63100 Rev D, Noveos Operators Manual

NOVEOS Operator’s Manual 11.8.3 Daily Logs The daily logs store user and instrument events that occur during use. The items logged include communications, events, instrument, LIS, software errors, and temperature. These items can be selected from the Log Type dropdown list in the Daily Logs window. Additional controls let the user: • delete old log files • print the currently displayed log file • refresh results • save logs to a zip file • set the date range for the report • refresh status display. Figure 11-36. Daily Logs Screen Rev. D 11-45 63100

11. Maintenance Communications Log This log records the communication stream between the PC and NOVEOS. Events Log This log stores user and instrument events that occur during use. They include but are not limited to date, time, system startup and shutdown, run start and stop. Instrument Log The log stores write error messages sent by NOVEOS. LIS Log This log stores status, transactions from the host and transactions from the instrument in different logs. Software Errors Log The log shows the date and time of software errors along with their description. Temperature Log This log records (with time stamps) these temperatures reported by NOVEOS: • Reaction Rotor • Reagent Rotor • Sample Rotor • Wash heaters • DI water heaters. During a run, the temperatures are recorded at 30 second intervals. 63100 11-46 Rev. D

NOVEOS Operator’s Manual 11.9 Disposing of Fluids and Plastic Containers An important element of maintenance is the disposal of waste fluids and plastic containers. Follow your laboratory procedures for proper disposal and be sure to wear the appropriate personal protective equipment. 11.9.1 Disposing of Fluids During NOVEOS operation, waste fluids collect in the containers under the deck. The contents include wash solution, bead residue, serum, conjugate, substrate, and calibrators. There are four waste containers with quick disconnects. They should be emptied when full or when a warning message displays. Instructions for these tasks are included in Section 5. 11.9.2 Disposable Plastics All plastic components touching the NOVEOS system are considered bio-hazardous and should be disposed of in properly marked containers. 11.10 Cleaning NOVEOS should be cleaned on a daily basis. Refer to Section 11.2.1.1 for instructions for cleaning the top deck. If necessary, wipe the front and sides of the unit with a lint-free tissue moistened with an approved laboratory disinfectant. Do not use anything that may pit or damage the surfaces. When cleaning the instrument, be sure to wear appropriate personal protective equipment. Rev. D 11-47 63100

11. Maintenance 11.11 Cleaning Spills 11.11.1 Top Deck If any sample or reagent is spilled on the top deck, be sure to clean it up immediately. Wipe down spills on the top deck using a lint-free tissue moistened with 5% bleach solution or an approved laboratory disinfectant. Do not use anything that may pit or damage the canopy and/or deck. See Section 11.2.2.5 for instructions on cleaning the Sample Rotor and Section 11.2.2.6 for instructions on cleaning the Reagent Rotor. 11.11.2 Waste Containers In the case of a waste container overflow, thorough cleaning of the instrument is required. CAUTION: Waste container contents are considered biohazardous. Wear appropriate personal protective equipment. To clean inside the instrument: 1. Open the front doors. 2. Remove the waste containers (see Section 5.3.8), empty if necessary and wipe them with using a lint-free tissue moistened with a 5% bleach solution or an approved laboratory disinfectant. 3. Thoroughly dry the interior of the instrument and wipe it using a lint-free tissue moistened with a 5% bleach solution or an approved laboratory disinfectant. 4. Replace the waste containers, making sure the caps are tight and the snap locks are securely connected. 63100 11-48 Rev. D

NOVEOS Operator’s Manual Other Containers Clean spills on other containers, for example, DI Water, Wash Buffer, and Cuvette Wash as needed. To clean spills on other containers: 1. Open the front doors. 2. Remove the containers, empty if necessary and wipe them with using a lint-free tissue moistened with a 5% bleach solution or an approved laboratory disinfectant. 3. Thoroughly dry the interior of the container compartment and wipe it using a lint-free tissue moistened with a 5% bleach solution or an approved laboratory disinfectant. 4. Replace the container(s), making sure the caps are tight and connectors are securely attached. 11.12 Cleaning Before Returning NOVEOS to Hycor Before returning NOVEOS to Hycor, a number of cleaning steps must be performed before shipping the unit. To clean NOVEOS before shipping: 1. Be sure all sample tubes, containers, cuvette arcs, etc. have been removed from the instrument. 2. Visually inspect the exterior of the instrument and clean all surfaces using a lint-free tissue moistened with an approved laboratory disinfectant. Do not use anything that may pit or damage the surfaces. 3. Perform all daily and weekly maintenance tasks as listed in Sections 11.2.1 and 11.2.2. 4. Empty and clean the waste containers as described in Section 11.9.1. 5. Empty the DI water and Wash Buffer containers and replace them in the instrument. See Section 5.3.6. 6. If the instrument needs to be decontaminated, this will be done by Hycor service personnel. Rev. D 11-49 63100

NOVEOS Operator’s Manual 12 Troubleshooting This section covers alerts, warnings, and flags and how to respond to them. Warnings are typically generated when there is a problem with a sub-system that does not compromise the test results but that must be addressed by the user. These are indicated on the Home screen before a run starts. Alerts can occur during a run as a result of any detected software or system error. “Alert” indicators on the screen inform users that errors have occurred and/or messages are available. All alerts are written to the log files. There are also audible alerts and the user can configure the system volume for these. Flags are displayed on the Schedule screen and on patient reports after a run and are for information purposes only. 12.1 Avoiding Error Conditions Most error conditions can be avoided with simple attention to detail. Check to assure the following: • All liquids on the rotors are within expiration date and of sufficient volume to run the programmed tests (otherwise software will provide a warning) • The necessary liquids are installed on the Sample and Reagent Rotors • Each tube or container on the rotors has a barcode. If not, manually enter the barcode • Rotor covers are on and aligned properly • Canopy is closed before starting the run • Fluo Beads tubes are installed and cover is closed • Substrate mix container is installed, seated properly and cover is closed • NOVEOS is connected to the computer • Tests have been defined and scheduled • Waste containers are installed and have sufficient capacity to complete the run • Sufficient cuvette wash, DI water, and wash buffer loaded to complete the run • All required maintenance has been performed and passed In most cases the warning, alert, and flag messages are self-explanatory and error conditions are simple to remedy. Some conditions can be ignored by users with sufficient privileges. Ignored warnings are noted in the Audit Trail log for that run. Rev. D 12-1 63100

12. Troubleshooting 12.2 Conditions That May Prevent a Run from Starting After barcodes have been scanned, the software prevents all users (except Tech Service, in some cases) from starting a run if any of the following conditions exist. They need to be corrected before continuing. Table 12-1. Conditions That May Prevent a Run from Starting Error Message User Action See Section Fluo Beads cover is open. Close cover 5.3.4 Fluo Beads solution is missing. Insert Fluo Beads tube(s) and close cover. 5.3.4 Canopy is open. Close canopy. Chassis is flooded. Check for source of liquid. Remove waste 11.9.2 containers, dry interior with lint free cloth. Rinse Insufficient calibrator solution with cloth dipped in 5% bleach solution or an 5.3.3 to complete the run approved laboratory disinfectant. Dry. Load a new tube of calibrator solution with the same 5.3.7 Insufficient cuvette wash to lot number or load a completely new set on the 5.3.6 complete the run Sample Rotor. 5.3.6 Insufficient DI water to Fill the Cuvette Wash bottle. 5.3.8 complete the run 5 Insufficient wash buffer to Fill the DI water container(s). 1.3.1.4 complete the run 5.3.4 Insufficient waste container Fill the Wash Buffer container(s). 5.3.4 capacity for the run. No tests to schedule. Empty the waste containers. NOVEOS is disconnected from the computer. Schedule tests. Please load a set <TYPE> of Connect NOVEOS to the computer. calibrators. Please load <REAGENT> lot # Load a complete set of calibrators to create a new <NNNNNN> to use saved curve saved curve. or load a set of Allergy Load a reagent <Beads, Conjugate, Substrate A, Calibrators to create a new Substrate B, or other reagent> with the requested saved curve. lot number <NNNNNN>, where N is a variable digit. If a reagent with that lot number is not available Reagent rotor cover is not in then the operator must load a full set of calibrators place. to create a new saved curve. Sample rotor is loaded with Replace the Reagent Rotor cover. duplicate sample IDs. Remove duplicate samples. 63100 12-2 Rev. D

