Vaccixcell GlucCell User manual

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GlucCellTM SYSTEM USER’S GUIDE
ver 2.3
Intended Use
The GlucCellTM Cell Culture Glucose Monitoring System
(The GlucCellTM System) is designed to quantitatively
measure the concentration of glucose during cell culture.
It is for use by laboratory researchers or bioreactor
professionals to obtain a quantitative measurement of
glucose in cell culture.
About the System
The GlucCellTM System uses the latest technology in Cell
Culture Glucose monitoring to provide you with easy and
reliable testing. The system requires only a 1.5μl of
medium sample to complete the testing in only 15
seconds.
The GlucCellTM System consists of 1) the GlucCellTM
Glucose Meter; 2) GlucCellTM Glucose Test Strips, and 3)
the GlucCellTM code key and program key.These products
are intended to be used together to get accurate Cell
Culture Glucose test results. Do not use other commercial
test strips with your GlucCell meter.
Important Information
The GlucCellTM System is intended for in vitro analysis
use with cell culture medium. The system should not be
used for diagnosis of diabetes.
Caution
A sample with large amounts of reducing agent such as
ascorbic acid and uric acid may cause result slightly
higher than the actual glucose level.
High altitudes above than 2,750 meter (8,800 feet) may
affect the test results.
Temperatures outside the range of 10°C to 40°C (50°F to
104°F) may affect the test results.
CELL CULTURE GLUCOSE METER

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DISPLAY: The large, easy to read display shows test
results, messages, cell culture glucose results stored
in memory, time and date.
S BUTTON: Press S button to enter the time setting,
and to decrease values in the setting mode.
M BUTTON: Press M button to enter memory mode to
recall the information stored in meter’s memory and to
increase values in the setting mode.
STRIP SLOT : Hold a GlucCellTM Glucose Test Strip in
place when you perform Cell Culture Glucose test or
perform check test.
DATA PORT : Allow you to transfer the information
stored in the meter’s memory to a computer to view,
analyze and print.
BATTERY COMPARTMENT : Hold one 3v Lithium
battery. The battery is not yet installed into meter when
new purchasing. Before using the meter, please install
the battery first.
TEST RESULT
BATTERY SYMBOL : Appear when battery is weak.
THERMOMETER SYMBOL : Appears when ambient
temperature is above or below the acceptable range
needed for testing.
DROP SYMBOL : Appear when the test strip is
inserted and meter is ready for testing.
STRIP SYMBOL
M188 : Memory capacity is 180 entries. The display
shows M188 to ensure that all digits are working
properly.
mg/dL mmol/L : The meter has two units of
measurement (mg/dL or mmol/L) available to choose
from.
DAY AVG : Appear when the meter is in the memory
mode while recalling 1/7/14/21/28 day test averages.
DATE : Month/date.
TIME : The meter is programmed for a 12 hour period
format.

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CELL CULTURE GLUCOSE TEST
STRIP
1: Aperture: apply the sample to either side of strip.
2: Test Confirmation Window: make sure the chamber
is filled up with test sample to ensure the correct result.
For example:
3. Gray Electrode End: insert this end of test strip into
meter.
IMPORTANT TEST STRIP INFORMATION
GlucCellTM System measures the amount of glucose in
cell culture medium. Sample can be applied both to the
right or left side of the test strip’s apertures and is
automatically drawn to the test confirmation window
where the reaction takes place.
GlucCellTM Glucose Test Strips are intended for in vitro
analysis use with cell culture medium. Results will not be
accurate if used with samples containing no electrolyte.
Do not use test strips beyond the expiration date indicated
on the strip vial label.
The discard date for test strips is 90 days after first
opening the vial. Record the discard date on the vial,
when you open a new vial of test strips.
GlucCellTM Glucose Test Strip could be damaged by heat
and light. Keep them sealed in the original vial.
Store the vial in a cool, dry place below to 400C/1040F and
above 100C/500F. Do not refrigerate.
Do not use damaged test strips or abnormal test strips.
Use the test strip immediately once after removing it from
the vial; replace the vial cap and close it tightly.
Do not transfer test strips to a new vial. Always carry test
strips in their original vial.
Do not place test strips in direct heat or sunlight.
Do not carry loose test strips in your carrying case.
Test strips are for single use only.

