Lifescan ONETOUCH INDUO User Manual

User’s Manual

www.InDuo.com

Diagram of the InDuo™ system

Look at the diagram inside this cover for the names of the different parts of the InDuo™ system. You can unfold the diagram to help you while you follow the instructions.

The InDuo™ system should be used only in combination with products that are compatible with it and allow the InDuo™ system to function safely and effectively.

OneTouch®Ultra test strips are designed to be used with the glucose meter.

PenFill®3 mL cartridges and NovoFine®needles are designed to be used with the

InDuo™ insulin doser. PenFill

PenFill IN TOUCH

and NovoFine®are trademarks of Novo Nordisk A/S.

and OneTouch®are trademarks of LifeScan, Inc.

not included.

InDuo™ is a trademark of Johnson and Johnson Co.

Protected by US Patent Nos. 5,957,889; 5,961,496; and 6,045,537. Additional patents pending.

The CE-mark on the InDuo™ doser indicates that the product conforms with the provisions in the EC Directive for Medical Devices 93/42/EEC. The InDuo™ insulin doser fulfils the specification limits for dose accuracy according to ISO 11608-1. Pen-Injectors for Medical use, Part 1: Requirements and test methods.

InDuo™ blood

InDuo™ SYSTEM AND ACCESSORIES

OneTouch®UltraClear™

cap for alternate

puncture site

OneTouch

Sterile Lancet

UltraSoft™

InDuo™

Blood Glucose Meter

InDuo™

Insulin Doser

OneTouch®Ultra Control Solution

NovoFine

Needles 10-pack

OneTouch®Ultra

Test Strips

OneTouch®UltraSoft™

Adjustable blood sampler

PenFill®3 mL

Insulin Cartridge

InDuo™ BLOOD GLUCOSE METER AND INSULIN DOSER InDuo™ METER AND INSULIN DOSER DISPLAY SYMBOLS InDuo™ COMPONENTS

Data port

Test port

Meter display

M button

C button

Dose selector

LOT number

Residual scale

Window

Slide

Insulin doser display

Push button Release button

Ctl

Indicates a control solution test result.

Code

Appears with the code number of the OneTouch®Ultra Test strip currently in use.

Apply symbol

Tells when to apply the sample.

Battery symbol

Appears when the meter battery power is low or must be replaced.

Time segment

The segments indicate the time passed since delivery. 1 segment represents 1 hour.

Month

Ketones?

Appears when a blood glucose test result falls above 240 mg/dL.

Mem

Indicates a test result stored in the memory.

Test result area

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

Unit of measurement

The meter has been pre-set in either mg/dL or mmol/L. Confirm that the

MinutesDay Hour

unit of measurement is correct when the apply symbol appears during blood application.

Circle

Confirms that the delivery has been completed.

Dose

Shows the number of insulin units dialed.

OneTouch®UltraSoft™ Adjustable blood sampler

Release button

Cap

OneTouch

Lancet

Protective disk

Ejection / Cocking control

Deep puncture Indicator mark

Puncture depth setting knob

Shallow puncture

OneTouch

Ultra Test strip

Top edge

Confirmation window

Contact bars

NovoFine

6 mm or 8 mm

Outer needle cap

Inner needle cap

Needle Protective

tab

PenFill

3 mL

Front rubber stopper White bar code band

Rear rubber stopper

Threaded plastic cap

Glass ball (for insulin suspensions only)

CONTENTS

Welcome 4 Getting your InDuoTMsystem ready for use 5

Preparing your InDuoTMmeter 5 Preparing your InDuoTMinsulin doser to inject insulin 21

Testing your blood glucose levels 27 Injecting your insulin 41

Using the InDuoTMmemory functions 51

Checking your previous test results 51 Checking your previous injection 54

Viewing blood glucose test results on a personal computer 55 Comparing InDuoTMmeter and laboratory results 58

Caring for your InDuoTMsystem 60 Important information 65 Display messages and problem-solving guide 68

The InDuoTMmeter 69 The InDuoTMinsulin doser 80

Specifications 86 Warranty 87 Blood value targets 88

WELCOME

You have chosen the InDuoTMsystem, a system designed to simplify the way you manage your diabetes. Featuring an integrated blood glucose meter and insulin doser, InDuo your blood glucose levels and administer insulin using one compact system. This manual contains instructions for using, storing, and looking after your InDuo system. Read it carefully.

