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TysonBio TB 100 User Manual

Blood glucose monitoring system
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TysonBio
Blood Glucose Monitoring System
User's Manual
For in vitro diagnostic use only
TB 100

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Summary of Contents for TysonBio TB 100

  • Page 1 TysonBio Blood Glucose Monitoring System User’s Manual For in vitro diagnostic use only TB 100...
  • Page 2 TB100 User’s Manual...

  • Page 3: Table Of Contents

    About the TysonBio TB 100 Meter ............9 About the TysonBio TB 100 Meter Display ..........11 About the TysonBio TB 100 Test Strip ..........13 About the TysonBio TB 100 Test Strip Vial ..........14 Installing/Replacing the Battery ............15 Setting Up the Meter ...................16 Setting Up the Date, Time ..............16...
  • Page 4 Testing Your Blood Glucose Level ............25 Preparing the Test Strip ..............26 Obtaining a Blood Sample ..............27 Applying Blood Sample to the TysonBio TB 100 Test Strip ....28 Memory Features ..................31 Transfer Test Results to a Computer ............33 Care and Storage ..................34 Display Messages ..................35...

  • Page 5: Important Information

    Important Information Available Alternate Sites Testing : Palm and Forearm. TysonBio TB 100 Blood Glucose Monitoring System provides you alternate sites testing (AST). This system provides you to test on the palm and the forearm with the equivalent results to fingertip testing.
  • Page 6 Alternative site results differ from fingertip results when glucose levels are changing rapidly such as after a meal, after taking insulin, during exercise, or when you are ill or under stress. Use blood from a fingertip rather than an alternative site if: ●...
  • Page 7 2. Talk to your doctor to see if alternate site testing is right for you. With a little bit of education, you can give your fingertips a rest and maybe test more often than you do now. For people with diabetes, more frequent test- ing is a good thing.
  • Page 8 (13.3 mmol/L) you should contact your healthcare professional and follow his or her treatment advice. ● Any change or administer of medication based on the TysonBio TB 100 blood glucose test results without the consent and advice of a physician or healthcare professional is not recommended.

  • Page 9: Introduction

    Adapted for its ease of use and quick response time, the TysonBio TB 100 System has the ability to process accurate results utilizing only a small vol- ume of blood for in vitro diagnostics.

  • Page 10: About The Product

    About the Product Your TysonBio TB 100 System is made up of several components. This booklet is designed to guide you through the operation of the system with detailed directions and pictures. Your TysonBio TB 100 System contains: ● TysonBio TB 100 Meter ●...

  • Page 11: About The Tysonbio Tb 100 Meter

    About the TysonBio TB 100 Meter TysonBio TB100 Blood Glucose Meter For in vitro diagnostic use only Manufacturer: Tyson Bioresearch, Inc. Chu-Nan,Taiwan Customer Ser vice Call:+886-37-585998 ser vice@tysonbio.com Tyson ID:T502-73401 0537 S/N:M05B13286 RESET...
  • Page 12 1. Display Your test results are displayed here. The large, easy to read screen guides you through the test by using numbers and symbols. 2. M Button The M (mode) button is used to set time, alarm, enters the memory mode to show the consecutive 7/14/30-day average results and turns the Meter on and off.

  • Page 13: About The Tysonbio Tb 100 Meter Display

    About the TysonBio TB 100 Meter Display 1. Date 2. Time 3. Control Solution Test Appears when doing a control solution test and marking the result as a control solution test. 4. Memory Symbol Indicates in memory mode. 5. Units of Measurement Unit of mmol/l or mg/dL will ap- pear with the test result.
  • Page 14 6. Battery Symbol Appears when the battery is low or must be replaced. 7. Blood Drop Symbol Flashes when it is ready to apply sample to Test Strip. 8. Warning Symbol Appears when result is out of the range of your setting reference value. 9.

  • Page 15: About The Tysonbio Tb 100 Test Strip

    About the TysonBio TB 100 Test Strip The TysonBio TB 100 Test Strip is used to perform the blood glucose test in conjunction with the Tyson- Bio TB 100 Meter. Each strip can be used only once. The Test Strip consists of the following parts: 1.

  • Page 16: About The Tysonbio Tb 100 Test Strip Vial

    About the TysonBio TB 100 Test Strip Vial VIAL LABEL TEST STRIP VIAL TysonBio TB100 0537 Use within 90 days after first opening. Store at 4-30°C ( 39-86°F). Do not refrigerate. Do not store test strips outside this vial. Use TysonBio TB 100 meter only ! Re-cap immediately.

