63100 Rev D, Noveos Operators Manual

10. Quality Control To select a calibration curve: 1. Touch the Quality Control button. 2. Touch the Calibration Data tab. 3. In the Search Criteria pane, choose an Assay Type from the dropdown list. 4. Choose a way to identify the data; either by touching Date Range and entering a date range or by touching Run Number and manually entering a run number. 5. The Curve Selection pane will display a list of curves from previous runs. 6. In the Curve Selection pane, touch the name of the curve. The curve and its related data are displayed on the right side of the screen. 7. Touch the Print button to print the data. Figure 10-2. Calibration Data Screen Showing Curve Selections and Selected Curve 63100 10-2 Rev. D

NOVEOS Operator’s Manual 10.2 Quality Control (QC) The software lets the user collate QC results for controls, calibrators and blanks via multiple search criteria (Date, Assay type, Reagent type, Test Code). QC results can be retrieved using the following search criteria: • Date range • Assay type (allergy) • Reagent type (Positive Control, Negative Control, Calibrator or Blank) • Specific Test (for example, D001, Blank) • Run Number Figure 10-3. Quality Control Screen Showing Selected Data Rev. D 10-3 63100

10. Quality Control To access and use QC results: 1. Touch the Quality Control button. 2. Touch the Quality Control tab. 3. In the Search Criteria pane, choose an Assay Type and/or Reagent Type from their respective dropdown lists. Choose a way to identify the data; either by entering a Date Range or by touching Run Number and entering a number. 4. In the Data pane, choose how to view the data by touching either Show Individual Results, Show Mean Results or Show Lot Numbers. The search results are presented in a tabular/list view and the following data is displayed for each test: • Run number • Date • Capture Reagent lot number • Result, Individual or Mean • Class • Analysis, Individual or Mean • Lower Limit • Upper Limit The report also shows the lots numbers for Control, Capture Reagent, Conjugate, Substrates A and B, Fluo Beads, and Diluent. 63100 10-4 Rev. D

NOVEOS Operator’s Manual 5. Touch the data row of interest. A Levey-Jennings chart displays in the right side of the window and plots the values of the selected test across the selected date range. A Levey-Jennings chart is a graph on which quality control data is plotted to give a visual indication whether a laboratory test is working well. The distance from the mean is measured in standard deviations (SD). When “All” is selected for the specific test, the software shows a Levey-Jennings chart that plots the values of all tests in the table. 6. Choose what happens to the data by touching either the Export to PDF, Export to Text, Send to LIS, or Print buttons. Rev. D 10-5 63100

10. Quality Control 63100 Figure 10-4. Sample QC Report Rev. D 10-6

NOVEOS Operator’s Manual For each item in the list, the following information is provided: • run number • date the run was started • the assay type • the control bracket within the run • if it has been Accepted / Rejected / Not Reviewed (not accepted or rejected) • if it has been transmitted to an LIS. 7. Select a row in the Run Brackets list. Results for the controls at the beginning and ending of the bracket will be displayed in the Controls pane. For each item, results include test code, result (concentration) pass/fail and pass/fail limits. 8. Users with access levels of lab supervisor or higher may mark the selected bracket as “accepted” by selecting the bracket and touching the Accept button. A comment window displays in which the user can enter text justifying the acceptance. 9. Users with access levels of lab supervisor or higher may mark the selected bracket as “rejected” by touching the Reject button. When a bracket is accepted or rejected, the action is logged to the audit trail along with the logged in username and justification, when accepted. 10. Results can be sent to the LIS, printed as a report, or saved to a .pdf file. Rev. D 10-7 63100

NOVEOS Operator’s Manual 11 Maintenance This section covers periodic maintenance functions accessed through the software and also cleaning and decontamination procedures. Ongoing attention to the maintenance tasks is essential to the smooth running of the instrument. Maintenance functions accessed by touching the Maint button include: • Periodic Maintenance • Updates • Cuvettes • Remote Assistance • Database • Logs When the Maint button is touched, a task screen displays with tabs for accessing all the maintenance functions listed above. Operator-performed maintenance involves wiping down the instrument, replacing cuvette arcs, testing fluidics, soaking multi-arm pipettes, cleaning spills and residues and pumping washing solution through all of the lines to clean them. These activities are done daily, weekly or monthly; also before and/or after runs. The instrument will provide periodic reminders that maintenance activities are due. When tasks have been completed, the user name, date, and list of tasks and any comments are saved to the Maintenance log. NOTE: Be sure to wear appropriate personal protective equipment as directed by your laboratory. Figure 11-1. Maint Button Rev. D 11-1 63100

