iSens CareSens N Voice User manual

Blood Glucose Monitoring System
El sistema de Monitoreo de Glucosa en Sangre
User's Manual
PGA1E3089 REV2 09/2015
Manual del Usuario

© 2015 i-SENS, Inc. All Rights Reserved.
Manufacturer: i-SENS, Inc.
43, Banpo-daero 28-gil, Seocho-gu, Seoul, 06646, Korea
www.i-sens.com
Contact Customer Service:
1-800-429-5001
9 am - 9 pm EST, Monday - Saturday
At all other times or in case of emergency, please contact your
healthcare professional or emergency medical response.
© 2015 i-SENS, Inc. All Rights Reserved.
Fabricante: i-SENS, Inc.
43, Banpo-daero 28-gil, Seocho-gu, Seul, 06646, Corea
www.i-sens.com
Servicio al Cliente:
1-800-429-5001
09:00 a 21:00 hrs EST, Lunes - Sábado
En diferentes horarios o en casos de emergencia, favor de ponerse
en contacto con su médico o la contestación médica de emergencia.
• Ninguna parte de este documento puede ser reproducida en
cualquier forma o por cualquier medio sin el consentimiento
previo y por escrito de i-SENS.
• La información en este manual es correcta en el momento de su
impresión. Sin embargo, i-SENS se reserva el derecho a realizar
cualquier cambio necesario en cualquier momento sin previo
aviso ya que nuestra política es una de mejora continua.
Thank you for choosing the CareSens® N 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. This booklet contains
important information about the CareSens® N Blood
Glucose Monitoring System. Please read it carefully before
testing your blood glucose.
Welcome to the CareSens® N
Blood Glucose Monitoring System
Gracias por elegir el Sistema de Monitoreo de Glucosa en Sangre
CareSens® N. El sistema le provee a Ud. un monitoreo diagnóstico
de glucosa en sangre in vitro (es decir, de uso externo) de manera
segura, rápida y conveniente. Usted puede obtener resultados
precisos en sólo 5 segundos con una pequeña muestra de sangre
de 0,5 μL. Este manual contiene la información importante sobre
el Sistema de Monitoreo de Glucosa de CareSens® N. Por favor,
lea con cuidado antes de probar su glucosa en sangre.
Bienvenido al Sistema de
Monitoreo de Glucosa CareSens® N
• 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.

www.i-sens.com 3
Table of Contents
Information
Important Information: Read This First! 4
Important Health-Related Information 5
Specifications 6
CareSens N Blood Glucose Monitoring System 7
Inserting or Replacing the Batteries 8
CareSens N Blood Glucose Test Strip 9
CareSens N Blood Glucose Meter 11
CareSens N Blood Glucose Meter Display 12
Preparation
Setting Up Your System 13
Adjusting the Date and Time 13
Setting the Sound On/OFF 16
Setting the ‘Test Result Reset’ 17
Checking the System 18
Control Solution Testing 19
Comparing the Control Solution Test Results 21
Blood Glucose Testing
Using the Lancing Device 22
Preparing the Lancing Device 23
Preparing the Meter and Test Strip 24
Flagging Post-meal Test Results 24
Applying the Blood Sample 26
Discarding Used Lancets 28
Alternative Site Testing 29
HI and Lo Messages 32
Target Blood Glucose Ranges 33
Transferring Test Results 33
Additional Functions
Meter Memory 34
Viewing Test Results Stored in the Meter’s Memory 34
Setting the Alarm Function 36
Setting the Post-meal Alarm (PP2 Alarm) 36
Setting the Time Alarms (Alarm 1 - 3) 37
Maintenance
Caring for Your System 39
Understanding Error and Other Messages 40
General Troubleshooting 42
Performance Characteristics 43
Warranty Information 46

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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:
• Do not use the system for diagnosis or screening of diabetes.
• Use only fresh capillary whole blood samples for testing.
• Alternative site and fingertip test results may differ
significantly due to rapid changes in the blood glucose level
after eating, insulin injection or exercise.
Intended Use
The CareSens N Blood Glucose Monitoring System is intended
for the quantitative measurement of glucose in fresh capillary
whole blood samples drawn from the fingertips and alternative
sites such as the forearm, palm, thigh, and calf. Alternative site
testing should be used only during steady-state blood glucose
conditions. The CareSens N Blood Glucose Monitoring System
is intended for self testing outside the body (in vitro) by people
with diabetes as an aid to monitor the effectiveness of diabetes
control. It is not intended for use on neonates and is not for the
diagnosis or screening of diabetes.
The CareSens N Blood Glucose Test Strips are for use with the
CareSens N Blood Glucose Meter to quantitatively measure
glucose in fresh capillary whole blood samples drawn from the
fingertips and alternative sites.
The CareSens Control Solutions are for use with the CareSens N
Meter and CareSens N Test Strips to check that the meter and
the test strips are working together properly and that the test is
performing correctly.
• The CareSens N Blood Glucose Monitoring System is
intended for self-testing outside the body (in vitro diagnostic
use).
• The CareSens N Blood Glucose Meter is designed to minimize
code related errors in monitoring by using the no-coding
function.
• Glucose in blood samples reacts with the chemical in 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 should be used only with
the CareSens N Test Strips.
• An abnormally high or low red blood cell count (hematocrit
level over 60% or below 20%) may produce inaccurate results.
• Inaccurate results may occur in severely hypotensive
(having low blood pressure) individuals or patients in shock.
Inaccurate low results may occur for individuals experiencing
a hyperglycemic-hyperosmolar state, with or without ketosis.
Critically ill patients should not be tested with blood glucose
meters.
• Inaccurate results may occur in patients undergoing oxygen
therapy.
• For questions or concerns, contact Customer Service: 1-800-
429-5001 (9 am - 9 pm EST, Mon - Sat). At all other times
or in case of emergency, please contact your healthcare
professional or emergency medical response.
Important Health-Related Information

