iSens KetoSens BT User manual

Manual del Usuario
User's Manual
PKTAA-0000005 REV0 2021/01
Para un solo usuario / uso en el hogar sólo
Sistema de Monitoreo deβ-Cetona en Sangre
PKTAA-0000005 REV0 2021/01
For single user / home use only
Bloodβ-Ketone Monitoring System
•Easy Data Transfer by
Bluetooth Connection
•2.5’’ Large, Backlit Display
•Strip Ejector for Easy
Ejection of Used Test Strips
•Fácil transferencia de
datos vía Bluetooth
•Pantalla Grande
Retroiluminada 2,5’’
•Eyector de Tira para
Eyección Fácil de Tiras
Reactivas Usadas
Ketosis Range Card on the last page of the English User's Manual
Tarjeta de Rango de Cetosis en la última página del manual del usuario en inglés

Welcome to the KetoSens®BT
Blood β-Ketone Monitoring System
Thank you for choosing the KetoSens®BT 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’ll receive an accurate result in eight seconds with a small
0.5 μL blood sample.
Bluetooth®wireless technology
Bluetooth
®
wireless technology is used by some smartphones and many
other devices. KetoSens
®
BT meter uses Bluetooth
®
wireless technology to
pair* and to send your β-Ketone results to a smartphone.
The KetoSens
®
BT meter is designed to work with the SmartLog™ mobile
app. When using the KetoSens
®
BT System, we suggest you pair your
KetoSens
®
BT meter with your smartphone and track your results.
Bien venido al Sistema de Monitoreo de β-Cetona
en Sangre KetoSens®BT
Gracias por elegir el Sistema de Monitoreo de β-Cetona en Sangre
KetoSens® BT . El sistema permite realizar un monitoreo de diagnóstico in
vitro (es decir, fuera del cuerpo) rápida y práctica de β-cetona en sangre.
Usted recibirá un resultado preciso en ocho segundos con una pequeña
muestra de sangre de 0,5 μL.
Tecnología inalámbrica Bluetooth®
Algunos telefonos inteligentes y muchos otros dispositivos emplean la
tecnologia inalambrica Bluetooth
®
. El medidor de β-Cetona en sangre
KetoSens
®
BT emplea la tecnologia inalambrica Bluetooth
®
para
emparejarse* con un telefono inteligente y enviarle los resultados de sus
pruebas de β-cetona en la sangre.
El medidor KetoSens
®
BT esta disenado para funcionar con la aplicacion
para dispositivos moviles SmartLog™. Cuando use el sistema de monitoreo
de β-cetona en sangre KetoSens
®
BT, le recomendamos que empareje el
medidor KetoSens
®
BT con su telefono inteligente y haga un seguimiento de
los resultados de sus pruebas.
• Ninguna parte de este documento puede ser reproducida en cualquier forma
o por cualquier medio sin el consentimiento previo y por escrito de i-SENS.
• La información en este manual es correcta en el momento de su
impresión. Sin embargo, i-SENS se reserva el derecho a realizar cualquier
cambio necesario en cualquier momento sin previo aviso ya que nuestra
política es una de mejora continua.
Manufacturer: i-SENS, Inc.
43, Banpo-daero 28-gil, Seocho-gu, Seoul 06646, Korea
www.i-sens.com
Fabricante: i-SENS, Inc.
43, Banpo-daero 28-gil, Seocho-gu, Seoul 06646, Corea
www.i-sens.com
© 2021 i-SENS, Inc. All Rights Reserved.
© 2021 i-SENS, Inc. Reservados todos los derechos.
Contact Customer Service:
1-800-429-5001
9 am–9 pm EST, Monday–Saturday
At all other times or in case of emergency, please contact your healthcare
professional or emergency medical response.
Servicio al Cliente:
1-800-429-5001
09:00 a 21:00 hrs EST, Lunes–Sábado En diferentes horarios o en casos
de emergencia, favor de ponerse en contacto con su médico profesional
o la contestación médica de emergencia.
• 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.

WARNING:
Turn off the Bluetooth®feature in areas where the use of
wireless devices is restricted, such as hospitals, some
healthcare professional offices, and airplanes.
Trademarks
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.
FCC Radiation Exposure Statement:
This equipment complies with FCC radiation exposure
limits set forth for an uncontrolled environment.
This equipment should be installed and operated with
minimum distance 8 inches (20 cm) between the radiator
and your body.
Any changes or modifications not expressly approved
by the manufacturer could void the user's authority to
operate this equipment.
Note
The SmartLog™ mobile app may not be compatible
with all smartphones.

Table of Contents
Information
Important Information: Read This First!....................................................... 6
Specifications ............................................................................................ 10
KetoSens BT Blood β-Ketone Monitoring System .................................... 12
Inserting or Replacing the Batteries .......................................................... 13
KetoSens Blood β-Ketone Test Strip......................................................... 15
KetoSens BT Blood β-Ketone Meter ......................................................... 17
KetoSens BT Blood β-Ketone Meter Display ............................................ 18
Preparation
Setting Up Your System............................................................................. 20
Adjusting the Date and Time.................................................................. 20
Setting Up Bluetooth®........................................................................... 21
Adjusting the Date and Time.................................................................. 23
Setting the Sound On/OFF .................................................................... 25
Turning on the Strip Expiration Date Indicator ....................................... 26
Setting the Strip Expiration Date Indicator ................................................ 27
Checking the System................................................................................. 28
Control Solution Testing......................................................................... 29
Comparing the Control Solution Test Results........................................ 32
Testing
Using the Lancing Device.......................................................................... 33
Preparing the Lancing Device................................................................ 34
Preparing the Meter and Test Strip ........................................................ 36
Applying Blood Sample ......................................................................... 36
Discarding Used Lancets....................................................................... 40
HI Message................................................................................................ 41
Additional Functions
Meter Memory ........................................................................................... 42
Viewing Test Results Stored in the Meter’s Memory ............................. 42
Setting the Alarm Function ........................................................................ 44
Setting the Time Alarms (alarm 1–3) ...................................................... 44
Caring for Your System.............................................................................. 46
Maintenance
Understanding Error Messages................................................................. 52
General Troubleshooting............................................................................ 54
Performance Characteristics ..................................................................... 55
EMC Table ................................................................................................. 57
Warranty Information ................................................................................. 58