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CHECK STRIP
The GlucCellTM Check Strip
can be used in 2 ways:
To check that the meter is
operating properly. Use when
performing quality control
check on your meter.
To change the measuring unit
of your meter.
1. How to check meter by check strip
Step 1: Insert the check strip into strip slot with label side
up as above.
Step 2: You should obtain an acceptable “OK“ reading
within 10 seconds, which mean your meter is working
properly.
Step 3: Remove the check strip to exit. Meter will
automatically off.
NOTE: IF YOU DO NOT GET “OK”READING BUT
APPEAR OTHER ERROR MESSAGE, PLEASE
FOLLOW BELOW PROCEDURES:
1. TURN OFF THE METER BY PRESSING M BUTTON
FOR 3 SECONDS AND REMOVE THE CHECK STRIP
FROM THE METER.
2. INSERT CHECK STRIP TO REPEAT TEST. IF THE
SECOND RESULT PERSISTS, CONSULT YOUR
LOCAL DISTRIBUTOR FOR HELP.
2. How to change measuring unit
The meter has two measuring units to choose from,
mg/dL and mmol/L. The default unit is mg/dL if you do not
change.
Step 1: Insert check strip into strip slot with label side up.
Step 2: After “OK“ displayed, press S button until
flashing mg/dL shows up.
Step 3: Press S button to switch from mg/dL to mmol/L.
Wait until new setting flash for 3 times to validate the
setting. Meter will display “OK”before off, and the unit is
been changed successfully.
Step 4: Remove the check strip from the meter.

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SETTING METER PARAMETERS
SETTING TIME & DATE
When you first time install the battery into the meter or
every time when replace a battery, the meter will
automatically enter to the setting mode. Please set
correct time and date before you begin testing.
How to set time and date
Press S BUTTON for 3 seconds to turn on the meter. The
meter will enter to the setting mode automatically.
At the beep sound, the year will flash - for example for the
year of 2009, number ”09 “will appear.
Press S or M button to obtain the desired year.
Wait the new setting flash 3 times to confirm and shifts to
the next setting.
Repeat to set the month, day, hour and minute. After
minute is set, the meter will display “OK”before turn off.
NOTE: WHILE SETTING THE TIME AND DATE, YOU
CAN EXIT THE SETTING MODE ANYTIME BY PRESS
M BUTTON FOR 3 SECONDS.

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CODING YOUR METER
Before you use your meter for the first time and every
time you open a new box of test strips, you need to set the
meter to “match” the strips. This is called coding. Insert
the test strip into the strip slot (FIG1), the meter will
activate. The last code number will appear on the screen.
Compare the code number shown on the meter display
against the code number on the test strip vial (FIG 2). If
the two numbers match, you may begin testing.
Otherwise continue to the next step.
Press S button until you hear the sound of buzzer and the
code value flashes, press S or M button to obtain the code
number indicated on the new test strip vial. (FIG 3)
Upon obtaining the right code number, wait the new
setting to flash 3 times to validate the change. (FIG 4)
After screen shows the proper code and a blinking drop
symbol shows up, your meter is ready to perform a test.
(FIG 5)
NOTE: THE NEW CODE NUMBER IS DISPLAYED ON
THE SCREEN TOO.(FIG 4)
FIG 1
FIG 2
FIG 3
FIG 4
FIG 5

