Lifescan SureStep blood glucose monitoring system User Manual

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Owner’s Booklet
Page 2
The SURESTEP®System is intended for use outside the body (in vitro diagnostic use). It should be used only for testing purposes and only with fresh whole blood samples. It should not be used for the diagnosis of diabetes.
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Welcome to LifeScan Congratulations! You’ve chosen a product
made by LifeScan, a leading company in providing products to help you manage your diabetes. SURESTEP
®
blood glucose monitoring products are widely available without a prescription.
Blood glucose monitoring plays an important role in controlling your diabetes. A recent study showed that keeping blood glucose levels close to normal can reduce the risk of complications by up to 60%. The results you get with the SURESTEP
®
System can
help you and your healthcare professional
monitor and adjust your treatment plan to gain better control of your diabetes.
Everything you need to know about using the SURESTEP System is included in this booklet. A free instructional videotape is also available by calling LifeScan Customer Services. If you have any ques­tions, please feel free to call the toll-free numbers to speak with our Customer Services Department.
Remember to complete and mail the Warranty Registration Card. A complimen-
tary gift is sent when we receive your Warranty Registration Card.
Important phone numbers:
Meter Serial Number _______________
LifeScan Customer Services (24 hours a day, 7 days a week): USA English 1 800 227-8862 Español 1 800 381-7226
Healthcare professional ________________________ Pharmacist _________________________ Diabetes educator _____________________________ Other ______________________________
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CAUTION: Before using any product to test your blood glucose (blood sugar), read all instructions 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.
IMPORTANT: If you have followed the tips to ensure accuracy and your blood glucose results are still out-of-range, call your healthcare professional.
®
The SURESTEP battery door, batteries, PENLET
System contains many small parts: test strip holder,
®
II Cap, lancets, control solution vial, test strips, test strip bottle cap, etc. Keep the system out of the reach of small children because these parts may be dangerous if swallowed.
If using a 10% bleach solution to disinfect the meter, be sure to completely remove any bleach from the meter and test strip holder with a cloth damp­ened with water. Bleach will react with the test strips and cause inaccurate results.
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TABLE OF CONTENTS
Glucos
Shake befor
Not Intende Discard 3 m Discard date Lot No. Exp. Date
© LIFESCAN
I
LEARNING THE SYSTEM 1
SURESTEP®Blood Glucose Meter 3
SURESTEP®Test Strips 4
Display Symbols 6
CODING THE METER
Three Easy Steps to Coding 10
CHECKING THE SYSTEM
SURESTEP®Glucose Control Solution 12
Control Solution Test 12
Control Solution Range 17
TESTING YOUR BLOOD
Getting a Drop of Blood 18
Step-by-Step Test Procedure 24
Optional Color Chart 32
LifeScan Customer Services (24 hours a day, 7 days a week):
USA English 1 800 227-8862 Español 1 800 381-7226
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UNDERSTANDING YOUR RESULTS Overview 34
Comparing Meter and Laboratory Results 35 Expected Test Results (Target Range) 36 Testing Tips to Ensure Accuracy 38 Health Conditions Causing
Out-of-Range Results 39
Recommendations for Better
Diabetes Control 41
RECALLING RESULTS FROM METER MEMORY Using the Meter for the First Time 42
Recalling All Results in Meter Memory 43 Recalling Your Last Result 44
CARING FOR YOUR METER
General Care 45 Cleaning the Meter 45 Changing the Batteries 49
LifeScan Customer Services (24 hours a day, 7 days a week):
USA English 1 800 227-8862 Español 1 800 381-7226
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CHANGING METER SETTINGS 52 (Set-Up Mode) Entering Set-Up Mode 53
Display of Last Result 53 Unit of Measurement (mg/dL or mmol/L) 54 Beep Signals 55
SOLVING PROBLEMS
Helpful Messages 57 Error Messages 59
SPECIFICATIONS
Performance Characteristics 64 Guarantee and Warranty 65
QUICK REFERENCE GUIDE 67
LifeScan Customer Services (24 hours a day, 7 days a week):
USA English 1 800 227-8862 Español 1 800 381-7226
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LEARNING THE SYSTEM
LEARNING
The SURESTEP®Blood Glucose Monitoring System is the next advance in the self-monitoring of blood glucose. The SURESTEP System is for people with diabetes who need to check the level of sugar (glucose) in their blood. A drop of blood is taken from the finger and placed on a SURESTEP
®
Test Strip, which is then inserted into the SURESTEP
®
Blood Glucose Meter. The meter measures the blood glucose level and displays the result on average in 30 seconds. The system
is calibrated to give a plasma value,
the measurement used by most clinical laboratories. Easy-to-under-
stand symbols guide you through the test procedure and help you if any problems arise.
SURESTEP Test Strips are the only test strips that have been specifical­ly designed, developed, and tested for use with the SURESTEP Meter to ensure consistent quality and accuracy. For reliable results and to maintain the manufacturer’s complete service, support, and warranty, use only SURESTEP Test Strips made by LifeScan.
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Glucose
Shake before
Not Intended
Discard 3 mo
Discard date:
Lot No.
Exp. Date
© LIFESCAN IN
Color Chart
LEARNING
QUICK
REFERENCE
BEFORE TESTING:
See inside for instructions on
proper blood application
and coding the meter.
*IMPORTANT: Read detailed instructions in your
SureStep®Owner’s Booklet before doing a test.
*
Lancets Inside Tray
Extra Space for Diabetes Supplies
and Syringes
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SURESTEP®Blood Glucose Meter
L 5037 ZG 00171
Toll-free customer service: UNITED STATES:
English
1 800 227-8862
Español
1 800 381-7226
CANADA:
1 800 663-5521
Milpitas, CA 95035
C22.2 No. 125; Risk Class 2
ÿ LIFESCAN INC. 1995
AW 052-178-01A Made in U.S.A.