6 www.i-sens.com
Important Information: Read This First!
Information
To receive safe and optimum system benefits, please read the
entire manual contents before using the system.
Intended use:
The KetoSens BT Blood β-Ketone Monitoring System is intended
to be used for the quantitative measurement of β-Ketone (beta-
hydroxybutyrate) level in capillary whole blood drawn from the
fingertip. The KetoSens BT Blood β-Ketone Monitoring Systems
are for self-testing outside the body (for in vitro diagnostic use)
in the home as an aid to monitor the effectiveness of diabetes
control program. The system is not intended for use in the
diagnosis of or screening for diabetes mellitus and is not intended
for use on neonates. This system is intended to be used by a
single person and should not be shared.
The KetoSens Blood β-Ketone Test Strips work with the KetoSens
BT Blood β-Ketone Meter to quantitatively measure Blood β-Ketone
in capillary whole blood samples drawn from the fingertip.
The KetoSens Control Solutions are intended for use with
the KetoSens BT Blood β-Ketone meter and KetoSens Blood
β-Ketone test strip to check that the meter and the test strip
are working together properly and that the test is performing
correctly.
• Please use this device only for the intended use described in
this User's Manual.
• Please follow the suggested cleaning and disinfection
procedures described in this User's Manual.
• KetoSens Blood β-Ketone Test Strips are intended for
self-testing only. Follow the instructions provided by your
healthcare professional on the safe disposal of used test strips.

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Important Safety Information:
• The meter and lancing device are for single patient use. Do not
share them with anyone including other family members. Do
not use on multiple patients.
• All parts of the kit are considered biohazardous and can
potentially transmit infectious diseases, even after you have
performed pre-cleaning and disinfection.
• “FDA Public Health Notification: Use of Fingerstick Devices on
More than One Person Poses Risk for Transmitting Bloodborne
Pathogens: Initial Communication” (2010) http://wayback.
archive-it.org/7993/20170111013014/http://www.fda.gov/
MedicalDevices/Safety/AlertsandNotices/ucm224025.htm
• “CDC Clinical Reminder: Use of Fingerstick Devices on More
than One Person Poses Risk for Transmitting Bloodborne
Pathogens” (2010) http://www.cdc.gov/injectionsafety/
Fingerstick-DevicesBGM.html

8 www.i-sens.com
Limitations
• Do not use for diagnosis of or screening for diabetes mellitus.
• The system should not be used to test neonates.
• Do not test samples other than fresh capillary whole blood
obtained from the fingertip.
• Do not use the system at altitudes above 10,000 feet
(3,000 meters).
• Do not use when hematocrit is outside the acceptable
hematocrit range for testing of 20 % to 55 %.
• Severe dehydration (excessive water loss) may cause
inaccurate results. If you believe you are suffering from severe
dehydration, consult your healthcare professional immediately.
• For in vitro diagnostic use only.
• Critically ill patients should not be tested with this device.
• Inaccurate results may occur in severely hypotensive
individuals or patients in shock.
• Incorrect result may occur in individuals who are dehydrated.
• The meter and lancing device are for single patient use. Do not
share these items with anyone, including other family members!
Do not use on multiple patients!
• Do not reuse; each test strip is for single use only.
• Do not use when humidity is higher than 90 % and lower than
10 %, as extremes in humidity may affect results.
• For single patient use only.
• For over-the-counter use.

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Important Information
• The KetoSens BT 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 BT
meter detects the electrical current which reflects the amount
of β-Ketone in the blood sample.
• The KetoSens BT Blood β-Ketone Meter is designed to
minimize code related errors in monitoring by using the
no-coding function.
• The KetoSens BT Blood β-Ketone Meter should be used only
with the KetoSens Test Strips.
If you need assistance, please contact Customer Service:
1-800-429-5001 Mon–Sat, 9 am–9 pm EST. At all other times or
in case of emergency, contact your healthcare professional or
emergency medical response.
This device is not intended for use in healthcare or assisted-
use settings such as hospitals, physician offices or long-term
care facilities because it has not been cleared by the FDA for
use in these settings, including for routine assisted testing or
as part of glycemic control procedures.
Use of this device on multiple patients may lead to the
transmission of Human Immunodeficiency Virus (HIV), Hepatitis
C Virus (HCV), Hepatitis B Virus (HBV), or other bloodborne
pathogens.

10 www.i-sens.com
Specifications
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 (fingertip)
Assay method Electrochemical Amperometry
Battery life 1,000 tests
Power Two 3.0 V lithium batteries
(disposable, type CR2032)
Memory 1,000 test results
Size 106 x 58 x 17 (mm)
Weight 72.6 g (with batteries)
Bluetooth®• Frequency range: technology
2.4–2.4835 GHz
• Operating range distance:
maximum 32 feet (10 meters)
unobstructed
• Operating channels: 40 channels
• Security encryption: 128-bit AES
(Advanced encryption standard)
Operating ranges
Temperature 50–104 ˚F (10–40 ˚C)
Relative humidity 10–90 %
Hematocrit 20–55 %