Lifescan ONETOUCH II User manual

®
BLOOD GLUCOSE MONITORING SYSTEM
a company
Owner’s Booklet
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Dear ONE TOUCH®II System Owner:
Congratulations! You’ve chosen a very easy-to-use
blood glucose monitoring system for home testing.
Your ONE TOUCH II System will give you the
accurate test results you need, just by following a
few simple steps.
Everything you need to know about using the
ONE TOUCH II System is included in this booklet.
An audiocassette has been included with your
meter. It contains the same information in a shorter
format, and will help you get to know your blood
glucose monitoring system. A free videotape is
also available by calling the LifeScan Customer
Services Department.
Blood glucose monitoring plays an important role
in controlling your diabetes. The results you get
with the ONE TOUCH II System can help you and
your healthcare professional monitor and adjust
your treatment plan (diet, exercise, and medication)
to help you gain better control of your diabetes.
If you have any questions, please feel free to call
our toll-free number and speak with our Customer
Services Department, 1 800 227-8862.
Thank you for choosing the ONE TOUCH II System.
Sincerely,
Richard P. Thompson
President, LifeScan Inc.
P.S. Don’t forget to complete and mail the warranty
registration card. When we receive your warranty
card, we’ll send you a complimentary gift to show
our appreciation. See your warranty card for details.
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LIFESCAN CUSTOMER SERVICES
1 800 227-8862
CAUTION: BEFORE USING ANY PRODUCT TO TEST
YOUR BLOOD GLUCOSE (SUGAR), READ ALL INSTRUC-
TIONS AND PRACTICE THE TEST. DO ALL QUALITY
CONTROL CHECKS AS DIRECTED AND CONSULT WITH
A DIABETES HEALTHCARE PROFESSIONAL. THESE
RECOMMENDATIONS APPLY TO ALL BLOOD GLUCOSE
MONITORING SYSTEMS AND ARE SUPPORTED BY THE
AMERICAN ASSOCIATION OF DIABETES EDUCATORS,
THE AMERICAN DIABETES ASSOCIATION, THE U.S.
FOOD AND DRUG ADMINISTRATION, AND THE
HEALTH INDUSTRY MANUFACTURERS ASSOCIATION.
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TABLE OF CONTENTS 1. GETTING STARTED 1
Description and Use 1
Getting to Know the Meter 2
Precautions and Limitations 5
2. BEFORE TESTING 8
Checking the System 8
Coding the Meter 14
3. GETTING AND TESTING A DROP OF BLOOD 17
Using the PENLET®II Automatic Blood Sampler 17
Testing Your Blood 22
Checking the Amount of Blood on the Test Strip 28
4. HELP! (Troubleshooting) 30
Test Procedure Messages 30
Error Messages 33
Special Function/Memory Messages 38
What to Do If You Think Your Test Results Are Wrong 40
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5. TAKING CARE OF THE METER 42
Infection Control Information 42
Doing a Daily Check 43
Cleaning the Meter 43
Replacing the Battery 47
6. SPECIAL FUNCTIONS 50
Setting the Clock 50
Setting Special Functions 54
Recalling Tests from the Meter Memory 63
Setting Event Numbers 65
7. QUESTIONS AND ANSWERS 68
8. SPECIFICATIONS 73
Performance Characteristics 73
Guarantee and Warranty 74
9. GLOSSARY AND INDEX 76
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1
Description and Use
The ONE TOUCH®II Blood
Glucose Monitoring System
is intended for in vitro diag-
nostic use. This statement
means that the system should
be used only for testing
purposes and only outside
of the human body. The
ONE TOUCH®II Meter and
ONE TOUCH®Test Strips are
used for monitoring whole
blood glucose for people
who have been diagnosed
with diabetes mellitus by
conventional means. This
device is not to be used for
the diagnosis of diabetes.
The ONE TOUCH II Blood
Glucose Monitoring System is
used to measure the amount of
glucose (sugar) in whole blood.
