iSens CareSens II Plus User manual
• Rapid Test Result with Very
Small Size of Sample
• Efficient Diabetes
Management with
Tagging Symbols
• Hypoglycemia Indicator
• Stores 1,000 Test Results
in Memory
HYPO
©2017 i-SENS, Inc. All Rights Reserved. PGA1E3513 REV0 05/2017
i-SENS, Inc.
43, Banpo-daero 28-gil, Seocho-gu,
Seoul 06646, Korea
www.i-sens.com
Medical Technology Promedt
Consulting GmbH,
Altenhofstrasse 80, D-66386
St. Ingbert, Germany
• No part of this document may be reproduced in any form or by any
means without the prior written consent of i-SENS.
• The information in this manual is correct at the time of printing.
However, i-SENS reserves the right to make any necessary changes at
any time without notice as our policy is one of continuous
improvement.
Thank you for choosing the CareSens II Plus Blood Glucose Monitoring
System. The system provides you with rapid and convenient 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 µL) blood
sample.
Welcome to the CareSens II Plus
Blood Glucose Monitoring System
Table of Contents
Information
Important Information: Read This First! -------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- 4
Specifications ---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- 6
CareSens II Plus Blood Glucose Monitoring System ----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- 7
Inserting or Replacing the Batteries ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- 8
Caring for Your System -------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- 9
CareSens Blood Glucose Test Strip ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ 10
CareSens II Plus Blood Glucose Meter --------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- 12
CareSens II Plus Blood Glucose Meter Display -------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- 13
Preparation
Setting Up Your System ---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- 14
Adjusting the Date and Time ---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- 14
Setting the Sound On/OFF ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- 17
Turning on the Strip Expiration Date Indicator --------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- 18
Turning on the Hypoglycemia (HYPo) Indicator ---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- 19
Setting the Strip Expiration Date Indicator ----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- 20
Coding Meter to Match Test Strips -------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- 21
Checking the System ----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- 23
Control Solution Testing -------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- 24
Comparing the Control Solution Test Results -------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- 27
Testing
Using the Lancing Device --------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- 28
Preparing the Lancing Device ---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- 29
Preparing the Meter and Test Strip --------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- 31
Applying Blood Sample ---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- 31
Discarding Used Lancets --------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- 35
Alternate Site Testing ----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- 36
HI and Lo Messages ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- 39
Target Blood Glucose Ranges --------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- 40
Transferring Test Results Using Cable ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- 40
Additional Functions
Meter Memory ----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- 41
Viewing Averages Stored in Memory ----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- 41
Viewing Test Results Stored in Memory ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- 44
Setting the Post-meal Alarm (PP2 alarm) --------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- 45
Maintenance
Understanding Error Messages ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- 47
General Troubleshooting -------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- 49
Performance Characteristics ---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- 50
Warranty Information ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- 54
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Important Information: Read This First!
For optimum safety and benefits, please read the entire manual
contents before using the system.
Intended use:
CareSens II Plus Blood Glucose Monitoring System is used for the
quantitative measurement of the glucose level in capillary whole
blood as an aid in monitoring diabetes management effectively
at home or in clinical settings. CareSens II Plus Blood Glucose
Monitoring System should be used only for self-testing outside the
body (in vitro diagnostic use only). CareSens II Plus Blood Glucose
Monitoring System should not be used for the diagnosis of diabetes
or for testing newborns. Testing sites include the traditional fingertip
testing along with alternate site testing on forearm and palm.
For in vitro diagnostic use Authorised representative
This product fulfills the requirements for Directive 98/79/EC on in
vitro diagnostic medical devices
Cautions for safety and optimum product use
Use by (unopened or opened test strip vial)
Do not discard this product with other household-type waste
Do not reuse Batch code
Consult instructions for use Manufacturer
Temperature limitation Serial number
Meaning of Symbols Used:
• Glucose in blood samples reacts with the chemical in the test strip
to produce a small electrical current. The CareSens II Plus meter
detects this electrical current and measures the amount of glucose
in the blood sample.
