iLine CHC0025AD MicroINR Chips Instruction Manual
- June 6, 2024
- iLine
Table of Contents
iLine CHC0025AD MicroINR Chips
INSTRUCTIONS FOR USE
INTENDED USE
The micro in System measures prothrombin time (PT) expressed in International
Normalized Ratio (INR), for monitoring oral anticoagulant therapy with
warfarin. The micro in System consists of a microINR Meter and microINR Chip
and uses fresh capillary whole blood from a fingerstick. The micro in System
is intended for patient self-testing use as well as for healthcare
professionals at Point of Care settings. The micro in System is intended for
use in patients 18 years old or older. Patients must be stable on warfarin
medication for at least 6 weeks before starting to use the microINR System.
For self-testing use: The system is intended for properly trained users under
specific prescription of a physician.
Caution : The microINR System is not intended for use in patients who are
transitioning from heparin treatment to VKA therapy. The microINR System is
not intended to be used for screening purposes.
BEFORE USING THE microINR® SYSTEM
These instructions for use will guide you on the handling and use of the
microINR Chips. Please, read them as well as the instructions for use of the
microINR Meter completely. Additionally, do not forget to read the
instructions for use of the disposable lancets and/or lancing device used to
obtain the capillary blood sample. Keep these instructions for use inside the
package of microINR Chips and refer to them if you have any questions about
the proper operation of the system. For self-testing use: Users must receive a
proper training before starting to use the microINR System.
STORAGE AND STABILITY OF THE microINR® CHIP
Store the Chips in a cool and dry place between 36°F to 77°F (2°C to 25°C).
You can store the Chips at room temperature. However, keep the Chips in the
refrigerator if the storage room temperature is above 77ºF or under 36ºF.
Protect them from sunlight and heat.
The Chips can be used until the expiration date printed on the pouch and
package of the Chips. The Meter will not accept expired Chips. Do not use the
Chip if you detect that the Chip is defective or its pouch is opened or
damaged. The Chips can be used within 15 minutes once the pouch is opened. Do
not manipulate the Meter or the Chip with wet or dirty hands/gloves.
PREPARING THE NECESSARY MATERIAL
- microINR Chips.
- microINR Meter (not supplied).
- Disposable lancets and/or lancing device (not supplied).
- Means for skin cleaning (not supplied).
COLLECTION AND TESTING BLOOD SAMPLE
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Clean and warm-up your hand.
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Take a pouch containing a Chip from the package, verify the expiration date and storage conditions, and open it.
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Hold the Chip by the yellow part so that the “microINR” logo can be read correctly. Insert the Chip into the microINR Meter slot and push it until it stops. Make sure the Chip has reached the end and the “microINR” logo can be correctly read.
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The Meter must be placed on a flat and steady surface.
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Once the Chip is inserted, the Meter automatically turns on and performs a quality control to check the System’s integrity before the sample application.
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While waiting for the device to be ready, make sure your hand is warm and the fAingertip clean.
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The Chip begins to flash and warms up until it reaches the appropriate temperature. Once that temperature is reached:
the device emits an audible signal (beep tone).
the drop symbol begins to flash on the display.
a countdown appears (80 s).
the Chip emits a steady light. -
Perform the fingerstick once the countdown begins. Place the lancet firmly against the fingertip and activate it. Massage the finger to bring blood to the finger tip and gently press to help form a drop of blood.
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Make sure to obtain a spherical and properly sized drop, equivalent to a teardrop. Do not press the fingerstick site or let the drop of blood spread on the finger.
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Apply the drop of blood to the Chip immediately by putting it in contact with the Chip’s entry channel, without resting the finger on the Chip.
The Meter will emit a beep tone when it detects that the sample volume is enough, the drop symbol will stop flashing and the countdown disappears. -
After the beep tone, gently remove the finger, trying to leave a small amount of blood at the Chip’s entry channel. Do not touch the Chip or add more blood during the test. Do not shake the Meter and prevent accidental falls.
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The INR result appears in a short time.
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Dispose the used lancet and Chip appropriately.
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The Meter automatically turns off after around 3 minutes of inactivity or by pressing the left button (EXIT) for 3-4 seconds.
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If you need to repeat the test, perform the fingerstick in a different finger using a new lancet and a new Chip.
NOTES FOR A PROPER SAMPLE APPLICATION
- Before lancing the finger, it is convenient to warm hands. There are several techniques that can be used for that purpose such as washing hands with warm water, keeping hands below the waist and massaging the fingertip softly. The fingerstick area must be clean, free of contaminants and completely dry.
