the following conditions:

SureStep®Meter.

◆

If you have recently eaten, exercised, taken medication, or experienced

stress.

If you have eaten recently, the blood glucose level from a fingerstick can be up to 3.9 mmol/L (70 mg/dL) higher than that of a venous sample (blood drawn from a vein) used for a lab test.

◆

For the most accurate comparison

between meter and laboratory results, the meter test must be done within 10 to 15 minutes of the laboratory test. If samples are taken more than 15 minutes apart, the two tests could have very different results because blood glucose levels can change significantly within short periods of time.

Page 48

◆

Factors such as a low or high hematocrit (the percentage volume of red blood cells in your blood). For example, if your hematocrit is too low (below 25%) or too high (above 60%).

◆

Severe dehydration (loss of body fluid) may also cause meter results to be different from a laboratory result. Repeated vomiting or diarrhea, both of which can occur when your glucose is very high, can cause this. Your blood may become thick, with not enough liquid to properly wet the test strip. This may cause your meter to give false low blood glucose results.

◆

If you test at a very low or high temperature or a low or high relative humidity or some other extreme environmental condition. If you test under these conditions, repeat the meter test in a climatecontrolled place as soon as possible. The operating temperature is

10–35°C (50–95°F). The operating humidity is 10–90%. You should always test within these ranges.

◆

You may also get inaccurate results if you test when both the temperature and relative humidity are near the limits defined above. If you test under these conditions, repeat the meter test in a climate-controlled place as soon as possible.

◆

Conditions affecting circulation to the hands may also lead to inaccurate results. These include shock, some drugs called vasoactive agents, and Raynaud’s disease.

4, 7, 8

See the Important Technical and Healthcare Professional Information section in the

OneTouch insert for typical accuracy and precision data for the OneTouch

SureStep®Test Strip package

SureStep®system. Make

RESULTS

Page 49

sure you read Important things to know before testing in the test strip package

insert. You should also review “Testing Tips for Accurate Results” in the Testing Your Blood

section.

Health Conditions Which Can Cause Out–of–Range Results

If you are getting results outside your target range and you believe the OneTouch OneTouch together properly, ask yourself the following

RESULTS

questions.

◆

“How do I feel?”

◆

“Do I have symptoms of low blood sugar (hypoglycemia): slurred speech, headache, tingling of lips, cool sweating, rapid heartbeat, disorientation, weakness,

SureStep®Meter and

SureStep®Test Strips are working

dizziness, fainting, hunger, nervousness, irritability, or tremors?”

◆

“Do I have symptoms of high blood glucose (hyperglycemia): fatigue, dry mouth and skin, increased thirst or hunger, blurry vision, increased urination, rapid deep breathing, or a fruity smell to the breath?”

◆

“What have I eaten?”

◆

“How much have I exercised?”

◆

“Am I ill (common cold, flu, etc.)?”

◆

“Have I been under stress lately?”

If your Healthcare Professional has not already instructed you in dealing with these situations, you should contact your Healthcare Professional.

Page 50

Caring for your Meter

General Care

◆

Keep your meter dry and avoid exposing it to extremes in temperature. Do not store your meter or test strips in your car or in the refrigerator or freezer.

◆

Dropping the meter can damage the electronics. If you drop your meter, do a control solution test (see Checking the System) and a display segment check (see Display Symbols) before using the meter to test your blood.

◆

Do not take the meter apart. Sensitive parts could be damaged causing inaccurate results. Taking the meter apart will also void your warranty.

Cleaning the Meter

CAUTION:

◆

Use water to clean the meter.

◆

Do not get water inside the meter case.

◆

Never immerse the meter or hold it under running water.

◆

Do not use alcohol, glass cleaners, or any other cleansers to clean the test strip holder or lens area.

NOTE: For Healthcare Professionals or

caregivers who assist multiple users, to disinfect the meter, cleanse the meter as described below using a 10% bleach solution (9 parts water, 1 part bleach) and then clean again with water to remove any remaining bleach. Thoroughly dry the meter. Failure to remove the excess bleach may result in an error message (, )

or an inaccurately high result.

MAINTENANCE

Page 51

Always clean the meter when this symbol appears.

1. Press down at the top end (near blue

power button) of the test strip holder and slide it away from the meter.

2. Wipe the test strip holder gently with a

cotton swab or soft cloth dampened with water. Thoroughly wipe the grey area on the inside cover. Clean both sides of the test strip holder base, especially around the hole. Dry the test strip holder com-

pletely with a soft cloth or lint–free tissue.

Cover

Inside Cover Grey Area Hole (clean both sides)

Top of Base

Bottom of Base

Base

MAINTENANCE

Page 52

3. Dampen a cotton swab or soft cloth with

water and wipe the lens area and contact points with it. Do not scratch the lens area. Dry with a soft cloth or tissue that

does not contain lint, lotion, or perfume. Do not use abrasive materials such as paper towels.

Contact Points

Lens Area

4. Slide the test strip holder into the meter,

press down, and push forward at the test strip insertion point until you hear a click. Make sure the test strip holder is firmly in place and does not extend beyond the meter.

5. Turn on the meter by pressing the blue

power button. The display check appears briefly. Carefully check that all symbols appear.

MAINTENANCE

Page 53

6. If the Er 5 symbol

appears after cleaning, check to see if you inserted the test strip holder completely and securely (see step 4 in this section).

Note: If you disinfected the meter

with a 10% bleach solution, you may not have completely removed the bleach residue from the grey area inside the test strip holder cover. Wipe this area with a cloth dampened with water and dry thoroughly. Failure to remove the excess bleach may result in an error message

(, )

or an

inaccurately high result.

Note: Clean the outside of the

meter by gently wiping it with a cloth dampened with water. Dry it with a soft cloth.

MAINTENANCE

Page 54

Changing the Batteries

CAUTION: The OneTouch®SureStep

Meter uses two AAA alkaline batteries.

Do not use rechargeable batteries.

1. When this symbol

appears constant on the display, the batteries are low and need to be replaced as soon as possible with new AAA alkaline batteries. If this symbol starts flashing, battery power is insufficient to run the meter. You will not be able to test.

Note: Low batteries and battery removal

will not affect test results stored in meter memory. However, the current time and date will be lost and must be reset each time you change the battery. See Changing Meter Settings for information on setting the current date and time.

2. Turn off the meter and remove the

battery door by squeezing the tab and lifting it up.

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MAINTENANCE

Page 55

3. Remove the old batteries with your fin-

gers, or by tapping the meter gently against the palm of your hand. Never tap the meter against a hard surface.

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4. Insert two new AAA alkaline batteries,

matching the + end of each battery with the + sign in the battery compartment.