• The CareSens II Plus blood glucose meter should be used only with
the CareSens Test Strips.
• An abnormally high or low red blood cell count (hematocrit level
over 65% or below 15%) may produce inaccurate results.
• If your test result is below 60 mg/dL (3.3 mmol/L) or above
240 mg/dL (13.3 mmol/L), consult a healthcare professional
immediately.
• Inaccurate results may occur in severely hypotensive individuals or
patients in shock. Inaccurate low results may occur for individuals
experiencing a hyperglycemic- hyperosmolar state, with or without
ketosis. Critically ill patients should not be tested with blood
glucose meters.
• Inaccurate results may occur in patients undergoing oxygen
therapy.
If you need assistance, please contact your authorised i-SENS sales
representative or visit www.i-sens.com for more information.
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CareSens II Plus Blood Glucose Monitoring System
CareSens II Plus BGM System includes the following items:
* CareSens II Plus Blood Glucose Meter
* Owner's Booklet
* Quick Reference Guide
* Batteries
Optional items:
* CareSens Blood Glucose Test Strips
* Lancets
* Lancing Device
* Logbook
* Carrying Case
• Check all the components after opening the CareSens II Plus Blood
Glucose Monitoring System package. The exact contents are listed
on the main box.
• The cable for data management software can be ordered separately.
Please contact your authorised i-SENS sales representative.
Specifications
Product specifications
Operating ranges
Storage Conditions
Measurement range 20–600 mg/dL (1.1-33.3 mmol/L)
Sample size Minimum 0.5 μL
Test time 5 seconds
Sample type Fresh capillary whole blood
Calibration Plasma-equivalent
Assay method Electrochemical
Battery life 3,000 tests
Power Two 3.0 V lithium batteries
(disposable, type CR2032)
Memory 1,000 test results
Size 91.5 x 45 x 15.9 (mm)
Weight 49.7 g (with batteries)
Temperature 5-45˚C (41-113˚F)
Relative humidity 10–90%
Hematocrit 15–65%
Glucose meter 0-50˚C (32-122˚F)
(with batteries)
Test strip 1-30˚C (34-86˚F)
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Caring for Your System
Use a soft cloth or tissue to wipe the meter exterior. If necessary, dip
the soft cloth or tissue in a small amount of alcohol.
Do not use organic solvents such as benzene or acetone, or household
and industrial cleaners that may cause irreparable damage to the
meter.
Caution:
• Do not expose the meter to direct sunlight, heat, or excessive
humidity for an extended period of time.
• Do not let dirt, dust, blood, or water enter into the meter’s test strip
port.
• Do not drop the meter or submit it to strong shock.
• Do not try to fix or alter the meter in any way.
• Strong electromagnetic radiation may interfere with the proper
operation of this device. Keep the device away from sources of
strong electromagnetic radiation, especially when measuring your
blood glucose.
• Store all the meter components in the carrying case to prevent loss
and help keep the meter clean.
Disposal of the meter
If you need to throw your meter away, you should follow
existing policies and procedures of your own country or region.
For information about correct disposal, please contact your
local council or authority. If you need assistance, contact your
authorised i-SENS sales representative or visit www.i-sens.com.
The CareSens II Plus meter uses two 3.0 V lithium batteries. Before
using the meter, check the battery compartment and insert batteries if
empty.
When the symbol appears on the display while the meter is in
use, the batteries should be replaced as soon as possible. The test
results may not be saved if the batteries run out.
Inserting or 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 used batteries one at a time. Slip
your index finger under the battery to lift and
pull out as shown. Insert two new batteries
with the + side facing up and make sure the
batteries are inserted firmly.
Step 3
Place the cover on the battery compartment.
Push it down until you hear the tab click into
place.