- Any alcohol (disinfectants, shaving creams, etc.), lotions or sweat on the fingerstick area or the blood sample may cause incorrect results.
- Washing the hands with warm soapy water is recommended. You may also use alcohol to clean the fingerstick area.
- Always dry the area thoroughly to remove any traces of substances that might interfere with the result. Always use a new, clean and dry gauze.
- Do not manipulate the Meter or the Chip with wet or dirty hands/gloves.
- Any finger can be used for finger sticking.
- Never lance the finger before the countdown has started.
- The sampling techniques can affect the result of the test. Do not squeeze or “milk” the fingerstick area as this can alter the coagulation process. Do not let the drop of blood spread on the finger.
- Before placing the sample on the Chip, make sure to obtain a spherical and properly sized drop (equivalent to a teardrop), large enough to leave a small amount of blood (remnant) at the entry channel.
- Samples must be applied immediately after collection since blood clotting does naturally occur upon fingerstick.
- Do not rest the finger on the Chip during the application.
- Apply the sample at once. Never re-apply more samples to
- If you get an error messaage, follow the steps described on the “Error Guide” section of the Meter’s instructions for use.a
- If you need to repeat the test, perform the fingerstick on a different finger with a new lancet and a new Chip.
WORKING PRINCIPLE
The technology used by the microINR System is based on the microfluidics of
the microINR Chip: The Chips contain human recombinant thromboplastin as a
reagent. The blood sample is applied to the Chip through the entry channel and
mixed with the reagents contained in the micro-reactors. The coagulation
cascade is triggered instantly. When the blood coagulates, a change in blood
flow behavior occurs. The Meter captures the position of the sample by means
of a Machine Vision System (MVS) and determines the INR result.
CALIBRATION
Each lot of microINR Chips is calibrated against a reference lot of human
recombinant thromboplastin traced to the International Reference
Thromboplastin Preparation of the World Health Organization. The calibration
parameters needed for the INR equation are encoded in each microINR Chip along
with information related to the expiration date. Therefore, every test is
automatically and individually calibrated reducing any risk of error.
INTERPRETING THE RESULTS
The results are shown as International Normalized Ratio (INR) units. The
microINR System´s results range is between 0.8 and 4.5. If you obtain a result
out of the measuring range, the display shows ↓ 0.8 (below 0.8) or ↑ 4.5
(above 4.5). If an error message is displayed, see the “Error Guide” section
of the Meter instructions for use and follow the indications described.
Some liver diseases, thyroid dysfunction and other diseases or conditions as
well as nutritional supplements or changes in dietary habits, can affect the
activity of warfarin and the INR results.
For healthcare professionals: If an unexpected result is obtained, repeat
the test making sure that the directions described in these instructions for
use are strictly followed. If an unexpected result is obtained again, the
result must be checked using another method. Results are unexpected when they
do not match the patient’s symptoms (i.e., hemorrhages, bruises, etc.).
For self-testing patients: If an INR result is obtained outside the specific
therapeutic range defined by your physician, contact your healthcare provider
and follow their instructions.
LIMITATIONS OF PROCEDURE
IMPORTANT INFORMATION
- The micro in System is intended to be used in Point Of Care settings such as physicians’ offices and anticoagulation clinics, as well as home settings. It is not intended to be used in nursing homes, emergency rooms and intensive care units.
- The micro in Meter is intended to be used exclusively with the microINR Chips manufactured by iLine Microsystems.
- Patients under treatment with Direct Oral Anticoagulants (DOACs), such as Apixaban, Rivaroxaban or Dabigatran, must not be tested with this system.
- Patients under treatment with Heparin or Fondaparinux must not be tested with this system.
- The performance of the microINR System has not been demonstrated in blood samples with hematocrit values outside the range of 25% to 55%. Hematocrits out of this range may affect test results. The device must not be used in patients with a hematocrit value below 25% or above 55%.
- The presence of anti-phospholipid antibodies (APAs) could be related to falsely elevated INR values. The use of an APA-insensitive laboratory method is recommended if the presence of APAs is known or suspected.
- Patients with total artificial heart (TAH) and left ventricular assist device (LVAD) have not been enrolled in the clinical evaluations performed for the product clearance. Therefore, the device must not be used in these patients.
- The system can only be used with fresh capillary whole blood samples from a fingerstick.
- The minimum sample volume required is 3 µL. Low sample volume applications will cause an error message.
- microINR Chips are for single use only.
- Make sure to store the microINR Chips correctly to avoid inaccurate results.