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PERFORMING TEST
Remove new test strip from vial. Be sure to tightly replace
vial cap after removing test strips. Insert test strip
immediately into strip slot as illustrated (FIG 1). The meter
turns on automatically.
Check that the code number in the meter matches the
code on the vial (FIG 2). If the two numbers match you
may begin testing. Otherwise refer to above section to
code your meter first.
When the drop symbol flashes (FIG 3), you are ready to
perform a test. To perform the test, you need only 1.5 uL
of test sample. Use a pipette tip to withdraw around 1.5 ul
test sample (FIG 4).
FIG 1
FIG 2
FIG 3
FIG 4
Carefully depress to form a 1.5uL droplet on the pipette
tip. Bring the droplet underneath the right or left aperture
of the testing strip and touch gently to the strip, allowing
the entire droplet to be wicked into the strip. (FIG 5 ).
Please allow the sample to be absorbed naturally to fill up
the confirmation window Make sure that the sample has
saturated the test confirmation window. Never push test
sample over the aperture and cause overloading of the
sample. When sample is applied to the strip, a line moves
on the screen until measurement is completed (FIG 6).
Test result will show up in 15 seconds (FIG 7 ).
After test complete, remove the strip from meter (FIG 8),
and discard the used strip safely.
The measuring range of the meter is from 20 to 600

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mg/dL (1.1 to 33.3 mmol/L). However, the accurate
testing range of the meter is from 30 to 500 mg/dL(1.67 to
27.78 mmol/L). If HI is displayed, your Cell Culture
Glucose result may be higher than 33.3 mmol/L or 600
mg/dL. If LO is displayed, your Cell Culture Glucose
result may be lower than 1.1 mmol/L or 20 mg/dL (FIG
9).When the measurement is higher than 500 mg/dL,
please dilute the sample. If the measurements is between
20~30mg/dL, the deviation may larger than ±15%.
FIG 5
FIG 6
FIG 7
FIG 8
FIG 9

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MEMORY RECALL
The GlucCellTM cell culture glucose Meter automatically
stores 180 test results, letting you review them in order
from the most recent to the oldest. If the memory is full
and a new result is added, the meter deletes the oldest
result.
The meter also calculates and displays the previous 1-, 7-,
14-, 21-, and 28-day averages.
To recall Results Stored in Memory
Turn meter on by press M button till you hear a beep
sound. The first result displayed on the screen is your
latest test result.
By pressing M button, you will see your test record from
the most recent to the oldest.
By pressing S button you will obtain the averages of the
last 1-, 7-, 14-, 21- and 28-days.
NOTE: ANYTIME IN MEMORY MODE, YOU CAN
PRESS M BUTTON UNTIL YOU HEAR THE BEEP TO
EXITAND TURN OFF THE METER.
To Delete Memory
While in the memory mode, select the test result you wish
to delete and display it on the screen.
Press S button until you hear a beep sound. The blink
“dEL” symbol will appear on the meter.
Press M button until the “OK” symbol appears which
confirms that the selected test result has been deleted
successfully.
The meter will return to memory mode and display next
result after deleting.

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SYSTEM SPECIFICATIONS
1
Assay Method
Electrochemical biosensor
2
Test Sample
Animal cell culture medium or buffer solution
3
Test Result
Glucose concentration in mg/dL or mmol/L
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Sample Size
1.5 μL
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Measuring Time
Less than 15 seconds
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Measuring Range
20 –600 mg/dL (1.1 –33.3 mmol/L). Alarm HI when
over 600 mg/dL, LO when over 20 mg/dL
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Accurate Testing Range
30 –500 mg/dL (1.67 –27.78 mmol/L)
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Operating Temp. Range
100C~400C(500F~1040F)
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Operating Relative Humidity
20% - 80% RH
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Memory Capacity
180 test results with time and date
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Power Supply
One 3-volt Lithium Battery
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Battery Life
Approximately 1000 tests
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Automatic shut-off
In 3 minutes

