ApexBio GlucoSure Plus User manual

Table of Contents
1. About Your GlucoSure®Plus Blood Glucose Monitoring System
Contents of Kit ........................................................................................................ 5
GlucoSure®Plus Blood Glucose Meter .................................................................. 6
Touch-In®Plus Blood Glucose Test Strip ................................................................ 8
Contrex™ Plus Glucose Control Solution (optional) ............................................ 9
2. Before Testing
Changing Unit of Measurement ............................................................................ 10
Monitor Checker Test ........................................................................................... 11
Quality Control Testing ......................................................................................... 12
3. Glucose Testing
Coding the Meter .................................................................................................. 17
Performing a Blood Glucose Test ......................................................................... 20
1
USER'S GUIDE
Table of Contents

4. Understanding Your Blood Glucose Test Results
Abnormal Blood Glucose Readings ..................................................................... 24
Recent Diabetes Findings..................................................................................... 25
What This Means for You...................................................................................... 25
5. Using Meter Memory .......................................................................................... 27
6. Caring for the Meter
Cleaning the Meter ............................................................................................... 28
Storage and Precautions ...................................................................................... 28
7. Changing the Battery ......................................................................................... 30
8. Message Interpretations & What to do ............................................................. 31
9. Performance Evaluation
Accuracy .............................................................................................................. 34
Precision ............................................................................................................... 35
2
USER'S GUIDE
Table of Contents

10. Specifications ..................................................................................................... 37
11. Supplies .............................................................................................................. 39
12. Symbols Used in this Manual ........................................................................... 40
13. Product Warranty ............................................................................................... 41
3
USER'S GUIDE
Table of Contents

Chapter 1. About Your GlucoSure®Plus Blood Glucose
Monitoring System
Thank you for choosing the GlucoSure®Plus Blood Glucose Monitoring System to help
you manage your blood glucose (blood sugar) levels. All of the information that will be
needed to use and maintain the GlucoSure®Plus Blood Glucose Meter is included in
this manual. Read it carefully before using the system.
Utilizing Biosensor Technology, your GlucoSure®Plus Blood Glucose Monitoring System
provides an easy and precise way of measuring the level of glucose (sugar) in capillary
blood from the finger at specific points in time. The results are plasma referenced, which
means that the results obtained from the GlucoSure®Plus Blood Glucose Monitoring
System is comparable to the results you get in a laboratory.
The GlucoSure®Plus Blood Glucose Monitoring System is intended for use outside the
body (in vitro diagnostic use) and provides important information relating to blood
glucose control. Your GlucoSure®Plus Blood Glucose Monitoring System is designed for
both self-testing by an individual and for use by healthcare professionals.
4
USER'S GUIDE
Chapter 1. About Your GlucoSure
®
Plus
Blood Glucose Monitoring System

Contents of Kit
The GlucoSure®Plus kit package includes the following items.
* The kit contents may vary in some certain areas.
Contact the dealer if you find difference from the above.
5
USER'S GUIDE
Chapter 1. About Your GlucoSure
®
Plus
Blood Glucose Monitoring System
GlucoSure®Plus
Blood Glucose
Meter (1)
Touch-In®Plus
Blood Glucose
Test Strips (10)
Adjustable
Lancing
Device (1)
Carrying Case (1)
Test strip insert for
Touch-In®Plus Blood
Glucose Test Strips (1)
Log Book (1)
User's Manual (1)
Monitor Checker (1)Code Card (1)Lancets (10)

GlucoSure®Plus Blood Glucose Meter
6
USER'S GUIDE
Chapter 1. About Your GlucoSure
®
Plus
Blood Glucose Monitoring System
L
Display Screen
Large, easy-to-read window guides you through testing, displaying
results, and error messages using simple words or symbols.
Push Button
• Recalls test results in the memory. Refer to chapter 5. p.30
"Using Meter Memory" for details .
• Press and hold to turn off meter.
Test Strip Holder
Insertion site for test strips and monitor checker. Located at the bottom-front
side of the meter. When a test strip or the monitor checker is inserted, the
meter will power on automatically. When the test strip or the monitor checker
is removed, the meter will power off automatically.

7
USER'S GUIDE
Chapter 1. About Your GlucoSure
®
Plus
Blood Glucose Monitoring System
R 2
R 1
IVD
PN 63105710808
REF
S6031
REV. 9/03
R1 Check R2 Check
Battery
Compartment
Located on the back of
the meter. Holds one 3V
Lithium coin cell battery
(CR2032). Refer to
Chapter 7. p.33
"Changing the Battery"
.
Code Card Port
Insertion site for the
code card. Located at
the top-back of the
meter.
Code Card
The code card programs the meter for a specific lot of
test strips. A new code card comes with each new
package of test strips.
Monitor Checker
Used to confirm that the GlucoSure®Plus Blood
Glucose Meter is functioning properly. Refer to
Chapter 2. p.12 "Monitor Checker Test" for
details .

