Lifescan ONE TOUCH BASIC BLOOD GLUCOSE MONITORING SYSTEM User Manual

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BLOOD GLUCOSE MONITORING SYSTEM
®
®
SYSTÈME DE CONTRÔLE DE LA GLYCÉMIE
OWNER’S BOOKLET MANUEL DU PROPRIÉTAIRE
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BLOOD GLUCOSE MONITORING SYSTEM
®
®
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Dear ONE TOUCH®BASIC®Owner:
Congratulations! You’ve chosen a very easy­to-use blood glucose monitoring system for home testing. Your ONE TOUCH
®
BASIC
®
System will give you the accurate test results you need, in just a few simple steps.
If you have any questions, please feel free to call our toll-free number and speak with our Technical Services Department, 1 800 663-5521.
Thank you for choosing the ONE TOUCH BASIC Meter.
Everything you need to know about using the ONE TOUCH BASIC System is includ­ed in this booklet.
Blood glucose monitoring plays an impor­tant role in controlling your diabetes. The results you get with the ONE TOUCH BASIC System can help you and your Health Care Professional monitor and adjust your treatment plan (diet, exercise, and medication) to help you gain better control of your diabetes.
Sincerely,
Jackie Graham Manager, Customer Service LifeScan Canada Ltd.
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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CAUTION: Before using any product to test your blood glucose
(sugar), read all instructions and practice the test. Consult your
diabetes health professional for advice regarding selection of
equipment, testing times and procedures. These recommenda-
tions apply to all blood glucose monitoring systems and are
supported by the Diabetes Educator Section of the Canadian
Diabetes Association.
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TABLE OF CONTENTS
1. GETTING STARTED Description and Use . . . . . . . . . . . . . . . . 1
Getting to Know the Meter . . . . . . . . . . . 2
Precautions and Limitations . . . . . . . . . . 5
2. SETTING THE METER Selecting the Display Language
and the Unit of Measurement . . . . . . . 7
Coding the Meter . . . . . . . . . . . . . . . . . . 8
3. CHECKING THE SYSTEM Checking with the Check Strip . . . . . . . 11
Checking with Control Solution . . . . . . 17
4. GETTING A DROP OF BLOOD Using the PENLET®II Automatic
Blood Sampler . . . . . . . . . . . . . . . . . 20
5. TESTING YOUR BLOOD Step-by-Step Instructions . . . . . . . . . . . 28
LifeScan Technical Services: Canada 1 800 663-5521
USA 1 800 227-8862
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6. AFTER TESTING Checking the Amount of Blood . . . . . . 36
Recording Your Test Results . . . . . . . . . 37
Displaying Last Test Result . . . . . . . . . 38
7. HELP! (Troubleshooting) Test Procedure Messages . . . . . . . . . . . 40
Error Messages . . . . . . . . . . . . . . . . . . . 43
8. TAKING CARE OF THE METER Daily Meter Check . . . . . . . . . . . . . . . . 55
Cleaning the Meter . . . . . . . . . . . . . . . . 55
Battery Replacement . . . . . . . . . . . . . . . 60
9. QUESTIONS AND ANSWERS 64
10. SPECIFICATIONS Performance Characteristics . . . . . . . . . 72
Guarantee and Warranty . . . . . . . . . . . . 73
11. INDEX 75
LifeScan Technical Services: Canada 1 800 663-5521
USA 1 800 227-8862
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BLANK
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1. GETTING STARTED
Description and Use
The ONE TOUCH®BASIC®Blood Glucose Monitoring System is intended for
in vitro diagnostic use. This statement means that the system should be used only for testing purposes and only outside of the human body. The ONE TOUCH
®
BASIC®Meter and Test Strips are used for monitoring whole blood glucose for people who have been diagnosed with diabetes mellitus. This device is not to be used for the diagnosis of diabetes.
The ONE TOUCH BASIC Blood Glucose Monitoring System meas­ures 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 BASIC Meter.
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Getting to Know the
C Button
Battery Compartment (on back)
Display
On/Off Button
Test Area with Protective Coating
Test Strip Holder
Meter
Study this diagram and become familiar with all the parts of your ONE TOUCH BASIC®Meter.
®
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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.
“C” BUTTON. Use the “C” Button
to match the Meter code with the code number on the Test Strip package. You can also use the “C”
Button to select display languages in English, French, Spanish, German, Dutch, Italian, Portuguese, Swedish, Danish, Norwegian, Finnish, Greek, Turkish, Hungarian, Czech, Polish, Russian or Japanese and each language’s corresponding unit of measurement, (mmol/L) or (mg/dL).
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.
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TEST AREA. When the Test Strip
TEST SUMMARY*
®
TM
TEST SUMMARY*
®
TM
TEST SUMMARY*
1 2 3
Press On/ Off Button, Insert test strip
Apply Blood Sample
Results in 45 Seconds
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1
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T E S T S T R I P
10
CODE:
TEST FOR GLUCOSE IN WHOLE BLOOD
OPEN
HERE
Milpites,CA Made in U.S.A. 51-453B
INC.
R
T E S T S T R I P
10
CODE:
TEST FOR GLUCOSE IN WHOLE BLOOD
OPEN
HERE
Milpites,CA Made in U.S.A. 51-453B
INC.
R
S T R I P
10
CODE:
OPEN
HERE
R
10
CODE:
OPEN
HERE
R
1
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 accurate results. Be careful not to scratch or damage this coating.
®
TEST STRIPS. ONE TOUCH
Strips are used to test your blood glucose (sugar) level. They are
Test
sensitive to moisture and light, so they come in a moisture-resistant, light-protected vial or foil package. Keep the Test Strips sealed in their original package until you’re ready
to use them. DO NOT store Test Strips outside of their packaging.
