iSens CareSens PRO User manual

©2018 i-SENS, Inc. All Rights Reserved. PGL5E1006 REVA11/2018
i-SENS, Inc.
43, Banpo-daero 28-gil, Seocho-gu,
Seoul 06646, Korea
www.i-sens.com
Medical Technology Promedt
Consulting GmbH
Altenhofstrasse 80,
66386 St. Ingbert, Germany
Owner’s Booklet

Thank you for choosing the CareSens™ PRO Blood Glucose
Monitoring System. The system provides you with safe, fast, 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 (0.4 μL) blood sample.
Welcome to the CareSens™ PRO Blood Glucose
Monitoring System
• 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.

Table of Contents
Information
Important Information: Read This First! --------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- 4
Specifications ----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- 6
CareSens PRO Blood Glucose Monitoring System ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- 7
Inserting or Replacing the Batteries --------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- 8
Caring for Your System ---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- 9
CareSens PRO Blood Glucose Test Strip ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- 10
CareSens PRO Meter ---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- 12
CareSens PRO 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
Setting the Hypoglycemia (HYPo) Indicator ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- 19
Setting the Strip Expiration Date Indicator ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ 20
Checking the System ---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- 21
Control Solution Testing ----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- 22
Comparing the Control Solution Test Results -------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- 25
Testing
Using the Lancing Device ---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- 26
Blood Glucose Testing ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- 29
Alternate Site Testing ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ 34
HI and Lo Messages ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ 37
Target Blood Glucose Ranges ---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- 38
Transferring Test Results ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- 38
Additional Functions
Meter Memory ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ 39
Viewing Averages Stored in Memory ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- 39
Viewing Test Results Stored in Memory --------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- 42
Setting the Alarm Function ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- 43
Setting the Post-meal Alarm (PP2 alarm) ---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- 43
Setting the Time Alarms (alarm 1–3) -------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- 45
Maintenance
Understanding Error Messages ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- 47
General Troubleshooting ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- 49
Performance Characteristics --------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- 50
Warranty Information -------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- 54

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• Glucoseinbloodsamplesreactswiththechemicalinthe
test strip to produce a small electrical current. The CareSens
PRO meter detects this electrical current and measures the
amount of glucose in the blood sample.
• TheCareSensPROBloodGlucoseMeterisdesignedto
minimise code related errors in monitoring by using the
no-coding function.
• TheCareSensPROBloodGlucoseMetershouldbeused
only with the CareSens PRO Test Strips.
• Anabnormallyhighorlowredbloodcellcount(hematocrit
level over 65% or below 15%) may produce inaccurate
results.
• Ifyourbloodglucose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bloodglucoseresultsmayoccurinseverely
hypotensive individuals or patients in shock. Inaccurate low
blood glucose 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.
• 
Do not use during or within 24 hours of receiving xylose
absorption testing as it may cause inaccurate results.
If you need assistance, please contact your authorised i-SENS
sales representative or visit www.i-sens.com for more information.
Important Information: Read This First!
For optimum safety and benefits, please read the entire manual
contents before using the system.
Intended use:
CareSens PRO 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. Fresh venous whole
blood drawn by healthcare professionals can be used also.
CareSens PRO Blood Glucose Monitoring System should be used
only for self-testing outside the body (in vitro diagnostic use
only). CareSens PRO Blood Glucose Monitoring System should
not be used for the diagnosis of diabetes. Testing sites include
the traditional fingertip testing along with alternate site testing
on forearm and palm.
For in vitro diagnostic use
This product fulfills the requirements for Directive 98/79/EC
on in vitro diagnostic medical devices.
Cautions for safety and optimum product use
Do not discard this product with other household-type
waste
Use by
Authorised representative
Do not reuse Batch code
Consult instructions for use Manufacturer
Temperature limitation Serial number
Meaning of Symbols Used:

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CareSens PRO System includes the following items:
* CareSens PRO Blood Glucose Meter
* Owner's Booklet
* Batteries
Optional items:
* CareSens PRO Blood Glucose Test Strips
* Quick Reference Guide
* Lancets
* Lancing Device
* Logbook
* Carrying Case
• CheckallthecomponentsafteropeningtheCareSens
PRO 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 CareSens PRO Blood Glucose Monitoring System
Operating ranges
Storage Conditions
Product specification
Measurement range 10-600 mg/dL (0.56-33.3 mmol/L)
Sample size Minimum 0.4 μL
Test time 5 seconds
Sample type Fresh capillary whole blood
Fresh venous whole blood
(healthcare professionals only)
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 106 x 58 x 17 (mm)
Weight 71.8 g (with batteries)
Temperature 5-45˚C (41-113˚F)
Hematocrit 15-65%
Relative humidity 10-90%
Meter (with batteries) 0-50˚C (32-122˚F)
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.
The CareSens PRO 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 upwards
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.
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.

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•Donotreuseteststrips.
•Donotuseteststripspasttheexpirationordiscard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 PRO 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.
Warning!
• TheCareSensPROTestStripshouldbeusedwithfresh
capillary whole blood samples, or with fresh venous whole
blood if drawn by healthcare professionals.
• Freshvenouswholebloodspecimenscontainingthe
anticoagulants EDTA and Heparin are acceptable. Iodoacetate
or fluoride/oxalate are not recommended.
CareSens PRO Blood Glucose Test Strip
The CareSens PRO 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 upwards, 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 PRO Meter Display
Test results
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 : indicates that the
meter is in Control Solution Test Mode and
appears when the control solution test
results are saved or displayed
Decimal point
mmol/L, mg/dL : unit for blood glucose
alarm: appears when the time alarm has been set
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
2 3 54
6
10
9
8
1
14
11 12 13
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.
4
5
1
2
3
7
6
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 PRO 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
hereTest Strip Ejector
Slide down to
discard the used
strips
F009400D0092

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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 ◀or ▶button to change values. Press and hold the
◀or ▶button to scroll faster.
Step 1 Entering 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 ◀or ▶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 ◀or ▶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 ◀or ▶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 ◀or ▶button until the screen
displays the correct date. Press the S button
to confirm the date and to go to the next
step.
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 ◀or ▶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.

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Step 8
On pressing the ◀or ▶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 the sound is set to On:
•When you press 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 go to the next step.
Step 7 Setting the Minute
Press the ◀or ▶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 ◀or ▶button until the correct
hour appears.
After the hour is set, press the S button to
go to the next step.

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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 ◀or ▶button, the screen
will display 'On' or 'OFF'. Press the S button when 'On' appears
to enter the setting. Press the ◀or ▶button until the desired
hypoglycemia level between 10 and 90mg/dL (0.56–5.0 mmol/L)
appears. Press the S button to confirm the hypoglycemia level and
go to the next step.
Setting the Hypoglycemia (HYPo) Indicator
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.
HYPo warning
will blink at the
bottom.
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 ◀or ▶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
Note:
If the pre-set expiration date
is reached, the meter will
display 'EP' when the test strip
is inserted and when the test
result is displayed right after
the test.
If the expiration date is set to
October of 2020, the meter will
display 'EP' at the beginning of
November, 2020.

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Setting the Strip Expiration Date Indicator
Step 1 Entering the Expiration Date Setting
Press and hold the ◀ 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 2 Setting the Year
A number indicating the year will blink at the
bottom left corner of the screen. Press the
◀or ▶ 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
◀or
▶
button until the correct month appears.
Press and hold the
S button for 3 seconds to
confirm the month and turn off the meter.
Checking the System
You may check your meter and test strips using the
CareSens PRO Control Solution (Control L and/or H).
The CareSens PRO Control Solution contains a
known amount of glucose and is used to check that
the meter and the test strips are working properly.
The CareSens PRO test strip vials have CareSens
PRO Control Solution ranges printed on their labels.
Compare the result displayed on the meter to the
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 22–24.
Notes:
• UseonlytheCareSensPROControlSolutions.
• Checktheexpirationdateprintedonthebottle.Whenyoufirst
open a CareSens PRO 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).

