ANKOVO TD-4267TS TD-4267 Blood Glucose Test Strips, High Anti-Interference Strips

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User Manual

This is the main product document for model TD-4267TS.

The file format is pdf, 27 pages, you can download this manual here .

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TD-4267
Blood Glucose Monitoring System
Owner’s Manual
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Dear ANKOVO System Owner:
Thank you for purchasing the ANKOVO Blood Glucose Monitoring
System. This manual provides important information to help you to
use the system properly. Before using this product, please read the
following contents thoroughly and carefully.
Regular monitoring of your blood glucose levels can help you and
your doctor gain better control of your diabetes. Due to its compact
size and easy operation, you can use the ANKOVO Blood Glucose
Monitoring System to easily monitor your blood glucose levels by
yourself anywhere, any time.
If you have other questions regarding this product, please contact
the local customer service or place of purchase.
Intended Use
This system is intended for use outside the body (in vitro diagnostic
use) by people with diabetes at home and by health care
professionals in clinical settings as an aid to monitoring the
effectiveness of diabetes control. It is intended to be used for the
quantitative measurement of glucose (sugar) in fresh capillary whole
blood samples from the finger, palm, forearm and upper arm.
It should not be used for the diagnosis or screening of diabetes.
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Test Principle
Your system measures the amount of glucose in whole blood. The
glucose testing is based on the measurement of electrical current
generated by the reaction of glucose with the reagent of the strip.
The meter measures the current, calculates the glucose level, and
displays the result. The strength of the current produced by the
reaction depends on the amount of glucose in the blood sample.
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IMPORTANT SAFETY PRECAUTIONS
READ BEFORE USE
1.
Use this device ONLY for the intended use described in this manual.
2.
Do NOT use accessories which are not specified by the
manufacturer.
3.
Do NOT use the device if it is not working properly or if it is
damaged.
4.
Do NOT use the equipment in places where aerosol sprays are
being used or where oxygen is being administered.
5.
This device does NOT serve as a cure for any symptoms or
diseases. The data measured is for reference only. Always consult
your doctor to have the results interpreted.
6.
Before using this device to test blood glucose, read all instructions
thoroughly and practice the test. Carry out all the quality control
checks as directed.
7.
Keep the device and testing equipment away from young children.
Small items such as the battery cover, batteries, test strips, lancets
and vial caps are choking hazards.
8.
Use of this instrument in a dry environment, especially if synthetic
materials are present (synthetic clothing, carpets etc.) may cause
damaging static discharges that may cause erroneous results.
9.
Do NOT use this instrument in close proximity to sources of strong
electromagnetic radiation, as these may interfere with the accurate
operation.
10.
Proper maintenance and periodically control solution test are
essential to the longevity of your device. If you are concerned about
your accuracy of measurement, please contact the local customer
service or place of purchase for help.
KEEP THESE INSTRUCTIONS IN A SAFE PLACE
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TABLE OF CONTENTS
BEFORE YOU BEGIN..............................................................................................1
Important Information. ...................................................................1
Meter Overview .............................................................................2
Display Screen ..............................................................................3
Test Strip .......................................................................................4
SETTING THE METER.............................................................................................4
THE FOUR MEASURING MODES ..........................................................................6
QUALITY CONTROL TESTING...............................................................................7
When Should the Control Solution Test be Performed?................7
Performing a Control Solution Test ...............................................7
TESTING WITH BLOOD SAMPLE ..........................................................................9
Preparing the Lancing Device for Blood Testing ...........................9
Preparing the Puncture Site ..........................................................9
Performing a Blood Glucose Test................................................10
Alternative Site Testing ...............................................................12
METER MEMORY ..................................................................................................13
Reviewing Test Results...............................................................13
Reviewing Blood Glucose Day Average Results..............................13
DOWNLOADING RESULTS ONTO A COMPUTER..............................................14
MAINTENANCE .....................................................................................................15
Battery .........................................................................................15
Replacing the Battery ..................................................................15
Caring for Your Meter..................................................................16
Caring for Your Test Strips ..........................................................16
Important Control Solution Information........................................17
MEASUREMENT RESULT READING...................................................................18
Result Readings ..........................................................................18
Reference Values........................................................................18
SYSTEM TROUBLESHOOTING ...........................................................................19
Error Messages ...........................................................................19
Troubleshooting...........................................................................20
SYMBOL INFORMATION ......................................................................................21
SPECIFICATIONS..................................................................................................22
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BEFORE YOU BEGIN
Important Information
Severe dehydration and excessive water loss may cause readings
which are lower than actual values. If you believe you are suffering
from severe dehydration, consult a healthcare professional
immediately.