11. Maintenance 11.1 General Maintenance Activities Several functions on the Maintenance Activity panel of the Periodic screen can be used at any time and are not necessarily related to daily, weekly, or monthly maintenance. These include Unlock Canopy, Home All, Perform Priming and Enter Comments. Table 11-1. General Maintenance Activities Task Section Unlock Canopy 11.3.4.1 Home All 11.3.4.2 Perform Priming 11.3.4.3 Enter Comments 11.2 Periodic Maintenance Periodic maintenance includes daily, weekly, and monthly maintenance as well as replacing the reaction cuvettes and multi-rinse soak. The following tables list the frequency of the tasks and reference the sections where details can be found. Before performing periodic maintenance, be sure the waste containers are empty and the DI water, Cuvette Wash and Wash Buffer containers are full. 63100 11-2 Rev. D

NOVEOS Operator’s Manual CAUTION: Before performing any maintenance, be sure probes have stopped moving. Table 11-2. Periodic Maintenance Tasks Task Section Periodic Maintenance Daily Weekly Monthly Move probes to inspection 11.2.1.1  Inspect probes 11.2.1.2  Wipe down probes 11.2.1.3  Wipe down top deck 11.2.1.4  Rinse all probes 11.2.1.5  Fluidics tests 11.2.1.6  Perform probe wash 11.2.2.1  Replace optics tip 11.2.2.2  Optics fluidics test 11.2.2.3  Wipe down Reagent Rotor 11.2.2.5  Wipe down Sample Rotor 11.2.2.6  Soak probes in tub 11.2.2.4.1  Multi-Rinse Soak** 11.2.2.4  ** Multi-rinse soak can also be done after a run or when the instrument is idle for more than 30 minutes. Rev. D 11-3 63100

11. Maintenance Table 11-2. Period Maintenance Tasks (continued) Task Section Periodic Maintenance Database cleanup 11.3.2.1 Daily Weekly Monthly  Check for errors 11.3.2.2  Wash station and waste line 11.3.2.3  cleaning* Table 11-3. Additional Tasks (Before Run) Task Section Check waste containers and empty 5.3.8 5.36 Check DI water and Wash Buffer and fill 11.3.3 as needed 5.3.5 Replace Reaction (Rxn) cuvette arcs 11.11 Load/replace Substrate Mix container Clean all spills using lint-free tissues moistened with a 5% bleach solution or a laboratory approved disinfectant. 63100 11-4 Rev. D

NOVEOS Operator’s Manual 11.2.1 Daily Maintenance Daily maintenance is typically performed at the start of the day or as determined by the laboratory. Daily maintenance includes wiping down the NOVEOS top canopy, inspecting the probes, wiping down the probes, rinsing all probes and conducting the fluidics tests. To run daily maintenance: 1. Touch the MAINT button. The Maintenance Activity screen displays and provides selections for running daily, weekly, and monthly maintenance and replacing the reaction cuvette arcs and multi- rinse soak. Figure 11-2. Daily Maintenance Tasks Screen 2. Touch Daily Maintenance in the panel on the left side of the screen. The panel on the right side will display the related tasks: move probes to inspection, inspect probes, wipe down probes, wipe down top deck, rinse all probes, and fluidics tests. Tasks are typically performed in order. Rev. D 11-5 63100

11. Maintenance Move Probes to Inspection This task moves the probes into a position where they may be inspected. With the canopy closed, touch the Move to Inspection button. Inspect Probes Inspection includes the multi-rinse, mono-rinse, sample, R1 and R2 probes which can be found on their respective arms. See Figure 11-3. Figure 11-3. Probe Locations 63100 11-6 Rev. D

NOVEOS Operator’s Manual To inspect the probes: 1. Touch the Unlock Canopy button, then open the NOVEOS canopy. 2. Touch the Inspect Probes task. NOVEOS moves the probes to an accessible location. 3. Perform a visual check on all probes, looking for discoloration, buildup, visible damage. If damaged, contact Technical Service. 4. When finished, touch the Complete Task button. Figure 11-4. Daily Maintenance – Inspect Probes Rev. D 11-7 63100