BLOOD GLUCOSE METER
Front
DISPLAY
Shows your test results and symbols that guide you through the test.
LENS AREA
Contains the meter optics that read the glucose level. Test strip holder covers the lens area.
Back
C BUTTON (Green)
Codes the meter, changes the meter settings, and scrolls through the memory.
POWER BUTTON (Blue)
Turns the meter on and off.
CONTACT POINTS
Sense the position and orientation of the SURESTEP®Test Strip.
TEST STRIP HOLDER
Closed
Opened
Cover
LEARNING
SERIAL NUMBER
(Example)
BATTERY COMPARTMENT
Holds two AAA alkaline batteries.
Test Strip
Insertion
Point
Base
The cover protects the lens area
®
and the base holds the SURESTEP Test Strip.
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SURESTEP®Test Strips
When blood is applied to the pink test square, it is absorbed and a chemical reaction takes place. A
LEARNING
blue color forms in the confirmation
dot on the back of the test strip and is read by the meter to determine the blood glucose level; the darker the color, the higher the blood glucose level.
White Tip is inserted
into the meter. The side where you apply blood must be face up when you insert the test strip.
Pink Test Square is
where you apply a drop of blood.
White Pad absorbs the
excess blood that may extend beyond the pink test square. not apply blood directly onto the white pad.
Do
White Tip
Pink Test Square
FRONT
White Pad
BACK
Black Tip
Confirmation Dot
Black Tip helps the
meter detect that the strip has been inserted properly.
Confirmation Dot on the
back of the test strip is where you check to confirm proper blood application. When it turns completely blue, enough blood has been applied for an accurate test.
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IMPORTANT TEST STRIP INFORMATION
Contact with air, moisture, and light can cause false results. Keep test strips sealed in the original moisture-resistant, light-protected package and store in a cool, dry place not above 86° F (30° C). Do not refrigerate, place in direct heat or sunlight, or leave bottle open.
DO NOT use SURESTEP®Test Strips beyond the expiration date.
If using test strips from a bottle, write the discard date on the bottle label. Discard unused test strips 4 months after first opening the bottle.
DO NOT use SURESTEP Test Strips that are bent, torn, cut, or changed in any way.
Before testing, the confirmation dot should be off-white. DO NOT use test strip if confirmation dot is darker than the color of an unused test strip shown on the Color Chart included with the test strip package.
Use each test strip immediately after removing it from the package.
Replace the test strip bottle cap immediately after removing a test strip and close the cap tightly.
Never transfer test strips to a new bottle or any other container.
DO NOT use bleach, or products containing bleach, with the test strips.
For reliable results, use only SURESTEP Test Strips made by LifeScan.
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LEARNING
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Display Symbols
The SURESTEP®Blood Glucose Meter uses symbols to guide you
LEARNING
through a test and to help you determine if something is wrong with your test strip or meter. To check that all display symbols are working, press and hold down the power button. All of these symbols should appear. Call LifeScan Customer Services at 1 800 227-8862 if any segments are missing.
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Meter Memory Result. Your
SURESTEP
®
Meter stores up to 10
blood glucose or control solution test results in its memory. Every time you turn the meter on, it will automatically recall and display your last (most recent) result.
Code Number. The number on the
display must match the code num­ber on your SURESTEP
®
Test Strip package. It must be checked every time you use a new package of test strips and changed if the code num­ber is different.
LEARNING
(Example)
(Example)
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Apply Blood Sample to Pink Test Square.
LEARNING
Push the Test Strip, Pink Side Up, Firmly into the Test Strip Holder Until It Stops.
If you fail to completely insert the test strip, the test may start. However, you may receive an inaccurate low result.
Meter Is Reading Your Result.
The result appears, on average, in 30 seconds. The clock may flash longer at cooler temperatures or shorter at warmer temperatures.
Test Result.
The meter displays results between 0–500 mg/dL (0–27.8 mmol/L).
(Example)
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HI mg/dL.
In virtually all cases above 500 mg/dL (27.8 mmol/L), the meter reads “.
(Example)
When proper procedures are fol­lowed, a reading of “ ” means very high blood glucose (severe hyperglycemia). In extremely rare circumstances, the meter will read “ ” instead of “ ” above 500 mg/dL (27.8 mmol/L). Compare the color of the test strip confirmation dot with the Color Chart on the test strip package (see pages 32–33).
Clean Meter and Test Strip Holder.
Replace the Two AAA Alkaline Batteries.
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LEARNING
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CODING THE METER
Code numbers are used to calibrate the SURESTEP the SURESTEP results.
You must code the meter
before using
®
Test Strip with
®
Meter for accurate
it for the first time. You must check the code every time you change to another package of test strips. Check that the code number
CODING
on the display matches the code number on the test strip package.
Caution: If the code numbers do not match, you may get inaccurate results.
Three Easy Steps to Coding
Step 1: Turn on the Meter.
Press the blue power button. The result from your last blood glucose or control solution test will appear.
(Example)
Next, the meter code will appear for a few seconds.
(Example)
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Step 2: Check the Code Numbers.
Step 3: Code the Meter.
The code number on the test strip package will range from 1 to 21. If the number on the display matches the code number on the SURESTEP Test Strip package, begin testing. If the two code numbers do not match, follow Step 3 to code the meter.
(Example)
After the
CODE
symbol appears, press the green C button. Continue pressing until the code number on the display
®
matches the code number on the test strip package.
(Example)
The code is now set for the package of test strips you are using. The meter will retain this code until you change it.
11
C Button
CODING
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CHECKING THE SYSTEM
Glucos
Shake befor
Not Intende Discard 3 m Discard date Lot No. Exp. Date
© LIFESCAN
I
The SURESTEP®System does not require a check strip. The meter performs an automatic check every time you turn it on.
SURESTEP
®
Glucose Control Solution
Control solution is used instead of blood to tell you that the SURESTEP Glucose Meter and SURESTEP
®
Blood
®
Test Strips are working together properly. The control solution contains a known amount of glucose that reacts with a SURESTEP Test Strip.
