Lifescan ONETOUCH ULTRASMART User Manual

AW 06078802A

LifeScan Customer Service toll-free numbers:

English 1 800 227-8862 Español 1 800 381-7226

Visit the LifeScan Web site at

www.LifeScan.com

Meter and Electronic Logbook In One

Owner’s

Booklet

Dear OneTouch®UltraSmart®System Owner:

You have chosen one of the best blood glucose monitoring systems available. This booklet has important information you must know about the OneTouch Monitoring System. Read it carefully.

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

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

Your OneTouch

UltraSmart®System requires a small drop of blood, at least 1μL (microliter), and five seconds to provide you with an accurate plasma-calibrated test result.

The OneTouch

UltraSmart®Meter also has a memory that allows it to function as an “electronic logbook.” Now you can store vital everyday information such as insulin and oral medication doses, food intake, amount of exercise, illnesses, and other pertinent data. You can use your OneTouch test or to serve as a complete storehouse of information regarding your diabetes treatment plan.

UltraSmart®Blood Glucose

UltraSmart®System simply to

A warranty registration card is included with your system. If you complete it and mail it to us, we will send you a gift. If you prefer to fill out a warranty card online, please visit www.LifeScan.com.

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

iii

INTENDED USE: The OneTouch®UltraSmart®Blood Glucose

Monitoring System is intended to be used for the quantitative measurement of glucose in fresh capillary whole blood. The OneTouch

UltraSmart®System is intended for use outside the body (for in vitro diagnostic use) by people with diabetes at home and healthcare professionals in a clinical setting as an aid to monitor the effectiveness of diabetes control. The OneTouch

UltraSmart®System should not be used for the diagnosis of diabetes or testing of newborns.

The OneTouch

UltraSmart® Blood Glucose Monitoring System provides the user with electronic logbook functions, which serve to store such data as insulin and oral medication doses, food intake, amount of exercise, health information such as illnesses, and other pertinent data. The meter includes a data port that enables the user to download logbook data to a personal computer.

CAUTION: Before using any product to test your 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 American Association of Diabetes Educators, the U.S. Food and Drug

the Advanced Medical Technology Association

Administration, and

WARNING: Keep the meter and testing supplies away from

young children. Small items such as the battery door, battery, test strips, lancets, protective disks on the lancets, stereo jack cover and the control solution vial cap are choking hazards.

Important Information

• Dehydration: Severe dehydration and excessive water loss may

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

• Low glucose results: If your test result is lower than 70 mg/dL

or is shown as “LOW GLUCOSE”, it may mean hypoglycemia (low blood glucose). This may require immediate treatment

according to your healthcare professional’s recommendations.

Although this result could be due to a test error, it is safer to treat first and then repeat the test.

• High glucose results: If your test result is greater than

180 mg/dL or is shown as “HIGH GLUCOSE”, it may mean hyperglycemia (high blood glucose). If you do not have symptoms, first repeat the test. Your healthcare professional can work with you to decide what actions, if any, you should take if you continue to get results higher than 180 mg/dL or if you have symptoms.

• Repeated unexpected results: If you continue to get

unexpected results, check your system with control solution. See Checking the System with Control Solution on page 12. If you are experiencing symptoms that are not consistent with your blood glucose results and you have followed all instructions in this booklet, call your healthcare professional. Never ignore symptoms or make significant changes to your diabetes control program without speaking to your healthcare professional.

• Hematocrit: A hematocrit (percentage of your blood that is red

blood cells) that is either very high (above 55%) or very low (below 30%) can cause false results.

