63100 Rev D, Noveos Operators Manual

Operator’s Manual hycorbiomedical.com May 2019 Copyright HYCOR© Biomedical, Inc., 2019. All rights reserved. HYCOR is a registered trademark; NOVEOS™ and Fluo Beads™ are trademarks of HYCOR Biomedical, Inc. Any other trademarked names mentioned are the property of their respective owners. The contents of this manual, all figures, tables and graphic representations are intellectual property of HYCOR Biomedical. Unauthorized commercial or non-commercial copying of any or all of the contents and use of this manual (in total or in part) is strictly prohibited without written permission from HYCOR Biomedical. This manual was written and reproduced with the utmost care. However HYCOR Biomedical does not take any responsibility and accepts no liability for incidents of any kind that may occur because of errors in this manual or for misuse of the instrument. Part No. 63100 Rev. D 63100

NOVEOS Operator’s Manual Rx only HYCOR Biomedical Inc. 7272 Chapman Avenue Garden Grove, CA 92841 - USA 1-800-382-2527 Advena Limited Tower Business Centre, 2nd Floor, Tower Street, Swatar, BKR 4013 Malta HYCOR Europe B.V. Branch Office Germany Waldauer Weg 84 34253 Lohfelden - Germany +49 (0)561 8167000-0 Made in USA Printed in USA Revision D May 2019 Rev. D i 63100

Contents Contents 1 Introduction ............................................................................................................................1-1 1.1 Cyber Security Guidelines..............................................................................................1-2 1.2 Documentation and Intended Audience ........................................................................1-2 1.3 What’s in This Manual...................................................................................................1-2 1.4 NOVEOS System Overview ............................................................................................1-4 1.4.1 Instrument Layout ................................................................................................1-6 1.4.1.1 Rotors and Other Components ..........................................................1-7 1.4.1.2 Arms....................................................................................................1-8 1.4.1.3 Barcode Readers...............................................................................1-10 1.4.1.4 Power and USB Connections ............................................................1-11 1.4.2 Technical Specifications......................................................................................1-12 1.4.3 NOVEOS Dimensions ..........................................................................................1-12 1.4.4 Floor Space Recommendation ...........................................................................1-12 1.4.5 Desk/Bench Space Requirement ........................................................................1-13 1.4.6 Shipping and Storage Requirements without Fluids ..........................................1-13 1.4.7 Environmental Requirements ............................................................................1-13 1.4.8 Power Requirements..........................................................................................1-14 1.4.9 Sample Tubes .....................................................................................................1-15 1.5 Reagents.....................................................................................................................1-15 1.5.1 Capture Reagents ...............................................................................................1-15 1.5.2 Reagent Kits........................................................................................................1-16 1.5.3 Consumables ......................................................................................................1-19 1.5.4 Supplies ..............................................................................................................1-20 2 Notices, Warnings, and Cautions..............................................................................................2-1 2.1 Notices .........................................................................................................................2-1 2.2 Warning, Caution and Note Definitions..........................................................................2-1 2.3 Summary of Warnings and Cautions ..............................................................................2-2 2.3.1 Warnings...............................................................................................................2-2 2.3.2 Cautions................................................................................................................2-2 2.4 Caution and Warning Symbol Definitions.......................................................................2-3 2.5 Symbols........................................................................................................................2-4 2.6 Safety Data Sheets ........................................................................................................2-5 3 User Interface..........................................................................................................................3-1 3.1 System Status Indicators ...............................................................................................3-2 3.2 Utility Functions Icons...................................................................................................3-3 3.3 Function Selection Buttons............................................................................................3-4 3.4 Action Buttons..............................................................................................................3-5 3.5 Screen Selection Tabs....................................................................................................3-6 4 Preparing NOVEOS Software for Use ........................................................................................4-1 63100 ii Rev. D

NOVEOS Operator’s Manual 4.1 Log In ...........................................................................................................................4-1 4.2 System Setup................................................................................................................4-1 4.3 Operator Setup .............................................................................................................4-6 4.3.1 User Privileges ......................................................................................................4-8 4.3.1.1 Lab User..............................................................................................4-9 4.3.1.2 Lab Supervisor ..................................................................................4-10 4.3.1.3 Lab Administrator.............................................................................4-10 4.4 Report Setup ..............................................................................................................4-11 4.5 Database ....................................................................................................................4-12 4.6 LIS Settings .................................................................................................................4-13 4.7 About .........................................................................................................................4-18 5 Running Tests ..........................................................................................................................5-1 5.1 Supplies........................................................................................................................5-1 5.2 Quickstart Workflow.....................................................................................................5-2 5.3 Preparing NOVEOS for Use ............................................................................................5-4 5.3.1 Loading the Sample Rotor ....................................................................................5-5 5.3.2 Loading the Reaction Rotor with Cuvette Arcs ....................................................5-9 5.3.3 Loading the Reagent Rotor.................................................................................5-13 5.3.4 Loading the Fluo Beads Tubes............................................................................5-16 5.3.5 Loading the Substrate Mix Container.................................................................5-17 5.3.6 Filling the Lower Deck DI and Wash Buffer Containers......................................5-18 5.3.7 Filling the Cuvette Wash Fluid Container ...........................................................5-21 5.3.8 Empty the Waste Containers..............................................................................5-22 5.4 Setting Up and Running Tests – Detailed......................................................................5-26 5.4.1 Linking a Sample to a Test ..................................................................................5-26 5.4.2 Adding Samples to a Run and Tests to a Sample................................................5-27 5.4.3 Running a Test ....................................................................................................5-28 5.5 After a Run .................................................................................................................5-31 6 Samples ..................................................................................................................................6-1 6.1 Sample Rotor Screen.....................................................................................................6-1 6.1.1 Information for Each Sample................................................................................6-2 6.1.2 Adding Info to the Sample Rotor Screen..............................................................6-3 6.1.3 Loading a Worklist onto the Sample Rotor Screen ..............................................6-4 6.1.4 Clearing Sample Rotor Data .................................................................................6-4 6.1.5 Manually Entering Patient Samples for the Sample Rotor...................................6-5 6.1.5.1.1 Unknown.........................................................................6-6 6.1.5.1.2 Sample.............................................................................6-6 6.1.5.1.3 Controls.........................................................................6-11 6.1.5.1.4 Calibrators.....................................................................6-11 6.1.5.1.5 Saved Curves.................................................................6-11 6.2 Setting Up a Control for an Assay ................................................................................6-12 Rev. D iii 63100

