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3 in 1 system for?....................................................................................3
TM
Important Information...........................................................................................................4
Items in the Package..................................................................................................................6
Items Need to be Purchased Separately.....................................................................................7
Multi-Function Monitoring System..............................................................................................8
Test Strips............................................................................................................................9
Setting Date and Time........................................................................................................10
Checking the Unit of Measurement....................................................................................10
The Batteries Installation...................................................................................................11
Using Check Strip to Check the Meter................................................................................12
Items You Need..................................................................................................................13
Steps for Running a Glucose Control Check......................................................................14
Steps for Running a Cholesterol Control Check.................................................................16
Steps for Running a Uric Acid Control Check................................................................18
How to Read the Label on the Test Strip Vial?....................................................................19
Analyzing Your Control Results..........................................................................................20

Table of Contents

3 in 1 Blood Glucose/Cholesterol/Uric Acid
TM
3 in 1 Multi-Function Monitoring System..................................10
TM
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Summary of Contents for in4 care GlucoAlpha 3 in 1

  • Page 1: Table Of Contents

    Table of Contents What is GlucoAlpha 3 in 1 system for?..................3 Important Information......................4 Items in the Package........................6 Items Need to be Purchased Separately..................7 Getting to Know GlucoAlpha 3 in 1 Blood Glucose/Cholesterol/Uric Acid Multi-Function Monitoring System....................8 Test Strips..........................9 Setting Up Your GlucoAlpha 3 in 1 Multi-Function Monitoring System........10 Setting Date and Time......................10 Checking the Unit of Measurement..................10...
  • Page 2 Blood Glucose/Cholesterol/Uric Acid Testing...............21 Items You Need........................21 Preparing the Puncturer (Lancing Device).................21 Structure of Puncturer and Lancet..................22 Steps for Using the Puncturer....................23 Testing Your Blood Glucose Level..................24 Understanding Your Blood Glucose Test Results...............26 Testing Your Blood Cholesterol Level.................27 Understanding Your Blood Cholesterol Test Results............29 Testing Your Blood Uric Acid Level................30 Understanding Your Blood Uric Acid Test Results............32 Using the Meter Memory......................33...
  • Page 3: What Is Glucoalpha

    What is GlucoAlpha 3 in 1 system for? ●The self-testing GlucoAlpha 3 in 1 Blood Glucose/Cholesterol/Uric Acid Multi- Function Monitoring System is designed for in vitro diagnostic use only (external use only). The system is for healthcare professionals and persons with diabetes, hypercholesterolemia, or hyperuricemia to measure glucose, cholesterol, and uric acid values in fresh capillary whole blood from finger stick quantitatively.
  • Page 4: Important Information

    ●Do not change your medical plan without doctor’s approval. The GlucoAlpha 3 in 1 system should not be used for the diagnosis of diabetes, hypercholesterolemia, and hyperuricemia or for the test of newborns. Important Information ●Blood specimens containing Ascorbic Acid (Vitamin C) greater than 150 mg/dL, Amiloride greater than 20mg/dL, Acetaminophen greater than 8mg/dL, L-Dopa greater than 20 mg/dL, Dopamine greater than 20 mg/dL, Methyl-Dopa greater than 4 mg/ dL, Galactose greater than 400 mg/dL, Uric Acid greater than 10.5 mg/dL and Xylose...
  • Page 5 ●Cholesterol up to 500 mg/dL or triglycerides up to 3000 mg/dL do not significantly affect the glucose results. Grossly lipaemic patient samples have not been tested and are not recommended for testing glucose level with the GlucoAlpha 3 in 1 System. ●Hematocrit (percentage of red blood cells in your blood) below 30% or higher than 55% was found to cause a higher or lower reading, respectively.
  • Page 6: Items In The Package

    Items in the Package 3 in 1 Meter 3 in 1 User’s Manual GlucoAlpha GlucoAlpha Puncturer (lancing device) Log Book Check Strip Lancets Two AAA Batteris Pouch        ...
  • Page 7: Items Need To Be Purchased Separately

    Items Need to be Purchased Separately Test Strip (comes with a code key) GlucoAlpha GlucoAlpha GlucoAlpha Blood Glucose Test Strips Cholesterol Test Strips Uric Acid Test Strips Control Solutions GlucoAlpha GlucoAlpha GlucoAlpha Glucose Control Solution (3 ml) Cholesterol Control Solution (1 ml) Uric Acid Control Solution (3 ml)
  • Page 8: Getting To Know Glucoalpha

