iSens CareSens II User manual

Accurate, complete blood glucose
monitoring through advanced
biosensor technology
Blood Glucose Monitoring System
Owner's Booklet
© 2012 i-SENS, Inc. All Rights Reserved. PGA1E3011 REVx 02/2012
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

Thank you for purchasing the CareSens II Blood Glucose
Monitoring System. The system provides you with fast, safe,
and convenient blood glucose in vitro (i.e., outside the body)
diagnostic monitoring.
You will receive an accurate results in only five seconds with a
small 0.5 ㎕blood sample.
Welcome to the CareSens II
Blood Glucose Monitoring System

3
Table of Contents
Welcome to the CareSens II Blood Glucose Monitoring System 2
Table of Contents 3
Important Information: Read This First! 5
CareSens II Blood Glucose Monitoring System 7
CareSens II Blood Glucose Meter 8
Meter Display 9
Setting the Meter 10
Setting the Month and Date 11
Setting the Time 12
Setting the Year and Measurement Unit 13
Storing Test Results in Meter Memory 14
Deleting Stored Test Results from Meter Memory 15
Checking the Meter with the CareSens II Check Strip 16
CareSens II Blood Glucose Test Strip 17
Coding Meter to Match Test Strips 19
Checking the System 21
CareSens Glucose Control Solution Storage and Handling 22
Testing Meter and Test Strip Performance 23
Comparing the Control Solution Test 25
Using the Lancing Device 26
Preparing the Lancing Device for Blood Sample Retrieval 27
Using the Lancing Device at Fingertip Sample Site 29
Testing Your Blood Glucose Levels 30
Alternative Site Testing
33
Discarding Used Lancets 36

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To receive safe and optimum system benefits, please read the entire
manual contents before using the system. Please note:
Do• not use the system for the diagnosis of diabetes or for testing
newborns.
The CareSens II blood glucose monitoring system is intended for•
self-testing outside the body (in vitro diagnostic use).
Use• only fresh capillary whole blood samples for testing.
The glucose in the blood sample mixes with special chemicals on•
the test strip to produce a small electrical current. The CareSens II
meter detects this electrical current and measures the amount of
glucose in the blood sample.
Alternative site and fingertip results may differ significantly due to•
rapid change in the glucose level after meal, insulin or exercise.
Use alternative site samples only for testing prior to, or more than•
two hours after, meal, insulin dose, or physical exercise.
The average hematocrit range is between 30 and 50%. However,•
people with severe anemia and newborns may have higher
hematocrit and this can affect the test results.
Very high (60% or more) or very low (20% or less) hematocrit can•
lead to incorrect test results.
The following chart explains the symbols you will find in the CareSens II
User Manual, product packaging, and product inserts.
If you need assistance, please contact your authorized i-SENS sales
representative or visit www.i-sens.com for more information.
Important Information: Read This First!
Table of Contents
4
Target Blood Glucose Ranges 37
Hi and Lo Messages 38
Caring for Your System 39
Replacing the Batteries 40
Specifications 41
Performance Characteristics 42
Understanding Error and Other Messages 44
General Troubleshooting 46
Warranty Information 47

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CareSens II Blood Glucose Monitoring System
Verify that all the following components are included in the
system box.
Use only CareSens Test Strips with the CareSens II Blood
Glucose Monitoring System.
• Helpful Tip
See page 40 for battery information and replacement instructions.
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.
1
2
3
4
5
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For in vitro diagnostic use
Cautions for safety and optimum product use
Consult instruction for use
Manufacturer
Authorized representative
Do not reuse
Batch code
Use by (unopened or opened test strip container)
Temperature limitations
Do not discard this product with other household-type waste
Serial number
This product fulfills the requirements for Directive 98/79/EC
on in vitro diagnostic medical devices.
•Pleasecontactyourauthorizedi-SENSsalesrepresentativeifany
component is missing or damaged.
CareSens II Blood Glucose Meter1.
Battery (1)2.
CareSens Blood Glucose Test Strip3.
CareSens Check Strip4.
Lancing Device5.
Lancet6.
Carrying Case7.
Owner's Booklet8.
Quick Reference Guide9.
Logbook10.
* CareSens Glucose Control Solution (Optional)