- Do not use the Chip if you detect that the Chip is defective or its pouch is opened or damaged. Dispose of the Chip and use a new one.
- These Chips are for use outside the body only.
- For self-testing patients: if you have any questions related to these limitations, please contact your healthcare provider.
INTERFERENCES
The following substances have shown no significant effects on the microINR results:
For self-testing patients: if you have any questions related with these interferences, please contact your physician.
QUALITY CONTROLS
The micro in System performs On-Board Quality controls on every test. These
quality controls are performed automatically, so there is no need to run extra
quality controls. To know more about the micro IR Quality Controls see the
microINR Meter instructions for use.
PERFORMANCE CHARACTERISTICS
Sensitivity
The sensitivity of the microINR System to coagulation factors (II, V, VII, and
X) has been determined by in vitro tests. Commercial single factor deficient
plasma was mixed with normal pooled plasma and red blood cells at various
dilutions. These samples were then tested using nine microINR Meters and three
microINR Chip lots for each factor sensitivity study. The sensitivity of the
microINR System to factors II, V, VII and X was estimated as 28%, 41%, 37% and
45%, respectively.
Accuracy by healthcare professionals
microINR System results with capillary blood from 260 control subjects and
patients recruited at three clinical sites were compared to the results
obtained in citrate venous plasma samples in a laboratory system ACL TOP 500.
Precision by healthcare professionals
Precision was determined based on duplicate measurements performed on 269
control subjects and patients at three clinical sites.
Accuracy by self-testing patients
A Method Comparison Study was conducted at four clinical sites comparing 225
INR test results obtained by self-testing patients (PST) to those obtained by
healthcare professionals (HCP) using the microINR System in two visits to the
sites. All measurements were done with capillary blood. In addition, the 112
INR test results obtained by the PST at the second visit were compared to the
results obtained in citrate venous plasma samples in a laboratory system ACL
TOP 500 as reference method. The results indicate that self-testing patients
are able to obtain results as accurate as healthcare professionals using the
microINR System.
Precision by self-testing patients
The micro in System precision was determined based on duplicate measurements
performed at four clinical sites by self-testing patients in the second visit
to the site.
Paired results
N| 110
Mean INR| 2.61
SD INR| 0.13
CV (%)| 5.0
Usability
117 self-testing patients participated in the study and filled in a
questionnaire about the user-friendliness of the microINR System after two
weeks of self-testing. The results summarized in the following table show that
the microINR System is easy to use and the labeling of the product is user-
friendly. Questions were rated on a scale of 1 (strongly disagree) to 5
(strongly agree) obtaining an overall score of 4.7.
ADDITIONAL INFORMATION
For healthcare professionals: If you need technical help, please contact your
local distributor. For self-testing patients: if you have any questions,
please contact your healthcare provider.
The micro in Meter instructions for use contain more information. These
microINR Chips are to be used with the micro IR Meter.
Caution : Federal law restricts the device to sale by or on the order of
a physician.
This insert is for self-testing patients and for healthcare professionals at
Point Of Care settings. This is a CLIA Waived test system. Facilities
performing testing must have a CLIA Certificate of Waiver (or higher).
Laboratories with a certificate of waiver must follow the manufacturer’s
instructions for performing a test. All applicable state and local laws must
be met. Any adverse reactions experienced with the use of this product, and/or
quality problems should be reported to your healthcare provider (for self-
testing patients) or local distributor (for professional users and healthcare
providers), to the manufacturer of this device and also to FDA’s Med Watch
Adverse Event Reporting program online [at www.fda. gov/MEDWatch/report.htm],
by phone (1-800-FDA-1088), or by returning the postage-paid FDA form 3500
(which may be downloaded from www.fda.gov/safety/medwatch-fda-safety-
information-and-adverse-event-reporting-program/reporting-serious-problems-
fda) by mail to (MedWatch, Food and Drug Administration, 5600 Fishers Lane,
Rockville, MD 20852) or fax (1-800-FDA-0178).
LIMITED WARRANTY
iLine Microsystems warrants that this product will meet the specifications
stated in the labelling when used in accordance with such labelling and will
be free from defects in material and workmanship until the expiration date.
SYMBOLS
iLine Microsystems S. L.
Paseo Mikeletegi 69
20009 Donostia – Gipuzkoa (SPAIN)
www.ilinemicrosystems.com
©2021 iLine Microsystems. All rights reserved. Made in Spain. iLine Microsystems and microINR are registered trademarks of iLine Microsystems S.L.