NOVEOS Operator’s Manual Substrate A, Substrate B, Load Conjugate, Substrates A and/or B on the 5.3.3 conjugate is missing. Reagent Rotor. 5.3.5 Diluent-A is missing. Load Diluent-A on the Sample Rotor. 5.3.8 11.9.2 Substrate mix cover is not Be sure substrate mix container is loaded and latched. securely latch the cover. Waste container is missing. Install the missing waste container. Waste is overflowed. Disconnect and remove waste containers and empty them. Dry the chassis interior and wipe with a towel soaked with a 5% bleach solution. Replace the waste containers and ensure the connections are tight. 12.3 Warning Messages When the NOVEOS detects a condition that requires a warning to the user, a red x displays on the related Run Status icon at the top of the Home screen and the background for the subsystem icon turns pink as shown below. A green check mark displays and the background is green when that subsystem status is good, i.e. no warnings are present. Rev. D 12-3 63100

12. Troubleshooting Figure 12-1. Run Status Icons with and without Warnings 63100 12-4 Rev. D

NOVEOS Operator’s Manual Warning messages are grouped into these subsystem types: • Temperature • Samples • Reagents • Rinse/Wash • Waste • Instrument A run will not start unless the overall status of all subsystems is “green”. A red x indicates an issue that must be corrected before the run can proceed. Touching anywhere on the icon bar causes the display of a Warning Message screen that summarizes all the current warnings. The Warning Message screen indicates current warning messages, lists the warning type, and includes controls for ignoring a warning, printing a list of warnings, cancelling changes, accepting changes and unlocking the canopy. Some warning messages may be ignored if the appropriate level of user chooses to ignore it by clicking the related Ignore button on the Warning Message screen. Some warning messages require special user privileges to ignore them. If the logged-in user does not have sufficient privilege to ignore any of the warnings, the software prompts for the username and password of a user who does have sufficient privilege. Once all warnings for a particular subsystem have been addressed or ignored, the subsystem will be “green”. Rev. D 12-5 63100

12. Troubleshooting 63100 Figure 12-2. Warning Message Screens Rev. D 12-6

NOVEOS Operator’s Manual 12.3.1 Temperature Status Warning Conditions The status of the temperature subsystem is shown as “red” if any of the following temperatures are out of the specified operating range: • Mono-rinse temperature • Multi-rinse temperature • Reagent Probe R1 temperature • Reagent Probe R2 temperature • Sample Probe temperature • Reaction Rotor • Reagent Rotor • Sample Rotor After turning NOVEOS on, be sure to allow 30 minutes for it to come to operating temperature. If the temperature warning condition(s) still exist, check the daily logs for reported temperature. (See Section 11.) Contact technical service if necessary. Rev. D 12-7 63100

12. Troubleshooting 12.3.2 Instrument Status Warning Conditions The instrument subsystem status is “red” if any of the warnings listed in the table below are present. Table 12-2. Instrument Status Warnings Error Message User Action See Section … A scheduled database backup Be sure the system is connected to the 4.6 failed. destination specified in the Database setup. 11 Any periodic maintenance Perform scheduled maintenance. activity is due (daily clean, weekly 5 clean, monthly clean, replace Check that Fluo Beads tubes are installed and 11.9.2 reaction cuvettes). close cover. Fluo Beads cover is not on. Close canopy. 1.3.1.4 Remove waste containers and empty them if 8.3 Canopy is open. needed. Dry the chassis interior and wipe with Chassis sensor detects moisture. a towel soaked with a 5% bleach solution. Replace the waste containers and be sure that Instrument is disconnected. the connections are tight. Reconnect the USB cable on the back of the Instrument is reporting an error. instrument. Be sure the computer is turned on. Check the error on the Alerts screen. Fix if possible. If not, contact technical service. 63100 12-8 Rev. D

NOVEOS Operator’s Manual Table 12-2. Instrument Status Warnings (continued) Error Message User Action See Section Logged in user changed while warnings Clear warnings if allowed for current were present. logged-in user, or correct warning 6, 7 conditions as needed to proceed with 5.3.5 Rotor covers not installed/open test. 6, 7 Replace the rotor cover making sure it is 11.9.2 Sample Rotor, Reagent Rotor, or Fluo properly aligned. Beads requires a barcode scan. Display the Sample or Reagent screen Substrate Mix cover positioned and touch the Scan Barcodes button. incorrectly. Ensure Substrate mix tube is inserted. Rotate the cover and ensure the tube is The sample or Reagent Rotor cover has seated down properly. been opened since the last barcode Display the Sample or Reagent screen scan of the respective rotor. and touch the Scan Barcodes button. Waste is overflowed. Remove waste containers and empty them. Dry the chassis interior and wipe with a towel soaked with a 5% bleach solution. Replace the waste containers and be sure that the connections are tight. Rev. D 12-9 63100

12. Troubleshooting While tests are running, the following conditions can cause a “red” status. Table 12-3. Instrument Status Warnings during Run Condition User Action See Section Fluo Beads vortexer failed Contact technical service. 12.7 Degasser liquid is low Contact technical service. 12.7 Degasser vacuum is low Contact technical service. 12.7 Substrate vortexer fails Contact technical service. 12.7 Leak is detected Contact technical service. 12.7 63100 12-10 Rev. D

NOVEOS Operator’s Manual 12.3.3 Sample Status Warning Conditions The samples subsystem status turns red if any conditions in the table below are present. Table 12-4. Sample Status Warnings Condition User Action See Section… Any sample has no tests assigned to it. Assign tests using the Samples 6.1.2 Screen. 5.3.1 Calibrator is expired or past its open Replace the Calibrator on the 5.3.1 stability date. Sample Rotor. 5.4 Diluent A is expired or past its open Replace Diluent A on the stability date. Sample Rotor. 5 Duplicate sample IDs on the Sample Remove one of the duplicate Rotor. samples from the Sample Rotor. Insufficient liquid (type listed) to Replace the needed item(s). complete the run. Loaded control has no tests assigned. Assign tests. May also need 5.4.1 to scan the 2D barcode for 6.1 More than one lot number loaded for that control lot number. the calibrators for an assay type. Check that Calibrators have the same lot number. Rev. D 12-11 63100

12. Troubleshooting Table 12-5. Sample Status Warnings (continued) Condition User Action See Section… More than one lot number of Diluent A Check that all Diluents have loaded. the same lot number. Replace 5.3.1 with matching lot numbers if 8.2 Negative Control is expired or past its necessary. 5.3.1 open stability date. Replace the Negative Control 5.3.3 No tests are scheduled. on the Sample Rotor. Use the Schedule tab on the 5.3.1 Positive Control is expired or past its Home screen to schedule open stability date. tests. 5.3.1 A Capture Reagent is required for a Replace the Positive Control 5.3.1 test, but there is no corresponding on the Sample Rotor. positive control (or negative) with Load Capture Reagent. assigned tests. Any patient sample is known to have Load new patient sample, insufficient volume to run all of the remove some of the assigned tests. requested tests, or continue the run. Insufficient unused Dilution Cups Install more dilution cups loaded. No patient samples are loaded. Load patient samples and/or manually enter barcodes for Use of saved curves is enabled, there is loaded samples a valid saved curve and a set of Remove all calibrators or calibrators is loaded. ignore warning and create a System runs out of (during run) new calibration curve. Tests will be dropped and run • Positive Control Solution. may be stopped. • Negative Control Solution. • Calibrator Solution. • Diluent A. • Patient sample solution 63100 12-12 Rev. D