  • Page 17: Installing/Replacing The Battery

    Installing/Replacing the Battery When the battery is low, the Meter will show a warning signal. When this display appears, it is time to replace a new battery. When the low battery warning signal is shown, the Meter will provide accurate results for ap- proximately 50 more measurements.

  • Page 18: Setting Up The Meter

    Setting Up the Meter To turn the Meter on, first insert a battery, then press the reset button located at the back of the Meter and proceed with the following instructions. Setting Up the Date, Time 1. Press the M button to enter this mode. Press and release S button to choose “24hr”...

  • Page 19: Setting Up Alarm

    4. To enter the day and move on to choose the hour setting, press the M button. (Fig.3) 5. To change the hour, press the S button. To enter the hour and move on to change the minutes, press the M button. (Fig.4) (Fig.4) 6.
  • Page 20 8. To set the second alarm, press the M button (y). If you press S button (n), it will be moved on to health manage- ment alarm setting (step 11). To change the hour, press S button. To enter the hour and move on to change the min- utes, press M button.
  • Page 21 10. To set the fourth alarm, press the M button (y). If you press S button (n), it will be moved on to health manage- ment alarm setting (step 11). To change the hour, press S button. To enter the hour and move on to change the minutes, press M button.

  • Page 22: Unit Selection

    1. Select unit, mg/dL or mmol/L on the back. Note: The mg/dL is the standard unit in the United States. Meters used in the United States must be set to read in mg/dL. TysonBio TB100 Blood Glucose Meter For in vitro diagnostic use only Manufacturer: Tyson Bioresearch, Inc.

  • Page 23: The Control Solution Test

    The Control Solution Test The Control Solution is used to check and ensure that the TysonBio TB 100 Meter and TysonBio TB 100 Test Strip are working together properly and that you are performing the test correctly. When to Perform a Control Solution Test 1.
  • Page 24 To Perform a Control Solution Test 1. Make sure the Control Solution is at room temperature (15ºC to 35ºC or 59ºF to 95ºF) prior to testing. 2. Insert a Test Strip, white side face up, Contact Bar’s end first, into the test port.
  • Page 25 5. Discard the first drop of Control Solution and squeeze a small drop of Control Solution on a clean nonabsorbent surface (such as a clean piece of wax paper). Do not apply Control Solution to the Test Strip directly from the bottle. 6.
  • Page 26 Comparing Control Solution Results The TysonBio TB 100 is functioning properly if the result falls inside the specified range printed on the Test Strip vial. If the test result falls outside the specified range, repeat the test. Results falling outside the specified range may be caused by ●...

  • Page 27: Testing Your Blood Glucose Level

    Testing Your Blood Glucose Level Before testing blood glucose, you need the following items: 1. TysonBio TB 100 Meter 2. TysonBio TB 100 Test Strip 3. Adjustable Automatic Lancing Device 4. Sterile Lancet Caution: To reduce the chances of infection: ●...

  • Page 28: Preparing The Test Strip

    Preparing the Test Strip 1. Wash hands using soap and warm water. Rinse and dry thor- oughly. 2. Pull out a Test Strip from the vial and re-cap the vial immedi- ately. 3. Insert the Test Strip, white side face up, into the test port. 4.

  • Page 29: Obtaining A Blood Sample

    Obtaining a Blood Sample SAMPLE MAY BE OBTAINED FROM FINGER, PALM or FOREARM For further instructions please see the insert provided with lancing device. 1. Unscrew and remove the endcap of the lancing device. 2. Insert the lancet into the lancet holder. 3.

  • Page 30: Applying Blood Sample To The Tysonbio Tb 100 Test Strip

    Applying Blood Sample to the TysonBio TB 100 Test Strip 1. After obtaining a blood sample, place the drop onto the test well of the Test Strip. Blood is automatically drawn into the Test Strip. 2. As soon as enough blood has filled the Confirmation Window (see picture) of the Test Strip, the Meter will beep and begin counting down from 5 to 1.
  • Page 31 3. After the test result appears, if no further tests are performed, the Meter will automatically shut off after 3 minutes. After finishing the test, we rec- ommend using a tissue to remove the used strip from the Meter for proper disposal.
  • Page 32 HI and LO Readings 1. The test results range between 20 to 600 mg/dL (1.1 to 33.3 mmol/l). If a “HI” message appears on the display, your Meter has detected that your blood glucose level is higher than 600 mg/dL(33.3 mmol/l). It is suggested that you review your testing procedure and test again with a (Fig.13) new Test Strip to confirm the result.

