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****** Page 1 ****** Abbott AFINlON2 AMNION 2 User Manual US 1116554, 1116663 1116752 Rev.A 2018/09

****** Page 2 ****** Dear Customer, Congratulations on the purchase of your Afinion•y 2 Analyzer. Upon arrival of your Afinion 2 Analyzer we recommend that the serial number along with the software version be recorded in the table provided below. The additional rows in the table are to be utilized if a software upgrade is performed on your Afinion 2 Analyzer. The recorded information will be of great value if and when a question is reported, or the desire to add a new Afinion Test to your analyzer arises. Serial number SN (for serial number (SN), see label on the rear side of the analyzer or on the transport container) Software records Date Upon receipt Software version* Afinion• Tests available I. 2. g. 4. 5. SW upgrade SW upgrade SW upgrade SW upgrade SW upgrade ‘k See start-up menu when you power on the analyzer (see “How to power on the analyzer”, page 11). Notes Technical Support Call 1.866.216.9505 2 | Us AFINIONÜ 2 User Manual

****** Page 3 ****** Intended use of the AFINIOBC 2 System Afinion 2 System, consisting of the Afinion 2 Analyzer and the Afinion Test Cartridges, is for in vitro diagnostic use only. Afinion 2 Analyzer is a compact multi-assay analyzer for point-of-care testing and is designed to analyze the Afinion Test Cartridges. CLIA Statements – Waived AfinionT” Tests Afinion HbA1 c is waived under the Clinical Laboratory Improvement Amendment of 1988 (CLIA88). A CLIA Certificate of Waiver is needed to perform testing in a waived setting. If the laboratory does not have a Certificate of Waiver, the Application for Certification (Form CMS-116), can be obtained at cms.gov/cmsforms/downloads/cmsl 16.pdf. The form should be mailed to the address of the local State Agency of the State in which the laboratory resides (cms.gov/C ce_C LIA_Contacts. as p). If the laboratory modifies the Afinion Test or Afinion 2 Analyzer system instructions, the test no longer meets the requirements for waived categorization. A modified test is considered to be highly complex and 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). North American product safety standards (CNUS mark) The Afinion 2 Analyzer has been tested and found to be in conformity with North American safety standards. See list of safety standards below. Safety standards The Afinion 2 Analyzer has been tested and found to be in conformity with standards for Safety requirements for electrical equipment for measurement, control, and laboratory use (IEC 61010-1:2010 , UL 61010-1:2012, CAN/CSA-C22.2: 61010-1 -12) and standard for Particular requirements for in vitro diagnostic (IVD) medical equipment (IEC 61010-2-101:2015). EMC standards The Afinion 2 Analyzer has been tested and found to be in conforrnity with standards for Electrical equipment for measurement, control, and laboratory use – EMC requirements (EN 61326-1:2013, EN 61326-2-6:2006, EN 61326-2-6:2013 and CFR 47 Telecommunications, Chapter l- FCC Part 15 – Radio Frequency Devices — Subpart B: unintentional radiators). AFINlOtsr 2 User Manual Us | 3

****** Page 4 ****** 4 | Us AFINIONÜ 2 User Manual

****** Page 5 ****** Table of contents Introduction Analyzer System Description Getting Started Configuration Quality Control About this user manual Examining the package contents Description of the AFINION’V 2 Analyzer Description of the Afiniorvu Test Cartridge How the AFINlOtsr 2 System works Internal process control The analyzer self-test The fail-safe mechanisms External process control Patients ID Operator ID Quality Control lockout Calibration Installing your analyzer Connecting power supply Connecting additional equipment Connectivity How to power ON the analyzer How to power OFF the analyzer How to operate the analyzer The 2 menus Setting the configuration Patient ID configuration Patient ID enable/disable Operator configuration Operator ID enable/disable Operator login expiration Operator list management Choosing language Adjusting screen/beeper settings Setting date and time QC lockout configuration General settings Erase all contents and configuration Analyzer network settings Connectivity settings Why quality control testing? Choosing control material Handling and testing controls Frequency of control testing AFINlOtsr 2 User Manual Table of Contents 7 7 8 8 9 9 9 9 9 9 9 9 9 10 10 10 10 11 11 11 12 13 13 13 14 14 14 14 15 15 15 16 17 17 17 18 19 19 19 19 Table of contents continues on next page US 15

****** Page 6 ****** Table of Contents Testing Procedures Information Codes and Troubleshooting Maintenance Warranty Technical Specifications Gallery of Icons Symbols and Abbrevations 6 | Us Operating precautions When operating the analyzer When handling the test cartridge Preparing for an AFINlOtsr 2 Analysis Collecting a sample Analysing a patient/control sample Using the operator ID function Entering operator ID Using the patient ID function Entering patient ID Using the control ID function Entering control ID Using the QC lockout function QC lockout status Running controls with enabled QC lockout function Patient and control results records View, print and export patient and control results When an information code appears Information codes caused by test-specific limitations Information codes caused by sample or test cartridge Information codes and messages caused by analyzer failure Other information codes Service information Cleaning and maintenance Cleaning the exterior Cleaning the cartridge chamber Disposal of the analyzer Software upgrade AFINIONE 2 Analyzer Additional equipment The touch buttons and their function Other symbols and signs AFINIONÜ 2 User Manual 20 20 20 20 21 21 22 22 22 22 23 23 23 23 24 25 25 26 26 27 27 28 28 29 29 29 29 29 go 31 31 32 34 35

****** Page 7 ****** Introduction About this user manual This user manual will guide you through installation, operation and maintenance of your Afinion 2 Analyzer. The user manual also explains how the analyzer works, describes the quality assurance system and assists you in troubleshooting. For analysing patient samples or controls, please also read the test specific information given in the package inserts following the Afinion Test Kits. The quick reference guides, available from your local Afinion supplier, highlight the main steps of the test procedures. It is recommended that you become familiar with 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 i 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 examine the components for signs of shipping damage. The Afinion 2 package unit includes: • Afinion 2 Analyzer • Power cable • Power supply, 24 VDC • User manual • Quick guides for the available Afinion Tests If the package unit is found incomplete, please report missing items or shipping damage to your supplier. It is recommended to keep the shipping box in case of later transportation of the analyzer. AFINlOtsr 2 User Manual US 17

****** Page 8 ****** Analyzer System Description Description of the AFINlOtsr 2 Analyzer Figure I shows the main exterior parts of the Afinion 2 Analyzer. 1 2 3 4 5 a Figure 1 1 ON/OFF button: 2 Red and green LEDs: 3 Touch screen: 4 The lid: 5 Connectors: Turns the power to the analyzer on and off. Light emitting diodes (LEDs) that indicates whether the analyzer is busy or not. Allows you to communicate with the analyzer through touch buttons and messages. Covers and protects the cartridge chamber. For connecting to mains power supply. Options for printer, barcode reader and/or LIS/HIS/EMR. ! Do not open the lid manually. Description of the AfiniontM Test Cartridge The Afinion Test Cartridge is unique for each analyte to be measured, as the reagent composition, reagent volumes and the integrated 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 test cartridge cannot be reused. Figure 2 illustrates an Afinion Test Cartridge with its functional parts: Left side Figure 2 Right side 2 7 5 6 3 I 2 3 4 5 6 7 Sampling device: Capillary: Reaction wells: Handle: Barcode label: Optical reading area: ID area: 8 | Us For collection of patient sample or control (Ia – closed position, lb – lifted position). Capillary to be filled with sample material. Contain all necessary reagents for one test. For correct finger grip. Contains assay and lot-specific information for the analyzer. Area for transmission measurement. Space for written or labelled sample identification. AFINIONÜ 2 User Manual

