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

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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
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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.
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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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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.
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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
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[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