SkyMed TD-4227 Owner's Manual
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SkyMed TD-4227 Owner's Manual

Blood glucose monitoring system
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Blood Glucose
Monitoring System
Ver. 1 12/2013
311-4223500-XXX
Owner's Manual

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  • Page 1 Blood Glucose Monitoring System Owner’s Manual Ver. 1 12/2013 311-4223500-XXX...
  • Page 2 Dear SureTest System Owner: This manual contains important information you must know about the system. Please read it thoroughly and carefully. The greatest feature of this system is its , which Bilingual Speaking Function is an acoustic aid for users especially with visual disability. Please note that this function is optional.

  • Page 3: Important Safety Instructions

    IMPORTANT SAFETY INSTRUCTIONS PLEASE 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, or handicapped persons. 2. Use the device only for the intended use described in this manual. 3.

  • 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 Speaking Function Appearance of the Test Strip PREPARATION BEFORE USE Battery Replacement Setting the Meter and Deleting the Memory...
  • Page 5 CARING FOR YOUR METER AND TEST STRIPS Cleaning Storage PROBLEM-SOLVING GUIDE Result Indicator Error Message Problem in Operation SPECIFICATIONS WARRANTY/CUSTOMER CARE...

  • 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. • Test results below 3.3 mmol/L* mean low blood glucose (hypoglycemia). Test results greater than 13.3 mmol/L* mean high blood glucose (hyperglycemia).

  • 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.
  • Page 8 Do NOT use AST if: • You think your blood glucose is low. • You are unable to notice symptoms of hypoglycemia. • Your AST results do not match the way you feel. • You are testing for hyperglycemia. • Your routine glucose results are often fluctuating.

  • 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 capillary 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 should be used with three main products: the blood glucose meter, test strips, and a control solution. These products have been designed, tested, and proven 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 TALKING SYMBOL TEST SLOT Indicates that the meter The test slot is where you contains speaking function. insert the test strip for test- ing. The meter will turn on automatically when you insert a test strip.

  • Page 12: Meter Display Segments

    Meter Display Segments Test Strip Symbol Appears when the meter is on. Test Result Area Blood Drop Symbol Test results are displayed here. This symbol tells you when to apply the sample. Voice Symbol Indicates speaking function is Temperature Symbol on/off.

  • Page 13: Speaking Function

    Speaking Function When the talking symbol is on the meter, it means that the meter provides speaking function. It “speaks” step by step and leads you through a blood glucose test. The following table tells you when and what the meter “speaks”. WHEN WHAT does the meter say?

  • Page 14: 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 15: Preparation Before Use

    PREPARATION BEFORE USE Battery Replacement Your meter comes with two 1.5V AAA size alkaline batteries. The meter will alert you when the power is getting low by displaying two different messages: 1. The symbol appears together with other display messages: the meter is functional and the result remains accurate, but it is time to change the batteries.
  • Page 16 To replace the batteries, 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 batteries and replace with two new 1.5V AAA size alkaline batteries. 3.

  • Page 17: Setting The Meter And Deleting The Memory

    Setting the Meter and Deleting the Memory Year, month, date, time, unit of temperature, memory deletion, speaking volume and language selection preset. However if you replace the batteries, you may need to reset the settings of the meter. Start with the meter off. Then press the Set button located in the battery compartment.
  • Page 18 STEP 2 Set the Month Press and release the button until the correct month appears. To move faster, hold the button down. With the correct month on the display, press the Set button and then the date segment flashes. STEP 3 Set the Date Press and release the button until the...
  • Page 19 STEP 5 Set the Minutes. Press and release the button to advance one minute. To move faster, hold the button down. With the correct minute on the display, press the Set button and then the current unit of temperature starts flashing.
  • Page 20 STEP 6 Delete the Memory When “dEL” and blinking “ ” symbol is displayed, if you do not want to delete memory, press the Set button again to skip this step. If you would like to delete ALL memory, press button, both “dEL”...
  • Page 21 STEP 7 Select Speaking Function The meter displays “VOL”, “ ” and flashing number. Press the button to select speaking volume from 0 to 7. Then press the Set button to proceed to the next step. Number 0 indicates that the speaking function is turned off, where “...