11. Maintenance Wipe Down Probes To wipe down probes: 1. If the multi-rinse, mono-rinse, sample, R1 and R2 probes have passed inspection in the previous step, touch the Wipe Down Probes task. 2. Carefully wipe each probe with DI water and lint-free tissues. DO NOT attempt to clean any portion of the arm – this may cause damage or malfunction. 3. When finished, touch the Complete Task button. Figure 11-5. Wipe Down Probes Screen 63100 11-8 Rev. D

NOVEOS Operator’s Manual Wipe Down Top Deck To wipe down the top deck: 1. Wipe down the top deck using a lint-free tissue moistened with a 5% bleach solution or an approved laboratory disinfectant. Do not use anything that may pit or damage the canopy and/or deck. 2. When finished, touch the Complete Task button to let NOVEOS software know this step has been completed. A checkmark appears next to the completed task and the next task in the list is highlighted and available to run. Figure 11-6. Wipe Down Top Deck Screen Rev. D 11-9 63100

11. Maintenance Rinse All Probes This function pumps DI water through the lines to flush out any salts while the canopy is closed. To rinse all probes: 1. Before this function is selected, check that there is enough DI water. 2. With Rinse All Probes highlighted in the Tasks panel, touch the Rinse Probes button. The screen will be grayed while the probes are being washed. NOVEOS washes the probes with the system DI water and returns them to the home position. This process takes 5 to 10 minutes. 3. Touch the Perform Priming button to start the first prime process. This operation will clear air bubbles from the line. Repeat the Perform Prime operation a total of five times. Note: The first prime in a cycle will take about two and a half minutes. The next four take about thirty seconds each. Figure 11-7. Rinse All Probes Screen 63100 11-10 Rev. D

NOVEOS Operator’s Manual Fluidics Tests This function performs four tests which are comprised of a fluidic precision test for each probe: multi- rinse, mono-rinse, sample, R1 and R2 and completes all tests even if one or more fail. A summary is provided in the event of a failure. The tests take about 10 minutes. To run fluidics tests: 1. Before starting these tests, check that there is sufficient DI water and that cuvette arcs are installed in arc 1 on the Reaction Rotor. 2. Replace the Reaction Rotor cover, making sure it is properly aligned. 3. Touch Fluidics Tests on the Tasks panel. 4. Touch the Perform Tests button. 5. Sometimes air bubbles in the lines will cause the Fluidics Test to fail. Perform Priming for six cycles and repeat the test. 6. When complete, touch the Complete Activity button. Figure 11-8. Fluidics Tests Screen Note: The All Tasks function lists each of the four tests separately so they can be run individually if desired. To do so, choose the task from the All Tasks list, then touch the Perform Test button. Rev. D 11-11 63100

11. Maintenance 11.2.2 Weekly Maintenance Weekly maintenance consists of inspecting and washing the probes, replacing the optics tip, performing the optics fluidics test and wiping the rotors. In addition to the items listed on the Maintenance screen, the multi-rinse soak should be performed. To run weekly maintenance: 1. Touch the Maint button. 2. In the Selected Activity panel on the Maintenance Activity screen, touch Weekly Maintenance. Figure 11-9. Weekly Maintenance Tasks Screen The panel on the right side will display the related tasks: perform probe wash, replace optics tip, and optics fluidics test. Tasks are typically performed in order. 63100 11-12 Rev. D

NOVEOS Operator’s Manual Performing the Weekly Probe Wash To perform the weekly probe wash: 1. Before starting this task, check that probe wash has been loaded on the inner ring of the Reagent Rotor. 2. With Weekly Maintenance selected, touch Perform Probe Wash in the Tasks panel. When Perform Probe Wash is selected, NOVEOS checks that there is enough probe wash solution and that none of it has expired. If additional Probe Wash solution is needed or if the Probe Wash is missing from the Reagent Rotor, a message will display instructing the operator to proceed to step 3 and add additional Probe Wash containers. Otherwise, skip to step 5. 3. Touch the Unlock Canopy button and open the NOVEOS canopy. 4. Ensure cuvette arcs are in every position on the Reaction Rotor. Note: Cuvette arcs can be reused after Probe Wash. 5. Close and lock the NOVEOS canopy. 6. With Perform Probe Wash highlighted in the Tasks panel, touch the Probe Wash button. 7. NOVEOS washes the probes with the Probe Wash solution and returns them to the home position. When the task is complete, a Complete Activity button is added to the screen. Rev. D 11-13 63100