CHECKING
SURESTEP Glucose
Control Solution
Control Solution Test
Do a control solution test:
Before testing with the SURESTEP Blood Glucose Meter for the first time.
Every time you open a new pack­age of test strips.
Whenever you suspect that the meter or test strips are not working properly.
When your results do not reflect how you feel.
If you drop the meter.
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IMPORTANT CONTROL SOLUTION TEST INFORMATION
Use only SURESTEP®Glucose Control Solution.
Check the expiration date. Write the discard date on the vial. Do not use if expired. Discard the vial 3 months after first opening it.
The control range printed on the test strip bottle is for SURESTEP Glucose Control Solution only. It is NOT a recommended range for
your blood glucose level.
Do not store the glucose control solution at room temperatures above 86° F (30° C). Do not refrigerate or freeze.
If a control solution test falls outside of the control range, do not use the meter to test your blood until you get a control solution test result within the range. Call LifeScan Customer Services at 1 800 227-8862 if you need assistance.
Warnings
Control solution is NOT TO BE USED as a cleaning solution.
DO NOT swallow or inject control solution or put it in your eyes.
Control solution contains a dye that stains clothing.
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CHECKING
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Follow the test procedure, using
®
SURESTEP
Glucose Control
Solution instead of blood.
Before Testing, Check the Code.
After turning the meter on, the last result appears, followed by the
CODE
symbol and number. If the code on the meter does not match the code on the test strip package, press the green C button until the codes match.
C Button
Step 1: Apply a Small Drop of Control Solution.
After shaking the control solution vial, apply one drop of control solution to the pink test square.
Note: Applying too much control solution may cause out-of-range results and dirty the meter.
CHECKING
(Example)
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Step 2: Check Confirmation Dot.
Check to see that the confirmation dot on the back of the test strip has turned completely blue to ensure you have applied enough control solution.
Step 3: Insert the Test Strip and Read Result.
Within two minutes after applying control solution, insert the test strip firmly into the test strip holder, pink side up, until it comes to a complete stop.
CHECKING
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The control solution result appears, on average, in 30 seconds.
(Example)
Compare the control solution test result with the control range printed on the SURESTEP
®
Test
Strip package.
SURESTEP Control Range
Note: Do not use the Color Chart to verify control solution tests.
CHECKING
(Example)
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When the control solution test result is within the control range, you are ready to test your blood. Your con­trol solution test will be stored in the meter memory. Record control solution tests in your logbook by placing a C next to the result to indicate a control solution test.
NOTES
DATE TEST
TEST
RESULT
DATE
TIME
INSULIN/ MEDICATION
TEST
RESULT
TIME
INSULIN/ MEDICATION
NOTESTEST
Control Solution Range
If test results fall outside the expected range, repeat the test. Results that fall outside the expected range may indicate the system is not working properly. Some possible causes are:
Procedural error
Expired or contaminated control solution
Test strip code and meter code do not match
Dirty meter or test strip holder
Test strip deterioration
Meter malfunction
Control solution that is outside of the temperature range 59–95˚F (15–35˚C)
If you are unable to resolve the problem, call LifeScan Customer Services, 1 800 227-8862.
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CHECKING
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TESTING YOUR BLOOD
Getting a Drop of Blood
TESTING
IMPORTANT: Getting an adequate drop of blood is one of the most important steps in getting an accurate result.
CAUTION:
Use a new, sterile lancet every time you test.
Do not uselancet ifprotective disk has been removed or damaged.
Never use a lancet that has been used by someone else.
If you share a PENLET®II, each person should always use a new lancet and a new or prop­erly disinfected cap.
For assistance, call LifeScan Customer Services,
1800227-8862.
Step 1: Insert a Lancet in the PENLET
®
II Automatic Blood
Sampler.
Remove the PENLET
®
pulling it straight off.
18
II Cap by
Page 27
Insert a new, sterile lancet into the lancet holder.
Hold the lancet firmly, and gently twist and pull off the protective disk.
Note: Save the protective disk for safe removal of the lancet after testing.
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TESTING
Page 28
Choose either the regular or deep penetration PENLET
®
II Cap and
slide it back onto the PENLET II
TESTING
Sampler.
Regular
Deep Penetration
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.
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Step 3: Get a Drop of Blood.
Wash your hands with soap and warm water and dry them thor­oughly. Warm water stimulates blood flow to the fingers. Hang your arm down for 10–15 seconds before you stick your finger. If you use alcohol to clean your finger, make sure you let it dry.
To avoid soreness, choose a site on the side of your fingertips. To avoid calluses, choose a different spot each time you test.
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TESTING
Page 30
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
TESTING
the puncture.) Press the dark gray release button.
By holding your hand down and kneading your palm, blood will flow more quickly and easily to your finger. If necessary, squeeze the finger gently.
Proceed with the blood glucose test. For information, see pages 24–33.
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Step 4: Remove the Lancet.
When removing the PENLET®II Cap, be careful not to prick your­self or anyone else. After removing
the cap, grasp the two dark gray prongs located near the release button, the lancet
pointing
down and away from you. Pull back on the dark gray sliding barrel until the lancet drops out. Another way to remove the lancet is to put the
protective disk back on the lancet. Place the disk on a hard surface and gently stick the lancet needle into the protective disk.
Now carefully pull the lancet out. Discard the used lancet in a con­tainer for sharp objects.
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TESTING
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Step-by-Step Test Procedure
When learning to use the meter for your own diabetes care, first do
TESTING
a control solution test. When the control solution test result is within the control range, you are ready to practice by testing your blood. Next you should perform three blood cose tests in a row. You will know you have applied blood correctly when the confirmation dot turns blue and you obtain a glucose result from the meter.
completely
glu-
Choose a clean, dry work surface. Make sure you have your:
Unused, sterile lancet
SURESTEP®Blood Glucose Meter
24
SURESTEP Test Strip
®
PENLET Sampler
®
II
Page 33
Before Testing.