Contents 6.2.1 Setup Control Tests ............................................................................................6-12 6.2.2 Scan the 2D Barcode on the Directional Insert ..................................................6-12 6.2.3 Choose Tests to Run ...........................................................................................6-13 6.2.4 Select Tests to Assign to a Control .....................................................................6-14 6.2.5 When Controls are Setup Correctly....................................................................6-14 6.3 JobList ........................................................................................................................6-16 6.3.1 Printing Job Lists.................................................................................................6-17 6.4 Panels.........................................................................................................................6-17 6.4.1 How to Create a Panel........................................................................................6-18 6.4.2 Creating a Panel for Controls .............................................................................6-19 6.4.3 Deleting a Panel..................................................................................................6-20 7 Reagents .................................................................................................................................7-1 7.1 Reagent Rotor and Beads ..............................................................................................7-2 7.2 Using the Reagent Rotor Screen ....................................................................................7-2 7.2.1 Clearing Reagent Rotor Information ....................................................................7-3 7.2.2 Manually Editing and Clearing Position Data for the Reagent Rotor ...................7-4 7.3 Using the Beads Screen .................................................................................................7-5 7.3.1 Adding Info to the Beads Screen ..........................................................................7-5 7.3.2 Clearing Bead Information ...................................................................................7-8 7.3.3 Manually Entering Data for Beads........................................................................7-9 8 Home/Schedule/Alerts ............................................................................................................8-1 8.1 Using the Home Screen .................................................................................................8-1 8.1.1 Scanning Barcodes................................................................................................8-5 8.1.2 Checking Warnings ...............................................................................................8-6 8.1.3 Running Tests .......................................................................................................8-7 8.1.4 Pausing Tests ........................................................................................................8-9 8.1.4.1 Resuming Paused Tests ......................................................................8-9 8.1.5 Stopping Tests ......................................................................................................8-9 8.1.5.1 Resuming Stopped Tests ....................................................................8-9 8.1.5.2 Abnormal Run Completion ...............................................................8-10 8.1.6 Conditions That May Prevent a Run from Starting ............................................8-10 8.1.6.1 Tests Can Be Run Despite These Conditions ....................................8-12 8.1.7 Errors During Tests .............................................................................................8-12 8.1.7.1 Error Handling...................................................................................8-14 8.1.8 Run Complete .....................................................................................................8-14 8.2 Schedule.....................................................................................................................8-15 8.2.1 Run Flags.............................................................................................................8-16 8.3 Alerts..........................................................................................................................8-17 9 Reports ...................................................................................................................................9-1 9.1 Report Contents and Setup ...........................................................................................9-2 9.2 Patient Reports.............................................................................................................9-5 63100 iv Rev. D

NOVEOS Operator’s Manual 9.3 LIS Results ....................................................................................................................9-8 10 Quality Control ......................................................................................................................10-1 10.1 Calibration Data..........................................................................................................10-1 10.2 Quality Control (QC)....................................................................................................10-3 For each item in the list, the following information is provided:..............................................10-7 11 Maintenance .........................................................................................................................11-1 11.1 General Maintenance Activities...................................................................................11-2 11.2 Periodic Maintenance .................................................................................................11-2 11.2.1 Daily Maintenance..............................................................................................11-5 Move Probes to Inspection...............................................................11-6 Inspect Probes ..................................................................................11-6 Wipe Down Probes...........................................................................11-8 Wipe Down Top Deck .......................................................................11-9 Rinse All Probes ..............................................................................11-10 Fluidics Tests...................................................................................11-11 11.2.2 Weekly Maintenance........................................................................................11-12 Performing the Weekly Probe Wash ..............................................11-13 Replacing the Optics Tip .................................................................11-15 Optics Fluidics Test .........................................................................11-17 Multi-Rinse Soak.............................................................................11-19 11.2.2.4.1 Soak in Tub..................................................................11-19 11.2.2.4.2 Home from Tub...........................................................11-20 11.2.2.4.3 Soak in Cuvettes..........................................................11-21 11.2.2.4.4 Home from Cuvettes...................................................11-22 Removing and Wiping Sample Rotor..............................................11-23 Removing and Wiping Reagent Rotor and Tub ..............................11-25 11.3 Cleaning Reagent Rotor Waste Lines..........................................................................11-27 11.3.2 Monthly Maintenance......................................................................................11-28 Database Cleanup...........................................................................11-28 Check for Errors ..............................................................................11-30 Cleaning Wash Stations and Waste Lines.......................................11-31 11.3.3 Replace Reaction Cuvette Arcs.........................................................................11-32 11.3.4 Run Tasks..........................................................................................................11-32 Unlock Canopy................................................................................11-32 Home All .........................................................................................11-32 Perform Priming .............................................................................11-33 Enter Comments.............................................................................11-33 11.3.5 All Tasks ............................................................................................................11-34 Reset Instrument ............................................................................11-35 11.4 Cuvettes ...................................................................................................................11-36 11.5 Database ..................................................................................................................11-37 Rev. D v 63100

Contents 11.5.1 Backing Up a Database to Local or External Drive ...........................................11-38 11.5.2 Restoring a Database from a Local or External Drive.......................................11-38 11.5.3 Deleting a Database .........................................................................................11-39 11.5.4 Purging a Database...........................................................................................11-39 11.6 Updates....................................................................................................................11-40 11.7 Remote Assistance....................................................................................................11-41 11.8 Logs..........................................................................................................................11-43 11.8.1 Audit Log...........................................................................................................11-43 11.8.2 Maintenance Log..............................................................................................11-44 11.8.3 Daily Logs..........................................................................................................11-45 Communications Log ......................................................................11-46 Events Log.......................................................................................11-46 Instrument Log ...............................................................................11-46 LIS Log.............................................................................................11-46 Software Errors Log ........................................................................11-46 Temperature Log ............................................................................11-46 11.9 Disposing of Fluids and Plastic Containers..................................................................11-47 11.9.1 Disposing of Fluids............................................................................................11-47 11.9.2 Disposable Plastics ...........................................................................................11-47 11.10 Cleaning ...................................................................................................................11-47 11.11 Cleaning Spills...........................................................................................................11-48 11.11.1 Top Deck...........................................................................................................11-48 11.11.2 Waste Containers .............................................................................................11-48 Other Containers ............................................................................11-49 11.12 Cleaning Before Returning NOVEOS to Hycor .............................................................11-49 12 Troubleshooting ....................................................................................................................12-1 12.1 Avoiding Error Conditions ...........................................................................................12-1 12.2 Conditions That May Prevent a Run from Starting........................................................12-2 12.3 Warning Messages......................................................................................................12-3 12.3.1 Temperature Status Warning Conditions...........................................................12-7 12.3.2 Instrument Status Warning Conditions..............................................................12-8 12.3.3 Sample Status Warning Conditions ..................................................................12-11 12.3.4 Reagents Status Warning Conditions ...............................................................12-13 12.3.5 Rinse/Wash Status Warning Conditions...........................................................12-14 12.3.6 Waste Status Warning Conditions....................................................................12-15 12.4 Command Light Bars – Run Time Conditions ..............................................................12-17 12.4.1 Yellow Alert Run Time Conditions....................................................................12-18 12.4.2 Red Alert Run Time Conditions ........................................................................12-19 12.5 Loading Additional Items...........................................................................................12-20 12.6 Alerts........................................................................................................................12-20 12.7 Run Flags ..................................................................................................................12-22 12.8 Technical/Customer Service ......................................................................................12-25 63100 vi Rev. D

NOVEOS Operator’s Manual Glossary and Acronyms..........................................................................................................13-1 13.1 Terms .........................................................................................................................13-1 13.2 Acronyms .................................................................................................................13-10 Index .................................................................................................................................................1 Rev. D vii 63100

