63100 Rev D, Noveos Operators Manual

NOVEOS Operator’s Manual To clear information on the screen: 1. Touch the Clear Pos button to clear all the information for the position. or Touch the red X in the Patient Information panel to clear patient information. and/or Touch the red X in the Physician information panel to clear physician information. A confirmation message is displayed in both cases. 2. Touch the Done button or touch the Cancel button to return to the Sample Rotor screen. To fill in data on the screen: The data can be automatically filled in by (1) the LIS, (2) by loading an external file, or (3) by manual entry. To manually enter all the required data: 1. Touch the sample position on the Sample Rotor screen. • Sample ID: This is copied form the barcode or can be typed in manually. Sample ID is required. • Liquid Type: select the sample type from the dropdown list. • Container Type: select from the dropdown list. • Sample Type: the only option is serum • Remaining volume (uL): the remaining volume can be estimated by the user or determined by NOVEOS. 2. For NOVEOS to determine the remaining volume, touch the Check Vol button. Rev. D Figure 6-6. Liquid Type – Sample Screen 63100 6-7

6. Samples 3. Touch Test Selection button to assign tests. Then touch the Done button to save the changes. Touching Cancel abandons changes and displays the Sample Rotor screen. To assign tests to the position: Note: If no tests are selected for a sample, it will not be processed. 1. On the Liquid Data for Sample Tray Position # screen (Figure 6-5), after all the data has been filled in and Sample is selected as the Liquid Type, touch the Test Selection button. The Tests Available panel on the left side of the screen shows available tests and the Tests Selected panel on the right side shows tests that have been selected for the sample. Figure 6-7. Test Selection Screen 63100 6-8 Rev. D

NOVEOS Operator’s Manual 2. On the Test Selection for Sample screen: In the Panel field, choose a panel. If no panels have been set up (see Section 6.4), the field will show “No Panel”. Test Filter: If desired, the user may filter tests by panel (text name). For example, typing “pen” in the Filter field would display tests with “penicillin” in their name in the panel on the left side of the screen. 3. On the Tests Available panel on the lower left side of the screen, touch the checkbox next to the test to run. A green checkmark will display in the box. The test can be added to the current sample or multiple samples depending on which radio button is selected. 4. Touch the Add Selected button. If Current Sample is selected: If Current Sample is selected, touching the Add box and touching the checkbox for the test name row copies it to the panel on the right side of the screen. One test type can be added multiple times. Tests listed in the right side panel can be removed by touching the associated Remove box and then touching the Remove Selected button. Rev. D 6-9 63100

6. Samples 5. Multiple Samples 6. Touch the Add Selected… button. The Assign Selected Tests to Samples window displays. Figure 6-8. Assign Selected Tests to Samples 7. Touch the box for the tests to assign. All rows can be selected or deselected by touching the Assign checkbox. 8. Touch the Done button to finish test selection for the current position or Cancel to return to test selection. 63100 6-10 Rev. D

NOVEOS Operator’s Manual 6.1.5.1.3 Controls Controls produce known NOVEOS Immunoassy results. Control test results from the NOVEOS instrument provide proof that test results, when compared to test results that are not known, are accurate. NOVEOS uses both Positive and Negative Controls. Positive Controls produce known levels of reaction; Negative Controls are known to not react. • One Positive and One Negative Control must be assigned to each Assay. • Controls must have at least one test assigned to them. • Positive and Negative controls do not use the same tests. • Controls are produced in lots and known test results are lot specific. • Controls ship with a list of lot-specific tests and test result ranges contained in the 2D barcode insert included in the packaging for controls. 6.1.5.1.4 Calibrators When the software detects a calibrator, its concentration and assay type are displayed and it is automatically assigned to the system-defined capture reagent for that assay type. Calibrators are only run at the beginning of the run. The user may select replicates from 2-4. NOTE: Users may not change the Capture Reagent automatically assigned to calibrators. The data screen for calibrators and its use is identical to that for controls. 6.1.5.1.5 Saved Curves Once a full set of calibrators has been run to create a valid calibration, the software can save that calibration curve and use it up to ten days. After ten days, the software will require a full set of calibrators be loaded to create a new saved curve. When using a saved curve the software checks for several things and warns if it detects any of these conditions: • When using the saved calibration curve, it is not necessary to load any calibrators on the system. If some but not all of the calibrators are loaded, NOVEOS software will display a warning. This warning may be ignored. The software will not however use any extra calibrators during the run. • In order to use the saved curve, the software requires that the lot numbers of common reagents (Substrate A, Substrate B, Conjugate, Fluo Beads, and Diluent A) remain the same as those used to generate the saved curve. If any different lot numbers are loaded on the instrument, the software will display a warning and not allow the run to proceed. • When using a saved curve the software requires that at least one positive and one negative control must be loaded and each control must be assigned at least one test. If either control fails during the run, a warning will display and the run will be stopped. • A full set of calibrators may be loaded before the ten day period if desired. If a full set of calibrators is loaded, the software will create a new saved curve, and the ten day period will start over. A warning will be displayed to indicate a new curve will be stored Rev. D 6-11 63100

