1. Manuals
  2. Brands
  3. iLine microsystems Manuals
  4. Personal Care Products
  5. microINR expert
  6. Instructions for use manual

iLine microsystems microINR expert Instructions For Use Manual

Hide thumbs
Table of Contents

Advertisement

Quick Links

Download this manual
INSTRUCTIONS FOR USE
friendly
technology

Advertisement

Table of Contents
loading
Need help?

Need help?

Do you have a question about the microINR expert and is the answer not in the manual?

Questions and answers

Related Manuals for iLine microsystems microINR expert

Summary of Contents for iLine microsystems microINR expert

  • Page 1 INSTRUCTIONS FOR USE friendly technology...
  • Page 2 PUBLICATION INFORMATION Revision Changes 2022-09 New document...

  • Page 3: Table Of Contents

    PERFORMING EQA CONTROL microINR Expert KIT DESCRIPTION Operator ID & EQA Control lot ID microINR Expert METER ELEMENTS Inserting the Chip microINR EXPERT ON / OFF Conducting the Test CHARGING THE microINR Expert METER EQA Test Result MENU ICONS OVERVIEW...

  • Page 4: Introduction

    Keep these instructions in a convenient place near the microINR Expert meter and refer to them if you have any queries about proper operation of the system.
  • Page 5 The microINR Expert meter should not be used adjacent to or stacked with other equipment and if it must be stacked or used in this way the microINR Expert meter must then be examined to verify normal operation in the configuration in which it will be used.

  • Page 6: Quality Controls

    The microINR system (Expert) performs automatic quality controls on every test. Electronic quality control The microINR Expert meter carries out automatic checks on electronic components, battery power level and ambient temperature conditions when the system is turned on. Integrated independent on-board quality controls On-board controls provide quality control checks for each individual microINR Chip used with the microINR Expert meter throughout testing.

  • Page 7: Prothrombin Time And Inr

    Prothrombin Time and INR The activity of the vitamin K antagonist drugs is monitored by measuring the prothrombin time (PT) – the time it takes for a fibrin clot to form – in seconds. Thromboplastin is used as a reagent to calculate the prothrombin time (PT).

  • Page 8: Microinr Expert Meter

    • USB Flash driver (contains PDF files of the Instructions for Use in other languages) • Transport Case The Instructions for Use in English are also available in iLine Microsystems S.L. webpage: https://www.ilinemicrosystems.com. Printed copies of the Instructions for Use in other languages can be made available.

  • Page 9: Microinr Expert On / Off

    2.3 microINR EXPERT ON / OFF The microINR Expert meter can be turned on by pressing the ON button located on the upper right side of the meter or by inserting a microINR Chip into the insertion slot. The meter can also be switched on by connecting it to the power source, ethernet adaptor or a computer through the USB-C cable.

  • Page 10: Menu Icons Overview

    2.5 MENU ICONS OVERVIEW Time between User logged off Off button noon and midnight (in 12-hour time format) Results are displayed User logged on Data synchronization in INR units Data synchronization Results are displayed Wi-Fi failed in seconds Reports troubleshooting when an error message Bluetooth Return to main menu...

  • Page 11: Operator Identification

    2.7 OPERATOR IDENTIFICATION The user who performs the tests may log on either through the dropdown menu or when a patient or QC test is initiated, depending on the meter’s configuration (see section 3.3). 1. Tap on the status bar in the main menu and then tap on the Log in button to log on through the dropdown menu.

  • Page 12: Administrator Identification

    2. Depending on the meter’s configuration (see section 3.3), when a patient or QC test is initiated the meter automatically displays the operator’s log- on identification options through the barcode scanner and the manual option with the keypad. Enter the identification through the barcode scanner if a valid barcode is available by tapping the Scan OID button.

  • Page 13: Microinr Expert Meter Configuration

    3. microINR Expert METER CONFIGURATION 3.1 SETTINGS The microINR Expert settings can be customized through the Settings option located in the main menu. Some of the setting options can be only entered or changed by the administrator. If the administrator is not logged on, these options will be clearly marked in grey with a padlock symbol.
  • Page 14 Menu Submenu Setting Values Administrator Change password OID Request Optional* Required ID Setup PID Request Optional* Required EasyControl Lockout ON / OFF* No / Daily / Weekly / Monthly / Frequency Number of tests EasyControl Settings Enable test with QC Warning Lockout Mode Meter lockout Ethernet...

  • Page 15: Meter Settings

    3.2 METER SETTINGS Tap on Settings on the main menu. Then tap Meter Settings to access the meter configuration. Some of the meter’s setting options can be only entered changed administrator. If the administrator is not logged on, these options will be clearly marked in grey with a padlock symbol Administrator logged-off Administrator logged-on...
  • Page 16 LANGUAGE Use this setting to select the meter Language. The selected language is highlighted in bold type with a check mark. The default setting is English. Tap the selected language on the screen. Tap Confirm to save this setting or Back to return to the previous screen without saving the changes. The following languages are available in the meter: •...