Note:
Removing the meter batteries will not affect your stored results.
However you may need to reset your meter
settings. See page 14.
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Warning!
• The CareSens Test Strips 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 vials and test strips in vials that have
been opened can be used up until the expiration date printed on
the test strip box and vial 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 between
1–30˚C (34–86°F).
• Keep test strips away from direct sunlight or heat and do not freeze.
• Store test strips only in their original vial.
• Close the vial tightly after taking out 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.
Caution:
• Keep the meter and testing supplies away from young children.
• Drying agents in the vial cap may be harmful if inhaled or
swallowed and may cause skin or eye irritation.
CareSens Blood Glucose Test Strip
The CareSens II Plus 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.
Insert
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
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CareSens II Plus Blood Glucose Meter Display
Test results : test results displaying panel
Memory recall mode : appears when test
results stored in the memory are displayed
PP2 alarm : appears when the post-meal
alarm has been set
Mute symbol : appears only when the
sound is set to OFF
Control Solution flag : appears when the
control solution test results are saved or
displayed
Decimal point : appears when the blood
glucose measuring unit is set to mmol/L
mmol/L, mg/dL : unit for measuring blood glucose
code : appears when a code number is displayed on the screen
Battery symbol : indicates meter battery is running low and needs
to be replaced
Blood insertion symbol : indicates meter is ready for the application
of a drop of blood or control solution
Pre-meal test flag : used for tests done before eating
Post-meal test flag : used for tests done after eating
Fasting test flag : used for tests done after fasting for at least 8
hours
Month/Day/Hour/Minute
10
12
7
8
9
11
13
14
Note:
It is recommended to check if the display screen on the meter
matches the illustration above every time the meter turns on. Do
not use the meter if the display screen does not exactly match the
illustration as the meter may show incorrect results.
Note:
• The cable for data management software can be ordered
separately. Please contact your authorised i-SENS sales
representative.
• The unit of measurement is fixed and it cannot be changed by the
user.
CareSens II Plus Blood Glucose Meter
Display
Shows results,
messages
S Button
Turns the meter
on/off, confirms
menu selections,
and changes
information
Data Port
Used to transfer data
from the meter to
a computer with a
cable
▶Button
Turns the meter on,
selects or changes
information
Test Strip Port
Insert test strip
here
2
1
87
11 12 13 10
9
6
3 4 5
14
1
2
3
4
5
6
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Step 5 Setting the Time Format
The meter can be set in the AM/PM 12-hour or the
24-hour clock format.
Press the ▶button to select a format. The AM•PM
symbol is not displayed in the 24-hour format. After
selecting the format, press the S button to go to the
next step.
Setting Up Your System
Press and hold the S button for 3 seconds to enter SET mode. After all
settings are finished, press and hold the S button for 3 seconds to turn
off the meter.
Press the ▶button to change values. Press and hold the ▶button to
scroll faster.
Step 1 Entering the SET Mode
Press and hold the S button for 3
seconds to enter SET mode. After all
the segments flash across the screen,
‘SET’ will show up.
Press the ▶button to select 'YES' and
press the S button to go to the next
step.
Adjusting the Date and Time
Step 2 Setting the Year
Press the ▶button to adjust until the correct year
appears. When the present year appears, press the
S button to confirm your selection and to go to the
next step.
Step 3 Setting the Month
A number indicating the month will blink on the
screen.
Press the ▶button until the correct month appears.
Press the S button to confirm your selection and to
go to the next step.
Step 4 Setting the Date
Press the ▶button until the screen displays the
correct date. Press the S button to confirm the date
and to go to the next step.
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Step 7 Setting the Minute
Press the ▶button until the correct minut appears.
After setting the minute,
press the S button to go to the next step.
Step 6 Setting the Hour
Press the ▶button until the correct hour appears.
After the hour is set, press the S button to go to the
next step.
Step 8
On pressing the ▶button, the screen will display
'On' or 'OFF'. Press the S button to confirm the
selection.
