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Blood Glucose Monitoring System

For in vitro

 diagnostic use only

User’s Manual

Do not reuse

Keep dry

Keep away from sunlight

In Vitro

 Diagnostics Medical Device

Caution, consult accompanying documents

Read Instructions for use

Store at +4ºC to +30ºC

ID:B03G106873
Revision:01

TysonBio

Summary of Contents for SuperB

Page 1: ...tro diagnostic use only User s Manual Do not reuse Keep dry Keep away from sunlight In Vitro Diagnostics Medical Device Caution consult accompanying documents Read Instructions for use Store at 4 C to...

Page 2: ...ou or even reaffirm your results Customer Service Hotline 1 800 948 3894 U S 24 hours a day 886 37 585998 our office hours are from 8 30 am GMT0030 5 30 pm GMT0930 or E Mail us at service tysonbio com...

Page 3: ...ations of the Procedure 47 Service and Warranty 47 Customer Service Important Information 3 Introduction 7 About the Product 8 About the TysonBio SUPERB Meter 9 About the TysonBio SUPERB Meter Display...

Page 4: ...r taking insulin during exercise or when you are ill or under stress We strongly recommend you do AST ONLY in the following intervals In a pre meal or fasting state more than 2 hours since the last me...

Page 5: ...testing is a good thing Just remember any time you want to be sure of an accurate up to date blood glucose reading test on your fingertip 1 2 Low or high blood glucose readings can indicate a potentia...

Page 6: ...know Self moni toring of blood glucose SMBG is a necessary part of the treatment plan for people with diabetes mellitus The Diabetes Control and Complications Trial DCCT has confirmed the significant...

Page 7: ...on mode Test port This is where you insert the Test Strip into the Meter Battery Cover Label Reset Button Press this button to re set the system Glucode Chip Insert the Glucode Chip for coding Data po...

Page 8: ...n the meter is ready for test Error Symbol Appears when the strip or meter error Day Average Symbol Shows the average value of test results from the last 7 14 or 30 days Test Result Area Display test...

Page 9: ...n be used only once Code Number Control Solution Range Lot Number Expiration Date VIAL LABEL TEST STRIP VIAL About the TysonBio SUPERB Test Strip About the TysonBio SUPERB Test Strip Vial 13 14 3 1 2...

Page 10: ...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 TysonBio SUPERB Meter will provide accurate results for...

Page 11: ...ter and proceed with the following instructions M S To enter the day and move on to choose the hour setting press the M button To change the hour press the S button To enter the hour and move on to ch...

Page 12: ...ig 3 10 11 12 To set the fourth alarm press the M button y If you press S button n it will move to health management alarm setting step 11 To change the hour press S button To enter the hour and move...

Page 13: ...etting RESET 19 Checking the Performance of Your TysonBio SUPERB Meter The Glucode Chip is used for checking and coding your TysonBio SUPERB Meter To Check your Meter 1 2 Insert the Glucode Chip into...

Page 14: ...test strip vial All segments of the LCD display will appear indicating that the TysonBio SUPERB Meter is functioning prop erly Then a beep will sound followed by the code number 1 2 Note If you are us...

Page 15: ...d first into the test port The TysonBio SUPERB Meter will turn on automatically All segments of the LCD display will appear indicating that the TysonBio SUPERB Meter is functioning properly A beep wil...

Page 16: ...test result will appear Caution Please remember that in order to prevent contamination follow the above instructions for perform ing the Control Solution test mg dL AM mg dL Comparing Control Solutio...

Page 17: ...nd lancing device 1 2 3 4 Wash hands using soap and warm water Rinse and dry thoroughly Pull out a TysonBio SUPERB Test Strip from the vial and re cap the vial immediately Insert the Test Strip white...

Page 18: ...m the lancing device Discard the used lancet properly in accordance with local state and federal law 1 2 3 4 5 6 7 8 After obtaining a blood sample place the drop onto the test well of the TysonBio SU...

Page 19: ...er tests are performed the TysonBio SUPERB Meter will shut off automatically after 4 minutes After finishing the test we recommend using a tissue paper to remove TysonBio SUPERB Test Strip from the Ty...

Page 20: ...can use your meter with TysonBio Link Health Management Software to transfer test results to your personal computer Obtain the required software and cable For order information please call Tyson Biore...

Page 21: ...ient please be aware that all items that come in contact with human blood should be handled as potential biohazards Users should follow the guidelines for prevention of blood borne transmittable disea...

Page 22: ...your physician immediately mg dL DISPLAY WHAT IT MEANS ACTION The TysonBio SUPERB Meter detects blood glucose level is lower than 20 mg dL 1 1 mmol L Temperature is too low to perform the test Temper...

Page 23: ...icating a problem with the coding of TysonBio SUPERB Meter An error message indicating a problem with the TysonBio SUPERB Meter Indicate the result is HIGHER than the HI alarm setting of the health ma...

Page 24: ...ed in the memory have been shown Press S or M button or wait for 4 minutes to turn off the meter DISPLAY WHAT IT MEANS ACTION Other problems that may occur ACTION The TysonBio SUPERB Test Strip has no...

Page 25: ...tative in the EU EMERGO EUROPE Molenstraat 15 2513 BH The Hague The Netherlands Authorized representative in the EU Medical Device Safety Service GmbH Schiffgraben 41 D 30175 Hannover Germany TEL 49 5...

Page 26: ...rocedure Caution The TysonBio SUPERB System is designed for in vitro use only and is not intended to test on newborns The TysonBio SUPERB Test Strips are designed for use with fresh capillary whole bl...

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