Table of ContentsTable of Contents

THE OneTouch®UltraSmart®SYSTEM . . . . . . . . . . . . . . 1

OneTouch®UltraSmart®Meter . . . . . . . . . . . . . . . . . 2

Navigation Buttons . . . . . . . . . . . . . . . . . . . . . . . . . . 3

SmartButtons® . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4

Display Symbols . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6

Display Contrast . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6

OneTouch®Ultra®Test Strips . . . . . . . . . . . . . . . . . . 7

BEFORE TESTING . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9

Checking the Display . . . . . . . . . . . . . . . . . . . . . . . . . 9

Setting the Meter . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9

Coding the Meter . . . . . . . . . . . . . . . . . . . . . . . . . . . 10

Checking the System with Control Solution . . . . . 12

TESTING YOUR BLOOD . . . . . . . . . . . . . . . . . . . . . . . . . 19

Preparing the OneTouch®UltraSoft

Adjustable Blood Sampler . . . . . . . . . . . . . . . . . . . .20

Lancing and Sampling from Your Fingertip . . . . . 23

Lancing and Sampling from an Alternate Site . . . 27

Step-by-Step Test Procedure . . . . . . . . . . . . . . . . . .31

Discarding Used Test Strips and Lancets . . . . . . . 37

Special Messages . . . . . . . . . . . . . . . . . . . . . . . . . . 38

COMPARING METER AND LABORATORY RESULTS . . 40

CARING FOR YOUR SYSTEM . . . . . . . . . . . . . . . . . . . . . 42

Maintenance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 42

Cleaning the OneTouch®UltraSoft

Adjustable Blood Sampler . . . . . . . . . . . . . . . . . . . 42

Batteries . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 43

DISPLAY MESSAGES . . . . . . . . . . . . . . . . . . . . . . . . . . . 46

WARNINGS AND ERROR MESSAGES . . . . . . . . . . . . . 51

PROBLEMS AND POSSIBLE CAUSES . . . . . . . . . . . . . .56

METER SET-UP . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 58

Entering Basic Set-up Mode . . . . . . . . . . . . . . . . . 58

Selecting Display Language . . . . . . . . . . . . . . . . . 59

Setting Date and Time . . . . . . . . . . . . . . . . . . . . . . 60

CUSTOM METER SET-UP SEQUENCE . . . . . . . . . . . . . . 62

Set-up Menu . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 62

Settings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 66

Diabetes Pill Set-up . . . . . . . . . . . . . . . . . . . . . .68

Insulin Set-up . . . . . . . . . . . . . . . . . . . . . . . . . . .70

Insulin Pump Set-up . . . . . . . . . . . . . . . . . . . . . .72

Advanced Feature Set-up . . . . . . . . . . . . . . . . .72

YOUR ELECTRONIC LOGBOOK . . . . . . . . . . . . . . . . . . . 77

Comments . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 77

Rules for Adding Comments . . . . . . . . . . . . . . . . . . 78

How to Add a Comment . . . . . . . . . . . . . . . . . . . . . 78

Logbook Entries . . . . . . . . . . . . . . . . . . . . . . . . . . . . 82

Using the SmartButtons® . . . . . . . . . . . . . . . . . . . . 82

Rules for Logbook Entries . . . . . . . . . . . . . . . . . . . 84

Entering the Date and Time . . . . . . . . . . . . . . . . . . 85

Exercise Logbook Entries . . . . . . . . . . . . . . . . . . . . .86

Health Logbook Entries . . . . . . . . . . . . . . . . . . . . . .87

vii

Table of Contents (continued)

