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TysonBio TB200 User Manual

For in vitro diagnostic use only
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TB200
Blood Glucose Monitoring System
User's Manual
For in vitro diagnostic use only

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Summary of Contents for TysonBio TB200

  • Page 1 TB200 Blood Glucose Monitoring System User’s Manual For in vitro diagnostic use only...
  • Page 2 TB200 Blood Glucose Monitoring System...
  • Page 3 Introduction ....................7 About the Product ..................8 About the TysonBio TB200 Meter ............9 About the TysonBio TB200 Meter Display .......... 11 About the TysonBio TB200 Test Strip ..........13 About the TysonBio TB200 Test Strip Vial ..........14 Installing/Replacing the Battery ............15 Setting Up the Meter ...................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 TB200 Test Strip ....28 Memory Features ..................31 Transfer Test Results to a Computer ............33 Care and Storage ..................
  • Page 5 Alternate Site Testing (AST) means you can use other parts of the body other than your more sensitive fingertips to check your blood glucose levels. The TysonBio TB200 Blood Glucose Monitoring System allows 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 testing is a good thing.
  • Page 8 • Any change or administer of medication based on the TysonBio TB200 blood glucose test results without the consent and advice of a physician or healthcare professional is not recommended. • Severe dehydration and excessive water loss may cause false low results.
  • Page 9 Thank you for choosing the TysonBio TB200 Blood Glucose Monitoring System, the latest advancement in biosensor technology. Recognized for its ease of use and quick response time, the TysonBio TB200 Blood Glucose Monitoring System is designed to process accurate results utilizing only a small amount of blood for in vitro diagnostics.
  • Page 10 About the Product Your TysonBio TB200 Blood Glucose Monitoring 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 TB200 Blood Glucose Monitoring System contains: •...
  • Page 11 About the TysonBio TB200 Meter S/N:M05B13286...
  • 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 TB200 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 appear with the test result.
  • Page 14 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. Alarm Function Symbol Appears when the clock alarm is set. 10.
  • Page 15 About the TysonBio TB200 Test Strip The TysonBio TB200 Test Strip is used to perform the blood glucose test in conjunction with the TysonBio TB200 Meter. Each strip can be used only once. The Test Strip consists of the following parts: 1.
  • Page 16 About the TysonBio TB200 Test Strip Vial VIAL LABEL TEST STRIP VIAL TysonBio TB200 B04U102136(01) Rev. date:10/2011 ysonBio 0537 Store at 4-30°C ( 39-86°F). Do not refrigerate. Use within 90 days after first opening. Do not store test strips outside this vial.
  • Page 17 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 approximately 50 more measurements.
  • Page 18 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 4. To set 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 set 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 (yes). If you press S button (no), it will be moved on to health management alarm setting (step 11). To change the hour, press S button. To set the hour and move on to change the minutes, press M button.
  • Page 21 10. To set the fourth alarm, press the M button (yes). If you press S button (no), it will be moved on to health management alarm setting (step 11). To change the hour, press S button. To set 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. mmol/L mg/dL...
  • Page 23 The Control Solution Test The Control Solution is used to check and ensure that the TysonBio TB200 Blood Glucose Monitoring System and TysonBio TB200 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 with the Contact Bar end first. Push all the way into test port until meter automatically turns on.(Fig.10) 3.
  • Page 25 5. Discard the first drop of Control Solution and squeeze a small drop of Control Solution on a clean nonabsorbent Do not surface (such as a clean piece of wax paper). apply Control Solution to the Test Strip directly from the bottle.
  • Page 26 Comparing Control Solution Results The TysonBio TB200 Blood Glucose Monitoring System is functioning properly if the results fall inside the specified range printed on the Test Strip vial. If the test results fall outside the specified range, repeat the test.
  • Page 27 Testing Your Blood Glucose Level Before testing blood glucose, you need the following items: 1. TysonBio TB200 Meter 2. TysonBio TB200 Test Strip 3. Adjustable Lancing Device 4. Sterile Lancet CAUTION: To reduce the chances of infection: • Never share a lancing device and lancet with another person.
  • Page 28 Preparing the Test Strip 1. Wash hands using soap and warm water. Rinse and dry thoroughly. 2. Pull out a Test Strip from the vial and re-cap the vial immediately. 3. Insert a Test Strip, white side face up with the Contact Bar end first. Push all the way into test port until meter automatically turns on.
  • Page 29 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 TB200 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 recommend 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 If the same with a new Test Strip to confirm the result.
  • Page 33 Memory Features The TysonBio TB200 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 With the TysonBio TB200 Blood Glucose Monitoring System, it is easy to transfer test results to your personal computer. Follow these simple instructions: 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 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 conditions, such as high humidity, heat, freezing cold or dust. 3.
  • Page 37 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 You may now apply a accept 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...
  • Page 39 DISPLAY WHAT IT MEANS ACTION Meter detects blood Indicates low blood glucose glucose level is lower than level. Repeat test. If result 20 mg/dL (1.1 mmol/L). still occurs, consult your physician immediately. Result may be larger Temperature is high during variation.
  • 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 An error message Press “reset” button and indicating a problem with check the meter again with the meter. the test strip. If the problem 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 ringing Press M or S button to shut 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 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 µl 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 TB200 Meter, TysonBio TB200 Test Strip and Control Solution are in conformity with the IVDD 98/79/EC. Manufacturer: EU authorized representative: Tyson Bioresearch, Inc. Medical Device Safety Service GmbH 5F. #22, Ke E. Road III, Science-Based Schiffgraben 41, D-30175 Hannover, Germany Industrial Park Chu-Nan, Miao-Li County, Taiwan, R.O.C.
  • Page 46 Limitations of the Procedure CAUTION: The TysonBio TB200 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 TB200 blood glucose test results without the consent advice of a physician or healthcare professional is not recommended.
  • Page 47 IMPORTANT: Tyson Bioresearch Inc. cannot endorse the performance of the TysonBio TB200 System when used with Test Strips other than those designed for the TysonBio TB200 Meter. The TysonBio TB200 System manufacturer warranty is valid only when used properly within the guidelines of the provided User’s Manual and is invalid when the TysonBio TB200 System and TysonBio TB200 Test Strip are used improperly.
  • Page 48 TysonBio TB200 Meter found defective with a new TysonBio TB200 Meter. This warranty does not apply to the performance of a TysonBio TB200 Me- ter that has been accidentally damaged, altered, misused, tampered with or abused in any way. In no event shall our company be liable to the purchaser...
  • Page 49 E-Mail us at service@tysonbio.com website: www.tysonbio.com When you call our Customer Service, please have your TysonBio TB200 Meter, TysonBio TB200 Test Strip and all other supplies available. This will allow us to answer any of your questions with speed and efficiency.
  • Page 50 B04U106134(02) 0537 Rev. date: 05/2016...