醫療器材仿單標籤粘貼表

醫療器材仿單標籤粘貼表
產品中文名稱
優瑞血糖測試系統
申請廠商 泰博科技股份有限公司
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、產品說明及注意事項等敘述,最後段須加刊製造
廠名稱、地址及藥商名稱、地址,如有附件、配件請一併列明
※ 仿單標籤等實物過大或印於玻璃金屬容器等不便於黏貼時可將照相影本代替黏貼報核
IMPORTANT SAFETY INSTRUCTIONS
BLOOD GLUCOSE
TD-4265 MONITORING SYSTEM
READ THIS BEFORE USE
Dear U-RIGHT TD-4265 Blood Glucose Monitoring System Owner:
The system consists of three main products: the meter, test strips, and
control solutions. These products have been designed, tested, and proven to
work together as a system to produce accurate blood glucose test results.
Use only U-RIGHT TD-4265 test strips and control solutions with the
U-RIGHT TD-4265 blood glucose meter.
Intended Use
This system is intended for use outside the body (in vitro diagnostic use only).
It is used for the quantitative measurement of glucose in fresh capillary whole
blood samples taken from the palm, forearm, upper arm, calf, thigh, or
fingers. It is not intended for the diagnosis of or screening for diabetes
mellitus, or for use on neonates.
NO
codE
Check your system to be sure that it is unopened prior to use and
that it contains all parts listed above. If there is anything missing or
damaged, please return your system to the place of purchase.
Appearance and Key Functions of the Meter
Test Slot
Is where you insert the test strip.
The meter will turn on
automatically after insertion.
Battery
Replace the
battery
when the
power is
low.
LCD Screen
Guides you through the test using
symbols and simple messages.
Set Button
Is used to set up the meter.
ver 1.0 2010.02
311-4265100-002
USING THE METER MEMORY
Viewing Results on the Meter
Your Meter stores the 150 most recent blood glucose test results with date
and time in its memory. You can review the test results in memory with
these easy steps.
STEP 1 Enter the Memory Mode
With the meter turned off, press the main button twice. The first test
result will appear, indicating that you are in the memory mode. If you
continue to press the main button, you can then review the last 150 results
in the memory.
When using the meter for the first time or
when the results has been deleted, “---” will
appear, showing that there are no test
results in memory.
STEP 2 Recall Test Results
After the last test result, the most recent test result with date and time
appears. Press the main button to review your last 150 test results in order.
When the memory is full, the oldest result is deleted as the newest record
is added.
Main Button
Located in front of the meter is
used to turn on the meter and
enter the memory.
SET
Press and hold the main button for three seconds to turn off the meter.
NOTE
The meter automatically turns off after 120 seconds without
action or you can press and hold the main button for 3 seconds
to turn off the meter.
SETTING THE METER AND DELETING THE MEMORY
Start with the meter off. Then press the set button located on the back.
The meter is now in the setting mode.
STEP 1. Set the Year
The year will appear first, with the year
flashing. Press and release the main button to
add one year. To move faster, press the main
button down longer. With the correct year
on the display, press the set button and the
date will appear on the display with the
month segment flashing.
STEP 2. Set the Month
Press and release the main button until the
correct month appears. To move faster,
press the main button down longer. With
the correct month on the display, press the
set button and the date will flash.
STEP 3. Set the Date
Appears with error
messages.
Indicates a test result
stored in memory.
Unit of Measurement
The unit of measurement
is fixed as mg/dL.
STEP 4. Select 12h or 24h
Your system measures the amount of sugar (glucose) in whole blood. Blood
is applied to the absorbent hole of the test strip and is automatically drawn
into the reaction cell where the reaction takes place.
Modes
Use when
General
(not display)
Any time of day without regard to time since last meal
AC
No food intake for at least 8 hours
PC
2 hours after a meal
QC
Testing with the control solution
STEP 3 Apply Blood Sample
Insert a test strip with contact bars end first and facing up, into the test port.
