TysonBio EVOLVE User Manual

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User’s Manual
For in vitro diagnostic use only
EVOLVE
Blood Glucose Monitoring System
TysonBio
Page 2
Page 3
Important Information ..................................................................................3
About the Product ........................................................................................8
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
Setting Up Alarm ................................................................................18
Unit Selection and Code Setting.........................................................21
Coding Your TysonBio EVOLVE Meter ......................................................22
Table of Contents
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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
Specications .............................................................................................45
Limitations of the Procedure ..............................................................47
Service and Warranty .................................................................................47
Customer Service
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Available Alternative Sites Testing : Palm and Forearm.
TysonBio EVOLVE Blood Glucose Monitoring System provides you alterna­tive sites testing (AST). This system provides you to test on the palm and the
forearm with the equivalent results to ngertip testing.
There are limitations for doing AST. Please consult your healthcare professional before you do AST.
Forearm
Palm
Important Information
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Alternative site results differ from ngertip 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 ngertip rather than an
alternative site if:
● you think your blood glucose is low,
● you don’t regularly have symptoms when your blood glucose is low, or
● how you feel doesn’t match the results from the alternative site.
● when you have just taken insulin, or any time during or after exercise.
● when there are unknown variables occurring in your day, such as illness.
● whenever you are about to drive.
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CAUTION:
1. Physiologic differences in the circulation between the nger and other test
sites like the forearm and palm may result in differences in blood glucose
measurements from the other test sites and your ngertips. Changes in
blood glucose may be observed in nger 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 ngertips.
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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 ngertips 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 ac-
curate, up-to-date blood glucose reading, test on your ngertip.
3. 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 uctuating.
● If you are pregnant.
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● Low or high blood glucose readings can indicate a potentially serious med-
ical 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 EVOLVE
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.
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Thank you for choosing the TysonBio EVOLVE 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 of 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 EVOLVE System has the ability to process accurate results utilizing only a small vol­ume of blood for in vitro diagnostics. The TysonBio EVOLVE Blood Glucose Monitoring System is intended for use in the home and in professional set-
tings to monitor whole blood glucose levels obtained from the ngertip, palm
and forearm. This is an over the counter (OTC) product.
Please read the entire User’s Manual carefully before using this product.
Introduction
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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
● One vial of TysonBio EVOLVE 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.
About the Product
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About the TysonBio EVOLVE Meter
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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.
3. S Button The S (select/set) button is used to select year, month, day,
time, memory of results and control solution mode.
4. Test Port This is where you insert the Test Strip into the Meter.
5. Unit Switch Switch for mmol/l or mg/dL.1 mmol/l =18 mg/dL
6. Battery Cover
7. Label
8. Reset Button Press this button to re-set the system.
9. Data Port Connect interface cable to transfer data.
10. Strip Ejection Button Push button to eject the used strip.
11. Glucode Chip Insert the Glucode Chip for coding.
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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.
5. Memory Symbol
Indicates in memory mode.
6. Units of Measurement Unit
of mmol/l or mg/dL will appear with the test result.
About the TysonBio EVOLVE Meter Display
6
4
8
3
5
2
9
11
7
12
10
14
1
13
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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. Alarm Function Symbol
Appears when the clock alarm is set.
11. Test Strip Symbol
Appears to tell you when the meter is ready for test.
12. Day Average Symbol
Shows the average value of test results.
13. Test Result Area
Display test results.
14. Temperature Message
Appears if your meter is out of operating temperature range.
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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. Conrmation Window
This is where you can conrm that enough blood
has been applied to the target area.
2. Target Area
This is where blood is drawn into the Test Strip.
3. Contact Bar
This end of the Test Strip is inserted into the Test Port to activate the Meter. (white side face up).
3
1
2
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About the TysonBio EVOLVE Test Strip Vial
Code Number
Control Solution Range
Lot Number
Expiration Date
VIAL LABELTEST STRIP VIAL
811
0537
Manufacturer:
Tyson Bioresearch, Inc. 5F, #22, Ke E. Road III Science­Based Industrial Park, Chu Nan, Ta iwan 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
EVOLVE
meter only !
811
H8T121205
Aug 2010
31-61 84-144 348-438
1.7-3.4
4.7-8.0
19.3-24.3
Low: Normal: High:
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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). After checking your Meter, the Glucode Chip is also used to code setting.
Note:
●
Always use the Glucode Chip to ensure your Meter is performing
properly.
● DO NOT misplace your Glucode Chip.