****** Page 9 ****** Analyzer System Description How the AFINIONTM 2 System works The Afinion 2 System uses different chemical and mechanical assay methods combined with advanced, computerized processing and measuring technology. A test cartridge with patient sample or control is placed in the cartridge chamber of the analyzer. By manually closing the lid, the test cartridge is transported into the analysis compartment of the analyzer. Test and lot-specific information is obtained from the barcode label (Figure 2). When the test cartridge enters the analyzer, the integrated camera reads the barcode which then initiates the processing of the test cartridge. The sample and reagents are automatically transferred between the wells. An internal camera monitors the entire process. Light-emitting diodes (LEDs) illuminate the reaction area, which can be either a coloured membrane or a reaction well. The camera detects the reflected or transmitted light, which is converted to a test result and displayed on the touch screen. When the user accepts the result, the lid covering the cartridge chamber opens automatically and the used test cartridge can be removed and discarded. The analyzer is then ready for the next run. Internal process control The analyzer self-test A self-test is performed during start-up of the analyzer to ensure that the instrument is operating according to established specifications. The self-test validates: • Hardware and software integrity • Test cartridge transport system • Liquid transport system • Camera vision system If the self-test fails at any point, the red LED will start flashing and an information code will be displayed on the touch screen (see “Information codes and troubleshooting”, page 26-28). When the analyzer is powered on for a longer period, it will automatically restart once a day to ensure that a self-test is done regularly. This procedure does not interrupt any analysis of the test cartridge. The fail-safe mechanisms Fail-safe mechanisms are included to secure safe processing. 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 safety mechanism, the process will be aborted and an information code will be displayed. External process control Patient ID The Afinion 2 patient ID functionality will, if configured, allow up to four patient ID fields to be entered. The patient ID will be stored with each patient test result in the result records. Operator ID The Afinion 2 operator functionality will, if configured, require the operators to login before testing. The functionality may also prevent unauthorized operators to login, perform tests and configuration. The operator ID will be stored with each test result in the result records. Quality Control lockout The Afinion 2 QC lockout function allows you to configure the instrument to automatically enforce your local required frequency of control testing. If the required control test has not been performed or the control result is outside the acceptable range, the instrument will disable patient testing for this assay. For manufacturer recommen- dations (see “Frequency of control testing” page 19). For more information regarding these functionalities, see “Configuration” page 12—18. Calibration The Afinion 2 Analyzer has been manufactured to deliver reliable and accurate results. During manufacturing, the analyzers are calibrated against a reference sys- tem. This procedure has been established to ensure that all analyzers operate within identical tolerance limits. Test specific calibration data are established for each lot of test cartridges and then stored in the barcode label (Figure 2). When the test cartridge enters the analyzer, the integrated camera reads the barcode. The calibration data for the actual lot are transferred to the instrument and used for calculating the results. Calibration by the operator is thus not required. AFINlOtsr 2 User Manual US 19

****** Page 10 ****** Getting Started Installing your analyzer Place your Afinion 2 Analyzer on a dry, clean, stable and horizontal surface. Make sure that the analyzer is located with sufficient surrounding airspace, at least 5 inches on each side. Placement of Afinion 2 Analyzer should allow easy disconnection from the wall outlet at any time. Acclimate the analyzer to ambient operating temperature (15-320C, 59-8909 before use. The analyzer might be impaired by: • Condensing humidity and water • Heat and large temperature variations • Direct sunlight Connecting power supply – Connect the power cable to the power supply. • Vibrations (e.g. from centrifuges and dishwashers) • Electromagnetic radiation • Movement of the analyzer during processing of a test cartridge – Insert the plug from the power supply into the power socket (Figure 3) in the back of the analyzer. – Plug in the power supply to a wall outlet. Only use the power supply and cable supplied with Afinion 2 Analyzer. Any other power supplies or cables can damage the analyzer and may cause possi- ble hazards. 2 3 Figure 3 1 Ethernet port for connection to LIS/HIS/EMR systems. Use shielded cable. 2 USB-A connectors for printer, USB flash and barcode reader. 3 Power input for power supply connection Connecting additional equipment Optional equipment, not provided with your Afinion 2 Analyzer are: • External barcode reader — for reading barcoded sample or operator 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 electric shock. Connectivity Afinion 2 Analyzer can reliably transfer test information to an information system. Use the Ethernet cable to interface the Afinion 2 Analyzer to an information system. Afinion 2 Analyzer automatically transfers patient and control results to a connected LIS/HIS/EMR system via TCP/IP networking using the protocols POCTI -A, HL7, ASTM 1381-85 (low level) or ASTM 1394-97 (high level), selectable by configuration. ASTM and HL7 protocols support the transfer of patient and QC results. POCTI-A protocol supports in addition functions such as device lockout and operator list management. Operator configuration allows for protection of connectivity settings. When operator configuration is set to operator ID with verification, the configuration of connectivity will only be available for operators at supervisor level. For relevant information, see chapter “Operator configuration”, page 14. When you export data that contains patient information, it is your responsibility to comply with your local regulations on protection of personal health information. Afinion 2 Analyzer POCTI -A, ASTM and HL7 communication protocols are available at alere.com or by contacting your local Afinion 2 supplier. 10 | Us AFINIONÜ 2 User Manual

****** Page 11 ****** Getting Started How to power ON the analyzer 1 Running 3 CAD Power on the analyzer by pressing the ON/OFF button (Figurel). An automatic start-up procedure will be initiated. Please wait. Do not open the lid manually. The automatic start-up procedure will be initiated shortly after the analyzer has been powered on. The red light on the top of the analyzer will turn on, indicating that the analyzer is busy. The analyzer is ready for use when the start-up menu is displayed and the green indicator light turns on. Start-up menu The analyzer’s software version (SW X.XX) will appear in the upper left corner of the Start-up menu screen. The temperature displayed in the Start-up menu is the operating analyzer temperature. Make sure that the operating temperature is within the recommended range for your Afinion Test (see the package insert for the Afinion Test). If the analyzer fails during the start-up procedure, an information code will appear referring to a message given in the section “Information codes and troubleshooting”, page 26-28. How to power OFF the analyzer Switch off the analyzer by pressing the ON/OFF button (Figure 1). The analyzer should be powered off after the end of a working day. The analyzer can only be powered off when the cartridge chamber is empty and the lid is closed. If the ON/OFF button is pressed and the lid is open, the message “Close lid” will appear on the screen. How to operate the analyzer The Afinion 2 Analyzer has two main user interfaces, the touch 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 Afinion 2 Analyzer is the cartridge chamber. The cartridge chamber is designed to receive the test cartridge in one orientation only. The lid must be manually closed, but opens automatically. When a new test cartridge is placed in the chamber, manually closing the lid will initiate the analysis. When the analysis is complete the lid will open automatically. The lid protects the cartridge chamber from dust, dirt, light and humidity during processing and when the analyzer is not in use. • The lid must be manually closed, but opens automatically. Do not open the lid manually. • Use the fingertips only on the touch screen. Do not use pens or other sharp instruments. 1 2 Screen saver 3 4 Figure 4 1 Text message 2 Touch buttons 3 The cartridge chamber with a test cartridge 4 The lid in open position The screen saver will turn on after 3 minutes, if the touch screen is not in use. To reactivate, touch the screen. Light signals (the red and green LEDs) The red diode is illuminated when the analyzer is busy. A flashing red light is seen when an information code is displayed. The green diode is illuminated when the analyzer is ready for use. A flashing green light indicates completion of an analysis. Sound signals A short beep indicates completion of an analysis. Two beeps mean that an information code or message is displayed. AFINlOtsr 2 User Manual US 11

