TysonBio SuperB User Manual

Blood Glucose Monitoring System
For in vitro diagnostic use only
User’s Manual
Do not reuseKeep dryKeep 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
User’s Manual
Customer Service
If you have any questions or concerns regarding this product or its operation, or any attempt to correct a problem fails, please call our Customer Service. Our trained specialists will be happy to assist you, train you, 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
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.
Coding Your TysonBio SUPERB Meter ............................................................23
The Control Solution Test .................................................................................25
Testing Your Blood Glucose Level ....................................................................29
   Preparing the Test Strip ..............................................................................30
   Obtaining a Blood Sample ..........................................................................31
   Applying Blood Sample to the TysonBio SUPERB Test Strip ....................32
Memory Features ................................................................................................34
Transfer Test Results to a Computer .................................................................36
Care and Storage ................................................................................................37
Display Messages ...............................................................................................38
Specifications .....................................................................................................45
   Limitations 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 ............................................11
   About the TysonBio SUPERB Test Strips .................................................13
   About the TysonBio SUPERB 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
   Setting Up the Alarm .................................................................................18
Setting Up the HI and LO Alarm ................................................................20
   Enter PC Link Mode ...................................................................................21
   Measure Unit and Code Setting .................................................................21
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Table of Contents
Important Information
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Forearm
Palm
Available Alternate Sites Testing : Palm and Forearm
TysonBio SUPERB 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.
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.
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 meal).
● Two hours or more after taking insulin.
● Two hours or more after exercise.
DO NOT use AST if:
● You think your blood glucose is low.
● You are unaware of hypoglycemia.
● Your AST results do not match the way you feel.
● You are testing for hyperglycemia.
● Your routine glucose results are often fluctuating.
● If you are pregnant.
There are limitations for doing AST. Please consult your healthcare professional before you do AST.
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Physiologic differences in the circulation between the finger and other test sites like the forearm and palm may result in differences in blood glucose measure­ments from the other test sites and your fingertips. Changes in blood glucose may be observed in finger blood samples sooner than blood samples from the forearm and other alternate sites. Rub the alternate test sites about 20 seconds before lancing. If you are testing for hypoglycemia (low blood glucose), or if you suffer from hypoglycemia unawareness, we recommend that you test on your fingertips.
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. Just remember: any time you want to be sure of an accurate, up-to-date blood glucose reading, test on your fingertip.
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Low or high blood glucose readings can indicate a potentially serious medical condition. If your blood glucose reading is unusually low or high, or if you do not feel the way your reading indicates, repeat the test with a new test strip. If your reading is not consistent with your symptoms or if your blood glucose result is less than 60 mg/dL (3.3 mmol/L) or higher than 240 mg/dL (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 SUPERB 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. If you believe you are suffering from severe dehydration, consult your physician immediately.
CAUTION:
Your TysonBio SUPERB 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 SUPERB System contains:
TysonBio SUPERB Meter
● One vial of TysonBio SUPERB Test Strips (10 strips)
● One Glucode Chip (outside the strip vial)
● One Lancing Device (Option)
● Ten Lancets (Option)
● One Control Solution
● One carrying case
● User’s Manual
● Log book (Option)
● Quick Reference Guide
Note: 25, 50 test strips vial can be purchased individually.
Thank you for choosing the TysonBio SUPERB Blood Glucose Monitoring System, the latest advancement in biosensor technology. As you already know, Self moni­toring 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 benefits from 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 SUPERB System has the ability to process accurate results utilizing only a small volume of blood for in vitro diagnostics. The TysonBio SUPERB Blood Glucose Monitoring System is intended for use in the home and in professional settings to monitor whole blood glucose levels obtained from the fingertip, palm and forearm. This is an over the counter (OTC) product.
Please read the entire User’s Manual carefully before using this product.
Introduction About the Product
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Display Your test results are displayed here. The large, easy to read screen
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.
S Button The S (select/set) button is used to select year, month, day, time,
memory of results and control solution 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 port Connect interface cable to transfer data. Unit Switch Switch for mmol/L or mg/dL.1 mmol/L =18 mg/dL
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RESET
FRONT BACK
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About the TysonBio SUPERB Meter
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mmol/L mg/dL
S/N:M05B13286
0537
For in vitro diagnostic use only
Manufacturer:
Tyson Bioresearch, Inc.
