Abbott Afinion 2 User Manual Download

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1116554, 1116663

1116752 Rev. A 2018/09

US

User Manual

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Summary of Contents for Afinion 2

Page 1: ...1116554 1116663 1116752 Rev A 2018 09 US User Manual ...

Page 2: ...r analyzer arises Serial number for serial number SN see label on the rear side of the analyzer or on the transport container Software records Date Software version Afinion Tests available Upon receipt 1 SW upgrade 2 SW upgrade 3 SW upgrade 4 SW upgrade 5 SW upgrade See start up menu when you power on the analyzer see How to power on the analyzer page 11 Notes _____________________________________...

Page 3: ...nd is subject to all applicable CLIA requirements Conformity to directives and standards European IVD directive and RoHS 2 directive CE marking The Afinion 2 Analyzer meets all provisions in the Directive 98 79 EC on in vitro diagnostic IVD medical devices and in the Directive 2011 65 EU on the restriction of the use of certain hazardous substances in electrical and electronic equipment RoHS 2 Nor...

Page 4: ...4 US AFINION 2 User Manual ...

Page 5: ... 10 Connectivity 10 How to power ON the analyzer 11 How to power OFF the analyzer 11 How to operate the analyzer 11 Configuration The AFINION 2 menus 12 Setting the configuration 13 Patient ID configuration 13 Patient ID enable disable 13 Operator configuration 14 Operator ID enable disable 14 Operator login expiration 14 Operator list management 14 Choosing language 15 Adjusting screen beeper set...

Page 6: ...rol results records 25 View print and export patient and control results 25 Information Codes and Troubleshooting When an information code appears 26 Information codes caused by test specific limitations 26 Information codes caused by sample or test cartridge 27 Information codes and messages caused by analyzer failure 27 Other information codes 28 Service information 28 Maintenance Cleaning and m...

Page 7: ...th these user instructions before you start operating the Afinion 2 Analyzer Some of the information in this user manual is accompanied with a symbol that points you to the following particulars Warnings and precautions References to the package inserts for the specific Afinion Tests and control kits Examining the package contents When unpacking check the contents against the list below and examin...

Page 8: ...grated devices are test specific The test cartridge label has a colour unique for the test The test cartridges are separately packed in foil pouches to protect the reagents and plastic devices from light dirt and humidity A single test cartridge contains all necessary reagents for one test and is ready to use An integrated sampling device is used for collection of the patient sample or control The...

Page 9: ...rocessing The integrated camera inspects the test cartridges initially before the process starts and during the assay If defects are detected e g broken capillary the cartridge is used past its expiry date the test cartridge is rejected and an information code is displayed During processing vital functions and components e g pumps heater are supervised When problems are detected by the built in sa...

Page 10: ...tor identification Printer for optional print out of test results For additional information regarding barcode reader and printer specifications please contact your local Afinion 2 supplier Connecting the equipment should be done while the analyzer is powered off All equipment connected to the USB and or Ethernet ports must have double or reinforced insulation from mains to prevent the risk of ele...

Page 11: ...uch screen and the cartridge chamber The analyzer is easily operated using the touch buttons that appear on the screen When a button is touched its function will be activated Text messages that appear on the screen will help guide you through the testing procedure The functions of the touch buttons are explained in the section Gallery of icons page 32 34 The other main operative part of the Afinio...

Page 12: ...iguration Main menu Start up menu Operator configuration menu Date Time menu Screen beeper menu QC lockout configuration menu Patient ID configuration menu Language setting General settings menu Configuration menu The AFINION 2 menus ...

Page 13: ...entification ID function can be enabled or disabled The patient ID function is enabled as a default setting by the manufacturer When the patient ID function is enabled the patient ID must be entered for each test cartridge to be analyzed If the patient ID function is disabled a run number will automatically replace the patient ID and be displayed in the upper left corner of the screen This numberi...

