TD GLUCO TD-4277B User manual

BLOOD SUGAR CONTROL SYSTEM
User Manual
TD-4277B version 2.0 2016/03
HT102015B-01G
311-4277200-002

TD-GLUCO Bluetooth (TD-4277B)
Thank you for purchasing the TD-GLUCO Bluetooth blood sugar control system.
This manual contains important information on the correct use of the system.
Please read it carefully and in full before using the product.
Regularly checking your blood sugar levels can help both you and your doctor
improve the control of your diabetes. Thanks to the small size and easy-to-use
functions, you can use the TD-GLUCO Bluetooth blood sugar control system to easily
measure your blood sugar levels, wherever and whenever you want.
Should you have any further queries after reading this manual, please contact your
local customer support or your distributor.
Use
This system is intended for exterior use (in vitro diagnostic use) in a non-clinical
environment by persons with diabetes and in a clinical environment by healthcare
professionals as an aid for assessing the effectivity of a person's diabetes treatment.
It is intended to quantitatively measure blood sugar (glucose) in fresh whole blood
(drawn from a nger, palm, lower arm or upper arm).
This meter is not designed to diagnose and screen for diabetes or to test newly born
babies.
Professionals can use the meter to test both capillary and venous blood samples.
Only capillary whole blood samples can be tested at home.
2 3

IMPORTANT SAFETY INSTRUCTIONS
READ BEFORE USING
INHOUD
1. ONLY use the device for the purposes stated in this manual.
2. Do not use ANY accessories not specied by the manufacturer.
3. Do NOT use the device if it is malfunctioning or damaged.
4. NEVER use the device on newly born babies or young children.
5. This device is NOT designed to treat given symptoms or diseases. The measured data
serve solely as reference values.Always consult your GP for the proper interpretation of
the results.
6. Read all the instructions carefully and practice the procedure a number of times before
actually testing your blood sugar with the device. Perform all quality checks in
accordance with the instructions.
7. Keep the device and testing equipment out of reach of young children. Small parts,
such as the battery cover, the batteries,test strips, lancets and caps are a potential
choking hazard.
8. Use the meter in a dry environment, especially if synthetic materials are present
(such as synthetic clothing or carpeting), which can cause a static charge that could
mean incorrect results.
9. Do NOT use the meter near sources of strong electromagnetic currents, as the accuracy
of the measurement could be affected.
10. Proper maintenance is essential to the operating life of your device.If you are
worried about the accuracy of your measurements, contact local customer support or
your distributor for support.
KEEP THESE INSTRUCTIONS IN A SAFE PLACE
BEFORE YOU START 07
Important information 07
Meter overview 08
Display 09
Test strip 09
SETTING UP THE METER 10
THE FOUR MEASURING MODES 11
QUALITY CONTROL TEST 12
Testing using a control solution 12
Performing a test with the control solution 12
TESTING USING BLOOD SAMPLES 14
Preparing the lancing device for a blood test 14
Preparing the puncture point 14
Performing a blood sugar test 15
METER MEMORY 17
Viewing the test results 17
Viewing the average of blood sugar results over a number of days 17
CONNECTING THE DEVICE TO YOUR SMARTPHONE 18
MAINTENANCE 20
Battery 20
Caring for your meter 21
Caring for your test strips 21
Important information on the control solution 22
TROUBLESHOOTING SYSTEM ISSUES 23
Result readings 23
Error messages 23
Troubleshooting 24
DETAILED INFORMATION 25
INFORMATION ON SYMBOLS 25
SPECIFICATIONS 26
4 5

BEFORE YOU START
Important information
• Extreme dehydration and excessive moisture-loss can lead to results being
measured that are below the actual levels. If you suspect you are suffering from
extreme hydration, contact your GP immediately.
• If your blood sugar levels are lower or higher than normal and you are not
displaying any symptoms of being ill, then repeat the test. If you are displaying
symptoms or if you continue to receive results that are lower or higher than normal,
then contact your GP and follow their advice.
• Only use fresh whole blood samples for testing your blood sugar levels. Using any
other substances will produce incorrect results.
• If you are displaying symptoms that do not match the blood sugar test results and if
you have followed all the instructions in this manual, then please contact your
healthcare professional.
• We do not recommend that this device be used by persons with very low blood
pressure or those in a state of shock. Contact your GP before use.
* Control solution is not included in the starter pack.
6 7
*

