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
4www.i-sens.com
www.i-sens.com 5
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
4www.i-sens.com
www.i-sens.com 5
•
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.
6www.i-sens.com
www.i-sens.com 7
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)
6www.i-sens.com
www.i-sens.com 7
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
8www.i-sens.com
www.i-sens.com 9
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.
8www.i-sens.com
www.i-sens.com 9
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.
10 www.i-sens.com
www.i-sens.com 11
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
Other manuals for KetoSens
2
Table of contents
Other iSens Measuring Instrument manuals