(Contact bars must be inserted all the way into the meter or you may get an
inaccurate test result.) The meter turns on automatically and displays the
followings in sequence:
LCD full display
→ CHK
→ flashing “ ”
CAUTION
To avoid contaminating the control solution with the content
of the test strip, it is recommended to discard the first drop
and place another drop of control solution on a clean surface
first. Then touch the test strip with the drop.
1. Start with the meter switched off. Insert a test strip to turn on the meter.
The screen will display a flashing blood drop.
While the
symbol appears on the display, press the main button and
“QC” will appear on the display. With the “QC” sign on the display, the
meter will not store your test result in memory. If you decide not to
perform a control solution test, press the main button again, and the “QC”
sign will disappear.
Hold this part to insert the test strip into the slot.
Confirmation Window
Apply a drop of blood here.
The blood will be automatically absorbed.
STEP 5. Set the Hour
Press and release the main button to add
one hour. To move faster, press the main
button down longer. With the correct
hour on the display, press the set button
and the minute will flash.
STEP 6. Set the Minute
Press and release the main button to add
one minute. To move faster, press the
main button down longer. With the
correct minute on the display, press the
set button to enter memory deleting
mode.
Checking the System with Control Solutions
TaiDoc control solutions contain a known amount of glucose that reacts
with test strips. By comparing your control solution test results with the
expected range printed on the test strip vial label, it is able to check that the
meter and the test strips are working together as a system and that you are
performing the test correctly. It is very important that you do this simple
check routinely to make sure you get accurate results.
STEP 1. Obtaining the required cable and installing the
software
To download the Health Care Software System, please visit TaiDoc’s
website at http://www.taidoc.com.
STEP 2. Connecting to a personal computer
Connect the cable to a USB port on your computer. With the meter
switched off, connect the other end of the USB cable to the meter data
port. "PC" will appear on the meter display, indicating that the meter is in
communication mode.
STEP 7. Delete Results And Exit The Setting Mode
With “no” flashing symbol on the display, you can easily delete all the results
in memory by pressing the main button once, the meter will display “yes“.
Press the set button to delete all the results, and “---“ will be displayed. The
meter will then automatically turn off. If you do not want to delete the
results, do not press the main button but press the set button again to turn
off the meter.
STEP 3. Data transmission
To transmit data, follow the instructions provided with the software.
Results will be transmitted with date and time. Remove the cable and the
meter will automatically switch off.
NOTE
While the meter is connecting to the PC, it will be unable to
perform a blood glucose test.
DISPLAY MESSAGES AND PROBLEM-SOLVING GUIDE
NOTE
While the meter is in the setting mode, it will also turn off
automatically after idle for 2 minutes.
DOWNLOADING RESULTS ONTO A COMPUTER
TESTING YOUR BLOOD
Insert the test strip with contact bars end in first and facing up into the test
port. The bars must be fully inserted into the meter for accurate results. The
meter turns on automatically and displays the the blood symbol:
Test Strip Handle
Absorbent Hole
After the meter counts to 0 the control solution test result will appear.
Compare the result with the range printed on the test strip vial. The result
should fall within this range.
STEP 1 Insert Test Strip
Insert this end of the test strip into the meter.
Push it in firmly until it will go no further.
The following is a summary of the display messages. If your meter displays an
error message, please follow the actions for the error message as described
in the table below. If the problem persists, please contact your local
customer service for help.
Message
What it means
Action
This means that the battery Replace the battery
does not have enough power immediately.
for a test.
Inserted a used test strip, or
an electrical problem.
Repeat test with a new test
strip. If the error message
appears again, please contact
the local customer service
for help.
CAUTION
Every time you perform a control solution test, you must enter
“QC” test mode so that the test will not be stored in the meter
memory.
STEP 2 Apply Control Solution
Shake the control solution vial well. Remove the cap from the control
solution bottle. Place cap on a flat surface. Squeeze the bottle, discard the
first drop, and wipe off the dispenser tip to prevent contamination. Squeeze
the bottle again to get another drop and on the top of cap.