Meter overview
1Ejecting a test strip
Eject a test strip by pushing this button upwards.
2Display
3Main button (M)
Open the meter memory and turn reminder notications on/off.
4Test strip slot and strip indicator light
Insert the test strip into this slot to activate the meter for a test.
5Bluetooth indicator
6SET button (S)
Input the meter settings and conrm them.
7Battery compartment
PLEASE NOTE:
The front of the test strip must be facing upwards when
you insert the test strip. The test results could be incorrect if
the contact point is not fully inserted into the test slot.
NOTE:
The TD-GLUCO Bluetooth meter may only be used with TD-GLUCO TD-4360
test strips. Using other test strips with this meter could produce inaccurate results.
Display
1Test result
2Ketone warning
3Error warning
4Memory symbol
5Control solution mode
QC (quality control) – testing with
the control solution
6Measuring mode
AC – before meals
PC – after meals
Gen – at any time
7Date
8Time
9Average over a number of days
10 Alarm symbol
Teststrip
11 Measurement unit
12 Low battery warning
13 Test strip symbol
14 Blooddrop symbol
1Absorbent opening
2Control window
3Test strip grip
4Contact points
Top
Left Front Right Back
8 9

SETTING UP THE METER When the hours/minutes are ashing, press M to select the hour/minutes. Then press S
and continue to the next reminder setting.
PLEASE NOTE:
When the reminder notication goes off, press Mto switch it off; hold Mdown to turn
the reminder off. If you don't, the reminder will sound for 2 minutes and then switch off
automatically.
Congratulations! Your device is now [properly set up!
NOTE:
• These parameters can ONLY be changed in the setup mode.
• If the meter is not used for a period of 5 minutes when in setup mode,
it turns off automatically
THE FOUR MEASURING MODES
There are four different ways to measure your blood sugar levels: General, AC (before
meals), PC (after meals) and QC (quality control). You can switch between the different
modes as follows:
1. Start with the meter switched off. Insert a test strip into the slot to turn the meter on.
The display shows a ashing " " and "Gen".
2. Press Mto switch between the General,AC, PC and QC modes.
Before using your meter for the rst time or whenever you replace the battery,
check and adjust the following settings.
Launching the setup mode (a)
Start with the meter switched off (no test strip inserted).
Press the button marked Sbeside the batteries.
1. Setting the date
The sequence for setting the date is YEAR ➞MONTH ➞DAY. When YEAR/MONTH/DAY
are ashing consecutively, press the button marked M until the correct year/month/day
are displayed. Next, press S.
2. Setting the time format
Press the main button Mon the front of the meter to select the required time format
– 12 or 24 hours. Then press S.
3. Setting the time
When HOUR/MINUTE are ashing consecutively, press the button marked Muntil the
correct time is displayed.Then press S.
4. Turning sound effects on/off
To turn sound effects on or off, press Mto switch between "On" and "Off".Then press S.
5. Setting reminder notications
Your meter has four reminder settings.The meter displays "OFF" and " ". If you do
not want reminders, press Sto skip this step. Otherwise press Mto select "On" and then
press S.
10 11