Press the blue power button.
Your last test result will appear.
(Example)
Next, the code number appears. It must match the code number on the SURESTEP
®
Test Strip package. If it does not match, change the meter code number following the instruc­tions on pages 10–11.
(Example)
25
TESTING
Page 34
Then these symbols will alternate on the display:
TESTING
Apply blood to Insert test strip
test strip. into meter.
The meter is ready for a test. You have two minutes to insert the test strip before the meter automatically turns off.
Step 1: Apply Blood to the Test Strip.
Apply a drop of blood to the center of the pink test square.
Note: Do not add more blood to the first drop. Adding more blood may give false results.
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You can apply blood to the pink test square in one of two ways.
TESTING
1) Hold the test strip under your finger and touch the drop of blood to the pink test square.
OR
2) Turn the test strip over and dab the pink test square to the finger. You can touch the test strip. The pink test square will quickly absorb the blood and the confirmation dot will begin changing color.
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You have applied too much blood to the test strip if the entire white pad is soaked. You must begin the
TESTING
test with a new test strip to avoid false results from too much blood.
Too Much Blood
Step 2: Check the Confirmation Dot.
After a few seconds, look at the confirmation dot on the back of the test strip. If it is completely blue, go on with the test.
Enough Blood
Front
28
Front
Confirmation Dot
Back
Page 37
If any white patches or white streaks appear on the confirmation dot, you have not applied enough blood for an accurate test. You must start the test over with a new test strip.
Not Enough Blood
Caution: If you do not insert the test strip properly, you may get an inaccurate result.
Step 3: Insert the Test Strip and Read Result.
Turn the SURESTEP
®
Test Strip to the front side and slide it into the test strip holder, pink side up. Push the test strip in firmly until it stops. Insert the test strip within two minutes after applying blood to obtain an accurate result.
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TESTING
Page 38
The flashing clock symbol appears while the meter is reading your result. You will hear a three-tone
TESTING
beep when the meter displays your result. Results appear, on average,
in 30 seconds.
(Example)
The meter displays results between 0 and 500 mg/dL. In virtually all cases above 500 mg/dL, the meter reads “.
Note: Your meter is designed to give accurate results at temperatures between 50° and 95°F (10–35°C). At the higher end of this tempera­ture range the test time may be as short as 15 seconds. At the lower end of this temperature range, the test time will be extended.
The SURESTEP
ed to give plasma
®
System is calibrat-
values. Because most clinical laboratories measure plasma glucose, the SURESTEP System enables you to more directly compare meter results with lab results. See pages 35–36 to learn how to compare meter and lab results
.
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IMPORTANT: When proper procedures are followed, the meter will display “
when your result is above 500 mg/dL (27.8 mmol/L). This indicates very
high blood glucose (severe hyperglycemia). Low and High Blood Glucose:
Test results below 60 mg/dLi(3.3 mmol/L) mean low blood glucose (hypoglycemia). Test results greater than 240 mg/dL (13.3 mmol/L) mean high blood glucose (hyperglycemia). If you get results below 60 mg/dL or above 240 mg/dL and you do not have symptoms that match your results, repeat the test following the guidelines on pages 38–39 to ensure testing accuracy. You may also use the Color Chart (see pages 32–33). If you have symptoms that match your results or if you continue to get results that fall below 60 mg/dL or above 240 mg/dL, follow the treatment advice of your healthcare professional.
Record your test result in your LifeScan logbook. The logbook allows you to keep a record of your test results, along with information on your meals and medication.
DATE TEST
TEST
RESULT
TIME
INSULIN/ MEDICATION
DATE
TEST
RESULT
TIME
INSULIN/ MEDICATION
i. Kahn, R., and Weir, G.: Joslin’s Diabetes Mellitus, 13th
ed. Philadelphia: Lea and Febiger (1994), 489.
ii. Krall, L.P., and Beaser, R.S.: Joslin Diabetes Manual.
Philadelphia: Lea and Febiger (1989), 261-263.
31
NOTES
NOTESTEST
TESTING
ii
Page 40
Press the blue power button to turn off the SURESTEP®Blood Glucose Meter. (To save energy, the meter automatically turns off three
TESTING
minutes after the meter displays your test result.)
Optional Color Chart
A Color Chart is included with each package of SURESTEP Strips. It is useful as an additional check that your meter and test strips are working properly. The
Color Chart is NOT a replacement for a SURESTEP Meter test.
The chart shows four shades of blue, each corresponding to a blood glucose level. It also shows an off­white shade for new, unused test strips. Use the Color Chart in the following two ways.
32
®
Test
Page 41
1. Before testing. Compare the
confirmation dot on the back of the new test strip to the shade marked
unused on the chart.
Do not use the test strip if the confirmation dot is darker than the color of an unused test strip on the Color Chart.
2. After testing. Directly after read-
ing a meter result, you can com-
pare the color of the test strip con­firmation dot with the colors on the chart. The color of the confir-
mation dot will either match one of the colors on the chart or fall between two colors. When the color of the blue dot falls between two colors, your blood glucose
level is between the values printed next to the two colors. This compar-
ison will give you a rough estimate of your blood glucose level.
Note: If your Color Chart reading and meter result do not agree and do not reflect how you feel, follow the testing tips for accuracy on pages 38–39. Do not use the Color Chart
with control solution tests.
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TESTING
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UNDERSTANDING YOUR RESULTS
Overview
Recent Diabetes Findings.
In 1993 the National Institutes of Health term diabetes. This study, called the Diabetes Control and Complications Trial (DCCT), found that by keeping
RESULTS
your blood glucose close to the levels of people without diabetes you can reduce involving the eyes, kidneys, and ner­vous system by approximately 60%.
concluded an extensive long-
study of people with Type 1
the risk of complications
What This Means for You.