The meter will beep in the following instances if
set to On.
• When you push a button to turn on the meter
• When the test strip is inserted in the meter
• When the blood sample is absorbed into the
test strip and the test starts
• When the test result is displayed
• When you press and hold the ▶ button to set
the post-meal (PP2) alarm
• When it is time for a pre-set blood glucose test
Setting the Sound On/OFF
Note:
The symbol is displayed only when the sound is set to OFF.
If the sound is set to OFF, none of the sound functions will work.
After setting the sound, press the S button to progress to the next step.
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Caution:
Ask your healthcare professional to help you decide what your
hypoglycemia level is before setting your level.
Note:
If the test result is lower than the
pre-set hypoglycemia level, the
meter will display the following.
Note:
If the pre-set expiration date
expires, the meter will display EP
when the test strip is inserted. EP
shows alternately also when the
test result is displayed right after
the test.
If the expiration date is set to
October of 2019, the meter
will display EP at the start of
November, 2019.
Step 9
This setting allows you to turn the strip expiration date indicator on or
off. This setting turns the function on or off only. See page 20 to set the
strip expiration date.
When 'EP' appears on the screen, press the ▶button. The screen will
display 'On' or 'OFF'. Press the Sbutton to confirm the setting.
If you do not want to set the indicator, press the Sbutton while the
screen displays 'OFF'.
Turning on the Strip Expiration Date Indicator
Step 10
This setting allows you to turn the hypoglycemia indicator (possible
low blood sugar) On or OFF and to select the desired level for the
indicator. You will be alerted any time your test result is lower than
the selected level. On pressing the ▶button, the screen will display
'On' or 'OFF'. Press the S button when 'On' appears to enter the setting.
Press the ▶button until the desired hypoglycemia level between 20
and 90 mg/dL (1.1–5.0 mmol/L) appears. Then, press the S button to
confirm the level and to return to step 2. See page 14.
Turning on the Hypoglycemia (HYPo) Indicator
HYPo
warning
will blink
on the left
bottom
corner.
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Setting the Strip Expiration Date Indicator Coding Meter to Match Test Strips
Step 1 Entering the Expiration Date Setting
Press and hold the S and ▶buttons at the same time for 3 seconds to
enter the expiration date settings. After all segments flash across the
screen, 'EP' will show up.
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 bend the
strip while pushing it in.
Code number 1 will appear when the meter is
used for the first time.
Step 2
The code number on the screen and test strip
vial 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 number on the CareSens II Plus 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 vial of
test strips. The code number on the meter display must match the one
on the test strip vial.
Step 2 Setting the Year
A number indicating the year will blink in the left
corner of the screen. Press the ▶button until the
correct year appears.
Press the S button to confirm the year and set the
month.
Note:
The strip expiration date is printed on the test strip vial.
Step 3 Setting the Month
A number indicating the month will blink at the
bottom of the screen. Press the ▶button until the
correct month appears. After setting, press and hold
the S button for 3 seconds to turn off the meter.
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Notes:
• Use only the CareSens Control Solution (available for purchase
separately).
• Check the expiration date printed on the bottle. When you first open
a control solution bottle, record the discard date (date opened plus
three (3) 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 bottle, discard the first
few drops and wipe the tip clean.
• Close the control solution bottle tightly and store at a temperature
between 8–30˚C (46–86°F).
You may check your meter and test strips using the
CareSens Control Solution (control A, B and/or C).
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,
you may conduct a control solution test following the
procedure on pages 24–26.
Caution:
If the meter is not correctly coded, you will get inaccurate results.
Step 3
Press the Sor ▶button to select the
correct code number. Each time you press
the ▶button, the number will increase by
one, and each time you press the Sbutton,
the number will decrease by one. Press
and hold the ▶button to quickly scroll
through the numbers.
After selecting correct code number, wait
for three (3) seconds until the
symbol appears on the screen.
