Lifescan In Duo User Manual

Combined blood glucose monitoring and insulin dosing system

User manual

InDuo™ SYSTEM AND ACCESSORIES

Manufactured by:

LifeScan Inc.

Milpitas, California 95035, U.S.A. © LifeScan / Novo Nordisk 2002 Revision date: 06/02

Diagram of the InDuo™ System and accessories

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

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

OneTouch

glucose meter.

Penfill

InDuo™ insulin doser.

Innovo

Novo Nordisk A/S and used by Novo Nordisk Canada Inc. under licence.

InDuo™, In Touch

are trademarks owned by Johnson & Johnson and used by LifeScan Canada Ltd.

Ultra Test Strips are designed to be used with the InDuo™ blood

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

, NovoFine®, Novolin-Pen®3, Penfill®and w are trademarks owned by

, OneTouch®, UltraClear™, UltraSoft™ and Penlet

InDuo™

Blood Glucose Meter

InDuo™

Insulin Doser

UltraClear™ Cap

for alternate puncture site

OneTouch®Ultra Control Solution

NovoFine®8 mm needles

(10-pack sample included in kit)

OneTouch

OneTouch®Ultra

Test Strips

OneTouch®UltraSoft™

Sterile Lancet

OneTouch®UltraSoft™

Adjustable Blood Sampler

Penfill®3 ml

Insulin cartridge

(not included)

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

Slide

Residual scale

Window

Piston rod

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 is above 13.3 mmol/L.

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 litre.)

Unit of measurement

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

MinutesDay Hour

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

OneTouch®UltraSoft™ Adjustable Blood Sampler

Release button

Cap

Ejection / Cocking control

OneTouch®UltraSoft™ Lancet

Protective disk

NovoFine

6 mm or 8 mm w

Penfill

Rubber membrane White bar code band

Deep puncture Indicator mark

Puncture depth setting knob

Shallow puncture

3 ml

Circle

Confirms that the delivery has been completed.

Dose

Shows the number of insulin units dialed.

Outer needle cap

Inner needle cap

Needle Protective

tab

Colour-coded cap

Colourcoded band

OneTouch®Ultra Test Strip

Top edge

Confirmation window

Contact bars

Rubber stopper

Glass ball (for insulin suspensions only)

CONTENTS

Welcome 4 Getting your InDuo™ System ready for use 5

Preparing your InDuo™ meter 5 Preparing your InDuo™ insulin doser to inject insulin 21

Testing your blood glucose levels 27 Injecting your insulin 41 Using the InDuo™ memory functions 51

Checking your previous test results 51 Checking your previous injection 54

Viewing blood glucose test results on a personal computer 55 Comparing the InDuo™ meter and laboratory results 58 Caring for your InDuo™ System 60 Important information 65 Display messages and problem-solving guide 68

The InDuo™ meter 69 The InDuo™ insulin doser 82

Specifications 88

The InDuo™ meter 88 The InDuo™ insulin doser 89

Guarantee 89 Blood glucose value targets 90

WELCOME

You have chosen the InDuo™ System, designed to simplify the way you manage your diabetes. Featuring an integrated blood glucose meter and insulin doser, InDuo™ System will enable you to check 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™ meter 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. The InDuo™ meter is designed for use only with OneTouch®Ultra Test Strips.

Your InDuo™ insulin doser provides you with state-of-the-art insulin delivery including a memory to tell you how much 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. Please complete it and mail it to us. Or if you prefer you may complete the warranty card online by visiting our Web site www.InDuo.ca. If you have any questions or need to change your address please call us at 1 888 729-2299.

We are sure that you will find the InDuo™ System simple and easy to use. Before using the InDuo™ System, see Important Information on page 65.

The InDuo™ meter 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 InDuo™ SYSTEM READY FOR USE 5

GETTING YOUR InDuo™ SYSTEM READY FOR USE

Preparing your InDuo™ meter

Setting the time, date and unit of measurement

Your InDuo™ meter comes with pre-set values for the 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™ meter also gives average values (14 days and 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™ meter display.

Enter the setting mode

• Press and hold down ˛ for 3 seconds.

• The InDuo™ meter is now in the setting mode and you are ready to change the time using the meter display.