When blood is applied to the
test strip, compounds on the
test strip react with the blood
and a blue color is formed.
The intensity of the color is
then measured and read by the
ONE TOUCH II Meter.
1. GETTING STARTED
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Getting to Know
the Meter
Study this diagram and
become familiar with
all the parts of your
ONE TOUCH®II Meter.
2
M Button C Button
Battery
Compartment
(on back)
Display
On/Off
Button
Data Port
Test Area with
Protective Coating
Test Strip
Holder
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ON/OFF BUTTON. This
button turns the meter on
and off.
DISPLAY. This is where you
read your test results and the
simple messages that help
guide you through the test.
BATTERY COMPARTMENT.
Holds one J-size battery. The
battery is already installed in
your meter. See page 47 for
replacement instructions.
M (MEMORY) BUTTON.
The ONE TOUCH®II Meter
automatically stores your test
results. Press the M button
when you want to recall past
results. For information, see
page 63.
C (CODE) BUTTON. Each
vial of ONE TOUCH®Test
Strips has a code number on
the label. Use the C button to
match the meter code with
the code number on the test
strip vial. For information,
see page 14.
TEST STRIP HOLDER. The
dark gray test strip holder
keeps the test strip in place.
The meter reads the color of
the reacted test strip through
the small hole in the test
strip holder. Remove the test
strip holder from the meter for
cleaning. For information, see
page 44.
TEST AREA. When the test
strip holder is removed, the
test area is exposed. The test
area has a clear, protective
coating over the meter optics
window that must be kept
clean and lint-free for accu-
rate results. Be careful not
to scratch or damage this
coating. For information, see
page 45.
3
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DATA PORT. This port lets
you access the information
stored in the meter’s memory
with a Data Manager™from
LifeScan, or other data
management systems. For
information, see page 55.
TEST STRIPS. ONE TOUCH®
Test Strips are used to test
your blood glucose (sugar)
level. They are sensitive to
moisture and light, so they
come in a moisture-resistant,
light-protected vial. Keep
the test strips sealed in their
original vial until you’re
ready to use them. Do not
carry loose test strips in your
meter case.
❏Carefully read this owner’s
booklet and all other
instructional material
provided with your blood
glucose monitoring system
and test supplies. Refer to
the glossary at the back
of this booklet for unfa-
miliar words.
❏For a free copy of the
“ONE TOUCH®II VIDEO
PROCEDURE GUIDE”, call
LifeScan Customer Services.
TEST SUMMARY
PASD'ALCOOL
NOALCOHOL
PASD'ALCOOL
NOALCOHOL
PASD'ALCOOL
NOALCOHOL
R
code10
T E S T S T R I P
10
CODE:
TESTFOR GLUCOSE
INWHOLE BLOOD
OPEN HERE
Milpites,CAMadein U.S.A. 51-453B
INC.
R
4
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Precautions and
Limitations
The following technical
information may be useful
if you or your healthcare
professional have concerns
about the precautions
or limitations of the
ONE TOUCH®II System.
Do not use ONE TOUCH®
Test Strips beyond the expira-
tion date printed on the vial.
Discard the vial and unused
test strips four months after
first opening the vial.
Do not use ONE TOUCH Test
Strips that are discolored,
wrinkled, torn, cut, or altered
in any way (the test spot of a
normal test strip is white or
ivory-colored).
Do not store test strips outside
of the vial.
Never make significant
changes to your medica-
tion program or ignore
physical symptoms with-
out consulting your
healthcare professional.
When the message high
appears on the meter
display, this indicates
severe hyperglycemia
(high blood sugar); contact
your healthcare profes-
sional immediately.
If you experience symp-
toms that are not consistent
with your blood glucose
results, and you have care-
fully followed the proce-
dure described in the
owner’s booklet, contact
your healthcare profession-
al immediately. 5
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ONE TOUCH®Test Strips
must be stored in a cool, dry
place, below 86°F (30°C). Do
not refrigerate test strips or
place test strips in heat or
direct sunlight.
