iLine microsystems microINR Manuel utilisateur
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Instructions for use
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.
01
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 AND DATA EXTRACTION TO
A COMPUTER
CLEANING AND DISINFECTING THE
microINR® METER
ERROR GUIDE
ADDITIONAL INFORMATION
SPECIFICATIONS
CE DECLARATION OF CONFORMITY
WARRANTY
TECHNICAL SERVIC
SYMBOLS
GLOSSARY
9
9
10
10
11
12
12
13
13
15
16
16
16
16
16
17
18
3.3
3.4
3.5
4.
5.
6.
7.
7.1
7.2
7.3
7.4
7.5
7.6
2
2
2
2
3
3
4
5
5
6
6
6
7
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8
8
8
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02
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
The microINR Meter is intended to be used exclusively with the
microINR Chips manufactured by iLine Microsystems.
Before starting to use the microINR system, read these
instructions for use completely, as well as the instructions for
use of the microINR Chip. Also, do not forget to read the
instructions for use of the lancing device and lancets used to
obtain the capillary blood sample.
Keep these instructions for use near the microINR system and
refer to them if you have any questions about proper
operation of the system.
Users of the microINR system (patients and healthcare
professionals) must receive proper training before
starting to use the system.
Before starting to use the microINR system, verify the
compatibility between the soware version of your Meter and
the reference of the Chips you are going to use.
REF SOFTWARE VERSION*
CHA0025AA All soware versions
CHB0025AA >07:03
*The soware version appears at the top of
the display, immediately aer turning the
Meter on. If you cannot read the version,
repeat the attempt by turning the Meter off
and on again.
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 damage of 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.
1. INTRODUCTION
03
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.
Infection Risk Control on Multi-Patient Tests
•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 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. The healthcare
professionals using the microINR system on several
patients must take into account that all objects that
come into contact with human blood are a possible
source of infection. (See: National Committee for
Clinical Laboratory Standards: Protection of Laboratory
Workers from Instrument Biohazards and Infectious
Disease Transmitted by Blood, Body Fluids and Tissue.
Approved Guideline, NCCLS document M29-A, 1997).
Electromagnetic Compatibility and Electrical Safety
The microINR system complies with electromagnetic
compatibility requirements according to IEC 61326-1 and
61326-2-6 standards.
Do not use the microINR system near sources of
intense electromagnetic radiation, as this could
interfere with its correct operation.
The microINR system complies with electrical safety
requirements according to standards IEC 61010-1 and IEC
61010-2-101.
Do not connect the Meter to computers that do not
comply with standard IEC 60950.
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 vein thrombosis, pulmonary
embolism or those linked to atrial fibrillation or replacement of
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 cause 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
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 on 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
04
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
on the PT results are to be expected.
Therefore, the WHO recommended a system standardisation
method in 1977. Prothrombin time values are converted into
INR values, International Normalized 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.
INR =PT ISI
MNPT
( )
ENTRY CHANNEL
MICROREACTORS
DATAMATRIX
MICROCAPILLARY
CHANNELS
CONTROL CHANNEL MEASURING
CHANNEL
05
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
- Power adapter
- Mini USB cable
- microINR Data Extraction Soware CD
- 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.
Do not place the device in a way that handling the
disconnection element is made difficult.
The recommended charging time is approximately 3 hours.
06
Charge the battery completely before using the Meter
for the first time.
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.
If opening the Meter is necessary, the equipment must
be sent to the manufacturer.
Use only the supplied USB cable and wall power
adapter provided by the manufacturer or you may
damage the Meter.
2.4 SETTING THE TIME AND DATE
• Date format: DD/MM/YY; Time format: 24 hours.
•Press and hold the left and right buttons (E and M) at the
same time for 10 seconds until the time fields flash.
•Press the left button (E) to set the hour.
•After selecting the right time, press the right button (M) and
set the minutes.
•After selecting the minutes, press the right button (M) again
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
MINI USB CONNECTION
EXIT (E) BUTTON
BOTÓN
MEMORY (M)
CHIP
INSERTION
AREA
DISPLAY
07
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.
Conducting a test without setting the date correctly
might cause a non-detection of expired Chips (E02).
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, date and time. When exporting the
microINR results to a PC, the PID will be exported as one more
piece of test information.
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
identifies failures when processing the sample during the test,
as well as proper pre-analytical treatment of the sample.
08
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 quality control for the microINR
system. This control is provided to help meet the regulatory
requirements applicable to your facility. Contact your local
distributor.
3.1 PREPARING THE NECESSARY MATERIALS
• microINR Meter
•microINR Chips (not supplied)
•Fingersticking material
- Professional use: disposable lancets (not supplied)
- Self-testing: lancing device and lancets (exclusive
Reference Kit KTA0001XX)
• Skin cleaning material (not supplied)
3. CONDUCTING THE TEST
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 stored conditions of the Chip
before conducting the test.
• Open the pouch. Hold the Chip by the yellow part and so the
“microINR” inscription can be read correctly. Insert the Chip
into the slot and push it until it stops. Make sure the Chip
has reached the end.
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