    Getting to Know GlucoAlpha 3in1 Blood Glucose/Cholesterol/Uric Acid Multi-Function Monitoring System Code Key Slot Test Strip Slot Unit-Changing Switch (To Switch between mg/dL and mmol/L (μmol/L)) Battery Cover Screen (Display Messages and Test Result) Memory Button (Recall Stored Data) Setting Date and Time Button Battery Compartment...
  • Page 9: Test Strips

    Test Strips GlucoAlpha GlucoAlpha GlucoAlpha Blood Glucose Test Strips Cholesterol Test Strips Uric Acid Test Strips Sample target area Sample target area Strip handle 15 L µ (Yon may touch here) Strip handle Strip handle (Yon may touch here) (Yon may touch here) Sample target area Sample target area (You may apply your blood...
  • Page 10: Setting Up Your Glucoalpha 3In1 Multi-Function Monitoring System

    Setting Up Your GlucoAlpha 3in1 Multi-Function Monitoring System Setting Date and Time NOTE: When you install the batteries into the meter every time or replace the batteries, the meter will enter setting mode automatically. You can set correct time and date before you begin testing.
  • Page 11: The Batteries Installation

    Push Switch Up Push Switch Down Unit Decimal point Unit Decimal point Glucose mmol/L mg/dL Cholesterol mmol/L mg/dL Uric Acid μmol/L mg/dL * You should check this setting every time you put batteries into your meter. * Use a screwdriver to adjust the switch. The Batteries Installation NOTE: Your meter comes with two AAA size batteries (1.5V).
  • Page 12: Using Check Strip To Check The Meter

    CAUTIONS: ●Make sure the “+” and “-“ ends of the batteries match the marks in the battery compartment. ●Always replace both batteries at same time. Both batteries should be the same brand. Using Check Strip to Check the Meter You would need to use the check strip to check the meter when ●You use GlucoAlpha 3in1 monitoring system for the first time.
  • Page 13: Control Check With Glucose/Cholesterol/Uric Acid Control Solutions

    Control Check with Glucose/Cholesterol/Uric Acid Control Solutions When to Run a Control Check with Glucose/Cholesterol/Uric Acid Control Solutions? ●You think there is something wrong with the glucose, cholesterol, or uric acid measurement you got and you want to check whether meter and test strips are working correctly or not.
  • Page 14: Steps For Running A Glucose Control Check

    Steps for Running a Glucose Control Check CAUTION: ●Always check the glucose code key number to make sure it matches the number labeled on the test strip vial when you run a glucose control test. Otherwise you may get incorrect results. ●Always write down the opening date of your glucose control solution vial and test strip vial.
  • Page 15 Cautions: Make sure that the code number shown on the screen is the same as the code number printed on the glucose test strip vial, otherwise you may get incorrect measurement. 4. Hold the glucose control solution bottle upside down, slowly squeeze the bottle to form a small drop, discard the first drop of the solution, let the second drop touch the edge of the sample targeting area on the test strip.
  • Page 16: Steps For Running A Cholesterol Control Check

    Steps for Running a Cholesterol Control Check CAUTION: ●Always check the cholesterol code key number to make sure it matches the number labeled on the test strip vial when you run a cholesterol control test. Otherwise you may get incorrect results. ●Always write down the opening date of your cholesterol control solution vial and test strip vial.
  • Page 17 Cautions: Make sure that the code number shown on the screen is the same as the code number printed on the cholesterol test strip vial, otherwise you may get incorrect measurement. 4. Hold the cholesterol control solution bottle upside down, slowly squeeze the bottle to form a small drop, discard the first drop of the solution, let the second drop touch the edge of the sample targeting area on the test strip.
  • Page 18: Steps For Running A Uric Acid Control Check

    Steps for Running a Uric Acid Control Check CAUTION: ●Always check the uric acid code key number to make sure it matches the number labeled on the test strip vial when you run a uric acid control test. Otherwise you may get incorrect results.
  • Page 19: How To Read The Label On The Test Strip Vial

    4. Hold the uric acid control solution bottle upside down, slowly squeeze the bottle to form a small drop, discard the first drop of the solution, let the second drop touch the edge of the sample target area on the test strip. The control solution will be drawn into the target zone automatically.
  • Page 20: Analyzing Your Control Results

    Analyzing Your Control Results You will find the acceptable range of glucose, cholesterol, and uric acid levels for the normal and high controls on the test strip vial label. If your control results fall within the acceptable range, you can begin to test your blood glucose, cholesterol, or uric acid levels.
  • Page 21: Blood Glucose/Cholesterol/Uric Acid Testing