Chu-Nan,Taiwan Customer Service
Call:+886-37-585998
service@tysonbio.com
Tyson ID:T502
Blood Glucose Meter
TysonBio
Memory Symbol Indicates in memory mode. Temperature Message Appears if your meter is out of operating tempera-
ture range.
Battery Symbol Appears when the battery is low or must be replaced. Blood Drop Symbol Flashes when it is ready to apply sample to Test Strip. Warning Symbol Appears when result is out of the range of your setting
reference value.
Alarm Function Symbol Appears when the clock alarm is set. Test Strip Symbol Appears to tell you when 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 results.
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Date Time Control Solution Test
Appears when doing a control solution test and marking the result as a control solution test.
Units of Measurement
Unit of mmol/L or mg/dL will appear with the test result.
Code Symbol Appears
with the code number of the Test Strips currently in use.
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DAY AM
PM
AVG
Mem
mmol/l mg/dL
Code
H L
About the TysonBio SUPERB Meter Display
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Confirmation Window This is where you can
confirm that enough blood has been applied to the target area.
Target Area This is where blood is drawn into the
Test Strip.
Contact Bar This end of the Test Strip is inserted
into the Test Port to activate the TysonBio SUPERB Meter. (white side face up, Front view).
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The TysonBio SUPERB Test Strip is used to perform the blood glucose test in conjunction with the TysonBio SUPERB Meter.
Each strip can 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
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3
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5-5D
Front Back
0537
Manufacturer:
Tyson Bioresearch, Inc. 5F, #22, Ke E. Road III Science­Based Industrial Park, Chu Nan, Taiwan Tel : +886-37-585998
Store at 4-30°C ( 39-86°F). Do not refrigerate. Do not store test strips outside this vial. Re-cap immediately.
WARNING: Always close lid tightly.
For testing of glucose in capillary whole blood.
For in vitro diagnostic use.
Use within 90 days after first opening. Use
TysonBio
SUPERB
meter only !
TysonBio
AUG.2011
The Glucode Chip is used to ensure that your TysonBio SUPERB Meter provides you with accurate results. Before performing the blood glucose test or starting a new strip vial, please check your TysonBio SUPERB Meter with the Glucode Chip to ensure proper performance (further instructions for use of the Glucode Chip is provided on page 22-24).
Note:
● Always use the Glucode Chip to ensure your TysonBio SUPERB Meter is performing properly.
● DO NOT misplace your Glucode Chip.
966
Code Number
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 TysonBio SUPERB Meter will provide accurate results for approximately 50 more measurements.
From the back of the Meter, gently slide and remove the battery cover. Insert a 3-Volt Lithium battery (CR-2032) with the “+” side facing up. Slide battery cover back into place.
RWSET
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About the Glucode Chip Installing/Replacing the Battery
How to Replace the Battery
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S/N:M05B13286
0537
For in vitro diagnostic use only
Manufacturer:
Tyson Bioresearch, Inc.
Chu-Nan,Taiwan Customer Service Call:+886-37-585998
service@tysonbio.com
Tyson ID:T502
Blood Glucose Meter
TysonBio
Press the M button for 3 seconds to enter setting mode. Press and release S button to choose “24Hr” or “12Hr” display. With your favorite clock mode, press M button and the Year setting will be appeared. Press and release the S button until the correct year appears. To enter the year and move on to choose the month, press the M button. To change the month, press the S button. To enter the month and move on to choose the day, press the M button. To change the day, press the S button.
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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.
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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 change the minutes, press the M button. To change the minutes, press the S button. To enter the minutes and move on to choose the alarm setting, press the M button.
To set the first 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 on to change the minutes, press M button. To change the minutes, press S button. To enter the minutes and move on to the second alarm setting, press the M button. (Fig.1)
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Fig.1
Setting Up the Alarm
Setting Up the Date, Time
Setting Up the Meter
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8.9.To set the second 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 on to change the minutes, press M button. To change the minutes, press S button. To enter the minutes and move on to the third alarm setting, press the M button. (Fig.2)
To set the third 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 on to change the minutes, press M button. To change the minutes, press S button. To enter the minutes and move on to the fourth alarm setting, press the M button. (Fig.3)
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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 on to change the minutes, press M button. To change the minutes, press S button. To enter the minutes and move on to health management “HI alarm setting” press the M button. (Fig.4)
Note: When the alarm is ringing, press S or M button to turn off or meter will turn off alarm automatically after 30 sec.
