Lifescan InDuo blood glucose meter 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
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 InDuo™ blood
glucose meter.
PenFill®3 mL cartridges and NovoFine®needles are designed to be used with the
InDuo™ insulin doser. PenFill®not included.
PenFill®and NovoFine®are trademarks of Novo Nordisk A/S.
IN TOUCH®and OneTouch®are trademarks of LifeScan, Inc.
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.
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
AW 06084101C
User’s Manual
www.InDuo.com
Distributed by:
LifeScan Inc.
Milpitas, California 95035, U.S.A.
In partnership with
Novo Nordisk A/S
2880 Bagsvaerd, Denmark
© LifeScan/Novo Nordisk 2001
Revision date: August 2004
For assistance or further
information please call InDuo™
Customer Services at our toll free
number:
(English) 1-877-520-9056
(Español) 1-800-381-7226
DCO_06084101C_InDuo_OBCVR_US 8/16/04 12:44 PM Page 1

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
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 InDuo™ blood
glucose meter.
PenFill®3 mL cartridges and NovoFine®needles are designed to be used with the
InDuo™ insulin doser. PenFill®not included.
PenFill®and NovoFine®are trademarks of Novo Nordisk A/S.
IN TOUCH®and OneTouch®are trademarks of LifeScan, Inc.
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.
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
AW 06084101C
User’s Manual
www.InDuo.com
Distributed by:
LifeScan Inc.
Milpitas, California 95035, U.S.A.
In partnership with
Novo Nordisk A/S
2880 Bagsvaerd, Denmark
© LifeScan/Novo Nordisk 2001
Revision date: August 2004
For assistance or further
information please call InDuo™
Customer Services at our toll free
number:
(English) 1-877-520-9056
(Español) 1-800-381-7226
DCO_06084101C_InDuo_OBCVR_US 8/16/04 12:44 PM Page 1

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
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 InDuo™ blood
glucose meter.
PenFill®3 mL cartridges and NovoFine®needles are designed to be used with the
InDuo™ insulin doser. PenFill®not included.
PenFill®and NovoFine®are trademarks of Novo Nordisk A/S.
IN TOUCH®and OneTouch®are trademarks of LifeScan, Inc.
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.
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
AW 06084101C
User’s Manual
www.InDuo.com
Distributed by:
LifeScan Inc.
Milpitas, California 95035, U.S.A.
In partnership with
Novo Nordisk A/S
2880 Bagsvaerd, Denmark
© LifeScan/Novo Nordisk 2001
Revision date: August 2004
For assistance or further
information please call InDuo™
Customer Services at our toll free
number:
(English) 1-877-520-9056
(Español) 1-800-381-7226
DCO_06084101C_InDuo_OBCVR_US 8/16/04 12:44 PM Page 1

NovoFine®
6 mm or 8 mm
OneTouch®UltraSoft™ Adjustable blood sampler OneTouch®
Ultra Test strip
OneTouch® Lancet
PenFill®3 mL
Needle Protective
tab
Inner
needle
cap
Threaded
plastic cap
Front rubber stopper White bar code band
Rear
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.
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 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
dialed.
Unit of measurement
The meter has been pre-set in either
mg/dL or mmol/L. 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
DCO_06084101C_InDuo_OBCVR_US 8/16/04 12:44 PM Page 2

NovoFine®
6 mm or 8 mm
OneTouch®UltraSoft™ Adjustable blood sampler OneTouch®
Ultra Test strip
OneTouch® Lancet
PenFill®3 mL
Needle Protective
tab
Inner
needle
cap
Threaded
plastic cap
Front rubber stopper White bar code band
Rear
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.
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 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
dialed.
Unit of measurement
The meter has been pre-set in either
mg/dL or mmol/L. 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
DCO_06084101C_InDuo_OBCVR_US 8/16/04 12:44 PM Page 2

NovoFine®
6 mm or 8 mm
OneTouch®UltraSoft™ Adjustable blood sampler OneTouch®
Ultra Test strip
OneTouch® Lancet
PenFill®3 mL
Needle Protective
tab
Inner
needle
cap
Threaded
plastic cap
Front rubber stopper White bar code band
Rear
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.
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 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
dialed.
Unit of measurement
The meter has been pre-set in either
mg/dL or mmol/L. 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
DCO_06084101C_InDuo_OBCVR_US 8/16/04 12:44 PM Page 2

