63100 Rev D, Noveos Operators Manual

4. Preparing NOVEOS Software for Use 4.3 Operator Setup Users can be added to the software via the Operators screen which provides the means to add users, change user types, and change passwords. It also shows a list of users which can be edited. If a laboratory loses all passwords for the system, Hycor can provide a special password that will grant the lab administrative access for one day. The lab may reestablish user names and passwords while using this administrative access. A list of users is shown in the panel on the right side of the screen. User privilege of lab supervisor or higher is required to make changes on this screen. Users may reset their own password and the passwords of other users having the same access level or lower. Figure 4-3. Operators Screen 63100 4-6 Rev. D

NOVEOS Operator’s Manual To setup a new operator: 1. Touch the Setup icon on the Utility Functions bar. 2. Touch the Operators tab. 3. Make changes on the Operators screen as desired. Enter the user name, telephone (optional), email (optional), login ID, and new password. 4. Confirm the password by re-entering it. 5. Choose the User Type from the dropdown list. Options are Lab User, Lab Supervisor, and Lab Administrator. Privileges for these users are covered in Section 4.3.1. 6. Touch the Save button. To change a user’s privileges: 1. On the Operators screen, touch the name of the user to change. 2. Touch the Edit button. 3. On the User Type dropdown list, set a new user type. 4. Touch Save. To change a user’s password: NOTE: users may change their own password. 1. On the Operators screen, touch the name of the user to change. 2. Touch the Change Password button. 3. Enter a new password. 4. Confirm the new password by entering the password again in the Confirm Password field. 5. Touch Save. Rev. D 4-7 63100

4. Preparing NOVEOS Software for Use To edit user information: 1. On the Operators screen, touch the name of the user for which information is to be changed. 2. Touch the Edit button. 3. The fields on the left side of the screen become active. User name, telephone, email, and user type can be changed with this function. 4. Touch Save. To delete a user: NOTE: users may not delete themselves. Requires Lab Supervisor or higher. 1. On the Operators screen, touch the name of the user to delete. 2. Touch the Delete button. 3. On the Confirm Delete screen, touch Yes to delete the user’s record or No to return to the Operators screen without making changes. 4.3.1 User Privileges The following sections list privileges for the various user types. All users may setup and run tests. Users at higher levels have all rights granted to lower levels. The hierarchy is as follows: lab user, lab supervisor, lab administrator. 63100 4-8 Rev. D

NOVEOS Operator’s Manual 4.3.1.1 Lab User Lab users can: • Setup and run tests. • Start a run when a patient sample(s) has no tests assigned. • Start a run when no patient samples are loaded. • Start a run when there is not enough Capture Reagent(s) to run any scheduled patient test. • Start a run when there is not enough substrate(s) to run any scheduled patient test. • Start a run when there is not enough conjugate(s) to run any scheduled patient test. • Start a run when there is not enough bead solution to run any scheduled patient test. • Start a run when there is not enough diluent to run any scheduled patient test • Start a run when there is a warning that a scheduled database backup has not occurred. • Start a run when there is a warning that unneeded calibrators are loaded. • Start a run with a patient sample has insufficient volume to run all of the tests assigned to that sample. • Start a run with missing calibrators or missing Calibrator Capture Reagent. Note that for Lab User or Lab Supervisor, no tests or controls of that assay type will be run. Rev. D 4-9 63100

4. Preparing NOVEOS Software for Use 4.3.1.2 Lab Supervisor Lab supervisors can: • Setup users and adjust program settings (see Sections 4.2 and 4.4). • Start a run when the positive control solution(s) is missing or insufficient. • Start a run when the negative control solution(s) is missing or insufficient. • Start a run having scheduled tests that do not have a corresponding positive control also scheduled. • Start a run having scheduled tests that do not have a corresponding negative control also scheduled. • Start a run having scheduled controls (positive or negative) but not having sufficient volume of corresponding Capture Reagents (including not being loaded) to complete the run. • Create, edit and delete lab users and lab supervisors. • Edit settings on the System Setup screen. • Install software updates provided by Hycor. • Start a run when one or more user maintenance activities are due. • Change lab name, report header and report header image. • Delete database backups. • Purge the database. 4.3.1.3 Lab Administrator Lab administrators can: • Restore the database backup. • Create, edit and delete lab users, lab supervisors and lab administrators. 63100 4-10 Rev. D