MAINTENANCE

6. Set the current time and date in the

meter as described in Changing Meter Settings.

Page 56

Storage Instructions

WARNING: The system contains small

parts such as lancets, vial 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.

◆

Store the OneTouch®SureStep®Meter at room temperature. If the meter is exposed to cold, direct heat, or sunlight (for example, when transported in a car), allow it to come to room temperature before testing your blood.

◆

Store your OneTouch®SureStep®Test Strips in a cool, dry place in the original moisture–resistant, light–protected vial. The storage temperature should not exceed 30°C (86°F). Do not refrigerate or

freeze test strips. Do not store test strips in any container other than the original vial. Do not expose the test strips to bleach fumes or hydrogen peroxide.

◆

Store OneTouch®SureStep®Glucose Control Solution in a cool, dry place at temperatures below 30°C (86°F). Do not refrigerate or freeze. When used for testing, the solution should be at normal room temperature above 15°C (59°F).

◆

Store the lancing device and lancets at room temperature out of reach of small children.

MAINTENANCE

Page 57

Error Messages

Troubleshooting

The meter displays specific error messages

TROUBLESHOOTING

when it detects a problem with its internal functions, the test strip, or the testing procedure. However, the meter cannot detect all problems. For those problems the meter can detect, it may not produce an error message every time the problem occurs.

When an error message appears, note the error number, turn off the meter, and then resolve the error by following the instructions in the “What to Do” column. If you continue to get an error message after following the instructions, call the OneTouch Customer Care Line at 1 800 663–5521.

Page 58

NOTE: If the actions listed below do not resolve the error, call the OneTouch®Customer Care Line at 1 800 663-5521.

ERROR POTENTIAL PROBLEM WHAT TO DO

The meter detected a problem with the colour of the test strip.

1. Repeat the test with a new test strip and:

◆

Apply blood to the pink test square only.

◆

Make sure the confirmation dot turns completely blue.

◆

Insert the test strip within 2 minutes of applying blood.

Note: If you continue to get any error message, com-

pare the colour of the test strip confirmation dot to the Colour Chart on the test strip vial. If the glucose level is very low (2.8 mmol/ L) or very high (19.4 mmol/L), follow the advice of your Healthcare Professional.

◆

Clean the meter and repeat the test with a new test strip. See Caring for Your Meter for further informa- tion.

If these actions do not resolve the error, call the OneTouch

Customer Care Line at 1 800 663–5521.

TROUBLESHOOTING

Page 59

NOTE: If the actions listed below do not resolve the error, call the OneTouch®Customer Care Line at 1 800 663-5521.

ERROR POTENTIAL PROBLEM WHAT TO DO

Er 1

continued

TROUBLESHOOTING

The meter detected a problem with the colour of the test strip.

Professional Use:

◆

Test the sample with an alternate method. While awaiting results: Compare the colour of the test strip confirmation dot

to the Colour Chart on the test strip vial label. If the glucose level is very low (2.8 mmol/L) or very high (19.4 mmol/L), take appropriate precautions immediately.

Before retesting verify that the sample hematocrit is within range.

◆

If these actions do not resolve the error, call the OneTouch

Customer Care Line at 1 800 663–5521.

The meter detected a problem with the test strip.

Repeat the test with a new test strip and:

◆

Check the test strip expiration date. Do not use test strips beyond the expiration or discard date.

Page 60

NOTE: If the actions listed below do not resolve the error, call the OneTouch®Customer Care Line at 1 800 663-5521.

ERROR POTENTIAL PROBLEM WHAT TO DO

Er 2

continued

The meter detected a problem with the test strip.

◆

Apply the sample to the pink test square only.

◆

Make sure the confirmation dot turns completely blue.

◆

Wait approximately 1 minute, but not more than 2 minutes, after applying sample before inserting the test strip into the meter.

◆

Do not alter the test strips.

Note: If you continue to get any error message, compare

the colour of the test strip confirmation dot to the

Colour Chart on the test strip vial. If the glucose level is very low (2.8 mmol/L) or very high (19.4 mmol/L), follow the advice of your Healthcare Professional.

◆

Clean the meter and repeat the test with a new test strip. See Caring for Your Meter for more information.

If these actions do not resolve the error, call the OneTouch

Customer Care Line at 1 800 663–5521.

TROUBLESHOOTING

Page 61

NOTE: If the actions listed below do not resolve the error, call the OneTouch®Customer Care Line at 1 800 663-5521.

ERROR POTENTIAL PROBLEM WHAT TO DO

The meter detected a problem with the

TROUBLESHOOTING

position of the test strip.

1. Repeat the test with a new test strip and:

◆

Clean the meter, especially the contact points, before retesting. See Caring for your Meter for more information.

Note: Before cleaning the meter, compare the colour

of the test strip confirmation dot to the Colour Chart on the test strip vial. If the glucose level is very low (2.8 mmol/L) or very high (19.4 mmol/L), follow the advice of your Healthcare Professional.

◆

Do not move the test strip after you insert it into the meter. Remove the test strip only when the test is complete.

2. If these actions do not resolve the error, call the

OneTouch

Customer Care Line at 1 800 663–5521.

Page 62

NOTE: If the actions listed below do not resolve the error, call the OneTouch®Customer Care Line at 1 800 663-5521.

ERROR POTENTIAL PROBLEM WHAT TO DO

The meter detected a temperature problem.

1. Repeat the test with a new test strip. Make sure the

meter and test strip are at room temperature.

◆

Do not apply heat or cold to the meter.

Note: If you continue to get any error message,

compare the colour of the test strip confirmation dot to the Colour Chart on the test strip vial. If the glucose level is very low (2.8 mmol/L) or very high (19.4 mmol/L), follow the advice of your Healthcare Professional.

TROUBLESHOOTING

2. If these actions do not resolve the error, call the

OneTouch

Customer Care Line at 1 800 663–5521.

Page 63

NOTE: If the actions listed below do not resolve the error, call the OneTouch®Customer Care Line at 1 800 663-5521.

ERROR POTENTIAL PROBLEM WHAT TO DO

The meter detected a problem with the

TROUBLESHOOTING

optical system.

1. Repeat the test with a new test strip and:

◆

Clean the meter, especially the grey area inside the test strip holder, before retesting. See Caring for Your

Meter.

Note: Before cleaning the meter compare the

colour of the test strip confirmation dot to the Colour Chart on the test strip vial. If the glucose level is

low (2.8 mmol/L) or very high (19.4 mmol/L)

, follow the

advice of your Healthcare Professional.

◆

Make sure the test strip holder is fully inserted into the meter. See Caring for Your Meter for more information.