****** Page 12 ****** Configuration The AFINlOt#.r 2 menus Start-up menu Patient ID configuration menu Patient ID Language setting Language: English Date/Time menu General settings menu 12 | Us Main menu CAD Configuration menu 1 AFINIONÜ 2 User Manual Operator configuration menu Operator ID Screen/beeper menu QC lockout configuration menu

****** Page 13 ****** Configuration Setting the configuration Before using your Afinion 2 Analyzer you should set the configuration according to your needs. To enter the Configuration menu, do the following: 1 2 3 Start-up menu Touch to enter Main menu. Main menu Touch CED to enter Configuration menu. Configuration menu Select an item for configuration (see following pages). C±DCL GDCÄD ((242) Patient ID configuration Patient ID enable/disable The patient identification (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 numbering is reset each day at midnight. Touch in the configuration menu to enter the patient ID on/off option. Patient Select @ X to disable the patient ID function. Select @ to enable the patient ID function. Touch to accept and return to the Configuration menu. AFINlOtsr 2 User Manual Us | 13

****** Page 14 ****** Configuration Operator configuration The operator ID function is disabled as a default setting by the manufacturer. Touch in the Configuration menu to enter the Operator configuration menu. Operator ID Operator ID enable/disable Touch in Operator configuration menu to enable/disable operator ID. 10 Select to disable the operator ID function. Select to enable operator ID. Any operator ID is accepted. Select to enable operator ID with verification. • To enable this function at least one supervisor is required to be present in the operator list. When operator ID with verification is enabled, analyzer configuration will only be available to the supervisors. To log in, the operator ID entered is required to be present in the operator list. See “Operator list management”, page 14. Touch to accept and return to the Configuration menu. Operator login expiration Touch in the Operator configuration menu to set automatic logout of the operator. Minutes Enter the number of minutes before automatic logout of operator. The operator will automatically be logged out after the configured number of minutes after ended test. Touch to confirm and return to previous view. Operator list management Touch 1 in Operator configuration menu to enter operator list. Touch + to add new operator. Touch desired operator ID and touch Copy operator list to delete or to edit the highlighted operator. 3322113″ 1123311 2 Enter operator ID 3 OPERATORIO USER SUPERVISOR CZD&D 14 | Us 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 export operator list from instrument to USB flash. Move USB to the new analyzer and touch to import operator list. Any existing operator list on the analyzer will be deleted. Enter new/edit operator ID Enter new/edit operator ID and touch to enter. Both letters and numbers can be entered (maximum 16 characters). If a barcode reader is connected to the analyzer, a barcoded operator ID can be entered. Configure the operator level Select USER to configure user access. Select SUPERVISOR to configure supervisor access. Configure tests accessible: Select the test accessible for this operator. Touch to return and edit the operator ID. Touch to accept and store new operator in the operator list. The operator list can store 1000 operator IDs. Supervisors will be marked with * in the operator list. When analyzer is configured to Operator ID with verification, configuration of the analyzer will only be available to the supervisors. AFINIONÜ 2 User Manual

****** Page 15 ****** Configuration Choosing language Touch I Language: Eng iSh in the Configuration menu to enter the language setting. The default setting by manufacturer is English. Other languages are available. Touch the arrow in the window to view other options. Scroll down until you find the preferred language. Touch to accept and return to the Configuration menu. Adjusting screen/beeper settings Touch Volume: in the Configuration menu to enter the Screen/beeper menu. Touch Touch to enter the Screen alignment setting. to enter the Beeper volume setting. A + sign is shown. Use a blunt pencil and tap 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 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 date format is YYYY:MM:DD, where YYYY is the year, MM is the month (01 to 12), and DD is the day (01 to 31). The time format is hh:mm, where hh is the hour from 00 to 23 and mm is minutes from 00 to 59. Touch in the Configuration menu to enter Date/time menu. 1 CED 2 YYYY:MMOO Touch Touch CÄD to enter Date setting. to enter Time setting. Enter today’s date or time. Touch •-a to confirm and return to the previous view. AFINlOtsr 2 User Manual Us | 15

****** Page 16 ****** Configuration QC lockout configuration Touch in the Configuration menu to enter the QC lockout configuration menu. Touch Touch Touch (ZELL) to configure QC lockout for the assay selected. to configure QC lockout interval. to view/add/delete stored control lots in the control lot database. 1 2 3 4 HbAfc QC lockout HbA1c QC lockout interval HbA1c RUN* 10189721, ACR 10190518: Cl Select assay for QC lockout configuration Touch the arrow in the window to open the drop down menu. Touch the assay to select. QC lockout Select to disable the QC lockout function. No QC runs will be required for this assay. Select to enable the QC lockout function. It is required to run ONE passed control, control level C I OR C II, to reset the QC lockout interval. a a to enable the QC lockout function. It is required to run TWO passed controls, Select both control level C I AND C II, to reset the QC lockout interval. Touch to confirm and return to the previous view. QC lockout interval Select RIJN# to configure QC lockout interval by number of runs. Select to configure QC lockout interval by hours. Touch to enter/edit number of runs/hours to QC lockout. xxJ displays the number of runs/hours configured in the QC lockout interval. Touch to confirm and return to the previous view. 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 (assay) • Control level (C I or C II) • Control expiry date • Acceptable control range • CRC (check sum to validate the previous data) 16 | Us The Afinion Control Data and its accompanying barcode is found in the Afinion Control Package Insert. If the Afinion Control Data is not available, contact your local supplier. Touch + and either manually enter the Control Data or if a barcode reader is connected to the analyzer (recommended), scan the barcode. The Afinion Control Data may also be entered before, during or after a control run. The control lot will automatically be stored in the database. See page 25. Select lot number and touch to delete a control from the list. When a control lot has reached its expiry date, the control will automatically be deleted from the instrument control database. The control lot database can store 100 control lots. AFINIONÜ 2 User Manual

****** Page 17 ****** General settings in the Configuration menu to enter the General settings menu. Touch ICLÄJ_) Touch Touch Touch to erase all content and configurations. to enter Instrument network settings. to enter Connectivity settings. Erase all contents and configurations (LLC.) Touch in General settings menu to erase all contents and configurations. Touch to erase all content and configurations. Touch to cancel and return to General settings menu. Analyzer network settings See Table 1 for description of the available analyzer network settings. Touch to enter Instrument network settings view. Touch to configure the network. jp Address Gasteway• mask Enter the IP Address. Touch +–•1 to confirm and continue to Gateway. Enter the Gateway. Touch to confirm and continue to Network mask. Enter the Network mask. Touch 4—-1 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 i Description of the available analyzer network settings Consult your network administrator and LIS/HIS/EMR administrator for required network settings. DHCP IP address Gateway Network Mask Host name DHCP is turned on/off by selecting “DHCP”. When using DHCP the instrument’s IP address will be assigned by the DHCP Server. No other network settings are necessary. NB! If DHCP is activated, only the hostname setting can be edited. Insert fixed IP address [0-255/0-255/0-255/1-2541 Insert Gateway [0-255/0-255/0-255/1-2541 Insert Network mask [0-255/0-255/0-255/0-2551 Insert Host name. Valid characters are [A-Zl, [0-91, [-1. The length can be from 1-16 characters AFINlOtsr 2 User Manual Configuration Us | 17