11. Maintenance 8. Touch the Complete Activity button to let NOVEOS know that the probe wash is complete. Figure 11-10. Weekly Probe Wash Screen 63100 11-14 Rev. D

NOVEOS Operator’s Manual Replacing the Optics Tip To replace the optics tip: 1. Open the NOVEOS canopy. 2. Touch the Maint button. 3. Touch Weekly Maintenance. 4. Touch Replace Optics Tip in the Tasks panel on the right side of the screen. Be sure to wear gloves for this procedure. Figure 11-11. Replace Optics Tip Screen 5. Remove the existing optics pipette tip by slightly twisting and pulling the tip downward. 6. Install the new tip by using upward pressure with a slight twisting motion. Rev. D 11-15 63100

11. Maintenance Figure 11-12. Removing the Optics Tip 7. Touch the Complete Task button. NOTE: Used optics tips are considered biohazardous. Dispose of them in properly marked containers. 63100 11-16 Rev. D

NOVEOS Operator’s Manual Optics Fluidics Test During this test, the optics tip aspirates Fluo Beads and measures their optical fluorescence, then repeats the measurement to detect any changes. To run the optics fluidics test: 1. On the Weekly Maintenance screen, touch the Unlock Canopy button and open the canopy. 2. Open the Reaction Rotor cover and enssure that cuvette arc is installed in arc 1. Install if needed. 3. Check that Fluo Beads tubes are installed in the Fluo Beads tubes holder. Install if needed. 4. Touch the Perform Test button. 5. When the test is complete, dispose of used cuvette arcs. NOTE: Used cuvettes arcs are considered biohazardous. Dispose of them in properly marked containers. Figure 11-13. Optics Fluidics Test Rev. D 11-17 63100

11. Maintenance Figure 11-14. Weekly Maintenance: Wipe Reagent Rotor A manual task. Follow the onscreen instructions. Figure 11-15. Weekly Maintenance: Wipe Sample Rotor A manual task. Follow the onscreen instructions. 63100 11-18 Rev. D

NOVEOS Operator’s Manual Multi-Rinse Soak The multi-rinse soak function soaks the multi-rinse probe with DI water. This function should be used weekly, when salt crystal buildup is observed, or if the instrument has been unused for an extended period. Figure 11-16. Multi-Rise Soak Screen 11.2.2.4.1 Soak in Tub This task starts the soaking procedure for the multi-arm pipettes. To soak in tub: 1. Touch the Maint button. Then touch the Periodic tab. 2. Be sure that the DI water is full before starting this task. 3. Place the multi-soak tub in the proper position on the instrument deck and fill it with DI water. 4. Close the instrument canopy. 5. Touch Soak in Tub on the Tasks panel. 6. Touch the Begin Soak button. 7. Touch the Unlock Canopy button, then open the canopy and remove the tub. Rev. D 11-19 63100

11. Maintenance 11.2.2.4.2 Home from Tub The Home from Tub task completes the soaking procedure for multi-arm pipettes after the Soak in Tub function has completed. To complete the soaking procedure: 1. Touch Home from Tub in the Tasks panel. 2. Touch the Complete Soak button and wait for the task to complete. The software will prompt for soak tub removal. 3. Touch OK. 4. Wash the soak tub and reuse it as needed. 5. If the instrument has been power cycled while the arm is soaking, the Complete Soak task will not work. In this case, press the Home All button to complete the task. The reaction rotor rotates during the Home All operation, so sample splashing may occur and should be wiped off. Figure 11-17. Home from Tub Screen 63100 11-20 Rev. D

NOVEOS Operator’s Manual 11.2.2.4.3 Soak in Cuvettes This task is automatically done by the software at the end of a run. It soaks the multi-arm pipettes in cuvette arcs. If it is necessary to perform this task at another time, follow the steps below. To soak in cuvette arcs: 1. Be sure that new cuvette arcs are installed in the Reaction Rotor. 2. Close the canopy. 3. Touch the Soak in Cuvettes task on the Tasks panel. Touch the Begin Soak button. Figure 11-18. Soak in Cuvettes Screen Rev. D 11-21 63100

