Holtex TysonBio TB100 User manual

TysonBio TB100
Blood Glucose Monitoring System
Glucomètre TysonBio TB100
User manual
Manuel d’u�lisa�on

Bl ood glucose monitoring system
Code free and Alternate Site Testing - AST available
For in vitro diagnostic use only
Introduction
Thank you for choosing the TysonBio TB100 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 TB100 system has the ability
to process accurate results utilizing only a small volume of blood for in vitro diagnostics.
TysonBio TB100 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.
1
2
GB TysonBio TB100
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 administration of medication based on the TysonBio TB100 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: Please read the entire user manual carefully before using this product
Important information

3
2About the glucometer
Your TysonBio TB100 Blood Glucose Monitoring System is made up of several components.
These instructions are designed to guide you through the operation of the system with detailed
directions and pictures.
our starter kit contains:
•One glucometer
•One vial of test Strips (10)
•One lancing device
•Ten lancets
•One control solution
•One carrying case
•User manual
•Log book
•Quick reference guide
Note: 50 test strip vials can be purchased individually
TysonBio TB100 parts
1.Display –Your test results are displayed here. The large and
easy to read screen guides you through the test by using
numbers and symbols.
2. M Button - The M 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 unit of measurement –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
3
0000
0000
01

TysonBio TB100 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. Temperature message: Appears if your meter is out of operating temperature range.
5. Memory symbol: Indicates memory mode.
6. Units of measurement: Unit of mmol/l or mg/dL will appear with the test
result.
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 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 testing.
12. Day average symbol: Shows the average value of test results.
13. Test result area: Display test results.
4
4

Alternate Site Testing - AST
TysonBio TB100 blood glucose monitoring system provides you with alternative sites for
testing –AST. This system allows you to test samples form the palm and forearm with
equivalent results to finger tip testing.
There are limitationsfor doing AST. Please consult with your healthcare professional before you
do AST.
Alternative site results differ from the 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.
In the following cases use blood from the finger tip rather then from an alternative site if:
•You think your blood glucose Is low.
•You do not regularly have symptoms when your blood glucose is low.
•How you feel does not match the results form the alternative site.
•When you have just taken insulin.
•During or after exercise.
•When there are unknown variables occurring in your day, such as illness.
•Whenever you are about to drive.
About the test strip
The test strip is used to perform in conjunction with the TysonBio TB100.
Each strip can be used only once
The test strip consists of the following parts:
1. Confirmation window: This is where you can confirm 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 up)
About the test strip vial
Vial label
Lot number
Expiry date
Control solution range
6
5
7
5

CAUTION:
Physiological differences in the circulation between the finger and other test sites like the forearm
and the 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 form the forearm and other alternative sites. Rub the alternative 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.
6
Talk to your doctor to see if alternative site blood testing is right for you. With some experience
you can rest your fingertips and test more often by using alternative sites. For people with
diabetes more frequent testing is an advantage. Just remember: any time you want to be sure of
an accurate and up-to-date blood glucose reading, test on a sample from a fingertip.
We strongly recommend you do AST only in the following intervals:
•In a pre-meal or fasting state i.e 2 hours after the previous 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 hyperglycaemia
•Your AST results do not match the way you feel
•You are testing for hyperglycaemia
•Your routine glucose results are often fluctuating
•If you are pregnant

Installing / replacing thebattery
Gently remove the battery cover at the back of the glucometer.
Turn the battery cover and insert one 3-volt lithium battery (CR 2032) with the “+” side facing down
Slide the battery cover back into place with the battery side facing down.
When the battery is low the meter will show a warning signal. When this display appears it is
time to replace the old battery with a new. When the low battery warning signal is shown, the
meter will provide accurate results for approximately 50 more measurements.
,
CR2032
3V
✔
8
7

Setting up the glucometer
First insert a battery and then press the reset button located at the back of the meter
and proceed with the following instructions.
Set date and time
1.Press the Mbutton to enter the date/time mode. Press and release the Sbutton to
choose “24hr” or “12hr” display. With your chosen clock setting, press the Mbutton
and the year setting will appear. Press and release the Sbutton at the correct year
appears. (Fig.1)
2.To enter the correct year and move on to the month, press the M button. To change the
month, press the S button.(Fig.2)
3.To enter the correct month and move on to the day, press the M button. To change the
day, press the S button. (Fig.3)
4.To enter the correct day and move on to the hour setting, press the M button.
5.To change the hour, press the S button. To enter the correct 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 correct minutes and move on to
the alarm setting, press the Mbutton.
9
MEM
Fig.4
8
Fig.3
Fig.2
Fig.1
Fig.5
Fig.6

9
Set the alarm
7.To set the first alarm, press the M button (yes). If you press S button (no), it will be
moved on to health management alarm setting (step 11). To change the hour, press the S
button. To enter the correct 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 second alarm setting, press the M button. (Fig.5)
8.To set the second alarm, press the M button (yes). If you press the S
button (no), it will be moved on to health management alarm setting (step 11). 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 third alarm setting, press the M button. (Fig.6)
9.To set the third alarm, press the M button (yes). If you press S button (no), it
will be moved on to health management alarm setting (step 11). 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 fourth alarm setting, press the M
button. (Fig.7)
Fig.7
Fig.8
Fig.9

