Lifescan OneTouch User Manual

Diabetes Blood Glucose

Monitoring System

Less Painful Testing / Tests moins douloureux

Owner’s Booklet Guide d’utilisation

AW 05265303A

OneTouch®Customer Care Line / Ligne InfoSoins OneTouch®:

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

Monday–Friday 9am–8pm Eastern Time 6am–5pm Pacific time Du lundi au vendredi 9 h à 20 h (heure de l’Est) 6 h à 17 h (heure du Pacifique)

www.OneTouch.ca

Distributed by / Distribué par : LifeScan Canada Ltd./ Produits médicaux LifeScan Canada ltée Burnaby, B.C./C.-B. V5C 6C6

Manufactured for / Fabriqué pour : LifeScan Inc. Milpitas, CA 95035 U.S.A./É.-U.

©LifeScan, Inc. 2003 Milpitas, CA 95035 01/2004

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 : D428, 150, 5,708,247, 6,045,567, 6,156,051, 6,197,040, 6,241,862 and/et 6,284,125

DIABETES BLOOD GLUCOSE MONITORING SYSTEM

Take

Fast

Owner’s Booklet

TEST SUMMARY

This summary is intended only for quick reference and not as a substitute for the OneTouch Please read the entire booklet before you begin testing.

1. Insert test strip. Meter turns on automatically.

2. Apply sample. Touch a small drop of blood (1.5 microlitres) to the TOP WHITE EDGE of the test strip.

3. Hold the blood drop to the TOP WH ITE EDGE of the test strip until blood has completely filled the confirmation window.

4. Accurate results in just 15 seconds.

FastTake®Owner’s Booklet.

(Example)

Dear OneTouch®FastTake®System Owner:

You have chosen one of the best blood glucose monitoring systems available today. Inside this booklet is everything you must know about using the OneTouch it carefully and thoroughly before you begin testing.

Your OneTouch

FastTake®System provides you with accurate, plasma-calibrated test results. This feature makes it easier for you and your doctor to compare your meter results with laboratory results.

Blood glucose monitoring plays an important role in diabetes control. A long-term study showed that keeping blood glucose levels close to normal can reduce the risk of diabetes complications by up to 60%.* The results you get with the OneTouch

FastTake®System can help you and your healthcare professional monitor and adjust your treatment plan to gain better control of your diabetes.

A warranty registration card is included with your OneTouch FastTake®System. Please complete it and mail it to us. If you prefer to fill out a warranty card online, please visit www.OneTouch.ca

*American Diabetes Association position statement on the Diabetes Control and Complications Trial (1993).

FastTake®System. Read

iii

The OneTouch®FastTake®System is intended for use outside the body (in vitro diagnostic use). It should be used only for testing glucose (sugar) and only with fresh capillary whole blood samples. The OneTouch

FastTake®System is intended for use in the home and in clinical settings. It should not be used for the diagnosis of diabetes or for the testing of newborns.

CAUTION: Before using any product to test your blood sugar (blood glucose), 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 Information

• Severe dehydration and excessive water loss may cause false

low results. If you believe you are suffering from severe dehydration, consult a healthcare professional immediately.

• Test results below 3.9 mmol/L (70 mg/dL) mean low blood

glucose (hypoglycemia). Test results greater than 10.0 mmol/L (180 mg/dL get results below 3.9 mmol/L (70 mg/dL) or above 10.0 mmol/L (180 mg/dL), and do not have symptoms, first repeat the test. If you have symptoms or continue to get results that fall below

3.9 mmol/L (70 mg/dL) or above 10.0 mmol/L (180 mg/dL), follow the treatment advice of your healthcare professional.

• If you are experiencing symptoms that are not consistent with

your blood glucose test results AND you have followed all instructions described in the OneTouch Booklet, call your healthcare professional.

• A red blood cell count (hematocrit) that is very high (above

55%) or very low (below 30%) can cause false results.