◆

Wait for the “Insert test strip” symbol to appear on the display before inserting the test strip.

2. If these actions do not resolve the error, call the

OneTouch

Customer Care Line at 1 800 663–5521.

very

Page 64

NOTE: If the actions listed below do not resolve the error, call the OneTouch®Customer Care Line at 1 800 663-5521.

ERROR POTENTIAL PROBLEM WHAT TO DO

The meter detected a problem with the electronics.

1. Repeat the test with a new test strip and:

◆

If you use bleach to disinfect the meter, before retesting, wipe the meter and contact points with a cloth moistened with water to remove residual bleach and thoroughly dry the meter. Failure to remove the excess bleach may result in an error message ( , ) or an inaccurately high result.

◆

Recheck the code number entered in the meter and make sure it matches the code number on the test strip package.

Note: If you continue to get any error message,

2. If these actions do not resolve the error, call the

OneTouch

Customer Care Line at 1 800 663–5521.

TROUBLESHOOTING

Page 65

Symbols

The following symbols appear on the meter display to help guide you through the testing process. If they occur during testing, they may indicate problems.

SYMBOL WHAT IT MEANS WHAT TO DO

Insert Test Strip

Firmly push the test strip into the test strip holder, with the tapered-end first and the confirmation dot facing down, until it stops. If you fail to completely insert the test strip, the test may start. However, you may receive an inaccurately low result.

Remove Test Strip

SYMBOLS

Remove the test strip from the meter. If white patches or streaks appear on the confirmation dot, you have not applied enough blood to obtain an accurate test. You must start over with a new test strip. When the “Insert Test Strip” symbol appears on the display, insert the test strip. Push it firmly and more slowly into the test strip holder until it stops.

Note: It is possible to push the test strip into the test strip holder

too fast. If this happens, the meter displays the “Remove Test Strip” symbol.

Page 66

NOTE: If the actions listed below do not resolve the error, call the OneTouch®Customer Care Line at 1 800 663-5521.

SYMBOL WHAT IT MEANS WHAT TO DO

Replace battery

Replace the batteries (see Caring for your Meter) as soon as possible. If this symbol appears constant, batteries are low. If this symbol is flashing, batteries are dead and the meter will no longer operate.

OTHER S YMBOLS

SYMBOL WHAT IT MEANS

Apply blood to test strip.

See p. 26-29

Meter and/or test strip holder need cleaning.

See p. 42-44

Meter is reading your result.

See p. 31

If you have never experienced blood glucose levels this high or have not been instructed in how to deal with them by your Healthcare Professional, you should contact your Healthcare Professional at once. If this reading does not reflect how you feel, repeat the test with a new test strip.

SYMBOL WHAT IT MEANS

Result from meter memory.

See p. 65-67P. -

Result is over 27.8 mmol/L (500 mg/dL).*

See p. 36 IMPORTANT

Match meter code with the code on the vial.

See p. 16

SYMBOLS

Page 67

Changing Meter Settings (Set–Up Mode)

The OneTouch®SureStep®Meter has been preset to meet the needs of most users in Canada. There are six features you can change in addition to the date and time.

FEATURE PRESET ALTERNATIVE SEE PAGE

Set time and date AM/PM Any 59

month/day/year

Automatic display of last result On Off 61

Unit of measurement mmol/L mg/dL 61

Beep signals during testing On Off 62

14– and 30–day averages On Off 63

Time format AM/PM 24 hour 64

Date format Month/Day Day/Month 64

SETTINGS

Page 68

Entering Set–Up Mode

1. Turn off the meter.

2. Press and hold down the green C button.

3. Press and release the blue power button

while holding down the green C button.

6. You can change the setting while it flash-

es by pressing the green C button.

NOTE: To move quickly through the

features, press the blue button repeatedly or press and hold it down to scroll.

4. Release the green C button.

Blue Power

Button

Green C Button

5. Each setting flashes on the display until

you press the blue power button to move to the next feature.

Setting the Date and Time

The OneTouch®SureStep®Meter records the time and date of each glucose test you perform. You may have to change the time and date, for example, when the batteries are changed. You will also need to reset the time when daylight savings time starts or ends. The accuracy of your glucose results is not affected if the date and time settings are incorrect.

When setting the date and time, if you pass the desired number (for example, day, month year), continue pressing the green C button to cycle through the values and back to the desired number.

SETTINGS

Page 69

Setting the Time

To set the time, enter the set-up mode as described in “Entering Set-Up Mode” above. The time appears with the hour flashing.

Press and release the green C button to advance 1 hour. To move faster, hold down the green C button. With the correct hour on the display, press and release the blue power button and the minutes will start flashing.

Press and release the green C button to advance 1 minute. To move faster, hold the green C button down. With the correct minutes on the display, press the blue power button and the year setting will appear on the display.

Note: Calculated 14–day and 30–day aver-

ages may change if you change the date and time. The averages are calculated from glucose results measured during the 14 or 30 days preceding the current date and time settings.

Setting the Year

With the year on the display, press and release the green C button to advance 1 year. To move faster, hold down the green C button. With the correct year on the display, press and release the blue power button and the month and day will appear on the screen with the month segment flashing (month/day format is preset).

SETTINGS

Page 70

Setting the Month

Press and release the green C button until the correct month number appears. To move faster, hold down the green C button. With the correct month on the display, press the blue power button and the day segment will start flashing.

Setting the Day

Press and release the green button until the correct day appears. To move faster, hold the green button down. With the correct day on the display, press the blue power button and the display of last result setting will appear.

Display of Last Result

The meter is preset to display your last glucose result when you turn on the meter.

To turn this feature off, press the green C button. This symbol will flash, indicating that automatic display is turned off. Press the blue power button to move to the unit of measurement setting.

Unit of Measurement

The meter is preset to display test results in millimoles per liter (mmol/L), the unit of measure most often used in Canada. You may change the setting to milligrams per deciliter (mg/dL) the unit of measure used in the

SETTINGS

Page 71

United States. If you are not sure which unit of measurement to use, please check with your Health Care Professional. The mmol/L results include a decimal point and the mg/dL results do not.

To change the unit of measurement to mg/dL, press the green C button. This symbol will flash on the display.

Press the blue power button to move to the beep signals setting.

Beep Signals

The OneTouch®SureStep®Meter uses beeping tones to signal certain steps in the procedure. However, these “beep” signals do not mean that the step was performed correctly. Three types of beep signals sound.

1. A single, short beep identifies each step

in the test procedure.

2. A single, long beep accompanies error

messages, a “ takes in doing the test procedure.

3. A three–tone beep sounds when the

meter displays a test result and when the meter moves to the beep signal feature in set–up mode.