Page 14: ... to confirm and return to previous view Operator list management Touch in Operator configuration menu to enter operator list 1 Touch to add new operator Touch desired operator ID and touch to delete or to edit the highlighted operator Copy operator list It is possible to copy an existing operator lists between analyzers using a USB flash drive Insert USB flash in the analyzer USB port Touch to exp...

Page 15: ...the center of the Repeat tapping the center of the each time it is shown When the process is finished the previous screen will return Adjust the beeper volume by touching or Touch to confirm and return to the previous view Setting date and time The correct date and time should always be set because the date and time for the analyses are stored and displayed in the patient and control records The d...

Page 16: ... enter edit number of runs hours to QC lockout displays the number of runs hours configured in the QC lockout interval Touch to confirm and return to the previous view 4 Control lot database To add a control to the control lot database the Afinion Control Data is required The Afinion Control Data is a numeric data string which contains all lot specific data Afinion Control lot number Control type ...

Page 17: ... the Gateway Touch to confirm and continue to Network mask Enter the Network mask Touch to confirm and return to Hostname Enter the Hostname Touch to confirm and return to Instrument network settings view Touch to accept and return to the General settings menu Table 1 Description of the available analyzer network settings Consult your network administrator and LIS HIS EMR administrator for require...

Page 18: ... for HL7 only HIS Patient ID Visit Number Touch to return to the General Settings menu Table 2 Connectivity settings Consult your network administrator and LIS HIS EMR administrator for required connectivity settings Protocol ASTM HL ASTM High Level The communication protocol is based on ASTM E 1394 97 ASTM LL ASTM Low Level The communication protocol is based on ASTM E 1381 95 HL7 HL7 The communi...

Page 19: ...dence of bacterial or fungal contamination of the control vial Correct any procedural error and retest the control material If no procedural errors are detected it is recommended to examine the laboratory s quality control record to investigate the frequency of control failures Ensure that there is no trend in out of range quality control results Retest the control material using a new control via...

Page 20: ... cartridges and sample collection equipment as potential biohazardous materials Use gloves Do not reuse any part of the test cartridge Consult the package insert that comes with each Afinion Test Kit for assay specific information Preparing for an AFINION 2 analysis Allow the Afinion Test Cartridges to reach the recommended operating temperature before use Power on your Afinion 2 Analyzer so it is...

Page 21: ...to the test cartridge The time from filling the capillary until analysing the test cartridge must be as short as possible Analysing a patient control sample 1 2 3 Touch to enter the patient sample mode Touch to enter the control mode The lid opens automatically Insert the test cartridge with the barcode label facing left Be sure that the test cartridge is correctly placed in the cartridge chamber ...

Page 22: ...g As long as this function is enabled the patient ID must be entered for each patient sample to be analyzed The patient ID function can be disabled see Patient ID configuration page 13 Entering patient ID It is recommended to enter the patient ID during processing of the test cartridge in the analyzer Entering the patient ID will not interrupt the processing It is also possible to enter the patien...

Page 23: ... is enabled for one or more assays approved control testing is required within the configured interval If the interval expires patient testing for the assay will be locked A passed control run must be performed according to configuration to reset the interval or to unlock the assay for patient testing A failed control run will disable patient testing see QC lockout configuration page 16 QC lockout...

Page 24: ...onnected recommended the control data barcode may be scanned The control lot will automatically be stored in the instrument control database 2 If the Afinion Control Data is previously stored in the instrument control database the operator will simply need to enter the 8 digit control lot number before during or after the control run If the instrument is configured to QC lockout and the control lo...

Page 25: ... control results 1 Main menu Touch to enter patient results Touch to enter control results 2 The last patient result or control is displayed To view more results touch or If a printer is connected touch to print the result Result records may be exported if an USB flash FAT 32 formatted is inserted to the Afinion 2 USB port Touch to export the results The results will be stored on the USB in a txt ...