6. Samples 6.2 Setting Up a Control for an Assay How Control Information is loaded into the NOVEOS: NOVEOS scans the Control tube and loads the data from the tube label. Then, the user scans a 2D barcode insert to load the data for other information about the Control. Together, the information scanned in for a Control is: • Type of control • Expiration date • Lot number • Serial number within the lot • Stability information (the number of days the control may be used after it has first been used. • Tests that can be assigned • Test result ranges for the tests that can be assigned. 6.2.1 Setup Control Tests Place a tube of positive and a tube of negative control on the Sample Rotor. Initiate a scan of the Sample Rotor if not done already. In the sample screen below, the Control in Positions 4 and 5 have no tests assigned. Tests must be assigned to a control. Figure 6-9. Sample Rotor Screen Missing Control Information Press the Test# to display the ‘Test Selection’ screen for that position on the Sample Rotor. 6.2.2 Scan the 2D Barcode on the Directional Insert • If the control/lot combination is being used for the first time on the instrument, the software prompts the user to scan the package insert barcode. *Controls are the only tests that use the 2D barcode scanner to collect data. • Once a 2D barcode has been scanned for a control lot number, the software will remember the tests and ranges and it does not need to be scanned again. 63100 6-12 Rev. D

NOVEOS Operator’s Manual Figure 6-10. Press the Scan 2D Barcode Button Touch the Scan 2D Barcode button. Use the 2D bar code scanner to scan the 2D barcode on the directional insert that came with the control. All controls have a lot number – with an expiration date. Figure 6-11. Scan Bar Code Progress Figure 6-12. Scan 2D Barcode Choose Tests to Run Once the barcode has been scanned, select tests to be run on the control. In the Tests Available panel, press the box next to a test to choose it. Then press ‘Add Selected’ to add the test to the Tests Selected panel. *Note: If the control/lot is known to the system, it will fill in the list of available tests, as shown below. Rev. D 6-13 63100

6. Samples Figure 6-13. Select Tests for a Control Tube 6.2.4 Select Tests to Assign to a Control Touch the checkbox next to a listed test, then Touch ‘Add Selected’ to move the selected test to the ‘Tests Selected’ panel. After adding tests to the Tests Selected panel, click Done to save the test configuration for this assay. 6.2.5 When Controls are Setup Correctly The Sample Rotor Screen below shows both Positive and Negative Controls setup for an assay run. The line is ‘Green’. If the control is not correctly configured this line will be ‘Orange’. In the example below, both controls have all the information needed and have tests assigned. 63100 6-14 Rev. D

NOVEOS Operator’s Manual Figure 6-14. Successful Control Setup on Sample Rotor Rev. D 6-15 63100

6. Samples 6.3 JobList A Joblist is a queue containing Sample IDs and which tests should be assigned to each sample. A Joblist can be populated when the software receives orders from an LIS or it can be populated from a file. When barcodes are scanned on the sample rotor, the software looks into the Joblist for any matching sample IDs and assigns tests to the sample as specified by the Joblist entry. To load a JobList: 1. Touch the Samples button. 2. Touch the JobList tab. 3. Touch the Load JobList… button. A window displays from which the user can choose the joblist. Note: A joblist can only be loaded from a USB drive plugged into the NOVEOS PC or from a connected network drive. 4. When the data displayed is as desired, touch the Apply to Rotor button. The data will only be applied when the user has the appropriate barcoded patient sample tubes installed and scanned. 63100 Figure 6-15. JobList Screen Rev. D 6-16

NOVEOS Operator’s Manual 6.3.1 Printing Job Lists Job lists (orders) can be printed. To print a job order: 1. Touch the Samples button. 2. Touch the JobList tab. 3. Touch the Load JobList… button and select the list to load. Job order tests and assay types are displayed in the right-side pane. 4. Touch Print to print the joblist data. The user-selected printer on the Settings, System Setup screen will be used. 6.4 Panels A test panel is a list of tests with a descriptive name. When common tests are run on multiple samples, it is faster and more accurate to use a panel than applying tests individually. Defined panels can be saved or deleted. Existing panels by be edited by removing or adding tests. However, duplicate tests cannot be assigned to a panel. Panels can be created for either patient or control samples. Rev. D Figure 6-16. Panels Screen 63100 6-17