10.To set the fourth alarm, press the M button (yes). If you press the S
button (no), it will be moved on to health management alarm setting (step
11).
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 health
management“HI alarm setting” press the M button. (Fig.8)
Note: To stop the alarm, press S or M button. The alarm will turn off
automatically after 30 sec.
11.To change the “HI alarm setting” press the Sbutton. 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. Further press the
M button to enter the “LO alarm setting” and finish the meter setting.
Turn off the meter. (Fig.9)
Unit selection
Select the unit of measurement mmol/L or mg/dL at the
back of the unit. 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.
10
0000000001

11
The control solution is used to check and ensure that the TysonBio TB100 meter and
TysonBio TB100 test strips
are working together properly and that you are performing the test correctly.
When to perform a control solution test
•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.
Note: Control solutions are required but not supplied.
For order information please contact Customer Services.
For more information about the standard control solution,
Please read your control solution package insert.
10 The control solution test
Perform a control solution test
1. Make sure that the control solution is at room temperature (15°C
to 35°C or 59 °F to 95°F) prior to testing.
2. Insert a test strip, white side face up and with the contact bar end
first into the test port. The meter will turn on automatically.
3. System checking. Dotted lines will appear and move clockwise. (Fig. 10)
4. The symbol for blood will start to flash. Press the S button for 3
seconds to switch to control solution mode. The “ ctl “ symbol (Fig. 11)
indicates that the meter will mark your current test as a control solution
test. Now you are ready to apply the control solution.
5. Discard the first drop of solution and squeeze a small drop of control
solution on a clean non-absorbent surface (such as a clean piece of wax
paper). Do not apply the 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.
The solution is automatically pulled into the strip through the tip. Hold
until the meter beeps. The meter will begin to count down from 5 to 1
and the control solution test result will appear.
Caution: Please remember in order to prevent contamination, follow the
above instructions for performing the control solution test.
Fig.10
Fig.11

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 specified range, repeat the test.
Results falling outside the specified 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
•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 contact your point of purchase or contact
the Customer Hotline service. See bottom of
manual for details.
Before testing blood glucose, you need the following items:
1.TysonBio TB100
2.TysonBio TB100 test strip
3.Adjustable automatic lancing device
4.Sterile lancet
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.
11 Testing your blood glucose level
12
•Always use a new test strip. Test strips are for singleuse only.
•Do not get lotion, oil, dirt or debris in or on the lancet and
lancing device.
Preparing the test strip
1.Wash hands using soap and warm water. Rinse and dry
thoroughly.
2.Pull out a test strip from the vial and re-cap the vial
immediately.
3.Insert the test strip, white side face up, into the test port.
4.A beep will sound and white side face up will appear
followed by a flashing “ “ symbol. Now you are ready
to obtain a blood sample.
M E
M

Obtaini ng a blood sample
A SAMPLE MAY BE OBTAINED FROM the FINGER, PALM or FOREARM
For further instructions please see the insert provided with lancing device.
1.Unscrew and remove the end cap 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.Recap and screw the end cap 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 firmly against the finger tip and press the release button.
7.After sampling, remove the end cap containing the used lancet carefully.
8.Remove the lancet from the lancing device. Discard the used lancet properly in accordance
with local regulations.
Warning: Always discharge of the used test strip in a
suitable waste container.
ME
M
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, use a tissue
paper to remove test strip from the meter for proper disposal.
Cod e fr ee Gl ucom e t e r
13
✔
Fig.12
Applying blood sample to the test strip
1.After obtaining a blood sample, place the drop on to 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 (Fig.12)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 confirmation window of the test strip
is completelyfilled with your blood sample.

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 confirm the
result. If the same result occurs, consult your healthcare
professional immediately. (Fig.13)
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 confirm the result. If the same result occurs,
consult your healthcare professional immediately. (Fig.14)
Fig.14
Fig.13
The TysonBio TB100 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 the M button to turn on the meter.
All segments of the LCD display will appear. The date and
time will appear first.
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.*
ME
M
14
12 Memory Features
* If there is no test results during this stage, the most recent test result will appear directly.
6. Press the Sbutton, the most recent test result will appear. If there is a14-day average
result this will show at the bottom of the screen at the same time.
Each time you press the Sbutton, 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 Sbutton to stop the memory, « 000 »will show. Then press the S
button again or press M button at anytime to turn off the meter.