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 minute 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 InDuo™ SYSTEM READY FOR USE 7

Setting the time format

• Press ˛ and the 12-hour format Ä 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. Your InDuo™ meter displays the date as mm/dd.

• 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 InDuo™ SYSTEM 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.

• Your meter has been preset to ﬁ which

is the unit of measurement generally used in Canada. It should be changed only at the recommendation of your healthcare professional.

• You can determine if the meter has been accidentally reset to the wrong unit of measurement by looking at a test result on the display. Either Á or ﬁ will appear with the result. Also, a test result in ﬁ will have a decimal point.

• If the unit is incorrect or has been changed, press Ñ to select the correct unit. If the unit is correct, just press the ˛ button to exit the setting mode.

The InDuo™ meter can display test results in milligrams per decilitre (Á) or in millimoles per litre (ﬁ). The Á unit is the standard used in the United States. The ﬁ unit is the standard used in Canada.

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

Ultra

Test Strip into the InDuo™ meter.

æ OneTouch®Ultra Test Strips

Your InDuo™ meter is designed for use only with OneTouch

• Store the OneTouch

Ultra Test Strips.

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 Strips and the vial 3 months

after the vial was first opened.

GETTING YOUR InDuo™ SYSTEM READY FOR USE 11

• Apply only OneTouch®Ultra 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 test 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 test 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 a sample applied to it. Refer to your OneTouch

Ultra Test Strip insert for

additional information.

12 GETTING YOUR InDuo™ SYSTEM READY FOR USE

Coding your InDuo™ meter

Code numbers are used to calibrate the OneTouch You must code the InDuo™ meter before using it for the first time, and then every time you change to another vial of OneTouch you do a blood glucose test, check that the code number on the meter display matches the code number on the OneTouch

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

Ultra Test Strips with the InDuo™ meter.

Ultra Test Strips. Each time

Ultra Test Strip vial.

(Example)

Entering the code mode for the first time

• Start with the InDuo™ meter turned off.

• Insert a OneTouch

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. If three dashes Q appear at any other time, see page 69 of the Display Messages and Problem Solving Guide.

GETTING YOUR InDuo™ SYSTEM READY FOR USE 13

Match the code numbers

The calibration code is stored in the meter memory until it is changed by the user. 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 two code numbers match, you may begin testing.

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

Code the InDuo™ 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, simply hold down Ñ.

• 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 unit of measurement (ﬁ or Á), 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 test results.

The control solution test should be used to:

• check that your meter and OneTouch 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 Test Strips.

• if you suspect that your InDuo™ meter or OneTouch

• 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.

Ultra Test Strips

Ultra

Ultra Test Strips are not working properly.

GETTING YOUR InDuo™ SYSTEM 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 30°C (86ºF).

• Do not refrigerate control solution.

• The control solution, the InDuo™ meter, and the OneTouch

Ultra Test Strips should be at room

temperature 20-25ºC (68-77ºF) 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 OneTouch to test meter and OneTouch

Ultra Test Strip vial is for

Ultra Control Solution only. It is used

Ultra Test Strip performance. It is not a recommended range for your blood glucose level.

16 GETTING YOUR InDuo™ SYSTEM READY FOR USE

Before you use your InDuo™ meter to test your blood for the first time, practice the procedure using the control solution test. When you can do 3 tests in a row that are within the range printed on the

Ultra Test Strip vial, you are then ready to

OneTouch test 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™ meter will turn on automatically.

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

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

Ultra Test Strip, contact bars

Ultra Test Strip in firmly until it will

GETTING YOUR InDuo™ SYSTEM 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™ SYSTEM READY FOR USE

Apply control solution

• Shake the control solution vial well.

• Remove the cap.

• Squeeze the vial and discard the first drop and wipe off the dispenser tip with a clean tissue 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 InDuo™ SYSTEM READY FOR USE 19

• If control solution test results fall 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™ meter may not be working properly.

• Do not use the InDuo™ meter 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 please call the InDuo™ Customer Care Line at 1 888 729-2299.

20 GETTING YOUR InDuo™ SYSTEM READY FOR USE

The control solution test troubleshooting

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

Ultra Test Strip vial label).