Contents Figures Figure 1-1. NOVEOS System.......................................................................................................................1-4 Figure 1-2. NOVEOS Allergy Assay Overview .............................................................................................1-5 Figure 1-3. NOVEOS Top Deck Showing Rotors and Other Components ..................................................1-7 Figure 1-4. Arms Locations.........................................................................................................................1-9 Figure 1-5. Barcode Reader Locations .....................................................................................................1-10 Figure 1-6. Power Switch Locations .........................................................................................................1-11 Figure 3-1. User Interface Components.....................................................................................................3-1 Figure 3-2. System Status Indicators..........................................................................................................3-2 Figure 3-3. Utility Function Icons ...............................................................................................................3-3 Figure 3-4. Screen/function Selection Buttons..........................................................................................3-4 Figure 3-5. Typical Action Button...............................................................................................................3-5 Figure 4-1. Setup Icon ................................................................................................................................4-1 Figure 4-2. System Setup Screen ...............................................................................................................4-2 Figure 4-3. Operators Screen .....................................................................................................................4-6 Figure 4-4. Report Setup Screen ..............................................................................................................4-11 Figure 4-5. Database Screen ....................................................................................................................4-12 Figure 4-6. LIS Screen...............................................................................................................................4-13 Figure 4-7. About Screen .........................................................................................................................4-18 Figure 5-1. Component Locations on Top Deck.........................................................................................5-4 Figure 5-2. Removing the Sample Rotor Cover..........................................................................................5-5 Figure 5-3. Loading the Sample Rotor .......................................................................................................5-6 Figure 5-4. Removing the Sample Rotor ....................................................................................................5-7 Figure 5-5. Diluent A Container in the Sample Rotor ................................................................................5-8 Figure 5-6. Replace Reaction Cuvettes Screen ..........................................................................................5-9 Figure 5-7. Removing the Reaction Rotor Cover .....................................................................................5-10 Figure 5-8. Reaction Rotor Latch Position for Removal...........................................................................5-10 Figure 5-9. Cuvette Arcs Location on Reaction Rotor..............................................................................5-11 Figure 5-10. Reaction Rotor Inner Cover Replaced with Latches in Locked Position ..............................5-11 Figure 5-11. Reagent Rotor......................................................................................................................5-13 Figure 5-12. Reagent Wedge....................................................................................................................5-13 Figure 5-13. Reagent Rotor Cover............................................................................................................5-14 Figure 5-14. Removing a Reagent Wedge................................................................................................5-15 Figure 5-15. Fluo Beads Tubes Holder and Lid.........................................................................................5-16 Figure 5-16. Loading the Substrate Mix Container ..................................................................................5-17 Figure 5-17. Wash Buffer Concentrate Pack............................................................................................5-18 Figure 5-18. DI Water and Wash Buffer Containers ................................................................................5-19 Figure 5-19. Cuvette Wash Pack ..............................................................................................................5-21 Figure 5-20. Cuvette Wash Container......................................................................................................5-21 Figure 5-21. Waste Containers Disconnect Label ....................................................................................5-22 Figure 5-22. Waste Container Location ...................................................................................................5-23 Figure 5-23. Waste Containers Disconnection.........................................................................................5-24 Figure 5-24. Using the Waste Containers Adapters.................................................................................5-25 Figure 5-25. Login Screen.........................................................................................................................5-26 Figure 5-26. Play (Start Run) Button ........................................................................................................5-28 Figure 5-27. Home Screen Showing Run Progress – Preparing System...................................................5-28 Figure 5-28. Home Screen Showing Run Progress – Programming Reagents and Tests .........................5-29 Figure 5-29. Home Screen Showing Run Progress – Programming Samples...........................................5-30 63100 viii Rev. D

NOVEOS Operator’s Manual Figure 5-30. Home Screen Showing Run Complete .................................................................................5-30 Figure 5-31. Status Light Bar ....................................................................................................................5-31 Figure 6-1. Sample Rotor Screen................................................................................................................6-1 Figure 6-2. Sample Rotor Screen with Data...............................................................................................6-2 Figure 6-3. Sample Rotor Data Erase Warning ..........................................................................................6-4 Figure 6-4. Liquid Data for Sample Tray Position #....................................................................................6-5 Figure 6-5. Liquid Type – Sample Screen ...................................................................................................6-6 Figure 6-6. Liquid Type – Sample Screen ...................................................................................................6-7 Figure 6-8. Test Selection Screen...............................................................................................................6-8 Figure 6-9. Assign Selected Tests to Samples ..........................................................................................6-10 Figure 6-9. Sample Rotor Screen Missing Control Information ...............................................................6-12 Figure 6-10. Press the Scan 2D Barcode Button ......................................................................................6-13 Figure 6-11. Scan Bar Code Progress .......................................................................................................6-13 Figure 6-13. Scan 2D Barcode ..................................................................................................................6-13 Figure 6-12. Select Tests for a Control Tube............................................................................................6-14 Figure 6-14. Successful Control Setup on Sample Rotor..........................................................................6-15 Figure 6-13. JobList Screen ......................................................................................................................6-16 Figure 6-14. Panels Screen.......................................................................................................................6-17 Figure 6-15. Panel Name Screen..............................................................................................................6-18 Figure 7-1. Reagents Screen.......................................................................................................................7-1 Figure 7-2. Reagent Rotor Screen with Data .............................................................................................7-2 Figure 7-4. Erase Rotor Positions Warning ................................................................................................7-3 Figure 7-5. Reagent Info Screen.................................................................................................................7-4 Figure 7-6. Beads Screen............................................................................................................................7-5 Figure 7-7. Beads Barcode Scan Alert ........................................................................................................7-6 Figure 7-8. Beads Screen with Data ...........................................................................................................7-6 Figure 7-9. Beads Info for Position Screen.................................................................................................7-9 Figure 8-1. Home Screen............................................................................................................................8-1 Figure 8-2. Rotor Position Status Colors ....................................................................................................8-2 Figure 8-3. Home Screen Showing Position Status ....................................................................................8-3 Figure 8-4. Selected Position Panel............................................................................................................8-4 Figure 8-6. Warnings Bar............................................................................................................................8-6 Figure 8-7. Play (Start Run) Button ............................................................................................................8-7 Figure 8-8. Run Complete ..........................................................................................................................8-8 Figure 8-9. Alerts and Errors Bar..............................................................................................................8-13 Figure 8-10. Run Alerts and Errors Window ............................................................................................8-13 Figure 8-11. Run Complete and Reset Status Button ..............................................................................8-14 Figure 8-12. Schedule Screen...................................................................................................................8-15 Figure 8-13. Alerts Screen........................................................................................................................8-17 Figure 9-1. Reports Screen.........................................................................................................................9-1 Figure 9-2. Report Setup Screen ................................................................................................................9-3 Figure 9-3. Sample Patient Report.............................................................................................................9-6 Figure 9-4. Patient Reports Screen ............................................................................................................9-7 Figure 9-5. LIS Results Screen ....................................................................................................................9-8 Figure 10-1. Quality Control Button.........................................................................................................10-1 Figure 10-2. Calibration Data Screen Showing Curve Selections and Selected Curve.............................10-2 Figure 10-3. Quality Control Screen Showing Selected Data...................................................................10-3 Figure 10-4. Sample QC Report................................................................................................................10-6 Figure 11-1. Maint Button........................................................................................................................11-1 Rev. D ix 63100