966
Code Number
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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.
1. From the back of the Meter, gently slide and remove the battery cover.
2. Turn over the battery cover and insert a 3-Volt Lithium battery (CR-2032) with the “+” side facing down.
3. Slide battery cover back into place with the battery side facing down.
Installing/Replacing the Battery
How to Replace the Battery
16
+
CR2032
3V
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Setting Up the Meter
Setting Up the Date, Time
To turn the Meter on, rst insert a battery, then press the reset button located
at the back of the Meter and proceed with the following instructions.
1. Press the M button to enter this 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. (Fig.1)
2. To enter the year and move on to choose
the month, press the M button. To change the month, press the S button. (Fig.2)
3. To enter the month and move on to choose
the day, press the M button. To change the day, press the S button. (Fig.3)
M S
(Fig.1)
(Fig.2)
(Fig.3)
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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)
6. To change the minutes, press the S button. To enter the
minutes and move on to choose the alarm setting, press the M button. (Fig.4)
7. To set the rst 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. To change the minutes, press S button. To enter the minutes and move on to choose the second alarm setting, press the M button. (Fig.5)
Setting Up Alarm
(Fig.4)
(Fig.5)
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8. To set the second alarm, press the M button (y). If you
press S button (n), it will be moved on 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 choose the third alarm setting, press the M button. (Fig.6)
9. To set the third alarm, press the M button (y). If you press S
button (n), it will be moved on 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 choose the fourth alarm setting, press the M button. (Fig.7)
(Fig.6)
(Fig.7)
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10. To set the fourth alarm, press the M button (y). If you
press S button (n), it will be moved on 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.8)
Note: When the alarm is ringing, press S or M button to
turn off or alarm will turn off automatically after 30 sec.
11. 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.9)
12. To change the “LO alarm setting” press the S button. Fur-
ther press M button to enter the “LO alarm setting” and
nish the meter setting, turn off the meter. (Fig.9)
(Fig.8)
(Fig.9)
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1. Select unit, mg/dL or mmol/l on the back.
2. Plug the Glucode Chip into the connector for strip coding.
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
Unit Selection and Code Setting
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Blood glucose Meter
For in vitro diagnostic
use only
Manufacturer:
Tyson Bioresearch.Inc.
Chu-Nan,Taiwan
Customer Service
Call:+886-37-585998
Tyson ID:T502
S/N:M05B13286
0537
353007
968917
4
RESET
mmol/l mg/dL
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Checking the Performance of Your TysonBio EVOLVE Meter
Coding Your TysonBio EVOLVE Meter
The Glucode Chip is used for checking and coding your TysonBio EVOLVE Meter.
Each batch of Test Strip is encoded with a number that must match one of the code numbers stored in the Meter. In order to ensure an accurate result, the code number on the display must also match the code number found on the Test Strip vial.
To check your Meter:
1. Insert the Glucode Chip into meter’s Glucode Chip
slot. All segments of the LCD display will appear in­dicating that the Meter is functioning properly.
2. If you are a rst time user or start a new strip vial,
please continue the coding procedure.
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1. Insert the Glucode Chip, Conductive Bar’s end rst, 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.
Note: If you are using the Meter for the rst time with-
out inserting the Glucode Chip, a “000” will appear on
the screen and then turn off automatically after 3 sec.
811
3. Match the code number on the Meter display with the code number on the
Test Strip vial. If the code matches, you may press the M button to turn off the meter 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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The Control Solution Test
When To Perform a 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 cor­rectly.
1. When you are using your Blood Glucose Monitoring System for the rst time.
2. When you are using a new batch of Test Strips.
3. Anytime you question the performance of the system, or on a regular basis
to ensure accuracy, e.g. once a week.
4. When you adjust your diabetic medication plans.
5. When your blood glucose test result is lower or higher than your normal level.
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Note: Control Solutions are required but not supplied.
For order information, please call Customer Service. There are three Con­trol Solutions at different desired range of aqueous glucose (Low, Normal or High). For more information about the Control Solution, please read your Control Solution package insert. Two sets of control solution should be used, a high level and a low level control solution of your choice.
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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
rst, into the test port. The Meter will automatically turn on.
3. All segments of the LCD display will appear, a beep will
sound and the code number will appear followed by a ash­ing “ “ symbol. Be sure the code number on the display matches the code number on the Test Strip vial. If the code numbers do not match, code the Meter by using Glucode Chip, accordingly. (Fig.10)
4. After the “ “ symbol appears, press the S button for 3 sec
to switch control solution mode. The “ ctl “ symbol indicates that the Meter will mark your current test as a Control Solu­tion test. Now you are ready to apply the Control Solution. (Fig.11)
To perform a Control Solution test
(Fig.10)
(Fig.11)
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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. 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 5 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
Solutio
n test.