6. Samples 6.4.1 How to Create a Panel Touch the Samples button 1. Touch the Panels tab. 2. Patient Sample or Control: 3. Touch Patient Sample. Name: from dropdown, choose New Panel. 4. Type: Choose a type. If Patient Sample, no options are available. If control, choose Positive or Negative. The Tests Available panel shows available tests. 5. Test Filter: Enter a test filter if desired to narrow the list of choices. Touch the checkbox for each test to add. Touch the Add Selected button. Selected tests display in the panel on the right side of the screen. Continue this step until all the tests for the panel are added. When all the tests for a panel are added, touch the Save Panel button. 6. Enter the panel name in the dialog that displays. The name can be up to 25 characters and may include letters, numbers, and special characters. Touch OK to save or touch Cancel (to NOT save) to return to the Panels screen. The new panel name will be available as an option on other screens where panel selection is available. Figure 6-17. Panel Name Screen 63100 6-18 Rev. D

NOVEOS Operator’s Manual 6.4.2 Creating a Panel for Controls A control panel may be defined for each lot number of a positive or negative control. When the software reads a control lot number that has a defined panel, it will automatically assign all tests that are included in the panel to the control. To create a panel for Controls: 1. Touch the Samples button. 2. Touch the Panels tab. 3. Patient Sample or Control: touch Control. 4. Name: undefined (automatically set to undefined by software). 5. Type: choose Positive or Negative Control. 6. Select the desired lot number in the Lot Number dropdown box. If it is not available, then proceed to the next step. 7. If the desired lot number is not available, touch the Scan 2D Barcode button and scan the barcode information of the selected control lot. 8. In the Tests Available panel, enable the checkbox for each test to add. 9. Touch the Add Selected button. Selected tests display in the panel on the right side of the screen. Continue this step until all the tests for the panel are added. 10. When all the tests for a panel are added, touch the Save Panel button. 11. The panel with the saved with a software-generated name based on the type of control and lot number. 12. When a control with the associated lot number of the panel is loaded, then all tests in the panel will be automatically be assigned to the control. Rev. D 6-19 63100

6. Samples 6.4.3 Deleting a Panel To delete a panel: 1. Touch the Samples button. 2. Touch the Panels tab. 3. In the Name dropdown list, choose the panel to delete. 4. In the panel on the right side of the screen, touch the Delete Panel button for the panel. 5. On the pop-up confirmation window, select Yes to continue with the deletion or No to cancel. The user is returned to the Panels Screen. See example for delete a control panel below. 63100 6-20 Rev. D

NOVEOS Operator’s Manual 7 Reagents Touching the Reagents button provides access to screens which let the user start the barcode scan for items loaded in the Reagent Rotor. This can be done when the Reagent Rotor cover and canopy are closed and while not processing tests. The user may sort the reagent position list by the following columns: • Reagent position in the Reagent Rotor • Reagent type • Reagent name • Reagent description • Expiration date • Tests available. In addition, the software indicates by color the status of each item on the Reagent Rotor as follows: • Ready (green) • No tests available or expired (orange) • Misplaced (purple) • Empty (white). Once the barcodes are read by NOVEOS, that information is displayed on the Reagent Rotor and Beads screens respectively. Information for up to 150 Reagent Rotor positions can be displayed on the Reagent Rotor Screen. There are two positions for the Fluo Beads™. Figure 7-1. Reagents Screen Rev. D 7-1 63100

7. Reagents 7.1 Reagent Rotor and Beads The Reagent Rotor houses Capture Reagent, Conjugate, Substrate A, Substrate B, and Probe Wash. Multiples of any reagent type can be loaded on the Reagent Rotor. Normally everything the software needs to know is read from the barcodes on the tubes installed (and scanned) in the Reagent Rotor. If the barcode is damaged, the user can provide the information by manually typing it or scanning it with the handheld reader into the NOVEOS software 7.2 Using the Reagent Rotor Screen The Reagent Rotor screen displays a list of Reagents by their position in the Reagent Rotor. Figure 7-2. Reagent Rotor Screen with Data 63100 7-2 Rev. D

