iSens CareSens N Premier User manual

Visit the webpage below
to see supported devices/
download app (scan the QR
code for easy access).
www.i-sens.com/smartlog
© 2021 i-SENS, Inc. All Rights Reserved
PGL4E1005 REV4 2021-11
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
User Manual
Blood Glucose
Monitoring System
• Easy Data Transfer by
Bluetooth Connection
• 2.5" Large, Backlit Display
• Efficient Diabetes
Management with
Tagging Symbols

Thank you for choosing the CareSens™ N Premier 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.
Test results can be sent to a smartphone through
Bluetooth®wireless connection.
Welcome to the CareSens™ N Premier
Blood Glucose Monitoring System
Bluetooth®wireless technology is used by some
smartphones and many other devices. CareSens N
Premier Meter uses Bluetooth®wireless technology to
pair* and to send your glucose results to a smartphone.
The CareSens™ N Premier Meter is designed to work
with the SmartLog™ mobile app. When using the
CareSens N Premier System, we suggest you pair your
CareSens N Premier Meter with your smartphone and
track your results.
Bluetooth®wireless technology
* The process of creating a connection between two
Bluetooth®devices. An auto-generated passkey has to be
exchanged between the two devices. Once the devices
are paired, they will automatically communicate with each
other when the Bluetooth®feature is activated.
• 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.

The Bluetooth®word mark and logos are registered
trademarks owned by Bluetooth®SIG, Inc. and any use
of such marks by i-SENS, Inc. is under license. All other
trademarks and trade names are those of their respective
owners.
WARNING:
Turn off the Bluetooth®feature in areas where the use of
wireless devices is restricted, such as hospitals, some
healthcare professional offices, and aeroplanes.
Trademarks
Note
The SmartLogTM mobile app may not be compatible with
all smartphones.

Table of Contents
Information
Important Information: Read This First! ......................................................6
Specifications ............................................................................................8
Inserting or Replacing the Batteries .........................................................11
Caring for Your System.............................................................................13
CareSens N Blood Glucose Test Strip...................................................... 15
CareSens N Premier Blood Glucose Meter ..............................................17
Preparation
Setting Up Your System............................................................................20
Setting Up Bluetooth®...........................................................................21
Adjusting the Date and Time................................................................. 24
Setting the Sound On/OFF ................................................................... 26
Turning on the Strip Expiration Date Indicator ...................................... 27
Turning on the Hypoglycemia (HYPo) Indicator .................................... 28
Setting the Strip Expiration Date Indicator ............................................... 29
Checking the System................................................................................30
Control Solution Testing........................................................................ 31
Comparing the Control Solution Test Results....................................... 34
Testing
Using the Lancing Device.........................................................................35
Preparing the Lancing Device...............................................................36
Preparing the Meter and Test Strip ....................................................... 38
Applying Blood Sample ........................................................................39
Discarding Used Lancets...................................................................... 43
Alternate Site Testing................................................................................44
HI and Lo Messages................................................................................. 47
Target Blood Glucose Ranges..................................................................48
Transferring Test Results Using Cable .....................................................49
Additional Functions
Meter Memory .......................................................................................... 50
Viewing Averages Stored in Memory ....................................................50
Viewing Test Results Stored in Memory ...............................................53
Setting the Alarm Function .......................................................................54
Setting the Post-meal Alarm (PP2 alarm)..............................................54
Setting the Time Alarms (alarm 1–3) ..................................................... 55
Maintenance
Understanding Error Messages................................................................57
General Troubleshooting........................................................................... 59
Performance Characteristics ....................................................................60
System Accuracy and Measurement Precision .................................... 60
Influence Quantities ..............................................................................62
User Performance Evaluation ............................................................... 64
Warranty Information ................................................................................ 65

6 www.i-sens.com
www.i-sens.com 7
Important Information: Read This First!
Information
For optimum safety and benefits, please read the entire manual
contents before using the system.
Intended use:
CareSens N Premier 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 Premier Blood Glucose Monitoring System should
be used only for selftesting outside the body (in vitro diagnostic
use only). CareSens N Premier Blood Glucose Monitoring
System should not be used for the diagnosis of diabetes or for
testing newborns. Testing sites include the traditional fingertip
testing along with alternate site testing on forearm and palm.
Meaning of Symbols Used:
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
Do not reuse Batch code
Consult instructions for use Manufacturer
Temperature limitation Serial number
Authorised representative

6 www.i-sens.com
www.i-sens.com 7
• Glucose in blood samples reacts with the chemical in
the test strip to produce a small electrical current. The
CareSens N Premier meter detects this electrical current and
measures the amount of glucose in the blood sample.
• The CareSens N Premier Blood Glucose Meter is designed
to minimise code related errors in monitoring by using the
no-coding function.
• The CareSens N Premier 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 65% or below 15%) may produce inaccurate results.
• If your test result is below 60mg/dL (3.3mmol/L) or above
240mg/dL (13.3mmol/L), consult a healthcare professional
immediately.
• Inaccurate results may occur in severely hypotensive
individuals or patients in shock. Inaccurate low results
may occur for individuals experiencing a hyperglycemic
hyperosmolar state, with or without ketosis. Critically ill patients
should not be tested with blood glucose meters.
• Inaccurate results may occur in patients undergoing oxygen
therapy.
If you need assistance, please contact your authorised i-SENS
sales representative or visit www.i-sens.com for more information.