Ketones . . . . . . . . . . . . . . . . . . . . . . . . . . . . .89

HbA1c . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .91

Microalbumin . . . . . . . . . . . . . . . . . . . . . . . .91

Cholesterol . . . . . . . . . . . . . . . . . . . . . . . . . .92

Blood Pressure . . . . . . . . . . . . . . . . . . . . . . .92

Eye Exam . . . . . . . . . . . . . . . . . . . . . . . . . . . .93

Foot Exam . . . . . . . . . . . . . . . . . . . . . . . . . . .93

Weight/Height . . . . . . . . . . . . . . . . . . . . . . .94

Doctor Visit . . . . . . . . . . . . . . . . . . . . . . . . . .94

Medication Logbook Entries . . . . . . . . . . . . . . .95

Food Logbook Entries . . . . . . . . . . . . . . . . . . . .101

Adding, Changing, or Deleting

Logbook Information . . . . . . . . . . . . . . . . . . . . . . . . . . . 103

OneTouch

UltraSmart®FastFacts®FEATURE . . . . . .108

FastFacts®Menu . . . . . . . . . . . . . . . . . . . . . . . . . . 109

Logbook Memory . . . . . . . . . . . . . . . . . . . . . . .110

Glucose by Meals . . . . . . . . . . . . . . . . . . . . . . .110

Glucose Analysis . . . . . . . . . . . . . . . . . . . . . . . .111

Interactive Graph of All Results . . . . . . . . .111

Graph by Time of Day . . . . . . . . . . . . . . . . .112

Average of All Results . . . . . . . . . . . . . . . . .113

Average by Time of Day . . . . . . . . . . . . . . .114

Average by Exercise . . . . . . . . . . . . . . . . . .114

Glucose Range Info . . . . . . . . . . . . . . . . . . .115

Insulin Intake . . . . . . . . . . . . . . . . . . . . . . . . . . .116

viii

Hypoglycemia Information . . . . . . . . . . . . . . .120

Food Averages . . . . . . . . . . . . . . . . . . . . . . . . . .121

Health Checks . . . . . . . . . . . . . . . . . . . . . . . . . .121

Data Downloading . . . . . . . . . . . . . . . . . . . . . . . . 122

SPECIFICATIONS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 125

PRODUCT SAFETY INFORMATION . . . . . . . . . . . . . . . 126

EXPLANATION OF SYMBOLS ON THE METER . . . . . . 127

GUARANTEE . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 127

INDEX . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 128

THE OneTouch®UltraSmart®SYSTEM

The OneTouch®UltraSmart®System uses the latest blood glucose monitoring technology. It measures the glucose content of a blood sample by means of an electrical current produced in the test strip and is measured by the meter. Test results are “plasma-calibrated.” This makes it easier for you and your diabetes-care team to compare your meter results with laboratory tests. If you have been using another type of meter—one that provides whole-blood results—you may notice that your test results with the OneTouch®UltraSmart System are about 12% higher.

The OneTouch®UltraSmart®Blood Glucose Monitoring System consists of three main products: the OneTouch®UltraSmart®Meter, OneTouch®Ultra®Test Strips, 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 no other test strips or control solution other than the OneTouch Ultra®brand with your meter.

Your system kit includes:

• OneTouch®UltraSmart®Meter

• OneTouch®Ultra®Control Solution

• OneTouch®UltraSoft

Adjustable Blood Sampler

• OneTouch®UltraClear®Cap

• OneTouch®UltraSoft

• Owner’s Booklet

• Carrying Case

• Quick Reference Guide

• Quick Start Guide

• Warranty Registration Card

• Two AAA Alkaline Batteries (Installed)

Sterile Lancets

OneTouch

Ultra®Test Strips sold separately

OneTouch®UltraSmart®Meter

OneTouch

Ultra®Test Strip

Test Port

The meter turns on when you insert the OneTouch

Ultra®Test Strip here.

Data Port

Used to download logbook memory to a computer.

Display with Backlight

Test results, messages, symbols, and other data appear here.

SmartButtons

(See pages 4–5 for description and use.)

Navigation Buttons

Note: Press and release buttons. Do Not hold

buttons down for an extended period of time.

Back Button (Off Button)

Go back to previous display on certain screens. Press and hold for two seconds to turn off the meter.

Arrow Button

Scroll through menus, code numbers, and logbook.

OK Button (Backlight Button)

Accept entries and move to next display. Press and hold for two seconds to turn on backlight.

SmartButtons

The SmartButtons®are your keys to getting the most

out of your OneTouch

UltraSmart®Meter. They allow you to enter information about your diabetes management plan into the large logbook memory.

There are SmartButtons medication, and food. The FastFacts

for exercise, health,

SmartButton®is

used to view the records in the logbook memory. You

may press any SmartButton

to turn on the meter and

move directly to the category.

Exercise SmartButton

Enter exercise amount and level.

Food SmartButton

Enter meal and snack information.

Health SmartButton

Enter information on health.

Medication SmartButton

Enter insulin and diabetes pill information.

FastFacts

SmartButton

Review test results and logbook memory.

Note: For complete information on using the Exercise, Health, Medication, and Food SmartButtons See pages 108–122 for more information on the FastFacts and the FastFacts

SmartButton®.

, please see pages 82–107.

Feature

Display Symbols

These symbols guide you while using your meter:

Symbol Meaning

▲

▼

▲▼

▲

▼

– – –

HIGHLIGHT

Scroll (move) up only.

Scroll down only.

Scroll up or down.

No entry.

Shows where you are on the display. Press the OK button

to accept highlighted area.

Display Contrast

You can change the contrast of the meter display. To make it darker, press and hold both the Back button

and the “up” Arrow button . To make it lighter, press and hold both the Back button and the “down” Arrow button .

OneTouch®Ultra®Test Strips

The OneTouch amount of glucose in whole blood. Blood is applied to the Top Edge of the OneTouch

UltraSmart®System measures the

Ultra®Test Strip and is automatically drawn into the reaction cell where the reaction takes place.