Carefully read this Owner’s Booklet and all other instructional material provided with your blood glucose monitoring system and test supplies.
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Precautions and Limitations
The following information may be useful to you and your Health Care Professional when using the
®
ONE TOUCH monitor your blood glucose level.
If you experience symptoms that are not consistent with your blood glucose results, and you have carefully followed the procedure described in the Owner’s Booklet, contact your Health Care Profes­sional immediately.
BASIC®System to
Never make significant changes to your medication program or ignore physical symptoms with­out consulting your Health Care Professional.
If the message HIGH appears on the meter display, this indicates severe hyperglycemia (high blood sugar); contact your Health Care Profes­sional immediately.
IMPORTANT: The ONE TOUCH BASIC®Meter is not intended for monitoring neonatal (newborn child) blood samples.
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®
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DO NOT use ONE TOUCH®Test Strips beyond the expiration date printed on the package label. If using Test Strips from a vial, discard the vial and unused Test Strips 4 months after the date first opened.
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 or carry Test Strips outside of their vial or foil package.
ONE TOUCH Test Strips must be stored in a cool, dry place, below 30°C (86°F). Do not refrigerate Test Strips or place Test Strips in heat or direct sunlight.
It is important to clean your Meter as described in this booklet to ensure that you get accurate results. (See Cleaning the Meter, page 55.)
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2. SETTING THE METER
Selecting the Display Language and the Unit of Measurement
The ONE TOUCH®BASIC®Meter displays easy-to-follow messages in English, French, Spanish, German, Dutch, Italian, Portuguese, Swedish, Danish, Norwegian, Finnish, Greek, Turkish, Hungarian, Czech, Polish, Russian, or Japanese to help guide you through the test procedure. The Meter is preset in English (mmol/L) at the factory.
To select another display language and its corresponding unit of measurement:
1. Press and hold the “C” Button.
2. Press and release the On/Off Button.
3. Release the “C” Button.
The following programs with their corresponding language and unit of measurement appear as you con­tinue pressing the “C” Button: “P 4” for French (mmol/L), “P 5” for French (mg/dL), “P 6” for German (mg/dL), “P 7” for German (mmol/L), “P 8” for Dutch (mg/dL), “P 9” for Dutch (mmol/L), “P 10” for Italian (mg/dL), “P 11” for Portuguese (mg/dL), “P 12” for Swedish (mmol/L), “P 13” for Danish (mmol/L), “P 14” for
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Norwegian (mmol/L), “P 15” for Finnish (mmol/L), “P 16” for Greek (mg/dL), “P 17” for Turkish (mg/dL), “P 18” for Hungarian (mmol/L), “P 19” for Czech (mmol/L), “P 20” for Polish (mmol/L), “P 21” for Russian (mmol/L), “P 22” for Japanese (mg/dL), “P 23” for Japanese (mmol/L), “P 1” for English (mg/dL), “P 2” for Spanish (mg/dL), “P 3” for English (mmol/L).
When your desired selection is displayed, press the On/Off Button. All messages will now appear in the language you have chosen.
Coding the Meter
IMPORTANT: Every time you test,
the code number on the Meter display must match the code number on the ONE TOUCH Strip package you’re using. If these two code numbers do not match, you will get inaccurate results.
Set the code:
Before using the Meter for the first time.
Every time you open a new package of Test Strips or change to a different package of Test Strips.
If the Meter is displaying reset code.
8
®
Test
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Step 1: Turn on the Meter
1
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:
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Press the On/Off Button to turn the Meter on. The result from your last blood glucose or Control Solution test will appear for 3 seconds.
Then
code 7
(example)
appears on the display for 2 seconds, followed
code 7
by
memory or memory mm 5 . 9
(example) c 5 . 4 (example)
(Your ONE TOUCH®BASIC®Meter auto­matically recalls and displays your last result—either from a blood glucose or Control Solution test—whenever the Meter is turned on. When using the Meter for the first time, memory/no data appears to indicate that there is no test result in the memory. See Displaying Last Test Result, page 38.)
9
insert strip
The code number on the Test Strip package (vial or foil) ranges from 1 to
16. If the number on the
display matches the code number on your Test Strip package, you may proceed with a blood test. If it is not the same, go on to Step 2.
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Step 2: Match the Code Number
code10
Press the “C” Button. With
code 7
(example)
on the display, press and release the “C” Button, and the number will increase by one. Continue pressing until the number on the display matches the code number on your Test Strip package.
The Meter is now properly coded and you may proceed with the test. From now on, the Meter will remember this code until you change the code for a new package of Test Strips.
code 10
(example)
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3. CHECKING THE SYSTEM
There are two ways to make sure
®
your ONE TOUCH is working properly. The Check
Strip
is used to check that the Meter is operating properly. The ONE TOUCH
Normal Glucose Control Solution— Blue Formula 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.
BASIC®System
Checking with the Check Strip
A purple and white Check Strip is included with your ONE TOUCH BASIC Meter. The Check Strip is used to make sure your Meter is working properly.
®
11
Front Back
1
2
Page 19
Before doing a Check Strip test,
code 7
make sure the Test Strip Holder, the Test Area and Check Strip are clean, dry, and lint-free. Do the Check Strip test at room temperature between 18°C and 26°C (64°F–79°F).
How to use the Check Strip
Step 1:
Press On/Off Button. Your last blood glucose or Control Solution test result will appear for 3 seconds,
memory or memory mm 5 . 9
(example) c 5 . 4 (example)
then
code 7
(example)
will appear on the display.