NOVEOS Operator’s Manual To add info to the Reagent Rotor screen by scanning the barcodes on the Reagent Rotor: 1. Touch the Reagents button. 2. Touch the Reagent Rotor tab. 3. Touch the Scan Barcodes button. 4. NOVEOS scans the barcodes, determines which reagents are loaded and fills in the screen. If the wrong type of container (for example, calibrator or control) is loaded, the software will display that position highlighted in purple. For each Reagent Rotor position on the Reagent Screen, the following information is displayed: • Type • Name • Reagent Description • Lot & Serial # • Expiration Date • Days to Expire • Tests Available • Slot Status • Ready 7.2.1 Clearing Reagent Rotor Information Information on the Reagent Rotor screen can be cleared all at once or by individual positions. To clear all information from the Reagent Rotor screen, touch the Clear Rotor button. A confirmation message is displayed so the user may continue or cancel. Rev. D Figure 7-3. Erase Rotor Positions Warning 63100 7-3

7. Reagents 7.2.2 Manually Editing and Clearing Position Data for the Reagent Rotor To manually edit or add info or clear a position on the Reagent Rotor screen: 1. On the Reagent Rotor screen, touch the number for the Reagent Rotor position you want to edit or clear. The Reagent Info for Position window displays. Figure 7-4. Reagent Info Screen The software fills in the status information for the selected position. If a barcode number is already displayed, touch the Clear Pos button to remove it. 2. To enter the barcode, type or use the hand barcode scanner and enter the code in the Barcode field, then touch the Enter Manual Code button. Note the Enter Manual Code button becomes displayed once characters are entered into the Barcode field. 3. Touch Done to accept the changes and return to the Reagent Rotor screen. 63100 7-4 Rev. D

NOVEOS Operator’s Manual 7.3 Using the Beads Screen The Beads screen displays information for two Fluo Beads tube positions. Figure 7-5. Beads Screen 7.3.1 Adding Info to the Beads Screen To add data to the Beads screen: 1. Touch the Reagents button. 2. Touch the Beads tab. 3. Touch the Scan Barcodes button. Be sure the rotor covers (Sample, Reaction and Reagent Rotors) and Fluo Beads tube holder lid are in place and that the canopy is closed before proceeding. Rev. D 7-5 63100

7. Reagents Figure 7-6. Beads Barcode Scan Alert 4. NOVEOS scans the barcodes, determines which Fluo Beads tubes are loaded and fills in the screen. If the wrong type of container is loaded, the software will display an error message. Figure 7-7. Beads Screen with Data 63100 7-6 Rev. D

NOVEOS Operator’s Manual On the Beads screen, the following information is displayed: • Position • Type • Name • Reagent Description • Lot # • Serial # • Expiration Date • Days to Expiration • Tests Available • Slot Status • Ready For each bead position, the following information is displayed: Bottle Information: • Status • Liquid Type • Name • Container Type • Lot Number • Lot Expiration Date • Serial Number • Stability Days Usage Information: • Expiration Date • Remaining Volume • First Seen Date • Days to Expiration • Estimated Remaining Tests Rev. D 7-7 63100

7. Reagents 7.3.2 Clearing Bead Information Information on the Beads screen can be cleared all at once or one position. To clear information from the Beads screen: Touch the Clear Positions button. There is a confirmation message displayed shown below. Select yes to continue or no to cancel. 63100 7-8 Rev. D

NOVEOS Operator’s Manual 7.3.3 Manually Entering Data for Beads Users with sufficient privilege may specify which Fluo Beads are loaded. To manually add info to the Beads screen: 1. Touch the number for the Fluo Beads position you want to clear. The Beads Info for Position window displays. Figure 7-8. Beads Info for Position Screen The software fills in the status information for the selected position. 2. To enter the barcode, type or use a hand scanned to enter the code in the Barcode field, then touch the Enter Manual Code button. Note that the Enter Manual Code button will be displayed once characters are entered into the Barcode field. 3. Touch Done to accept the changes and return to the Beads screen. Rev. D 7-9 63100

NOVEOS Operator’s Manual 8 Home/Schedule/Alerts Touching the Home button provides access to screens which let the user run tests, view current alerts, and schedule tests. Figure 8-1. Home Screen 8.1 Using the Home Screen Controls on the Home screen let the user scan barcodes for tubes installed in the sample and reagent rotors, unlock/lock the canopy, review NOVEOS status, and start tests. The status of each position on the sample and reagent rotors is indicated by color which is interpreted by the legend at the bottom left side of the screen. If no samples or reagents have been loaded, all positions will be black, indicating they are unassigned. Assigned positions are indicated by colors. Rev. D 8-1 63100

8. Run/Schedule/Alerts Figure 8-2. Rotor Position Status Colors Once samples (see Section 6) and reagents (see Section 7) are loaded and the Scan Barcodes button is touched, the status of all positions on the sample and reagent rotors is indicated. The workflow for this screen is: • Scan barcodes. • Check warnings then fix or ignore. • Perform Priming (3X) (See Section 11.) • Run tests. The Unlock Canopy button lets the user unlock the canopy when NOVEOS is not running tests or scanning barcodes. 63100 8-2 Rev. D

