iLine microsystems microINR Bedienungsanleitung
© 2020 iLine Microsystems. All rights reserved. Made in Spain. This product
is covered by patent technology EP2201365(B1). iLine Microsystems and
microINR are registered trademarks of iLine Microsystems S.L.
INA0001AA - Rev 2020-06
Charge completely the battery of the Meter before its first use.
Cargue la batería del Monitor por completo antes del primer uso.
Carregue totalmente a bateria do Monitor antes de sua primeira utilizaçao.
Caricare completamente la batteria del dispositivo prima del suo primo utilizzo.
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Instructions for use
Instrucciones de uso
Instruções de utilização
Istruzioni per l’uso
No part of these instructions for use or the products it describes may be reproduced by any means or in any form without prior consent in writing
from iLine Microsystems.
The information contained in these instructions for use was correct at the time of printing. However, iLine Microsystems reserves the right
to introduce changes to the specifications, equipment and maintenance procedures of the system at any time, without prior notification. Any
substantial changes will be added to the next revision of these instructions for use. In case of conflict between the information of the instructions
for use of the microINR Meter and the microINR Chip, the information contained in the instructions for use of the microINR Chip will have priority.
microINR is trademark of iLine Microsystems.
No está permitida la reproducción de estas instrucciones de uso o de los productos que describe, por ningún medio o de ninguna forma sin la
autorización previa por escrito de iLine Microsystems.
La información de estas instrucciones de uso era correcta en el momento de su impresión. No obstante, iLine Microsystems se reserva el derecho
de aportar cambios a las especificaciones, el equipo y los procedimientos de mantenimiento del sistema en cualquier momento, sin previo aviso.
Cualquier cambio sustancial será incorporado en la próxima revisión de estas instrucciones de uso. En caso de conflicto entre la información de las
instrucciones de uso del Monitor microINR y el Chip microINR, prevalecerá la información contenida en las instrucciones de uso del Chip microINR.
microINR es una marca registrada de iLine Microsystems.
Nenhuma parte destas instruções de utilização ou os produtos descritos poderão ser reproduzidos através de qualquer meio ou sob qualquer
forma sem o consentimento prévio por escrito da iLine Microsystems.
As informações contidas nestas instruções de utilização estavam corretas no momento da impressão. Contudo, a iLine Microsystems reserva-se o
direito de introduzir alterações às especificações, equipamento e procedimentos de manutenção do sistema a qualquer momento, sem aviso prévio.
Quaisquer alterações substanciais serão acrescentadas à revisão seguinte estas instruções de utilização. No caso de conflito entre as informações
contidas nas instruções de utilização do Medidor microINR e o Chip microINR, as informações contidas nas instruções de utilização do Chip microINR
deverão prevalecer.
microINR é uma marca registada da iLine Microsystems.
È vietata la riproduzione, in ogni forma e con ogni mezzo, delle presenti istruzioni per l’uso o dei prodotti ivi descritti, senza previo consenso
scritto di iLine Microsystems.
Le informazioni contenute nelle presenti istruzioni per l’uso sono corrette al momento della stampa. Tuttavia, iLine Microsystems si riserva il diritto di
introdurre modifiche alle specifiche, alle apparecchiature e alle procedure di manutenzione del sistema in qualunque momento, senza previa notifica.
Eventuali modifiche sostanziali verranno aggiunte alla prossima revisione delle presenti istruzioni per l’uso. In caso di conflitto tra le informazioni
contenute nelle istruzioni per l’uso del Monitor microINR Link e del Chip microINR, prevalgono le istruzioni per l’uso del Chip microINR.
microINR è un marchio di iLine Microsystems.
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For monitoring of oral anticoagulation
treatment based on Vitamin K
antagonist drugs.
CONTENTS
English
microINR®Meter
INTRODUCTION
INTENDED USE
BEFORE STARTING TO USE THE
microINR® SYSTEM
Safety information
ORAL ANTICOAGULANT THERAPY
INR and Prothrombin Time
MEASURING PRINCIPLE
microINR® SYSTEM
DESCRIPTION OF THE microINR® KIT
PARTS OF THE microINR® METER
CHARGING THE microINR® METER
SETTING THE TIME AND DATE
PATIENT IDENTIFICATION (OPTIONAL)
QUALITY CONTROL
CONDUCTING THE TEST
PREPARING THE NECESSARY MATERIALS
MEASUREMENT PROCEDURE
Turning the Meter On
Inserting the Chip
1.
