Lifescan In Duo User manual

InDuo™
Blood Glucose Meter
InDuo™ SYSTEM AND ACCESSORIES
OneTouch®Ultra
Test Strips
OneTouch®Ultra
Control Solution
InDuo™
Insulin Doser
NovoFine®8 mm needles
(10-pack sample included in kit)
Penfill®3 ml
Insulin cartridge
(not included)
OneTouch®UltraSoft™
Adjustable Blood Sampler
OneTouch®UltraSoft™
Sterile Lancet
OneTouch®
UltraClear™ Cap
for alternate puncture site
Combined blood glucose
monitoring and
insulin dosing system
User manual
Manufactured by:
LifeScan Inc.
Milpitas, California 95035, U.S.A.
© LifeScan / Novo Nordisk 2002
Revision date: 06/02
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®Ultra Test Strips are designed to be used with the InDuo™ blood
glucose meter.
Penfill®3 ml cartridges and NovoFine®needles are designed to be used with the
InDuo™ insulin doser.
Innovo®, NovoFine®, Novolin-Pen®3, Penfill®and ware trademarks owned by
Novo Nordisk A/S and used by Novo Nordisk Canada Inc. under licence.
InDuo™, In Touch®, OneTouch®, UltraClear™, UltraSoft™ and Penlet®
are trademarks owned by Johnson & Johnson and used by LifeScan Canada Ltd.
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.
2
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NovoFine®
6 mm or 8 mm w
OneTouch®UltraSoft™ Adjustable Blood Sampler OneTouch®Ultra
Test Strip
Penfill®3 ml
Needle Protective
tab
Inner
needle
cap
Colour-coded
cap
Colour-
coded
band
Rubber membrane White bar code band
Rubber
stopper
Glass ball
(for insulin
suspensions only)
Outer needle
cap
Top edge
Confirmation
window
Contact bars
Ejection / Cocking control
Release button
Indicator mark
Puncture depth
setting knob
Deep puncture
Shallow puncture
Cap
Test port
Meter display
Data port
M button
C button
Push button
Release button
Dose selector
Insulin doser
display
LOT number
Window
Piston rod
Residual scale
Slide
Protective disk
Ketones?
Appears when a blood glucose test
result is above 13.3 mmol/L.
Ctl
Indicates a control solution
test result.
Month
Mem
Indicates a test result stored in the
memory.
MinutesDay Hour
Test result area
Test results are displayed here.
(A decimal point appears when the unit
of measurement is millimoles per litre.)
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.
Circle
Confirms that the delivery has been
completed.
Dose
Shows the number of insulin units
dialed.
Unit of measurement
The meter has been pre-set in either
mmol/L or mg/dL. Confirm that the
unit of measurement is correct when
the apply symbol appears during
blood application.
InDuo™ BLOOD GLUCOSE METER AND INSULIN DOSER InDuo™ METER AND INSULIN DOSER DISPLAY SYMBOLS InDuo™ COMPONENTS
OneTouch®UltraSoft™ Lancet
DCO_06153701A_ID_OBC_CAN 9/6/02 11:34 AM Page 2

3
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
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4
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.
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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.
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Setting the hour
• The time will appear first, with the hour digits
flashing.
• Press and release Ñuntil the correct hour is
displayed.
• To scroll faster, hold Ñdown.
• After setting the hour, press ˛to set the minutes.
The minute digits will start flashing.
Setting the minutes
• Press and release Ñuntil the correct minute is
displayed.
• To scroll faster, hold Ñdown.
6GETTING YOUR InDuo™ SYSTEM READY FOR USE
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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 Ñagain 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 Ñuntil the correct year is
displayed.
• To scroll faster, hold Ñdown.
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8GETTING 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 Ñuntil the correct month is
displayed.
• To scroll faster, hold Ñdown.
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 Ñdown.
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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 fiwhich
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 Áor fiwill appear with
the result. Also, a test result in fiwill have
a decimal point.
• If the unit is incorrect or has been changed, press
Ñto 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 Áunit is the standard used
in the United States. The fiunit is the standard
used in Canada.
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10 GETTING YOUR InDuo™ SYSTEM READY FOR USE
æOneTouch®Ultra Test Strips
Your InDuo™ meter is designed for use only with
OneTouch®Ultra Test Strips.
• Store the OneTouch®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.
Contact bars
Insert this end of
OneTouch®Ultra
Test Strip into the
InDuo™ meter.
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.
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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.
DCO_06153701A_ID_OB_CAN 9/6/02 11:36 AM Page 11

(Example)
12 GETTING YOUR InDuo™ SYSTEM READY FOR USE
Coding your InDuo™ meter
Code numbers are used to calibrate the
OneTouch®Ultra Test Strips with the InDuo™ meter.
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.
æ Caution: If the code numbers do not match,
your blood glucose tests may be inaccurate.
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 Qappear at any other time,
see page 69 of the Display Messages and Problem
Solving Guide.
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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 Ñto 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 Rwill appear with the unit of
measurement (fior Á), indicating that
the InDuo™ meter is ready for testing.
(Example)
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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®Ultra 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 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®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™ meter or
OneTouch®Ultra 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 your InDuo™ meter.
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GETTING YOUR InDuo™ SYSTEM READY FOR USE 15
æCaution:
• 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®Ultra Test Strip vial is for
OneTouch®Ultra Control Solution only. It is used
to test meter and OneTouch®Ultra Test Strip
performance. It is not a recommended range for
your blood glucose level.
DCO_06153701A_ID_OB_CAN 9/6/02 11:36 AM Page 15

a
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
OneTouch®Ultra Test Strip vial, you are then ready to
test your blood.
How to do a control solution test
Insert OneTouch®Ultra Test Strip
• Insert a OneTouch®Ultra Test Strip, contact bars
end first aand facing up, into the test port. Push
the OneTouch®Ultra Test Strip in firmly until it will
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 Rwith the unit of measurement
(fior 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).
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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 Ësymbol 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 Ñagain and the Ësymbol
will disappear.
•Every time you perform a control solution test,
you must mark the test result with the Ësymbol
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.
DCO_06153701A_ID_OB_CAN 9/6/02 11:36 AM Page 17

b
c
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®Ultra Test Strip (where it meets the
narrow channel) until the drop is drawn into the
OneTouch®Ultra Test Strip, the confirmation
window is filled, and the meter display begins to
count down.
Read test results
• The meter will count down from Nto Aand the
control solution test result will appear c.
• Compare the result with the range printed on the
OneTouch®Ultra Test Strip vial label. The result
should fall within this range.
18 GETTING YOUR InDuo™ SYSTEM READY FOR USE
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GETTING YOUR InDuo™ SYSTEM READY FOR USE 19
æCaution
• 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.
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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 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
Error in performing the test
Improper coding of the meter
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®Ultra Control Solution
OneTouch®Ultra Test Strip
deterioration
InDuo™ meter malfunction
DCO_06153701A_ID_OB_CAN 9/6/02 11:36 AM Page 20