iLine microsystems microINR Instructions For Use Manual Download

Page: 1 / 22

is covered by patent technology EP2201365(B1). iLine Microsystems and

microINR are registered trademarks of iLine Microsystems S.L.

INC0001AD - Rev 2021-02

Paseo Mikeletegi, 69

20009 Donostia - Gipuzkoa (SPAIN)

www.ilinemicrosystems.com

iLine Microsystems S.L.

friendly

technology

Instructions for use

Summary of Contents for microINR

Page 1: ...d by patent technology EP2201365 B1 iLine Microsystems and microINR are registered trademarks of iLine Microsystems S L INC0001AD Rev 2021 02 Paseo Mikeletegi 69 20009 Donostia Gipuzkoa SPAIN www ilin...

Page 2: ...ntained 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...

Page 3: ...NT PROCEDURE Turning the Meter On Inserting the Chip Conducting the Test 1 1 1 1 2 1 3 1 4 2 2 1 2 2 2 3 2 4 2 5 3 3 1 3 2 Test Result and Assay End Turning the Meter Off COLLECTION AND TESTING THE BL...

Page 4: ...rget to read the instructions for use of the disposable lancets and or lancing device used to obtain the capillary blood sample Federal law restricts the device to sale by or on the order of a physici...

Page 5: ...after use on each patient Please follow the directions in these instructions for use for cleaning and disinfection section 5 When using the Meter in a multi patient setting use only auto disabling si...

Page 6: ...r dose adjustment Prothrombin Time and INR The activity of oral anticoagulants is monitored by measuring the Prothrombin Time PT in seconds Depending on the nature of the reagent and the equipment use...

Page 7: ...provided by the manufacturer or you may damage the Meter Other cables and accessories may negatively affect the Meter and even can lead to an injury 2 4 SETTING THE TIME AND DATE Before using the micr...

Page 8: ...performance is automatically checked for electronic components correct power battery level and environmental temperature conditions Then On Board Controls provide a quality control check for each ind...

Page 9: ...the device to be ready make sure your hand is warm and the fingertip clean see section 3 3 of these instructions for use If the quality control is correct the Control symbol will appear on the screen...

Page 10: ...p the Meter If the Meter is dropped or gets wet and the frequency of error messages increases contact your local distributor For self testing patients do not shake or drop the Meter If the Meter is dr...

Page 11: ...l amount of blood remnant at the entry channel Sampling technique 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...

Page 12: ...le attempt Never add more blood to the Chip 10 After the beep tone gently remove the finger leaving a small amount of blood remnant at the entry channel as shown in the picture If you need to repeat t...

Page 13: ...hecking the memory a new test will begin normally 11 For healthcare professionals If an unexpected result is obtained repeat the test making sure that the directions in these instructions for use are...

Page 14: ...time 12 Cleaning and disinfecting the Meter is essential to prevent blood borne transmission of pathogens Disinfection of the Meter destroys most but not all pathogenic and other types of microorganis...

Page 15: ...the Meter Not doing so could cause incorrect results If you notice any signs of deterioration of the Meter after cleaning or disinfecting stop using the system and contact your distributor or healthca...

Page 16: ...amination E06 E07 E08 E09 E10 Turn the Meter off and switch it on again If the problem persists the device may be damaged Verify that the temperature is above 59 F 15 C Repeat the test in a warmer loc...

Page 17: ...the sample see section 3 2 and 3 3 Do not hit touch or move the Chip or Meter during the test Verify proper Chip storage conditions see microINR Chips instructions Repeat the test with a new Chip Stri...

Page 18: ...ystem is free of material and manufacture defects for one year after the purchase date This warranty does not cover any component damaged due to inadequate storage in environmental conditions outside...

Page 19: ...er Temperature limit Consult the instructions for use Direct current Batch code Lot Number Type BF Applied Part Class II Equipment Degree of Ingress Protection Provided by Enclosure Protected against...

Page 20: ...k end image processing hardware and software Microfluidics Microfluidics is the science and technology of systems that process or manipulate small amounts of fluids using channels measuring from tens...

Page 21: ...al domestic commercial or hospital environment Electromagnetic environment guidance IEC 60601 test level Compliance level Immunity test Surge IEC 61000 4 5 Voltage dips short interruptions and voltage...

Page 22: ...jacent or stacked use is necessary the microINR should be observed to verify normal operation in the configuration in which it will be used Use only the supplied charger provided by the manufacturer o...