Message
What it means
Action
The temperature of the
environment, meter, or
test strip is outside the
system operating range.
You can not perform a
test until the meter and
test strip are within the
operating range of
10°C to 40°C
(50°F to 104°F ).
Repeat the test after the
meter and test strip within
the operating temperatures.
Problem with the meter.
Review the instructions and
try again with a new test
strip. If the problem persists,
please contact the local
customer service for help.
You may have removed
the strip after applying
blood to the absorbent
hole.
LCD full display
→ CHK
→ flashing “ ”
NOTE
If you do not apply a blood sample within 3 minutes, the meter
will turn itself off. You must remove the test strip and insert it
back into the meter to restart the test.
STEP 4 Get Results
Your blood glucose test result will appear
after the meter counts to 0. Blood glucose
test results are automatically stored in the
meter memory.
Turn the meter off by removing the test strip. Discard the used
test strip and lancet carefully according to your local regulations.
WARNING
Please do not change your treatment on the basis of the result
NOTE
without first consulting your health care professional.
STEP 5 Eject the used test strip and remove the lancet
pressing main button.
STEP 2 Select the appropriate measurement mode by
pressing main button.
For selecting the measuring mode of AC, PC, or Gen, please refer to the
“FOUR MEASURING MODES” section.
SYMBOL INFORMATION
Symbol
Referent
In vitro Diagnostic medical device
Do not reuse
Consult instructions for use
Keep away from sunlight
Keep dry
Keep the test strip in the
meter after it has absorbed
blood until the meter
displays the test result.
Repeat test with a new test
strip. If the problem persists,
please contact the local
customer service for help.
Temperature limitation
Use by/ Expiry date
Batch code
Manufacturer
Result is below
measurement limit,
20 mg/dL (1.1 mmol/L).
This indicates hypoglycemia
(low blood glucose.) Please
seek immediate medical
assistance.
Serial number
Result is above
measurement limit,
600 mg/dL (33.3 mmol/L).
This indicates severe
hyperglycemia (high blood
glucose). Please seek
immediate medical
assistance.
Caution, consult accompanying
documents
Authorised representative in the
European Community
Appears when your result
is between 20-69 mg/dL
(1.1 and 3.8 mmol/L) or
greater than 120 mg/dL
(6.6 mmol/L).
It indicates the result is
below or higher reference
range.
CE mark
Appears when your result
is in the reference range
from 70 to 119 mg/dL (3.9
and 6.6 mmol/L).
It indicates the result is fall
within reference range.
For questionable results, please see test strip package insert for important
information.
The blood should completely fill the confirmation window before the
meter begins to count down. If the confirmation window is not filled
completely before the meter begins to count down, do not add more
blood to the test strip. Discard the test strip and try again. If you have
trouble filling the test strip, please call your customer service for help.
STEP 3 Check Results
Be sure to read this section and the test strip package insert found in the test
strip box carefully before testing. Make sure you have all items needed to test.
Contact Bars
This is where you confirm if enough blood
has been applied to the absorbent hole of the strip.
When the “ ” symbol appears on the display, touch the drop of blood
with the absorbent hole of the test strip. Do not push the blood sample
against the test strip or try to apply a smeared sample.
Hold the meter to meet the absorbent hole of the test strip and the drop
will be automatically drawn into the test strip. Make sure the confirmation
window fills completely. The meter begins to count down.
You can switch between each mode by:
2. Press main button to switch between General, AC, PC and QC mode.
Obtain a drop of blood at least 0.5 µL with a lancing device. To obtain
blood from other sites other than the fingertip, use the clear cap provided
and refer to the strip package insert for more details..
STEP 1 Insert Test Strip
The test strip consists of the following parts:
You can use the meter with an USB cable and the Health Care Software
System to view your test results on your personal computer. To learn
more about the Health Care Software System or to obtain a USB cable
separately, please contact local customer services or the place of purchase
for assistance.
After finishing setting 12h or 24h, press the set button and then the hour
will flash on the screen.