11. Maintenance 11.2.2.4.4 Home from Cuvettes The instrument automatically soaks cuvette arcs with DI water after every run. When you are ready to use the instrument, touch Home from Cuvettes. To Home from Cuvettes: 1. Touch Home from Cuvettes on the Tasks panel. 2. Touch the Complete Soak button. 3. The software prompts for a comment. Enter a comment and touch OK. Cuvette arcs may be reused after this procedure. Figure 11-19. Home from Cuvettes Screen 63100 11-22 Rev. D

NOVEOS Operator’s Manual Removing and Wiping Sample Rotor To remove and wipe 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 11-20. Removing the Sample Rotor Cover 3. Remove the Sample Rotor by pulling up on the handle. Set the Sample Rotor aside. Rev. D 11-23 63100

11. Maintenance Figure 11-21. Removing the Sample Rotor 4. Dry the Sample Rotor with a paper towel, then wipe it with a paper towel moistened with a 5% bleach solution or approved laboratory disinfectant. Set aside and allow to dry. 5. Dry the Sample Rotor tub with a paper towel, then wipe it with a paper towel moistened with a 5% bleach solution or approved laboratory disinfectant. Allow to dry completely. 6. Replace the Sample Rotor into the tub. 7. Replace the Sample Rotor cover, making sure it is properly aligned. 63100 11-24 Rev. D

NOVEOS Operator’s Manual Removing and Wiping Reagent Rotor and Tub To remove and wipe the Reagent Rotor and tub: 1. Open the NOVEOS canopy. 2. Remove the cover from the Reagent Rotor by pulling up on the handle. Set the cover aside. Figure 11-22. Reagent Rotor Cover Rev. D 11-25 63100

11. Maintenance Figure 11-23. Removing a Reagent Rotor Wedge 3. Remove each of the Reagent Rotor wedges by pulling up on them. 4. Dry each wedge with a paper towel, then wipe it with a paper towel moistened with a 5% bleach solution to disinfect. Set them aside and allow to dry. 5. Dry the Reagent Rotor tub with a paper towel then wipe it with a paper towel moistened with a 5% bleach solution to disinfect the tub. Allow to dry completely. 6. Replace the wedges into the Reagent Rotor tub. 7. Replace the Reagent Rotor cover, making sure it is properly aligned. 63100 11-26 Rev. D

NOVEOS Operator’s Manual 11.3 Cleaning Reagent Rotor Waste Lines Reagent waste lines must be cleaned monthly by pouring 5% bleach solution to the reagent drain as described below. Note: Prepare the bleach solution before starting the task. 1. Remove the Reagent Rotor Cover 2. Remove all 5 Reagent Rotor Wedges, which will expose the Reagent Tub drain. 3. Pour 100-200 mL of 5% bleach solution into the reagent tube drain using a squirt bottle. 4. Use a lint-free wipe to clean any residual bleach solution from the Reagent Rotor tub. 5. Return the reagent wedges to their correct positions Figure 11-24. Pour Bleach Solution into Reagent Tub and Drain Rev. D 11-27 63100

11. Maintenance 11.3.2 Monthly Maintenance Monthly maintenance consists of cleaning up the database, checking for errors, and cleaning the wash stations and waste lines. Database Cleanup Selecting the Database Cleanup function deletes all daily logs older than 1 year. Note: See Section 11.5 for details on how to backup and restore databases. This function also scans for software exceptions since the last time the function was invoked and gives the user an opportunity to save the list of exceptions to an external drive (for sending to Hycor). The following are purged: • patient and physician records older than three months Test results are not affected. To cleanup the database: 1. Touch the Maint button. 2. On the Maintenance Activity screen, touch Monthly Maintenance. 3. Touch Database Cleanup. 4. Touch the Cleanup Database button. 63100 11-28 Rev. D

NOVEOS Operator’s Manual Figure 11-25. Database Cleanup Rev. D 11-29 63100

11. Maintenance Check for Errors This function checks for errors, packages the error logs and saves them to an external drive for emailing to Hycor Technical Service. To check for errors: 1. Ensure that all rotor covers have been replaced and the canopy is closed and locked. 2. Insert a USB drive into the front of the computer. 3. Touch the Maint button. 4. On the Maintenance Activity screen, touch Monthly Maintenance. 5. Touch Check for Errors, then touch the Check for Errors button. NOVEOS will prompt whether the user wants to save the logged errors to a network or external drive where the error file can be saved. 6. Touch Yes. If there are errors, a dialog displays in which the location for saving the file can be entered. Select the letter for the USB drive and then touch OK. 7. Touch the Complete Activity button. A dialog opens in which the user can add comments which are saved to the maintenance log file. 8. Touch OK. 63100 Figure 11-26. Check for Errors Rev. D 11-30