1.1
1.2
1.3
1.4
2.
2.1
2.2
2.3
2.4
2.5
2.6
3.
3.1
3.2
Modes of Use
Conducting the Test
Test Result and Assay End
Turning the Meter Off
OBTAINING AND APPLYING THE CAPILLARY
BLOOD SAMPLE
INTERPRETING THE RESULTS
LIMITATIONS OF USE
MEMORY
CLEANING AND DISINFECTING THE
microINR® METER
ERROR GUIDE
ADDITIONAL INFORMATION
SPECIFICATIONS
WARRANTY
TECHNICAL SERVICE
SYMBOLS
GLOSSARY
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12
13
13
14
15
16
16
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17
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3.3
3.4
3.5
4.
5.
6.
7.
7.1
7.2
7.3
7.4
7.5
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1.1 INTENDED USE
The microINR system is intended to monitor oral
anticoagulation therapy (OAT) with vitamin K antagonist drugs.
The microINR system determines quantitative prothrombin
time (PT) in INR (International Normalized Ratio) units with
fresh capillary blood performed by fingersticking.
The microINR system is a medical device for in-vitro
diagnostics intended for professional and self-testing use.
1.2 BEFORE STARTING TO USE THE
microINR® SYSTEM
These instructions for use will guide you, with comprehensive
information, on the handling and use of the microINR Meter.
Please, read them as well as the instructions for use of the
microINR Chip carefully. Furthermore, do not forget to read the
instructions for use of the disposable lancets and/or lancing
device used to obtain the capillary blood sample.
The microINR Meter refers to the reader device.
The microINR Chips refer to the test strips, intended to be used
exclusively with the microINR or microINR Link Meters.
The microINR System refers to reader (microINR or microINR
Link Meters) and the strips (microINR Chips).
Keep these instructions for use near the microINR Meter and
refer to them if you have any questions about proper
operation of the system.
At the end of these instructions you will find a glossary.
Self-testing or self-management of vitamin K antagonists
may only be prescribed by a doctor.
Users of the microINR system (patients and healthcare
professionals) must receive proper training before
starting to use the system.
Safety Information
General Safety Warnings
Throughout these instructions for use you will find safety
warnings and information on the correct use of the microINR
system:
This warning symbol indicates a possibility of danger
which could result in death, injury or harm to the
patient or user if the procedures and instructions for
use are not strictly followed.
This precaution symbol indicates the possibility of
deteriorating or damaging the equipment and losing
data, if the procedures and instructions for use are not
strictly followed.
Important information regarding the correct use of the
system that does not affect the safety of the patient or the
integrity of the device is displayed over a blue background.
1. INTRODUCTION
03
Infection Risk Control on Multi-Patient Test System
•Healthcare professionals must wear gloves during the entire
process of the test.
•A separate lancet or lancing device should be used for each
individual.
•Used Chips, lancets and gloves might be source of infection.
Dispose of them in accordance with local regulations to
prevent infections.
•Also, comply with your centre’s internal hygiene and safety
regulations.
There is a potential risk of infection. Healthcare
professionals using the microINR system on multiple
patients must take into account that all objects that
come into contact with human blood are a possible
source of infection. (See: Clinical and Laboratory
Standards Institute: Protection of Laboratory Workers
from Occupationally Acquired Infections; Approved
Guideline, Fourth Edition CLSI document M29-A4, 2014).
Electromagnetic Compatibility and Electrical Safety
The microINR Meter complies with electromagnetic
compatibility requirements according to IEC 61326-1 and
61326-2-6 standards.
Do not use the microINR Meter near sources of intense
electromagnetic radiation, as this could interfere with
its correct operation.
The microINR Meter complies with electrical safety
requirements according to standards IEC 61010-1 and IEC
61010-2-101.
The Meter must be disposed of as indicated in the WEEE
Directive (Waste Electrical and Electronic Equipment
2012/19/UE).