Your InDuo accurate, plasma-calibrated test results. This feature makes it easier for you and your doctor to compare your meter results with laboratory results. If you have been using another type of meter, you may notice that the results with the InDuo about 12% higher than with your previous system. The InDuo use with OneTouch

Your InDuo with state-of-the-art insulin delivery including a memory to tell you how much

will enable you to check

meter provides you with

meter are

meter is designed for

Ultra test strips only.

insulin doser provides you

you injected, and how long ago you made your injection. By combining meter and insulin doser into one, the InDuo

system helps you simplify your insulin therapy and increase your confidence in managing your diabetes.

A warranty registration card is included

with your InDuo

system. If you complete it

and mail it to us, we will send you a gift.

We are sure that you will find your

InDuo If you have any questions regarding your InDuo

system simple and easy to use.

system, please do not hesitate to call InDuo Customer Services at our toll free number 1-877-520-9056.

The InDuoTMmeter 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. It should not be used for the diagnosis of diabetes or for the testing of newborns.

GETTING YOUR InDuoTMSYSTEM READY FOR USE 5

GETTING YOUR InDuoTMSYSTEM READY FOR USE

Preparing your InDuoTMmeter

Setting the time, date, and unit of measurement

Your InDuo time, date, and unit of measurement. However, you can reset these if you need to change the date or time, or if you remove the meter battery. Since the InDuo 30 days) for your blood glucose tests (see page 53), you may find that changing the date and time will also alter the values for the 14-day and 30-day averages. To set the time, date, and unit of measurement, you must first enter the setting mode on the InDuo

Enter the setting mode

• Press and hold down ˛ for 3 seconds.

• The InDuo you are ready to change the time using the meter display.

meter comes with pre-set values for the

meter also gives average values (14 days and

meter display.

meter is now in the setting mode and

6 GETTING YOUR InDuo

SYSTEM READY FOR USE

Setting the hour

• The time will appear first, with the hour digits flashing.

• Press and release Ñ until the correct hour is displayed.

• To scroll faster, hold Ñ down.

• After setting the hour, press ˛ to set the minutes. The minutes digits will start flashing.

Setting the minutes

• Press and release Ñ until the correct minute is displayed.

• To scroll faster, hold Ñ down.

GETTING YOUR InDuoTMSYSTEM READY FOR USE 7

Setting the time format

• Press ˛ and the 12-hour format will start flashing.

• Your InDuo

meter can display the time in either a

12-hour format ¸ or a 24-hour format | to ‹.

• The 12-hour format is pre-set in the meter.

• If you wish to display the time in 24-hour format,

press and release Ñ. Pressing Ñ again will return you to the 12-hour format.

Setting the year

Before setting the date you must first set the time.

• With the preferred time format on the display,

press ˛ and the year digits will start flashing.

• Press and release Ñ until the correct year is

displayed.

• To scroll faster, hold Ñ down.

8 GETTING YOUR InDuo

SYSTEM READY FOR USE

Setting the month

• Press ˛ and the date will appear on the display with the month display flashing.

• Press and release Ñ until the correct month is displayed.

• To scroll faster, hold Ñ down.

Setting the day

• Press ˛ and the day setting will start flashing.

• Press and release Ñ until the correct day is displayed.

• To scroll faster, hold Ñ down.

GETTING YOUR InDuoTMSYSTEM READY FOR USE 9

Selecting the unit of measurement

• With the correct day on the display, press

˛ and the current unit of measurement will start flashing.