****** Page 18 ****** Configuration Connectivity settings See Table 2 for description of the available Connectivity settings. Touch in General settings to enter Connectivity settings Select appropriate communication protocol • ASTM I-IL • ASTM LL HL7 • POCTI -A Communication protocol is disabled as default. Select which results to be transferred to LIS/HIS/EMR by selecting the appropriate button • Patient results only • Patient and control results Select “New results only” and previous obtained results will not be transferred to the LIS/HIS/EMR Touch to enter page 2 of the configuration or to return to the General settings menu Server gool O as Touch for HL7 only). to enter Server IP and Port number, Receiving application (available for ASTM HI-y ASTM LL and HL7 only) and Receiving facility (available Enter the server IP address: Press to continue to the Port number setting. Enter the server port number setting: Touch to continue to the Receiving application setting or to close the text input. Enter the Receiving application setting: Press to continue to the Receiving facility setting or to close the text input. Use the button to select Patient ID as (available 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 Results Server IP port Receiving Application Receiving Facility Patient ID As ASTM I-IL ASTM LL HL7 POCTI-A Disabled Patient results only Patient and quality control HIS Patient ID Visit Number ASTM High Level: The communication protocol is based on ASTM E 1394 – 97 ASTM Low Level: The communication protocol is based on ASTM E 1381 – 95 HL7: The communication protocol is based on HL7 version 2.4 POCTI-A: The communication protocol is based on CLSI: POCTOI -A2 Point-of-Care Connectivity; Approved Standard — Second Edition Data connectivity is disabled Only patient results will be transferred to the LIS/HIS/EMR Both patient and QC results will be transferred to the LIS/HIS/EMR Insert the IP address of the receiving system [0-255.0-255.0-255.1-254] [0-655351 (0 = not set) (ASTM HL, ASTM LL and HL7 only) Receiving application name (O 30 characters) (HL7 only) Receiving facility name (0-30 characters) (HL7 only) (HL7 only) For further information about the connectivity settings, see the Afinion 2 data sheets for POCTI -A, ASTM and HL7 which can be obtained at Alere.com or through your local Afinion supplier. 18 | Us AFINIONÜ 2 User Manual

****** Page 19 ****** Quality Control Why quality control testing? Quality control testing should be done to confirm that your Afinion 2 System is working properly and provides reliable results. Accurate results for patient samples can only be assured when controls are used routinely and the values are within the acceptable ranges. Choosing control material Controls supplied by Alere Technologies AS are recommended for use with the Afinion 2 System. These control kits contain control materials with established acceptable ranges for the Afinion 2 System. If you decide to use controls from another supplier, you will need to determine their precision and to establish acceptable control ranges for the Afinion 2 System. Handling and testing controls i Consult the package insert that comes with each control kit for detailed instructions on handling and storage of the control material. To run a control, follow the procedure in the section “Testing procedures”, page 20-25. The measured value should be within the acceptable range stated on the control vial label or in the control package insert. If the control results are within the acceptable ranges, patient samples may be tested and results reported. If the result obtained for a control is out of range, make sure that: – The control vial has not passed its expiration date. – The control vial has not passed the declared stability for opened vials. – The control vial and Afinion Test Cartridges have been stored according to recommendations. – There is no evidence 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 vial. Patient results must be declared invalid when controls do not perform as expected. Contact your Technical service representative (1.866.216.9505) for advice before analyzing patient samples. Frequency of control testing It is recommended that controls are analyzed: • When starting up an Afinion 2 Analyzer for the first time. • With each new shipment of Afinion Test Kits. • With each new lot of Afinion Test Kits. Anytime an unexpected patient test result is obtained. • When training new personnel in the correct use of the Afinion 2 System. • If national or local regulations require more frequent testing of control materials, perform quality control in compliance with the regulations for your facility. • Users with a low frequency of testing should analyze controls at least every 30 days. The controls should always be analyzed if an unexpected test result is obtained (see the Afinion Test Package Insert, section Test result reporting). If local, state and/or federal regulations require more frequent testing of control materials, then quality control should be performed in compliance with these regulations. Each laboratory site can benefit from establishing a quality control plan. The laboratory director should determine whether additional testing is appropriate for their laboratory. AFINlOtsr 2 User Manual US 19

****** Page 20 ****** Testing Procedures Operating precautions When operating the analyzer: Use your fingertip to operate the touch screen. Do not use pens or other objects that may scratch or damage the screen. Exception: If the screen alignment function is required, you will need to use a blunt pencil. • The lid opens automatically, but must be closed manually. Do not try to open the lid manually. The lid protects the cartridge chamber from dust, dirt, light and humidity. Empty the cartridge chamber and keep the lid closed when the analyzer is not in use. If an information code appears on the screen during the analysis, please consult the “Information codes and troubleshooting” section, page 26-28. Do not move the analyzer when a test cartridge is being processed. When handling the test cartridge: • Do not use test cartridges after the expiration date, or if the test cartridges are not stored in accordance with the recommendations. • Do not touch the test cartridge optical reading area. Hold the test cartridge by the handle. (Figure 2). • Do not use the test cartridge if the foil pouch, the desiccant bag or the test cartridge itself is damaged. • The test cartridges must reach recommended operating temperature before use. • Do not open the foil pouch until just before use. Once opened, the test cartridge has limited stability. • Handle and dispose the test 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 AFINlOt•r 2 analysis Allow the Afinion Test Cartridges to reach the recommended operating temperature before use. – Power on your Afinion 2 Analyzer so it is ready for the day’s first analysis. – Enter the operator ID (optional). See procedure on page 22. – The patient ID, control ID or Afinion Control Data can be entered before or during processing of the test cartridge in the analyzer. See procedures on page 22-25. Consult the package insert that comes with each Afinion Test Kit for assay specific information. Tear strip a 1 Open the foil pouch. Grip the handle and remove the test cartridge from the pouch. Discard the desiccant bag and foil pouch in suitable waste containers. When first opened the test cartridge has limited stability. wvmja. 2 Optkal readvng area Inspect the cartridge. Do not use the test cartridge if it is damaged or if loose desiccant particles are found on the test cartridge. Use the handle to avoid touching the optical reading area. ID area XX-NN 3 Mark the test cartridge with the patient or control ID. Use the ID area on the test cartridge. An ID label can also be used. Do not write on the barcode label or allow it to become wet, dirty or scratched. If an ID label is used, this must fit into the ID area. If a barcode reader is connected to the analyzer, a barcoded patient II), control ID or Afinion Control Data can be entered. 20 | Us AFINIONÜ 2 User Manual

****** Page 21 ****** Testing Procedures Collecting a sample • The patient sample material and control material to be used is specific for each Afinion Test. • The length of the capillary in the sampling device, and thereby the sample volume, might also vary for the different Afinion Tests. • The time from filling the capillary until analysing the test cartridge must be as short as possible. • Do not use the test cartridge if dropped on the bench or floor after the sample has been collected. i Consult the package insert that comes with each Afinion Test Kit for assay specific information. 1 Remove the sampling device from the test cartridge. Use the handle to keep the test cartridge steady against the table and pull the sampling device straight up. Examples: Collecting ‘*ary centre 2 Fill the capillary; hold the sampling device almost horizontally and bring the tip of the capillary in surface contact with the sample. Make sure that the capillary fills completely. It is not possible to overfill. Do not wipe off the capillary. Avoid air bubbles and excess sample on the outside of the capillary. Analysing a patient/control sample 1 CÄJ_) Touch to enter the patient sample mode. Touch to enter the control mode. The lid opens automatically. 2 Insert the test cartridge with the barcode label facing left. Be sure that the test cartridge is correctly placed in the cartridge chamber. A “C” in the upper left corner indicates that the Touch Touch Touch Control Data. Touch e.-J and enter the patient ID. to confirm. and enter the control ID or Afinion to confirm. analyzer is in the control mode. 5 Record the result, then touch If a printer is connected, touch the result. The lid opens automatically. to accept. to print The result will be saved in the result records. 3 Immediately and carefully replace the sampling device into the test cartridge. The time from filling the capillary until analysing the test cartridge must be as short as possible. 3 Close the lid manually. The analyzer will start processing the test cartridge. The processing time depends on the test in use. 6 Remove the used test cartridge from the cartridge chamber and discard it in a suitable waste container. Insert a new test cartridge or close the lid manually. Keep the lid closed to protect the cartridge chamber when the analyzer is not in use. Entering the patient ID, control ID or Afinion Control Data will not interrupt the processing. i Consult the package insert that comes with each Afinion Test Kit for assay specific information. AFINlOtsr 2 User Manual Us | 21