NOVEOS Operator’s Manual 12.3.4 Reagents Status Warning Conditions The reagents subsystem status turns red if any conditions listed in the table below are present. Table 12-5. Reagents Status Warnings Condition User Action See Section Volume based on last known reagent Add another container/tube. 5.3.3 volumes is insufficient. (An unknown Never add volume to an existing volume is assumed to be sufficient, container/tube. 5.3.3 missing is always insufficient). 5 Any sample has an assigned test, but the Load the corresponding Capture corresponding Capture Reagent is not Reagent on the Reagent Rotor. 5.3.4 loaded on the system. 5.3.3 Insufficient (liquid types). Add another container/tube. 5.3.3 Never add volume to an existing 5.3.5 More than one lot number loaded for container/tube. Fluo Beads, Substrate A, Substrate B, Check that all items of the same Conjugate or the Capture Reagent type have the same lot number. needed for a Calibrator Antibody This can be read on tubes and Reagent. solo containers. Any needed Fluo Beads solution is expired or past its open stability date. Load new Fluo Beads tubes of Any needed Capture Reagent is expired the same lot number. or past its open stability date. Load fresh Capture Reagent. (Capture Reagent can have Any needed Conjugate is expired or past multiple lot numbers.) its open stability date. Load fresh Conjugate of the Any needed Substrate is expired or past same lot number. its open stability date. Load fresh Substrate of the same Use of saved curve is enabled and the lot number. loaded beads, conjugate, substrate (A or Load the correct reagent lot B), or Diluent-A lot numbers are different number or load a set of than the reagent used to create the calibrators to generate a new saved curve. saved (calibration) curve. Rev. D 12-13 63100

12. Troubleshooting 12.3.5 Rinse/Wash Status Warning Conditions The rinse/wash subsystem status is “red” if any of the conditions listed in the table below are present. Table 12-6. Rinse/Wash Status Warnings Condition User Action See Section Wash Buffer container has insufficient Fill the Wash Buffer container. 5.3.6 fluid to complete the run. A DI water container has insufficient Check the DI water container and fill 5.3.6 fluid to complete the run. as needed. All DI water containers are empty. Fill the DI water containers. 5.3.6 Wash Buffer container(s) empty. Fill the Wash Buffer container(s). 5.3.6 The Cuvette Wash container is empty. Fill the Cuvette Wash container. 5.3.7 63100 12-14 Rev. D

NOVEOS Operator’s Manual 12.3.6 Waste Status Warning Conditions The waste subsystem status is “red” if any of the conditions in the table below are present. Table 12-7. Waste Status Warnings Condition User Action See Section Waste container is missing. Replace waste container. 5.3.8 Waste container is too full for the Empty waste container. 5.3.8 run. Rev. D 12-15 63100

12. Troubleshooting The software prevents users with insufficient user privilege from starting a run if any of the following conditions exist. They must be corrected before continuing, or a user with sufficient privilege must log in. • Any loaded Calibrator has a different lot number than any other loaded Calibrator. • Any system covers are not in place. • Any temperature is out of specification. • Calibrator is expired or past its open stability date. • Capture Reagent is expired or past its open stability date. • Conjugate is expired or past its open stability date. • Diluent A is expired or past its open stability date. • Fluo Beads solution is expired or past its open stability date. • Insufficient o Capture Reagent for any of the needed controls. o Control Solution to complete the run. • Multiple lot numbers of any reagent used with a Calibrator are loaded (Diluent, Conjugate, Substrate, Fluo Beads or Capture Reagent). • Negative Control is expired or past its open stability date. • Negative Controls with at least one test are not scheduled. • Periodic maintenance activity is due (daily, weekly, monthly, Cuvette Arcs replacement). • Positive Control is expired or past its open stability date. • Positive Controls with at least one test are not scheduled. • Sample or Reagent cover has been removed since the last barcode scan. • Substrate is expired or past its open stability date. • Use of saved curves is enabled and the loaded beads, diluent, conjugate or substrate reagent lot numbers are different than that used to create the saved curve. 63100 12-16 Rev. D

NOVEOS Operator’s Manual 12.4 Command Light Bars – Run Time Conditions The command light bar is at the top right side of the Home screen. It indicates system status via red, yellow, and green lights. The same scheme is implemented on the system’s light pole. Table 12-8. Command Light Bars Green: Idle, 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 stop Red: tests from proceeding (for example, sample ran out, control failure). An audible alert is sounded once. Testing is in progress, and an error occurred that prevents any further testing (for example, instrument error). An audible alert is sounded until the message is acknowledged. Alerts are cleared when the user dismisses alerts from the Alerts screen. Rev. D 12-17 63100

12. Troubleshooting 12.4.1 Yellow Alert Run Time Conditions Yellow alert conditions mean a condition occurred that does not stop tests from proceeding. The system tries to complete the tests in progress as much as possible. The run-time conditions in the table below generate a “Yellow” alert. Table 12-9. Yellow Alert on Command Light Bar Error Message User Action See Section … Controls fail or cannot be Stop or pause the run, replace 5.3.1 processed Controls, restart the run. 4.2 Calibrators fail or cannot be Defined in system settings. 12.8 processed 12.8 Reaction Rotor goes out of Contact technical service. 12.8 temperature range 12.8 Reagent Rotor goes out of Contact technical service. 12.8 temperature range 5 Any of the three pipette water Contact technical service. temperatures go out of range 12.8 Either of the two wash buffer Contact technical service. 12.8 temperatures go out of range 5.3.7 Sample Rotor temperature goes Contact technical service. out of range The system has run out of Allow run to complete and then (specified) liquid. replace specified items and start another run. The instrument reports a Refer to specific message. May recoverable error contact technical service. The sample pipette becomes Contact technical service. clogged Fluo Beads vortexer stops Contact technical service. working Cuvette Wash becomes empty Allow run to complete and fill Cuvette Wash container for next run. 63100 12-18 Rev. D

NOVEOS Operator’s Manual 12.4.2 Red Alert Run Time Conditions Red alert conditions mean that all testing stops. No new tests can be added until the red alert condition is cleared. Testing can be resumed by touching the Start button on the Home screen. The run-time conditions in the table below generate a “Red” alert. Table 12-10. Red Alert on Command Light Bar Error Message User Action See Section The system runs out of Substrate Replace Substrates A & B. 5.3.3 solution 5.3.4 The system runs out of bead solution Replace Fluo Beads. 5.3.6 (finish tests in progress) 5.3.3 All of the DI water containers become Fill DI water containers. 11.7.1 empty 11.7.1 The Wash buffer container(s) become Fill Wash Buffer containers. 11.9.2 empty The waste containers become full Empty waste containers. 12.8 The waste containers are removed Replace waste containers. 12.8 The canopy is opened Close canopy. 1.3.1.4 Chassis sensor reports moisture Open doors, dry chassis and clean. Instrument reports unrecoverable Refer to the specific message. 12.8 error 12.8 The multi-rinse, mono-rinse, R1 or R2 Contact technical service. pipette becomes clogged Substrate vortexer stops working Contact technical service. Communication with the instrument is Check USB cables on the back of the lost system and reseat if necessary. The software reports an All completed tests are ok. Restart the unrecoverable error software. The software comes up in a pre-run state. Perform all the pre-run The degasser vacuum fails checks then restart the run. The degasser liquid level fails Contact technical service. Contact technical service. Rev. D 12-19 63100

12. Troubleshooting 12.5 Loading Additional Items For error or warning conditions for which liquids were replaced, touch the Scan Barcodes button on the related screens or manually enter barcode information for the new item. 12.6 Alerts The Alerts screen lets the user know that date and time errors have occurred or messages are available and indicates those that have not been cleared. Alerts are written to the event log. The list of alerts and messages may be printed. Errors and messages are viewed related to run numbers. Figure 12-3. Alerts Screen To view errors and messages: 1. Touch the Run button. 2. Touch the Alerts tab. 3. In the Run Number box, enter the Run number for which errors and messages should be displayed. A complete list of errors and messages for the run will be displayed along with date/time, title, description, and cleared status. 4. To view errors and messages for another run, enter another run number and touch the Refresh button. 63100 12-20 Rev. D