To change the “HI alarm setting” press the S button. To enter the ‘HI alarm setting” and move on to “LO alarm setting” press M button. (Fig.5)
To change the “LO alarm setting” press the S button. To enter the “LO alarm setting” and move on to PC link setting, press M button. To finish the setting, press S button (no) to turn off the meter.
Fig.4
Fig.5
PM
mg/dL
mg/dL
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Fig.2
Fig.3
AM
PM
Setting Up the HI and LO Alarm
13. If you press M button (yes), "PC" link mode for transferring test data will appear. Further instruction on transferring test data, see page 36. Further press M button to turn off the meter. (Fig.6)
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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.
Plug the Glucode Chip into the Glucode Chip slot for strip coding.
Note: 1mmol/L = 18mg/dL
Fig.6
Enter PC Link Mode
Measure Unit and Code Setting
RESET
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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 meter’s Glucode Chip slot. All segments of the LCD display will appear indicating that the TysonBio SUPERB Meter is functioning properly.
If you are a first time user or start a new strip vial, please continue the coding procedure.
DAY AM
PM
AVG
Mem
mmol/l mg/dL
Code
H L
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mmol/L mg/dL
S/N:M05B13286
0537
For in vitro diagnostic use only
Manufacturer:
Tyson Bioresearch, Inc.
Chu-Nan,Taiwan Customer Service Call:+886-37-585998
service@tysonbio.com
Tyson ID:T502
Blood Glucose Meter
TysonBio
Each batch of TysonBio SUPERB Test Strip is encoded with a number that must match one of the code numbers stored in the TysonBio SUPERB Meter. In order to ensure an accurate result, the code number on the display must also match the code number found on the TysonBio SUPERB Test Strip vial.
Insert the TysonBio SUPERB Glucode Chip, Conduc­tive Bar’s end first, into the slot. The TysonBio SUPERB Meter will automatically be turned on.
Note: Code the TysonBio SUPERB Meter whenever you start a new test strip vial.
All segments of the LCD display will appear indicating that the TysonBio SUPERB Meter is functioning prop­erly. Then a beep will sound, followed by the code number.
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Note: If you are using the Meter for the first time without inserting the Glucode Chip, a “000” will appear on the screen and then turn off automati­cally after 3 sec.
Match the code number on the TysonBio SUPERB Meter display with the code number on the Test Strip vial. If the code matches, you may press the M button to turn it off and begin to test lately.
If the meter code and vial code do not match, please ask the store/distributor to replace a new vial.
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Code
Code
Coding Your TysonBio SUPERB Meter
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The Control Solution is used to check and to ensure that the TysonBio SUPERB Meter and TysonBio SUPERB Test Strip are working together properly and that you are performing the test correctly.
When you are using your Blood Glucose Monitoring System for the first time. When you are using a new batch of Test Strips. Anytime you question the performance of the system, or on a regular basis to ensure accuracy, e.g. once a week. When you adjust your diabetic medication plans. When your blood glucose test result is lower or higher than your normal level.
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Make sure the Control Solution is at room temperature prior to testing.
Insert a TysonBio SUPERB Test Strip, white side face up, Contact Bar’s end 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 will sound and the code number will appear followed by a flashing “ “ symbol. Be sure the code number on the display matches the code number on the TysonBio SUPERB Test Strip vial. If the code numbers do not match, code the TysonBio SUPERB Meter by using Glucode Chip, accord­ingly.
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Note: Control Solutions are required but not supplied.
There are three Control Solutions at different desired range of aqueous glucose (Low, Normal or High). Two levels of Control Solutions should be performed. For more information about the Control Solution, please read your Control Solution package insert.
To Perform a Control Solution test:
M
S
The Control Solution Test
When to perform a Control Solution Test
mg/dL
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After the “ “ symbol appears, press the S button for 3 sec to switch control solution mode. The “ “ symbol indicates that the Meter will mark your current test as a Control Solution test. Now you are ready to apply the Control Solution. 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.