****** Page 22 ****** Testing Procedures Using the operator ID function Entering operator ID If enabled, the operator’s identification (ID) is required before processing an Afinion Test Cartridge (see “Operator configuration”, page 14). Both letters and numbers can be entered (maximum 16 characters). The operator ID will be displayed with the result and stored along with the other specific data for this run (see “Patient and control results records”, page 25). If configured to “enabled with verification” the operator ID entered is required to be present in the operator ID list (see “Operator configuration”, page 14). Enter the operator ID by numbers and/or touch ABC to enter letters. If a barcode reader is connected to the analyzer, a bar coded operator ID can be entered. Touch to confirm and return to previous view. The operator will be automatically logged out according to the configuration (see “Operator configuration” page 14). The operator may also manually logout by using the operator logout button displayed in the Start-up menu. Using the patient ID function The patient ID function is enabled as a default setting. 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 patient ID before the processing. 1 2 Touch to enter the patient ID option. (Test name] (Test name] It is possible to enter up to four patient ID entries for each patient, P-ID I to 4. When enabled, P-ID I is required to be entered. Scrolling between the patient IDs is done with the Enter patient ID by numbers and/or touch ABC to enter letters (maximum 16 characters). If a barcode reader is connected to the analyzer, a barcoded patient ID can be entered. Touch to confirm and return to previous view. The entered P-ID 1 will appear on the screen. The patient ID touch button will remain in the view and it is possible to make corrections. The P-ID 1 will be stored in the memory and displayed along with the other specific data for this run (see “Patient ID configuration” page 13). Patient ID 2-4 will not be displayed in the result records but will be stored in the memory and appear on printouts and data transferred to data management systems. 22 | Us AFINIONÜ 2 User Manual

****** Page 23 ****** Testing Procedures Using the control ID function In quality control testing, a suitable control ID must always be entered. The lot number of the control material is recommended as a suitable control ID. The control ID function cannot be disabled. Entering Control ID It is recommended to enter the control ID during processing of the test cartridge in the analyzer. Entering the control ID will not interrupt the processing. It is also possible to enter the control ID before processing. Both letters and numbers can be entered (maximum 16 characters). The control ID will be stored in the memory and displayed along with the other specific data for this run. To enter the control ID during processing, do the following: 1 c (Test name) 2 control (Test name) Touch to enter the control ID option. Enter control ID by numbers and/or touch ABC to enter letters. Touch to confirm and return to the previous view. The entered control ID will appear on the screen. The control ID touch button will remain in the view and make corrections possible. Using the QC lockout function When the QC lockout function 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 status The status of the active QC lockouts is presented with a QC lockout status button (padlock symbol) visible in the Start-up menu. This gives the operator the status of QC lockout before he attempts to run any tests. The padlock symbol will only be visible if QC lockout function is enabled for one or more assay types. The padlock symbols used are: _ OF CAD CAD CAD CAD CAD Enabled-unlocked II controls are within the configured interval. It is possible to run patient tests for all assays. Warning-unlocked All controls are within the configured interval. When one or more of the assays has 10 % or less of the configured interval remaining the warning icon will be displayed. It is possible to run patient tests for all assays. Expired-locked One or more controls have expired according to the configured interval. Patient testing on the expired assay has been locked. AFINlOtsr 2 User Manual Us | 23

****** Page 24 ****** Testing Procedures Touch the QC lockout status button (padlock symbol) in the Start-up menu to enter the QC lockout status view. Status The information is displayed as a list. Only the assays with QC lockout activated are displayed in this window. Red text indicates expired assays and orange text indicates assays within warning period. Control level How to reset QC lockout interval and/or unlock expired assays. If no control level is specified, it is required to run ONE passed control, control level C I OR C II, to reset the QC lockout interval and unlock the assay for patient testing. ACRC*: E.g. 58 a HbA1c: If the control level is specified it is required to run TWO passed controls, both control level C I AND C II, to reset the QC lockout interval and unlock the assay for patient testing. • ACRC;E a ACR C l: OO.OO.OO a ACR C II: OO.OO.OO Remaining time/runs Remaining time (dd:hh:mm) or number of runs for each assay with active QC lockout is shown. dd is the number of days, hh is the number of hours, and mm is the number of minutes until the assay will be locked. # is number of patient tests. Running controls with enabled QC lockout function When running controls with the QC lockout function enabled, the Afinion Control C)ata is required to be entered or previously stored in the instrument control lot database. See “QC lockout configuration”, page 16. I) The Afinion Control Data is entered before, during or after the control run. If a barcode scanner is connected (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 lot number is not found in the Afinion Control database or the Afinion Control Data entered is not valid, the instrument will present an option to retry the input or discard the control run result. If discarded, the result will not be stored in the instrument result records. c HbAIc 5.6% c HbAIc 24 | Us Passed (result within the acceptable control range) The result of the control is checked against the acceptable ranges for the corresponding lot number. If the result is within the limits, a pass symbol is displayed on the screen and the QC lockout interval is reset according to the QC lock- out configuration. If QC lockout is configured to require two control levels (C I and C II), both levels must pass to reset the lockout interval. Only the interval for the control level used in the test is reset. Failed (result above or below the acceptable control range) When a control result is not within the acceptable ranges specified for the control lot, a failed symbol X is shown on the screen. The result is stored in the instrument and is sent to the data management system if connected. The QC lockout interval will not be reset. The arrow symbol will specify whether the result is above t or below the acceptable ranges. See “Handling and testing controls”, page 19. AFINIONÜ 2 User Manual