Exiting the Memory mode
1.Press the M button to turn off the meter.
2.The 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 consecutive7/14/30-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.
PC Transfer of test results
Available on request only. Contact the Customer Hotline.
15

DISPLAY WHAT ITMEANS ACTION
No action
necessary.
System check for
verifying that all
segments of the meter
are functioning.
The system is ready to
accept a blood
sample.
The system is ready to
accept a control
solution sample.
Indicates the result is
HIGHER than the “HI
alarm setting” of the
health management.
Indicates the result is
LOWER than the “LO
alarm setting” of the
health management.
You may now apply
a blood sample.
Temperature is high
during the test
procedure.
Result may be larger variation.
Move to a cooler environment
(10 - 40˚C or 50 -104˚F) and wait 15
minutes before re-testing.
13 Display Messages
16
For your reference or you
can change the default
setting value 70 mg/dL
according to page 7.
You may now apply a
control solution
sample.
For your reference or you
can change the default
setting value 100 mg/dL
according to page 7.
Meter detects blood
glucose level is lower than
20mg/dL (1.1 mmol/l)
Indicates low blood glucose
level. Repeat test. If result
still occurs, consult your
physician immediately.
Meter detects blood
glucose level is lower than
600mg/dL (33.3 mmol/l)
Indicates high blood glucose
level. Repeat test. If result still
occurs, consult your physician
immediately.

DISPLAY WHAT ITMEANS ACTION
Temperature is low
during the test
procedure.
Result may be larger variation.
Move to a warmer environment
(10 - 40˚C or 50 -104˚F) and wait
15 minutes before re-testing.
Temperature is too high
to perform the test.
Temperature is too low
to perform the test.
Repeat the test in a
cooler setting (10 - 40°C
or 50 - 104°F). Wait 15
minutes before re-
testing.
Repeat the test in a
warmer setting (10 - 40°C
or 50 - 104°F). Wait 15
minutes before re-testing.
Battery power is low.
Meter will provide
approximately 50
more measurements.
Battery power is too low
for further usage.
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.
All testing values recorded in
the memory have been
shown.
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 test strip. If the
problem persists, contact
Customer Service for help.
17

DISPLAY WHAT ITMEANS ACTION
The setting alarm is ringing
as a reminder to do the
blood glucose test.
The meter is in the
PC communication
mode.
Press M or S button to shut
off or the alarm will turn
off automatically after 30
sec.
Follow the instructions
provided in the software to
download the test results
from the meter.
OTHER PROBLEMS THAT MAY OCCUR ACTION
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).
Defective test strip. Replace with a new test strip.
Insufficient blood sample. Repeat the test with new test strip.
Test strip remains in the
test port for more than 3
minutes prior to testing.
Meter will automatically turn-off. Re-
insert
the test strip into the test port.
LCD display on the meter is blank
when trying to perform a test. Contact Customer Service for help.
18

1. Handle the glucometer with care. Dropping or throwing the meter may cause damage
to the device.
2. Do not expose the meter, test strips or control solution to extreme conditions such as
high humidity, heat, freezing cold or dust.
3. Always wash hands with soap and water and rinse and dry completely before
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 accessories in the provided carrying case.
19
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 recom- mended 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].
14 Care and storage

Limitations of theProcedure
Caution: The TysonBio TB100 is designed for in vitro use only and is not intended to test on newly
borns.
The TysonBio TB100 test strips are designed for use with fresh capillary whole blood samples
obtained from the fingertip, palm and forearm. Falseresults may occur when performing the test
while severely dehydrated, severely hypoten- sive, 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 Glucometer is TysonBio TB100 designed for in vitro diagnostic use only. Tyson
Bioresearch Inc. cannot endorse the performance of the TysonBio TB100 system when used with test
strips other than those designed for the TysonBio TB100 meter. The TysonBio TB100 system
manufacturer warranty is valid only when used properly within the guidelines of the provided User’s
Manual and is invalid when the TysonBio TB100 System and TysonBio TB100 Test Strips
Manufacturer Warranty
Tyson Bioresearch Inc. guarantee that this device will be free of defects in materials and workmanship
for a period of 3 years from the date of original purchase. During stated three-year period, our
company shall repair or replace any TysonBio TB100 Meter found defective with a new TysonBio TB100
Meter. 20
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 μl
Measuring unit: mg/dL or mmol/L
Measuring range: 20-600 mg/dL (1.1-33.3 mmol/L)
The lancing devices and the lancets are in
conformity with the MDD 93/42/EEC
Manufacturer:
Shandong Lianfa Medical Plastic Products Co.,
Ltd No.1 Shuangshan Sanjian Road 250200
Zhangqiu City, Jinan, Shandong, P.R China
EU authorized representative:
Shanghai International Holding
Corp, GmbH (Europe) Eiffestrasse
80, 20537 Hamburg, Germany.
Test time:5sec
Memory capacity: 300 most recent results
Average: 7/14/30 days average results External
output: USB data port
Power supply: 3-Volt lithium battery (CR-2032) Battery
life: Approximately 1000 tests
Dimension and weight: 92 x58 x19 mm; 60 g
The Glucometer TysonBio TB 100, Glucometer Test
Strip and Control Solution are inconformity with the
IVDD 98/79/EC.
Manufacturer:
Tyson Bioresearch, Inc., 5F, #22, Ke E. Road III,
Science-Based Industrial Park, Chu Nan, Taiwan
EU authorized representative: Medical Device
Safety Service GmbH Schiffgraben 41, D-30175
Hannover, Germany