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TysonBio SuperB User Manual

Blood glucose monitoring system
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Keep away from sunlight
In Vitro Diagnostics Medical Device
ID:B03G106873
Caution, consult accompanying documents
Revision:01
Keep dry
Do not reuse
Store at +4ºC to +30ºC
Read Instructions for use
TysonBio

Blood Glucose Monitoring System

User's Manual
For in vitro diagnostic use only

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Summary of Contents for TysonBio SuperB

  • Page 1: Blood Glucose Monitoring System

    TysonBio Blood Glucose Monitoring System User’s Manual For in vitro diagnostic use only Keep away from sunlight Keep dry Do not reuse In Vitro Diagnostics Medical Device Store at +4ºC to +30ºC ID:B03G106873 Caution, consult accompanying documents Read Instructions for use...
  • Page 2 E-Mail us at service@tysonbio.com website:www.tysonbio.com When you call our Customer Service, please have your TysonBio SUPERB Meter, TysonBio SUPERB Test Strip and all other system supplies available. This will allow us to answer any of your questions with speed and efficiency.

  • Page 3: Table Of Contents

    　　　Obtaining a Blood Sample ................31 About the TysonBio SUPERB Meter Display ..........11 　　　About the TysonBio SUPERB Test Strips ..........13 　　　Applying Blood Sample to the TysonBio SUPERB Test Strip ....32 　　　About the TysonBio SUPERB Test Strip vial ..........14 Memory Features ....................34 　　　About the Glucode Chip ................15...

  • Page 4: Important Information

    Available Alternate Sites Testing : Palm and Forearm Alternative site results differ from fingertip results when glucose levels are chang- TysonBio SUPERB Blood Glucose Monitoring System provides you alternate sites ing rapidly such as after a meal, after taking insulin, during exercise, or when you testing (AST).
  • Page 5 ● Any change or administer of medication based on the TysonBio SUPERB blood Talk to your doctor to see if alternate site testing is right for you. With a little bit glucose test results without the consent and advice of a physician or healthcare of education, you can give your fingertips a rest and maybe test more often than professional is not recommended.

  • Page 6: Introduction

    ● One Glucode Chip (outside the strip vial) ● One Lancing Device (Option) Adapted for its ease of use and quick response time, the TysonBio SUPERB ● Ten Lancets (Option) System has the ability to process accurate results utilizing only a small volume of ●...

  • Page 7: About The Tysonbio Superb Meter

    About the TysonBio SUPERB Meter Display Your test results are displayed here. The large, easy to read screen FRONT BACK guides you through the test by using numbers and symbols. M Button The M (mode) button is used to set the year, month, day and time, enters the memory mode to show the consecutive 7/14/30-day average results, and turns the Meter on and off.

  • Page 8: About The Tysonbio Superb Meter Display

    About the TysonBio SUPERB Meter Display Date Memory Symbol Indicates in memory mode. Time Temperature Message Appears if your meter is out of operating tempera- Control Solution Test ture range. Battery Symbol Appears when doing a Appears when the battery is low or must be replaced.

  • Page 9: About The Tysonbio Superb Test Strips

    About the TysonBio SUPERB Test Strip About the TysonBio SUPERB Test Strip Vial The TysonBio SUPERB Test Strip is used to perform VIAL LABEL TEST STRIP VIAL the blood glucose test in conjunction with the TysonBio SUPERB Meter. TysonBio Back Front Each strip can be used only once.

  • Page 10: About The Glucode Chip

    About the Glucode Chip Installing/Replacing the Battery The Glucode Chip is used to ensure that your TysonBio SUPERB Meter provides When the battery is low, the Meter will show a warning signal. you with accurate results. Before performing the blood glucose test or starting a When this display appears, it is time to replace a new battery.

  • Page 11: 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 To enter the day and move on to choose the hour setting, back of the Meter and proceed with the following instructions. press the M button.

  • Page 12: Setting Up The Hi And Lo Alarm

    To set the second alarm, press the M button (y). If you press S To set the fourth alarm, press the M button (y). If you press S button button (n), it will move to health management alarm setting (step (n), it will move to health management alarm setting (step 11).