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TAKING CARE OF YOUR METER
REPLACING THE BATTERY
The GlucCellTM Glucose Meter comes with a battery (not
yet be installed when new purchasing). Please install
your battery before started.
Battery life will vary depending on usage, so always
keep a spare on hand.
The battery should last about 12 months when testing 3
times a day.
When the battery symbol appears on the meter display,
battery is getting low. You will still be able to test with low
battery, but you should replace it as soon as possible.
When battery symbol appears flashing on the display,
the meter will no longer give results and you must
replace the battery immediately.
TO REPLACE THE BATTERY
Make sure the meter is turned off.
Let the front of meter rest in the palm of your hand.
Slide battery compartment door open.
Remove the old battery and insert the new 3 volt Lithium
battery into the metallic hood of the battery holder with
the plus(+) side up.
Slide battery compartment door closed. Check to see
that your meter is working. If it fails to turn on, the battery
may have been inserted incorrectly. Remove the battery
and reinsert it as illustrated.
NOTE: EVERY TIME WHEN YOU REPLACE THE
BATTERY, THE METER WILL TURN ON
AUTOMATICALLYAND ENTER TO THE TIME/DATE
SETTING. PLEASE SET CORRECT TIME AND DATE
BEFORE TESTING.
CLEANING
Clean the outside of the meter with a soft cloth, slightly
dampened with water. Do not get moisture into the strip
slot and data port.
STORAGE AND HANDLING
Keep your meter free of dust. Protect it from extreme
temperature and humidity.
DISPLAY MESSAGES AND
PROBLEM-SOLVING GUIDE
When any of the following messages appear, there is a
problem with your GlucCellTM Cell Culture Glucose
Meter or the way in which you are performing a test.
These messages will help you to identify certain
problems. If error messages appear that are not listed
on the following pages, contact with your local distributor
for help.

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DISPLAY
DESCRIPTION
ACTION TO TAKE
Display check
If some parts of the display are not working. Contact
your local distributor for help
Cell Culture Glucose result is
higher than 600 mg/dL or 33.3
mmol/L.
If this not confirmed by the way you feel, review proper
testing procedure and perform a quality check with
control solution. Repeat test, if “HI” still appears,
contact your local distributor for help
Cell Culture Glucose result is
lower than 20 mg/dL or 1.1
mmol/L.
If this not confirmed the way you feel, review proper
testing procedure and perform a quality check with
control solution. Repeat test, if “LO” still appears,
contact your local distributor for help
Temperature is above or below
the operating range of test
strips.
The result you have obtained may not be accurate.
Move to an area with temperature between 10ºC to
40ºC (50ºF - 104ºF). Do not artificially heat or cool the
meter.
Battery is low
Change battery soon.

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Battery is dead.
Change battery now.
Test strip may be damaged.
Perform the test with new test strip.
Test strip is used or test was
not performed correctly.
Perform the test with a new test strip and follow the test
procedure correctly.
No responses when
strip is inserted into the
meter
Maybe:
1. Battery is dead
2. Wrong strip be inserted
3. Meter is defective
You have to:
1. Replace battery
2. Insert the test strip correctly
3. Contact us for help
No responses when
sample is applied to the
strip
Maybe:
Sample is not sufficient
Meter is defective
You have to:
1. Repeat test with sufficient sample
2. Perform Meter Check by inserting check strip.
NOTE : If there is any error message displayed but not listed here, or your meter shut down
for no reason, you can reset the meter by following two ways:
1. Replace the battery.
2. Open the battery door and use a needle to prink the “reset”hole (with a reset mark beside)
the battery component.

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PERFORMANCE EVALUATIONS
PRECISION
Tests were carried by trained technicians in the
laboratory setting. The sample from one subject was
adjusted to 3 different levels. Strips out of a single lot
were tested. The results are shown in the following
table.
Level
No. of tests
Mean (mg/dL )
Within-Run C.V. (%)
Low
Normal
High
20
20
20
43.3
96.2
381.0
4.7
3.4
2.4
ACCURACY
Tests were carried by trained technicians in the
laboratory setting. Samples from the subjects were
tested with both GlucCell Meter and YSI Model 2300
Glucose Analyzer as reference. The results are shown in
the following table.
Slope
1.07
y-intercept
-5.9 mg/dL; -0.3 mmol/L
Correlation Coefficient (R)
0.99
Number of tests
120
Range tested
54-490 mg/dL
3.0–27.2 mmol/L
SYMBOL
Lot number
Do not reuse
Caution, consult
accompanying
document
Please consult
instructions for
use
Use by /Expiry date
EU
representative
Temperature
limitation / Store at
Manufacturer
This product fulfils the requirements of
Directive 98/79/EC in vitro diagnostic medical
device.
CONTACT INFORMATION
21 Changi South Street 1, 486777 Singapore
Tel: [phone]
Fax: [phone]
E-mail: [e-mail]
Website: www.vaccixcell.com