) mean high blood glucose (hyperglycemia). If you

FastTake®Owner’s

Table of Contents

GETTING STARTED . . . . . . . . . . . . . . . . . . . . . . . . . 1

The OneTouch

FastTake

Blood Glucose Monitoring System . . . . . . . . . 1

OneTouch

FastTake®Blood Glucose Meter . . 2

BEFORE TESTING . . . . . . . . . . . . . . . . . . . . . . . . . 8

Checking the Display . . . . . . . . . . . . . . . . . . . . 8

Coding the Meter . . . . . . . . . . . . . . . . . . . . . . . 8

Checking the System with OneTouch

Ultra®Control Solution . . . . . . . . 11

TESTING YOUR BLOOD . . . . . . . . . . . . . . . . . . . . 17

Getting a Drop of Blood . . . . . . . . . . . . . . . . . 18

Fingertip Blood Sampling . . . . . . . . . . . . . . . 21

Forearm Blood Sampling (“Alternate Site”) . 22

Step-by-Step Test Procedure . . . . . . . . . . . . 26

Used Lancet Disposal . . . . . . . . . . . . . . . . . . 28

Special Messages . . . . . . . . . . . . . . . . . . . . . 29

USING THE METER MEMORY . . . . . . . . . . . . . . .30

VIEWING TEST RESULTS

ON A PERSONAL COMPUTER . . . . . . . . . . . . . . .33

Data Downloading . . . . . . . . . . . . . . . . . . . . .33

COMPARING METER

AND LABORATORY RESULTS . . . . . . . . . . . . . . . 34

SETTING UP THE METER . . . . . . . . . . . . . . . . . . .36

Setting the Date, Time,

and Unit of Measurement . . . . . . . . . . . . . . .36

CARING FOR YOUR METER . . . . . . . . . . . . . . . . . 40

Maintenance . . . . . . . . . . . . . . . . . . . . . . . . . 40

Batteries . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 41

DISPLAY MESSAGES

AND PROBLEM-SOLVING GUIDE . . . . . . . . . . . . 44

SPECIFICATIONS . . . . . . . . . . . . . . . . . . . . . . . . . 54

GUARANTEE . . . . . . . . . . . . . . . . . . . . . . . . . . . . 55

vii

viii

GETTING STARTED

The OneTouch®FastTake®Blood Glucose Monitoring System

The OneTouch®FastTake®Blood Glucose Monitoring System consists of three main products: the OneTouch®FastTake®Blood Glucose Meter, OneTouch® FastTake® Test Strips (sold separately), and OneTouch®Ultra®Control Solution. These products have been designed, tested, and proven to work together as a system to produce accurate blood glucose test results. Use only OneTouch FastTake®Test Strips and OneTouch®Ultra®Control Solution with the OneTouch®FastTake®Blood Glucose Meter.

Your OneTouch®FastTake®System includes:

• OneTouch®FastTake®Meter

• OneTouch®Ultra®Control Solution

• OneTouch®UltraSoft™Adjustable Blood Sampler

• OneTouch®UltraClear™Cap

• OneTouch®UltraSoft™Lancets

• Owner’s Booklet

• Sporty Carrying Case

• Quick Reference Guide

• Warranty Registration Card

• Logbook

• Two pre-installed 1.5 V (#357 or equivalent) silver oxide batteries

OneTouch®FastTake®Test Strips Sold Separately

OneTouch®FastTake®Blood Glucose Meter

DISPLAY

Your test results are displayed here. The large, easy-to-read display guides you through the test using symbols and simple messages.

M BUTTON

The M (Mode) button is used to set up the meter, enter the memory mode, and turn the meter on and off.

TEST/DATA PORT

The test/data port is where you insert the OneTouch

FastTake®Test Strip for testing. The meter will turn on automatically when you insert a test strip. The test/data port also accepts the OneTouch

FastTake®Adapter, which can be used to help download your test results to a computer for further analysis using OneTouch

™

Diabetes Management

Software.

C BUTTON

The C (Change) button is used to change the date and time, code number, and unit of measurement, as well as to indicate control solution tests and to review test results while in the memory mode.

OneTouch®FastTake®Meter Display Segments

CTL

Indicates a control solution test result.

CODE

Appears with the code number of the test strips currently in use.

BLOOD DROP SYMBOL

This symbol tells you when to apply the sample.

BATTERY SYMBOL

Appears when batteries are low or must be replaced.

KETONES?

Appears when a blood glucose test result falls between 13.3 and

33.3 mmol/L.

MONTH

DAY HOUR

MEM

Indicates a test result stored in memory.

MINUTES

TEST RESULT AREA

Test results are displayed here. (A decimal point appears when the unit of measurement is millimoles per litre.)

UNITS OF MEASUREMENT

Depending upon how the meter is set, either mmol/L or mg/dL will appear with the test result.

OneTouch®FastTake®Test Strips (Sold Separately)

The OneTouch amount of sugar (glucose) in whole blood. Blood is applied to the TOP WHITE EDGE of the OneTouch

FastTake®System measures the

FastTake®Test Strip. The test strip automatically draws the blood into the reaction cell where the reaction takes place.