NOVEOS Operator’s Manual Figure 12-4. Alerts Screen Showing Errors and Messages To print errors and messages: 1. Touch the Run button. 2. Touch the Alerts tab. 3. Touch the Print button. Rev. D 12-21 63100

12. Troubleshooting 12.7 Run Flags Run flags appear on the Schedule screen once a run is complete. They also appear on the patient report and are sent to the LIS. They indicate any issues that occurred during the run. Tests that could not be run will be remember by the software and will remain assigned to the patient samples. Table 12-11. Run Flags Flag Condition User Action See Section F01 Not enough patient sample Load additional patient sample on the Sample 5.3.1 to complete the test. Rotor. Be sure the correct sample volume is set in 4 the system settings. Visually inspect sample for 12.8 bubbles. If condition persists, contact tech service. F02 Not enough Diluent A to Load additional Diluent A on the Sample Rotor. 5.3.1 complete the test. If a panel has been setup for the sample, the 5.3.3 system will try to complete other tests. F03 Not enough conjugate to complete the test. Load additional Conjugate on the Reagent Rotor and rerun incomplete tests. F04 Not enough substrate to Load additional Substrate on the Reagent Rotor 5.3.3 complete the test. and rerun incomplete tests. F05 Not enough Capture Reagent Load the correct Capture Reagent for the test 5.3.3 to complete the test. being run on the Reagent Rotor and rerun incomplete tests. F06 Not enough bead solution to Load fresh Fluo Beads tubes and rerun 5.3.4 complete the test. incomplete tests. F07 Not enough control solution Load additional Positive/Negative control 5.3.1 to complete the test. solution on the Sample Rotor. 63100 12-22 Rev. D

NOVEOS Operator’s Manual Table 12-11. Run Flags (continued) Flag Condition User Action See Section 5.3.1 F08 No results computed Use the System Setup screen to determine what 4 because there was not a the system does if calibration fails. Visually valid calibration. inspect the Calibrator to assure there are no 4.2 bubbles. Ensure no clogs on multi-rinse probes. 4.2 F09 Positive controls were not Decide whether to accept test results. 12.8 run prior to this test. F10 Negative controls were not Decide whether to accept test results. run prior to this test. F11 Positive controls run prior to Define the Failed Control action in the System this test failed. Setup screen. Decide whether to accept test results. F12 Negative controls run prior Define the Failed Control action in the System to this test failed. Setup screen. Decide whether to accept test results. F13 Positive controls run after Decide whether to accept test results. this test failed. F14 Negative controls run after Decide whether to accept test results. this test failed. F15 Reserved for future use. F16 Reserved for future use. F17 Temperature of the Reaction Allow 30 minutes for the system to come to Rotor fell out of spec while operating temperature after startup. Check this test was in progress. clearance from walls and between units. If condition persists, contact technical service. Rev. D 12-23 63100

12. Troubleshooting Table 12-11. Run Flags (continued) Flag Condition User Action See Section F18 Reserved for future use. F19 Test could not be run If there is enough information about the error, because the instrument try to fix it and re-run the test. If the error can’t reported an error. be fixed, contact technical service. F20 Test was not run because the Empty waste containers. 5.3.8 waste container is full. 5.3.6 F21 Test was not run because the Prepare Wash Buffer solution and fill the Wash Wash Buffer container is Buffer container. empty. F22 Test was not run because the Fill DI water container. 5.3.6 de-ionized water container is empty. F23 Test was not run because Check that all required liquids are loaded, then 5.4.3 operator stopped the testing. restart the test. F24 Test was not run because the Fill Cuvette Wash container. 5.3.7 Cuvette Wash container is empty. F25 Test was not run because the Check USB cables on the back of the instrument 1.3.1.4 instrument was disconnected and PC and reseat if necessary. (quit communicating). F26 Test was not run for an Clear any other errors or warnings and rerun test. 5 unknown reason. F27 Test result was higher than Decide whether to accept test results. the highest calibrator. F28 Test stopped automatically Use the System Setup screen to determine what 5.3.1 because of failed calibration. the system does if calibration fails. Visually 4 inspect the Calibrator to assure there are no bubbles. Ensure multi-rinse probes are not clogged. F29 Test stopped automatically Use the System Setup screen to determine what 5.3.1 because of failed controls. the system does if control fails. Visually inspect 4 the control to assure there are no bubbles. F30 Positive controls not run Decide whether to accept test results. after test. F31 Negative controls not run Decide whether to accept test results. after test. 63100 12-24 Rev. D

NOVEOS Operator’s Manual 12.8 Technical/Customer Service HYCOR is dedicated to helping healthcare professionals find the answers they need to make informed decisions. Our experienced and knowledgeable customer service and support specialists are available to help you select the optimal combination of products for your laboratory, answer your questions, and provide training and technical assistance as required - at your site, over the phone, or over the internet. Please check www.NoveosDX.com for reagent package inserts and other important reference materials. Please contact the service team in the event of a malfunction. In USA: 1-800-382-2527 1-714-901-1264 Option 1 for Technical Service Option 2 for Customer Service In Europe: Hycor Europe B.V. Branch Office Germany Waldauer Weg 84 34253 Lohfelden Germany Telephone – +49 (0)561 8167000-0 Fax: +49 (0)561 8167000-99 E-Mail: [email protected] Rev. D 12-25 63100

NOVEOS Operator’s Manual Glossary and Acronyms The following are terms and acronyms used in this manual. 13.1 Terms Any detected software or system error can produce an alert. “Alert” indicators on the screen inform users that errors have occurred and/or Alert messages are available. All alerts are written to the log files. There are also Assay Type audible alerts and the user can configure the system volume for these. Audit Trail Allergy Available Tests • User Log On, including User ID. • Run started including number of samples to run and number of tests to run • Definition or modification of a patient • Definition or modification of a test • Changes to dilution, correlation between other reagents, name and class type • Definition or modification of a report template • Software updates • Definition or modification of a calibration curve • Any ignored run-status warnings, including user(s) who authorized the ignored warning(s) or event(s) and their justification. The calculated number of tests that can be done with the remaining fluid in the tube. Backup All information required to restore a new install of the software to its current state. Rev. D 13-1 63100

13. Glossary and Acronyms Barcode Label A barcode label is a series of parallel black bars and white spaces - both of varying widths. Bars and spaces together are called elements. Different Blanks combinations of the bars and spaces represent different characters, such as Calibration Curve numbers or letters. Each combination or sequence of bars and spaces is a code that can be translated into information. NOVEOS supports Code 128, Calibrator Code 39, and Interleaved 2 of 5 formats. Cancel Canopy Interlock A blank is a type of assay processed like a sample. NOVEOS adds an equivalent Capture Reagent amount of diluent. The Capture Reagent used for a blank is the same capture Capture Reagent Code reagent used by the Calibrators of the assay type. Blanks are run automatically as specified by the user in the configuration settings. A method for determining the concentration of a substance in a sample by comparing the sample to a set of standard samples of known concentration. Concentrations in the sample must lie within the working range defined or the test will be invalid. The software uses a 4 Parameter Logistic equation to represent the correlation between concentration and measured light output of each calibrator. Calibrators are used by the software to derive the parameters of a function used to translate raw individual test measurements into concentrations of the Antibody to measure. The user may choose to run multiple repetitions of the Calibrators. A control button available on many screens in the application that cancels user entries that have not been saved. Also closes the detail screen and returns to the selection screen. A physical lock on canopy. Tests cannot run until the canopy interlock is closed. Biotinylated proteins that bind analytes (immunoglobulin protein) from the patient sample. HYCOR manufactures Capture Reagents to test for allergies. The code letter/number designation assigned to each Capture Reagent. (for example, D001, D002, E001, F001, F002, F003, F013, G006, W006, I003, M006, T007). 63100 13-2 Rev. D