Bring the tip of the Test Strip to lightly touch the drop of Control Solution. Control Solution is automatically pulled into the strip through the tip. Hold until the meter beeps. The meter will now being counting down from 8 to 1 and the Control Solution test result will appear.
Caution: Please remember that in order to prevent contamination, follow the above instructions for perform­ing the Control Solution test.
mg/dL
AM
mg/dL
Comparing Control Solution Results
The TysonBio SUPERB 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:
● Error in performing the test
● Expired or contaminated Control Solution
● Expired or contaminated TysonBio SUPERB Test Strips
● Improper coding of the TysonBio SUPERB Meter
● TysonBio SUPERB Meter malfunction
Note: The result will not be incorporated into the average in the Control Solution test “ “ mode. DO NOT use the system if the problem persists.
Please call Tyson Bioresearch, Inc., Customer Service at +886-37-585998 or website of www.tysonbio.com
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Before testing blood glucose, you need the following items:
1. TysonBio SUPERB Meter
2. TysonBio SUPERB Test Strip
3. Adjustable Automatic Lancing Device
4. Sterile Lancet
5. Glucode Chip
Caution: To reduce the chances of infection:
Never share a lancing device and lancet with another person.
Always use a new and sterile lancet. Lancets are for single use only.
Always use a new TysonBio SUPERB Test Strip.
Test Strips are for single use only.
Do not get lotion, oil, dirt or debris in or on the lancet and lancing device.
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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 side face up, into the test port. A beep will sound and the code number will appear followed by a flashing “ “ symbol. Now you are ready to obtain a blood sample.
Reminder: Make sure that the code number on the display matches the code number displayed on the Test Strip vial. If the code number on the display does not match the code number on the Test Strip vial, code the Meter by using Glucode Chip, accordingly.( See page 23)
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mg/dL
Testing Your Blood Glucose Level Preparing the Test Strip
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SAMPLE MAY BE OBTAINED FROM FINGER, PALM or FOREARM
For further instructions please see the insert provided with lancing device.
Unscrew and remove the endcap of the lancing device. Insert the lancet into the lancet holder. Twist and remove the protective lancet cover to expose the sterile needle tip. Recapping and screwing the endcap to the body of the lancing device. Pull back on the cocking mechanism until it comes to a stop. Place the lancing device firmly against the finger tip and press the release button. After sampling, remove the endcap containing the used lancet carefully. Remove the lancet from the lancing device. Discard the used lancet properly in accordance with local, state, and federal law.
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After obtaining a blood sample, place the drop onto the test well of the TysonBio SUPERB Test Strip. Blood is automatically drawn into the TysonBio SUPERB Test Strip. As soon as enough blood has filled the Confirmation Window (see picture) of the Test Strip, the TysonBio SUPERB Meter will beep and begin counting down from 8 to 1. Your blood glucose result will appear on the LCD panel and will be stored into the Meter memory automatically.
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Note: To ensure accurate results, make sure the Confirmation Window of the Test Strip is completely filled with your blood sample.
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mg/dL
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AM
mg/dL
Obtaining a Blood Sample Applying Blood Sample to the TysonBio SUPERB Test Strip
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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 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 new TysonBio SUPERB Test Strip to confirm the result. If the same result
occurs, consult your healthcare professional immediately.
(Fig.7)
If a “LO” message appears on your display, your TysonBio SUPERB Meter has detected that your blood glucose level is lower than 20 mg/dL (1.1 mmol/L). It is suggested that you review your testing procedure and test again with a new TysonBio SUPERB Test Strip to confirm the result. If the same result occurs,
consult your healthcare professional immediately.
(Fig.8)
If no further 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 TysonBio SUPERB Meter for proper disposal.
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The TysonBio SUPERB 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.
Press the M button to turn on the TysonBio SUPERB Meter. All segments of the LCD display will appear. The date and time will appear first. Press S button, the result of control solution will appear on display.* Press S button, the consecutive 7-day average will be shown.* Press S button, the consecutive 14-day average will be shown.* Press S button, the consecutive 30-day average will be shown.*
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Note : * If there is no test results during this stage, it will directly appear the most recent test result.