Contents Figure 11-2. Daily Maintenance Tasks Screen .........................................................................................11-5 Figure 11-3. Probe Locations ...................................................................................................................11-6 Figure 11-4. Daily Maintenance – Inspect Probes ...................................................................................11-7 Figure 11-5. Wipe Down Probes Screen ..................................................................................................11-8 Figure 11-6. Wipe Down Top Deck Screen...............................................................................................11-9 Figure 11-7. Rinse All Probes Screen......................................................................................................11-10 Figure 11-8. Fluidics Tests Screen ..........................................................................................................11-11 Figure 11-9. Weekly Maintenance Tasks Screen ...................................................................................11-12 Figure 11-10. Weekly Probe Wash Screen.............................................................................................11-14 Figure 11-11. Replace Optics Tip Screen................................................................................................11-15 Figure 11-12. Removing the Optics Tip..................................................................................................11-16 Figure 11-13. Optics Fluidics Test ..........................................................................................................11-17 Figure 11-14. Weekly Maintenance: Wipe Reagent Rotor ....................................................................11-18 Figure 11-15. Weekly Maintenance: Wipe Sample Rotor......................................................................11-18 Figure 11-16. Multi-Rise Soak Screen ....................................................................................................11-19 Figure 11-17. Home from Tub Screen....................................................................................................11-20 Figure 11-18. Soak in Cuvettes Screen...................................................................................................11-21 Figure 11-19. Home from Cuvettes Screen............................................................................................11-22 Figure 11-20. Removing the Sample Rotor Cover..................................................................................11-23 Figure 11-21. Removing the Sample Rotor ............................................................................................11-24 Figure 11-22. Reagent Rotor Cover........................................................................................................11-25 Figure 11-23. Removing a Reagent Rotor Wedge..................................................................................11-26 Figure 11-24. Pour Bleach Solution into Reagent Tub and Drain ..........................................................11-27 Figure 11-25. Database Cleanup ............................................................................................................11-29 Figure 11-26. Check for Errors ...............................................................................................................11-30 Figure 11-27. Wash Station Locations ...................................................................................................11-31 Figure 11-28. Reset Instrument Screen .................................................................................................11-35 Figure 11-29. Cuvettes Screen ...............................................................................................................11-36 Figure 11-30. Maintenance – Backup/Restore/Purge Database ...........................................................11-37 Figure 11-31. Maintenance – Updates Screen.......................................................................................11-40 Figure 11-32. Maintenance – Remote Assistance .................................................................................11-41 Figure 11-33. Maintenance – TeamViewer Window .............................................................................11-42 Figure 11-34. Maintenance – Audit Log Screen.....................................................................................11-43 Figure 11-35. Maintenance Log Screen .................................................................................................11-44 Figure 11-36. Daily Logs Screen .............................................................................................................11-45 Figure 12-1. Run Status Icons with and without Warnings......................................................................12-4 Figure 12-2. Warning Message Screens...................................................................................................12-6 Figure 12-3. Alerts Screen......................................................................................................................12-20 Figure 12-4. Alerts Screen Showing Errors and Messages.....................................................................12-21 63100 x Rev. D

NOVEOS Operator’s Manual Tables Table 1-1. Rotating Arms and Their Function ............................................................................................1-8 Table 1-1. Capture Reagents and Reagent Kits........................................................................................1-16 Table 1-2. Consumables...........................................................................................................................1-19 Table 1-3. Supplies ...................................................................................................................................1-20 Table 2-1. Warning, Caution, and Note Definitions...................................................................................2-1 Table 2-2. Caution and Warning Symbol Definitions.................................................................................2-3 Table 2-3. Symbol Definitions ....................................................................................................................2-4 Table 3-1. Function Selection Buttons .......................................................................................................3-5 Table 3-2. Screen Selection Tabs ...............................................................................................................3-6 Table 4-1. System Setup - User Setup Values and Functions.....................................................................4-3 Table 4-2. System Setup - Run Setup Values and Functions......................................................................4-4 Table 4-3. System Setup - Results Setup Values and Functions ................................................................4-5 Table 4-4. System Setup - Network Settings..............................................................................................4-5 Table 4-5. System Setup - Operating Conditions .......................................................................................4-5 Table 4-6. Database Settings....................................................................................................................4-12 Table 4-7. LIS Protocol and Connection Settings .....................................................................................4-14 Table 4-8. LIS Results Transmit Options...................................................................................................4-15 Table 4-9. LIS Joblist and Communication Options..................................................................................4-17 Table 4-10. LIS Screen Buttons.................................................................................................................4-17 Table 5-1. Quickstart Workflow .................................................................................................................5-2 Table 8-1. Rotor Position Color Legend .....................................................................................................8-3 Table 11-1. General Maintenance Activities............................................................................................11-2 Table 11-2. Periodic Maintenance Tasks .................................................................................................11-3 Table 11-3. Additional Tasks (Before Run)...............................................................................................11-4 Table 11-4. All Tasks...............................................................................................................................11-34 Table 12-1. Conditions That May Prevent a Run from Starting ...............................................................12-2 Table 12-3. Instrument Status Warnings .................................................................................................12-8 Table 12-4. Instrument Status Warnings during Run.............................................................................12-10 Table 12-5. Sample Status Warnings .....................................................................................................12-11 Table 12-6. Reagents Status Warnings ..................................................................................................12-13 Table 12-7. Rinse/Wash Status Warnings..............................................................................................12-14 Table 12-8. Waste Status Warnings.......................................................................................................12-15 Table 12-9. Command Light Bars ...........................................................................................................12-17 Table 12-10. Yellow Alert on Command Light Bar .................................................................................12-18 Table 12-11. Red Alert on Command Light Bar......................................................................................12-19 Table 12-12. Run Flags ...........................................................................................................................12-22 Rev. D xi 63100

NOVEOS Operator’s Manual 1 Introduction The NOVEOS™ system is an automated chemiluminescent and fluorescent immunoanalyzer. When used with the appropriate NOVEOS reagents, it is intended for in-vitro diagnostic testing for allergy in the clinical laboratory environment. In the United States it is intended for use with FDA approved, cleared or exempt assays only. NOVEOS performs tests in a patient oriented, random access mode. For one run, it can be loaded with a combination of up to 60 samples/controls/calibrators and up to 150 liquid reagents. Assays are processed in a Reaction Rotor with 20 cuvette arcs. Each cuvette arc has 10 individual cuvettes. The cuvette arcs are washed automatically after the assay is completed. Test requests are made on the NOVEOS software which runs on an external PC, connected to the system through a USB port. Reagents and samples are automatically pipetted, and results are measured in the optical reader. This manual provides an overview for setup and instrument preparation for typical daily usage and serves as a supplement to customer service training sessions. Please read this manual carefully to become familiar with the safe and effective usage procedures. This manual contains important informationonthefunctions, operation and maintenance of the NOVEOS system. It is designed for use with the software base version starting with the designation 1.0 and is intended for anyone who will operate the system and must have a thorough knowledge of it. Read this manual carefully before operating NOVEOS. NOTE: If this equipment is used in any manner not specified by HYCOR, the warranty may be voided. Read all product manuals and consult with HYCOR trained personnel before operating the system for the first time. Always follow the product labels and the manufacturer’s recommendations. For more information, contact HYCOR customer service. This section includes an overview of NOVEOS. The information is for both operators and service personnel. This section includes: • Cyber Security Guidelines • List of related documents • System overview • NOVEOS components • NOVEOS supplies and consumables • Technical specifications • Reagents, consumables, and supplies. Rev. D 1-1 63100