The OneTouch

FastTake®Test Strip consists of the

following parts:

Top White Edge

This is where you apply a drop of blood.

Confirmation Window

This is where you confirm if enough blood has been applied to the top white edge.

Contact Bars

This end of the test strip is inserted into the meter.

See pages 17–29, Testing Your Blood, for complete instructions.

Important Test Strip Information

• Store the test strip package in a cool, dry place below 30°C (86°F ). Keep away from direct sunlight and heat. Do not refrigerate.

• Store your test strips in their original vial only; do not transfer them to a new bottle or any other container.

• After removing a OneTouch immediately replace the vial cap and close it tightly.

• With clean, dry hands, you may touch the test strip anywhere on its surface when removing it from the vial or inserting it into the meter.

• Use each test strip immediately after removing it from the vial.

• Write the discard date on the vial label when you first open it. Discard remaining OneTouch three months after first opening date.

• Apply only OneTouch sample to the top white edge. Applying other substances to the top white edge will cause inaccurate results.

• Do not use test strips beyond the expiration date printed on the package since they may cause inaccurate results.

• Do not bend, cut, or alter a OneTouch any way.

FastTake®Test Strip from the vial,

FastTake®Test Strips and the vial

Ultra®Control Solution or a blood

FastTake®Test Strip in

WARNING: Keep the test strip vial away from children; the cap is a choking hazard. Also, the cap contains a pouch filled with drying agents that may be harmful if inhaled or swallowed and may cause skin or eye irritation.

BEFORE TESTING

Checking the Display

Each time you insert a test strip into the OneTouch meter on, all segments of the display will appear briefly. This tells you that the system is performing several self-checks and allows you to confirm that all display segments are working properly. (See pages 4 and 5 for all display segments.)

Coding the Meter

Code numbers are used to calibrate the OneTouch OneTouch results. You must code the meter before using it for the first time and then every time you change to another vial of OneTouch you test, check that the code number on the meter display matches the code number on the test strip vial.

FastTake®Meter or turn the

FastTake®Test Strips with the

FastTake®Meter for accurate

FastTake®Test Strips. Each time

CAUTION: If the code number displayed on the meter does not match the number printed on the vial, test results may be inaccurate.

STEP 2

Enter the Code Mode.

STEP 1

Start with the meter turned off. Insert a OneTouch

FastTake®Test Strip to turn on the meter. All segments of the display will appear followed by the date and time. Next, the code number will appear on the display for three seconds.

Match the Code Numbers.

Compare the code number on the meter display with the code number on the test strip vial. If the two code numbers match, you may begin testing. If they do not match, follow Step 3. When you first use the meter, three dashes (Q) will appear, showing that there is no code stored in the memory.

(Example)

STEP 3

(Example)

Code the Meter.

Press the C button to select the correct code. Each time you press and release the C button, the number will increase by one. To move faster, simply press and hold the C button. After you have selected the correct code number, it will flash for three seconds and then appear solid for three seconds. Then the symbol will appear, indicating that the OneTouch

FastTake®System is ready

for testing.

Checking the System with OneTouch® Ultra

Control Solution

OneTouch®Ultra®Control Solution is used to check that the meter and test strips are working together as a system and that you are performing the test correctly. It is very important that you do this simple check routinely to make sure you get accurate results.

OneTouch known amount of glucose that reacts with OneTouch

Ultra®Control Solution contains a

FastTake®Test Strips. Compare your control solution test results with the expected

range printed on the test strip vial label.

Control solution should be used to:

• Practice the test procedure.

• Make sure your meter and test

strips are working together properly.

• Ensure you are performing the

test correctly.

Before you use the OneTouch®FastTake®Meter to test your blood for the first time, practice the procedure using control solution. When you can do three tests in a row that are within the expected range, you are ready to test your blood.

Do a control solution test:

• When you begin using a new vial of test strips.

• At least once a week.

• Whenever you suspect that the meter or test strips are not working properly.

• When your blood glucose test results are not consistent with how you feel, or when you think your results are not accurate.

• If you drop the meter.

The control solution test is similar to a blood test except that you use OneTouch

Ultra®Control

Solution instead of a drop of blood.

Important Control Solution Test Information

• Use only OneTouch®Ultra®Control Solution.

• Check the expiration date on the control solution vial.

Do not use if expired.

• Control solution, meter, and test strips should come to room temperature (20-25°C/68-77°F) before testing.

• Shake the vial, discard the first drop of OneTouch Solution, and wipe off the dispenser tip to ensure a good sample and an accurate result.