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Memory Features
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(Fig.7)
(Fig.8)
Press S button, the most recent test result will appear. Each time you press the S button, the TysonBio SUPERB 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. Press and release the S button to the end of the memory, “000” will show. Then press the S button again or M button to turn the meter off.
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To Record Your Results
We have provided a log book for your recording convenience. To learn more about how to record your results, please refer to the log book for further instructions.
Exiting the Memory Mode
1. Press the M button to turn off the meter.
2. Meter will shut down automatically after 4 minutes with no further action.
Note: The consecutive 7/14/30-day average is calculated from the blood glucose results obtained during the last consecutive 7/14/30-day.
AM
Mem
mg/dL
Mem
You 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 Bioresearch, Inc., Customer Service at +886-37-585998 or website of www.tysonbio.com
Install the software on a computer
Follow the instructions provided with software to install the software.
Transfer data
Follow the instructions provided in the software to download the results from the meter. After finishing the data transfer, press M button to turn off the meter.
Note: While in the communication mode, you will be unable to perform a blood glucose test. If the meter is not in the PC link mode, it will not respond to computer commands.
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Transfer Test Results to a Computer
Get ready to transfer test results
Setting the meter to the PC link mode, see page.21. “PC” will appear on the display. Connect the interface cable to a serial port on your computer. Then connect the other end of interface cable to the data port located on the side of the meter with the meter turned off.
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Handle the TysonBio SUPERB Meter with care. Dropping or throwing the Meter may cause damage to the device. Do not expose the Meter, Test Strips, and Control Solution to extreme conditions, such as high humidity, heat, freezing cold or dust. Always wash hands with soap and water and rinse and dry completely before handling the Meter and Test Strips. When cleaning the Meter, gently wipe the exterior surface using a damp soft cloth. DO NOT USE
ANY ORGANIC SOLVENT for cleaning.
The Meter should be stored at room temperature in a dry and clean space. DO NOT STORE IN
DIRECT SUNLIGHT OR AREAS WITH HIGH HUMIDITY AND/OR DUST. It is advised that you
store the Meter and its accessories into the provided carrying case.
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For healthcare professionals using this system on multiple patient, 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 diseases in a healthcare setting for potentially infectious human blood specimens as recommended in the National Committee for Clinical Laboratory Standards, Protection of Laboratory Workers from Instrument Biohazards and Infectious Disease Transmitted by Blood, Body Fluids and Tissue: Approved Guideline.
NCCLS document M29-A [ISBN 1-56238-339-6].
Care and Storage
DAY AM
PM
AVG
Mem
mmol/l mg/dL
Code
H L
Code
Code
DISPLAY WHAT IT MEANS ACTION
System check for verifying that all segments of the Meter are functioning.
This message appears immediately if your Meter has not been encoded.
This is the current code number in use.
No Action Necessary.
Code Meter. (see page 23)
This code number should match the code number printed on your TysonBio SUPERB Test Strip vial.
Display Messages
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mg/dL
The system is ready to accept a blood sample.
The system is ready to accept a Control Solution sample.
TysonBio SUPERB Meter detects blood glucose level is higher than 600 mg/dL(33.3 mmol/L).
You may now apply a blood sample.
You may now apply a drop of Control Solution sample.
Indicates high blood glucose level. Repeat test. If result still occurs, consult 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.
Temperature is too high to perform the test.
Indicates low blood glucose level. Repeat test. If result still occurs, consult your physician immediately.
Repeat the test in a warmer setting (10 - 40°C or 50 ­104°F). Wait 15 minutes before re-testing.
Repeat the test in a cooler setting (10 - 40°C or 50 ­104°F). Wait 15 minutes before re-testing.
DISPLAY WHAT IT MEANS ACTION
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An error message indicating a problem with the TysonBio SUPERB Test Strip.
Battery power is too low for further usage.
Battery power is low. Meter will provide approximately 50 more measurements.
Review the instructions and try again with a new TysonBio SUPERB Test Strip.
Replace with a new 3-Volt lithium battery (CR-2032) immediately.
Replace with a new 3-Volt lithium battery (CR-2032).
DISPLAY WHAT IT MEANS ACTION
An error message indicating 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 management.
Check the meter again with the Glucode Chip. If the problem persists, contact Tyson Biore­search, Inc. Customer Service for help.