NOVEOS Operator’s Manual 4.4 Report Setup The Report Setup screen lets users with a privilege of lab supervisor or higher define the information that appears on reports. This function is the same as the Reports function which is detailed in Section 9. Figure 4-4. Report Setup Screen Rev. D 4-11 63100

4. Preparing NOVEOS Software for Use 4.5 Database The Database screen lets users: • Identify the main SQL database server • Define the location to which backups are directed • Set up automatic backups. Figure 4-5. Database Screen Table 4-6. Database Settings Setting/Button Label Value Options/Function Direct backups to: Choose a destination for backups from the dropdown list. Automatic Backup: (checkbox) When the box is checked, additional options for specifying daily, weekly, and time are added to the screen. Touching the Save button saves all the settings made on the screen. Touching the Cancel button clears any changes from the screen. 63100 4-12 Rev. D

NOVEOS Operator’s Manual 4.6 LIS Settings The LIS (Laboratory Information System) screen lets users set parameters for communication with the LIS system connected to the NOVEOS. Changing these settings requires a user privilege of lab supervisor or higher. Setting up an LIS connection requires cooperation between Hycor and a lab’s IT department. Figure 4-6. LIS Screen Rev. D 4-13 63100

4. Preparing NOVEOS Software for Use Table 4-7. LIS Protocol and Connection Settings Setting Options Protocol Options are none, Generic CSV, HYCOR-ASTM, HYCOR-HL7. There may be laboratory-specific options as well. Connection Connection options vary depending on the selected protocol. Protocol Connection Options Generic-CSV Socket, file, serial HYCOR-ASTM Serial, socket HYCOR-HL7 Socket, file Further options display depending on the combination of protocol and connection. The software auto-connects to the LIS and the HYCOR-LIS Interface program at startup if the protocol and connection settings are compatible. The software auto-connects to the LIS and the HYCOR-LIS Interface program at startup if the protocol and connection settings are compatible. Hycor has a separate LIS interface document that laboratories can give to their LIS provider for setting up a new LIS connection. 63100 4-14 Rev. D

NOVEOS Operator’s Manual Table 4-8. LIS Results Transmit Options Note: These options are not available when no protocol is selected. Setting Options Suppress blank results When checked, suppresses blank results. (checkbox)* Suppress control results When checked, suppresses control results. (checkbox)* Suppress calibrator results When checked, suppresses calibrator results. (checkbox)* Suppress patient results When checked, suppresses patient results. (checkbox)* Suppress consumable details When checked, suppresses consumable details; i.e. (checkbox)* information for conjugate, substrate, bead, and diluent (as a group). *(when checked, suppresses transmission of specified data to the LIS. Flags options Defines how flags are transmitted. Options are Code, Description, Code And Description Auto-transmit interval (seconds) Defines the frequency with which results are transmitted to the LIS. Options are 1, 10, 60, Never. Rev. D 4-15 63100

4. Preparing NOVEOS Software for Use Setting Table 4-8. LIS Results Transmit Options (continued) Posting frequency Options Options are Never, Manual, After Sample, After Run. When set to Never, individual results are not transmitted automatically and are not available to be transmitted to the LIS from the Reports or QC screens. When set to Manual, individual results are not transmitted automatically but are available to be transmitted to the LIS from the Reports or QC screen. When set to After Sample and the “Only post results after successful QC” checkbox is not checked, results are transmitted after a sample completes. Post only after successful QC This option is only available if “After Sample” or “After Run” is (checkbox) selected as the posting frequency. Keep results in queue (days) When checked, posts data only after successful QC. Defines how long results will remain in the database with retransmission to the LIS continued at the selected frequency before they are automatically deleted. Options are 1, 2, 7, 14, 30, 60, 90, 180, 360, Forever. 63100 4-16 Rev. D

NOVEOS Operator’s Manual Table 4-9. LIS Joblist and Communication Options Setting Options Keep requests in queue (days) JobList Options Query LIS automatically after Defines the number of days for which joblist requests are kept in sample scan the queue before they are automatically deleted. Options are 1, (checkbox) 2, 7, 14, 30, 60, 90, 180, 360, Forever. Communication Options When checked, the software queries the LIS for the sample IDs on the Sample Rotor after a Sample Rotor scan. Button Table 4-10. LIS Screen Buttons Function Touching the Save button saves all the settings made on the screen. Touching the Defaults button clears any changes from the screen and returns the Protocol setting to none. Only the following Results Transmit options are checked: Suppress blank results, Suppress calibrator results, Suppress consumable details. Flags options is set to Code. Auto-transmit interval is set to Never. Posting frequency is Manual. Keep results in queue is 7. Rev. D 4-17 63100

