GlucoRx TD-4230 Owner's Manual
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GlucoRx TD-4230 Owner's Manual

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BLOOD GLUCOSE
MONITORING SYSTEM
Owner's
Manual
TD-4230
311-4230200-003
Version 1.0 2009-11

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Summary of Contents for GlucoRx TD-4230

  • Page 1: Blood Glucose Monitoring System

    TD-4230 BLOOD GLUCOSE MONITORING SYSTEM Owner’s Manual 311-4230200-003 Version 1.0 2009-11...
  • Page 2 Dear GlucoRx TD-4230 System Owner: Thanks for choosing our GlucoRx TD-4230 system. This manual provides extremely important information which helps you operate this meter smoothly. Before using this product, please read the following contents thoroughly and carefully. The most prominent feature of this system is its strip-ejection function, which helps you take out the used strip without touching used test strip.
  • Page 3 IMPORTANT SAFETY INSTRUCTIONS READ THIS BEFORE USE The following basic safety precautions should always be taken. 1. This device does NOT serve as a cure for any symptoms or diseases. The data measured are for reference only. Always consult your physician to have the results interpreted. 2.

  • Page 4: Table Of Contents

    TABLE OF CONTENTS IMPORTANT INFORMATION ABOUT ATERNATIVE SITE TESTING (AST) GETTING STARTED Intended Use Principle of Measurement Contents of the System Appearance and Key Function of the Meter LCD Display Appearance of the Test Strip PREPARATION BEFORE USE Battery Replacement Setting the Meter and Deleting the Memory Alarm Function BEFORE TESTING...
  • Page 5 PROBLEM-SOLVING GUIDES Result Indicator Error Message Problem in Operation SPECIFICATIONS SYMBOL INFORMATION SUMMARY OF OPERATION...

  • Page 6: Important Information

    IMPORTANT INFORMATION Severe dehydration and excessive water loss may cause false low results. If you believe you are suffering from severe dehydration, consult a healthcare professional immediately. If you get your blood glucose results lower or higher than usual, and do not have symptoms, first repeat the test.

  • Page 7: About Aternative Site Testing (Ast)

    ABOUT ALTERNATIVE SITE TESTING (AST) Important: There are limitations for doing AST. Please consult your healthcare professional before you do AST. What is AST? Alternative site testing (AST) means that people use parts of the body other than fingertips to check their blood glucose levels. This system allows you to test on the plam, the forearm, the upper arm, the calf, and the thigh with the equivalent results to fingertip testing.
  • Page 8 Do NOT use AST if: You think your blood glucose is low. You are unaware of hypoglycaemia. Your AST results do not match the way you feel. You are testing for hyperglycaemia. Your routine glucose results are often fluctuating. How to increase the accuracy? Stimulating blood perfusion by rubbing the puncture site prior to blood extraction has a significant influence on the glucose value obtained.

  • Page 9: Getting Started

    GETTING STARTED Intended Use The system is intended for use outside the body (in vitro diagnostic use). It should be used only for testing glucose (sugar) and only with fresh capillary whole blood samples taken from the finger and the alternative sites including the palm, forearm, upper arm, calf and thigh.

  • Page 10: Contents Of The System

     Your first time user guide  Daily log book  Warranty card  Lancing device with clear cap for Alternative Site Testing  Control solution TD-4230 TD-4230 SELF-TEST LOG BOOK WA R R A N TY C A R D CUADERNO DE REGISTRO For recording ¡D Blood glucose test results...

  • Page 11: Appearance And Key Function Of The Meter

    Appearance and Key Function of the Meter 1. STRIP-EJECTION BUTTON is where the used strip will be ejected after you push up the button. 2. TEST SLOT is where you insert the test strip. The meter will turn on automatically after insertion.

  • Page 12: Lcd Display

    LCD Display TEST STRIP SYMBOL Appears when the meter is turned on. BLOOD DROP LOW BATTERY SYMBOL SYMBOL Flashes when it is Appears when the ready to apply the battery power is low. sample. TEST RESULT AREA Displays glucose results. A decimal point appears when the measurement unit is mmol/L.