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[1] code
Shows code for three (3) seconds after
test strip insertion
[2] mem
Shows previously stored test results
[3] check
Appears during meter testing
[4] Battery Symbol
Indicates low battery
[5] mmol/L
Appears when test result is set to
mmol/L
[6] Decimal Point
Appears when the blood glucose measuring unit is set to mmol/L
[7] mg/dL
Appears when test result is set to mg/dL
[8] Blood Drop Symbol
Indicates meter is ready to receive blood sample
[9] Month [10] Day [11] Hour [12] Minute
Meter Display
1 2 3
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121110 9
CareSens II Blood Glucose Meter
[1] Meter Display
Test result, symbol and simple message display.
[2] М Button
On-off power button. Also used to call memory or setting modes.
[3] C Button
Power button to review previous test results or change code, date,
time, year or measurement units.
[4] Test Strip Port
Insert test strip here.
1
2
3
4

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[1] Setting the Month
Press and hold the MButton for three (3)
seconds. A blinking number indicating the
month will appear on the lower left display
corner. Press and release the CButton until
correct month appears. Press the MButton
to set. You are now ready to set the date.
[2] Setting the Date
Press the CButton until blinking number
represents correct date. Press the MButton
to set and move to time setting mode.
Setting the Month and Date
• Helpful Tip
Press and hold the MButton for three (3) seconds to begin and
end the setting of the date, time, year or measurement unit on
the meter. Use the CButton for scrolling. To scroll more quickly,
hold the CButton down.
Setting the Meter
When you turn on your CareSens II Meter
the first time, its display will show the
following setting:
Display format for the date: MM-DD•
(Month-Date)
Display format for the time: 12 h•
(AM/PM)
Year: year of manufacture•
• Helpful Tip
To set any date, time, or unit of measurement, you must begin
by setting the month and date mode and consecutively go
through the process.
To set the display, press and hold the M
Button for three (3) seconds.

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[7] Setting the Measurement Unit
The meter is set to mg/dL. Press the C
Button to change to mmol/L or return to
mg/dL. After selecting measurement unit,
press the MButton for three (3) seconds to
exit setting mode.
• Helpful Tip
The unit setting on the meter may be fixed for your meter, so that
you will not be able to change the setting.
[6] Setting the Year
Press the CButton until correct year appears.
After setting the year, press the MButton to
move to unit setting mode.
Setting the Year and Measurement Unit
[4] Setting the Hour
Press the M Button to move to hour setting
mode. Press the CButton until correct hour
appears. After hour is set, press the MButton
to enter minute setting mode.
[5] Setting the Minute
Press the CButton until correct minute
appears. After minute is set, press the M
Button to move to year setting mode.
[3] Setting the Time
The meter can be set in an AM/PM 12-hour
or 24-hour format. Press the CButton to
select format.
Setting the Time

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[1] Begin with meter off. Enter time and unit
setting mode (see Setting the Meter pages
10-13). Press the MButton seven times to set
meter to memory deleting mode. Press the
CButton to call up Yes or no.
[2] To delete all memory, choose Yes. Press
the MButton. All past stored test results and
their dates and times will be deleted.
The number zero will appear.
Or, If you do not wish to delete the memory,
choose no. Press the MButton to enter
Step 1 of the time and unit setting mode.
• Helpful Tip
The meter will turn off if you press the MButton for more than
three (3) seconds at any stage of the setting. The meter will turn
itself off after two (2) minutes if the MButton is not pressed.
Deleting Stored Test
Results from Meter Memory
To delete all past stored test results, follow this procedure.
Storing Test Results in Meter Memory
• Helpful Tip
Each time you press the CButton, you’ll see previous test results,
dates and times displayed in chronological order. To see test
results displayed more quickly, press and hold the CButton.
[3] Press the MButton to turn the meter off.
[1] Press the MButton to turn on meter. The
current date and time will appear at the
bottom of the screen for two (2) seconds,
followed by the 14-day average and number
of tests performed.
[2] Press the CButton. The most recent test
result, its date and time will appear.
The CareSens II Meter provides storage for up to
250 blood glucose test results. It also stores the
14-day average and number of tests performed.
The following procedure lets you store your test
results.