” result, and certain mis-

SETTINGS

Page 72

In set–up mode, a three–tone beep sounds and the following symbol flashes when you move to the beep signals feature.

To operate without beep signals, press the green C button. The following display will appear.

You will hear a three–tone beep when

OFF

is displayed. Press the blue power button to move to the 14– and 30–day test averages setting.

14– and 30–Day Test Averages

The meter is preset to display 14–day and 30–day averages of your blood glucose results in memory mode.

For accurate 14–day and 30–day blood glucose averages, you must mark control solution test results by pressing the green

C button again while the glucose level is

displayed. This will keep them from being included in your blood glucose test averages.

If you wish to turn the averages off, press the green button. The following display will appear:

No averages will be displayed in memory mode. Press the blue power button to move to the time format setting.

SETTINGS

Page 73

Time Format

The meter is preset to display time in the AM/PM format. An alternative 24–hour time format is available.

Date Format

The meter is preset to display the date in month/day format. An alternate day/month format is available.

To change to the 24–hour time format, press the green C button. Press the blue power button to move to the date format setting.

SETTINGS

To change the display of the date to the day/month format, press the green C button. Press the blue power button to turn off the meter.

Exiting the Set–Up Mode

You may exit the set–up mode at any time by pressing and holding the blue power button down until the display is blank.

Page 74

Getting Results from Meter Memory

MEMORY

Background Information on Meter Memory

When you turn on the OneTouch®SureStep Blood Glucose Meter you will see the result of your last test. The meter stores your last 150 results (blood glucose or control solution test) with the date and time in its memory. When the meter’s memory is filled with 150 results, the oldest result is dropped and the newest one is added. The meter also gives 14–day and 30–day averages of your blood glucose test results. Results marked as control solution results will not be included in your averages.

Getting All Results from Meter Memory

To get the results stored in the meter’s memory:

1. Press the blue power button and hold it down for about 5 seconds.

2. When the display flashes, let go of the blue button.

You are now in memory mode.

3. First, the 14–day average will appear. This is the average of your blood glucose results during the last 14 days. (Ask your Healthcare Professional how to use these averages.)

4. Then, when you press the green C button, your 30–day average appears. (Ask your Healthcare Professional how to use these averages.)

Note: A“HI” result is included in

your 14–day and 30–day averages as

27.8 mmol/L.

Page 75

5. Each time you press and let go of the

green C button, the meter displays the next most recent of your 150 stored test results. The date and time of each result is displayed alternately under the test

MEMORY

result. If the test result was marked as a control solution result, appears under the result.

6. To scroll quickly through the results,

press and hold the green C button.

Green Button

Blue Power Button

(Examples)

7. If a test resulted in an error message, the error message is stored in the memory.

Note: A “HI” result is

included in your 14–day and 30–day averages as 27.8 mmol/L.

(Example)

Page 76

First Time Turning on Meter

The first time you turn on your meter you will see the following symbol. This shows that there are no test results in memory.

You will also see this symbol after you turn on your meter when your last test ended in an error and the meter did not display a glucose result.

Uploading Memory Data

Test results stored in the memory may be uploaded to a personal computer using OneTouch

™

Diabetes Management software.

See www.OneTouch.ca or call The OneTouch

Customer Care Line at

1 800 663-5521 for more information.

MEMORY

Page 77

Specifications

The performance of the OneTouch®SureStep®Blood Glucose Monitoring System was tested under the conditions below. See “Important Technical and Healthcare Professional Information” in the OneTouch precision data.

SureStep®Test Strips package insert for typical accuracy and

Power Supply: Two AAA alkaline batteries

Battery Life: Approximately 18 months when

doing two tests per day

Result Range: 0–27.8 mmol/L

(0–500 mg/dL). Higher results are virtually always displayed as “HI”

SPECIFICATIONS

Display: Liquid crystal

Blood Source: Whole blood

Calibration: Plasma equivalent

Hematocrit Range: 25–60%

*See “Comparing Meter and Laboratory Results” for additional information.

Size: 8.9 cm x 6.1 cm x 2.0 cm

(3.5” x 2.4” x 0.8”)

Weight: 108 grams (with batteries)

(3.8 ounces)

Operating Temperature Range*: 10–35°C

(50–95°F)

Operating Humidity Range*: 10–90% relative

humidity (noncondensing)

Memory: 150 results (blood glucose and

control solution).

Page 78

Guarantee and Warranty

30–Day Money–Back Guarantee

If you are not fully satisfied with the OneTouch receive a full refund by calling a OneTouch Customer Services Representative at 1 800 663-5521 (Canada) within 30 days of purchase. You will need to return the OneTouch your receipt to receive a refund. The Warranty Policy does not apply to the performance of the OneTouch when used with any test strip other than OneTouch LifeScan, or when the OneTouch Meter or Test Strips are modified in any way.

This warranty is in lieu of all other warranties, express or implied, including any implied warranty of merchantability or fitness for a particular purpose.

SureStep®System, you may

SureStep®Meter and a copy of

SureStep®Meter

SureStep®Test Strips from

SureStep

Three–Year Warranty

The OneTouch®SureStep®Meter has a full 3-year warranty from the date of purchase. If, at any time during the first 3 years after purchase, the meter does not work for any reasons (except for obvious abuse), LifeScan will replace it with a new meter or equivalent product free of charge.

The Warranty Policy applies only to the original purchaser of this meter and does not include the batteries supplied with the meter.

Please complete the Warranty Registration Card and mail it to LifeScan.

Write your date of purchase here:

______________________________________

Before you return your meter or any product, first call your OneTouch Services Representative at 1 800 663-5521 (Canada) for instructions.

Customer

SPECIFICATIONS

Page 79

CODING THE METER

Before testing, make sure the meter is coded correctly.

PERFORMING A TEST

Press blue power button

to turn on meter. Make sure a test strip is not in the meter when you turn it on.

(Example)

. . . and then the code

number is displayed

afterward.

QUICK REFERENCE

The meter automatical-

ly displays the last test

result with the date. . .

Green C Button

→

(Example)

Compare the code

number on the meter to the code number on the test strip vial. If the code numbers do not match, press the green C button until the code number on the meter matches the code number on the test strip vial.

Press blue power button

to turn on meter. Make sure a test strip is not in the meter when you turn it on.

Check confirmation dot

on back of test strip and make sure it is completely blue.

Apply blood to the

centre of the pink test

square. Never add a second

drop of blood.

Firmly push the test

strip into the test strip holder, with the tapered-end first and the confirmation dot facing down, until it stops. Read result. Do not remove strip until countdown is complete.