  • Page 33: Memory Features

    Memory Features The TysonBio TB 100 Meter automatically stores the 300 most recent blood glucose results with date and time in its memory. It also provides you with a consecutive 7/14/30-day average of your blood glucose test results. 1. Press M button to turn on the Meter. All segments of the LCD display will appear.
  • Page 34 6. Press S button, the most recent test result will appear. If it has 14-day average result, it will show under the screen at the same time. Each time you press the S button, the meter will recall the last 300 test results accordingly. When the memory is full, the oldest result is removed and replaced with the newest result.

  • Page 35: Transfer Test Results To A Computer

    Transfer Test Results to a Computer You can use your meter with TysonBio Link Health Management Software to transfer test results to your personal computer. 1. Obtain the required software and cable For order information please call Customer Service or visit website of www.tysonbio.com...

  • Page 36: Care And Storage

    Care and Storage 1. Handle the Meter with care. Dropping or throwing the Meter may cause damage to the device. 2. Do not expose the Meter, Test Strips, and Control Solution to extreme con- ditions, such as high humidity, heat, freezing cold or dust. 3.

  • Page 37: Display Messages

    Display Messages DISPLAY WHAT IT MEANS ACTION System check for verifying No action necessary that all segments of the Meter are functioning. The system is ready to ac- You may now apply a cept a blood sample. blood sample. The system is ready to You may now apply a accept a Control Solution drop of Control Solution...
  • Page 38 DISPLAY WHAT IT MEANS ACTION Indicate the result is For your reference or you can change the default HIGHER than the “HI setting value 100 mg/dL alarm setting” of the health according to page 19. management. Indicate the result is For your reference or you LOWER than the “LO can change the default set-...
  • Page 39 DISPLAY WHAT IT MEANS ACTION Meter detects blood glu- Indicates low blood glucose cose level is lower than 20 level. Repeat test. If result mg/dL (1.1 mmol/l). still occurs, consult your physician immediately. Result may be larger varia- Temperature is high during tion.
  • Page 40 DISPLAY WHAT IT MEANS ACTION Temperature is too high to Repeat the test in a cooler perform the test. setting (10 - 40°C or 50 - 104°F). Wait 15 minutes before re-testing. Temperature is too low to Repeat the test in a warmer perform the test.
  • Page 41 DISPLAY WHAT IT MEANS ACTION Press “reset” button and An error message indicat- check the meter again with ing a problem with the the test strip. If the problem Meter. persists, contact Customer Service for help. Battery power is low. Meter Replace with a new 3-Volt will provide approximately lithium battery (CR-2032).
  • Page 42 DISPLAY WHAT IT MEANS ACTION All testing values recorded Press M or S button or wait in the memory have been for 3 minutes to turn off the shown. meter. The setting alarm is ring- Press M or S button to shut ing to remind of doing the off or the alarm will turn off blood glucose test.
  • Page 43 Other problems that may occur Action Review the instructions and re-insert The Test Strip has not been inserted the Test Strip correctly (white side into the Meter properly. face up). Replace with a new Test Strip. Defective Test Strip. Insufficient blood sample. Repeat the test with new Test Strip.

  • Page 44: Specifications

    Specifications Meter Operating Conditions Temperature 10°C - 40°C(50°F - 104°F) Humidity 10-90% RH Hematocrit 35 - 55% Test Sample Capillary Whole Blood from Fingertip, Palm and Forearm Sample Volume >0.5 µ l Measuring Unit mg/dL or mmol/L Measuring Range 20-600 mg/dL (1.1-33.3 mmol/L) Test Time 5 sec Memory Capacity...
  • Page 45 ■ The TysonBio TB 100 Meter, TysonBio TB 100 Test Strip and Control Solution are in conformity with the IVDD 98/79/EC. The Lancing device is in conformity with the MDD 93/42/EEC. Manufacturer: EU authorized representative: Medical Device Safety Service GmbH Tyson Bioresearch, Inc.

  • Page 46: Limitations Of The Procedure

    Limitations of the Procedure Caution: The TysonBio TB 100 System is designed for in vitro diagnostic use only and is not intended to test on newborns. Any change or administer of medication based on the TysonBio TB100 blood glucose test results without the consent advice of a physician or healthcare professional is not recom- mended.
  • Page 47 TysonBio TB 100 Meter found defective with a new TysonBio TB 100 Meter. This warranty does not apply to the performance of a TysonBio TB 100 Me- ter that has been accidentally damaged, altered, misused, tampered with or abused in any way.

  • Page 48: Customer Service

    When you call our Customer Service, please have your TysonBio TB 100 Meter, TysonBio TB 100 Test Strip and all other system supplies available. This will allow us to answer any of your questions with speed and efficiency.
  • Page 49 B03Q106847(01)

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