Frequent blood glucose testing is the best means you have for keeping track of how well you are doing with the factors that affect your diabetes—medication, diet, exercise, Blood glucose
and stress management.
test results can also tell you whether your diabetes is changing in ways that might require an adjustment to plan. Always
1
care professional before making
your treatment
consult your health-
any adjustments.
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Page 43
Frequency of Testing.
How often you need to test your blood glucose will vary according to your age, the type of diabetes you have, the medications you are taking,
your physical and emotional
and health. Your healthcare professional will guide you. After you decide when and how often you should test, it is important that you make testing part of your daily routine.
Comparing Meter and Laboratory Results
The SURESTEP®System’s plasma calibration enables you to more
directly compare SURESTEP Meter results with your lab results because
most laboratories measure plasma glucose; however, your meter blood glucose test result may be different from your laboratory result (by up
2
to 20%)
due to normal sources of variation. Make sure you are follow­ing Testing Tips to Ensure Accuracy on pages 38–39. To make an accurate comparison between meter and laboratory results, the meter test must be done within 10 to 15 min­utes of the laboratory test. If samples are taken more than 15 minutes
the two tests could have very
apart, different results.
Blood glucose levels can change significantly over short periods, especially
if you have recently eaten,
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RESULTS
Page 44
exercised, experienced stress.
taken medication, or
3
In addition, if you have eaten recently, the blood glucose level from a fingerstick can be up to 70 mg/dL higher than that of a venous sample (blood drawn from a vein) used for a laboratory
4
Therefore it is best to fast for
test. eight hours before doing the com­parison tests. Factors such or low hematocrit (amount of red
RESULTS
blood cells in the blood) or severe
as a high
dehydration (loss of body fluid) may also cause a meter result to be different from a laboratory result. For more detail, see pages 39–40.
Expected Test Results
(Target Range)
Your test results will vary somewhat from test to test. Blood glucose levels change throughout the day. T and amounts
of food you eat, your activity and stress levels, and how much insulin or other medication you take affect your blood glucose levels. If you are controlling your diabetes well, your test results should fall within a personal target range recommended by your health­care professional. Once you have established your target range, you will be able to detect when your results are high or low and can take action with advice from your health­care professional.
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he types
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GLUCOSE RANGES FOR PEOPLE WITHOUT YOUR TARGET DIABETES,5mg/dL RANGES, mg/dL
Before breakfast 70–105 ______________________
Before lunch or dinner 70–110 ______________________
1 hour after meals Less than 160 ______________________
2 hours after meals Less than 120 ______________________
Between 2 and 4 a.m. Greater than 70 ______________________
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RESULTS
Page 46
Testing Tips to Ensure Accuracy
If you have a test result that falls outside of your target range and you cannot link it to diet, exercise, medication, or stress, repeat the test. If the result is similar and still outside of your range, try these troubleshooting steps:
Before Testing
Wash your hands.
RESULTS
Use a new, sterile lancet.
Check the expiration date on the test strip package. If it has passed, discard the unused test strips and open a new package. When using test strips from a bottle, discard any remaining strips 4 months after first opening.
:
test
Make sure the confirmation dot on the unused test strip is not darker than the color of an unused test strip shown on the Color Chart.
Make sure the code on the meter matches the code on the test strip package.
Do a test with SURESTEP®Glucose Control Solution to verify that the test strip and meter are working properly.
Make sure the meter test strip holder, lens area, and contact points are clean. Follow instructions on pages 45–49.
After Testing:
Make sure you applied enough blood to the test strip by inspecting
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the test strip confirmation dot to be certain it turned completely blue.
Make sure you did not apply too much blood to the test strip. You have applied too much
blood if there is no white visible on the white pad.
Directly after the meter displays a result, compare the color of the test strip confirmation dot with the Color Chart on the test strip package (see pages 32–33).
IMPORTANT:
If you have followed the tips to ensure accuracy and your blood glucose results are still out-of-range, call your health­care professional.
Health Conditions Causing Out-of-Range Results
If you are getting results outside your range of expected blood glucose levels, and you are certain that the SURESTEP
®
SURESTEP
Test Strips are working together properly, ask yourself the following questions:
“How do I feel?”
“Do I have symptoms of low blood
glucose (hypoglycemia): slurred speech, headache, tingling of lips, cool sweating, rapid heartbeat, disorientation, weakness, dizziness, fainting, hunger, nervousness, irritability, or tremors?”
39
®
Meter and
RESULTS
Page 48
“Do I have symptoms of high blood
glucose (hyperglycemia): fatigue, dry mouth and skin, increased thirst or hunger, blurry vision, increased uri­nation, rapid deep breathing, or a fruity smell to the breath?”
“What have I eaten?”
“How much have I exercised?”
“Am I ill (common cold, flu, etc.)?”
“Have I been under stress lately?”
RESULTS
In addition to these factors, there are other abnormal conditions that can affect your results.
1. Extremes in hematocrit (the
amount of red blood cells in the blood) can affect test results. Very high hematocrits (above 60%) and
very low hematocrits (below 25%) can cause false results.
6
2. Severe dehydration and excessive water loss may cause
7, 8
false low results.
Severe dehy­dration, which may lead to many serious medical complications, can be caused by:
Vomiting and diarrhea
Prescription drugs (e.g., diuretics)
Inability to recognize or respond to “thirst” sensations
Uncontrolled diabetes Shock
9
If you believe you are suffering from severe dehydration, consult a health­care professional immediately.
40
Page 49
Recommendations for Better Diabetes Control
Follow the advice of your healthcare professional.
Follow the exercise and meal plans recommended by your healthcare professional.
Take insulin or diabetes medication at your scheduled times.
Keep in touch with your emotional and physical condition. Stress or illness can affect diabetes.
Watch for symptoms of hypo­glycemia (low blood glucose) and hyperglycemia (high blood glucose).