NOVEOS Operator’s Manual Capture Reagent Name The name assigned to the Capture Reagent (for example; Penicillin G, Cow Chemiluminescence Milk, Orange Tree). Collection Date Comm Log Production of light from a chemical reaction. Company Conjugate The date the sample was drawn from the patient. Control The data file that stores all communications between NOVEOS and the software. Can be viewed, printed, and exported. Days to Expire DI Water HYCOR Biomedical Diluent A Reagent Done Protein that binds to analytes and contains an enzyme that will cause a substrate to emit light. It is added to the Substrate /Bead /Sample/ Capture Reagent compound to enable NOVEOS to measure the amount of photons emitted which determines the strength of the reaction between the Sample and the Capture Reagent. Controls are a serum with an expected value. They are used to ensure that Reagents and machine operations in an assay are working properly. Controls are processed just like patient samples, and yield known expected results. Positive Controls are expected to show results within prescribed limits for all Capture Reagents they are tested against. Negative Controls should be negative (below prescribed limits) for their respective tests. Controls are specific to the type of Capture Reagents used. Controls are shipped with an insert that must be scanned with the handheld barcode scanner whenever a new lot number of Control is loaded into the sample rotor. The number of days left before the expiration date. Assays that use the fluid after the expiration date are considered either invalid or not as reliable. De-ionized Water. Used in diluting patient samples. A control button available on many screens in the software application that accepts any user entries that have not been saved. Also closes the detail screen and returns to the selection screen. Rev. D 13-3 63100

13. Glossary and Acronyms Expiration Date The last date the test element can be used by the system. all have expiration dates. Tests cannot be completed if the expiration date for the test element External Drive has passed. Filter A hard drive external to the system used to backup and restore the system. Finished A set of parameters to select data. Can include a ‘from date’ and a ‘to date’, a Fluo Beads letter/number combination, or other data used by NOVEOS. Fluo Beads Solution Indicates the tests linked to a sample have completed. Found on the Run screen. Gender Green Biotinylated iron spheres with bonding points for test reagents. Very small in Incubation size and suspended in fluid. Stored in the Fluo Beads tubes on the upper deck Temperature for the assay. Ends up in the waste container below deck after the assay. Instrument The Fluo Beads are suspended in a solution inside the Fluo Beads tubes. The Instrument Operator solution is inert and does not react with any of the Reagent, Conjugate, Substrate, or Wash fluids. Instrument Serial Number Male or Female. Used as an attribute in the Sample screen. Lab Administrator Normal operation. Green indicates no problems detected. Lab Supervisor Temperature at which the reaction rotor is kept. If the test temperature is out of specification the test will fail. 37 o C +/- .5o C (98.6o F +/-16o F). Refers to NOVEOS. Everything except the control PC, the printer, handheld barcode reader, and touch screen attached to the PC. The user ID of the person logged in. Recorded as part of run and error information in reports and logs. The unique identifier assigned to each HYCOR device. User with rights and privileges to override expiration dates and run without controls. Also has rights to override additional warnings and halts. User with rights and privileges to add and change users and to adjust program settings. Also has rights to override certain warnings and halts. 63100 13-4 Rev. D

NOVEOS Operator’s Manual Lab User User with rights and privileges to set up and run tests. Levey-Jennings A graph that plots quality control data. It is a visual way to see if a laboratory Liquid Level test is working. The distance from the mean is measured in standard deviations (SD). The x-axis uses date. Each point indicates how far off the Liquid Type actual result was from the mean (which is the expected value for the control). The y-axis uses lines run across the graph at the mean, as well as four Log Files standard deviations either side of the mean. The idea is to make it easy to see Lot Number how far off the mean the result is. Mono-Rinse Arm Multi-Rinse Arm The level of liquid in the test tube measured on the sample rotor or reagent Needle rotor. The liquid level is used to calculate the amount of the substance Negative Control available for a test or panel of tests. Too little of any substance required will Onboard Stability Date stop a test from running Liquid types on the sample rotor can be defined as sample, Control, Calibrator, blank, Diluent. Liquid types on the reagent rotor can be defined as test, Conjugate, Substrate, Fluo Beads. Liquid types are unique to each rotor. Unknown is an empty position or barcode not read. System created record files that can record: start, stop, shutdown, run status, errors, updates, backups, login, and other information recorded during operation. The unique number assigned to a particular quantity or lot. It is a HYCOR- assigned value. Washes cuvettes in the reaction rotor. Used to wash one cuvette arc (10 cuvettes) at the same time in the reaction rotor. Pipette-/Tip-/Probe… Means for pipetting liquids (i.e., sample, reagents…) Company-provided serum sample that is expected to show results below prescribed limits for the Capture Reagents they are tested against. The last date the fluid can be used for reliable assay results. Fluids have varying lengths of stability. This value is assigned by HYCOR. Fluids are onboard when they are placed on the Sample or Reagent Rotor and scanned. Rev. D 13-5 63100

13. Glossary and Acronyms Onscreen Keyboard This touchscreen system provides an onscreen keyboard for data entry. User may toggle it on or off in the System Settings screen. Optics Arm Takes reaction samples to read chemiluminescence and fluorescence in the Panel Optics Box. Patient Address A set of tests performed as a group. Patient Birth Date The physical address linked to the patient ID. Can be the street address with Patient Comments city- state or province- country- and postal code. Patient First, Patient The date the patient was born in MM DD YYYY format. Use the Date Selection Last, Patient Middle control to choose the month, day and year. Patient ID Patient Phone Number Any text comments entered or scanned into the system for the unique patient PC Application ID. Pipette Pipette Alignment The First- Middle- and Last name of the patient linked to the patient ID and to the sample. Position on the Rotor Positive Control A unique number assigned to each patient. Probe Arm Alignment The phone number linked to the patient ID. Probe Arms User interface that controls NOVEOS data processing and data management. R1 Arm Part of the moving arm(s) used to transport a measured volume of liquid. The physical alignment of the pipette is critical to the safe and accurate operation of the device. The physical location on the Reagent or Sample Rotor. Company provided serum sample expected to show results within prescribed limits for all Capture Reagents they are tested against. The physical alignment of the arm(s) determines the location of the pipette and is critical to the safe and accurate operation of the device. The moving arms holding the pipettes. Transfers Fluo Beads and reagents from containers on the Reagent Rotor into cuvettes in the Reaction Rotor. 63100 13-6 Rev. D

NOVEOS Operator’s Manual R2 Arm Transfers reagents from containers on the Reagent Rotor into the cuvettes in the Reaction Rotor. Reaction Rotor The rotor that holds the reaction cuvette arcs. Samples and reagents are Reagent combined in the cuvettes on the Reaction Rotor. The resulting reaction is measured in the Optics Box. Reagent Rotor Any of the manufactured chemicals or solutions that are part of the assay Reagent Temperature reactions. Restore Run The Reagent Rotor houses Capture Reagents, Conjugates, Substrate A, Run Date Range Substrate B. Run Status Bar Temperature at which the Reagent Rotor is measured. Run ID Running Install of a prior backup of the system and software. Sample The process used by NOVEOS to complete an assay. Sample Arm User sets a ‘from date’ (ex: ‘04/22/2017’) and a ‘to date’ (example - Sample ID 05/01/2017) to select all data within those two dates. Sample Rotor On the Home screen, a bar of icons used to display the status of NOVEOS. Sample Volume Saved Curve A unique number identifier assigned to each run. An indicator that tells the user that the test is in progress. The status light bar on the Home screen flashes green while running. Serum from patient. Used to transfer samples from the tubes in the Sample Rotor to the cuvettes in the Reaction Rotor. A unique number identifier assigned by the user to the sample. The rotor used to hold and process patient samples. Holds a total of up to 60 sample tubes and specific Reagent containers. Sample amount required to complete a test. A full calibration curve stored in memory by the software. A curve is valid for 10 days and during that time calibrators do not need to be loaded to run an immunoassay. Rev. D 13-7 63100