Top Edge

Apply a drop of blood to the narrow channel here in the top edge of the test strip.

Confirmation Window

Check here to confirm if enough blood has been applied.

Contact Bars

Insert this end of the test strip, contact bars facing up, into the meter. Push it all the way in until it will go no further.

WARNING: Do Not swallow test strips. The test strip vial may

contain drying agents that are harmful if swallowed and may cause skin or eye irritation.

See pages 19–39, Testing Your Blood, for complete instructions.

Important Test Strip Information

• Store test strip vials in a cool, dry place below 86˚F (30˚C).

Keep away from direct sunlight and heat. Do Not refrigerate.

• Store test strips in their original vial only. To avoid damage or contamination, Do Not transfer test strips to any other place.

• After removing a test strip from the vial, replace the vial cap immediately and close it tightly.

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

• Do Not use test strips from any vial that is damaged or left open to air.

• Write the discard date (3 months after first opening the vial) on the vial label when you first open it. Discard remaining OneTouch

• Do Not use test strips beyond the expiration (printed on the package) or discard date, whichever comes first, because they may cause inaccurate results.

• Avoid getting dirt, food or liquids on the test strip. With clean, dry hands you may touch the test strip anywhere on its surface.

• Do Not bend, cut, or alter OneTouch

• OneTouch

reuse a test strip that has had either blood or control solution applied to it.

• Apply only OneTouch sample to the test strip.

• Refer to additional information in the OneTouch Strip package.

Ultra®Test Strips after the discard date.

Ultra®Test Strips in any way.

Ultra®Test Strips are for single use only. Never

Ultra®Control Solution or a blood

Ultra®Test

BEFORE TESTING

UltraSmart

Checking the Meter Display

Each time you turn the meter on, the display background will quickly change from dark to light and form the words “OneTouch UltraSmart”. This tells you that the system is performing several self-checks to confirm that the meter is working properly. If, at any time during the life of the meter, these graphics appear to be different, call LifeScan

Customer Service at 1 800 227-8862.

Setting the Meter

The OneTouch factory to display results in the English language using milligrams per deciliter (mg/dL) as the unit of measure. The time and date are also factory-set in Pacific Standard Time. If you are using the meter for the first time and simply wish to test, insert a test strip into the test port and begin by coding the meter. If you wish to change the date, time, or language, see Meter Set-up, pages 58–61. To customize your meter, see Custom Meter Set-up Sequence, pages 62–76.

UltraSmart®Meter is set at the

Note: It is important that the time of day is

correct and that your medication set-up and mealtimes are set according to your personal daily schedule. Otherwise, some FastFacts information will not be correct.

Coding the Meter

Code numbers are used to calibrate the OneTouch UltraSmart®Meter with the OneTouch®Ultra®Te st Strips for accurate results. You must code the meter before using it for the first time and then every time you change to another vial of test strips.

CAUTION: Matching the code on the meter and the code on the

test strip vial is essential to obtain accurate results. Each time you test, check to make sure the code numbers match.

STEP 1

Enter the Code Mode.

Insert a OneTouch®Ultra®Test Strip to turn on the meter. Push it all the way in until it will go no further. “OneTouch UltraSmart” will appear on the display briefly. The first time you turn the meter on, three dashes [---] will appear, showing that there is no code stored in the memory. Follow Step 4 to code the meter.

STEP 2

See the Code Number.

The code number will appear on the display. (After every 25 tests the meter will display the code number and will prompt “Check Code Press OK”. Press the OK button if the code number is still

correct.)

STEP 3

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 4.

Note: The code number appears on the display

briefly. If you were unable to change the code in time or entered a code number in error, press the Back button to return to Step 3.

(Example)

STEP 4

Code the Meter.

Move up or down using the Arrow button

to the code number that matches the code number on the test strip vial. The new code number will flash on the display for about three seconds, after which the meter will prompt you to “Apply Blood”.

Checking the System with Control Solution

Why you should do a control solution test:

• OneTouch

Ultra®Control Solution

is used to check that the meter and the 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 an accurate result.

Before you begin:

• Use only OneTouch®Ultra®Control Solution.

• Check the expiration date on the control solution vial. Record the discard date (date opened plus three months) on the vial label. Do Not use after expiration or discard date, whichever comes first.

• Control solution, meter, and test strips should be at room temperature (between 68° and 77°F/between 20 ° and 25°C) before testing with control solution (see Specifications section on page 125 for blood testing temperature ranges).