1. Introduction 1.1 Cyber Security Guidelines HYCOR has implemented many features to protect the NOVEOS system from malicious cyber threats. No system is completely safe from dedicated attacks, so HYCOR recommends that you follow these guidelines to keep the NOEVEOS system as safe as possible. • Promptly apply all updates provided by HYCOR for your NOVEOS system. • Do not try to “hack” system passwords. HYCOR technical service or your local distributor can help with any system configuration needed to operate NOVEOS on a lab network. • Do not use a NOVEOS computer to charge devices using a USB cable. • Do not attempt to start (boot) the NOVEOS computer from a USD connected drive. • The NOVEOS computer has an administrative Windows account that is required to make some changes to the computer, like installing printer drivers. For assistance in connecting the NOVEOS system to a printer or to your laboratory network, please contact HYCOR Customer Support. Before attempting to make a change to the NOVOES system, confirm that the request to do so was initiated by HYCOR. • Call HYCOR or your distributor to confirm the change is prescribed by HYCOR (best). • Send an email to HYCOR or your distributor, do not reply to or follow a link from a suspect email. 1.2 Documentation and Intended Audience Operator’s Manual Intended for all levels of users. This manual provides information (This manual) on how to use the system software, including administrator, operator, and other levels of operation. It also contains details on Doc. # 63100 how to run tests and perform scheduled and periodic maintenance. Installation and Service Manual Intended for trained installation and service personnel and includes Doc. # 63115 details on how to install the system, perform preventive maintenance, and service the system. 1.3 What’s in This Manual This manual is intended for all users. It describes all the screens in the software and how to run tests on the NOVEOS unit. Section 1 – Introduction, Overview, NOVEOS Components and Specifications Section 2 – Warnings and Cautions Section 3 – User Interface Section 4 – Preparing NOVEOS Software for Use Section 5 – Running Tests Section 6 – Samples Section 7 – Reagents Section 8 – Run/Schedule/Alerts Section 9 – Reports 63100 1-2 Rev. D

NOVEOS Operator’s Manual Section 10 – Quality Control Section 11 – Maintenance Section 12 – Warnings, Alerts, Flags and Troubleshooting Section 13 – Glossary and Acronyms Index. Rev. D 1-3 63100

1. Introduction 1.4 NOVEOS System Overview The NOVEOS system includes the instrument, a computer that runs the system software, touch screen monitor, handheld barcode scanner, keyboard, mouse and the HYCOR-supplied items needed to run tests. Figure 1-1. NOVEOS System 63100 1-4 Rev. D

NOVEOS Operator’s Manual In the NOVEOS specific IgE procedure, fluorescently-labeled and streptavidin-coated beads are incubated with a biotinylated allergen that binds to the streptavidin molecule on the surface of the beads. The allergen-coated beads are then washed and incubated with allergen-specific IgE from the patient’s serum. After the incubation period, the solid phase is washed and IgE from the sample remains bound to the beads. The beads are subsequently incubated with enzyme-antibody Conjugate and then washed. The beads bind the enzyme in proportion to the amount of analyte (human IgE) in the sample. Substrate solution is added and incubated, resulting in the development of a chemiluminescent signal which is measured. The concentration of allergen-specific IgE is directly proportional to the light intensity and is compared to an IgE reference curve traceable to World Health Organization (WHO) reference preparations. Figure 1-2. NOVEOS Allergy Assay Overview Rev. D 1-5 63100

1. Introduction 1.4.1 Instrument Layout The instrument interior has the following major components: rotors, arms, and barcode readers. Details are in the sections that follow. Rotors hold samples and liquids. See Section 1.3.1.1. Arms transfer liquids to and from various locations. See Section 1.3.1.2. Barcode readers read barcodes on the tubes and containers installed on the rotors. See Section 1.3.1.3. 63100 1-6 Rev. D

NOVEOS Operator’s Manual 1.4.1.1 Rotors and Other Components NOVEOS has three rotors and other notable components as described below. The Sample Rotor has 60 positions to hold sample tubes and barcoded reagent tubes supplied by HYCOR. These tubes contain Positive and Negative Controls, Calibrators, and Diluent A. The Reaction Rotor holds up to 20 cuvette arcs (each arc has 10 cuvettes) for a total of 200 cuvettes. The Reagent Rotor has 150 positions and holds Capture Reagents, Probe Wash, Conjugate, and Substrates A and B. The Optics Box is where the chemiluminescence and fluorescence of reaction samples are read. The Fluo Beads tube holder holds up to two Fluo Beads tubes. Sample Rotor Reaction Rotor Reagent Rotor Optics Box Fluo Beads Tube Holder Figure 1-3. NOVEOS Top Deck Showing Rotors and Other Components Rev. D 1-7 63100

1. Introduction 1.4.1.2 Arms Rotating arms perform a variety of functions as described in the table below. Table 1-1. Rotating Arms and Their Function Function Arm/Probe Transfers From To Dispensing R1 First 100 tests: Reagent Rotor Reaction Cuvettes Sample Capture Reagent in the Reaction Probes are Fluo Beads Tube Rotor washed with DI Then: Conjugate Sample Rotor water after each aspiration and Fluo Beads 10X at the end of a run. Patient Samples, Calibrators, Controls, Diluent A Start of run: Reagent Rotor Substrate Mixing Chamber Substrate A and B Substrate Substrate Mixing Reaction Cuvette R2 Chamber Arcs in the Reaction Rotor Then takes over Reagent Rotor Reaction Cuvette for R1 dispensing Arcs in the Capture Reagent Reaction Rotor Optics Reaction Mixture Reaction Cuvette Optics box Arcs The Sample Arm transfers samples from tubes in the Sample Rotor to cuvette arcs on the Reaction Rotor. The Multi-rinse Arm washes multiple cuvettes at the same time in the Reaction Rotor. Two probes dispense and one rinses in a one-step action. The Mono-rinse Arm dispenses Wash Buffer to cuvettes in the Reaction Rotor. The R2 Arm (Reagent Arm 2) transfers reagents from the Reagent Rotor into cuvette arcs in the Reaction Rotor. The R1 Arm (Reagent Arm 1) transfers reagents from the Reagent Rotor and beads from the Fluo Beads tubes into the cuvette arcs on the Reaction Rotor. The Optics Arm moves reaction samples from the Reaction Rotor to the optics box where their chemiluminescence and fluorescence are read. 63100 1-8 Rev. D

NOVEOS Operator’s Manual Mono-rinse Arm Sample Arm Multi--rinse Arm R2 Arm Optics Arm R1 Arm Figure 1-4. Arms Locations Rev. D 1-9 63100

1. Introduction 1.4.1.3 Barcode Readers Five barcode readers on the system (see illustration below) read the barcodes on tubes and containers installed in the rotors and are essential elements of the instrument’s automation. Sample Rotor Barcode Reader Fluo Beads Barcode Reagent Rotor Readers (2) Barcode Readers (2) Figure 1-5. Barcode Reader Locations 63100 1-10 Rev. D

NOVEOS Operator’s Manual 1.4.1.4 Power and USB Connections NOVEOS has two power switches: one on the back of the unit on the left and one on the left side panel as indicated in Figure 1-7 below. Both switches can be used to power the instrument on and off. Both switches need to be in the ON position to turn the instrument on. However, only one needs to be in the OFF position to turn it off. The power cord attaches at the back of the instrument near the back power switch. There are two USB ports on the back of the instrument; the NOVEOS PC must be connected to the top USB port. Back Panel View Power Switch USB-NOVEOS PC Power Switch USB-Service Only Power Cable Power Switch USB Connections Power Connection Figure 1-6. Power Switch Locations Rev. D 1-11 63100