    Blood Glucose/Cholesterol/Uric Acid Testing Items You Need ●GlucoAlpha 3in1 Meter ●GlucoAlpha Blood Glucose Test Strips ●GlucoAlpha Cholesterol Test Strips ●GlucoAlpha Uric Acid Test Strips ●Glucose code key (green color) in the glucose test strips box ●Cholesterol code key (blue color) in the cholesterol test strips box ●Uric Acid code key (orange color) in the Uric Acid test strips box ●Puncturer ●Lancets...
  • Page 22: Structure Of Puncturer And Lancet

    CAUTIONS: ●For safety and to prevent cross-contamination, always place the protective cover back before discarding the used lancets. ●To avoid infection, you should- - Never reuse the lancets. - Never share your puncturer with others. - Use an alcohol pad to wipe off blood from puncturer’s tip. ●To avoid accidental injury, do not leave a lancet in the puncturer.
  • Page 23: Steps For Using The Puncturer

    Steps for Using the Puncturer 1. Unscrew and remove the puncturer’s adjustable tip. 2. Insert a lancet into the carrier. 3. Twist off the protective cover. 4. Replace the adjustable tip tightly. Choose a desired skin penetration depth by rotating the top portion of the adjustable tip until the setting number lines up to the arrow.
  • Page 24: Testing Your Blood Glucose Level

    Testing Your Blood Glucose Level CAUTIONS: You can only use GlucoAlpha Blood Glucose Test Strips and check strip on GlucoAlpha 3in1 meter. 1. When you first time use the GlucoAlpha 3in1 meter or open a new test strip vial, insert the code key from the test strip vial. Each test strip vial contains one code key.
  • Page 25 6. Press the trigger on the puncturer. 7. Lift up the puncturer. 8. Get a drop of blood. 9. Put the drop of blood on the edge of the test strip target area. The blood will be absorbed and cause the target area to turn red. The testing reaction starts when the meter beeps.
  • Page 26: Understanding Your Blood Glucose Test Results

    12. Put the protective cover of the lancet back on the lancet. Grip the puncturer holder firmly and pull the lancet out. 13. Discard the used lancet in an appropriate container with a lid. 14. Screw the adjustable tip back on the puncturer. CAUTION: To avoid accidental injury, do not leave used lancet in the puncturer.
  • Page 27: Testing Your Blood Cholesterol Level

    Testing Your Blood Cholesterol Level CAUTIONS: You can only use GlucoAlpha Cholesterol Test Strips and check strip on GlucoAlpha 3in1 meter. 1. When you first time use the GlucoAlpha 3in1 meter or open a new test strip vial, insert the code key from the test strip vial. Each test strip vial contains one code key.
  • Page 28 6. Press the trigger on the puncturer. 7. Lift up the puncturer. 8. Get a drop of blood. 9. Put the drop of blood on the edge of the test strip target area. The blood will be absorbed and cause the target area to turn red. The testing reaction starts when the meter beeps.
  • Page 29: Understanding Your Blood Cholesterol Test Results

    10. Record the cholesterol value in your log book. 11. Pull the test strip out of the meter. The meter will turn off by itself. Unscrew the adjustable tip of the puncturer. 12. Put the protective cover of the lancet back on the lancet. Grip the puncturer holder firmly and pull the lancet out.
  • Page 30: Testing Your Blood Uric Acid Level

    Testing Your Blood Uric Acid Level CAUTIONS: You can only use GlucoAlpha Uric Acid Test Strips and check strip on GlucoAlpha meter. 1. When you first time use the GlucoAlpha 3in1 meter or open a new test strip vial, insert the code key from the test strip vial. Each test strip vial contains one code key.
  • Page 31 6. Press the trigger on the puncturer. 7. Lift up the puncturer. 8. Get a drop of blood. 9. Put the drop of blood on the edge of the test strip target area. The blood will be absorbed and cause the target area to turn red. The testing reaction starts when the meter beeps.
  • Page 32: Understanding Your Blood Uric Acid Test Results

    12. Put the protective cover of the lancet back on the lancet. Grip the puncturer holder firmly and pull the lancet out. 13. Discard the used lancet in an appropriate container with a lid. 14. Screw the adjustable tip back on the puncturer. Understanding Your Blood Uric Acid Test Results The expected blood uric acid value is as following: Male: 3 ~ 7.2 mg/dL (179 ~ 428 μmol/L)
  • Page 33: Using The Meter Memory

    Using the Meter Memory GlucoAlpha 3in1 Meter can automatically store glucose, cholesterol, and uric acid most recent test results. You can review the test results in order from the newest to the oldest. If the memory is full, the oldest result is deleted as the newest result is added. The memory is not affected by replacing/removing the batteries.
  • Page 34: Review The Stored Cholesterol Test Results