4. Preparing NOVEOS Software for Use 4.7 About The About screen lists PC and instrument (NOVEOS) information: PC Information: • PC ID (network name) • Application Software Version • Application Executable Date and Time • NOVEOS Database Version • LIS Database Version • Windows .NET Version • Windows OS Version • Available Disk and Database Space Instrument (NOVEOS) Information: • Serial Number • Connection Port • Instrument firmware versions 63100 Figure 4-7. About Screen Rev. D 4-18

NOVEOS Operator’s Manual 5 Running Tests This section outlines the workflow for using NOVEOS to run tests and lists the tasks to perform. Details for each procedure are included in other sections which are referenced. NOVEOS is intended for use by trained medical laboratory technicians or medical technologists. After the software has been setup (see Section 4), the NOVEOS unit can be prepared for use. Tasks include loading Cuvette Arcs, Reagents, Substrates, Fluo Beads tubes and Diluents, DI water and Cuvette Wash Solution. This section assumes that: • NOVEOS software has been installed and is running normally. • Users have been setup and passwords assigned (see Section 4.2). • Default values have been set up (see Section 4.1). • The user has read this entire manual and completed operator training. When working with NOVEOS, wear all personal protective equipment required by your workplace. The user interacts with both NOVEOS software and hardware. The user loads samples and Reagents into the NOVEOS, enters patient data and required tests into the software, and tells the software to start the tests. The basic sequence of operations is listed in Section 5.2. 5.1 Supplies Be sure to have the following on hand before starting. IMPORTANT! Check www.NoveosDX.com for instructions on how to handle and store supplies. • Barcoded Calibrator Antibody-IgE Reagent • Cuvette Arcs • Barcoded Calibrator Tubes • Cuvette Wash Solution • Barcoded Conjugate • DI water • Barcoded Diluent A Container • Empty Substrate Mix Container • Barcoded Fluo Beads tubes • Optics Tips • Barcoded Positive and Negative Control • Probe Wash Solution • Wash Buffer Concentrate Tubes • Barcoded Substrates A and B Rev. D 5-1 63100

5. Running Tests 5.2 Quickstart Workflow This section is a quick overview of tasks and is intended for experienced users. Details are included after this section. Table 5-1. Quickstart Workflow Step Details in this section Turn on NOVEOS power with the switch on the left side of the unit and 1 allow 30 minutes for the instrument to come to operating temperature. 1.3.1.4 Proceed with the following tasks while the instrument is stabilizing. 2 Turn on the computer and log in to the software. 5.4 3 Fill and load the Cuvette Wash container located above the DI water and 5.3.7 Wash Buffer containers in the lower deck. 5.3.6 5.3.8 Prepare Wash Buffer from the concentrate as needed. Fill the Wash 4 Buffer container with Wash Buffer and the three DI water containers with DI water as needed. Load in the lower deck. 5 Assure that waste containers are empty; empty if needed. 6 Perform daily (or weekly or monthly) maintenance. 11 Load samples, reagents, and consumables into the Samples, Reaction, 5.3.1 7 and Reagent Rotors. Load the Substrate Mix container. Replace all rotor 5.3.2 5.3.3 covers. 5.3.4 Note: Before installing, externally vortex the Fluo Beads tube(s) until no clumps are visible. Install the Fluo Beads tubes in the bead holder. Close the canopy. 63100 5-2 Rev. D

NOVEOS Operator’s Manual Table 5-1. Quickstart Workflow (continued) Step Details in this section 8 On the Home screen, touch the Scan Barcodes button. Samples and 5.4.3 reagents detected will be populated in the rotors. 9 If the sample tubes are not barcoded or information is missing, return to 5.3.1 Sample screen and manually enter the information. 10 If using a new lot of controls, scan the lot-specific information from the 5.3.1, 6.1.2, 6.2 control package insert 2D barcode using the external handheld barcode reader. 11 Scan the barcodes using the Scan Barcodes button on the Sample screen. Assign tests to the patient samples by going to the Samples screen and 5.4.1, 5.4.2 loading a worklist or joblist or assign tests manually. (Skip this step if using LIS.) 12 Check the Home screen for warning messages; i.e., insufficient or missing reagents. Resolve or ignore all errors until run is enabled (indicated by a green background and green checks on all subsystems of the Status and 5.4.3 5.4.3 Warnings bar and blue arrow on the Sample Rotor graphic on the Home screen). With all rotor covers in place and canopy closed, touch the Start Run 13 button on the Home screen to start the tests. The software uploads all test information to the instrument, and NOVEOS provides status and a countdown time as it begins to autonomously run the tests and communicate status to the software. The software updates status information and results in real time and communicates results to the LIS if available. 14 On the Home screen, any sample position can be touched to view its 5.4.3 real-time results during a run. 15 Reports are automatically printed for each sample, if so configured in the 4.3 System Settings. Rev. D 5-3 63100

