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
17
18
19
21
22
23
25
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26
27
29
32
33
34
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36
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37
39
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43
45
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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.
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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

18 Blood Glucose Monitoring System 19
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Shake the COOL Control Solution
vial before each test. Remove the
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the first drop. Then wipe the tip
with a clean tissue or cloth.
After the symbol appears on
the display, apply the solution to
the narrow edge of the test strip until the meter beeps.
Make sure the confirmation window fills completely.
Step 1
Insert a test strip into the meter’s test strip
port, with the contact bars facing upwards.
Gently push the test strip into the port until
the meter beeps. Be careful not to break the
strip while pushing it in. The icon will be
displayed on the screen.
Step 2
Control Solution Testing
If all the results you get on testing three times continuously
are within the range printed on the test strip, the meter and
test strips are working properly and you may use them for
your blood glucose test.
Caution
Checking the System
You may check your meter and test strips using the
COOL Control Solution.
The COOL Control Solution contains a known
amount of glucose and is used to check that the
meter and the test strips are working properly.
The test strip vials have COOL Control Solution
ranges printed on their labels. Compare the result
displayed on the meter to the COOL Control
Solution range printed on the test strip vial. Before
using a new meter or a new vial of test strips, you
may conduct a control solution test following the
procedure on page 19 ~ 20.
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a control solution vial, record the discard date (date opened plus 3
months) in the space provided on the label.
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temperature before testing. Control Solution tests must be done at
room temperature (20 ~ 25 °C, 68 ~ 77 ˚F).
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few drops and wipe the tip clean.
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8 ~ 30 °C (46 ~ 86 ˚F).
Notes:
t When using the meter for the first time
t Whenever you open a new vial of test strips
t If the meter or test strips do not function properly
t If your symptoms are inconsistent with the blood glucose test
results and you feel that the meter or test strips are not working
properly
t If you drop or damage the meter
You may do a co ntro l s oluti o n test:

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Repeat the control test if the test result falls outside the range
printed on label of the test strip vial. Out of range results may
occur due to the following factors:
Comparing the Control Solution Test Results
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contaminated,
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to high or low temperatures,
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discarded or the tip of the vial was not wiped clean,
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The COOL Control Solution can be purchased separately.
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Note
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and test strip may not work properly. Then, stop using the
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Control Solution only. It does not have any connection to
your blood glucose level.
Caution
The meter may switch off, if the blood sample is not applied
within 2 minutes of the icon appearing on the screen. If
the meter turns off, remove the strip, reinsert, and start from
step 1.
Note
Step 3
A test result will appear after the meter counts
down from 5 to 1.
After your control solution result appears on the
display, press ▼for 3 seconds till the‘check’ icon
appears on the display. When the ‘check’ icon is
displayed, the result is not stored in the meter’s
memory and is not included in the 14-day
averages.
Step 4
Compare the result displayed on the meter
to the range printed on the test strip vial.
The result should fall within that range.
Used strips should be discarded safely in
disposable containers.

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Preparing the Lancing Device for Blood Sample
Retrieval
Unscrew lancing device tip.
Wash hands and fingertip sample site
with soap and warm water. Rinse and
dry thoroughly.
Firmly insert new lancet into the lancet
holder. Hold lancet firmly. Gently twist
to pull off protective disk. Save disk to
recap lancet after use. Replace lancing
device tip.
Step 1
Step 2
Step 3
Using the Lancing Device
You will need a lancing device in order to collect a blood sample.
You may use the lancing device contained in the COOL Blood
Glucose Monitoring System or any other medically approved
lancing device.
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communal use is strongly discouraged.
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necessary, a small amount of alcohol on a soft cloth or tissue
may be used.
To avoid infection when drawing a sample, use a lancet only
one time, and:
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Caution
Repeated puncturing at the same sample site may cause pain or
skin calluses. Choose a different site each time you test.
Note
Adjustable Tip
Lancet Holder
Sliding Barrel
Release Button
Ejection System