    5. If you decide to stop checking the results, stop pressing the “M” button. The meter will turn off automatically in 30 seconds or via pressing “S” button. 6. No test can be performed when you are checking the stored results. If you wish to perform a new test, please turn off the meter first and restart the steps described in the section 【...
  • Page 35: Review The Stored Uric Acid Test Results

    Review the Stored Uric Acid Test Results 1. Please enter the uric acid test mode first. Insert the uric acid code key (orange color) and press “M” button. 2. The stored results with date are displayed in order from the most recent to the oldest via pressing and releasing the “M”...
  • Page 36: Taking Care Of Your Meter

    Taking Care of Your Meter Maintaining the Meter ●Do not drop, hit or smash your meter. ●Keep your meter between -10°C and 60°C (14°F and 140°F) and below 95% of relative humidity. Do not store meter in area such as the kitchen, bathroom, laundry room or car.
  • Page 37: Cleaning The Meter

    Cleaning the Meter You can clean your meter with 70% isopropyl alcohol swab CAUTIONS: ●DO NOT spray any cleaning solution directly onto the meter. ●DO NOT dampen the code key slot or the test strip slot. ●DO NOT soak the meter in liquid. Troubleshooting Guide SYMBOL WHAT IT MEANS...
  • Page 38 SYMBOL WHAT IT MEANS ACTION Repeat the test in a warm place about The environmental 14°C~40°C (57.2°F~104°F). You may need temperature is too low to to wait as long as 20 minutes for the meter perform a test. to warm up before testing again. Repeat the test in a cool place about The environmental 14°C~40°C (57.2°F~104°F).
  • Page 39 SYMBOL WHAT IT MEANS ACTION Your blood glucose level Re-check your blood glucose level. If “LO” is displayed again, call your doctor is lower than 20 mg/dL (1.1mmol/L). immediately. CHOL Re-check your blood cholesterol level. If Your blood cholesterol level is higher than 400 mg/dL “HI”...
  • Page 40: Specifications

    SYMBOL WHAT IT MEANS ACTION Operating procedure is incorrect. Repeat the test with a new test The test strip has been used, or the strip. If the symbol is displayed meter is not performing correctly. again, contact Customer Service. 1. Check the code key. Be sure 1.
  • Page 41 Specifications (cont.) ET-311 Glucose Cholesterol Uric Acid Operating Condition Temperature 14 ~ 40°C (57.2 ~ 104 ℉ ) Humidity ≦ 85% Relative Humidity Meter Storage Condition (Transportation Condition) Temperature -10 ~ 60°C (14 ~ 140 ℉ ) Humidity ≦ 95% Relative Humidity ≧...
  • Page 42: Customer Services

    Customer Services Thank you for choosing the GlucoAlpha 3in1 Blood Glucose/Cholesterol/Uric Acid Multi-Function Monitoring System. IN4 Technology Corporation, Inc. is honored to present this new product to you. Our customer services include: (1) Our customers are entitled to free repair and replacement of spare parts. If you have problems with the product, please contact local distributor/agent for further information.
  • Page 43: Labeling And Information

    Labeling and Information Description Description Item Item Do not reuse Consult instruction for use Temperature Keep away from sunlight limitation Manufacturer Used by Caution, consult Authorized representative in the accompanying European Community documents Batch code Catalogue number Serial number Control In vitro diagnostic Sterilized using irradiation device...
  • Page 44 Guidance and manufacturer’s declaration – electromagnetic emissions This device is intended for use in the electromagnetic environment specified below. The customer or the user of this device should assure that it is used in such an environment. Emissions test Compliance Electromagnetic environment –...
  • Page 45 Guidance and manufacturer’s declaration – electromagnetic immunity This device is intended for use in the electromagnetic environment specified below. The customer or the user of this device should assure that it is used in such an environment. Immunity test IEC 60601 test level Compliance level Electromagnetic environment –...
  • Page 46 Recommended separation distances between portable and mobile RF communications equipment and this device This device is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The customer or the user of this device can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and this device as recommended below, according to the maximum output power of the communications equipment.
  • Page 47 Lancet (lncluded in the package) Specification: Sterile, 30G Manufacturer: Sterilance Medical (Suzhou) Inc. Address: No. 68 Litanghe Road, Xiangcheng, Suzhou, Jiangsu 215133, P. R. China Lancing Device (lncluded in the package) Manufacturer: Global Medical Market Corp. Address: Room No. 1112, Ace Tower 9th Bldg., 345-30, Kasan-Dong, Kumchon-Ku, Seoul, Korea...

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