If your blood glucose results are lower or higher than usual, and
you do not have any symptoms of illness, first repeat the test. If
you have symptoms or continue to get results which are higher or
lower than usual, follow the treatment advice of your healthcare
professional.
Use only fresh whole blood samples to test your blood glucose.
Using other substances will lead to incorrect results.
If you are experiencing symptoms that are inconsistent with your
blood glucose test results and you have followed all the
instructions given in this owner’s manual, contact your healthcare
professional
We do not recommend using this product on severely hypotensive
individuals or patients in shock. Please consult the healthcare
professional before use.
The measurement unit used for indicating the concentration of
blood or plasma glucose can either have a weight dimension (mg/
dL) or a molarity (mmol/L). The approximate calculation rule for
conversion of mg/dL in mmol/L is:
mg/dL
Divided by 18
= mmol/L
mmoL/L
Times 18
= mg/dL
For example:
1) 120 mg/dL ÷ 18 = 6.6 mmol/L
2) 7.2 mmol/L x 18 = 129 mg/dL approximately.
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2
Meter Overview
Test Strip Ejector
Eject the used strip by pushing up this button.
Test Strip Slot
Insert test strip here to turn the meter on for testing.
Display Screen
Main Button (M)
Enter the meter memory and silence a reminder alarm.
No
Up Button (UP)
Down Button (DOWN)
SET Button (S)
Enter and confirm the meter settings.
Battery Compartment
1
2
3
4
5
6
7
8
9
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3
4
12
13
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Display Screen
Test Result Measurement Unit
Error Warning Low Battery Symbol
Face/Low/High Symbol Test Strip Symbol
Measuring Mode
AC – before meal
PC – after meal
Gen – any time of day
Alarm Symbol
Date
Time
Day Average
Memory Symbol
Control Solution Mode
QC – control solution test
Ketone Warning
Blood Drop Symbol
1
2
3
4
5
6
7
8
9
10
11
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4
Test Strip
ATTENTION:
Absorbent Hole
Confirmation Window
Test Strip Handle
Contact Bars
The front side of test strip should face up when inserting test strip.
Test results might be wrong if the contact bar is not fully inserted into the
test slot.
SETTING THE METER
Before using your meter for the first time or if you change the meter
battery, you should check and update these settings.
Entering the Setting Mode (a)
Start with the meter off (no test strip inserted). Press S.
1. Setting the date
The sequence of the date setting is: YEAR MONTH DAY.
With the YEAR / MONTH / DAY flashing in sequence, press UP
or DOWN until the correct year/month/day appears. Press S.
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2
3
4
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2. Setting the time format
Press UP or DOWN to select the desired time format (12h or
24h). Press S.
3. Setting the time
With the HOUR / MINUTE flashing in sequence, press UP or
DOWN until the correct hour/minute appears. Press S.
4. Setting the unit of measurement
Press UP or DOWN to switch between mg/dL and mmol/L.
Press S.
5. Setting the buzzer
With the buzzer displays, press UP or DOWN to switch between
“On” and “OFF”. Press S.
6. Deleting the memory
With “dEL” and “ ” on the display, press UP or DOWN and
select “no” to keep the results in memory then press S to skip.
To delete all the results, press UP or DOWN and select “yes” to
delete all the memory records.
7. Setting the reminder alarm
Your meter has four reminder alarms. The meter will display
“OFF” and ”. If you don’t want to set an alarm, press S to
skip this step. Or press UP or DOWN to select “On”, then press
S.
With the hour/minute flashing in sequence, press UP or DOWN
to select the correct hour/minute. Press S and go to the next
alarm setting.
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NOTICE:
When the alarm beeping: Press M to silence it or press and hold M
to switch it off. Otherwise, it will beep for 2 minutes then switch off.
Congratulations! You have completed all settings!
THE FOUR MEASURING MODES
The meter provides you with four modes for measuring, General,
AC, PC and QC. You can switch between each mode by:
1. Start with the meter switched off. Insert a test strip to turn on the
meter. The screen will display ”, a flashing “ ” and “Gen”.