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The CareSens Test Strip supports the accurate measurement
of glucose levels in a capillary whole blood sample.
[1] Contact Bars
Gently push the test strip, with its contact bars facing up, into the
test strip port of meter.
[2] Confirmation Window
Check here to see whether sufficient blood sample has been
applied.
[3] Edge to apply blood sample
Apply blood sample here for testing.
CareSens II Blood Glucose Test Strip
Insert
1
2
3
[1] Start with meter off.
Remove CareSens II Check Strip from the
package.
Insert CareSens II Check Strip contact end
into test strip port.
[2] After a few seconds, meter displays 'YES’.
'YES’ in the display of the meter means the
meter is functioning properly.
Remove the CareSens II Check Strip.
Return to the package.
• Helpful Tip
If segments are missing from display or 'no’ appear, do not use
meter for testing. Contact your authorized i-SENS representative.
Checking the Meter
with the CareSens II Check Strip
The CareSens II Check Strip is used to determine if the meter
is functioning properly. To perform the test, start with the
meter turned off.
Perform a CareSens II Check Strip when:
the• CareSens II meter is used for the first time
the battery is replaced•
the test result seems inaccurate or does not reflect how you feel•
the• CareSens II meter seems to be not working properly
the• CareSens II meter is dropped or banged

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[1] Gently push test strip in until meter
beeps. Code numbers will appear for
three (3) seconds. Code number 1 will
appear when the meter is first used.
[2] Code numbers on display and test
strip bottle should match. If so, wait until
the symbol appears on the
screen to begin the test.
If not, follow Step 3.
For accurate results, the code numbers on the CareSens II Meter
and CareSens Test Strips must match. You must code your meter
before using it for the first time and each time you open a new
bottle of test strips. The code number on the meter display must
match the one on the test strip bottle.
Coding Meter to Match Test Strips
You must code your meter before using it for the first time
and each time you open a new bottle of test strips. The
code numbers on the display and test strip bottle must
match. If the meter is not correctly coded, you will get
inaccurate results.
Warning!
The CareSens test strip should be used only with fresh capillary•
whole blood samples.
Do not reuse test strips.•
Do not use test strips past the expiration date.•
Test strips in new, unopened containers and test strips in•
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.
Store test strips in a cool and dry place at a temperature of•
1 ~ 30°C (34 ~ 86°F).
Keep away test strips from direct sunlight or heat and do not•
refrigerate or freeze.
Store test strips only in their original vial.•
Close the vial tightly after removing a test strip for testing and•
use the strip immediately.
Handle test strips only with clean and dry hands.•
Do not bend, cut, or alter test strips in any way.•
For detailed storage and usage information, refer to the•
CareSens test strip package insert.
• Helpful Tip
For detailed storage and usage information, refer to the CareSens
Test Strip package insert.
Keep test strips and the test strip bottle away from children.
The test strips and bottle cap may be choking hazards.
Drying agents in the bottle cap may be harmful if inhaled
or swallowed and may cause skin or eye irritation.

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CareSens Control Solution:
You may check your meter and test strips using the
CareSens Control Solution.
The CareSens 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 CareSens Control Solution ranges
printed on their labels. Compare the result displayed on
the meter to the CareSens Control Solution range printed
on the test strip vial.
Before using a new meter or a new vial of test strips, conduct a control
solution test following the procedure on page 23.
Note:
Use only the CareSens Control Solution.•
Check the expiration dates printed on the vial. When you first•
open a control solution vial, record the discard date (date opened
plus three months) in the space provided on the label.
Make sure your meter, test strips, and control solution are at room•
temperature before testing. Control Solution tests must be done
at room temperature (20 ~ 25˚C, 68 ~ 77˚F).
Before using the control solution, shake the vial, discard the first•
few drops and wipe the tip clean.
Close the control solution vial tightly and store at a temperature•
of 8 ~ 30˚C (46 ~ 86˚F).
Checking the System
Do a control solution test:
When using the meter for the first time.•
Whenever you open a new vial of test strips.•
If the meter or test strips do not function properly.•
If your symptoms are inconsistent with the blood glucose test results.•
and you feel that the meter or test strips are not working properly.
If you drop or damage the meter.•
[3] Press the Mor the CButton to select the
correct code number. Each time you press
the Mbutton, the number will increase by
one, and each time you press the CButton,
the number will decrease by one. Press and
hold the CButton to scroll code numbers
down.
[4] After selecting correct code number,
wait for three (3) seconds until the
symbol appears on display.
[5] When the symbol appears,
meter is ready for testing.