1.3 ORAL ANTICOAGULANT THERAPY
Oral anticoagulant therapy is given to patients to prevent
thromboembolic events such as venous thrombosis and
pulmonary embolism or those linked to atrial fibrillation or
artificial heart valves.
The treatment entails the need to monitor and adjust the
doses periodically for each patient based on a blood test.
Depending on the reason for oral anticoagulant therapy a
therapeutic range is defined for each patient meaning the
value of the test should lie within that range.
INR and Prothrombin Time
The activity of oral anticoagulants is monitored by measuring
the prothrombin time (PT) in seconds, which is the time it
takes for a fibrin clot to form. Thromboplastin is used as a
reagent to calculate the prothrombin time (PT). Depending on
the nature of this reagent and the equipment used variations
of the PT results are to be expected.
Therefore, the World Health Organization (WHO) recommended
a system standardisation method in 1977. Prothrombin time
values are converted into INR values, International Normalized
1.4 MEASURING PRINCIPLE
The technology used by the microINR system is based on the
microfluidics of the microINR Chip, which allows storing,
dosing, moving and/or mixing small volumes of liquids to
perform a chemical reaction.
The microINR Chips contain two channels, one for
measurement and the other for control. An image of the Chip
is shown below:
Each channel consists of a micro-reactor that contains the
reagent and a microcapillary where the INR is determined. The
reagent used in the measuring channel contains human
recombinant thromboplastin and the reagent in the control
channel contains recombinant thromboplastin and human
coagulation factors to normalize the patient’s blood.
The blood is applied to the Chip through the entry channel,
separated into two channels and mixed with the reagents
contained in each micro-reactor. The coagulation cascade is
triggered instantly. When blood coagulates, its viscosity
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Ratio, using the following equation:
Where PT is the prothrombin time obtained in the test, MNPT
is the mean normal prothrombin time and ISI the international
sensitivity index corresponding to the thromboplastin. The
values of the MNPT and ISI parameters come from clinical
calibration studies.
The pharmacological activity of vitamin K-antagonist
oral anticoagulants can be modified by other drugs;
therefore, you should only take the medicines
prescribed by your physician.
Certain liver diseases, thyroid disorders and other
diseases or conditions, as well as nutritional
supplements, medicinal herbs or changes in diets can
affect the therapeutic activity of oral anticoagulants
and INR results.
ENTRY CHANNEL
MICROREACTORS
DATAMATRIX
MICROCAPILLARY
CHANNELS
CONTROL CHANNEL MEASURING
CHANNEL
INR =PT ISI
MNPT
( )
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increases, which results into a change in blood flow behaviour.
The Meter captures the position of the sample by means of a
Machine vision system and the position is transformed
mathematically into speed and acceleration curves, from
which an INR value is obtained.
Calibration
Each batch of microINR Chips has been calibrated against a
reference batch of human recombinant thromboplastin traced
to International Reference Thromboplastin of the World Health
Organization1.
These calibration values (ISI and MNPT) are encoded in the
printed Datamatrix of each microINR Chip. Therefore, every
test is automatically and individually calibrated eliminating
any risk of human error.
(1). Expert committee of the WHO on biological normalization.
Report forty-eight. Geneva, World Health Organization, 1999
(WHO technical report series No. 889)
2.1 DESCRIPTION OF THE microINR® KIT
The microINR kit includes:
- Case
- microINR Meter
- Charger
- Plug adapter
- Instructions for use of the microINR Meter
- Quick guide
- Error guide
- Lancing device (exclusive for Reference Kit KTA0001XX)
- Lancets (exclusive for Reference Kit KTA0001XX)
microINR Chips are sold separately.
Always carry the Meter inside its case.
2. microINR® SYSTEM
2.2 PARTS OF THE microINR® METER
2.3 CHARGING THE microINR® METER
The Meter uses a lithium battery that can be recharged
through the mini USB connection on the top of the Meter.
The recommended charging time is approximately 3 hours.
Charge the battery completely before using the Meter
for the first time.
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Do not open or manipulate the Meter.
Do not pierce or burn the battery.
Do not change the battery. The manufacturer will not
warranty Meters that have been opened.