  • Page 13: Appearance Of The Test Strip

    Appearance of the Test Strip This system measures the amount of sugar (glucose) in whole blood. Blood is applied to the absorbent hole of the test strip and is automati- cally drawn into the reaction cell where the reaction takes place. The test strip consists of the following parts: Contact Bars Insert this end of the test strip into the meter.

  • Page 14: Preparation Before Use

    PREPARATION BEFORE USE Battery Replacement Your meter comes with one 3V CR2032 Lithium battery. The meter will alert you when the power is getting low by displaying two different messages: 1. When symbol is displayed on the screen: the meter is functional and the result remains accurate, but it is time to change the battery.
  • Page 15 To replace the battery, make sure that the meter is turned off. STEP1 Press the buckle on battery cover and lift up to remove cover. STEP2 Remove the old battery and replace with one 3V CR2032 Lithium battery. STEP3 Close the battery cover. STEP 1 STEP 2 STEP 3...

  • Page 16: Setting The Meter And Deleting The Memory

    Setting the Meter and Deleting the Memory Your meter comes with the time, date, unit of measurement, memory deletion and alarm function setting. If you need to set these parameters, please follow below steps. Start with the meter off. Then press the set button located in the battery compartment.
  • Page 17 STEP 3. Set the Day Press and release the M button until you see the correct day. To move faster, keep pushing the M button down. When the desired month is displayed, press the set button and the hour will be shown on the screen.
  • Page 18 PLEASE NOTE The time and date can ONLY be changed in the setting mode. Therefore, when you perform a glucose testing, those parameters cannot be changed. The meter cannot automatically update Daylight Saving Time. You have to manually adjust the time in the meter according to the procedures.
  • Page 19 STEP 6. Delete Memory “dEL” and “ ” and flashing Yes/no is displayed on the screen. If you do NOT want to delete memory, press the M button to select “no” and then press set button to go to step 7. If you’d like to delete ALL memory, press M button to select “yes”.
  • Page 20 If you press the M button to select “On”, then press set button to set hour. While the hour is flashing, press the M button to plus an hour, and then press the set button. Blinking minute is displayed on the screen.
  • Page 21 Alarm 3 setting If you press the M button to select “OFF”, then press the set button to go to set Alarm 4. If you press the M button to select “On”, then press set button to set hour. Set hour and minute according to the instruction described in Alarm 1.
  • Page 22 Alarm 4 setting If you press the M button to select “OFF”, press the set button to turn off the meter. If you press the M button to select “On”, then press set button to set hour. Set hour and minute according to the instruction described in Alarm 1.

  • Page 23: Alarm Function

    Alarm Function The meter provides four alarms. The alarm function alerts you to perform your blood glucose regularly. If you need to set alarm function, please refer to page19 " Select and Set Alarm Function" for information. If you have turned on the alarm function, the meter will auto-start at the time point you set with short beeps for two minutes.
  • Page 24 An example if set Alarm 1 at 10:00 AM and Alarm 2 at 2:00 PM The meter automatically turns on at 10:00 AM first and next turns on at 2:00 PM. You can directly insert a new strip to perform a test. If you don’t want to perform a test after the meter turns on: Press the M button.

  • Page 25: Before Testing

    BEFORE TESTING Checking the Display Each time you insert a test strip, the meter displays ”CHK” and ” ”. This tells you that the system is checking if the meter and test strip can work together. Checking with TaiDoc Control Solutions TaiDoc control solutions contain a known amount of glucose that reacts with test strips.

  • Page 26: Important Control Solution Information

    Important Control Solution Information Use only TaiDoc control solutions. Check the expiry date on the control solution vial. Do not use if expired. Control solution, meter, and test strips should come to room temperature (2°C-25°C) before testing. Shake the vial, discard the first drop of control solution, and wipe off the dispenser tip to ensure a good sample and an accurate result.