This test using control solution is not required when rst using the TD-GLUCO
Bluetooth blood sugar control system.
Performing a test with the control solution
When should you perform a test with control solution?
• When you think that either the meter or the test strips are defective.
• When your test results do not match the way you are feeling, or when you believe
the results are not accurate.
• When practicing the test procedure.
• If you have dropped the meter or have reason to believe it is damaged.
Test strips (c), control solution (d), lancing device (e) or sterile lancets (f) might not be
included in the kit (please check the list of contents on your product's packaging). These
articles can be ordered separately.
Performing a test with the control solution.
In order to perform a test with the control solution, you will need (b), (c) and (d).
1. Insert the test strip into the meter to activate it.
Wait until the meter displays " " and a ashing " ".
2. Apply the control solution (g)
Shake the bottle of control solution well before use. Squeeze out the rst droplet and
wipe it off. Squeeze another droplet onto the point of the bottle's cap. Hold the meter so
that the absorbent opening of the test strip comes into contact with the drop and absorbs
the control solution. Once the test strip's control window contains sufcient control
solution, the meter starts an automatic countdown.
QUALITY CONTROL TEST
12 13
3. Reading and comparing the results
Once the countdown to 0is completed, the result of the test using control solution is shown
on the display. Compare the result with the range stated on the test strip packaging.
The result must be within this range of values. If that is not the case, re-read the instructions
and repeat the test with control solution.
NOTE:
• The range for the control solution that is stated on the test strip tube is only valid
when control solution is used. It is not a recommended range for your blood
sugar levels.
• See the section under MAINTENANCE for important information concerning
the control solution
WARNING:
When you perform a test using control solution mark it as such so that the test result
is NOT confused with the blood sugar TEST RESULTS in the device's memory. If you
do not do this the blood sugar test results will be mixed up with the test results in
the device's memory.

NOTE
• Every time you test, use a different puncture point. Repeatedly puncturing the
same point can cause a sore to form and callousing.
• We recommend that you wipe away the rst blooddrop, as it could contain tissue
uid that will affect the test results.
Performing a blood sugar test
In order to test your blood sugar levels, you require the following: (b), (c), (e) and (f)
1. Insert a test strip in order to activate the meter
Wait until " " and " " are displayed.
2. Select the required mode by pressing M
3. Taking a blood sample (j)
Use the pre-set lancing device to puncture your skin at the selected point. We
recommend that you wipe away the rst blooddrop with a clean cotton swab. The
size of the blooddrop must be at least as large as (actual size), which equals around
0.5 microliter (µI) volume. Carefully squeeze the area around the puncture point to
draw a further blooddrop.Take care NOT to smear out the blood sample.
4. Applying the sample (k)
Carefully allow the blooddrop to come into contact with the absorbent opening of
the test strip at an angle. The test strip's control window must be completely full
when enough blood is applied. Do NOT take your nger away before the device
beeps.
WARNING:
In order to limit the chance of an infection:
• Never share a lancet or lancing device with others.
• Always use a new sterile lancet. Lancets are single-use only.
• Ensure that you do not get any hand lotion, oil or residual dirt in or on the lancets
or lancing device.
.
Preparing the lancing device for a blood test
Follow the instructions on the package insert of the lancing device for drawing
a blood sample.
Preparing the puncture point
Stimulating blood perfusion by rubbing the puncture point before taking a sample has a
major impact upon the obtained blood sugar levels.
We recommend that you perform the following steps before drawing
a drop of blood:
• Wash and dry your hands before starting.
• Clean the puncture point with a cotton swab moistened with a 70% alcohol solution
and allow your skin to air-dry.
• Rub the puncture point for around 20 seconds before inserting the lancet.
• Use a clean cap (included in the kit) when setting the lancing device
• Testing using a ngertip (h)
Firmly press the lancing device against the underneath part of your ngertip.
Press the release button to puncture your nger and the device will click when
the procedure is complete.
TESTING USING BLOOD SAMPLES
14 15