Page 80

BLOOD APPLICATION

FrontBackFront Back

Pink

Test

Square

White

Pad

Confirmation

Dot

Front Back

Test Strip Enough Blood Not Enough Blood Too Much Blood

How you can be sure that you have applied the right amount of blood:

QUICK REFERENCE

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

Apply a drop of blood to the centre of the pink test square on the front of the test strip. The confirmation dot on the back should be completely blue for an accurate test.

white pad.

Confirmation dot

of test strip is where you check to confirm proper

onback

If any white patches or streaks appear on the blue confirmation dot, you have not applied enough blood for an accurate test. You must start the test over with a new test strip to avoid inaccurately low results.

* Never add a second

drop of blood.

blood application.

If there is no white visible on the white pad, you have applied too much blood. You must start the test over with a new test strip to avoid inaccurately high results.

* Be careful not to apply

too much blood, espe-

cially if you tend to

bleed easily or are

taking blood-thinning

medications.

Page 81

Numerics

14-and 30-day averages . . . . . . . . . . . . . .

Accuracy . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 39

Applying sample

INDEX

– Adequate amount . . . . . . . . . . . . . . . . . . . . . . . . . . 30

– Blood . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 28-30

– Control solution . . . . . . . . . . . . . . . . . . . . . . . . . . 17

– Not enough . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 30

– Pink test square . . . . . . . . . . . . . . . . . 11, 17, 28-29

– Too much . . . . . . . . . . . . . . . . . . . . . . . . . 17, 23, 29

Batteries

– Changing . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 44-46

– Symbol indicating replacement . . . . . . . . . . . 12, 44

Battery compartment . . . . . . . . . . . . . . . . . . . 7, 45-46

Beep signals . . . . . . . . . . . . . . . . . . . . . . . . . . . . 62-63

Blood

– Applying . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 28-30

– Obtaining . . . . . . . . . . . . . . . . . . . . . . . . . . 24-25, 28

Blood glucose

– Results . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 31-33

– Target ranges . . . . . . . . . . . . . . . . . . . . . . . . . 35, 40

– Test . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 22-34

Button . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7

– Changing code number . . . . . . . . . . . . . . . . . . . . 14

19, 60, 63, 65

– Changing meter settings . . . . . . . . . . . . . . . . . 58-64

– Marking control solution result . . . . . . . . . . . . . . . 19

Changing

– Batteries . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 44-46

– Code number . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14

– Meter settings . . . . . . . . . . . . . . . . . . . . . . . . . 58-64

Checking

– Code number . . . . . . . . . . . . . . . . . . . . . . . . . 16, 26

– Confirmation dot . . . . . . . . . . . . . . . . . . . . . . 18, 30

– System . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15-21

Cleaning

– Contact points . . . . . . . . . . . . . . . . . . . . . . . . . . . 43

– Disinfecting . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 41

– Display symbol . . . . . . . . . . . . . . . . . . . . . . . . 12, 42

– Lens area . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 43

– Meter . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 41-44

– Test strip holder . . . . . . . . . . . . . . . . . . . . . . . 42-43

Code number . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11

– Changing . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13-14

– Displayed at meter power up . . . . . . . . . . 13, 16, 26

Coding the meter . . . . . . . . . . . . . . . . . . . . . . . . 13-14

Colour Chart . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9

– Checking confirmation dot against . . . . . . . . . 32-33

– Unused test strip . . . . . . . . . . . . . . . . . . . . 7, 23, 27

– Very low or very high . . . . . . . . . . . . . . . . . . . . 9, 36

Comparing meter and lab results . . . . . . . . . . 3, 38-40

Confirmation dot . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8

– Checking (control solution test) . . . . . . . . . . . . . . 18

Page 82

– Checking (blood test) . . . . . . . . . . . . . . . . . . . . . . 30

– Colour of unused test strip . . . . . . . . . . . . 17, 23, 27

– Comparing to Colour Chart . . . . . . . . . . . . . 9, 32-33

– Facing down when inserting test strip . . . 11, 18, 31

– Patches or streaks appear . . . . . . . . . . . . . . . . . . 30

Control solution

– Applying . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 17

– Discard date . . . . . . . . . . . . . . . . . . . . . . . . . . . 4, 17

– Expiration date . . . . . . . . . . . . . . . . . . . . . . . . . 4, 17

– Marking result . . . . . . . . . . . . . . . . . . . . . . . . . . . 19

– Out of range . . . . . . . . . . . . . . . . . . . . . . . 17, 20-21

– Results . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 20-21

– Storage . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 47

– Test . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15-21

Contact points . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7

– Cleaning . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 43

Data port . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7

Date and time

– Changing . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 59-61

– Format . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 64

Discard date

– Control solution . . . . . . . . . . . . . . . . . . . . . . . . 4,17

– Test strip . . . . . . . . . . . . . . . . . . . . . . . . 4, 16, 23, 27

Display

– Of last result . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 61

– Screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7

– Symbols . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-12

Error message

– Instead of blood glucose result . . . . . . . . . 32-33, 35

– Troubleshooting . . . . . . . . . . . . . . . . . . . . . . . 48-57

Expiration date

– Control solution . . . . . . . . . . . . . . . . . . . . . . . . 4, 17

– Test strip . . . . . . . . . . . . . . . . . . . . . . . . 4, 16, 23, 27

Glucose

– See also control solution

– Levels . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2

– Results (blood) . . . . . . . . . . . . . . . . . . . . . . . . 31-33

– Target ranges . . . . . . . . . . . . . . . . . . . . . . . . . 35, 40

– Test . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 22-34

Hematocrit . . . . . . . . . . . . . . . . . . . . . . . . . . 39, 50, 68

“

”