The InDuo

meter can display test results in

milligrams per deciliter (Á) or in millimoles per liter (ﬁ). The Á unit is standard in the United States. The ﬁ unit is commonly used in Canada and some European countries.

• Consult your healthcare professional before you change the unit of measure.

• If the units are incorrect or have been changed, press Ñ to select the correct units. If the units are correct, just press the ˛ button to exit the setting mode.

10 GETTING YOUR InDuo

SYSTEM READY FOR USE

Top edge

Apply a sample here, where the narrow channel meets the top edge of OneTouch

Ultra

test strip.

Confirmation window

This is where you confirm if a large enough sample has been applied to the top edge.

Contact bars

Insert this end of OneTouch test strip into the InDuo

Ultra

meter.

æ OneTouch®Ultra test strips

Your InDuo OneTouch

• Store the OneTouch

meter is designed for use with

Ultra test strips only.

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

• Store your OneTouch

Ultra test strips in their

original vial only; do not transfer them to a new

bottle or any other container.

• After removing a OneTouch

Ultra test strip from the vial, 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 OneTouch

Ultra test strip immediately

after removing it from the vial.

•

Write the discard date on the vial label when you open it for the first time. Discard remaining OneTouch®Ultra test strip

s and the vial 3 months

after the vial was first opened.

GETTING YOUR InDuoTMSYSTEM READY FOR USE 11

• Apply only control solution or a blood sample to the top edge of the OneTouch

Ultra test strip. Applying other substances to the top edge may cause inaccurate results.

• Do not use OneTouch

Ultra test strips beyond the expiration date printed on the package since using expired OneTouch

Ultra test strips may produce

inaccurate results.

• Do not bend, cut, or alter a OneTouch

Ultra test

strip in any way.

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

OneTouch

Ultra test strips are single use. Do not reuse a test strip that has had sample applied to it. Refer to your OneTouch

Ultra test strip insert for additional

information.

12 GETTING YOUR InDuo

SYSTEM READY FOR USE

(Example)

Coding your InDuoTMmeter

Code numbers are used to calibrate the OneTouch Ultra test strips with the InDuoTMmeter. You must code the InDuo

meter before using it for the first time, and then every time you change to another vial of OneTouch

Ultra test strips. Each time you do a blood glucose test, check that the code number on the meter display matches the code number on the OneTouch

Ultra test strip vial.

CAUTION: If the code numbers do not match, your blood glucose tests may be inaccurate.

Entering the code mode

• Start with the InDuo

• Insert a OneTouch

meter turned off.

Ultra test strip to turn on the meter. Push the test strip in until it will go no further.

• All segments of the meter display will appear. When you first use the InDuo

meter, 3 dashes Q

will appear, showing there is no code stored in the meter memory.

GETTING YOUR InDuoTMSYSTEM READY FOR USE 13

Match the code numbers

The calibration code is stored in the meter memory until you change it. The current code number will appear on the display for 3 seconds.

•

Compare the code number on the meter display with the code number on the OneTouch

Ultra test strip vial

• If the 2 code numbers match, you may begin testing.

• If the code numbers do not match, follow the next procedure to recode the InDuo

Code the InDuo

meter

meter.

• Press Ñ to select the correct code.

• Each time you press and release Ñ, the number on the display will increase by one.

• To scroll faster, hold Ñ down.

• After you have selected the correct code number, it will flash for 3 seconds and then appear solid for 3 seconds.

• The apply symbol R will appear with the units of measurement (Á or ﬁ), indicating that the InDuo

meter is ready for testing.

(Example)

14 GETTING YOUR InDuo

SYSTEM READY FOR USE

The control solution test

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

Ultra test strips

The control solution test should be used to:

• check that your meter and OneTouch

Ultra test

strips are working together properly.

• check that you are performing the test correctly.