13. Glossary and Acronyms Settings A main icon. System Setup, Report Setup, User Defined Tests, and About are all accessed by clicking on this icon. Shut Down Slot Status A system shutdown button. Substrate A Indicates status of loaded samples or reagents for a given position on the system. Values can be barcoded, manual value barcoded, or empty. Substrate B Chemical that will emit light when catalyzed by an appropriate enzyme Substrate Mix conjugate. System Tech Service Chemical that will emit light when catalyzed by an appropriate enzyme conjugate. Test The combination of equal parts of Substrates A and B. Test Code Test ID Refers to NOVEOS and PC together. Test Panel Test Run User with rights to access machine alignment and logs and to override most Time & Date Formats warnings and halts. These are typically HYCOR associates. Unassigned A single result generated when processing a patient sample against an allergen. User Privileges The abbreviation used for allergy tests. A unique identifier, assigned by the system, for each scheduled test. See Panel. See Run. Display and report time and date format is defined as: U.S.: mm/dd/yyyy European: dd/mm/yyyy. Ability to set 12h vs 24h. Indicates the position on the rotor is not recognized by NOVEOS. Most of the time this position is empty. Also indicates an unreadable barcode. All users are set up as part of a group including Lab User, Lab Supervisor, Lab Administrator. 63100 13-8 Rev. D

Version Number NOVEOS Operator’s Manual Warning Wash The revision number of the software. It is accessible on the Settings, About Waste screen, splash screen, and help screen. Problem with a sub-system that does not compromise the test results but that must be addressed by the user. A fluid used by NOVEOS to clean a pipette or cuvette as part of the processing cycle. All fluids tested and consumed during a run. Rev. D 13-9 63100

13. Glossary and Acronyms 13.2 Acronyms Acronym Definition DI De-ionized HIPAA Abbreviation for Health Insurance Portability and Accountability Act. HIPAA sets privacy standards to protect patients' medical records and other health information provided to laboratories- health plans- doctors- and hospitals. IgE Immunoglobulin E antibodies produced by the immune system. LIMS Laboratory Information Management Software LIS Laboratory Information System LLD Liquid Level Detection OSK Onscreen keyboard PC Refers to the personal computer and peripherals. PPE Personal Protective Equipment RoHS Restriction of Hazardous Substances. RoHS, also known as Directive 2002/95/EC, originated in the European Union and restricts the use of specific hazardous materials found in electrical and electronic products. All applicable products in the EU market after July 1, 2006 must pass RoHS compliance. Rxn Reaction SD Standard Deviation SDS Safety Data Sheet UPS Uninterrupted Power Supply WB Wash Buffer WEEE Waste Electrical and Electronic Equipment 63100 13-10 Rev. D

NOVEOS Operator’s Manual Index beads barcode scan alert, 7-6 beads screen 10 ml tube adapter, 1-21 13 mm caps, 1-21 adding info to, 7-5 2D bar code scanner, 6-13 Beads screen with data, 7-6 2D barcode biological hazards, 2-3 blanks, 13-2 scanning, 6-12 calibration curve, 10-1, 13-2 5 ml tube adapter, 1-21 calibration data, 10-1 5% bleach solution, 11-27, 11-48 Calibration Data Screen Showing Curve Selections abnormal run completion, 8-10 About screen, 4-18 and Selected Curve, 10-2 acronyms, 13-1, 13-10 calibrator, 13-2 action buttons, 3-1, 3-5 calibrator allergy set, 1-15 adding info to the Sample Rotor screen, 6-3 Calibrator Allergy Set, 1-17 Air bubbles in the lines, 11-11 calibrators, 6-11 alarm conditions callibration curve monitoring on a PC, 5-30 selecting, 10-2 alert, 13-1 cancel d efined, 13-2 Alerts, 8-1 canopy alerts and errors bar, 3-2, 8-13 Alerts screen, 8-17, 12-20 unlocking, 11-32 Alerts Screen Showing Errors and Messages, 12-21 canopy interlock, 13-2 alerts volume, 4-5 capture reagent, 13-2 all tasks, 11-34 allergy assay overview, 1-5 code, 13-2 allergy common kit, 1-15 name, 13-3 Allergy Common Kit, 1-16 Capture Reagents, 1-16 approved laboratory disinfectant, 11-48 Capture Reagents, types, 1-15 arms, 1-6 Caution Arms locations, 1-9 symbol definition, 2-3 audit log, 11-43 Cautions, 2-1 audit trail, 13-1 cautions summary, 2-2 automatic system shutdown, 4-5 change user privileges, 4-7 automatic user logout, 4-5 check for errors, 11-30 available tests - defined, 13-1 chemiluminescence, 13-3 backup, 13-1 cleaning, 11-47 backup database, 11-38 before returning instrument to Hycor, 11-49 barcode cleaning wash station, 11-31 cleaning waste lines, 11-31 formats supported, 6-3 cleaning inside the instrument, 11-48 barcode label, 13-2 Cleaning Reagent Rotor Waste Lines, 11-27 Barcode Reader locations, 1-10 cleaning spills, 11-48 barcode readers, 1-6, 1-10 cleaning the Reagent Rotor, 11-25 Barcode Scan cleaning the Sample Rotor, 11-23 Clear Positions button, 6-5 confirmation message, 8-5 Clear Rotor button, 7-3 barcode scan alert clearance for power connection, 1-12 clearing reagent rotor information, 7-3 for reagent rotor, 7-3 clearing Sample Rotor data, 6-4 barcodes scanning, 8-6 Rev. D Index-1 63100

Index date format, 4-3 days to expire, 13-3 clearing selected rows of data, 6-5 delete database, 11-39 collection date, 13-3 deleting a user, 4-8 comm log, 13-3 desk/bench space requirement, 1-13 command light bar, 3-2 DI, 13-10 command light bars, 3-2 DI water, 13-3 Command Light Bars filling, 5-18 Color Meanings, 12-17 dimensions, 1-12 comments, 11-33 disposable plastics, 11-47 Communication Options, 4-17 disposal of plastic containers, 11-47 communications log, 11-46 disposal of waste fluids, 11-47 Company, 13-3 documentation, 1-2 Complete Activity button, 11-14 Documentation Complete Task button, 11-9 conditions that may prevent a run from starting, Intended Audience, 1-2 Done, 13-3 8-10 edit user information, 4-8 conjugate, 13-3 empty print queue, 4-3 consumables, 1-19 Enable Position Clearing, 6-5 control, 13-3 environmental requirements, 1-13 controls, 6-11 EppendorfTM tube adapter, 1-21 Customer Service, 12-25 error conditions Cuvette Arcs, 5-9 avoiding, 12-1 location on Reaction Rotor, 5-11 Error Conditions cuvette wash container, 1-21 Cuvette Wash fluid Run Will Not Start, 8-11 Run Will Start, 8-12 filling, 5-21 error handling, 8-14 cuvette wash pack, 5-21 Error Message Cuvette Wash Pack, 1-18 Canopy is open, 12-2 cuvettes Chassis is flooded, 12-2 Diluent-A is missing, 12-3 installing, 5-9 Fluo Beads cover is open, 12-2 Cuvettes function, 11-36 Fluo Beads solution is missing, 12-2 Cuvettes screen, 11-36 Insufficient calibrator solution to complete the Cyber Security Guidelines, 1-2 daily log, 11-45 run, 12-2 Daily Logs screen, 11-45 Insufficient cuvette wash to complete the run, Daily Maintenance, 11-5 Daily Maintenance Tasks screen, 11-5 12-2 data Insufficient DI water to complete the run, 12-2 Insufficient wash buffer to complete the run, clearing selected rows, 6-5 data for controls, 6-11 12-2 database Insufficient waste container to complete the backup, 11-38 run, 12-2 delete, 11-39 Load Missing Calibrators, 12-2 purge, 11-39 Load Set of Calibrators, 12-2 restore, 11-38 No tests to schedule, 12-2 Database, 11-37 NOVEOS is disconnected from the computer, database cleanup, 11-28 Database Screen, 4-12 12-2 database settings, 4-12 Reagent rotor cover is not in place, 12-2 63100 Index-2 Rev. D