For battery replacement or meter repairs, the
equipment must be sent to the manufacturer.
Use only the supplied charger and wall power adapter
provided by the manufacturer or you may damage the
Meter.
2.4 SETTING THE TIME AND DATE
Before using the microINR System, check that the
Meter’s time and date are correct, since those are
necessary to determine the Chips’ expiration date.
Those parameters are set during the manufacturing process,
so it probably will not be necessary to change them.
Time format: 24 hours. Date format: DD-MM-YYYY.
Follow the steps described below to change the Meter’s time
and date. Change only the digits needed to be set and confirm
the rest digits:
•Press and hold the left and right buttons (E and M) at the
same time for 10 seconds until the time field flashes.
•Press the left button (E) to set the hour.
•After selecting the correct hour, press the right button (M) and
set the minutes.
•After selecting the minutes, press the right button (M) again
MINI USB CONNECTION
EXIT (E) BUTTON
MEMORY (M)
BUTTON
CHIP
INSERTION
AREA
DISPLAY
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and the date fields will start flashing.
•Use the left button (E) to select the correct day.
•When you reach the correct day, press the right button (M) to
set the month. Use the left button (E) to select the correct month.
•When you reach the correct month, press the right button (M)
to set the year. Use the left button (E) to select the correct year.
•After setting the month, time and date, press the right button
(M) again to save your settings.
If the time and date setting is mistakenly initiated or a digit is
unintentionally changed, the Meter will automatically exit that
setting without saving any change aer 10 seconds of inactivity.
2.5 PATIENT IDENTIFICATION (OPTIONAL)
To identify the patient (PID), take the following steps before
conducting a test:
•Hold the right button while inserting a Chip and release it
afterwards. Upon releasing the button, “PID” and a 24
alphanumeric field will be displayed, to fill in.
•To enter the characters corresponding to the PID:
- The first field will flash when selected.
- To enter the first character, press the le button until you
reach the desired character.
- Validate the character with the right button and go to the
next field.
- Repeat the previous steps until you reach the last field.
- Aer accepting the last field, the first field is automatically
selected in case you want to correct any characters.
- To confirm the ID entered and go back, hold the right
button for 3 seconds.
While you are entering the PID, if one minute elapses
without pressing any buttons, an E01 message will be
displayed.
When consulting the results on the Meter, the result of a test
(INR or error message) is displayed along with its corresponding
PID (if entered), date and time.
When entering the PID, do not include patient sensitive
information (name, age, etc.) since it can be viewed in the Meter.
2.6 QUALITY CONTROL
Internal quality control
Meter performance is automatically checked when the system
is turned on.
Integrated and independent on-board quality controls
Level 1 – Pre-test
•Chip integrity check
•Correct insertion check
•Automatic system calibration and rejection of expired
Chips
Level 2 - Measuring channel
•Analytic verification performed on the measuring channel that
08
identifies failures when processing the sample during the test,
as well as proper pre-analytical treatment of the sample.
Level 3 - Control channel
•Control channel provides highly controlled clotting times.
System reliability is assured when control clotting time lies
within a pre-defined range.
PROFESSIONAL USE:
Liquid control:
The microINR system has a number of on-board quality
control functions integrated into the Meter and the Chip and
therefore there is no need to run quality control tests with
liquid quality controls. However, iLine Microsystems has
available an optional liquid control (plasma) for the microINR
system. This control is provided to help meet the regulatory
requirements applicable to your facility. To purchase, contact
your local distributor.
3.1 PREPARING THE NECESSARY MATERIALS
•microINR Meter
•microINR Chips CHB0001UU (not supplied)
•Fingersticking material
- Professional use: disposable lancets (not supplied)
- Self-testing: lancing device and lancets (exclusive
3. CONDUCTING THE TEST
Reference Kit KTA0001XX)
•Skin cleaning material (not supplied)
Always use CE marked lancing devices and lancets.
3.2 MEASUREMENT PROCEDURE
Turning the Meter On
The Meter can be turned on:
- By inserting the Chip: - By pressing any button:
Inserting the Chip
Verify the expiry date and the storage conditions of the
Chip before conducting the test..
•Open the pouch.
Andere Handbücher für microINR
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