The meter provides you with four modes for measuring, General, AC, PC
and QC.
U-RIGHT TD-4265 Test Strips
*To set the time, you must set the date first.
Press and release the main button to select 12h or 24h. It differs in time
presentation format. If you select 12h, AM or PM will be shown together
with the time. If you select 24h, format of time will be from 00:00 to 23:59
without AM or PM.
NOTE
The control solution results are NOT stored in the memory.
Saved results are blood glucose results only.
Error Warning
BATTERY
Press and release the main button until the
correct day appears. To move faster, press
the main button down longer. With the
correct date on the display, press the set
button and the time will appear on the
display with the hour flashing.
STEP 3 Exit The Memory Mode
Appears when the
battery is low.
Memory
Month-Date / Hour-Minute
③ Lancing device with a clear cap
⑥ Control solutions (optional)
Battery Symbol
Flashes when meter is
ready for sample
application.
The standard kit of this system includes:
② Owner’s booklet
⑤ Warranty card
⑧ Carrying case
Face symbol
Blood Drop Symbol
Measuring Mode
PLEASE NOTE
Owner’s Booklet
Test results are displayed here.
This system provides you with plasma equivalent results.
① Meter
④ Lancets
⑦ Test strip
STRIP EJECTION
Test Result Area
How to do a control solution test
The Four Measuring Modes
Meter Display
To eject the test strip, point the strip at a disposal container for sharp
items. The meter will switch itself off automatically after the test strip is
ejected.
Discard the used test strip and lancet carefully according to your local
regulations.
SPECIFICATION
Dimension: 125(L) x 33(W) x 14(H) (mm)
Weight: 39.8g (exclude battery)
Power source: one CR2032 3V lithium battery
(for 300 measurements at least)
Display: LCD
Memory: 150 measurement results with date and time
Auto electrode inserting detection
Auto reaction time count-down
Temperature warning
Operating condition: 10°C~40°C (50°F ~ 104°F), below 85% R.H.
Storage/Transportation condition: -20°C~ 60°C (-4°F~140°F ),
below 95% R.H.
Measurement Units: mg/dL
Measurement Range: 20~600 mg/dL (1.1~33.3 mmol/L)
When battery is low, you can still do 50 tests at most.
The device has been tested to meet the electrical and safety
requirements of:
IEC/EN 61010-1, IEC/EN 61010-2-101, EN 61326.
CARING FOR YOUR METER
To avoid the monitor and test strips getting dirt, dust or other contaminants,
wash and dry your hands thoroughly before use.
Cleaning
1. To clean the monitor, wipe the surface with a clean cloth dampened with
clean water, then dry the device thoroughly with a soft dry cloth. Ensure that
neither water nor the detergent solution enters the test slot or the battery
compartment. Do NOT rinse under water.
2. Do NOT use organic solvents to clean the monitor.
Do not use if package is damaged
3M
Use within 3 months after opening
Sterilised using irradiation
TaiDoc Technology Corporation
3F, 5F, No.127, Wugong 2nd Rd., Wugu Dist.,
New Taipei City 248, Taiwan
www.taidoc.com
MedNet GmbH
Borkstrasse 10, 48163 Muenster - Germany
Tel:+49 251 322660 Fax:+49 251 3226622
For self-testing
312-4265100-001
Strip Appearance
TD-4265
1
2
Test Strip
Warnings
3
► For in vitro diagnostic use (for use outside of the body only).
► For single use only.
► Healthcare professionals and other users testing multiple patients with this system should handle
everything that has comes into contact with human blood carefully to prevent transmitting infectious
diseases, including sanitized objects.
► Please read this sheet and your Blood Glucose Monitoring System Owner’s Booklet before you use this
test strip. Use only U-RIGHT TD-4265 Test Strips with U-RIGHT TD-4265 Blood Glucose Monitoring System
to obtain accurate results, and be covered by the manufacturer’s warranty.
► Results may be inaccurate when testing on patients with abnormally low blood pressure or those who are
in shock.