NOTE:
• Do not press the puncture point against the test strip and try not to smear the blood.
• If you do not apply a blood sample to the test strip within 5 minutes the meter
switches off automatically.Should this happen,remove the test strip and re-insert it
in order to start a new test.
• The control window must be lled with blood before the meter automatically starts
to countdown. NEVER try to add more blood to the test strip once the blooddrop
has been absorbed. Dispose of the test strip, insert a new test strip and repeat
the test.
• If you struggle to ll the control window, please contact your healthcare professional
or local customer support for assistance.
5. Reading the results
The blood sugar test results will be displayed once the meter has counted down to 0.
The blood sugar value is automatically stored in the device's memory.
6. Eject the used test strip (L)
Eject the test strip by pressing the ejector button on the side of the device. Use a
specially designated waste container for disposing of the used test strips. The meter
switches off automatically.
Always follow the instructions on the lancing device's package insert for disposing
of the used lancet.
NOTE:
Used test strips and lancets could pose a biological hazard. Dispose of them properly
in accordance with the local regulations.
16 17
The meter stores the 1,000 most recent blood sugar test results together with their dates
and times. In order to access these records, start with the device turned off.
Viewing the test results
1. Press and release M.
" "will appear on the display. Press M again, the rst measurement displayed is
the most recent blood sugar result, together with the date, time and meter mode.
2. Press Mto call up the test results stored in the meter each time you press the
button. After the nal result, press Mand the meter switches off.
Viewing the average of blood sugar results over
a number of days
1. Press and release M. When " " appears on the display, keep the Mbutton
depressed for 3 seconds until the ashing "DAY AVG" (average over a number of
days) appears. Release M; your averaged results over 7 days, as measured in Gen
mode, appear on the display.
2. Press Mto view the average results over 14, 21, 28, 60 and 90 days, as stored
in each meter mode under Gen, AC and nally PC.
3. Shutting down the meter's memory. Press Mrepeatedly; the meter switches off
after displaying the most recent test results.
NOTE:
• If you want to turn the memory off, keep the Mbutton depressed for 5 seconds or
leave the meter alone for 3 minutes, after which it automatically switches off.
• The results of tests using control solution are NOT included in the average daily
results.
METER MEMORY

Creating a data link using Bluetooth® (Bluetooth® can be optionally switched
on or off)
Using Bluetooth®, you can create a data link between your meter and a Bluetooth®-
enabled smartphone (iOS or Android). Download the GlucoCheck app to your
smartphone from the App Store or from Google Play (iOS or Android).The GlucoCheck
app has been created to assist you simply and intuitively in monitoring your blood sugar
and ketone levels over an extended period. For further information, please contact your
local customer support or distributor.You must link your meter and smartphone using
Bluetooth® before you can transmit data.
Linking your meter and smartphone (using a security code)
1. Turn on Bluetooth® on your smartphone.
2. Follow the instructions in the GlucoCheck app on your smartphone for connecting
to your meter.
3. Use "Search" to nd your meter, which is called Ht One TD Gluco xxxx (xxxx = the
unique four-digit/letter combination of the Bluetooth® MAC associated with
your meter).
4. Add your meter,press and press "Yes" to save the settings.
5. Once the devices are linked, the data in your meter will be sent via Bluetooth®
to the GlucoCheck app.
CONNECTING TO A SMARTPHONE
18 19
Bluetooth® indicator on your meter:
WARNING:
• The meter cannot perform a test while it is transmitting data.
• Ensure that your smartphone supports Bluetooth® smart technology and that
Bluetooth® is activated before trying to transmit data.Also make sure that your
meter and smartphone are sufciently close together so that they can connect.
For the required parameters for your (mobile) operating system, check the App
Store or Google Play before downloading and installing the app.
• Bluetooth® functionality is implemented in various ways by different
manufacturers.This could mean that there are compatibility issues between your
smartphone and meter.
For further information, see ht-one.nl/support
BLUETOOTH®
INDICATOR
STATUS
Solid blue
Flashing
blue
Bluetooth® is on
and waiting for a
connection
Bluetooth®
linked