****** Page 25 ****** Testing Procedures Patient and control results records The patient and control results are stored in the memory of the Afinion 2 Analyzer. The last 500 patient results and the last 500 control results are saved in separate records. When exceeding the capacity of 500 results, the oldest result will be deleted. The following parameters are listed for each run: Date and time, run number, patient ID/control ID, operator ID, lot number of test cartridge and the test result. View, print and export patient and control results 1 2 Main menu Touch Touch to enter patient results. to enter control results. c The last patient result or control is displayed IXX•NNI txxxxxxxxl To view more results touch If a printer is connected, touch or 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 file for each assay tested on the Afinion 2 Analyzer. These files may be opened in e.g. Microsoft Excel for further processing. c 1 Test type 2 HbAIC HbA1c 3 4 HbA1c HbA1c 5 6 HbA1c 7 HbAIC 8 HbA1c 9 HbAIC HbA1c 10 11 HbA1c 12 HbAIC 13 HbA1c 14 HbAIC 15 HbA1c 16 Serial number Cartridge lot no Patient ID Patient Patient 103 Patient 104 PATIENTID2 PATIENTID3 PATIENTID4 PATIENT102 PATIENTID3 PATIENTID4 PATIENTID2 PATIENTID3 PATIENTID4 PATIENT102 PATIENTID3 PATIENTID4 pATlENTlD3 PATIENT102 PATIENTID3 PATIENTID4 PATIENTID3 PATIENTID2 PATIENTID3 PATIENTID4 PATIENTID2 PATIENTID3 PATIENTID4 PATIENT102 PATIENTID3 PATIENTID4 PATIENTID3 PATIENTID2 PATIENTID3 PATIENTID4 PATIENTID2 PATIENTID3 PATIENT102 PATIENTID3 pATlENTlD2 PATIENTID2 PATIENT102 PATIENTID3 PATIENTID2 PATIENTID4 PATIENTID4 PATIENTID4 PATIENTID4 PATIENTID4 PATIENTID4 OPROOOI OPROOOI OPROOOI OPROOOI OPROOOI OPROOOI OPRtxm OPROOOI OPROOOI OPROOOI OPROOOI OPROOOI OPROOOI OPROOOI OPROOOI Test date 20130924 08:11 20130926 08:29 20130926 08:39 20130926 09:50 20130926 10:01 20130926 11:23 20130926 12:01 20130926 13:20 20130926 13:56 20130926 14:01 20130926 14:12 20130926 15:04 20130926 15:12 20130926 15:25 20130926 16:20 % HbA1c 5.2% 3.1% 3.3% 8.2% 5.1% 5.3% 3.8% 3.3% 9.2% 5.1% 5.2% 6.1% 3.3% 8.2% 5.1% mmol/mo eAG ASCKX)7962 Ascm7962 Ascm7962 AS(XD7962 ascm7962 AS(XD7962 ascm7962 AS.(m7962 Ascm7%2 ascm7962 Ascm7%2 AS.cm7962 10125.032 10125113 10125034 10125-032 10125032 10125113 10125034 10125113 10125034 10125034 10125-034 10125032 10125034 10125034 10125034 PATIENTIDI PATIENTIDI PATIENTIDI PATIENTIDI PATIENTIDI PATIENTIDI PATIENTIDI PATIENTIDI PATIENTIDI PATIENTIDI PATIENTIDI PATIENTIDI PATIENTIDI PATIENTIDI PATIENTIDI When you export data that contains patient inforrnation, it is your responsibility to comply with your local regulations on protection of personal health information. AFINlOtsr 2 User Manual Us | 25

****** Page 26 ****** Information Codes and Troubleshooting When an information code appears Inforrnation codes that might appear during use of the Afinion 2 Analyzer refer to specific information or error messages. The code numbers, the possible causes and actions to take are listed below. If the analyzer detects a problem during processing of a test cartridge, the test will automatically be aborted and the test cartridge will be safely moved to the cartridge chamber. Proceed as follows: 1 “torn-vation code 2 3 Record the code number (#) and touch to accept. The lid opens automatically. Remove the test cartridge. If the test cartridge is not ejected, restart the analyzer. Do not reuse the test cartridge. 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 i 03 104 i 05 406 107 f 08 26 | Us Cause Hemoglobin too low Hemoglobin too high HbA1 c too low HbA1 c too high Creatine too high Blood in urine Action to take Consult the Afinion HbAI c Package Insert. Consult the Afinion HbA1 c Package Insert. Consult the Afinion HbA1c Package Insert. Consult the Afinion HbA1c Package Insert. Consult the Afinion ACR Package Insert. Consult the Afinion ACR Package Insert. AFINIONÜ 2 User Manual

****** Page 27 ****** Information Codes and Troubleshooting Information codes caused by sample or test cartridge 201 202 203 204 205 206 207 208 209 210 212 213 214 215 217 218 Cause Insufficient sample volume: – Empty capillary – Air bubble in capillary – Capillary incompletely filled Excess sample on the sampling device exterior Wrong sample material Coagulated sample Hemolysed blood sample or poor sample quality Test cartridge or analyzer failure Capillary cracked or damaged Barcode label not readable (dirty or damaged) – No sampling device inserted – Sampling device belongs to another Afinion Test – Label on sampling device not readable (dirty or damaged) Test cartridge previously used Test cartridge has passed expiration date The date in the analyzer is incorrectly set Test cartridge temperature too low Test cartridge temperature too high Software upgrade is required to run this test. Test cartridge or analyzer failure Test cartridge or analyzer failure Hemolysed blood sample or poor sample quality (Afinion HbA1c) Hemolysed blood sample or poor sample quality (Afinion HbA1 c) Condensation detected on cartridge Action to take Repeat the test with a new sample and test cartridge. Ensure that the capillary is completely filled with no air bubbles (see package insert for the Afinion Test in use). Repeat the test with a new sample and test cartridge. Ensure that only the tip of the capillary is in contact with the sample (see package insert for the Afinion Test in use). Repeat the test with a new sample and test cartridge. Ensure that proper sample material is used (see package insert for the Afinion Test in use, section “Specimen collection and storage”). Repeat the test with a new sample and test cartridge. The time from filling the capillary until analyzing the test cartridge should be as short as possible. Consult the Afinion Package Insert. Repeat the test with a new sample and test cartridge. Repeat the test with a new sample and test cartridge. If the problem persists, restart the analyzer and run controls. Repeat the test with a new sample and test cartridge. Inspect the sampling device before use and handle with care. Repeat the test with a new sample and test cartridge. If the problem persists, restart the analyzer and run controls. Repeat the test with a new sample and test cartridge. Ensure that the correct sampling device is in place and that the sampling device label is clean. Repeat the test with a new sample and test cartridge. Check expiry date on the foil pouch or kit container. Repeat the test using a new sample and a new test cartridge from another lot. Check the date in the analyzer to make sure it is set correctly. Repeat the test with a new sample and test cartridge. 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). 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). Contact your local supplier for assistance. Repeat the test with a new sample and test cartridge. If the problem persists, restart the analyzer and run controls. Repeat the test with a new sample and test cartridge. If the problem persists, restart the analyzer and run controls. Consult the Afinion HbA1 c Package Insert. Repeat the test with a new sample and test cartridge. Consult the Afinion HbAI c Package Insert. Repeat the test with a new sample and test cartridge. Run a new test cartridge. Ensure that the cartridge is equilibrated to room temperature before the foil pouch is opened. Information codes and messages caused by analyzer failure 27 28 29 Self-test error. Analyzer in non- operative mode 302 303 304 Cause Start-up procedure failed Analyzer failure Self-test failed Analyzer failure Analyzer temperature is too high Analyzer temperature is too low Action to take Contact your local supplier for assistance. Restart analyzer. If the problem persists, contact your local Afinion 2 supplier. Restart the analyzer. Restart the analyzer and run controls. Repeat the test with a new sample and test cartridge. Ensure that the operating temperature is within recommended range (15-320C, 59-89 OF). Wait until the analyzer has cooled down. Repeat the test with a new sample and test cartridge. Ensure that the operating temperature is within recommended range for the Afinion Test in use (see package insert). The analyzer temperature is displayed in the Start-Up menu (see page 11). Repeat the test with a new sample and test cartridge. AFINlOtsr 2 User Manual Us | 27