result . . . . . . . . . . . . . . . . . . . . . . . 12, 32, 37, 66

Humidity . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 39, 68

Lancing device . . . . . . . . . . . . . . . . . . . . . 24-25, 33-34

– Storage . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 47

Lens area . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7

– Cleaning . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 43

Logbook

– Recording blood glucose results . . . . . . . . . . . . . 33

INDEX

Page 83

– Recording control solution results . . . . . . . . . . . . 20

Matching code number . . . . . . . . . . . . . . . . 11, 16, 26

Memory . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 65-67

Meter

INDEX

– Care . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 41

– Cleaning . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 41-44

Coding . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13-14

– Description . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7

– Display symbols . . . . . . . . . . . . . . . . . . . . . . . . . . 10

– Serial number . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7

– Settings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 58-64

– Storage . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 47

– Turning on . . . . . . . . . . . . . . . . . . . . . . . . . . . 16, 25

Meter settings

– 14- and 30-day averages . . . . . . . . . . . . . . . . . . . 63

– Beep signals . . . . . . . . . . . . . . . . . . . . . . . . . . 62-63

– Date format . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 64

– Date and time . . . . . . . . . . . . . . . . . . . . . . . . . 59-61

– Display of last result . . . . . . . . . . . . . . . . . . . . . . . 61

– Time format . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 64

– Unit of measurement . . . . . . . . . . . . . . . . . . . . 61-62

Optional Colour Chart . . . . . . . . . . . . . . . . . . . . . . . . 9

Pink test square . . . . . . . . . . . . . . . . . . . . . . . . . . 8, 11

– Applying blood . . . . . . . . . . . . . . . . . . . . . . . . 28-29

– Applying control solution . . . . . . . . . . . . . . . . . . . 17

– Plasma glucose value . . . . . . . . . . . . . . . . . . . 35, 38

– Power button . . . . . . . . . . . . . . . . . . . . . . . 7, 16, 25

– Precautions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-5

Result

– 14-and 30-day averages . . . . . . . . . . . . . . . . . 19, 63

– Blood glucose . . . . . . . . . . . . . . . . . . . . . . . . . 31-33

– Comparing to lab result . . . . . . . . . . . . . . . . 3, 38-40

– Control solution . . . . . . . . . . . . . . . . . . . . . . . 20 -21

– With date and time . . . . . . . . . . . . . . . . . . . . . . . . 12

– Getting results from meter memory . . . . . . . . 65-67

– High . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12, 33, 36

– Low . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 36

– Out-of-range (control) . . . . . . . . . . . . . . . . . . . 20-21

– Recording in logbook . . . . . . . . . . . . . . . . . . . 20, 33

– Target ranges . . . . . . . . . . . . . . . . . . . . . . . . . 35, 40

– Tips to ensure accuracy. . . . . . . . . . . . . . . . . . . . . 23

– Turning on the meter . . . . . . . . . . . . . . . . . . . . . . 10

– Understanding . . . . . . . . . . . . . . . . . . . . . . . . 35-40

– Units . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12

– Uploading to PC . . . . . . . . . . . . . . . . . . . . . . . . . . 67

– Using the Colour Chart . . . . . . . . . . . . . . . . 9, 32-33

Segment . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10

Settings (meter) . . . . . . . . . . . . . . . . . . . . . . . . . 58-64

Symbols

– Apply sample . . . . . . . . . . . . . . . . . . . . . . . . . 11, 26

Page 84

– Battery . . . . . . . . . . . . . . . . . . . . . . . . . . . 12, 44, 57

– Clean meter . . . . . . . . . . . . . . . . . . . . . . . . . . . 12,

– Clock . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12, 19, 31

– Descriptions . . . . . . . . . . . . . . . . . . . . . . . . . . 56-57

– Empty memory . . . . . . . . . . . . . . . . . . . . . . . . . . . 65

– Insert test strip . . . . . . . . . . . . . . . . . . . . . 11, 26, 56

– Remove test strip . . . . . . . . . . . . . . . . . . . . . . . . . 56

Temperature . . . . . . . . . . . . . . . . . . . . . . . . . . . 39, 68

Test strip . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8

– Code number . . . . . . . . . . . . . . . . . . . . . . . . . 11, 14

– Colour of unused confirmation dot . . . . . . 17, 23, 27

– Discard date . . . . . . . . . . . . . . . . . . . . . 4, 16, 23, 27

– Expiration date . . . . . . . . . . . . . . . . . . . 4, 16, 23, 27

– Inserting firmly . . . . . . . . . . . . . . . . . . . . . . . . 18, 31

– Storage . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 46-47

– Storage precautions . . . . . . . . . . . . . . . . . . . . . . . 27

Test strip holder . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7

– Cleaning . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 42

– Removing . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 42

– Replacing . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 43

Troubleshooting . . . . . . . . . . . . . . . . . . . . . . . . . 48-55

Unit of measurement . . . . . . . . . . . . . . . . iv, 12, 61-62

Warnings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-5

White pad . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8

FOOTNOTES

American Diabetes Association, “Implications of the Diabetes Control and Complications Trial,” (Position Statement), S88-S90.

2 Wickham, NWR et al.: Practical Diabetes, Vol. 3, No. 2

(1986), 100.

3 Cohen, FE et al.: Diabetes Care, Vol 9, No. 3 (1986),

320–322.

4 Atkin, SH, et al. Fingerstick glucose determination in

shock. Ann of Intern Med. 1991;114:1020–1024.

5 Surwit RS, Feinglos MN Diabetes Forecast 1988;

April 49-57

6 Sacks, DB in “Carbohydrates”, Burtis, CA, Ashwood,

ER (ed), Tietz Textbook of Clinical Chemistry. Philadelphia, WB Saunders Company (1994), p. 959

7 Sylvain, HF, et al. American Journal of Critical Care.

1995; 4:44–48.

Rushakoff RJ, Lewis SB. Case of Pseudohypoglycemia

(letter), Diabetes Care 2001; 24:2157-2158.

Diabetes Care

1988; 21; (Supplement 1);

Page 85

Page 86

Owner's Booklet Guide d'utilisation

Blood Glucose

Monitoring System

Système de surveillance

de la glycémie

INCLUDES 150-Test

Memory Time & Date

AVEC mémoire de 150

tests, date et heure

Page 87

Le système OneTouch®SureStep®est conçu pour être utilisé à l’extérieur du corps (utilisation diagnostique in vitro) Il devrait être utilisé seulement pour faire des tests avec des échantillons de sang entier fraîchement prélevés. Il ne devrait pas être utilisé pour le diagnostic du diabète.

Page 88

Bienvenue chez LifeScan. Félicitations! Vous avez choisi un produit fabriqué par

LifeScan, un chef de file dans le domaine des produits conçus pour vous aider à maîtriser votre diabète. Les produits pour la surveillance de la glycémie de marque OneTouch®SureStep®sont largement répandus et sont accessibles sans ordonnance.

La surveillance de la glycémie joue un rôle important dans le contrôle de votre diabète. En effet, une étude à long terme a montré que le maintien de la glycémie à des valeurs près de la normale peut réduire les risques de complications du diabète dans des proportions pouvant aller jusqu’à 60 %. Les résultats que vous obtenez grâce au système OneTouch®SureStep®peuvent vous aider, ainsi que votre professionnel de la santé, à surveiller et à ajuster au besoin votre plan de traitement pour mieux contrôler votre diabète.