8 www.i-sens.com
www.i-sens.com 9
Specifications
Product specifications
Measurement range 20–600mg/dL (1.1–33.3mmol/L)
Sample size Minimum 0.5μL
Test time 5seconds
Sample type Fresh capillary whole blood
Calibration Plasma-equivalent
Assay method Electrochemical
Battery life 1,000 tests
Power Two 3.0V lithium batteries
(disposable, type CR2032)
Memory 1,000 test results
Size 103 x 54 x 17mm
Weight 71.7g (with batteries)
Bluetooth®
technology
• Frequency range: 2.4–2.4835GHz
• Operating range distance:
maximum 10 meters (unobstructed)
• Operating channels: 40 channels
• Security encryption: 128-bit AES
(Advanced Encryption Standard)

8 www.i-sens.com
www.i-sens.com 9
Operating ranges
Temperature 5–50°C
Relative humidity 10–90%
Hematocrit 15–65%
Storage/transport conditions
Temperature
Meter (with batteries) 0–50°C
Test strip 1–30°C
Control solution 8–30°C
Relative humidity Test strip 10–90%

10 www.i-sens.com
www.i-sens.com 11
CareSens N Premier Blood Glucose Monitoring System
CareSens N Premier Blood Glucose Monitoring System
includes the following items:
• CareSens N Premier Blood Glucose Meter
• Owner's Booklet
• Quick Reference Guide
• Batteries
CareSens N Premier Blood Glucose Monitoring System may
include the following items:
• CareSens N Blood Glucose Test Strips
• Lancets
• Lancing Device
• Logbook
• Carrying Case
• Check all the components after opening the
CareSens N Premier 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.

10 www.i-sens.com
www.i-sens.com 11
Inserting or Replacing the Batteries
The CareSens N Premier 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.
Step 1
Make sure the meter is turned off. Push the
cover in the direction of the arrow to open
the battery compartment.
Step 2
Remove the used batteries one at a time.
Slip your index finger under the battery to
lift and pull out as shown. Insert two new
batteries with the + side facing up and make
sure the batteries are inserted firmly.

12 www.i-sens.com
www.i-sens.com 13
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 20.

12 www.i-sens.com
www.i-sens.com 13
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.
• Avoid getting any liquid or moisture in the test strip vial. This
can affect the test strips and cause inaccurate test results.
• Do not apply samples other than capillary whole blood or
control solution to the test strip.
• Store the meter in a cool and dry place between between
0–50°C.

14 www.i-sens.com
www.i-sens.com 15
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.

14 www.i-sens.com
www.i-sens.com 15
CareSens N Blood Glucose Test Strip
The CareSens N Premier 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
Warning!
• The CareSens N Test Strips should be used only with fresh
capillary whole blood samples.
• Do not reuse test strips.
• Do not use test strips past the expiration date.

16 www.i-sens.com
www.i-sens.com 17
• 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 and 10–90% relative humidity.
• 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.
• Avoid getting any liquid or moisture in the test strip vial. This
can affect the test strips and cause inaccurate test results.
• Do not apply samples other than capillary whole blood or
control solution to the test strip.
• 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.
• Drying agents in the vial cap may be harmful if inhaled or
swallowed and may cause skin or eye irritation.

16 www.i-sens.com
www.i-sens.com 17
CareSens N Premier Blood Glucose Meter
Display
Shows results,
messages
Button
Turns the meter
on/off, confirms
menu selections,
and changes
information
Test Strip Ejector
Slide down to
discard the used
strips
, Button
Turns the meter
on, selects
or changes
information
Test Strip Port
Insert test strip
here
Data Port
Used to transfer
data from the
meter to a
computer with a
cable
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.

18 www.i-sens.com
www.i-sens.com 19
CareSens N Premier Blood Glucose Meter Display
8
6
11 12 13
15
1 2 43 5
10
7
9
14
1 Memory symbol appears when test results stored in
the memory are displayed
2 PP2 alarm appears when the post-meal alarm
has been set
3Bluetooth®symbol indicates that Blutooth®is turned on
4 Mute symbol appears only when the sound is set
to OFF
5Control Solution
flag
appears when the control solution test
results are saved or displayed
6 Test results test results displaying panel
7 Decimal point appears when the blood glucose
measuring unit is set to mmol/L
8 alarm appears when the time alarm has
been set
9 mmol/L, mg/dL unit for measuring blood glucose

18 www.i-sens.com
www.i-sens.com 19
0 Battery symbol indicates meter battery is running low
and needs to be replaced
! 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
$ Blood insertion
symbol
indicates meter is ready for the
application of a drop of blood or
control solution
%Month/Day/Hour/
Minute appears date and time
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.

20 www.i-sens.com
www.i-sens.com 21
Setting Up Your System
Preparation
Press and hold the button for 3seconds to enter SET mode.
After all settings are finished, press and hold the 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 the SET Mode
Press and hold the 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
button to go to the next step.
Note
Follow steps 2–3 to pair your meter and smartphone. Pairing
allows the meter to communicate wirelessly with your
smartphone. Ensure that devices are within the maximum
Bluetooth®range (10 metres). Before pairing your meter and
smartphone, download and install the SmartLogTM mobile app
on your smartphone.