5. Running Tests 5.3 Preparing NOVEOS for Use Once all the required information has been entered in the System Setup screens, the next step is to load the Sample, Reaction and Reagent Rotors, the Fluo Beads tube holder(s) and the Substrate Mix container. Be sure to handle all supplies in accordance with the instructions on www.NoveosDx.com. Reaction Rotor Substrate Mix Container Sample Rotor Fluo Beads Reagent Rotor Tube Holder Figure 5-1. Component Locations on Top Deck 63100 5-4 Rev. D

NOVEOS Operator’s Manual 5.3.1 Loading the Sample Rotor The Sample Rotor has 60 tube positions to hold: • Sample tubes (with or without barcodes) (See Table 4-1 for sizes) • Barcoded Positive Control Tube • Barcoded Negative Control Tube • Barcoded Calibrator Tubes • Barcoded Diluent A Container The standard size is a 5ml container with a barcode to provide information about the contents. If different sized containers are used, be sure to use an adapter to get a good fit in the rotor. Each assay requires a Positive and a Negative Control and Calibrator to be placed on the Sample Rotor. During the run, the software evaluates the control results to the designated ranges assigned by Hycor. The control information is lot-specific and will need to be uploaded to the software when a lot number changes. This is accomplished by using the handheld barcode scanner provided by Hycor and reading the 2D barcode on the package insert. (See Section 6.2 for details.) To load the Sample Rotor: 1. Open the NOVEOS canopy. 2. Remove the Sample Rotor cover by pulling up on the handle. Set the cover aside. Figure 5-2. Removing the Sample Rotor Cover Rev. D 5-5 63100

5. Running Tests 3. Insert the sample tubes and Diluent A required for the test in the Sample Rotor. Be sure the barcode faces away from the center of the rotor. Depending on the sample tube size, it may be necessary to use an adapter to ensure the container fits securely in the rotor. Figure 5-3. Loading the Sample Rotor 63100 5-6 Rev. D

NOVEOS Operator’s Manual NOTE: for ease of loading, the entire rotor can be removed from NOVEOS by pulling up on the tab in the center of the rotor. Figure 5-4. Removing the Sample Rotor Rev. D 5-7 63100

5. Running Tests 4. Insert the Diluent A container into the inner ring of the Sample Rotor. Note that adaptors cannot be used adjacent the Diluent A container. Remove the tube adapter before installing the Diluent A container. Diluent A Container Figure 5-5. Diluent A Container in the Sample Rotor 5. Replace the Sample Rotor cover making sure that it is properly aligned. 6. On the Samples screen, touch the Scan Barcodes button. The grid on the screen will fill in to show what is loaded in each position of the Sample Rotor. 7. If not using LIS, use the Samples screen to assign tests if the samples’ barcodes do not contain this information. 63100 5-8 Rev. D

NOVEOS Operator’s Manual 5.3.2 Loading the Reaction Rotor with Cuvette Arcs Cuvette Arcs are installed on the Reaction Rotor. It has 20 arc positions; each holds an arc of 10 cuvettes for a total of 200. Reaction cuvette arcs should be replaced whenever NOVEOS prompts for this to occur. The frequency is defined by tech service during system setup. Reaction cuvette arcs are on the Reaction Rotor. You will need 20 new cuvette arcs. Be sure to wear gloves for this procedure. To install Cuvettes Arcs: 1. Touch the Maint button, then the Periodic tab. 2. On the Maintenance Activity panel, touch Move Probes to Park Location, then touch the Move to Park button. 3. On the Selected Activity panel, touch Replace Reaction Cuvettes. 4. On the Tasks panel, touch Replace Cuvettes. Figure 5-6. Replace Reaction Cuvettes Screen 5. Remove the Reaction Rotor cover by lifting up on the tabs. Set the cover aside. Rev. D 5-9 63100