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When
insert strip
strip
appears, slide the notched end of the Check Strip into the Test Strip Holder with Side 1 (purple) facing up.
wait
appears for a few seconds.
Step 2:
When
apply
sample
sample
appears, slide the
1
Check Strip from the Test Strip
1
Holder.
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Step 3:
When
insert side 2
appears, turn the Check Strip over and slide it back into the Test Strip Holder, notched end first, Side 2 (white) facing up. The Meter counts down from 4 to 0, then
side 2
2
appears if the number falls within the acceptable Check Strip range. The Meter automatically tells you if your reading falls within the correct Check Strip range. (The range is also printed on the back of the Meter.)
These messages will continue to display until you turn the Meter off or for 2 minutes, when the Meter automatically turns off.
A 4 . 4 A ok
(example)
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If the reading is not within the printed range, the Meter displays will read
(example)
A 2.1 Anotok redo A
glucose or Control Solution test result will appear for 3 seconds the next time you turn on your Meter, then
redo A code 7
(example)
Go back to Step 1 and repeat the Check Strip test. If this message appears again, clean your Meter and repeat the test. For further assistance, call LifeScan Technical Services.
If you do not obtain an acceptable Check Strip reading, your last blood
will appear, indicating your Check Strip was out of range at the last reading.
This message will appear each time the Meter is turned on until you obtain a Check Strip reading that falls in the printed range.
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CAUTION: If your Check Strip
result falls outside the printed range, the Meter is not working properly. DO NOT use the Meter to test your blood until you get a Check Strip reading that is within the printed range. For assistance, call LifeScan Technical Services.
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 2.1
(example)
Anotok redo A
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.
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If you lose or damage the Check Strip, call LifeScan Technical Services for a free replacement.
Checking with Control Solution
R
Solution - Blue Formula
Normal Glucose Control
ONE TOUCH Normal Glucose
Control Solution—Blue Formula
ONE TOUCH®Normal Glucose Control Solution—Blue Formula should be used to make sure your Meter and Test Strips are working properly.
Before you use the Meter to test your blood glucose for the first time, practice the procedure using the Control Solution in place of blood. When you can do three tests in a row that are within the ONE TOUCH Normal Control range, you are ready to test your blood.
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Use only ONE TOUCH®Normal Glucose Control Solution—Blue Formula, available from your drug store 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 vial vigorously before using.
To do a Control Solution test, follow the same procedure you would if you were testing your blood. (See Testing Your Blood, page 27.)
Your Control Solution results will appear on the Meter display as follows:
c 5 . 4
(example)
contrl
c 5. 4
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The range for the ONE TOUCH
®
Normal Glucose Control Solution— Blue Formula is printed on the Test Strip vial or the foil wrapper. This range is for the Glucose Control Solution only; it is not intended as a recommended range for your blood glucose test results.
CAUTION: If your Control Solution result falls outside the printed range, the system is not working properly. DO NOT use the system to test your blood until you get a reading that falls within the printed range. For assistance, call LifeScan Technical Services.
You should use the Glucose Control Solution:
At least once a week.
When you begin using a new package of Test Strips.
Whenever you suspect the Meter or Test Strip may not be working properly (for example, when your results are not consistent with how you feel).
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4. GETTING A DROP OF BLOOD
The PENLET®II Automatic Blood Sampler is an easy, safe tool for obtaining a good drop of blood for testing.
Using the PENLET II Automatic Blood Sampler
Sliding Barrel
Release Button
Cap
Step 1: Insert a Lancet
Remove the PENLET II Cap by pulling it straight off.
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Insert a new, sterile Lancet into the Lancet Holder. The Lancet will slide into the Lancet Holder easier if you DO NOT line up the ridges on the Lancet with the slots in the Lancet Holder. (NOTE: Inserting the Lancet
may automatically cock the
®
PENLET
II.)
Hold the Lancet firmly and gently twist off the Lancet Protective Disk.
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Regular
Deep Penetration
Replace the PENLET®II Cap. The PENLET II Sampler includes
two Caps. The Cap that comes attached to the PENLET II Sampler has a single line on the flat side and works well for children and most adults. The other Cap has two lines on the flat side and works well for very thick or calloused skin, or when a deeper puncture is needed.
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Step 2: Cock the PENLET®II Sampler
Holding the lower portion of the PENLET II Sampler, pull out the dark gray sliding barrel until it clicks. If it does not click, the PENLET II Sampler may have been cocked when the Lancet was inserted.
Step 3: Get a Drop of Blood
Wash your hands with soap and warm water and dry them thoroughly. Warm water stimulates the flow of blood to the fingers. Hanging your arm down at your side for 10–15 seconds before the fingerstick will make it easier, too. If you use alcohol to clean your finger, make sure you let it dry before sticking your finger.
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Choose a spot on the side of a different finger each time you test. Repeated punctures in the same spot can make your finger sore and calloused.
®
Hold the PENLET
II Sampler firmly against the side of the finger, with the Cap resting on the finger. (The harder you press, the deeper the puncture.)
Press the dark gray Release Button.
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Squeeze the finger gently to obtain a large, hanging drop of blood.
Proceed with the blood glucose test. (See Testing Your Blood, page 27.)
Step 4: Remove the Lancet
Always use caution when removing the Lancet and PENLET
®
II Cap. Remove the PENLET II Cap.
Grasp the ridges on the dark gray prongs located on the shaft near the Release Button. Point the Lancet down and away from you. Pull back on the dark gray sliding barrel until the Lancet drops out.
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CAUTION:
Never use a Lancet that has been used by someone else.
Dispose of the Lancet in a container for sharp objects.
To help avoid infection, use a new sterile Lancet every time you test.