NOVEOS Operator’s Manual Cleaning Wash Stations and Waste Lines The Reagent waste line should be cleaned monthly using the steps that follow. Mono-rinse Sample Wash Multi-rinse R2 Optics R1 Figure 11-27. Wash Station Locations Rev. D 11-31 63100

11. Maintenance 11.3.3 Replace Reaction Cuvette Arcs 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. Details for this procedure are in Section 5.3.2. 11.3.4 Run Tasks Run tasks are miscellaneous tasks performed at will and are not tied to any maintenance activity. They are available on Periodic tab and include Unlock Canopy, Home All, Perform Priming and Enter Comments. Unlock Canopy This function lets the user unlock the canopy when NOVEOS is not running tests or scanning barcodes. This is necessary to access the top deck for some maintenance and service tasks. To unlock the canopy, touch the Unlock Canopy button on the Periodic screen. Home All When the canopy is closed, this function causes all arms and rotors to return to their home positions. To Home All, touch the Home All button on the Periodic screen. This function may be cancelled by touching the Stop button on the screen. 63100 11-32 Rev. D

NOVEOS Operator’s Manual Perform Priming The priming function ensures that the multi-rinse and mono-rinse lines are filled with liquid. The task takes approximately five minutes. To perform priming: 1. Check for sufficient DI water and Wash Buffer solution; replenish if needed. 2. Touch the Perform Priming button on the Periodic screen. 3. Prime four cycles. Enter Comments The enter comments function allows you to record anything done with the system that are not part of the regular maintenance activities. To enter comments 1. Touch the Enter Comments… button on the Periodic screen. 2. Any text entered here will be saved in the Maintenance log. Rev. D 11-33 63100

11. Maintenance 11.3.5 All Tasks Touching this selection displays a summary of all the maintenance tasks available. Each task can be run individually and they function as described in the previous sections. Table 11-4. All Tasks All Tasks Section Move probes to inspection 11.2.1.1 Inspect Probes 11.2.1.2 Wipe Down Probes 11.2.1.3 Wipe Down Top Deck 11.2.1.4 Perform Probe Wash 11.2.2.1 Rinse All Probes 11.2.1.5 Replace Cuvettes 11.3.3, 5.3.2 Replace Optics Tip 11.2.2.2 Fluidics Tests 11.2.1.6 Optics Fluidics Test 11.2.2.3 Multi & Mono Fluidics Test 11.2.1.6 Reagent Arm 1 Fluidics Test 11.2.1.6 Reagent Arm 2 Fluidics Test 11.2.1.6 Sample Arm Fluidics Test 11.2.1.6 Database Cleanup 11.3.2.1 Check for Errors 11.3.2.2 Reset Instrument 11.3.5.1 63100 11-34 Rev. D

NOVEOS Operator’s Manual Reset Instrument This function is only available when All Tasks is touched in the Selected Activity panel. It resets NOVEOS if it is no longer responding. It causes all arms and rotors to rehome if needed and return to their parked positions. This task does not reboot the NOVEOS software. To reset NOVEOS: 1. Touch All Tasks in the Selected Activity panel. 2. Scroll down the task list to the very end, then touch Reset Instrument. 3. Touch the Reset button. Figure 11-28. Reset Instrument Screen Rev. D 11-35 63100

11. Maintenance 11.4 Cuvettes The Cuvettes function lets the user determine which cuvettes will be used by the instrument. To enable/disable cuvettes: 1. Touch the Maint button. 2. Touch the Cuvettes tab. 3. Touch the box at the top of any row to enable/disable Cuvette status for the entire row. 4. Touch the box at the side of any column to enable/disable Cuvette status for the entire column. or 5. Touch individual Cuvette locations to toggle their status on or off. Two columns of 10 pretest arcs are available. Of these, up to five Cuvettes may be disabled from each. 6. Touch the Save button to save the settings. 63100 Figure 11-29. Cuvettes Screen Rev. D 11-36