Review your logbook of test results with your healthcare professional regularly.
References
1. American Diabetes Association position state­ment on the Diabetes Control and Complications Trial (1993).
2. Clarke, W.L., et al.: Diabetes Care, Vol. 10, No. 5 (1987), 622-628.
3. Surwit, R.S., and Feinglos, M.N.: Diabetes Forecast (1988), April, 49-51.
4. Sacks, D.B.: “Carbohydrates.” Burtis, C.A. and Ashwood, E.R. (ed.), Tietz Textbook of Clinical Chemistry. Philadelphia: W.B. Saunders Company (1994), 959.
5. Krall, L.P., and Beaser, R.S.: Joslin Diabetes Manual. Philadelphia: Lea and Febiger (1989),
138.
6. LifeScan data on file.
7. Wickham, N.W.R., et al.: Practical Diabetes, Vol. 3, No. 2 (1986), 100.
8. Cohen, F.E., et al.: Diabetes Care, Vol. 9, No. 3 (1986), 320-322.
9. Atkin, S.H., et al.: “Fingerstick glucose determi­nation in shock.” Annals of Internal Medicine, Vol. 114 (1991), 1020-1024.
41
RESULTS
Page 50
RECALLING RESULTS FROM METER MEMORY
The SURESTEP®Blood Glucose Meter is pre-set to automatically display your last test result when the meter is turned on. You can also review your last result immediately after a new test is completed. The meter stores your 10 most recent blood glucose or control solution test results in its memory. When the memory is full, the oldest result is dropped as the newest is added.
MEMORY
Using the Meter for the First Time
The first time you turn on your meter the following symbol will appear briefly, showing that there is no test result in the memory:
This symbol will also appear after turning on your meter when your previous test ended in an error the meter did not display a result.
42
and
Page 51
Recalling All Results in Meter Memory
To access the meter memory, press the blue power button and hold down for five seconds. When the display flashes, release the blue power button. You are now in memory mode. Your most recent result will appear on the display.
Press the green C button to scroll through the memory. Each time you press the green C button, a number from most recent (1) to oldest (10) will appear, telling you the order of the test result, followed by the result.
Green C Button
Order of test result Result
(most recent test first) (Example)
MEMORY
Order of test result Result
(second most recent) (Example)
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If a previous test resulted in an error condition, the error will be stored in the memory.
Order of test result Result (third most recent) (Example)
Recalling Your Last Result
Immediately after completing a test, you can also review your previous test result.
Current result
(Example)
With the current test result displayed, press and hold the green C button. Your previous result will appear.
Green C Button
MEMORY
Previous result
(Example)
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CARING FOR YOUR METER
MAINTENANCE
Your SURESTEP
®
Blood Glucose Meter is easy to maintain. However, to keep it in good operating condi­tion, follow these simple rules:
General Care
Keep your meter dry and avoid exposing it to extremes in temper­ature. Do not store your meter or test strips in a car or refrigerator.
Dropping the meter could damage its electronics. If you drop your meter, do a control solution test to ensure it is working properly.
Do not take the meter apart. Sensitive parts could be damaged, causing false results and voiding the warranty.
Cleaning the Meter
Clean the test strip holder (cover and base), lens area, and contact points with water when there is dirt, blood, or lint present.
CAUTION:
Use only water when cleaning the meter. Do not get water inside the SURESTEP Meter. Never immerse the meter or hold it under running water.
Do not use cleansers or glass cleaners with ammonia.
When disinfecting the meter, use a 10% bleach solution (9 parts water, 1 part bleach) and remove with water.
45
Page 54
Always clean your meter when this symbol appears:
MAINTENANCE
If you are concerned that your test results do not compare with how you feel, clean the meter and do a control solution test to check if it is working properly. Clean the meter using these easy steps:
Step 1: Remove the Test Strip Holder.
Press down at the top end (near the power button) of the test strip holder and slide it away from the meter.
Step 2: Clean the Test Strip Holder.
Remove debris from the test strip holder by wiping gently with a cotton
swab or cloth dampened with water.
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Make sure you thoroughly wipe the gray area on the inside cover. Wash both sides of test strip holder base; carefully clean around the hole. Dry
the test strip holder completely with a soft cloth or lint-free tissue.
Cover
Inside Cover
Top of Base
Gray Area
Bottom of Base
Hole (clean both sides)
Base
MAINTENANCE
Step 3: Clean the Lens Area and Contact Points.
Use a cotton swab or a soft cloth dampened with water to wipe the lens area and contact points. Be careful not to scratch the lens area.
Dry with a soft cloth or tissue that does not contain lint, lotion, or per­fume. Do not use abrasive materials
such as paper towels.
Contact Points
Lens Area
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Step 4: Replace the Test Strip Holder.
Slide the test strip holder into the meter, press down, and push
MAINTENANCE
forward at the strip insertion point until you hear a click. Make sure the test strip holder is firmly in place. Make sure it does not extend beyond the meter.
Note: You can clean the outside of the meter by lightly wiping it with a damp cloth.
Turn on the meter.
48
Page 57
If this symbol appears after cleaning the meter, check to see if you insert­ed the test strip holder completely and securely. The test strip holder may be out of position. See pages 59–63 for error descriptions.
Note: If using a 10% bleach solution, this message may indicate that you have not completely removed the bleach residue on the gray area of the inside of the test strip holder cover. Wipe with a cloth dampened with water.
MAINTENANCE
Changing the Batteries
The SURESTEP®Blood Glucose Meter comes with two AAA alka­line batteries already installed. When this symbol appears
the batteries are low and you should replace them as soon as possible. The meter will still provide accurate test results with
49
Page 58
low batteries. If the symbol is flash­ing, the batteries are dead and you should replace them immediately. You will not be able to do the symbol is flashing. Replace both
MAINTENANCE
a test when
batteries with new AAA alkaline batteries. Do not use rechargeable
batteries.