****** Page 28 ****** Information Codes and Troubleshooting 305 Touch screen error 401 402 404 501 502 503 504 601 Cause Printer improperly connected Malfunction of the printer Touch screen failure/ Touch screen buttons do not respond accurately Action to take Switch off the analyzer, reconnect the printer and restart the analyzer. If the message persists, see the printer user manual. Restart analyzer and realign screen. Other information codes Cause No registered supervisors in operator list Cannot delete last supervisor This assay type is not accessible to the operator Operator ID is not found in operator list Cause The control lot has passed expiration date Afinion Control Data is not recognised and is not stored in control lot database Control verification aborted. Required control test interval has expired. Patient testing is disabled for this assay. Cause Operator list or control lot database is full Action to take At least one supervisor is required in the operator list when the analyzer is configured to operator ID verified, (see page 14). At least one supervisor is required in the operator list when the analyzer is configured to operator ID verified, (see page 14). The operator logged in does not have access to run this assay type. Please contact your supervisor. When Operator ID with verification is enabled, operator ID entered is required to be present in the operator list, (see page 14). Please contact your supervisor. Action to take Check the expiration date on the control lot package insert or kit box. Repeat the test using a sample from a new control lot. Reenter the Afinion Control Data, (see page 16). 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. A passed control run must be performed according to configuration to unlock this assay for patient testing. Action to take The operator list can store 1000 operators and the control lot database can store 100 control lots. Delete an operator or control lot to enter a new item Service information The laboratory must notify the manufacturer of this test system of any performance, perceived or validated, that does not meet the performance specifications as outlined in the instructions. The manufacturer provides a toll free line for technical support: I .866.216.9505 The toll free number is available for use only in the United States of America. Before asking for assistance, please record the following information: Afinion 2 serial number (SN) see label on the backside of the analyzer Software version number — see Start-up menu. Afinion Test type Test cartridge or kit lot number — see foil pouch or kit container Control identification and lot number — see vial label Control results obtained Description of the problem with reference to information codes or messages 28 | Us AFINIONÜ 2 User Manual

****** Page 29 ****** Maintenance Cleaning and maintenance No maintenance of the Afinion 2 Analyzer is required other than cleaning the exterior and cartridge chamber. Cleaning the exterior Cleaning the exterior of the Afinion 2 Analyzer should be performed whenever necessary. Most spills and stains can be removed with water or a mild detergent. – Power off the analyzer. Unplug the power supply when the shut down procedure is completed. – Clean the outside of the analyzer and the touch display with a clean, lint-free and non-abrasive cloth dampened in water or a mild detergent. – To disinfect the exterior of the analyzer use a I : 10 solution of household bleach (i.e., 0.5% sodium hypochlorite), 2% glutaraldehyde solution or 70% alcohol solution. The surface of the analyzer should be exposed to the disinfectant for at least 10 minutes. – Allow the analyzer to air dry. Plug in the power supply and power on the analyzer. • The analyzer must be powered off and unplugged before cleaning. • Do not use any cleaning liquid or equipment other than those recommended above. • Do not immerse the analyzer in water or other liquids. Cleaning the cartridge chamber The Cleaning Kit ( 1116048) should always be used for cleaning the cartridge chamber. The cartridge chamber should be cleaned immediately if materials or liquids are spilled in the cartridge chamber. For regular maintenance (removal of dust particles etc.), the cartridge chamber should be cleaned every 30 days. to open the lid. – Touch 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 I : 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 moistened swab. – To disinfect the cartridge chamber, the surface of the chamber should be exposed to the disinfectant for at least 10 minutesl. – Wipe off any residual liquid from the cartridge chamber using a new, dry Cleaning Swab. Plug in the power supply, and power on the analyzer by pressing the on/off button. – The lid will close automatically during the self-test. If it doesn’t, then close it manually and restart the analyzer. • The analyzer must be unplugged before cleaning. • Do not use any cleaning liquid or equipment other than those recommended above. • Do not allow liquid to drip off the Cleaning Swab into the analyzer. If liquid drips into the analyzer, optics can be destroyed. • Do not immerse the analyzer in water or other liquids. • Do not move or tilt the analyzer when cleaning the cartridge chamber. Disposal of the analyzer For correct disposal according to the Directive 2012/19/EU (WEEE), contact your local Afinion 2 supplier. Software upgrade Consult the Afinion USB Flash Drive Package Insert for software upgrade. t Clinical and Laboratory Standards Institute (CLSI) Guideline M29-A3: “Protection of Laboratory Workers From Occupationally Acquired Infections; Approved Guideline – Third Edition”. ISBN I -56-238-567-4 AFINlOtsr 2 User Manual Us | 29

****** Page 30 ****** Warranty Alere Technologies AS warrants solely to the Buyer that the Afinion 2 Analyzer will be free from defects in materials and workmanship, when given normal, proper and intended usage, and will perform in accordance with Alere Technologies AS’s specifications for a period of twelve months from the date of delivery. At its expense, Alere Technologies AS agrees to repair, or at Alere Technologies AS’s option, replace with a new or reconditioned unit, any Afinion 2 Analyzer which is under warranty and not performing substantially in accordance with applicable product specifications, provided that the Buyer has given Alere Technologies AS notification of such warranty claim within the warranty period. If Alere Technologies AS is unable after reasonable efforts to repair or replace the Afinion 2 Analyzer not performing substantially in accordance with applicable product specifications, the Buyer’s sole remedy shall be the refund of an amount not to exceed the actual purchase price paid by the Buyer for the Afinion 2 Analyzer. All repairs will be done during normal working hours. All replaced parts shall become Alere Technologies AS’s property. Alere Technologies AS may require the Buyer to ship the Afinion 2 Analyzer to Alere Technologies AS or elsewhere at Alere Technologies AS’s expense, for warranty service to be performed. Notwithstanding the foregoing, Alere Technologies AS shall have no obligation to make repairs, replacements 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 authorized Alere Technologies AS service representative; (vi) use of the Afinion 2 Analyzer in a manner for which it was not designed, (vii) causes external to the Afinion 2 Analyzer such as, but not limited to, power failure or electric power surges, or (viii) use of the Afinion 2 Analyzer in combination with equipment, components or software not supplied by Alere Technologies AS. EXCEPT AS STATED IN THIS SECTION OF THE USER MANUAL, ALERE TECHNOLOGIES AS DISCLAIMS ALL WARRANTIES, WHETHER EXPRESS OR IMPLIED, WRITTEN OR ORAL, WITH RESPECT TO THE AFINION 2 ANALYZER, INCLUDING ANY WARRANTY OF MERCHANTABILITY OR FITNESS FOR A PARTICULAR PURPOSE. ALERE TECHNOLOGIES AS’S MAXIMUM LIABILITY ARISING OUT OF THE SALE OF THE AFINION 2 ANALYZER OR ITS USE, WHETHER BASED UPON WARRANTY, CONTRACT, TORT OR OTHERWISE, SHALL NOT EXCEED THE ACTUAL PURCHASE PRICE PAID BY THE BUYER FOR THE AMNION 2 ANALYZER. IN NO EVENT SHALL ALERE TECHNOLOGIES AS BE LIABLE FOR SPECIAL, INCIDENTAL OR CONSEQUENTIAL DAMAGES, INCLUDING, BUT NOT LIMITED TO, LOSS OF PROFITS, LOSS OF DATA OR LOSS OF USE DAMAGES, ARISING HEREUNDER OR FROM THE SALE OF THE AFINION 2 ANALYZER. THIS WARRANTY MAY NOT BE TRANSFERRED BY THE BUYER. The acknowledgement of claims shall be reported to your Technical Care Specialist at 1.866.216.9505 30 | Us AFINIONÜ 2 User Manual