1. Introduction 1.4.2 Technical Specifications This section summarizes NOVEOS specifications including size, clearances, power, and temperature requirements. 1.4.3 NOVEOS Dimensions NOVEOS Length Height Depth Doors Open 61.5 in. (1562 mm) 51 in. (1295 mm) 32.5 in. (826 mm) 80 in. (2032 mm) 51 in. (1295 mm) 57.5 in. (1461 mm) Canopy Open 73.5 in. (1867 mm) Status Pole 64 in. (1625 mm) Weight: 881 lbs. (400 Kg), with empty waste, wash and DI water containers. 1.4.4 Floor Space Recommendation NOVEOS basic Length Depth floor space 98 in. (2489 mm) 65 in. (1651 mm) requirement 63100 1-12 Rev. D

NOVEOS Operator’s Manual 1.4.5 Desk/Bench Space Requirement Computer and Length Depth Height Monitor Overall 36 in. (914 mm) 30 in. (762 mm) 16.1 in. (409 mm) 7.3 in. (185 mm) 7.3 in. (185 mm) 1.6 in. (40 mm) Computer 20.5 in. (521 mm) 4 in. (102 mm) 16.1 in. (409 mm) 18 in. (457 mm) 6 in. (152 mm) Touchscreen 2.6 in. (66 mm) 4.2 in (107 mm) 1 in. (25 mm) Monitor LCD 6.6 in (168 mm) Keyboard Handheld Barcode Reader 1.4.6 Shipping and Storage Requirements without Fluids Ambient Temperature -20°C to 50°C (-4°F to 122°F) Humidity 20 to 95% (non-condensing) relative humidity at 24°C (75°F) 1.4.7 Environmental Requirements Ambient Temperature 18°C to 30°C (64.5°F to 86°F) Humidity 20 to 80% (non-condensing) relative humidity at 24°C (75°F) Altitude Up to 6561 ft. (2000 m) 20 dB Noise Output 4,265 BTU/hr. Heat Output Rev. D 1-13 63100

1. Introduction Requirements 100-240 VAC 50/60 Hz 1250W 1.4.8 Power Requirements North America Item Input: 120VAC 60 Hz NOVEOS Output: 120 VAC 60 Hz Power Conditioner Input Plug: 5-15P Ametek Powervar Standard Conditioner Output Receptacles: (6) 5-15R ABC1200-11 Attention: RoHS Compliant Only NOVEOS System, PC and Touchscreen Weight: 43 lbs. (20 Kg) Monitor may be connected to the Power 11.15 in. (283 mm) H x 5.6 in. (142 mm) W Conditioner x 16.1 in. (409 mm) D International Input: 230VAC 50/60 Hz Ametek Powervar Standard Conditioner ABC1500-22INT Output: 230VAC 50/60 Hz Input Plug: IEC 320 RoHS Compliant Output Receptacles: Weight: 43 lbs. (20 Kg) 11.15 in. (283 mm) H x 5.6 in. (142 mm) W (9) IEC 320 C13 x 16.1 in. (409 mm) D Attention: Only NOVEOS System, PC and Touchscreen Monitor may be connected to the Power Conditioner. 63100 1-14 Rev. D

NOVEOS Operator’s Manual 1.4.9 Sample Tubes NOVEOS ships with 60 tube adapters to support standard 5 ml sample tubes (0.472 x 2.95 in.; 12 x 75 mm). Optional adapters are available to order. Sample Tube Size Volume Dimensions (diameter x length) 1.5 ml 0.425 in. x 1.53 in. (10.8mm x 39mm) 2 ml 0.425 in. x 1.73 in. (10.8mm x 44mm) 5 ml 0.472 in. x 2.95 in. (12mm x 75mm) 0.618 in. x 2.95 in. (15.7mm x 75mm) 7 ml 0.618 in. x 3.94 in. (15.7mm x 100mm) 11 ml 1.5 Reagents Reagents used with NOVEOS include Capture Reagents, Cuvette Wash, Probe Wash, Fluo Beads tubes, Allergy Common Kit-IgE, Calibrator Allergy Sets, Positive Controls, Negative Controls, and `Wash Concentrate. 1.5.1 Capture Reagents The following types of Capture Reagents are available. • Epidermal and Animal Proteins • Food • Grass/Weeds • Mites, Insects & Parasites • Occupational • Trees • Calibrator Antibody for IgE (CAE) Rev. D 1-15 63100

1. Introduction 1.5.2 Reagent Kits Reagent kits include the Allergy Common Kit-IgE and the Calibrator Allergy Set and others as described in the following table. Table 1-2. Capture Reagents and Reagent Kits Item Contents Installed On Capture Reagents Capture Reagents packaging is color-coded for the type of reagent. Reagent Rotor 4 x 75 tests Reagent Kits 2 x 600 tests Fluo Beads tubes Fluo Beads tubes Allergy Common Kit 2 x 600 tests Diluent A holder 2 x 600 tests Conjugate – IgE Sample Rotor 1 x 1200 tests Substrate A 1 x 1200 tests Substrate B Reagent Rotor Reagent Rotor Reagent Rotor 63100 1-16 Rev. D

NOVEOS Operator’s Manual Table 1-1. Capture Reagents and Reagent Kits (continued) Item Contents Installed On Reagent Kits Calibrator Allergy Set 1 of each IgE Calibrator level Sample Rotor Calibrator Antibody – IgE 4x Calibrator Antibody – IgE (CAE) Reagent Rotor Positive Control Pack – IgE Sample Rotor 4 x 150 tests Sample Rotor Negative Control Pack – IgE 4 x 150 tests Rev. D 1-17 63100

1. Introduction Table 1-1. Capture Reagents and Reagent Kits (continued) Item Contents Installed On Wash Packs Wash Buffer Concentrate Pack 6 x 1000 ml Wash Buffer Lower deck Concentrate Probe Wash Pack 4 x containers of Reagent Rotor Cuvette Wash Pack Probe Wash Lower deck 6 x 1000 ml Cuvette Wash 63100 1-18 Rev. D

NOVEOS Operator’s Manual 1.5.3 Consumables Consumables include optics tips, substrate mix containers, and Cuvette Arcs and are shown in the following table. Table 1-3. Consumables Item Optics Tips Substrate Mix Containers Cuvette Arcs Rev. D 1-19 63100

1. Introduction 1.5.4 Supplies Supplies that can be ordered separately are listed in the table below. Table 1-4. Supplies Item Item Wash Buffer Container De-ionized Water Container Waste Container Empty Waste Container Devices Soaking Bath For Multi-Rinse Funnel 63100 1-20 Rev. D

NOVEOS Operator’s Manual Item Table 1-3. Supplies Item 5 ml Tube Adapter 13 mm Caps 11 ml Tube Adapter HitachiTM Tube Adapter EppendorfTM Tube Adapter Cuvette Wash Container Reagent Wedge Sample Carousel Rev. D 1-21 63100