Note: Low batteries, dead batteries, and battery removal will not affect the test results stored in the memory.
To change the batteries, turn off the meter and turn it over. Follow these steps:
Step 1: Remove the Battery Door.
Squeeze the tab and lift up.
L 5037 ZG 00171
®
50
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Step 2: Remove the Old Batteries.
MAINTENANCE
Step 4: Close the Battery Door.
Use your fingers or gently tap the meter on the palm of your hand. Never tap the meter against a hard surface.
L 5037 ZG 00171
®
Step 3: Insert New Batteries.
Insert two new AAA alkaline batteries, matching the + end of each battery with the + signs inside the meter.
Insert the two hinges into the slots and press down until the tab catches.
AW 052-178-01A Made in U.S.A.
C22.2 No. 125; Risk Class 2
© LIFESCAN INC. 1995
Milpitas,CA 94035
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CHANGING METER SETTINGS (Set-Up Mode)
The SURESTEP®Meter has been pre-set to meet the needs of most users. There are three features you can change. Be sure you want to
FEATURE PRE-SET ALTERNATIVE
Automatic display On Off
SETTINGS
of last result
Unit of mg/dL mmol/L measurement
Beep signals On Off during testing
change these settings before enter­ing the set-up mode to avoid having meter settings that do not meet your needs.
52
Page 61
Entering Set-Up Mode
1. Make sure the meter is off.
2. Press and hold down the green
C button.
3. Press and release the blue
power button while holding the C button.
4. Release the C button. In the set-up mode, the current set-
ting for each of the three changeable features is automatically displayed in sequence. Each setting flashes on the display for five seconds. While it flashes, the setting may be changed by pressing the C button. After the last feature is displayed,
the meter automatically turns off. To re-enter set-up mode, begin with Step 2.
Display of Last Result
The SURESTEP®Meter is pre-set to automatically display your last test result when you turn on the meter.
After you release both the power and C buttons, this symbol will flash on the display:
53
SETTINGS
Page 62
If you wish to turn off the auto­matic display of your last result, press the C button. This symbol will flash
indicating that the automatic
SETTINGS
display is turned off. Then, wait for the next feature setting (unit of measurement) to appear.
Unit of Measurement
The meter is pre-set to display test results in milligrams per deciliter
(mg/dL). You have the option to select millimoles per liter (mmol/L), the unit of measurement used in Canada and some European countries. The mmol/L results include a decimal point, but mg/dL results do not.
In set-up mode the unit of measure­ment will be the second feature to flash on the display.
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Page 63
If you wish to change the unit of measurement to mmol/L, press the C button. This symbol will flash on the display.
Then, wait for the next feature set­ting (beep signals) to appear.
Beep Signals
The SURESTEP®Blood Glucose Meter uses beeping tones to signal various steps in the meter
procedures. However, these tones do not indicate that the procedures are being performed correctly. The meter is pre-set to emit three differ­ent beep signals:
1. A single short beep signals each step in the test procedure.
2. A single long beep accompanies
error messages, a
result, and certain mistakes in doing the test procedure.
3. A three-tone beep sounds when the meter displays a test result and when the meter is in set-up mode on the beep signal feature.
55
SETTINGS
Page 64
If you want the meter to operate without beeps, enter the set-up mode. After the meter displays the memory and unit of measurement features, the meter will sound a three­tone beep and flash this message
SETTINGS
Press the C button to turn off the beep signals. The following display will appear
You will hear a three-tone beep when is first displayed. Then it will flash silently until the meter turns off.
The meter will continue to use these settings until you change them.
56
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SOLVING PROBLEMS
When any of the following symbols or error messages appear, there may be a problem with the meter, test strip, or the way in which you are doing the procedure. These messages help to identify certain
problems but do not appear in all cases when a problem has occurred. In most cases, a problem is easy to solve. Assistance is available from LifeScan Customer Services 24 hours a day at 1 800 227-8862.
Helpful Messages
SYMBOL MESSAGE WHAT TO DO
The test strip was not Push the test strip in firmly fully inserted. until it stops.
57
MESSAGES
Page 66
SYMBOL MESSAGE WHAT TO DO
1. The test strip was 1. Remove the test strip inserted before the and reinsert the meter was turned on strip after this or before the insert test symbol appears. strip symbol appeared, or
2. The test strip was inserted 2. Reinsert the test strip, tip incorrectly, or first, with the pink side
facing up.
3. The test strip was 3. Reinsert test strip slowly. inserted too quickly.
If the symbol is constant, Replace the batteries the batteries are low. If the (see pages 49–51). symbol is flashing, the batteries are dead.
MESSAGES
58
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Error Messages
The meter gives specific error mes­sages when it detects a problem with its internal functions, the test strip, or the testing procedure. However, improper use may cause an inaccurate
ERROR POSSIBLE CAUSE WHAT TO DO
1. Blood was applied to 1. Clean the meter. Repeat the test the wrong side of the with a new test strip, applying test strip, or blood to the pink test square.
2. Not enough blood is 2. Repeat the test with a new test on the test strip, or strip. Apply a larger drop of blood
result without producing an error message or a symbol. When error mes­sages appear, note the error number, turn off the meter, then resolve the error by following these instructions:
to the pink test square and verify that the confirmation dot on the back of the test strip has turned completely blue.
59
Confirmation
Dot
Pink Test
Square
MESSAGES
Page 68
ERROR POSSIBLE CAUSE WHAT TO DO
3. The test strip was 3. Repeat the test with a new test inserted more than
strip. Insert it within 2 minutes 2 minutes after after applying blood. applying blood, or
4. You may have a 4. Do a visual check of the color of very high blood the confirmation dot versus the glucose level, Color Chart on the test strip pack­possibly exceeding age. A color that matches or is 500 mg/dL. darker than the 350 mg/dL color
on the chart indicates a high blood glucose level. Follow the treatment advice of your health­care professional.