If you share a PENLET®II Sampler, each person should always use a new Lancet and a new or properly disinfected Cap. For assistance, call LifeScan Technical Services.
Cleaning the PENLET II Sampler
Clean the PENLET II Sampler and Cap with soap and water as needed.
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5. TESTING YOUR BLOOD
You can test your blood glucose by following these three simple steps:
insertinsert
mm 6. 0
PAS D'ALCOOL
Step 1: Press On/Off Button (last test result
Step 2: Apply blood sample.
Step 3: Accurate
results in 45 seconds. appears), insert Test Strip.
NOTE: Be sure to read the following section carefully before testing.
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Step-by-Step Instructions
Choose a clean, dry work surface. Make sure you have all the materials needed for a test:
ONE TOUCH®BASIC®Meter
ONE TOUCH®Test Strips
PENLET®II Automatic Blood Sampler (with choice of Caps)
Sterile Lancet
IMPORTANT:
The Test Strip Holder and Test Area of the Meter must be clean, dry and lint-free.
Check the expiration date on the Test Strip package. If the date has passed, discard the Test Strips and open a new package.
If using vial Test Strips, discard unused Test Strips 4 months after opening.
If you have questions about the testing procedure, call LifeScan Technical Services.
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Deep Regular
T E S T S T R I P
10
CODE:
TEST FOR GLUCOSE IN WHOLE BLOOD
OPEN
HERE
Milpites,CA Made in U.S.A. 51-453B
INC.
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Step 1: Press On/
Off Button to turn the Meter on
Then
code 10
(example)
appears on the display for 2 seconds. Make sure the code number on the Meter display matches the code number on the Test Strip package you are using. (See Coding the Meter, page 8.)
Your last blood glucose or Control Solution test result will appear for 3 seconds.
memory or memory mm 5 . 9
(example) c 5 . 4 (example)
The message
insert strip
then appears.
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Insert Test Strip
Remove a Test Strip from the package. DO NOT touch the white Test Spot. When using Test Strips from a vial, replace the cap imme­diately. When using a foil-wrapped Test Strip, be careful not to tear the Test Strip when opening the foil.
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TEST STRIPS
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Vial Test Strips Foil-Wrapped Test Strips
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Page 39
The Test Spot should be white or ivory-colored, with no tears or wrinkles.
Test Spot
When
insert strip
insertinsert
wait
appears, slide the notched end of the Test Strip into the Holder with the Test Spot side up. Make sure you push the Test Strip all the way into the Holder until it stops.
appears for a few seconds. Then,
apply sample
appears until you apply blood to the Test Spot (or for 5 minutes).
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Step 2: Apply blood sample
With the Test Strip in the Meter and
apply sample
on the display, apply a drop of blood to the Test Spot.
sample
The Meter will beep when the blood has been applied to the Test Spot.
Make sure that you:
Do not remove the Test Strip from the Meter to apply blood.
Do not smear blood on the Test Spot or apply a second drop after the test begins.
Do not move the Test Strip when you are applying blood. If the Test Strip moves, push it back to its original position.
Touch only the tip of the drop of blood to the Test Spot.
Apply enough blood to form a round, shiny drop that covers the Test Spot completely and stays wet during the entire test.
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Step 3: Accurate results in 45 seconds
The Meter then counts down from 45 to 0 seconds, followed by a series of beeps when your result is displayed.
mm 6 . 0
(example)
IMPORTANT: Always check that “MM” and a decimal point are displayed with your blood glucose result. If not, you may have accidentally changed the display language and unit of mea­surement to “P 1” English (mg/dL) or an electronic malfunction may have occurred. See Setting the Meter, page 7, to reset the language and unit of measurement to “P 3” English (mmol/L).
Be sure to wait for the beeps before
mm 6. 0
you note your result. Your result will continue to display until you turn the meter off or for 2 minutes,
when the meter automatically turns off. The Meter displays results which are between 0 and 33.3 mmol/L. Results above
33.3 mmol/L are displayed as
high
Press the On/Off Button to turn the Meter off.
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6. AFTER TESTING
Although the ONE TOUCH®BASIC System requires only a small drop of blood, it is very important that the drop be large enough to cover the Test Spot completely.
In many cases, the Meter can detect if the drop of blood was too small to give an accurate reading. If
not
enough
blood
retest
or
®
c 5 . 8
(example)
contrl
appears on the display, your drop of blood was too small or smeared, or the Test Strip was inserted only part­way into the Test Strip Holder. Repeat the test with a new Test Strip and enough blood to cover the entire Test Spot.
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Checking the Amount of Blood on the Test Strip
The Meter cannot always tell if a sample is too small, so it is impor­tant that you also look at the Test Strip to make sure that you applied enough blood.
Remove the Test Strip from the Meter and look at the Test Spot. It should still have a wet, shiny drop
Front Side
that completely covers the circle. If the blood sample has a dull, dry appearance, you may not have applied enough blood, or you may have smeared it.
Look at the back of the Test Strip. You should see a full, dark circle.*
*The white portion on
the back of the Test Strip may also appear as a small square, due to different manufacturing processes. This difference will not affect your blood glucose results.
36
Back
Page 44
(Incorrect)
If there are any white patches or streaks, you may have smeared the blood or the drop was too small. In
either case, you may have an inaccurately low result. Repeat the test with a new Test Strip.
Recording Your Test Results
Your ONE TOUCH®BASIC®System Kit comes with a Logbook that you can use to keep a permanent record of your test results, along with information on diet and medication.
If you run out of space in your Log­book, you can get a new one from your Authorized LifeScan Distributor, drug store, or directly from LifeScan.