2. Press M to switch between General, AC, PC and QC mode.
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QUALITY CONTROL TESTING
When Should the Control Solution Test be
Performed?
if it is mandatory following the local regulations in your country,
if you suspect the meter or test strips are not working properly,
if your test results are not consistent with how you feel, or if you
think the results are not accurate,
to practice the testing process, or
if you have dropped or think you may have damaged the meter.
Test strips (c), control solutions (d), lancing device (e) or sterile
lancets (f) may not be included in the kit (please check the contents
on your product box). They can be purchased separately. Please
make sure you have those items needed for a blood glucose test
beforehand.
Performing a Control Solution Test
To perform a control solution test, you will need: (b), (c) and (d).
1. Insert the test strip to turn on the meter
Insert the test strip into the meter. Wait for the meter to display
the “ ” and “ ”.
2. Press M to mark this test as a control solution test
With “QC” displayed, the meter will not store your test result in
memory. If you press M again, the QC” will disappear and this
test is no longer a control solution test.
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3. Apply control solution (g)
Shake the control solution vial thoroughly before use. Squeeze
out the first drop and wipe it off, then squeeze out another drop
and place it on the tip of the vial cap. Hold the meter to move the
absorbent hole of the test strip to touch the drop. Once the
confirmation window fills completely, the meter will begin
counting down.
4. Read and compare the result
After counting down to 0, the control solution test result will
appear on the display. Compare this result with the range printed
on the test strip vial and it should fall within this range. If not,
please read the instructions again and repeat the control
solution test.
Control Solution Range(Normal)
129~175/7.2~9.7
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TESTING WITH BLOOD SAMPLE
Preparing the Lancing Device for Blood Testing
Please follow the instructions in the lancing device insert for
collecting a blood sample.
Preparing the Puncture Site
Stimulating blood perfusion by rubbing the puncture site before
blood extraction has a significant influence on the glucose value
obtained. Blood from a site that has not been rubbed exhibits a
measurably different glucose concentration than blood from the
finger. When the puncture site was rubbed prior to blood extraction,
the difference was significantly reduced.
Please follow the suggestions below before obtaining a drop of
blood:
Wash and dry your hands before starting.
Select the puncture site either at fingertips or another body parts
(please see section “Alternative Site Testing” (AST) on how to
select the appropriate sites).
Rub the puncture site for about 20 seconds before penetration.
Clean the puncture site using cotton moistened with 70% alcohol
and let it air dry.
Use a clear cap (optional) while setting up the lancing device.
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Fingertip testing (h)
Press the lancing device’s tip firmly against the lower side of your
fingertip. Press the release button to prick your finger, then a click
indicates that the puncture is complete.
Blood from sites other than the fingertip (i)
Replace the lancing device cap with the clear cap for AST. Pull the
cocking control back until it clicks. When lancing the forearm,
upper arm, or hand, avoid lancing the areas with obvious veins
because of excessive bleeding.
Performing a Blood Glucose Test
To perform a blood glucose test, you will need: (b), (c), (e) and (f).
1. Insert the test strip to turn on the meter
Wait for the meter to display the “ ” and “ ”.
2. Select the appropriate measuring mode by pressing M.
3. Obtaining a blood sample (j)
Use the pre-set lancing device to puncture the desired site. The
size of the drop should be at least as big as(actual size),
which is 0.5 microliter (μL) of volume. Gently squeeze the
punctured area to obtain another drop of blood. Be careful NOT
to smear the blood sample.
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Apply the sample (k)
Gently apply the drop of blood to the absorbent hole of the test
strip at a tilted angle. Confirmation window should be completely
filled if enough blood sample has been applied. Do NOT remove
your finger until you hear a beep sound.
4. Read Your Result
The result of your blood glucose test will appear after the meter
counts down to 0. The blood glucose result will be stored in the
memory automatically.
5. Eject the used test strip (l)
Eject the test strip by pushing the eject button on the side. Use a
sharp bin to dispose of used test strips. The meter will switch
itself off automatically.
Always follow the instructions in the lancing device insert when
removing the lancet.
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Alternative Site Testing
You can test on a variety of locations on your body.
Important:
There are limitations with AST
(Alternative Site Testing).
Please consult your health care
professional before you perform AST.
When to use AST?