Tout ce que vous devez savoir pour utiliser le système OneTouch®SureStep®se trouve dans ce guide d’utilisation et dans le feuillet d’information des bandelettes de test contenu dans chaque emballage de bandelettes de test. Il est important de lire ce guide d’utilisation et le feuillet d’information de l’emballage des bandelettes pour bénéficier de renseignements importants sur la façon d’utiliser ce produit. Si vous avez des questions, n’hésitez pas à appeler sans frais un de nos préposés du service à la clientèle.

N’oubliez pas de remplir et de poster la fiche d’enregistrement de la garantie.

Numéros de téléphone importants :

Ligne InfoSoins OneTouch®:

Canada 1 800 663-5521

www.OneTouch.ca

Numéro de série du lecteur : __________________________________

Professionnel(le) de la santé _________________________________________ Pharmacien(ne) ___________________________________________________ Éducateur(trice) en diabète __________________________________________ Autre ____________________________________________________________

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ATTENTION: Avant d’utiliser un produit quelconque pour vérifier votre glycémie (taux de sucre dans le sang), lisez attentivement toutes les instructions et exercez-vous à effectuer les tests. Effectuez tous les tests de contrôle de la qualité suggérés et consultez un professionnel de la santé qui s’occupe de diabète. Ces recommandations sont communes à tous les systèmes de surveillance de la glycémie, et elles ont reçu l’appui de la section des éducateurs dans le domaine du diabète de l’Association canadienne du diabète.

IMPORTANT: Si vous avez suivi les conseils pour assurer la précision de vos résultats de glycémie et que ces derniers sont encore à l’extérieur de l’échelle visée, communiquez avec votre professionnel de la santé.

Le système OneTouch®SureStep®contient plusieurs petits éléments comme le support de bandelette, le couvercle du logement des piles, les piles, les lancettes, le flacon de solution de contrôle, les bandelettes de test, le bouchon du flacon de bandelettes de test, etc. Puisque ces éléments peuvent être dangereux s’ils sont avalés, gardez le système hors de portée des enfants.

Si vous utilisez une solution d’eau de Javel à 10 % pour désinfecter le lecteur, prenez soin d’éliminer toute trace d’eau de Javel du lecteur et du support de bandelette avec un chiffon humidifié d’eau. L’eau de Javel pourra réagir avec les bandelettes de test et fausser les résultats. En n’enlevant pas les résidus d’eau de Javel vous risquez d’obtenir un message d’erreur « ,

ou un résultat faussement élevé.

iii

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Unités de mesure pour les lectures avec l’appareil

mmol/L millimoles/litre point décimal

Votre lecteur mesure, les millimoles par litre (mmol/L) ou les milligrammes par décilitre (mg/dL). Au Canada les mmol/L sont utilisées comme unité standard. Aux États-Unis, les mg/dL sont utilisées comme unité standard. Veuillez communiquer avec votre professionnel de la santé pour déterminer quelle unité de mesure vous devriez utiliser. Si vous utilisez la mauvaise unité de mesure, vous risquez d’obtenir des résultats inexacts qui peuvent mener à un traitement inadéquat.

OneTouch®SureStep®peut afficher les résultats en utilisant deux types d’unités de

mg/dL milligrammes/décilitre sans point décimal

VEUILLEZ LIRE

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Table des matières

Apprentissage 2

Objet 2 Qu’attendre de votre système 3 Mises en garde et précautions 4 Importance de suivre les instructions 5 Les bandelettes de test OneTouch Échelle colorimétrique optionnelle 9 Symboles de l’affichage 10

Codage 13

Codage du lecteur 13

Vérification 15

Vérification du système 15 Comprendre les résultats des épreuves de contrôle 20

Test 22

Test sanguin 22 Conseils pour obtenir des résultats exacts 23 Comment effectuer un test 24

Ligne InfoSoins OneTouch®: CANADA 1 800 663-5521 www.OneTouch.ca

SureStep

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Résultats 35

Compréhension de vos résultats 35 Comment vérifier si votre lecteur fonctionne correctement 37 Comparaison des résultats du lecteur à ceux du laboratoire 38 États de santé pouvant causer des résultats hors limites 40

Entretien 41

Soins à porter à votre lecteur 41 Soins généraux 41 Nettoyage du lecteur 41 Comment changer les piles 44 Instructions d’entreposage 47

Dépannage 48

Messages d’erreur 48

Symboles 56

Réglages 58

Modification des réglages du lecteur 58 Comment entrer en mode de réglage 59 Modification de la date et de l’heure 59 Réglage de l’heure 60

Ligne InfoSoins OneTouch®: CANADA 1 800 663-5521 www.OneTouch.ca

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Réglage de l’année 60 Réglage du mois 61 Réglage du jour 61 Affichage des derniers résultats 61 Unité de mesure 61 Signaux sonores 62

Moyennes sur 14 et 30 jours 63

Format de l’heure 64 Format de la date 64 Sortie du mode de réglage 64

Mémoire 65

Documentation de base à propos de la mémoire du lecteur 65 Comment obtenir tous les résultats de la mémoire du lecteur 65 Première mise en marche du lecteur 67 Téléchargement des données en mémoire 67

Spécifications 68

Spécifications 68 Garanties 69

Aide-mémoire 70

Ligne InfoSoins OneTouch®: CANADA 1 800 663-5521 www.OneTouch.ca

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Objet

Les personnes atteintes du diabète utilisent le système de surveillance de la glycémie OneTouch®SureStep®pour mesurer le niveau de glucose (sucre) dans leur sang. Le système est conçu pour analyser un échantillon de

APPRENTISSAGE

sang entier au moment de son prélèvement.

Pourquoi vérifier votre glycémie

Le diabète est une maladie caractérisée par la difficulté du corps à contrôler correctement les niveaux de glucose. Les niveaux de glucose peuvent changer considérablement et rapidement. Les niveaux de glucose qui sont trop hauts ou trop bas peuvent entraîner de sérieux problèmes de santé. Ce test permet à une personne de connaître sa glycémie au moment où elle est mesurée.

En 1993, le National Institute of Health terminait une étude nommée : Diabetes Control and Complications Trial (DCCT). Il s’agissait d’une étude à long terme de personnes atteintes de diabète de type 1. Cette étude a démontré que

vous devriez maintenir votre glycémie près des valeurs obtenues par les personnes qui ne sont pas diabétiques.

Vous pouvez réduire le risque de complications aux yeux, aux reins et au système nerveux par approximativement 60%. Par contre, vous devriez savoir qu’en maintenant votre glycémie près des niveaux affichés par les personnes non diabétiques vous augmentez le risque d’épisodes d’hypoglycémie

(bas niveaux de

glucose dans le sang). La fréquence avec laquelle vous devriez effec-

tuer vos tests de glycémie dépend de plusieurs facteurs. Parmi ces facteurs, on retrouve l’âge, le type de diabète (type 1 ou type 2), les médicaments et l’état de santé. Votre professionnel de la santé pourra vous guider. Il est important d’insérer la vérification de la glycémie dans votre routine quotidienne.

