Lifescan SureStep blood glucose monitoring system User Manual

Owner’s Booklet
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.
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 ______________________________
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.
TABLE OF CONTENTS
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© 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
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
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
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.
1
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
2
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.
3
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.
4
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.
5
LEARNING
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.
6
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)
7
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)
8
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.
9
LEARNING
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)
10
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
CHECKING THE SYSTEM
Glucos
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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.
12
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.
13
CHECKING
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)
14
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
15
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)
16
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