iSens KetoSens User manual

KETONE
Blood β-Ketone Monitoring System
User Manual
• β-Ketone Measurement
• 2.5’’ Large, Backlit Display
• Strip Ejector for Easy
Ejection of Used Test Strips
© 2022 i-SENS, Inc. All Rights Reserved PKTAA-0000008 REV0 2022-11
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

Thank you for choosing the KetoSens Blood β-Ketone
Monitoring System. The system provides you with rapid and
convenient blood β-Ketone in vitro (i.e., outside the body)
diagnostic monitoring. You can obtain accurate results in
just 8 seconds with a small (0.5 μL) blood sample.
Welcome to the KetoSens
Blood β-Ketone 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.

Information
Important Information: Read This First! 4
Specifications 6
KetoSens Blood β-Ketone Monitoring System 7
Inserting or Replacing the Batteries 8
Caring for Your System 9
KetoSens Blood β-Ketone Test Strip 10
KetoSens Blood β-Ketone Meter 12
KetoSens Blood β-Ketone 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 Strip Expiration Date Indicator 19
Checking the System 20
Control Solution Testing 21
Comparing the Control Solution Test Results 24
Testing
Using the Lancing Device 25
Preparing the Lancing Device 26
Preparing the Meter and Test Strip 28
Applying Blood Sample 29
Discarding Used Lancets 31
HI and Lo Messages 32
Additional Functions
Meter Memory 33
Viewing Averages Stored in Memory 33
Viewing Test Results Stored in Memory 35
Setting the Alarm Function 36
Setting the Time Alarms (alarm 1–3) 36
Maintenance
Understanding Error Messages 38
General Troubleshooting 40
Performance Characteristics 41
System Accuracy and Measurement Precision 41
Influence Quantities 42
Warranty Information 44
Table of Contents

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Important Information: Read This First!
For optimum safety and benefits, please read the entire manual
contents before using the system. Please note the following
instructions:
Intended use:
The KetoSens Blood β-Ketone Monitoring System is used with
the KetoSens Blood β-Ketone Meter for quantitatively measuring
ketone in whole blood. The KetoSens Blood β-Ketone Monitoring
System is intended for self-testing outside the body (in vitro)
by people with diabetic ketoacidosis at home or professional
healthcare settings as an aid to monitor the effectiveness of
diabetic ketoacidosis control. Do not use the system for the
diagnosis of diabetic ketoacidosis without the guidance of a
healthcare professional.
Meaning of Symbols Used:
CE Mark
Authorised representative in the European Community/
European Union
In vitro diagnostic medical device
Caution Biological risks
Do not re-use
Consult instructions for use
WEEE (waste electrical and electronic equipment)
Temperature limit Manufacturer
Batch code Serial number
Use-by date

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• The KetoSens Blood β-Ketone Monitoring System is
intended for self-testing outside the body (in vitro diagnostic
use).
• β-Ketone in blood samples reacts with the chemical in the
test strip to produce a small electrical current. The KetoSens
meter detects this electrical current and measures the
amount of β-Ketone in the blood sample.
• The KetoSens Blood β-Ketone Meter is designed to
minimise code related errors in monitoring by using the
no-coding function.
• The KetoSens Blood β-Ketone Meter should be used only
with the KetoSens β-Ketone Test Strips.
• An abnormally high or low red blood cell count (hematocrit
level over 60 % or below 20 %) may produce inaccurate
results.
• Critically ill patients should not be tested with blood
β-Ketone meters.
If you need assistance, please contact your authorised
i-SENS sales representative or visit www.i-sens.com for more
information.

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Specifications
Operating ranges
Temperature 10–40 ˚C
Relative humidity 10–90 %
Hematocrit 20–60 %
Storage/transport conditions
Temperature Meter (with batteries) 0–50 ˚C
Test Strip 4–30 ˚C
Control solution 8–30 ˚C
Relative humidity Test strip 10–90 %
Product specifications
Measurement range 0.1–8.0 mmol/L
Sample size Minimum 0.5 µL
Test time 8 seconds
Sample type • Fresh capillary whole blood
• Fresh venous whole blood
(healthcare professionals only)
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)

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KetoSens Blood β-Ketone Monitoring System
• Check all the components after opening the KetoSens blood
β-Ketone 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.
KetoSens Blood β-Ketone Monitoring System includes the
following items:
* KetoSens Blood β-Ketone Meter
* Instructions for Use
KetoSens Blood β-Ketone Monitoring System may include
the following items:
* KetoSens Blood β-Ketone Test Strips
* Lancets
* Lancing Device
* Batteries
* Logbook
* Carrying Case

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The KetoSens 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 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.