5. Running Tests Lift here Lift here Figure 5-7. Removing the Reaction Rotor Cover 6. Remove the Reaction Rotor inner cover by pulling up on it. Set it aside. Figure 5-8. Reaction Rotor Latch Position for Removal 7. Insert the cuvette arcs into the blank spaces. 63100 5-10 Rev. D

NOVEOS Operator’s Manual Figure 5-9. Cuvette Arcs Location on Reaction Rotor Figure 5-10. Reaction Rotor Inner Cover Replaced with Latches in Locked Position Rev. D 5-11 63100

5. Running Tests 8. Replace the inner and outer covers making sure they are properly aligned and move the latches to the locked position. 9. Replace the Reaction Rotor inner and outer covers and ensure they are properly aligned. 10. Touch the Complete Task button. 11. A Comments window displays. Enter comments and touch OK. Comments are saved to the Maintenance log. NOTE: Used cuvettes arcs are considered biohazardous. Dispose of them in properly marked containers. 63100 5-12 Rev. D

NOVEOS Operator’s Manual 5.3.3 Loading the Reagent Rotor The Reagent Rotor is comprised of five removable wedges keyed to specific numbered locations. Each wedge can be removed if desired for easier loading. Each wedge has space for two large containers and 28 tubes. Each container must be barcoded. The rotor has a total of 150 positions. Figure 5-11. Reagent Rotor Rev. D Figure 5-12. Reagent Wedge 63100 5-13

5. Running Tests The following liquids in tubes and containers may be installed on the rotor. • Substrates A and B • Conjugate • Probe Wash • Capture Reagents • Calibrator Antibody – IgE (CAE) To load the Reagent Rotor: 1. Open the NOVEOS canopy. 2. Remove the Reagent Rotor cover by pulling up on it. Set it aside. Figure 5-13. Reagent Rotor Cover The Reagent Rotor can be loaded in NOVEOS, but if desired, the wedges can be loaded outside the unit. Remove the wedges one at a time by pulling up on them as shown in Figure 5-14. 63100 5-14 Rev. D

NOVEOS Operator’s Manual Figure 5-14. Removing a Reagent Wedge 3. Load the wedge and replace it on the rotor in the same position from which it was removed. Be sure to remove caps from all tubes and containers. 4. Replace the Reagent Rotor cover making sure that it is properly aligned. Rev. D 5-15 63100

5. Running Tests 5.3.4 Loading the Fluo Beads Tubes Fluo Beads are fluorescently tagged magnetic micro particles used as the solid phase in which the Capture Reagent will bind via the streptavidin-biotin interaction. NOVEOS accepts use of one or two Fluo Beads tubes. When using one tube, it can be installed in either position. If using two tubes, be sure they both have the same lot number. To load the Fluo Beads tubes: NOTE: Before installing the Fluo Beads tubes, vortex them externally until no clumps are visible. 1. Open the NOVEOS canopy. 2. Pull up slightly on the lid of the Fluo Beads tube holder and push it forward (towards the back of the instrument) to open. (1) Pull up Cap on (2) Push forward Closed Open Fluo Beads tube Figure 5-15. Fluo Beads Tubes Holder and Lid 3. Remove the cap and insert the Fluo Beads tube(s) into the slots. 4. Close the Fluo Beads tube holder lid. Push down lightly to ensure the cover is seated properly. 63100 5-16 Rev. D

NOVEOS Operator’s Manual 5.3.5 Loading the Substrate Mix Container Install a new empty Substrate Mix container in the top deck before each run. Rotate both tabs to the left, then slightly push down on the top. Rotate the blue piece to Tabs remove or install Substrate Mix container. Push down to install/ pull up to remove Substrate Mix container. Figure 5-16. Loading the Substrate Mix Container On the Reagent screen, touch the Reagent Rotor tab and then Scan Barcodes button. The grid on the screen will fill to provide information on what is loaded in each position on the Reagent Rotor. This also scans the Fluo Beads tubes. The grid on the Beads screen will fill to provide information on the Fluo Beads tubes loaded in the Bead Tube holder. Rev. D 5-17 63100

5. Running Tests 5.3.6 Filling the Lower Deck DI and Wash Buffer Containers NOVEOS has three DI water containers and one wash buffer container located on a drawer in the right side of the lower deck. (The configuration may differ; this is setup when NOVEOS is installed.) Wash Buffer (WB) is a fluid used to clean cuvette arcs as part of the processing cycle. The Wash Buffer is prepared using DI water and a Hycor-supplied Wash Buffer concentrate. The prepared Wash Buffer is stored in the Wash Buffer Container – far right in the lower deck - before use and ends up in the Waste Container below deck after use. Figure 5-17. Wash Buffer Concentrate Pack 63100 5-18 Rev. D