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[1] Insert test strip contact bars facing
up into the meter’s test strip port. Gently
push test strip into the port until meter
beeps. A code number will appear for
three (3) seconds.
The symbol will show on the display.
Confirm matching code numbers on
display and test strip bottle. If code
numbers do not match, see Coding Meter
to Match Test Strips on pages 19-20.
[2] Shake the bottle well.
Discard first drop of the
control solution.
Wipe off the bottle tip.
After the symbol
appears on the display,
apply the solution to
narrow top edge of the
test strip until the meter
beeps.
Perform the following steps to check the combined performance
of your CareSens II Meter and Test Strips or to assess proper testing
procedure performance.
The glucose level printed on the bottle is for the CareSens
Control Solution only.
It does not refer to your blood glucose level.
Testing Meter and Test Strip Performance
Discard the CareSens Control Solution after its expiration date
on the bottle or discard date, whichever comes first. Add three
(3) months to the date you open the bottle and write it on the
bottle label. This is the discard date. Do not use the solution
after the discard or expiration date, whichever comes first.
For accurate results:
Store control solution in tightly capped bottle at•
temperature 8-30°C /46-86°F.
Do not refrigerate or freeze.•
Keep the control solution, meter, and test strips at room•
temperature (20-25°C/68-77°F) for at least 30 minutes
before testing.
Do not use the control solution after the expiration or
discard date, whichever comes first. Only use CareSens
Control Solution to test CareSens Test Strips and the
CareSens II Meter.
CareSens Gloucose Control Solution
Storage and Handling
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.

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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:
When the control solution vial was not shaken well,•
When the control solution is past its expiration date or is•
contaminated,
When the meter, the strip or the control solution were•
exposed to high or low temperatures,
When the first few drops of the control solution were not•
discarded or the tip of the vial was not wiped clean,
When the test strip is past its expiration date,•
When the meter is not functioning properly.•
Comparing the Control Solution Test Results
The CareSens Control Solution can be purchased separately.
Please contact your authorized i-SENS sales representative.
[3] Test results appear after the meter
counts down from five-to-one (5-to-1).
To mark test result, press and hold the
CButton for three (3) seconds. Check
will appear on the display. Marked test
results will not be shown in your
averages.
[4] Compare results with range printed on
test strip bottle. If results fall within range,
you are ready to test your blood.
[5] Remove used test strip. The Meter will
turn off.

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[1] Wash hands and fingertip sample
site with soap and warm water.
Rinse and dry thoroughly.
[2] Unscrew lancing device tip.
[3] Firmly insert new lancet into carrier.
Hold lancet firmly. Gently twist to
pull off protective disk. Save disk to
recap lancet after use. Replace
lancing device tip.
Preparing the Lancing Device for
Blood Sample Retrieval
You will need a lancing device in order to collect a blood sample.
You may use the lancing device contained in the CareSens II Blood
Glucose Monitoring System or any other medically approved
lancing device.
Using the Lancing Device
The lancing device should be used by one individual and•
communal use is strongly discouraged.
Use a soft cloth or tissue to wipe the lancing device.•
If 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:
Do not use a lancet that has been used by others.•
Always use a new sterile lancet.•
Keep the lancing device clean.•
• Helpful Tip
Repeated puncturing at the same sample site may cause pain or
skin calluses. Choose a different site each time you test.
Adjustable Tip Ejection System
Sliding Barrel
Release Button
Lancet Holder