  • Page 17: Id Setup

    These settings must be configured by the administrator (the administrator must be logged on). There are three types of user profile used with the microINR Expert meter: Administrator: The administrator has special credentials to specify configurable meter settings and is the only one who can enter and change these settings.

  • Page 18: Easycontrol Settings

    Operator ID (OID) configuration: Tap the Operator ID request of choice on the screen: • No: The meter does not request operator identification when a patient or QC test is initiated. • Optional: The meter requests an operator identification when a patient or QC test is initiated and if the operator has not previously logged on, but this request may be skipped.

  • Page 19: Connectivity

    DMS via Ethernet. Wi-Fi: The microINR Expert meter can communicate and transfer results to a DMS by Wi-Fi to a specific Access Point (AP) Wireless Local Area Network (WLAN). The meter recognizes the existing AP WLAN protocol configuration (802.11b, 802.11g or 802.11n) and automatically transmits data using the POCT1-2A communication protocol.
  • Page 20 Wi-Fi with a DMS. Bluetooth: The microINR Expert meter can communicate and transfer results to a DMS or other electronic devices (suitable smartphone/tablet Apps) through wireless Bluetooth connection. Enable Bluetooth on the meter by sliding the ON/OFF button to set the Bluetooth Settings.

  • Page 21: About This System

    3.6 ABOUT THIS SYSTEM Information about the meter such as software and hardware data can be found in this section. Tap Settings and then About to access this information. There are various sections on the About screen: • System updates: tap this option to perform a meter software update. This option can only be performed by the administrator.

  • Page 22: Conducting A Patient Test

    Always use CE-marked lancing devices or lancets and follow the manufacturer’s instructions. 4.2 PRIOR STEPS BEFORE THE TEST Check the system status information before performing a test with the microINR Expert: • Check the battery level. See section 2.4 of these instructions for battery-related information.

  • Page 23: Inserting The Chip

    Inserting the Chip Verify the expiry date and the storage conditions of the chip before conducting the test. Open the pouch and remove the chip from the package. Hold the chip by the yellow part so that the “microINR” logo is facing up. When the “Insert microINR Chip”...

  • Page 24: Conducting The Test

    Conducting the Test • Place the meter on a flat, stable surface during testing or hold it in your hand and avoid sudden movements. Once the chip is inserted, the meter will conduct a sequence of automatic steps to execute the on-board quality controls that lead to the chip warming- up.

  • Page 25: Test Result

    Test Result The meter displays the test result in INR units and optionally in PT seconds. See example attached. Error messages (EXX) may also be displayed. Errors detected include a number and a short description. If an error message is shown, tap on the information symbol for further details or follow the steps described in the Troubleshooting section (see section 6).

  • Page 26: Obtaining And Applying The Capillary Blood Sample

    4.4 OBTAINING AND APPLYING THE CAPILLARY BLOOD SAMPLE The steps to properly obtain and apply a capillary blood sample are set forth below: • Read the instructions of the fingerstick device or lancet. • The fingerstick site must be clean, completely dry and free of contaminants. Washing the hands with warm soapy water is recommended.

  • Page 27: Interpreting The Results

    4.5 INTERPRETING THE RESULTS The results are shown as International Normalized Ratio (INR) units. The microINR Expert system’s results range between 0.8 and 8.0. INR results outside the measuring range will be shown as < 0.8 (below 0.8) or >...

  • Page 28: Quality Control

    5. QUALITY CONTROL As described at Quality Control section in 1.2, the microINR Expert meter’s performance is automatically checked when the system is turned on and during testing. Additionally, liquid controls can be analyzed in the meter. In order to perform an optional liquid quality control test using plasma control solutions, these elements are necessary: •...

  • Page 29: Inserting The Chip

    Place the barcode at a suitable distance to enable scanning. The meter will emit a beep (if enabled) once the barcode has been successfully read. The meter displays the microINR EasyControl lot information with the lot number, the expiry date and the acceptance values range. Verify and Confirm the microINR EasyControl lot information or tap Back to restart the microINR EasyControl identification process.

  • Page 30: Microinr Easycontrol Test Result

    • Apply the control sample to the chip. Always follow the microINR EasyControl instructions. • The meter displays a “Sample detected” message, emits a beep (if enabled) and the countdown disappears once the sample has been detected. • It is then time to gently move the capillary dropper away and wait until the result is displayed on the screen.

