iSens COOL User manual

Ⓒ2012 i-SENS, Inc. All Rights Reserved. PGD1E3002 REV3x
i-SENS, Inc.
465-6 Wolgye4-dong, Nowon-gu
Seoul 139-845, Korea
www.i-sens.com
Medical Technology Promedt
Consulting GmbH, Altenhofstrasse 80,
D-66386 St. Ingbert, Germany
Owner’s Booklet

Thank you for purchasing the COOL Blood Glucose Monitoring
System. The system provides you with safe, convenient and
painless blood glucose in vitro (i.e., outside the body) diagnostic
monitoring. You can obtain accurate results in just 5 seconds with
a small (0.5 ㎕) blood sample.
Welcome to the COOL
Blood Glucose Monitoring System

Information
Important Information
Specifications
COOL Blood Glucose Monitoring System
Replacing the Batteries
COOL Blood Glucose Test Strip
COOL Blood Glucose Meter
COOL Blood Glucose Meter Display
Preparation
Setting up Your System
Adjusting the Date, Time and Unit
Setting the Sound On/OFF
Setting the Test Result Reset
Checking the System
Control Solution Testing
Comparing the Control Solution Test Results
Testing
Using the Lancing Device
Preparing the Lancing Device for Blood Sample Retrieval
Preparing the Meter and Test Strip
Flagging Post-mealTest Results
Applying Blood Sample
Discarding Used Lancets
Alternative Site Testing
HI and Lo Messages
Target Blood Glucose Ranges
Additional Functions
Meter Memory
ViewingTest Results Stored in the Meter’s Memory
Setting the Alarm Function
Setting the Post-meal Alarm (PP2 alarm)
Setting the Time Alarm (alarm 1 ~ 3)
Maintenance
Caring for Your System
Understanding Error and Other Messages
General Troubleshooting
Performance Characteristics
Warranty Information
Table of Contents
4
6
7
8
9
11
12
13
13
16
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18
19
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To receive safe and optimum system benefits, please read the
entire manual contents before using the system. Please note
the following instructions:
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testing newborns.
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significantly due to rapid change in the glucose level post
meal, insulin injection or exercise.
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self-testing outside the body (in vitro diagnostic use).
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on the test strip where to produce a small electrical current.
The COOL meter detects this electrical current and measures
the amount of glucose in the blood sample.
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related errors in monitoring by using the no-coding function.
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COOL strip.
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However, people with severe anemia and newborns may have
higher hematocrit and this can affect the test results.
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can lead to incorrect test results.
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indicate hypoglycemia and a value of more than 240 mg/dL
(13.3 mmol/L) may indicate hyperglycemia.
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sales representative or visit www.i-sens.com for more
information.
Important Information:Read this First! Important Information
The following chart explains the symbols you’ll find in the COOL User
Manual, product packaging, and product inserts.
For in vitro diagnostic use
This product fulfills the requirements for Directive
98/79/EC on in vitro diagnostic medical devices.
Cautions for safety and optimum product use
Consult instruction for use
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Do not reuse. Batch code
Do not discard this product with other household-type
waste
Serial number
Temperature limitations
Use by (unopened or opened test strip container)
0123

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Specifications COOL Blood Glucose Monitoring System
Product specifications
4BNQMFTJ[F
Test time
Sample type
Calibration
Assay method
Battery life
Memory
4J[F
Weight
Power
Reported result range
20 ~ 600 mg/dL (1.1 ~ 33.3 mmol/L)
Minimum 0.5 ㎕
5 seconds
Fresh capillary whole blood
Plasma-equivalent
Electrochemical
1,000 tests
250 test results
93 X 45 X 15 (mm)
54 g (with batteries)
Two 3.0 V lithium batteries
(disposable, type CR2032)
Operating ranges
Temperature
Relative humidity
Hematocrit
10 ~ 40 °C (50 ~ 104 ˚F)
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_
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if any component is missing or damaged.
tThe cable for data transmission can be ordered separately.
1MFBTFDPOUBDUZPVSBVUIPSJ[FEJ4&/4TBMFTSFQSFTFOUBUJWF
or visit www.i-sens.com.
❶ COOL Blood Glucose Meter
❷ Lancing Device
❸ Lancets (10)
❹ Owner’s Booklet
❺ Quick Reference Guide
❻ Logbook
❼ Carrying Case
❽ COOL Blood Glucose Test Strip
❾ Batteries (2)
Components
①
②③
④
⑥
⑤
⑦
⑧⑨
The components of the product is identical to what's listed
in the meter manual, however you need to check the meter
box for the quantity of the strip.

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Insert
COOL Blood Glucose Test Strip
The COOL blood glucose monitoring system measures blood
glucose quickly and accurately. It automatically absorbs the
small blood sample applied to the narrow edge of the strip.
Contact bars
Gently push the test strip, with
its contact bars facing up, into
the test strip port of meter
Confirmation window
Check here to see whether
sufficient blood sample has
been applied
Edge to apply blood sample
Apply blood sample here for
testing
Replacing the Batteries
Step 1
Make sure the meter is turned off. Push the
cover in the direction of the arrow to open
the battery compartment.
Step 2
Remove the old battery by lifting the battery
with the index finger and pulling out the
battery with your thumb and index fingers as
shown in the figure on the right one by one.
Insert two new batteries with the + side
facing up and make sure the battery is
inserted firmly.
Step 3
Place the cover on the battery compartment.
Push down until you hear the tab click into
place.
The COOL meter comes with two 3.0 V lithium batteries.
When the icon appears on the display for the first time, the
battery should be replaced as soon as possible.
The test results might not be saved if the battery runs out.
Removing the meter batteries will not affect your stored result.
However, you may need to reset your meter settings.
See pages 12 ~ 14.
Note