Sample rotor is loaded with duplicate sample NOVEOS Operator’s Manual IDs, 12-2 green indicator defined, 13-4 Substrate A, Substrate B, conjugate is missing, GUI, 3-1 12-3 handheld barcode scanner, 1-4 Health Insurance Portability and Accountability Substrate mix cover is not latched, 12-3 Waste container is missing, 12-3 Act, 13-10 Waste is overflowed, 12-3 heat output, 1-13 Error Messages Help icon, 3-3 Conditions that may prevent a run from HIPAA, 13-10 HitachiTM tube adapter, 1-21 starting, 12-2 home all, 11-32 errors Home from Cuvettes Screen, 11-22 home from tub, 11-20 checking for, 11-30 Home from Tub Screen, 11-20 printing, 8-17 HYCOR XE \"LIS:serial parameters\" \\b -LIS Interface viewing, 8-17 Errors program, 4-14 Printing, 12-20 IgE, 13-10 Viewing, 12-20 Immunoglobin E antibodies, 13-10 events log, 11-46 improper shutdown, 3-3 expiration date, 13-4 incubation temperature, 13-4 Export to PDF, 10-5 inspect probes, 11-6 Export to Text, 10-5 inspecting probes, 11-7 external drive, 13-4 Installation and Service Manual, 1-2 external waste container, 4-5 installing cuvettes, 5-9 failed calibrator action, 4-4 instrument, 13-4 failed control action, 4-4 instrument connection, 3-2 filter, 13-4 instrument layout, 1-6 finished, 13-4 instrument log, 11-46 floor space requirement, 1-12 instrument operator, 13-4 fluidics tests, 11-11 instrument serial number, 13-4 Fluidics Tests screen, 11-11 Instrument Status Fluo Bead info clearing, 7-8 Red, 12-8 manually entering, 7-9 Instrument Status During Run Fluo Beads defined, 13-4 Red, 12-10 solution, 13-4 Instrument Status Warning Conditions, 12-8, 12- Fluo Beads barcode readers, 1-10 Fluo Beads holder tubes, 5-16 11 Fluo Beads tube holder, 1-7 instrument status warnings during run, 12-10 Fluo Beads tubes Introduction, 1-1 loading, 5-16 joblist free disk space minimum, 4-5 printing, 6-17 function selection buttons, 3-1, 3-4, 3-5 Joblist funnel, 1-20 gender, 13-4 options, 4-17 glossary, 13-1 keyboard icon, 3-2 graphical user interface, 3-1 lab administrator, 13-4 lab administrator privileges, 4-10 lab supervisor, 13-4 lab supervisor privileges, 4-10 lab user, 13-5 lab user privileges, 4-9 Rev. D Index-3 63100

Index maintenance before a run, 11-4 Maintenance log, 11-44 Laboratory Information System, 13-10 Maintenance Log screen, 11-44 Laboratory Information Management Software, Maintenance-Audit Log screen, 11-43 manually entering data 13-10 language selection, 4-3 for reagents, 7-4 Levey-Jennings, 13-5 manually entering data for controls, 6-11 Levey-Jennings chart, 10-5 manually entering liquid data for the sample rotor, LIMS, 13-10 liquid 6-5 messages level, 13-5 type, 13-5 printing, 8-17 liquid data viewing, 8-17 manually entering for sample rotor, 6-5 Messages liquid data for sample tray, 6-5 Printing, 12-20 Liquid Level Detection, 13-10 Viewing, 12-20 liquid type - sample screen, 6-6 minimum free disk space LIS, 13-10 minimum, 4-5 connection settings, 4-14 mono-rinse arm, 1-8, 13-5 protocol settings, 4-14 monthly maintenance, 11-28 results transmit options, 4-15 Monthly Maintenance serial parameters, 4-14 Check for Errors, 11-30 LIS results, 9-8 Database Cleanup, 11-29 LIS Results screen, 9-8 move probes to inspection, 11-6 LIS Screen, 4-13 multi-rinse arm, 1-8, 13-5 buttons on, 4-17 multi-rinse soak, 11-19 LLD, 13-10 Multi-Rise Soak Screen, 11-19 loading a worklist to the Sample Rotor screen, 6-4 needle, 13-5 Loading Additional Items, 12-20 negative control, 13-5 loading the Reagent Rotor Negative Control Pack – IgE, 1-17 loading, 5-13 network settings, 4-5 loading the Sample Rotor, 5-5 new operator setup, 4-7 log noise output, 1-13 audit, 11-43 Notices, 2-1 communications, 11-46 NOVEOS Software daily, 11-45 preparing for use, 4-1 events, 11-46 number of replicates, 4-4 instrument, 11-46 onboard stability date, 13-5 maintenance, 11-44 onscreen keyboard, 4-3, 13-6 PC, 11-46 operating conditions, 4-5 software errors, 11-46 operator setup, 4-6 temperature, 11-46 optic box, 1-7 log files, 13-5, 13-6 optics arm, 1-8 logs, 11-43 optics fluidics test. lot number, 13-5 Optics Fluidics Test, 11-17 Maint button, 3-5, 8-7, 11-1 optics tip maintenance, 11-1 replacing, 11-15 Maintenance, 11-1 panel, 6-17, 13-6 Remote Assistance Screen, 11-41 deleting, 6-20 Updates Screen, 11-40 63100 Index-4 Rev. D

panels NOVEOS Operator’s Manual defining, 6-1 probe arms, 13-6 Panels screen, 6-17 probe wash password weekly, 11-13 changing, 4-7 Probe Wash Pack, 1-18 setting, 4-7 probe wash solution, 5-1 patient address, 13-6 probes patient birth date, 13-6 patient comments, 13-6 inspecting, 11-7 patient ID, 13-6 move to inspection, 11-6 patient report, 9-5 rinse all, 11-10 sample, 9-6 wiping, 11-8 patient reports purge consumables tables, 11-28 running, 9-7 purge database, 11-39 Patient Reports screen, 9-5, 9-7 purge patient records, 11-28 patient samples purge physician records, 11-28 manually entering, 6-5 purge service broker log entries, 11-28 Pause button, 8-9 QC report, 10-6 pausing tests, 8-9 QC Report PC, 13-10 Data on the Report, 10-7 PC application, 13-6 User Access, 10-7 PC information, 4-18 Where it can be sent, 10-7 PC log, 11-46 QC results, 10-3, 10-4 Perform Priming button, 8-7 search criteria, 10-3 periodic maintenance, 11-1, 11-2 QC Results chart, 11-3 Individual Results, 10-4 Periodic tab, 8-7 Mean Results, 10-4 Pinch Point, 2-3 Show Lot Numbers, 10-4 pipette, 13-6 quality control, 10-1, 10-3 alignment, 13-6 Quality Control button, 3-5, 10-1 plastic containers Quality Control screen, 10-3 disposing of, 11-47 Quality Control Screen Play (Start Run) Button, 8-7 Selected Data, 10-3 position on the rotor, 13-6 quickstart workflow, 5-2 positive control, 13-6 R1 arm, 1-8, 13-6 Positive Control Pack – IgE, 1-17 R2 arm, 1-8, 13-7 power conditioned UPS, 1-14 reaction cuvette arcs power connection clearance, 1-12 replacing, 11-32 power requirements, 1-14 reaction diluent, 6-11 power switch locations, 1-11 reaction diluent container, 5-8 PPE, 13-10 reaction rotor, 1-7, 13-7 preparing Noveos for use, 5-4 Reaction Rotor preparing Noveos software for use, 4-1 Cuvette Arcs, 5-9 priming, 11-33 loading, 5-9 Print, 10-5 reagent, 13-7 privileges Reagent Arm 1, 1-8 changing, 4-7 Reagent Arm 2, 1-8 probe arm alignment, 13-6 reagent diluent, 13-3 reagent drain, 11-27 Rev. D Reagent Kits, 1-16, 1-18 Index-5 63100

