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Sugarteck TD-4207B Owner's Manual

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BLOOD GLUCOSE

MONITORING SYSTEM

Ver 2.0
2011 June
311-4207200-002

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Summary of Contents for Sugarteck TD-4207B

  • Page 1: Blood Glucose

    BLOOD GLUCOSE MONITORING SYSTEM Ver 2.0 2011 June 311-4207200-002...
  • Page 2 Dear System Owner: This manual contains important information that you must know about your system. Please read it carefully and keep it for future reference. For other questions regarding this system, please contact your local customer service. At all other times, you should contact your health care professional for assistance.

  • Page 3: Important Safety Instructions

    IMPORTANT SAFETY INSTRUCTIONS READ THIS BEFORE USING The following basic safety precautions should always be taken. 1. Close supervision is necessary when the device is used by, on, or near children, handicapped persons or invalids. 2. Use the device only for the intended use described in this manual.

  • Page 4: Table Of Contents

    TABLE OF CONTENTS IMPORTANT SAFETY INSTRUCTIONS IMPORTANT INFORMATION ABOUT ATERNATIVE SITE TESTING (AST) INTRODUCTION OF THE SYSTEM Intended Use Principle of Measurement Contents of the System Appearance and Key Function of the Meter Meter Display Segments Appearance of the Test Strip PREPARATION BEFORE USE Battery Replacement Setting the Meter and Deleting the Memory...
  • Page 5 CARING FOR YOUR METER AND STRIP Cleaning Storage PROBLEM-SOLVING GUIDE Error Message Problem in Operation SPECIFICATIONS SUMMARY OF OPERATION SYMBOL INFORMATION...

  • Page 6: Important Information

    IMPORTANT INFORMATION Severe dehydration and excessive water loss may cause false low re- sults. 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 use of body parts other than fingertips to check their blood glucose levels. This system allows you to test on the palm, the forearm, the upper arm, the calf, or the thigh with the results equiv-...
  • Page 8 Do NOT use AST if: You think your blood glucose is low. Your AST results do not match the way you feel. Your routine glucose results are often fluctuating. You are pregnant. How to increase the accuracy? Stimulating blood perfusion by rubbing the puncture site prior to blood ex- traction has a significant influence on the glucose value obtained.

  • Page 9: Introduction Of The System

    INTRODUCTION OF THE SYSTEM 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 capil- lary whole blood samples taken from the finger and the alternative sites including the palm, the forearm, the upper arm, the calf and the thigh.

  • Page 10: Contents Of The System

    Contents of the System The system consists of two main products: the blood glucose meter and test strips. The test strips should be bought separately which is available in vial pack of 15s. These products have been designed, tested, and prov- en to work together as a system to produce accurate blood glucose test results.

  • Page 11: Appearance And Key Function Of The Meter

    Appearance and Key Function of the Meter TEST PORT The test port is where you insert the test strip for testing. The meter will turn on automatically when you insert a test strip. DISPLA Your test results are displaye here. The large, easy-to-read display guides you through the test using symbols and simple messages.

  • Page 12: Meter Display Segments

    Meter Display Segments UNITS OF Indicates a test CODE MEASUREMENT result stored in Appears with the Depending upon how the memory. code number meter is set, either mmol/L of the test strips or mg/dL will appear with currently in use. the test result.

  • Page 13: Appearance Of The Test Strip

    Appearance of the Test Strip Your system measures the amount of sugar (glucose) in whole blood. Blood is applied to the absorbent hole of the test strip and is automatically 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 3.0 V (CR2032) lithium battery that is already installed. The meter will alert you when the power is getting low by displaying two different messages: 1. The symbol appears on the display when the meter is turned on and all other display messages are functional.
  • Page 15 To replace the battery, make sure that the meter is turned off. 1. Press the buckle on battery cover and lift up to remove cover. 2. Remove the old battery and replace with one new 3.0 V (CR2032) lithium battery. Make sure that the positive “+” side is facing up. 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 and unit of temperature preset. But if you replace the battery, you may need to reset the meter. Start with the meter off. Then press the set button located in the battery com- partment.
  • Page 17 STEP 4 Set the Hour Press and release the Main button to ad- vance one hour. To move faster, hold the Main button down. With the correct hour on the display, press the Set button and then the minute segment flashes. STEP 5 Set the Minutes Press and release the Main button to ad- vance one minute.
  • Page 18 STEP 7 Select ºC or ºF Press and release the Main button to select the unit of temperature you want to use. Press the Set button and the meter will dis- play “dEL” with flashing “ ” symbol. STEP 8 Delete Memory and Exit the Set- ting Mode With “dEL”...
  • Page 19 If you do not want to delete the memory, press the Set button to skip this step and then the meter will be turned off. Congratulations! You have finished all settings now! PLEASE NOTE The time, date, unit of measurement and unit of temperature can ONLY be changed in the setting mode.

  • Page 20: Before Testing

    BEFORE TESTING Coding the meter Code numbers are used to calibrate the test strips with the meter for accurate results. You must insert code strip to the meter before using it for the first time and them every time you change to another vial of test strips.