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

• Store the control solution tightly closed at temperatures below 86°F (30°C). Do Not refrigerate.

WARNING:

• Do Not swallow control solution; it is not for human consumption.

• Do Not apply control solution to the skin or eyes as it may cause irritation.

When you should do a control solution test:

• To practice the test process instead of using blood.

• When you open a new vial of test strips.

• Once a week.

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

• If you have had repeated unexpected blood glucose results (as described on page v).

• After dropping the meter.

Note: Refer to additional information in the

OneTouch

Ultra®Control Solution package.

STEP 1

Insert a Test Strip into the Meter.

To turn on the meter, insert a test strip, contact bars end first and facing up, into the test port. Push it all the way in until it will go no further.

“OneTouch UltraSmart” will appear briefly on the display.

Then “Code 9 (Example), Check Code” is displayed. Be sure the meter and test strip codes match. If they do not, code the meter correctly (see pages 10–12).

(Example)

STEP 2

Select “Control Solution”.

“Apply Blood” will appear on the display first. Use the Arrow button to select “Control Solution”. The meter will automatically identify the test as a control solution test in the logbook.

There are three choices in test mode. Use the Arrow button to select one. Do Not apply a sample until your choice appears on the display.

• “Apply Blood” for fingertip blood sample.

• “Alternate Site” for forearm and palm blood samples.

• “Control Solution” for checking the system.

Apply Blood

Control Solution

Note: You must select “Control Solution” to distinguish control

solution tests from blood glucose tests. Marked control solution tests will not be included in your averages. Do Not use Control Solution mode for testing blood.

STEP 3

To ensure an accurate control solution test, shake the vial, discard the ﬁrst drop and wipe

the dispenser tip before you begin.

Apply Control Solution to the Test Strip.

NARROW CHANNEL

➧

Apply

TOP EDGE

Note: If you do not apply the control solution within three

minutes, the meter will turn itself off. Remove the test strip and insert it back into the test port to restart the test procedure.

Drop Here

Touch and hold a drop of control solution where the narrow channel meets the TOP EDGE of the strip.

CONFIRMATION WINDOW

The control solution will be drawn into the narrow channel. When the confirmation window is full, the meter will count down from 5 to 1.

➧

(Example)

The control solution test result will appear on the display.

WARNING:

If mg/dL does not appear with the

Control Solution result, call LifeScan Customer Service at 1 800 227-8862.

STEP 4

Compare Control Solution Result to the Control Range Printed on the TEST STRIP VIAL.

CAUTION: The control

solution range printed on the test strip vial is for OneTouch

Ultra®Control Solution only. It is not a recommended range for your blood glucose level.

CONTROL RANGE

(Example)

If the results are not within the control range printed on the test strip vial, the meter and strips may not be working properly. Repeat the control solution test. When using Control Solution mode, very high or very low readings will be displayed as a number rather than a “HIGH” or “LOW” warning screen.

Control solution out-of-range results may be due to:

• Incorrect unit of measure.

• Error in performing the test.

• Failure to shake the control solution vial well.

• Improper meter coding.

• Test strip deterioration.

• Meter malfunction.

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

• Expired or contaminated control solution.

• The meter, test strips, or control solution are too warm or too cold.

• Testing blood in Control Solution mode.

CAUTION: If you continue to get control solution test results

that fall outside of the range printed on the test strip vial, the system may not be working properly. Do Not use the meter. Call

LifeScan Customer Service at 1 800 227-8862.

TESTING YOUR BLOOD

Read this section and the test strip package insert carefully before testing. Make sure you have all items needed to test.

• OneTouch

• OneTouch Blood Sampler

• OneTouch (for forearm and palm sampling)

• OneTouch

CAUTION: It is important to learn the correct blood application

technique (see pages 33–35). If you do not apply blood to the test strip correctly you may get an inaccurately low or high test result or an error message. LifeScan recommends that you develop good technique by practicing with control solution prior to using the OneTouch

CAUTION: If you cannot test due to a problem with your testing

supplies, contact your healthcare professional or LifeScan Customer Service at 1 800 227-8862. Failure to test could delay

treatment decisions and lead to a serious medical condition.

UltraSmart®Meter

Ultra®Test Strips

UltraSoft®Adjustable

UltraClear®Cap

UltraSoft®Sterile Lancets

UltraSmart®Meter for the first time.

+ 118 hidden pages