Index restore database, 11-38 Restriction of Hazardous Substances, 13-10 reagent rotor, 1-7, 13-7 result records, 9-8 manually entering data, 7-4 results setup, 4-5 what is loaded on, 7-2 results transmit options, 4-15 resuming paused tests, 8-9 Reagent Rotor resuming stopped tests, 8-9 loading, 5-13 rinse all probes, 11-10 Rinse All Probes, 11-10 reagent rotor and tub weekly maintenance, 11-25 Perfrom Priming, 11-10 Rinse All Probes Screen, 11-10 reagent rotor barcode readers, 1-10 Rinse/Wash Status Warning Conditions, 12-14 Reagent Rotor Cover, 11-25 RoHS, 13-10 reagent rotor information Rotor Position Color clearing, 7-3 Black, 8-3 reagent rotor position status Blue, 8-3 Error, 8-3 color codes, 7-1 Finished, 8-3 Reagent Rotor screen, 7-2 Green, 8-3 Loaded/Unused, 8-3 adding info, 7-2 Purple, 8-3 using, 7-2 Ready, 8-3 reagent rotor wedge Red, 8-3 removing, 11-26 Running, 8-3 reagent temperature, 13-7 Unassigned, 8-3 reagent wedge, 1-21, 5-13 Yellow, 8-3 Reagent wedge rotor position color legends, 8-3 removing, 5-15 rotor position status colors, 8-2 reagents, 7-1 rotors, 1-6 Reagents button, 3-5, 7-1 run Reagents Status Warning Conditions, 12-13 complete, 8-14 Remote Assistance, 11-41 Run, 8-1, 13-7 Removing the Optics Tip, 11-16 run alerts and errors window, 8-13 Removing the Sample Rotor, 11-24 Run button, 3-5 repeat controls as last tests, 4-4 Run Complete, 8-8 replace reaction cuvette arcs, 11-32 Run Complete and Reset Status Button Screen, 8- Replace Rxn Cuvettes screen, 11-20 14 replacing the optics tip, 11-15 run complete indication, 8-8 Report run completion contents, 9-1 abnormal, 8-10 Setup screen, 9-1 run date range, 13-7 report footer, 9-2 run flags, 8-16 report header, 9-2 Run Flags, 12-22 report setup, 4-11, 9-2 Run ID, 13-7 Report Setup screen, 4-11 Run ID number, 8-7 reports, 9-1 run release, 10-1 Reports Run screen button, 9-1 color legends, 8-3 screen, 9-1 Reports button, 3-5 Index-6 Rev. D Reset Image button, 9-4 Reset instrument, 11-35 Reset Status button, 8-8, 8-14 restore, 13-7 63100

showing run complete, 5-30 NOVEOS Operator’s Manual showing run progress, 5-28, 5-29, 5-30 using, 8-1 schedule, 8-15 Run screen showing position status, 8-3 view, 8-16 run setup, 4-4 Run status bar, 13-7 Schedule, 8-1 run status icons, 12-4 Schedule screen run status light bar, 5-30 run tasks, 11-32 order, 8-15 run tests, 8-7 run flags, 8-16 running, 13-7 Schedule Screen, 8-15 Rxn, 13-10 screen selection buttons, 3-4 safety data sheets, 2-5 screen selection tabs, 3-1, 3-6 sample, 13-7 screen/function selection buttons, 3-4 as liquid type selection, 6-6 SD, 13-10 linking to a test, 5-26 selected position panel, 8-4 sample arm, 1-8, 13-7 Send to LIS, 10-5 sample carousel, 1-21 Service icon, 3-3 sample ID, 13-7 settings, 13-8 sample rotor, 1-7, 13-7 Setup icon, 3-3, 4-1 cover, 11-23 shipping and storage requirements without fluids, Sample Rotor 1-13 loading, 5-5 shut down, 13-8 sample rotor and tub Shutdown icon, 3-3 weekly maintenance, 11-23 slot status, 13-8 sample rotor barcode reader, 1-10 soak in cuvettes, 11-21 Sample Rotor data Soak in Cuvettes Screen, 11-21 clearing, 6-4 soak in tub, 11-19 sample rotor data erase warning, 6-4 software errors log, 11-46 sample rotor screen software setup, 4-1 color codes, 6-3 Standard Deviation, 13-10 Sample Rotor screen, 6-1 Start button, 8-7 adding info, 6-3 status and warnings, 3-1 Sample Rotor screen with data, 6-2 status warnings Sample Status sample, 12-11 Red, 12-11 stopped tests sample status warnings, 12-11 resuming, 8-9 sample tube size, 1-15, 4-4 stopping tests, 8-9 sample type, 4-4 substrate A, 13-8 sample volume, 13-7 substrate B, 13-8 samples, 6-1 Substrate Mix, 13-8 adding to a run, 5-27 Substrate Mix container assigning tests to, 6-5 loading, 5-17 Samples button, 3-5, 6-1 supplies, 1-20, 5-1 saved curve, 6-11 supported barcode formats, 6-3 Saved Curve, 13-7 symbol definitions, 2-3 scan barcodes, 8-5 Symbols, 2-4 scanning a 2D barcode, 6-12 system, 13-8 system overview, 1-4 Rev. D system setup changing, 4-1 system setup, 4-3 Index-7 63100

Index troubleshooting, 12-1 unassigned, 13-8 system setup, 4-4 Universal Power Supply, 13-10 system setup, 4-5 unknown, 6-6 system setup, 4-5 unlock canopy, 11-32 system setup, 4-5 updates, 11-40 system setup screen, 4-1 system shutdown installing, 11-40 UPS, 1-14, 13-10 automatic, 4-5 USB ports, 1-11 system status indicators, 3-1, 3-2 user alerts and errors, 3-2 deleting, 4-8 command light bar, 3-2 user information instrument connection, 3-2 keyboard, 3-2 editing, 4-8 LIS connection, 3-2 User Interface, 3-1 TeamViewer, 11-42 user interface components, 3-1 Technical Service, 12-25 user logout technical specifications, 1-12 temperature log, 11-46 automatic, 4-5 Temperature Status Warning Conditions, 12-7 user privilege, 4-6 terms, 13-1 user privileges, 4-8, 13-8 test user setup, 4-3 code, 13-8 Utility Function icons, 3-3 defined, 13-8 utility functions, 3-3 linking a sample to, 5-26 utility functions icons, 3-3 running, 5-28 warning test ID, 13-8 test panel, 6-17, 13-8 defined, 13-9 test run, 13-8 Warning test schedule, 8-15 order, 8-15 symbol definition, 2-3 Test Selection Warning Message screens, 12-6 button, 6-8 Test selection for sample Saved Curve Errors, 12-6 position screen, 6-8 Warning Message Types, 12-5 tests, 5-1 Warning Messages, 12-3 adding to a sample, 5-27 warning summary, 2-2 assigning to a position, 6-8 Warnings, 2-1 errors during, 8-12 warnings bar, 8-6 pausing, 8-9 warranty, 1-1 resuming, 8-9 wash resuming stopped, 8-9 running, 8-7 defined, 13-9 running - details, 5-26 Wash Buffer, 13-10 settings up - details, 5-26 stopping, 8-9 filling, 5-18 time & date formats, 13-8 Wash Buffer Concentrate time format, 4-3 top deck, 1-7 How to Dilute and Mix, 5-20 wiping down, 11-9 Wash Buffer Concentrate pack, 5-18 Wash Buffer Concentrate Pack, 1-18 Wash Buffer fluid filling, 5-20 wash station cleaning, 11-31 waste defined, 13-9 63100 Index-8 Rev. D

waste container, 4-5 NOVEOS Operator’s Manual waste container adapters, 5-25 waste containers Wipe Sample Rotor, 11-18 Weekly Maintenance Tasks screen, 11-12 emptying, 5-22 weekly probe wash, 11-13 waste fluids Weekly Probe Wash screen, 11-14 Wipe Down Probes, 11-8 disposing of, 11-47 Wipe Down Top Deck Screen, 11-9 waste line cleaning, 11-31 wipe reagent rotor and tub, 11-25 Waste Status Warning Conditions, 12-15 wiping probes, 11-8 WB, 13-10 workflow, 5-2 Weekly Maintenance, 11-12 Worklist Optics Fluidics Test, 11-17 loading to the Sample Rotor screen, 6-4 Perform Probe Wash, 11-13 Yellow Alert Run Time Conditions, 12-18 Replace Fluidics Tip, 11-15 Wipe Reagent Rotor, 11-18 Rev. D Index-9 63100