3
CONTENTS
Welcome 4
Getting your InDuoTM system ready for use 5
Preparing your InDuoTM meter 5
Preparing your InDuoTM insulin doser to inject insulin 21
Testing your blood glucose levels 27
Injecting your insulin 41
Using the InDuoTM 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 InDuoTM meter and laboratory results 58
Caring for your InDuoTM system 60
Important information 65
Display messages and problem-solving guide 68
The InDuoTM meter 69
The InDuoTM insulin doser 80
Specifications 86
Warranty 87
Blood value targets 88
DCO_06084101C_InDuo_OB_US 8/16/04 1:08 PM Page 3

4
WELCOME
You have chosen the InDuoTM system, a
system designed to simplify the way you
manage your diabetes. Featuring an
integrated blood glucose meter and insulin
doser, InDuoTM 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 InDuoTM
system. Read it carefully.
Your InDuoTM 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. If you have been
using another type of meter, you may notice
that the results with the InDuoTM meter are
about 12% higher than with your previous
system. The InDuoTM meter is designed for
use with OneTouch®Ultra test strips only.
Your InDuoTM 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 InDuoTM system
helps you simplify your insulin therapy and
increase your confidence in managing your
diabetes.
A warranty registration card is included
with your InDuo
TM
system. If you complete it
and mail it to us, we will send you a gift.
We are sure that you will find your
InDuoTM system simple and easy to use.
If you have any questions regarding your
InDuoTM system, please do not hesitate to
call InDuo Customer Services at our toll free
number 1-877-520-9056.
The InDuo
TM
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.
DCO_06084101C_InDuo_OB_US 8/16/04 1:08 PM Page 4

GETTING YOUR InDuoTM SYSTEM READY FOR USE 5
GETTING YOUR InDuoTM SYSTEM
READY FOR USE
Preparing your InDuoTM meter
Setting the time, date, and unit of measurement
Your InDuoTM 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
InDuoTM 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 InDuoTM meter display.
Enter the setting mode
• Press and hold down ˛for 3 seconds.
• The InDuoTM meter is now in the setting mode and
you are ready to change the time using the
meter display.
DCO_06084101C_InDuo_OB_US 8/16/04 1:08 PM Page 5

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 InDuoTM SYSTEM READY FOR USE
DCO_06084101C_InDuo_OB_US 8/16/04 1:08 PM Page 6

GETTING YOUR InDuoTM SYSTEM READY FOR USE 7
Setting the time format
• Press ˛and the 12-hour format will start flashing.
• Your InDuoTM 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.
• 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.
DCO_06084101C_InDuo_OB_US 8/16/04 1:08 PM Page 7

8GETTING YOUR InDuoTM 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.
DCO_06084101C_InDuo_OB_US 8/16/04 1:08 PM Page 8

GETTING YOUR InDuoTM 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 InDuoTM 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.
• Consult your healthcare professional before you
change the unit of measure.
• 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.
DCO_06084101C_InDuo_OB_US 8/16/04 1:08 PM Page 9

10 GETTING YOUR InDuoTM SYSTEM READY FOR USE
æOneTouch®Ultra test strips
Your InDuoTM meter is designed for use with
OneTouch®Ultra test strips only.
• 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
InDuoTM 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.
DCO_06084101C_InDuo_OB_US 8/16/04 1:08 PM Page 10

GETTING YOUR InDuoTM 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.
DCO_06084101C_InDuo_OB_US 8/16/04 1:08 PM Page 11

(Example)
12 GETTING YOUR InDuoTM SYSTEM READY FOR USE
Coding your InDuoTM meter
Code numbers are used to calibrate the OneTouch®
Ultra test strips with the InDuoTM meter. You must
code the InDuoTM 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 InDuoTM 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 InDuoTM meter, 3 dashes Q
will appear, showing there is no code stored in the
meter memory.
DCO_06084101C_InDuo_OB_US 8/16/04 1:08 PM Page 12

GETTING YOUR InDuoTM SYSTEM 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 InDuoTM meter.
Code the InDuoTM 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, hold Ñdown.
• 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 InDuoTM meter is ready for testing.
(Example)
DCO_06084101C_InDuo_OB_US 8/16/04 1:08 PM Page 13

14 GETTING YOUR InDuoTM 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.
• 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 InDuoTM 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 InDuoTM meter.
DCO_06084101C_InDuo_OB_US 8/16/04 1:08 PM Page 14

GETTING YOUR InDuoTM 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 86ºF (30°C).
• Do not refrigerate control solution.
• The control solution, the InDuoTM meter, and the
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 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_06084101C_InDuo_OB_US 8/16/04 1:08 PM Page 15

a
16 GETTING YOUR InDuoTM SYSTEM READY FOR USE
Before you use your InDuoTM meter 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®Ultra test strip vial, you are 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 InDuoTM 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 page 5 and 9
for additional information on the unit of
measurement.)
DCO_06084101C_InDuo_OB_US 8/16/04 1:08 PM Page 16