Caring for your meter
Cleaning the meter
• To clean the exterior of the meter, wipe it off with a cloth that has been lightly
dampened with tap water or a mild detergent, then dry it using a soft and dry cloth.
DO NOT rinse off with water.
• DO NOT use organic solvents to clean the meter.
Storing the meter
• Storage conditions: -20 °C to 60 °C (-4 °F to 140 °F), and under
95% relative humidity.
• Always store or transport the meter in its original case.
• Do not drop the meter or subject it to strong shocks.
• Keep it out of direct sunlight and high humidity levels.
Disposing of your meter
A used meter must be treated as contaminated waste that carries a risk of infection while
performing measurements.The batteries of the meter must be removed and the meter
must be disposed of in accordance with the local regulations.
The meter does not fall under European Directive 2002/96/EC on waste electrical and
electronic equipment (WEEE).
Caring for your test strips
• Storage conditions: 20 °C to 32 °C (35.6 °F tot 89.6 °F), and under 85% relative
humidity. DO NOT freeze.
• Keep the tests strips in their original tube. Do not place in a different tube.
• Store the packaging containing the test strips in a cool and dry place.
Keep away from direct sunlight and heat.
• Reseal the tube immediately after removing a test strip.
• Ensure that your hands are clean and dry before touching a test strip.
Battery
Your meter comes with two 1.5 V AAA alkaline batteries.
Low battery warning
The meter will warn you in one of the following ways when it is low on power.
1. The symbol " " appears together with notications on the display: the meter is
working and the results are still accurate, but the batteries must be replaced.
2. The symbol " " appears with E-b, Error and Low: there is not enough power to
perform a test. The batteries must be replaced immediately.
Replacing the batteries (m)
The meter must be switched off when you replace the batteries.
1. Press the rim of the battery cover and lift it out.
2. Remove the empty batteries and replace them with two new 1.5 V AAA
alkaline batteries.
3. Close the battery cover. If the batteries are correctly inserted, the device will beep.
NOTE
• Replacing the battery will not affect the test results stored in the device's memory.
• As with all small batteries, the batteries must be kept out of reach of children.
Alert the emergency services immediately if a battery is swallowed.
• Batteries can leak chemicals if they are not used for extended periods.
Remove the batteries if you will not be using the device for a lengthy period
(i.e. 3 months or more).
• Dispose of used batteries properly, in accordance with the local regulations.
MAINTENANCE
20 21

• Use a test strip immediately after removing it from the tube.
• On the label, write the date you rst opened the tube. Dispose of any remaining test
strips after 3 months.
• Do not use a test strip after its expiry date, as the result may be inaccurate.
• Do not bend, cut or alter the blood sugar test strip.
• Keep tubes and foil packaging containing test strips out of reach of children, as the
cap and test strips could be a choking hazard. Immediately alert the emergency
services if any part is swallowed.
For further information, see the test strips package insert.
Important information on the control solution
• Only use our control solution for your meter.
• Do not use the control solution after its expiry date or more than 3 months after
opening it. Write the date you opened it on the control solution bottle and dispose
of any remaining solution after 3 months.
• The recommended room temperature when performing a test with the control
solution is between 20 °C and 25 °C (68 °F and 77 °F). Ensure that the control
solution, your meter and the test strips are at the recommended temperature
before conducting a test.
• Shake the control solution well before use. Discard the rst droplet of control
solution and wipe the dispensing tip clean in order to guarantee a pure sample
and accurate result.
• Keep the control solution properly sealed at a temperature between 2 °C and 30 °C
(35.6 °F and 86 °F). DO NOT freeze.
If you perform the recommended action but the issue continues, please call your local
customer support services.
TROUBLESHOOTING SYSTEM ISSUES
Reading the results
MESSAGE WHAT IT MEANS
or 1,6 mmol/L 1.6 mmol/L (29 mg/dL)
KETONE? 13.3 mmol/L (240 mg/dL)
> 33.3 mmol/L (600 mg/dL)
Foutmeldingen
MESSAGE WHAT IT MEANS ACTION
22 23
* See the user instructions (video) at ht-one.nl/support or read the procedure to be followed
E-b
E-U
E-t
E-F
E-0,
E-A,
E-C,
E-E
Appears when the batteries are
almost drained.
Appears when a used test strip
is inserted or a test strip is
incorrectly used *
Appears when the temperature
is higher or lower than the
system's operating range.
Appears when the test strip is
removed during the countdown
or when there is not enough
blood present.
There is a problem with the
meter.
Immediately replace the batteries.
Repeat the test with a new test strip.
The system's operating range is
between 10 °C and 40 °C (50 °F and
104 °F). Repeat the test when the
meter and test strip are within that
range.
Read the instructions and repeat the
test using a new test strip. If the issue
continues, contact your local customer
support for assistance.
Repeat the test using a new test strip.
If the meter continues to malfunction,
contact your local customer support for
assistance.