► Low results may be inaccurate when testing on patients in hyperglycemic-hyperosmolar state, with or
without ketosis.
► Please do not use this Blood Glucose Monitoring System on critically ill patients.
► Keep test strips and lancets away from small children. If swallowed, consult a doctor immediately for
advice.
Intended Use
4
Chemical Components
1. Absorbent Hole
Apply a drop of blood here. The blood will be automatically absorbed.
2. Confirmation Window
This is where you confirm if enough blood has been drawn into the absorbent
hole of the strip.
3. Test Strip Handle
Hold this part to insert the test strip into the slot.
4. Contact Bars
Insert this end of the test strip into the meter. Push it in firmly until it will go
no further.
ATTENTION
Test results might be wrong if
the contact bar is not fully
inserted into the test slot.
The front side of the test strip
should face up when inserting
the test strip.
Front
Back
Testing Your Blood Glucose
PLEASE WASH AND DRY YOUR HANDS BEFORE PERFORMING ANY TESTS.
STEP 1
Insert the test strip fully into the slot of the meter until it will go no further.
When the strip is fully inserted, the meter will do several self-checks.
U-RIGHT TD-4265 test strips, when used together with U-RIGHT TD-4265 Blood Glucose Monitoring System,
allow your blood glucose levels to be measured by yourself at home or by healthcare professionals. It uses
fresh whole blood samples from the finger, and the following areas: the palm, forearm, upper arm, calf and
thigh. This system is not intended for use in the diagnosis or screening of diabetes mellitus.
> Glucose oxidase (A. Niger)
> Electron shuttle
> Enzyme protector
> Non-reactive ingredients
13%
39%
6%
42%
Performance Characteristics
Diabetes experts have suggested that glucose meters should be within 15 mg/dL of the reference method
when the glucose concentration is lower than 75 mg/dL, and be within 20% of the reference method when
the glucose concentration is 75 mg/dL or higher. The table below displays how often U-RIGHT TD-4265
achieves this target. The chart is based on a study carried out on 120 patients to see how well U-RIGHT
TD-4265 performed compared to reference method results.
For glucose results < 75 mg/dL (4.2 mmol/L), the percentage (number) of U-RIGHT
TD-4265 results that were within 15 mg/dL (0.83 mmol/L) of the reference method.
100%
(17/17)
For glucose results ≥ 75 mg/dL (4.2 mmol/L), the percentage (number) of U-RIGHT
TD-4265 results were within 20% of the reference method.
100%
(103/103)
*Acceptance criteria in ISO 15197: 95% of all differences should be within ±15 mg/dL (0.83 mmol/L)
for glucose concentration < 75 mg/dL (4.2 mmol/L), and within 20% for glucose concentration ≥ 75
mg/dL (4.2 mmol/L).
Note: When meter results are compared to the laboratory results, results below 75 mg/dL are
compared in mg/dL.
Precision
The CV (%) is less than 5% both in intermediate precision and repeatability.
Symbol Information
About Alternative Site Testing (AST)
STEP 2
Collect a blood sample with the test strip. A sufficient quantity of blood is
required for the test to provide accurate results. Touch the blood drop with
the absorbent hole of the test strip, and wait until the confirmation window is
fully covered. Do NOT apply a smeared blood sample. The meter will start
counting down.
IMPORTANT: There are limitations for performing AST. Please consult your doctor before you perform AST.
Alternative site testing (AST) is when individuals check their blood glucose levels using areas of the body
other than the fingertip. The U-RIGHT TD-4265 test strips allow AST to be performed on sites other than the
fingertip including the palm, forearm, upper-arm, calf, and thigh. We strongly recommend that you perform
AST ONLY at the following times:
■ During 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 may not notice if you are hypoglycemic.
■ Your AST results are inconsistent with the way you feel.
■ You are testing for hyperglycemia.
■ Your routine glucose results often fluctuate.
To obtain a blood sample from the alternative sites, please rub the puncture site for approximately 20
seconds.