Touch-In®Plus Blood Glucose Test Strips
Contact Points Sense the position and orientation of the Test Strip.
Test Strip Handle The only area to be touched when handling the Test Strip.
Reaction Zone The area where the blood sample or Control Solution is applied.
The GlucoSure®Plus Blood Glucose Meter is designed specifically to detect glucose in
whole blood with the Touch-In®Plus Blood Glucose Test Strip only. The Touch-In®Plus
Blood Glucose Test Strips come in a moisture-proof, light-protected bottle . It is
important that the bottle is kept well sealed at all times and the cap is replaced
immediately after a strip is removed.
8
USER'S GUIDE
Chapter 1. About Your GlucoSure
®
Plus
Blood Glucose Monitoring System
Test Strip
Handle
Reaction Zone: Apply Blood Here
Contact Points

Contrex™ Plus Glucose Control Solution (optional)
Standard glucose concentration solution required to perform the "Quality Control
Testing” in Chapter 2, p.13 to check for system accuracy, practice test procedure, and
when using a new lot of Touch-In®Plus Blood Glucose Test Strips.
9
USER'S GUIDE
Chapter 1 able of Contents
Suitable for self-testing
StorageTem perature
15
PN63105010311
orbeforethe expiration
Usewithin3 months afte
For the GlucoSure Plus and Multisure Meter
to be used The TestStrip

Chapter 2. Before Testing
Changing Unit of Measurement
Your GlucoSure®Plus Blood Glucose Meter can display test results in either mg/dL or
mmol/L. The factory setting is mg/dL. Consult your healthcare professional before
changing the unit of measurement.
Material you will need:
• Your GlucoSure®Plus Blood Glucose Meter
Step 1: Remove the battery cover at the backside of the Meter.
10
USER'S GUIDE
Chapter 2. Before Testing
12345

Step 2: Remove the battery from the battery compartment.
Step 3: Locate a switch on the left side in the battery compartment.
Step 4: Slide the switch downwards for setup of measurement unit at mg/dL, or push
the switch upwards for setup at mmol/L.
Step 5: Install the battery, and re-place the battery cover.
Monitor Checker Test
The Monitor Checker Test will help ensure that the electronics in your GlucoSure®Plus
Blood Glucose Meter is working properly. This test should be done on a brand new
meter or when the performance of the meter needs to be confirmed.
Materials you will need:
• Monitor Checker (included in kit)
• Your GlucoSure®Plus Blood Glucose Meter
Step 1: Insert the Monitor Checker (R1 end) into the test strip holder until you hear a
"beep".
Step 2: When the Meter Display Screen shows smiling face ""it means your meter
11
USER'S GUIDE
Chapter 2. Before Testing

12
USER'S GUIDE
Chapter 2. Before Testing
is functioning properly and you can proceed to the next step. If the display screen
shows a crying face ""then repeat the testing procedure. If ""continues
to appear, refer to Chapter 8, p.34 "Message Interpretations & What to do"
.
Step 3: Repeat the testing procedures steps 1 through 2 on the R2 end of the Monitor
Checker.
Quality Control Testing
Perform Quality Control Testing when:
• You first get your meter, before performing a blood glucose test.
• You first begin to use a new bottle of Touch-In®Plus Blood Glucose Test Strips.
•
You suspect your GlucoSure®Plus Blood Glucose meter and Test Strips are not working properly.
• The blood glucose results do not reflect how you feel.
• When your Test Strips have been exposed to extreme temperatures ( see Touch-In®
Plus Blood Glucose Test Strip Insert for operation ranges).
• Practice the test procedure.
Two levels of Contrex™ Plus Glucose Control Solutions are available for quality control
testing. Each level tests a different range of glucose concentration.

IMPORTANT:
•The acceptable range for the control solution is listed on the package of test
strips.
•Use only the Contrex™ Plus Glucose Control Solutions with the Touch-In®Plus
Blood Glucose Test Strips. Other brands of glucose solution may produce
inaccurate result.
•Always check the expiration date . DO NOT use control solutions if expired.
•Mark the newly opened bottle of control solution with the date opened; discard
any unused control solution three months after opening .
•DO NOT FREEZE. Store the control solutions at room temperature .
•If the result of the control solution test is outside of the expected range printed on
the test strip package, DO NOT use the system to test for blood glucose. Repeat
the control solution test until the result falls within the expected range. If the
result continues to be outside of the expected range, call our authorized dealer
for service.
•DO NOT touch the test area with the tip of the control solution bottle.
•DO NOT apply a second drop of control solution to the test strip.
•Replace the bottle cap on the control solution bottle immediately after use.
13
USER'S GUIDE
Chapter 2. Before Testing