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Comparing Control Solution Results
The system is functioning properly if the result falls inside the specified
range printed on the Test Strip vial. If the test result falls outside the specied
range, repeat the test.
Results falling outside the specied range may be caused by
● Error in performing the test
● Control solution temperature is lower than 15°C(59°F) or higher than
35°C(95°F)
● Expired or contaminated Control Solution
● Expired or contaminated Test Strips
● Improper coding of the Meter
● Meter malfunction
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
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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:
● 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 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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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. A beep will sound and the code number will appear followed
by a ashing “
“ 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 22-23)
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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. Twist and remove the protective lancet cover to expose the sterile needle
tip.
4. Recapping and screwing the endcap to the body of the lancing device.
5. Pull back on the cocking mechanism until it comes to a stop.
6. Place the lancing device rmly against the nger tip and press the release
button.
7. After sampling, remove the endcap containing the used lancet carefully.
8. Remove the lancet from the lancing device. Discard the used lancet prop-
erly in accordance with local, state, and federal law.
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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 lled the Conrmation 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.
Note: To ensure accurate results, make sure the Conrmation Window of the Test Strip is completely lled with your blood sample.
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MS
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3. After the test result appears, if no further tests are performed, the Meter
will automatically shut off after 3 minutes.
After nishing 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.
MS
Warning: Always discharge the used test strip into suitable waste container. Please DO NOT point the test strip at people or animal when ejecting, and avoid pointing at eyes, nose, and mouth while test strip is in load position.
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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
new Test Strip to conrm the result. If the same result oc-
curs, consult your healthcare professional immediately.
(Fig.12)
2. If a “LO” message appears on the display, your 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 Test
Strip to conrm the result. If the same result occurs, con-
sult your healthcare professional immediately. (Fig.13)
(Fig.12)
(Fig.13)
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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. The date and time will appear rst.
2.
Press S button, the result of control solution will appear on
display.*
3.
Press S button, the consecutive 7-day average will be shown.*
4.
Press S button, the consecutive 14-day average will be shown.*
5.
Press S button, the consecutive 30-day average will be shown.*
Note : * If there is no test results during this stage, it will directly appear the most recent test result.
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Exiting the Memory Mode
1. Press the M button to turn off the meter.
2. Meter will shut down automatically after 3 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.
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.
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.
7. Press and release the S button to the end of the memory,
“000” will show. Then press the S button again or press M button at anytime to turn off the meter.
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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
2. Install the software on a computer
Follow the instructions provided with software to install the software.
3. Get ready to transfer test results
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. “PC” will appear on the display, indicating that the meter is in the communication mod
e.
4. Transfer data
Follow the instructions provided in the software to download the results from the meter. After nishing 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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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].
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. Always wash hands with soap and water and rinse and dry completely be-
fore handling the Meter and Test Strips.
4. When cleaning the Meter, gently wipe the exterior surface using a damp
soft cloth. DO NOT USE ANY ORGANIC SOLVENT for cleaning.
5. 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 ac-
cessories into the provided carrying case.
Care and Storage
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DISPLAY WHAT IT MEANS ACTION
Display Messages
System check for verifying that all segments of the Meter are functioning.
This message appears im­mediately if your Meter has not been encoded.
No Action Necessary
Code Meter (see page 22 Coding Your TysonBio EVOLVE Meter)
This is the current code number in use.
This code number should match the code number printed on your Test Strip vial.
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DISPLAY WHAT IT MEANS ACTION
The system is ready to ac­cept a blood sample.
The system is ready to accept a Control Solution sample.
Indicate the result is HIGHER than the “HI alarm setting” of the health management.
You may now apply a
blood sample.
You may now apply a
drop of Control Solution sample.
For your reference or you can change the default setting value 100 mg/dL according to page 20.
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DISPLAY WHAT IT MEANS ACTION
Indicate the result is LOWER than the “LO alarm setting” of the health management.
For your reference or you can change the default set­ting value 70 mg/dL accord­ing to page 20.
Meter detects blood glu­cose level is higher than 600 mg/dL(33.3 mmol/l).
Meter detects blood glu­cose level is lower than 20 mg/dL (1.1 mmol/l).