NOVEOS Operator’s Manual Table 8-1. Rotor Position Color Legend Color Sample Rotor Reagent Rotor Unassigned. No detected barcode/sample. Unassigned. No detected barcode/Reagent in this position. Error. Tests could not be completed on this sample Error. The position is occupied but position due to an error in optical measurements, an cannot be used (is expired, has too little error in results calculation, or an expired fluid to run tests, has been tampered Reagent/solution. with, or is misplaced). Finished. All tests completed on this sample n/a position. n/a Running. The first event for this sample position has been received from NOVEOS. Will remain this color Ready. The position contains a useable until finished or error. fluid. Unused. The Reagent is not needed for Ready. For Diluent A or any fluid that can be the currently defined run. assigned tests, at least one test has been assigned. Loaded/Unused. For any fluid that can be assigned tests, no tests have been programmed. Figure 8-3. Home Screen Showing Position Status Rev. D 8-3 63100

8. Run/Schedule/Alerts Touching any numbered position on the Sample or Reagent Rotor representation on the Home screen causes the display of related information in the Selected Position panel on the right side of the screen. This information is derived from data input in the Samples (see Section 6) and Reagents (see Section 7) screens. Figure 8-4. Selected Position Panel 63100 8-4 Rev. D

NOVEOS Operator’s Manual 8.1.1 Scanning Barcodes Barcodes can be scanned whenever the Sample Rotor cover, the Reagent Rotor cover, and the Beads cover are on, the canopy is closed, and no tests are running. To scan barcodes: 1. Be sure no tests are running. 2. Check to assure nothing is blocking the rotors. 3. Install covers on rotors. 4. Close the canopy. 5. On the Home screen, touch the Scan Barcodes button. NOVEOS scans the barcodes for everything that can be scanned; i.e., Fluo Beads, Reagents, etc. and uses the information to validate that the correct items are in each rotor position to run the requested tests. If the barcodes have already been scanned there is a confirmation message displayed, see below. Rev. D 8-5 63100

8. Run/Schedule/Alerts 8.1.2 Checking Warnings The status bar at the top of the Home screen shows status for NOVEOS Temperature, Samples, Reagents, Rinse/Wash, Waste, and Instrument subsystems. NOVEOS is ready to run tests when each element in the status bar has a green background and shows a green check ( ). A pink background and red X ( ) indicate a warning that must be resolved before tests can be run. Figure 8-5. Warnings Bar Before tests can be run, the software must check many criteria for the run (liquid levels, cover and lid interlocks, expiration dates, etc.). Some of these criteria generate warnings that the operator can ignore and others are hard constraints that must be satisfied. When there are warnings they are also indicated as specified in the Run Status section. Details on warning messages are covered in Section 12. When the user logs out during standby and there are ignored warnings or new warnings, the software generates a warning when another user logs on to review the warnings list. When a user ignores the \"User change\" warning, the software removes the warning from the list of warnings. 63100 8-6 Rev. D

NOVEOS Operator’s Manual 8.1.3 Running Tests Once barcodes have been scanned, all warnings have been cleared or ignored, and the canopy is closed, tests can be run. To run tests: 1. Perform priming (3X) by touching the Maint button, then the Periodic tab, and touching the Perform Priming button once for each prime. 2. On the Home screen, touch the Start button control below the rotor graphic. The tests will run and the timer will indicate estimated time to completion. The Run ID number will display above the timer. The start and completion of runs is logged to the event log. NOVEOS runs some checks and programs the instrument before the run starts. A progress bar shows the percent complete before the run starts. Rev. D Figure 8-6. Play (Start Run) Button 63100 8-7

8. Run/Schedule/Alerts As each test is run, the status of the containers on each rotor is indicated by the colors shown in Table 8-1. When tests are complete, Run Complete will be indicated in the center of the sample rotor graphic on the Home screen and the timer is reset to 00:00:00. When a run is stopped, paused, or complete, a Reset Status button is added to the screen so that NOVEOS can be reset to a pre-run state. Another run cannot be started until NOVEOS is physically reset and programmed with new Reagents before another run begins. A new run will not start unless the Substrate Mix container is empty. Figure 8-7. Run Complete All pipettes are washed with DI water after: • A run completes normally. • A user stops or pauses a run. • A run is aborted by NOVEOS (for example, NOVEOS reports an error). 63100 8-8 Rev. D

