iSens CareSens N Pop User manual

©2014 i-SENS, Inc. All Rights Reserved PGC8E3018 REV0 11/2014
The Biosensor Expert
Medical Technology Promedt
Consulting GmbH, Altenhofstrasse 80,
D-66386 St. Ingbert, Germany
i-SENS, Inc.
27-36, Gwangun-ro, Nowon-gu
Seoul 139-845, Korea
www.i-sens.com
Owner's Booklet
Spirit Healthcare Ltd.
Spirit House, Selbury Drive, Oadby,
Leicester, LE2 5NG
Customer Support Tel : [phone]
www.spirit-healthcare.co.uk
®
®

Thank you for choosing the CareSens N POP 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 (0.5 μL) blood sample.
* 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.
Welcome to the CareSens N POP
Blood Glucose Monitoring System

Table of Contents
Information
Important Information:Read This First! 4
Specifications 6
CareSens N POP Blood Glucose Monitoring System 7
Inserting or Replacing the Batteries 8
CareSens N Blood Glucose Test Strip 9
CareSens N POP Blood Glucose Meter 11
CareSens N POP Blood Glucose Meter Display 12
Preparation
Setting Up Your System 13
Adjusting the Date and Time 13
Setting the Sound On/OFF 16
Turning on the Strip Expiration Date Indicator 17
Turning on the hypoglycaemia (HYPo) Indicator 18
Checking the System 19
Control Solution Testing 20
Comparing the Control Solution Test Results 22
Testing
Using the Lancing Device 23
Preparing the Lancing Device 24
Preparing the Meter and Test Strip 26
Marking Post-meal Test Results 26
Applying Blood Sample 27
Discarding Used Lancets 29
Alternative Site Testing 30
HI and Lo Messages 33
Target Blood Glucose Ranges 34
Transferring Test Results 35
Additional Functions
Meter Memory 36
Viewing Averages 36
Viewing Test Results 38
Setting the Post-meal Alarm (PP2 Alarm) 39
Setting the Strip Expiration Date Indicator 40
Maintenance
Caring for Your System 42
Understanding Error and Other Messages 43
General Troubleshooting 45
Performance Characteristics 46
Warranty Information 50

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Important Information:Read This First!
To receive safe and optimum system benefits, please read the
entire manual contents before using the system. Please note the
following instructions:
Intended use:
CareSens N POP 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 POP
Blood Glucose Monitoring System should be used only for
self-testing outside the body (in vitro diagnostic use only).
CareSens N POP 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POPBloodGlucoseMonitoringSystemis
intended for self-testing outside the body (in vitro diagnostic
use).
• Glucoseinbloodsamplesreactswiththechemicalinthe
test strip to produce a small electrical current.
• TheCareSensNPOPBloodGlucoseMeterisdesignedto
minimize code related errors in monitoring by using the
no-coding function.
• TheCareSensNPOPBloodGlucoseMetershouldbeused
only with the CareSens N Test Strips.
• Anabnormallyhighorlowredbloodcellcount(haematocrit
level over 65% or below 15%) 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.
• 
Alternative site and fingertip test results may differ
significantly due to rapid change in the blood glucose level
after meal, insulin injection, or exercise.
•  Inaccurate results may occur in severely hypotensive
individuals or patients in shock. Inaccurate low results
may occur for individuals experiencing a hyperglycaemic-
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 the Spirit Healthcare 24/7
Freephone Support Line at 0800 881 5423 or go to www.spirit-
healthcare.co.uk.
Important Information
The following chart explains the symbols you’ll find in the
CareSens N POP 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 discard this product with other household-type
waste
Authorised representative
Do not reuse Batch code
Consult instruction for use Manufacturer
Temperature limitations Serial number

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Specifications CareSens N POP Blood Glucose Monitoring System
• 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 2,000 tests
Power Two 3.0 V lithium batteries
(disposable, type CR2032)
Memory 1,000 test results
Size 95 X 33 X 19 (mm)
Weight 41.4 g (with batteries)
Temperature 5-50˚C (41-122°F)
Relative humidity 10-90%
Haematocrit 15-65%
Components
1. CareSens N POP Blood Glucose Meter
2.
CareSens N Blood Glucose Test Strips
3. CareLance(Lancing Device)
4. Lancets
5. Owner’s Booklet
6. Quick Reference Guide
7. Logbook
8. Carrying Case
9. Batteries
10. Patient Guarantee Card
11. Customer Support Line Card
12. Prescription Order References
• CheckallthecomponentsafteropeningtheCareSensNPOP
Blood Glucose Monitoring system package.
• PleasecontacttheSpiritHealthcare24/7FreephoneSupport
Line for a free data transmission cable at 0800 881 5423 or go
to www.spirit-healthcare.co.uk.