Probable reasons

Error in performing the test

Improper coding of the meter

Failure to shake the OneTouch

Ultra

Control Solution vial vigorously

Expired or contaminated OneTouch

InDuo™ meter, OneTouch

Ultra Control Solution

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

Action

Repeat the test, closely following the instructions on page 18

Check that the meter is coded correctly

Shake the control solution vial and repeat the test

Please check the expiration date or use another new control solution

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

Repeat the test

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

Call the InDuo™ Customer Care Line at 1 888 729-2299 for advice

GETTING YOUR InDuo™ SYSTEM READY FOR USE 21

PREPARING YOUR InDuo™ INSULIN DOSER TO INJECT INSULIN

To use the InDuo™ insulin doser to inject your insulin, you must first insert a Penfill attach a NovoFine

6 mm or 8 mm needle and prime

3 ml cartridge,

the InDuo™ insulin doser.

How to load Penfill

Before inserting a Penfill®3 ml insulin cartridge check that it is full and intact (e.g. no cracks). Do not use

Penfill

if any damage is seen, or if more of the rubber stopper is visible than equal to the width of the white bar code band.

If your Penfill suspension (cloudy insulin) such as Novolin Novolin this hold Penfill

cartridge contains an insulin

ge 30/70 you must first mix the insulin. To do

in your hand and carefully move

ge NPH or

your arm up and down 10 times as shown in your

Penfill

package insert.

22 GETTING YOUR InDuo™ SYSTEM READY FOR USE

To insert 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 InDuo™ SYSTEM READY FOR USE 23

• Insert Penfill

into the InDuo™ insulin doser by

pushing it slightly backwards as shown d. The end with the rubber stopper goes in first. Make sure that the colour-coded 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 it is time to change Penfill

• See page 42 for what to do if the slide is opened while the InDuo™ insulin doser contains a partially filled Penfill

24 GETTING YOUR InDuo™ SYSTEM READY FOR USE

How to attach a NovoFine®needle

• Take the protective tab off a NovoFine®needle.

• Screw the NovoFine colour-coded cap.

• Pull off the outer and inner needle caps before priming the InDuo™ insulin doser.

How to prime the InDuo™ insulin doser

Priming the InDuo™ insulin doser makes sure that insulin will flow when you give your injection. The InDuo™ insulin doser is primed when a drop of insulin appears at the tip of the NovoFine

æ The InDuo™ insulin doser should always be

primed:

needle firmly onto the

needle.

• Before each injection.

• After changing Penfill

• After changing the NovoFine

needle.

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

Priming your InDuo™ insulin doser for the first time

GETTING YOUR InDuo™ SYSTEM READY FOR USE 25

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 b.

26 GETTING YOUR InDuo™ SYSTEM READY FOR USE

• Dial 8 units c.

• Hold the InDuo™ insulin doser with the NovoFine

needle pointing upwards and tap the slide gently with your finger a few times d, to ensure that any air in Penfill

rises to the top.

• Press the push button completely in until it locks e.

• A drop of insulin should appear at the needle-tip.

• If the slide is opened while the InDuo™ insulin doser contains a partially filled Penfill

see priming

instructions on page 42.

If a drop of insulin does not appear, repeat the procedure dialing 1 unit at a time until a drop of insulin appears. It is important that insulin appears at the tip of the needle before you dial your dose. This ensures that the piston rod is in the proper position to deliver your next dose.

• If not injecting immediately remove the NovoFine

needle and discard it safely.

• If you are injecting immediately, leave the NovoFine

needle on the insulin doser until you have completed the injection then discard the needle safely.

TESTING YOUR BLOOD GLUCOSE LEVELS 27

TESTING YOUR BLOOD GLUCOSE LEVELS

Be sure to read this section, Important Information on page 65, and the OneTouch

Ultra Test Strip package insert found in this system kit box carefully before testing.

Before using your InDuo™ meter to test your blood glucose level, check that you have all the items needed to complete the procedure.

You will need:

• InDuo™ meter

• OneTouch

Ultra Test Strips

UltraSoft™ Sterile Lancets

UltraSoft™ Adjustable Blood Sampler

UltraClear™ Cap for alternate

puncture site

+ 63 hidden pages