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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. It is recommended to
store and use the test system indoors.
• 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.
• Store all the meter components in the portable case to
prevent loss and help keep the meter clean.
• Do not apply samples other than capillary, venous whole
blood or control solution to the test strip.
• Store the meter in a cool and dry place between 0–50 °C.
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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KetoSens Blood β-Ketone Test Strip
The KetoSens Blood β-Ketone Monitoring System measures
blood β-Ketone 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 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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Warning!
• The KetoSens Blood β-Ketone Test Strips should be used
with fresh capillary whole blood samples, or with fresh venous
whole blood samples if drawn by healthcare professionals.
• Do not reuse test strips.
• Do not use test strips past the expiration date.
• Test strips in new, unopened test strip box can be used
up until the expiration date printed on the foil packet 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 4–30 ˚C and 10–90 % relative humidity. Do not freeze.
• Keep test strips away from direct sunlight or heat and do not
freeze.
• Store test strips only in their original box.
• Open the foil test strip packet to take out a test strip for
testing and use the test strip immediately. Do not use the test
strip if the foil is damaged or torn.
• Do not apply samples other than capillary, venous 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
KetoSens test strip package insert.
Caution:
• Keep the meter and testing supplies away from young
children.
• The test strips and foil packet may be choking hazards.

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KetoSens Blood β-Ketone Meter
Data Port
Used to transfer data
from the meter to a
computer with
a cable
◀,▶Button
Turns the meter
on, selects
or changes
information
Display
Shows results
and messages
S Button
Turns the
meter on/off,
confirms menu
selections,
and changes
information
Test Strip Port
Insert test strip
here
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.
Test Strip Ejector
Slide down to
discard the used
strips

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Memory symbol: appears when
test results stored in the memory
are displayed
Mute symbol: appears only when
the sound is set to OFF
Control solution flag: appears
when the control solution test
results are saved or displayed
Test results: test results displaying
panel
Blood insertion symbol: indicates
meter is ready for the application of a drop of blood or control
solution
alarm: appears when the time alarm has been set
mmol/L: unit for measurinig blood β-Ketone
KETONE: appears when the KetoSens strip is inserted, and
when the test results are saved or displayed
Battery symbol: indicated meter battery is running low and
needs to be replaced
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.
KetoSens Blood β-Ketone Meter Display
1
4
8
9
2 3
10
1
6
2
7
8
3
9
4
10
5
7
6
5

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Setting Up Your System
Press and hold the Sbutton for 3 seconds to enter SET mode.
After all settings are finished, press and hold the Sbutton for
3seconds to turn off the meter.
Press the ◀or ▶button to change values. Press and hold the ◀
or ▶button to scroll faster.
Adjusting the Date and Time
Step 1 Entering SET Mode
Press and hold the Sbutton for
3seconds to enter SET mode. After
all the segments flash across the
screen, the 'SET' will show up.
Press the ◀or ▶button to select
'YES' and press the Sbutton to go
to the next step.
Step 2 Setting the Year
Press the ◀or ▶button to adjust until the
correct year appears. When the present
year appears, press the Sbutton to confirm
your selection and to go to the next step.

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Adjusting the Date and Time
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 Sbutton 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 Sbutton
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 Sbutton to go to the next step.

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Step 6 Setting the Hour
Press the ◀or ▶button until the correct
hour appears.
After the hour is set, press the Sbutton to
go to the next step.
Step 7 Setting the Minute
Press the ◀or ▶button until the correct
minute appears. After setting the minute,
press the Sbutton 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 it is time for a pre-set 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 go to the next step.
Setting the Sound On/OFF
Note:
The symbol is displayed only when the sound is set to OFF.

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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
19 to set the strip expiration date.
When 'EP' appears on the screen, press the ◀or ▶button. The
screen will display 'On' or 'OFF'. Press and hold the Sbutton to
confirm the strip expiration date indicator and turn the meter 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 2024, the meter
will display 'EP' at the beginning
of November, 2024.

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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 Sbutton to confirm the year and set
the month.
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.
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.
Turning on the Strip Expiration Date Indicator
Note:
The strip expiration date is printed on the test strip box.
Setting the Strip Expiration Date Indicator

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Checking the System
You may check your meter and test strips using the
KetoSens Control Solutions(control L and/or M).
The KetoSens Control Solution contains a known amount
of β-Ketone and is used to check that the meter and the
test strips are working properly.
KetoSens Control Solution ranges are printed on the
KetoSens test strip box. Compare the result displayed on
the meter to the KetoSens Control Solution range printed
on the test strip box.
Before using a new meter or a new box of test strips,
you may conduct a control solution test following the
procedure on pages 21–23.
Note:
• Use only the KetoSens Control Solution (available for
purchase separately).
• Check the expiration date printed on the bottle. When you
first open a 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).
• Before using the control solution, shake the bottle, discard
the first drop and wipe the tip clean.
• Close the control solution bottle tightly and store at a
temperature between 8–30 ˚C.