Press “reset” button and check the meter again with the Glucode Chip. If the problem persists, contact Tyson Biore­search, Inc. Customer Service for help.
For your reference or you can change the default setting value 100 mg/dL according to page 20.
AM
Mem
mg/dL
Code
DISPLAY WHAT IT MEANS ACTION
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42
Indicate the result is LOWER than the “LO alarm setting” of the health management.
Temperature is low during the test procedure.
Temperature is high during the test procedure.
For your reference or you can change the default setting value 70 mg/dL according to page 20.
Result may be larger variation. Move to a warmer environment
(10 - 40˚C or 50 - 104˚F) and
wait 15 minutes before re-testing.
Result may be larger variation. Move to a cooler environment
(10 - 40˚C or 50 - 104˚F) and
wait 15 minutes before re-testing.
mg/dL
L
mg/dL
H
DISPLAY WHAT IT MEANS ACTION
Mem
All testing values recorded 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 not been inserted into the Meter properly. Defective TysonBio SUPERB Test Strip.
Insufficient blood sample.
Test Strip remains in the test port for more than 4 minutes prior to testing. LCD Screen on the Meter is blank when trying to perform a test.
Review the instructions and re-insert the Test Strip correctly (white side face up).
Replace with a new TysonBio SUPERB Test Strip. Repeat the test with new TysonBio SUPERB Test Strip. Meter will automatically turn-off. Re-insert the Test Strip to the test port. Contact Tyson Bioresearch, Inc. Customer Service for help.
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AM
Mem
mg/dL
■ The TysonBio SUPERB Meter, TysonBio SUPERB Test Strips and Control
Solution are in conformity with the IVDD 98/79/EC. The Lancing Device is in conformity with the MDD 93/42/EEC.
■ The Lancets are in conformity with the MDD 93/42/EEC.
Manufacturer: Tyson Bioresearch, Inc. 5F. #22, Ke E. Road III, Science-Based Industrial Park Chu-Nan 350, Miao-Li County, Taiwan, R.O.C. TEL: +886 37 585998
Manufacturer: Wuxi Xinda Medical Device Co., Ltd. No.42 Xixin Road, Zhangjing Town, Wuxi, Jiangsu,214194,China
Authorized representative 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: +49 511 62628630
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Specifications
Operating Conditions: Hematocrit: Test Sample: Sample Volume: Measuring Range: Test Time: Memory Capacity: Average: External Output Power supply: Battery Life: Dimension and Weight:
10°C - 40°C(50°F - 104°F) and 10 - 90% RH 35 - 55% Capillary Whole Blood from Fingertip, Palm and Forearm >1.5 20 - 600 mg/dL (1.1 - 33.3 mmol/L) 10 sec 300 most recent results 7/14/30 days average results Standard RS232 PC interface 3-Volt lithium battery (CR-2032) Approximately 1000 tests 102 x50 x15 mm ; 55 g
Manufacturer Warranty: Tyson Bioresearch, Inc. guarantees that this device will be free of defects in materials and workmanship for a period of three years from the date of original purchase. During the stated three-year period, our company shall repair or replace any TysonBio SUPERB Meter found defective with a new Tyson­Bio SUPERB Meter.
This warranty does not apply to the performance of a TysonBio SUPERB Meter 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 or any other person for any incidental, consequential, or punitive damages arising from or in any way connected with the purchase or operation of the TysonBio SUPERB Meter or its parts.
For manufacturer warranty services, purchaser must contact Tyson Bioresearch, Inc. for help.
Limitations of the Procedure
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 blood samples obtained from the fingertip, palm and forearm. False results may occur when performing the test while severely dehydrated, severely hypotensive, in shock or in a hyperglycemic-hyperosmolar state. If you believe you are suffering from any of the above symptoms, consult a healthcare professional immediately.
Service and Warranty
IMPORTANT: The TysonBio SUPERB Blood Glucose Monitoring System is designed for in vitro diagnostic use only. Tyson Bioresearch Inc. cannot endorse the performance of the TysonBio SUPERB System when used with Test Strips other than those designed for the TysonBio SUPERB Meter. The TysonBio SUPERB System manufacturer warranty is valid only when used properly within the guidelines of the provided User’s Manual and is invalid when the TysonBio SUPERB System and TysonBio SUPERB Test Strip are used improp­erly.
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