  • Page 22: Before Testing

    BEFORE TESTING Checking with SureTest or SureTest Control Solutions SureTest and SureTest control solutions contain a known amount of glucose that reacts with test strips. By comparing your control solution test results with the expected range printed on the test strip vial label, it is able to check that the meter and the test strips are working together as a system and that you are performing the test correctly.

  • Page 23: Important Control Solution Information

    Important Control Solution Information • Use only SureTest or SureTest control solutions. • Check the expiration date on the control solution vial. Do not use if expired. • Control solution, meter, and test strips should come to room temperature (20-25°C/68-77°F) before testing. •...

  • Page 24: Performing A Control Solution Test

    Performing a Control Solution Test 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 followings in sequence: “CH” and “ ”...
  • Page 25 STEP 2 Press the button While the “ ” symbol appears on the display, press the 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.
  • Page 26 STEP 4 Apply Control Solution. Move your finger (with control solution on it) to meet the absorbent hole of the test strip and the drop will be automatically drawn into the test strip. Remove your finger until the confirmation window is filled. The meter begins to count down.

  • Page 27: 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: 1. Blood Glucose Meter 2. Test Strip 3.

  • Page 28: Testing Procedure

    Testing Procedure WASH AND DRY YOUR HANDS FIRST BEFORE STARTING. The SureTest lancing device offers you 6 depths of skin penetration. Shallow Deep Soft or thin skin Average skin Thick or calloused skin The longer the length of the indicator line, the greater the depth of penetration. STEP 1 Setting up the SureTest lancing device Twist and pull off the cap of the...
  • Page 29 Replace the cap by aligning the arrow on the cap with the release button, and then push and turn the cap. 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.
  • Page 30 Blood from sites other than the fingertip A clear cap, included with the kit, makes it easier to get a drop of blood for AST. When you want to obtain blood from sites other than the finger, replace the lancing Turn the device cap with the clear cap.
  • Page 31 STEP 3 Get a Drop of Blood Before collecting a drop of blood: • Wash and dry your hands before you start. • Select the puncture site either at the fingertip or another part of the body. • Rub the puncture site for about 20 seconds before penetration. •...
  • Page 32 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 with blood. The meter then begins covered to count down automatically.

  • Page 33: Removing The Lancet

    STEP 6 Remove the Lancet. Always use caution when removing the lancet. To remove the lancet, pull the cap off. Place the protective disk on a hard surface, and push the exposed tip into the disk. Slide the ejector forward to remove the used lancet.

  • Page 34: Expected Test Results

    Expected Test Results Blood glucose monitoring plays an important role in diabetes control. A long-term study showed that can reduce keeping blood glucose levels close to normal the risk of diabetes complications by up to 60%* . The results you get with the SureTest system can help you and your healthcare professional monitor and adjust your treatment plan to gain better control of your diabetes.

  • Page 35: Comparing Meter And Laboratory Results

    COMPARING METER AND LABORATORY 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. (See test strip package insert for typical accuracy and precision data, and for important information on Limitations.) To make an accurate comparison between meter and laboratory results, follow the guide-lines below.
  • Page 36 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 higher than blood drawn from a vein (venous sample) used for a lab test* Therefore, it is best to fast for eight hours before doing comparison tests.

  • Page 37: Using The Meter Memory

    USING THE METER MEMORY View 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.