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Specifications
Operating ranges
Temperature 50 - 104˚F
Relative humidity 10 - 90%
Hematocrit 20 - 60%
Product specifications
CareSens N Blood Glucose Monitoring System
CareSens N System includes the following items:
① CareSens N Blood Glucose Meter
② User's Manual
③ Quick Reference Guide
④ Batteries (2)
CareSens N System may include the following items:
① CareSens N Blood Glucose Test Strips (10)
② Lancing Device
③ Lancets (10)
④ Logbook
⑤ Carrying Case
• Check all the components after opening the CareSens N Blood
Glucose Monitoring System package. The exact contents are
listed on the main box.
• The CareSens Control Solutions (Control A & B) are necessary
but not included. The CareSens Control Solutions and
the cable for data management software can be ordered
separately. Please contact Customer Service: 1-800-429-5001
(9 am - 9 pm EST, Monday - Saturday).
Measurement Range 20 - 600 mg/dL
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 250 test results
Size 93 X 47 X 15 mm (3.66 x 1.85 x 0.59 in)
Weight 51.5 g (1.82 oz) (with batteries)

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Insert
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
The CareSens N Meter comes with 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 finger as
shown in the figure 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 13-17.

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Note: The cable for data management software can be
ordered separately. Please contact Customer Service: 1-800-
429-5001 (9 am - 9 pm EST, Monday - Saturday).
CareSens N Blood Glucose Meter
Data Port
Used to transfer data
from the meter to a
computer with
a cable
Button
Turns the meter
on and selects
or changes
information
Display
Shows results,
messages
Test Strip Port
Insert test strip here
Button
Selects or
changes
information
S Button
Turns the meter
on/off and confirms
menu selections
Important Safety Instruction
• The CareSens N Test Strip should be used only with fresh
capillary whole blood samples.
• Do not reuse test strips.
• Do not use CareSens N Test Strips beyond the expiration
date. This may cause inaccurate results.
• Test strips in new, unopened vial and test strips in vial 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
34-86˚F (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.
• 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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Setting Up Your System
You should check and update the meter-settings such as time and
date before using your meter or after changing the meter batteries.
Press and hold the Sbutton for 3 seconds to enter the SET mode.
While you are setting the meter, current settings will appear on the
display. Press and hold to scroll faster. Whenever you want to
complete the settings and exit from the SET mode, press and hold
the Sbutton for 3 seconds again.
Adjusting the Date and Time
Step 1 Entering the SET Mode
Press and hold the Sbutton for 3 seconds. After
all the segments flash across the screen, SET
is displayed on the screen. Press the Sbutton
again to progress to the next step.
Note: The unit of measurement for your CareSens N Meter is
preset and fixed in mg/dL.
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 mark
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
Mute symbol
appears only when
the sound is set to
OFF
check
appears when test
results have not been
saved
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
Blood insertion
symbol
indicates meter
is ready for the
application of a drop
of blood or control
solution
CareSens N Blood Glucose Meter Display
Month
Day
Hour
Minute
Step 2 Setting the Year
Press or button until correct year appears.
Press and hold to scroll faster. After setting the
year, press the Sbutton to confirm your selection
and progress to the next step.

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Step 3 Setting the Month
A number indicating the month will blink on
the bottom left corner of the screen. Press or
button until the correct month appears. Press
the Sbutton to confirm your selection and
progress to the next step.
Step 4 Setting the Date
Press or button until blinking number
shows the correct date. Press the Sbutton to
confirm the date and progress 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 or button to
select a format. The AM/PM is not displayed in
the 24-hour format. After selecting the format,
press the Sbutton to progress to the next step.
Step 6 Setting the Hour
Press or button until the correct hour
appears. Press the Sbutton to confirm the hour
and progress to the next step.
Step 7 Setting the Minute
Press or button until the correct minute
appears. After setting the minute, press the S
button to progress to the next step.

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Step 8
On pressing or , the screen will display the
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. After setting the sound,
press the Sbutton to progress to the next step.
Setting the Sound On/OFF
Note: symbol is displayed only when the sound is set to
OFF.
Step 9
In this mode all the test results stored in the meter can be deleted.
Please note that if you select YES, all the stored test results will be
deleted and can not be restored.
After the beeper mode is set,
press the Sbutton to enter the
‘Test Result Reset’ mode. The
‘dEL’ character will blink on the
screen. Press or to alternate
between ‘YES’or ‘no’.
To delete all the stored test
results press the Sbutton while
the screen displays‘YES’. Then, all the test results stored in the
meter will be deleted and the screen will be similar to the picture
on the right.
If you do not want to delete the results press the Sbutton while
the screen displays‘no’. Then, the screen will return to step 2 (See
page 13).
Setting the ‘Test Result Reset’
(Deleting all the saved test results)
Note: At any stage, if the Sbutton is pressed for 3 seconds, Time
and Date will finish and the meter will be turned off. Press and
hold to scroll through numbers quickly.