Food, medication, illness, stress and exercise can affect blood
glucose levels. Capillary blood at the fingertip reflects these changes
faster than capillary blood at other sites. Thus, when testing blood
glucose during or immediately after a meal, physical exercise, or any
other event, take a blood sample from your finger only.
We strongly recommend that you perform AST ONLY at the
following times:
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
You are testing for hyperglycemia
Your AST results do not match the way you feel.
Your routine glucose results often fluctuate.
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METER MEMORY
The meter stores the 450 most recent blood glucose test results
along with respective dates and times in its memory. To enter the
meter memory, start with the meter switched off.
Reviewing Test Results
1. Press and release M.
” will appear on the display. Press M again, and the first
reading you see is the last blood glucose result along with date,
time and the measuring mode.
2. Press M to recall the test results stored in the meter each time
you press. After the last test result, press M again and the
meter will be off.
Reviewing Blood Glucose Day Average Results
1. Press and release M. When “ appears on the display, keep
pressing M for 3 seconds until the flashing “ ” appears.
Release M and then your 7-day average result measured in
general mode will appear on the display.
2. Press M to review 14-, 21-, 28-, 60- and 90- day average
results stored in each measuring mode in the order of Gen, AC,
then PC.
3. Exit the meter memory.
Keep pressing the M and the meter will turn off after displaying
the last test result.
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MAINTENANCE
Battery
Your meter comes with one 3V CR2032 lithium battery.
Low Battery Signal
The meter will display one of the messages below to alert you when
the meter power is getting low.
1. The “ ” symbol appears along with display messages: The
meter is functional and the result remains accurate, but it is time
to change the battery.
2. The “ ” symbol appears with E-b, Error and low:
3. The power is not enough to do a test. Please change the
battery immediately.
Replacing the Battery
To replace the battery (m), make sure the meter is turned off.
1. Press the edge of the battery cover and lift it up to remove.
2. Remove the old battery and replace with one 3V CR2032 lithium
battery.
3. Close the battery cover. If the battery is inserted correctly, you
will hear a “beep” afterwards.
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Caring for Your Meter
Cleaning
1. To clean the meter exterior, wipe it with a cloth moistened with
tap water or a mild cleaning agent, then dry the device with a
soft dry cloth. Do NOT rinse with water.
2. Do NOT use organic solvents to clean the meter.
Meter Storage
Storage conditions: -20°C to 60°C (-4°F to 140°F), between 10%
and 93% relative humidity (non-condensing).
Always store or transport the meter in its original storage case.
Avoid dropping and heavy impact.
Avoid direct sunlight and high humidity.
Meter Disposal
The used meter should be treated as contaminated that may carry a
risk of infection during measurement. The batteries in this used
meter should be removed and the meter should be disposed in
accordance with local regulations.
The meter falls outside the scope of the European Directive
2002/96/EC-Directive on waste electrical and electronic equipment
(WEEE).
Caring for Your Test Strips
Storage conditions: 4°C to 40°C (39.2°F to 104°F), between 10%
and 85% relative humidity (non-condensing). Do NOT freeze.
Store your test strips in their original vial only. Do not transfer to
another container.
Store test strip packages in a cool dry place. Keep away from
direct sunlight and heat.
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After removing a test strip from the vial, immediately close the vial
cap tightly.
Touch the test strip with clean and dry hands. Use each test strip
immediately after removing it from the vial.
Write the opening date on the vial label when you first opened it.
Discard remaining test strips after 6 months.
Do not use test strips beyond the expiry date. This may cause
inaccurate results.
Do not bend, cut, or alter a test strip in any way.
Keep the strip vial away from children since the cap and the test
strip may be a choking hazard. If swallowed, promptly see a doctor
for help.
For further information, please refer to the test strip package insert.
Important Control Solution Information
Use only our control solutions with your meter.
Do not use the control solution beyond the expiry date or 3 months
after first opening. Write the opening date on the control solution
vial and discard the remaining solution after 3 months.
It is recommended that the control solution test be done at room
temperature 20°C to 25°C (68°F to 77°F). Make sure your control
solution, meter, and test strips are at this specified temperature
range before testing.
Shake the vial before use, discard the first drop of control solution,
and wipe off the dispenser tip to ensure a pure sample and an
accurate result.
Store the control solution tightly closed at temperatures between
2°C to 30°C (35.6°F to 86°F). Do NOT freeze.