NOVEOS Operator’s Manual 8.1.4 Pausing Tests The user can pause tests by touching the Pause button on the Home screen, but NOVEOS continues to process all running tests before pausing. The pause, therefore, may take up to 1.5 hours to be accomplished. If the Sample or Reagent Rotor covers have been removed, it will be necessary to rescan. Pause can be used to finish tests in progress but not start any new tests. When the Pause button is touched, the software will require confirmation of the action. Once the pause is complete, the user may add and remove tests from the paused run. All arms are homed. Reagents can be added to the rotors. Barcodes will need to be scanned again if reagents or samples were added or removed. 8.1.4.1 Resuming Paused Tests All completed tests from the sample rotor screen and underlying test selection screen are removed after completing the tests during a pause. By touching the Run button, the user may restart the tests that were paused and run all tests that are still possible from the original run while adding all newly defined tests to the run. 8.1.5 Stopping Tests The user can stop running tests by touching the Stop button. To confirm the stop, the user will need to enter a valid user name and password. When this occurs, all running tests will be invalidated. The software will immediately stop processing tests, wash all pipette tips and bring all arms to their parked position. Tests may be added and removed from a stopped run. The software will remove all completed tests from the Sample screen and underlying Test Selection screen after a run is stopped. Touching the Stop button stops everything immediately and initiates an end of run wash sequence – finished tests remain, in-process tests are stopped and no new tests are initiated. The software will remember what has it has not started. Stop can be used if controls have failed and the operator doesn’t want to continue, saving time and reagents by stopping the run. 8.1.5.1 Resuming Stopped Tests By touching the Start button, users may resume tests that stopped, repeating all invalidated tests, continuing all tests that are still possible from the original run and adding all newly defined tests to the run. Rev. D 8-9 63100

8. Run/Schedule/Alerts 8.1.5.2 Abnormal Run Completion A run may not complete for many reasons including that it was deliberately paused or stopped, a reagent runs out, a critical instrument error, etc. If the tests for a sample are not completed (or never started), the software remembers which tests were not finished and associates them with that sample until it is removed from the Sample Rotor screen. 8.1.6 Conditions That May Prevent a Run from Starting After barcodes have been scanned, the software prevents all users from starting a run if any of the following conditions exist. They need to be corrected before continuing. • Fluo Beads cover is open. • Fluo Beads solution is missing. • Canopy is open. • Chassis sensor detects presence of liquid. • Insufficient: o Calibrator solution to complete the run o Cuvette wash. o DI water to complete the run o Wash buffer to complete the run o Waste container capacity to complete the run. • No tests scheduled. • NOVEOS is disconnected from the computer. • Reagent and/or Sample Rotor cover is not in place or not properly aligned. • Sample Rotor is loaded with duplicate sample IDs. • Substrate A or Substrate B missing. • Substrate Mix container latch is not properly engaged. • Waste container is missing. • At least one waste container is full. 63100 8-10 Rev. D

NOVEOS Operator’s Manual The software prevents users from starting a run if any of the following conditions exist. They must be corrected before continuing, or a user with sufficient privilege must log in. See Section 12 for details. • Any loaded Calibrator has a different lot number than any other loaded Calibrator of the same assay type. • Any system covers are not in place or properly aligned. • Any temperature is out of specification. • Any tube has a discrepancy between actual and expected volume. • Calibrator is expired or past its open stability date. • Capture Reagent is expired or past its open stability date. • Conjugate is expired or past its open stability date. • Diluent is expired or past its open stability date. • Fluo Beads solution is expired or past its open stability date. • Insufficient o Capture Reagent for any of the needed controls. o Control Solution to complete the run. • Multiple lot numbers of any reagent used with a Calibrator are loaded (Diluent, Conjugate, Substrate, Fluo Beads or Capture Reagent). • Negative Control is expired or past its open stability date. • Negative Controls with at least one test are not scheduled. • Periodic maintenance activity is due (daily, weekly, monthly, cuvette arcs replacement). • Positive Control is expired or past its open stability date. • Positive Controls with at least one test are not scheduled. • Sample or Reagent Rotor cover has been removed since the last barcode scan. • Substrate is expired or past its open stability date. • Use of saved curves is enabled and the beads, conjugate, substrate (A or B), Diluent-A lot numbers are different from those that were used to create the saved curve. Rev. D 8-11 63100