Page 26: ... reuse the test cartridge 3 Look up the possible cause from the table below and take actions to solve the problem If the problem persists contact your local Afinion supplier see Service information page 28 Do not reuse a test cartridge that has been rejected by the analyzer Collect a new sample and repeat the test with a new test cartridge Information codes caused by test specific limitations Caus...

Page 27: ...alyzer is incorrectly set Check the date in the analyzer to make sure it is set correctly Repeat the test with a new sample and test cartridge 210 Test cartridge temperature too low Repeat the test with a new sample and a new test cartridge Ensure that the operating temperature is within acceptable range see package insert for the Afinion Test in use 211 Test cartridge temperature too high Repeat ...

Page 28: ... Control Data is not recognised and is not stored in control lot database Reenter the Afinion Control Data see page 16 503 Control verification aborted The Afinion Control Data entered was not recognised The control test was aborted by the operator Test result was not stored Run new control test to reset QC lockout interval 504 Required control test interval has expired Patient testing is disabled...

Page 29: ...hamber should be cleaned every 30 days Touch to open the lid Unplug the power supply Wet a Cleaning Swab with 3 drops of water and gently rinse the cartridge chamber To disinfect the surface use a 1 10 solution of household bleach i e 0 5 sodium hypochlorite 2 glutaraldehyde solution or 70 alcohol solution Do not soak Carefully remove spills and particles from the cartridge chamber using the moist...

Page 30: ...s or corrections which result in whole or in part from i an act of God or other unforeseen catastrophe ii any error omission or negligence of the Buyer iii improper or unauthorized use of the Afinion 2 Analyzer iv operating errors or the disregard of warnings and pre cautions described in this Afinion 2 Analyzer User Manual v repairs performed to the Afinion 2 Analyzer by any person other than an ...

Page 31: ...r supply Separate AC to DC power supply Double insulated Input 100 240 VAC 50 60 Hz Output 24 VDC 5 1 75 A 42 W Output connector 0 2 x 0 1 in 5 5 x 2 5 mm plug Positive on inner pin Operating conditions Temperature 15 32 C 59 89 F Relative humidity 10 80 non condensing Altitude Max 4000 MASL Location Dry clean horizontal surface Avoid direct sunlight Test cartridge temperature According to specifi...

Page 32: ...trol records View control result records View print or export control results Configuration menu Enter configuration menu language patient ID on off date time and screen volume Configuration menu Patient ID configuration menu Configure patient ID function Operator configuration menu Configure operator function Language setting Enter language configuration Screen Volume menu Configure screen and vo...

Page 33: ...ume Enter beeper volume setting Date Time menu Date Enter date setting Time Enter time setting General settings menu Erase Erase all content and configurations Instrument network settings Enter analyzer network settings Connectivity settings Enter connectivity settings QC lockout configuration menu QC lockout Enable disable QC lockout function QC lockout interval Configure QC warning and lockout i...

Page 34: ... to the LIS HIS EMR server Quality control pass Control result is within acceptable range Quality control failed Control result is outside acceptable range Result is above acceptable range The displayed control result is above acceptable range Result is below acceptable range The displayed control result is below acceptable range C Control The letter C will appear on the screen when the control mo...

Page 35: ... the Afinion User Instructions Conformity to the RoHS 2 directive Conformity to the technical regulations for EurAsian Conformity Mark UL 61010 1 CAN CSA 22 2 No 61010 1 Conformity to the North American product safety standards Direct current USB port Ethernet port Double insulation LED Light emitting diode PC Personal computer ID Identification HIS Hospital information system LIS Laboratory infor...

Page 36: ... Box 6863 Rodeløkka NO 0504 Oslo Norway www alere com ISO 13485 certified company 2018 Abbott All rights reserved All trademarks referenced are trademarks of either the Abbott group of companies or their respective owners 1116752 Rev A 2018 09 ...

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