  • Page 21: 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 22: Testing Procedure

    Testing Procedure PLEASE NOTE If your lancing device differs from the one show above, please refer to the manufacturer’s manual to ensure proper usage. WASH AND DRY YOUR HANDS FIRST BEFORE STARTING. 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 secured.
  • Page 23 Select the depth of penetration by turning the adjustable tip in either direction so that the arrow on the cap points to the desired depth. Pull the cocking control back until it clicks. You will see a color change inside the release button when it is ready.
  • Page 24 STEP 2 Insert Test Strip Insert a test strip with contact bars end first and facing up into the test slot. The meter will turn on automatically and the meter display the followings in sequence : → “CHK” and “ ” →...

  • Page 25: Fingertip Testing

    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 testing Press the lancing device’s tip firmly against the lower side of your fingertip.
  • Page 26 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 au- tomatically.
  • Page 27 STEP 6 Remove the Lancet Always use caution when removing the lancet. Take the lancet out carefully. Place the disk on a hard surface and push the exposed tip into the pro- tective disk. WARNING The used lancet and the used test strip may be potentially biohazard.

  • Page 28: Expected Test Results

    Expected Test Results Blood glucose monitoring plays an important role in diabetes control. A long-term study showed that keeping blood glucose levels close to nor- mal can reduce the risk of diabetes complications by up to 60%* . The results you get with the blood glucose system can help you and your healthcare professional monitor and adjust your treatment plan to gain better control of your diabetes.

  • Page 29: Special Messages

    Special Messages meter displays results between 20 to 600 mg/dL (1.1 to 33.3 mmol/L). If your test result is lower than 20 mg/dL (1.1 mmol/L), “Lo” will appear on the meter display. This indicates severe hypoglycemia (low blood glucose). You should immediately treat hypoglycemia as recommended by your healthcare profes- sional.

  • Page 30: Comparing Meter And Laboratory Results

    COMPARING METER AND LABORATORY RESULTS The meter provides you with whole blood equivalent results. 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 31 References *3: Surwit, R.S., and Feinglos, M.N.: Diabetes Forecast (1988), April, 49-51. *4: Sacks, D.B.: “Carbohydrates. “ Burtis, C.A., and Ashwood, E.R.( ed.), Tietz Text book of Clinical Chemistry. Philadelphia: W.B. Saunders Company (1994), 959.

  • Page 32: Using The Meter Memory

    USING THE METER MEMORY Viewing Results on the Meter Your meter stores the 450 most recent blood glucose test results with date and time in its memory. It also provides you with 7-, 14-, 21-, 28-, 60-, and 90-day averages of your blood glucose test results. You can review the test results in memory with these easy steps.
  • Page 33 STEP 2 Recall Test Results After 90-day average, the most recent test result with date and time ap- pears. Press the Main button to review your last 450 test results in or- der. When the memory is full, the oldest result is dropped as the latest is added.

  • Page 34: Caring For Your Meter And Strip

    CARING FOR YOUR METER AND STRIP To avoid the meter and test strips getting dirt, dust or other contami- nants, 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 35: Strip Storage

    2.Strip Storage Storage condition: 4°C~ 40°C (39.2°F~104°F), below 85% relative humidity. 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.

  • Page 36: Control Solution Storage

    3.Control solution storage Storage condition: Store the control solution tightly closed at temperatures 2~30°C(35.6~86°F). Do NOT freeze. Record the discard date (date opened plus 90 days) on the control solution vial. Discard after 90 days.

  • Page 37: Problem-Solving Guide

    PROBLEM-SOLVING GUIDE Following is a summary of some display messages and symbols. These messages help to identify certain problems but do not appear in all cases when a problem has occurred. Improper use may cause an inaccurate result without producing an error message or a symbol. In the event of a problem, refer to the information under action.

  • Page 38: Error Message

    Error Message Message Meaning Action Error message indicates that there Review the instructions and try is a problem with the mete again with a new test strip. If t problem persists, please call your local agent for help. symbol appears with Replace the battery at once.

  • Page 39: 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 a.Battery exhausted. Replace the Battery. b.Battery incorrectly Check that the battery is correctly installed or absent. . installed with the positive “+” side up. Insert the test strip correctly with the c.Test strip inserted upside down or incompletely.
  • Page 40 3. If the control solution test result is out of range. POSSIBLE CAUSE WHAT TO DO Error in performing the test Read the instruction thoroughly and repeat the test again. Check if the code number on the Improper code number. display matches the code number on the test strip vial.

  • Page 41: Specifications

    SPECIFICATIONS Model No.:TD-4207 Dimension: 78mm*48mm*15mm Weight: 40.17g Power source: one CR2032 3V lithium coin battery Display: LCD Memory: 450 measurement results with date and time External output: RS232 PC interface Auto electrode inserting detection Auto sample loading detection Auto reaction time count-down Auto turn-off after 3 minutes without action Temperature warning Operating condition: 10°C~40°C(50°F~104°F), below 85%R.H.

  • Page 42: Summary Of Operation

    SUMMARY OF OPERATION This summary is intended only for quick reference and can not 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 and displayed room temperature and the code number.
  • Page 43 STEP 2 Apply Sample Hold the drop of blood and make it fully contact to the absorbent hole of test strip until the confirmation window is complete- ly filled. 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 win- dow is not fulfilled.

  • Page 44: Symbol Information

    SYMBOL INFORMATION Symbol Referent In vitro diagnostic medical device Do not reuse Consult instructions for use Keep away from sunlight Keep dry Temperature limitation Use by Date of manufacture Batch code Manufacturer Serial number Caution, consult accompanying documents Biological risks...

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