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If you want to attach an post-meal flag ( ) to a
test result, press and hold ▼for 3 seconds after
inserting the test strip. The post-meal flag ( )
and the symbol will appear on the screen.
The test result will also be displayed with the
post-meal flag ( ).
If you do not want to save the result as an post-
meal test, move on to the step 8 after the step 6.
Step 7
Flagging Post-meal Test Results
The meter allows you to flag a result of an post-meal test
with ( ) icon. The post-meal test flag ( ) can be attached
just before applying the blood sample. Once you attach the
post-meal flag ( ) to the test results, it cannot be deleted.
Insert a test strip with the contact bars
facing upwards into the meter’s test strip
port. Push the strip in gently until the
meter beeps. Be careful not to bend the
test strip.
The symbol will appear on the
screen.
Step 6
Preparing the Meter and Test Strip
To cock the lancing device, hold the tip
in one hand. Pull the sliding barrel on
with the other hand. The lancing device
is cocked when you feel a click.
Select a desired depth of one-to-five
(1-5) on lance’s adjustable tip. Rotate
ring to align desired number with
arrow.
A beginning setting of three (3) is
recommended.
Step 4
Step 5
The skin depth to retrieve samples will vary for various
people at different sample sites. The lance’s adjustable tip
allows the best depth of skin penetration for an adequate
TBNQMFTJ[F
A beginning setting of three (3) is recommended.
Note

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Step 10
The test result will appear after the meter
counts down from 5 to 1. The result will
be automatically stored in the meter’s
memory. If the test strip is removed after
the test result is displayed, the meter will
automatically switch off after 3 seconds.
Discard used test strips safely in
disposable containers.
The meter may switch off if the blood sample is not applied
within 2 minutes of the icon appearing on the screen.
If the meter turns off, remove the strip and reinsert after
switching on the meter.
Note
Obtain a blood sample using the lancing
device. Place the device against the pad
of the finger. The best puncture sites are
on the middle or ring fingers. Press the
release button. Remove the device from
the finger.
Wait a few seconds for a blood drop to form.
A minimum volume of 0.5 microliter is needed to fill the
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After the symbol appears on the
screen, apply the blood sample to the
narrow end of the test strip till the meter
beeps. If the confirmation window is not
filled before the meter finishes counting
down then discard the test strip and
insert a new one.
If confirmation window is not filled in
time because of abnormal viscosity or
insufficient volume, Er4 message will
appear.
Step 9
Good
Sample
Insufficient
Sample
Applying Blood Sample
Step 8

28 Blood Glucose Monitoring System 29
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Usually, when someone tests their glucose, they take the blood
sample from the tip of the finger. However, since there are many
nerve endings distributed there, it is quite painful. When doing
a glucose test, using different parts of the body such as the
arms, palms, thighs, and calves can reduce the pain during
testing. This method of testing with different parts of the body
is called Alternative Site Testing. While AST may reduce the pain
during testing, it may not be simple for everyone and the
following precautions should be observed during testing.
What is AST (Alternative Site Testing)?
Alternative Site Testing
Alternative Site for Testing
Unscrew general lancing device tip.
Discarding Used Lancets
Step 1
Place protective cover on lancet.
Push the lancet ejector forward
with the thumb and
simultaneously pull out the
sliding barrel to dispose of the
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container.
Step 2
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Always dispose of lancets properly.
Caution

30 Blood Glucose Monitoring System
31
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t%POPUJHOPSFUIFTZNQUPNTPGIZQFSHMZDFNJBPS
hypoglycemia.
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using the fingertip test. If the test results do not reflect one’s
opinion, please consult a doctor.
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method.
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person.
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AST Precautions
Results from alternative site and fingertip samples may
appear differently as there is a time lag for the glucose levels
to reach the same value. Use a fingertip for drawing if you
suffer from hypoglycemia or have experienced
hypoglycemic shock or symptoms.
Note
If the sample drop of blood runs or spreads due to contact with
hair or with a line in you palm, do not use that sample.
Try puncturing again in a smoother area.
Note
Acceptable situations for AST
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two hours after a meal or exercise
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value
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Situations requiring fingertip test
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Please understand the following things before testing outside
of the fingertip (arms, thighs, calves).
The capillary blood of the fingertip shows the change in
glucose more rapidly than AST. Therefore, the test results from
the fingertip test and AST may differ. This is because things
such as lifestyle and ingested food have an effect on glucose
levels.
Things to know when using AST