NOVEOS Operator’s Manual 11.5 Database The Database Maintenance function includes functions to purge, backup, and restore data. The software will require the user to provide a Hycor-generated password before allowing the restore to proceed. Touching the Maint button followed by touching the Database tab displays the screen from which the database can be backed up and/or restored. Databases can also be restored from a local or external drive. Figure 11-30. Maintenance – Backup/Restore/Purge Database Rev. D 11-37 63100

11. Maintenance 11.5.1 Backing Up a Database to Local or External Drive To back up a database: 1. Touch the Backup button to create a backup of the current database. 2. To copy a backup to an external drive, choose a database from the list on the Database screen by touching it. 3. Connect an external USB drive to the NOVEOS computer. 4. Touch the Copy to External Drive button, and select the letter of the USB drive. The screen will update the backup date/time and backup location information and the software writes to the event log whenever a backup occurs. 11.5.2 Restoring a Database from a Local or External Drive To restore a database: 1. Choose a database from the list on the Database screen by touching it. 2. Touch either the Restore or Restore from External Drive button, depending on the location from which the database is restored. 3. The screen will update the date/time restored. The software writes to the event log whenever a restore occurs. Note restoring a database requires a special password and assistance of a service representative. 63100 11-38 Rev. D

NOVEOS Operator’s Manual 11.5.3 Deleting a Database This function removes a database. NOTE: This function requires Lab Supervisor or higher permission. To delete a database: 1. Choose a database from the list on the screen by touching it. 2. Touch the Delete button. 3. The database name will be removed from the screen. 11.5.4 Purging a Database Purging frees up space in the database by removing patient results prior to a selected date. To purge a database: 1. Touch the Purge button. 2. Purging data is permanent. Accept the warning. 3. Select a date. All data from that date and prior will be removed from the database. Note that after a purge, the software will immediately shut down. Rev. D 11-39 63100

11. Maintenance 11.6 Updates Updates can be sent to users by email and then put on a USB drive to load onto the system. Figure 11-31. Maintenance – Updates Screen To install updates: 1. Copy the update to a USB drive—do not put it in a folder on the USB drive 2. Ensure there are no other update files on the USB drive 3. Touch the Maint button then touch the Updates tab 4. Touch Install Updates. A dialog displays requiring the user to select a letter from which the new software will be installed. Select the USB drive letter and touch OK. 5. The NOVEOS software will close and the update progress screen will appear. Follow any prompts that are presented. 6. The NOVEOS software will be restarted after the update. For some updates the computer will be restarted. 63100 11-40 Rev. D

NOVEOS Operator’s Manual 11.7 Remote Assistance The Remote Assistance screen lets the user give secure access to TeamViewer so that a Hycor support team member can help evaluate any problems. Figure 11-32. Maintenance – Remote Assistance To use remote assistance: 1. Touch the Maint button. 2. Touch the Remote Assistance tab. 3. Touch the Launch TeamViewer button. 4. A window displays with the customer ID and password. A green light in the window indicates that the system is ready to connect. Rev. D 11-41 63100

11. Maintenance Figure 11-33. Maintenance – TeamViewer Window 5. When the service call is complete, touch the Close TeamViewer button, or close the support window using the X. 63100 11-42 Rev. D

NOVEOS Operator’s Manual 11.8 Logs Touching the Logs tab gives access to the Audit, Maintenance, and Daily logs. The software logs the user name and action taken whenever the software is used to modify data. 11.8.1 Audit Log The software writes to the Audit Trail log whenever an update is performed, including the log date and time, login ID of the user, action, and description of the item logged. The contents of the window can be filtered by date, refreshed, saved to a text file, and/or printed. Figure 11-34. Maintenance – Audit Log Screen To access the Audit log: 1. Touch the Maint button. 2. Touch the Logs tab. 3. Touch the Audit Log tab. Rev. D 11-43 63100

11. Maintenance 11.8.2 Maintenance Log The software writes to the Maintenance log whenever periodic maintenance is performed and records the user’s login ID, description of the maintenance activity, and any comments entered by the user at the time the maintenance was performed. The contents of the window can be saved to a text file and/or printed. Figure 11-35. Maintenance Log Screen To access the Maintenance log: 1. Touch the Maint button. 2. Touch the Logs tab. 3. Touch the Maintenance Log tab. 63100 11-44 Rev. D