NOVEOS Operator’s Manual 2 Notices, Warnings, and Cautions This section includes safety notices that must be considered when operating the NOVEOS. It also includes a summary of warning and cautions, as well as definitions of the symbols used. 2.1 Notices • NOVEOS is designed for use in laboratories only. Always follow the general safety regulations for laboratories while working with it. Personal Protective Equipment (PPE) should be worn and Good Laboratory Practices (GLP) should be followed. • The operation of NOVEOS is only guaranteed in the configuration as delivered. Do not install other software on the PC. Do not change the hardware of the PC and do not add other hardware. • Do not remove any service panels. There are no user-serviceable parts below the top deck. 2.2 Warning, Caution and Note Definitions Table 2-1. Warning, Caution, and Note Definitions Term Definition WARNING Indicates a potentially hazardous situation which, if not avoided, could cause death CAUTION or serious injury. Warning can also indicate the possibility of erroneous data that could cause an incorrect diagnosis. NOTE Indicates a potentially hazardous situation which, if not avoided, can cause minor or moderate injury. Caution can also alert against unsafe practices, or indicate the possibility of erroneous data that could cause an incorrect diagnosis. Indicates notable information to follow. Highlights important facts, gives helpful information, and clarifies procedures. Rev. D 2-1 63100

2. Notices, Warnings, and Cautions 2.3 Summary of Warnings and Cautions 2.3.1 Warnings • Use the equipment only as specified by HYCOR. • The software will warn if expired Reagents are on the system and will not run tests with expired Reagents. • HYCOR provides labelled waste containers. Ensure waste is disposed of in accordance with the appropriate local, state, and federal regulations. • NOVEOS is plugged directly into a UPS unit provided by HYCOR. The receptacle is three-prong. • Failure to recognize and follow electrical safety guidelines can be dangerous. The system contains many electrical / electronic components, meaning servicing personnel can be exposed to potential shock hazards. • Wear proper personal protective equipment and follow all laboratory procedures when operating or servicing NOVEOS. 2.3.2 Cautions • To reduce the risk of electric shock:  keep fluids away from the accessories (computer, monitor and printer)  do not use an extension cord  do not remove any panels unless under the direction of qualified personnel. • Do not block any ventilation openings. • Before opening the waste drawer, disconnect all waste containers by pressing the quick connector release and disconnecting the quick connector on all waste containers. 63100 2-2 Rev. D

NOVEOS Operator’s Manual 2.4 Caution and Warning Symbol Definitions The following are cautions and warnings to observe to ensure safe system operation. Table 2-2. Caution and Warning Symbol Definitions Symbol Meaning WARNING: Potentially hazardous situations that could result in serious injury to laboratory personnel. WARNING: Potential biological hazards in the area. Wear personal protective equipment (PPE) such as gloves, eye shields, and lab coats. Handle and dispose of biohazardous materials according to your laboratory procedures. CAUTION: Hazardous voltage or risk of electric shock. Unplug before handling. CAUTION: Indicates that operators must read the NOVEOS operator’s manual for an explanation of the caution, warning, or danger. Indicates a potentially hazardous situation which could cause injury or physical damage. CAUTION: Class 2 Laser Radiation. WHEN OPEN do not stare into beam. The Class 2 laser complies with US Requirements (21 CFR 1040.10 and 1040.11). CAUTION: Pinch Point. Indicates moving parts that can pinch or crush. Only operate NOVEOS when all covers are in position and the canopy is closed. Use caution to reduce the risk of personal injury. Do not insert fingers or hands into any system opening. CAUTION: Risk of burning by touching the surface directly. CAUTION: Corrosive Material Rev. D 2-3 63100

2. Notices, Warnings, and Cautions 2.5 Symbols The following is a list of symbols used on the product labeling and their meaning. Table 2-3. Symbol Definitions Symbol Meaning Indicates that a product has been assessed before being placed on the market, and has been found to meet European Union safety, health, and environmental protection requirements In-Vitro diagnostic medical device Waste of electrical and electronic equipment compliant. WEEE Manufacturer identification Authorized representative in the European Union Date of manufacture Consult NOVEOS operator’s manual for an explanation of the caution, warning, or danger Indicates an unlock button that unlocks a door when pressed Alternating current Protective conductor terminal Power standby Fuse Non-ionizing electromagnetic radiation 63100 2-4 Rev. D

Symbol NOVEOS Operator’s Manual Rx Only Table 2-3. Symbol Definitions (continued) Meaning Part number Lot number Serial number Expiration date Temperature limits Number of tests Relative humidity limits Pressure limits of operation Do not to reuse the product USB connection For use by order of a licensed healthcare practitioner 2.6 Safety Data Sheets Refer to Safety Data Sheets (SDS) for information about fluids used on NOVEOS. These available at www.NoveosDX.com. Rev. D 2-5 63100

NOVEOS Operator’s Manual 3 User Interface Users interact with the NOVEOS application through a graphical user interface (GUI) which occupies the entire screen when it is open and remains the topmost window while the application is running. It cannot be minimized or hidden. Each user is granted or denied access to certain functions of the software, but all users may assign and run tests. User privileges are covered in Section 4.3.1. The user enters sample information, configures tests to be performed on each sample, reviews and prints the results via a touch screen (with on-screen keyboard), and/or mouse or keyboard. The main components of the user interface are available on all screens. They include: • System status indicators • Utility function icons • Function selection buttons • Action buttons • Screen selection tabs • Status and warnings (see Section 12). The center part of the screen will change depending on the function and tab selected. System status indicators Tabs Utility functions Action buttons Main window Status and warnings Function selection buttons Figure 3-1. User Interface Components Rev. D 3-1 63100

3. User Interface 3.1 System Status Indicators The top part of the NOVEOS screen includes the system status indicators. USER NAME … Figure 3-2. System Status Indicators User Name: At the top center, the name of current logged in user is displayed. Touching the user name displays a dropdown list from which the user name can be changed or the current user can be logged out. When no user is logged in, the NOVEOS serial number displays. Date/Time: Current date and time are shown at the top right corner of the screen. Keyboard: Touching the keyboard icon causes a virtual keyboard to overlay the screen. Touching the X at the top right of the virtual keyboard or touching the keyboard icon removes it from the screen. LIS connection: Indicates NOVEOS connection to a LIS. Icon is green when LIS and connectivity layer are connected, yellow when LIS is not connected, red when the software LIS interface is not running. Instrument connection: A green checkmark indicates NOVEOS connection to a PC. A red X indicates not connected. Command light bars: Green: No test in progress. Green Testing is in progress and no errors or alerts are active. flashing: Yellow: Testing is in progress, and an alert has been generated that does not Red: stop tests from proceeding (for example, sample ran out, control failure). An audible alert is sounded until the message is acknowledged. Testing is in progress, and an error occurred that prevents any further testing (for example, instrument error, database error). An audible alert is sounded until the message is acknowledged. ALERTS AND ERRORS Alerts and errors bar: Added to the top of the screen along with an audible tone when an alert or error condition exists. Details on working with this bar are in Section 12. 63100 3-2 Rev. D