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Displaying Last Test Result
The ONE TOUCH®BASIC®Meter automatically recalls and displays your last result—either from a blood glucose or Control Solution test—whenever the Meter is turned on.
Only blood glucose or Control Solution test results are recalled and displayed. Check Strip test results are not stored in the Meter memory.
When using the Meter for the first time
memory or memory mm 5 . 9
(example) c 5 . 4 (example)
appears for 3 seconds, then the Meter immediately displays test messages starting with
code 7
(example)
memory nodata
appears to indicate that there is no blood glucose or Control Solution test result in the Meter’s memory.
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7. HELP! (Troubleshooting)
The display messages that appear on the Meter will guide you through the glucose test and quality control test procedures and alert you to problems as they occur. This section provides you with a complete listing of the display messages, what they mean, and what to do if there is a problem.
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Test Procedure Messages
These messages appear during routine testing. Just follow them carefully and they will guide you through the test.
MESSAGE APPEARS WHEN
You press and hold the On/Off Button. It provides a visual test that all display segments are working.
memory
.
0 (example)
mm 6
memory
.
4 (example)
c 5
code 7 (example)
The Meter is turned on. The value displayed is your last blood glucose test result. (When using the Meter for the first time, memory nodata will appear.)
The Meter is turned on. The value displayed is your last Control Solution test result.
The Meter is in a code-setting mode. The code number (1–16) displayed must match the code number on the Test Strip package.
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MESSAGE APPEARS WHEN
insert strip
wait
apply sample
45, 44, 43...0
mm 6.0 (example)
The Meter is ready for you to perform a blood, Check Strip, or Control Solution test.
The Meter is performing internal checks.
The Meter is ready to receive a blood or Control Solution sample. If performing a Check Strip test, this is your signal to remove the Check Strip (Side 1) from the Meter.
The Meter is counting down from 45 seconds to 0.
A blood test is completed. This indicates a blood glucose result.
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MESSAGE APPEARS WHEN
c 5. 4 (example) contrl
insert side 2
.
4 (example)
A 4 A ok
high
A Control Solution test is completed. However, if this appears after a blood test, it means that your test result was not accurate because the blood sample was too small and the Meter read it as a Control Solution sample.
You are performing a Check Strip test. Turn the Check Strip over and slide it back into the Test Strip Holder with Side 2 up.
The Check Strip result falls into the acceptable range.
Your blood glucose result is above 33.3 mmol/L, indicating severe hyperglycemia. Contact your physician immediately.
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MESSAGE APPEARS WHEN
p 1R23
You are setting the display language and the unit of measurement. This means that messages will appear in the selection program. “P 3” corresponds to the English (mmol/L) selection. “P 4” corresponds to the French (mmol/L) selection.
Error Messages
When any of these messages appear, there is a problem with the Meter or the way in which you are performing a procedure. In most cases, problems are easy to fix. If you need it, help is available from LifeScan Technical Services.
MESSAGE PROBLEM WHAT TO DO
Some parts of the display Call LifeScan are not working. The Services. messages will be incomplete.
43
Technical
Page 51
MESSAGE PROBLEM WHAT TO DO
(example)
114
[No “mm” before the result and no decimal point]
battry
clean test area
The language and unit of See Setting the Meter, page 7, measurement have been to reset the language and changed to “P 1” English unit of measurement to (mg/dL) either accidentally “P 3” English (mmol/L). or through an electronic malfunction.
T
he battery is too low. The Replace the battery.
Meter will not operate.
1) There is dirt, blood, or lint Clean the Test Area on the Test Area. and Test Strip Holder
according to instructions.
2) Your hand or an object Repeat the test. Keep covered the Test Area while Test Area clear. the Meter was turned on.
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Page 52
MESSAGE PROBLEM WHAT TO DO
3) The Test Strip was Repeat the test. Wait for inserted before insert insert strip before strip appeared on the inserting a new Test Strip. display.
4) The center of the Test Strip Depress the center by Holder where the small hole pressing forward on the is located is raised. base, or by pressing down
on the center, or by inserting a check strip into the Test Strip Holder.
c 3.8 (example) contrl
If this message appears after Repeat the test with a new a blood test, your blood Test Strip and a larger drop sample was too small, of blood. smeared, or another drop was added after the test began.
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MESSAGE PROBLEM WHAT TO DO
error1 retest
error2 retest
The sample was applied Repeat test with a new before apply sample Test Strip and wait for appeared. apply sample to appear.
Error in the test procedure such as:
1) The Test Strip moved Repeat the test with a new during the test. Test Strip.
2) The Test Strip was not Repeat the test, pushing a inserted correctly. new Test Strip all the way
into the Test Strip Holder.
3) The Test Strip was Repeat the test with a new removed before the test Test Strip. was completed.
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MESSAGE PROBLEM WHAT TO DO
4) There was not enough Repeat the test with a new blood on the Test Strip. Test Strip and a larger drop
of blood.
5) The Meter was used in Move the Meter out of very bright light. direct light and repeat the
test with a new Test Strip.
6) The Check Strip procedure Repeat the Check Strip test. was incorrect.
7) The Meter may not be Call LifeScan Technical operating correctly. Services.
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MESSAGE PROBLEM WHAT TO DO
insert
insert
insert
(example)
memory retest
When any message flashes Test results will still be continually, it means the accurate, but replace the battery is getting low. battery as soon as possible.
Your last test result was not stored in the Meter’s memory for one of the following reasons:
1) A not enough blood Repeat the test with a new retest message was dis- Test Strip and a larger drop played during your last of blood. blood or Control Solution test due to a too small or smeared sample.
