iSens KetoSens User manual

KETONE
Blood β-Ketone Monitoring System
Owner’s Booklet
• β-Ketone Measurement
• 2.5’’ Large, Backlit Display
• Strip Ejector for Easy
Ejection of Used Test Strips
© 2019 i-SENS, Inc. All Rights Reserved PKTAA-0000003 REV0 2019/09
Medical Technology Promedt
Consulting GmbH
Altenhofstrasse 80,
66386 St. Ingbert, Germany
i-SENS, Inc.
43, Banpo-daero 28-gil,
Seocho-gu, Seoul 06646, Korea

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 23
Testing
Using the Lancing Device 24
Preparing the Lancing Device 25
Preparing the Meter and Test Strip 27
Applying Blood Sample 28
Discarding Used Lancets 30
HI Message 31
Additional Functions
Meter Memory 32
Viewing Averages Stored in Memory 32
Viewing Test Results Stored in Memory 34
Setting the Alarm Function 35
Setting the Time Alarms (alarm 1–3) 35
Maintenance
Understanding Error Messages 37
General Troubleshooting 39
Performance Characteristics 40
Warranty Information 41
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:
KetoSens Blood β-Ketone Monitoring System is used for the
quantitative measurement of the β-Ketone level in capillary/
venous whole blood as an aid in monitoring diabetic ketoacidosis
management effectively at home or in clinical settings.
Fresh venous whole blood may be used only if drawn by healthcare
professionals.
KetoSens Blood β-Ketone Monitoring System should be used only
for self-testing outside the body (in vitro diagnostic use only). Test
blood β-Ketone in fresh capillary/venous whole blood samples
from the traditional fingertip testing.
•    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 Test Strips.
• Anabnormallyhighorlowredbloodcellcount(hematocrit
level over 60 % or below 30 %) 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.
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
Do not discard this product with other household-type waste
Do not reuse Batch code
Consult instruction for use Manufacturer
Temperature limitations Serial number
Authorised representative

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Specifications 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.
Operating ranges
Temperature 15–30 ˚C (59–86 ˚F)
Relative humidity 10–90 %
Hematocrit 30–60 %
Storage/transport conditions
Temperature Meter (with batteries) 0–50 ˚C (32–122 ˚F)
Test Strip 4–30 ˚C (39–86 ˚F)
Control solution 8–30 ˚C (46–86 ˚F)
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)
KetoSens BKM System includes the following items:
* KetoSens Blood β-Ketone Meter
* Owner's Booklet
* Batteries
Optional items:
* KetoSens Blood β-Ketone Test Strips
* Lancets
* Lancing Device
* Logbook
* Carrying Case
* Quick Reference Guide

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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 pages 14–19.
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 β-ketone.
• Storeallthemetercomponentsintheportablecaseto
prevent loss and help keep the meter clean.
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
Insert
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 (39–86 ˚F).
• 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.
• 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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Memory recall mode: 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
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
Date
Time
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.
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
Test Strip Ejector
Slide down to
discard the used
strips
1
8
9
2 3
10 11
1
6
2
7
8
3
9
4
10
5
11
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.
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.
Step 8
On pressing the ◀or ▶button the screen
will display 'On' or 'OFF'. Press the Sbutton
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.