NOVEOS Operator’s Manual 3.2 Utility Functions Icons Utility functions include help, setup, service and shutdown. Icons for these functions are located directly under the system status indicators at the top right of every screen. They turn green when selected. Figure 3-3. Utility Function Icons Help: Not implemented. Setup: Touching this icon displays the system setup screen and its related tabs. See Section 4 for details. Service: Touching this icon displays the Service screen. This is intended for technical support users only and is covered in the Service manual. Shutdown: Touching this icon causes display of a sub-window that lets the user shutdown the NOVEOS software or cancel and return to the previous screen. Touching this icon does not turn off the instrument. NOTE: Before shutting down the software, be sure to go to the Home screen and touch the Stop Run button. When the software closes, it will shut down the computer. Shutdown can be cancelled by touching the Cancel button. Further conditions apply to this function: • If tests are running, this function is disabled. • If the canopy is opened, the user is prompted to close the canopy and abort the shutdown sequence. • At bootup, the user is notified if an improper shutdown was detected. • The shutdown operation is logged to the event log and audit trail. Rev. D 3-3 63100

3. User Interface 3.3 Function Selection Buttons Screen/function selection buttons are located on the left side of every screen and provide access to additional screens and functions when touched. When touched, the button turns green to indicate it is active and the related screen displays. Function selection buttons Figure 3-4. Screen/function Selection Buttons 63100 3-4 Rev. D

NOVEOS Operator’s Manual Table 3-1. Function Selection Buttons Button Function Button Function Touching the Samples button Touching the Reports button provides access to screens for provides access for screens for loading the Sample Rotor, patient reports and test counts assigning tests, and defining a report. Details are in Section 9. panel. Details are in Section 6. Touching the Reagents button Touching the Quality Control provides access to screens for button provides access to screens loading the Reagent Rotor and for calibration and quality control Fluo Beads tubes. Details are in data. Details are in Section 10. Section 7. Touching the Maint button Touching the Home button provides access to periodic provides access for screens for maintenance, cuvettes, database starting the run, viewing the updates, remote assistance, and schedule and progress, and logs screens. Details are in Section alerts. Details are in Section 5. 11. 3.4 Action Buttons Action buttons are found on all screens. Their labels change depending on the function. Figure 3-5. Typical Action Button Rev. D 3-5 63100

3. User Interface 3.5 Screen Selection Tabs When a function selection button or the system setup icon is touched, the main window displays tabs for each screen related to the function selected. Tabs turn green to indicate the active screen. The screens can be selected by touching the tabs. Buttons and their related tabs are listed in the table below. Some of the tabs shown below are still in development and the features are not yet available. Table 3-2. Screen Selection Tabs Button/ Tabs Icon 63100 3-6 Rev. D

NOVEOS Operator’s Manual Table 3-2. Screen Selection Tabs (continued) Rev. D 3-7 63100

NOVEOS Operator’s Manual 4 Preparing NOVEOS Software for Use This section covers preparing NOVEOS software for use via settings. Software settings include system setup, operator privilege setup, and report setup. Touching or clicking on the Setup icon on the Utility Functions bar displays the System Setup screen and provides access to three additional screens for all system setup operations. Setup icon Figure 4-1. Setup Icon 4.1 Log In To work with the software, users must log in by entering a user name and password. See Section 4.3 for instructions on setting up users and related privileges. 4.2 System Setup The System Setup screen lets users with appropriate privilege define the user setup, run setup, results, network settings, and operating conditions. Details on each setting are provided in Tables 4-1 through 4-5. System settings take effect when they are saved, except changing the language which requires a restart. Navigating away from the form before settings are saved causes display of a warning message indicating that settings have not been saved. To change system setup: 1. Touch the Setup icon on the Utility Functions bar. 2. Touch the System Setup tab. 3. Make changes on the System Setup screen as desired. 4. Touch the Save button. Rev. D 4-1 63100

4. Preparing NOVEOS Software for Use Figure 4-2. System Setup Screen 63100 4-2 Rev. D

NOVEOS Operator’s Manual Table 4-1. System Setup - User Setup Values and Functions Default value indicated in bold, italic font. The initial values will be adjusted at installation to accommodate site-specific preferences. Panel Setting/Button Label Value Options/Function User Setup Language Czech, German, English, Spanish, French, Croatian, Italian, Dutch, Polish, Portuguese, Date Format Slovak (see note). Time Format Decimal Delimiter MMDDYYYY, DDMMYYYY Printer AM/PM, 24 hour Use On Screen Keyboard (OSK) Comma (,), Period (.) checkbox When comma is selected, Excel exports are delimited with semicolon (;). When period is selected Excel exports are delimited with commas. Options depend on what is connected to the system. When checked, OSK is active. Default, not checked. The keyboard may still be displayed at will by touching the icon in the status bar. Touching the Empty Print Queue button removes reports queued for the printer. NOTE: Language can be selected for the following: user interface screens, text in prompts and messages, text in Patient, QC, Test Counting, and Inventory reports, and text in audit trails. Communication logs, error logs, and Windows internal error messages are in English only. Rev. D 4-3 63100

4. Preparing NOVEOS Software for Use Table 4-2. System Setup - Run Setup Values and Functions Panel Setting/Button Label Volume Value Options/Function Run Setup Sample Tube Size Dimensions (diameter x length) Sample Type 1.5 ml 0.425 in. x 1.53 in. (10.8mm x 39mm) Failed Control Action: (by assay type) 2 ml 0.425 in. x 1.73 in. (10.8mm x 44mm) Failed Calibrator 5 ml 0.472 in. x 2.95 in. (12mm x 75mm) Action: (by assay type) 7 ml 0.618 in. x 2.95 in. (15.7mm x 75mm) Repeat Controls Interval (Hours) 11 ml 0.618 in. x 3.94 in. (15.7mm x 100mm) Number of Replicates Serum Repeat Controls as Last • Complete All Tests Tests (checkbox) • Abort All Tests • Abort Pending, Complete Tests In-Progress • Complete All Tests • Abort All Tests • Abort Pending, Complete Tests In-Progress 0 – 12 The number of replicates for Blanks, Calibrators, and Controls. The range is as follows: • Blanks: 0-4 (4) • Calibrators: 1-4 (2) • Controls: 1-4 (1) When checked, specifies that replicates should be repeated as the last test of a run. Default checked. 63100 4-4 Rev. D

NOVEOS Operator’s Manual Table 4-3. System Setup - Results Setup Values and Functions Panel Setting/Button Label Value Options/Function Results When checked, a control is assessed by class Interpret Control ranges. Default not checked. Pass/Fail by Class: (allergy assay type only) When checked, the software will use the last (checkbox) calibration curve to generate results. Default not checked. Use Last Curve (checkbox) Table 4-4. System Setup - Network Settings Network Settings Server Allows user to enter the path for the server. User Name User name to be used to access the network. Password Password for user name used to access the network. The server, user name and password are provided by the laboratory’s IT department. Touching the Connect button connects the NOVEOS to the specified network. Table 4-5. System Setup - Operating Conditions Panel Setting/Button Label Value Options/Function Operating Conditions Minimum Free Disk Space Default is 50 GB. When the minimum free disk space condition is reached, the system will Use External Waste issue a warning. (checkbox) Check the box to indicate the system is Automatic User plumbed to laboratory waste, in which case Logout the software ignores the status of the waste (checkbox) containers. Default not checked. Check the box to automatically log user out of Automatic System the software after a specified time of Shutdown inactivity. Time period is defined in the (checkbox) Supervisor Settings. Default r 60 minutes. Check the box to automatically shut down Alerts Volume non-essential sub-systems. Time period is defined in the Supervisor Settings. Default not checked. Slider bar to increase/decrease volume of audible alerts. Touching the Save button saves all the settings made on the screen. They take effect when the software is restarted. Rev. D 4-5 63100