• practice testing your blood.

The control solution test should be done:

• at least once a week.

• when you begin using a new vial of OneTouch Ultra test strips.

• if you suspect that your InDuo OneTouch

Ultra test strips are not working properly.

meter or

• 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 your InDuo

meter.

GETTING YOUR InDuoTMSYSTEM READY FOR USE 15

æ Caution

• Use only OneTouch®Ultra Control Solution

• Check the expiration date on the control solution vial. Do not use if expired.

• Store control solution tightly closed at temperatures below 86ºF (30°C).

• Do not refrigerate control solution.

• The control solution, the InDuo OneTouch

Ultra test strips should be at room

temperature 68–77ºF (20–25ºC) before testing.

•

Shake the vial, discard the first drop of control solution, and wipe off the dispenser tip with a clean tissue to obtain a good sample and an accurate result.

• Use only for 3 months after the first opening. Record the discard date (date opened plus 3 months) on the control solution vial. Discard after 3 months.

• The control solution range printed on the

OneTouch Ultra control solution only. It is used to test meter and OneTouch

Ultra test strip vial is for OneTouch

Ultra test strip performance. It is not a recommended range for your blood glucose level.

meter, and the

16 GETTING YOUR InDuo

SYSTEM READY FOR USE

Before you use your InDuoTMmeter to test your blood for the first time, practice the procedure using the control solution test. When you can do three tests in a row that are within the range printed on the OneTouch your blood.

How to do a control solution test

Insert OneTouch®Ultra test strip

• Insert a OneTouch

end-first a and facing up, into the test port. Push the OneTouch go no further.

• The InDuo

• All segments will appear briefly on the meter display. Then the code number is displayed, followed by the apply symbol R with the units of measurement (Á or ﬁ).

• Verify that the calibration code and units of measurement are set correctly. (See page 5 and 9 for additional information on the unit of measurement.)

Ultra test strip vial, you are ready to test

Ultra test strip, contact bars

Ultra test strip in firmly until it will

meter will turn on automatically.

GETTING YOUR InDuoTMSYSTEM READY FOR USE 17

• After the apply symbol R appears on the display, press Ñ.

• The Ë symbol will appear on the display. With the Ë symbol on the display, the meter will mark your next test in the memory as a control solution test. If you decide not to perform a control solution test, press Ñ again and the Ë symbol will disappear.

• Every time you perform a control solution test,

you must mark the test result with the Ë symbol so that the test will be distinguished from a blood glucose test in the memory and not included in the 14-day and 30-day blood glucose test averages.

18 GETTING YOUR InDuo

(Example)

SYSTEM READY FOR USE

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 obtain an accurate result.

• Squeeze the vial again to get a small hanging drop.

• Apply the hanging drop b to the top edge area of the OneTouch narrow channel) until the drop is drawn into the OneTouch window is filled, and the meter display begins to count down.

Read test results

• The meter will count down from N to A and the

control solution test result will appear c.

• Compare the result with the range printed on the OneTouch should fall within this range.

Ultra test strip (where it meets the

Ultra test strip, the confirmation

Ultra test strip vial label. The result

æ Caution

GETTING YOUR InDuoTMSYSTEM READY FOR USE 19

• If the control solution test result falls outside the range printed on the OneTouch

Ultra test strip

vial, repeat the test.

• If you continue to get control solution test results that fall outside of the range printed on the vial, the InDuo

• Do not use the InDuo

system may not be working properly.

system to continue testing your blood if the control solution test results continue to fall outside the expected range.

• If you are unable to resolve the problem, call InDuo Customer Services at our toll free number 1-877-520-9056.

20 GETTING YOUR InDuo

SYSTEM READY FOR USE

The control solution test troubleshooting

There are several reasons why a control solution test result may fall outside the expected range (as printed on the OneTouch

Ultra test strip vial label).