NOVEOS Operator’s Manual Be sure the Wash Buffer and DI Water containers are filled before each run. *Note: DI Water Containers are not required if the NOVEOS instrument is connected to an external DI water line. Cuvette Wash Fluid Wash Buffer Container (1) DI Water Containers (3) Figure 5-18. DI Water and Wash Buffer Containers Rev. D 5-19 63100

5. Running Tests To fill the DI and Wash Buffer containers: 1. Open the door to the right side of the lower deck. 2. Disconnect the DI and Wash Buffer containers. 3. Carefully slide the drawer out of the unit. 4. Skip this step if you are using an external De ionized water line for the NOVEOS instrument. Fill DI water containers with DI water as needed. Total capacity is 30 liters (7.92 gallons). A funnel is provided to make it easy to fill the containers. 5. Prepare diluted wash solution from the Wash Buffer Concentrate by mixing 1 bottle (1 liter) of Wash Buffer Concenrate with 9 L of deionized water. The total volume of the diluted solution will be 10 liters. • When Wash Buffer Concentrate cools to temperatures below 15°C, precipitation of salt crystals may be seen. This can occur during shipment or refrigeration. Crystals do not affect assay performance. Use the process below to de-crystalize the Wash Buffer, if crystals are seen: 1) Dispense the 1 L bottle of Wash Buffer Concentrate directly into the NOVEOS Wash Buffer Container. 2) Pour 4 L of deionized water into the NOVEOS Wash Buffer Container and gently swirl the contents to dissolve the crystals. 3) Pour the remaining 5 L of deionized water into the NOVEOS Wash Buffer Container. 6. Ensure the cap is tight to avoid overflow and then gently shake to mix the two solutions. 7. Install the DI water and Wash Buffer containers into the NOVEOS, connecting the tubes from left to right and assuring the connections are tight. 8. The NOVEOS software expects the DI containers to be full before a run. A Wash Buffer container may be partially consumed—the software will show a warning if there is not enough wash buffer in the container for the scheduled run. 9. Close the doors. 63100 5-20 Rev. D

NOVEOS Operator’s Manual 5.3.7 Filling the Cuvette Wash Fluid Container Check the Cuvette Wash Fluid container and fill with Hycor-provided Cuvette Wash fluid to the 500 ml mark. A filled Cuvette Wash Fluid container can support up to 2100 tests. Figure 5-19. Cuvette Wash Pack Note: It is acceptable if the Cuvette Wash container is filled slightly more or less than the 500 ml fill line. Cuvette Wash Fluid 500 ml fill Iine Rev. D Figure 5-20. Cuvette Wash Container 63100 5-21

5. Running Tests 5.3.8 Empty the Waste Containers *This does not apply to systems that are setup to use an external waste line. NOVEOS has four waste containers located in a drawer in the left side of the lower deck. They must be emptied before or after each run. Figure 5-21. Waste Containers Disconnect Label 63100 5-22 Rev. D

NOVEOS Operator’s Manual To empty the waste containers: 1. Open the door to the left side of the lower deck. 2. Disconnect snap locks for the waste lines before sliding the drawer forward. 3. Carefully slide the drawer out of the unit. 4. DO NOT OPEN THE CAPS. Use the adapters provided by Hycor to dispense the waste. Reinstall the containers, making sure snap locks are reconnected. Waste Containers (4) Figure 5-22. Waste Container Location Rev. D 5-23 63100

5. Running Tests Push tabs to disconnect all waste containers before pulling out drawers. All waste containers disconnected. Figure 5-23. Waste Containers Disconnection 63100 5-24 Rev. D

NOVEOS Operator’s Manual CAUTION: waste fluids are considered biohazardous and should be disposed of according to laboratory procedures. CAUTION: filled waste containers can weigh up to 20 lbs. (9.1 Kg). Moving them may require two people. Small Adapter Push the small adapter Push the large adapter Waste container is Large Adapter with Hose firmly against the with the hose firmly now ready to empty matching connector on against the matching through the hose. the waste container. connector on the waste container. Figure 5-24. Using the Waste Containers Adapters Rev. D 5-25 63100