Indicates high blood glu­cose level. Repeat test. If result still occurs, consult your physician immediately.
Indicates low blood glucose level. Repeat test. If result still occurs, consult your physician immediately.
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DISPLAY WHAT IT MEANS ACTION
Temperature is high during the test procedure.
Result may be larger varia­tion. Move to a cooler envi-
ronment (10 - 40˚C or 50 ­104˚F) and wait 15 minutes
before re-testing.
Temperature is low during the test procedure.
Temperature is too high to perform the test.
Result may be larger varia­tion. Move to a warmer
environment (10 - 40˚C or 50 - 104˚F) and 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.
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DISPLAY WHAT IT MEANS ACTION
Temperature is too low to perform the test.
Repeat the test in a warmer setting (10 - 40°C or 50 ­104°F). Wait 15 minutes before re-testing.
An error message indicat­ing a problem with the Test Strip.
An error message indicat­ing a problem with the Meter.
Review the instructions and try again with a new Test Strip.
Press “reset” button and check the meter again with the Glucode Chip. If the problem persists, contact Customer Service for help.
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DISPLAY WHAT IT MEANS ACTION
Battery power is low. Meter will provide approximately 50 more measurements.
Battery power is too low for further usage.
All testing values recorded in the memory have been shown.
The setting alarm is ring­ing to remind of doing the blood glucose test.
Replace with a new 3-Volt lithium battery (CR-2032).
Replace with a new 3-Volt lithium battery (CR-2032) immediately.
Press M or S button or wait for 3 minutes to turn off the meter.
Press M or S button to shut off or the alarm will turn off automatically after 30 sec.
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DISPLAY
Other problems that may occur ACTION
WHAT IT MEANS ACTION
An error message indicat­ing a problem with the coding of Meter.
The Test Strip has not been inserted into the
Meter properly.
Review the instructions and re-insert the Test
Strip correctly (white side face up).
Replace with a new Test Strip.
Repeat the test with new Test Strip.
Meter will automatically turn-off. Re-insert the
Test Strip to the test port.
Contact Customer Service for help.
Defective Test Strip.
Insufcient blood sample.
Test Strip remains in the test port for more
than 3 minutes prior to testing.
LCD display on the Meter is blank when try-
ing to perform a test.
Check the meter again with the Glucode Chip. If the problem persists, contact Customer Service for help.
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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: 300 most recent results Average: 7/14/30 days average results External Output: Standard RS232 PC interface
Power supply: 3-Volt lithium battery (CR-2032)
Battery Life: Approximately 1000 tests Dimension and Weight: 92 x58 x19 mm ; 60 g
Specications
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■ 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:
Tyson Bioresearch, Inc. 5F. #22, Ke E. Road III, Science-Based Industrial Park Chu-Nan, Taiwan, R.O.C. TEL: +886-37-585998
■ The Lancets are in conformity with the MDD 93/42/EEC.
Manufacturer:
Wuxi Xinda Medical Device Co., Ltd.
No.42 Xixin Road, Zhangjing Town,
Wuxi, Jiangsu,214194,China TEL: +86-510-379-3149
EU authorized representative:
Medical Device Safety Service GmbH Schiffgraben 41, D-30175 Hannover, Germany TEL: +49-511-62628630
EU authorized representative:
EMDAR BV
Ijsselburecht 3, Postbus 5486
6802 EL Arnhem, Netherlands TEL: +31-263-653-375
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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 ngertip, 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 EVOLVE Blood Glucose Monitoring System is designed for in vitro diagnostic use only. Tyson Bioresearch Inc. cannot endorse the performance of the TysonBio EVOLVE System when used with Test Strips other than those designed for the TysonBio EVOLVE Meter. The TysonBio EVOLVE System manufacturer warranty is valid only when used
properly within the guidelines of the provided User’s Manual and is invalid
when the TysonBio EVOLVE System and TysonBio EVOLVE Test Strip are used improperly.
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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 EVOLVE Meter found defective with a new Tyson­Bio EVOLVE Meter.
This warranty does not apply to the performance of a TysonBio EVOLVE 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 EVOLVE Meter or its parts.
For manufacturer warranty services, purchaser must contact Tyson
Bioresearch, Inc. for help.
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Customer Service
If you have any questions or concerns regarding this product and 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 reafrm your results.
Customer Service Hotline:
1-800-948-3894 (U.S.) (24 hours a day)
+886-37-585998
or E-Mail us at
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 efciency.
Page 52
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:B03K106703
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