If the symbol appears before you
select the correct code number, remove
the strip and reinsert it, and then start from
Step 3.
When the symbol appears, meter is
ready for testing.
Checking the System
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Step 3
Shake the bottle before each test.
Remove the cap and squeeze the
bottle to discard the first drop. Then
wipe the tip with a clean tissue or
cloth. Dispense a drop of control
solution onto a clean non-absorbent
surface. It helps to squeeze a drop
onto the top of the cap as shown. 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.
Note:
The meter may switch off if the control solution sample is not applied
within 5 minutes of the symbol appearing on the screen. If the meter
turns off, remove the strip, reinsert, and start from Step 1.
Control Solution Testing
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 bend the strip
while pushing it in.
The symbol will show up.
Step 2
You can flag the control solution test result by
pressing the ▶button for 3 seconds. To undo the
control solution flag, press the ▶button for 3
seconds again.
You may do a control solution test:
• When you want to practice the test procedure using the control
solution instead of blood
• 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
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Comparing the Control Solution Test Results
The test result of each control solution should be within the range
printed on the label of the test strip vial. Repeat the control solution
test if the test result falls outside of the range. Out of range results may
occur in following situations:
If results continue to fall outside the range printed on the test strip
vial, the CareSens Test Strip and CareSens II Plus meter may not be
working properly. Do not use your system and contact i-SENS sales
representative.
Situations
• When the control solution bottle was not
shaken well,
• When the meter, test strip, or the control
solution were exposed to high or low
temperatures,
• When the first drop of the control solution was
not discarded or the tip of the bottle was not
wiped clean,
• When the meter is not functioning properly.
• When the control solution is past the
expiration date printed on the bottle,
• When the control solution is past its discard
date (the date the bottle was opened plus
three (3) months),
• When the control solution is contaminated.
Do This
Repeat the
control solution
test by referring
to the notes on
page 23.
Discard the used
control solution
and repeat the
test using a new
bottle of control
solution.
Step 4
The display segments will rotate
clockwise and a test result will
appear after the meter counts down
from 5 to 1.
When flagged, the result is stored
in the meter's memory but it is not
included in the averages.
Step 5
Compare the result displayed on the meter
to the range printed on the test strip vial.
The result should fall within the range.
Caution:
The range printed on the test strip vial is for the CareSens Control
Solution only. It has nothing to do with your blood glucose level.
Control Solution Range
Control A: 101–151 mg/dL (5.6–8.4 mmol/L)
Control B: 184–276 mg/dL (10.2–15.3 mmol/L)
Note:
The CareSens Control Solution can be purchased separately. Please
contact your authorised i-SENS sales representative.
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Step 1
Wash hands and sample site with soap and
warm water. Rinse and dry thoroughly.
Step 2
Unscrew and remove the lancing
device tip.
Step 3
Firmly insert a new lancet into the lancet
holder. Hold the lancet firmly. Gently twist
to pull off protective disk. Save disk to recap
lancet after use. Replace lancing device tip.
Step 4
Turn the adjustable tip until it is aligned with
the load confirmation window and release
button as shown.
Preparing the Lancing Device
Caution:
To avoid infection when drawing a sample, do not use a lancet more
than once, and:
• Do not use a lancet that has been used by others.
• Always use a new sterile lancet.
• Keep the lancing device clean.
Note:
Repeated puncturing at the same sample site may cause pain or skin
calluses (thick hard skin). Choose a different site each time you test.
Using the Lancing Device
Adjustable Tip Lancet Holder
Sliding Barrel
Release Button
Load Confirmation
Window
Ejection System
Lancet
You will need a lancing device in order to collect a blood sample.
You may use the lancing device that is included in the CareSens II Plus
Blood Glucose Monitoring System or any other medically approved
lancing device.
• The lancing device is for use by a single user only and should not be
shared with anyone.
• 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.