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Blood Glucose Meter
Note
The PC care cable for data transmission to PC can be
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sales representative or visit www.i-sens.com.
Transmission Port
Used to transfer data from the meter
to a computer with a PC care cable
Display
Shows results, messages
▲
Button
Selects or changes information
SButton
Turns the meter on/off and confirms
menu selections
▼ Button
Selects or changes information
Test Strip Port
Insert test strip here
Warning!
t The COOL test strip should be used only with fresh capillary
whole blood samples.
t Do not reuse test strips.
t Do not use test strips past the expiration date.
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containers that have been opened can be used up until
the expiration date printed on the test strip box and
container label if the test strips are used and stored
according to its storage and handling methods.
t
Store test strips in a cool and dry place at a temperature of
1 ~ 30 °C (34 ~ 86 ˚F).
t Keep away test strips from direct sunlight or heat and do not
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t Store test strips only in their original vial.
t Close the vial tightly after removing a test strip for testing and
use the strip immediately.
t Handle test strips only with clean and dry hands.
t Do not bend, cut, or alter test strips in any way.
t For detailed storage and usage information, refer to the COOL
test strip package insert.
Caution
Keep the meter and testing supplies away from young children.

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Setting up Your System
Press and hold the Sbutton for 3 seconds to switch on the
meter.
After all settings are finished, press and hold the Sbutton for 3
seconds to turn off the meter.
Press ▲or ▼to reach the accurate value. Press and hold ▼to
scroll faster.
Press and hold the Sbutton for 3 seconds to
switch on the meter. After all the segments flash
across the screen, the‘SET’ character icon will be
displayed on the screen.
Press the Sbutton again to enter the year setting
mode.
Step 1 Entering the SET Mode
Press and release ▲or ▼to adjust until the
correct year appears. Press and hold ▼button to
scroll through the numbers quickly. After setting
the year, press the Sbutton to confirm your
selection and enter the month setting mode.
Step 2 Setting the Year
Adjusting the Date, Time and Unit
Blood Glucose Meter Display
mem
appears when test
results stored in the
memory are displayed
alarm
appears when
the time alarm
has been set
Battery icon
indicates meter
battery is running
low and needs to
be replaced
Alarm icon
appears when
the post meal
alarm has been set
mmol/L
unit for measuring blood
glucose
Post-meal test
flag
appears during
post-meal testing
and when postmeal
test results
are displayed
Sound icon
appears only when
the sound is set to
OFF
check
appears when test
results have not
been saved
Test results
test results
displaying panel
mg/dL
unit for measuring
blood glucose
Blood insertion
icon
indicates meter is
ready for the
application of a drop
of blood or control
solution
Decimal point
appears when the
blood glucose
measuring unit is set
to mmol/L
Month Day Hour Minute

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Press ▲or ▼until the correct hour appears.
After the hour is set, press the Sbutton to
enter the minute setting mode.
Step 6 Setting the Hour
Press ▲or ▼until the correct minute
appears. After setting the minute, press the S
button to enter the unit setting mode.
Step 7 Setting the Minute
Step 8 Setting the Measurement Unit
The COOL meter can display results in mg/dL or
mmol/L. You may be able to change the unit by
pressing the ▲or ▼button, and then press the
Sbutton to confirm your setting.
However, in some countries, the meter may
have been set to the unit generally used in the
country (mg/dL or mmol/L). In this case, the unit
can not be changed and the unit change setting
step will be excluded.
The unit setting on the meter may be fixed for your meter, so
that you may not be able to change the setting.
Note
A number indicating the month will be
blinking on the left corner of the screen.
Press▲or ▼until the correct month appears.
Press the Sbutton to confirm your selection
and enter the date setting mode.
Step 3 Setting the Month
Press ▲or ▼until the screen displays the
correct date. Press the Sbutton to confirm the
date and enter the time setting mode.
Step 4 Setting the Date
The meter can be set in the AM/PM 12-hour or
the 24-hour clock format. Press ▲or▼to
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displayed in the 24-hour format. After
selecting the format press the Sbutton to
enter the hour setting mode.
Step 5 Setting the Time

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Step 10
In this mode all the test results stored in the meter can be
deleted. Please note that if you
select YES, all the stored test
results will be deleted and can
not be restored.
After the beeper mode is set,
press the Sbutton to enter the
‘Test Result Reset’ mode. The
‘dEL’ character will blink on the
screen.
Press ▲or ▼to alternate between‘YES’ or ‘no’. To delete all the
stored test results press the S button while the screen displays
‘YES’. Then, all the test results stored in the meter will be
deleted and the screen will be similar to the picture on the
right. If you do not want to delete the results press the Sbutton
while the screen displays ‘no’. Then, the screen will return to
step 2. See page 12.
At any stage, if the Sbutton is pressed for 3 seconds, Time,
Date and Unit setting mode will finish and the meter will be
turned off. Press and hold ▼to scroll through numbers quickly.
Note
Setting the‘Test Result Reset’
(Deleting all the saved test results)
On pressing ▲or ▼, the screen will display the
On or OFF. Press the S button to confirm the
selection.
The meter will beep in the following instances,
if set to On.
t When the test strip is inserted in the meter
t When the blood sample is absorbed into the
test strip and the test starts
t When the test result is displayed
t When you push the Sbutton or ▲button to
check the memory
t When you push the ▲button to set the
postmeal (PP2) alarm
t When it is time for a preset blood glucose test
If the sound is set to OFF, none of the sound
functions will work.
Step 9
Only when the sound is set to OFF, icon appears on the
display.
Note
Setting the Sound On/OFF