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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oranewbox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.
Control Solution Testing
Step 1 Inserting Test Strip
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 Activating Control Solution Test Mode
Press and hold the ▶button for 3 seconds to
activate the Control Solution Test Mode. This will
also flag the control solution test result. To undo the
control solution flag, press and hold the ▶button
for another 3 seconds.
Step 3 Applying Control Solution to Test Strip
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 2 minutes of the symbol
appearing on the screen. If the meter turns off, remove the
strip, reinsert, and start from step 1.

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Step 4 Waiting for the Result
The display segments will rotate
clockwise and a test result will
appear after the meter counts
down from 5 to 1.
The test result with control
solution flag is stored in the
memory but not included in the
averages.
2.0-3.8 mmol/L
Control Solution Range
Control L: 101–151 mg/dL 5.6–8.4 mmol/L
Control H: 184–276 mg/dL10.3–15.3 mmol/L
Step 5 Comparing the Result
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
Control Solution only. It has nothing to do with your blood
glucose level.
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, the test strip and
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,
•Whenthecontrolsolutionis
contaminated.
Do This
Repeat the
control solution
test by referring
to the notes on
page 21.
Discard the used
control solution
and repeat the
test using a new
bottle of control
solution.
Note: The CareSens PRO Control Solution can be purchased
separately. Please contact your authorised i-SENS sales
representative.

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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
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
PRO 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.
Adjustable Tip Lancet Holder
Sliding Barrel
Release Button
Load Confirmation
Window
Ejection System
Lancet
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 in the diagram.
Preparing the Lancing Device

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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. You need a minimum volume
of 0.4 microliter for blood glucose test with CareSens PRO test
strip. (Actual size of 0.4 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
Blood Glucose Testing
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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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 7.
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.
Test result
Step 10
At this time, the display segments will rotate clockwise while the
blood is going in.
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.
Caution:
Do not allow any foreign substances, such as dirt, blood, or
water, enter into the meter. The meter may be damaged or
may malfunction. Follow the warning information provided
below to prevent possible damage to the meter.
•Donotapplythebloodsampledirectlytotheteststripport.
•Donotapplythebloodsampletotheteststripwhile
holding the meter in a way that the tip of the test strip faces
upwards. The blood sample may run down the surface of
the test strip and flow into the test strip port.
•Donotstoreyourmeterinunsanitaryorcontaminatedsites.

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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 blood glucose test result to indicate
particular situations while the strip is still in the meter. When
the result is displayed right after a test, press ◀or ▶button
to select a pre-meal flag ( ), a post-meal flag ( ), or a fasting
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
Step 1
Unscrew the lancing device tip.
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.

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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 0.4 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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HI and Lo Messages
HI Message
The meter displays blood glucose results
between 10–600 mg/dL (0.56–33.3 mmol/L).
'HI' appears when the blood glucose level is
greater than 600 mg/dL (33.3 mmol/L) and
indicates severe hyperglycemia (much higher
than normal glucose levels).
If 'HI' is displayed again upon retesting,
please contact your healthcare professional
immediately.
Lo Message
'Lo' appears when a blood glucose test
result is less than 10 mg/dL (0.56 mmol/L)
and indicates severe hypoglycemia (very
low glucose levels).
If 'Lo' is displayed again upon retesting,
please contact your healthcare professional
immediately.
AST Precautions
• BeforeusingAST,pleaseconsultyourhealthcare
professional.
• Donotignorethesymptomsofhyperglycemiaor
hypoglycemia.
• Whentheresultsofthetestdonotreflectyouropinion,
retest using the fingertip test. If the fingertip result still does
not reflect the way you feel, please consult your healthcare
professional.
• DonotrelyontheASTresultsforchangingyourtreatment
method.
• Theamountofglucoseinalternatesitesdiffersfromperson
to person.
Note:
• Resultsfromalternatesitesandfingertipsamplesmay
differ from each other as there is a time lag for the glucose
levels to reach the same value. Use a fingertip for testing
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 your palm, do not use that sample.
Try puncturing again in a smoother area. Note:
Please contact your authorised i-SENS sales representative if
such messages are displayed even though you do not have
hyperglycemia or hypoglycemia.