TysonBio EVOLVE User Manual
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TysonBio EVOLVE User Manual

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

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Summary of Contents for TysonBio EVOLVE

  • Page 1 TysonBio Blood Glucose Monitoring System User’s Manual For in vitro diagnostic use only EVOLVE...

  • Page 3: Table Of Contents

    About the TysonBio EVOLVE Meter .............9 About the TysonBio EVOLVE Meter Display ........11 About the TysonBio EVOLVE Test Strip ..........13 About the TysonBio EVOLVE Test Strip Vial ........14 About the Glucode Chip ..............15 Installing/Replacing the Battery ............16 Setting Up the Meter ...................17 Setting Up the Date, Time ..............17...
  • Page 4 The Control Solution Test ................24 Testing Your Blood Glucose Level ............28 Preparing the Test Strip ..............29 Obtaining a Blood Sample ..............30 Applying Blood Sample to the Test Strip ..........31 Memory Features ..................34 Transfer Test Results to a Computer ............36 Care and Storage ..................37 Display Messages ..................38 Specifications .....................45 Limitations of the Procedure ..............47...

  • Page 5: Important Information

    Important Information Available Alternative Sites Testing : Palm and Forearm. TysonBio EVOLVE Blood Glucose Monitoring System provides you alterna- tive 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 alternative 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 EVOLVE blood glucose test results without the consent and advice of a physician or healthcare professional is not recommended.

  • Page 9: Introduction

    SMBG when practiced as part of a larger intensive strategy to tightly control blood glucose concentrations. Adapted for its ease of use and quick response time, the TysonBio EVOLVE 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 EVOLVE 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 EVOLVE System contains: ● TysonBio EVOLVE Meter ●...

  • Page 11: About The Tysonbio Evolve Meter

    About the TysonBio EVOLVE Meter...
  • 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 Evolve Meter Display

    About the TysonBio EVOLVE 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. Code Symbol Appears with the code number of the Test Strips in use.
  • Page 14 7. Battery Symbol Appears when the battery is low or must be replaced. 8. Blood Drop Symbol Flashes when it is ready to apply sample to Test Strip. 9. Warning Symbol Appears when result is out of the range of your setting reference value. 10.

  • Page 15: About The Tysonbio Evolve Test Strip

    About the TysonBio EVOLVE Test Strip The TysonBio EVOLVE Test Strip is used to per- form the blood glucose test in conjunction with the TysonBio EVOLVE Meter. Each strip can be used only once. The Test Strip consists of the following parts: 1.

  • Page 16: About The Tysonbio Evolve Test Strip Vial

    About the TysonBio EVOLVE Test Strip Vial VIAL LABEL TEST STRIP VIAL 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. EVOLVE meter only ! Re-cap immediately.

  • Page 17: About The Glucode Chip

    About the Glucode Chip The Glucode Chip is used to ensure that your Meter provides you with accurate results. Before performing the blood glucose test or starting a new strip vial, please check your Meter with the Glucode Chip to ensure proper performance (further instructions for use of the Glucode Chip is provided on page 22-23).

  • Page 18: 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 19: 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 20: 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 21 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 22 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 23: Unit Selection And Code Setting

    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. 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 0537 S/N:M05B13286 RESET mmol/l mg/dL...

  • Page 24: Coding Your Tysonbio Evolve Meter

    Checking the Performance of Your TysonBio EVOLVE Meter The Glucode Chip is used for checking and coding your TysonBio EVOLVE Meter. To check your Meter: 1. Insert the Glucode Chip into meter’s Glucode Chip slot. All segments of the LCD display will appear in- dicating that the Meter is functioning properly.
  • Page 25 1. Insert the Glucode Chip, Conductive Bar’s end first, into the connector. The Meter will automatically be turned on. Note: Code the Meter whenever you start a new test strip vial. 2. All segments of the LCD display will appear. Then a beep will sound, followed by the code number.

  • Page 26: The Control Solution Test

    The Control Solution Test The Control Solution is used to check and ensure that the Meter and Test Strip are working together properly and that you are performing the test cor- rectly. When To Perform a Control Solution Test 1. When you are using your Blood Glucose Monitoring System for the first time. 2.
  • Page 27 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. The Meter will automatically turn on. 3.
  • Page 28 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 29 Note: The result will not be incorporated into the average in the Control Solution test “ ctl “ mode. DO NOT use the system if the problem persists. Please call Tyson Bioresearch, Inc., Customer Service or website of www. tysonbio.com...