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MESSAGE PROBLEM WHAT TO DO
2) An error2 retest Review the error2 message was displayed retest problems listed during your last test due on pages 46–47 before to a procedural error. repeating the test.
3) A not ok message was Call LifeScan Technical displayed during your last Services. test.
4) A power loss, including Repeat the test with a new turning the meter off, Test Strip. occurred during your last test.
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MESSAGE PROBLEM WHAT TO DO
not enough blood retest
not ok
A 5.8 (example) Anotok redo A
1) The blood sample was Repeat the test with a new too small or smeared. Test Strip and a large, shiny
drop of blood.
2) The Test Strip was not Repeat the test. This time inserted all the way into push the Test Strip all the the Test Strip Holder. way into the Test Strip
Holder.
Your Meter may have an Call LifeScan Technical electronic problem. Services.
The Check Strip test result is Clean the Meter and outside the acceptable range. Check Strip. Repeat the
Check Strip test.
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MESSAGE PROBLEM WHAT TO DO
redo A code 7
remove strip
(example)
The last Check Strip test was Stop and do a Check Strip outside the acceptable range test. and a repeat test that passed has not been performed.
The Test Strip was inserted Remove the Test Strip. before the Meter was ready. Wait for insert strip
message.
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MESSAGE PROBLEM WHAT TO DO
reset code
The Meter has lost some Use the “C” Button to reset important information, the Meter code to match the including the code number, Test Strip package code. and the language and the Reset the language and unit unit of measurement have of measurement to “P 3” changed to “P 1” English for English (mmol/L) as (mg/dL) either accidentally described in the section or through an electronic Setting the Meter, page 7. malfunction. If this continues to happen,
there may be a problem with your Meter. Call LifeScan Technical Services.
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8. TAKING CARE OF THE METER
Your ONE TOUCH®BASIC®Meter is simple to use and easy to main­tain. However, it must be handled carefully and cleaned regularly to remain in good operating condition. You should follow these rules at all times:
Strip Holder is still securely in place and check the Meter with the Check Strip before doing a blood glucose test.
Avoid exposing the Meter or Test Strips to extremes in temperature or humidity for long periods of time. For example, do not store the Meter or Test Strips in your car.
Keep the Test Strip Holder and Test Area clean.
Do not drop or toss the Meter. The Meter’s electronics could be damaged by such treatment. If you drop the Meter, make sure the Test
Never let your Meter get wet. The Meter could be permanently damaged if water or other liquids get inside.
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Do not take the Meter apart. Sensitive parts could be damaged and cause inaccurate results. Taking the Meter apart will invalidate the Meter warranty.
IMPORTANT: Infection Control Information
If you are sharing the ONE TOUCH®BASIC®Meter with another person, always use a new or properly disinfected Test Strip Holder for each person.
If you are sharing the PENLET®II Automatic Blood Sampler with another person, always use a new sterile Lancet and a new or properly disinfected PENLET II Cap for each person.
For disinfecting information, an additional Test Strip Holder, or a PENLET II Cap, please call LifeScan Technical Services.
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Daily Meter Check
Look through the small hole in the Test Strip Holder to make sure there is no lint, dirt, or blood blocking any part of the hole.
If there is anything blocking the hole, or if the Test Area has dirt, lint, or blood on it, remove the Test Strip
Holder. Clean the Test Strip Holder and Test Area by following the instructions in the next section.
Cleaning the Meter
The Meter and Test Strip Holder should be cleaned once a week. In addition, they must be cleaned whenever the Test Area looks dirty or the message
clean
test area
appears on the display.
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Step 1: Remove Test Strip Holder
Hold the Meter and place your thumbs on the two raised dots on the Test Strip Holder.
Slide the Test Strip Holder toward you.
Remove the Test Strip Holder to expose the Test Area.
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Step 2: Clean Test Strip Holder
Wash the Test Strip Holder with soap and water.
Clean the underside of the Test Strip Holder and check the small hole for any dirt, blood, or lint. Rinse well.
Dry completely with a soft cloth or tissue.
Step 3: Clean Test Area
CAUTION: DO NOT GET WATER INSIDE THE METER.
The following cleaning agents will damage the Meter.
DO NOT USE:
Alcohol
Cleansers with ammonia or phenol
Windex®or other glass cleaners
Abrasive cleansers
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Check the clear, protective coating over the Meter optics to make sure it is not scratched or damaged.
Rub Test Area with a cotton swab or soft cloth dampened with water to remove all blood, dirt, or lint from the Test Area. If necessary, a mild liquid dishwashing detergent mixed with water may also be used. Do not apply full-strength detergent to the Test Area. Be careful not to scratch the Test Area.
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Dry the Test Area with a soft, dry cloth or tissue that doesn’t contain lotion or perfume. Remove any lint.
Step 4: Replace Test Strip Holder
Hook the bottom of the Test Strip Holder onto the square notch on the Meter.
R
Press down on the raised dots of the Test Strip Holder until it snaps firmly into place. Press forward on the base, then down on the center of the Test Strip Holder to make sure the small hole over the Test Area is not raised. You are now ready to do a Check Strip test. If the Check Strip will not slide into the Test Strip Holder, repeat Step 4.
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Battery Replacement
6-VOLT
The ONE TOUCH®BASIC®Meter comes with a battery already in­stalled. When the battery must be
®
replaced, use only a Duracell alkaline battery (J-size, 6 volts, part #7K67), which is commonly available in drug and hardware stores. This will ensure you get the best performance from your ONE TOUCH BASIC Meter.
brand
The battery should last about one year with typical home use.
When the battery is getting low, the display will flash.
insert
(example)
insert
insert
The Meter will still provide accurate test results with a low battery, but you should replace it as soon as possible.
