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ApexBio GlucoSure Plus User Manual

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Contents of Kit ........................................................................................................ 5
®
Plus Blood Glucose Meter .................................................................. 6
®
Plus Blood Glucose Test Strip ................................................................ 8
Contrex™ Plus Glucose Control Solution (optional) ............................................ 9
Changing Unit of Measurement ............................................................................ 10
Monitor Checker Test ........................................................................................... 11
Quality Control Testing ......................................................................................... 12
Coding the Meter .................................................................................................. 17
Performing a Blood Glucose Test ......................................................................... 20
®
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  • Page 1: Table Of Contents

    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.
  • Page 2 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.
  • Page 3 10. Specifications ..................... 37 11. Supplies ......................39 12. Symbols Used in this Manual ................40 13. Product Warranty ....................41...

  • Page 4: About Your Glucosure

    ® 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 ®...

  • Page 5: Contents Of Kit

    Contents of Kit The GlucoSure ® Plus kit package includes the following items. Carrying Case (1) User's Manual (1) Touch-In Plus ® Blood Glucose Test Strips (10) Log Book (1) Adjustable Lancing Test strip insert for Device (1) Touch-In Plus Blood ®...

  • Page 6: Glucosure ® Plus Blood Glucose Meter

    GlucoSure Plus Blood Glucose Meter ® 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 •...
  • Page 7 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. PN 63105710808 R1 Check S6031...

  • Page 8: Touch-In ® Plus Blood Glucose Test Strip

    Touch-In Plus Blood Glucose Test Strips ® Contact Points Test Strip Handle Reaction Zone: Apply Blood Here 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.

  • Page 9: Contrex™ Plus Glucose Control Solution (Optional)

    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.

  • Page 10: Before Testing

    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: •...

  • Page 11: Monitor Checker Test

    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.

  • Page 12: Quality Control 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.
  • Page 13 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.
  • Page 14 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 "...
  • Page 15 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.
  • Page 16 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.

  • Page 17: Glucose 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 ®...
  • Page 18 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.
  • Page 19 3. Re-coding needs to be done when the battery is replaced or a new package of test strip is opened for use. 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...

  • Page 20: Performing A Blood Glucose Test

    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.
  • Page 21 Step 1: After you have performed the previous section, "Coding the Meter," the meter will now self-test the environment temperature. If the temperature is below or above operation range, the screen will display the flashing symbol of thermometer " ". When the temperature is within the testing range of 18°C to 38°C (64°F to 100°F), the screen will show a symbol "...
  • Page 22 NOTE: If the temperature is outside of the operating range, the meter needs to be moved to an area that is within the meter's operating range of 18°C to 38°C (64° to 100° ) and allow 10 to 15 minutes for it to reach the new temperature before use. Measurement outside the temperature range will affect accuracy of test result.
  • Page 23 • DO NOT add or apply a second drop of blood. This may cause false result. • DO NOT proceed testing if the yellow window is not full of blood sample. Insufficient blood sample may cause inaccurate test result. Step 5: The meter screen will display timing bars "-----". The bars will flash and gradually diminish for countdown.

  • Page 24: Understanding Your Blood Glucose Test Results

    Chapter 4. Understanding Your Blood Glucose Test Results Blood glucose levels fluctuate naturally, causing test results to vary over time and can also be affected by several factors. Some of which include but are not limited to the following: • The time of day the test is performed. •...

  • Page 25: Recent Diabetes Findings

    Always record your results in logbook. The logbook assists in keeping a record of blood glucose results, along with information on food intake, exercise, and medication. Recent Diabetes Findings In 1993 the National Institute of Health concluded an extensive long-term study of people with Type I diabetes, the Diabetes Control and Complications Trial (DCCT) found that by keeping your blood glucose close to the level of people without diabetes you could reduce the risk of complications involving the eyes, kidneys, and nervous system...
  • Page 26 References 1. American Diabetes Association position statement on the Diabetes Control and Complication Trial (1993). 2. Clarke, W.L., et al.: Diabetes Care, 1987, Vol.10, No. 5, p. 628-662 3. Surwit, R.S., and Feinglos, M.N.: Diabetes Forecast, April 1988, p.49-51 4. Wickham, N. W.R., et al: Practical Diabetes, 1986, Vol. 3, No. 2, p.100 5.

