iSens CareSens N Voice User manual

Owner’s Booklet
i-SENS, Inc.
27-36, Gwangun-ro, Nowon-gu
Seoul 139-845, Korea
www.i-sens.com
Australian distributor:
Pharmaco (Australia) Limited
Gordon, NSW 2072
Phone: [phone]
Website: www.caresens.com.au
© 2014 i-SENS, Inc. All Rights Reserved PGJ5E3017 REV2 04/2014
NZ Distributor:
Pharmaco (NZ) Ltd
Auckland
Phone: 0800 GLUCOSE (0800 458267)
Website: www.caresens.co.nz

Thank you for choosing the CareSens N 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 N
Blood Glucose Monitoring System

Information
Important Information:Read This First! 4
Specifications 6
CareSens N Blood Glucose Monitoring System 7
Inserting or Replacing the Batteries 8
Caring for Your System 9
CareSens N Blood Glucose Test Strip 10
CareSens N Blood Glucose Meter 12
CareSens N Blood Glucose Meter Display 13
Preparation
Setting up Your System 14
Adjusting the Date and Time 14
Setting the Sound On/OFF 17
Checking the System 18
Control Solution Testing 19
Comparing the Control Solution Test Results 21
Testing
Using the Lancing Device 22
Preparing the Lancing Device 23
Preparing the Meter and Test Strip 25
Marking Post-meal Test Results 25
Applying Blood Sample 26
Discarding Used Lancets 28
Alternative Site Testing 29
HI and Lo Messages 32
Target Blood Glucose Ranges 33
Transferring Test Results 34
Additional Functions
Meter Memory 35
Viewing Averages Stored in the Meter’s Memory 35
Viewing Test Results Stored in the Meter’s Memory 37
Setting the Alarm Function 38
Setting the Post-meal alarm (PP2 alarm) 38
Setting the Time Alarm (alarm 1 ~ 3) 39
Maintenance
Understanding Error and Other Messages 41
General Troubleshooting 43
Performance Characteristics 44
Warranty Information 46
Table of Contents

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Important Information:Read This First!
To receive optimum system benefits, please read the entire
manual contents before using the system. Please note the
following instructions:
Intended use:
CareSens N 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 N Blood Glucose Monitoring System should be used
only for self-testing outside the body (in vitro diagnostic use only).
CareSens N 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 sites testing on forearm, palm, thigh and calf.
•    The CareSens N Blood Glucose Monitoring System
is intended for self-testing outside the body (in vitro
diagnostic use).
•    The glucose in the blood sample mixes with special
chemicals on the test strip to produce a small electrical
current. The CareSens N meter detects this electrical
current and measures the amount of glucose in the blood
sample.
•    The CareSens N Blood Glucose Meter is designed to
minimize code related errors in monitoring by using the
no-coding function.
•  The CareSens N Blood Glucose Meter should be used only
with the CareSens N test strip.
• Anabnormallyhighorlowredbloodcellcount(hematocrit
level over 60% or below 20%) may produce inaccurate
results.
• Ifyourtestresultisbelow3.3mmol/Lorabove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.1
If you need assistance, please contact your authorized i-SENS
sales representative.
Reference 1. American Diabetes Association. “Standards of Medical Care in
Diabetes –2012.” Diabetes Care. January 2012; 35(1):S11-S63.
Important Information
The following chart explains the symbols you’ll find in the
CareSens N Owner’s Booklet, product packaging, and product
inserts.
For in vitro diagnostic use
This product fulfills the requirements for Directive 98/79/EC
on in vitro diagnostic medical devices
Cautions for safety and optimum product use
Use by (unopened or opened test strip vial)
Do not reuse Batch code
Consult instruction for use Manufacturer
Temperature limitations Serial number
Do not discard this product with other household-type
waste

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Specifications CareSens N Blood Glucose Monitoring System
• CheckallthecomponentsafteropeningtheCareSensNblood
glucose monitoring system package. The exact contents are
listed on the main box.
• Thedatatransmissioncablecanbeorderedseparately.
Please contact your authorised i-SENS sales representative.
04
05
06
07
08
09 03
01
02
10
• Productspecifications
• Operatingranges
Reported result range 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 5,000 tests
Power Two 3.0 V lithium batteries
(disposable, type CR2032)
Memory 500 test results
Size 93 X 47 X 15 (mm)
Weight 51.5 g (with batteries)
Temperature 5-50˚C
Relative humidity 10-90%
Hematocrit 20-60%
Components
CareSens N Blood Glucose Meter
CareLance (Lancing Device)
Lancets (50)
Owner’s Booklet
Quick Reference Guide
Logbook
01
02
03
04
05
06
Registration Card
Carrying Case
CareSens N Blood Glucose
Test Strips (10)
Batteries (2)
07
08
09
10

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The CareSens N 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 completely.
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 old batteries one by one by
lifting with the index finger and pulling it
out with your thumb and index fingers as
shown in the diagram on the right. 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 down until you hear the
tab click into place.
Note: Removing the meter batteries will not affect your
stored result. However, you may need to reset your meter
settings. See pages 14-16 .
Caring for Your System
Use a soft cloth or tissue to wipe the meter exterior. If necessary,
the soft cloth or tissue might be dipped 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shocks.
• Donottrytofixoralterthemeterinanyway.
• Keepthemeterawayfromstrongelectromagneticfields
such as cell phones and microwave ovens.
• CareSensNmetershouldbeusedonlywithCareSensNtest
strips.
• Storeallthemetercomponentsintheportablecaseto
prevent loss and help keep the meter clean.