Materials you will need:
• Contrex™ Plus Glucose Control Solutions Level 1&2 (optional items, contact our
authorized dealer for purchasing information).
• A brand new Touch-In®Plus Blood Glucose Test Strip.
• Your GlucoSure®Plus Blood Glucose Meter.
Step 1: Perform the Monitor Checker Test, refer to
Chapter 2, p.12 "Monitor Checker Test " .
Step 2: After the display screen of the meter showing
"", the screen will then display the current
code number being used. Verify that code
number on screen is the same with the code
number printed on the bottle label and
remove a test strip from the test strip bottle.
IMPORTANT:
1. Do not use test strip that has expired. Check the expiration date that is printed
on the test strip bottle and package.
14
USER'S GUIDE
Chapter 2. Before Testing

15
USER'S GUIDE
Chapter 2. Before Testing
2. Use each test strip immediately after removing it from the bottle.
3. After removing a test strip from the bottle, replace the bottle cap immediately and
close it tightly.
4. Do not use wet, bent, or scratched test strips.
5. Keep away from direct sunlight and heat. Store the test strip bottle in a dry, cool
place .
6. Record the "date opened" on the test strip bottle label when you first open it.
Discard the bottle and any remaining test strips after 3 months .
Step 3: Insert a brand new Touch-In®Plus Blood Glucose Test Strip into the test strip
holder of the Meter. The screen will show "ctrl." This will ensure the control
results will not be stored into memory.
Step 4: When the screen shows a symbol
"", apply a drop of Contrex™
Plus Level 1 Glucose Control
Solution (solution with green bottle
cap) on top of the yellow reaction
zone of the test strip. Do not apply

the control solution at the edge of the yellow reaction zone.
Step 5: The display screen will show timing bars"-----". The bars will flash and gradually
diminish for countdown.
Step 6: After the timing bars disappear, the screen will show test result. Compare the
reading on the screen to the Level 1 range printed on the test strip package. The
test result falling within the range means the meter and the test strip are working
together properly. Remove the test strip.
Step 7: To perform test of Level 2 control solution (solution with blue bottle cap), repeat
steps 1-6.
IMPORTANT:
If the test result is not within the expected range, repeat the control solution testing.
If the results continue falling outside the expected range, call our authorized dealer.
16
USER'S GUIDE
Chapter 2. Before Testing

Chapter 3. Glucose Testing
Coding the Meter
Before you can begin testing on your GlucoSure®Plus Blood Glucose Meter, you must
"code" the meter. Coding the meter ensures accurate test results when you perform a
test. A new code card is packaged along with each box of Touch-In®Plus Blood Glucose
Test Strips.
Materials your will need:
• A code card for the Touch-In®Plus Blood Glucose Strips
• A Touch-In®Plus Blood GlucoseTest Strip
• Your GlucoSure®Plus Blood Glucose Meter
NOTE:
Make sure the Touch-In®Plus Blood Glucose Test Strips are not expired. Check the
test strip expiration date on the box and the test strip bottle.The month printed
refers to the end of the month.
17
USER'S GUIDE
Chapter 3. Glucose Testing

Step 1: Locate the code card ()in the package of test strip.
Step 2: Verify that the code number on the code card matches the code number on the
test strip package
Step 3: Insert the code card with the code number facing up firmly and completely into
the code card port on the backside of the meter.
Step 4: Obtain a test strip ( ) and insert the strip into the test strip holder located
at front bottom of the meter. The meter will turn on with a beep sound. Close
the test strip bottle immediately after you take out a strip.
Step 5: A 3-digit code number will display on the meter screen. Verify the code number
on the screen with that on the code card and on the test strip package. All three
sets of numbers should be the same.
NOTE:
1. The code card found in the test strip package is for use with that particular
package only. Test strips from different packages and other brands of test strip
may produce inaccurate results.
2. Make sure the three sets of numbers from the meter display screen, the code
card, and the test strip package match.
18
USER'S GUIDE
Chapter 3. Glucose Testing

3. Re-coding needs to be done when the battery is replaced or a new package of
test strip is opened for use.
19
USER'S GUIDE
Chapter 3. Glucose Testing
The code number displayed on the meter should match the code number
on the gray code card and on the front of the test strip package. Code Card
➟

20
USER'S GUIDE
Chapter 3. Glucose Testing
Performing a Blood Glucose Test
Materials you will need:
• A brand new Touch-In®Plus Blood Glucose Test Strip
• Your GlucoSure®Plus Blood Glucose Meter
IMPORTANT:
1. Do not use test strip that has expired. Check the expiration date that is printed
on the test strip bottle and box.
2. Use each test strip immediately after removing it from the bottle.
3. After removing a test strip from the bottle, replace the bottle cap immediately and
close it tightly.
4. Do not use wet, bent, or scratched test strip.
5. Keep away from direct sunlight and heat. Store the test strip bottle in a dry, cool
place .
6. Record the "date opened" on the test strip bottle label when you first open it.
After 3 months since first opened date, discard the bottle and any remaining test
strip.