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