Use only ONE TOUCH Test
Strips with the ONE TOUCH®
II Meter.
Cleaning your meter as
described in this booklet is
important for accurate results.
For information, see page 43.
Clinical Information
For use in hospitals, institu-
tions, and clinics, refer to
the ONE TOUCH®II Blood
Glucose Monitoring System
Manual and Inservice Guide
for Hospitals and Clinics.
The ONE TOUCH II Meter
is not intended for monitoring
neonatal whole blood samples.
Do not use ONE TOUCH Test
Strips with plasma or serum
samples. Results will be inaccu-
rate. ONE TOUCH Test Strips
are intended for use with fresh
whole blood or ONE TOUCH®
Normal Control Solution.
Hematocrit: Extremes in
whole blood hematocrits
(above 60%) or very low
hematocrits (below 25%) can
cause inaccurately low results.
Reducing substances, such as
ascorbic acid, do not signifi-
cantly affect blood glucose
results when occurring in
normal blood concentrations.
However, abnormally high
concentrations of reducing
substances in blood will cause
inaccurately low blood
glucose results.
Do not use samples with
preservatives that contain
fluoride (gray-top test tubes).
6
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The results will be inaccu-
rately low.
Blood glucose results obtained
with the ONE TOUCH®II
Meter may be significantly
lower than the true concentra-
tions if excessive water loss
or dehydration occurs. This
has been reported in the
medical literature for leading
blood glucose monitoring
products.1,2 Severe dehydration
can lead to many serious
complications. One complica-
tion which is of particular
importance in diabetes man-
agement is a hyperglycemic-
hyperosmolar state, with or
without ketosis, which may be
life-threatening if left untreated.
The following factors can lead
to severe dehydration:
•vomiting and diarrhea
•prescription drugs; i.e.,
diuretics
•inability to recognize
or respond to “thirst”
sensations
•sustained uncontrolled
diabetes (very high blood
glucose over a long period
of time)
•shock (severe hypertension
or high blood pressure)2,10
7
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8
Checking the System
There are two ways to make
sure your ONE TOUCH®II
System is working properly.
The check strip is used to
check that the meter is oper-
ating properly. ONE TOUCH®
Normal Control Solution is
used to check that both the
meter and the test strips are
working together as a system,
and that you are doing the test
correctly. It is very important
that you do these simple
checks routinely to make sure
you get accurate results.
1. Checking Your
ONE TOUCH®II
System with
Control Solution
ONE TOUCH®Normal Control
Solution should be used to
practice the test procedure
and to make sure your meter
and test strips are work-
ing properly.
Before you use the meter to
test your blood glucose for the
first time, practice the proce-
dure using the control solu-
tion. When you can do three
tests in a row that are within
the acceptable range, you are
ready to test your blood.
ONE TOUCH
Normal Control Solution
NormalControl
Solution
2. BEFORE TESTING
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❏Use only ONE TOUCH®
Normal Control Solution,
available from your
drugstore or authorized
LifeScan distributor.
❏Check the expiration date
on the control solution vial.
If it has expired, replace it
with new control solution.
❏Shake the control solution
well, before using.
To do a control solution test,
follow the same procedure
you would if you were testing
your blood. For information,
see page 22.
Your control solution results
will appear on the meter
display as follows:
c 98
contrl
(example)
The acceptable range* for
ONE TOUCH Normal Control
Solution is printed on the test
strip vial. This range is for the
control solution only; it is not
intended as a recommended
range for your blood glucose
test results.
*The control solution range is shown
in two different units of measure—
mg/dL (used in the United States)
and mmol/L (used in Canada and
some European countries).
R
9
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You must use the
control solution:
❏At least once a week.
❏When you begin using a
new package of test strips.
❏Whenever you suspect
the meter or test strips are
not working properly (for
example —when your
results are not consistent
with how you feel).