• Use only for three months after first opening. Record the discard date (date opened plus three months) on the control solution vial. Discard after three months.

• Store the control solution tightly closed at room temperature below 30°C (86°F ). Do not refrigerate.

Ultra®Control

CAUTION: The control solution range printed on the test strip vial is for OneTouch

Ultra®Control Solution only. It is used to test

meter and test strip performance. It is not a recommended range

for your blood glucose level.

STEP 1

How to do a control solution test:

NOTE: You cannot perform a control solution test until you

have set up the meter completely (see pages 8–10).

Insert Test Strip.

Insert a test strip, contact bars end first and facing up, into the test port. (Contact bars must be inserted all the way into the meter or you may get an inaccurate test result.) The meter will turn on automatically. All segments will appear briefly on the display followed by the

date and time. Then “

”

(example) is displayed, followed by the

symbol. Be sure the code number on the display matches the code number on the test strip vial. If the code numbers do not match, code the meter correctly.

After the

symbol appears on the

display, press and hold the C button until

“

” begins flashing on the display. When you see the “ C button. With the “

” sign, release the

” sign on the display, the meter will mark your next test in memory as a control solution test.

If you decide not to perform a control

STEP 3

STEP 2

solution test, the “

” sign will disappear

when you press the C button again.

NOTE: Every time you perform a control solution test, you must mark the test with the “

” sign so that the test will be distinguished from a blood glucose test in the meter memory and not included in the 14-day average.

Apply Control Solution.

Shake the control solution vial well. Remove the cap. Squeeze the vial, discard the first drop, and wipe off the dispenser tip to ensure an accurate result. Squeeze the vial again to get a hanging drop. Apply the hanging drop to the TOP WHITE EDGE of the test strip until the drop is drawn onto the test strip, the confirmation window is filled, and the meter begins to count down.

Result Appears in 15 Seconds.

The meter will count down from “D” to “A” second and the control solution test result will appear. Compare the result with the range printed on the test strip vial.

(Example)

The result should fall within this range.

Comparing control solution results

If test results fall outside the range printed on the test strip vial, repeat the test. Out-of-range results may be caused by one or more of the following:

• Error in performing the test.

• Failure to shake the control solution vial vigorously.

• Expired or contaminated control solution.

• Control solution that is too warm or too cold.

• Failure to discard the first drop of control solution and wipe the dispenser tip clean.

• Improper coding of the meter.

• Test strip deterioration.

• Meter malfunction.

CAUTION: If you continue to get control solution test results that fall outside of the range printed on the vial, the system may not be working properly. Do not use the system to test your blood if you continue to get test results that fall outside of the range. If you are unable to resolve the problem, call the OneTouch

Customer Care Line at 1 800 663-5521.

TESTING YOUR BLOOD

Be sure to read this section and the test strip package insert found in the test strip box carefully before testing. Make sure you have all items needed to test.

• OneTouch

• OneTouch Blood Sampler

• OneTouch

FastTake®Meter

FastTake®Test Strips

UltraSoft™Adjustable

UltraSoft™Sterile Lancet

STEP 1

Getting a Drop of Blood

CAUTION: To reduce the chance of infection:

• Never share a lancet with another person.

• Always use a new, sterile lancet. Lancets are for single use only.

• The OneTouch

UltraSoft™Blood Sampler should be used

by only one person.

• Avoid getting hand lotion, oils, dirt, or debris in or on the lancets and the blood sampler.

Insert a Lancet.

Remove the OneTouch®UltraSoft

™

Adjustable Blood Sampler Cap by twisting it counterclockwise.

Insert the lancet into the lancet holder. Push down firmly until the lancet is fully seated in the holder. Do not twist the lancet. To avoid contamination and to prevent the cap from rolling away, set the cap down on a flat surface with its small hole pointing up.

While the lancet is in the OneTouch

UltraSoft™Adjustable Blood Sampler, twist off the protective disk. Make two full turns to ensure that the lancet separates from the protective disk.

Replace the OneTouch®UltraSoft™Cap. Turn

STEP 2

the cap clockwise until it is snug but not too tight.

Adjust the puncture depth setting if necessary. Twist the knob counterclockwise, toward the smaller bumps for a shallower puncture. Twist the knob clockwise, toward the larger bumps for a deeper puncture.

Cock the Sampler.

Slide the ejection/cocking control backward until it clicks. If it does not click, the sampler may have been cocked when the lancet was inserted.

Wash Your Hands and

STEP 3

the Puncture Site.

Use warm, soapy water. Rinse and dry thoroughly.

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