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When
battry
appears on the display, the Meter will no longer give results and you must replace the battery before you can perform another test.
Turn the Meter upside down.
A dead battery or battery removal will not affect the previous test result stored in the Meter’s memory, as long as the battery is replaced within 30 days.
Replacing the battery
Make sure the Meter is turned off before you remove the battery.
With your thumb, firmly press in and up on the ridges on the side of the battery door until the door releases from the clasp. Remove the battery door by sliding it out.
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6
-V O L
T
Remove the old battery and discard properly. Insert a new J-size battery in the battery compartment.
To replace the battery door, insert the tabbed side of the door into the slot in the battery compartment.
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With your thumb, press in and down on the ridged side of the battery door until it snaps shut.
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9. QUESTIONS AND ANSWERS
In the following pages, we’ve provided answers to some of the most common questions people have about home blood glucose monitoring and the ONE TOUCH BASIC®Meter. If you have a question that isn’t covered here, consult your Health Care Professional or call LifeScan Technical Services.
Q. Why should I test my blood glucose (sugar)?
A. No doubt your Health Care Professional has explained the importance of keeping your diabetes
®
under control. Your ONE TOUCH BASIC System helps you check whether or not you are in control by monitoring your blood glucose levels.
The test results provide a good picture of how diet, exercise, and medication are affecting your diabetes.
Test results can also indicate whether your diabetes is changing in ways that might require an adjustment in your treatment program.
Always consult your Health Care Professional before making changes in your diabetes control plan.
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Q. How often should I test my blood glucose?
A. This is best decided by you and your Health Care Professional. It may vary according to your age, the type of diabetes you have, any medication you are using, whether you are ill, and any physical or emotional changes in your life.
Q. Should my test results always be the same?
A. No. Results will vary somewhat from test to test, depending on diet, activity level, and time of day. These
variations provide useful clues about your condition and how well your treatment program is working.
With your Health Care Professional, determine your own personal target blood glucose values, as well as what an unusually high or low test result is for you. In most cases, your test results should stay within that range.
Q. What can I do to be sure I get accurate test results?
A. Make sure that you do the following:
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Keep your Meter clean at all times.
Use enough blood. The entire Test Spot must be completely covered with blood. Touch the drop of blood lightly to the middle of the Test Spot to fill the entire Spot. The drop of blood should form a round, shiny circle over the entire Spot, and stay wet during the entire test.
Do not smear the blood or touch the Test Spot with your finger. Do not add more blood after you’ve applied the first drop.
Never use Test Strips beyond their expiration date. Do not store Test Strips outside of their packaging.
Make sure the Meter code number is set to match the code number on the package of Test Strips you are using.
Periodically review your use of the Meter with your Health Care Professional.
Q. What should I do if my blood glucose test results are consistently high for my own diabetes control plan?
A. The goal of diabetes management is to maintain a “near normal” amount of glucose in the blood. Normal, low, and high blood glucose values for your individual treatment plan should be determined with
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your Health Care Professional. If your blood glucose test results remain consistently high, contact your Health Care Professional.
Q. What are the expected blood glucose values associated with well-controlled diabetes?
A. Fasting: 3.3–7.2 mmol/L
After meals (1 hour): Less than
10.0 mmol/L
After meals (2 hours): Less than
8.3 mmol/L
1,2
Q. What do I do if test results still seem too low or too high?
A. Remember, the test results you obtain will vary from time to time depending on food intake, insulin dose, exercise, etc. Ask yourself the following questions:
“How do I feel?”
“Do I have symptoms of low blood sugar (hypoglycemia) or high blood sugar (hyperglycemia)?”
“What have I eaten?”
“How much exercise have I had?”
“Am I ill (e.g., common cold, flu, etc.)?”
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In addition to the common factors listed above which cause real variations in blood glucose results, there are certain abnormal condi­tions which can interfere with the accuracy of your blood glucose monitoring results. These limitations are described below and should be discussed with your physician:
Extremes in hematocrit (the amount of red blood cells in the blood) can affect test results. High hematocrits (above 60%) cause inaccurately low results. Very low hematocrits (below 25%) can also cause inaccurately low results.
Severe dehydration and excessive water loss may cause inaccurately
low results. This has been reported in the medical literature for leading blood glucose monitoring products. Severe dehydration can lead to many serious medical complications. One complication which is of particular importance in diabetes management is a “hyperglycemic-hyperosmolar” state, with or without ketosis, which may be life-threatening if left un­treated. The following are some of the factors which could lead to severe dehydration:
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Vomiting and diarrhea
Prescription drugs, e.g., diuretics
Inability to recognize or respond to “thirst” sensations
Sustained uncontrolled diabetes
Whenever inadequate fluid intake or excessive water loss occurs, CONSULT A PHYSICIAN IMMEDIATELY.
Remember, if you ever experience symptoms which are not consistent with your blood glucose monitoring results and you have eliminated common procedural errors described
in this Owner’s Booklet as the cause, you should contact a physician immediately!
Never make significant changes to your medication program or ignore physical symptoms without consulting a physician.
IMPORTANT: When the message HIGH appears on the Meter display, this indicates severe hyperglycemia (blood sugar too high); contact your physician immediately.
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Q. Why don’t my Meter results match the results that I got from my doctor’s laboratory exactly?
A. Many Health Care Professionals believe that the result that you get with your Meter should fall within 15% to 20% of the result obtained when whole blood is tested on
5
laboratory equipment.
However, there are a number of reasons why the blood glucose result from your Meter may vary even more than 20%
6
from a laboratory result.
