iLine microsystems microINR Instructions For Use Manual
For monitoring of oral anticoagulation treatment based on vitamin k antagonist drugs
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Table of Contents
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Summary of Contents for iLine microsystems microINR
- Page 1 friendly technology Instructions for use...
- Page 2 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...
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Page 3: Table Of Contents
INTERPRETING THE RESULTS MEASURING PRINCIPLE LIMITATIONS OF USE microINR® SYSTEM MEMORY AND DATA EXTRACTION TO A COMPUTER DESCRIPTION OF THE microINR® KIT CLEANING AND DISINFECTING THE PARTS OF THE microINR® METER microINR® METER CHARGING THE microINR® METER ERROR GUIDE SETTING THE TIME AND DATE... -
Page 4: Introduction
This warning symbol indicates a possibility of danger use of the microINR Chip. Also, do not forget to read the which could result in death, injury or damage of the... -
Page 5: Oral Anticoagulant Therapy
Do not use the microINR system near sources of Important information regarding the correct use of the intense electromagnetic radiation, as this could system that does not affect the safety of the patient or the interfere with its correct operation. -
Page 6: Measuring Principle
Thromboplastin is used as a reagent to calculate the prothrombin time (PT). Depending on The technology used by the microINR system is based on the the nature of this reagent and the equipment used variations microfluidics of the microINR Chip, which allows storing, on the PT results are to be expected. -
Page 7: Microinr® System
The microINR kit includes: - Case Calibration - microINR Meter Each batch of microINR Chips has been calibrated against a - Charger reference batch of human recombinant thromboplastin traced - Power adapter to International Reference Thromboplastin of the World Health... -
Page 8: Parts Of The Microinr® Meter
2.2 PARTS OF THE microINR® METER Charge the battery completely before using the Meter for the first time. Do not open or manipulate the Meter. MINI USB CONNECTION Do not pierce or burn the battery. Do not change the battery. The manufacturer will not warranty Meters that have been opened. -
Page 9: Patient Identification (Optional)
(INR or error message) is displayed along with its might cause a non-detection of expired Chips (E02). 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. 2.5 PATIENT IDENTIFICATION (OPTIONAL) -
Page 10: Conducting The Test
PROFESSIONAL USE: Liquid control: Turning the Meter On The microINR system has a number of on-board quality control functions integrated into the Meter and the Chip and The Meter can be turned on: therefore there is no need to run quality control tests with... -
Page 11: Modes Of Use
- A count down appears (80s). - The Chip emits a steady light. • Perform the fingerstick (see section 3.3 of these instructions iLine Microsystems only recommends the option of approaching for use). the Meter to the sample for users who are experienced in •... -
Page 12: Test Result And Assay End
• After the beep, gently move the finger away and wait until If the message E08 appears, do not attempt a new the INR results are displayed on the screen. test and proceed to charge the Meter. If you apply the sample and no sound is emitted, this means •... -
Page 13: Obtaining And Applying The Capillary Blood Sample
3.3 OBTAINING AND APPLYING THE CAPILLARY • You can use any finger for the BLOOD SAMPLE fingerstick. The recommended site is the one shown on the The steps to obtain and apply a capillary blood sample following image. correctly are detailed below: •... -
Page 14: Interpreting The Results
Otherwise, the results might be incorrect. 3.4 INTERPRETING THE RESULTS The results are shown as International Normalized Ratio (INR) units. The microINR system’s results range between 0.8 The sample must be applied immediately after and 8.0. obtaining it, otherwise coagulation would start If an error message is displayed, see the “Error guide”... -
Page 15: Memory And Data Extraction Toa Computer
A COMPUTER Datamatrix code Acceptance range of the control channel The microINR Meter can store up to 199 results of patients 10. Type of sample (blood or plasma) and liquid quality controls. Each result is stored with the date and time of the test. When conducting a test, if there is no free storage space, the oldest result will be automatically 5. - Page 16 the Meter. Do not spray fluids on the Meter or submerge the Meter. Before cleaning or disinfecting the Meter, turn it off and make Make sure that no fluids enter the Meter or the Chip insertion sure the cables are unplugged. area.
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Page 17: Error Guide
If error E18 is displayed again, use a different measurement method. This error occurs mainly in patients with a hematocrit outside the defined range for the microINR system (25%-55%). Other messages Failure while checking the electronic If the problem persists, contact your local distributor. -
Page 18: Additional Information
Microsystems warranties to the original buyer that the - Battery: Lithium 2400mAh/2800mAh; 3.7 V. Consumption: 1 A. microINR system is free of material and manufacture defects - Power supply: Only plug the charger to power supplies with for two years after the purchase date. -
Page 19: Symbols
7.5 SYMBOLS TEST RESULTS IN INR DATE UNITS OR ERROR CODE. (DAY : MONTH : YEAR). “Legal Manufacturer” TIME (HOURS : MINUTES). “Serial number” BLINKING INDICATES “APPLY ”Catalogue reference” SAMPLE”. THE RESULT IS “CE Mark” ABOVE OR BELOW 0120 Number of Notified Body 0120 THE MEASURING RANGE OF THE... -
Page 20: Glossary
Microcapillary: site on which the INR test takes place. Microfluidics: technology for storing, dosing, transferring and/ or mixing small volumes of fluid to cause a chemical reaction. MicroINR Meter: electronic device that serves to conduct INR tests. Microreactor: area of the Chip meant to store the reagents. - Page 22 Microsystems S.L. Paseo Mikeletegi, 69 20009 Donostia - Gipuzkoa (SPAIN) www.ilinemicrosystems.com © 2016 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.
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