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MEASUREMENT RESULT READING
Result Readings
MESSAGE
WHAT IT MEANS
Lo
< 20 mg/dL (1.1 mmol/L)
LOW
20 to 69 mg/dL(1.1 and 3.8 mmol/L)
AC
PC
Gen
70 to 129 mg/dL
(3.8 to 7.1 mmol/L)
70 to 179 mg/dL
(3.8 to 9.9 mmol/L)
70 to 119 mg/dL
(3.8 to 6.6 mmol/L)
AC
PC
Gen
HIGH
130 to 239 mg/dL
(7.2 to 13.2 mmol/L)
180 to 239 mg/dL
(10 to 13.2 mmol/L)
120 to 239 mg/dL
(6.6 to 13.2 mmol/L)
KETONE?
240 mg/dL (13.3 mmol/L)
Hi
> 600 mg/dL (33.3 mmol/L)
Reference Values
The meter provides you with plasma equivalent results.
Time of day
Normal plasma glucose range for
people without diabetes (mg/dL)
Fasting and before meal
< 100 mg/dL (5.6 mmol/L)
2 hours after meals
< 140 mg/dL (7.8 mmol/L)
Source: American Diabetes Association. Standards of Medical Care in
Diabetes- 2018 Jan; 41(Supplement 1): S1-S2.
Please consult your doctor to determine a target range that
works best for you.
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SYSTEM TROUBLESHOOTING
If you follow the recommended action but the problem persists,
please call your local customer service.
Error Messages
MESSAGE
WHAT IT MEANS
WHAT TO DO
E-b
Appears when the battery
is too low.
Replace the battery immediately.
E-U
Appears when a used
test strip is inserted.
Repeat with a new test strip.
E-t
Appears when ambient
temperature is above or
below system operation
range.
System operation range is 10°C to
40°C (50°F to 104°F). Repeat the
test after the meter and test strip are
in the above temperature range.
E-0
E-A
E-E
E-C
Problem with the meter.
Repeat the test with a new test strip.
If the meter still does not work,
please contact the customer service
for assistance.
E-F
Appears when test strip is
removed while counting
down, or insufficient
blood volume.
Review the instructions and repeat
test with a new strip.
If the problem persists, please
contact the local customer service
for help.
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Troubleshooting
1. If the meter does not display a message after inserting a test
strip:
POSSIBLE CAUSE
WHAT TO DO
Batteries exhausted.
Replace the batteries.
Test strip inserted upside down or
incompletely.
Insert the test strip with contact bars
end first and facing up.
Defective meter or test strips.
Please contact customer services.
2. If the test does not start after applying the sample:
POSSIBLE CAUSE
WHAT TO DO
Insufficient blood sample.
Repeat the test using a new test strip
with larger volume of blood sample.
Defective test strip.
Repeat the test with a new test strip.
Sample applied after automatic
switch-off (3 minutes after last user
action).
Repeat the test with a new test strip.
Apply sample only when flashing ”
appears on the display.
Defective meter.
Please contact customer services.
3. If the control solution testing result is out of range:
POSSIBLE CAUSE
WHAT TO DO
Error in performing the test.
Read instructions thoroughly and
repeat the test again.
Control solution vial was poorly
shaken.
Shake the control solution vigorously
and repeat the test again.
Expired or contaminated control
solution.
Check the expiry date of the control
solution.
Control solution that is too warm
or too cold.
Control solution, meter, and test
strips should be at room temperature
20°C to 25°C (68°F to 77°F) before
testing.
Defective test strip.
Repeat the test with a new test strip.
Meter malfunction.
Please contact customer services.
Improper working of meter and
test strip.
Please contact customer services.
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SYMBOL INFORMATION
SYMBOL
REFERENT
SYMBOL
REFERENT
In vitro diagnostic
medical device
Manufacturer
Consult instructions
for use
Authorized
representative in the
European Community
Temperature limit
Caution
Use-by date
Humidity limitation
Batch code
CE mark
Serial number
RoHS compliance
This device does not belong to household waste and must
be returned to a collection point for recycling electric and
electronic devices according to local laws. If it contains
batteries, the batteries should be removed and disposed in
accordance with locations for separate collection of spent
batteries.
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For self-testing
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Specifications

ANKOVO TD-4267TS Questions and Answers