5. Running Tests 5.4 Setting Up and Running Tests – Detailed 1. If NOVEOS has been powered down, allow 30 minutes for the instrument to come up to operating temperature. The NOVEOS software will present temperature warnings until temperatures are within range. 2. Turn on the computer. The software starts up automatically. 3. Enter your user name and password to log in. Figure 5-25. Login Screen 4. Perform daily maintenance. (See Section 11.1). 5. Assure that all samples, Reagents, etc. are loaded as described in 5.3 and that the canopy is closed. 5.4.1 Linking a Sample to a Test NOTE: more details on using the Samples screen are in Section 6. After you’ve loaded NOVEOS, use the software to verify that the assay can be run. Details on this operation are in Section 6. 63100 5-26 Rev. D

NOVEOS Operator’s Manual To link a sample to a test: 1. Touch the Samples button to display the Samples screen. If there is a user-supplied barcode label, the system reads that and fills in the data content for the sample. The system shows ‘Unknown’ for any location on the Sample Rotor that does not contain a tube or for which the barcode on the tube is unreadable. See Section 6.1.6. for details on manually entering a barcode. If a sample tube does not have a readable barcode label or if patient information and/or test list is not supported by a barcode the user must use the software to define that sample to the system. 2. The user will need to know the position on the rotor (1-60), the sample ID, and manually assign this information using the Sample screen. 5.4.2 Adding Samples to a Run and Tests to a Sample To add samples to a run: 1. Place sample tubes in any empty slot on the Sample Rotor. 2. Know the position the sample tube on the Sample Rotor (1-60). 3. Go to the Sample Rotor screen to display the list of tubes present on the Sample Rotor. 4. Recalling the tube slot where the sample is, touch the Pos # for the sample. 5. Enter or edit information for a new or existing sample. Sample ID, and container type are the minimum required entries for a sample. 6. Add tests if not connected to LIS. 7. Touch the Done button to save entries. Rev. D 5-27 63100

5. Running Tests 5.4.3 Running a Test 1. Touch the Scan Barcodes button on the Home screen. 2. Check the Home screen for warning messages (see Sections 8.1 and 8.3) and resolve or ignore them before continuing. NOTE: some warnings cannot be ignored. (See Section 12.) 3. When all warnings have been resolved, touch the Play button on the Sample Rotor image on the Home screen. (The Play button is grayed until the barcodes are scanned.) The screen will display a progress bar and details of the current function. Play button Figure 5-26. Play (Start Run) Button When the run is complete, reports will print automatically, if so configured in the system settings. Figure 5-27. Home Screen Showing Run Progress – Preparing System 63100 5-28 Rev. D

NOVEOS Operator’s Manual Figure 5-28. Home Screen Showing Run Progress – Programming Reagents and Tests Rev. D 5-29 63100

5. Running Tests Figure 5-29. Home Screen Showing Run Progress – Programming Samples Figure 5-30. Home Screen Showing Run Complete As the run progresses, patient results are displayed in the panel on the right side of the screen. Alarm conditions can be monitored on the PC and on the light bar on NOVEOS. An audible alert sounds when the run is complete. See Sections 8 and 12 for details. Normal running is displayed as a flashing green light. 63100 5-30 Rev. D

NOVEOS Operator’s Manual Status light bar Figure 5-31. Status Light Bar 5.5 After a Run After a run is complete, empty the waste containers as described in Section 5.3.8. Before shutting NOVEOS down, remove all items that require temperature control and be sure they are capped to prevent evaporation. At the end of an assay run, if no other assay is to be run, the NOVEOS instrument automatically places the multi-rinse probes into Cuvette Arc #1 for soaking. Replace Reaction cuvette arcs after every run. Rev. D 5-31 63100

NOVEOS Operator’s Manual 6 Samples This section covers the functions available when touching the Samples button, loading the Sample Rotor and defining panels. Touching the Samples button displays the Sample Rotor screen and provides access to the Joblist (see Sect ion 6.3) and Panels screens (see Section 6.4). Figure 6-1. Sample Rotor Screen 6.1 Sample Rotor Screen The Sample Rotor screen displays a list view of the Sample Rotor contents as shown below. Each row corresponds to a position on the Sample Rotor. If the software detects a container on the Sample Rotor that belongs on the Reagent Rotor (e.g. Capture Reagent) or the Fluo Beads position, the software indicates this error on the Sample Rotor screen by highlighting the row position purple. Rev. D 6-1 63100

6. Samples Figure 6-2. Sample Rotor Screen with Data 6.1.1 Information for Each Sample For each position on the Sample Rotor, the following information is provided on the screen: • Position # in Sample Rotor • Type of sample • Sample ID/Name • Patient ID/Lots # • Physician/Serial number • Container • Tests Available • Slot Status • From LIS (configuration required) • Test # • Ready. 63100 6-2 Rev. D