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Step 8
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 confirmation window. (Actual size of 0.5 μL: )
Applying Blood Sample
Step 7
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.
Preparing the Meter and Test Strip
Step 5
The lancing device has six puncture depth
settings (0 for a shallow puncture, 5 for a
deeper puncture). Choose a depth by rotating
the top portion of the adjustable tip until the
desired number aligns with the arrow.
Step 6
To cock the lancing device, hold the body
of lancing device in one hand and pull the
sliding barrel with the other hand. The device
is loaded when you feel a click and the load
confirmation
window turns red.
Note:
The skin depth to get blood samples will vary for various people at
different sample sites. The lancing device's adjustable tip allows the
best depth of skin penetration to get an adequate sample size.
Note:
0 = a shallow puncture for softer skin
5 = a deeper puncture for thick or calloused skin
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Step 10
Apply the blood sample to the narrow end of the test strip until you
hear a ‘beep’. At this time, the display segments will rotate clockwise
while the blood is going in.
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.
It is recommended to place the test strip vertically into the blood
sample site as shown below.
Note:
The meter may switch off if the blood sample is not applied within 2
minutes of the symbol appearing on the screen. If the meter
turns off, remove the strip and reinsert it, and start from Step 2.
Step 9
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 in time because of abnormal
viscosity (thickness and stickiness) or insufficient volume, the Er4
message may appear.
Good Sample Insufficient
Sample Test result
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Step 2
Stick the lancet into the saved protective
disk.
Push the lancet ejector forward with the
thumb to dispose of the used lancet in a
proper biohazard container.
Step 1
Unscrew the lancing device tip.
Discarding Used Lancets
Caution:
The lancet is for single use only. Never share or reuse a lancet.
Always dispose of lancets properly.
Step 11
You can attach a flag to a result to indicate particular situations while
the strip is still in the meter. When the result is displayed right after
a test, press the Sor ▶button to select a pre-meal flag ( ), a post-
meal flag( ), a fasting flag( ), or a control solution flag( ). When
you remove the test strip while the desired flag is blinking, the test
result is stored with the flag.
If you do not want to add any flags on the test result, remove the strip
after the test result is displayed.
No flag Pre-meal flag Post-meal flag
Fasting flag Control solution flag
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Things to Know When Using AST
Please read the following before testing at alternate sites (forearms
and palms).
The capillary whole blood of the fingertips reflects changes in glucose
levels more rapidly than in alternate sites. The test results from the
fingertip testing and AST may differ due to factors such as lifestyle and
ingested food which affect glucose levels.
Acceptable Situations for AST
When your blood glucose levels are stable
• Fasting period
• Before a meal
• Before going to bed
Situations Requiring Fingertip Test
When your blood glucose levels are unstable
• During two (2) hours after a meal or exercise
• When sick or when glucose levels seem quite lower than test value
• When hypoglycemia is not well recognised
• When insulin has the biggest effect
• During two (2) hours after an insulin injection
Alternate Site Testing
What is AST (Alternate Site Testing)?
Usually, we take the blood sample from the tip of the finger. However,
since there are many nerve endings in the fingertip, it can be quite
painful.When doing a glucose test, using different parts of the body
such as the forearms and palms can reduce the pain during testing.
This method of testing with different parts of the body is called
Alternate 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.
Alternate Sites for Testing
Alternate Site Blood Sampling (forearm and palm)
Select a clean, soft and fleshy sample site area free of visible veins and
hair and away from bones. Gently massage the sample site to help
blood circulation to minimise result differences between fingertip
and alternate site sampling. Firmly press and hold the lancing device
against site. Wait until the skin surface under the lancing device
changes color. Then press the release button while continuing to
apply pressure. Keep holding the lancing device against your skin
until sufficient (at least 0.5 μL, actual size: ) blood is drawn. Carefully
lift the lancing device away from your skin.
Before using AST, please consult your healthcare professional.
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