8. Run/Schedule/Alerts 8.1.6.1 Tests Can Be Run Despite These Conditions The software warns users of the following conditions, but allows them to start a run if they so elect. Note: The system will drop results for tests without enough reagents present. • Any patient sample loaded with no tests assigned. • Insufficient o Capture Reagent loaded (including not loaded) to run any of the tests, (excepting Controls, which need permission). o Fluo Beads solution to complete all of the patient tests. o Patient sample to complete all of the tests assigned to that sample. o Substrate (A or B) to complete all of the tests (but not missing). • Logged in user changed while warnings were present (cleared after ignored first time). • No patient samples are loaded. In this case, only blanks, calibrators and programmed controls will be processed. • Scheduled backup has not occurred. • Use of saved curve is enabled and a valid saved curve is available and a set of calibrators is also loaded. • Logged in user changed while there were warnings present. 8.1.7 Errors During Tests If errors occur during a run, an audible alarm sounds and a red (or yellow) alerts and errors bar blinks at the top right side of the Home screen. Touching the bar overlays the Home screen with a Run Alerts and Errors window that indicates the time of the error, title, and description. Each alert and error can be individually cleared or all can be acknowledged by touching the Acknowledge All button. Alerts and errors are written to the event log. 63100 8-12 Rev. D

NOVEOS Operator’s Manual Figure 8-8. Alerts and Errors Bar Figure 8-9. Run Alerts and Errors Window Rev. D 8-13 63100

8. Run/Schedule/Alerts 8.1.7.1 Error Handling If any Reagent or patient sample becomes empty, the software finishes the tests in progress, does not start any new tests using that reagent, flags the tests that cannot be completed, and informs the operator. No results are reported for tests that have not been processed. The report will indicate that the test was not processed with the appropriate flag. Calibrators need to be in the same run as patient samples, unless saved curve option is enabled. If the software is unable to process the calibrators, it informs the instrument to stop adding new tests, flags the running tests and informs the operator. The operator may stop the run and correct the issue, then restart it. If a control fails or cannot be processed, the software informs the operator and depending upon the setting for the Failed Control Action, the run may abort, complete or abort pending and complete those tests in progress. Errors related to Drop Test messages should be reported to Technical Service. In some cases it is possible to continue processing assays until a service engineer can resolve the issue. 8.1.8 Run Complete When a run is complete, it is indicated on the Home screen. Touch the Reset Status button before starting another run. Figure 8-10. Run Complete and Reset Status Button 63100 8-14 Rev. D

NOVEOS Operator’s Manual 8.2 Schedule After all of the tests are programmed for the loaded samples, the PC sends NOVEOS all the parameters needed for it to create and implement the schedule. The software can schedule 1200 tests*, including all controls, blanks and calibrators. *Assumes proper configuration, including plumbed water/waste, appropriate amount of Wash Buffer volume, etc. Tests are scheduled in the following order ascending by position: • Blanks • Calibrators • Controls • Patient Samples • Control repeats, if configured • End of run controls. (User configured.) The software schedules tests so that a reagent or container is fully consumed before using the next loaded container of the same type. Figure 8-11. Schedule Screen Rev. D 8-15 63100

8. Run/Schedule/Alerts To view the run schedule (all subsystem icons green): 1. Touch the Home button. 2. Touch the Schedule tab. 3. The Schedule screen displays with the following information: • Time • Run ID • Run Schedule grid displaying: ID number, Sample ID, Type, Assay, Test, Status, Current stage (Curr Stage), Sample position, reaction cuvette used (filled in after run), adjusted RLU (filled in after run), results (filled in after run), analysis (filled in after run: pass, fail, or class, depending upon the sample type), Flags with their description (if applicable). 8.2.1 Run Flags Run flags appear in the lasts column of the Schedule screen. They are “after the fact” and for information only. Their descriptions are listed in Section 12 and are provided on the run schedule as well. 63100 8-16 Rev. D

NOVEOS Operator’s Manual 8.3 Alerts The Alerts screen lets the user know the date and time the alerts and/or errors that occurred during the run and indicates those that have not been cleared. The list of alerts and messages may be printed. Errors and messages are presented and viewed for each run number. More details on alerts are included in Section 12. Figure 8-12. Alerts Screen Rev. D 8-17 63100

NOVEOS Operator’s Manual 9 Reports The NOVEOS software creates several types of reports. The primary reports are the patient (sample) reports that present the results of each test that was performed for a patient sample. Additionally there are QC reports for the controls and calibrators which are described in Section 10. The software creates formatted reports for each of the samples tested. Depending on the report type, it can be printed and/or saved as a delimited text or .pdf file or sent to the LIS. Report functions are available by touching the Reports button. Figure 9-1. Reports Screen Rev. D 9-1 63100