One of the most common reasons is that laboratories use serum or plasma samples, while home blood glucose monitors use whole blood. Whole blood results are approximately
10%–12% lower than serum or plasma values from the same blood sample (at average hemocrit levels of 41%–45%). To adjust for this difference, divide the laboratory value by 112% or 1.12.
7
Example:
Let’s assume your lab (plasma) result is 8.3 mmol/L.
8.3 divided by 1.12 = 7.4 mmol/L.
Compare your Meter result to
7.4 mmol/L.
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There is a difference in the glucose levels of venous blood (usually drawn from a vein in your arm) and capillary blood (blood from a fingerstick). After a meal, the glucose levels in the capillaries may be
1.1–3.9 mmol/L higher than the
6
levels in venous blood.
If your lab test is taken while you are in the fasting state (before breakfast), this difference will be minimal (0.1–0.3 mmol/L).
7
Variation may also occur between your Meter and the lab if the two tests were not done within 10–15 minutes of each other. Blood glucose values
change rapidly, especially after you have eaten, and the two tests could have very different results.
1 Skyler JS, et al: Postgraduate Medicine (1987) 81(6):163–174. 2 Skyler JS, et al: Diabetes Care (1981) 4:311–318. 3 Wickham NWR, et al: Practical Diabetes (1986) 3(2):100. 4 Cohen FE, et al: Diabetes Care (1986) 9(3):320–322. 5 Clarke WL, et al: Diabetes Care (1987) 10:622–628. 6 Gadsen RH: Challenges in Diabetes Management, Milpitas
CA, LifeScan, Inc. (1988) 63–66.
7 Caraway WT: Carbohydrates, in Tietz NW (ed). Fundamentals
of Clinical Chemistry. Philadelphia, WB Saunders Company (1976) 242–244.
8 Surwit RS and Feinglos MN: Diabetes Forecast (1988) April:
49–51.
9 Nelson RL: Diabetes Spectrum (1989) 2:219–223.
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8,9
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10. SPECIFICATIONS
Performance Characteristics
See the ONE TOUCH®Test Strip package insert for ONE TOUCH System accuracy and precision.
®
Dimensions:
3
5
1
/80)
/40)
/160)
Length—12.07 cm (4 Width—6.70 cm (2 Height—2.70 cm (1 Weight— approx. 135 g (4.8 oz.) [including battery]
Power Supply: One Duracell
®
alkaline battery, size J (6V) part # 7K67 is included with Meter.
Battery Life: Approximately one
year (at two tests per day).
Result Range: 0–33.3 mmol/L.
Higher values displayed as HIGH.
Display Type: Alphanumeric;
6-character, 14-segment LCD.
Operating Temperature Range:
15°C–35°C (59°F–95°F)
Operating Humidity Range:
0%–90% relative humidity (non-condensing).
Memory: Last result — either a blood
glucose or Control Solution test.
Code Numbers: 1–16.
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Guarantee and Warranty
30-Day Money-Back Guarantee
If you are not fully satisfied with the
®
ONE TOUCH refund may be obtained by calling a LifeScan Technical Representative at the toll-free number within 30 days of purchase. You must return the ONE TOUCH a copy of your receipt to receive a refund.
BASIC®System, a full
®
BASIC®Meter and
replace it with a new or rebuilt Meter or equivalent product free of charge.
The warranty policy applies only to the original purchaser of this Meter and does not include the battery supplied with the Meter.
Please complete the Warranty Registration Card and mail it to LifeScan.
Three-Year Warranty
If, at any time during the first three years after purchase, the Meter does not work for any reason (except for obvious abuse), LifeScan will
The ONE TOUCH BASIC Meter has a full three-year warranty from the original date of purchase. Write your date of purchase here:
__________________________________
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The warranty policy does not apply to the performance of the
®
ONE TOUCH
BASIC®Meter when
used with any test strip other than
®
ONE TOUCH
Test Strips, or when the ONE TOUCH BASIC Meter or Test Strips are changed or modified in any way.
Before you return your Meter, or any product for warranty replace­ment, first call your LifeScan Technical Representative at the toll-free number for detailed instructions.
This warranty is in lieu of all other warranties, express or implied, including any implied warranty of merchantability or fitness for a particular purpose.
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11. INDEX
Battery Replacement . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 60
Blood Glucose Values (expected) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 67
Blood Sample Size . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 36
Check Strip . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11
Cleaning and Maintaining
Check Strip . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 16
PENLET
Test Area of the Meter . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 57
Test Strip Holder . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 57
®
II . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 26
LifeScan Technical Services: Canada 1 800 663-5521
USA 1 800 227-8862
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Coding the Meter . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8
Control Solution . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11, 17
Displaying Last Test Result . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9, 38
Error Messages . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 43–52
Hematocrit . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 68, 70
Infection Control . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 54
Language Setting and Unit of Measurement . . . . . . . . . . . . . . . . . . . . . . . . . . 7
Money-Back Guarantee . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 73
PENLET
®
II Automatic Blood Sampler . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 20
Performance Characteristics . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 72
LifeScan Technical Services: Canada 1 800 663-5521
USA 1 800 227-8862
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Precautions and Limitations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5
Questions and Answers . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 64
Specifications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 72
Testing Your Blood . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 27–34
Test Procedure Messages . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 40–43
Test Strips . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4, 31–32
Troubleshooting . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 39
Warranty . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 73
LifeScan Technical Services: Canada 1 800 663-5521
USA 1 800 227-8862
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Toll-Free customer service: Appels sans frais:
Canada 1 800 663-5521 U.S.A. 1 800 227-8862
Burnaby, B.C. V5C 6C6
AW *05160052A* Imprimé aux États-Unis © 1994 LIFESCAN INC. 6/94
Printed in U.S.A.
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