  • Page 30: Testing Your Blood Glucose Level

    Testing Your Blood Glucose Level Before testing blood glucose, you need the following items: 1. TysonBio EVOLVE Meter 2. TysonBio EVOLVE Test Strip 3. Adjustable Automatic Lancing Device 4. Sterile Lancet 5. Glucode Chip Caution: To reduce the chances of infection: ●...

  • Page 31: 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 32: 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 33: Applying Blood Sample To The Test Strip

    Applying Blood Sample to the 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.Your blood glucose result will appear on the LCD display and will be stored into the Meter memory automatically.
  • Page 34 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, you can push the strip eject button to remove the used strip or using a tissue paper to remove Test Strip from the Meter for proper disposal.
  • Page 35 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.12) new Test Strip to confirm the result.

  • Page 36: Memory Features

    Memory Features The TysonBio EVOLVE 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 37 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 38: 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 Tyson Bioresearch, Inc., Customer Ser- vice or visit website of www.tysonbio.com...

  • Page 39: 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 40: Display Messages

    Meter are functioning. This message appears im- Code Meter mediately if your Meter has (see page 22 Coding not been encoded. Your TysonBio EVOLVE Meter) This is the current code This code number should number in use. match the code number printed on your Test Strip vial.
  • Page 41 DISPLAY WHAT IT MEANS ACTION 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 sample.
  • Page 42 DISPLAY WHAT IT MEANS ACTION Indicate the result is For your reference or you LOWER than the “LO can change the default set- alarm setting” of the health ting value 70 mg/dL accord- management. ing to page 20. Meter detects blood glu- Indicates high blood glu- cose level is higher than cose level.
  • Page 43 DISPLAY WHAT IT MEANS ACTION Result may be larger varia- Temperature is high during tion. Move to a cooler envi- the test procedure. ronment (10 - 40˚C or 50 - 104˚F) and wait 15 minutes before re-testing. Result may be larger varia- Temperature is low during tion.
  • Page 44 DISPLAY WHAT IT MEANS ACTION Temperature is too low to Repeat the test in a warmer perform the test. setting (10 - 40°C or 50 - 104°F). Wait 15 minutes before re-testing. An error message indicat- Review the instructions ing a problem with the and try again with a new Test Strip.
  • Page 45 DISPLAY WHAT IT MEANS ACTION Battery power is low. Meter Replace with a new 3-Volt will provide approximately lithium battery (CR-2032). 50 more measurements. Replace with a new 3-Volt Battery power is too low lithium battery (CR-2032) for further usage. immediately.
  • Page 46 DISPLAY WHAT IT MEANS ACTION Check the meter again with An error message indicat- the Glucode Chip. If the ing a problem with the problem persists, contact coding of Meter. Customer Service for help. Other problems that may occur ACTION The Test Strip has not been inserted into the Review the instructions and re-insert the Test Meter properly.

  • Page 47: 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 48 ■ The TysonBio EVOLVE Meter, TysonBio EVOLVE Test Strip and Con- trol 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 49: Limitations Of The Procedure

    Limitations of the Procedure Caution: The TysonBio EVOLVE System is designed for in vitro use only and is not intended to test on newborns. The TysonBio EVOLVE Test Strips are designed for use with fresh capillary whole blood samples obtained from the fingertip, palm and forearm. False results may occur when performing the test while severely dehydrated, se- verely hypotensive, in shock or in a hyperglycemic-hyperosmolar state.
  • Page 50 TysonBio EVOLVE Meter found defective with a new Tyson- Bio EVOLVE Meter. This warranty does not apply to the performance of a TysonBio EVOLVE 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 51: Customer Service

    E-Mail us at service@tysonbio.com website: www.tysonbio.com When you call our Customer Service, please have your TysonBio EVOLVE Meter, TysonBio EVOLVE Test Strip and all other system supplies available. This will allow us to answer any of your questions with speed and efficiency.
  • Page 52 Keep away from sunlight Keep dry Do not reuse In Vitro Diagnostics Medical Device Store at +4ºC to +30ºC ID:B03K106703 Caution, consult accompanying documents Read Instructions for use...

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