9. Reports 9.1 Report Contents and Setup The NOVEOS software lets the user create different report layouts that include the following: • Report Header (repeated at the top of every page) o Report type in header, for example, “Patient Report” (automatically added by the software) o Sample ID in the header (automatically added by the software) o Laboratory name and address lines o Laboratory-specific logo in the header. If no laboratory-specific logo is defined, the Hycor logo will be included in the header by default. • Report Footer (repeated at the bottom of every page). This information is automatically added by the software. o Name of the user who created the report o Date the report was created o Software version o Page number and total number of pages in the report 63100 9-2 Rev D

NOVEOS Operator’s Manual Figure 9-2. Report Setup Screen NOTE: The report setup function is also accessible with the system setup tools. Rev. D 9-3 63100

9. Reports To set up a report: 1. Touch the Reports button. 2. Touch the Report Setup tab. 3. Touch the relevant checkboxes to automatically print patient results and/or run release reports. (Run releases are discussed in Section 10.) 4. Choose the printing method: either to printer or PDF. 5. Enter the laboratory name in header line 1. 6. Enter the laboratory address in header lines 2 and 3. 7. Enter any addition informational information in header line 4. 8. Define the export destination; either a network drive or drive connected to a USB port. 9. If desired, load an image to use in the header by touching the Load Image button and choosing a graphic file. Allowable formats are .jpg and .png. The ideal aspect ratio is 3.5:1. The software will resize the image as needed. To return to the previous image, touch the Reset Image button. 10. Touch the Save button to save the report setup. Navigating away from the current screen without touching Save will result in the changes not being saved. A warning displays asking the user to confirm that they wish to continue without saving. 63100 9-4 Rev D

NOVEOS Operator’s Manual 9.2 Patient Reports The Patient Reports screen lets the user search for patient reports with any or all of the following parameters: • Run ID • Sample ID • Patient ID • Patient Last Name • Physician Last Name • Instrument Operator • Capture Reagent • Reagent Lot Number • Run Date Once a patient report has been created, its contents never change. Patient Report Body The software includes the following patient information in the body of the report: • Patient first and last name • Patient ID, gender, • Patient comments • Patient birthdate • Sample ID • Sample Drawn date • Physician first and last name • Physician address • Physician phone number • Run ID • Run date • Instrument operator • Instrument serial number • Sample comments • Capture Reagent • Individual test results for each capture reagent tested against the patient Each test result includes, as appropriate per the assay type, the following: o Capture reagent code o Capture reagent name o Computed result o Interpreted result o Error flags Rev. D 9-5 63100

9. Reports Conc kU/L Figure 9-3. Sample Patient Report 63100 9-6 Rev D

NOVEOS Operator’s Manual Figure 9-4. Patient Reports Screen To run patient reports: 1. Touch the Reports button. 2. Touch the Patient Reports tab. 3. Enter the search criteria, then touch the Search button. Search results display at the bottom left section of the screen. Results can be sorted by touching any of the headers, for example, to sort by Run Date, etc. 4. Select the report(s) to export by touching the box to their right. A green checkmark will display indicating it can be exported. Search results may be saved as text or PDF on an external drive and sent to the LIS using the buttons at the bottom of the screen. It is also possible to export all reports found for given search criteria by selecting the Export box on the column heading. Rev. D 9-7 63100

9. Reports 9.3 LIS Results The LIS Results screen displays existing result records not yet transmitted by the application and received by the LIS. Users can delete some or all of the selected Result records from the displayed list following confirmation and send all displayed result records on demand to the LIS. Deleted data is not sent to the LIS. Data can also be sent from the patient report. Figure 9-5. LIS Results Screen The following results are displayed for each order: • Run ID • Type • ID/patient name • # Tests • Measurement data and time • Status (for example, Not Sent to LIS, Waiting for Acknowledgement) 63100 9-8 Rev D

NOVEOS Operator’s Manual Each LIS results column can be sorted by touching the header. Results records are transmitted to the LIS at the frequency set in the LIS configuration screen. (See Section 4.) To work with LIS results: 1. Touch the Reports button. 2. Touch the LIS Results tab. All available results will be displayed on the screen. 3. For each result, choose Delete or Send by touching the checkbox, or touch Select All Not Sent. or Touch the Delete All button to delete all the tests on the screen. or Touch Delete Selected to delete the selected results. 4. Touch Send to LIS. Rev. D 9-9 63100

NOVEOS Operator’s Manual 10 Quality Control Quality control includes calibration data, quality control, and run release functions. When the Quality Control button is touched, a screen displays with tabs for accessing all the quality control functions. Figure 10-1. Quality Control Button 10.1 Calibration Data The software computes a new calibration curve using the loaded calibrators and saves the calibration parameters used for each test. For information regarding using the saved curve option, please see section 6.1.5.1.5. Rev. D 10-1 63100