  • Page 13: Enter Pc Link Mode

    13. If you press M button (yes), "PC" link mode for transferring test data will appear. Further instruction on transferring test data, The Glucode Chip is used for checking and coding your TysonBio SUPERB Meter. To see page 36. Further press M button to turn off the meter. (Fig.6) Check your Meter: Insert the Glucode Chip into meter’s Glucode Chip slot.

  • Page 14: Coding Your Tysonbio Superb Meter

    Coding Your TysonBio SUPERB Meter Note: If you are using the Meter for the first time Each batch of TysonBio SUPERB Test Strip is encoded with a number that must without inserting the Glucode Chip, a “000” will match one of the code numbers stored in the TysonBio SUPERB Meter. In order...

  • Page 15: The Control Solution Test

    The Control Solution Test To Perform a Control Solution test: The Control Solution is used to check and to ensure that the TysonBio SUPERB Make sure the Control Solution is at room temperature Meter and TysonBio SUPERB Test Strip are working together properly and that you prior to testing.
  • Page 16 The “ “ symbol indicates that The TysonBio SUPERB is functioning properly if the result falls inside the speci- the Meter will mark your current test as a Control Solution fied range printed on the Test Strip vial. If the test result falls outside the specified mg/dL test.

  • Page 17: Testing Your Blood Glucose Level

    Wash hands using soap and warm water. Rinse and dry thoroughly. 1. TysonBio SUPERB Meter Pull out a TysonBio SUPERB Test Strip from the vial and re-cap 2. TysonBio SUPERB Test Strip the vial immediately. 3. Adjustable Automatic Lancing Device Insert the Test Strip white side face up, into the test port.

  • Page 18: Obtaining A Blood Sample

    Obtaining a Blood Sample Applying Blood Sample to the TysonBio SUPERB Test Strip After obtaining a blood sample, place the drop onto the test well of the TysonBio SAMPLE MAY BE OBTAINED FROM FINGER, PALM or FOREARM SUPERB Test Strip.

  • Page 19: Memory Features

    Memory Features The TysonBio SUPERB Meter automatically stores the 300 most recent blood The TysonBio SUPERB results range between 20 to 600 mg/dL (1.1 to 33.3 mmol/L). If a “HI” message appears on your display, your TysonBio SUPERB glucose results with date and time in its memory. It also provides you with a Meter has detected that your blood glucose level is higher than 600 mg/dL(33.3...

  • Page 20: 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 Press S button, the most recent test result will appear. Each personal computer. time you press the S button, the TysonBio SUPERB Meter will Obtain the required software and cable recall the last 300 test results accordingly.

  • Page 21: Care And Storage

    Display Messages DISPLAY WHAT IT MEANS ACTION Handle the TysonBio SUPERB Meter with care. Dropping or throwing the Meter may cause damage to the device. System check for verifying No Action Necessary. Do not expose the Meter, Test Strips, and Control Solution to extreme conditions, such as high that all segments of the Meter humidity, heat, freezing cold or dust.
  • Page 22 ACTION DISPLAY WHAT IT MEANS ACTION You may now apply a blood The system is ready to The TysonBio SUPERB Indicates low blood glucose sample. Meter detects blood glucose level. Repeat test. If result still accept a blood sample. level is lower than 20 mg/dL...
  • Page 23 An error message indicating Review the instructions and try Glucode Chip. If the problem a problem with the coding of a problem with the TysonBio again with a new TysonBio persists, contact Tyson Biore- TysonBio SUPERB Meter. SUPERB Test Strip.
  • Page 24 Other problems that may occur ACTION Move to a warmer environment test procedure. The TysonBio SUPERB Test Strip has not been Review the instructions and re-insert the Test (10 - 40˚C or 50 - 104˚F) and Strip correctly (white side face up).

  • Page 25: Specifications

    Specifications ■ The TysonBio SUPERB Meter, TysonBio SUPERB Test Strips and Control Operating Conditions: 10°C - 40°C(50°F - 104°F) and 10 - 90% RH Solution are in conformity with the IVDD 98/79/EC. Hematocrit: 35 - 55% The Lancing Device is in conformity with the MDD 93/42/EEC.

  • Page 26: Limitations Of The Procedure

    Manufacturer Warranty: Tyson Bioresearch, Inc. guarantees that this device will Caution: The TysonBio SUPERB System is designed for in vitro use only and is not be free of defects in materials and workmanship for a period of three years from the intended to test on newborns.

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