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[1] Place cocked lancing device
against fingertip side.
• Helpful Tip
Choose a different fingertip each time you retrieve a sample to
minimize discomfort.
Using the Lancing Device at Fingertip Sample Site
Abnormally viscous blood or insufficient amount of blood
may result in Er4 on the display after the measurement (See
Error Messages and Troubleshooting on page 44).
[2] Press release button. Massage
fingertip to obtain a round drop
(at least 0.5 ㎕, actual size: ) of
blood. Apply test strip tip to blood
sample.
[4] Select a desired depth of one-to-five
(1-5) on lancing device’s adjustable
tip. Rotate ring to align desired
number with the arrow.
A beginning setting of three (3) is
recommended.
[5] To cock the lancing device, hold the
tip in one hand. Pull the sliding
barrel with the other hand.
The lancing device is cocked when
you feel a click.
• Helpful Tip
The skin depth to retrieve samples will vary for various people at
different sample sites. The lancing device’s adjustable tip allows
the best depth of skin penetration for an adequate sample size.
A beginning setting of three (3) is recommended.

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If confirmation window has not filled in time because of
abnormal viscosity or insufficient volume, Er4 message will
appear.
If the confirmation window is not completely filled when results
appear, it is recommended that you perform a second test for
more accurate results.
• Helpful Tip
If the test strip dose not receive a blood sample, please contact your
authorized i-SENS sales representative.
[3] Meter will count down from five-to-one
(5-1) on the display. Test results, time,
and date will appear and automatically
store in meter memory. Remove used
test strip from the port. Meter will turn off
after three (3) seconds.
Completely
filled
Correct Poorly
filled
Incorrect
[2] Use lancing device to get blood sample. Sample must be at
least 0.5 ㎕(actual size: ) to fill the test strip reaction cell.
When the symbol appears on display, apply blood sample to
narrow top edge of test strip until meter beeps.
When testing from forearm, hold the meter as shown.
[1] Insert test strip with contact bars
facing up into a port. Push strip
gently until meter beeps. A code
number will appear for three (3)
seconds.
The symbol will appear.
Display code number should match
the one on the test strip bottle. If
not, see Coding Meter to Match
Test Strips on pages 19-20.
Testing Your Blood Glucose Levels

What is AST (Alternative Site Testing)?
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.
Alternative Site Testing
Alternative Site for Testing
333232
Alternative site and fingertip results may differ significantly due
to rapid changes in the glucose level after meals or exercise,
hypoglycemic symptoms, dehydration or effects of drugs such
as insulin. Rubbing the site before drawing the sample reduces
these differences. If you suffer from hypoglycemia or have
experienced hypoglycemic shock, secure blood samples from
your fingertips.
The meter will automatically turn off if a sample is not applied
within two (2) minutes. If this happens, remove the test strip
from the port. Reinsert the test strip to restart the meter.
Discard used test strips and lancets properly in a container
for sharp objects.

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AST Precautions
Do not ignore the symptoms of hyperglycemia or•
hypoglycemia.
When the results of the test do not reflect one’s opinion, retest•
using the fingertip test. If the test results do not reflect one’s
opinion, please consult a doctor.
Do not rely on the AST results for changing one’s treatment•
method.
The amount glucose in alternative sites differs from person to•
person.
Before using AST, please consult your regular physician.•
• Helpful Tip
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.
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.
Situations requiring fingertip test
Fasting period•
Before a meal•
Before sleeping•
Things to know when using AST
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.
Acceptable situations for AST
When the glucose levels are rapidly increasing during•
the two hours after a meal or exercise
When sick or when glucose levels seem quite lower•
than test value
When hypoglycemia is not well recognized•
When insulin has the biggest effect•
2 hours after an insulin injection•

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Target Blood Glucose Ranges
Source : Diagnosis of Diabetes, NIH Publication
No. 05-4642, January 2005
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.
Discarding Used Lancets
[1] Unscrew general lancing device tip.
[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 used lancet in a
proper biohazard container.
Proper discarding of used lancets protects you and others from
infection and injury. The following shows the correct process.
The lancet is for single use only. Never share or reuse a
lancet. Always dispose of lancets properly.