  • Page 38: Recall Test Results

    The 14 day average is calculated from the blood glucose results obtained during the last 14 days. It also indicates how many blood glucose tests have been performed, e.g., 28 (28 tests in the last 14 days). It is all the same for the 21, 28, 60 and 90 day average.
  • Page 39 When reaching the last set of result, “End” and “ “ will be shown on LCD display, and the meter will be turned off automatically. STEP 3 Exit the Memory Mode Keep pressing the button for 5 seconds to turn off the meter.
  • Page 40 PLEASE NOTE The control solution results are stored in the memory (please also go to page 24 for information). The list of past results and the result average WARNING are for blood glucose results only. When pressing the button to recall the test results, the meter will displayed date, time and the unit of measurement first.

  • Page 41: Viewing Results On A Personal Computer

    Viewing Results on a Personal Computer Results in memory can be transmitted to a personal computer. An Interface Cable is required for data transmission, but is not included. Please ask your local agent or call toll free for help. The software is available on the enclosed CD or can be downloaded from .
  • Page 42 Step 3 Transmit Data Follow the instructions provided in the software to transmit data. Results transmitted will include date and time. Remove the cable and the meter will automatically turn off. PLEASE NOTE While the meter is connected to the PC, it is unable to perform a blood glucose test.

  • Page 43: Caring For Your Meter And Test Strips

    CARING FOR YOUR METER AND TEST STRIPS To avoid the meter and test strips getting dirt, dust or other contaminants, please wash and dry your hands thoroughly before use. Cleaning Your meter does not require special maintenance. As no blood or control solution comes in contact with the meter, there is no special cleaning required.

  • Page 44: Strip Storage

    • Avoid dropping and strong impact. • Avoid direct sunlight and humidity. 2. Strip Storage • Storage condition: 4°C ~ 40°C below 85% relative humidity. Do not refrigerate. • Store your test strips in their original vial only. Do not transfer to other container. •...

  • Page 45: Control Solution Storage

    • Use each test strip immediately after removing it from the vial. • Write the discard date (the date opened plus 90 days) on the vial label when you first open it. Discard remaining test strips 90 days after first opening date.

  • Page 46: 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.

  • Page 47: 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. KETONE? appears when your result is equal or higher than 13.3 mmol/L. This indicates there is a possibility of ketone accumulation if you are Type 1 diabetes.

  • Page 48: Error Message

    Error Message ACTION MESSAGE WHAT IT MEANS Appears when the batteries can not provide Replace the batteries immediately. enough power for a test. Appears when inserting a Test with a new test strip. used test strip. Appears when ambient temperature is below system operation range.

  • Page 49: 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 Check that the battery is correctly installed or absent. installed. Test strip inserted upside Insert the test strip correctly with the down or incompletely.
  • Page 50 3. If the control solution test result is out of range. PROBABLE CAUSE WHAT TO DO Read the instructions thoroughly and repeat the Error in performing the test. test again. Shake the control solution vigorously and repeat Did not shake the control solu- the test again.

  • Page 51: Specifications

    SPECIFICATIONS Model No.: TD-4227 Dimension &Weight: 96mm(L) x 20mm(W) x 46mm(H), 69.87 g Power Source: two 1.5V AAA alkaline batteries Display: LCD Memory: 450 measurement results with date and time averaging Auto electrode inserting detection Auto sample loading detection Auto reaction time count-down...

  • Page 52: Warranty/Customer Care

    RESULTING FROM BREACH OF WARRANTY OR ANY OTHER LEGAL THEORY, EVEN IF SKYMED HAS BEEN ADVISED OF THE POSSIBILITY OF SUCH INCONVENIENCE, DAMAGE OR LOSS. SkyMed Inc. reserves the right to change the terms and conditions of this guarantee without informing the original purchaser.
  • Page 53 Symbol efer ent 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 Serial number Caution, consult accompanying documents...
  • Page 56 RESULTING FROM BREACH OF WARRANTY OR ANY OTHER LEGAL THEORY, EVEN IF SKYMED HAS BEEN ADVISED OF THE POSSIBILITY OF SUCH INCONVENIENCE, DAMAGE OR LOSS. SkyMed Inc. reserves the right to change the terms and conditions of this guarantee without informing the original purchaser.

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