32 Blood Glucose Monitoring System
33
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Target Blood Glucose Ranges
Reminders
Time of day
Your target ranges
from your healthcare expert
Before breakfast
Before lunch or dinner
1 hour after meals
2 hours after meals
Between 2 a.m. and 4 a.m.
Source : Diagnosis of Diabetes, NIH Publication
No. 05-4642, January 2005
HI and Lo Messages
The meter displays results between 20 ~ 600 mg/
dL (1.1 ~ 33.3 mmol/L). The HI icon appears when
the blood glucose level is more than 600 mg/dL
(33.3 mmol/L) and indicates hyperglycemia.
If the HI icon is displayed again on retesting,
please contact your healthcare professional
immediately.
Lo Message
The Lo icon appears when the result is less than
20 mg/dL (1.1 mmol/L) and indicates
hypoglycemia.
If the Lo icon is displayed again on retesting,
please contact your healthcare professional
immediately.
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such messages are displayed even though you do not have
hyperglycemia or hypoglycemia.
Note
HI Message

34 Blood Glucose Monitoring System 35
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Step 3
Use the ▼button to scroll through the test results, starting
from the most recent and ending with the oldest. Press ▲to
return to the result seen previously.
After checking the stored test result, press the Sbutton to turn
off the meter.
On pressing ▼, the latest test result saved in the meter’s
memory will be displayed on the screen along with the date
and time. Press and hold ▼to scroll through the test results.
Note
Meter Memory
The meter can save up to 250 glucose test results with time and
date. If the memory is full, the oldest test result will be deleted and
the latest test result will be stored.
The meter calculates and displays the averages of total test results,
pre-meal test results, and post-meal test ( ) results from the last
14 days.
Step 1
Press the ▲or Sbutton to turn the meter on. The
current date and time will be displayed on the
bottom of the screen for 2 seconds, followed by
the average value and the number of the test
results saved within the last 14 days.
Step 2
Press ▼to view the average value
and the number of tests performed
before eating a meal for the last 14
days. On pressing ▼again, the
average value and the number of
tests performed post meals for the
same period will appear on the
screen.
Viewing Test Results Stored in the Meter’s Memory
▲button
▼button
The number of
total tests
The number of
pre-meal tests
The number of
post-meal tests

36 Blood Glucose Monitoring System 37
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Step 1
Without inserting a test strip, press ▲and
the Sbutton simultaneously for 3 seconds
to enter the time alarm mode. The‘alarm1’
will be displayed while the‘OFF’character
blinks on the screen.
Step 2
On pressing ▼, the ‘alarm1’ is set and the
‘On’character is displayed on the screen.
Press ▼again to cancel the ‘alarm1’. The
‘OFF’icon will blink on the screen .
Setting the Time Alarms (alarm1 ~ 3)
Step 3
Press ▲to adjust the time of the ‘alarm1’.
A number representing the time will blink
on the screen. Press ▼to set the time. Press
▲to end.
Without inserting a test strip, press
and hold ▲for 3 seconds to set the
post-meal alarm. The‘PP2’character,
the bell ( ) icon and then the‘On’
character will be displayed.The
screen will then automatically
change to the memory check mode.
At this time, the bell ( ) icon,
indicating that the PP2 alarm has been set, will be displayed on the
screen.
Setting the Alarm Function
Four types of alarms can be set in the meter: one post-meal alarm
(PP2 alarm) and three time set alarms (alarm1 ~ 3).
The PP2 alarm goes off 2 hours after setting the alarm.
The alarms ring for 15 seconds and can be silenced by pressing ▼,
▲or the Sbutton or by inserting a test strip.
Step 1 Setting the PP2 alarm On
Step 2 Setting the PP2 alarm OFF
To turn off the PP2 alarm, press and
hold ▲for 3 seconds. The
‘PP2’character, the bell ( ) icon and
then the‘OFF’character will appear
on the screen.Then the screen will
change automatically to the
memory check mode without the
bell ( ) icon being displayed.
Setting the Post-meal alarm (PP2 alarm)
icon vanishes