POSSIBLE CAUSE ACTION
Troubleshooting other issues
1. If nothing is displayed on the meter after a test strip is inserted:
Time of day
Before meals on an empty stomach
2 hours after meals
Normal plasma glucose range for
nondiabetics (mg/dL)
< 5.6 mmol/L (100 mg/dL)
< 7.8 mmol/L (140 mg/dL)
1. The meter returns plasma-equivalent results:
Source: American Diabetes Association. Standards of medical care in diabetes- 2016;39
(supp. 1 Diabetes Care): S16.
Consult your GP to determine a target range that suits you best.
2. If the test does not commence after the sample is applied:
3. If the test using the control solution is outside of the specied range:
DETAILED INFORMATION
INFORMATION ON SYMBOLS
SYMBOL REFERS TO
In-vitro diagnostic medical
device
See the
user manual
Temperature limits
Use before
Batch code
CE mark
SYMBOL REFERS TO
Manufacturer
Serial number
Authorised representative in
the European Community
Please note, consult the
accompanying documentation
Dispose in accordance with
regulations
Humidity limit
85%
24 25
Batteries are drained.
The test strip has been inserted upside down
or not full inserted.
Meter or test strips are defective.
Insufcient blood sample.
Defective test strip.
Sample has been applied after the device
automatically switched off (5 minutes after
the user performed the last action).
Defective meter.
Test performed incorrectly.
The control solution bottle was not shaken
properly.
The control solution has expired or is
contaminated.
The control solution is too hot or cold.
Defective test strip.
Meter malfunction.
The meter and test strip are defective.
Carefully read the instructions and repeat
the test.
Shake the control solution well and repeat
the test.
Check the expiry date of the control solution.
Control solution, meter and test strips must
be at room temperature, 20 °C to 25 °C
(68 °F to 77 °F) when testing.
Repeat the test with a new test strip.
Contact customer support.
Contact customer support.
Repeat the test using a new test strip. Use
more blood for the sample.
Repeat the test using a new test strip.
Repeat the test using a new test strip.Apply
the blood sample when the ashing
" "
appears on the display.
Contact customer support.
Replace the batteries.
Insert the part of the strip containing the
contact points in the meter, facing upwards.
Contact customer support.
POSSIBLE CAUSE ACTION
POSSIBLE CAUSE ACTION

26 27
NOTES
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Model no.: TD-4277B
Dimensions and weight: 96 (L) x 61(B) x 26 (H) mm, 67,2 g
Power source: Two 1.5 V AAA alkaline batteries
Display: LCD
Memory: 1,000 test results with associated dates and times
Export options: Bluetooth
Automatic electrode placement detection
Automatic sample detection
Automatic response time countdown
Automatic switch-off after 5 minutes of inactivity
Temperature warning
Operating conditions:
10 °C to 40 °C (50 °F to 104 °F), under 85% relative humidity (non-condensing)
Meter storage/transport conditions:
-20 °C to 60 °C (-4 °F to 140 °F), under 95% relative humidity
Test strips storage/transport conditions:
2 °C to 32 °C (35.6 °F to 89.6 °F), under 85% relative humidity
Measuring unit:
mmol/L
Measuring range:
1.6 to 33.3 mmol/L (29 to 600 mg/dL)
This device has been tested for compliance with the electrical and safety requirements of:
IEC/EN 61010-1. lEC/EN 61010-2-101. EN 61326-1. IEC/EN 61326-2-6, EN 301489-17,
EN 301489-1, EN 300 328.
SPECIFICATIONS

For self-testing
TD-4277B
TaiDoc Technology Corporation
Bi.7F,No.127,Wugong 2nd Rd.,
Wugu Dist., 24888 New Taipei City, Taiwan
MedNet EC-REP GmbH
BorkstraBe 10, 48163 Münster, Germany
Import Europa: HT Medical BV
Distributor: GD Medical Pharma BV
Hastelweg 224, 5652 CLEindhoven
[email protected]
The Bluetooth® word mark and logos are registered trademarks
owned by Bluetooth SIG, Inc.and any use of such marks by HT Medical BV
is under license.Other trademarks and trade names are those of their
respective owners.