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The CareSens N POP 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.
Press down and slide off the battery
compartment cover.
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
in place.
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 13.
CareSens N Blood Glucose Test Strip
The CareSens N POP 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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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 (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 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.
Note: Please contact the Spirit Healthcare 24/7 Freephone
Support Line for a free data transmission cable at 0800 881
5423 or go to www.spirit-healthcare.co.uk.
CareSens N POP Blood Glucose Meter
Data Port
Used to transfer data
from the meter to
a computer with
a cable
S Button
Turns the meter on/off,
confirms menu selections,
and changes information
Display
Shows results,
messages
Test Strip Port
Insert test strip
here
>> Button
Selects or
changes
information

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Test results : test results
displaying panel
Battery symbol : indicates
meter battery is running
low and needs to be
replaced
mem : appears when test results stored in the memory are
displayed
alarm : appears when the post-meal alarm has been set
check : appears when the control solution test results are
displayed
hypoglycaemia symbol : appears when the test result is
below the hypoglycaemic level
Mute symbol : appears only when the sound is set to OFF
Post-meal test flag : appears during post-meal testing and
when post-meal test results are displayed
Day / Month / Hour / Minute
Temperature symbol : displays recorded temperature when
blood glucose levels are tested
Blood insertion symbol : indicates meter is ready for the
application of a drop of blood or control solution
Decimal point : appears when the blood glucose measuring
unit is set to mmol/L
mmol/L : unit for measuring blood glucose
Setting Up Your SystemCareSens N POP Blood Glucose Meter Display
10
12
4
5
6
7
8
9
13
Press and hold the button for 3 seconds to enter the SET
mode. After all settings are finished, press and hold the
button for 3 seconds to turn off the meter.
Press to reach the accurate value. Press and hold to
scroll faster.
It is recommended to check if the display screen on the meter
matches the illustration below 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.
Adjusting the Date and Time
Step 1 Entering the SET Mode
Press and hold the button 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 button again to progress to
setting the year.
Step 2 Setting the Year
Press and release to adjust until the
correct year appears. After setting the
year, press the button to confirm
your selection and progress to setting the
month.
1
12
2 3
4
5
6
78
9
13
10
11
Note: The unit of measurement is fixed in mmol/L and it
cannot be changed to mg/dL by the user.
1
2
3
11

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Step 3 Setting the Month
A number indicating the month will be
blinking on the left corner of the screen.
Press until the correct month
appears. Press the button to
confirm your selection and progress to
setting the date.
Step 7 Setting the Minute
Press until the correct minute
appears.
After setting the minute, press the
button to progress to setting the sound.
Step 4 Setting the Date
Press until the screen displays the
correct day. Press the button to
set the date and progress to setting the
time.
Step 5 Setting the Time Format
The meter can be set in the AM/PM
(12-hour) or the 24-hour clock format.
Press to select a format. The
AM•PMsymbolisnotdisplayedinthe
24-hour format. After selecting the format,
press the button to progress to setting
the hour.
Step 6 Setting the Hour
Press until the correct hour appears.
After the hour is set, press the
button to progress to setting the
minute.

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Setting the Sound On/OFF
Note:
• symbol is displayed only when the sound is set to OFF.
•At any stage, press the button for 3 seconds to exit SET
mode and turn off the meter. Press and hold to quickly
scroll through the numbers.
Step 9
This mode allows you to turn the
strip expiration date indicator on or
off.
When “EP” blinks on the screen,
press . The screen will display
“On” or “OFF”. Press the button
to confirm the setting and move to
the next mode.
This mode turns the function on or
off only. See page 40 to set the strip
expiration date.
Turning on the Strip Expiration Date Indicator
Note: If the pre-set expiration date
expires, the meter will display the
following. For example, in the case
when the expiration date is set to
October of 2017, the meter displays
"EP" at the start of November of 2017.
Step 8
On pressing , the screen will
display the On or OFF. Press the
button to confirm the selection.
The meter will beep in the following
instances, if set to On.
•When you push the button 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 button and the
screen will switch off.