Lifescan INDUO User manual

InDuo™
Blood Glucose Meter
InDuo™ SYSTEM AND ACCESSORIES
OneTouch®Ultra™
Test Strips
OneTouch®Ultra™
Control Solution
InDuo™
Insulin Doser
NovoFine®
Needles 10-pack
Penfill®3 ml
Insulin Cartridge
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:
Novo Nordisk A/S
2880 Bagsvaerd, Denmark
in cooperation with
LifeScan Inc.
Milpitas, California 95035, U.S.A.
© LifeScan / Novo Nordisk 2001
Revision date: 01/2003
The InDuo™ system should only be used in combination with products that are
compatible therewith 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®3ml cartridges and NovoFine® needles are designed to be used with the
InDuo™ insulin doser.
InDuo™, Penfill®and NovoFine®are trademarks owned by Novo Nordisk A/S.
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.
The CE-mark on the InDuo™ blood glucose meter, test strips and control solution indicates that the
products conform with the provisions in the EC Directive for In Vitro Diagnostic Medical Devices 98/79/EC.
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.
2

NovoFine®
6 mm or 8 mm w
OneTouch®UltraSoft™ Adjustable blood sampler OneTouch®Ultra™
Test strip SYMBOLS
æAttention: See instructions for use
SN Serial Number
In Vitro Diagnostic Medical Device
Expiration Date
Sterilised by irradiation
LOT number
OneTouch®Lancet
Penfill®3 ml
Needle Protective
tab
Inner
needle
cap
Colour-coded
cap Coloured
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
Residual scale
Slide
Protective disk
Ketones?
Appears when a blood glucose test
result falls above 240 mg/dL.
Ctl
Indicates a control solution
test result.
Day
Mem
Indicates a test result stored in the
memory.
MinutesMonth Hour
Test result area
Test results are displayed here.
(A decimal point appears when the unit
of measurement is millimoles per liter.)
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
dialled.
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 SYMBOLS 91

3
CONTENTS
Welcome 4
Getting your InDuo™ system ready for use 5
Preparing your InDuo™ meter 5
Preparing your InDuo™ insulin doser 21
Testing your blood glucose levels 27
Injecting your insulin 41
Using the InDuo™ memory functions 51
How to check your previous test results 51
How to check 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™ 60
Important information 65
Display messages and problem-solving guide 68
The InDuo™ meter 69
The InDuo™ insulin doser 82
Specifications 88
Guarantee 89
Blood glucose value targets 90
Symbols 91

4
WELCOME
You have chosen the InDuo™ system, a
system designed to simplify the way you
manage your diabetes. Featuring an
integrated blood glucose meter and
insulin doser, InDuo™ 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. The InDuo™ meter is designed
for use only with OneTouch®Ultra™
test strips. If you have been using
whole blood calibrated test strips, you
will notice that the results recorded on
the InDuo™ meter are about 12%
higher than with your previous system.
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 to simplify
your insulin therapy and to increase your
confidence in managing your diabetes.
A warranty registration card is included
with your InDuo™ system. If you prefer you
may complete the warranty card online by
visiting our website - “induo.com”.
We are sure that you will find your
InDuo™ system simple and easy to use.
If you have any queries regarding your
InDuo™ system, please do not hesitate
to call Customer Service at your local
Novo Nordisk or LifeScan office.
The InDuo™ meter is intended for self-
test 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.

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 minutes 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

GETTING YOUR InDuo™ SYSTEM READY FOR USE 7
Setting the time format
• Press ˛and the 24-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 24-hour format is pre-set in the meter.
• If you wish to display the time in 12-hour format,
press and release Ñ. Pressing Ñagain will return
you to the 24-hour format.
Setting the year
Before setting the date you must have first set the time.
Your InDuo™ meter displays the date as dd/mm/yy.
• 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.

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.

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.
The InDuo™ meter can display test results in
milligrams per deciliter (Á) or in millimoles per
liter (fi). The Áunit is standard in the
United States. The fiunit is commonly used in
Canada and some European countries.
• Your meter was set at the factory to the unit
generally used in your country. 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 measure by
looking at a test result on the display. Either
Áor fiwill appear with the result.
Also, a test result in mmol will have a decimal point.
• If the units are incorrect or have been changed,
press Ñto 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
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 strip s 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.

GETTING YOUR InDuo™ SYSTEM 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
re-use a test strip that has had sample applied to it.
Refer to your OneTouch®Ultra™ test strip insert for
additional information.

(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
• 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 3 dashes Q appear at any other time, then 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 2 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 units of
measurement (Áor 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®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 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.
• practise 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.

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 approved
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.

a
16 GETTING YOUR InDuo™ SYSTEM READY FOR USE
Before you use your InDuo™ meter to test your
blood for the first time, practise 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. Then the code number is displayed,
followed by the apply symbol R with the units of
measurement (Áor fi).
• Verify that the calibration code and units of
measurement are set correctly. (See pages 5 and 9
for additional information on the unit of
measurement).

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.

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 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
(Example)

GETTING YOUR InDuo™ SYSTEM READY FOR USE 19
æCaution
• If test results fall outside the range printed on the
OneTouch®Ultra™ test strip vial, repeat the test
with a new test strip.
• If you continue to get control solution test results
that fall outside of the range printed on the vial,
the InDuo™ system may not be working properly.
• Do not use the InDuo™ 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
Customer Service at your local
Novo Nordisk or LifeScan office.

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 above
Shake the control solution vial and
repeat the test
Please check the expiration date or use
new control solution
Check that the room temperature is
about 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 Customer Service at your local Novo
Nordisk or LifeScan office for advice
Check that the meter is coded correctly
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®Ultra™ control solution
OneTouch®Ultra™ test strip deterioration
InDuo™ meter malfunction
Improper coding of the meter