  • Page 27: Doing A Control Solution Test

    Doing a Control Solution Test TAKE A TEST STRIP OUT WITH CLEAN AND DRY HANDS FIRST. STEP 1. Insert the Test Strip Insert a test strip with contact bars end first and facing up into the test slot. The meter turns on automatically and displays the following in sequence: →...
  • Page 28 STEP 2. Press the C button While the “ ” symbol appears on the display, press the C button and then “CTL” will appear on the display. With the “CTL” sign on the display, the meter will not store your test result in memory. If you decide not to perform a control solution test, press the C button again, and the “CTL”...
  • Page 29 STEP 3. Obtain Control Solution. Shake the control solution vial well. Remove the cap from the control solution bottle. Place cap on flat surface.squeeze the vial, discard the first drop, and wipe off the dispenser tip to prevent contamination. Squeeze the vial again to get another drop and apply the drop to the top of cap.
  • Page 30 STEP 5. Read and Compare the Result After counting to 0, the test result of control solution is shown on the screen. Compare this result with the range printed on the test strip vial. It should fall within this range. Out-of-range results If test results fall outside the range printed on the test strip vial, check the section “Problem in Operation”...

  • Page 31: Testing Your Blood

    TESTING YOUR BLOOD Be sure to read this section and the test strip package insert found in the test strip box carefully before testing. Make sure you have all items needed to test: A.Blood Glucose Meter B.Test Strip C.Lancing Device D.Sterile Lancet E.Clear Cap (For AST use) WARNING...

  • Page 32: Test Procedure

    Testing Procedure Wash and dry your hands first before testing. STEP 1. Set the Lancing Device Pull off the cap of the lancing device. Insert a lancet into the lancet holder and push down firmly until it is fully in place. Twist the protective disk off from the lancet.
  • Page 33 Pull the cocking control back until it clicks. Hold your fingers on the body You will see a color change inside the NOT the cap. release button when it is ready. ► If it does not click the device may have been cocked when the lancet was inserted.
  • Page 34 STEP 3. Get a Drop of Blood Select the puncture site either in finger or in other parts (AST). Clean the puncture site with 70% alcohol cotton and let it air-dry. Fingertip Press the lancing device’s tip firmly against the side of your fingertip. Press the release button to prick your finger, then a click indicates that the puncture is complete.
  • Page 35 STEP 4. Apply Blood into the Test Strip When “ “ is flashing on the screen, apply your blood to the absorbent hole of the test strip until the confirmation window is fully covered with blood. The meter then begins to count down automatically. STEP 5.
  • Page 36 STEP 6. Eject the Used Test Strip After finishing the measurement, you can either take out the used strip by simply pushing up the Strip-Ejection button or remove the test strip directly by your hand. “OFF” is shown after the used strip is ejected and the meter will turn off automatically afterwards.

  • Page 37: Expected Test Results

    A long-term study showed that keeping blood glucose levels close to normal can reduce the risk of diabetes complications by up to 60%* . The results you get with the GlucoRx TD-4230 system can help you and your healthcare professional monitor and adjust your treatment plan to gain better control of your diabetes.

  • Page 38: Comparing Meter And Laboratory Results

    COMPARING METER AND LABORATORY RESULTS Test results from the meter and laboratory are both expressed in whole blood equivalent units. However, the result you obtain from your meter may differ somewhat from your laboratory result due to normal variation. Meter results can be affected by factors and conditions that do not affect laboratory results in the same way.
  • Page 39 You may still have a variation from the result because blood glucose levels can change significantly over short periods, especially if you have recently eaten, exercised, taken medication, or experienced stress* . In addition, if you have eaten recently, the blood glucose level from a finger stick can be up to 3.9 mmol/L(70 mg/dL) higher than blood drawn from a vein (venous sample) used for a lab test* .

  • Page 40: Using The Meter Memory

    USING THE METER MEMORY Your meter stores the latest 450 results of your blood glucose with date and time in its memory. It also automatically calculates the averages of your blood glucose in the intervals of 7, 14, 21, 28, 60 and 90 days.
  • Page 41 STEP 2. Press the M button once by once to recall the test results stored in the meter consecutively. STEP 3. After the last test result, press the M button again and the meter will be turned off. 2. Read the Average of Blood Glucose Results: STEP 1.
  • Page 42 The 7- day average is calculated from the blood glucose results obtained during the last 7 days. The average of glucose tests.   Result indicator.  The average was calculated from the test results of the last 7 days. 6 glucose tests have been performed ...
  • Page 43 2. When using the meter for the first time, “---“ is displayed when you recall the test results or review the average result. It means that there is no test result in memory. 3. Anytime when you want to exit the memory, keep pressing the M button for 3 seconds until “OFF”...