2. Checking the Meter with
the Check Strip
A purple and white check
strip is included with your
ONE TOUCH®II Meter. The
check strip is used to make
sure your meter is work-
ing properly.
Before doing a check strip
test, make sure the test strip
holder and the test area are
clean, dry, and lint-free. For
information, see page 42.
Make sure both sides of the
check strip are clean and dry.
1
✔
2
✔
Check Strip
Front Back
CAUTION: If your control
solution result falls outside
the acceptable range, the
system is not working prop-
erly. Do not use the system
to test your blood until
you get a reading that falls
within the acceptable range.
For assistance, call LifeScan
Customer Services.
10
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Do the check strip test at room
temperature (between 64°F
and 79°F [18°–26°C]).
How to use the check strip:
Step 1:
Press on/off
button.
code 7
(example)
will appear
on the dis-
play. (The
code num-
ber does
not need to
match the
code number on the test
strip vial to do a check
strip test.)
insert
strip
appears.
Slide the
check
strip into
the test
strip
holder
with the
notched
end first,
Side 1
(purple)
facing up.
wait
appears for a few moments.
1
✔
code 7
11
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Step 2:
When
apply
sample
appears,
remove
the check
strip from
the test
strip
holder.
Step 3:
When
insert
side 2
appears,
turn the
check
strip over
and put it
back into
the test
strip
holder, notched end first,
Side 2 (white) facing up.
The meter counts down from
4 to 0, then
A 70
A ok
(example)
appears if the number falls
within the acceptable check
strip range. The meter auto-
matically tells you if your
reading falls within the correct
check strip range. (The range
is also printed on the back
of the meter in both mg/dL
and mmol/L.)
2
✔
1
✔
12
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These messages will continue
to display until you turn the
meter off or for two minutes,
after which the meter auto-
matically turns off. You may
now proceed with a blood
glucose test.
If the reading is not within the
acceptable range, the meter
display will read
A 38
A not ok
redo A
(example)
Go back to Step 1 and repeat
the check strip test. If this
message appears again, clean
your meter. For information,
see page 42. For further
assistance, call LifeScan
Customer Services.
The next time you turn on
your meter,
code 7
redo A
(example)
will appear, indicating that
your check strip test result
was out of range at the
last reading.
This message will appear each
time the meter is turned on
until you perform a check
strip test that falls in the
acceptable range.
CAUTION: If your check
strip test result falls outside
the acceptable range, the
meter is not working
properly. Do not use the
meter to test your blood
until you get a check strip
test result that is within
the acceptable range. For
assistance, call LifeScan
Customer Services.
13
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You must use the
check strip:
❏At least once a day.
❏After cleaning the meter.
❏Whenever your results
are not consistent with
how you feel, or when
you think your results
are not accurate.
❏Whenever this message
appears:
A 38
Anot ok
redo A
(example)
Cleaning and maintaining
the check strip:
❏Make sure both sides of the
check strip are clean. If not,
wipe with a soft cloth or
tissue dampened with
water. Dry completely.
❏Do not put blood, alcohol,
control solution, or any
other fluid (except water)
on the check strip.
❏Do not scratch the
check strip.
❏Do not leave the check
strip in sunlight for long
periods of time.
❏If you lose or damage the
check strip, call LifeScan
Customer Services for a
free replacement.
Coding the Meter
CAUTION: You must
match the code number
on the meter display
with the code number
on the test strip vial that
you are using. If these
two code numbers do
not match, you will get
inaccurate results.
14
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Set the code:
❏Before using the meter for
the first time.
❏Every time you open a
new vial of test strips or
change to a different vial
of test strips.
Step 1: Turn On the Meter.
Press the
on/off
button to
turn the
meter on.
code
and a
number
code 7
(example)
appears on the display for
several seconds, followed by
insert strip.
The code numbers on test
strip vials range from 1 to
16. If the
number on
the display
matches
the code
number on
your test
strip vial, you may proceed
with a blood test. For infor-
mation, see page 22. If it is not
the same, go on to Step 2.
code 7
15
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