****** Page 31 ****** Technical Specifications AFINIONTM Analyzer Size Weight Display Camera 2 Analyzer Capacity of result records Capacity of operator list Capacity of control lot database SW update Communication interface Power supply Power supply Input Output Output connector Operating conditions Temperature Relative humidity Altitude Location Test cartridge temperature 200 mm w x 186 mm H x 328 mm D 3.4 kg Standard LCD colour display with back light and integrated touch panel. Resolution: 240 x 320 pixels. Visible area: 58 x 77 mm. 640 x 480 pixels 500 patient results and 500 control results 1000 operators 100 control lots Via USB flash drive USB 2.0 High Speed, Ethernet 10/100 Mbps Separate AC to DC power supply. Double insulated. 100-240 VAC, 50-60 Hz 24 VDC ± , 1.75 A, 42 W 0.2 x 0.1 in. / 5.5 x 2.5 mm plug. Positive (+) on inner pin. 15-320C (59-8909 10-80%, non-condensing Max 4000 MASL Dry, clean, horizontal surface. Avoid direct sunlight. According to specifications for the Afinion Assay in use. Storage and transport (in the original container) Temperature Relative humidity -40 to wC (-40 to 15809 10-93 % at 400C Additional equipment For information regarding recommended barcode reader, printer, the Afinion Analyzer Cleaning Kit or USB flash drive, please call I .866.216.9505. AFINlOtsr 2 User Manual Us | 31

****** Page 32 ****** Gallery of Icons The touch buttons and their function Touching a button on the screen will activate the function of this button. All the touch buttons that may appear during operation of the Afinion 2 Analyzer are explained below by their function. Start-up menu Main menu Configuration menu Patient ID configuration menu Operator configuration menu Patient and control records Universial buttons 32 | Us CED CED CED CZD CEIL) Patient sample mode Control mode Main menu QC lockout status QC lockout status QC lockout status Operator logout button Patient records Control records Configuration menu Patient ID configuration menu Operator configuration menu Language setting ScreenNolume menu Date/Time menu QC lockout configuration menu General settings menu Patient ID disabled Patient ID enabled Operator ID configuration Automatic operator logout Operator list print Result records export Patient ID Control ID Enter Backspace Increase Select patient sample mode. Select control mode. Enter Main menu (operator II), patient records, control records and configuration menu). Enabled-unlocked All controls are within the configured interval. It is possible to run patient tests for all assays. Warning-unlocked All controls are within the configured interval. When one or more of the assays has 10 % or less of the configured interval remaining the warning icon will be displayed. It is possible to run patient tests for all assays. Expired-locked One or more controls have expired according to the configured interval. Patient testing on the expired assay has been locked. Manual operator logout button. View patient result records. View, print or export patient results. View control result records. View, print or export control results. Enter configuration menu (language, patient ID on/off, date/time and screen/volume). Configure patient ID function. Configure operator function. Enter language configuration. Configure screen and volume settings (screen contrast, screen adjustment and beeper volume). Enter date/time settings (date and time). Configure QC lockout function. Enter the general settings menu. Patient ID disabled. Patient ID enabled and required. Configure operator ID function. Configure number of minutes before automatic logout of operator. Manage operator list. Mew, add, edit and delete operators. Print result on connected printer. Export result records to connected USB flash. Enter patient ID. Enter control ID. Enter and return to previous view. Delete previous character. Increase contrast/volume. AFINIONÜ 2 User Manual

****** Page 33 ****** Menu Operator ID configuration Language settings Screen/Beeper menu Date/Tme menu General settings menu QC lockout configuration menu Operator list QC lockout QC lockout interval Touch button CED CCC) CAD (CÄD @ RUN# Name Decrease Scroll up Scroll down Exit Accept Abort Add button Delete button Edit button Operator ID disabled Operator ID enabled Operator ID enabled with verification Language Screen alignment Beeper volume Date Time Erase Instrument network settings Connectivity settings QC lockout QC lockout interval Control lot information Operator list export Operator list import QC lockout disabled QC lockout enabled QC lockout enabled Interval by number of patient tests Interval by number of hours Gallery of Icons Function Decrease contrast/volume. View previous View next Exit current menu and return to previous screen view. Accept (a setting or a test result). Abort the test result or cancel operation. Add new operator or control lot. Delete operator or control lot. Edit QC lockout interval or operator ID. Operator ID function is disabled. Operator ID is required to be entered to run an Afinion Test Cartridge Operator ID is required to be entered to run an Afinion Test Cartridge. The operator ID is veri- fied against the analyzer operator list. Enter language configuration. Enter screen alignment function. Enter beeper volume setting. Enter date setting. Enter time setting. Erase all content and configurations. Enter analyzer network settings Enter connectivity settings Enable/disable QC lockout function. Configure QC warning and lockout interval. View, add or delete control lots stored on analyzer. Export operator list from analyzer to USB flash. Import operator list from USB flash to analyzer. QC lockout is disabled for this test. One passed control run of either C I or C II is required to reset QC lockout interval. Two passed control runs, C I and C II are required to reset QC lockout interval. QC reminder and lockout active after a configured set of patient tests. QC reminder and lockout active after a configured set of hours. AFINlOtsr 2 User Manual Us | 33

****** Page 34 ****** Gallery of Icons Other symbols and signs Other symbols, signs and abbreviations that may appear during operation of the Afinion 2 Analyzer are explained below. These symbols or signs are only inform- ative and can not be activated like the buttons. Symbol x c O-ID p-lD C-ID RUN# LOT# USER SUPERVISOR 34 | Us Meaning Wait! Information code Operator ID Patient ID Control ID Connected Appears when? Hour-glass icon that appears in the start-up procedure. Icon used along with a code number [#] that corresponds to code specific information messages [#] (see “Information codes and troubleshooting”). Icon illustrates the operator ID. Icon illustrates the patient ID. Icon illustrates the control ID. The instrument is connected to the LIS/HIS/EMR server. When no symbol, the instrument is not connected 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 Result is below acceptable range Control Operator ID Patient ID Control ID Run number Lot number User Supervisor The displayed control result is above acceptable range. The displayed control result is below acceptable range. The letter C will appear on the screen when the control mode is selected. Abbreviation used in the patient and control records. Abbreviation used in the patient records. Abbreviation used in the control records. Abbreviation used in the patient and control records for the run number of the analysis. This numbering is reset each day at midnight. Abbreviation used in the patient and control records for the lot number of the test cartridge. Operator with user privileges. Operator with supervisor privileges. AFINIONÜ 2 User Manual

****** Page 35 ****** Symbols and Abbreviations The following symbols and abbreviations are used in the product labeling of the Afinion 2 System. Symbol/Abbreviation IVD REF LOT CONTROL C I CONTROL C II CLEANING KIT Explanation The product conforms to all applicable EC Directives and Regulations In vitro diagnostic medical device Catalogue number Lot number Serial number Test cartridge Control C I Control C II Cleaning kit Waste electrical and electronic equipment (WEEE) Biological risks Contents sufficient for “n” number of tests Expiration date Storage temperature limitations Manufacturer Date of manufacture Fragile, handle with care Keep away from sunlight Keep dry Warnings and precautions Consult the Afinion User Instructions Symbol/Abbreviation UL 61010-1 cm,vc.SA222 No. LED HIS LIS LCD DC ASTM POCTI-A EMR DHCP AFINlOtsr 2 User Manual Explanation Conformity to the RoHS 2 directive Conformity to the technical regulations for EurAsian Conformity Mark Conformity to the North American product safety standards Direct current USB port Ethernet port Double insulation Light emitting diode Personal computer Identification Hospital information system Laboratory information system Liquid crystal display Alternating current Direct current American Society for Testing and Materials Health Level Seven Point-of-Care Connectivity; approved standard Electronic medical record Dynamic host configuration protocol Internet protocol Us | 35

****** Page 36 ****** a life. to the fullest-TM Abbott Alere Technologies AS Kjelsåsveien 161 PO. Box 6863 Rodeløkka NO-0504 Oslo, Norway alere.com ISO 13485 certified company 0 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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