  • Page 44: Viewing Results On A Personal Computer

    Health Care System Software and the Interface Cable are required before installation. You can download this software directly from the homepage of GlucoRx. The interface cable is an optional accessory. To learn more about Health Care System Software or to obtain an Interface Cable separately, please contact your local customer service.

  • Page 45: Take Care Of Your Meter And Strip

    TAKE CARE OF YOUR METER AND STRIP To avoid the meter and test strips getting dirt, dust or other contaminants, please wash and dry your hands thoroughly before use. Cleaning 1. To clean the meter exterior, wipe with a cloth moistened with tap water or a mild cleaning agent, then dry the device with a soft and dry cloth.
  • Page 46 2. Strip Storage Storage condition: 4°C to 40°C, below 85% relative humidity. Do not freeze. Store your test strips in their original vial only. Do not transfer to other container. Store test strip packages in a cool and dry place. Keep away from direct sunlight and heat. After removing a test strip from the vial, immediately replace the vial cap and close it tightly.

  • Page 47: Problem-Solving Guides

    PROBLEM-SOLVING GUIDES If you get any problem in performing test with this meter, please refer to the following problem-solving guides. They help you to identify and solve certain problems, but not in all circumstances. Improper use may cause inaccurate results without showing any error message or symbol.

  • Page 48: Result Indicator

    Result Indicator Special symbols and messages appear together with your test result. Message What it means appears when your result is below measurement limit, which is less than 1.1 mmol/L (20 mg/dL) appears when your result is between 1.1 and 3.9 mmol/L (20 and 70 mg/dL).It indicates that the result is below reference range.

  • Page 49: Error Message

    Error Message Message What it means Action Appear when the Replace the battery battery can not immediately. provide enough power for a test. Appear when Test with a new test inserting a used test strip. strip. Appear when environmental temperature is below System operation range system operation is 10°C to 40°C (50°F to 104°F).

  • Page 50: Problem In Operation

    Problem in Operation 1 . If the meter does not display a message after inserting a test strip: PROBABLE CAUSE WHAT TO DO Battery exhausted. Replace the battery. Battery incorrectly installed or Check that the battery is cor- absent. rectly installed. Test strip inserted upside Insert the test strip correctly down or incompletely.
  • Page 51 3. If the control solution test result is out of range. POSSIBLE CAUSE WHAT TO DO Error in performing the test. Read the instruction thor- oughly and repeat the test again. Do not shake the control Shake the control solution vigorously and repeat the test solution vial very well.

  • Page 52: Specifications

    SPECIFICATIONS Model No.:TD-4230 D i m e n s i o n & W e i g h t : 8 8 m m ( L ) x 5 3 m m ( W ) x 1 5 m m ( H ) , 43.58g...

  • Page 53: Symbol Information

    SYMBOL INFORMATION Symbol Referent For in vitro diagnostic use only Do not reuse Read instructions before use Keep away from sunlight Keep dry Temperature limitation Use by Batch code Manufacturer Serial number Caution, consult accompanying documents Biological risks Authorised representative in the European Community CE mark Do not use if package is damaged...

  • Page 54: Summary Of Operation

    SUMMARY OF OPERATION This summary is intended only for quick reference and can't be taken as the substitute for the owner’s manual. Please read the entire manual before you begin doing test. STEP 1. Insert test strip The meter is automatically turned on. STEP 2.
  • Page 55 STEP 3. Obtain a result The meter starts to count down. Never try to add any blood into the absorbent hole even if you find that the confirmation window is not fulfilled. Discard the strip and retest with a new strip. STEP 4.
  • Page 56 MEMO...

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