NOVEOS Operator’s Manual Rows on the Sample Rotor screen are color-coded to indicate the following status options: • Ready (green) • Expired or no tests assigned (controls and patient samples) (orange) • Misplaced (purple) • Empty slot (White) • Has a duplicate sample ID (purple) • Empty tube (orange). If no tests are selected for a sample, it will not be processed. A sample may be loaded and scanned onto the rotor, but when no tests are assigned to it, the sample screen will still populate a row with its information. The column with “Tests #” will just indicate “0” and will be highlighted in orange. 6.1.2 Adding Info to the Sample Rotor Screen After samples have been loaded into the Sample Rotor, replace the Sample Rotor cover, assuring that it is properly aligned. Close the canopy. Touching the Scan Barcodes button causes NOVEOS to scan the Sample Rotor for the barcodes on the sample tubes and display sample information for all detected samples. NOVEOS can interpret barcodes created with CODABAR, interleaved 2 of 5, code 128, and code 39 formats. Rev. D 6-3 63100

6. Samples 6.1.3 Loading a Worklist onto the Sample Rotor Screen A worklist is a comma delimited text file, usually created in excel and saved in *.CSV format. This file can be imported into the software to define programmed tests. Note: A worklist can only be loaded from a USB drive plugged into the NOVEOS PC or from a connected network drive. Use a worklist when sample tubes are not barcoded. The worklist will define the Samples and their locations on the Sample Rotor. Contact HYCOR or your distributor to learn how to create a NOVEOS worklist or joblist. To load a worklist: 1. On the Sample Rotor screen, touch the Load Worklist… button. 2. On the window that displays, navigate to the file to load and touch Open. After the worklist file is specified by the user, the software reads information from the file and parses it for each specified position. If the specified test is valid, the software automatically programs the position with the specified test. If a worklist includes a test not known by the software, the software informs the user and does not assign the unknown test. The software rejects the worklist file unless all samples have positions. 6.1.4 Clearing Sample Rotor Data Sample rotor data can be cleared all at once or by line number. Multiple lines can be selected for clearing. To clear all data: 1. Touch the Clear Rotor button. 2. On the Warning screen, touch Yes to clear all rotor data. 63100 Figure 6-3. Sample Rotor Data Erase Warning Rev. D 6-4

NOVEOS Operator’s Manual To clear selected rows of data: 1. Touch the Enable Position Clearing checkbox. The name on the Clear Rotor button changes to Clear Positions. 2. Touch anywhere on a row to clear it. Multiple rows can be selected. 3. Touch the Clear Positions button. A confirmation message will be displayed and the user may continue or cancel the clearing of the selected positions. 6.1.5 Manually Entering Patient Samples for the Sample Rotor Data related to the patient samples in the Sample Rotor can be manually entered for any position in the Sample Rotor. If information has been supplied by the LIS, the user can only edit the following info: • Sample Comments • Sample Type • Container Type (1.5 ml, 2 ml, etc.) • Patient Comments To manually enter patient samples for the Sample Rotor: 1. Touch the Samples button. 2. On the Sample Rotor screen, touch the position for which the data should be entered. The Liquid Data for Sample Tray Position # screen displays. Figure 6-4. Liquid Data for Sample Tray Position # 3. Touching the Clear Pos button removes all data for the selected position. Rev. D 6-5 63100

6. Samples 4. Choose the Liquid Type from the dropdown list. Options are Unknown and Sample. NOTE: Users may only specify patient samples with this method of entry. 5. Alternately, in the Barcode field, type the barcode, then touch the Enter Manual Code button. NOTE: the barcode can be entered without selecting a liquid type. The Enter Manual Code button will display once characters are entered into the Barcode field. 6. Touch the Done button to save the entries or touch Cancel to return to the Sample Rotor screen. 6.1.5.1.1 Unknown This is a placeholder for an empty position. There are two reasons this can happen. • Barcode was not scanned after the tube was loaded onto the rotor. • Barcode label may not be readable by the barcode scanner. If the Sample Rotor cover is removed, there will be a warning message that asks the user to scan the Sample Rotor. 6.1.5.1.2 Sample When Sample is selected as the Liquid Type, the following screen displays. (Sample refers to Patient Sample.) 63100 Figure 6-5. Liquid Type – Sample Screen Rev. D 6-6