  • Page 27: Using Meter Memory

    Chapter 5. Using Meter Memory Your GlucoSure ® Plus Blood Glucose Meter automatically stores 10 test results. When more than 10 test results have been performed, the oldest result will be dropped from memory each time a new result is added. When the test results are recalled from memory, the most recent result is always displayed first.

  • Page 28: Caring For The Meter

    Chapter 6. Caring for the Meter Cleaning the Meter Your GlucoSure ® Plus Blood Glucose Meter does not require special cleaning. If the meter gets dirty, use a moist (NOT WET) lint-free cloth dampened with a mild detergent. NOTE: ® 1.
  • Page 29 in an extremely hot or cold car. • Do not store or use the meter or test strips where they may be exposed to high humidity levels, such as in a bathroom or kitchen. • Never immerse or hold the meter under running water. •...

  • Page 30: Changing The Battery

    Chapter 7. Changing the Battery The GlucoSure ® Plus Blood Glucose Meter operates on one 3V lithium coin cell battery (CR2032). When the display screen shows a flashing symbol of " " , this indicates the battery is low and should be replaced as soon as possible. NOTE: ®...

  • Page 31: Message Interpretations & What To Do

    Chapter 8. Message Interpretations & What to Do If there is a problem with the way you are performing a test or if there is a problem with your GlucoSure ® Plus Blood Glucose Meter, any of the following messages may appear on the meter screen.
  • Page 32 Message Meaning What To Do " " The temperature of your The meter needs to be moved to an meter, the surrounding air, area that is within the system's or the test strip is outside of operation range of 18°C to 38°C system's operation range.
  • Page 33 Message Meaning What To Do The blood glucose result Check using right code card and is higher than 550mg/dL new test strip, and the blood volume (30.6mmol/L) is suitable for applying, then repeat the test to confirm the test result. If it reads HI again, contact your healthcare professional.

  • Page 34: Performance Evaluation

    Chapter 9. Performance Evaluations The performance evaluation is determined in both clinical and laboratory settings. Accuracy Accuracy describes how well the readings from a testing system (meter and test strips) agree with the readings from an internationally accepted reference system (laboratory glucose analyzer) and are performed according to an internationally recognized standard.

  • Page 35: Precision

    Clinical Site Studies Number of Samples: Range: 39 mg/dL to 496 mg/dL Slope: 1.037 Intercept: -4.68 mg/dL Correlation Coefficient: 0.988 Precision Precision describes the variation between readings in the test system. A test system with little variation is defined as precise. A study was conducted with the GlucoSure ®...
  • Page 36 Individual Use Method Number of Readings: Average (mg/dL): S.D. (mg/dL): 11.0 C.V%: For more information on the Touch-In ® Plus Blood Glucose Test Strips, please refer to the packaging insert found in each box of test strips.

  • Page 37: Specifications

    Chapter 10. Specifications Test Strips: Touch-In ® Plus Blood Glucose Test Strips Test Range: 30 - 550 mg/dL (1.7 - 30.6 mmol/L) Blood Source: Capillary whole blood Hematocrit Range: 30-55% Display Type: Large LCD screen Memory: 10 blood glucose test result Dimension: 100L x 58W x 21H (mm) Weight:...
  • Page 38 Applied Product Standards: ISO/DIS 15197 IEC 61010-1 IEC 60601-1 EN 60601-1 EN 61010-1 EN 60601-1-2 EN 61326...

  • Page 39: Supplies

    Chapter 11. Supplies Part Number Product Name S6031 GlucoSure ® Plus Blood Glucose Monitoring System S5635103 Touch-In ® Plus Blood Glucose Test Strips 100's S5635066 Touch-In ® Plus Blood Glucose Test Strips 50's S5635067 Touch-In ® Plus Blood Glucose Test Strips 2 x 25's 65235010001 Lancing Device 80050000003...

  • Page 40: Symbols Used In This Manual

    Chapter 12. Symbols Used in this Manual (EXP) Expiration date (use by last day of month) (LOT) Batch code Temperature limitations Consult instructions for use In vitro diagnostic device Caution / warning, consult accompanying documents Product code number Keep away from sunlight/direct light Do not re-use...

  • Page 41: Product Warranty

    Chapter 13. Product Warranty The GlucoSure ® Plus Blood Glucose Meter is guaranteed to be free of defects in workmanship and materials under normal use for a period of five (5) years from the date of purchase to the consumer. The liability of Apex Biotechnology Corp is limited to repair or replacement and in no event shall Apex Biotechnology Corp be liable for any collateral or consequential damages or loss.

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