STEP 3
After a few seconds, the meter will display your blood glucose level. The last
reading will be automatically saved in the meter. Turn it off by removing the
test strip and throw away the used test strip.
Please refer to your Owner’s Booklet for more information.
The used lancet and test strip are potentially biohazardous. Please dispose of them carefully according to
your local regulations.
Symbol
Referent
Symbol
Referent
For in vitro diagnostic use only
Manufacturer
Do not reuse
Serial number
Read instructions before use
Caution, consult accompanying
documents
Keep away from sunlight
Authorized representative in
the European Community
Keep dry
CE mark
Temperature limitation
Do not use if package is
damaged
Use by
Batch code
3M
Use within 3 months after
opening
Sterilized using irradiation
Reading Your Result
Limitations
► Hematocrit: The hematocrit level is limited to between 20% and 60%. Please ask your healthcare
professional if you do not know your hematocrit level.
► Neonatal Use: This test strip must not be used for the testing of newborns.
► Metabolites: Dopamine, L-Dopa, methyldopa, uric acid, ascorbic acid, and acetaminophen at normal
blood concentration do not significantly affect blood glucose test results.
► Lipemic Effects: Blood triglycerides up to 2000 mg/dL (22.8 mmol/L) do not affect the results
significantly, but may affect results at higher levels.
► Altitude Effects: Altitudes up to 10,742 feet (3,275m) do not affect test results.
Storage and Handling
IMPORTANT: Do not use the test strips if they have expired.
► Test strips expire 3 months after first opening. Write the first opening date on the test strip vial when you
first opened it.
► Store the test strips in a cool, dry place between 4° C and 40° C (39.2° F and 104° F) and below 85%
relative humidity.
► Keep the test strips away from direct sunlight. Do not store the test strips in high humidity.
► Store the test strips in their original vial ONLY. Do not transfer them to a new vial or any other containers.
► Do not touch the test strips with wet hands.
► Use each test strip immediately after taking it out of the vial. Close the vial immediately after taking out a
strip.
► Keep the vial closed at all times.
► Do not bend, cut, or alter the test strip.
Your blood glucose readings deliver plasma equivalent results and are displayed in milligrams of glucose per
deciliter of blood (mg/dL).
Reference values
Time of day
Normal plasma glucose range for people without diabetes
Fasting and before meal
Less than 100 mg/dL (5.6 mmol/L)
2 hours after meals
Less than 140 mg/dL (7.8 mmol/L)
Source: American Diabetes Association (2008). Clinical Practice Recommendations.
Diabetes Care, 31 (Supplement 1): S1-108.
Please consult your doctor to determine a target range that works best for you.
Questionable or inconsistent results
If your test results are unusual or inconsistent with how you are feeling:
■ Make sure the confirmation window of the test strip is completely filled with blood.
■ Check the expiration date of the test strips.
■ Check the performance of your meter and test strip with the control solutions.
PLEASE NOTE: Unusually high or low blood glucose levels may be symptoms of a serious medical condition.
If most of your results are unusually high or low, please contact your healthcare professional.
Quality Control Testing
IMPORTANT: The reference range of the control solutions may vary with each new vial of test strips. Make
sure you check the range on the label of your current vial. For more information, please see the control
solution insert.
Our TaiDoc control solutions contain a known amount of glucose that can react with test strips. You can
check the performance of the meter, test strip and your technique by comparing the control solution results
with the range printed on the label of test strip vial. Checking regularly can ensure your test results are
accurate. Please refer to the Owner's Booklet for complete testing instructions.
TaiDoc Technology Corporation
3F, 5F, No.127, Wugong 2nd Rd., Wugu Dist.,
New Taipei City 248, Taiwan
www.taidoc.com
MedNet GmbH
Borkstrasse 10, 48163 Muenster – Germany
Tel:+49 251 322660 Fax:+49 251 3226622
Use Only With U-RIGHT TD-4265
Blood Glucose Monitoring System
40°C
4°C
ver 1.0
For self-testing
2009/12