Quand ne faut-il pas l’utiliser

N’utilisez pas les résultats de glycémie obtenus avec le lecteur OneTouch®SureStep

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APPRENTISSAGE

pour déterminer si vous êtes atteint ou atteinte du diabète. Seul votre médecin peut diagnostiquer cette maladie.

Qu’attendre de votre système

◆

Les lecteurs de glycémie sont cliniquement exacts, mais ne peuvent remplacer un résultat obtenu en laboratoire. Conçus selon des méthodes utilisées en laboratoire, les systèmes de surveillance de la glycémie fournissent un moyen pratique et portatif de vérifier la glycémie rapidement et à faible coût. Toutefois, les résultats du lecteur peuvent être influencés par des facteurs et des conditions qui n’ont pas le même effet sur les résultats obtenus en laboratoire. Souvenez-vous que les conditions des tests en laboratoire sont soigneusement contrôlées et très automatisées. Le résultat obtenu avec le lecteur devrait, dans des conditions normales, être à ±20% des valeurs obtenues en laboratoire. Un résultat de cet ordre est considéré cliniquement précis lorsque que vous vérifiez avec le lecteur

OneTouch®SureStep®. Toutefois, l’écart entre les résultats peut être supérieur à ±20% dans certaines situations. Pour plus de renseignements, consultez la rubrique

Comparaison des résultats du lecteur à ceux du laboratoire.

◆

Les lecteurs de glycémie augmentent votre capacité de vérifier fréquemment votre glycémie à un coût raisonnable de sorte que vous pouvez voir l’effet de la nourriture, de l’activité physique et des médicaments sur votre glycémie. Vous pouvez mieux contrôler votre glycémie avec ces appareils.

◆

Assurez-vous de bien connaître les limites du système avant de vérifier votre glycémie. Lire les renseignements importants contenus dans l’emballage des bandelettes de test OneTouch®SureStep®. Apprenez les facteurs qui peuvent influencer la précision de vos résultats.

◆

Assurez-vous de comprendre vos résultats avant d’agir en fonction de ceux-ci, spécialement si vos résultats ne reflètent pas ce que

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vous ressentez. Voir la rubrique

Compréhension de vos résultats à la page 35.

Mises en garde et précautions

◆

Prenez le temps de lire toutes les instructions, y compris le feuillet d’information de l’embal-

APPRENTISSAGE

lage des bandelettes de test et exercez-vous à effectuer les tests avec la solution de contrôle (voir la rubrique Vérification du système) avant de vérifier votre glycémie. Faites toutes les vérifications de contrôle de la qualité tel que suggéré, y compris la vérification des symboles de l’affichage (voir la description du système) et consultez un professionnel de la santé avant d’utiliser ce produit.

◆

Le système contient de petits éléments comme les lancettes, les bouchons des flacons, etc. Puisque ces éléments peuvent être dangereux s’ils sont avalés, gardez le système hors de portée des enfants. L’emballage des bandelettes de test contient un agent dessiccatif qui peut irriter la peau et les yeux et être nocif s’il est inhalé ou avalé.

◆

N’utilisez pas les bandelettes de test après la date de péremption imprimée sur l’étiquette du flacon ou plus de quatre mois après avoir ouvert le flacon pour la première fois, le premier des deux prévalant. Vous pourriez obtenir des résultats inexacts si vous utilisez les bandelettes de test après ces dates.

◆

N’utilisez pas les bandelettes qui ont été pliées, coupées ou modifiées de quelque manière que ce soit.

◆

N’utilisez pas la solution de contrôle après la date de péremption imprimée sur l’étiquette du flacon ou plus de trois mois après avoir ouvert le flacon pour la première fois, la première des deux prévalant. Les épreuves de contrôle ne seront peut-être pas fiables si vous utilisez la solution après ces dates.

◆

Une humidité relative ou une température très élevée ou très basse peuvent avoir un effet sur les résultats, surtout si les deux valeurs sont élevées ou basses. Si vous faites un test dans ces conditions, refaites le

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APPRENTISSAGE

test dans un milieu contrôlé aussitôt que possible.

◆

Une perte excessive de liquides (déshydratation importante) peut donner des résultats inférieurs aux valeurs réelles.

2,3

Une déshydratation grave, si elle n’est pas traitée, peut entraîner des complications médicales sérieuses pouvant causer la mort comme l’acidocétose diabétique. Voici quelques facteurs qui peuvent entraîner une déshydratation : les vomissements, la diarrhée, l’absorption inadéquate de liquides, certains médicaments (par exemple, les diurétiques), le diabète non contrôlé pendant une période prolongée et un état de choc.4Si vous avez ces symptômes, consultez immédiatement un professionnel de la santé, même si votre glycémie n’est pas plus élevée que d’habitude.

◆

Parce que certaines maladies peuvent être transmises par le sang, soyez prudent lorsque vous jetez les lancettes et les bandelettes de test usagées.

REMARQUE: Vous avez besoin d’un profes-

sionnel de la santé pour la surveillance de la glycémie. Travaillez avec votre professionnel de la santé pour fixer vos propres objectifs de glycémie, organiser votre horaire de test et discuter de la signification de vos résultats de glycémie.

Importance de suivre les instructions

Votre système de surveillance de la glycémie OneTouch®SureStep®donnera des résultats de glycémie exacts qui vous aideront à maîtriser votre diabète, si vous suivez les directives de ce guide d’utilisation et du feuillet d’information des bandelettes de test. Assurez-vous de vérifier le feuillet d’information des bandelettes chaque fois que vous ouvrez un nouveau flacon de bandelettes pour voir les mises à jour importantes. Si vous ne suivez pas ces instructions, vous risquez d’obtenir des résultats inexacts qui pourront entraîner un traitement inadéquat.

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Tout ce que contient le système de surveillance de la glycémie OneTouch

■

Lecteur de glycémie

SureStep

OneTouch®SureStep

(piles installées)

■

Guide d’utilisation

■

Aide-mémoire

■

Solution de contrôle

■

Dispositif réglable de prélèvement sanguin Penlet

■

Lancettes

OneTouch®FinePointe

■

Étui de transport

■

Carnet de résultats

■

Bandelettes de test OneTouch®SureStep

OneTouch®SureStep

Plus

(peuvent être vendues séparément)

Lifescan SPD2410BD User Manual

Specifications and Main Features

Frequently Asked Questions

User Manual