1. Not enough blood 1. Repeat the test with a was applied to the new test strip. Apply a test strip, or larger drop of blood to the
pink test square and verify that the confirmation dot
MESSAGES
on the back of the test strip has turned completely blue.
60
Confirmation
Dot
Page 69
ERROR POSSIBLE CAUSE WHAT TO DO
2. The test strip has 2. Check the expiration date on been altered, exposed your test strip package. Do not to air, or has passed store test strips outside of the its expiration date. original bottle. Do not alter test
strips.
1. The test strip was 1. Do not remove the test strip removed or partially until the meter displays the removed before the result. result was displayed,
or
2. The meter contact 2. Clean meter contact points. points are dirty.
Note: If more than two minutes have passed since you applied blood to the test strip, repeat the test with a new test strip.
61
MESSAGES
Page 70
ERROR POSSIBLE CAUSE WHAT TO DO
The meter is not Allow the meter to warm or within the temperature cool slowly before performing range of 50–95°F another test. Do not apply heat (10–35°C). or cold to the meter or test strips.
1. The meter test strip 1. Clean; refer to pages 45–49. holder, lens area, and contact points are dirty, or
2. The test strip holder 2. Slide the test strip holder is not fully in place, into the meter until it is or completely inserted.
MESSAGES
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ERROR POSSIBLE CAUSE WHAT TO DO
3. The test strip was 3. Remove test strip and turn partially inserted meter off. Turn meter on, then before turning the reinsert test strip when insert meter on. test strip symbol appears.
A possible failure has Turn meter on. Before testing, occurred in the meter. check that the code on your
meter matches the code on your test strip package. If continues, call LifeScan Customer Services at 1 800 227-8862.
63
MESSAGES
Page 72
SPECIFICATIONS
Performance Characteristics
See the SURESTEP®Test Strip
SPECIFICATIONS
package precision information.
Power Supply: Two AAA alkaline
batteries.
Battery Life: Approximately 18
months when doing two tests a day.
Result Range: 0–500 mg/dL
(0–27.8 mmol/L). Higher results are displayed as “.
Display: Liquid crystal. Blood Source: Whole blood.
insert for accuracy and
Calibration: Plasma equivalent. Hematocrit Range: 25–60%. Dimensions: Length, 3.5 inches;
Width, 2.4 inches; Height, 0.80 inches; Weight, 3.8 ounces with batteries.
Operating Temperatures: 50–95˚ F
(10–35˚ C).
Operating Humidity Range:
10–90% relative humidity (noncondensing).
Memory: 10 test results.
64
Page 73
Guarantee and Warranty
30-Day Money-Back Guarantee
If you are not fully satisfied with the SURESTEP refund may a LifeScan Customer Services Representative at the toll-free number within 30 days After calling LifeScan, you will need to return the SURESTEP Meter and a copy of your receipt to receive a refund.
Three-Year Warranty
If, at any time during the first three years after purchase, the meter does
®
System, a full
be obtained by calling
of purchase.
®
not work for any reason (except for obvious abuse), LifeScan will replace it with a new meter or equivalent product free of charge.
The Warranty Policy applies only to the original purchaser of this meter and does not include the batteries supplied with the meter.
Please complete the Warranty Registration Card and mail it to LifeScan.
The SURESTEP Meter has a full three-year warranty from the origi­nal date of purchase. Write your date of purchase here:
________________________________
65
WARRANTY
Page 74
The Warranty Policy does not apply to the performance of the SURESTEP
®
Meter when used with any test strip other than SURESTEP
®
Test Strips from LifeScan, or when the SURESTEP Meter or Test Strips are modified in any way.
Before you return your meter, or any product, first call your
WARRANTY
LifeScan Customer Services Representative at the toll-free number for 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.
66
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CODING THE METER
Before testing, make sure the
meter is coded correctly.
(Example)
3-STEP TEST PROCEDURE
Press power button
1
and apply blood to
pink test square.
QUICK REFERENCE
Press power button. 2Meter automatically
1
(Example)
Code number is
3
automatically displayed.
displays last test result.
C Button
(Example)
Press C button until
4
code number on meter matches code number on test strip package.
67
Check confirma­tion dot on back
2
of test strip.
Firmly insert test strip pink side up,
3
until it comes to a complete stop, and read result (30-second average test time).
Page 76
How you can be sure that you have applied the right amount of blood:
Front
Pink Test
Square
Pink test square is where you apply a drop of blood.
White pad absorbs the excess blood that may
QUICK REFERENCE
extend beyond the pink test square. Do not apply blood directly onto the white pad.
Confirmation dot
of test strip is where you check to confirm proper blood application.
Back Not Enough
Confirmation
White
Pad
Dot
on back
BLOOD APPLICATION
Enough Blood
Front
Apply a drop of blood to the pink test square on the front of the test strip. The confirmation dot on the back should be completely blue for an accurate test.
Back
If any white patches or streaks appear on the blue confirmation dot, you have not applied enough blood for an accurate test. You must start the test over with a new test strip to avoid false low results.
68
Blood
Too Much Blood*
Back
Front
If there is no white visible on the white pad, you have applied too much blood. You must start the test over with a new test strip to avoid false high results.
*Be careful not to
apply too much blood, especially if you tend to bleed easily or are taking blood-thinning medications.
Page 77
El Folleto para el Propietario del SURESTEP®se encuentra disponible en
*05225103A*
español. Para recibir su copia gratuita, favor del llamar al número gratis 1 800 381-7226.
The SURESTEP instructional materials are available in Spanish. To receive your free copy, please call toll-free 1 800 381-7226.
LifeScan Customer Services toll-free numbers:
(24 hours a day, 7 days a week)
U.S.A. English 1 800 227-8862
Español 1 800 381-7226
Milpitas, California 95035
Printed in U.S.A.
AW 052-251-03A Patents Pending © LIFESCAN INC. 1998
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