Lifescan SPD2410BD User Manual

The system described herein is covered by one or more of the following U.S. Patents/ Le système décrit aux présentes est protégé par un ou plusieurs

des brevets américains suivants: D367,109,D371,198, D428,150, 5,418,142, 5,515,170, 5,526,120, 5,563,031, 5,605,837, 5,780,304, 5,789,255, 5,922,530, 5,968,836, 6,045,567, 6,156,051, 6,197,040, 6,335,203 and/et 6,491,870. Use of the monitoring device described herein is protected under

the U.S. patents 4,935,346/L’utilisation du dispositif de surveillance décrit aux présentes est protégée par le brevet américain 4,935,346.

Purchase of the monitoring system described herein does not act to grant a use license under this patent. Such a license is granted only when the device is used with SureStep

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.

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.

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 _____________________________________________________

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

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

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

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

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

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

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

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

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.

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)

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

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.

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

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)

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

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.

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.

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.

▼

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

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

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

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

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

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

◆

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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