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CareSens N Blood Glucose Test Strip
The CareSens N blood glucose monitoring system measures
blood glucose quickly and accurately. It automatically absorbs
the small blood sample applied to the narrow edge of the strip.
Contact bars
Gently push the test strip, with its
contact bars facing up, into the test
strip port of meter
Confirmation window
Check here to see whether sufficient
blood sample has been applied
Edge to apply blood sample
Apply blood sample here for testing
Insert
Warning!
• TheCareSensNTestStripshouldbeusedonlywithfresh
capillary whole blood samples.
• Donotreuseteststrips.
• Donotuseteststripspasttheexpirationdate.
• Teststripsinnew,unopened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of
1-30˚C.
• 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 N Test Strip package insert.
Caution:
• Keepthemeterandtestingsuppliesawayfromyoung
children.
•Theteststripvialcontainsdryingagentsthatareharmfulif
inhaled or swallowed and may cause skin or eye irritation.

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CareSens N Blood Glucose Meter
Data Port
Used to transfer data
from the meter to a
computer with
the cable available
from your
authorised i-SENS
representative
Button
Selects or changes
information
Display
Shows results,
messages
Test Strip Port
Insert test strip here
Button
Selects or
changes
information
Note: The cable for data transmission to PC can be ordered
separately. Please contact your authorised i-SENS sales
representative. Note: The unit of measurement is fixed in mmol/L and it
cannot be changed to mg/dL by the user.
mem
appears when test
results stored in
the memory are
displayed
alarm
appears when the
time alarm has been
set
Battery symbol
indicates meter
battery is running
low and needs to be
replaced
Post-meal test flag
appears during post-
meal testing and
when post-meal test
results are displayed
Alarm symbol
appears when the
post-meal alarm has
been set
mmol/L
unit for measuring
blood glucose
Sound symbol
appears only when
the sound is set to
OFF
check
appears when the
control solution test
results are saved or
displayed
Test results
test results displaying
panel
Decimal point
appears when the
blood glucose
measuring unit is set
to mmol/L
mg/dL
unit for measuring
blood glucose
CareSens N Blood Glucose Meter Display
Month
Day
Hour
Minute
S Button
Turns the meter
on/off, confirms
menu selections,
and changes
information
Blood insertion symbol
indicates meter is ready for
the application of a drop of
blood or control solution

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Setting up Your System
Press and hold the Sbutton for 3 seconds to enter the SET
mode. After all settings are finished, press and hold the Sbutton
for 3 seconds to turn off the meter.
Press or to reach the correct value. Press and hold to scroll
faster.
Adjusting the Date and Time
Step 1 Entering the SET Mode
Press and hold the Sbutton for 3 seconds
to enter the SET mode. After all the
segments flash across the screen, the ‘SET’
character will be displayed on the screen.
Press the Sbutton again to progress to
setting the year.
Step 2 Setting the Year
Press and release or to adjust until
the correct year appears. Press and hold
button to scroll through the numbers
quickly. After setting the year, press the
Sbutton to confirm your selection and
progress to setting the month.
Step 3 Setting the Month
A number indicating the month will be
blinking on the left corner of the screen.
Press or until the correct month appears.
Press the Sbutton to confirm your selection
and progress to setting the date.
Step 4 Setting the Date
Press or until the screen displays the
correct date. Press the Sbutton to confirm
the date and progress to setting the time.
Step 5 Setting the Time
The meter can be set in the AM/PM 12-hour
or the 24-hour clock format. Press or to
selectaformat.TheAM•PMsymbolisnot
displayed in the 24-hour format.
After selecting the format, press the Sbutton
to progress to setting the hour.

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Step 6 Setting the Hour
Press or until the correct hour appears.
After the hour is set, press the Sbutton to
progress to setting the minute.
Step 7 Setting the Minute
Press or until the correct minute
appears. After setting the minute, press
the Sbutton to progress to setting the
sound.
Step 8
On pressing or , the screen will display
On or OFF. Press the Sbutton to confirm
the selection.
The meter will beep in the following instances,
if set to On.
•When you push the Sbutton or 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 push the button to set the
post-meal (PP2) alarm
•When it is time for a preset blood glucose test
If the sound is set to OFF, none of the sound
functions will work.
To confirm all settings, press and hold the Sbutton and the
screen will switch off.
Setting the Sound On/OFF
Note:
•Only when the sound is set to OFF, symbol appears on
the display.
•At any stage, if the Sbutton is pressed for 3 seconds, Time
and Date setting mode will finish and the meter will be
turned off. Press and hold to scroll through numbers
quickly.