Probable reasons

Error in performing the test

Failure to shake the OneTouch

Ultra

control solution vial vigorously

Expired or contaminated OneTouch

Ultra control solution

InDuo

meter, OneTouch®Ultra control solution, or test strips that are too warm or too cool

Failure to discard the first drop of OneTouch

OneTouch

Ultra control solution

Ultra test strip

deterioration

InDuo

meter malfunction

Improper coding of the meter

Action

Repeat the test, closely following the instructions on pages 16–18

Shake the control solution vial and repeat the test

Check the expiration date or use new control solution

Check that the room temperature is between 68–77°F (20–25°C)

Repeat the test

Repeat the test with a new vial of test strips. Remember to recode the meter

Call InDuo

Customer Services at

1-877-520-9056 Check that the meter is coded correctly

GETTING YOUR InDuoTMSYSTEM READY FOR USE 21

PREPARING YOUR InDuoTMINSULIN DOSER TO INJECT INSULIN

Before you are ready to inject your insulin, the InDuo insulin doser must be loaded with a PenFill®insulin cartridge. A needle must be attached and the InDuo insulin doser must be primed by doing an air shot.

How to load your PenFill

• Before loading PenFill®, read the Information For The Patient that accompanies it carefully. In the Information For The Patient, you will find instructions on how to:

• Check that the PenFill

is full and intact. If not,

do not use it.

• Resuspend the insulin, if PenFill

contains an insulin

suspension (cloudy insulin).

æ Use only a new PenFill

when loading the InDuo

insulin doser. Never load a partially filled PenFill®.

æ Each PenFill

use the same PenFill even though you attach a new NovoFine

is for single person use only. Do not

for more than one person,

needle

for each injection.

22 GETTING YOUR InDuo

SYSTEM READY FOR USE

To load PenFill®:

• Pull out the InDuo

insulin doser a.

• The very first time the insulin doser is pulled out, the insulin doser display stays blank until the slide is opened.

• Make sure that the push button is pressed completely in b. Otherwise the slide will remain locked.

• Open the slide in the direction of the arrow shown below c. The insulin doser display now shows 0

GETTING YOUR InDuoTMSYSTEM READY FOR USE 23

• Insert PenFill

into the InDuoTMinsulin doser by

pushing it slightly backwards as shown d. The end with the rear rubber stopper goes in first. Make sure that the threaded plastic cap fits firmly into place e.

• Close the slide completely f. The release button is

locked until the slide has been closed.

• You should keep the slide closed until PenFill

empty and must be changed.

24 GETTING YOUR InDuo

SYSTEM READY FOR USE

How to attach a NovoFine®needle

needle.

with

• Never place a NovoFine®needle on your InDuo insulin doser until you are ready to prime your

InDuo

insulin doser by doing an air shot before

giving an injection.

• Wipe the front rubber stopper of the PenFill an alcohol swab.

• Take the protective tab off a NovoFine

• Screw the NovoFine

needle tightly onto the

threaded plastic cap.

• Pull off the outer and inner needle caps before priming the InDuo

insulin doser by doing an air

shot.

How to prime the InDuoTMinsulin doser by doing an air shot

Priming the InDuoTMinsulin doser is a method of making sure that the insulin is ready to flow when you make your injection. Otherwise, you will not receive the full insulin dose. You will know that the

InDuo of insulin appears at the tip of the NovoFine

insulin doser has been primed when a drop

needle.

GETTING YOUR InDuoTMSYSTEM READY FOR USE 25

æ The InDuoTMinsulin doser should always be primed:

• Before each injection.

• After changing PenFill

• After changing the NovoFine

needle.

• After opening and closing the slide on the InDuo insulin doser.

Priming your InDuo

insulin doser

for the first time

æMake sure that a NovoFine

needle is attached, the push button is pressed completely in, and the slide is closed. If the slide is not closed, the release button will be locked.

• Press the release button a.

You will see that the push button jumps out.

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