  • Page 31: Adding Comments

    Always follow the applicable regulations and protocols of the competent agencies when performing EQA tests. The control material provided by EQA programs are from unknown sources independent of the manufacturer. iLine Microsystems expressly declines all liability for results obtained using control materials that have not been validated by the manufacturer.

  • Page 32: Operator Id & Eqa Control Lot Id

    The meter displays information and emits acoustic signals (if the beeper is enabled) to guide the user throughout the testing process. Operator ID & EQA Control lot ID The user performing the test may log on either through the dropdown menu or when a patient test is initiated depending on the meter’s configuration (see section 3.3).

  • Page 33: Conducting The Test

    Conducting the Test • Place the meter on a flat, stable surface during testing or hold it in your hand avoid sudden movements. Once the chip is inserted, the meter will conduct a sequence of automatic steps to execute the on-board quality controls that lead to the chip warming- up.

  • Page 34: Eqa Test Result

    EQA Test Result The meter displays the control test result in INR units or an error message. Error messages are displayed as a letter “E” followed by a number and a short description. If an error message is shown, tap on the information symbol for further details or follow the steps described in the Troubleshooting section (see section 6).

  • Page 35: Troubleshooting

    6. TROUBLESHOOTING The microINR Expert meter’s performance is automatically checked when the system is turned on and during testing. The microINR on-board quality control checks for unforeseen conditions that may arise due to mishandling or technical issues (faulty components, consumables or external conditions).

  • Page 36: Memory

    7. MEMORY The microINR Expert meter can store up to 2,000 patient test results and 500 quality control test results together with their respective times and dates. A maximum of 5,000 Operator and 4,000 Patient IDs are allowed. If there is no free storage space when conducting a test, the oldest result will be automatically deleted to store the new one.

  • Page 37: Search

    Tap on Search to get a result list with the defined filters applied. Tap on Clear all to clear the defined filters. Generate Report microINR Expert can generate a PDF file containing all the memory data stored in the meter. Tap on Generate Report in the Memory menu.

  • Page 38: Advanced Functionalities

    • Aztec Code 8.2 DATA HANDLING The microINR Expert meter can be connected to a computer or host system (DMS) through various channels. The meter connectivity settings are available at the Settings option on the main menu (see section 3.5). The administrator must be logged on to set or modify the connectivity settings.

  • Page 39: Wi-Fi

    DMS. Users should keep in mind that real-time data communication cannot be guaranteed by the microINR Expert meter as it depends on various external factors such as the type and number of connected devices, the performance of the Access Point, the distance to the Access Point, the presence of electromagnetic disturbances and other potential interferences.

  • Page 40: Ethernet

    In line with the ISO11073 industry communication standard, the DMS or app must acknowledge the meter’s request for connection and actively seek the result. The microINR Expert meter can also transfer all the test results stored by tapping the Send Data option in the Bluetooth Settings menu.

  • Page 41: Operator & Patient Lists

    • OID: max. 20 characters. • PID or LOT: max. 20 characters. • microINR EasyControl test: Lot ID and expiry date. • Patient result: INR + PT values or error message. • microINR EasyControl and EQA results: INR value or error message. •...

  • Page 42: Microinr Expert Meter Care

    9. microINR Expert METER CARE 9.1 STORAGE CONDITIONS • It is recommended to store the microINR Expert meter in the same environment in which it is used and keep it in its transport case when not use. • Do not store the meter in direct sunlight or under extreme temperature conditions.

  • Page 43: Additional Information

    *Test conducted at 22 º C with a 10-minute period between tests. 10.2 WARRANTY iLine Microsystems guarantees that the microINR Expert meter is free of material and manufacturing defects on the purchase date. The statutory warranty provisions on consumer rights in relation to the purchase of goods in the country of purchase shall apply.

  • Page 44: Technical Service And Reporting

    Please contact your local distributor if a problem persists after taking the measures set forth in the troubleshooting table or for further information. Note: the microINR Expert meter may only be repaired or serviced by personnel authorized by iLine Microsystems.

  • Page 45: Index

    11. INDEX About this system Operating conditions Administrator Operator Description Description Log in Log in Log out Log out Password Setup Auto off Operator lists Oral anticoagulant therapy Barcode scanner Beeper Prothrombin Time Bluetooth Vitamin K antagonist drugs Brightness Patient Calibration Description Capillary blood sample...
  • Page 46 Microsystems. The information contained in these Instructions for Use was correct at the time of printing. However, iLine Microsystems S.L. reserves the right to make changes to the specifications, equipment and maintenance procedures of the system at any time without prior notice.
  • Page 48 Microsystems S.L. Paseo Mikeletegi, 69 20009 Donostia - Gipuzkoa (SPAIN) www.ilinemicrosystems.com © 2022 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.

Table of Contents